BioNTech SE
BNTX 20-F Report ended Dec. 31, 2024
A C T I N G T O G E T H E R — C R E A T I N G S Y N E R G I E S
BioNTech SE
Annual Report on Form 20-F
for the
year ended December 31, 2024
UNITED
STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C.
20549
FORM
20-F
(Mark One)
OF
1934
OR
For the fiscal year ende
d
December 31
, 2024
OR
OR
Commission file number:
001-39081
(Exact name of Registrant as specified in its charter)
Federal Republic of
Germany
(Jurisdiction of incorporation or organization)
(Address of principal executive offices)
c/o BioNTech SE
(Name, Telephone, E-mail and/or Facsimile number and Address of Company Contact Person)
Securities registered or to be registered, pursuant to Section 12(b) of the Act
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Title of each class
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Trading
Symbol(s)
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Name of each exchange on which registered
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American Depositary Shares, each Representing one
ordinary share
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Ordinary shares, no par value, with a notional amount
attributable to each ordinary share of €1*
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—
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Securities registered or to be registered pursuant to Section 12(g) of the Act:
None
Securities for which there is a reporting obligation pursuant to Section 15(d) of the Act:
None
Indicate the number of outstanding shares of each of the issuer’s classes of capital stock or common stock as of the close of business
covered by the annual report.
Ordinary shares, no par value, with a notional amount attributable to each share of €1 outstanding u
p until
March 3, 2025
, the most recent
practicable date
, no par value:
239,970,804
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.
Yes
☒ No ☐
If this report is an annual or transition report, indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or
15(d) of the Securities Exchange Act of 1934. Yes ☐
No
☒
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days.
Yes
☒ No ☐
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to
Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was
required to submit such files).
Yes
☒ No ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or an emerging growth
company. See the definitions of “large accelerated filer,” “accelerated filer,” and “emerging growth company” in Rule 12b-2 of the Exchange
Act.
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☒
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Accelerated filer
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☐
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Non-accelerated filer
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☐
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Emerging growth company
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If an emerging growth company that prepares its financial statements in accordance with U.S. GAAP, indicate by check mark if the registrant
has elected not to use the extended transition period for complying with any new or revised financial accounting standards † provided
pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its
internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public
accounting firm that prepared or issued its audit report.
☒
If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant
included in the filing reflect the correction of an error to previously issued financial statements.
☐
Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based
compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b).
☐
Indicate by check mark which basis of accounting the registrant has used to prepare the financial statements included in this filing:
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U.S. GAAP ☐
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Accounting Standards Board ☒
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Other ☐
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If “Other” has been checked in response to the previous question indicate by check mark which financial statement item the registrant has
elected to follow. Item 17 ☐ Item 18 ☐
If this is an annual report, indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
Yes ☐ No
☒
* Listed not for trading or quotation purposes, but only in connection with the registration of American Depositary Shares representing such ordinary shares
pursuant to the requirements of the Securities and Exchange Commission. The American Depositary Shares are registered under the Securities Act of 1933, as
amended, pursuant to a separate registration statement on Form F-6 (File No. 333-233898).
1
Annual Report on Form 20-F for the
year ended December 31, 2024
TABLE OF CONTENTS
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Page
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PART I
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ITEM 1.
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ITEM 2.
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ITEM 3.
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ITEM 4.
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ITEM 4A.
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ITEM 5.
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ITEM 6.
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F. Disclosure of a Registrant’s Action to Recover Erroneously Awarded
Compensation
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ITEM 7.
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2
Annual Report on Form 20-F for the
year ended December 31, 2024
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ITEM 8.
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ITEM 9.
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ITEM 10.
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ITEM 11.
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ITEM 12.
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PART II
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ITEM 13.
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ITEM 14.
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ITEM 15.
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ITEM 16.
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[RESERVED]
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ITEM 16A.
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ITEM 16B.
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ITEM 16C.
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ITEM 16D.
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ITEM 16E.
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ITEM 16F.
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3
Annual Report on Form 20-F for the
year ended December 31, 2024
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ITEM 16G.
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ITEM 16H.
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ITEM 16I.
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Disclosure Regarding Foreign Jurisdictions that Prevent Inspections
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ITEM 16J.
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Insider Trading Policies
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ITEM 16K.
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Cybersecurity
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PART III
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ITEM 17.
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ITEM 18.
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ITEM 19.
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4
Annual Report on Form 20-F for the
year ended December 31, 2024
GENERAL INFORMATION
In this Annual Report on Form 20-F, or the Annual Report, “BioNTech,” the “Group,” the “Company,” “we,” “us,”
and “our” refer to BioNTech SE and its consolidated subsidiaries, except where the context otherwise requires.
In response to the fact that our consolidated financial statements are published in Euro, the selected
consolidated financial data is presented in Euro as well. Amounts in U.S. dollar are translated into Euro using the
exchange rates as per period end or average exchange rates for the periods indicated as published by the
German Central Bank (Deutsche Bundesbank).
All references in this Annual Report to “$” mean U.S. dollars and all references to “€” mean Euros.
This Annual Report contains references to our trademarks and to trademarks belong to other entities. Solely for
convenience, trademarks and trade names referred to, including logos, artwork and other visual displays, may
appear without the ® or TM symbols, but such references are not intended to indicate, in any way, that their
respective owners will not assert, to the fullest extent under applicable law, their rights thereto. We do not intend
our use or display of other companies’ trade names or trademarks to imply a relationship with, or endorsement or
sponsorship of us by, any other companies.
Our trademark portfolio includes, but is not limited to,
Comirnaty
,
BioNTainer
,
FixVac
,
RiboCytokine
,
RiboMab
,
Recon
and
Neo-Stim
, including logo versions of some of these trademarks. Brand names appearing in italics
throughout this report are trademarks owned by BioNTech. All other trademarks are the property of their
respective owners.
5
Annual Report on Form 20-F for the
year ended December 31, 2024
CAUTIONARY STATEMENT REGARDING
FORWARD-LOOKING
STATEMENTS
This Annual Report contains forward-looking statements concerning our business, operations and financial
performance and condition as well as our plans, objectives and expectations for our business operations and
financial performance and condition. Any statements that are not of historical facts may be deemed to be
forward-looking statements. Many of the forward-looking statements contained in this Annual Report can be
identified by the use of forward-looking words such as “believes”, “estimates”, “anticipates”, “expects”, “plans”,
“intends”, “may”, “could”, “might”, “will”, “should”, “aims” or other similar expressions that convey uncertainty of
future events or outcomes.
These forward-looking statements are subject to known and unknown risks, uncertainties, assumptions and
other factors that could cause our actual results of operations, financial condition, liquidity, performance,
prospects, opportunities, achievements or industry results, as well as those of the markets we serve or intend to
serve, to differ materially from those expressed in, or suggested by, these forward-looking statements. These
forward-looking statements are based on assumptions regarding our present and future business strategies and
the environment in which we expect to operate in the future. Important factors that could cause those differences
include, but are not
limited
to:
•
the extent to which COVID-19 vaccines continue to be necessary in the future and any effects of
reduced demand for our COVID-19 vaccine, including the write-down of inventory and costs relating to
contract manufacturing production capacities that become redundant or unutilized;
•
our expected revenues and net profit related to sales of our COVID-19 vaccine (also referred to as
Comirnaty
in the United States and in the European Union to the extent authorized for use), respectively,
in territories controlled by our collaboration partners, particularly for those figures that are derived from
preliminary estimates provided by our partners
;
•
our
pricing and coverage negotiations for
our COVID-19 vaccine
with governmental authorities, private
health insurers and other third-party payors after our initial sales to national governments;
•
competition from other COVID-19 vaccines or related to our other product candidates, including those
with different mechanisms of action and different manufacturing and distribution constraints, on the basis
of, among other things, efficacy, cost, convenience of storage and distribution, breadth of approved use,
safety, side-effect profile and durability of immune response;
•
the timing and ability of us and our collaborators to obtain regulatory approval for our COVID-19 vaccine
and our product candidates, and to commercialize our approved and investigational product candidates,
if approved;
•
the
pricing
and reimbursement of our COVID-19 vaccine and our product candidates, if approved;
•
the rate and degree of market acceptance of our COVID-19 vaccine and our product candidates, if
approved;
•
the initiation, timing, progress, results, and cost of our research and development programs and our
current and future preclinical studies and clinical trials, including statements regarding: the timing of
initiation and completion of studies or trials and related preparatory work, the period during which the
results of the trials will become available,
and our research and development programs
;
•
our ability to identify research opportunities and discover and develop product candidates;
•
our ability to utilize our resources on-hand and to focus on the development of product candidates that
will maximize shareholder value and our corporate pillars;
6
Annual Report on Form 20-F for the
year ended December 31, 2024
•
our measures anticipated to be taken in connection with our strategic vision, including estimated FTE
increases and decreases;
•
the ability and willingness of our third-party collaborators to continue research and development
activities relating to our product candidates;
•
our expectations regarding the size of the patient populations for our product candidates, if approved for
commercial use;
•
the impact of COVID-19 on our development programs, supply chain, collaborators and financial
performance;
•
unforeseen safety issues and claims for personal injury or death arising from the use of our COVID-19
vaccine and other products and product candidates developed or manufactured by us;
•
our estimates of our expenses, future revenue and capital requirements and our needs for or ability to
obtain additional financing;
•
our ability to identify, recruit and retain key personnel;
•
our and our collaborators’ ability to protect and enforce our intellectual property protection for our
proprietary and collaborative product candidates, our ability to protect and defend against potential
claims of others' intellectual property, and the scope of such protection;
•
the development of and projections relating to our competitors or our industry;
•
the amount of and our ability to use net operating losses and research and development credits to offset
future taxable income;
•
our abil
ity, and that of our collaboration partners, as applicable, to manage development and expansion;
•
regulatory developments in the United States and foreign countries;
•
political uncertainty;
•
our ability to effectively scale our production capabilities and manufacture our products, including our
COVID-19 vaccine, and our product candidates;
•
our expectations with respect to the timing and amount of any dividends and any potential repurchases
of our outstanding American Depositary Shares, or ADSs;
•
our expectations regarding the timing of customer payments for delivered COVID-19 vaccine;
•
our ability to implement, maintain and improve effective internal controls; and
•
o
ther factors not known to us at this time.
The preceding list is not intended to be an exhaustive list of all of our forward-looking statements. The forward-
looking statements contained in this Annual Report speak only as of the date of this report, and unless otherwise
required by law, we do not undertake any obligation to update them in light of new information or future
developments or to release publicly any revisions to these statements in order to reflect later events or
circumstances or to reflect the occurrence of unanticipated events.
7
Annual Report on Form 20-F for the
year ended December 31, 2024
PART I
Item 1. Identity of Directors, Senior Management and Advisers
Not applicable.
Item 2. Offer Statistics and Expected Timetable
Not applicable.
Item 3. Key Information
A. [Reserved]
B. Capitalization and Indebtedness
Not applicable.
C. Reasons for the Offer and Use of Proceeds
Not applicable.
D. Risk Factors
Our business is subject to various risks, including those described below. You should consider carefully the risks
and uncertainties described below and in our future filings. If any such risks are realized, our business, financial
condition, results of operations and prospects could be materially and adversely affected. Additionally, risks and
uncertainties not currently known to us or that we currently deem to be immaterial also may materially adversely
affect our business, financial condition, results of operations and/or prospects.
Risk Factor Summary
•
Demand for our COVID-19 vaccine, though difficult to predict, is expected to continue to decrease in the
near future.
Changing market dynamics, including as a result of the political climate and public
sentiment,
will impact our
revenue
, which currently depends heavily on sales of our COVID-19 vaccine,
and result in challenges relating to production of our COVID-19 vaccine.
•
Our reported commercial revenue is partially based on preliminary estimates of COVID-19 vaccine sales
and costs from Pfizer Inc., or Pfizer, that are likely to change in future periods, which may impact our
reported financial results.
•
We may be unsuccessful in adapting our COVID-19 vaccine or developing future versions of our
COVID-19 vaccine to protect against variants of the SARS-CoV-2 virus and, even if we are successful, a
market for vaccines against these variants may not develop.
•
Significant adverse events may occur during our clinical trials or even after receiving regulatory
approval, which could delay or terminate clinical trials and delay or prevent regulatory approval or
market acceptance of any of our product candidates. Since commercialization, we have received, and
expect to continue to receive, product liability claims related to our COVID-19 vaccine.
•
If we are unable to continue to increase our marketing and sales capabilities on our own or through third
parties, we may not be able to market and sell our product candidates effectively in the United States
and other jurisdictions, if approved, or generate product sales revenue.
•
Other companies or organizations may challenge our intellectual property rights or may assert
intellectual property rights that prevent us from developing and commercializing our COVID-19 vaccine
or our product candidates and other technologies, or that negatively affect our results of operations.
8
Annual Report on Form 20-F for the
year ended December 31, 2024
•
Even if we obtain regulatory approval for our product candidates, the products may not gain the market
acceptance among physicians, patients, hospitals, treatment centers and others in the medical
community necessary for commercial success.
•
Our operating results may fluctuate significantly, which makes our future operating results difficult to
predict. If our operating results fall below expectations, the price of the ADSs representing our shares
could decline.
•
If we identify material weaknesses in our internal control over financial reporting and fail to remediate
such material weaknesses, we may not be able to report our financial results accurately or to prevent
fraud.
•
As a “foreign private issuer,” we are exempt from a number of rules under U.S. securities laws, as well
as Nasdaq rules, and we are permitted to file less information with the Securities and Exchange
Commission, or the SEC, than U.S. companies. This may limit the information available to holders of the
ADSs and may make our ordinary shares and the ADSs less attractive to investors.
•
Clinical development involves a lengthy and expensive process with an uncertain outcome, and delays
can occur for a variety of reasons outside of our control. Clinical trials of our product candidates may be
delayed, and certain programs may never advance in the clinic or may be more costly to conduct than
we anticipate, any of which can affect our ability to fund our company and would have a material adverse
impact on our business.
•
mRNA drug development has substantial clinical development and regulatory risks due to limited
regulatory experience with mRNA immunotherapies.
•
Our approved product and product candidates are based on novel technologies and they may be
complex and difficult to manufacture. We may encounter difficulties in manufacturing, product release,
shelf life, testing, storage, supply chain management or shipping. If we or any of the third-party
manufacturers we work with encounter such difficulties, our ability to supply materials for clinical trials or
any approved product could be delayed or stopped.
•
If our efforts to obtain, maintain, protect, defend and/or enforce the intellectual property related to our
COVID-19 vaccine or our product candidates and technologies are not adequate, we may not be able to
compete effectively in our market.
•
We have experienced and may continue to experience significant volatility in the market price of the
ADSs representing our ordinary shares.
•
Our principal shareholders and management own a significant percentage of our ordinary shares and
will be able to exert significant control over matters subject to shareholder approval.
Risks Related to our COVID-19 Vaccine and the Commercialization of our Pipeline
Demand for our COVID-19 vaccine, though difficult to predict, is expected to continue to decrease in the
near future.
Changing market dynamics
will impact our revenue, which currently depends heavily on
sales of our COVID-19 vaccine, and result in challenges relating to production of our COVID-19 vaccine.
Prior to the commercialization of our COVID-19 vaccine, we had not sold or marketed any products in our
pipeline. As a result, a majority of our total revenues to date are attributable to sales of our COVID-19 vaccine.
However, we have experienced and we expect to continue to experience increasing reductions in demand for
COVID-19 vaccination generally, including for our vaccine, now that the virus has entered an endemic stage and
as a growing proportion of the population becomes vaccinated. We expect that future revenues from sales of our
COVID-19 vaccine will decrease as demand for vaccination wanes. Such revenues will depend on numerous
factors, including:
9
Annual Report on Form 20-F for the
year ended December 31, 2024
•
the extent to which a COVID-19 vaccine, including any booster shot, continues to be necessary while
COVID-19 remains an endemic virus;
•
competition from other COVID-19 vaccines, including those with different mechanisms of action and
different manufacturing and distribution constraints, on the basis of, among other things, efficacy, cost,
convenience of storage and distribution, breadth of approved use, side-effect profile and durability of
immune response;
•
our ability to successfully and timely develop effective vaccines targeting new variants and mutations of
COVID-19;
•
the extent to which changes in local, national and state government policy preferences in the United
States and other jurisdictions resulting from new elected leadership and evolving public sentiment affect
demand for COVID-19 vaccines or mRNA therapeutics and our ability to successfully commercialize our
product candidates, if approved;
•
our ability to receive full regulatory approvals where we currently have emergency use authorizations or
equivalents;
•
our ability to expand our geographic customer base;
•
our pricing and reimbursement negotiations with governmental authorities, private health insurers and
other third-party payors after our initial sales to national governments, including the transition towards
ordinary-course insurance coverage in the public and private sectors;
•
the ability of countries and jurisdictions to store and distribute doses of our COVID-19 vaccine to end
users at cold temperatures;
•
the safety profile of our COVID-19 vaccine, including if previously unknown undesirable effects or
increased incidence or severity of known undesirable effects are identified with our COVID-19 vaccine;
•
intellectual property litigation involving our COVID-19 vaccine and COVID-19 vaccines in general; and
•
our manufacturing and distribution capabilities for our COVID-19 vaccine.
We cannot accurately predict the revenues our COVID-19 vaccine will generate in future periods or for how long
our COVID-19 vaccine will continue to generate material revenues, and we cannot ensure it will maintain its
competitive position. Uncertainty in the demand for our COVID-19 vaccine and difficulties in targeting appropriate
supply of our COVID-19 vaccines have in the past resulted, and may in the future result, in significant inventory
write-downs and cancellations of contract manufacturing orders. Our business and financial condition could be
materially affected by lowered COVID-19 vaccine revenues resulting from any of the above factors, or by
production and supply chain difficulties. In addition, if our revenues or market share of, or other financial metrics
relating to, our COVID-19 vaccine do not meet the expectations of investors or securities analysts, the market
price of the ADSs representing our ordinary shares may decline.
Our reported commercial revenue is based in part on preliminary estimates
of COVID-19 vaccine sales
and costs from Pfizer that are likely to change in future periods, which may impact our reported financial
results.
Our reported commercial revenue is based in part on preliminary estimates from Pfizer and other assumptions
and judgments that we have made, which may be subject to significant uncertainties. Our commercial revenue
includes preliminary estimates in part due to a difference in Pfizer’s financial quarter for subsidiaries outside the
United States, which consequently creates an additional time lag between the recognition of revenues and the
receipt of payment. Although our revenue recognition policy is based on facts and circumstances known to us
and various other assumptions that we believe to be reasonable under the circumstances, our actual results may
deviate from such reported revenue.
10
Annual Report on Form 20-F for the
year ended December 31, 2024
We depend on Pfizer to determine and provide estimates of the costs and profits to be shared with us in the
countries where it is commercializing our COVID-19 vaccine under our collaboration agreement with Pfizer for
our COVID-19 vaccine, which we refer to as the Pfizer Agreement. Because the information supplied by Pfizer is
preliminary and subject to change, the commercial revenue we report based on such information is also subject
to finalization. This is particularly true for vaccine sales outside of the United States, where Pfizer has a different
reporting cycle than ours. As a result, we may not have the complete sales and costs results outside of the
United States for months not covered by the reporting period, but we are nonetheless required to report
estimated figures.
Pfizer has historically provided us with profit figures for our COVID-19 vaccine sales in the United States using
standard U.S. transfer prices and manufacturing and shipping cost variances (as far as those have been
identified) that could be subject to adjustment (e.g., due to changes in manufacturing costs or the price of our
COVID-19 vaccine). Pfizer has also provided estimated profits for COVID-19 vaccine sales outside of the United
States that were preliminary in nature for the last month of a quarter, as Pfizer’s subsidiaries outside of the
United States have a different reporting cycle than ours. These estimated figures have changed, and in the
future such estimated figures are likely to change, as we receive final data from Pfizer for the applicable period in
accordance with the reporting cycle of Pfizer’s ex-U.S. subsidiaries and as actual costs become known. Further,
to the extent that Pfizer does not provide such preliminary information in the future, our provisional sales figures
for territories outside of the United States will be subject to an even greater level of estimate and judgment. Any
changes to the preliminary data we report herein may have an impact on our reported revenues and expenses,
profitability or financial position.
We may be unsuccessful in adapting our COVID-19 vaccine or developing future versions of our
COVID-19 vaccine to protect against variants of the SARS-CoV-2 virus, and even if we are successful, a
market for vaccines against these variants may not develop and our ability to continue to generate
income from sales of our COVID-19 vaccine is uncertain.
The COVID-19 disease itself is unpredictable and each variant comes with varying levels of transmissibility and
severity. Consequently, the burden of the disease may wane or dissipate such that our and other COVID-19
vaccines may be considered less essential from individual and public health perspectives.
Our COVID-19 vaccine was initially developed based upon the genetic sequence of the original SARS-CoV-2
virus that was first detected. The SARS-CoV-2 virus continues to evolve, and new strains of the virus or those
that are already in circulation may prove more transmissible or cause more severe forms of COVID-19 disease
than the predominant strains observed to date. Our vaccine may not be as effective in protecting against existing
and future variant strains of the SARS-CoV-2 virus as it is against the original virus or currently known strains of
the SARS-CoV-2 virus. We and Pfizer intend to continue to observe our COVID-19 vaccine, including variant-
adapted vaccine candidates, in global clinical trials. It is possible that subsequent data from these clinical trials
may not be as favorable as data we submitted to regulatory authorities to support our applications for emergency
use authorization or marketing or conditional marketing approval or that concerns about the safety of our variant-
adapted COVID-19 vaccines will arise from widespread use outside of clinical trials. While we continue to
monitor emerging SARS-CoV-2 strains, undertake investigations into the immunogenicity of our COVID-19
vaccine against new variants as they emerge and develop modified versions of our COVID-19 vaccine against
new variants, these efforts may be unsuccessful, and failure to timely and successfully adapt our vaccine to
variants of the SARS-CoV-2 virus could lead to significant reputational harm and adversely affect our financial
results. Furthermore, variant-adapted COVID-19 vaccines may not receive approval or emergency use
authorization in all jurisdictions, which could adversely affect our business prospects. It is also possible that we
may expend significant resources adapting our COVID-19 vaccine to protect against certain variants of the
SARS-CoV-2 virus, but that a market for adapted vaccines does not develop for one or more variants or that
demand does not align with our projections or cost expenditures. Moreover, even if we are successful in
developing an adapted vaccine and there is a market for the new vaccine, new variants continue to emerge and
any adapted vaccine may not be as effective in protecting against such future variant strains.
If we discover safety issues with our products, including our COVID-19 vaccine, that were not known at
the time of approval, commercialization efforts for our products could be negatively affected, approved
11
Annual Report on Form 20-F for the
year ended December 31, 2024
products could lose their approval or sales could be suspended, we could be subject to product liability
claims and our business and reputation could be materially harmed.
Our COVID-19 vaccine and any other product candidates for which we receive approval or emergency use
authorization are subject to continuing regulatory oversight, including the review of additional safety information.
Billions of doses of our COVID-19 vaccine have been delivered worldwide, and our COVID-19 vaccine is being
more widely used by patients as an authorized product than it was used in clinical trials. As a result, undesirable
effects and other problems may be observed that were not seen or anticipated, or were not as prevalent or
severe, during clinical trials. We cannot provide assurance that newly discovered or developed safety issues will
not arise, and we have received, and expect to continue to receive, product liability claims relating to our
COVID-19 vaccine. With the use of any vaccine by a wide patient population, serious adverse events may occur
from time to time that did not arise in clinical trials or that initially appeared to be unrelated to the vaccine itself
and only with the collection of subsequent information were found to be causally related to the product. Safety
events that arise outside of a clinical trial setting are difficult to monitor, and given the widespread use of our
COVID-19 vaccine, we have experienced difficulty tracking potential treatment-related adverse events on a
global basis. Any safety issues could cause us to suspend or cease marketing of our approved products,
possibly subject us to substantial liabilities, and adversely affect our ability to generate revenue and our financial
condition. The subsequent discovery of previously unknown problems with a product could negatively affect
commercial sales of the product, result in restrictions on the product or lead to the withdrawal of the product from
the market. The reporting of adverse safety events involving our products or public speculation about such
events could cause the price of the ADSs representing our ordinary shares to decline or experience periods of
volatility.
Unexpected safety issues, including any that we have not yet observed in our clinical trials for our COVID-19
vaccine or in real world data, could lead to significant reputational damage for us and our product development
platforms going forward and other issues, including delays in our other programs, the need for re-design of our
clinical trials and the need for significant additional financial resources.
Failure to comply with continuing regulatory requirements by us or our collaboration partners could
adversely impact regulatory approvals for our products, result in product recalls or suspensions, and/or
subject us to fines and/or other types of liabilities.
If we or our collaborators fail to comply with applicable continuing regulatory requirements, including good
industry practices, such as good manufacturing practices, or GMP, we or our collaborators may be subject to
fines, suspension or withdrawal of regulatory approvals for specific drugs, product recalls and seizures,
operating restrictions and/or criminal prosecutions. We and the manufacturers we engage to make our products
and the manufacturing facilities in which our products are made are subject to periodic review and inspection by
the U.S. Food and Drug Administration, or the FDA, and other regulatory authorities. If problems are identified
during a review or inspection, we or our collaborators may be the subject of adverse regulatory action, including
the issuance of untitled or warning letters, which could result in our inability to use the facility to make our
product or a determination that inventories are not safe for commercial sale. Any of these factors could adversely
affect our business prospects and our financial position could be materially harmed.
The successful commercialization of our product candidates will depend in part on the extent to which
governmental authorities, private health insurers and other third-party payors provide coverage and
adequate reimbursement levels and implement pricing policies favorable to our product candidates.
Failure to obtain or maintain coverage and adequate reimbursement for our product candidates, if
approved, and/or delayed payments from government authorities could limit our ability to market those
products and decrease our ability to generate revenue.
The availability and extent of reimbursement by governmental and private payors is essential for most patients to
be able to afford certain treatments, including our COVID-19 vaccine and other product candidates we may
develop and sell. In addition, because our mRNA product candidates represent an entirely new therapeutic
modality, we cannot accurately estimate how future products we may develop and sell would be priced, whether
reimbursement could be obtained, or any potential revenue. Sales of our product candidates will depend
substantially, both domestically and abroad, on the extent to which the costs of our product candidates will be
paid by health maintenance, managed care, pharmacy benefit, and similar healthcare management
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Annual Report on Form 20-F for the
year ended December 31, 2024
organizations, or reimbursed by government health administration authorities, private health coverage insurers
and other third-party payors. If reimbursement is not available, or is available only to limited levels, we may not
be able to successfully commercialize our product candidates. Even if coverage is provided, the approved
reimbursement amount may not be high enough to allow us to establish or maintain pricing sufficient to realize
an adequate return on our investment in any of our products. Additionally, even if pricing terms with
governmental authorities are agreed upon, there may be delayed or denied payments.
There is significant uncertainty related to the insurance coverage and reimbursement for newly approved
products in particular in the United States, including genetic medicines. In the United States, the principal
decisions about reimbursement for new medicines are typically made by the Centers for Medicare & Medicaid
Services, or CMS, an agency within the U.S. Department of Health and Human Services, or HHS, as CMS
decides whether and to what extent a new medicine will be covered and reimbursed under Medicare. Private
payors tend to follow CMS to a substantial degree. It is difficult to predict what CMS will decide with respect to
reimbursement for novel products such as ours. Reimbursement agencies in Europe may be more conservative
than CMS. For example, a number of cancer drugs have been approved for reimbursement in the United States
but have not been approved for reimbursement in certain European countries.
Outside the United States, certain countries, including a number of member states of the European Union, set
prices and reimbursement for pharmaceutical products, with limited participation from the marketing
authorization holders. We cannot be sure that such prices and reimbursement will be acceptable to us or our
collaborators. If the regulatory authorities in these jurisdictions set prices or reimbursement levels that are not
commercially attractive for us or our collaborators, our revenues from sales by us or our collaborators, and the
potential profitability of our drug products, in those countries would be negatively affected. An increasing number
of countries are taking initiatives to attempt to reduce large budget deficits by focusing cost-cutting efforts on
pharmaceuticals for their state-run health care systems. These international price control efforts have impacted
all regions of the world but have been most drastic in the European Union. Additionally, some countries require
approval of the sale price of a product before it can be marketed. In many countries, the pricing review period
begins after marketing or product licensing approval is granted. As a result, we might obtain marketing approval
for a product in a particular country, but then may experience delays in the reimbursement approval of our
product or be subject to price regulations that would delay our commercial launch of the product, possibly for
lengthy time periods, which could negatively impact the revenues we are able to generate from the sale of the
product in that particular country.
Moreover, increasing efforts by governmental and third-party payors in the United States and abroad to cap or
reduce healthcare costs may cause such organizations to limit both coverage and level of reimbursement for
new products approved and, as a result, they may not cover or provide adequate payment for our product
candidates. The Inflation Reduction Act, or IRA, enacted in August 2022 allows HHS to negotiate the price of
certain drugs and biologics that CMS reimburses under Medicare Part B and Part D. The IRA’s negotiation
program will apply to high-expenditure single-source drugs that have been approved for at least 7 years (11
years for biologics), among other negotiation selection criteria. The negotiated prices, which will become
effective in 2026 for the first round of selected drugs, will be capped at a statutorily-determined ceiling price. The
IRA also penalizes drug manufacturers that increase prices of Medicare Part B and Part D drugs at a rate
greater than the rate of inflation. In addition, the law eliminates the “donut hole” under Medicare Part D beginning
in 2025 by significantly lowering the beneficiary maximum out-of-pocket cost and requiring manufacturers to
subsidize, through a newly established manufacturer discount program, once the out-of-pocket maximum has
been reached. The IRA permits the Secretary of HHS to implement many of these provisions through guidance,
as opposed to regulation, for the initial years. Manufacturers that fail to comply with the IRA may be subject to
various penalties, including civil monetary penalties. These IRA provisions have begun to take effect
progressively starting in 2023, although the drug negotiation provisions of the IRA are currently the subject of
legal challenges. The effects of the IRA on our business and the healthcare industry in general are not yet
known. These laws and regulations may result in additional reductions in Medicare and other healthcare funding
and otherwise affect the prices we may obtain for any of our products for which we may obtain regulatory
approval or the frequency with which any such product is prescribed or used. At the state level, legislatures are
increasingly passing legislation and implementing regulations designed to control pharmaceutical and biological
product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product
access, and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage
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Annual Report on Form 20-F for the
year ended December 31, 2024
importing from other countries and bulk purchasing. Officials appointed by the new presidential administration to
oversee the implementation of the IRA may take a different approach, and the new administration and Congress
could also pursue statutory changes to the program, either of which could negatively affect our revenues.
We expect to experience pricing pressures in connection with the sale of any of our product candidates due to
the trend toward managed healthcare, the increasing influence of health maintenance organizations and
additional legislative changes. The downward pressure on healthcare costs in general, particularly prescription
drugs, surgical procedures and other treatments, has become very intense. As a result, increasingly high barriers
are being erected to the entry of new products in the marketplace.
Government policies, including relating to manufacturing or export controls, and negative public
perception regarding vaccines and mRNA-based therapeutics could severely and adversely impact the
manufacturing and sales of our COVID-19 vaccine and other product candidates we may develop, if
approved.
There is a heightened risk that vaccines could be subject to export controls, adverse emergency actions or
supply requirements by governmental and other authorities. In the past, the European Union and other regions
have imposed, or threatened to impose, export controls that would limit or block the delivery of COVID-19
vaccines manufactured in or outside their territories in instances where manufacturers have been delayed or
have not fully satisfied their delivery obligations to such governments, which could have prohibited us from
delivering our COVID-19 vaccine to other jurisdictions. Vaccines are also at risk of being subject to adverse
emergency actions taken by governmental entities in certain countries, including intellectual property
expropriation, compulsory licenses, strict price controls or other actions, such as the requirement that specific
quantities of vaccine doses be set aside for designated purposes or geographic areas.
Furthermore, changes in
governmental policy preferences and regulatory decision-making may have an adverse effect on our ability to
commercialize products or, if approved, product candidates.
Furthermore, public sentiment regarding commercialization of vaccines, the safety and efficacy of our COVID-19
vaccine, other COVID-19 vaccines and treatments, and other public perceptions and misinformation relating to
COVID-19, mRNA technology, and our and other COVID-19 vaccines may limit our ability to generate income
from sales of our COVID-19 vaccine and other product candidates we may develop and sell, including due to
changes in local, national and state government policies in the U.S. and other jurisdictions, and cause
reputational damage.
We face significant competition with other makers of COVID-19 vaccines and may be unable to maintain
a competitive market share for our COVID-19 vaccine.
A number of vaccine manufacturers, academic institutions and other organizations currently have programs to
develop COVID-19 vaccine candidates, including vaccines developed by
Moderna, Inc. and Novavax, Inc
. Our
competitors pursuing vaccine candidates may have greater financial, product candidate development,
manufacturing and marketing resources than we do. Larger pharmaceutical and biotechnology companies have
extensive experience in clinical testing and obtaining regulatory approval for their products, and may have the
resources to invest heavily to accelerate discovery and development of their vaccine candidates.
Our efforts to continue successful commercialization of our COVID-19 vaccine may fail if competitors develop
and commercialize COVID-19 vaccines that are safer, more effective, produce longer immunity against
COVID-19, require fewer administrations, have fewer or less severe undesirable effects, have broader market
acceptance, are more convenient to administer or distribute or are less expensive than any vaccine candidate
that we have developed or we may develop.
Our COVID-19 vaccine is sensitive to temperature, shipping and storage conditions and could be subject
to risk of loss or damage.
Our COVID-19 vaccine is, and other product candidates we develop could be, sensitive to temperature, storage
and handling conditions.
In particular, while we have improved the required shipping and storage conditions of
our COVID-19 vaccine, it must be shipped and stored at cold temperatures.
Loss in supply of our COVID-19
vaccine and our product candidates could occur if the product or product intermediates are not stored or handled
14
Annual Report on Form 20-F for the
year ended December 31, 2024
properly. Shelf life for our product candidates may vary by product, and it is possible that supply of our COVID-19
vaccine or our product candidates could be lost due to expiration prior to use. This has in the past led, and could
in the future lead, to additional manufacturing costs and delays in our ability to supply required quantities for
clinical trials or for commercial purposes. Such distribution challenges may make our COVID-19 vaccine a less
attractive product than other COVID-19 vaccines that do not require as cold storage, and our COVID-19 vaccine
may become increasingly less competitive as additional other vaccines become authorized for emergency use. If
we, our partners and customers are unable to adequately manage these issues, we may be exposed to product
liability claims and the market opportunity for our COVID-19 vaccine may be reduced, each of which could
adversely affect our business prospects and materially harm our financial condition.
We are developing other product candidates and services in an environment of rapid technological and
scientific change, and our failure to effectively compete would prevent us from achieving significant
market penetration. Most of our competitors have significantly greater resources than we do and we may
not be able to compete successfully.
The pharmaceutical market is intensely competitive and rapidly changing. Many large pharmaceutical and
biotechnology companies, academic institutions, governmental agencies, and other public and private research
organizations are pursuing the development of novel drugs for the same diseases that we are targeting or expect
to target. Many of our competitors have:
•
greater financial, technical and human resources than we have at every stage of the discovery,
development, manufacture and commercialization of products;
•
more extensive experience in preclinical testing, conducting clinical trials, obtaining regulatory approvals
and manufacturing, marketing and selling drug products;
•
product candidates that are based on previously tested or accepted technologies;
•
products that have been approved or are in late stages of development; and
•
collaborative arrangements in our target markets with leading companies and research institutions.
We will continue to face intense competition from products that have already been approved and accepted by
the medical community for the treatment of the conditions for which we may develop products in the future. We
also expect to face competition from new products that enter the market. There are a number of products
currently under development, which may become commercially available in the future, for the treatment of
conditions for which we are trying, or may in the future try, to develop drugs. These drugs may be more effective,
safer, less expensive, or marketed and sold more effectively than any products we develop.
We anticipate competing with the largest pharmaceutical companies in the world, many of which are currently
conducting research in the fields of infectious diseases, immuno-oncology, rare genetic diseases and cancer
immunotherapies. Some of these companies have greater financial and human resources than we currently
have. In addition to these large pharmaceutical companies, we may directly compete with fully-integrated
biopharmaceutical companies and other immunotherapy-focused oncology companies, as well as a number of
companies focused on immunotherapies or shared tumor antigen and neoantigen therapeutics, some of which
have entered into collaboration and funding agreements with larger pharmaceutical or biotechnology companies.
If we successfully develop other product candidates, and obtain approval for them, we will face competition
based on many different factors, including:
•
the safety and effectiveness of our products relative to alternative therapies, if any;
•
the ease with which our products can be administered and the extent to which patients accept relatively
new routes of administration;
•
the timing and scope of regulatory approvals for these products;
15
Annual Report on Form 20-F for the
year ended December 31, 2024
•
the availability and cost of manufacturing, marketing and sales capabilities;
•
the price of any approved immunotherapy;
•
reimbursement coverage; and
•
intellectual property position.
Following our acquisition of InstaDeep Ltd., or InstaDeep, we also face competition in the rapidly growing and
developing artificial intelligence, or AI, industry. Our competitors may develop or commercialize products and
services with significant advantages over any products we develop based on any of the factors listed above or
on other factors. In addition, our competitors may develop collaborations with or receive funding from larger
pharmaceutical, biotechnology or technology companies, providing them with an advantage over us. Our
competitors therefore may be more successful in commercializing their products and services than we are, which
could adversely affect our competitive position and business. Competitive products and services may make any
products and services we develop obsolete or non-competitive before we can recover the expenses of
developing and commercializing such products, if approved, and services.
The market opportunities for some of our product candidates may be small due to the rarity of the
disease, or limited to those patients who are ineligible for or have failed prior treatments. As the target
patient populations for some of our programs are small, we may be unable to achieve or maintain
profitability in future periods without obtaining regulatory approval for additional indications.
The FDA often approves new cancer therapies initially only for use by patients with relapsed or refractory
advanced cancer. We expect to seek approval initially for some of our product candidates in this context.
Subsequently, for those products that prove to be sufficiently beneficial, we would expect to seek approval in
earlier lines of treatment and potentially as a first-line therapy, but there is no guarantee that our product
candidates, even if approved, would be approved for earlier lines of therapy, and, prior to any such approvals,
we may have to conduct additional clinical trials. We are also developing product candidates for the treatment of
rare diseases.
Our projections of the number of people who have or will have the diseases we may be targeting may prove to
be incorrect. Further, new studies may change the estimated incidence or prevalence of these diseases. The
number of trial participants may turn out to be lower than expected. Additionally, the potentially addressable
patient population for our product candidates may be limited or may not be amenable to treatment with our
product candidates. Even if we obtain significant market share for our products, if approved, because the
potential target populations may be small, we may be unable to achieve or maintain profitability in future periods
without obtaining regulatory approval for additional indications.
If we are unable to continue to increase our marketing and sales capabilities on our own or through third
parties, we may not be able to market and sell our product candidates effectively in the United States
and other jurisdictions, if approved, or generate sufficient product sales revenue.
We have only relatively recently developed our sales, distribution or marketing capabilities in Germany and
Türkiye, and, other than for our COVID-19 vaccine, we have not historically designed our preclinical studies and
clinical trials with specific commercialization or marketing considerations in mind. In addition, with respect to our
COVID-19 vaccine, we rely heavily on the sales, distribution, and marketing capabilities of our partners, except
in Germany and Türkiye. To successfully commercialize any other products that may result from our
development programs, several of which are undergoing pivotal clinical trials, we will need to continue
developing sales and marketing capabilities in the United States, Europe and other regions, either on our own or
with others. We may enter into collaborations with other entities to utilize their mature marketing and distribution
capabilities, but we may be unable to enter into marketing agreements on favorable terms, if at all. If our current
and future collaborators do not commit sufficient resources to further commercialize our COVID-19 vaccine and
our future products, if any, and we are unable to develop the necessary marketing capabilities on our own, we
may be unable to generate sufficient product sales revenue to sustain our business. We compete with many
companies that currently have extensive and well-funded marketing and sales operations. Without continuing to
16
Annual Report on Form 20-F for the
year ended December 31, 2024
grow our internal team or obtaining the support of third parties to perform marketing and sales functions, we may
be unable to compete successfully against these more established companies.
Our ability to achieve or maintain profitability in future periods depends in part on our and our
collaborators’ ability to penetrate global markets, where we would be subject to additional regulatory
burdens and other risks and uncertainties associated with international operations that could materially
adversely affect our business.
Our ability to achieve or maintain profitability in future periods will depend in part on our ability and the ability of
our collaborators to commercialize any products that we or our collaborators may develop in markets throughout
the world. Commercialization of products in various markets could subject us to risks and uncertainties,
including:
•
obtaining, on a country-by-country basis, the applicable marketing authorization from the competent
regulatory authority;
•
the burden of complying with complex and changing regulatory, tax, accounting, labor and other legal
requirements in each jurisdiction that we or our collaborators pursue;
•
reduced protection for intellectual property rights;
•
differing medical practices and customs affecting acceptance in the marketplace;
•
import or export licensing requirements;
•
governmental controls, trade restrictions or changes in tariffs;
•
economic weakness, including inflation, or political instability;
•
production shortages resulting from any events affecting raw material supply or manufacturing
capabilities abroad;
•
longer accounts receivable collection times;
•
longer lead times for shipping;
•
language barriers;
•
foreign currency exchange rate fluctuations;
•
the impact of epidemics, pandemics and other public health developments, such as COVID-19, on
employees and the global economy;
•
reimbursement, pricing and insurance regimes; and
•
the interpretation of contractual provisions governed by local laws in the event of a contract dispute.
We do not have prior experience in all of these areas, and the experience we do have in some of these areas is
limited. Our collaborators may have limited experience in these areas as well. Failure to successfully navigate
these risks and uncertainties may limit or prevent market penetration for any products that we or our
collaborators may develop, which would limit their commercial potential and our revenues.
Even if we obtain regulatory approval for our product candidates, the products may not gain the market
acceptance among physicians, patients, hospitals, treatment centers and others in the medical
community necessary for commercial success.
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Annual Report on Form 20-F for the
year ended December 31, 2024
Even with the requisite approvals, the commercial success of our products will depend in part on the medical
community, patients, and third-party or governmental payors accepting immunotherapies in general, and our
products in particular, as medically useful, cost-effective and safe.
Any product that we bring to the market may not gain market acceptance by physicians, trial participants, third-
party payors, and others in the medical community. Additionally, ethical and legal concerns and social
preferences about research involving mRNA could result in additional regulations restricting or prohibiting the
products and processes we may use. If these products do not achieve an adequate level of acceptance, we may
not generate significant product sales revenue and may not be able to achieve or maintain profitability in future
periods. The degree of market acceptance of our product candidates, if approved for commercial sale, will
depend on a number of factors, including:
•
the potential efficacy and potential advantages over alternative treatments;
•
the ability to offer our products, if approved, at competitive prices;
•
the prevalence and severity of any undesirable effects, including any limitations or warnings contained in
a product’s approved labeling;
•
the prevalence and severity of any undesirable effects resulting from checkpoint inhibitors or other drugs
or therapies with which our products are administered;
•
the relative convenience and ease of transportation, storage and administration;
•
any restrictions on the use of our products, if approved, together with other medications;
•
the willingness of the target patient population to try new therapies, such as mRNA vaccines and
therapies, and of physicians to prescribe these therapies;
•
the strength of marketing and distribution support and timing of market introduction of competitive
products;
•
the extent to which changes in local, national and state government policy preferences in the United
States and other jurisdictions resulting from new elected leadership and evolving public sentiment affect
demand for COVID-19 vaccines or mRNA therapeutics and our ability to successfully commercialize our
product candidates, if approved;
•
publicity concerning our products or competing products and treatments; and
•
sufficient third-party insurance coverage or reimbursement, and patients’ willingness to pay out-of-pocket
in the absence of third-party coverage or adequate reimbursement.
Even if a potential product displays a favorable efficacy and safety profile in preclinical studies and clinical trials,
market acceptance of the product will not be known until after it is launched. Our efforts to educate the medical
community and third-party payors on the benefits of the products may require significant resources and may
never be successful. Our efforts to educate the marketplace may require more resources than are required by
the conventional technologies marketed by our competitors due to the complexity and uniqueness of our
programs.
In addition, for our products that are approved for marketing, we and/or our collaborator are subject to significant
regulatory obligations regarding the submission of safety and other post-marketing information and reports for
such product, and will need to continue to comply (or ensure that our third-party providers comply) with current
GMP and current good clinical practices, or GCP, for any clinical trials that we or a collaborator conduct post-
approval. In addition, there is always the risk that we or a collaborator or regulatory authority might identify
previously unknown problems with a product post-approval, such as adverse events of unanticipated severity or
frequency. Compliance with these requirements is costly, and any such failure to comply or other issues with our
18
Annual Report on Form 20-F for the
year ended December 31, 2024
product candidates identified post-approval could have a material adverse impact on our business, financial
condition and results of operations.
Coverage and reimbursement may be limited or unavailable in certain market segments for our product
candidates, which could make it difficult for us to sell our product candidates, if approved, profitably.
Successful sales of our product candidates, if approved, depend on the availability of coverage and adequate
reimbursement from third-party payors including governmental healthcare programs, such as Medicare and
Medicaid in the United States, managed care organizations and commercial payors, among others. Significant
uncertainty exists as to the coverage and reimbursement status of any product candidates for which we obtain
regulatory approval. In addition, because certain of our product candidates represent new approaches to the
treatment of cancer, we cannot accurately estimate the potential revenue from our product candidates.
Patients who are provided medical treatment for their conditions generally rely on third-party payors to reimburse
all or part of the costs associated with their treatment. Obtaining coverage and adequate reimbursement from
third-party payors is critical to new product acceptance.
Third-party payors decide which drugs and treatments they will cover and the amount of reimbursement.
Reimbursement by a third-party payor may depend upon a number of factors, including, but not limited to, the
third-party payor’s determination that use of a product is:
•
a covered benefit under its health plan;
•
safe, effective and medically necessary;
•
appropriate for the specific patient;
•
cost-effective; and
•
neither experimental nor investigational.
Obtaining coverage and reimbursement of a product from a government or other third-party payor is a time-
consuming and costly process that could require us to provide to the payor supporting scientific, clinical and
cost-effectiveness data for the use of our products. Third-party payors could require us to conduct additional
studies, including post-marketing studies related to the cost effectiveness of a product, to qualify for
reimbursement, which could be costly and divert our resources. Even if we obtain coverage for a given product,
if the resulting reimbursement rates are insufficient, hospitals may not approve our product for use in their facility
or third-party payors may require co-payments that patients find unacceptably high. Patients are unlikely to use
our product candidates unless coverage is provided and reimbursement is adequate to cover a significant
portion of the cost of our product candidates. Separate reimbursement for the product itself may or may not be
available. Instead, the hospital or administering physician may be reimbursed only for providing the treatment or
procedure in which our product is used. Further, from time to time, CMS revises the reimbursement systems
used to reimburse healthcare providers, including the Medicare Physician Fee Schedule and Outpatient
Prospective Payment System, which may result in reduced Medicare payments. In some cases, private third-
party payors rely on all or portions of Medicare payment systems to determine payment rates. Changes to
government healthcare programs that reduce payments under these programs may negatively impact payments
from private third-party payors, and reduce the willingness of physicians to use our product candidates.
In the United States, no uniform policy of coverage and reimbursement for products exists among third-party
payors. Therefore, coverage and reimbursement for products can differ significantly from payor to payor. Further,
one payor’s determination to provide coverage for a product does not assure that other payors will also provide
coverage for the product. Adequate third-party reimbursement may not be available to enable us to maintain
price levels sufficient to realize an appropriate return on our investment in product development.
We intend to seek approval to market our product candidates in the United States, the European Union and
other selected jurisdictions. If we obtain approval for our product candidates in any particular jurisdiction, we will
19
Annual Report on Form 20-F for the
year ended December 31, 2024
be subject to rules and regulations in that jurisdiction. In some countries, particularly those in Europe, the pricing
of biologics is subject to governmental control. In these countries, pricing negotiations with governmental
authorities can take considerable time after obtaining marketing approval of a product candidate. Some of these
countries may require the completion of clinical trials that compare the cost-effectiveness of a particular product
candidate to currently available therapies. Other member states allow companies to fix their own prices for
medicines, but monitor and control company profits. The downward pressure on health care costs has become
very intense. As a result, increasingly high barriers are being erected to the entry of new products into the
marketplace. In addition, in some countries, cross-border imports from low-priced markets exert a commercial
pressure on pricing within a country.
The marketability of any product candidates for which we receive regulatory approval for commercial sale may
suffer if government and other third-party payors fail to provide coverage and adequate reimbursement. We
expect downward pressure on pharmaceutical pricing to continue. Further, coverage policies and third-party
reimbursement rates may change at any time. Even if favorable coverage and reimbursement status is attained
for one or more products for which we receive regulatory approval, less favorable coverage policies and
reimbursement rates may be implemented in the future.
The advancement of healthcare reform legislation and changes to the regulatory environment in the
United States, the European Union and elsewhere may increase the difficulty and cost for us to obtain
marketing approval of and commercialize any product candidates we or our collaborators develop and
may adversely affect the prices for such product candidates.
In the United States, there have been and continue to be a number of legislative initiatives to contain healthcare
costs. For example, in March 2010, the Patient Protection and Affordable Care Act, as amended by the Health
Care and Education Reconciliation Act of 2010, or the ACA, was passed, which substantially changed the way
health care is financed by both governmental and private insurers, and significantly impacted the U.S.
pharmaceutical industry. The ACA, among other things, increased the minimum Medicaid rebates owed by
manufacturers under the Medicaid Drug Rebate Program and extended the rebate program to individuals
enrolled in Medicaid managed care organizations, established annual fees and taxes on manufacturers of
certain branded prescription drugs, and promoted a new Medicare Part D coverage gap discount program.
Considerable uncertainty remains regarding the implementation and impact of the ACA.
In August 2022, the IRA was enacted, which sets forth meaningful changes to drug product reimbursement by
Medicare. The IRA is anticipated to have significant effects on the pharmaceutical industry and may reduce the
prices we can charge and reimbursement we can receive for our products in the United States, among other
effects. Any reduction in reimbursement from Medicare resulting from the IRA or other legislative or policy
changes or from other government programs may result in a similar reduction in payments from private payers.
On August 16, 2024, the CMS announced the results of a first round of discounted prices effectively set by CMS
under the IRA, applicable to ten products of other manufacturers; those discounted prices, set to take effect for
calendar year 2026, were as high as 79% from 2023 list prices. Additional products will be discounted in future
years. We cannot be sure whether additional legislative changes will be enacted, or the effect of forthcoming
guidance implementing the IRA, or what the impact of such changes on our products and product candidates
may be. Officials appointed by the new presidential administration to oversee the implementation of the IRA or
other statutes may take a different approach, and the new administration and Congress could also pursue
statutory changes to this or other programs, either of which could negatively affect our revenues.
The delivery of healthcare in the European Union, including the establishment and operation of health services
and the pricing and reimbursement of medicines, is almost exclusively a matter for national, rather than
European Union, law and policy. National governments and health service providers have different priorities and
approaches to the delivery of healthcare and the pricing and reimbursement of products in that context. In
general, however, the healthcare budgetary constraints in most EU member states have resulted in restrictions
on the pricing and reimbursement of medicines by relevant health service providers. Coupled with ever-
increasing European Union and national regulatory burdens on those wishing to develop and market products,
this could prevent or delay marketing approval of our product candidates, restrict or regulate post-approval
activities, and affect our ability to commercialize any products for which we obtain marketing approval.
20
Annual Report on Form 20-F for the
year ended December 31, 2024
We expect that additional healthcare reform measures or proposals will be adopted in the future, any of which
could limit the amounts that governments will pay for healthcare products and services, including public health
measures, which could result in reduced demand for our products and product candidates or additional pricing
pressures. In the event that the pricing structures for healthcare products, such as the product candidates we are
developing, change materially and limit payments for such product candidates, our business will be adversely
impacted as our products may no longer be commercially viable based on their expected net present value; we
may have invested significant resources in product candidates that cannot be commercially developed; or we
may determine that assets that have reached an early phase of development cannot or will not be taken into
further development, notwithstanding their clinical viability. In addition, development assets or clinical programs
that are part of our collaborations may no longer be deemed commercially viable to pursue based on our
collaborators’ assessments of the impact of any proposed, announced, or legislated pricing reforms.
We cannot predict what healthcare reform initiatives may be adopted in the future. Further legislative and
regulatory developments are likely, and we expect ongoing initiatives to increase pressure on drug pricing. Such
reforms could have an adverse effect on anticipated revenues from our approved products and from product
candidates that we may successfully develop and for which we may obtain regulatory approval, and may affect
our overall financial condition and ability to develop product candidates.
Drug marketing and reimbursement regulations in the
European Union and elsewhere
may materially
affect our ability to market and receive coverage for our products in the member states of the European
Union and elsewhere.
Our COVID-19 vaccine is currently approved in the United States, the European Union, and other jurisdictions,
and we intend to seek approval to market other product candidates in the United States, the European Union
and other selected jurisdictions. If we obtain approval for our products or product candidates in a particular
jurisdiction, we will be subject to rules and regulations in that jurisdiction. In some countries, particularly those in
the European Union, the pricing of biologics is subject to governmental control and other market regulations that
could put pressure on the pricing and usage of our products or product candidates. In these countries, pricing
negotiations with governmental authorities can take considerable time after obtaining marketing approval of a
product candidate. In addition, market acceptance and sales of our product candidates will depend significantly
on the availability of adequate coverage and reimbursement from third-party payors for our product candidates
and may be affected by existing and future healthcare reform measures.
In addition, in most countries outside the United States, the proposed pricing for a drug must be approved before
it may be lawfully marketed. The requirements governing drug pricing and reimbursement vary widely from
country to country. For example, the European Union provides options for its member states to restrict the range
of medicinal products for which their national health insurance systems provide reimbursement and to control the
prices of medicinal products for human use. Reference pricing used by various member states and parallel
distribution, or arbitrage between low-priced and high-priced member states, can further reduce prices. A
member state may approve a specific price for the medicinal product or it may instead adopt a system of direct
or indirect controls on the profitability of the company placing the medicinal product on the market. In some
countries, we may be required to conduct a clinical trial or other studies that compare the cost-effectiveness of
any of our product candidates to other available therapies in order to obtain or maintain reimbursement or pricing
approval. There can be no assurance that any country that has price controls or reimbursement limitations for
pharmaceutical products will allow favorable reimbursement and pricing arrangements for any of our products.
Historically, products launched in the European Union do not follow price structures of the United States and,
generally, prices tend to be significantly lower in the European Union. Publication of discounts by third-party
payors or authorities may lead to further pressure on the prices or reimbursement levels within the country of
publication and other countries. If pricing is set at unsatisfactory levels or if reimbursement of our products is
unavailable or limited in scope or amount, our revenues from sales by us or our collaborators and the potential
profitability of any of our product candidates in those countries would be negatively affected.
Risks Related to our Financial Condition and Capital Requirements
Long-term sustainable profitability is difficult to achieve and maintain over time and is highly dependent
on various factors.
21
Annual Report on Form 20-F for the
year ended December 31, 2024
Our ability to continue to generate revenues and achieve and maintain long-term sustainable profitability
depends on our ability, alone or with collaborators, to successfully complete the development of, and obtain the
regulatory approvals necessary to commercialize, our product candidates. We continue to generate revenues
from sales of our COVID-19 vaccine and additional limited revenues from other transactions. While we expect to
maintain revenue from ongoing COVID-19 vaccine sales, future demand for COVID-19 vaccination is subject to
uncertainty. Although we anticipate COVID-19 vaccination rates to remain relatively stable in the near term,
variations driven by factors such as new virus variants, regional policy changes, and public health measures may
impact long-term demand. Consequently, our revenue projections are influenced by this inherent unpredictability.
The amount of long-term revenue from such sales, including the sales of our COVID-19 vaccine, is uncertain at
this time. Our ability to generate future revenues from pharmaceutical product sales and sales of our other
products and services depends heavily on our success in:
•
completing research and preclinical and clinical development of our product candidates;
•
seeking and obtaining U.S. and non-U.S. marketing approvals for product candidates for which we
complete clinical trials;
•
seeking and obtaining market access and favorable pricing terms in the United States, the European
Union, and other key geographies;
•
furthering the development of our own manufacturing capabilities and manufacturing relationships with
third parties in order to provide adequate (in amount and quality) products and services to support
clinical development and the market demand for our approved products and product candidates, if
approved;
•
obtaining market acceptance of our approved products and product candidates as a treatment option;
•
launching and commercializing products for which we obtain marketing approval and reimbursement,
either through collaborations or, if launched independently, by establishing a sales force, marketing and
distribution infrastructure;
•
addressing any competing technological and market developments, in particular, declining demand for
any of our approved products;
•
implementing additional internal systems and infrastructure;
•
negotiating favorable terms in any collaboration, licensing or other arrangements into which we may
enter;
•
managing our expenses;
•
maintaining, defending, protecting, enforcing and expanding our portfolio of intellectual property rights,
including patents, trade secrets and know-how; and
•
attracting, hiring and retaining qualified personnel.
Additionally, we have incurred significant costs associated with the commercialization of our COVID-19 vaccine.
Our expenses could increase beyond our expectations if we are required by the FDA, the European Medicines
Agency, or EMA, or other regulatory agencies to perform clinical and other trials or make changes to our
manufacturing or quality systems in addition to those that we currently anticipate. Accordingly, such costs could
adversely affect our future ability to achieve and maintain profitability.
Our operating results may fluctuate significantly, which makes our future operating results difficult to
predict. If our operating results fall below expectations, the price of the ADSs representing our ordinary
shares could decline.
22
Annual Report on Form 20-F for the
year ended December 31, 2024
Our financial condition and operating results have varied in the past and will continue to fluctuate from one
financial period to the next due to a variety of factors, many of which are beyond our control.
Factors relating to our business that may contribute to these fluctuations include the following, as well as other
factors described elsewhere in this report:
•
the size and timing of orders for our COVID-19 vaccine;
•
delays or failures in advancement of existing or future product candidates into the clinic or in clinical
trials;
•
the occurrence of adverse events during our clinical trials or post marketing authorization;
•
our ability to develop and manufacture our product candidates and commercialize and manufacture our
COVID-19 vaccine and, if approved, our product candidates, at commercial scale, including risks
associated with quality compliance, such as product design, manufacturing processes, supply chain
management, and compliance with regulatory requirements;
•
our ability to manage our growth and spending;
•
our ability to execute our corporate objectives;
•
strategic decisions related to portfolio prioritization, which may result in certain potential one-time effects
and charges and other material adverse effects on our financial condition and results of operations;
•
the outcomes of research programs, clinical trials, or other product development or approval processes
conducted by us and our collaborators;
•
the
ability of our collaborators to develop and successfully commercialize products developed from our
suite of therapeutic classes;
•
our relationships, and any associated exclusivity terms, with collaborators;
•
our contractual or other obligations to provide resources to fund our product candidates, and to provide
resources to our collaborators or to the collaborations themselves, including take-or-pay or similar
obligations;
•
the extent to which we repurchase outstanding ADSs under any share repurchase plans we may enter
into in the future;
•
risks associated with the international aspects of our business, including the conduct of clinical trials in
multiple l
ocations, and the risks associated with potential international commercialization, including
regulatory approval, market competition, public sentiment and consumer demand, supply chain
disruptions, and changes to the law and regulatory policy in different jurisdictions, such as the United
States;
•
our ability to minimize and manage product recalls or inventory losses caused by unforeseen events,
cold chain interruption, testing difficulties or decreased demand, and our ability to write down certain
inventory;
•
our ability to report our financial results accurately and in a timely manner;
•
our dependence on, and the need to attract and retain, key management and other personnel;
•
our ability to obtain, protect, maintain, defend and enforce our intellectual property rights;
23
Annual Report on Form 20-F for the
year ended December 31, 2024
•
our ability to prevent the theft or infringement, misappropriation or other violation of our intellectual
property, trade secrets, know-how or technologies;
•
our and our collaborators’ ability to defend against claims of infringement of the intellectual property
rights of third parties;
•
potential advantages that our competitors and potential competitors may have in securing funding,
obtaining the rights to critical intellectual property or developing competing technologies or products;
•
our ability to obtain additional capital that may be necessary to expand our business;
•
our collaborators’ ability to obtain and devote additional capital that may be necessary to develop and
commercialize products under our collaboration agreements, including our COVID-19 vaccine;
•
our ability to minimize and manage product liability claims arising from the use of our COVID-19 vaccine
and our product candidates and other future products, if approved;
•
business interruptions such as power outages, strikes, acts of terrorism or natural disasters;
•
our ability to use our net operating loss carryforwards to offset future taxable income;
•
risks of counterparty defaults within our asset management portfolio; and
•
increased or unpredictable pricing for the commodities we rely on, including as a result of inflation.
Each of the factors listed above may be affected by the changing impact of COVID-19 on the global community
and the global economy.
Due to the various factors mentioned above, and others, the results of any of our periods should not be relied
upon as indications of our future operating performance. Our operating results may fluctuate significantly from
one reporting period to the next, such that a period-to-period comparison of our results of operations may not be
a good indication of our future performance.
In any particular period, our operating results could be below the expectations of securities analysts or investors,
which could cause the price of the ADSs to decline. While as a general matter we intend to periodically report on
the status of our product candidate pipeline, including articulating anticipated next steps in the form of
development plans or potential data readouts, we may not always be able to provide forward-looking guidance
on the timing of those next steps. In addition, we do not control the timing of disclosures of any milestones
related to any of our programs that are managed by our collaborators. Any disclosure by a collaborator of data
that are perceived as negative, whether or not such data are related to other data that we or others release, may
have a material adverse impact on the price of the ADSs or our overall valuation. The price of the ADSs may
decline as a result of unexpected clinical trial results in one or more of our programs, including adverse safety
events reported for any of our programs.
We have incurred significant losses in the past and we may incur significant losses in the future.
Prior to the first full year of commercialization of our COVID-19 vaccine,
and for the
year ended December 31,
2024
, we incurred significant losses
due to our significant research and development expenses and our
investment in our manufacturing capabilities, and funded our operations primarily from private placements or
issuances of ordinary shares (including in the form of ADSs) in connection with our public offerings, generation of
proceeds under our collaboration agreements, secured bank loans and issuance of a convertible note.
We have experienced, and we expect to continue to experience, increasing reductions in demand for COVID-19
vaccination generally, including for our vaccine. We expect that future revenues from sales of our COVID-19
vaccine will decrease as demand for vaccination wanes. We plan to continue to invest heavily in research and
development as we make a strong drive to build out our global development organization and diversify our
24
Annual Report on Form 20-F for the
year ended December 31, 2024
therapeutic area footprint. Additionally, we plan to enhance capabilities through complementary acquisitions,
technologies, infrastructure and manufacturing. Even for those products for which we have obtained or may
obtain regulatory approval or emergency use authorization, our future revenues will depend upon the size of any
markets in which such products have received approval or authorization to market, our ability to achieve
sufficient market acceptance, reimbursement from third-party payors, and adequate market share in those
markets.
If achieved, profitability is difficult to maintain over time and is highly dependent on various factors. Our future
financial results will depend, in part, on the rate of our future expenditures, the extent to which we experience
long-term success of our commercial products and our ability to obtain funding through revenue from commercial
sales, equity or debt financings, sales of assets, collaborations or grants.
As part of our capital allocation strategy, we expect to continue to incur significant and increasing operating
expenses for the foreseeable future. We anticipate that our expenses will increase substantially if and as we and
our collaborators:
•
continue, expand, or modify the research or development of our programs in preclinical development;
•
continue, expand, or modify the scope of our clinical trials for our product candidates;
•
initiate additional preclinical, clinical, or other trials for our product candidates, including under our
collaboration agreements;
•
execute on our strategic decisions related to portfolio prioritization, which may result in certain potential
one-time effects and charges and other material adverse effects on our financial condition and results of
operations;
•
continue to invest in our immunotherapy platforms to conduct research to identify novel technologies;
•
change our manufacturing capacity or capability;
•
change or add additional suppliers;
•
make changes to our infrastructure in connection with our quality control, quality assurance, legal,
compliance and other groups to support our operations as a public company and our product
development and commercialization efforts, including changes to our sites globally;
•
attract and retain skilled personnel;
•
seek marketing approvals and reimbursement for our product candidates;
•
develop our sales, marketing, and distribution infrastructure for our COVID-19 vaccine and any other
products for which we may obtain marketing approval or emergency use authorization;
•
seek to identify and validate additional product candidates;
•
acquire or in-license other product candidates and technologies;
•
acquire other companies;
•
make milestone or other payments under any in-license agreements;
•
maintain, protect, defend, enforce and expand our intellectual property portfolio; and
•
experience any delays or encounter issues with any of the above.
25
Annual Report on Form 20-F for the
year ended December 31, 2024
The amount of, and our ability to use, net operating losses and research and development credits to
offset future taxable income may be subject to certain limitations and uncertainty. In addition, pending
and future tax audits within our Group, disputes with tax authorities and changes in tax law or fiscal
regulations could lead to additional tax liabilities. We are subject to routine tax audits by the respective
local tax authorities. Any additional tax liability could have an adverse effect on our business, financial
conditions, results of operations or prospects.
In Germany, we have unused German tax loss carryforwards for corporate taxes for German group entities with
pre tax group losses, though we generally have not recognized deferred tax assets related to such loss
carryforwards for International Financial Reporting Standards, or IFRS, reporting purposes as of
December 31,
2024
. Deferred tax assets are recognized for unused tax losses only to the extent that it is probable that taxable
profit will be available against which the losses can be utilized. In general, net operating loss, or NOL,
carryforwards in Germany do not expire. Furthermore, under current German tax laws, certain substantial
changes in the Company’s ownership and business may further limit the amount of NOL carryforwards that can
be used annually to offset future taxable income.
For the German tax group, we incurred tax losses up to and including December 31, 2020
. Even though we
recognized deferred tax assets on a majority of German tax loss carry forwards in 2020 which were fully utilized
in 2021, they are, however, subject to review and possible adjustment by the German tax authorities. In addition,
the incurred tax losses up to and including December 31, 2024 also remain subject to review.
In addition, we have U.S. federal and state NOL carryforwards due to our subsidiaries in the United States,
which may be subject to limitations on use after an ownership change.
We may not be able to utilize a material portion of our historic or current NOLs or credits in either Germany
(resulting from our German tax group or non-tax group entities in Germany) or the United States until these have
been finally assessed by the tax authorities or when the limitation period has passed. In addition, the rules
regarding the timing of revenue and expense recognition for tax purposes in connection with various transactions
are complex and uncertain in many respects, and, if challenged, our recognition may be subject to a revised
assessment. In the event any such challenge is sustained, our NOLs could be materially reduced or we could be
determined to be a material cash taxpayer for one or more years, which could have an adverse effect on our
business, financial conditions, results of operations or prospects.
Furthermore, our ability to use our NOLs or credits is conditioned upon our attaining profitability and generating
taxable income. Taxable income exceeding NOLs will be subject to taxation resulting tax liabilities. As described
above, we incurred significant net losses in every year since our inception other than 2018, 2021, 2022 and 2023
and anticipate that in the future,
we may incur losses for the majority of the group entities.
Our ability to utilize
our NOL or credit carryforwards in the United States and for some other group entities is uncertain, however we
do recognize deferred tax assets on NOLs and tax credit carryforwards in the United States, as the requirements
of IAS 12 are fulfilled.
Under German tax laws, we are obligated to withhold a percentage of wage tax and social security
contributions on personnel expenses if contract services providers are considered to be our internal
employees and remit those withholdings to German tax authorities and social security institutions. Late
payments may subject us to penalties and fees.
Under German tax and social security laws, we are obligated to withhold a percentage of payments we make to
third parties in consideration of the services provided, in case these are considered employment payments, and
remit those withholdings to German tax authorities and social security institutions. After a significant volume of
service providers were engaged to assist with research, development, manufacturing and supply of our
COVID-19 vaccine, we discovered after internal review that we and certain of our subsidiaries did not withhold,
report and remit certain German wage taxes and social security contributions in connection with certain contract
service providers engaged in a manner comparable to internal employees, which we notified tax authorities
about. If we do not properly and timely make required payments in the future, we could be subjected to fees,
administrative offenses or other proceedings or penalties.
26
Annual Report on Form 20-F for the
year ended December 31, 2024
It is not possible to seek the refund of these wage taxes or social security contributions from either the German
tax authorities or social security institutions after filing returns. In Germany, employers are considered
secondarily liable for wage taxes.
In addition, value added taxes, or VAT, on invoices received by contract services providers who are considered
internal employees are considered non-deductible and must be repaid to the German tax authorities. It is
possible to reclaim the VAT repaid to the German tax authorities from the service provider. There is a possibility
that the relevant input VAT claims against the contract service providers may, in some instances, not be
enforceable as a result of a contract service provider no longer existing, the lapse of time or any other facts
preventing the enforcement of such claims.
We may require substantial additional financing to achieve our goals, and a failure to obtain this capital
on acceptable terms, or at all, could force us to delay, limit, reduce or terminate our product
development programs, commercialization efforts or other operations.
Our operating plans may change as a result of many factors currently unknown to us, and we may need to seek
additional funds sooner than planned, through public or private equity or debt financings, government or other
third-party funding, sales of assets, marketing and distribution arrangements, other collaborations and licensing
arrangements, or a combination of these approaches. We may require additional capital to obtain regulatory
approval for, and to commercialize, future product candidates. Even if we believe we have sufficient funds for our
current or future operating plans, we may seek additional capital if market conditions are favorable or if we have
specific strategic considerations. Our spending will vary based on new and ongoing development and corporate
activities. Due to the high uncertainty of the length of time and activities associated with discovery and
development of our product candidates, we are unable to estimate the actual funds we will require for
development, marketing and commercialization activities.
Our future funding requirements, both near and long term, will depend on many factors, including, but not limited
to:
•
the initiation, progress, timing, costs, and results of preclinical or nonclinical studies and clinical trials for
our product candidates;
•
the amount and timing of revenues and associated costs from sales of our COVID-19 vaccine;
•
the results of research and our other platform activities;
•
the clinical development plans we establish for our product candidates;
•
the terms of any agreements with our current or future collaborators, and the achievement of any
milestone payments under such agreements to be paid to us or our collaborators;
•
the terms of any other strategic transactions, including relating to any acquisitions, into which we enter;
•
the number and characteristics of product candidates that we develop or may in-license;
•
the outcome, timing and cost of meeting regulatory requirements established by the FDA, the EMA and
other comparable regulatory authorities;
•
the cost of filing, prosecuting, obtaining, maintaining, protecting, defending and enforcing our patent
claims and other intellectual property rights, including actions for patent and other intellectual property
infringement, misappropriation and other violations brought by third parties against us regarding our
products or product candidates or actions by us challenging the patent or intellectual property rights of
others;
•
the effect of competing technological and market developments, including other products that may
compete with one or more of our product candidates;
27
Annual Report on Form 20-F for the
year ended December 31, 2024
•
the cost and timing of completion and further expansion of clinical and commercial scale manufacturing
activities sufficient to support all of our current and future programs, including the development of
modular production and clinical facilities in various markets via our BioNTainer network; and
•
the cost of establishing sales, marketing, and distribution capabilities for any product candidates for
which we may receive marketing approval and reimbursement in regions where we choose to
commercialize our products on our own.
To date, we have financed our operations primarily through the sale of equity securities, revenue from
collaborations, and revenue from sales of our COVID-19 vaccine. While we are currently generating product
sales and royalty revenue to finance our operations, we cannot be certain that we will continue to generate
sufficient revenue from product sales and royalties to finance our operations. If we were to seek financing from
outside sources, that additional funding may not be available on favorable terms, or at all. Should our revenues
from product sales sufficiently decrease in the future, we expect to finance our future cash needs through a
combination of product sales, public or private equity offerings, debt financings, collaborations, licensing
arrangements, and other marketing or distribution arrangements. Any fundraising efforts may divert our
management from their day-to-day activities, which may adversely affect our ability to develop and
commercialize our product candidates. In addition, we cannot guarantee that future financing will be available in
sufficient amounts, at the right time, on favorable terms, or at all, including as a result of the impact that the shift
of COVID-19 towards an endemic phase and other global events, such as political upheavals and economic
downturns, may have on the capital markets.
Negative clinical trial data or setbacks, or perceived setbacks, in our programs or with respect to our technology
could impair our ability to raise additional financing on favorable terms, or at all. Moreover, the terms of any
financing may adversely affect the holdings or the rights of our shareholders, and the issuance of additional
securities, whether equity or debt, by us, or the possibility of such issuance, may cause the market price of the
ADSs representing our ordinary shares to decline. If we raise additional funds through public or private equity
offerings, the terms of these securities may include liquidation or other preferences that may adversely affect our
shareholders’ rights.
Further, to the extent that we raise additional capital through the sale of ADSs, ordinary shares or securities
convertible or exchangeable into ordinary shares or ADSs, share ownership interests will be diluted. If we raise
additional capital through debt financing, we would be subject to fixed payment obligations and may be subject
to security interests in our assets and covenants limiting or restricting our ability to take specific actions, such as
incurring additional debt, making capital expenditures or declaring dividends. If we raise additional capital
through marketing and distribution arrangements, sales of assets, collaborations, or licensing arrangements with
third parties, we may have to relinquish certain valuable rights to our product candidates, technologies, future
revenue streams or research programs. We also could be required to seek collaborators for one or more of our
current or future product candidates at an earlier stage than otherwise would be desirable or relinquish our rights
to product candidates or intellectual property that we otherwise would seek to develop or commercialize
ourselves. If we are unable to raise additional capital in sufficient amounts, at the right time, on favorable terms,
or at all, we may have to significantly delay, scale back or discontinue the development or commercialization of
one or more of our products or product candidates, or one or more of our other research and development
initiatives. Any of the above events could significantly harm our business, prospects, financial condition and
results of operations, cause the price of the ADSs to decline, and negatively impact our ability to fund operations.
We may encounter difficulties in developing and expanding our company and managing such
development and expansion, which could disrupt our operations.
To manage our anticipated development and expansion, we must continue to implement and improve our
managerial, operational, legal, compliance and financial systems, expand our facilities, and continue to recruit
and train additional qualified personnel. This includes our acquisition in January 2025 of Biotheus, Inc., or
Biotheus, a clinical-stage biotechnology company, as part of our oncology strategy, and our strategic initiatives
more generally. In addition, our management may need to divert a disproportionate amount of its attention away
from its day-to-day activities and devote a substantial amount of time to managing these development activities.
28
Annual Report on Form 20-F for the
year ended December 31, 2024
As an evolving biotechnology company, we are actively pursuing drug classes, platforms and product candidates
in many therapeutic areas and across a wide range of diseases. Successfully developing products for, and fully
understanding the regulatory and manufacturing pathways to, all of these therapeutic areas and disease states
requires a significant depth of talent, resources and corporate processes in order to allow simultaneous
execution across multiple areas. Due to our limited resources, we may not be able to effectively manage this
simultaneous execution and the expansion of certain operations or recruit and train additional qualified
personnel. This may result in weaknesses in our infrastructure and/or give rise to operational mistakes, legal or
regulatory compliance failures, loss of business opportunities, loss of employees and reduced productivity
among remaining employees. The physical expansion of our operations may lead to significant costs and may
divert financial resources from other projects, such as the development of our product candidates. If our
management is unable to effectively manage our expected development, our expenses may increase more than
expected, our ability to generate or increase our revenue could be reduced and we may not be able to effectively
implement our business strategy. Our future financial performance and our ability to compete effectively and
commercialize our COVID-19 vaccine and our product candidates, if approved, will depend in part on our ability
to effectively manage the current and future development of our company.
We incur significant costs as a result of operating as a public company, and our management is required
to devote substantial time to compliance initiatives. We are subject to financial reporting and other
requirements for which our accounting and other management systems and resources may not be
adequately prepared. We may fail to comply with the rules that apply to public companies, including
Section 404 of the Sarbanes-Oxley Act of 2002, which could result in sanctions or other penalties that
would harm the business.
As a public company, we incur significant legal, accounting and other expenses. The U.S. federal securities laws,
including the Sarbanes-Oxley Act of 2002, or the Sarbanes-Oxley Act, and rules subsequently implemented by
the SEC and the Nasdaq Stock Market LLC, or Nasdaq, have imposed various requirements on public
companies, including requirements to file annual and event-driven reports with respect to our business and
financial condition, and to establish and maintain effective disclosure and financial controls and corporate
governance practices. Our management and other personnel need to devote a substantial amount of time to
these compliance initiatives. Moreover, these rules and regulations result in substantial legal and financial
compliance costs and have made some activities time-consuming and costly. We may not be able to produce
reliable financial statements or file these financial statements as part of a periodic report in a timely manner with
the SEC or comply with Nasdaq listing requirements. In addition, we could make errors in our financial
statements that could require us to restate our financial statements.
Pursuant to Section 404 of the Sarbanes-Oxley Act, or Section 404, we are required to furnish a report by our
management on our internal control over financial reporting, including the attestation report on internal control
over financial reporting issued by our independent registered public accounting firm. To maintain compliance with
Section 404, we document and evaluate our internal control over financial reporting, which is both costly and
challenging. In this regard, we have needed to continue to dedicate internal resources, have engaged outside
consultants, and have adopted a detailed work plan to assess and document the adequacy of internal control
over financial reporting. We will continue to implement steps to improve control processes as appropriate,
validate through testing that controls are functioning as documented, and implement a continuous reporting and
improvement process for internal control over financial reporting. Despite our efforts, there is a risk that in the
future neither we nor our independent registered public accounting firm will be able to conclude within the
prescribed timeframe that our internal control over financial reporting is effective as required by Section 404. This
could result in an adverse reaction in the financial markets due to a loss of confidence in the reliability of our
financial statements.
Shareholder activism, the current political environment, and the current high level of government intervention
and regulatory reform may lead to substantial new regulations and disclosure obligations, which may lead to
additional compliance costs and impact the manner in which we operate our business in ways we cannot
currently anticipate. Our management and other personnel need to devote a substantial amount of time to these
compliance initiatives.
29
Annual Report on Form 20-F for the
year ended December 31, 2024
If we identify material weaknesses in our internal control over financial reporting and fail to remediate
such material weaknesses, we may not be able to report our financial results accurately or to prevent
fraud.
Our management is responsible for establishing and maintaining internal control over financial reporting,
disclosure controls, and compliance with the other requirements of the Sarbanes-Oxley Act and the rules
promulgated by the SEC thereunder. Internal control over financial reporting is a process designed to provide
reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements in
accordance with international financial reporting standards. A material weakness is defined as a deficiency, or a
combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility
that a material misstatement of a company’s annual or interim financial statements will not be prevented or
detected by the company’s internal controls on a timely basis
.
If we fail to comply with the relevant rules and regulations or otherwise fail to prepare our financial statements in
accordance with international financial reporting standards, a material weakness may arise. If we are unable to
successfully remediate any material weaknesses, our financial statements could contain material misstatements
discovered in the future that could cause us to fail to meet our future reporting obligations and cause the price of
the ADSs to decline.
We have various international trade obligations, including customs value calculation, customs tariff
number classification and other related securities requirements. Late payments to customs authorities
may subject us to penalties and fees.
Our supply chain, production and distribution network across the globe creates an increasing level of complexity
in customs and foreign trade processes. The requirements for internal control systems are increasing and must
be developed simultaneously. The risk management system for customs and foreign trade, which we are
continuously improving, determines which stakeholders, goods, and means of transport should be examined and
to what extent. These risks include the potential for non-compliance with customs value calculation, customs
tariff number classification, trade restrictions, security regulations as well as the potential failure to facilitate
international trade. We have in the past discovered that certain of our and our subsidiaries’ customs value
calculations were not applied correctly, following which we notified the customs authorities of potential late
payments.
We are, and will likely continue to be, subject to various audits that arise from time to time, including customs
and potential future foreign trade audits. If we do not properly address our international trade and customs
requirements, we could be subjected to penalties and fees.
As a “foreign private issuer,” we are exempt from a number of rules under the U.S. securities laws, as
well as Nasdaq rules, and we are permitted to file less information with the SEC than U.S. companies.
This may limit the information available to holders of the ADSs and may make our ordinary shares and
the ADSs less attractive to investors.
We are a “foreign private issuer,” as defined in the rules and regulations of the SEC, and, consequently, we are
not subject to all of the disclosure requirements applicable to companies organized within the United States. For
example, we are exempt from certain rules under the U.S. Securities Exchange Act of 1934, as amended, or the
Exchange Act, that regulate disclosure obligations and procedural requirements related to the solicitation of
proxies, consents or authorizations applicable to a security registered under the Exchange Act. In addition, our
officers and directors are exempt from the reporting and “short-swing” profit recovery provisions of Section 16 of
the Exchange Act and related rules with respect to their purchases and sales of our securities. Moreover, we are
not required to file periodic reports and financial statements with the SEC as frequently or as promptly as U.S.
public companies. Accordingly, there may be less publicly available information concerning our company than
there is for U.S. public companies.
As a foreign private issuer, we file an Annual Report on Form 20-F within four months of the close of each
financial year ending December 31 and reports on Form 6-K relating to certain material events promptly after we
publicly announce these events. Additionally, we rely on a provision in Nasdaq’s Listed Company Manual that
allows us to follow German company law and European law applicable to European stock corporations in
30
Annual Report on Form 20-F for the
year ended December 31, 2024
general, the German Stock Corporation Act (Aktiengesetz), the Council Regulation (EC) No 2157/2001 of
October 8, 2001 on the Statute for a European company (SE), or the SE Regulation, and the German Act on the
Implementation of Council Regulation (EC) No 2157/2001 of October 8, 2001 on the Statute for a European
company (SE) (Gesetz zur Ausführung der Verordnung (EG) NR. 2157/2001 des Rates vom 8. Oktober 2001
über das Statut der Europäischen Gesellschaft (SE)) (SE-Ausführungsgesetz-SEAG), in particular with regard to
certain aspects of corporate governance. This allows us to follow certain corporate governance practices that
differ in significant respects from the corporate governance requirements applicable to U.S. companies listed on
Nasdaq.
For example, we are exempt from regulations of Nasdaq that require a listed U.S. company to:
•
have a majority of the board of directors consist of independent directors;
•
require non-management directors to meet on a regular basis without management present;
•
adopt a code of conduct and promptly disclose any waivers of the code for directors or executive officers
that should address certain specified items;
•
have an independent compensation committee;
•
have an independent nominating committee;
•
solicit proxies and provide proxy statements for all shareholder meetings;
•
review related party transactions; and
•
seek shareholder approval for the implementation of certain equity compensation plans and issuances of
ordinary shares.
As a foreign private issuer, we are permitted to follow home country practice in lieu of the above requirements.
We therefore continue to follow German corporate governance practices in lieu of the corporate governance
requirements of Nasdaq in certain respects. In particular, we follow German corporate governance practices in
connection with the distribution of annual and interim reports to shareholders, the application of our code of
conduct to our employees and the Supervisory Board, executive remuneration disclosure, proxy solicitation in
connection with shareholders’ meetings, and obtaining shareholder approval in connection with the
establishment of, or material amendment to, certain equity-based compensation plans.
Our audit committee is required to comply with the provisions of Section 301 of the Sarbanes-Oxley Act and Rule
10A-3 of the Exchange Act, both of which are also applicable to U.S. companies listed on Nasdaq. As we are a
foreign private issuer, however, our audit committee is not subject to additional requirements of Nasdaq
applicable to listed U.S. companies, including an affirmative determination that all members of the audit
committee are “independent,” using more stringent criteria than those applicable to us as a foreign private issuer.
Due to the above exemptions for foreign private issuers, our shareholders will not be afforded the same
protections or information generally available to investors holding shares in public companies organized in the
United States, some investors may find the ADSs less attractive as a result, and there may be a less active
trading market for the ADSs.
We face risks related to catastrophic global events including natural disasters, political crises, or public
health epidemics and pandemics and other public health developments, that could adversely affect our
operations.
Our business could be adversely impacted by the effects of catastrophic global events, including natural
disasters such as an earthquake, fire, hurricane, tornado, flood or significant power outage; public health crises
such as the COVID-19 pandemic; political crises, such as terrorist attacks, war and other political instability,
31
Annual Report on Form 20-F for the
year ended December 31, 2024
including the ongoing geopolitical conflicts in eastern Africa, the Middle East and Ukraine, and resulting
sanctions imposed and retaliatory actions taken in response to such sanctions; or other catastrophic events.
F
or example, prolonged or expanded conflicts, and political responses to global actions, could destabilize oil and
gas supply and demand patterns, increase energy volatility and have severe adverse effects on regional and
global supply chains and economies and our business. Our commercial production of our COVID-19 vaccine is
currently run on natural gas, although we believe our production could be powered by alternative fuel sources if
needed.
We also continue to evaluate the impacts that energy shortages may have on our partners, suppliers
and service providers. Were any of these parties to experience significant impacts from this or any other energy
shortage, our business could be materially harmed. We cannot predict with certainty the impact that volatility in
energy prices could have on our or their operations, including on the manufacturing of our COVID-19 vaccine
and the manufacturing and testing of our product candidates.
Although we have generated revenues from sales of our COVID-19 vaccine, there remains uncertainty regarding
other potential effects of COVID-19 on our business. For example, if a new variant of COVID-19 emerges for
which existing vaccines, including our COVID-19 vaccine, are ineffective, infections may become even more
widespread, negatively impact our ability to enroll patients in clinical studies and complete clinical trials on the
timelines we currently anticipate, or result in an economic downturn that could affect demand for our products
and services or our ability to raise capital, which could have a material adverse effect on our business, operating
results and financial condition. Our suppliers, licensors or collaborators could also be disrupted by conditions
related to COVID-19 or other pandemics and epidemics, possibly resulting in disruption to our supply chain,
clinical trials, partnerships or operations.
Our insurance policies are expensive and protect us only from some business risks, which leaves us
exposed to significant uninsured liabilities.
We do not carry insurance for all categories of risk that our business may encounter and insurance coverage is
becoming increasingly expensive. We do not know if we will be able to maintain existing insurance with
adequate levels of coverage, and any liability insurance coverage we acquire in the future may not be sufficient
to reimburse us for any expenses or losses we may suffer. We currently maintain insurance coverage for losses
relating to property damage, business interruption, transportation, product liability, cyber matters, clinical trials,
and several other areas of coverage. For example, attracting and retaining qualified individuals to serve on our
Supervisory Board and our Management Board requires that we obtain and maintain adequate director and
officer liability insurance, which has increased in cost as our operations have evolved. We are dedicating
resources to exploring additional avenues for more adequate coverage as our business evolves. However, the
coverage or coverage limits of our insurance policies may not be adequate. If our losses exceed our insurance
coverage, our financial condition would be adversely affected. In the event of contamination or injury, we could
be held liable for damages or be penalized with fines in an amount exceeding our resources. Clinical trials or
regulatory approvals for any of our product candidates could be suspended, which could adversely affect our
results of operations and business, including by preventing or limiting the development and commercialization of
any product candidates that we or our collaborators may develop.
Additionally, operating as a public company has made it more expensive for us to obtain director and officer
liability insurance. As a result, it may be more difficult for us to attract and retain qualified individuals to serve on
our Supervisory Board, our Management Board, or our board committees.
Adverse developments affecting financial institutions, companies in the financial services industry or
the financial services industry generally, such as actual events or concerns involving liquidity, defaults
or non-performance, could adversely affect our operations and liquidity.
Actual events involving limited liquidity, defaults, non-performance or other adverse developments that affect
financial institutions or other companies in the financial services industry or the financial services industry
generally, or concerns or rumors about any events of these kinds, have in the past and may in the future lead to
market-wide liquidity problems.
There is no guarantee that the U.S. Department of Treasury, the Federal Deposit Insurance Corporation, and
Federal Reserve Board will provide access to uninsured funds in a timely fashion, or at all, in the event of the
closure of banks or financial institutions.
32
Annual Report on Form 20-F for the
year ended December 31, 2024
While we maintain our cash and cash equivalents in multiple financial institutions worldwide, our access to our
cash and cash equivalents in amounts adequate to finance our operations could be significantly impaired by the
financial institutions with which we have arrangements directly facing liquidity constraints or failures. In addition,
investor concerns regarding the U.S. or international financial systems could result in less favorable commercial
financing terms, including higher interest rates or costs and tighter financial and operating covenants, or
systemic limitations on access to credit and liquidity sources, thereby making it more difficult for us to acquire
financing on acceptable terms or at all. Any material decline in available funding or our ability to access our cash
and cash equivalents could adversely impact our ability to meet our operating expenses, result in breaches of
our contractual obligations or result in violations of federal or state wage and hour laws, any of which could have
material adverse impacts on our operations and liquidity.
Risks Related to our Business
Our business is dependent on the successful development, regulatory approval and commercialization
of product candidates based on our technology platforms. If we and our collaborators are unable to
obtain approval for and effectively commercialize our product candidates for the treatment of patients in
their intended indications, our business would be significantly harmed.
Even if we complete the necessary preclinical studies and clinical trials, the marketing approval process is
expensive, time-consuming and uncertain, and we may not be able to obtain approvals for the commercialization
of product candidates we may develop. Any product candidates we may develop and the activities associated
with their development and commercialization, including design, testing, manufacture, recordkeeping, labeling,
storage, approval, advertising, promotion, sale and distribution, are subject to comprehensive regulation by the
FDA and by comparable global health authorities. To obtain the
requisite regulatory approvals required to
commercialize
any of our product candidates, we and our collaborators must demonstrate through extensive
preclinical studies and clinical trials that our
product candidates
are safe and effective for their intended use in
the relevant
target population.
Successful completion of clinical trials is a prerequisite to submitting a biologics
license application, or BLA, or a new drug application, or NDA, to the FDA, a Marketing Authorization
Application, or MAA, to the EMA, and similar marketing applications to comparable global regulatory authorities,
for each product candidate and, consequently, the ultimate approval and commercial marketing of any product
candidates.
Failure to obtain marketing approval for a product candidate will prevent us from commercializing the product
candidate in a given jurisdiction. Although our COVID-19 vaccine has received emergency use authorization
and/or regulatory approvals in certain countries, it is possible that none of our other product candidates, or any
product candidates we may seek to develop in the future, will ever obtain regulatory approval. We have limited
experience in filing and supporting the applications necessary to gain marketing approvals and may need to rely
on third-party contract research organizations, or CROs, regulatory consultants or collaborators to assist us in
this process. We expect to submit initial BLAs/MAAs for our mRNA-based product candidates in the United
States, the European Union and in other countries globally. In some of these jurisdictions, mRNA-based
medicinal products may be classified in different ways and may be subject to specific requirements. Securing
regulatory approval requires the submission of extensive quality, preclinical and clinical data and supporting
information to the various regulatory authorities for each therapeutic indication to establish the product
candidate’s safety and efficacy. Securing regulatory approval also requires the submission of information about
the product manufacturing process to, and inspection of manufacturing facilities by, the relevant regulatory
authority. Benefit and risk are regularly assessed, and any product candidates we develop may not be effective,
may be only moderately effective, or may prove to have undesirable or unintended side effects, toxicities or other
characteristics that may preclude our obtaining marketing approval or prevent or limit commercial use.
The process of obtaining marketing approvals in the United States, the European Union and elsewhere is
expensive, may take many years if additional clinical trials are required, if approval is obtained at all, and can
vary substantially based upon a variety of factors, including the type, complexity and novelty of the product
candidates involved. Changes in marketing approval policies and standards of care during the development
period, changes in or the enactment of additional statutes or regulations, or changes in regulatory review for
each submitted product application may cause delays in the approval or rejection of an application. The FDA,
EMA and comparable regulatory authorities in other countries have substantial discretion in the approval process
and may refuse to accept any application or may decide that the data are insufficient for approval and require
33
Annual Report on Form 20-F for the
year ended December 31, 2024
additional preclinical, clinical or other trials. In addition, varying interpretations of the data obtained from
preclinical and clinical testing could delay, limit or prevent marketing approval of a product candidate. Any
marketing approval we ultimately obtain may be limited or subject to restrictions or post-approval commitments
that render the approved product not commercially viable. Additional delays or non-approval may result if an FDA
panel of experts, referred to as an Advisory Committee, or other regulatory authority recommends non-approval
or restrictions on approval. In addition, we may experience delays or rejections based upon additional
government regulation from future legislation or administrative action, or changes in regulatory agency policy
during the period of product development, clinical trials, and the review process. Officials appointed by the new
U.S. presidential administration to oversee the agencies involved with approval of drugs and biologics may seek
to change regulatory requirements for approval or the approach to reviewing applications. Together with changes
of regulatory policy priorities and allocated resources, this could cause further delays, expense or non-approvals.
Regulatory agencies also may approve a product candidate for fewer or more limited indications or patient
populations than requested or may grant approval subject to the conduct of post-marketing studies. In addition,
regulatory agencies may not approve the labeling claims that are necessary or desirable for the successful
commercialization of our product candidates.
The FDA, EMA and other regulatory agencies review the Quality or Chemistry, Manufacturing and Controls, or
CMC, section of regulatory filings. Any aspects found unsatisfactory by regulatory agencies may result in delays
in clinical trials and commercialization. In addition, the regulatory agencies typically conduct pre-approval
inspections at the time of a BLA, MAA or comparable filing. Any findings by regulatory agencies and failure to
comply with requirements may lead to delay in approval and failure to commercialize the potential mRNA product
candidate.
If we experience delays in obtaining, or if we fail to obtain, approval of any product candidates we may develop,
the commercial prospects for those product candidates will be harmed, and our ability to generate revenues will
be materially impaired. Additionally, even if we are successful in obtaining marketing approval for product
candidates, because our preclinical studies and clinical trials have not been designed with specific
commercialization considerations, the commercial prospects for those product candidates could be harmed, and
our ability to generate revenues could be materially impaired.
mRNA drug development carries substantial clinical development and regulatory risks due to limited
regulatory experience with mRNA immunotherapies.
To our knowledge, other than our and Moderna, Inc.’s COVID-19 vaccines, no mRNA immunotherapies have
been approved or received emergency use authorization or conditional marketing authorization to date by the
FDA or the EMA. Successful discovery and development of mRNA-based (and other) immunotherapies by either
us or our collaborators is highly uncertain and depends on numerous factors, many of which are beyond our or
their control. Our product candidates that appear promising in the early phases of development may fail to
advance, experience delays in the clinic or clinical holds, or fail to reach the market for many reasons, including:
•
discovery efforts aimed at identifying potential immunotherapies may not be successful;
•
nonclinical or preclinical study results may show product candidates to be less effective than desired or
have harmful or problematic side effects;
•
clinical trial results may show the product candidates to be less effective than expected, including a
failure to meet one or more endpoints or have unacceptable side effects or toxicities;
•
manufacturing or distribution failures or insufficient supply of GMP materials for clinical trials or higher
than expected cost could delay or set back clinical trials, or make our product candidates commercially
unattractive;
•
our improvements in the manufacturing processes may not be sufficient to satisfy the clinical or
commercial demand of our product candidates or regulatory requirements for clinical trials;
34
Annual Report on Form 20-F for the
year ended December 31, 2024
•
changes that we make to optimize our manufacturing, testing or formulating of GMP materials could
impact the safety, tolerability and efficacy of our product candidates;
•
pricing or reimbursement issues or other factors could delay clinical trials or make any immunotherapy
uneconomical or noncompetitive with other therapies;
•
changing social and political preferences regarding vaccines and mRNA therapies;
•
the failure to timely advance our programs or receive the necessary regulatory approvals, or a delay in
receiving such approvals, due to, among other reasons, slow or failure to complete enrollment in clinical
trials, withdrawal by trial participants from trials, failure to achieve trial endpoints, additional time
requirements for data analysis, data integrity issues, BLA, MAA or the equivalent application,
discussions with the FDA or the EMA, a regulatory request for additional nonclinical or clinical data, or
safety formulation or manufacturing issues may lead to our inability to obtain sufficient funding; and
•
the proprietary rights, products and technologies of our competitors may prevent our immunotherapies
from being commercialized.
For administrative purposes, some
mRNA-based medicinal products may be classified together with gene
therapy products by the FDA or other regulatory agencies
. Unlike certain gene therapies that irreversibly alter
cell DNA
and
may be subsequently subject to specific safety concerns
, most
mRNA
products are not designed to
localize to the cell nucleus or interact with the genome. Side effects observed in other gene therapies, however,
could negatively impact the perception of immunotherapies despite the differences in mechanism. In addition,
unclear or inconsistent regulatory classification of mRNA products may result in
uncertainties regarding the
regulatory requirements and pathways for marketing approval.
On the other hand, mRNA-based vaccines for the
prevention of infectious diseases, like our COVID-19 vaccine,
are not currently classified as gene therapies in
most regions
. The regulatory pathway for an individualized therapy, such as our Individualized Neoantigen
Specific Immunotherapy, or iNeST, an mRNA-based immunotherapy where each patient receives a different
combination of mRNAs, remains undetermined. The number and design of the clinical and preclinical studies
required for the approval of these types of medicines have not been established, may be different from those
required for advanced medicinal therapy products or therapies that are not individualized or may require safety
testing like gene therapy products. Moreover, the length of time necessary to complete clinical trials and submit
an application for marketing approval by a regulatory authority varies significantly from one pharmaceutical
product to the next and may be difficult to predict.
Our product candidates may not work as intended, may cause undesirable effects or may have other
properties that could delay or prevent their regulatory approval, limit the commercial profile of an
approved label, or result in significant negative consequences following marketing approval, if any.
As with most medicinal products, use of our product candidates could be associated with undesirable effects or
adverse events which can vary in severity from minor reactions to death and in frequency from infrequent to
prevalent. The potential for adverse events is especially acute in the oncology setting, where patients may have
advanced disease, have impaired organ function, compromised immune and other systems and may be
receiving numerous other therapies. Undesirable side effects or unacceptable toxicities caused by our product
candidates could cause us or regulatory authorities to interrupt, delay or halt clinical trials and could result in a
more restrictive label or the delay or denial of regulatory approval by the FDA, the EMA or comparable regulatory
authorities. Results of our trials could reveal a high and unacceptable severity and prevalence of side effects.
If unacceptable side effects arise in the development of our product candidates, we, the FDA, competent
authorities of EU member states, ethics committees, the institutional review boards, or IRBs, at the institutions in
which our studies are conducted, or the Data Safety Monitoring Board, or DSMB, could suspend or terminate our
clinical trials. The FDA or comparable regulatory authorities could also order us to cease clinical trials or deny
approval of our product candidates for any or all targeted indications. Treatment-related side effects could also
affect patient recruitment or the ability of enrolled patients to complete any of our clinical trials or result in product
liability claims. In addition, these side effects may not be appropriately recognized or managed by the treating
medical staff. We expect to have to train medical personnel using our product candidates to understand the side
35
Annual Report on Form 20-F for the
year ended December 31, 2024
effect profiles for our clinical trials and upon any commercialization of any of our product candidates. Inadequate
training in recognizing or managing the potential side effects of our product candidates could result in patient
injury or death. Any of these occurrences may harm our business, financial condition and prospects significantly.
Clinical trials are strictly regulated and monitored by regulatory agencies, ethics committees, and
sponsors. Despite this rigorous oversight, unexpected events may occur that could adversely impact
patients’ safety and/or affect our ability to obtain regulatory approvals and, if approved, commercialize
our product candidates.
In our ongoing and planned clinical trials, we have contracted, and are expected to continue to contract, with
academic medical centers and hospitals experienced in the assessment and management of toxicities arising
during clinical trials. Nonetheless, these centers and hospitals may have difficulty observing patients and treating
toxicities, which may be more challenging due to personnel changes, inexperience, shift changes, house staff
coverage or related issues. This could lead to more severe or prolonged toxicities or even patient deaths, which
could result in us or the FDA, the EMA or other comparable regulatory authority delaying, suspending or
terminating one or more of our clinical trials, and which could jeopardize regulatory approval. The centers using
our products, if and when approved, could also have difficulty managing any adverse effects of our products, or
use medicines that do not adequately control such undesirable effects or that have a detrimental impact on the
efficacy of the treatment.
In addition, even if we successfully advance our product candidates into and through clinical trials, such trials will
likely only include a limited number of pa
tients and limited d
uration of exposure to our product candidates. As a
result, we cannot be assured that adverse effects of our product candidates will not be uncovered when a
significantly larger number of patients are exposed to the product candidate. Further, any clinical trials may not
be sufficient to determine the effects and safety consequences of taking our product candidates over a multi-year
period.
If any of our product candidates receives marketing approval and we or others later identify undesirable effects
caused by such products, a number of potentially significant negative consequences could result, including:
•
regulatory authorities may withdraw their approval of the product;
•
we may be required to recall a product or change the way such product is administered to patients;
•
additional restrictions may be imposed on the marketing of the particular product or the manufacturing
processes for the product or any component thereof;
•
regulatory authorities may require the addition of labeling statements, such as a “black box” warning or a
contraindication;
•
we may be required to implement a Risk Evaluation and Mitigation Strategy, or REMS, or create a
Medication Guide outlining the risks of such side effects for distribution to patients;
•
we could be sued and held liable for harm caused to patients;
•
the product may become less competitive; and
•
our reputation may be negatively impacted.
Any of the foregoing events could prevent us from achieving or maintaining market acceptance of the particular
product candidate, if approved, and result in the loss of significant revenues to us, which would materially and
adversely affect our results of operations and business. In addition, if one or more of our product candidates or
our immunotherapy approach generally prove to be unsafe, our technology platforms and pipeline could be
affected, which would have a material and adverse effect on our business, financial condition, results of
operations and prospects.
36
Annual Report on Form 20-F for the
year ended December 31, 2024
Preclinical development is uncertain. Our preclinical programs may experience delays or may never
advance to clinical trials, which would adversely affect our ability to obtain regulatory approvals or
commercialize these programs on a timely basis or at all and would have an adverse effect on our
business.
Much of our pipeline is in preclinical development and these programs could be delayed or not advance into the
clinic. Before we can initiate clinical trials for product candidates, we must complete extensive preclinical studies,
including IND-enabling Good Laboratory Practice toxicology testing, that support our planned Investigational
New Drug applications, or INDs, in the United States or similar applications in other jurisdictions. We must also
complete extensive work on CMC activities (including collecting yield, purity and stability data) to be included in
the IND filing. CMC activities for a new category of medicines such as mRNA therapies require extensive
manufacturing processes and analytical development, which are uncertain and lengthy. For instance, batch
failures have occurred as we scale up our manufacturing and may occur in the future. In addition, we have had
in the past, and may in the future have, difficulty identifying appropriate buffers and storage conditions to enable
sufficient shelf life of batches of our preclinical or clinical product candidates. If we are required to produce new
batches of our product candidates due to insufficient shelf life, it may delay the commencement or completion of
preclinical or clinical trials of such product candidates. For example, we cannot be certain of the timely
completion or outcome of our preclinical testing and studies and cannot predict if the FDA or other regulatory
authorities will accept the results of our preclinical testing or our proposed clinical programs or if the outcome of
our preclinical testing, studies and CMC activities will ultimately support the further development of our
programs. As a result, we cannot be sure that we will be able to submit INDs or similar applications for our
preclinical programs on the timelines we expect, if at all, and we cannot be sure that submission of INDs or
similar applications will result in the FDA or other regulatory authorities allowing clinical trials to begin.
Clinical development involves a lengthy and expensive process with an uncertain outcome, and delays
can occur for a variety of reasons outside of our control. Clinical trials of our product candidates may be
delayed, certain programs may never advance in the clinic or may be more costly to conduct than we
anticipate, and we may have difficulty recruiting patients to participate in clinical trials, any of which can
affect our ability to fund our company and would have a material adverse impact on our business.
Clinical testing is expensive and complex and can take many years to complete. Its outcome is inherently
uncertain. We may not be able to initiate, may experience delays in, or may have to discontinue clinical trials for
our product candidates. We and our collaborators also may experience numerous unforeseen events during, or
as a result of, any clinical trials that we or our collaborators conduct that could delay or prevent us or our
collaborators from successfully developing our product candidates, including:
•
the FDA, other regulators, IRBs or ethics committees may not authorize us or our investigators to
commence a clinical trial or conduct a clinical trial at a prospective trial site for any number of reasons,
including concerns regarding safety and aspects of the clinical trial design;
•
we may experience delays in reaching, or fail to reach, agreement on favorable terms with prospective
trial sites and prospective CROs, the terms of which can be subject to extensive negotiation and may
vary significantly among different CROs and trial sites;
•
we have optimized in the past and may in the future optimize our manufacturing processes, including
through changes to the scale and site of manufacturing, which may lead to additional studies (including
bridging and bioequivalence studies) or potentially significant changes in our clinical trial designs,
requiring additional cost and time, and, as a consequence, lead to a delay in plans for progressing one
or more product candidates;
•
the outcome of our preclinical studies and our early clinical trials may not be predictive of the success of
later clinical trials, and interim results of a clinical trial do not necessarily predict final results;
•
we may be unable to establish clinical endpoints that applicable regulatory authorities would consider
clinically meaningful;
37
Annual Report on Form 20-F for the
year ended December 31, 2024
•
in an effort to optimize product features, we have made in the past and may continue to make changes
to our product candidates after we commence clinical trials of a medicine which may require us to repeat
earlier stages of clinical testing or delay later-stage testing of the medicine;
•
clinical trials of any product candidates may fail to show safety or efficacy, or may produce negative or
inconclusive results, and we may decide, or regulators may require us, to conduct additional nonclinical
studies or clinical trials, or we may decide to abandon product development programs;
•
differences in trial design between early-stage clinical trials and later-stage clinical trials may make it
difficult to extrapolate the results of earlier clinical trials to later clinical trials;
•
preclinical and clinical data are often susceptible to varying interpretations and analyses, and many
product candidates believed to have performed satisfactorily in preclinical studies and clinical trials have
nonetheless failed to obtain marketing approval;
•
our product candidates may have undesirable effects or other unexpected characteristics. One or more
of such effects or events could cause regulators to impose a clinical hold on the applicable trial, or cause
us or our investigators, IRBs or ethics committees to suspend or terminate the trial of that product
candidate or any other of our product candidates for which a clinical trial may be ongoing;
•
the number of trial participants required for clinical trials of any product candidates may be larger than
we anticipate, identification of trial participants for such trials may be limited, enrollment in these clinical
trials may be slower than we anticipate due to perceived adverse effects, limited patient populations,
competitive trials, risks related to COVID-19 or other reasons, or participants may withdraw from clinical
trials or fail to return for post-treatment follow-up at a higher rate than we anticipate;
•
despite robust sponsor oversight, our and our collaborators’ third-party contractors may fail to comply
with regulatory requirements or meet their contractual obligations in a timely manner, or at all, or may
deviate from the clinical trial protocol or withdraw from the trial, which may require the addition of new
clinical trial sites;
•
regulators may elect to impose a clinical hold, or we, our investigators, IRBs or ethics committees may
elect to suspend or terminate clinical research or trials for various reasons, including noncompliance with
regulatory requirements or a finding that the participants are being exposed to an unacceptable benefit-
risk ratio;
•
with respect to infectious disease vaccine trials in particular, we have to wait for particular level of
infection in the placebo arm in order to assess protection provided by vaccine, and we cannot control the
rate of exposure or infection which can make timing uncertain;
•
the cost of preclinical or nonclinical testing and studies and clinical trials of any product candidates may
be greater than we anticipate;
•
the supply or quality of our product candidates or other materials necessary to conduct clinical trials may
be insufficient or inadequate;
•
safety or efficacy concerns regarding our product candidates may result from any concerns arising from
nonclinical or clinical testing of other therapies targeting a similar disease state or other therapies, such
as gene therapy, that are perceived as similar to ours; and
•
the FDA or other regulatory authorities may require us to submit additional data, such as long-term
toxicology studies, or impose other requirements before permitting us to initiate a clinical trial.
We could also encounter delays if a clinical trial is suspended or terminated by us, the FDA or other regulatory
authorities, ethics committees, or the IRBs of the institutions in which such trials are being conducted, or if such
trial is recommended for suspension or termination by the DSMB. We may in the future be delayed in gaining
38
Annual Report on Form 20-F for the
year ended December 31, 2024
clearance from the FDA or other regulators to initiate clinical trials through, among other things, the imposition of
a clinical hold in order to address comments from such regulators on our clinical trial design or other elements of
our clinical trials. A suspension or termination may be imposed due to a number of factors, including failure to
conduct the clinical trial in accordance with regulatory requirements or our clinical protocols; inspection of the
clinical trial operations or trial site by the FDA or other regulatory authorities resulting in the imposition of a
clinical hold; unforeseen safety issues or adverse side effects; failure to demonstrate a benefit, or adequate
benefit-risk ratio, from using a product candidate; failure to establish or achieve clinically meaningful trial
endpoints; changes in governmental regulations or administrative actions; or lack of adequate funding to
continue the clinical trial. Many of the factors that cause or lead to a delay in the commencement or completion
of clinical trials may also ultimately lead to the denial of regulatory approval of our product candidates. We could
also experience delays if physicians encounter unresolved ethical issues associated with enrolling patients in
clinical trials of our product candidates in lieu of prescribing existing treatments that have established safety and
efficacy profiles. We must also complete extensive work on CMC activities that require extensive manufacturing
processes and analytical development, which are uncertain and lengthy.
We expect the novel nature of our product candidates to create further challenges in obtaining regulatory
approval. For example, the FDA and regulatory authorities in other jurisdictions have limited experience with
commercial development of several of our technologies. The FDA may require an Advisory Committee to
deliberate on the adequacy of the safety and efficacy data to support licensure. The opinion of the Advisory
Committee, although not binding, may have a significant impact on our ability to obtain licensure of the product
candidates based on the completed clinical trials, as the FDA often adheres to the Advisory Committee’s
recommendations. Accordingly, the regulatory approval pathway for our product candidates may be uncertain,
complex, expensive and lengthy, and approval may not be certain.
Moreover, the FDA and other regulatory authorities have indicated that, prior to commencing later stage clinical
trials for our mRNA-based product candidates, we will need to scale up and further refine assays to measure
and predict the potency of a given dose of these product candidates. Any delay in the scaling and refining of
assays that are acceptable to the FDA or other regulatory authorities could delay the start of future clinical trials.
Further, the FDA or other regulatory authorities may disagree with our clinical trial design and our interpretation
of data for our clinical trials or may change the requirements for approval even after they have reviewed and
commented on the design for our clinical trials.
Significant additional preclinical or nonclinical testing and studies or clinical trial delays for our product
candidates also could allow our competitors to bring products to market before we do, potentially impairing our
ability to successfully commercialize our product candidates and harming our business and results of operations.
Any delays in the development, or the suspension of development, of our product candidates may harm our
business, financial condition and prospects significantly.
In addition, on June 28, 2024, the Supreme Court overturned the
Chevron
doctrine in the combined cases of
Loper Bright Enterprises v. Raimondo
and
Relentless Inc. v. Department of Commerce
. The
Chevron
doctrine
gave deference to regulatory agencies in litigation against the FDA and other agencies. In addition, the Supreme
Court decided
Corner Post, Inc. v. Board of Governors of the Federal Reserve System
, which lengthened the
time in which some challenges to agency rules can be initiated. As a result of these cases, more plaintiffs may
bring lawsuits against the FDA to challenge longstanding decisions and policies of the FDA, which could
undermine the FDA’s authority, lead to uncertainties in the industry, and disrupt the FDA’s normal operations,
which could delay the FDA’s review of our marketing applications.
If we or our collaborators encounter difficulties enrolling participants in our clinical trials, our clinical
development activities could be delayed or otherwise adversely affected.
We depend on enrollment of participants in our clinical trials for our product candidates. In the past, our
collaborators have found, and we or our collaborators may in the future find, it difficult to enroll trial participants in
our clinical studies, which could delay or prevent clinical studies of our product candidates. Identifying and
qualifying trial participants to participate in clinical studies of our product candidates is critical to our success.
The timing of our clinical studies depends on the speed at which we can recruit trial participants to participate in
testing our product candidates. Delays in enrollment may result in increased costs or may affect the timing or
39
Annual Report on Form 20-F for the
year ended December 31, 2024
outcome of the planned clinical trials, which could prevent completion of these trials and adversely affect our
ability to advance the development of our product candidates. If trial participants are unwilling to participate in
our studies because of negative publicity from adverse events in our trials or other trials of similar products, or
those related to specific a therapeutic area, or for other reasons, including competitive clinical studies for similar
patient populations, the timeline for recruiting trial participants, conducting studies, and obtaining regulatory
approval of potential products may be delayed. These delays could result in increased costs, delays in
advancing our product development, delays in testing the effectiveness of our product, or termination of the
clinical studies altogether.
We may not be able to identify, recruit and enroll a sufficient number of trial participants, or those with required or
desired characteristics to achieve diversity in a study, to complete our clinical trials in a timely manner. Patient
and subject enrollment is affected by factors including:
•
severity of the disease under investigation;
•
complexity and design of the study protocol;
•
size of the patient population;
•
eligibility criteria for the study in question;
•
proximity and availability of clinical study sites for prospective trial participants;
•
availability of competing therapies and clinical trials, including between our own clinical trials;
•
efforts to facilitate timely enrollment in clinical trials;
•
patient referral practices of physicians;
•
ability to monitor trial participants adequately during and after treatment;
•
ability to recruit clinical trial investigators with the appropriate competencies and experience;
•
clinicians’ and trial participants’ perceptions of the potential advantages and side effects of the product
candidate being studied in relation to other available therapies, including any new drugs or treatments
that may be approved for the indications we are investigating;
•
our ability to obtain and maintain participant informed consent;
•
major changes in the approval status of competitor investigational products during the clinical trial
period; and
•
the risk that trial participants enrolled in clinical trials will not complete a clinical trial.
In addition, our clinical trials may compete with other clinical trials for product candidates that are in the same
therapeutic areas as our product candidates, and this competition will reduce the number and types of trial
participants available to us because some trial participants who might have opted to enroll in our trials may
instead opt to enroll in a trial being conducted by a third party. Since the number of qualified clinical investigators
is limited, we expect to conduct some of our clinical trials at the same clinical trial sites that some of our
competitors use, which will reduce the number of trial participants who are available for our clinical trials at such
clinical trial sites. Moreover, because in some cases our product candidates represent a therapeutic novelty in
contrast to more traditional methods for disease treatment and prevention, potential trial participants and their
doctors may be inclined to use conventional therapies or other investigational therapies rather than enroll trial
participants in any future clinical trial involving more novel product candidates. Additionally, if new product
candidates, such as gene editing therapies, show encouraging results, potential trial participants and their
doctors may be inclined to enroll trial participants in clinical trials using those product candidates. If such new
40
Annual Report on Form 20-F for the
year ended December 31, 2024
product candidates show discouraging results or other adverse safety indications, potential trial participants and
their doctors may be less inclined to enroll trial participants in our clinical trials.
In particular, certain conditions for which we plan to evaluate our current product candidates are rare diseases
with limited patient pools from which to draw for clinical trials. The eligibility criteria of our clinical trials will further
limit the pool of available trial participants. Additionally, the process of finding and diagnosing patients may prove
costly. Each of the foregoing risks may continue to be affected by the spread of seasonal viral infections,
including COVID-19, as well as the potential for any new pandemic caused by an as-yet-unknown agent.
We, our collaborators, and other third parties on whom we rely conduct various activities, including
research, clinical trials, manufacturing and, where approved, marketing, in jurisdictions across the
globe. Such activities are subject to a variety of risks which could materially and adversely affect our
business.
Our activities increasingly span different jurisdictions. For example, clinical trials of our product candidates are
currently being conducted in several countries, and we plan to commercialize our product candidates, if
approved, globally. Accordingly, we are subject to additional risks related to operating in multiple countries,
including:
•
differing regulatory requirements in such countries;
•
unexpected changes in tariffs, trade barriers, price and exchange controls and other regulatory
requirements;
•
increased difficulties in managing the logistics and transportation of storing and shipping product
candidates produced in Germany and shipping the product candidate to the patient abroad;
•
import and export requirements and restrictions;
•
restrictions on transfers of information, including certain technologies and personal data;
•
economic weakness, including inflation, or changes to the political climate, public sentiment, and
government policy preferences in certain economies and markets;
•
compliance with tax, employment, immigration and labor laws for employees living or traveling abroad;
•
taxes, including withholding of payroll taxes;
•
currency fluctuations, which could result in increased operating expenses and reduced revenue, and
other obligations incident to doing business in another country;
•
difficulties staffing and managing operations outside of Germany;
•
workforce uncertainty in countries where labor unrest is more common;
•
differing payor reimbursement regimes, governmental payors or patient self-pay systems, and price
controls;
•
potential liability under the U.S. Foreign Corrupt Practices Act of 1977 or comparable regulations in other
jurisdictions;
•
challenges enforcing our contractual and intellectual property rights, especially in those countries that do
not respect and protect intellectual property rights to the same extent as Germany and the United
States;
41
Annual Report on Form 20-F for the
year ended December 31, 2024
•
production shortages resulting from any events affecting raw material supply or manufacturing
capabilities abroad; and
•
business interruptions resulting from geopolitical actions, including war and terrorism, or public health
epidemics or pandemics.
As part of our global operations, we and our collaborators rely on relationships with entities based in various
jurisdictions, including for clinical research and manufacturing activities and other regional operational needs.
Such relationships may involve the use of our or others’ intellectual property. We expect to continue to rely on
such entities, which include locally-based contract manufacturing organizations, or CMOs, and CROs, in the
future. For example, we and our collaborators rely on WuXi Biologics Co., Ltd. and its affiliates for outsourcing
activities related to manufacturing and the supply chain, research and development, certain IP, and
commercialization readiness for certain of our product candidates. Such entities are subject to evolving
local
regulatory requirements, and may also be subject to U.S. and EU legislation,
including the proposed U.S.
BIOSECURE Act
, sanctions, trade restrictions, and/or other regulations. Such requirements could increase the
cost or reduce the supply of material available to us, delay the procurement or supply of such material, or have
an adverse affect on our ability to secure significant commitments from governments to purchase our potential
therapies.
The extent to which the COVID-19 virus continues to impact our operations, including our clinical trial operations,
in its endemic stage will depend on future developments, which are highly uncertain and cannot be predicted
with confidence, including new outbreaks, new information which may emerge concerning the severity of
COVID-19 and the actions to contain COVID-19 or treat its impact, among others. In the future, similar events
could affect our ability to manufacture and commercialize our product candidates.
As noted above, we and our partners have conducted and are expecting in the future to conduct clinical trials for
our product candidates at clinical sites located outside of the United States. Although the FDA may accept data
from clinical trials outside the United States that are not conducted under an IND, acceptance of this data in
support of a marketing application or IND requires the clinical trial to have been conducted in accordance with
GCPs, and that the FDA is able to validate the data from the clinical trial through an onsite inspection if it deems
such inspection necessary. Where data from non-U.S. clinical trials are intended to serve as the sole basis for
marketing approval in the United States, the FDA will not approve the application on the basis of non-U.S. data
alone unless those data are considered applicable to the U.S. patient population and U.S. medical practice, the
clinical trials were performed by clinical investigators of recognized competence, and the data is considered valid
without the need for an onsite inspection by the FDA or, if the FDA considers such an inspection to be necessary,
the FDA is able to validate the data through an onsite inspection or other appropriate means. There can be no
assurance the FDA will accept data from clinical trials conducted outside of the United States in support of a
marketing application. If the FDA does not accept data from our clinical trials of our product candidates, it would
likely result in the need for additional clinical trials, which would be costly and time-consuming and delay or
permanently halt our development of a product candidate.
These and other risks associated with our international operations and our collaborations with our collaborators
may materially adversely affect our ability to attain or maintain profitable operations.
Interim top-line and preliminary data from studies or trials that we announce or publish from time to time
may change as more data become available and are subject to audit and verification procedures that
could result in material changes in the final data.
From time to time, we may publish interim top-line or preliminary data from preclinical studies or clinical trials.
Interim data are subject to the risk that one or more of the outcomes may materially change as more data
become available. We also make assumptions, estimations, calculations and conclusions as part of our analyses
of data, and we may not have received or had the opportunity to fully evaluate all data. As a result, the top-line
results that we report may differ from future results of the same studies, or different conclusions or
considerations may qualify such results, once additional data have been received and fully evaluated.
Preliminary or top-line data also remain subject to audit and verification procedures that may result in the final
data being materially different from the preliminary data we previously published. As a result, interim and
42
Annual Report on Form 20-F for the
year ended December 31, 2024
preliminary data should be viewed with caution until the final data are available. Additionally, interim data from
clinical trials that we may complete are subject to the risk that one or more of the clinical outcomes may
materially change as patient enrollment continues and more patient data become available. Adverse differences
between preliminary or interim data and final data could significantly harm our business prospects.
Further, others, including regulatory agencies, may not accept or agree with our assumptions, estimates,
calculations, conclusions or analyses or may interpret or weigh the importance of data differently, which could
impact the value of the particular program, the approvability or commercialization of the particular product
candidate or product and our company in general. In addition, the information we choose to disclose publicly
regarding a particular study or clinical trial is based on what is typically extensive information, and our
securityholders may not agree with what we determine is the material or otherwise appropriate information to
include in our disclosure. Any information we determine not to disclose may ultimately be deemed significant by
our securityholders or others with respect to future decisions, conclusions, views, activities or otherwise
regarding a particular product candidate or our business. If the top-line data that we report differ from actual
results, or if others, including regulatory authorities, disagree with the conclusions reached, our ability to obtain
approval for, and commercialize, product candidates may be harmed, which could significantly harm our
business prospects.
Results of earlier studies and trials of our product candidates may not be predictive of future trial
results.
Success in preclinical studies and early clinical trials does not ensure that later clinical trials will be successful. A
number of companies in the biotechnology and pharmaceutical industries have suffered significant setbacks in
clinical trials, even after positive results in earlier preclinical studies or clinical trials. These setbacks have been
caused by, among other things, preclinical findings made while clinical trials were underway and safety or
efficacy observations made in clinical trials, including previously unreported adverse events. Notwithstanding any
potential promising results in earlier studies and trials, we cannot be certain that we will not face similar
setbacks. Even if our clinical trials are completed, the results may not be sufficient to obtain regulatory approval
for our product candidates. In addition, the results of our preclinical studies may not be predictive of the results of
outcomes in human clinical trials. For example, our tumor-specific cancer immunotherapy candidates and any
future product candidates may demonstrate different chemical, biological and pharmacological properties in
patients than they do in laboratory studies or may interact with human biological systems in unforeseen or
harmful ways. Product candidates in later stages of clinical trials may fail to show the desired pharmacological
properties or safety and efficacy traits despite having progressed through preclinical studies and initial clinical
trials. Even if we are able to initiate and complete clinical trials, the results may not be sufficient to obtain
regulatory approval for our product candidates.
Our planned clinical trials or those of our collaborators may be less efficacious or may reveal significant
adverse events not seen in our preclinical or nonclinical studies and may result in a safety profile that
could delay or terminate clinical trials, or delay or prevent regulatory approval or market acceptance of
any of our product candidates.
There is typically an extremely high rate of attrition for product candidates across categories of medicines
proceeding through clinical trials.
These product candidates may fail to show the desired safety and efficacy profile in later stages of clinical trials
despite having progressed through nonclinical studies and initial clinical trials. A number of companies in the
biopharmaceutical industry have suffered significant setbacks in later-stage clinical trials due to lack of efficacy
or unacceptable safety profiles, notwithstanding promising results in earlier trials. Most product candidates that
commence clinical trials are never approved as products and there can be no assurance that any of our current
or future clinical trials will ultimately be successful or support further clinical development of any of our product
candidates.
Many of our product candidates are being developed or are intended to be co-administered with other
developmental therapies or approved medicines. For example, autogene cevumeran (BNT122/RO7198457) is
being developed to be co-administered with checkpoint inhibitors. Such combinations may have additional side
effects, which may be difficult to predict in future clinical trials.
43
Annual Report on Form 20-F for the
year ended December 31, 2024
If significant adverse events or other side effects are observed in any of our current or future clinical trials, we
may have difficulty recruiting trial participants to any of our clinical trials, trial participants may withdraw from
trials, or we may be required to abandon the trials or our development efforts of one or more product candidates
altogether. We, the FDA or other regulatory authorities, ethics committees or an IRB may impose a clinical hold
on, or suspend or terminate, clinical trials of a product candidate at any time for various reasons, including a
belief that participants in such trials are being exposed to unacceptable health risks or adverse side effects.
Some potential therapeutics developed in the biotechnology industry that initially showed therapeutic promise in
early-stage trials have later been found to cause side effects that prevented their further development. Even if
the side effects do not preclude the drug from obtaining or maintaining marketing approval, an unfavorable
benefit-risk ratio may inhibit market acceptance of the approved product due to its tolerability versus other
therapies. Any of these developments could materially harm our business, financial condition and prospects.
If we are not successful in discovering, developing and commercializing additional product candidates
beyond our current portfolio, our ability to expand our business and achieve our strategic objectives
would be impaired.
Although a substantial amount of our efforts focus on the clinical trials and potential approval of our existing
product candidates, a key element of our strategy is to discover, develop and potentially commercialize
additional products beyond our current portfolio to treat various conditions and in a variety of therapeutic areas.
We intend to do so by investing in our own drug and target discovery efforts, exploring potential collaborations
for the development of new products, and in-licensing technologies. Identifying new product candidates requires
substantial technical, financial and human resources, whether or not any product candidates are ultimately
identified. Even if we identify product candidates that initially show promise, we may fail to develop and
commercialize such products successfully for many reasons, including the following:
•
the research methodology used may not be successful in identifying potential product candidates;
•
competitors may develop alternatives that render our product candidates obsolete;
•
product candidates we develop may nevertheless be covered by third parties’ patents or other exclusive
rights;
•
a product candidate may, on further study, be shown to have harmful side effects or other characteristics
that indicate it is unlikely to be effective or otherwise does not meet applicable regulatory criteria;
•
we may discontinue the development of a product candidate;
•
a product candidate may not be capable of being produced in commercial quantities at an acceptable
cost, or at all; and
•
an approved product may not be accepted as safe and effective by trial participants, the medical
community or third-party payors.
If we are unsuccessful in identifying and developing additional products, our potential for growth may be
impaired.
Our future success depends on our ability to retain key employees, consultants and advisors and to
attract, retain and motivate qualified senior management and scientific personnel.
Our ability to compete in the highly competitive biotechnology and pharmaceutical industries depends upon our
ability to attract and retain highly qualified managerial, scientific and medical personnel. We are highly
dependent upon members of our management and scientific teams. We may not be able to retain these persons
due to the competitive environment in the biotechnology industry, as well as a current global shortage of these
highly qualified individuals. The loss of any of these persons’ services may adversely impact the achievement of
our research, development, financing and commercialization objectives. We are also aware of physical threats
made against certain of these people. In response to these threats, we have deployed personal protection for
44
Annual Report on Form 20-F for the
year ended December 31, 2024
such employees and increased our security generally. We currently do not have “key person” insurance on any
of our employees.
In addition, we rely on consultants, contractors and advisors, including scientific and clinical advisors, to assist
us in formulating our research and development, regulatory approval and commercialization strategy. Our
consultants and advisors may be employed by employers other than us and may have commitments under
consulting or advisory contracts with other entities that may limit their availability to us. The loss of the services
of one or more of our current employees or advisors might impede the achievement of our research,
development, regulatory approval and commercialization objectives. In addition, we have flexibly grown our
workforce through the use of contractors and part-time workers. We may not be able to retain the services of
such personnel, which might result in delays in the operation of our business.
Recruiting and retaining other qualified employees, consultants and advisors for our business, including scientific
and technical personnel, will be critical to our success as well. Competition for skilled personnel, including in
mRNA research, clinical development, clinical operations, regulatory affairs, therapeutic area management,
manufacturing, and AI, is intense and the turnover rate can be high. We may not be able to attract and retain
personnel on favorable terms given the competition among numerous pharmaceutical and biotechnology
companies and academic institutions for individuals with similar skill sets. In addition, adverse publicity, and the
failure to succeed in preclinical studies or clinical trials or in applications for marketing approval may make it
more challenging to recruit and retain qualified personnel. The inability to recruit or loss of services of certain
executives, key employees, consultants or advisors may impede the progress of our research, development and
commercialization objectives and have a material adverse impact on our business, financial condition, results of
operations and prospects.
Our employees, principal investigators and consultants may engage in misconduct or other improper
activities, including non-compliance with regulatory standards and requirements and insider trading,
which could have an adverse effect on the results of our operations.
We are exposed to the risk of fraud or other misconduct by our employees, principal investigators and
consultants, despite our robust efforts to prevent such misconduct through sponsor oversight. Misconduct by
these parties could include intentional failures to comply with FDA regulations or the regulations applicable in the
European Union and other jurisdictions, to provide accurate information to the FDA, the EMA and other
regulatory authorities, to comply with healthcare fraud and abuse laws and regulations in the United States and
abroad, to report financial information or data accurately or to disclose unauthorized activities to us. Such
misconduct also could involve the improper use of information obtained in the course of clinical trials or
interactions with the FDA or other regulatory authorities, which could result in regulatory sanctions and cause
serious harm to our reputation. We have adopted a code of conduct applicable to all of our employees, but it is
not always possible to identify and deter employee misconduct, and the precautions we take to detect and
prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting us
from government investigations or other actions or lawsuits stemming from a failure to comply with laws or
regulations. If any such actions are instituted against us and we are not successful in defending ourselves or
asserting our rights, those actions could have a significant impact on our business, financial condition, results of
operations and prospects, including the imposition of significant fines or other sanctions.
Employment-related disputes, including employee litigation and unfavorable publicity, could negatively
affect our future business.
From time to time we may be subject to claims by our employees or regulatory authorities with respect to
employment and workplace matters, including lawsuits or proceedings against us regarding injury, creating a
hostile workplace, discrimination, wage and hour disputes, sexual harassment or other employment issues. In
recent years, there has been an increase in the number of discrimination and harassment claims generally.
Coupled with the expansion of social media platforms and similar devices that allow individuals access to a
broad audience, these claims have had a significant negative impact on some businesses. Certain companies
that have faced employment- or harassment- related lawsuits have had to terminate management or other key
45
Annual Report on Form 20-F for the
year ended December 31, 2024
personnel, and have suffered reputational harm that has negatively impacted their business. If we were to face
any employment-related claims, our business could be negatively affected.
The illegal distribution and sale by third parties of counterfeit versions of our COVID-19 vaccine, or, if
approved, our other product candidates, could have a negative impact on our financial performance or
reputation.
Third parties have in the past and may continue to illegally distribute and sell counterfeit versions of COVID-19
vaccines. Counterfeit products are frequently unsafe or ineffective, and may even be life-threatening. Counterfeit
medicines may contain harmful substances or the wrong dosage. However, to distributors and users, counterfeit
products may be visually indistinguishable from the authentic version.
Reports of adverse reactions to counterfeit products, increased levels of counterfeiting, or unsafe vaccines could
materially affect public confidence in our COVID-19 vaccine or other product candidates. It is possible that
adverse events caused by unsafe counterfeit vaccines will mistakenly be attributed to our COVID-19 vaccine, or,
if approved, our other product candidates. In addition, thefts of inventory at warehouses, plants or while in-
transit, which are subsequently improperly stored and which are sold through unauthorized channels, could
adversely impact patient safety, our reputation, and our business. Public loss of confidence in the integrity of our
COVID-19 vaccine or, if approved, our other product candidates, as a result of counterfeiting or theft could have
a material adverse effect on our business, results of operations, and financial condition.
We and our collaborators or other contractors or consultants depend on information technology
systems, and any failure of these systems could harm our business. Security breaches, loss of data and
other disruptions could compromise sensitive information related to our business or prevent us from
accessing critical information and expose us to liability, which could adversely affect our business,
results of operations and financial condition.
Our internal computer systems and those of our current and any future collaborators, vendors, and other
contractors or consultants are vulnerable to damage from computer viruses, unauthorized access, natural
disasters, terrorism, cybersecurity threats, war, and telecommunication and electrical failures. If any such
material system failure, accident or security breach were to occur and cause interruptions in our operations, it
could result in a material disruption of our development programs and our business operations, whether due to a
loss of our trade secrets or other proprietary information or other similar disruptions. For example, the loss of
clinical trial data from one or more ongoing or completed or future clinical trials could result in delays in our
regulatory approval efforts and significantly increase our costs to recover or reproduce the data. In addition,
because of our approach of running multiple clinical trials in parallel, any breach of our computer systems may
result in a loss of data or compromised data integrity across many of our programs in many stages of
development. Any such breach, loss or compromise of clinical trial participant personal data may also subject us
to civil fines and penalties, including under the EU General Data Protection Regulation, or the GDPR, relevant
law of an EU member state, HIPAA, and other relevant state and federal privacy laws in the United States or in
other jurisdictions. To the extent that any disruption or security breach were to result in a loss of, or damage to,
data or applications, or inappropriate disclosure of confidential or proprietary information, we could incur liability,
our competitive position could be harmed, and the further development and commercialization of our product
candidates could be delayed.
While we have not experienced any material system failures, accidents or security breaches to date, in
December 2020, we were informed by the EMA that the agency was subject to a cyberattack and that some
documents relating to our regulatory submission for our COVID-19 vaccine candidate, which was stored on an
EMA server, had been unlawfully accessed. None of our systems were breached in connection with this incident
and we are unaware that any study participants were identified through the data being accessed.
We have put systems and procedures in place to minimize the likelihood of such incidents reoccurring; however,
we cannot guarantee that third parties will not be able to gain unauthorized access to or otherwise breach our
systems in the future. Any such unauthorized access or breach could adversely affect our business, results of
operations and financial condition.
46
Annual Report on Form 20-F for the
year ended December 31, 2024
Product liability lawsuits against us could cause us to incur substantial liabilities and could limit
commercialization of our current or future product candidates.
We face an inherent risk of product liability exposure related to the testing of any of our current or future product
candidates in clinical trials, and an even greater risk related to any commercialized products, such as our
COVID-19 vaccine. We have received product liability claims against our COVID-19 vaccine, and expect to
receive additional product liability claims in the future. If we cannot successfully defend ourselves against claims
that our products and/or our product candidates have caused injuries, we could incur substantial liabilities.
Regardless of merit or eventual outcome, liability claims may result in:
•
decreased demand for any product or product candidate that we may develop;
•
loss of revenue;
•
substantial monetary awards to patients, healthy volunteers or their children;
•
significant time and costs to defend the related litigation;
•
withdrawal of clinical trial participants;
•
the inability to commercialize any products or product candidates that we may develop; and
•
injury to our reputation and significant negative media attention.
We carry clinical trial insurance and product liability insurance, which we believe to be sufficient in light of our
current clinical programs and commercial operations. However, the amount of coverage we have obtained may
not be adequate, and we may seek to further increase insurance coverage limits as our pipeline moves towards
commercialization. As we evolve, we may not be able to maintain insurance coverage at a reasonable cost or in
sufficient amounts to protect us against losses due to liability. On occasion, large judgments have been awarded
in class action lawsuits based on drugs or medical treatments that had unanticipated adverse effects. A
successful product liability claim or series of claims brought against us could cause the price of the ADSs to
decline and, if judgments exceed our insurance coverage, could adversely affect our results of operations and
business.
If our products become subject to a product recall it could harm our reputation, business and financial
results.
The FDA and similar governmental authorities in other jurisdictions have the authority to require the recall of
certain commercialized products. In the case of the FDA, the authority to require a recall of a biologic product
must be based on an FDA finding that a batch, lot of other quantity of the biologic product presents an imminent
or substantial hazard to the public health. In addition, some governmental bodies outside the United States have
the authority to require the recall of any product or product candidate in the event of material deficiencies or
defects in design or manufacture. Manufacturers may, under their own initiative, recall a product if any material
deficiency in a product is found. A government-mandated or voluntary recall by us could occur as a result of
manufacturing errors, design or labeling defects or other deficiencies and issues.
Recalls of any of our products or, if approved, our product candidates, would divert managerial and financial
resources and have an adverse effect on our financial condition and results of operations. A recall
announcement could harm our reputation with customers and negatively affect our sales, if any.
Issues in the development and use of AI, combined with an uncertain regulatory environment, may result
in reputational harm, liability or other adverse consequences to our business.
We are investing in AI technology systems, including through our acquisition of InstaDeep, and such systems are
complex and rapidly changing. We face significant competition from other companies with respect to our AI and
machine learning services, along with an evolving regulatory landscape. The introduction of AI into the
development and manufacturing of our product candidates, or the provision of services relating to AI
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Annual Report on Form 20-F for the
year ended December 31, 2024
technologies and applications, may result in new or enhanced governmental or regulatory scrutiny, litigation,
intellectual property risks, confidentiality or security risks, ethical concerns or other complications that could harm
our business, reputation or financial condition.
Uncertainty around AI may require additional investment in the development and maintenance of proprietary
datasets and development of appropriate protections and safeguards for handling the use of customer data with
AI technologies, which may be costly and could impact our expenses. In addition, AI may create content that
appears correct but is inaccurate or flawed, and if created by third parties, may be mistakenly attributed to us.
Our customers or others may rely on or use this flawed content to their detriment, which may expose us to brand
or reputational harm, competitive harm or legal liability.
Our ability to effectively monitor and respond to the rapid and ongoing developments and expectations
relating to environmental, social and governance, or ESG, matters, including related social expectations
and concerns, may impose unexpected costs or result in reputational or other harm that could have a
material adverse effect on our business, financial condition, cash flows and results of operations and
could cause the price of ADSs representing our ordinary shares to decline.
There are rapid and ongoing developments and changing, sometimes conflicting, expectations relating to ESG
matters and factors such as the environmental impact of our operations, access to our COVID-19 vaccine,
corporate governance, our product stewardship practices, management of business ethics, human rights due
diligence in our own operations and our supply chain, and workforce development. At the same time, ESG
matters, including climate change, are the subject of increased politicization, particularly in the United States.
These factors may result in increased regulatory, social or other scrutiny on us.
We believe we must address climate risks from our own contribution to climate change (inside-out perspective),
risks to our own operations due to physical effects of climate change as well as transition risks (outside-in
perspective), and interactions between both perspectives. To this end, we have set ourselves near-term
scienced-based emissions reduction targets for our own operations (scope 1, 2) and for our supply chain
(supplier engagement target for scope 3), validated by the Science Based Targets initiative, or SBTi, in early
February 2024.
Additionally, we are addressing increasingly complex regulatory requirements with respect to human rights risks.
These requirements include German legislation such as the Act on Corporate Due Diligence Obligations for the
Prevention of Human Rights Violations in Supply Chains (Lieferkettensorgfaltspflichtengesetz – LkSG), potential
legislative planning by the European Union, and local or regional regulations. Regulatory frameworks require us
to identify, prevent, mitigate and ideally end the extent of any potential adverse impacts or violations throughout
our own operations and value chain.
Finally, we are faced with increasing ESG related transparency and reporting obligations. These requirements
arise, for example, from the EU Corporate Sustainability Reporting Directive regulation, the European
Sustainability Reporting Standards, and the respective German implementation law, any potential SEC rules that
could require registrants to provide additional climate-related disclosures in future periods, and other possible
obligations.
Should we fail to meet our climate protection targets or if we are unable to adequately recognize and respond to
such developments and governmental, societal, investor and NGO expectations relating to such ESG matters,
we may have to pay substantial fines, forego corporate opportunities, become subject to additional scrutiny, incur
unexpected costs or experience damage to our reputation or our various brands. If any of these events were to
occur, there may be a material adverse effect on our business, financial condition, cash flows and results of
operations, and the price of ADSs representing our ordinary shares may decline.
We have observed that in addition to the importance of their financial performance, companies are increasingly
being judged by their performance on ESG matters. A variety of organizations measure the performance of
companies on such ESG topics, and the results of these assessments are widely publicized. We may fail to
comply with standards or best practices put forth by such organizations or by governmental or regulatory bodies.
There can be no certainty that we will manage such issues successfully, or that we will successfully meet
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Annual Report on Form 20-F for the
year ended December 31, 2024
society’s expectations as to our proper role. Any failure or perceived failure by us in this regard could have a
material adverse effect on our reputation and on our business, the price of ADSs representing our ordinary
shares, financial condition, or results of operations, including the sustainability of our business over time.
Risks Related to the Manufacturing of our COVID-19 Vaccine, our Product Candidates and Future
Pipeline
Our COVID-19 vaccine and product candidates are based on novel technologies and they may be
complex and difficult to manufacture. We may encounter difficulties in manufacturing, product release,
shelf life, testing, storage, supply chain management or shipping. If we or any of the third-party
manufacturers we work with encounter such difficulties, our ability to supply materials for clinical trials
or any approved product could be delayed or stopped.
Th
e manufacturing processes for our COVID-19 vaccine and our product candidates are novel and complex
.
Due to the novel nature of this technology and the recency of our experience at larger scale production, we may
encounter difficulties in manufacturing, product release, shelf life, testing, storage and supply chain
management, or shipping. These difficulties could be due to any number of reasons, including, but not limited to,
complexities of producing batches at larger scale, equipment failure, choice and quality of raw materials and
excipients, analytical testing technology, and product instability. In an effort to optimize product features, we have
in the past and may in the future make changes to our product candidates in their manufacturing and stability
formulation and conditions. This has resulted in the past, and may in the future result, in our having to resupply
batches for preclinical, clinical, or commercial activities when there is insufficient product stability during storage
and insufficient supply. Insufficient stability or shelf life of our products or product candidates could materially
delay our or our collaborators’ ability to continue the clinical trial for that product candidate or require us to begin
a new clinical trial with a newly formulated drug product, due to the need to manufacture additional preclinical,
clinical or commercial supply.
Our rate of innovation is high, which has resulted in, and will continue to cause a high degree of, technology
change that can negatively impact product comparability during and after clinical development. Furthermore,
technology changes may drive the need for changes in, modification to, or the sourcing of, new manufacturing
infrastructure or may adversely affect third-party relationships.
The process to generate mRNA medicines is complex and, if not developed and manufactured under well-
controlled conditions, can adversely impact pharmacological activity. We may encounter difficulties in scaling up
our manufacturing process, thereby potentially impacting clinical and commercial supply. Additionally, for
individualized therapies, we may encounter issues with our ability to timely and efficiently manufacture product
given the on-demand requirements of such therapies, thereby potentially impacting clinical and commercial
supply.
As we continue developing new manufacturing processes for our drug substance and drug product, the changes
we implement to the manufacturing process may impact, in turn, specification and stability of the drug product.
Changes in our manufacturing processes may lead to failure of lots and this could lead to a substantial delay in
our clinical trials or an inability to supply sufficient commercial quantities of drug product. Our mRNA product
candidates may prove to have a stability profile that leads to an unfavorable shelf life. This poses risk in supply
requirements, wasted stock and higher cost of goods.
We are dependent on a number of equipment providers who are also implementing novel technology.
Further, we have developed our own custom manufacturing equipment for certain of our product
candidates. If such equipment malfunctions or we encounter unexpected performance issues, we could
encounter delays or interruptions to clinical and commercial supply.
Due to the number of different programs, we may in the future have cross contamination of products inside of our
factories, CROs, external CMOs, suppliers or in the clinic that affect the integrity of our products. Additionally, for
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Annual Report on Form 20-F for the
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some programs the manufacturing scale is extremely small compared to the standard volumes of supply, such
that we run the risk of contaminating the process each time we reopen a container to use remaining supplies.
As we scale the manufacturing output for particular programs, we plan to continuously improve yield, purity and
the pharmaceutical properties of our product candidates from IND-enabling studies through commercial launch,
including shelf life stability and solubility properties of drug product and drug substance. Due to continuous
improvement in manufacturing processes, we may switch processes for a particular program during
development. However, after the change in process, more time is required for pharmaceutical property testing,
such as six- or 12- month stability testing. That may require resupplying clinical or commercial material, or
making additional GMP batches to keep up with clinical trial demand before such pharmaceutical property
testing is completed.
We are utilizing a number of raw materials and excipients that are either new to the pharmaceutical industry or
are being employed in a novel manner
. Some of these raw materials and excipients have not been scaled to a
level to support commercial supply and could experience unexpected manufacturing or testing failures, or supply
shortages. Such issues with raw materials and excipients could cause delays or interruptions to clinical and
commercial supply of our COVID-19 vaccine and our product candidates. Further, now and in the future, one or
more of our programs may have a single source of supply for raw materials and excipients. Some of our
suppliers are located in countries different from our manufacturing sites. Export restrictions could lead to
unplanned interruptions in manufacturing, thus impacting supply of both clinical and commercial material.
We have established a number of analytical assays, and may have to establish several more, to assess the
quality of our mRNA products and product candidates. We may identify gaps in our analytical testing strategy
that might prevent release of product or could require product withdrawal or recall. For example, we may
discover new impurities that have an impact on product safety, efficacy or stability. This may lead to an inability to
release mRNA products or product candidates until the manufacturing or testing process is rectified.
Our product and product intermediates are extremely temperature sensitive, and we may learn that any or all of
our products are less stable than desired. We may also find that transportation conditions negatively impact
product quality. This may require changes to the formulation or manufacturing process for one or more of our
products or product candidates and result in delays or interruptions to clinical or commercial supply. In addition,
the cost associated with such transportation services and the limited pool of vendors may also add additional
risks of supply disruptions. As we transport intermediate products with holding times in refrigeration (TIR) and
allowed times out of refrigeration (TOR) across long distances and crossing borders, traffic issues and customs
delays could lead to the loss of batches which would need to be replaced.
Certain of our product candidates are uniquely manufactured for each patient and we may encounter
difficulties in production, particularly with respect to scaling our manufacturing capabilities. If we or any
of the third-party manufacturers with whom we contract encounter these types of difficulties, our ability
to provide such product candidates for clinical trials or, if approved, products for patients could be
delayed or stopped, or we may be unable to maintain a commercially viable cost structure.
We custom design and manufacture certain product candidates that are unique and tailored specifically for each
patient. Manufacturing unique lots of these product candidates is susceptible to product loss or failure due to
issues with:
•
logistics associated with the collection of a patient’s tumor, blood or other tissue sample;
•
shipping such samples to a facility for genetic sequencing;
•
next-generation sequencing of the tumor mRNA;
•
biopsy of a sufficient quantity of cancerous tissue to allow for proper sequencing and identification of
tumor-specific mutations;
•
identification of appropriate tumor-specific mutations;
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Annual Report on Form 20-F for the
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•
the use of a software program, including proprietary and open source components, which is hosted in
the cloud and a part of our product candidate, to assist with the design of the patient-specific mRNA,
which software must be maintained and secured;
•
effective design of the patient-specific mRNA that encodes for the required neoantigens;
•
batch-specific manufacturing failures or issues that arise due to the uniqueness of each patient-specific
batch that may not have been foreseen;
•
quality control testing failures;
•
unexpected failures of batches placed on stability;
•
shortages or quality control issues with single-use assemblies, consumables or critical parts sourced
from third-party vendors that must be changed out for each patient-specific batch;
•
significant costs associated with individualized manufacturing that may adversely affect our ability to
continue development;
•
successful and timely manufacture and release of the patient-specific batch;
•
shipment issues encountered during transport of the batch to the site of patient care;
•
the ability to define a consistent safety profile at a given dose when each participant receives a unique
treatment; and
•
our reliance on single source suppliers.
We also continue to evolve our own custom manufacturing equipment. This equipment may not function as
designed, which may lead to deviations in the drug product being produced. This can lead to increased batch
failure and the inability to supply patients enrolled in the clinical trial. If our clinical development plans are
expanded, we may not be able to supply this expanded need reliably without significant investments due to the
custom nature of the equipment and single-use assemblies. In addition, there will be considerable time to scale
up our facilities or build new facilities before we can begin to meet any commercial demand if one or more of our
individualized product candidates are approved. This expansion or addition of new facilities could also lead to
product comparability issues, which can further delay introduction of new capacity.
For those of our product candidates that are manufactured for each individual patient, we are required to
maintain a chain of identity with respect to each patient’s tissue sample, the sequenced data derived from such
tissue sample, the results of such patient’s genomic analysis and the custom manufactured product for such
patient. Maintaining such a chain of identity is difficult and complex, and failure to do so could result in product
mix-up, adverse patient outcomes, loss of product, or regulatory action, including withdrawal of any approved
products from the market. Further, as our product candidates are developed through early-stage clinical studies
to later-stage clinical trials towards approval and commercialization, we expect that multiple aspects of the
complicated collection, analysis, manufacture and delivery processes will be modified in an effort to optimize
processes and results. These changes may not achieve the intended objectives, and any of these changes could
cause our product candidates to perform differently than we expect, potentially affecting the results of clinical
trials.
Our inability to manufacture sufficient or appropriate quantities of our COVID-19 vaccine
or any of our
product candidates, or our failure to comply with applicable regulatory requirements, could materially
and adversely affect our business.
Manufacturing is a vital component of our individualized immunotherapy approach, and we have invested
significantly in our manufacturing facilities, including the acquisition of a manufacturing site in Marburg, Germany,
the construction of a novel modular manufacturing facility that we refer to as a “BioNTainer,” and the construction
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Annual Report on Form 20-F for the
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of a facility to support manufacturing of our Individualized Vaccines Against Cancer candidates. All internal
manufacturing is performed under GMP guidelines. We also rely on a network of CMOs for the manufacture of
our COVID-19 vaccine. We do not rely on any external CMOs for the manufacture of our individualized product
candidates and at this time, and we have limited redundancy among our facilities. Due to the individualized
nature of our product candidates, we do not maintain product reserves. If any of our or our external CMOs’
manufacturing facilities, including our BioNTainer units, experience difficulties, including related to
manufacturing, product release, shelf life, testing, storage and supply chain management or shipping, our clinical
development programs may be delayed or suspended until we or our external CMOs can resume operations.
We may also be required to incur significant expenditures to resolve such difficulties.
We and our collaboration partner also have experienced, and continue to face the risk of, inventory write-downs
or redundant production capacities with respect to our COVID-19 vaccine. Planned new formulations of our
COVID-19 vaccine, including versions that could protect against new variants of COVID-19, have resulted or
may result in significant research and development expense that was not or may not be recouped. In addition,
we have experienced in the past, and may experience in the future, redundant production capacities under our
agreements with CMOs due to planned new formulations, adaptations of our COVID-19 vaccine and increased
internal manufacturing capacities. Significant inventory write-downs or redundant manufacturing expenses would
negatively impact our results of operations.
Our facilities are subject to various regulatory requirements and may be subject to announced or unannounced
inspections by the FDA or other regulatory authorities at any time during the development or commercialization
phase. If we or our external CMOs cannot successfully manufacture material that conforms to our specifications
and the strict regulatory requirements of the FDA, the EMA or comparable regulatory authorities in other
jurisdictions, we may not be able to rely on our or our external CMOs’ manufacturing facilities for the
manufacture of our product candidates. If the FDA, the EMA or another comparable regulatory authority finds our
or our external CMOs’ facilities inadequate for the manufacture of our COVID-19 vaccine or our product
candidates or otherwise deficient, including as a result of a site inspection, such facilities may be the subject of
adverse regulatory action, including the issuance of untitled or warning letters. If such facilities are subject to
enforcement action in the future or are otherwise inadequate, we may need to find alternative manufacturing
facilities, which would significantly delay or otherwise impact our ability to develop, obtain regulatory approval for
or market our COVID-19 vaccine or our product candidates.
Additionally, we may experience manufacturing difficulties due to resource constraints, labor disputes or unstable
political environments. If we were to encounter any of these difficulties, our ability to provide our product
candidates to patients in clinical trials, or to provide approved products for the treatment of patients, would be
jeopardized.
We are subject to regulatory and operational risks associated with the physical and digital infrastructure
at both our internal manufacturing facilities and at those of our external service providers.
The designs of our facilities are based on current standards for biotechnology facilities. They have been
reviewed and approved by local authorities and have also received GMP manufacturing licenses. We have
designed our facilities to incorporate a significant level of automation of equipment with integration of several
digital systems to improve efficiency of operations. We have attempted to achieve a high level of digitization for
clinical and commercial manufacturing facilities relative to industry standards. While this is meant to improve
operational efficiency, this may pose additional risk of process equipment malfunction and even overall
manufacturing system failure or shutdown due to internal or external factors including, but not limited to, design
issues, system compatibility or potential cybersecurity breaches. This may lead to a delay in supply or shutdown
of our facilities. Any disruption in our manufacturing capabilities could cause delays in our production capacity for
our drug substances or drug products, impose additional costs, or require us to identify, qualify and establish an
alternative manufacturing site, the occurrence of which could have a material adverse effect on our business,
financial condition, results of operations and prospects.
As we expand our development and commercial capacity, we may continue to establish additional manufacturing
capabilities in different jurisdictions, which may lead to regulatory delays or prove costly. If we fail to select the
correct location, complete the construction in an efficient manner, recruit required personnel, and/or generally
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Annual Report on Form 20-F for the
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manage our growth effectively, the development and production of our products or product candidates could be
delayed or curtailed. Additional investments may be needed if changes in our manufacturing process lead to
required changes in our infrastructure.
Our COVID-19 vaccine and certain of our product candidates rely on the availability of specialty raw
materials, which may not be available to us on acceptable terms or at all.
Our product candidates require many specialty raw materials, some of which are manufactured by small
companies with limited resources and experience to support a commercial product, and suppliers may not be
able to deliver raw materials to our specifications. In addition, some such suppliers normally support blood-based
hospital businesses and generally do not have the capacity to support commercial products manufactured under
GMP by biopharmaceutical firms. These suppliers may be ill-equipped to support our needs, especially in non-
routine circumstances like an FDA inspection or medical crisis, such as widespread contamination. We also do
not have contracts with many of these suppliers, and we may not be able to contract with them on acceptable
terms or at all. Accordingly, we have experienced and we may in the future experience delays in receiving key
raw materials to support clinical or commercial manufacturing.
In addition,
some raw materials are currently available from a single supplier, or a small number of suppliers
. We
cannot be sure that these suppliers will remain in business or that they will not be purchased by one of our
competitors or another company that is not interested in continuing to produce these materials for our intended
purpose. In addition, the lead time needed to establish a relationship with a new supplier can be lengthy, and we
may experience delays in meeting demand in the event we must switch to a new supplier. The time and effort to
qualify a new supplier could result in additional costs, diversion of resources or reduced manufacturing yields,
any of which would negatively impact our operating results. Further, we may be unable to enter into agreements
with a new supplier on commercially reasonable terms or at all, which could have a material adverse impact on
our business.
We are subject to significant regulatory oversight with respect to manufacturing our products and
product candidates. Our manufacturing facilities or the manufacturing facilities of our third-party
manufacturers or suppliers may not meet regulatory requirements. Failure to meet GMP requirements
set forth in regulations promulgated by the FDA, the EMA and other comparable regulatory authorities
could result in significant delays in and costs of our products.
The manufacturing of immunotherapies for clinical trials or commercial sale is subject to extensive regulation.
GMP requirements govern manufacturing processes and procedures, including record-keeping, and the
implementation and operation of quality systems to control and assure the quality of products and materials used
in our products and product candidates. Poor control of the GMP production processes can lead to product
quality failures that can impact our ability to supply product, resulting in loss of potential product sales revenue,
cost overruns and delays to clinical timelines for our clinical programs, which could be extensive. Such
production process issues include but are not limited to:
•
critical deviations in the manufacturing process;
•
facility and equipment failures;
•
contamination of the product due to an ineffective quality control strategy;
•
facility contamination as assessed by the facility and utility environmental monitoring program;
•
ineffective process, equipment or analytical change management, resulting in failed lot release criteria;
•
raw material failures due to ineffective supplier qualification or regulatory compliance issues at critical
suppliers;
•
ineffective product stability;
•
failed lot release or facility and utility quality control testing;
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Annual Report on Form 20-F for the
year ended December 31, 2024
•
ineffective corrective actions or preventative actions taken to correct or avoid critical deviations due to
our developing understanding of the manufacturing process as we scale; and
•
failed or defective components or consumables.
We must supply all necessary documentation in support of a BLA or other marketing authorization application on
a timely basis and must adhere to the FDA’s, the EMA’s and other countries’ GMP requirements, which are
enforced, in the case of the FDA, in part through its facilities inspection program.
Regulatory authorities typically require representative manufacturing site inspections to assess adequate
compliance with GMPs and manufacturing controls as described in the filing. If either we or one of our third-party
manufacturing sites fail to provide sufficient quality assurance or control, approval to continue delivery of our
commercial product or to commercialize our product candidates may not be granted. Inspections by regulatory
authorities may be announced or unannounced and may occur at any time during the development or
commercialization phase. The inspections may be product-specific or facility-specific for broader GMP
inspections, or as a follow up to market or development issues that the regulatory agency may identify. Deficient
inspection outcomes may result in adverse regulatory action, including the issuance of untitled or warning letters,
which could influence our ability, or the ability of our third-party manufacturers or suppliers, to fulfill supply
obligations, impacting or delaying supply or delaying programs. Our failure, or the failure of our third-party
manufacturers, to comply with applicable regulations could result in sanctions being imposed on us, including,
but not limited to, clinical holds, fines, injunctions, civil penalties, delays, suspension or withdrawal of approvals,
license revocation, seizures or recalls of product candidates or products, operating restrictions, and criminal
prosecutions, any of which could significantly and adversely affect supplies of our products and product
candidates (including those of our collaborators) and our overall business operations.
The manufacturing process for any product is subject to the FDA’s, the EMA’s and other regulatory authorities’
approval processes, and we may need to contract with manufacturers whom we believe can meet applicable
regulatory authority requirements on an ongoing basis. If we or our third-party manufacturers are unable to
reliably manufacture to specifications acceptable to the FDA, the EMA or other regulatory authorities, we or our
collaborators may not obtain or maintain the approvals we or they need to release and deliver such products.
Even if we or our collaborators obtain regulatory approval for any of our immunotherapies, there is no assurance
that either we or our CMOs will be able to manufacture our product candidates to specifications acceptable to
the FDA, the EMA or other regulatory authorities, to produce it in sufficient quantities to meet the requirements
for the potential launch of the product, or to meet potential future demand. Any of these challenges could delay
completion of clinical trials, require bridging clinical trials or the repetition of one or more clinical trials, increase
clinical trial costs, delay approval of our product candidates, impair commercialization efforts or increase our cost
of goods. The occurrence of any of the foregoing could have an adverse effect on our business, financial
condition, results of operations and growth prospects.
In addition, we may not have direct control over the ability of our CMOs to maintain adequate quality control,
quality assurance and qualified personnel. Furthermore, all of our CMOs are engaged with other companies to
supply or manufacture materials or products for such companies, which exposes our CMOs to regulatory risks
for the production of such materials and products. As a result, failure to meet the regulatory requirements for the
production of those materials and products may generally affect the regulatory status of our CMOs’ facilities, and
could result in the sanctions and other adverse outcomes described above. Our potential future dependence
upon others for the manufacture of our products, product candidates and raw materials may adversely affect our
future operating results and our ability to commercialize any products that receive regulatory approval on a
timely and competitive basis.
The FDA, the EMA and other regulatory authorities may require us to submit product samples of any lot of any
approved product together with the protocols showing the results of applicable tests at any time. Under some
circumstances, the FDA or other regulatory authorities may require that we do not distribute a lot or lots until the
relevant agency authorizes such release. Deviations in the manufacturing process, including those affecting
quality attributes and stability, may result in unacceptable changes in the product that could result in lot failures
or product recalls. Our CMOs have, in the past, experienced lot failures and some may have experienced
product recalls. Lot failures or product recalls with respect to product produced by either our own facilities or
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Annual Report on Form 20-F for the
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those of our third-party manufacturers could cause us and our collaborators to delay clinical trials, product
launches or product supply, which could be costly to us and otherwise harm our business, financial condition,
results of operations and prospects.
We also may encounter problems hiring and retaining the experienced scientific, quality-control and
manufacturing personnel needed to operate our manufacturing processes and operations, which could result in
delays in production or difficulties in maintaining compliance with applicable regulatory requirements. While we
train and qualify all personnel around the appropriate handling of our products and materials, we may not be
able to control for or ultimately detect intentional sabotage or negligence by any employee or contractor.
Risks Related to our Reliance on Third Parties
We rely on third parties in the conduct of significant aspects of our preclinical studies and clinical trials
and intend to rely on third parties in the conduct of future clinical trials. If these third parties do not
successfully carry out their contractual duties, fail to comply with applicable regulatory requirements or
fail to meet expected deadlines, we may be unable to obtain regulatory approval for our product
candidates.
We currently rely, and expect to continue to rely, on third parties, such as CROs, clinical data management
organizations, collaborators, medical institutions and clinical investigators, to conduct various and significant
elements of our clinical trials. Furthermore, we currently rely, and expect to continue to rely, on third parties to
conduct certain research and preclinical testing activities. In some cases, these third parties may terminate their
engagements with us. If we need to enter into alternative arrangements, it would delay our discovery or product
development activities.
Our reliance on these third parties for research and development activities will reduce our control over these
activities but will not relieve us of our regulatory or contractual responsibilities. We are responsible for ensuring
that each of our preclinical studies and clinical trials is conducted in accordance with the applicable protocol,
legal and regulatory requirements and scientific standards. For example, we are responsible for ensuring that
each of our clinical trials is conducted in accordance with the general investigational plan and protocols for the
trial.
Moreover, the FDA requires us to comply with GCP for conducting, recording and reporting the results of clinical
trials to assure that data and reported results are credible and accurate and that the rights, integrity and
confidentiality of trial participants are protected. We are also required to register ongoing clinical trials and post
the results of completed clinical trials on a U.S. government-sponsored database, ClinicalTrials.gov, within
certain timeframes. Failure to do so can result in fines, adverse publicity, and civil and criminal sanctions. For
any violations of laws and regulations during the conduct of our preclinical studies and clinical trials, we could be
subject to warning letters or enforcement action that may include civil penalties up to and including criminal
prosecution.
We and our CROs
are required to comply with regulations, including GCP, for conducting, monitoring, recording
and reporting the results of preclinical studies and clinical trials to ensure that the data and results are
scientifically credible and accurate and that the trial participants are adequately informed, among other things, of
the potential risks of participating in clinical trials. We are also responsible for ensuring that the rights of our
clinical trial participants are protected. These regulations are enforced by the FDA, the regulatory authorities of
the EU member states, and comparable regulatory authorities of other jurisdictions for any product candidates in
clinical development. The FDA enforces GCP regulations through periodic inspections of clinical trial sponsors,
principal investigators and trial sites.
If we or our CROs
fail to comply with applicable GCP, the clinical data
generated in our clinical trials may be deemed unreliable and the FDA or comparable regulatory authorities of
other jurisdictions may require us to perform additional clinical trials before approving our marketing applications.
We cannot be sure that, upon inspection, the FDA will determine that any of our future clinical trials will comply
with GCP. In addition, our clinical trials must be conducted with product candidates produced in accordance with
the requirements of GMP regulations. Our failure or the failure of our CROs to comply with these regulations may
require us to repeat clinical trials, which would delay the regulatory approval process and could also subject us
to enforcement action.
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Annual Report on Form 20-F for the
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Although we have designed, and in the future intend to design the clinical trials for certain of our product
candidates, our collaborators will design the clinical trials that they are managing (in some cases, with our input)
and in the case of clinical trials controlled by us, we expect that CROs will conduct all of the clinical trials. As a
result, many important aspects of our development programs, including their conduct and timing, are outside of
our direct control. Our reliance on third parties to conduct future preclinical studies and clinical trials results in
less direct control over the management of data developed through preclinical studies and clinical trials than
would be the case if we were relying entirely upon our own staff. Communicating with outside parties can also
potentially lead to mistakes as well as difficulties in coordinating activities. Outside parties may:
•
have staffing difficulties;
•
fail to comply with contractual obligations;
•
experience regulatory compliance issues;
•
undergo changes in priorities or become financially distressed;
•
form relationships with other entities, some of which may be our competitors;
•
make human errors; or
•
be subject to cyberattacks.
These factors may materially adversely affect the willingness or ability of third parties to conduct our preclinical
studies and clinical trials and may subject us to unexpected cost increases that are beyond our control. If the
CROs do not perform preclinical studies and clinical trials in a satisfactory manner, breach their obligations to us
or fail to comply with regulatory requirements, the development, regulatory approval and commercialization of
our product candidates may be delayed, we may not be able to obtain regulatory approval and commercialize
our product candidates, or our development programs may be materially and irreversibly harmed. If we are
unable to rely on preclinical and clinical data collected by our CROs, we could be required to repeat, extend the
duration of, or increase the size of any clinical trials we conduct and this could significantly delay
commercialization and require significantly greater expenditures.
We also rely on other third parties to transport, store and distribute the required materials for our clinical trials. In
the past, certain of our third-party vendors have mishandled our materials, resulting in loss of full or partial lots of
material. Any further performance failure on the part of these third parties could result in damaged products and
could delay clinical development or marketing approval of any product candidates we may develop or
commercialization of our medicines, if approved, producing additional losses and depriving us of potential
product sales revenue, causing us to default on our contractual commitments, result in losses that are not
covered by insurance, and damage our reputation and overall perception of our products in the marketplace.
Our existing collaborations, or any future collaboration arrangements that we may enter into, may not be
successful, which could significantly limit the likelihood of receiving the potential economic benefits of
the collaboration and adversely affect our ability to develop and commercialize our products and
product candidates.
We have entered into collaborations under which our collaborators have provided, and may in the future provide,
funding and other resources for developing and commercializing our products and product candidates. We
expect to enter into additional collaborations to access additional funding, capabilities and/or expertise in the
future. Our existing collaborations, and any future collaborations we enter into, may pose a number of risks,
including the following:
•
collaborators may not perform or prioritize their obligations as expected;
•
the clinical trials conducted as part of such collaborations may not be successful;
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Annual Report on Form 20-F for the
year ended December 31, 2024
•
collaborators may not pursue development and commercialization of any product candidates and
products that achieve regulatory approval or may elect not to continue or renew development or
commercialization of programs based on clinical trial results, changes in the collaborators’ focus or
available funding (for example, we are aware that there have been allegations that Fosun International
Ltd., an affiliate of our collaboration partner Fosun Pharma, is facing liquidity risks), or external factors,
such as an acquisition, that divert resources or create competing priorities;
•
collaborators may delay clinical trials, provide insufficient funding for clinical trials, stop a clinical trial,
abandon a product candidate, repeat or conduct new clinical trials, or require a new formulation of a
product candidate for clinical testing;
•
collaborators could independently develop, or develop with third parties, products that compete directly
or indirectly with our product candidates if the collaborators believe that competitive products are more
likely to be successfully developed or can be commercialized under terms that are more economically
attractive than ours;
•
product candidates developed in collaborations with us may be viewed by our collaborators as
competitive with their own product candidates or products, which may cause collaborators to cease to
devote resources to the development or commercialization of our product candidates;
•
a collaborator with marketing and distribution rights to one or more of our product candidates that
achieve regulatory approval may not commit sufficient resources to the marketing and distribution of any
such product;
•
disagreements with collaborators, including disagreements over proprietary rights, contract interpretation
or the preferred course of development of any product candidates, may cause delays or termination of
the research, development or commercialization of such product candidates, may lead to additional
responsibilities for us with respect to such product candidates, or may result in litigation or arbitration,
any of which would be time-consuming and expensive;
•
collaborators may not properly maintain, protect, defend or enforce our intellectual property rights or may
use our proprietary information in such a way as to invite litigation that could jeopardize or invalidate our
intellectual property or proprietary information or expose us to potential litigation;
•
disputes may arise with respect to the ownership of intellectual property developed pursuant to our
collaborations;
•
collaborators may infringe, misappropriate or otherwise violate the intellectual property rights of third
parties, which may expose us to litigation and potential liability;
•
collaborations may be terminated for the convenience of the collaborator and, if terminated, the
development of our product candidates may be delayed, and we could be required to raise additional
capital to pursue further development or commercialization of the applicable product candidates;
•
future relationships may require us to incur non-recurring and other charges, increase our near- and
long-term expenditures, issue securities that dilute our existing shareholders, or disrupt our management
and business;
•
we could face significant competition in seeking appropriate collaborators, and the negotiation process is
time-consuming and complex; and
•
our international operations through any future collaborations, acquisitions or joint ventures may expose
us to certain operating, legal and other risks not encountered in Germany or the United States.
If our collaborations do not result in the successful development and commercialization of programs, or if one of
our collaborators terminates its agreement with us, we may not receive any future research funding or milestone,
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Annual Report on Form 20-F for the
year ended December 31, 2024
earn-out, royalty or other contingent payments, or otherwise yield the expected benefits under the collaborations.
As a result, our development of product candidates and commercialization efforts could be delayed and we may
need additional resources to develop and commercialize our product candidates. If one of our collaborators
terminates its agreement with us, we may find it more difficult to attract new collaborators and the perception of
us in the business and financial communities could be adversely affected. All of the risks relating to product
development, regulatory approval and commercialization described in this report apply to the activities of our
collaborators.
If we are not able to establish collaborations on commercially reasonable terms, we may have to alter
our research, development and commercialization plans.
Our research and product development programs and the potential commercialization of any product candidates
we develop alone or with collaborators will require substantial additional cash to fund expenses, and we expect
that we will continue to seek collaborative arrangements with others in connection with the development and
potential commercialization of current and future product candidates or the development of ancillary
technologies. We face significant competition in establishing relationships with appropriate collaborators. In
addition, there have been a significant number of recent business combinations among large pharmaceutical
companies that have resulted in a reduced number of potential future collaborators. Whether or not we reach a
definitive agreement for a collaboration will depend, among other things, upon our assessment of the
collaborator’s resources and expertise, the terms and conditions of the proposed collaboration and the proposed
collaborator’s evaluation of a number of factors. Those factors may include, among other things and as
applicable for the type of potential product or technology, an assessment of the opportunities and risks of our
technology, the design or results of studies or trials, the likelihood of approval, if necessary, of the FDA or
comparable regulatory authorities outside the United States, the potential market for the subject product
candidate, the costs and complexities of manufacturing and delivering such product candidate to patients, the
potential of competing products and technologies and industry and market conditions generally.
Current or future collaborators may also consider alternative product candidates or technologies for similar
indications that may be available to collaborate on and whether such a collaboration could be more attractive
than the one with us. Additionally, we may be restricted under existing collaboration agreements from entering
into future agreements on certain terms or for certain development activities with potential collaborators. For
example, we have granted exclusive rights or options to Pfizer for certain targets, and under the terms of our
respective collaboration agreements with them, we will be restricted from granting rights to other parties to use
our mRNA technology to pursue potential products that address those targets. Similarly, our collaboration
agreements have in the past and may in the future contain non-competition provisions that could limit our ability
to enter into collaborations with future collaborators.
Collaborations are complex and time-consuming to negotiate and document. We may not be able to negotiate
collaborations on a timely basis, on acceptable terms, or at all. If we do enter into additional collaboration
agreements, the negotiated terms may force us to relinquish rights that diminish our potential profitability from
development and commercialization of the subject product candidates or others. If we are unable to enter into
additional collaboration agreements, we may have to curtail the research and development of the product
candidate or technology for which we are seeking to collaborate, reduce or delay research and development
programs, delay potential commercialization timelines, reduce the scope of any sales or marketing activities or
undertake research, development or commercialization activities at our own expense. If we elect to increase our
expenditures to fund research, development or commercialization activities on our own, we may need to obtain
additional capital, which may not be available to us on acceptable terms or at all.
We have entered into in-licensing arrangements and may form or seek to enter into additional licensing
arrangements in the future, and we may not realize the benefits of such licensing arrangements.
We are a party to licenses that give us rights to third-party intellectual property, including patents and patent
applications, that are necessary or useful for our business. For example, we have obtained licenses from
Acuitas
Therapeutics, Inc., or Acuitas, CellScript LLC, or CellScript, and its affiliate, mRNA RiboTherapeutics, Inc
., to
patent rights claiming certain uses of modified RNA, as well as licenses from certain other parties for intellectual
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Annual Report on Form 20-F for the
year ended December 31, 2024
property useful in pharmaceutical formulations. We may enter into additional licenses to third-party intellectual
property in the future.
The success of products developed based on in-licensed technology will depend in part on the ability of our
current and future licensors to prosecute, obtain, maintain, protect, enforce and defend patent protection for our
in-licensed intellectual property. Our current and future licensors may not successfully prosecute the patent
applications we license. Even if patents were issued in respect of these patent applications, our licensors may
fail to maintain these patents, may determine not to pursue litigation against other companies that are infringing
these patents, or may pursue such litigation less aggressively than we would. Without protection for the
intellectual property we license, other companies might be able to offer substantially identical products for sale,
which could adversely affect our competitive business position and harm our business prospects. In addition, we
sublicense our rights under various third-party licenses to our collaborators. Any impairment of these sublicensed
rights could result in reduced revenues under our collaboration agreements or result in termination of an
agreement by one or more of our collaborators.
Disputes may also arise between us and our licensors regarding intellectual property subject to a license
agreement, including:
•
the scope of rights granted under the license agreement and other interpretation-related issues;
•
whether and the extent to which our technology and processes infringe, misappropriate or otherwise
violate the intellectual property of the licensor that is not subject to the licensing agreement;
•
our right to sublicense patent and other intellectual property rights to third parties under collaborative
relationships;
•
our diligence obligations with respect to the use of the licensed intellectual property and technology in
relation to our development and commercialization of our product candidates, and what activities satisfy
those diligence obligations;
•
the ownership of inventions, trade secrets, know-how and other intellectual property resulting from the
joint creation or use of intellectual property by our licensors and us and our collaborators;
•
the priority of invention of patented technology; and
•
the amounts to be paid pursuant to certain program milestones being achieved or to royalty obligations,
including the triggering of royalty obligations and amounts to be paid pursuant thereto.
If disputes over intellectual property that we have in-licensed or other related contractual rights prevent or impair
our ability to maintain our current licensing arrangements on favorable terms, we may be unable to successfully
develop and commercialize the affected product candidates.
We are generally also subject to all of the same risks with respect to protection of intellectual property that we
license, as we are for intellectual property that we own, which are described below. If we, our co-owners or our
licensors fail to adequately protect, defend, maintain or enforce this intellectual property, our ability to
commercialize products could suffer.
We and our collaborators rely on third parties to manufacture certain of our clinical product supplies,
and we may have to rely on third parties to produce and process our product candidates, if approved.
Although we expect to continue using our own clinical manufacturing facilities where available, we also rely on
outside vendors to manufacture supplies and process our product candidates. We only manufacture our
COVID-19 vaccine on a commercial scale and may not be able to achieve commercial-scale manufacturing and
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Annual Report on Form 20-F for the
year ended December 31, 2024
processing for our other product candidates, if approved, and may be unable to create an inventory of mass-
produced, off-the-shelf product to satisfy demands for our product candidates, if approved.
We do not yet have sufficient information to reliably estimate the cost of the commercial manufacturing and
processing of our product candidates, and the actual cost to manufacture and process our product candidates
could materially and adversely affect the commercial viability of our product candidates. As a result, we may not
be able to develop commercially viable products other than our COVID-19 vaccine.
In addition, our reliance on a limited number of CMOs exposes us to the following risks:
•
we may be unable to identify manufacturers on acceptable terms or at all because the number of
potential manufacturers is limited and the FDA or other regulatory authorities may have questions
regarding any replacement contractor. This may require new testing and regulatory interactions. In
addition, a new manufacturer would have to be educated in, or develop substantially equivalent
processes for, production of our products after receipt of regulatory authority questions, if any;
•
our CMOs might be unable to timely formulate and manufacture our product or produce the quantity and
quality required to meet our clinical and commercial needs, if any;
•
CMOs may not be able to execute our manufacturing procedures appropriately;
•
our future CMOs may not perform as agreed or may not remain in the contract manufacturing business
for the time required to supply our clinical trials or to successfully produce, store and distribute our
products;
•
manufacturers are subject to ongoing periodic unannounced inspection by the FDA, the U.S. Drug
Enforcement Administration and corresponding state agencies and by regulatory authorities in other
jurisdictions to ensure strict compliance with GMP and other government regulations and corresponding
standards in other jurisdictions. We do not have control over CMOs’ compliance with these regulations
and standards;
•
we may not own, or may have to share, the intellectual property rights to any improvements made in the
manufacturing process for our products;
•
our CMOs could breach or terminate their agreement with us; and
•
our CMOs would also be subject to the same risks we face in developing our own manufacturing
capabilities, as described above.
Each of these risks could delay our clinical trials, the approval, if any, of our COVID-19 vaccine or product
candidates by the FDA or regulatory authorities in other jurisdictions or the commercialization of our COVID-19
vaccine or product candidates, or result in higher costs or deprive us of potential product sales revenue. In
addition, we will rely on third parties to perform release tests on our COVID-19 or our product candidates prior to
delivery to patients. If these tests are not appropriately done and test data are not reliable, patients could be put
at risk of serious harm.
Certain of our collaborators currently rely on CMOs located outside of the United States to manufacture their
clinical materials, and we expect to rely on CMOs located outside of the United States in the future
. Such ex-
U.S. CMOs may be subject to or affected by U.S. legislation, executive orders, regulations, or investigations,
including but not limited to the proposed BIOSECURE Act, the Department of Justice’s Final Rule issued on
December 27, 2024 implementing the Executive Order on Preventing Access to Americans’ Bulk Sensitive
Personal Data and United States Government-Related Data by Countries of Concern, sanctions, trade
restrictions and other U.S. and other regulatory requirements, which could increase the cost or reduce the supply
of material available to us, delay the procurement or supply of such material, delay or impact clinical trials, have
an adverse effect on our ability to secure significant commitments from governments to purchase our potential
therapies and adversely affect our financial condition and business prospects.
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Annual Report on Form 20-F for the
year ended December 31, 2024
We are dependent on
single source suppliers
for some of the components and materials used in, and the
processes required to develop, our COVID-19 vaccine and our product candidates.
We currently depend on single source suppliers for some of the components and materials used in, and
manufacturing processes required to develop, our COVID-19 vaccine and our product candidates. We cannot
ensure that these suppliers or service providers will remain in business, or have sufficient capacity or supply to
meet our needs, or that they will not be purchased by one of our competitors or another company that is not
interested in continuing to work with us. Our use of single source suppliers of raw materials, components, key
processes and finished goods exposes us to several risks, including disruptions in supply, price increases or late
deliveries. There are, in general, relatively few alternative sources of supply for substitute components. These
vendors may be unable or unwilling to meet our future demands for our clinical trials or commercial sale.
Establishing additional or replacement suppliers for these components, materials and processes could take a
substantial amount of time and it may be difficult to establish replacement suppliers who meet regulatory
requirements. Any disruption in supply from any single source supplier or service provider could lead to supply
delays or interruptions which would damage our business, financial condition, results of operations and
prospects.
If we have to switch to a replacement supplier, the manufacture and delivery of our product candidates could be
interrupted for an extended period, which could adversely affect our business. Establishing additional or
replacement suppliers for any of the components or processes used in our COVID-19 vaccine and our product
candidates, if required, may not be accomplished quickly. If we are able to find a replacement supplier, the
replacement supplier would need to be qualified and may require additional regulatory authority approval, which
could result in further delay. While we seek to maintain adequate inventory of the single source components and
materials used in our COVID-19 vaccine and our product candidates, any interruption or delay in the supply of
components or materials, or our inability to obtain components or materials from alternate sources at acceptable
prices in a timely manner, could impair our ability to meet the demand for our COVID-19 vaccine and product
candidates.
In addition, as part of the FDA’s approval of our product candidates, we will also require FDA review of the
individual components of our process, which include the manufacturing processes and facilities of our single
source suppliers.
Our reliance on these suppliers, service providers and manufacturers subjects us to a number of risks that could
harm our reputation, business and financial condition, including, among other things:
•
delays to the development timelines for our product candidates;
•
interruption of supply resulting from modifications to or discontinuation of a supplier’s operations;
•
delays in product shipments resulting from uncorrected defects, reliability issues, or a supplier’s variation
in a component;
•
a lack of long-term supply arrangements for key components with our suppliers;
•
inability to obtain adequate supply in a timely manner, or to obtain adequate supply on commercially
reasonable terms;
•
difficulty and cost associated with locating and qualifying alternative suppliers for our components in a
timely manner;
•
production delays related to the evaluation and testing of components from alternative suppliers, and
corresponding regulatory qualifications;
•
delay in delivery due to our suppliers’ prioritizing other customer orders over ours;
•
damage to our reputation caused by defective components produced by our suppliers; and
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Annual Report on Form 20-F for the
year ended December 31, 2024
•
fluctuation in delivery by our suppliers due to changes in demand from us or their other customers.
If any of these risks materialize, costs could significantly increase and our ability to meet demand for our
products could be impacted.
Risks Related to Intellectual Property
If our efforts to obtain, maintain, protect, defend and/or enforce the intellectual property related to our
COVID-19 vaccine or our product candidates and technologies are not adequate, we may not be able to
compete effectively in our market.
Our commercial success depends in part on our ability to obtain, maintain, protect, defend and enforce patent
and other intellectual property, including trade secret and know-how, protection for our COVID-19 vaccine and
for our product candidates, proprietary technologies and their uses, as well as our ability to operate, develop,
manufacture and commercialize our COVID-19 vaccine or one or more of our product candidates without
infringing, misappropriating or otherwise violating the intellectual property or other proprietary rights of our
competitors or any other third parties, including any non-practicing entities or patent assertion entities. We
generally seek to protect our intellectual property position by filing and/or licensing patent applications in the
European Union, the United States and elsewhere related to our product candidates, proprietary technologies
(including methods of manufacture) and their uses that are important to our business. Our patent applications
cannot be enforced against third parties practicing the technology claimed in such applications unless, and until,
patents issue from such applications, and then only to the extent that the issued claims cover third parties’
activities in the countries in which they are performed. We cannot be certain that the claims in any of our patent
applications will be considered patentable by the United States Patent and Trademark Office, or the USPTO,
courts in the United States or the patent offices and courts in other jurisdictions, including Europe, nor can we be
certain that any claim in our issued patents will not be found invalid or unenforceable if challenged. Accordingly,
there can be no assurance that our patent applications or those of our licensors will result in additional patents
being issued or that issued patents will adequately cover our COVID-19 vaccine or our product candidates, or
otherwise afford sufficient protection against competitors with similar technology, nor can there be any assurance
that issued patents will not be infringed, designed around, invalidated or held unenforceable. Furthermore, we
may not be able to apply for patents on certain aspects of our current or future products or product candidates,
proprietary technologies and their uses in a timely fashion, at a reasonable cost, in all jurisdictions, or at all, and
any potential patent protection we obtain may not be sufficient to prevent substantial competition.
Even claims of issued patents may later be found invalid or unenforceable, or may be modified or revoked in
proceedings before various patent offices or in courts in the United States, Europe or other jurisdictions. The
degree of future protection for our intellectual property and other proprietary rights is uncertain. Only limited
protection may be available and may not adequately protect our rights or permit us to gain or keep any
competitive advantage. If we do not adequately obtain, maintain, protect, defend and enforce our intellectual
property and proprietary technology, competitors may be able to use our products, product candidates and
proprietary technologies and erode or negate any competitive advantage we may have, which could have a
material adverse effect on our financial condition and results of operations.
The patent application process is subject to numerous risks and uncertainties, and there can be no assurance
that we or any of our current or future licensors or collaborators will be successful in prosecuting, obtaining,
protecting, maintaining, enforcing or defending patents and patent applications necessary or useful to protect our
products or product candidates, proprietary technologies (including methods of manufacture) and their uses.
These risks and uncertainties include, from time to time, the following:
•
the USPTO and various other governmental patent agencies require compliance with a number of
procedural, documentary, fee payment and other provisions during the patenting process, the
noncompliance with which can result in abandonment or lapse of a patent or patent application or a
finding that a patent is unenforceable, and partial or complete loss of patent rights in the relevant
jurisdiction;
•
patent applications may not result in any patents being issued;
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Annual Report on Form 20-F for the
year ended December 31, 2024
•
claims of issued patents that we own (solely or jointly) or have in-licensed may be challenged,
invalidated, modified, revoked, circumvented, found to be unenforceable or otherwise may not provide
any competitive advantage;
•
other parties may have designed around our patent claims or developed technologies that may be
related or competitive to our COVID-19 vaccine or to our product candidates or other technologies, may
have filed or may file patent applications and may have received or may receive patents that overlap or
conflict with our patent filings, either by claiming the same or overlapping methods, products, reagents,
tools or devices or by claiming subject matter that could dominate one or more of our patent claims;
•
any successful opposition to claims of any patents owned by or in-licensed to us could deprive us of
rights necessary for the development and exploitation of our COVID-19 vaccine or our product
candidates and other technologies, or the successful commercialization of any product candidates and
other technologies that we may develop;
•
because patent applications in the United States and most other jurisdictions are confidential for a period
of time after filing, we cannot be certain that we, our co-owners or our licensors were the first to file any
patent application related to our product candidates, proprietary technologies and their uses;
•
a court or patent office proceeding, such as a derivative action or interference, can be provoked or
instituted by a third party or a patent office, and might determine that one or more of the inventions
described in our patent filings, or in those we licensed, was first invented by someone else, so that we
may lose rights to such invention(s);
•
a court or other patent proceeding, such as an inter partes review, post grant review or opposition, can
be instituted by a third party to challenge the inventorship, scope, validity and/or enforceability of our
patent claims and might result in invalidation or revision of one or more of our patent claims, or in a
determination that such claims are unenforceable;
•
there may be significant pressure on the U.S. government and international governmental bodies to limit
the scope of patent protection both inside and outside the United States for disease treatments that
prove successful, as a matter of public policy regarding worldwide health concerns; existing legislation
(for example, in the United States, the Public Readiness and Emergency Preparedness Act, etc.) may
be interpreted, and new legislation may be passed, to permit third-party use of patented technologies
relating to a public health concern, with little or no compensation to the patent holder(s); and
•
countries other than the United States may have patent laws less favorable to patentees than those
upheld by U.S. courts, allowing competitors a better opportunity to create, develop and market
competing product candidates.
The patent position of biopharmaceutical companies generally is highly uncertain, involves complex legal and
factual questions, and has been the subject of much litigation in recent years. The standards that the USPTO
and its counterparts use to grant patents are not always applied predictably or uniformly and can change.
Similarly, the ultimate degree of protection that will be afforded to biotechnology inventions, including ours, in the
United States and other countries, remains uncertain and is dependent upon the scope of the protection decided
upon by patent offices, courts and lawmakers. Moreover, there are periodic changes in patent law, as well as
discussions in the U.S. Congress and in other jurisdictions about modifying various aspects of patent law. There
is no uniform, worldwide policy regarding the subject matter and scope of claims granted or allowable in
pharmaceutical or biotechnology patents. In certain countries, for example, methods for the medical treatment of
humans are not patentable. More generally, the laws of some countries do not protect intellectual property rights
to the same extent as U.S. or EU laws, and those countries may lack adequate rules and procedures for
granting, maintaining, protecting, defending and enforcing our intellectual property rights.
Furthermore, the patent prosecution process is expensive and time-consuming, and we may not be able to file,
prosecute, maintain, protect, defend, enforce or license all necessary or desirable patents or patent applications,
as applicable, at a reasonable cost or in a timely manner. It is possible that we will fail to identify patentable
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Annual Report on Form 20-F for the
year ended December 31, 2024
aspects of our research and development output in time to obtain patent protection. Although we enter into non-
disclosure and confidentiality agreements with parties who have access to confidential or patentable aspects of
our research and development output, such as our employees, corporate collaborators, outside scientific
collaborators, CROs, CMOs, consultants, advisors and other third parties, if any of these parties were to breach
such agreements and improperly disclose such output before a patent application is filed, this could jeopardize
our ability to seek patent protection. We also rely to a certain extent on trade secrets, know-how, and technology,
which are not protected by patents, to maintain our competitive position. If any trade secret, know-how or other
technology not protected by a patent were to be disclosed to or independently developed by a competitor, our
business and financial condition could be materially adversely affected.
The issuance of a patent is not conclusive as to its inventorship, priority date, scope, term, validity or
enforceability so that any patents that may issue or that we may license may be challenged in the courts or
patent offices in the United States, Europe and other jurisdictions. Once granted, patents may remain open to a
variety of challenges, including opposition, interference, re-examination, post-grant review, inter partes review,
nullification or derivation action in court or before patent offices or similar proceedings, and furthermore, may be
challenged as a defense in any enforcement action that we might bring. Such challenges may result in loss of
exclusivity or in patent claims being narrowed, terminated, disclaimed, invalidated, assigned to others or held
unenforceable, any or all of which could limit our ability to stop others from using or commercializing similar or
identical products, or limit the scope and/or term of patent protection of our products and product candidates
and/ or eliminate it altogether, thus hindering or removing our ability to limit third parties from making, using or
selling products or technologies that are similar or identical to ours, and/or reduce or eliminate royalty payments
to us from our licensees. Given the amount of time required for the development, testing and regulatory review of
new product candidates, patents protecting such candidates might expire before or shortly after such candidates
are commercialized. Furthermore, our pending and future patent applications may not result in patents being
issued which protect our technology or our product(s) or product candidates, or which effectively prevent others
from commercializing competitive technologies and products. As a result, our intellectual property may not
provide us with sufficient rights to exclude others from commercializing products similar or identical to ours.
Our ability to enforce our owned and in-licensed patent and other intellectual property rights depends on our
ability to detect infringement, misappropriation and other violation of such patents and other intellectual property.
It may be difficult to detect infringers, misappropriators and other violators who do not advertise the components
or methods that are used in connection with their products and services. Moreover, it may be difficult or
impossible to obtain evidence of infringement, misappropriation or other violation in a competitor’s or potential
competitor’s product or service, and in some cases we may not be able to introduce obtained evidence into a
proceeding or otherwise utilize it to successfully demonstrate infringement. We may not prevail in any lawsuits
that we initiate and the damages or other remedies awarded if we were to prevail may not be commercially
meaningful.
Furthermore, patents or other intellectual property rights that we may be able to secure for our COVID-19
vaccine or our other COVID-19 vaccine candidates could be restricted or preempted if governments determine
that they will not enforce, or will require compulsory licensing of, technologies useful to address the spread of
COVID-19.
In addition, proceedings to enforce or defend our owned or in-licensed patents could put our patents at risk of
being invalidated, held unenforceable or interpreted narrowly. Such proceedings could also provoke third parties
to assert claims against us, including that some or all of the claims in one or more of our patents are invalid or
otherwise unenforceable. Such challenges may result in loss of patent rights, loss of exclusivity, or in patent
claims being narrowed, invalidated or held unenforceable, which could limit our ability to stop others from using
or commercializing similar or identical technology and products, or limit the duration of the patent protection of
our technology and product candidates. If any of our owned or in-licensed patents covering our product
candidates or other technologies are narrowed, invalidated or found unenforceable, or if a court found that valid,
enforceable patents held by third parties covered one or more of our product candidates or other technologies,
our competitive position could be harmed or we could be required to incur significant expenses to protect,
enforce or defend our rights. If we initiate lawsuits to protect, defend or enforce our patents, or litigate against
third-party claims, such proceedings would be expensive and would divert the attention of our management,
technical personnel, and other employees even if the eventual outcome is favorable to us.
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Annual Report on Form 20-F for the
year ended December 31, 2024
The degree of future protection for our intellectual property and other proprietary rights is uncertain, and we
cannot ensure that:
•
any of our patents, or any of our pending patent applications, if issued, or those of our licensors, will
include claims having a scope sufficient to protect our product(s), our product candidates and other
technologies;
•
any of our pending patent applications or those of our licensors may issue as patents;
•
others will not or may not be able to make, use, offer to sell or sell products that are the same as or
similar to our own but that are not covered by the claims of the patents that we own or license;
•
we will be able to successfully commercialize our products on a substantial scale, if approved, before the
relevant patents that we own or license expire;
•
we were the first to make the inventions covered by each of the patents and pending patent applications
that we own or license;
•
we, our co-owners or our licensors were the first to file patent applications for these inventions;
•
others will not develop similar or alternative products or technologies that do not infringe the patents we
own or license;
•
any of the claims of patents we own or license will be found to ultimately be valid and enforceable;
•
any patents issued to us or our licensors will provide a basis for an exclusive market for our
commercially viable product candidates and other technologies or will provide us with any competitive
advantages;
•
a third party may not challenge the claims of patents we own or license and, if challenged, a court would
hold that such patent claims are valid, enforceable and infringed;
•
we may develop or in-license additional proprietary technologies that are patentable;
•
the patents of others will not have an adverse effect on our ability to issue patents, or otherwise on our
business;
•
our competitors do not conduct research, development, testing or commercialization activities in
countries where we do not have enforceable patent rights and then use the information learned from
such activities to develop competitive products for sale in our major commercial markets;
•
we will develop additional proprietary technologies, product(s) or product candidates that are separately
patentable; and
•
our, or our collaborators’, development and commercialization activities, including our manufacturing
processes, or products will not infringe patents of our competitors or any other third parties, including
any non-practicing entities or patent assertion entities.
Other companies or organizations may challenge our intellectual property rights or the intellectual
property rights of our partners or may assert intellectual property rights that prevent us or our partners
from developing and commercializing our COVID-19 vaccine or our product candidates and other
technologies.
We practice in new and evolving scientific fields, the continued development and potential use of which has
resulted in many different patents and patent applications from organizations and individuals seeking to obtain
intellectual property protection in the fields. We own and in-license patent applications and issued patents that
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Annual Report on Form 20-F for the
year ended December 31, 2024
describe and/or claim certain technologies, including products, reagents, formulations, tools and methods
including uses and manufacturing methods, or features or aspects of any of these. These issued patents and
pending patent applications claim certain compositions of matter and methods relating to the discovery,
development, testing, manufacture and commercialization of therapeutic modalities and our delivery
technologies, including lipid nanoparticles, or LNPs. If we, our co-owners or our licensors are unable to obtain,
maintain, protect, defend or enforce patent protection with respect to our products, product candidates and other
technology and any other products, product candidates and technology that we may develop, our business,
financial condition, results of operations and prospects could be materially harmed.
As the scientific fields mature, our known competitors and other third parties, many of whom have substantially
greater resources than we do and many of whom have made significant investments in competing technologies,
may seek or may have already obtained patents, and they have filed and will continue to file patent applications
claiming inventions in the fields in the United States and elsewhere. This may limit, interfere with or eliminate our
and our partners’ ability to make, use, sell, import or otherwise exploit our COVID-19 vaccine or our product
candidates or other technologies. There is uncertainty about which patents will issue, and, if they do, as to when,
to whom and with what claims. With respect to both in-licensed and owned intellectual property, we cannot
predict whether the patent applications we and our licensors are currently pursuing will issue as patents in any
particular jurisdiction or whether the claims of any issued patents will provide sufficient protection from
competitors.
We, our co-owners, our partners or our licensors may in the future become a party to patent proceedings or
priority disputes in the United States, Europe or other jurisdictions. In the United States, the Leahy-Smith
America Invents Act, or the America Invents Act, includes a number of significant changes that affect the way
patent applications are prosecuted and also may affect patent litigation. These include allowing third-party
submission of prior art to the USPTO during patent prosecution and additional procedures to attack the validity of
a patent through USPTO-administered post-grant proceedings, including post-grant review, inter partes review
and derivation proceedings. We expect that our competitors and other third parties will institute litigation and
other proceedings, such as interference, reexamination and opposition proceedings, as well as inter partes and
post-grant review proceedings against us and the patents and patent applications that we own and in-license.
Additionally, we face ongoing COVID-19 vaccine-related patent litigation. Alnylam Pharmaceuticals Inc., or
Alnylam, has brought litigation against us and Pfizer regarding U.S. Patent Nos. 11,245,933; 11,382,979;
11,633,479; 11,633,480; 11,612,657; and 11,590,229, the latter five of which are continuations of the ‘933 Patent.
In addition, CureVac SE, or CureVac, has brought litigation against us in Germany regarding three European
patents, 1857122B1, or EP’122, 3708668B1, or EP’668, and 4023755B1, or EP’755, and three German utility
models, DE202015009961, DE202015009974, and DE202021004130, or the CureVac IP. BioNTech filed a
nullity action in the Federal Patent Court of Germany seeking a declaration that EP’122 is invalid, initiated
cancellation actions against the CureVac IP in the German Patent and Trademark Office, and filed opposition
proceedings in the European Patent Office, or EPO, seeking the revocation of EP’668 and EP’755. In the United
States, CureVac asserts seven U.S. patents against us and Pfizer: U.S. Patent Nos. 11,135,312; 11,149,278;
10,760,070; 11,286,492; 11,345,920; 11,596,686, and 11,667,910. BioNTech and Pfizer also initiated
proceedings seeking the revocation of EP’122, EP’668, and EP’755 in the Business and Property Courts of
England and Wales. ModernaTX, Inc., or Moderna, has brought litigation against us and Pfizer regarding
European patents 3590949B1, or EP’949, and 3718565B1, or EP’565, in Germany, England and Wales, the
Netherlands, Ireland, and Belgium, and regarding U.S. Patent Nos. 10,898,574, 10,702,600, and 10,933,127 in
the United States. BioNTech and Pfizer also initiated proceedings seeking the revocation of EP’949 and EP’565
in the Business and Property Courts of England and Wales and have filed opposition proceedings in the EPO
seeking the revocation of EP’949 and EP’565. BioNTech and Pfizer have filed petitions for
inter partes
review
before the Patent Trial and Appeal Board in the United States with respect to U.S. Patent Nos. 10,702,600 and
10,933,127. Arbutus Biopharma Corp., or Arbutus, and Genevant Sciences GmbH, or Genevant, have brought
litigation against us and Pfizer in the United States regarding U.S. Patent Nos. 9,504,651; 8,492,359;
11,141,378; 11,298,320; and 11,318,098. Promosome initiated litigation against us and Pfizer in the United
States regarding U.S. Patent No. 8,853,179; it has since been dismissed with prejudice. Promosome LLC, or
Promosome, has initiated litigation against us and Pfizer in the Unified Patent Court (Munich Division) regarding
one European patent, EP 2 401 365. GlaxoSmithKline Biologicals SA and GlaxoSmithKline LLC, or collectively,
GSK, have brought litigation against us and Pfizer in the United States regarding U.S. Patent Nos. 11,638,693;
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Annual Report on Form 20-F for the
year ended December 31, 2024
11,638,694; 11,666,534; 11,766,401; 11,786,467; 11,759,422; 11,655,475; and 11,851,660. We cannot guarantee
that we will not become subject to additional COVID-19 vaccine patent infringement lawsuits in the future. In
addition, should Pfizer not prevail in any of the ongoing COVID-19 vaccine patent infringement lawsuits to which
it is a party, Pfizer may seek to require us to indemnify Pfizer for losses suffered therefrom as well as any losses
from future COVID-19 vaccine patent infringement lawsuits in which it does not prevail. We believe we have
strong defenses against each of these claims and intend to vigorously defend ourselves in each proceeding, but
we can make no assurances regarding the ultimate outcome of any of these matters.
We expect that we will continue to be subject to similar proceedings or priority disputes, including oppositions, in
Europe or other jurisdictions relating to patents and patent applications in our
portfolio
.
If we, our co-owners, our partners or our licensors are unsuccessful in any interference proceedings or other
priority or validity disputes, including any derivations, post-grant review, inter partes review or oppositions, to
which we or they are subject, we may lose valuable intellectual property rights through the narrowing or loss of
one or more patents owned or in-licensed, or our owned or in-licensed patent claims may be narrowed,
invalidated or held unenforceable. In many cases, the possibility of appeal exists for either us or our opponents,
and it may be years before final, unappealable rulings are made with respect to these patents in certain
jurisdictions. The timing and outcome of these and other proceedings is uncertain and may adversely affect our
business if we are not successful in defending the patentability and scope of our pending and issued patent
claims. Even if our rights are not directly challenged, disputes could lead to the weakening of our intellectual
property rights. Our defense against any attempt by third parties to circumvent or invalidate our intellectual
property rights could be costly to us, could require significant time and attention of our management, technical
personnel and other employees and could have a material adverse impact on our business and our ability to
successfully compete against our current and future competitors.
There are many issued and pending patent filings that claim aspects of technologies that we may need for our
mRNA products or product candidates, or other product candidates, including patent filings that relate to relevant
delivery technologies. There are also many issued patents that claim targeting genes or portions of genes that
may be relevant for immunotherapies we wish to develop. In addition, as evidenced by the lawsuits brought
against Moderna, Pfizer and us, there may be additional issued and pending patent applications that may be
asserted against us in a court proceeding or otherwise based upon the asserting party’s belief that we may need
such patents for the development, manufacturing, testing and commercialization of our COVID-19 vaccine or of
our product candidates. Thus, it is possible that one or more organizations, ranging from our competitors to non-
practicing entities or patent assertion entities, has or will hold patent rights to which we may need a license, or
hold patent rights which could be asserted against us. Such licenses may not be available on commercially
reasonable terms or at all, or may be non-exclusive. If those organizations refuse to grant us a license to such
patent rights on reasonable terms, if we fail to invalidate relevant patents, or if a court or other governing body
determines that we need such patent rights that have been asserted against us and we are not able to obtain a
license on reasonable terms or at all, we may be unable to perform research and development or other activities
or market products covered by such patents, and we may need to cease the development, manufacture, testing
and commercialization of one or more of the product candidates we may develop. Any of the foregoing could
result in a material adverse effect on our business, financial condition, results of operations or prospects.
We may not be successful in obtaining, maintaining, protecting or defending the necessary intellectual
property rights to allow us to identify and develop product candidates, and test product components and
manufacturing processes for our development pipeline.
We currently have rights to certain intellectual property through our owned and in-licensed patents and other
intellectual property rights relating to identification, development and testing of our product candidates or other
technologies. As our activities may involve additional product candidates or services that could require the use of
intellectual property and other proprietary rights held by third parties, the growth of our business could depend in
part on our ability to acquire, in-license or use such intellectual property and proprietary rights. In addition, our
product candidates may require specific formulations to work effectively and efficiently and these intellectual
property and other proprietary rights may be held by others. We may be unable to secure such licenses or
otherwise acquire or in-license any compositions, methods of use, processes or other third-party intellectual
property rights from third parties that we identify as necessary, on reasonable terms, or at all, for product
candidates and other technologies that we may develop. The licensing and acquisition of third-party intellectual
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Annual Report on Form 20-F for the
year ended December 31, 2024
property rights is a competitive area, and a number of more established companies are also pursuing strategies
to license or acquire third-party intellectual property rights that we may consider attractive or necessary. These
established companies may have a competitive advantage over us due to their size, cash resources, and greater
clinical development and commercialization capabilities.
We sometimes collaborate with academic institutions and/or utilize services of CROs and CMOs in certain
aspects of our research or development under written agreements with these parties. These agreements may
not ensure protection of intellectual property rights in developed technology, or may fail to provide us with
sufficient control of or access to such intellectual property rights. For example, agreements with these academic
institutions typically provide us with an option to negotiate a license to any of the institution’s rights in technology
resulting from the collaboration. However, these institutions may not honor our option and right of first negotiation
for intellectual property rights or we may otherwise be unable to negotiate a license within the specified time
frame or under terms that are acceptable to us. If we are unable to do so, the institution may offer the intellectual
property rights to other parties, potentially blocking our ability to pursue our program or otherwise continue to
develop certain product candidates or other technologies. CROs and/or CMOs may control certain technologies
that were utilized in and/or developed through work on our behalf, and may not pursue protection of such
technologies, or may provide us with only non-exclusive rights in such technologies, so that relevant
technologies may be shared with other parties including our competitors. In any relationship with a third party,
there is a risk of disagreement over intellectual property rights (including inventorship or ownership of, rights to
protect and/or enforce, and/or rights to use) in utilized or developed technologies.
Moreover, some of our owned patents and patent applications are, and may in the future be, co-owned with third
parties. If we are unable to obtain, or continue to maintain, exclusive rights to any such third-party co-owners’
interest in such patents or patent applications, such co-owners may be able to license their rights to other third
parties, including our competitors, and our competitors could market competing products and technologies. In
addition, we may need the cooperation of any such co-owners of our patents in order to enforce such patents
against third parties, and such cooperation may not be provided to us. Any of the foregoing could have a material
adverse effect on our competitive position, business, financial conditions, results of operations and prospects.
In addition, third parties that perceive us to be a competitor may be unwilling to assign or license rights to us. We
also may be unable to license or acquire third-party intellectual property rights on terms that would allow us to
make an appropriate return on our investment. If we are unable to successfully obtain rights to required third-
party intellectual property rights or maintain, protect, defend or enforce the existing intellectual property rights we
have, we may have to abandon the development and commercialization of the relevant program or product
candidate, which could have a material adverse effect on our business, financial condition, results of operations
and prospects.
The lifespans of our patents may not be sufficient to effectively protect our products or product
candidates, technologies and business.
Patents have a limited lifespan. In the United States, the natural expiration of a patent is generally 20 years after
its first effective non-provisional filing date, assuming maintenance fees are timely paid after the patent has
issued. Most other jurisdictions also provide a 20-year nominal patent term, though many require payment of
regular, often annual, annuities to maintain pendency of an application or viability of an issued patent. In some
jurisdictions, one or more options for extension of a patent term may be available, but even with such
extensions, the lifespan of a patent, and the protection it affords, is limited. Even if patents covering our product
candidates, proprietary technologies and their uses are obtained, once the patent term has expired, we may be
subject to competition from third parties that can then use the inventions included in such patents to create
competing products and technologies. In addition, although upon issuance in the United States a patent’s life
can be increased based on certain delays caused by the USPTO, this increase can be reduced or eliminated
based on certain delays caused by the patent applicant during patent prosecution. The USPTO can also require,
in certain circumstances, that the expiration date of a subject patent be shortened by the filing of a terminal
disclaimer over one or more patents that may expire sooner than the subject patent. Given the amount of time
required for the development, testing and regulatory review of new product candidates, patents protecting such
product candidates might expire before or shortly after such candidates are commercialized. If any patents that
we own or in-license expire, we would not be able to stop others from using or commercializing similar or
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Annual Report on Form 20-F for the
year ended December 31, 2024
identical technology and products, and our competitors could market competing products and technology. Any of
the foregoing could have a material adverse effect on our competitive position, business, financial conditions,
results of operations and prospects.
If we do not obtain patent term extension and data exclusivity for any product candidates we may
develop, our business may be materially harmed.
Depending upon the timing, duration and specifics of any FDA marketing approval of any product candidates we
may develop, one or more of our U.S. patents may be eligible for limited patent term extension under the Drug
Price Competition and Patent Term Restoration Action of 1984, or Hatch-Waxman Amendments. The Hatch-
Waxman Amendments permit a patent extension term of up to five years as compensation for patent term lost
during the FDA regulatory review process for a drug product subject to the provisions of the Hatch-Waxman Act.
A patent term extension cannot extend the remaining term of a patent beyond a total of 14 years from the date of
product approval, only one patent may be extended and only those claims covering the approved drug, a method
for using it, or a method for manufacturing it may be extended. However, we may not be granted an extension
because of, for example, failing to exercise due diligence during the testing phase or regulatory review process,
failing to apply within applicable deadlines, failing to apply prior to expiration of relevant patents, or otherwise
failing to satisfy applicable requirements. For example, we did not extend any patent for our COVID-19 vaccine.
Moreover, the applicable time period or the scope of patent protection afforded could be less than we request. If
we are unable to obtain patent term extension or the term of any such extension is less than we request, our
competitors may obtain approval of competing products following our patent expiration, and our business,
financial condition, results of operations and prospects could be materially harmed.
If we fail to comply, or are viewed to have failed to comply, with our obligations in the agreements under
which we license intellectual property rights from third parties or otherwise experience disruptions to
our business relationships with our licensors or other third parties, we could lose license rights that are
important to our business or suffer monetary losses.
We are heavily reliant upon licenses to certain intellectual property and other proprietary rights from third parties
that are important or necessary to the development and commercialization of our technology and product(s) or
product candidates, and we expect to enter into similar license agreements in the future. Licensing of intellectual
property is important to our business and involves complex legal, business and scientific issues and is
complicated by the rapid pace of scientific discovery in our industry. Our licenses may not provide exclusive
rights to use such intellectual property and technology in all relevant fields of use and in all territories in which we
may wish to develop, test, or commercialize our technology and products in the future. As a result, we may not
be able to prevent competitors from developing and commercializing competitive products in territories included
in any or all of our licenses.
Where we obtain licenses from, or collaborate with, third parties, in some circumstances we may not have the
right to control the preparation, filing, prosecution, maintenance, enforcement and defense of patents and patent
applications covering the technology that we license from, or that arises through collaboration with, such third
parties, or such activities, if controlled by us, may require the input of such third parties. In some cases, patent
prosecution (including preparation and filing) of our in-licensed intellectual property or of intellectual property
developed through collaboration, is controlled solely by the licensor or collaborator. We may also require the
agreement and/or cooperation of our licensors and collaborators to protect, enforce, utilize, or defend any in-
licensed patent rights, and such agreement and/or cooperation may not be provided. Therefore, we cannot be
certain that these patents and patent applications will be prepared, filed, prosecuted, maintained, protected,
enforced or defended in a manner consistent with the best interests of our business. Any patents or patent
applications that we in-license may be challenged, narrowed, circumvented, invalidated or held unenforceable,
or our licensors may not properly maintain such patents or patent applications and they may expire. If our
licensors fail to obtain, maintain, defend, protect or enforce the intellectual property we license from them, we
could lose our rights to the intellectual property and our competitors could market competing products using the
inventions in such intellectual property. In certain cases, we control the prosecution of patents included from in-
licensed technology. In the event we breach any of our obligations related to such prosecution, we may incur
significant liability to our collaborators. If we and our licensors or collaborators disagree over IP protection
strategies for relevant technologies, disputes may arise, and we could lose access to or control over protection
of technologies important to our business. If so, we may not be able to adequately protect our product(s) or
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Annual Report on Form 20-F for the
year ended December 31, 2024
product candidates, including not being able to prevent a competitor or other third party from developing the
same product(s) or product candidates for the same or a different use. Any of the foregoing could have a
material adverse effect on our competitive position, business, financial conditions, results of operations and
prospects.
Moreover, we may disagree from time to time with licensors or collaborators regarding, among other things, the
interpretation of each party’s obligations or the amounts payable under our agreements. For example, we were
in discussions with the University of Pennsylvania, or UPenn, and the National Institutes of Health, or the NIH,
concerning royalties and other related amounts allegedly owed on sales of our COVID-19 vaccine since
commercialization. UPenn subsequently filed suit against us in the U.S. District Court for the Eastern District of
Pennsylvania in connection with this dispute. On December 20, 2024, we entered into a Settlement Agreement
with the NIH pursuant to which we agreed, among other things, to pay
$791.5 million
to the NIH. On December
23, 2024, we entered into a binding Term Sheet with UPenn pursuant to which we agreed to enter into a
separate settlement agreement with UPenn, which would provide, among other things, that we pay
$400.0
million
as royalties for calendar years 2020-2023 to UPenn. For more information regarding our settlement with
the NIH and UPenn, s
ee
Note
12.2
of our con
solidated financial statements included elsewhere in this Annual
Report.
If we are found to have failed to satisfy obligations or materially breached any of our agreements, such as
licenses to third-party intellectual or any disagreements between us and our licensors, a licensor could
potentially have the right or reason to terminate the license, to exercise the option of a non-exclusive license,
which would allow our competitors to have access to the same intellectual property and technology licensed to
us. Our existing license agreements impose, and we expect that future license agreements will impose, various
diligence, milestone and royalty payment, exclusivity and other obligations on us. If we fail to comply with our
obligations under these agreements, including royalty payments, or we are subject to a bankruptcy, the licensor
may have the right to terminate the license agreement, in which event we would not be able to develop, market
and commercialize product(s) or product candidates covered by the license agreement. In spite of our best
efforts and even if we disagree, our licensors might still conclude that we have materially breached our license
agreements and might therefore terminate the license agreements, thereby removing our ability to develop, test
and commercialize the product(s) or product candidates covered by these license agreements. In the event that
any of our license agreements were to be terminated by the licensor, we may need to negotiate new or
reinstated agreements, which may not be available to us on equally favorable terms, or at all. If these license
agreements are rightfully terminated, or if the underlying patents or other intellectual property fail to provide the
intended exclusivity, competitors would have the freedom to seek regulatory approval of, and to market and
commercialize, products similar or identical to ours, and our licensors may be able to seek additional judicial
remedies. In addition, we may seek to obtain additional licenses from our licensors and, in connection with
obtaining such licenses, we may agree to amend our existing license agreements in a manner that may be more
favorable to the licensors, including by agreeing to terms that could enable third parties (potentially including our
competitors) to receive licenses to a portion of the intellectual property that is subject to our existing licenses.
Failure to prevail with respect to any contractual disagreements could result in a material adverse effect on our
competitive position, business, financial conditions, results of operations or prospects, particularly if discussions
result in legal or other dispute resolution proceedings.
We are generally also subject to all of the same risks with respect to protection of intellectual property that we
license, as we are for intellectual property that we own, which are described in this section. If we, our co-owners
or our licensors fail to adequately protect this intellectual property, our ability to develop, test, market and
commercialize our product(s) or product candidates could suffer. Moreover, if disputes over intellectual property
that we have in-licensed prevent or impair our ability to maintain our current licensing arrangements on
commercially acceptable terms, we may be unable to successfully develop, test, market and commercialize the
affected product(s) or product candidates, which could have a material adverse effect on our business, financial
condition, results of operations and prospects.
Some of our in-licensed intellectual property has been discovered through government-funded
programs and thus may be subject to federal regulations such as “march-in” rights and certain reporting
requirements, and compliance with such regulations may limit our exclusive rights and our ability to
contract with manufacturers.
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Annual Report on Form 20-F for the
year ended December 31, 2024
Certain intellectual property rights that have been in-licensed, including patent applications and patents that we
in-license from the University of Pennsylvania, the Louisiana State University, the Broad Institute, the NIH,
Genevant, and CellScript, have been generated through the use of U.S. government funding and are therefore
subject to certain federal regulations. The U.S. government may have certain rights to intellectual property
embodied in our current or future product candidates pursuant to the Bayh-Dole Act of 1980, or the Bayh-Dole
Act. These U.S. government rights may include a non-exclusive, non-transferable, irrevocable worldwide license
to use inventions covered by that Act for any governmental purpose. In addition, the U.S. government may have
the right, under certain limited circumstances, to require the licensor to grant exclusive, partially exclusive or
non-exclusive licenses to any of these inventions to a third party if it determines that (i) adequate steps have not
been taken to commercialize the invention, (ii) government action is necessary to meet public health or safety
needs or (iii) government action is necessary to meet requirements for public use under federal regulations (also
collectively referred to as “march-in rights”). The U.S. government may also have the right to take title to these
inventions if the licensor fails to disclose the invention to the government or fails to file an application to register
the intellectual property within specified time limits. Any exercise by the government of such rights could harm
our competitive position, business, financial condition, results of operations and prospects. Intellectual property
generated under a government-funded program is also subject to certain reporting requirements, compliance
with which may require us to expend substantial resources.
In addition, the U.S. government requires that any products embodying any such inventions or produced through
the use of any such inventions be manufactured substantially in the United States. This preference for U.S.
industry may be waived by the federal agency that provided the funding if the owner or assignee of the
intellectual property can show that reasonable but unsuccessful efforts have been made to grant licenses on
similar terms to potential licensees that would be likely to manufacture the products substantially in the United
States or that under the circumstances domestic manufacture is not commercially feasible. We may not be able
to obtain a waiver of this preference for U.S. industry, and this preference may limit our ability to contract with
non-U.S. product manufacturers for products covered by such intellectual property. To the extent any of our
owned or in-licensed future intellectual property is generated through the use of U.S. government funding, the
provisions of the Bayh-Dole Act may similarly apply. If we or our licensors are unable to secure an exemption to
these manufacturing requirements, if we comply with them, or if we are unable to comply with them, we may
experience a material adverse effect on our competitive position, business, financial conditions, results of
operations and prospects.
Our current proprietary position for certain products and product candidates depends upon our owned
or in-licensed patent filings covering components, manufacturing-related methods, formulations and/or
methods of use, which may not adequately prevent a competitor or other third party from using the same
product candidate for the same or a different use.
Composition of matter patent protection is generally considered to be desirable because it provides protection
without regard to any particular method of use or manufacture or formulation. While we have pursued or
obtained patent protection covering components of certain product candidates and tests, manufacturing-related
methods, formulations and/or methods of use, we have not yet obtained patent protection for all components of
certain product candidates and tests, manufacturing-related methods, formulations and/or methods of use. For
instance, we do not currently have any claims in our owned or in-licensed issued U.S. patents that cover the
overall construct used in our iNeST product candidates. We also cannot be certain that claims in any future
patents issuing from our pending owned or in-licensed patent applications or our future owned or in-licensed
patent applications will cover the composition of matter, tests, manufacturing-related methods, formulations and/
or methods of use of our current or future product candidates. Method of use patents protect the use of a product
for the specified method and formulation patents cover formulations to deliver therapeutics. These types of
patents do not prevent a competitor or other third party from developing, testing, marketing or commercializing a
similar or identical product for an indication that is outside the scope of the patented method or from developing
a different formulation that is outside the scope of the patented formulation. Moreover, with respect to method of
use patents, even if competitors or other third parties do not actively promote their product for our targeted
indications or uses for which we may obtain patents, physicians may recommend that patients use these
products off-label, or patients may do so themselves. Although off-label use may infringe or contribute to the
infringement of method of use patents, the practice is common and this type of infringement is difficult to prevent
71
Annual Report on Form 20-F for the
year ended December 31, 2024
or enforce. Consequently, we may not be able to prevent third parties from practicing our inventions in the United
States or abroad.
Intellectual property rights of third parties could adversely affect our ability to commercialize our
product(s) and product candidates, and we might be required to litigate or obtain licenses from third
parties in order to develop, test or market our product(s) and product candidates.
Because our products and product candidates are still in early stages of development, testing or
commercialization, and one or more features of the products or product candidates, or related technologies such
as their manufacture, formulation, testing or use, may still change, we cannot be confident that we are aware of
all third-party intellectual property that might be relevant to products that we eventually hope to commercialize.
Furthermore, even if all aspects of our product(s) or product candidates, or of other technology, were known, it is
possible that third-party intellectual property, which may or may not currently be public, could develop in a
manner (for example, through issuance of additional patents) that could impede our ability to make or use
relevant products or product candidates, or other technology. Various third-party competitors practice in relevant
spaces, and may have issued patents, or patent applications that will issue as patents in the future, that will
impede or preclude our ability to commercialize products. Furthermore, while U.S. patent laws provide a “safe
harbor” to our clinical product candidates under 35 U.S.C. § 271(e)(1), which exempts from patent infringement
activities related to pursuing FDA approval for a drug product, that exemption expires when an NDA or BLA is
submitted. Accordingly, after such submission (including for certain formulations of our COVID-19 vaccine), the
271(e)(1) safe harbor may no longer provide the same level of protection from third party patent infringement
claims for that product. We may become exposed to lawsuits from third parties who consider our COVID-19
vaccine to infringe their patents. More generally, given the uncertainty of clinical trials, we cannot be certain of
the timing of their completion and it is possible that we might want to submit an NDA or BLA at a time when one
or more relevant third-party patents is in force. Thus, it is possible that at the time that we commercialize our
product candidates, one or more third parties may have issued patent claims that cover such products or critical
features of their production, testing or use. We may not be able to commercialize our products if patents issued
to third parties or other third-party intellectual property rights cover, or may be alleged to cover, our products or
elements thereof, or their methods of manufacture, testing or use at the time that we seek to commercialize
them. In such cases, we may not be in a position to develop, test or commercialize product candidates unless
we successfully pursue litigation to nullify or invalidate the third-party intellectual property right concerned,
successfully design around their claims, or enter into a license agreement with the intellectual property right
holder(s). Such litigation or licenses could be costly, licenses could not be available on commercially reasonable
terms or at all, and design-around could be prohibitively expensive or impossible.
Additionally, with respect to our products, product candidates and related technologies that may play a role in
addressing a pandemic or other public health emergency, it is unclear whether governments around the world
will protect vaccine manufacturers for liability from infringement of third party intellectual property, at least during
the period of such public health emergency. Thus, it is possible that third parties may assert intellectual property
rights against us relating to our COVID-19 vaccine, and that we will not be successful in arguing that
commercialization of our COVID-19 vaccine is exempted from infringement and/or liability for infringement (for
example, under 35 U.S.C. § 271(e)(1), discussed above, or under the Public Readiness and Emergency
Preparedness Act, or the PREP Act, etc.). Furthermore, even if such commercialization was deemed protected
from infringement during the period of the pandemic crisis, now that various global and U.S. agencies have
declared an end to the global COVID-19 public health emergency, any such exemption may be terminated so
that continuing commercialization could expose us to liability, and might even be precluded if third party(ies) who
hold relevant intellectual property rights are able to secure injunction(s) or are unwilling to license to us on
commercially feasible terms.
It is also possible that we have failed to identify relevant third-party patents that cover, or applications that will
mature into patents that cover, one or more aspects of our platform or product(s) and product candidates. Given
that, in most jurisdictions, a patent application is confidential when initially filed, and typically remains so until it is
published about 18 months after the initial filing, it may not be possible for us to identify certain relevant filings in
time to avoid using the technology that they claim. Additionally, the claims of pending patent applications can,
subject to certain limitations, be amended over time, so that even patent applications whose claims did not cover
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Annual Report on Form 20-F for the
year ended December 31, 2024
our products or activities when published could be amended to cover one or more aspects of our platform or
product candidates over time, and we might not be aware that such amendment had been made.
We may be involved in lawsuits or other legal proceedings to protect or enforce our intellectual property
or the intellectual property of our licensors, or to defend against third-party claims that we infringe,
misappropriate or otherwise violate such third party’s intellectual property, each of which could be
expensive, time consuming and unsuccessful.
There is a substantial amount of litigation, both within and outside the United States, involving patent and other
intellectual property rights in the biotechnology and pharmaceutical industries, including patent infringement
lawsuits, interferences, oppositions, ex parte reexaminations, post-grant review, and inter partes review
proceedings before the USPTO and corresponding European and other non-U.S. patent offices.
Competitors and other third parties may infringe, misappropriate or otherwise violate our intellectual property
rights or those of our licensors. To prevent infringement, misappropriation or other unauthorized use, we may be
required to file claims, which can be expensive and time-consuming. In certain instances, we have instituted and
may in the future institute inter partes review proceedings against issued U.S. patents and opposition
proceedings against European patents owned by third parties. We have a number of opposition proceedings
ongoing at the EPO against third-party patents related to mRNA technologies. As the biotechnology and
pharmaceutical industries expand and more patents are issued, the risk increases that our products, product
candidates and services may be subject to claims of infringement of the patent rights of third parties.
In addition, in a patent infringement proceeding, our owned or in-licensed patents may be challenged and a court
may decide that a patent we own or in-license is not valid, is unenforceable and/or is not infringed. If we or any
of our potential future collaborators were to initiate legal proceedings against a third party to enforce a patent
directed at one of our product(s) and/or product candidates, the defendant could counterclaim that our patent is
invalid and/or unenforceable in whole or in part. In patent litigation in the United States, defendant counterclaims
alleging invalidity and/or unenforceability are commonplace. Grounds for a validity challenge include an alleged
failure to meet any of several statutory requirements, including novelty, non-obviousness, enablement or written
description. Grounds for an unenforceability assertion could include an allegation that someone connected with
prosecution of the patent withheld relevant information from the USPTO or made a misleading statement during
prosecution. Third parties may also raise similar claims before the USPTO, even outside the context of litigation.
Similar mechanisms for challenging the validity and enforceability of a patent exist in ex-U.S. patent offices and
may result in the revocation, cancellation or amendment of any ex-U.S. patents we hold in the future. The
outcome following legal assertions of invalidity and unenforceability is unpredictable, and prior art could render
our patents or those of our licensors invalid. If a defendant were to prevail on a legal assertion of invalidity and/or
unenforceability, we could lose at least part, and perhaps all, of the patent protection on a product and/or product
candidate. Such a loss of patent protection would have a material adverse impact on our competitive position,
business, financial conditions, results of operations and prospects.
Third parties, including our competitors to non-practicing entities or patent assertion entities, may assert that we
are employing their intellectual property and other proprietary technology without authorization. There may be
third-party patents or patent applications with claims to materials, formulations, testing, methods of manufacture
or methods for treatment related to the use, development, testing, manufacture or commercialization of our
COVID-19 vaccine or product candidates.
F
or example, BioNTech SE and certain of our wholly owned
subsidiaries are defendants in litigations initiated by CureVac, Alnylam, Moderna, Arbutus, Genevant, GSK, and
Promosome regarding
Comirnaty
.
See “Legal Proceedings” in this Annual Report. As patent applications can
take many years to issue, there may be currently pending patent applications which may later result in issued
patents that our product(s) and/or product candidates may infringe. In addition, third parties may obtain patents
in the future and claim that our technologies infringe upon these patents. If any third-party patents were held by a
court of competent jurisdiction to cover the testing or manufacturing processes of any of our product(s) and/or
product candidates, any molecules formed during the testing and manufacturing processes or any final product
itself, the holders of any such patents may obtain injunctive or other equitable relief, which could effectively block
our ability to develop, test and commercialize such product and/or product candidate unless we obtained a
license under the applicable patents, or until such patents expire. Similarly, if any third-party patents were held
by a court of competent jurisdiction to cover aspects of our formulations, processes for testing or manufacture or
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Annual Report on Form 20-F for the
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methods of use, including combination therapy, the holders of any such patents may be able to block our ability
to develop, test and commercialize the applicable product and/or product candidate unless we obtained a license
or until such patent expires. In either case, such a license may not be available on commercially reasonable
terms, or at all, or may be non-exclusive.
Interference or derivation proceedings provoked by third parties or brought by us or declared by the USPTO may
be necessary to determine the priority of inventions with respect to our patents or patent applications or those of
our licensors. An unfavorable outcome could require us to cease using the related technology or to attempt to
license rights to it from the prevailing party. Our business could be harmed if the prevailing party does not offer
us a license on commercially reasonable terms or at all, or if a non-exclusive license is offered and our
competitors gain access to the same intellectual property and technology. Our defense of litigation, interference,
derivation or similar proceedings may fail and, even if successful, may result in substantial costs and distract our
management, technical personnel and other employees. In addition, the uncertainties associated with litigation
could have a material adverse effect on our ability to raise the funds we need to continue our clinical trials and
research programs, to license necessary technology from third parties or to enter into development or
manufacturing collaborations that would help us bring our product(s) and/or product candidates to market.
Even if resolved in our favor, litigation or other legal proceedings relating to our intellectual property rights may
cause us to incur significant expenses, and could distract our management, technical personnel and other
employees from their normal responsibilities. Such proceedings could substantially increase our operating losses
and reduce the resources available for development activities or any future sales, marketing or distribution
activities. We may not have sufficient financial or other resources to conduct such proceedings adequately.
Some of our competitors may be able to sustain the costs of such proceedings more effectively than we can
because of their greater resources in one or more aspects, or for other reasons. Uncertainties resulting from the
initiation and continuation of patent litigation or other proceedings could compromise our ability to compete in the
marketplace.
In the event of a successful claim of infringement, misappropriation or other violation against us, we may have to
pay substantial damages, including treble damages and attorneys’ fees for willful infringement, pay royalties,
redesign our infringing products, or obtain one or more licenses from third parties, which may not be made
available on commercially favorable terms, if at all, or may require substantial time and expense.
Such licenses are likely to be non-exclusive and, therefore, our competitors may have access to the same
intellectual property and technology licensed to us. If we fail to obtain a required license and are unable to
design around a patent, we may be unable to effectively market some of our technology and product(s) and/or
product candidates, which could limit our ability to generate revenues or achieve or maintain profitability and
possibly prevent us from generating revenue sufficient to sustain our operations. Moreover, certain of our
collaborations provide, and we expect additional collaborations to provide, that royalties payable to us for
licenses to our intellectual property may be offset by amounts paid by our collaborators to third parties for
licenses to such third parties’ intellectual property in the relevant fields, which could result in significant
reductions in our revenues from products developed through collaborations.
In addition, in connection with certain license and collaboration agreements, we have agreed to indemnify certain
third parties for certain costs incurred in connection with litigation relating to intellectual property rights or the
subject matter of the agreements. The cost to us of any litigation or other proceeding relating to intellectual
property rights, even if resolved in our favor, could be substantial.
Furthermore, because of the substantial amount of discovery required in connection with intellectual property
litigation, there is a risk that some of our confidential information could be compromised by disclosure during this
type of litigation. There could also be public announcements of the results of hearings, motions or other interim
proceedings or developments in any litigation or other intellectual property proceedings. If securities analysts or
investors perceive these results to be negative, the price of the ADSs representing our ordinary shares could
decline.
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Obtaining and maintaining our patent protection depends on compliance with various procedural, document
submission, fee payment and other requirements imposed by governmental patent agencies, and our patent
protection could be reduced or eliminated for non- compliance with these requirements.
Periodic maintenance fees, renewal fees, annuity fees, and various other governmental fees on patents and
applications will be due to be paid to the USPTO and various governmental patent agencies outside of the
United States in several stages over the lifetime of the patents or applications. We have systems in place to
remind us to pay these fees and we employ an outside firm and rely on our outside counsel to pay these fees
due to non-U.S. patent agencies; however, we cannot guarantee that we will successfully pay these fees. The
USPTO and various non-U.S. governmental patent agencies require compliance with a number of procedural,
documentary, fee payment, and other similar provisions during the patent application process. We employ
reputable law firms and other professionals to help us comply, and in many cases, an inadvertent lapse can be
cured by payment of a late fee or by other means in accordance with the applicable rules. However, there are
situations in which non-compliance can result in abandonment or lapse of the patent or patent application,
resulting in partial or complete loss of patent rights in the relevant jurisdiction. We are also dependent on our
licensors to take the necessary action to comply with these requirements with respect to our in-licensed
intellectual property, and we cannot guarantee that they will do so. In such an event, our competitors might be
able to enter the market with similar or identical products or technology, and this would have a material adverse
impact on our business, financial condition, results of operations and prospects.
Changes in patent law in the United States or in other countries could diminish the value of patents in
general, thereby impairing our ability to protect our products.
As is the case with other biotechnology companies, our success is heavily dependent on our intellectual property
rights, particularly patents that we own and in-license. Obtaining and enforcing patents in the biotechnology
industry involve both technological and legal complexity, and therefore obtaining and enforcing biotechnology
patents is costly, time-consuming and inherently uncertain. Moreover, there are periodic changes in patent law.
For example, after March 2013, under the America Invents Act, the United States transitioned to a first inventor
to file system in which, assuming that other requirements for patentability are met, the first inventor to file a
patent application will be entitled to the patent on an invention regardless of whether a third party was the first to
invent the claimed invention. The America Invents Act also includes a number of significant changes that have
affected the way patent applications are prosecuted and also affect patent litigation. Such legislation and its
implementation could increase the uncertainties and costs surrounding the prosecution of our patent applications
and the enforcement or defense of our issued patents, all of which could have a material adverse effect on our
business, financial condition, results of operations and prospects.
In addition, decisions by courts and governmental bodies in the United States and other jurisdictions may affect
the value of patent applications, issued patents or other intellectual property that we own or in-license. For
example, recent U.S. Supreme Court rulings have narrowed the scope of patent protection available in certain
circumstances and weakened the rights of patent owners in certain situations. In addition to increasing
uncertainty with regard to our ability to obtain patents in the future, this combination of events has created
uncertainty with respect to the value of patents, once obtained. Depending on decisions by the U.S. Congress,
the federal courts, the USPTO and other administrative agencies, and their equivalents in other jurisdictions, the
laws and regulations governing patents could change in unpredictable ways that could have a material adverse
effect on our existing patent portfolio and our ability to obtain, maintain, protect, defend or enforce our intellectual
property in the future.
If we are unable to protect the confidentiality of our trade secrets, our business and competitive position
would be harmed.
In addition to seeking patent protection for some of our technology, product(s) and product candidates, we also
seek to rely on trade secret protection and confidentiality agreements to maintain our competitive position and
protect proprietary know-how that is not patentable, processes for which patents are difficult to enforce and any
other elements of our product discovery development, testing, manufacturing and commercialization processes
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Annual Report on Form 20-F for the
year ended December 31, 2024
that involve proprietary know-how, information or technology that is not covered by patents. However, trade
secrets and know-how may be difficult to protect.
We seek to protect these trade secrets, know-how and other proprietary technology, in part, by entering into non-
disclosure and confidentiality agreements with parties who have access to them, such as our employees,
corporate collaborators, outside scientific collaborators, CROs, CMOs, consultants, advisors and other third
parties. We also enter into confidentiality and invention or patent assignment agreements with our employees
and consultants and require all of our employees and key consultants who have access to our trade secrets,
proprietary know-how, information or technology to enter into confidentiality agreements. We cannot guarantee
that we have entered into such agreements with each party that may have or have had access to our trade
secrets or proprietary technology and processes. To the extent we become involved in litigation that may require
discovery of our trade secrets, know-how and other proprietary technology, we seek to secure protective orders
from the court that bind the parties with access to the discovered information. Despite our best efforts, we cannot
be certain that our trade secrets and other confidential proprietary information will not be disclosed or that
competitors will not otherwise gain access to our trade secrets or independently develop substantially equivalent
information and techniques. Any of these parties who may have access to our trade secrets, know-how and
other proprietary technology may breach such agreements or orders. For example, a former employee of our
COVID-19 vaccine collaborator, Pfizer, has reportedly misappropriated trade secrets on our COVID-19 vaccine.
We may not be able to obtain adequate remedies for such breaches. Enforcing a claim that a party illegally
disclosed or misappropriated a trade secret or know-how is difficult, expensive and time-consuming, and the
outcome is unpredictable. In addition, some courts inside and outside the United States are less willing or
unwilling to protect trade secrets and know-how. In addition, we cannot be certain that our proprietary technical
information and related confidential documents that we have shared with our collaborators and/or have
submitted to governmental agencies including regulatory agencies for evaluation and supervision of
pharmaceutical products will be kept confidential. For example, certain documents relating to our COVID-19
vaccine were unlawfully accessed after a cyberattack on the EMA in December 2020. If any of our trade secrets
or know-how were to be lawfully obtained or independently developed by a competitor or other third party, we
would have no right to prevent them from using that technology or information to compete with us. If we are
unable to prevent unauthorized material disclosure of our intellectual property to third parties, we may not be
able to establish or maintain a competitive advantage in our market, which could materially adversely affect our
business, operating results, financial condition and prospects.
We may be subject to claims that we have wrongfully hired an employee from a competitor, or that our
employees, consultants or independent contractors have wrongfully used or disclosed confidential
information of third parties, including alleged trade secrets of their former employers.
We have received confidential and proprietary information from third parties in the course of our research and
other collaborations with others in the industry, academic institutions and other third parties. In addition, many of
our employees, consultants and advisors are currently or were previously employed at universities or other
biotechnology or pharmaceutical companies, including our competitors or potential competitors. Although we try
to ensure that our employees, consultants, independent contractors and advisors do not use the confidential or
proprietary information, trade secrets or know-how of others in their work for us, we may be subject to claims
that we have inadvertently or otherwise used or disclosed confidential or proprietary information, trade secrets or
know-how of these third parties, or that our employees, consultants, independent contractors or advisors have
inadvertently or otherwise used or disclosed confidential information, trade secrets or know-how of such
individual’s current or former employer. If we fail in defending any such claims, in addition to paying monetary
damages, we may lose valuable intellectual property rights or personnel. Litigation may be necessary to defend
against these claims. Even if we are successful in defending against these claims, litigation could result in
substantial cost and be a distraction to our management, technical personnel and other employees. Claims that
we or our employees, consultants or advisors have misappropriated the confidential or proprietary information,
trade secrets or know-how of third parties could have a material adverse effect on our business, financial
condition, results of operations and prospects.
We may be subject to claims challenging the inventorship or ownership of our patents and other
intellectual property.
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Annual Report on Form 20-F for the
year ended December 31, 2024
In the future, we may be subject to claims that current or former employees, consultants, independent
contractors, collaborators or other third parties have an interest in our patents or other intellectual property as an
inventor or co-inventor. While it is our policy to require our employees, consultants, independent contractors,
collaborators and other third parties who may be involved in the conception, development or reduction to
practice of intellectual property to execute agreements assigning such intellectual property to us, we may be
unsuccessful in executing such an agreement with each party who, in fact, conceives, develops or reduces to
practice such intellectual property that we regard as our own. In addition, certain such agreements, even if
successfully executed may distribute ownership or control of intellectual property rights between or among
parties, for example based on subject matter, relationship to other intellectual property, and/or one or more
aspects of development of the intellectual property; after the agreements are in place disputes may arise over
such distribution principles or over proper treatment of particular developed intellectual property in accordance
with them. Disagreements may be difficult or impossible to resolve, may be expensive to address, and may
result in our failing to secure or maintain ownership in or control of intellectual property necessary or important to
our business.
The assignment of intellectual property rights may not be self-executing, or the assignment agreements may be
breached. For example, we may have inventorship or ownership disputes arise from conflicting obligations of
employees, consultants, independent contractors, collaborators or other third parties who are involved in
developing and commercializing our product(s) and/or product candidates. Litigation may be necessary to
defend against these and other claims challenging inventorship or ownership. If we fail in defending any such
claims, in addition to paying monetary damages, we may lose valuable intellectual property rights, such as
exclusive ownership of, or right to use, valuable intellectual property. Such an outcome could have a material
adverse effect on our business, operating results and financial condition. Even if we are successful in defending
against such claims, litigation could result in substantial costs and be a distraction to management, technical
personnel and other employees.
Furthermore, the laws of some other countries do not protect intellectual property and other proprietary rights or
establish ownership of inventions to the same extent or in the same manner as the U.S. laws. A majority of our
employees work in Germany and are subject to German employment law. Ideas, developments, discoveries and
inventions made by such employees are subject to the provisions of the German Act on Employees’ Inventions,
which regulates the ownership of, and compensation for, inventions made by employees. We face the risk that
disputes can occur between us and our employees or former employees pertaining to alleged non-adherence to
the provisions of this act that may be costly to defend and take up our management’s, technical personnel’s and
other employees’ time and efforts whether we prevail or fail in any such dispute. There is a risk that the
compensation we provided to employees who assign patents to us may be deemed to be insufficient and we
may be required under German law to increase the compensation due to such employees for the use of the
patents. In those cases, where employees’ rights have not been assigned to us, we may need to pay
compensation for the use of those patents. If we are required to pay additional compensation or face other
disputes under the German Act on Employees’ Inventions, our business, results of operations and financial
condition could be adversely affected.
We will not seek to protect our intellectual property rights in all jurisdictions throughout the world, and
we may not be able to adequately enforce our intellectual property rights even in the jurisdictions where
we seek protection.
Filing, prosecuting and defending patents on product(s) and/or product candidates in all countries throughout the
world would be prohibitively expensive, and our intellectual property rights in some countries outside the United
States, particularly those in Asia, including China, can be less extensive than those in the United States. In
addition, the laws of some countries do not protect intellectual property rights to the same extent as laws in
Germany and the United States. Consequently, we may not be able to prevent third parties from practicing our
inventions in all countries outside the United States to the same extent as within the United States, or from
selling or importing products made using our inventions in and to the United States or other jurisdictions.
Competitors may use our technologies in jurisdictions where we have not obtained patent protection to develop
their own product candidates and further, may export otherwise infringing products to territories where we have
patent protection, but enforcement is not as strong as that in the United States. These products may compete
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Annual Report on Form 20-F for the
year ended December 31, 2024
with our product(s) and/or product candidates, and our patents or other intellectual property rights may not be
effective or sufficient to prevent them from competing.
Many companies have encountered significant problems in protecting and defending intellectual property rights
in certain jurisdictions, particularly outside of Europe and the United States. The legal systems of certain
countries, particularly certain developing countries, do not favor the enforcement of patents, trade secrets and
other intellectual property protection, particularly those relating to biotechnology products, which could make it
difficult for us to stop the infringement, misappropriation or other violation of our patents and other intellectual
property or development, testing, marketing and commercialization of competing products in violation of our
owned or in-licensed intellectual property and other proprietary rights generally. Proceedings to enforce our
intellectual property rights in such jurisdictions could result in substantial costs and divert our efforts and
attention from other aspects of our business, could put our patents at risk of being invalidated or interpreted
narrowly and our patent applications at risk of not issuing and could provoke third parties to assert claims against
us. We may not prevail in any lawsuits that we initiate and the damages or other remedies awarded, if any, may
not be commercially meaningful. Accordingly, our efforts to enforce our intellectual property rights around the
world may be inadequate to obtain a significant commercial advantage from the intellectual property that we
develop or in-license. In particular, the validity, enforceability and scope of protection of intellectual property in
China, where we derive net sales and maintain collaboration partnerships including licensing, are still evolving
and historically, have not protected and may not protect in the future, intellectual property rights to the same
extent as laws developed in Europe, including Germany, and the United States. Consequently, the time required
to enforce our intellectual property rights in the legal regime of China may be lengthy and delay our recovery.
Many countries have compulsory licensing laws under which a patent owner may be compelled to grant licenses
to third parties. In addition, many countries limit the enforceability of patents against government agencies or
government contractors. In these countries, the patent owner may have limited remedies, which could materially
diminish the value of such patent. If we or any of our licensors is forced to grant a license to third parties with
respect to any patents relevant to our business, our competitive position may be impaired, and our business,
financial condition, results of operations and prospects may be adversely affected.
If our trademarks and trade names are not adequately protected, we may not be able to build name recognition
in our markets of interest and our business may be adversely affected.
Our registered or unregistered trademarks or trade names may be challenged, infringed, circumvented or
declared generic or determined to be infringing on other marks. We may not be able to protect our rights to these
trademarks and trade names, which we need to build name recognition among potential collaborators or
customers in our markets of interest. At times, competitors may adopt trade names or trademarks similar to ours
or collaborators may fail to use our trade names or trademarks appropriately or at all, thereby impeding our
ability to build brand identity and possibly leading to market confusion. In addition, there could be potential trade
name or trademark infringement claims brought by owners of other trademarks or trademarks that incorporate
variations of our registered or unregistered trademarks or trade names. Over the long term, if we are unable to
establish name recognition based on our trademarks and trade names, we may not be able to compete
effectively and our business may be adversely affected. We may license our trademarks and trade names to
third parties, such as distributors and collaborators. Though these license agreements may provide guidelines
for how our trademarks and trade names may be used, a breach of these agreements or misuse or failure to use
of our trademarks and trade names by our licensees may jeopardize our rights in or diminish the goodwill
associated with our trademarks, and trade names. Our efforts to enforce or protect our proprietary rights related
to trademarks, trade names, trade secrets, know-how, domain names, copyrights or other intellectual property
may be ineffective and could result in substantial costs and diversion of resources and could adversely affect our
business, financial condition, results of operations and prospects.
Intellectual property rights do not necessarily address all potential threats to our competitive advantage.
The degree of future protection afforded by our intellectual property rights is uncertain because intellectual
property rights have limitations, and may not adequately protect our business or permit us to maintain our
competitive advantage. For example:
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Annual Report on Form 20-F for the
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•
others may be able to make COVID-19 vaccines or therapies, and/or individualized cancer
immunotherapies that are similar to our COVID-19 vaccine and/or any product candidates we may
develop and commercialize or utilize similar technologies that are not covered by the claims of the
patents that we now or may in the future own or have exclusively in-licensed;
•
we, our co-owners or our licensors or future collaborators might not have been the first to make the
inventions covered by the issued patents or pending patent applications that we own or have exclusively
in-licensed;
•
we, our co-owners or our licensors or future collaborators might not have been the first to file patent
applications covering certain of our or their inventions;
•
others may independently develop similar or alternative technologies or duplicate any of our
technologies without infringing our owned or in-licensed intellectual property rights;
•
it is possible that our pending patent applications or those that we may own or in-license in the future will
not lead to issued patents;
•
claims of issued patents that we own or have exclusively in-licensed may be held invalid or
unenforceable, including as a result of legal challenges by our competitors;
•
our competitors might conduct research, development, testing or commercialization activities in
countries where we do not have patent rights and then use the information learned from such activities
to develop competitive products for sale in our major commercial markets;
•
we may not develop additional proprietary technologies that are patentable;
•
the patents of others may have an adverse effect on our business; and
•
we may choose not to file a patent in order to maintain certain trade secrets or know-how, and a third
party may subsequently file a patent covering such intellectual property.
Should any of these events occur, they could have a material adverse effect on our business, financial condition,
results of operations and prospects.
Risks Related to Government Regulation
We may not be able to develop or obtain approval for companion diagnostics required for
commercialization of some of our product candidates.
Administration of some of our product candidates may require the use of immuno-assays and bioinformatic tools
in which patients are screened for optimal target antigens of our product candidates. If safe and effective use of
a biologic product depends on an in vitro diagnostic, then the FDA generally requires approval or clearance of
the diagnostic, known as a companion diagnostic, concurrently with approval of the therapeutic product. To date,
the FDA has generally required in vitro companion diagnostics intended to select the patients who will respond to
cancer treatment to obtain a pre-market approval, or PMA, for that diagnostic, which can take up to several
years, simultaneously with approval of the biologic product. Similarly, in the European Union, an in vitro
companion diagnostic may be placed on the market only if it conforms to certain “essential requirements” and
bears the Conformité Européene Mark, or CE Mark. The conformity assessment process to obtain the CE Mark
can be lengthy and we may fail to demonstrate such conformity. Further, the applicable regulatory framework for
in vitro diagnostics in the EU changed in May 2022 when a new EU regulation with stricter regulatory
requirements for in vitro diagnostics became applicable.
For our individualized immunotherapy candidates, the FDA and comparable regulatory authorities outside of the
United States may require the development and regulatory approval of a companion diagnostic assay as a
condition to approval. The FDA may require PMA supplemental approvals for use of that same companion
diagnostic as a condition of approval of additional individualized therapeutic candidates. We do not have
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experience or capabilities in developing or commercializing companion diagnostics and plan to rely in large part
on third parties to perform these functions. Companion diagnostic assays are subject to regulation by the FDA
and other comparable regulatory authorities in other jurisdictions as medical devices and require separate
regulatory approval prior to the use of such diagnostic assays with our individualized therapeutic candidates. If
we, or any third parties that we engage to assist us, are unable to successfully develop companion diagnostic
assays for use with our individualized therapeutic candidates, or are unable to obtain regulatory approval or
experience delays in either development or obtaining regulatory approval, we may be unable to identify patients
with the specific profile targeted by our product candidates for enrollment in our clinical trials. Accordingly, further
investment may be required to further develop or obtain the required regulatory approval for the relevant
companion diagnostic assay, which would delay or substantially impact our ability to conduct additional clinical
trials or obtain regulatory approval.
Because we are developing some of our product candidates for the treatment of diseases in which there
is little clinical experience and, in some cases, using new endpoints or methodologies, the FDA, the EMA
or other regulatory authorities may not consider the endpoints of our clinical trials to provide clinically
meaningful results.
There may not be pharmacologic therapies approved to treat the underlying causes of many diseases that we
may address in the future. For instance, we and our collaborators are applying our technology to develop
therapeutics in indications such as certain rare diseases, including some for which no or few clinical trials have
been attempted. As a result, any future design and conduct of clinical trials of product candidates for the
treatment of certain rare diseases may take longer, be more costly, or be less effective as part of the novelty of
development in these diseases. Even if we decide to conduct clinical trials and the FDA does find our success
criteria to be sufficiently validated and clinically meaningful, we may not achieve the pre-specified endpoint to a
degree of statistical significance in any pivotal or other clinical trials we or our collaborators may conduct for our
programs. Further, even if we do achieve the pre-specified criteria, our trials may produce results that are
unpredictable or inconsistent with the results of the more traditional efficacy endpoints in the trial. The FDA also
could give overriding weight to other efficacy endpoints over a primary endpoint, even if we achieve statistically
significant results on that endpoint, if we do not do so on our secondary efficacy endpoints. The FDA also weighs
the benefits of a product against its risks and the FDA may view the efficacy results in the context of safety as
not being supportive of licensure. Other regulatory authorities in Europe and other jurisdictions may make similar
findings with respect to these endpoints.
The FDA, the EMA or other comparable regulatory authorities may disagree with our regulatory plan and
we may fail to obtain regulatory approval of our product candidates.
If the results of our clinical trials are sufficiently compelling, we or our collaborators intend to discuss with the
FDA and regulatory authorities in other countries the submission of a BLA or respective applications in other
countries for our product candidates. However, we do not have any agreement or guidance from the FDA that
our regulatory development plans will be sufficient for submission of a BLA for any of our product candidates.
The FDA, the EMA or other regulatory agencies may grant accelerated approval for our product candidates and,
as a condition for accelerated approval, the FDA, the EMA or other regulatory agencies may require a sponsor of
a drug or biologic receiving accelerated approval to perform post-marketing studies to verify and describe the
predicted effect on irreversible morbidity or mortality or other clinical endpoint, and the drug or biologic may be
subject to withdrawal procedures by the FDA, the EMA or other regulatory agencies that are more accelerated
than those available for regular approvals. In addition, the standard of care may change with the approval of new
products in the same indications that we are studying. This may result in the FDA, the EMA or other regulatory
agencies requesting additional studies to show that our product candidate is superior to the new products.
Our clinical trial results may also not support approval. In addition, our product candidates could fail to receive
regulatory approval for many reasons, including the following:
•
the FDA, the EMA or comparable regulatory authorities may disagree with the design or implementation
of our clinical trials;
•
we may be unable to demonstrate to the satisfaction of the FDA, the EMA or comparable regulatory
authorities that our product candidates are safe and effective for any of their proposed indications;
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•
the results of clinical trials may not meet the level of statistical significance required by the FDA, the EMA
or comparable regulatory authorities for approval, including due to the heterogeneity of patient
populations;
•
we may be unable to demonstrate that our product candidates’ clinical and other benefits outweigh their
safety risks;
•
the FDA, the EMA or comparable regulatory authorities may disagree with our interpretation of data from
preclinical studies or clinical trials;
•
the data collected from clinical trials of our product candidates may not be sufficient to the satisfaction of
the FDA, the EMA or comparable regulatory authorities to support the submission of a BLA or other
comparable submissions or to obtain regulatory approval in the United States or elsewhere;
•
the FDA, the EMA or comparable regulatory authorities will inspect our manufacturing facilities and may
not approve our facilities or our manufacturing processes and controls;
•
the approval policies or regulations of the FDA, the EMA or comparable regulatory authorities may
significantly change in a manner rendering our clinical data insufficient for approval; and
•
appointees of the new presidential administration in the United States may seek to change regulatory
requirements for the approval of products or the approach to the review of product applications.
We may not be able to file INDs with the FDA, clinical trial applications with the competent authorities of
the member states of the European Union or similar applications with other comparable regulatory
authorities to commence additional clinical trials on the timelines we expect, and even if we are able to,
one or more of these regulatory authorities may not permit us to proceed.
The timing of filing on our product candidates is dependent on further preclinical, clinical and manufacturing
success. We cannot be sure that submission of an IND or IND amendment with the FDA, a clinical trial
application with the regulatory authorities of the EU member states or similar application with other comparable
regulatory authorities will result in the FDA, the regulatory authorities of the EU member states or any
comparable regulatory authority allowing testing and clinical trials to begin, or that, once begun, issues will not
arise that result in the suspension or termination of such clinical trials. Additionally, even if such regulatory
authorities agree with the design and implementation of the clinical trials set forth in an IND, clinical trial
application or similar applications, we cannot guarantee that such regulatory authorities will not change their
requirements in the future.
We may seek Orphan Drug Designation for some or all of our product candidates across various
indications, but we may be unable to obtain such designations or to maintain the benefits associated
with Orphan Drug Designation, including market exclusivity, which may cause our revenue, if any, to be
reduced.
Our strategy includes filing for Orphan Drug Designation where available for our product candidates. Under the
U.S. Orphan Drug Act, the FDA may grant Orphan Drug Designation to a drug or biologic intended to treat a rare
disease or condition, which is defined as one occurring in a patient population of fewer than 200,000 in the
United States, or a patient population of 200,000 or greater in the United States where there is no reasonable
expectation that the cost of developing the drug or biologic will be recovered from sales in the United States. In
the United States, Orphan Drug Designation entitles a party to financial incentives, such as opportunities for
grant funding toward clinical trial costs, tax advantages, and user-fee waivers. In addition, if a product that has
Orphan Drug Designation subsequently receives the first FDA approval for the disease for which it has such
designation, the product is entitled to orphan drug exclusivity, which means that the FDA may not approve any
other applications, including a full new drug application or a BLA, to market the same drug or biologic for the
same indication for seven years, except in limited circumstances, such as a showing of clinical superiority to the
product with orphan drug exclusivity or where the original manufacturer is unable to assure sufficient product
quantity. Similar rules apply in the European Union with respect to drugs or biologics designated as orphan
medicinal products.
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In addition, exclusive marketing rights in the United States may be limited if we seek approval for an indication
broader than the orphan-designated indication or may be lost if the FDA later determines that the request for
designation was materially defective. Further, even if we obtain orphan drug exclusivity for a product, that
exclusivity may not protect the product effectively from competition because different drugs with different active
moieties may receive and be approved for the same condition, and only the first applicant to receive approval will
receive the benefits of marketing exclusivity. Even after an orphan-designated product is approved, the FDA can
subsequently approve a later drug with the same active moiety for the same condition if the FDA concludes that
the later drug is clinically superior if it is shown to be safer, more effective, or makes a major contribution to
patient care. Similar considerations apply in the European Union with respect to drugs or biologics designated as
orphan medicinal products. Orphan Drug Designation neither shortens the development time or regulatory
review time of a drug, nor gives the drug any advantage in the regulatory review or approval process. In addition,
while we may seek Orphan Drug Designation for our product candidates, we may never receive such
designations.
We may seek Breakthrough Therapy or Fast Track designation for one or more of our product
candidates, but we may not receive such designations. Even if we do, it may not lead to a faster
development or regulatory review or approval process, and it may not increase the likelihood that such
product candidates will receive marketing approval.
We may seek a Breakthrough Therapy Designation in the United States for one or more of our product
candidates. A breakthrough therapy is defined as a drug that is intended, alone or in combination with one or
more other drugs, to treat a serious or life-threatening disease or condition, and preliminary clinical evidence
indicates that the drug may demonstrate substantial improvement over existing therapies on one or more
clinically significant endpoints, such as substantial treatment effects observed early in clinical development. For
drugs that have been designated as breakthrough therapies, interaction and communication between the FDA
and the sponsor of the trial can help to identify the most efficient path for clinical development while minimizing
the number of patients placed in ineffective control regimens. Drugs designated as breakthrough therapies by
the FDA are also eligible for priority review if supported by clinical data at the time of the submission of the BLA.
Designation as a breakthrough therapy is at the discretion of the FDA. Accordingly, even if we believe that one of
our product candidates meets the criteria for designation as a breakthrough therapy, the FDA may disagree and
instead determine not to make such designation. In any event, the receipt of a Breakthrough Therapy
Designation for a drug may not result in a faster development process, review or approval compared to drugs
considered for approval under conventional FDA procedures and it would not assure ultimate approval by the
FDA. In addition, even if one or more of our product candidates qualify as breakthrough therapies, the FDA may
later decide that the product candidate no longer meets the conditions for qualification or it may decide that the
time period for FDA review or approval will not be shortened.
We may also seek Fast Track Designation in the United States for some of our product candidates. If a therapy
is intended for the treatment of a serious or life-threatening condition and the therapy demonstrates the potential
to address significant unmet medical needs for this condition, the drug sponsor may apply for Fast Track
Designation. The FDA has broad discretion whether or not to grant this designation, and even if we believe a
particular product candidate is eligible for this designation, we cannot be sure that the FDA would decide to grant
it. Even if we do receive Fast Track Designation, we may not experience a faster development process, review
or approval compared to conventional FDA procedures. The FDA may withdraw Fast Track Designation if it
believes that the designation is no longer supported by data from our clinical development program. Fast Track
Designation alone does not guarantee qualification for the FDA’s priority review procedures.
We expect some of the product candidates we develop will be regulated as biologics in the United States
and therefore they may be subject to competition from biosimilars approved through an abbreviated
regulatory pathway.
The ACA includes a subtitle called the Biologics Price Competition and Innovation Act of 2009, or the BPCIA,
which created an abbreviated approval pathway for biological products that are biosimilar to or interchangeable
with an FDA-approved reference biological product. Under the BPCIA, an application for a biosimilar product
may not be submitted to the FDA until four years following the date that the reference product was first approved
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by the FDA. In addition, the approval of a biosimilar product may not be made effective by the FDA until 12 years
from the date on which the reference product was first approved.
During this 12-year period of exclusivity, another company may still market a competing version of the reference
product if the FDA approves a BLA for the competing product containing the sponsor’s own preclinical data and
data from adequate and well-controlled clinical trials to demonstrate the safety, purity and potency of the other
company’s product. The law is complex and is still being interpreted and implemented by the FDA. As a result, its
ultimate impact, implementation and meaning are subject to uncertainty.
We believe that any of our product candidates approved as a biological product under a BLA should qualify for a
12-year period of exclusivity. However, there is a risk that this exclusivity could be shortened due to
congressional action or otherwise, or that the FDA will not consider our product candidates to be reference
products for competing products, potentially creating the opportunity for generic competition sooner than
anticipated. Other aspects of the BPCIA, some of which may impact the BPCIA exclusivity provisions, have also
been the subject of recent litigation. Moreover, the extent to which a biosimilar, once approved, will be
substituted for any one of our reference products in a way that is similar to traditional generic substitution for
non-biological products is not yet clear, and will depend on a number of marketplace and regulatory factors that
are still developing.
Some of our product candidates are classified as gene therapies by the FDA and the EMA, and the FDA
has indicated that our product candidates will be reviewed within its Center for Biologics Evaluation and
Research, or CBER. Even though our mRNA product candidates are designed to have a different
mechanism of action from gene therapies, the association of our product candidates with gene therapies
could result in increased regulatory burdens, impair the reputation of our product candidates, or
negatively impact our platform or our business.
There have been few approvals of gene therapy products in the United States and other jurisdictions, and there
have been well-reported significant adverse events associated with their testing and use. Gene therapy products
have the effect of introducing new DNA and potentially irreversibly changing the DNA in a cell. In contrast, mRNA
is highly unlikely to localize to the nucleus, be reverse transcribed or integrated into the genome. Consequently,
we expect that our products or product candidates will have a different potential side effect profile from gene
therapies because they lack risks associated with altering cell DNA irreversibly. Further, we may avail ourselves
of ways of mitigating side effects in developing our products and product candidates to address safety concerns
that are not available to other products or product candidates classified as gene therapies, such as lowering the
dose of our products or product candidates during repeat dosing or stopping treatment to potentially ameliorate
undesirable side effects.
Regulatory requirements governing gene and cell therapy products have evolved and may continue to change in
the future, and the implications for mRNA-based therapies is unknown. For example, the FDA has established
the Office of Tissues and Advanced Therapies within CBER to consolidate the review of gene therapy and
related products, and convenes the Cellular, Tissue and Gene Therapies Advisory Committee to advise CBER
on its review. In the European Union, mRNA has been characterized as a gene therapy medicinal product. In
certain countries, mRNA therapies have not yet been classified or any such classification is not known to us.
Notwithstanding the differences between our mRNA product candidates and gene therapies, the classification of
some of our mRNA product candidates as gene therapies in the United States, the European Union and
potentially other counties could adversely impact our ability to develop our product candidates, and could
negatively impact our platform and our business. For instance, a potential future clinical hold on gene therapy
products across the field due to risks associated with altering cell DNA irreversibly could apply to our mRNA
product candidates irrespective of the mechanistic differences between gene therapies and mRNA.
Adverse events reported with respect to gene therapies or genome editing therapies could adversely impact one
or more of our programs. Although our mRNA product candidates are designed not to make any permanent
changes to cell DNA, regulatory agencies or others could believe that adverse effects of gene therapy products
caused by introducing new DNA and irreversibly changing the DNA in a cell could also be a risk for our approved
mRNA products or investigational therapies, and as a result may delay one or more of our trials or impose
additional testing for long-term side effects. Any new requirements and guidelines promulgated by regulatory
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review agencies may have a negative effect on our business by lengthening the regulatory review process,
requiring us to perform additional or larger studies, or increasing our development costs, any of which could lead
to changes in regulatory positions and interpretations, delay or prevent advancement or approval and
commercialization of our product candidates or lead to significant post-approval studies, limitations or
restrictions. As we advance our product candidates, we will be required to consult with these regulatory agencies
and advisory committees and comply with applicable requirements and guidelines. If we fail to do so, we may be
required to delay or discontinue development of some or all of our product candidates.
The regulatory landscape that will govern our product candidates is uncertain. Regulations relating to
more established gene therapy and cell therapy products are still developing, and changes in regulatory
requirements could result in delays or discontinuation of development of our product candidates or
unexpected costs in obtaining regulatory approval.
The regulatory requirements to which our product candidates will be subject are not entirely clear. Even with
respect to more established products that fit into the categories of gene therapies or cell therapies, the regulatory
landscape is still developing. For example, regulatory requirements governing gene therapy products and cell
therapy products have changed frequently and may continue to change in the future. Moreover, there is
substantial, and sometimes uncoordinated, overlap in those responsible for regulation of existing gene therapy
products and cell therapy products. Although the FDA decides whether individual gene therapy protocols may
proceed, the review process and determinations of other reviewing bodies can impede or delay the initiation of a
clinical study, even if the FDA has reviewed the study and approved its initiation. Conversely, the FDA can place
an IND application on clinical hold even if such other entities have provided a favorable review. Furthermore,
gene therapy clinical trials are also subject to review and oversight by an institutional biosafety committee, a
local institutional committee that reviews and oversees basic and clinical research conducted at the institution
participating in the clinical trial. In addition, adverse developments in clinical trials of gene therapy products
conducted by others may cause the FDA or other regulatory bodies to change the requirements for approval of
any of our product candidates.
Complex regulatory environments exist in other jurisdictions in which we might consider seeking regulatory
approvals for our product candidates, further complicating the regulatory landscape. For example, in the
European Union, a special committee called the Committee for Advanced Therapies was established within the
EMA in accordance with Regulation (EC) No 1394/2007 on advanced-therapy medicinal products, or ATMPs, to
assess the quality, safety and efficacy of ATMPs, and to follow scientific developments in the field. ATMPs
include gene therapy products as well as somatic cell therapy products and tissue engineered products.
These various regulatory review committees and advisory groups and new or revised guidelines that they
promulgate from time to time may lengthen the regulatory review process, require us to perform additional
studies, increase our development costs, lead to changes in regulatory positions and interpretations, delay or
prevent approval and commercialization of our product candidates or lead to significant post-approval limitations
or restrictions. As the regulatory landscape for our CAR-T-cell immunotherapy product candidates is new, we
may face even more cumbersome and complex regulations than those emerging for gene therapy products and
cell therapy products. Furthermore, even if our product candidates obtain required regulatory approvals, such
approvals may later be withdrawn as a result of changes in regulations or the interpretation of regulations by
applicable regulatory agencies.
Delay or failure to obtain, or unexpected costs in obtaining, the regulatory approval necessary to bring a potential
product to market could decrease our ability to generate sufficient product sales revenue to maintain our
business.
We may be unable to obtain regulatory approval for our product candidates under applicable
international regulatory requirements.
The denial or delay of such approval would delay commercialization of our product candidates and adversely
impact our potential to generate revenue, our business and our results of operations.
Approval by the FDA in the United States, if obtained, does not ensure approval by regulatory authorities in other
countries or jurisdictions. In order to market our products or product candidates in any other jurisdiction, we must
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establish and comply with numerous and varying regulatory requirements on a jurisdiction-by-jurisdiction basis
regarding safety and efficacy. In addition, clinical trials conducted in one country may not be accepted by
regulatory authorities in other countries, and regulatory approval in one country does not guarantee regulatory
approval in any other country. Approval processes vary among countries and can involve additional product
testing and validation and additional administrative review periods.
Seeking regulatory approval in other jurisdictions could result in difficulties and costs for us and require
additional preclinical studies or clinical trials which could be costly and time-consuming. Regulatory requirements
can vary widely from country to country and could delay or prevent the introduction of our products in those
countries. The European Union and other jurisdictions’ regulatory approval processes involve all of the risks
associated with the FDA approval. If we fail to comply with regulatory requirements in certain markets or to
obtain and maintain required approvals, or if regulatory approvals in certain markets are delayed, our target
market will be reduced and our ability to realize the full market potential of our products will be unrealized.
Certain jurisdictions may have submission requirements for drug clinical trial and marketing applications that
require us or our partners to submit substantial detailed materials related to non-clinical and clinical development
and manufacturing and quality control to drug regulators or testing laboratories. This can include confidential
standard operating procedures or executed batch records for the production of biological products or other
records or documents that set forth detailed information about the manufacturing process. If these materials are
disclosed, lost, or diverted to third parties or competitors during the application preparation process, this could
negatively affect our ability to protect our intellectual property.
Our partners in different countries are subject to local regulatory requirements on the manufacturing and
distribution of drugs and the implementation of clinical and non-clinical research. These include but are not
limited to good manufacturing, distribution, laboratory, clinical practice, and pharmacovigilance rules. If these
companies do not comply with applicable standards, they could become the subjects of investigations and
enforcement, including orders to cease the activities pending remediation that is acceptable to the government.
Such an order or other similar enforcement could interfere with our clinical development activities both in that
jurisdiction and others, if it impacts supply or the quality and transfer of data.
A third-party investigational product candidate used in combination with our product candidates may be
unable to obtain regulatory approval, which may delay commercialization of our product candidates.
We are developing several of our product candidates to be used in combination with our and third-party product
candidates. Even if any product candidate we develop were to receive marketing approval or be commercialized
for use in combination with other existing products, we would continue to be subject to the risks that the FDA, the
EMA or comparable regulatory authorities in other jurisdictions could revoke approval of the product used in
combination with our product or that safety, efficacy, manufacturing or supply issues could arise with any of those
existing products. If the products or product candidates we use in combination with our product candidates are
replaced as the standard of care for the indications we choose for any of our product candidates, the FDA, the
EMA or comparable regulatory authorities in other jurisdictions may require us to conduct additional clinical trials.
The occurrence of any of these risks could result in our own products, if approved, being removed from the
market or being less successful commercially. We also plan to evaluate current and future product candidates in
combination with one or more product candidates that have not yet been approved for marketing by the FDA, the
EMA or comparable regulatory authorities in other jurisdictions. We will not be able to market any product
candidate we develop in combination with an unapproved product candidate if that unapproved product
candidate does not ultimately obtain marketing approval. In addition, unapproved product candidates face the
same risks described with respect to our product candidates currently in development and clinical trials, including
the potential for serious adverse effects, delay in their clinical trials and lack of FDA, EMA or comparable
regulatory authority approval.
If the FDA, the EMA or comparable regulatory authorities in other jurisdictions do not approve these other
product candidates or revoke their approval of, or if safety, efficacy, manufacturing or supply issues arise with,
the products or product candidates we choose to evaluate in combination with any product candidate we
develop, we may be unable to obtain approval of or market any product candidate we develop.
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Our COVID-19 vaccine and any other product candidates for which we receive approval or emergency
use authorization are subject to continuing regulatory oversight, and we will be subject to ongoing
regulatory obligations and continued regulatory review, which may result in significant additional
expense. We may be subject to penalties if we fail to comply with regulatory requirements or experience
unanticipated problems with our products or product candidates.
Our COVID-19 vaccine and any other product candidates for which we receive approval or emergency use
authorization are subject to continuing regulatory oversight, including the review of additional safety information,
and the applicable regulatory authority may still impose significant restrictions on the indicated uses or marketing
of our product or impose ongoing requirements for potentially costly post-approval studies or post-market
surveillance. For example, the holder of an approved BLA is obligated to monitor and report adverse events and
any failure of a product to meet the specifications in the BLA. The holder of an approved BLA must also submit
new or supplemental applications and obtain FDA approval for certain changes to the approved product, product
labeling or manufacturing process. Similar requirements apply to holders of (conditional) approvals in other
countries. Advertising and promotional materials must comply with FDA rules and are subject to FDA review, in
addition to other potentially applicable federal and state laws. In other countries, advertising and promotional
material may be subject to similar rules.
If we fail to comply with applicable regulatory requirements following approval of any of our product candidates, a
regulatory agency may:
•
issue adverse public statements about our business or products;
•
issue a warning letter asserting that we are in violation of the law;
•
seek an injunction or impose civil or criminal penalties or monetary fines;
•
suspend or withdraw regulatory approval or revoke a license;
•
suspend any ongoing clinical studies;
•
refuse to approve a pending BLA (or comparable approval) or supplements to a BLA (or comparable
approval) submitted by us;
•
seize product; or
•
refuse to allow us to enter into supply contracts, including government contracts.
Any government investigation of alleged violations of law could require us to expend significant time and
resources in response and could generate negative publicity. The occurrence of any event or penalty described
above may inhibit our ability to commercialize any approved products and generate revenues.
If any of our products or product candidates cause undesirable side effects, it could delay or prevent their
regulatory approval, limit their commercial potential, or result in significant negative consequences following any
potential marketing approval. Products or product candidates we may develop may be associated with an
adverse immune response or other serious adverse events, undesirable side effects or unexpected
characteristics. In addition to serious adverse events or side effects caused by any of our products or product
candidates, the administration process or related procedures also can cause undesirable side effects. If any
such events occur, the clinical trials of any of our product candidates could be suspended or terminated.
If in the future we are unable to demonstrate that such adverse events were caused by factors other than our
product candidate, the FDA, the EMA or other regulatory authorities could order us to cease further development
of, or deny approval of, any of our product candidates for any or all targeted indications. Even if we are able to
demonstrate that all future serious adverse events are not product-related, such occurrences could affect patient
recruitment or the ability of enrolled trial participants to complete the trial. Moreover, if we elect, or are required,
to delay, suspend or terminate any clinical trial of any of our product candidates, the commercial prospects of
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such product candidates, if approved, may be harmed and our ability to generate product sale revenues from
any of these product candidates may be delayed or eliminated. Any of these occurrences may harm our ability to
identify and develop product candidates, and may harm our business, financial condition, result of operations
and prospects significantly.
Additionally, following regulatory approval of a product candidate, the FDA or other regulatory authority could
require us to adopt a REMS or a risk management plan to ensure that the benefits of treatment with such
product candidate outweigh the risks for each potential patient, which may include, among other things, a
medication guide outlining the risks of the product for distribution to patients, a communication plan to health
care practitioners, extensive patient monitoring, or distribution systems and processes that are highly controlled,
restrictive, and more costly than what is typical for the industry.
Furthermore, if we or others later identify undesirable side effects caused by any product that we develop,
several potentially significant negative consequences could result, including:
•
regulatory authorities may suspend or withdraw approvals or revoke licenses of such product;
•
regulatory authorities may require additional warnings on the label;
•
regulatory authorities may make unfavorable statements about the safety of our products;
•
we may be required to change the way a product is administered or conduct additional clinical trials;
•
we could be sued and held liable for harm caused to patients and their children; and
•
our reputation may suffer.
Any of these events could prevent us from achieving or maintaining market acceptance of any products we may
identify and develop and could have a material adverse effect on our business, financial condition, results of
operations and prospects.
Upon the successful approval of a product candidate, we will continue to face significant regulatory oversight of
its manufacturing and distribution. Product manufacturers and their facilities are subject to payment of user fees
and continual review and periodic inspections by the FDA and other regulatory authorities for compliance with
GMP and adherence to commitments made in the BLA or comparable approval. If we or a regulatory agency
discovers previously unknown problems with a product such as adverse events of unanticipated severity or
frequency, or problems with the facility where the product is manufactured, a regulatory agency may impose
restrictions relative to that product or the manufacturing facility, including requiring recall or withdrawal of the
product from the market or suspension of manufacturing.
We may be subject, directly or indirectly, to federal and state healthcare fraud and abuse laws, false
claims laws, and other healthcare laws. If we are unable to comply, or have not fully complied, with such
laws, we could face substantial penalties.
We may be subject to additional healthcare regulation and enforcement by the U.S. federal government and by
authorities in the United States, the European Union and other jurisdictions in which we conduct our business.
Our operations may be directly, or indirectly through our prescribers, customers and purchasers, subject to
various federal and state fraud and abuse laws and regulations, including, without limitation, the federal Health
Care Program Anti-Kickback Statute, the federal civil and criminal False Claims Act, and the Physician Payments
Sunshine Act and regulations. Many states and other jurisdictions have similar laws and regulations, some of
which may be broader in scope. These laws will impact, among other things, our proposed sales, marketing and
educational programs. In addition, we may be subject to patient privacy laws enacted by both the federal
government and the states in which we conduct our business. The laws that will affect our operations include,
but are not limited to the following:
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•
The U.S. federal Anti-Kickback Statute, which prohibits, among other things, persons or entities from
knowingly and willfully soliciting, receiving, offering or paying any remuneration (including any kickback,
bribe or rebate), directly or indirectly, overtly or covertly, in cash or in kind, in return for the purchase,
recommendation, leasing or furnishing of an item or service reimbursable under a federal healthcare
program, such as the Medicare and Medicaid programs. This statute has been interpreted to apply to
arrangements between pharmaceutical manufacturers on the one hand, and prescribers, purchasers,
and formulary managers on the other. The ACA amends the intent requirement of the federal Anti-
Kickback Statute to provide that a person or entity no longer needs to have actual knowledge of this
statute or specific intent to violate it;
•
The U.S. federal civil and criminal false claims laws and civil monetary penalty laws, which prohibit,
among other things, individuals or entities from knowingly presenting, or causing to be presented, false
or fraudulent claims for payment or approval from Medicare, Medicaid or other government payors. The
ACA provides, and recent government cases against pharmaceutical and medical device manufacturers
support, the view that federal Anti-Kickback Statute violations and certain marketing practices, including
off-label promotion, may implicate the False Claims Act;
•
The U.S. federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, which created
new federal criminal statutes that prohibit a person from knowingly and willfully executing a scheme or
making false or fraudulent statements to defraud any healthcare benefit program, regardless of the
payor (e.g., public or private);
•
HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act and
their implementing regulations, which imposes certain requirements relating to the privacy, security and
transmission of individually identifiable health information without appropriate authorization by entities
subject to the rule, such as health plans, health care clearinghouses and health care providers;
•
The U.S. Federal Food, Drug, and Cosmetic Act, which prohibits, among other things, the adulteration or
misbranding of drugs, biologics and medical devices;
•
The U.S. Public Health Service Act, which prohibits, among other things, the introduction into interstate
commerce of a biological product unless a biologics license is in effect for that product;
•
Federal transparency laws, including the federal Physician Payment Sunshine Act, which require
disclosure of payments and other transfers of value provided to physicians and teaching hospitals, and
ownership and investment interests held by physicians and other healthcare providers and their
immediate family members and applicable group purchasing organizations;
•
U.S. state law equivalents of each of the above federal laws, state laws that require drug manufacturers
to report information related to payments and other transfers of value to physicians and other healthcare
providers or marketing expenditures, and state laws governing the privacy and security of health
information in certain circumstances which are also applicable to us, and many of them differ from each
other in significant ways and may not have the same effect, thus complicating compliance efforts in
certain circumstances;
•
The U.S. Foreign Corrupt Practices Act of 1977, as amended, which prohibits, among other things, U.S.
companies and their employees and agents, as well as non-U.S. companies that are registered with the
SEC, from authorizing, promising, offering or providing, directly or indirectly, corrupt or improper
payments or anything else of value to foreign government officials, employees of public international
organizations and foreign government owned or affiliated entities, candidates for foreign political office,
and foreign political parties or officials thereof; and
•
Similar statutes, healthcare laws and regulations in the European Union and other jurisdictions, including
reporting requirements detailing interactions with and payments to healthcare providers.
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Due to the breadth of these laws and the narrowness of the statutory exceptions and safe harbors available, it is
possible that some of our business activities could be subject to challenge under one or more of such laws. If our
operations are found to be in violation of any of the laws described above or any other government regulations
that apply to us, we may be subject to penalties, including civil and criminal penalties, damages, fines, exclusion
from participation in government health care programs, such as Medicare and Medicaid, imprisonment, and the
curtailment or restructuring of our operations, any of which could adversely affect our ability to operate our
business and our results of operations.
The provision of benefits or advantages to physicians to induce or encourage the prescription, recommendation,
endorsement, purchase, supply, order or use of medicinal products is prohibited in the European Union. The
provision of benefits or advantages to physicians is also governed by the national anti-bribery laws of European
Union member states and other jurisdictions, such as the U.K. Bribery Act 2010. Infringement of these laws
could result in substantial fines and imprisonment.
Payments made to physicians in certain EU member states must be publicly disclosed. Moreover, agreements
with physicians often must be the subject of prior notification and approval by the physician’s employer, his or
her competent professional organization or the regulatory authorities of the individual EU member states. These
requirements are provided in the national laws, industry codes, or professional codes of conduct, applicable in
the EU member states. Failure to comply with these requirements could result in reputational risk, public
reprimands, administrative penalties, fines or imprisonment.
We are subject to certain anti-corruption, anti-money laundering, export control, sanctions, and other
trade laws and regulations. We can face serious consequences for violations.
Among other matters, anti-corruption, anti-money laundering, export control, sanctions, and other trade laws and
regulations, which are collectively referred to as “trade laws,” prohibit companies and their employees, agents,
CROs, legal counsel, accountants, consultants, contractors and other collaborators from authorizing, promising,
offering, providing, soliciting, or receiving directly or indirectly, corrupt or improper payments or anything else of
value to or from recipients in the public or private sector. Violations of trade laws can result in substantial criminal
fines and civil penalties, imprisonment, the loss of trade privileges, debarment, tax reassessments, breach of
contract and fraud litigation, reputational harm, and other consequences. We have direct or indirect interactions
with officials and employees of government agencies or government-affiliated hospitals, universities and other
organizations. We plan to engage third parties for clinical trials and/or to obtain necessary permits, licenses,
intellectual property (including patents) and other regulatory approvals, and we can be held liable for the corrupt
or other illegal activities of our personnel, agents or collaborators, even if we do not explicitly authorize or have
prior knowledge of such activities.
We are subject to stringent privacy laws, information security policies and contractual obligations
governing the use, processing, and cross-border transfer of personal information and our data privacy
and security practices.
We receive, generate and store significant and increasing volumes of sensitive information, such as employee,
personal and patient data.
We are subject to a variety of local, state, national and international laws, directives and regulations that apply to
the collection, use, storage, retention, protection, disclosure, transfer and other processing of personal data,
collectively referred to as “data processing”, in the different jurisdictions in which we operate, including
comprehensive regulatory systems in the United States and Europe. Legal requirements relating to data
processing continue to evolve and may result in ever-increasing public scrutiny and escalating levels of
enforcement, sanctions and increased costs of compliance.
Compliance with U.S. and international data protection laws and regulations could cause us to incur substantial
costs or require us to change our business practices and compliance procedures in a manner adverse to our
business. Moreover, complying with these various laws could require us to take on more onerous obligations in
our contracts, restrict our ability to collect, use and disclose data, or in some cases, impact our ability to operate
in certain jurisdictions. Failure to comply with U.S. and international data protection laws and regulations could
result in government enforcement actions (which could include civil or criminal penalties), private litigation and/or
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adverse publicity and could negatively affect our operating results and business. Claims that we have violated
individuals’ privacy rights, failed to comply with data protection laws, or breached our contractual obligations,
even if we are not found liable, could be expensive and time consuming to defend, could result in adverse
publicity and could have a material adverse effect on our business, financial condition and results of operations.
The collection and use of personal data in the European Union had previously been governed by the provisions
of the EU Data Protection Directive, which EU member states were required to implement. While the Data
Protection Directive did not apply to organizations based outside the European Union, the GDPR has expanded
its reach to include any business, regardless of its location, that targets goods or services to residents in the
European Union or that “monitors” their behavior in the European Union. The GDPR imposes strict requirements
on controllers and processors of personal data, including special protections for “sensitive information” which
includes health and genetic information of patients residing in the European Union. The GDPR also imposes
strict rules on the transfer of personal data out of the European Union to the United States and other countries.
In addition, the GDPR provides that EU member states may make their own further laws and regulations limiting
the processing of personal data, including genetic, biometric or health data.
Since we are located in the European Union, we are subject to the GDPR. Additionally, as the GDPR applies
extraterritorially, we are also subject to the GDPR even where our data processing activities occur outside of the
European Union if such activities involve the personal data of individuals located in the European Union and the
above-mentioned applicable law triggers apply. GDPR regulations have imposed additional responsibility and
liability in relation to the personal data that we process and we may be required to put in place additional
mechanisms to ensure compliance with the new data protection rules. This may be onerous and may interrupt or
delay our development activities, and adversely affect our business, financial condition, results of operations and
prospects.
Other jurisdictions outside the European Union are similarly introducing or enhancing privacy and data security
laws, rules and regulations, which could increase our compliance costs and the risks associated with non-
compliance. In particular, in China, where some of our clinical data are originated, the cybersecurity, data
privacy, data protection, or other data-related laws and regulations, including the Human Genetic Resources
Regulation (which regulates transfer human genetic data generated in clinical research to foreign or foreign
controlled parties), may require approvals or filings prior to transferring those data to foreign-owned entities or
overseas, and these regimes are continually evolving, meaning their interpretation and application may be
uncertain. In the United States, we may be subject to restrictions and requirements under the Department of
Justice’s Final Rule issued on December 27, 2024 implementing the Executive Order on Preventing Access to
Americans’ Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern,
signed on February 28, 2024. Practices regarding the collection, use, storage, transmission and security of
personal information by companies have also been subject to increasing regulatory focus. As such, we cannot
assure you that we will be compliant with such new regulations in all respects, and we may be ordered to rectify
and terminate any actions that are deemed illegal by the government authorities and become subject to fines
and other government sanctions, which may materially and adversely affect our business, financial condition,
and results of operations. In addition, the uncertainties regarding further interpretation and implementation of
these laws and regulations may adversely affect the secure storage of documented work as well as the cross-
border transfer of important data and personal information originated from our clinical trial activities, which are
critical to the development of our pipelines.
We cannot guarantee that we are, or will be, in compliance with all applicable international regulations as they
are enforced now or as they evolve. For example, our privacy policies may be insufficient to protect any personal
information we collect, or may not comply with applicable laws, in which case we may be subject to regulatory
enforcement actions, lawsuits or reputational damage, all of which may adversely affect our business. There is
significant uncertainty related to the manner in which data protection authorities will seek to enforce compliance
with the GDPR and other international data protection regulations, especially with regard to clinical trial activities.
For example, it is not clear if the authorities will conduct random audits of companies doing business in the
European Union, or if the authorities will wait for complaints to be filed by individuals who claim their rights have
been violated, as enforcement practices vary from country to country. Enforcement uncertainty and the costs
associated with ensuring GDPR compliance may be onerous and adversely affect our business, financial
condition, results of operations and prospects. If we fail to comply with the GDPR and the applicable national
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Annual Report on Form 20-F for the
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data protection laws of the EU member states, or if regulators assert we have failed to comply with these laws, it
may lead to regulatory enforcement actions, which can result in monetary penalties of up to €20,000,000 or up to
4% of the total worldwide annual turnover of the preceding financial year, whichever is higher, and other
administrative penalties. If any of these events were to occur, our business and financial results could be
significantly disrupted and adversely affected.
Although we take measures to protect sensitive data from unauthorized access, use or disclosure, our
information technology and infrastructure may be vulnerable to attacks by hackers or viruses or breached due to
employee error, malfeasance or other malicious or inadvertent disruptions. Any such breach or interruption could
compromise our networks and the information stored there could be accessed by unauthorized parties,
manipulated, publicly disclosed, lost or stolen. Any such access, breach or other loss of information could result
in legal claims or proceedings, and liability under federal or state laws that protect the privacy of personal
information, as well as regulatory penalties. In many jurisdictions, there are legal requirements to provide notice
of breaches to affected individuals and/or regulators in certain circumstances. Such a notice could harm our
reputation and our ability to compete. Regulators may also have the discretion to impose penalties without
attempting to resolve violations through informal means. Although we have implemented security measures to
prevent unauthorized access to patient data, such data is currently accessible through multiple channels, and
there is no guarantee we can protect our data from breach. Unauthorized access, loss or dissemination could
also damage our reputation or disrupt our operations, including our ability to conduct our analyses, deliver test
results, process claims and appeals, provide customer assistance, conduct research and development activities,
collect, process and prepare company financial information, provide information about our tests and other patient
and physician education and outreach efforts through our website, and manage the administrative aspects of our
business.
If we or our third-party suppliers fail to comply with environmental, health and safety laws and
regulations, we could become subject to fines or penalties or incur costs that could harm our business.
We are subject to numerous environmental, health and safety laws and regulations, including those governing
laboratory procedures and the handling, use, storage, treatment and disposal of hazardous materials and
wastes. Our operations involve the use of hazardous and flammable materials, including chemicals and
biological materials. Our operations also may produce hazardous waste products. We generally anticipate
contracting with third parties for the disposal of these materials and wastes. We will not be able to eliminate the
risk of contamination or injury from these materials. In the event of contamination or injury resulting from any use
by us of hazardous materials, we could be held liable for any resulting damages, and any liability could exceed
our resources. We also could incur significant costs associated with civil or criminal fines and penalties for failure
to comply with such laws and regulations.
Although we maintain workers’ compensation insurance to cover us for costs and expenses we may incur due to
injuries to our employees resulting from the use of hazardous materials, this insurance may not provide
adequate coverage against potential liabilities.
In addition, we may incur substantial costs in order to comply with current or future environmental, health and
safety laws and regulations. These current or future laws and regulations may impair our research, development
or production efforts. Our failure to comply with these laws and regulations also may result in substantial fines,
penalties or other sanctions.
Our business operations and current and future relationships with investigators, healthcare
professionals, consultants, third-party payors, patient organizations and customers will be subject to
applicable healthcare regulatory laws, which could expose us to penalties.
Our business operations and current and future arrangements with investigators, healthcare professionals,
consultants, third-party payors, patient organizations and customers, may expose us to broadly applicable fraud
and abuse and other healthcare laws and regulations. These laws may constrain the business or financial
arrangements and relationships through which we conduct our operations, including how we research, market,
sell and distribute our product candidates, if approved.
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Ensuring that our internal operations and future business arrangements with third parties comply with applicable
healthcare laws and regulations will involve substantial costs. It is possible that governmental authorities will
conclude that our business practices do not comply with current or future statutes, regulations, agency guidance
or case law involving applicable fraud and abuse or other healthcare laws and regulations.
If any of the physicians or other providers or entities with whom we expect to do business are found to not be in
compliance with applicable laws, they may be subject to criminal, civil or administrative sanctions, including
exclusions from government-funded healthcare programs and imprisonment, which could affect our ability to
operate our business. Further, defending against any such actions can be costly and time-consuming and may
require significant personnel resources. Therefore, even if we are successful in defending against any such
actions that may be brought against us, our business may be impaired.
Risks Related to Ownership of the
ADSs
We have experienced and may continue to experience significant volatility in the market price of the
ADSs representing our ordinary shares.
Biopharmaceutical companies such as BioNTech SE that are developing potential therapeutics and vaccines to
combat COVID-19, as well as conducting mRNA-based research in oncology and infectious disease more
generally, have experienced significant volatility in the price of their securities upon publication of preclinical and
clinical data as well as news about their development programs and commercialization activities.
For example,
during 2024, the closing sales price of the ADSs representing our ordinary shares on the Nasdaq Global Select
Market ranged from $78.36 to $124.71
, with significant volatility occurring, for example, shortly after
announcements by us or others related to regulatory matters, to our COVID-19 vaccine, to other COVID-19
vaccines, to development and commercialization pipelines in oncology and infectious disease, and to our
transactions with third parties. Additionally, we have observed the trading price of the ADSs respond significantly
to news and statements by us, government agencies, other vaccine developers, financial analysts or others
relating to our business as well as to other COVID-19 vaccines and COVID-19 therapeutics and the spread of
COVID-19 generally, even in cases in which we believe the news does not affect our business or vaccine
specifically. Given the attention being paid to COVID-19 worldwide and the public scrutiny of COVID-19
development and commercialization announcements, and given that our COVID-19 vaccine is currently among
the primary vaccines being used worldwide, any news regarding manufacturing, supply and distribution of our
COVID-19 vaccine or unanticipated side effects of our COVID-19 vaccine, whether or not accurate, will attract
significant attention and scrutiny and, as a result, the price of the ADSs representing our ordinary shares likely
will continue to be volatile. In addition, volatility in the overall market and in the market price of a particular
company’s securities can result in securities litigation, including shareholder class action lawsuits. Any securities
litigation can result in substantial costs and a diversion of our management’s attention and resources.
Acquisitions, joint ventures and collaborations may increase our capital requirements, dilute our
shareholders, cause us to incur debt or assume contingent liabilities, and subject us to other risks. We
may not realize the benefits of these acquisitions, joint ventures or collaborations.
We may evaluate various acquisitions and collaborations, including licensing or acquiring complementary
products, intellectual property rights, technologies or businesses. Any potential acquisition, joint venture or
collaboration may entail numerous risks, including:
•
increased operating expenses and cash requirements;
•
the assumption of additional indebtedness or contingent liabilities;
•
assimilation of operations, intellectual property and products of an acquired company, including
difficulties associated with integrating new personnel;
•
the diversion of our management’s attention from our existing product programs and initiatives in
pursuing such a strategic merger or acquisition;
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Annual Report on Form 20-F for the
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•
retention of key employees, the loss of key personnel, and uncertainties in our ability to maintain key
business relationships;
•
risks and uncertainties associated with the other party to such a transaction, including the prospects of
that party and their existing products or product candidates and regulatory approvals; and
•
our inability to generate revenue from acquired technology or products sufficient to meet our objectives
in undertaking the acquisition or even to offset the associated acquisition and maintenance costs.
In addition, if we undertake acquisitions, we may utilize our cash, issue dilutive securities, assume or incur debt
obligations, incur large one-time expenses and acquire intangible assets that could result in significant future
amortization expense.
For example, in July 2023, we acquired InstaDeep, a leading global technology company
in the field of AI and machine learning, for upfront consideration of cash and BioNTech shares, and potential
future milestone payments. Although we believe that AI and machine learning technology has the potential to
accelerate the development of therapeutic programs and further optimize manufacturing and supply chain
processes, it is possible that our use of the acquired technology will not achieve the desired results, and that we
will not be able to retain and grow InstaDeep’s business around the world. If demand for the services developed
by InstaDeep does not continue, or if we are unable to improve our AI and machine learning technology in a
timely, effective and competitive manner, we may not be able realize the expected outcomes from the InstaDeep
acquisition. In
January
2025, we acquired Biotheus, a clinical-stage biotechnology company, for upfront
consideration predominantly of cash, with a small portion in our ADSs, and potential future milestone payments.
Although the Biotheus acquisition expands our operations in China, our expectations regarding the creation of
long-term value for shareholders and potential future commercialization in oncology may not be realized. There
is no guarantee that we will realize any anticipated benefits of these or future acquisitions, or that the
diversification of our business through acquired technology or products will be successful.
Moreover, we may not be able to locate suitable acquisition or collaboration opportunities and this inability could
impair our ability to grow or obtain access to technology or products that may be important to the development of
our business.
Our Articles of Association designate specific courts in the United States as the exclusive forum for
certain U.S. litigation that may be initiated by our shareholders, which could limit our shareholders’
ability to obtain a favorable judicial forum for disputes with us.
Our Articles of Association provide that the United States District Court for the Southern District of New York shall
be the competent court of jurisdiction for the resolution of any litigation on the grounds of or in connection with
U.S. federal or state capital market laws. In the absence of these provisions, under the Securities Act of 1933, as
amended, or the Securities Act, U.S. federal and state courts have been found to have concurrent jurisdiction
over suits brought to enforce duties or liabilities created by the Securities Act.
The choice of forum provision contained in our Articles of Association may limit a shareholder’s ability to bring a
claim in a judicial forum that it finds favorable for disputes with us or our executive officers, directors, or other
employees, or impose additional litigation costs on shareholders in pursuing any such claims, particularly if the
shareholders do not reside in or near the state of New York, which may discourage such lawsuits. In addition,
while the Delaware Supreme Court ruled in March 2020 that federal forum selection provisions purporting to
require claims under the Securities Act be brought in federal court are “facially valid” under Delaware law, there
is uncertainty as to whether other U.S. or German courts will enforce our choice of forum provision. The
enforceability of similar choice of forum provisions in other companies’ governing documents has been
challenged in recent legal proceedings, and it is possible that a court in the relevant jurisdictions with respect to
us could find the choice of forum provision contained our Articles of Association to be inapplicable or
unenforceable. If the relevant court were to find the choice of forum provision contained in our articles of
association to be inapplicable or unenforceable, we may incur additional costs associated with resolving such
matters in other jurisdictions, which could adversely affect our business, financial condition and operating results.
The choice of forum provision may also impose additional litigation costs on shareholders who assert that the
provision is not enforceable or invalid. The United States District Court for the Southern District of New York may
also reach different judgments or results than would other courts, including courts where a shareholder
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considering a U.S.-based action may be located or would otherwise choose to bring the action, and such
judgments may be more or less favorable to us than our shareholders.
Holders of the ADSs may not be able to participate in any future preemptive subscription rights issues
or elect to receive dividends in shares, which may cause additional dilution to their holdings.
Under German law, the existing shareholders of a company generally have a preemptive right in proportion to
the amount of shares they hold in connection with any issuance of ordinary shares, convertible bonds, bonds
with warrants, profit participation rights and participating bonds. However, our shareholders in a shareholders’
meeting may vote, by a majority representing at least three-quarters of the share capital represented at the
meeting, to waive this preemptive right provided that, from the company’s perspective, there exists good and
objective cause for such waiver.
The deposit agreement provides that the depositary need not make rights available to you unless the distribution
to ADS holders of both the rights and any related securities are either registered under the Securities Act or
exempted from registration under the Securities Act. We are under no obligation to file a registration statement
with respect to any such rights or securities or to endeavor to cause such a registration statement to be declared
effective. Moreover, we may not be able to establish an exemption from registration under the Securities Act.
Accordingly, ADS holders may be unable to participate in our future rights offerings and may experience dilution
in their holdings. For example, ADS holders were unable to participate in our summer 2020 rights offering. In
addition, if the depositary is unable to sell rights that are not exercised or not distributed or if the sale is not lawful
or reasonably practicable, it will allow the rights to lapse, in which case you will receive no value for these rights.
The amount and frequency of our dividends and ADS repurchases may fluctuate.
The amount, timing and execution of any ADS repurchase program we conduct in the future and the amount and
timing of any dividends we pay may fluctuate based on our priorities for the use of cash for other purposes, and
any ADS repurchases would be subject to the parameters contained in the applicable repurchase plan. These
purposes may include operational spending, capital spending, acquisitions and repayment of debt. Additionally,
we may choose to repurchase ADSs so that such ADSs may be used to settle outstanding and future equity
awards granted to our employees. Changes in cash flows, tax laws and the price of the ADSs could also impact
any ADS repurchase program. Additionally, we may enter into a Rule 10b5-1 trading plan governing the
repurchases, and if we do, we would have no discretion over the particular purchases made and would only be
able to set minimum price floors and maximum ADS count ceilings.
Our principal shareholders and management own a significant percentage of our ordinary shares and
will be able to exert significant control over matters subject to shareholder approval.
Our executive officers, directors, five percent shareholders, and their affiliates beneficially own a majority of our
ordinary shares (including ordinary shares represented by ADSs) as of December 31, 2024, and will have the
ability to influence us through their ownership positions. For example, these shareholders, acting together, may
be able to exert
significant influence
over matters such as elections of directors, amendments of our
organizational documents, or approval of any merger, sale of assets or other major corporate transaction. This
may prevent or discourage unsolicited acquisition proposals or offers for our ordinary shares that shareholders
may believe are in their best interest. Such insiders may also act in concert to waive rights to participate in rights
offerings, as was done in our summer 2020 rights offering, which would have the effect of permitting the ADSs or
shares underlying such waived rights to be offered to the public in an underwritten offering without contravening
German law pricing requirements.
The large number of shares eligible for sale or subject to rights requiring us to register them for sale
could cause the market price of the ADSs to drop significantly, even if our business is performing well.
We have filed registration statements on Form S-8 under the Securities Act to register all ordinary shares issued
or issuable under our equity plans. Such Form S-8 registration statements have become, and any other
registration statements on Form S-8 we file in the future will become, effective upon filing, upon which shares
registered under such registration statements become available for sale in the open marke
t.
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Additionally, certain sales of ADSs or our ordinary shares that we have made have included, and we may in the
future make sales including, holding period restrictions or registration rights. Sales of ADSs or our ordinary
shares as restrictions end or pursuant to registration rights may make it more difficult for us to finance our
operations through the sale of equity securities in the future at a time and at a price that we deem appropriate.
These sales also could cause the trading price of the ADSs to fall and make it more difficult to sell the ADSs on
favorable terms.
If we are a “passive foreign investment company” for U.S. federal income tax purposes, there may be
adverse U.S. federal income tax consequences to U.S. investors.
Based on our income and assets, we believe that we should be treated as a “passive foreign investment
company,” or PFIC, for the preceding taxable year. However, the determination of our PFIC status is made
annually based on the factual tests described below. Consequently, while we may be a PFIC in future years, we
cannot estimate with certainty at this stage whether or not we are likely to be treated as a PFIC in the current
taxable year or any future taxable years. Generally, if, for any taxable year, at least 75 percent of our gross
income is “passive income” or at least 50 percent of our gross assets during the taxable year (based on the
average of the fair market values of the assets determined at the end of each quarterly period) are assets that
produce or are held for the production of passive income, we will be characterized as a PFIC for U.S. federal
income tax purposes. Passive income for this purpose generally includes, among other things, dividends,
interest, rents, royalties, gains from commodities and securities transactions, and gains from assets that produce
passive income. However, rents and royalties received from unrelated parties in connection with the active
conduct of a trade or business should not be considered passive income for purposes of the PFIC test. For
example, if we were to be characterized as a PFIC for U.S. federal income tax purposes in any taxable year
during which a U.S. Holder (as defined in “Taxation —Material United States federal income tax considerations”
in this Annual Report) holds ordinary shares or ADSs, such U.S. Holder could be subject to additional taxes and
interest charges upon certain distributions by us and any gain recognized on a sale, exchange or other
disposition of our shares, whether or not we continue to be characterized as a PFIC. Certain adverse
consequences of PFIC status can be mitigated if a U.S. Holder makes a “mark to market” election or a “Qualified
Electing Fund,” or QEF, election. We have made available to U.S. Holders the information necessary to make
and maintain a QEF election for the year ended December 31, 2024, and intend to provide U.S. holders with the
necessary information for any taxable year in which we are treated as a PFIC. See “Taxation —Material United
States federal income tax considerations —Passive foreign investment company considerations” in this Annual
Report.
Whether we are a PFIC for any taxable year will depend on the composition of our income and the composition
and value of our assets from time to time. Each U.S. Holder is strongly urged to consult its tax advisor regarding
these issues and any available elections to mitigate such tax consequences.
Item 4. Information on the Company
A.
History and Development of the Company
We are committed to improving the health of people worldwide with our fundamental research and development
of immunotherapies. S
cientific rigor, innovation and passion are our driving forces
. BioNTech was founded by
scientists and physicians to translate science into survival by combining fundamental research and operational
excellence.
We were founded and incorporated on June 2, 2008 as Petersberg 91, V AG, a German stock corporation
(Aktiengesellschaft). We changed our name to BioNTech AG on December 11, 2008. On March 8, 2019, we
converted to a European stock corporation (Societas Europaea, or SE) under the laws of Germany and the
European Union called BioNTech SE. We completed our initial public offering in October 2019. ADSs
representing our ordinary shares are currently listed on the Nasdaq Global Select Market under the symbol
“BNTX”.
Our principal executive offices are located at An der Goldgrube 12, D-55131 Mainz, Germany. Our telephone
number is +49 6131-9084-0. Our website address is www.biontech.com. The information contained on, or that
can be accessed through, our website is not part of this document. Our agent for service of process solely for the
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purpose of notices and communications from the SEC in the United States is c/o BioNTech US Inc., 40 Erie
Street, Suite 110, Cambridge, Massachusetts 02139, +1 (617) 337-4701.
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B. Business
Overview
I.
Overview
We are a global next-generation immunotherapy company pioneering novel medicines against cancer, infectious
diseases and other serious diseases. Since our founding in 2008, we have focused on harnessing the power of
the immune system to address human diseases with unmet medical needs and major global health burdens. Our
fully integrated model combines decades of research in
immunology with
a multi-technology innovation engine,
GMP manufacturing, translational drug discovery, clinical development,
commercial capabilities
, computational
medicine, data science, artificial intelligence, or AI, and machine learning, or ML, capabilities to discover, develop
and commercialize our marketed products and product candidates.
We have built a broad toolkit across multiple technology platforms, including a diverse range of potentially first-
in-class therapeutic approaches.
This includes investigational messenger ribonucleic acid, or mRNA
immunotherapies
, protein-based therapeutics (including targeted antibodies such as monoclonal, bispecific and
antibody-drug conjugates, or ADCs) and cell therapies
.
Our multi-technology combination of platforms and product candidates positions us as pioneers in the field of
individualized, patient-centric therapeutic approaches in oncology and infectious diseases.
Our primary focus is oncology, where we endeavor to address the full
continuum of cancer from early to late
disease stages.
The root causes of cancer treatment failure are cancer heterogeneity and interindividual
variability. Driven by random sequential mutations, every patient’s cancer is different and within one patient’s
tumor, every cell is different. Addressing these two challenges is the core of our strategy. To augment anti-tumor
activity and to counteract resistance mechanisms, we seek to combine compounds with non-overlapping,
synergistic mechanisms of action.
In infectious disease,
we aim to develop new prophylactic vaccines as well as therapeutics, as there are
substantial unmet medical and global health needs.
Our approach
has generated a robust product pipelin
e
, and
has led to the approval of our first marketed product,
Comirnaty
.
II. T
he BioNTech
Approach
Our key objectives are to develop an innovative immunotherapy pipeline i
n oncology
targeting multiple product
approvals in the coming years and to
build a
sustainable respiratory infectious disease vaccine business based
on the BioNTech-Pfizer
Comirnaty
franchise
. We are uniquely positioned to pursue our objectives by leveraging
our technology agnostic approach rooted in decades of research in immunology coupled with expertise in
emerging mRNA technologies. Our vision is to establish a multi-product company based on our pioneering
technologies and science
to contribute to improving the health of people worldwide
.
Oncology Pipeline Strategy
Cancer is one of the most profound medical
challenges of humankind. Genetic and phenotypic heterogeneity,
the tumor microenvironment and immune diversity make cancer a complex and heterogeneous disease.
Our
long-term oncology vision is to expand the number of available treatment options for cancer patients. We aim to
address the full continuum of cancer treatment by developing novel therapies to b
est serve
the needs of cancer
patients from adjuvant to late-stage settings.
Since our founding, we have been a multi-
technology
company. We believe that by combining complementary
treatment modalities, we can leverage the potential of each technology to provide precise and personalized
treatments to patients. Such treatments, if approved, could both increase the likelihood of therapeutic success
and reduce the risk of therapeutic resistance. By building a diverse toolkit and clinical portfolio with synergistic
mechanisms of action, we aim to exploit the potential of our technologies:
•
mRNA Cancer Immunotherapies
.
We are developing a portfolio of mRNA-based therapeutic
candidates to treat cancer: cancer immunotherapies, including
FixVac
(fully owned) and iNeST (in
collaboration with Genentech, Inc., a member of the Roche Group, or Genentech), and mRNA-encoded
cytokines and antibodies. We believe that mRNA cancer immunotherapy candidates, if successful, could
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Annual Report on Form 20-F for the
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have the potential to eliminate polyclonal residual disease by targeting multiple antigens at once for
potential long-term impact.
•
Immunomodulators
. We are building a modality agnostic toolkit to focus on crucial immuno-oncology
pathways. We target different but complementary players in the complex cancer immunity cycle to
promote a thorough and durable antitumor effect. We use our in-house capabilities and collaborate with
Genmab A/S, or Genmab, and OncoC4, Inc., or OncoC4,
to develop next-generation immunomodulators
that are designed to modulate the patient’s immune response to cancer.
•
Targeted Therapies
. We aim to develop potent and precise therapies that could reduce tumor burden
across the entire disease continuum, including late lines. We collaborate with Duality Biologics (Suzhou)
Co. Ltd., or DualityBio, and MediLink Therapeutics (Suzhou) Co., Ltd., or MediLink Therapeutics, to
develop next-generation ADCs. ADCs will transform cancer care. We believe they have the potential to
supplement or replace chemotherapy in the future. We believe that a differentiated ADC linker
technology could improve efficacy and safety compared to currently approved ADCs, and novel
mechanisms of action may be able to improve tumor specific activation. We are also developing a range
of cell therapies against solid tumors, including chimeric antigen receptor, or CAR-T,-cell therapies,
neoantigen-based T-cell therapies and T-cell receptor, or TCR therapies in which the patient’s T cells are
modified or primed to target cancer-specific antigens.
From our diverse clinical portfolio, we have identified two high-priority assets with pan-tumor potential and
programs that we believe will enable us to realize our vision of
addressing the full continuum of cancer
: first, our
mRNA cancer immunotherapy programs,
FixVac
and iNeST, which we believe are particularly suited for early-
stage or low tumor burden cancers; and second, our
late-stage clinical asset BNT327
, formerly also known as
PM8002,
an investigational bispecific antibody targeting PD-L1 and VEGF-A
, and for which
we obtained full
global rights with the acquisition of Biotheus Inc., or Biotheus. We believe that BNT327
has the potential to
become a next-generation immuno-oncology backbone suitable for a broad range of cancers.
We plan to continue building our oncology pipeline and commercial capabilities in 2025 in anticipation of
potential commercial oncology launches as soon as
2026
, if approved.
I
nfectious Disease Pipeline
Strateg
y
Infectious diseases remain among the leading causes of death and disability worldwide
.
Low- and middle-
income countries continue to bear much of the burden of communicable diseases, which include
tuberculosis,
human immunodeficiency virus, or HIV, malaria, neglected tropical diseases and hepatitis B
. Climate change,
rising population numbers and global travel may all contribute to an increased risk of global infectious disease
outbreaks.
Our goal is to advance our infectious disease programs by developing vaccines and therapeutics for infectious
diseases caused by respiratory viruses, latent viruses, bacteria and parasites. We believe our scientific approach
and our mRNA technology have the potential to significantly contribute to the fight against global health threats
caused by infectious diseases. We have pursued both strategic partnerships and corporate collaborations to
partially fund our infectious disease global health programs and aim to continue to do so.
Our infectious disease
programs aim to contribute to equitable access to effective and well tolerated vaccines for high medical need
indications.
To
gether with our collaborator Pfizer Inc., or Pfizer, we plan to continue to invest into the research and
development of next-generation COVID-19 vaccines and COVID-19 / influenza combination vaccines. We
expect seasonal COVID-19 vaccination to continue, driven by the continuous evolution of the virus. We aim to
maintain COVID-19 vaccine market leadership and expect continued revenues from COVID-19 vaccine sales in
the near term.
We and our partners are also committed to researching and developing product candidates against latent
viruses, including herpes-simplex virus, or HSV, varicella-zoster virus, or shingles and mpox (formerly known as
monkeypox). Latent viruses remain in the body after an infection and can lead to lifelong medical complications.
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In addition, we have ongoing t
rials evaluating mRNA vaccine candidates against diseases caused by bacteria
(tuberculosis) and parasites (malaria).
We see the potential for applications of our technologies beyond oncology and infectious disease, including
autoimmune diseases, inflammatory diseases, cardiovascular diseases, neurodegenerative diseases and
regenerative medicines.
III
. Strategic Outlook
We are committed to translating science into survival for patients by advancing BioNTech’s strategy and
executing it to become a global immunotherapy powerhouse with multiple approved products and revenue
streams.
As part of this continued approach, we have built a unique pipeline by targeting technologies and candidates
with disruptive potential. In oncology, we focus on therapeutic approaches with pan-tumor potential, including our
personalized mRNA cancer immunotherapies and our bispecific antibody candidate BNT327. We plan to
significantly invest in their broad clinical evaluation across multiple cancer indications with significant (unmet)
medical needs, as well as their commercialization in key markets. We aim to further enhance the therapeutic
profile of our investigational therapies through the evaluation of novel combinations, including our differentiated
portfolio of ADCs and targeted therapy candidates.
As we continue to invest in executing our vision, we remain committed to cost-effective value generation. We
actively manage our pipeline and assess our sites according to key criteria: strategic alignment, operational
efficiency, and sustainable value creation. Consequently, we plan to significantly invest in essential areas while
optimizing capacities in others. While capacities may shift in accordance with our strategic criteria, we expect our
overall headcount to remain relatively stable over the next three years.
We have implemented, or expect to start implementing in 2025, measures aimed at expanding our research,
development, manufacturing and commercialization capabilities, which we currently anticipate may result in the
creation of up to between 800 and 1,200 FTE positions over the period of 2025 to 2027, including:
•
The construction of our first large-scale mRNA immunotherapy manufacturing facility in Mainz, Germany,
which we started in 2019 and for which we plan to initially fill approximately 350 FTE positions in 2025.
•
The completion of the acquisition of Biotheus in February 2025, through which we obtained full global
rights to BNT327 as well as rights to all other candidates and have increased our presence in mainland
China by approximately 325 FTE positions.
•
The strategic expansion of workforce in selected areas across our sites worldwide, such as clinical
development and commercial operations.
We intend to implement measures between 2025 and 2027 to adjust capacities in some areas by between 950
and 1,350 FTE positions, including:
•
An optimization of our manufacturing network by (i) establishing focused centers of excellence for early-
stage mRNA manufacturing in Idar-Oberstein and Cell & Gene manufacturing in Gaithersburg, while (ii)
right-sizing our center of excellence for late-stage mRNA manufacturing in Marburg. We currently expect
that this will involve consolidating and adjusting capacities within our manufacturing network, which
could lead to an estimated reduction of the workforce in Marburg of between 250 and 350 FTE positions
and in Idar-Oberstein (Germany) of between 100 and 200 FTE positions over this time period.
•
The consolidation and adjustment of capacities across administrative functions and preclinical research
in Europe and North America, resulting in an estimated workforce reduction of between 550 and 700
FTE positions over this time period.We will continue to drive progress with a focus on our highest
potential opportunities and we believe we are well-positioned to continue advancing our strategic vision.
We look forward to another year of meaningful progress building on our achievements in 2024.
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year ended December 31, 2024
IV. Execution in 2024
In 2024, we executed across our four key strategic pillars to strengthen our technology platforms, digital
capabilities and infrastructure, through strategic investments, acquisitions, licensing agreements and public-
private partnerships impacting patients, shareholders and other stakeholders.
1. Innovative and Diversified Pipeline
We continued to develop our innovative oncology and infectious disease pipeline.
Today, our pipeline consists of
18 clinical
programs
in oncology, with more than 20 Phase 2 and Phase 3 clinical trials, and seven clinical
programs in infectious disease.
In 2024, we and our partners reported data across our portfolio at multiple
medical meetings and published manuscripts in peer reviewed journals.
In oncology, we started multiple clinical trials and brought several assets into mid- and late-stage development,
namely Phase 2 and Phase 3 clinical trials, across a range of technologies, including our bispecific antibody
BNT327, mRNA cancer immunotherapies and ADCs.
Over the next year, we aim to advance additional product candidates to late-stage development, and we expect
to continue building our pipeline towards our potential first oncology launch in 2026.
2. Leadership in COVID-19 Vaccine Development
We continued to build our COVID-19 vaccine franchise and maintained market leadership in multiple key
geographies.
In 2024, we and Pfizer distributed approximately
180 million
COVID-19 vaccine doses to more than
40 countries and regions globally.
In 2024, we also increased our supply of prefilled syringes in several markets.
3.
Healthcare and Social Responsibility
We advanced our goal of contributing to equitable access to medicine around the globe, with over
30%
of
Comirnaty
doses delivered to low- and middle-income countries in 2024, in line with demand.
We continue to
work with non-governmental organizations, institutes and governments to plan for equitable access to novel
medicines, especially in low- and middle-income countries and regions.
We are developing
mRNA vaccine candidates for infectious diseases with high medical need, including vaccine
candidates against tuberculosis, malaria and HIV, as well as against infectious diseases with pandemic potential,
such as mpox.
In May 2024, we and the Coalition for Epidemic Preparedness Innovations, or CEPI, announced
the expansion of our strategic partnership to support the establishment of RNA vaccine R&D, clinical and
commercial-scale manufacturing capabilities at our facility in Kigali, Rwanda. These capabilities will contribute to
develop potential mRNA vaccines in Africa, for Africa, and better prepare for potential future epidemic and
pandemic threats in Africa. CEPI will provide funding of up to $145 million.
In 2024, our near-term science-based emission reduction targets were approved by the Science Based Targets
Initiative, or SBTi, a climate action organization which develops methods and criteria for effective corporate
climate action and validates corporate targets. This validation underlines that our scope 1 and scope 2 climate
targets are ambitious and in line with the United Nations’ Paris Climate Agreement to limit global warming to 1.5
degrees Celsius above pre-industrial levels. The SBTi has validated our near-term emission reduction targets in
the following form:
•
BioNTech commits to reducing absolute scope 1 and scope 2 greenhouse gas emissions by 42% by
2030 from a 2021 base year.
•
BioNTech commits that 72% of its suppliers by emissions covering purchased goods and services,
capital goods and upstream transportation and distribution, will have science-based targets by 2027.
4. Innovation at Scale
We are building and scaling biotech innovation with the aim of becoming a patient-centric, AI-driven, multi-
product immunotherapy
company
. Our diverse workforce consists of almost 6,772 employees (full-time
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year ended December 31, 2024
equivalents) as of 31 December 2024, and we have subsidiaries in countries across
five continents, having
further expanded our organization in Asia, Africa,
North America
, Australia and Europe.
In February 2024,
we entered into a strategic collaboration with Autolus Therapeutics plc, or Autolus, aimed at
advancing both companies’ autologous CAR-T programs towards commercialization, pending regulatory
authorizations. As part of the strategic collaboration, we have the option to access Autolus’ commercial and
clinical site network, manufacturing capacities in the United Kingdom, or UK, and commercial supply
infrastructure in a cost-efficient set-up allowing for the accelerated development of our product candidate
BNT211.
Effective as of July 1, 2024, and with a view to BioNTech’s first oncology product launch anticipated for 2026, our
Supervisory Board appointed Annemarie Hanekamp to the Management Board as Chief Commercial Officer.
Annemarie Hanekamp is a seasoned pharmaceutical executive, experienced in developing patient-focused
commercial strategies for innovative oncology products encompassing sales, marketing and market access. In
her role, she is driving and executing our global commercialization strategy to leverage BioNTech’s full potential
as a vertically integrated biopharmaceutical company.
In February 2025, we announced the completion of the acquisition of Biotheus. With the acquisition, we obtained
full global rights to the bispecific antibody clinical asset BNT327,
an investigational bispecific antibody targeting
PD-L1 and VEGF-A,
formerly also known as PM8002, and Biotheus’ pipeline candidates. This follows an initial
exclusive global license and collaboration agreement with Biotheus in 2023 to develop, manufacture and
commercialize BNT327 globally, ex-Greater China
. The transaction is part of our oncology strategy, aimed at
enhancing the Company’s capabilities to research, develop and commercialize combination therapies using
BNT327. Clinical trials with BNT327 have demonstrated encouraging clinical activity in various tumor types
including in patients with PD-L1-low and -negative tumors who have typically been less responsive to current
checkpoint inhibitor treatments.
In 2024, we maintained a strong balance sheet through disciplined financial performance, ending the year with
approximately
€17.4 billion
in total cash, cash equivalents and security investments.
With a strong financial
position, leading COVID-19 vaccine franchise and innovative oncology and infectious disease pipeline, we
believe we are well positioned to continue executing our vision of pioneering novel medicines against cancer,
infectious diseases and other serious diseases.
V
.
Ma
rketed Products:
Comirnaty
,
our COVID-19 Vaccine Program (BNT162)
Our commercial product,
Comirnaty
, was the first-ever approved mRNA-based product, and, to our knowledge,
represents the
fastest ever developed prophylactic vaccine from viral sampling to approval
.
As of December
2024
, our COVID-19 vaccine products have been authorized or approved for emergency or temporary use or
granted marketing authorization in more than 180 countries and regions worldwide. Our efforts have resulted in
more than 4.9 billion doses shipped globally.
Under our collaboration with Pfizer, we are the Marketing Authorization Holder in the United States, the
European Union, or EU, the UK, Canada and other countries. Additionally, we are the holder of emergency use
authorizations, or EUAs, or equivalents in the United States (jointly with Pfizer) and other countries for the
COVID-19 vaccine program. Pfizer has marketing and distribution rights worldwide apart from Greater China,
Germany, and
Türkiye
. We have the marketing and distribution rights to
Comirnaty
in Germany and Türkiye.
Under our collaboration with Fosun Pharma, Fosun Pharma has marketing and distribution rights in Mainland
China, Hong Kong Special Administrative Region, or SAR, Macau SAR and Taiwan.
1.
Commercial Update
In 2024, we and Pfizer continued our global COVID-19 vaccine leade
rship with our Omicron JN.1 and Omicron
KP.2-adapted monovalent COVID-19 vaccines
directed against the Omicron JN.1 and Omicron KP.2 v
ariants
respectively.
Since the declaration of the
pandemic
, we have developed and
commercialized six COVID-19
vaccine products: the original COVID-19 vaccine, two Original/Omicron-adapted bivalent vaccines (Original/
BA.1- and Original/Omicron BA.4-5-adapted bivalent vaccines), the Omicron XBB.1.5-adapted monovalent
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Annual Report on Form 20-F for the
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COVID-19 vaccine, and the Omicron JN.1 and Omicron KP.2 monovalent COVID-19 vaccines. Each is referred
to as
Comirnaty
.
Between December 2020 and March 2023, COVID-19 vaccination programs across 34 World
Health Organization, or WHO, European Region countries prevented an estimated 1.6 million deaths. In the first
two years of the COVID-19 vaccine being available in the United States, the country’s vaccination program is
estimated to have prevented more than 18 million additional hospitalizations and more than 3 million additional
deaths.
In August 2024, following regulatory approvals, we and Pfizer began distribution of our Omicron KP.2 variant-
adapted vaccine in the United States. The KP.2 adaptation is based on guidance from the U.S. Food and Drug
Administration, or FDA, which stated that KP.2 is the preferred strain of the JN.1 lineage for COVID-19 vaccines
for use in the United States during the 2024-2025 fall and winter season, if feasible.
In September 2024, following regulatory approvals, we and Pfizer began distribution of our Omicron KP.2
variant-adapted vaccine in Europe following the initial rollout of our Omicron JN.1 variant-adapted vaccine in July
2024.
We believe that we and Pfizer are well positioned for the future as leading COVID-19 vaccine providers. We
expect that as the market dynamics evolve across different geographies in 2025, there will be continued demand
for vaccine boosting and primary
vaccinations of immunologically naïve individuals, especially amongst older
and immunocompromised populati
ons
.
Studies have demonstrated that natural immunity acquired by SARS-
CoV-2 infection is variable across individuals and that the protection it offers wanes over time. A booster
vaccination can restore and enhance infection-acquired immune protection and further reduce the risk of
reinfection. The risk of severe COVID-19 disease remains high in vulnerable populations. Vaccination not only
reduces the risk of severe COVID-19
but can also mitigate the risk of health impairments related to long COVID
.
Given this, and our current understanding of COVID-19’s seasonality and its burden on healthcare systems
during the autumn/winter season, we anticipate the need for annual adapted vaccines to be a long-term
component of COVID-19 vaccination practices.
2.
Manufacturing and Distribution
We and Pfizer have established an efficient and robust global vaccine supply chain and manufacturing network
capable of meeting global demand
.
In 2024, we continued transitioning from an advanced purchase agreement framework to commercial market
ordering in some geographies, including the UK, Japan, Switzerland, Australia, South Korea, Singapore and
Brazil.
W
e and Pfizer have an ongoing COVID-19 Vaccine Purchase Agreement with the European Commission, or the
EC, to deliver COVID-19 vaccines to the EU. The agreement reflects our and Pfizer’s commitment to working
collaboratively to help address ongoing public health needs. The 2023 agreement rephased delivery of doses
annually through 2026.
In addition, the agreement includes an aggregate volume reduction, providing additional
flexibility for EU Member States. The EC will maintain access to future adapted COVID-19 vaccines and the
ability to donate doses.
More details on our manufacturing operations and facilities can be found in “
IX. Manufacturing
.”
3.
Clinical Development
Omicron JN.1 and Omicron KP.2-adapted monovalent COVID-19
Vaccines
The Omicron JN.1 sublineages currently account for the majority of COVID-19 cases globally and are
antigenically distant from previously circulating SARS-CoV-2 lineages, including Omicron XBB.1.5, Omicron
BA.4-5 and the original SARS-CoV-2 strain.
Although Omicron XBB.1.5-adapted monovalent vaccines provided
some protection against a range of outcomes from JN.1-related COVID-19 disease, evidence suggests that
vaccines better matched to currently circulating sublineages would provide improved protection against
symptomatic and severe COVID-19 disease.
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Our and Pfizer
’s regulatory filings have been based on the full body of previous clinical, non-clinical and real-
world evidence supporting the safety and efficacy of the Pfizer-BioNTech COVID-19 vaccines.
The submissions
included manufacturing and
non-clinical
data showing that the JN.1- and KP.2-adapted monovalent vaccines
elicited a markedly improved immune response against multiple Omicron JN.1 sublineages, such as KP.3.1.1, or
LB.1 and other currently circulating variants, when compared with the Omicron XBB.1.5-adapted monovalent
vaccine.
Clinical immunogenicity data demonstrated that the Omicron JN.1-adapted vaccine induces a strong and broad
neutralizing antibody response across multiple JN.1 sublineages including XEC.
Early vaccine effectiveness data from a nationwide test-negative case-control study involving U.S. Veterans
Affairs Healthcare System patients indicate that the Omicron KP.2-adapted vaccine was 56-68% effective in
preventing various COVID-19 outcomes during the early 2024-2025 respiratory virus season.
A second study of
U.S. adults aged 18 and older who visited CVS MinuteClinics found that those who received the vaccine were
48% less likely to have COVID-19-related clinic visits.
Although
the COVID-19 outbreak has moved from a pandemic to an endemic stage,
new SARS-CoV-2
infections, hospitalization and deaths continue to be reported. However, trends in these figures should be
interpreted with caution, as testing and sequencing have decreased, and many countries face reporting delays.
Wastewater surveillance, an important component of SARS-CoV-2 monitoring, plays a crucial role in early
warning and tracking of the circulation of variants. Estimates from wastewater surveillance suggest that SARS-
CoV-2 circulation is approximately 2 to 19 times higher than what is identified and reported through clinical
testing.
Older adults (aged 65 and above), comorbid
or
immunocompromised
individuals continue to face a heightened
risk of severe disease, hospitalization, and death from SARS-CoV-2.
4.
Regulatory Updates
Our and Pfizer’s Omicron JN.1 and Omicron KP.2-adapted monovalent COVID-19 vaccines rec
eived multiple
regulatory
approvals and authorizations
in more than 40 countries and regions in 2024.
In April 2024, the WHO and the European Medicines Agency, or EMA, followed
in later months
by other health
authorities, provided guidance highlighting evidence that updated vaccines targeting Omicron JN.1 or JN.1
sublineages may contribute to maintaining protection against COVID-19 during the upcoming fall and winter
seasons.
In June 2024, the FDA’s Vaccines and Related Biological Products Advisory Committee, or VRBPAC, issued
guidance recommending the manufacturing of a JN.1-adapted monovalent COVID-19 vaccine for the 2024/2025
fall and winter seasons. Also in June 2024, the FDA announced the KP.2 strain as the preferred JN.1-lineage for
COVID-19 vaccines, if feasible.
Omicron JN.1-adapted monovalent COVID-19 vaccine
In 2024, we and Pfizer received the following approvals for our Omicron JN.1-adapted monovalent COVID-19
vaccine:
•
June 2024: the Committee for Medicinal Products for Human Use, or CHMP, of the EMA recommended
marketing authorization for our and Pfizer’s Omicron JN.1-adapted monovalent COVID-19 vaccine for
active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals six months of age and
older. The adaptation was based on the recommendation from the WHO Technical Advisory Group on
COVID-19 Vaccine Composition and the EMA’s Emergency Task Force, or ETF, to update COVID-19
vaccines to target the SARS-CoV-2 variant JN.1 for the 2024/2025 fall and winter vaccination campaign.
In July 2024, the EC adopted an EC Decision in accordance with the CHMP’s recommendation.
•
July 2024:
the respective EC Decision also covered
that Comirnaty may be administered concomitantly
with seasonal influenza vaccine in individuals 12 years of age and older and authorized a new
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Annual Report on Form 20-F for the
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presentation for the 30-mcg adapted vaccine, namely glass pre-filled syringe (refrigerated storage
conditions).
•
July 2024: the UK’s Medicines and Healthcare products Regulatory Agency, or MHRA, approved our and
Pfizer’s Omicron JN.1-adapted vaccine.
Omicron KP.2-adapted monovalent COVID-19 vaccine
In 2024, we and Pfizer received the following approvals for our Omicron KP.2-adapted monovalent COVID-19
vaccine:
•
June 2024: we and Pfizer submitted a regulatory application to the FDA for an Omicron JN.1-adapted
monovalent vaccine and initiated a rolling supplemental Biologics Licensing Application, or sBLA, for an
Omicron KP.2-adapted monovalent vaccine. In August 2024, the FDA approved the sBLA for our
Omicron KP.2-adapted 2024-2025 formula COVID-19 vaccine for individuals 12 years of age and older
and granted EUA for individuals six months through 11 years of age.
•
September 2024: the CHMP of the EMA also recommended marketing authorization for our and Pfizer’s
Omicron KP.2-adapted monovalent COVID-19 vaccine for active immunization to prevent COVID-19 in
individuals six months of age and older. The EC adopted an EC Decision in accordance with the CHMP
recommendation one week later.
•
October 2024: the FDA approved the sBLA to include safety and immunogenicity data from a study in
which individuals 18 through 64 years of age received
Comirnaty
concomitantly with a seasonal
influenza vaccine.
•
October 2024: the UK’s MHRA approved our Omicron KP.2-adapted vaccine.
We and Pfizer intend to continue to monitor the evolving epidemiology of COVID-19 and remain prepared to
develop modified vaccine formulas as the data support and as regulatory agencies recommend.
VI.
Pipeline of Product Candidates
We are
advancing
a broad portfolio of product candidates derived from multiple platforms and are focused on
immunotherapies for the potential treatment of cancer and mRNA vaccines to potentially prevent or treat
infectious diseases.
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Annual Report on Form 20-F for the
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|
Oncology
|
||||||||||||||||||||||
|
Drug class
|
Platform
|
Product candidate
|
Indication (target)
|
Phase 1
|
Phase 1/2
|
Phase 2
|
Phase 3
|
BioNTech
rights
(1)
|
Collaborator
/Partner
|
|||||||||||||
|
mRNA
|
FixVac
|
BNT111
|
Advanced, R/R melanoma
|
Fully
owned
(2)
|
||||||||||||||||||
|
BNT113
|
Metastatic / R/R HPV16+ head and
neck cancer
|
|||||||||||||||||||||
|
BNT116
|
1L metastatic NSCLC
|
|||||||||||||||||||||
|
Advanced/metastatic NSCLC
|
||||||||||||||||||||||
|
iNeST
|
BNT122 / RO7198457
(autogene cevumeran)
|
1L advanced melanoma
|
Collaboration
|
Genentech
(3)
|
||||||||||||||||||
|
Adjuvant colorectal cancer
|
||||||||||||||||||||||
|
Adjuvant muscle-invasive urothelial
carcinoma
|
||||||||||||||||||||||
|
Adjuvant pancreatic ductal
adenocarcinoma
|
||||||||||||||||||||||
|
Multiple solid tumors
|
||||||||||||||||||||||
|
RiboMabs
|
BNT142
|
Multiple solid tumors (CD3×CLDN6)
|
Fully owned
|
|||||||||||||||||||
|
RiboCytokines
|
BNT152 + BNT153
|
Multiple solid tumors (IL-7, IL-2)
|
Fully owned
|
|||||||||||||||||||
|
Cell
therapies
|
CAR T cells + CARVac
|
BNT211
|
Multiple solid tumors (CLDN6)
|
Fully owned
|
||||||||||||||||||
|
Neoantigen-based T cells
|
BNT221
|
Refractory metastatic melanoma
|
Fully owned
|
|||||||||||||||||||
|
Protein-
based
therapeutics
|
Next-generation
immune checkpoint
modulators
|
BNT311 / GEN1046
(acasunlimab
)4
|
aPD(L)1-R/R metastatic NSCLC
(PD-L1×4-1BB)
|
Collaboration
|
Genmab
|
|||||||||||||||||
|
BNT312 / GEN1042
|
Multiple solid tumors (CD40×4-1BB)
|
|||||||||||||||||||||
|
BNT314 / GEN1059
|
Multiple solid tumors
(EpCAM×4-1BB)
|
|||||||||||||||||||||
|
BNT315 / GEN1055
|
Multiple solid tumors (OX40)
|
|||||||||||||||||||||
|
BNT322 / GEN1056
|
Multiple solid tumors
|
|||||||||||||||||||||
|
BNT316 / ONC-392
(gotistobart)
|
aPD(L)1-R/R metastatic NSCLC
(CTLA-4)
|
Collaboration
|
OncoC4
|
|||||||||||||||||||
|
Platinum-resistant ovarian cancer
(CTLA-4)
|
||||||||||||||||||||||
|
Metastatic castration-resistant
prostate cancer (CTLA-4)
|
||||||||||||||||||||||
|
Multiple solid tumors (CTLA-4)
|
||||||||||||||||||||||
|
BNT317
|
Multiple solid tumors
|
Fully owned
|
||||||||||||||||||||
|
BNT327
|
1L ES-SCLC (PD-L1 x VEGF-A)
|
Fully owned
|
||||||||||||||||||||
|
1L Advanced/metastatic TNBC
(PD-L1 x VEGF-A)
(5)
|
||||||||||||||||||||||
|
2L SCLC (PD-L1 x VEGF-A)
(5)
|
||||||||||||||||||||||
|
1/2L+ ES-SCLC (PD-L1 x VEGF-A)
|
||||||||||||||||||||||
|
1L/2L metastatic TNBC (PD-L1 x
VEGF-A)
|
||||||||||||||||||||||
|
1L NSCLC (PD-L1 x VEGF-A)
(6)
|
||||||||||||||||||||||
|
1L ES-SCLC (PD-L1 x VEGF-A)
(5)
|
||||||||||||||||||||||
|
2L ES-SCLC (PD-L1 x VEGF-A)
(5)
|
||||||||||||||||||||||
|
2L NEN (PD-L1 x VEGF-A
(5)
|
||||||||||||||||||||||
|
1L MPM (PD-L1 x VEGF-A)
(5)
|
||||||||||||||||||||||
|
EGFRm NSCLC
(PD-L1 x VEGF-A)
(5)
|
||||||||||||||||||||||
|
1L HCC (PD-L1 x VEGF-A)
(5)
|
||||||||||||||||||||||
|
Multiple solid tumors
(PD-L1 x VEGF-A)
(5)
|
||||||||||||||||||||||
|
1L Advanced/metastatic TNBC
(PD-L1 x VEGF-A)
(5)
|
||||||||||||||||||||||
|
BNT327 + PM1009
|
1L HCC (PD-L1 x VEGF-A +
TIGIT x PVRIG)
(5)
|
Fully Owned
|
||||||||||||||||||||
|
BNT327 + BNT325/
DB-1305
|
Multiple solid tumors
(PD-L1 x VEGF-A + TROP2)
|
Collaboration
|
Duality
Biologics
|
|||||||||||||||||||
|
Antibody-drug
conjugates
|
BNT323 / DB-1303
(trastuzumab
pamirtecan)
|
HR+/HER2-low metastatic breast
cancer (HER2)
|
Collaboration
|
Duality
Biologics
|
||||||||||||||||||
|
Multiple solid tumors (HER2)
|
||||||||||||||||||||||
|
BNT324 / DB-1311
|
Multiple solid tumors (B7H3)
|
|||||||||||||||||||||
|
BNT325 / DB-1305
|
Multiple solid tumors (TROP2)
|
|||||||||||||||||||||
|
BNT326 / YL202
|
Multiple solid tumors (HER3)
|
Collaboration
|
MediLink
Therapeutics
|
|||||||||||||||||||
105
Annual Report on Form 20-F for the
year ended December 31, 2024
|
Infectious Diseases
|
|||||||||||||||||||||||
|
Drug class
|
Product candidate
|
Indication
|
Phase 1
|
Phase 1/2
|
Phase 2
|
Phase 3
|
Commercial
|
BioNTech
rights
(1)
|
Collaborator/
Partner
|
||||||||||||||
|
mRNA
|
BNT162b2
|
COVID-19
|
Collaboration
|
Pfizer
Fosun Pharma
|
|||||||||||||||||||
|
BNT162b + BNT162b4
|
|||||||||||||||||||||||
|
BNT162b2+BNT161
|
COVID-19 – Influenza
combination
|
Collaboration
|
Pfizer
|
||||||||||||||||||||
|
BNT161
|
Influenza
|
Collaboration
(7)
|
Pfizer
|
||||||||||||||||||||
|
BNT163
|
HSV
|
Collaboration
|
University of
Pennsylvania
|
||||||||||||||||||||
|
BNT164
|
Tuberculosis
|
Fully owned
|
Funded by the
Gates Foundation
|
||||||||||||||||||||
|
BNT165
|
Malaria
|
Fully owned
|
|||||||||||||||||||||
|
BNT166
|
Mpox
|
Fully owned
|
Funded by CEPI
(8)
|
||||||||||||||||||||
|
BNT167
|
Shingles
|
Collaboration
|
Pfizer
|
||||||||||||||||||||
|
Protein-based
therapeutics
|
BNT331
|
Bacterial vaginosis
|
Fully owned
|
||||||||||||||||||||
(1)
For further details about BioNTech’s rights,
see elsewhere in this Annual Report
.
(2)
The
FixVac
platform is fully owned by BioNTech. The BNT111 and BNT116 Phase 2 trials are jointly conducted with
Regeneron as part of a cost-sharing strategic collaboration.
(3)
A member of the Roche group.
(4)
Ph
ase 3 development run by Genmab. BioNTech retains a tiered single-digit royalty on any potential sales.
(5)
Trial ongoing in China only.
(6)
Part of a Phase 2/3 clinical trial.
(7)
Out-licensed to Pfizer.
(8)
Coalition for Epidemic Preparedness Innovations.
A
.
Oncology Programs
1.
mRNA Product Class in Oncology
a)
FixVac
FixVac
is our fully owned, systemic, off-the-shelf mRNA-based
cancer immunotherapy
approach, from which we
are developing several potential first-in-class product candidates.
FixVac
product candidates contain our
optimized uridine-RNA delivered in our proprietary RNA-lipoplex nanoparticles, or RNA-LPX, formulation for
intravenous administration. The
Proprietary RNA-LPX protects the RNA from degradation by RNAse and is
designed for RNA delivery into antigen-presenting cells in lymphoid organs body-wide.
FixVac
candidates are
designed to target shared antigens that have been identified to be frequently expressed across patients with a
specific cancer type. These product candidates are designed to trigger both innate and adaptive immune
responses.
i. BNT111 in Advanced Melanoma
BNT111 is designed to elicit an immune response to four antigens (NY-ESO-1, MAGE-A3, tyrosinase, TPTE) that
have each been found to be associated with cutaneous melanoma.
Ongoing Phase 2 Trial
An open-label,
randomized, multi-site,
Phase 2 clinical trial (BNT111-01; NCT04526899)
is being conducted in
collaboration with Regeneron Pharmaceuticals Inc.,
or Regeneron
, to evaluate
BNT111 in combination with
cemiplimab versus both agents as monotherapy in 184 patients with anti-PD-1-/anti-PD-L1 refractory/relapsed,
unresectable Stage III or IV melanoma. The primary endpoint is objective response rate,
or ORR. Secondary
endpoints include duration of response, or DOR, disease control rate, or DCR, time to response, or TTR,
progression-free survival, or PFS, overall survival, or OS, and safety.
•
In July 2024, we announced that the trial met its primary efficacy outcome measure, demonstrating a
statistically significant improvement in ORR in patients treated with BNT111 in combination with
106
Annual Report on Form 20-F for the
year ended December 31, 2024
cemiplimab, as compared to a historical control in this indication and setting. The ORR in the cemiplimab
monotherapy arm was in line with the historical control of anti-PD-(L)1 or anti-CTLA-4 treatments in this
patient group. The treatment was generally well tolerated and the safety profile of BNT111 in
combination with cemiplimab was consistent with previous clinical trials assessing BNT111 in
combination with anti-PD-(L)1-containing treatments.
The Phase 2 trial will continue as planned to
further assess the secondary endpoints which were not mature at the time of the primary analysis.
We
plan to present these data at an upcoming
medical conference in 2025.
Phase 1 Trial
A m
ulti-center, open-label, first-in-human, Phase 1, dose escalation clinical trial (
Lipo-MERIT
; NCT02410733)
evaluating the safety and tolerability of BNT111 in patients with advanced melanoma was
completed in 2023
.
This was the first clinical trial worldwide in which an mRNA-based cancer immunotherapy was administered
intravenously for systemic treatment.
•
The trial started in 2015. Enrollment was completed in 2020 with 115 patients, and the last patient visit
under the follow-up period took place in June 2023.
Final biomarker and clinical data of the trial have
been gathered and compiled in a clinical study report.
ii. BNT112 for the Treatment of Prostate Cancer
BNT112 is designed to elicit an immune response to five antigens expressed in de novo and metastatic
prostate
cancer
, including prostate-specific antigen, or PSA, a transmembrane protein that is expressed by virtually all
prostate cancers, prostatic acid phosphatase, or PAP, and three additional tumor-associated
antigens
.
Phase 1/2a Clinical Trial
PRO-MERIT is a first-in-human Phase 1/2a, open-label dose titration and expansion clinical trial (
PRO-MERIT;
NCT04382898) to evaluate the safety, immunogenicity and preliminary efficacy of BNT112 monotherapy and in
combination with
cemiplimab
in patients with metastatic castration resistant prostate cancer, or mCRPC and
high-risk localized prostate cancer who are eligible for treatment with androgen deprivation therapy followed by
radical prostatectomy. The trial
has been discontinued and the follow-up period ended in January 2024.
Final
data of the trial was gathered
and compiled in a clinical study report, and
are planned to be presented at a future
scientific conference as well as in a publication.
iii. BNT113
for the Treatment of Head and Neck Squamous Cell Carcinoma, or HNSCC, which is positive for
Human Papilloma Virus 16, or HPV16+
BNT113 contains two different RNAs encoding the two HPV16 oncoproteins E6 and E7, which are exclusively
expressed in pre-malignant and malignant tissue. The global incidence of HPV-associated cancers has been
increasing, particularly HPV16+ HNSCC in younger populations.
Most patients with HPV16+ HNSCC are
diagnosed at more advanced clinical stages.
We see a significant opportunity to improve the treatment
landscape with BNT113 given that it has the potential to augment clinical responses in patients being treated
with checkpoint inhibitors.
Ongoing BNT113 Phase 2 Trial
A global, randomized Phase 2 clinical trial (AHEAD-MERIT; NCT04534205) evaluating BNT113 in combination
with pembrolizumab (Merck & Co., Inc.’s KEYTRUDA®) versus pembrolizumab monotherapy as a first-line
treatment in patients with unresectable recurrent or metastatic HPV16+ HNSCC expressing PD-L1 is ongoing.
Part A is a non-randomized run-in portion designed to demonstrate the safety of the combination of BNT113 and
pembrolizumab. Part B is the randomized portion of the trial designed to generate efficacy and safety data. The
trial plans to enroll a total o
f 350 patients.
•
In September 2024, an exploratory analysis of antitumor activity (15 patients) and immunogenicity from
the safety run-in of AHEAD-MERIT was presented at the 2024 Congress of the European Society of
Medical Oncology, or ESMO. The ORR was found to be 40.0% as assessed by blinded independent
central review, or BICR, and 33.3% as assessed by the investigator, and a medium PFS, or mPFS, of
107
Annual Report on Form 20-F for the
year ended December 31, 2024
3.9 months as per BICR and 6.0 months as per investigator. BNT113 was observed to induce de novo T-
cell responses against HPV16 E6 and E7 oncoproteins. The combination of BNT113 and pembrolizumab
was well tolerated. Treatment emergent adverse events, or TEAEs, were mostly Grade 1 and 2. In
summary, the safety run-in cohort of the ongoing AHEAD-MERIT trial supported the tolerability of
BNT113 and clinical activity in combination with pembrolizumab was observed.
Phase 1/2 Trial
(Investigator-Initiated and Sponsored)
BNT113 was investigated by the University Hospital Southampton National Health Service, or NHS, Foundation
Trust in an investigator-sponsored, open-label, Phase 1/2 dose escalation basket clinical trial (HARE-40;
NCT03418480) with two different arms in
29
patients with HPV16+ head and neck and other cancers in the post-
adjuvant and metastatic setting. The trial
has been terminated
and the patient follow-up period ended in July
2023.
•
In September 2024, results were presented at ESMO. BNT113 was shown to induce immune responses
in patients in the adjuvant and end-stage clinical settings and to be overall well tolerated with a
manageable
safety profile.
iv
.
BNT116
for
the Treatment of Non-small Cell Lung Cancer, or NSCLC
BNT116 is comprised of six different NSCLC-associated tumor-associated antigens for the induction of
polyepitopic anti-tumor CD8+ and CD4+ T cell responses. BNT116
is being evaluated in two clinical trials as
monotherapy and in combination with other immunotherapies and chemotherapies in patients with advanced or
metastasized NSCLC.
Ongoing Phase 2 Trial in 1L NSCLC
A randomized, controlled Phase 2 clinical trial (EMPOWERVAX Lung-1; NCT05557591) is ongoing in
collaboration with Regeneron to evaluate BNT116 in combination with
cemiplimab
versus cemiplimab alone as
first-line treatment of patients with advanced NSCLC whose tumors express PD-L1 in ≥ 50% of their tumor cells.
The primary objective of the Phase 2 trial is to assess safety and tolerability as well as ORR and tumor burden
reduction.
Ongoing Phase 1 Trial in NSCLC
A Phase 1 clinical trial (LuCa-MERIT-1; NCT05142189) is being conducted to evaluate the safety, tolerability and
preliminary efficacy of BNT116 as monotherapy and in several combinations including cemiplimab, and
chemotherapy regimens in locally advanced or unresectable or metastatic NSCLC.
A cohort examining the
combination of BNT116 with
a cytotoxic T-lymphocyte-associated, or
CTLA-4 antibody in patients who have
received prior PD-1 inhibitor therapy and platinum-based chemotherapy was recently added.
•
In April 2024, data from
cohort 3
of the Phase 1 trial were presented at the American Association for
Cancer Research, or AACR, Annual Meeting. Patients were treated with BNT116 in combination with
docetaxel after progression on a PD-1/PD-L1 inhibitor and a platinum-based chemotherapy. Preliminary
data of BNT116 in combination with docetaxel showed encouraging antitumor activity, consistent
induction of immune responses, a manageable safety profile, and no signs of additive toxicity.
Combination therapy with BNT116 and docetaxel was observed to have an ORR of 30% and a DCR of
85%.
•
In November 2024, data from cohort 2 of the Phase 1 trial were presented at the Society for
Immunotherapy of Cancer, or SITC, Annual Meeting. Patients were treated with BNT116 in combination
with cemiplimab. Safety and clinical activity of BNT116+cemiplimab in NSCLC with PD-L1≥50%
progressing after at least stable disease, or SD, on PD-1 inhibitor-based first-line treatment was
reported. Preliminary data of BNT116 in combination with cemiplimab showed a
manageable
safety
profile, an encouraging DCR of 80% and median PFS of 5.5 months in patients previously progressing
on PD-1 inhibition.
b) Autogene Cevumeran (BNT122/RO7198457), or iNeST
108
Annual Report on Form 20-F for the
year ended December 31, 2024
A
utogene cevumeran is an investigational individualized cancer immunotherapy based on specific neoantigens
that are present on a patient’s tumor. Similar to our FixVac programs, our iNeST approach is also based on
pharmacologically optimized uridine mRNA, or uRNA, delivered in our proprietary RNA-LPX formulation. The
RNA-LPX is designed to deliver RNA to dendritic cells, or DCs, the antigen-presenting cells in the lymphoid
organs that are crucial for the initiation of adaptive immune responses, and protects RNA from degradation by
RNAse. iNeST candidates are informed by the mutation profile of a patient’s individual cancer and manufactured
on-demand. The RNA encodes a unique composition of neoantigens selected on a patient-by-patient basis and
results in generation of neoantigen specific CD4+ and CD8+ T cell responses against the respective
neoantigens.
The aim of this approach is to generate and amplify anti-tumor immune responses and thus
broaden the spectrum of tumor targets that can be recognized by the immune system, which is a prerequisite for
clinical activity.
Since 2014, autogene cevumeran has been researched in clinical trials including the IMCODE study program
which was initiated in 2017 to further advance the research and development of individualized neoantigen-
specific immunotherapies. The study program is designed broadly to evaluate autogene cevumeran in various
treatment settings and multiple solid tumor indications, including treatment of early and late-stage cancers. The
aim of the program is to study potential treatment settings and patient populations that could benefit most from
individualized mRNA cancer immunotherapy. Data generated to date indicate that autogene cevumeran is highly
proficient in inducing and expanding high-magnitude and long-lived T cell responses across various tumor types
and treatment settings (Lopez, J. et al., 2025).
Furthermore, early clinical data from a small size patient cohort
indicate that autogene cevumeran alone and in combination with anti-PD-(L)1 treatment can elicit T cell
responses that persist up to three years in the adjuvant treatment of pancreatic ductal adenocarcinoma,
potentially correlating with delayed disease recurrence (Sethna, Z. et al., 2025).
Based on the available data, we decided to pursue autogene cevumeran as one of our priority pan-tumor
programs in our oncology portfolio to address one of the biggest challenges in oncology, which is preventing
disease recurrence. Therefore, with this approach we aim to address the unmet medical need in the treatment of
resectable cancers and in adjuvant or minimal residual disease treatment settings where the tumor burden is
typically low and immune resistance mechanisms are not fully established. We believe individualized mRNA
cancer immunotherapies have the potential to change the current standard of care and improve overall survival
by delaying or preventing recurrence or cancer metastasis. Consequently, BioNTech and Genentech have
focused on initiating multiple clinical trials as part of the IMCODE study program with autogene cevumeran in
high unmet medical need indications in the adjuvant setting, with currently three ongoing randomized clinical
trials.
Autogene cevumeran
is partnered with
Genentech
as part of a collaboration.
Ongoing Phase 2 Clinical Trial in Adjuvant High-risk Muscle-invasive Urothelial Carcinoma, or MIUC
A randomized, double-blind, multi-site Phase 2 clinical trial (IMCODE-004; NCT06534983) evaluating autogene
cevumeran as an adjuvant treatment with nivolumab in patients with high-risk MIUC is ongoing.
•
In December 2024, the first patient
was treated
. The trial is expected to enroll approximately 360
patients to evaluate the efficacy of autogene cevumeran in combination with nivolumab compared to
nivolumab alone. The primary endpoint for the study is investigator-assessed disease-free survival, or
DFS. Secondary objectives include OS and safety.
Ongoing Phase 2 Clinical Trial in Adjuvant Colorectal Cancer, or CRC
A randomized, multi-site, open-label Phase 2 clinical trial (BNT122-01; NCT04486378) evaluating autogene
cevumeran as an adjuvant treatment of circulating tumor DNA, or ctDNA, positive, surgically resected Stage II
(high risk)/Stage III CRC is ongoing. The trial is expected to enroll about 200 patients to evaluate the efficacy of
autogene cevumeran compared to watchful waiting after surgery and chemotherapy, the current standard of care
for these high-risk patients. The primary endpoint for the study is
DFS
. Secondary objectives include OS and
safety. The trial is currently enrolling in the United States, Germany, Spain, Belgium, Sweden and
the
UK. We
plan to disclose
the first data from the ongoing Phase 2 clinical trial in Stage II (high-risk)/ Stage III ctDNA+
adjuvant CRC
in
late 2025 or early 2026
.
109
Annual Report on Form 20-F for the
year ended December 31, 2024
•
In June 2024, at the Annual Meeting of the American Society of Clinical Oncology, or ASCO, preliminary
epidemiologic data were presented, including post-operative ctDNA prevalence and prognostic value in
disease-free survival, from an observational study (NCT04813627) in patients with resected high-risk
stage II/III CRC. This observational study provides supportive epidemiological and prognostic data for
the ongoing interventional Phase 2 clinical trial (NCT04486378).
•
Also in June 2024, at the ESMO Gastrointestinal, or ESMO GI, Cancers Congress, immunogenicity data
of the biomarker cohort of the ongoing Phase 2 (NCT04486378) that enrolled patients irrespective of
post-surgical ctDNA status were presented. The data suggest that autogene cevumeran is highly
immunogenic and induces de novo polyepitopic, ex vivo detectable T-cell responses in all evaluable
patients with resected Stage II/III CRC after completion of adjuvant chemotherapy. Among patients
included in the immunogenicity analysis, 100% (12/12) were disease-free at data cut off.
Ongoing Phase 2 Clinical Trial in Adjuvant Pancreatic Ductal Adenocarcinoma, or PDAC
A randomized Phase 2 clinical trial (IMCODE003; NCT05968326) evaluating the safety and efficacy of autogene
cevumeran in combination with atezolizumab followed by standard-of-care chemotherapy (mFOLFIRINOX) in
patients with resected PDAC compared to chemotherapy alone is recruiting. The Phase 2 study is expected to
enroll 260 patients with resected PDAC who have not received prior systemic anti-cancer treatment and showed
no evidence of disease after surgery. The primary endpoint is DFS. Secondary endpoints include OS and safety.
In April 2024
, at the AACR Annual Meeting, long-term follow-up data were presented from an investigator-
initiated Phase 1 trial (NCT04161755) in patients with resected PDAC indicating that autogene cevumeran
continues to show polyspecific T-cell responses up to three years after vaccination and that immunotherapy-
specific response correlates with delayed tumor recurrence. At the third year, autogene cevumeran was
observed to induce de novo neoantigen-specific, functional and durable CD8 T cells at substantial magnitudes
for multiple neoantigens. After a median follow-up of three years, eight patients with immunotherapy-induced T-
cell responses continued to have longer median recurrence-free survival (not reached) compared with those who
did not experience an immune response (13.4 months). The investigator-initiated, single center Phase 1 trial
evaluated the safety of autogene cevumeran in sequential combination with the anti-PD-L1 immune checkpoint
inhibitor atezolizumab and standard-of-care chemotherapy in 16 patients with resected PDAC. Data from the
1.5-year median follow-up had been published in Nature (Rojas, L.A. et al., 2023).
In February 2025, the longer-term follow up of the investigator-initiated, single center Phase 1 trial in PDAC has
now also been published in Nature (Sethna, Z. et al., 2025).
Phase 2 Clinical Trial
in First-line Advanced
Melanoma
The IMCODE001 (NCT03815058) trial was the first randomized Phase 2 clinical trial with an iNeST-based
candidate as part of the broader IMCODE study program. The trial was initiated in 2019 with the aim to
investigate autogene cevumeran in combination with PD-L1 checkpoint blockade in the advanced treatment
setting of unresectable or complex metastatic tumors. The trial evaluated the efficacy and safety of autogene
cevumeran in combination with pembrolizumab versus pembrolizumab alone as a potential first-line treatment for
patients with previously untreated advanced melanoma. The primary endpoint was progression free survival
(“PFS”) and was events-based. Secondary endpoints included overall survival (“OS”), overall response rate
(“ORR”), duration of response (“DOR”) and safety.
In January 2025, the IMCODE001 trial was completed. While the initial data of the primary analysis support our
data across the broader autogene cevumeran study program demonstrating that autogene cevumeran can
induce and expand high-magnitude and long-lived de novo immune responses against the encoded neoantigens
in this aggressive stage of melanoma, the trial did not meet its primary efficacy endpoint of statically significant
improvement of PFS in this advanced treatment setting. A numerical trend
favoring the combination arm in
overall survival
was observed. The combination of autogene cevumeran with PD-L1 checkpoint blockade was
well tolerated and adverse events were consistent with the known safety profiles of the individual trial treatments,
with no new safety signals observed. The analysis of the results of the IMCODE001 trial, including further
exploratory endpoints and extensive biomarker correlations, is ongoing.
110
Annual Report on Form 20-F for the
year ended December 31, 2024
These topline data support proof of concept for our mRNA cancer immunotherapy approach and our therapeutic
strategy to pursue autogene cevumeran to address the unmet medical need in the treatment of resectable
cancers and in adjuvant or minimal residual disease treatment settings, while we are evaluating novel immune-
oncology (“IO”) combinations for the treatment of advanced, rapidly progressing high-volume tumors.
Ongoing Phase 1a/1b Clinical Trial Advanced/Metastatic Solid Tumors
An open-label Phase 1a monotherapy/1b in combination with atezolizumab clinical trial (NCT03289962) of
autogene cevumeran in patients with locally advanced or metastatic solid tumors, including patients with
melanoma, NSCLC, bladder cancer, CRC, triple-negative breast cancer, or TNBC, renal cancer, head and neck
cancer and sarcomas as well as other solid tumors is fully enrolled and follow-up is ongoing.
•
In January 2025, a manuscript summarizing the results of the trial was published in Nature Medicine
(Lopez, J. et al., 2025).
c)
RiboMabs
Our
RiboMab
product candidate is an mRNA that encodes cancer cell targeting antibodies. This fully-owned
product candidate is nucleoside-modified to minimize immunogenicity and our improved mRNA backbone
designs with the aim of maximizing protein expression. Our
RiboMab
product candidate is formulated using liver-
targeting lipid nanoparticles, or LNPs, for intravenous delivery. This RNA-LNP technology is designed to address
the challenges of recombinantly expressed proteins, including limited serum half-life and manufacturing process
challenges.
i. BNT142 for the Treatment of Solid Tumors
BNT142 encodes a T-cell engaging bispecific antibody targeting Claudin 6, or CLDN6. An open-label, multi-site
Phase 1/2 clinical trial (NCT05262530) in patients with CLDN6-positive advanced solid tumors that have
exhausted available standard therapy or are not eligible for such available therapy is ongoing.
e)
R
iboCytokine
s
Our
RiboCytokine
product candidates are designed to address the limitations of recombinantly expressed
cytokines, including limited serum half-life and production costs. BNT151 and BNT152+153 are nucleoside-
modified mRNAs encoding human cytokines fused to human serum albumin. The modified mRNA is formulated
with liver-targeting LNPs for intravenous delivery. BNT151 encodes an IL-2 variant, BNT152 encodes IL-7, and
BNT153 encodes IL-2.
i. BN
T151 for the Treatment of Solid Tumors
A first-in-human, open-label, multi-center Phase 1/2 clinical trial (NCT04455620) in multiple solid tumor
indications has been discontinued after the completion of enrollment for the Part 1 monotherapy dose escalation,
as previously communicated. The safety follow-up phase for enrolled patients had been completed and the
clinical data of the trial were reported to the appropriate regulatory bodies.
ii. BNT152+BNT153 for the Treatment of Solid Tumors
An open-label, multi-site, first-in-human Phase 1 clinical trial (NCT04710043) in multiple solid tumor indications
is ongoing to evaluate the safety, pharmacokinetics, pharmacodynamics and preliminary anti-tumor activity of a
combination of BNT152 and BNT153. The clinical trial consists of two parts: Part 1, the separate monotherapy
dose escalation of BNT152 and BNT153, was completed in May 2023, as a result of which
a maximum tolerated
dose, or MTD, was defined for each product.
Part 2 is currently investigating the combination treatment of
BNT152 and BNT153.
2.
Oncology Cell Therapy Product Candidates
a) CAR-T-cell therapy - CAR-T
111
Annual Report on Form 20-F for the
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i. BNT211 for the Treatment of CLDN6+ Solid Tumors
BNT211 consists of two investigational medicinal products: our first CAR-T-cell product candidate, which targets
CLDN6-positive solid tumors, in combination with an mRNA named CARVac (CLDN6 RNA-LPX) encoding
CLDN6. The CAR-T cells are equipped with a second-generation CAR of high sensitivity and specificity for the
tumor-specific carcino-embryonic antigen CLDN6. CARVac is intended to support in vivo expansion of
transferred CAR-T cells to increase their persistence and efficacy. As with
FixVac
and iNeST, CARVac is also
based on a pharmacologically optimized-backbone equipped uRNA delivered in our proprietary RNA-LPX
formulation. BNT211 has been granted Priority Medicines, or
PRIME,
designation by the EMA for the third- or
later-line treatment of testicular germ cell tumors, and Regenerative Medicine Advanced Therapy, or RMAT,
designation by the FDA.
Ongoing Phase 1 Clinical Trial
A first-in-human, open-label, multi-site Phase 1 dose escalation and dose expansion basket trial (NCT04503278)
is being conducted to
evaluate CLDN6 CAR-T cells as monotherapy or in combination with CARVac in patients
with CLDN6-positive relapsed or refractory solid tumors, including ovarian cancers and testicular germ cell
tumors. The primary outcome measure of the trial is safety, with secondary efficacy outcome measures to
include ORR, DCR and DOR.
•
In June 2024, we presented an analysis of real-world data that investigated the OS, treatment patterns
and prognostic variables of patients with testicular germ cell tumors receiving palliative chemotherapy at
the ASCO Annual Meeting. This analysis will inform the design of our planned pivotal clinical trial to
evaluate BNT211 in patients with germ cell tumors.
•
In September 2024, data from the ongoing trial were presented at the ESMO Congress which showed
encouraging signs of antitumor activity across indications.
Among patients who received dose levels of
1x10
8
CAR T cells or above with or without CARVac, ORR was observed to be 41.7% for patients with
testicular cancer and 58.3% for those with ovarian cancer.
CARVac was shown to improve CAR-T
persistence in some patients. The data also suggest that the safety profile of CLDN6 CAR T cells with
and without CARVac is consistent with the previously published effects of CAR-T therapies and that
repeated CARVac administration does not significantly increase toxicity.
•
In January 2025, the FDA granted RMAT designation for BNT211. The RMAT designation is designed to
expedite the development and review process for promising pipeline products, including cell therapies.
•
A pivotal Phase 2 trial in patients with testicular germ cell tumors is planned to start in 2025 based on
encouraging activity in this patient group observed in the Phase 1 trial.
b) Neoantigen-Targeting T Cells
Our neoantigen-targeting T-cell stimulation platform can be utilized to develop product candidates across several
neoantigen-targeting non-engineered and engineered T-cell therapies. Autologous, neoantigen-specific T cells
are primed, activated and expanded ex vivo utilizing a proprietary antigen-specific T-cell induction protocol,
Neo-
Stim
, to target either a personal set of neoantigens for each patient or a set of selected shared neoantigens. Our
lead product candidate under this platform is our individualized neoantigen-targeting T-cell therapy, BNT221.
i. BNT221 for the Treatment of Cancer
BNT221 is our autologous, fully personalized, polyspecific T-cell therapy directed against selected sets of
individual neoantigens. BNT221 is generated through a
proprietary stimulation process (
Neo-Stim
) and allows for
the induction of T cells from the
naïve compartment
, as well as expansion of pre-existing memory T cells. Other
product characteristics are (i) cells with high specificity profile towards the mutant epitope; (ii) cells exhibiting
multiple effector functions; (iii) a product that contains both central and effector memory T cells; and (iv) cells that
have a cytotoxic response towards endogenously processed and presented antigens as well as recognition of an
autologous tumor.
The neoantigens are selected using our proprietary
Recon
bioinformatics engine.
Ongoing Phase 1 Clinical Trial
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A first-in-human Phase 1 dose
escalation
clinical trial (NCT04625205) evaluating BNT221 in patients with
checkpoint inhibitor unresponsive or refractory metastatic melanoma is ongoing. The first portion of the trial
consists of a monotherapy dose escalation of BNT221, for which recruitment and treatment of patients is
complete. Currently, BNT221 is being dosed in
combination with anti-PD-1
therapy after first-line treatment.
Additional enrollment has been stopped for non-safety related reasons, with health authorities notified. Major
objectives of this study include evaluation of the safety and feasibility of administering BNT221, as well as
evaluations of immunogenicity and preliminary efficacy.
•
In January 2025, a manuscript summarizing the results of the monotherapy portion of the trial was
published in Nature Medicine (Borgers, J. et al., 2025).
3.
Protein-based Therapeutic
Product Candidates in Oncology
a)
Next-Generation Immune Checkpoint Modulators
We and Genmab are developing antibodies that are designed to function as tumor-targeted and dual
immunomodulators, applying Genmab’s proprietary technologies in combination with our joint target identification
and product concept expertise. In addition, we and Genmab are developing antibodies that are designed to
enhance pre-existing immunity.
We and Genmab have three product candidates currently in clinical development
as part of a 50:50 collaboration in which development costs and future profits are shared:
BNT312/GEN1042
(DuoBody CD40x4-1BB), BNT314/GEN1059 (DuoBody-EpCAMx4-1BB) and BNT315/GEN1055 (HexaBody-
OX40)
.
We and OncoC4 have an ongoing strategic collaboration,
which includes joint development of BNT316/ONC-392
(Gotistobart), an anti-CTLA-4 antibody, in a range of solid tumor indications, with the parties equally sharing
development costs for such joint development studies. BioNTech holds the exclusive worldwide
commercialization
rights for this product candidate.
In February 2025, we announced the completion of our acquisition of Biotheus. With the acquisition, we obtained
full global rights to the bispecific antibody clinical asset BNT327, a PD-L1 x VEGF-A bispecific antibody formerly
known as PM8002, and Biotheus’ pipeline candidates. This follows an initial exclusive global license and
collaboration agreement with Biotheus in 2023 to develop, manufacture and commercialize of
BNT327
globally
outside of Greater China.
i.
BNT311/GEN104
6 (acasunlimab)
a PD-L1x4-1BB Bispecific Antibody for the Treatment of Solid Tumors
BNT311/GEN1046 (acasunlimab) is an investigational, potential first-in-class bispecific antibody combining PD-
L1 checkpoint inhibition with 4-1BB stimulation. BNT311/GEN1046 (acasunlimab) is being developed for the
treatment of solid tumors using Genmab’s proprietary DuoBody technology platform. BNT311/GEN1046
(acasunlimab) is currently being evaluated in multiple clinical trials.
In August 2024, we announced that while the emerging clinical profile of BNT311/GEN1046 (acasunlimab) was
encouraging, for reasons relating to portfolio strategy, we opted not to participate in the further development of
the program, including an ongoing Phase 3 trial. In the event that the program is commercialized, we will retain a
tiered single-digit royalty on any potential sales. We and Genmab will continue our collaboration on other
programs under the existing agreements.
ii.
BNT312/GEN1042
, a CD40x4-1BB Bispecific Antibody for the Treatment of Solid
Tumors
BNT312/GEN1042 is a jointly owned, novel, agonistic, bispecific antibody that combines targeting and
conditional activation of the costimulatory molecules CD40 and 4-1BB on immune cells.
BNT312
/GEN1042 is
being developed for the treatment of solid cancers using Genmab’s proprietary DuoBody technology platform
and
our CD40 and 4-1BB antibodies
. We and Genmab
are
currently evaluating BNT312/GEN1042 in several
clinical trials.
Ongoing Clinical Trials
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A Phase 1/2 dose-escalation clinical trial (NCT04083599) with expansion cohorts evaluating safety and anti-
tumor activity of BNT312/GEN1042 as monotherapy and in combination therapies in patients with solid tumors is
ongoing.
We and Genmab plan to determine next steps for this program in 2025
.
A
n open-label Phase 1/2 clinical trial (NCT05491317) evaluating the safety and clinical activity of BNT312/
GEN1042 in combination with radiotherapy with or without pembrolizumab in patients with metastatic solid
tumors is ongoing.
A Phase 1 clinical trial (NCT06057038) in Japan evaluating the safety, tolerability, pharmacokinetics,
pharmacodynamics and antitumor activity of BNT312/GEN1042 monotherapy and in combination with
pembrolizumab with or without chemotherapy in patients with multiple solid tumors is ongoing.
iii. BNT313/GEN1053, an Agonistic HexaBody-CD27 Antibody for the Treatment of Malignant Solid Tumor
s
BNT313/GEN1053 is a novel CD27 antibody with an immunoglobulin G, or IgG, Fc domain engineered to induce
clustering of CD27 on the plasma membrane of T cells with the aim of enhancing T-cell activation, proliferation
and differentiation
without depleting T cells.
In preclinical studies, BNT313/GEN1053 increases T-cell activation,
proliferation, cytokine secretion and cytotoxic activity.
Phase 1/2 Clinical Trial
A Phase 1/2 clinical trial (NCT05435339) evaluating the safety, tolerability, and preliminary efficacy of CD27-
targeting antibody BNT313/GEN1053 on solid tumors as monotherapy has been discontinued due to the
strategic evaluation of BNT313/GEN1053 within the context of BioNTech’s and Genmab’s portfolios.
iv. BNT314/GEN1059, an EpCAMx4-1BB Bispecific Antibody for the Treatment of Advanced or Metastatic Solid
Tumors
BNT314/GEN1059 is a potential first-in-class bispecific antibody product candidate
designed to boost antitumor
immune responses through EpCAM-dependent 4-1BB agonistic activity.
A BioNTech-sponsored first-in-human Phase 1/2 clinical trial (NCT06150183) is being conducted to investigate
the safety and preliminary antitumor activity of BNT314/GEN1059
in patients with advanced or metastatic solid
tumors.
•
A Trial-in-Progress poster from this trial was presented at the 2024 ESMO Congress.
v.
BNT315/GEN1055
, a HexaBody-OX40 Antibody for the Treatment of Advanced Solid Tumors
BNT315/GEN1055 is an OX40 agonist antibody designed to induce OX40 clustering independently of Fc-gamma
receptor-, or FcγR-mediated crosslinking to enhance antitumor T-cell responses.
A first-in-human Phase 1/2 clinical trial (NCT06391775) is being conducted to investigate the safety and
preliminary antitumor activity of BNT315/GEN1055 in patients with advanced or metastatic solid tumors.
vi
. BNT322/GEN1056, an Antibody for the Treatment of Solid Tumors
BNT322/GEN1056 is an antibody product candidate co-developed with Genmab for the treatment of solid tumors
and for potential use in combination with other products. The development program for BNT322/GEN1056 has
been discontinued due to strategic evaluation of the development program within the context of BioNTech’s and
Genmab’s portfolios.
A first-in-human Phase 1 clinical trial (NCT05586321) of BNT322/GEN1056 in patients with advanced solid
tumors is ongoing.
vii. BNT317, an Antibody for the Treatment of Advanced Solid Tumors
BNT317 is a product candidate we are developing for the treatment of solid tumors. A first-in-human, open-label,
dose escalation Phase 1 clinical trial (NCT06750185) was initiated in January 2025 to evaluate the safety,
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tolerability, pharmacokinetics, and immunogenicity of increasing doses of BNT317 in participants with advanced
solid tumors.
viii.
BNT327
,
a Bispecific Antibody
Candidate
Targeting PD-L1 and VE
GF
BNT327 is an anti-VEGF-A antibody candidate fused to a humanized anti-PD-L1 VHH, previously being
developed in collaboration with Biotheus. In February 2025, we announced the completion of our acquisition of
Biotheus. With the acquisition, we obtained full global rights to the late-stage clinical asset BNT327.
BNT327 is currently being evaluated in multiple Phase 2 and Phase 3 global and
China-only clinical trials
to
assess the efficacy and safety of the candidate as monotherapy or in combination with chemotherapy in various
indications. BNT327 is also being evaluated in combination with BNT325/DB-1305, a next-generation ADC
candidate, in a Phase 1/2 clinical trial. We also plan to evaluate BNT327 in combination with our other clinical-
stage ADCs, BNT323/DB-1303, BNT324/DB-1311 and BNT326/YL202.
Ongoing Phase 3 Clinical Trial in
Extensive-Stage Small Cell Lung Cancer, or ES-SCLC
In December 2024, BioNTech initiated a global, randomized Phase 3 clinical trial (NCT06712355) evaluating
BNT327 plus chemotherapy compared to atezolizumab plus chemotherapy in first-line ES-SCLC.
Ongoing Phase 3 Clinical Trial in Locally Advanced/Metastatic TNBC
A Phase 3 clinical trial (NCT06419621) evaluating BNT327 in combination with chemotherapy compared to
chemotherapy as a first-line treatment for patients with locally advanced/metastatic TNBC is ongoing in China.
Ongoing Phase 3 Clinical Trial in Second-Line
Small-Cell Lung Cancer, or SCLC
A Phase 3 clinical trial (NCT06616532) evaluating BNT327 in combination with chemotherapy compared to
investigator’s choice chemotherapy as a second-line treatment for patients with SCLC is ongoing in China.
Ongoing Phase 2 Clinical Trial in
ES-SCLC
In September 2024, the first patient was dosed in a multi-site, open-label Phase 2 clinical trial (NCT06449209) to
evaluate BNT327 in combination with chemotherapy in patients with untreated ES-SCLC and in patients with
SCLC that progressed after first- or second-line treatment. The study is recruiting in the United States, Türkiye,
Australia, South Korea and the UK.
Ongoing Phase 2 Clinical Trial in L
ocally Advanced/Metastatic TNBC
In October 2024, the first patient was dosed in a multi-site, open-label Phase 2 clinical trial (NCT06449222) to
evaluate the safety, efficacy, and pharmacokinetics of BNT327 at two dose levels in combination with
chemotherapy in the first- and second-line treatment of patients with locally advanced/metastatic TNBC. The
study is recruiting in the United States, Australia, Türkiye and the UK. A Phase 3 clinical trial in first-line TNBC is
expected to start in 2025.
Ongoing Phase 2/3 Clinical Trial in
First-Line NSCLC
In December 2024, BioNTech initiated a global, randomized Phase 2/3 clinical trial (NCT06712316) evaluating
BNT327 plus chemotherapy compared to pembrolizumab and chemotherapy in first line NSCLC.
Ongoing Phase 2 Clinical Trial in First-Line ES-SCLC
A Phase 2 clinical trial (NCT05844150) evaluating BNT327 in combination with chemotherapy as a first-line
treatment for patients with ES-SCLC is ongoing in China.
Ongoing Phase 2 Clinical Trial in Second-Line ES-SCLC
A Phase 2 clinical trial (NCT05879068) evaluating BNT327 in combination with chemotherapy as a second-line
treatment for patients with SCLC is ongoing in China.
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Ongoing Phase 2 Clinical Trial in Neuroendocrine Neoplasm, or NEN
A Phase 2 clinical trial (NCT05879055) evaluating BNT327 in combination with chemotherapy as a second-line
treatment for patients with NEN is ongoing in China.
Ongoing Phase 2 Clinical Trial in Malignant Mesothelioma, or MPM
A Phase 2 clinical trial (NCT05918107) evaluating BNT327 in combination with chemotherapy as a first-line
treatment for patients with MPM is ongoing in China.
Ongoing Phase 2 Clinical Trial in EGFR-mutant Non-Squamous NSCLC
A Phase 2 clinical trial (NCT05756972) evaluating BNT327 in combination with chemotherapy as a treatment for
patients with EGFR-mutant NSCLC who have failed EGFR-tyrosine kinase inhibitor treatment is ongoing in
China.
•
In September 2024, at the ESMO Congress, data were presented from trial. The 64 patients were
observed to have an ORR of 60.9%, a cORR of 57.8% and DCR of 95.3%. In the 28 patients with PD-L1
tumor proportion score, or TPS, <1%, the ORR was observed to be 46.4% and DCR was observed to
92.9%. In the 23 patients with TPS 1-49%, the ORR was observed to be 60.9% and DCR was observed
to be 100%. Among the 13 patients with TPS ≥50%, the ORR was observed to be 92.3% and DCR was
observed to be 92.3%. Any-grade TRAEs occurred in 98.4% patients and Grade ≥ 3 TRAEs occurred in
60.9% of patients. Nine patients discontinued BNT327 and/or chemotherapy administration due to
TRAEs, plus one case of TRAE-related death. In summary, we believe that the observations of BNT327
in combination with chemotherapy in mutated NSCLC patients that progressed on prior EGFR-TKI
therapy showed encouraging anti-tumor activity independent of PD-L1 expression levels with a positive
correlation seen between higher tumor PD-L1 expression levels and overall response rates, and a
generally manageable safety profile.
Ongoing Phase 2 Clinical Trial in Hepatocellular Carcinoma, or HCC
A Phase 2 clinical trial (NCT05864105) evaluating BNT327 in combination with chemotherapy as a first-line
treatment for unresectable HCC is ongoing in China.
Ongoing Phase 1/2 Clinical Trial in Advanced Solid Tumors
A Phase 1/2 clinical trial (NCT05918445) evaluating BNT327 as a monotherapy in patients with advanced solid
tumors is ongoing in China.
•
In June 2024, data from the trial were presented at the ASCO Annual Meeting. Data on 48 patients with
advanced cervical cancer, or CC, showed an ORR of 42.2% (52.4% in patients with PD-L1-positive
tumors), a DCR of 93.3%, and an mPFS of 8.3 months. Data on 39 patients with PROC showed an ORR
of 20.6%, a DCR of 67.7%, and an mPFS of 5.5 months. TRAEs occurred in 95.4% of patients (83/87),
with ≥ Grade 3 TRAEs in 36.8% (32/87). 14.9% (13/87) of patients discontinued BNT327 treatment due
to TRAEs. Median follow-up time in patients with CC and PROC was 13.8 months and 14.8 months,
respectively.
•
At the ASCO Annual Meeting, data on 61 patients with non-squamous NSCLC were also presented.
Data on 17 evaluable patients with untreated NSCLC wild-type and PDL1-positive showed an ORR of
47.1%, a DCR of 100% and an mPFS of 13.6 months at a median follow-up of 11.3 months. Data on 36
evaluable patients with EGFR-mutant NSCLC after progression on prior EGFR-tyrosine kinase inhibitor,
or TKI, treatment showed an ORR of 19.4%, a DCR of 69.4% and an mPFS of 5.5 months at a median
follow-up of 12.6 months. Data from eight evaluable patients with EGFR/ALK wild-type NSCLC that
progressed after anti-PD-1/L1 therapy and platinum-based chemotherapy showed an ORR of 12.5%, a
DCR of 62.5%, and an mPFS of 5.8 months at a median follow-up of 5.8 months. TRAEs occurred in
85.2% of patients (52/61), with ≥ Grade 3 TRAEs in 19.7% (12/61). Serious adverse events were
observed in 24.6% (15/61) of patients, and 8.2% (5/61) of patients discontinued BNT327 treatment due
to TRAEs.
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•
In September 2024, at the ESMO Congress, data from the trial were presented. 28 patients with clear
cell RCC, or ccRCC, who progressed after combination of anti-PD-(L)1 and VEGF-TKI therapy or VEGF-
TKI monotherapy, were observed to have an ORR of 25%, a DCR of 82.1%, a mPFS of 10.9 months
and a mDOR of 19.6 months. The 22 patients with previously untreated non-clear cell RCC, or nccRCC,
were observed to have an ORR of 36.4%, a DCR of 90.9% and a mPFS of 15.1 months. Any-grade and
Grade ≥3 TRAEs of the combination regimen occurred in 100% and 41.5% of patients, respectively.
TRAEs leading to treatment discontinuation occurred in 1.9% of patients. In summary, BNT327
monotherapy was observed to have encouraging anti-tumor activity and a manageable safety profile in
patients with previously untreated advanced nccRCC or previously treated advanced ccRCC.
Ongoing Phase 1/2 Clinical Trial in Locally Advanced/Metastatic TNBC
A Phase 1b/2 clinical trial (NCT05918133) evaluating BNT327 in combination with chemotherapy in patients with
locally advanced or metastatic TNBC without previous systematic treatment is ongoing in China.
•
In September 2024, at the ESMO Congress, data from the trial were presented. The 42 patients were
observed to have an ORR of 78.6%, a confirmed ORR, or cORR, of 73.8% with a DCR of 95.2%, an
mPFS of 13.5 months and a median duration of response, or mDOR, of 11.7 months. Among the 42
patients treated, 38 patients had available PD-L1 expression results assessed by means of a PD-L1
immunohistochemistry, or IHC, E1L3N assay. cORR was observed to be 76.9% in 13 patients with PD-
L1 combined positive scores, or CPS, <1, 56.3% in the 16 patients with PD-L1 1≤CPS<10, and 100% in
the nine patients with PD-L1 CPS≥10. Any-grade and Grade ≥3 TRAEs of the combination regimen
occurred in 100% and 57.1% of patients, respectively. TRAEs leading to treatment discontinuation
occurred in 4.8% of patients. The most common TRAEs included neutropenia, leukocytopenia, anemia,
proteinuria and alopecia. In summary, first line treatment of locally advanced/metastatic TNBC with
BNT327 in combination with nab-paclitaxel was observed to be associated with clinically meaningful
antitumor activity regardless of PD-L1 status and manageable toxicity with no new safety signals
observed beyond those typically described for anti-PD-(L)1 therapies, anti-VEGF therapies and
chemotherapy.
•
In December 2024, at the San Antonio Breast Cancer Symposium, or SABCS, updated data were
presented from the trial. In 42 patients with locally advanced or metastatic TNBC, first-line therapy with
BNT327 combined with nab-paclitaxel showed clinically meaningful survival outcomes and antitumor
activity regardless of PD-L1 status, together with a manageable safety profile. The confirmed ORR was
73.8% with a DCR of 95.2%. The median TTR, or mTTR, was 1.9 months and the mDOR was 11.7
months. The matured mPFS was 13.5 months for the intention to treat, or ITT, population. The median
OS, or mOS, was not reached, while the matured 12-month OS rate was 80.8%, the matured 15-month
OS rate was 78.1%, and the nearly matured 18-month OS rate was 69.7%.
Ongoing Phase 1/2 Clinical Trial in First Line HCC
A Phase 1/2 clinical trial (NCT06584071) evaluating BNT327 in combination with PM1009 in patients with locally
advanced or metastatic HCC is ongoing in China. The study is divided into two parts. The first part is a Phase
1b, single-arm study. The second part is a Phase II randomized controlled study.
Ongoing BNT325/DB-1305 Phase 1/2 Clinical Trial in Advanced Solid Tumors
A multi-center, non-randomized, open-label, multiple-dose, first-in-human Phase 1/2a clinical trial
(NCT05438329) evaluating BNT325/DB-1305 in patients with advanced solid tumors is ongoing. As part of this
clinical trial, BNT325/DB-1305 is being studied in combination with BNT327 in various solid tumor indications.
We plan to present first clinical data from the ongoing global Phase 1/2 expansion cohorts evaluating BNT327
plus BNT325/DB-1305 in multiple solid tumors
in 2025
.
i
x.
BNT316/ONC-39
2
(gotistobart), an Anti-CTLA-4 Monoclonal Antibody Candidate in Development in
Collaboration with OncoC4
BNT316/ONC-392 (gotistobart) is an anti-cytotoxic T-lymphocyte associated protein 4, or CTLA-4, monoclonal
antibody candidate being developed in collaboration with OncoC4. CTLA-4 is a molecule which inhibits T-cell
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immune response and reduces the activity of T cells in recognizing and eliminating cancer cells. Blocking
CTLA-4 preserves T-cell activity and enhances anti-tumor activity. BNT316/ONC-392 (gotistobart) is designed to
offer a differentiated safety profile that may allow for higher dosing and longer duration of treatment both as
monotherapy and in combination with other therapies. The program received Fast Track Designation from the
FDA in 2022.
Ongoing Phase 3 Clinical Trial in Metastatic, Immunotherapy-resistant NSCLC
In December 2024, we were informed by our partner OncoC4 that the FDA had lifted the partial clinical hold on
PRESERVE-003 (NCT05671510), a two-stage, open-label, randomized Phase 3 trial evaluating the efficacy and
safety of BNT316/ONC-392 (gotistobart) as monotherapy in patients with metastatic NSCLC that progressed
under previous platinum-based chemotherapy and PD-(L)1-inhibitor treatment. Based on the available trial data
and following an alignment with the FDA, the companies will continue enrollment solely of patients with
squamous NSCLC.
We had previously announced the partial clinical hold on the study in October 2024, following OncoC4’s
communication to the FDA after an assessment of the trial data by the independent Data Monitoring Committee
which identified a possible variance in results between the squamous and non-squamous NSCLC patient
populations. The partial clinical hold only affected new patient enrollment and did not impact patients already
enrolled in the trial. Trials evaluating BNT316/ONC-392 in other indications also remained unaffected.
Ongoing Phase 2 Clinical Trial in Platinum-resistant Ovarian Cancer
A Phase 2 clinical trial (PRESERVE-004; NCT05446298) is being conducted to evaluate BNT316/ONC-392
(gotistobart) therapy in combination with pembrolizumab in patients with PROC. The clinical trial is designed to
evaluate multiple doses of BNT316/ONC-392 (gotistobart) in combination with a fixed dose of pembrolizumab in
participants with ovarian cancer who are resistant to platinum-based chemotherapy. The primary endpoints are
ORR and safety. Secondary endpoints include DOR, DCR, PFS and OS.
•
In September 2024, preliminary data from the ongoing trial were presented
at the ESMO Congress
. The
data were also presented at the International Gynecologic Cancer Society Annual Global Meeting in
October 2024. 33 and 29 patients in 1 mg/kg and 2 mg/kg BNT316/ONC-392 (gotistobart) dose groups,
respectively, were observed to have an unconfirmed ORR of 25% and 27.6%, respectively. Grade ≥3
TEAEs related to either drug were observed in 45.5% and 41.4% of patients in the 1 mg/kg and 2 mg/kg
groups, respectively. In summary, these data suggest encouraging preliminary clinical activity and a
manageable tolerability profile with no new safety signals detected.
Ongoing
Phase 1/2
Clinical Trial in Metastatic Castration Resistant Prostate Cancer
A Phase 1/2 clinical trial (PRESERVE-006; NCT05682443) is being conducted to evaluate the safety and
efficacy of BNT316/ONC-392 (gotistobart) in combination with lutetium Lu-177 vipivotide tetraxetan in patients
with mCRPC who have disease progressed on androgen receptor pathway inhibition. The trial is expected to
enroll approximately 144 patients at clinical trial sites in the United States. The primary endpoint is PFS.
Ongoing Phase 1/2 Clinical Trial in Advanced or Metastatic Solid Tumors
A first-in-human Phase 1/2 open-label dose escalation clinical trial
(NCT04140526)
evaluating BNT316/ONC-392
(gotistobart) as monotherapy and in combination with pembrolizumab in patients with advanced or metastatic
solid tumors is ongoing.
b) Targeted Cancer Antibodies
i.
BNT321
fo
r the Treatment of Pancreatic Cancer
BNT321 is a high affinity, fully human IgG1 monoclonal antibody targeting sialyl Lewis A, or sLea, an epitope on
CA19-9 which is expressed in pancreatic and other gastrointestinal cancers. sLea plays a role in tumor adhesion
and metastasis formation and is a marker of an aggressive cancer phenotype.
In January 2025, clinical trials involving BNT321 were
discontinued
.
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Phase 1 Clinical Trial
A Phase 1 trial (NCT02672917) evaluated BNT321 monotherapy and in combination with mFOLFIRINOX in
patients with advanced PDAC and other CA19-9+ tumors.
•
Data from the trial were presented at the ASCO Gastrointestinal Cancer Symposium 2024. Preclinically,
BNT321 binding was observed to be highly specific and restricted to cancer tissues with sLea
expression. The most frequent dose-limiting toxicities, or DLTs, for both monotherapy and for
mFOLFIRINOX combination therapy were hepatic transaminase elevations. DLTs generally occurred in
cycle 1 and did not preclude subsequent BNT321 administration at reduced doses. BNT321 in
combination with mFOLFIRINOX was tolerable for multiple cycles. Clinical activity (27% PR, RECIST)
was observed in patients receiving the combination as first or subsequent line therapy for advanced
disease.
Phase 1/2 Clinical Trial
In April 2024, the first patient was dosed in a Phase 1/2 trial (NCT06069778) evaluating the safety, tolerability,
and efficacy of BNT321 in combination with mFOLFIRINOX as an adjuvant therapy following curative resection
in patients with PDAC.
c)
Antibody Drug Conjugates
i. BNT323/DB-1303, an ADC in Development in Collaboration with
DualityBio
BNT323/DB-1303 is a topoisomerase-1 inhibitor-based ADC directed against Human Epidermal Growth Factor
Receptor 2, or HER2, a target that is over-expressed in a variety of cancers and contributes to the aggressive
growth and spread of cancer cells. The program received Fast Track Designation from the FDA for endometrial
cancer in 2023. In 2023, the FDA also granted Breakthrough Therapy designation for BNT323/DB-1303 for the
potential treatment of advanced endometrial cancer in patients who progressed on or after treatment with
immune checkpoint inhibitors.
Ongoing BNT323/DB-1303 Phase 3 Clinical Trial in Advanced or Metastatic Hormone Receptor-positive, or HR+,
HER2-low Breast Cancer
An ongoing randomized, multi-site, open-label, pivotal Phase 3 clinical trial (DYNASTY-Breast02; NCT06018337)
is recruiting to evaluate BNT323/DB-1303 versus the investigator’s choice of chemotherapy in advanced or
metastatic HR+, HER2-low breast cancer subjects whose disease has progressed on at least two lines of prior
endocrine therapy or within six months of first-line endocrine therapy and cyclin-dependent 4/6, or CDK4/6,
inhibitor and no prior chemotherapy. The first patient was dosed in January 2024. The trial aims to enroll
approximately 532 patients. The primary endpoint is PFS. Secondary endpoints include OS, ORR, DCR, DOR
and safety, as well as patient-reported outcomes.
•
In September 2024, a Trial-in-Progress poster was presented at the ESMO Congress.
Topline data from the ongoing Phase 3 in patients with HR+ and HER2-low metastatic breast cancer who have
progressed on hormone therapy and/or CDK4/6 inhibition is expected in 2026.
Ongoing BNT323/DB-1303 Phase 1/2 Clinical Trial in Advanced or Metastatic HER2-expressing Solid Tumors
BNT323/DB-1303 is being evaluated in an ongoing multi-center, non-randomized, open-label, multiple dose,
first-in-human Phase 1/2 clinical trial (NCT05150691) in patients with advanced/unresectable, recurrent, or
metastatic HER2-expressing solid tumors, including HER2-expressing breast cancer and endometrial cancer.
•
A potential registrational single-arm trial enrolling HER2-expressing (IHC3+, 2+, 1+ or ISH-positive)
patients
with endometrial carcinoma has completed enrollment.
•
A confirmatory Phase 3 trial (NCT06340568) to evaluate BNT323/DB-1303 in patients with advanced
endometrial cancer is in planning.
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ii.
BNT324/DB-1311
, an ADC in Development in Collaboration with DualityBio
BNT324/DB-1311 is a topoisomerase-1 inhibitor-based ADC directed against B7H3. In June 2024, we and
DualityBio received Fast Track Designation for BNT324/DB-1311 from the FDA for the treatment of patients with
advanced/unresectable, or metastatic CRPC
, who have progressed on or after standard systemic regimens. In
July 2024, we and DualityBio received Orphan Drug Designation for BNT324/DB-1311 from the FDA for the
treatment of patients with advanced or metastatic esophageal squamous cell carcinoma.
Ongoing BNT324/DB-1311 Phase 1/2 Clinical Trial in Advanced Solid Tumors
A first-in-human, multi-center, open-label, dose escalation and dose-expansion Phase 1/2 clinical trial evaluating
the safety and tolerability of BNT324/DB-1311 in patients with advanced solid tumors has been initiated and the
first patient was dosed in September 2023.
•
In December 2024, preliminary tumor-specific dose optimization data from the trial were presented at the
ESMO Asia Congress, demonstrating encouraging efficacy and manageable safety across a range of
advanced solid tumors.
iii.
BNT325
/DB-1305, an ADC in Development in Collaboration with DualityBio
BNT325/DB-1305 is a topoisomerase-1 inhibitor-based ADC directed against TROP2. In January 2024, we and
DualityBio received Fast Track Designation for BNT325/DB-1305 from the FDA for the treatment of patients with
PROC, fallopian tube, or primary peritoneal cancer in patients who have received one to three prior systemic
treatment regimens.
Ongoing BNT325/DB-1305 Phase 1/2 Clinical Trial in Advanced Solid Tumors
A multi-center, non-randomized, open-label, multiple-dose, first-in-human Phase 1/2a clinical trial
(NCT05438329) evaluating BNT325/DB-1305 in patients with advanced solid tumors is ongoing. As part of this
clinical trial, BNT325/DB-1305 is being studied in combination with BNT327 in various solid tumor indications.
We plan to present first clinical data from the ongoing global Phase 1/2 expansion cohorts evaluating BNT327
plus BNT325/DB-1305 in multiple solid tumors in 2025.
iv.
BNT326
/YL202,
an ADC in Development in Collaboration with MediLink Therapeutics
BNT326/YL202 is a topoisomerase-1 inhibitor-based ADC directed against HER3. HER3 is a target that is
overexpressed in various cancer types, such as NSCLC and breast cancer, and is closely associated with tumor
metastasis and disease progression. Furthermore, HER3 expression is upregulated after frontline drug therapy,
making it an adequate target for cancer treatment resistance.
Ongoing BNT326/YL202 Phase 1 Clinical Trial in NSCLC and Breast Cancer
A multi-site, international, open-label, first-in-human Phase 1 clinical trial (NCT05653752), sponsored by
MediLink, is being conducted to evaluate BNT326/YL202 as a later-line treatment in patients with locally
advanced or metastatic EGFR-mutated NSCLC or HR-positive and HER2-negative breast cancer. On August 15,
2024, the FDA lifted the partial clinical hold that was placed on this trial, initially announced on June 17, 2024.
Trial recruitment has been reinitiated, and clinical development will focus on dose levels no higher than 3 mg/kg,
where the safety profile was manageable and encouraging clinical activity was observed.
4. Oncology Small Molecule Immunomodulator Product Candidates
a
.
BNT411
, a Small Molecule TLR7 Agonist
for
the Treatment of Solid Tumors, including SCLC
BNT411 is a TLR7 agonist that is designed to activate both the adaptive and innate immune system through the
TLR7 pathway. This activity and the release of cytokines and chemokines are designed to result in the potent
stimulation of antigen-specific CD8+ T cells, B cells and innate immune cells such as natural killer cells, or NK
cells, and macrophages.
Phase 1/2 Trial
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A Phase 1/2, first-in-human, open-label, dose escalation trial (NCT04101357) with expansion cohorts evaluating
safety, pharmacokinetics, progression of disease and preliminary efficacy of BNT411 as monotherapy in patients
with solid tumors and in combination with atezolizumab, carboplatin and etoposide in patients with
chemotherapy-naïve ES-SCLC
has been discontinued
. Final data of the trial have been gathered and evaluated
in a clinical study report. The final data were presented at SITC Annual Meeting 2024 and are expected to be
published in a scientific journal.
B
. Infectious
Disease
Programs
1. Next-Generation COVID-19 Vaccine
BNT162b2 + BNT162b4
In collaboration with Pfizer, we are aiming to develop a vaccine candidate that enhances and broadens SARS-
CoV-2 T-cell responses.
BNT162b4 is a next-generation COVID-19 vaccine component designed to elicit T-cell
immunity across epitopes. BNT162b4 encodes variant-conserved, immunogenic segments of the SARS-CoV-2
nucleocapsid
, membrane, and ORF1ab proteins, targeting diverse human leukocyte antigen, or HLA, alleles.
•
A Phase 1 clinical trial (NCT05541861) to evaluate the safety, tolerability and immunogenicity of
BNT162b4 alone or in combination with BNT162b2 is ongoing.
2.
COVID-19 – Influenza Combination mRNA Vaccine Program – BNT162b2 + BNT161
We and Pfizer are investigating respiratory combination vaccine approaches that aim to simplify immunization
practices for health care providers and recipients, helping to reduce the burden of these diseases. Combination
vaccines have been an effective approach in overcoming barriers to vaccination by allowing for simple
scheduling and fewer injections compared to vaccinations administered separately and/or at different visits to
healthcare providers.
•
In August 2024, we and Pfizer announced top-line results from the Phase 3 clinical trial (NCT06178991)
evaluating the companies’ mRNA combination vaccine candidate against influenza and COVID-19 in
healthy individuals 18-64 years of age. In this clinical
trial
, the vaccine candidate was compared to a
licensed influenza vaccine and the companies’ licensed COVID-19 vaccine given at the same visit. The
primary immunogenicity objectives were to demonstrate that the antibody responses to influenza
(hemagglutination inhibition) and to SARS-CoV-2 (neutralizing titer) elicited by the combination vaccine
candidate were non-inferior to standard of care. The trial did not meet one of its primary immunogenicity
objectives of non-inferiority against the influenza B strain despite obtaining higher influenza A responses
and comparable COVID-19 responses versus the comparator vaccines. No safety signals with the
combination vaccine have been identified in an ongoing safety data review.
•
In November 2024, we and Pfizer initiated a randomized, observer-blinded Phase 1/2 clinical trial
(NCT06683352) to evaluate the safety, tolerability and immunogenicity of the companies’ mRNA
combination vaccine
candidate
against influenza and COVID-19. The trial aims to enroll 1350 healthy
individuals aged 18 years and older.
•
In February 2025, we and Pfizer initiated a randomized, double-blinded Phase 1/2 clinical trial
(NCT06821061) to evaluate the safety, tolerability and immunogenicity of the companies’ mRNA vaccine
candidates against influenza and COVID-19. The trial aims to enroll 2050 healthy individuals aged 18
years and older.
3.
Influenza Vaccine Program – BNT161
In 2018, we and Pfizer entered into an agreement to collaborate on an mRNA program in influenza for an initial
period of three years, which ended in 2021. Pfizer has since had the sole responsibility, authority and control of
the development, manufacturing and commercialization of all candidates and products related to the program.
Upon potential approval and commercialization, BioNTech is eligible to receive royalties on Pfizer’s sales.
•
A Pfizer-initiated randomized Phase 3 clinical trial (NCT05540522) to evaluate the efficacy, safety,
tolerability and immunogenicity of an
mRNA
influenza immunotherapy candidate has been completed.
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•
Pfizer is developing second-generation candidates with the goal of improving immunogenicity and
potentially breadth of protection, including new trivalent formulations that match updated
recommendations by the WHO and the FDA’s VRBPAC. These candidates are currently in Phase 2.
4
Herpes Simplex Virus
Vaccine Program –
BNT163
We have an ongoing research collaboration with the University of Pennsylvania, or UPenn, under which we have
the exclusive option to develop and commercialize mRNA vaccine candidates for various infectious disease
candidates. This agreement was originally executed in 2018.
•
As part of this collaboration, we have the exclusive license to a combination of three HSV antigens for
use in a vaccine. This combination of HSV antigens has been further developed into an HSV mRNA
vaccine candidate (BNT163), which we are currently evaluating in a Phase 1 clinical trial. This controlled,
dose-escalation Phase 1 clinical trial (NCT05432583) aims to evaluate the safety, tolerability and
immunogenicity for the prevention of genital lesions caused by HSV-2 and potentially HSV-1. Part A
(first-in-human, dose escalation) has been completed. Part B (dose evaluation) has completed dosing,
and Part C (population expansion) will start enrollment across sites in the United States.
5
.
Tuberculosis Vaccine Program - BNT164
We have collaborated with the Gates Foundation since 2019 to develop vaccine candidates aimed at preventing
tuberculosis disease.
•
A randomized, controlled, dose-finding Phase 1 clinical trial (NCT05537038, Germany) evaluating
BNT164 is fully enrolled and ongoing.
•
A randomized, controlled, dose-finding two-part Phase 1/2 clinical trial (NCT05547464, Republic of
South Africa and Republic of Mozambique) evaluating BNT164 is ongoing. Part A of the Phase 1/2 trial is
fully enrolled.
•
Both the Phase 1 and Phase 1/2 clinical trials are designed to assess the safety, reactogenicity, and
immunogenicity of mRNA vaccine candidates against tuberculosis.
6
.
M
alaria Vaccine Program
–
BNT165
Our
malaria program aims to develop a well-tolerated and highly effective mRNA vaccine with durable immunity
to prevent P. falciparum malaria infection, thereby aiming to reducing morbidity, mortality and onward
transmission.
We plan
to assess several vaccine candidates, featuring components of known targets such as
circumsporozoite protein, or CSP, and conserved, immunogenic segments of liver stage-expressed proteins.
•
A first-in-human Phase 1 clinical trial (NCT05581641) to evaluate the safety, tolerability and exploratory
immunogenicity of the vaccine candidate BNT165b1, the first candidate from our BNT165 program, has
been completed.
•
A randomized, dose escalation Phase 1/2 trial (NCT06069544) to evaluate the safety, tolerability,
immunogenicity and efficacy of a second investigational RNA-based vaccine candidate is on clinical hold
by the U.S. FDA, as announced on March 4, 2025.
BioNTech has complied with the hold by the FDA
and, in accordance with the clinical trial protocol, had proactively paused the study.
BioNTech is taking
actions to address the U.S. FDA’s requests and will work with the U.S. FDA to assess next steps.
7.
Mpox Vaccine Program – BNT166
Our fully-owned
BNT166
program aims to deliver an effective, well-tolerated and accessible vaccine for the
prevention of
mpox
. The multivalent BNT166 mRNA vaccine candidates encode surface antigens that are
expressed in
the
two infectious forms of the mpox virus to efficiently prevent virus replication and infectivity. The
program is supported through a partnership with CEPI to provide equitable access to the vaccine, if successfully
developed and approved, in low- and middle-income
countries
.
•
A Phase 1/2 trial clinical trial (NCT05988203) evaluating the safety, tolerability, reactogenicity and
immunogenicity of two mRNA-based multivalent vaccine candidates is ongoing. Phase 1 substudies are
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fully enrolled and enrollment is ongoing for an open-label, Phase 2a substudy. The trial aims to
enroll
a
total of 96 healthy participants with and without prior history of known or suspected smallpox
vaccination
.
8.
Shingles Vaccine Program – BNT167
We are collaborating with Pfizer to develop the first mRNA-based vaccine candidate against shingles (also
known as herpes zoster). While there are currently approved vaccines for shingles, the goal is to develop an
mRNA vaccine candidate that potentially shows high efficacy and better tolerability and is more efficient to
produce globally.
•
A randomized, controlled, dose-selection Phase 1/2 clinical trial (NCT05703607) to evaluate the safety,
tolerability, and immunogenicity of BNT167 in up to 900 healthy volunteers 50 through 69 years of age is
ongoing.
9
.
Bacterial Vaginosis –
BNT331
BioNTech R&D (Austria) GmbH, a wholly owned subsidiary of BioNTech SE, is focused on developing novel anti-
bacterial drugs to treat persistent bacterial infections. Its development programs are based on our proprietary
LysinBuilder platform, which allows for the targeted development of precision anti-bacterials. Our development
pipeline focuses on chronic bacterial infections where antibiotics fail to cure or destroy the natural microbiomes.
•
A two-part, randomized, double-blind Phase 1 clinical trial (NCT06469164) is being conducted to
evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BNT331 in healthy women
and women diagnosed with bacterial vaginosis. It also aims to explore the efficacy of BNT331 in women
diagnosed with bacterial vaginosis.
VII. The mRNA Technology
In the last
decade
, mRNA has progressed into a promising new class of medicine, with the potential to treat a
wide variety of diseases with high unmet medical needs. mRNA is a long, polymeric molecule, composed of four
different building blocks called nucleotides. In mRNA, hundreds or thousands of these nucleotides are linked in a
unique order to convey genetic information to cells, where it is used to express proteins with biological effects.
Since the COVID-19 pandemic, mRNA-based immunization for the prevention of infectious diseases is
considered an innovative alternative to conventional vaccine approaches. mRNA has shown the potential to elicit
potent protective immune responses against various pathogens and may offer advantages over the use of live
and inactivated virus vaccines, subunit vaccines, and other nucleic-acid-based vaccine formats. According to
Beissert et al (2020), “RNA is non-infectious, non-integrating and, by virtue of rapid degradation by normal
cellular processes, is only transiently active.
RNA can be administered repeatedly to both prime and boost
immune responses and is not limited by anti-vector immunity. Moreover, the RNA backbone engages pattern
recognition receptors in the host cell, thereby naturally adjuvanting the response to the encoded immunogen.”
According to the same study, mRNA can also enable “rapid, cost-efficient,
cell- and animal-material-free
,
scalable production without the use of egg- or cell-based culture.
Thus, RNA may facilitate how vaccines are
made and has the potential to enable a rapid response to emerging infections.”
Synthetic mRNA can be engineered to resemble mature and processed mRNA molecules that naturally occur in
the cytoplasm of eukaryotic cells and can be used to transiently deliver proteins. Established mRNA
manufacturing technologies can be quickly adapted to produce mRNAs of different sequences, allowing for the
rapid development of mRNAs with the potential to address a variety of different conditions, including cancer,
infectious disease and rare diseases. Our mRNA pipeline addresses each of these therapeutic areas.
A.
General Principles of mRNA Pharmacology
As a drug, manufactured mRNA provides instructions to a target cell to produce specific encoded protein(s) or
protein chunks with a desired prophylactic or therapeutic effect. Based on these instructions, the proteins will be
either secreted, remain intracellular or on the membrane while protein epitopes are being processed to be
presented to the immune system. The mRNA drug will eventually be degraded and eliminated from the body.
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Our mRNA drugs are synthesized in a cell-free system by in vitro transcription from a DNA template. This
template encodes all the structural elements of functional mRNA, except for the 5’ cap structure, which is co-
transcriptionally incorporated. After in vitro transcription is performed, the template is then digested by DNase
and the mRNA is purified by conventionally used methods for isolating nucleic acids. The mRNA molecule
comprises:
•
an open reading frame, or ORF, which encodes the protein of interest;
•
untranslated regions, or UTRs, which flank the ORF; and
•
the cap and the poly(A) tail, which are the two terminal structures of the linear mRNA and are
responsible for increased stability and translational efficiency of mRNA.
The mRNA drug needs to be appropriately formulated in order to protect mRNA molecules against enzymatic
degradation by ribonucleases and to facilitate their delivery to the target cells. The formulation is selected based
on the intended application and route of delivery. After uptake into the target cell, the mRNA molecules are
loaded into ribosomes, where translation into protein takes place. Subsequently, the mRNA is degraded by
cellular mechanisms. Proteins encoded by the mRNA can be secreted or maintained in or on the cell.
Encoded proteins can perform functions in the body, for example, replacing deficient activities, or they can trigger
immune responses, for example by acting as antigens (as in the case of vaccines), or by directing the immune
system to a target of interest (as in the case of many therapeutic antibodies). Also, proteins encoded by the
mRNA are processed by the cellular machinery and can be displayed by specialized complexes, namely major
histocompatibility complexes, or MHC, I or MHC II complexes, to trigger
T-cell responses
to epitopes present
within them. These complexes present the epitopes to immune cells to elicit the desired immune response. In the
case of other mRNA applications, the mRNA encodes proteins that are secreted from the cells, such as
antibodies, and function extracellularly.
The structural elements of the mRNA have an impact on its performance. This includes potential immunogenicity,
efficiency of translation and molecular stability. We leverage our extensive experience to design, synthesize,
manufacture and formulate our therapeutic mRNA, and to adapt its composition to suit the desired application.
•
The cap is added to the 5’ end of the mRNA during its synthesis. Our studies have demonstrated that
incorporation of a unique cap analogue into the mRNA helps to achieve superior translational
performance by stabilizing the mRNA molecule and directing the immune response.
•
The composition and structure of the 5’ and 3’ UTRs of the mRNA molecule are important determinants
of the intracellular stability of mRNA. Through rigorous screening of different mRNA sequences, we
identified specific UTRs that promote increased protein translation for long duration.
•
We have performed extensive research on the structure of the poly(A) tail and the translational
performance of mRNA and customized our template design accordingly.
The translational performance of mRNA can be increased by reducing contaminating double-stranded RNA, or
dsRNA, from the mRNA. We have extensive expertise in different mRNA purification procedures. We have also
invented a novel mRNA purification method that greatly impacts translatability of our mRNA. Depending on the
protein characteristics needed for treatment of a disease, we optimize the DNA template through a proprietary
codon optimization process, changing the nucleotide sequence of the template without altering the amino acid
composition of the encoded protein. We make further adjustments during mRNA production to minimize the
occurrence of dsRNA by-products. We believe fine-tuning the respective molecules provides a great benefit to
the purpose-adapted performance of our mRNA.
B. mRNA Formats
1. Optimized Uridine mRNA, or uRNA
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The nucleotide sequence of mRNA determines the amino acid sequence of the protein. In addition, the nature of
nucleosides used for production of mRNA drugs can also influence recognition of the molecule by the immune
system.The presence of naturally occurring uridine (U) in our optimized uRNA makes it immunogenic by
activating immune sensors. We have further optimized our uRNA for immunogenicity of the encoded antigen
(augmented presentation on MHC I and MHC II) and pharmacological activity (enhanced stability and
translational efficiency). Immunogenicity of the mRNA is an added benefit when mRNA is used for
immunotherapy applications, by acting as an immunotherapy adjuvant. We believe this makes our therapeutics
for iNeST and
FixVac
even more potent.
2. Nucleoside-modified mRNA, or
modRNA
Immunogenic reaction against mRNA drugs needs to be avoided in applications where therapeutic proteins are
produced, such as in our
RiboMab
and
RiboCytokine
platforms. We have profound expertise in incorporating
naturally-occurring modified nucleosides into our therapeutic mRNAs. We have demonstrated that the presence
of a variety of modified nucleosides in the manufactured mRNA suppresses its intrinsic immune activation, while
leading to superior protein production for long duration.
Deimmunizing
mRNA by incorporating modified
nucleosides helps to avoid the production of anti-drug antibodies and to broaden the therapeutic application of
these types of mRNA drugs. We believe this customization has resulted in therapeutic mRNA that is both potent
and well tolerated. Together with the increased tolerability, we believe the high yield of antigen delivered by
mRNA makes this format suitable for prophylactic vaccines against infectious diseases inducing a strong cellular
and also humoral immune response.
3. Self-amplifying mRNA, or saRNA
Our saRNA drugs use the concept of viral mRNA replication, while not being infectious, disease-causing agents
themselves. saRNA resembles conventional mRNA, encoding the protein of interest, but it also encodes an
RNA-dependent RNA-polymerase, called replicase, that multiplies part of the mRNA within the target cell. Thus,
lower amounts of saRNA are needed compared to a regular mRNA to obtain the same amount of active protein.
As we have demonstrated, our saRNA ensures high levels of sustained antigen production with a small amount
of initial mRNA input. Our scientific team has designed this mRNA technology to act as a potent tool for
prophylactic vaccination, with the potential for application in infectious diseases.
4. Trans-amplifying mRNA, or taRNA
We have expanded our self-amplifying mRNA capabilities and developed a novel mRNA amplification technology
which
separates amplification of the target mRNA and the replicase encoding mRNA
. This advancement
broadens the spectrum of applications by making the development of therapeutic and prophylactic mRNAs even
more flexible, as the replicase can amplify multiple mRNAs allowing the expression of multiple proteins with only
one replicase encoding mRNA. In the case of vaccines, this allows us to produce the replicase mRNA in
advance for use with different vaccines. Our taRNA is a proprietary mRNA format that we believe is particularly
well-suited for prophylactic vaccines to prevent infectious diseases. We believe that taRNA-based split-vector
systems may be advantageous over saRNA with regard to safety, versatility, and manufacturing.
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mRNA offers a broad technology toolbox
:
We have developed and optimized mRNA formats and delivery formulations for
their potency and performance, each optimized for different therapeutic applications.
C
. mRNA Delivery Formulation
Technologies
We have deep and broad expertise in the targeted delivery of mRNA therapeutics. We are convinced that the
development of suitable delivery formulations in conjunction with our own therapeutic mRNAs is a key
competitive advantage.
Our main mRNA delivery formulations, each designed for different functions and optimized for therapeutic
product needs, are described below:
1. Lipoplex nanoparticles, or lipoplex, or LPX, formulation
Our LPX formulation embed the mRNA between a lipid bilayer and is used for our
FixVac
and iNeST platforms.
We use a proprietary size- and charge-based non-viral LPX formulation that we
have developed
to deliver mRNA
to dendritic cells in lymphoid compartments (such as the spleen) for optimal antigen presentation and immune
response activation. A synchronized adjuvant effect is mediated by TLR7-triggering and type-I interferon-driven
innate and adaptive immune stimulation. Our LPX formulation allows for intravenous administration of our
investigational mRNA-based cancer immunotherapies. The LPX formulation protects mRNA from degradation
outside of the cell and mediates its efficient uptake and expression of encoded antigens in various DC
populations. Our LPX formulation technology is designed to deliver multiple antigens in parallel, enabling the
induction of poly-specific T-cell responses. We have demonstrated in the clinic that systemic DC targeting by
mRNA-based cancer immunotherapies can result in potent activity against shared tumor-associated antigens at
very low doses. Consequently, less material would be required for treating high patient numbers, making
manufacturing potentially more cost-effective.
2. Lipid nanoparticles, or LNP, formulation
For other applications, we encapsulate our mRNA into LNPs. These LNP formulations are suitable for our
RiboMab and
RiboCytokine
oncology therapies
and our prophylactic vaccines against infectious disease.
Our
COVID-19 vaccines are
based on an LNP formulation platform encapsulating
nucleoside modified RNA,
which has blunted innate immune sensor activating capacity
and thus augmented antigen expression.
Encapsulation of the mRNA into LNPs enables its transfection into host cells after intramuscular injection. These
LNP formulations are composed of four different lipids in a defined ratio. During the mixing of the mRNA and
dissolved lipids, the lipids form nanoparticles encapsulating the mRNA. After injection, the LNPs are taken up by
the cells, and the mRNA is released into the cytosol. In the cytosol, the mRNA is translated into the encoded viral
protein.
3. Polymer nanoparticles, or polyplex, or PLX, formulation
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Our portfolio also includes PLX formulations, in which the mRNA is bound to a polymer and then forms
nanoparticles, which are being utilized in various of our discovery programs.
D
. mRNA Platforms
We are developing multiple mRNA-based therapeutics in the oncology space, including mRNA cancer
immunotherapy programs (e.g.,
FixVac
and iNeST),
RiboMabs
, and
RiboCytokines
, using different RNA formats
and delivery formulations. We have also implemented mRNA platforms for the development of infectious disease
vaccines.
Importantly, each of these platforms enables the development of multiple pharmaceutical product candidates or
programs.
Our mRNA Platforms.
We have multiple mRNA-based platforms utilizing different mRNA formats and delivery
formulations
that are directed at a range of biological targets in oncology and infectious and rare diseases.
VIII. Sales, Marketing and Distribution
Our commercial organization currently focuses on supporting sales of our COVID-19 vaccine in
Germany and
Türkiye
. Our commercial organization is responsible for promoting our products to health care providers and
providing information to stakeholders, including governmental organizations, in Germany and Türkiye.
As a result of our partnership with Pfizer, under which our commercialization responsibilities are limited to
Germany and Türkiye, we maintain a lean fixed cost base for our COVID-19 vaccine business.
Our commercial organization is also responsible for preparing and obtaining reimbursement from third-party
payors, including governmental organizations, for our COVID-19 vaccine.
We aim to build a specialized oncology sales force in major markets, including North America and Europe, while
leveraging our commercial partners for co-commercialization. We are working towards being commercial-ready
in oncology by the end of 2025, in anticipation of potential commercial oncology launches as soon as 2026, if
approved.
IX
. Manufacturing
We are building a fully integrated biotechnology company, with operations spanning from research through
clinical development, manufacturing and sales and marketing. To successfully bring individualized
immunotherapies and vaccines to people around the world, we believe that it is crucial to have in-house
manufacturing capabilities that can be efficiently scaled for global clinical and commercial distribution. We have
several manufacturing sites capable of developing automated production processes for on-demand production of
our investigational therapies and vaccines. These can be classified into distinct GMP manufacturing capabilities.
We operate four GMP-certified manufacturing facilities in Germany, where we manufacture mRNA therapeutics
and engineered cell therapies for both, our own pipeline and for external customers, including a state-of-the art,
multi-platform, GMP-certified manufacturing facility located in a life science industrial park in Marburg, Germany,
which we acquired in October 2020 from Novartis to increase manufacturing capacity of our COVID-19 vaccine
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for commercial supply. We also operate a fifth facility in Germany where we manufacture custom peptides both
to support our extensive immunomonitoring activities within our development programs and for third parties. Our
subsidiary BioNTech Innovative Manufacturing Services GmbH, or BioNTech IMFS, has been manufacturing
GMP-certified cellular products since 1999.
Our approach has been to proactively build capacity in anticipation of demand from both internal research and
development from our collaborators. We have done so by continuing to make significant investments in our
manufacturing infrastructure, including our capacity to manufacture mRNA, viral vectors, cellular products and
peptides. We have also collaborated with Siemens AG to develop a process for automated, on-demand
production of mRNA therapies. We believe that the development and optimization of our manufacturing
processes in parallel to drug development is crucial to our success.
A. Manufacturing Operations
COVID-19 Vaccine
. Our manufacturing site in Marburg was approved by the EMA for manufacturing of our
COVID-19 drug product
in March 2021.
This approval made it
one of the largest mRNA manufacturing sites
worldwide. In addition, we have
another
GMP facility
that currently produces our
COVID-19 vaccine candidates
for clinical trial
s.
We have a network of sub-contractors established to provide drug products, and fill and finish
services to enable production.
mRNA
. We believe scaling up manufacturing for mRNA can best be executed as part of a proprietary
manufacturing approach, rather than as part of an outsourcing strategy. We believe this approach allows us to
maintain control of our proprietary processes and gives us the flexibility we need for scheduling batch production
for our drug substances to match our development plans as they evolve. Our mRNA manufacturing is currently
conducted at our in-house BioNTech IMFS facility, our BioNTech East Wing facility, and our Marburg facility.
The
East Wing facility manufactures iNeST (finished product).
In 2024, we undertook sterile filtration and final filling of
over 77,000
vials
of various sizes in the East Wing and over 22,000 vials at IMFS. Drug substance batch sizes
range from a few milligrams for individualized applications (i.e., iNeST) to 10g for standard mRNA applications
(i.e.,
FixVac
, intratumoral immunotherapies and infectious diseases), and up to approximately
720g batches for
COVID-19.
Our manufacturing facility in Marburg is one of the largest mRNA vaccine manufacturing sites
worldwide with an annual capacity of up to three billion doses of mRNA drug substance and we believe we are
well positioned to supply the quantities required by global market demand.
To date, we have produced more than
2,000 batches
of mRNA drug substance to support our clinical studies.
We currently have infrastructure capable of producing about 100 batches of mRNA drug substance and
formulated drug product per month with a turnaround time of about 30 to 40 days from sequence identification to
released product. We believe we have the capacity to meet the supply needs of our current product candidates
in clinical trials through registration.
We have successfully decreased the time required to deliver iNeST to
patients
. In 2014, it took us over three
months to manually manufacture and deliver individualized immunotherapies to patients. Since December 2017,
with the implementation of semiautomatic GMP manufacturing in collaboration with partners,
we have been
consistently
manufacturing and delivering individualized immunotherapies in under six weeks
. This advancement
represents significant progress toward our target commercial manufacturing turnaround time of less than 28
days, and we were able to demonstrate less than 30 days in 2021. We plan to continue to develop additional
process improvements,
which we expect will further reduce our turnaround times as we progress through clinical
development.
C
ell Therapy Products
. We have end-to-end capabilities and teams in Germany and the United States with over
20 years of experience in cell therapy manufacturing, quality control and release. Our cell therapy programs
target novel and known tumor-specific antigens, including patient-specific mutant neoantigens. We also leverage
our mRNA vaccine technology to further boost T-cell activation, expansion, and persistence. Our state-of-the-art
manufacturing processes of cellular products involve the isolation of primary human blood cells and
subpopulations, such as, e.g., CD3+ T cells. Cell products are cultured, expanded and genetically modified (e.g.,
CAR-T cells) in aseptic production processes in specialized cleanroom facilities. We also have the capability for
in-house mRNA production for the genetic modification of such innovative cell therapy products.
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Peptides
.
Our custom peptide synthesis business has developed unique technologies to produce several million
peptides over the past ten years to support our growing clinical pipeline. These include fast small-scale
manufacturing of peptides for target and epitope discovery as well as for neoepitope characterization and
production of high content arrays. It is important to synthesize highly purified peptides in order to avoid false
positives in immunomonitoring in our mRNA immunotherapy trials. We also use peptides as starting materials in
our engineered cell therapies as well as in some drug formulations and biomarker discovery studies. We have
developed proprietary technologies to produce highly complex and purified peptide pools that consist of
overlapping peptides spanning entire antigens or neoepitopes. In September 2025, we plan to move into a new
manufacturing plant of 7,500 square meters in Berlin, which we expect will double our manufacturing capacity to
produce Active Pharmaceutical Ingredient peptides and diversify our peptide activities towards new fast-growing
markets.
B. Manufacturing Facilities
The information included herein is as of the date of this Annual Report. For more information about our plans to
implement measures to adjust capacities in some areas, see Item 4.B.III, “Strategic Outlook” of this Annual
Report.
Manufacturing sites in Germany
Marburg
Marburg is one of our fully owned, state-of-the-art manufacturing facilities for just-in-time delivery and scalable
production. Our Marburg manufacturing facility was acquired from Novartis in 2020 for less than a hundred
million euros and comprises eight large and small molecule production suites across more than 100,000 square
feet. Within 6 months from acquisition, the facility was retrofitted to produce mRNA vaccines.
It is now one of the
largest mRNA vaccine manufacturing sites globally.
T
he facility has the capacity to produce up
to three billion
doses of mRNA d
rug substance
vaccine annually.
Marburg is our central hub for innovation and development of novel manufacturing solutions. It is a center of
excellence, not only in terms of facilities and devices, but as a know-how hub with appropriate and forward-
looking staff training. We have
about
650
employees
on site. To ensure production, we work in flexible/different
shift models, e.g. 24/5.
In 2023, we completed our first proprietary plasmid DNA manufacturing facility in Marburg. This aims to increase
our flexibility and autonomy in manufacturing starting materials for our oncology and COVID-19 vaccine
pipelines, as well as our independence for pandemic preparedness due to local production. We also expect this
manufacturing facility will facilitate faster production cycles and shorter delivery times for plasmid DNA for a
number of clinical product candidates and commercial products.
Idar-Oberstein
BioNTech IMFS: Our manufacturing operations for cell therapy products and mRNA are housed in our wholly
owned subsidiary. Founded in 1997, BioNTech IMFS specializes in services for innovative therapeutic
approaches. In 2009, BioNTech IMFS became our wholly owned subsidiary, giving us access to synergistic
platforms and complementary expertise for development, testing and manufacturing services. BioNTech IMFS
and its predecessors have had GMP-certified cell and gene therapy manufacturing capabilities since 1999, and
obtained GMP manufacturing authorization for mRNA production in 2011. In 2017, BioNTech IMFS began
automated manufacturing of the iNeST product candidate and entered its first commercial supply contract for
retroviral vectors. Located near Mainz, the BioNTech IMFS facility occupies over 30,000 square feet. Over 500
staff members are employed at this facility, with collective expertise in molecular biology, cell biology and virology
and a close working relationship with our R&D teams in Mainz. We consider BioNTech IMFS our powerhouse for
early-stage mRNA material.
Mainz
BioNTech iNeST Clinical Manufacturing (East Wing): We utilize our GMP-certified manufacturing facility at our
headquarters in Mainz, Germany for the production of iNeST immunotherapies
. In 2015, our wholly owned
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subsidiary, BioNTech RNA Pharmaceuticals GmbH, or BioNTech RNA, and Siemens announced a collaboration
for developing an automated, paperless and digitalized production site for individualized mRNA. We obtained our
GMP manufacturing authorization for iNeST production at our East Wing facility in June 2018 and manufactured
our first drug product there the following month.
This facility contains approximately
17,000
square feet of laboratory and office space, including 4,300 square
feet of GMP facilities.
Over 300
staff members are employed at this facility and operate it seven days per week.
In its first year of operation, the facility manufactured and released more than 250 batches of mRNA and has
manufactured and released more than
1,700 ba
tches of mRNA since inception.
To perform our target identification process to feed into the iNeST downstream GMP manufacturing process, our
headquarters also hold our core facility, which operates under Good Clinical Practice, or GCP, for labs. Incoming
patients’ materials (blood and tumor samples) are received and analyzed to identify characteristic mutations to
generate the patient-specific target list used for individualized mRNA production.
BioNTech Clinical Manufacturing: Our GMP-certified manufacturing facility in Kupferbergterrasse, Mainz is
authorized to conduct secondary packing, labeling, storage and batch release of primary packed investigational
medicinal products. This facility contains approximately 11,500 square feet of laboratory and office space,
including 1,250 square feet of GMP facilities.
Berlin
JPT: JPT, our peptide manufacturing facility, was established in 2004 and became a wholly owned subsidiary of
BioNTech in 2008. JPT is located in Berlin and occupies over 16,000 square feet of clean rooms, laboratory and
office space.
Global manufacturing sites
Outside of Europe, we maintain a site in the United States and a site in Singapore.
Gaithersburg R&D and GMP Manufacturing Facility
We acquired our site in Gaithersburg, Maryland from Kite Pharma, Inc., a Gilead Sciences company, in August
2021. Since then, we have been building capabilities for research, late-stage technical development and clinical
manufacturing of cell & gene therapy products. In 2024, we added a new R&D facility, expanding our campus
footprint to approximately 92,000 square feet, to continue to advance our cell & gene portfolio and further
develop U.S.-based technical and operational capabilities in support of our pipeline and commercialization
efforts in the United States.
Singapore Manufacturing Facility
In November 2022, our Singapore affiliate, BioNTech Pharmaceuticals Asia Pacific Pte. Ltd., entered into an
agreement with Novartis Singapore Pharmaceutical Manufacturing Pte. Ltd. to acquire one of its GMP-certified
manufacturing facilities. The acquisition is part of our expansion strategy to strengthen our global footprint in
Asia. The facility is intended to create regional manufacturing capacities in support of our growing pipeline
therapeutics across the Asia Pacific region, with the potential to expand the production to other drug classes,
such as cell therapies or anti-bodies.
The BioNTainer: a platform for localized and sustainable mRNA production
The
BioNTainer
is an example of our innovative approach to establishing scalable vaccine production. It was
developed to ensure sustainable,
equitable access to our programs, particularly in low-income countries and
regions with limited infrastructure.
Introduced in February 2022, the
BioNTainer
allows scalable vaccine
production by developing and delivering mRNA manufacturing facilities based on a containerized clean room
solution with
a modular design, standardized equipment, and software components
. Each
BioNTainer
unit is a
clean room, which we equip with state-of-the-art manufacturing solutions for the manufacture and formulation of
mRNA-based vaccines. Each
BioNTainer
unit is built of six to eight ISO-sized containers. A
BioNTainer
unit can
be equipped to manufacture a range of mRNA-based vaccines targeted to regional needs: for example, our
COVID-19 vaccine and our investigational malaria and tuberculosis vaccines, if they are successfully developed,
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approved, and authorized by regulatory authorities and in line with regional demand. Each
BioNTainer
facility is
intended to become a node in our global manufacturing network, aiming to offer greater independence and faster
regional vaccine supply. We believe this solution is an important step towards improving global vaccine supply.
In addition to our
BioNTainer
facility in Kigali, Rwanda, in 2023, we announced our intention to set up and
operate a clinical-scale mRNA manufacturing facility with
BioNTainer
units in Melbourne in the State of Victoria,
Australia. The site is intended to support R&D and clinical-scale manufacturing of investigational mRNA-based
medicines from the local ecosystem as well as from other third parties globally.
Kigali Manufacturing Facility
The Kigali facility was planned to initially house two sets of
BioNTainer
units for commercial-scale bulk
production of mRNA vaccines and is intended to enable robust end-to-end manufacturing in Africa for mRNA-
based medicines. The first
BioNTainer
unit arrived in Kigali, Rwanda in 2023. That same year, we inaugurated
our Kigali site on the occasion of the set-up of the first
BioNTainer
unit.
In May 2024, we announced that CEPI would be committing up to $145 million to support us to establish mRNA
vaccine R&D, clinical and commercial-scale manufacturing capabilities at the Kigali facility.
The setup of clinical-
scale manufacturing capabilities for mRNA-based vaccine candidates involves the installation of two additional
BioNTainer
units at the Kigali facility. This will allow the facility to manufacture on both a clinical and commercial
scale, and thus broaden the manufacturing scope, in support of a sustainable use case for the facility while
strengthening the wider African vaccine development ecosystem
. Under the terms of the agreement, we intend
to provide
sustainable supply
of our prophylactic vaccines manufactured at the Kigali facility if successfully
developed and authorized, such as vaccines against malaria, mpox and tuberculosis, to low and lower middle-
income countries, with priority supply to African countries.
Once fully operational, the facility’s capacity would depend on the product, production-scale and its dosage. For
example, if used to produce the Pfizer-BioNTech COVID-19 vaccine, the first set of
BioNTainer
units could
produce an estimated initial annual capacity of up to 50 million doses. The facility is expected to employ
approximately 100 people once operational, spanning a range of disciplines.
BioNTech plans to manufacture
mRNA-based vaccine batches required for process validation in 2025
.
In line with the continent’s and partner countries’ needs, we are committed to establishing additional
manufacturing facilities in Africa upon the successful validation of the facility in Kigali.
C. Other Certifications
BioNTech Diagnostics has a quality management system that is certified according to ISO 13485:2016 and JPT
maintains an ISO 9001:2015 certified Quality Management System to allow production of European CE marked
companion diagnostics.
D. Quality Assurance
We have implemented and maintain several Quality Assurance systems. BioNTech IMFS, BioNTech Clinical
Manufacturing and BioNTech iNeST Clinical Manufacturing have implemented GMP-certified quality assurance
systems. BioNTech Diagnostics has a quality management system that is certified according to ISO 13485:2016
and JPT maintains an ISO 9001:2015 certified Quality Management System.
X
. Third-Party Collaborations
We have forged
productive
collaborations with pharmaceutical companies and
academic research institutions
with area expertise and resources in an effort to advance and accelerate our discovery and development
programs in oncology, and also to leverage our drug classes into additional disease indications while minimizing
our incremental costs.
Our
collaborations
include,
without limitation:
•
Autolus for certain binders and the right to utilize its manufacturing capacity;
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Annual Report on Form 20-F for the
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•
Biotheus, now our wholly owned subsidiary, for certain antibodies;
•
DualityBio for the research and development of certain antibody drug conjugates
;
•
Fosun Pharma for our COVID-19 vaccine program;
•
Genentech for our iNeST platform in our mRNA drug class;
•
Genmab for our next-generation checkpoint immunomodulator platform in our protein-based
therapeutics drug class;
•
InstaDeep, our wholly owned subsidiary, for AI and ML;
•
OncoC4 for the research and development of certain monoclonal anti-CTLA4 antibodies; and
•
Pfizer for our COVID-19, influenza and joint COVID-19/influenza vaccine programs, which leverage
technology from our infectious disease mRNA-based platform.
We either wholly own or retain significant rights to all of our clinical stage programs, either in the form of a global
share of profit and co-commercialization rights with our collaborators in certain markets or significant royalties
and milestones. We plan to continue to identify potential collaborators who can contribute meaningful resources
and insights to our programs and allow us to more rapidly expand our impact to broader patient populations.
A
.
Autolus Collaboration
License and Option Agreement
On February 6, 2024 (with effect as of February 13, 2024), we entered into a License and Option Agreement, or
the Autolus License Agreement,
with Autolus Therapeutics plc’s wholly-owned subsidiaries Autolus Limited and
Autolus Holdings (UK) Limited, which collectively we refer to as Autolus
, pursuant to which Autolus granted to us
an exclusive, worldwide, sublicensable license, which we refer to as the Autolus License, to certain binders and
to exploit products that express in vivo such binders, which we refer to as the Binder Licensed Products. Autolus
also granted to us several time-limited options, or the Autolus Options, to acquire additional rights to specified
clinical-stage product candidates, binders and technologies of Autolus, described in more detail below.
In the event that all Autolus Options are fully exercised, Autolus would be eligible to receive maximum aggregate
payments of up to
$582
million pursuant to the Autolus License Agreement.
This maximum amount includes
upfront payments, the potential milestone payments for the Binder Licensed Products described below, all option
exercise fees and potential milestone payments for licenses to optioned products and technologies, and
additional payments that we may pay to Autolus for an increased revenue interest with respect to Autolus’s
product candidate, obe-cel
, as described below.
In consideration for the Autolus License and the Autolus Options, we made an initial payment to Autolus of $10
million. Autolus is eligible to receive milestone payments of up to $32 million in the aggregate upon the
achievement of specified clinical development and regulatory milestones for each Binder Licensed Product that
achieves such milestones. Autolus is also eligible to receive a low single-digit royalty on net sales of Binder
Licensed Products, subject to customary reductions, which reductions are subject to specified limits. The royalty
will be increased if we, our affiliates or our
sublicensees
commercialize a Binder Licensed Product in an
indication and country in which Autolus or its affiliates or licensees also commercializes a product containing the
same binders. Under the License Agreement, we are solely responsible for, and have sole decision-making
authority with respect to, at our own expense, the exploitation of Binder Licensed Products.
Under the terms of the License Agreement, Autolus has agreed to grant us the following time-limited Autolus
Options:
•
an option to obtain exclusive rights to co-fund development costs of Autolus’s development-stage
programs
AUTO1/22
and AUTO6NG, in return for agreed upon economic terms, including an option
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exercise fee, milestone payments and a profit-sharing arrangement for each such product candidate,
with additional options to co-promote or co-commercialize such product candidate;
•
an option to obtain an exclusive worldwide license to exploit products that express certain additional
binders in vivo or, with respect to certain binders, in an antibody drug conjugate, or the Binder Option;
•
an option to obtain a co-exclusive worldwide license to exploit products that express in vivo Autolus’s
modules for activity enhancement, with a non-exclusive right, in certain agreed instances, to exploit
products that include Autolus’s modules for activity enhancement but do not express in vivo such
modules, or the Activity Enhancement Option; and
•
an option to obtain a non-exclusive worldwide license to exploit products that contain Autolus’s safety
switches or the Safety Switch Option, and, together with the Binder Option and the Activity Enhancement
Option, the Technology Options.
The option exercise fee for each Technology Option is a low seven-digit amount. Each of the Activity
Enhancement Option and the Safety Switch Option must be exercised with respect to a given biological target or
combination of targets. There is a cap on the total option exercise fee if multiple Technology Options are
exercised with respect to a given target.
There is also a cap on milestone payments across all agreements entered into as the result of our exercising
one or more of the Technology Options and a cap on royalties payable on any given product for which multiple
Technology Options are exercised.
Under the Autolus License Agreement, we have also agreed to financially support the expansion of the clinical
development program for, and planned commercialization of, Autolus’s
lead product candidate obecabtagene
autoleucel, known as obe-cel
. On November 8, 2024, the FDA approved obe-cel for the treatment of adults with
relapsed or refractory B-cell precursor acute lymphoblastic leukemia. In exchange for Autolus’s grant of rights to
future revenues from the sales of obe-cel products, we made an upfront payment to Autolus of $40 million.
Autolus will pay us a low single-digit percentage of annual net sales of obe-cel products,
which may be
increased up to a mid-single digit percentage in exchange for milestone payments of up to $100 million in the
aggregate on achievement of certain regulatory events for specific new indications.
Under the terms of the Autolus License Agreement, Autolus has agreed to grant to us the option to negotiate a
joint manufacturing and commercial services agreement pursuant to which the parties may access and leverage
each other’s manufacturing and commercial capabilities, in addition to Autolus’s commercial site network and
infrastructure, with respect to certain of each parties’ CAR-T products, including our product candidate, BNT211,
or the Autolus Manufacturing and Commercial Agreement.
Unless earlier terminated, the Autolus License Agreement will continue for so long as royalties are payable in
respect of Binder Licensed Products and the revenue interest is payable in respect of obe-cel products. Subject
to a cure period, either party may terminate the Autolus License Agreement in the event of the other party’s
uncured material breach or the insolvency of the other party. We may terminate the Autolus License Agreement,
in whole or in part, for any or no reason upon a specified period of prior written notice to Autolus.
Securities Purchase Agreement, Registration Rights Agreement and Letter Agreement
Concurrently with the execution of the Autolus License Agreement, we entered into a Securities Purchase
Agreement, or the Autolus Purchase Agreement, pursuant to which we purchased from Autolus American
Depositary Shares, or the Autolus ADSs, each representing one ordinary share of Autolus, or the Autolus
Ordinary Shares, in a private placement transaction, or the Autolus Private Placement.
At the initial closing on February 13, 2024, or the Initial Closing, Autolus issued 33,333,333 Autolus ADSs, or the
Initial ADSs, to us for a total aggregate purchase price of $200 million. In the event that we and Autolus enter into
a an Autolus Manufacturing and Commercial Agreement within 18 months of the Initial Closing, we have agreed
to purchase additional Autolus ADSs, or the Subsequent ADSs and, together with the Initial ADSs, the Private
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Placement ADSs, not to exceed 15,000,000 Autolus ADSs, for an aggregate purchase price of up to $20 million.
The total number of Subsequent ADSs that may be issued is subject to additional limitations and restrictions. The
Autolus Purchase Agreement contains customary representations, warranties, and covenants.
Concurrently with entry into the Purchase Agreement, we entered into a letter agreement, or the Autolus Letter
Agreement, providing us with certain additional rights and subjecting our investment in Autolus to certain
restrictions. Pursuant to the Autolus Letter Agreement, we received the right to nominate a director to Autolus’s
board of directors. If we acquire beneficial ownership of at least 30% of the issued and outstanding Autolus
Ordinary Shares within five years of the date of the Autolus Letter Agreement, we will have the right to designate
an additional director, who shall be independent. Our director nomination rights under the Autolus Letter
Agreement shall automatically terminate upon our ownership of Autolus Ordinary Shares dropping below certain
specified percentages. Additionally, pursuant to the Autolus Letter Agreement, we have the right to purchase
equity securities sold by Autolus in bona fide financing transactions in amounts that are based on our
maintaining specified ownership thresholds following such financing transactions. Pursuant to the Autolus Letter
Agreement, subject to specified exceptions, we may not sell the Private Placement ADSs without Autolus’s
approval for a period of six months following the applicable closing date for such Autolus ADSs. The Autolus
Letter Agreement terminates upon the earlier of (a) the later of (i) three years from its signing date and (ii) such
time as no securities of Autolus are held by us or our affiliates and (b) the consummation of a change of control
transaction involving Autolus.
We and Autolus also entered into a registration rights agreement, pursuant to which Autolus filed a registration
statement with the SEC to register the resale of the Private Placement ADSs.
B.
Biotheus Acquisition
On November 13, 2024, our subsidiary, BioNTech Collaborations GmbH, entered into an agreement and plan of
merger, or the Merger Agreement, with Biotheus, a clinical-stage biotechnology company dedicated to the
discovery and development of novel antibodies to address unmet medical needs of patients with oncological or
inflammatory diseases. The acquisition supports the global execution of our oncology strategy and provides full
global rights to BNT327/PM8002, an investigational PD-L1 x VEGF-A bispecific antibody, with potential to
replace current checkpoint inhibitor standard of care treatments for solid tumors.
Following the satisfaction of several customary closing conditions and regulatory approvals as defined in the
Merger Agreement, the acquisition closed on January 31, 2025.
Upon closing and under the terms of the agreement, we paid Biotheus shareholders upfront of approximately
$850.0 million
, predominantly in cash, with a small portion in ADSs, to acquire
100%
of the issued share capital
of Biotheus, subject to customary purchase price adjustments, and agreed to pay additional performance-based
contingent payments of up to
$150.0 million
if certain milestones are met.
By closing the acquisition, we gained full rights to Biotheus’s pipeline candidates and its in-house bispecific
antibody drug conjugate capability. The acquisition has expanded our footprint in China, adding a local research
and development hub to conduct clinical trials. In addition, we have gained a biologics manufacturing facility to
contribute to our future global manufacturing and supply, and more than 300 Biotheus employees in R&D,
manufacturing and enabling functions have joined the BioNTech workforce.
C
. DualityBio Global Strategic Partnership
In 2023, we entered into three License and Collaboration Agreements with DualityBio, which we refer to as the
DualityBio Agreements. Each of the DualityBio Agreements relates to specific ADC assets. The first agreement,
the HER2 Agreement, relates to the ADC asset targeting HER2 and was entered into on March 16, 2023. The
second agreement, the B7H3 Agreement, relates to the ADC asset targeting B7H3 and was entered into on
March 31, 2023. The third agreement, the TROP2 Agreement, relates to the ADC asset targeting TROP2 and
was entered into on August 4, 2023.
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Each of the three DualityBio Agreements relates to a license granted to us with respect to certain patents and
know-how owned or otherwise controlled by DualityBio and our collaboration with DualityBio in the research and
development of ADC therapeutics.
In each of the DualityBio Agreements, DualityBio granted us the exclusive, royalty-bearing and sublicensable
right to exploit certain patents and know-how, which we refer to as the DualityBio IP, for the research,
development, manufacture and commercialization of the respective ADC compound and pharmaceutical
products comprising such compound, which we refer to as the DualityBio Products, in any field in the territory,
which is all countries of the world except for mainland China, Hong Kong and Macau, which we refer to as the
DualityBio Retained Territory. We were also granted the sole right to exploit the DualityBio IP to develop and
manufacture the DualityBio Products in the DualityBio Retained Territory solely for the purpose of developing,
manufacturing and commercializing the DualityBio Products in the territory.
Each party has final decision-making authority and is generally responsible for clinical trial supply costs and
regulatory activities and costs with respect to their respective territory.
We are responsible for the commercialization of any DualityBio Products in the territory.
The B7H3 Agreement also grants DualityBio the option to share the development and commercialization costs
and the profits and losses from the exploitation of the first original DualityBio Product in the United States. Under
the B7H3 Agreement, we have further granted to DualityBio the option to assume a percentage of the total sales
force of the first original DualityBio Product in the United States.
In partial consideration of DualityBio’s granting of the licenses and rights to us under the DualityBio Agreements,
we have made upfront payments to DualityBio in an aggregate amount of $220 million. In addition, we agreed to
make potential payments upon the achievement of specified development, regulatory and commercial
milestones. Such milestone payments could amount up to $2.6 billion in the aggregate (the TROP2 Agreement
also provides for additional sales milestone payments in the event DualityBio works on, and we exercise, the
option regarding the next-generation product). We further agreed to between single-digit to double-digit tiered
royalties on net sales of all DualityBio Products, which also differ between the DualityBio Agreements. Royalties
are subject to stacking provisions and will be reduced in case of respective biosimilar products entering the
market. Furthermore, we agreed to reimburse DualityBio for certain development costs.
The DualityBio Agreements end on a country-by-country and DualityBio Product-by-DualityBio Product basis
upon expiration of the respective last DualityBio royalty term for a DualityBio Product in that country. Thereafter,
the licenses granted to us with respect to such product in such country will convert into a perpetual, exclusive,
fully paid-up and royalty-free license. In addition to termination rights granted to each party in the case of the
other party’s uncured material breach or insolvency, we may terminate each DualityBio Agreement, in whole or in
part, for convenience upon prior written notice.
O
n November 12, 2024, we and DualityBio entered into a side letter to the DualityBio Agreements to undertake
certain development activities in the territory and DualityBio Retained Territory with DualityBio Products in
combination with other product(s) that are proprietary to or owned or controlled by us or our affiliates.
D.
Fosun COVID-19
Vaccine
Collaboration
On March 13, 2020, we entered into a Development and License Agreement with Fosun Pharma for the
development and commercialization in mainland China, Hong Kong special administrative region, or SAR,
Macau SAR and in the region of Taiwan, or collectively the Fosun Collaboration Territory, of immunogenic
compositions generated by BioNTech and comprising uridine RNA, modified RNA and/or replicon technology for
prophylaxis against SARS-CoV-2 in humans. We refer to this agreement as the Fosun Agreement.
The details of the development activities to be undertaken by Fosun Pharma are to be set forth in a development
plan that is being overseen by a Joint Steering Committee. Fosun Pharma’s development activities are to be
undertaken at its
own
cost and expense. Fosun Pharma has the sole responsibility to prepare, obtain and
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maintain regulatory approvals for the vaccine candidates in the Fosun Territory. We agreed to give Fosun
Pharma reasonable assistance with the regulatory aspects of these activities.
Fosun Pharma has the sole responsibility, authority and control of the commercialization of a vaccine candidate
in the Fosun Collaboration Territory, but must use commercially reasonable efforts to do so in accordance with
an agreed commercialization plan, including by launching a vaccine product in the Fosun Collaboration Territory
within three months after receiving marketing approval for it, provided sufficient quantities of the vaccine have
been delivered.
We retain the sole right to manufacture (or have manufactured) and supply any vaccine candidates and products
for development purposes and commercial sale in the Fosun Territory. We agreed to manufacture and supply all
quantities of vaccine from a GMP-certified RNA manufacturing facility. As compensation for supply of the vaccine
Fosun Pharma will reimburse us our manufacturing costs plus an administrative fee that is between
10 and 19
percent
.
Under the Fosun Agreement, we granted Fosun Pharma an exclusive license under certain of our owned or in-
licensed intellectual property, including our patents relating to replicons, uridine RNA and modified RNA and
other mRNA technology or a vaccine to use, develop, commercialize and otherwise exploit the vaccine
candidates in the Fosun Territory. In the event of any failure of the development of a vaccine, we agreed to grant
Fosun Pharma a right of first negotiation on a separate competent vaccine for the prophylaxis of COVID-19 in
the Fosun Collaboration Territory.
In consideration of the rights granted to Fosun Pharma under the Fosun Agreement, Fosun Pharma subscribed
for $50 million of our ordinary shares under a separate investment agreement. In addition, under the Fosun
Agreement, Fosun Pharma made an upfront payment of $1 million and agreed to potential payments of up to
$14 million upon the achievement of specified development and regulatory milestones and up to $70 million
upon the achievement of specified sales milestones. Fosun Pharma further agreed to pay us a royalty rate that is
between
30 and 50 percent of its profits
on net sales of a vaccine product, if approved, for a period of 15 years
from launch of that vaccine in the Fosun Territory
.
The Fosun Agreement ends upon expiration of the royalty term. Fosun Pharma may elect to continue to pay
royalties and extend the agreement and its rights thereunder. In addition to termination rights granted to each
party in the case of the other party’s uncured material breach or insolvency, Fosun Pharma may terminate the
agreement, in whole, for convenience and with or without reason at any time upon 180 days’ prior written notice.
If the agreement is terminated by Fosun Pharma for cause, the licenses to Fosun Pharma survive, we will
manufacture and deliver the vaccine candidate or product for one year and we will grant a non-exclusive license
to a reasonably acceptable contract manufacturing organization for manufacturing of the vaccine candidate or
product thereafter for development and commercialization by Fosun Pharma in the Fosun Collaboration Territory.
During the term of the Fosun Agreement, we have committed not to license to any other third party in the Fosun
Collaboration Territory the intellectual property licensed to Fosun for the same purpose and not to develop or
commercialize the same vaccine candidate or any coronavirus vaccine in the Fosun Collaboration Territory.
E
.
Genentech iNeST Collaboration
Collaboration Agreement
On September 20, 2016, we entered into a Collaboration Agreement with Genentech and F. Hoffman-La Roche
Ltd, together with all amendments thereto, collectively referred to as the Genentech Collaboration Agreement, to
jointly research, develop, manufacture and commercialize certain pharmaceutical products that comprise
neoepitope RNAs
, or the Genentech Collaboration Products,
which include our iNeST development candidates,
for any use worldwide. Under the Genentech Collaboration Agreement, we and Genentech agreed to perform
joint research under a research plan to further improve our technology platform for the manufacturing of
Genentech
Collaboration Products. Under the terms of the Genentech Collaboration Agreement, Genentech paid
us $310 million in upfront and near-term milestone payments.
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We and Genentech must use commercially reasonable efforts to jointly develop one or more Genentech
Collaboration Products in accordance with an agreed global development plan, with the costs of such
development to be shared equally.
We continued certain clinical studies that were initiated prior to the execution
of the Genentech Collaboration Agreement at our sole expense. Genentech may access and use any data
generated in these clinical studies.
In addition to the clinical studies included in the global development plan, we may propose certain additional
clinical studies for indications not included in the global development plan, and if the joint development
committee formed by the parties does not elect to include the proposed studies in the global development plan,
then we may conduct the study at our sole expense under certain conditions, and subject to certain restrictions.
Genentech has the option to select any candidate in such studies for potential further joint development and/or
commercialization by Genentech as a Genentech Collaboration Product
.
In the case that Genentech wishes to
pursue the clinical development of a Genentech Collaboration Product in an indication that we are not interested
in pursuing, then under certain conditions, we may opt out of the co-funding of such development and
Genentech may continue do so at its own costs,
except that we are obligated to repay Genentech’s development
costs in the event that such product subsequently receives regulatory approval
.
Genentech has the sole right to commercialize the
Genentech Collaboration Products
on a worldwide basis, with
all profits and losses from such commercialization to be split equally with us. If we exercise our right to opt out of
sharing equally in future development costs for any Genentech Collaboration Products, then we will no longer
split all such profits and losses for such Genentech Collaboration Products equally with Genentech and will
instead receive a royalty on annual worldwide net sales of such Genentech Collaboration Products that are
covered by a valid claim included in certain of our patents and certain joint patents that arise out of the
collaboration. Furthermore, for certain Genentech Collaboration Products for which we share co-promotion rights
with Genentech, we have the option to assume a percentage to be determined of the total sales force in the
United States and certain other countries, including Germany and other major European markets. In addition,
under certain regulatory and other circumstances, we have the right to independently commercialize Genentech
Collaboration Products in indications that the joint development committee declines to pursue and that
Genentech does not subsequently elect to commercialize, provided that we market such Genentech
Collaboration Products under a separate brand and trademark that is approved by the joint commercialization
committee established by the parties as not confusingly similar to the Genentech Collaboration Products being
commercialized by Genentech. Our ability to research, develop, co-promote and/or independently commercialize
Genentech Collaboration Products may be terminated or limited in the event we undergo a change of control.
We granted to Genentech an exclusive license under certain of our intellectual property, and our interest in any
jointly-owned intellectual property developed under this agreement, to research, develop, make, sell and import
any pharmaceutical products that comprise
neoepitope RNA
. Genentech granted to us an exclusive, non-
transferable, sublicensable licenses under certain Genentech intellectual property, our intellectual property
exclusively licensed to Genentech, and their interest in any jointly-owned intellectual property developed under
this agreement for the performance of our ongoing clinical studies and the exercise of our rights and obligations
under the Genentech Collaboration Agreement.
Until the first marketing approval for a Genentech Collaboration Product, we have granted Genentech the first
right to negotiate an exclusive license to develop, manufacture and commercialize combination therapies
involving pharmaceutical products based on neoepitope RNA and pharmaceutical products based on non-
neoepitope RNA for the treatment of cancer in humans.
The Genentech Collaboration Agreement will remain in effect so as long as Genentech Collaboration Products
are in development or commercialization, or until the date of the expiration of the last royalty term if BioNTech
has exercised its option to opt-out of joint development of Genentech Collaboration Products. If the agreement
expires, the licenses granted to Genentech become fully-paid up, royalty-free and irrevocable. Genentech may
terminate the Collaboration Agreement if we fail to achieve certain milestone targets or at any time for
convenience with or without reason upon 60 days’ prior written notice. In the event of any such termination, all
rights to the development and commercialization of Genentech Collaboration Products developed under the
collaboration would revert to us and Genentech would grant us licenses under its intellectual property to further
develop and commercialize Genentech Collaboration Products. We would be required to pay certain royalties to
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Genentech for such license(s). In addition, either party may terminate the agreement upon the other party’s
uncured material breach or insolvency.
Manufacturing Development and Supply Agreement
Concurrent with the Genentech Collaboration Agreement,
we
entered into a Manufacturing Development and
Supply Agreement with Genentech and F. Hoffman-La Roche Ltd, or the
Genentech Manufacturing Agreement
,
which governs the manufacturing, related manufacturing development activities and supply of Genentech
Collaboration Products. Pursuant to the Genentech Manufacturing Agreement, we are responsible for clinical
manufacturing and supply, for developing and implementing manufacturing processes (including pursuant to
specified target turnaround times), and for constructing, commissioning, qualifying and obtaining permits for the
clinical facilities. We are permitted to subcontract certain steps in the clinical manufacturing process to our
affiliate, BioNTech IMFS.
In addition, we are responsible for developing the commercial manufacturing process, which requires more
stringent turnaround times than the clinical manufacturing process. Genentech will generally be responsible for
conducting commercial manufacturing. We are obligated to use commercially reasonable efforts to achieve
certain predetermined clinical manufacturing capacity commitments.
Under the Genentech Manufacturing Agreement, we and Genentech will jointly develop a manufacturing network
plan detailing the location, capacity, scale-out, associated timing and other appropriate details of the commercial
manufacturing facilities. We may participate in commercial manufacturing through our right to include as part of
the commercial manufacturing network one of our own facilities in the European Union or the United States and
one of our own facilities in another region to be agreed upon with Genentech (provided that in each region our
facility is not the first facility to be included in the commercial manufacturing network).
F
.
Genmab Next-generation Immunomodulator Collaboration
On May 19, 2015, we entered into a License and Collaboration Agreement with Genmab, which was
subsequently amended and supplemented by side letters, to jointly research, develop and commercialize
polypeptide-based bispecific antibodies against certain target combinations for the treatment of cancer
worldwide, or the Genmab Agreement Field, using certain Genmab technology. In connection with our entry into
that License and Collaboration Agreement, Genmab paid us an upfront fee of $10 million. On July 18, 2022, this
agreement was amended and restated by an Amended and Restated License and Collaboration Agreement
(which, as amended, is referred to as the Genmab Agreement).
Under the Genmab Agreement, we and Genmab must use commercially reasonable efforts to research and
develop clinical candidates, including our next-generation checkpoint immunomodulators, with costs split equally
during the research and evaluation phase. Our joint activities in this phase were governed by a research plan,
which was subject to annual review and updates, and which specifies the clinical candidates to be developed.
This research and evaluation phase expired on September 18, 2022.
We and Genmab must use commercially reasonable efforts to develop candidates selected by the joint research
committee, or the LCA Products, through preclinical and clinical development. The preclinical and clinical
development of the LCA Products would be performed pursuant to a development plan to be agreed upon by us
and Genmab, with costs to be split equally. The joint steering committee may designate a third party as a
manufacturer of an LCA Product or of any of its components.
We and Genmab must use commercially reasonable efforts to jointly commercialize all LCA Products and share
equally all expenses and profits arising from such commercialization. We and Genmab, on a product-by-product
basis and at least 12 months prior to the anticipated start of a pivotal clinical trial for an LCA Product, will jointly
designate between the two of us a lead party responsible for establishing the distribution and marketing
operations in each geographical region. Each party would be entitled to equally co-commercialize the products
pursuant to a separately negotiated global commercialization agreement that the parties agree to negotiate.
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Unless otherwise agreed by the joint steering committee established under the agreement, Genmab is
responsible for all regulatory actions and shall own all regulatory approvals obtained for the LCA Products.
Genmab is obligated to provides regular updates to us on regulatory activities.
Each party grants to the other party a worldwide, co-exclusive, sublicensable, royalty-free license under certain
of such first party’s intellectual property, including certain patents and know-how, to perform the research under
this agreement and to research, develop, make, import, use and sell LCA Products in the Genmab Agreement
Field pursuant to the terms of the Genmab Agreement. These licenses shall continue on a country-by-country
and product-by-product basis for as long as development or commercialization activities are contemplated under
the Genmab Agreement.
During the preclinical and clinical development phase for any LCA Product, engagement in research and
development activities in the Genmab Agreement Field unilaterally by a party relating to an LCA Product or its
Back-up Candidate or any bispecific antibody which targets the same target combination for which such LCA
Product or Back-up Candidate has been developed would require the other party’s prior written consent.
Each party has the right to discontinue its participation in the further development and commercialization of an
LCA Product at two points: (i) when an IND submission package has been agreed upon by the parties and (ii)
when the draft clinical trial report from the first Phase 1/2 clinical trial becomes available. The other party may
elect to continue the development and commercialization of the LCA Product or divest its interest in such LCA
Product. If the other party elects to pursue development and commercialization of such LCA Product alone as a
Unilateral Product, at its sole cost and subject to pre-defined milestone and royalty payments and certain
additional pre-defined terms. If the other party wishes to not pursue such continued development and
commercialization on such pre-defined payment and additional terms, then the parties will jointly divest their
interest in such LCA Product to a third party, and if such divestiture fails, the parties will cease all development
and commercialization of such LCA Product.
The Genmab Agreement will remain in effect until the later of (i) the expiration of the last-to-expire royalty term
for any Unilateral Product or (ii) the time when no LCA Products, Joint Combination Products or Proprietary
Combination Products are being developed or commercialized under this agreement. Either party may terminate
the agreement in its entirety or on a product-by-product basis with immediate effect upon the other party’s
uncured material breach or insolvency.
On August 5, 2022, we and Genmab expanded our global strategic collaboration to develop and commercialize
novel immunotherapies for the treatment of cancer patients. Under this expansion, we and Genmab will jointly
work to research, develop and commercialize novel monospecific antibody candidates for various cancer
indications.
Under the expanded collaboration, the companies will jointly develop and commercialize, subject to regulatory
approval, monospecific antibodies leveraging Genmab’s proprietary HexaBody technology platform. The first
monospecific antibody candidate, GEN1053/BNT313,
entered clinical trials in late 2022
. GEN1053/BNT313 is a
CD27 antibody based on the HexaBody technology, specifically engineered to form an antibody hexamer (a
formation of six antibodies) upon binding its target on the cell membrane of the T cells. Under the terms of the
agreement, the companies will equally share the development costs and potential future profit deriving from
GEN1053/BNT313.
G.
InstaDeep Acquisition
O
n January 10, 2023, we entered into a share purchase agreement, or SPA, with the shareholders of InstaDeep
Ltd., or InstaDeep, a leading global technology company in the field of AI and ML, under which we agreed to
acquire 100% of the remaining shares in InstaDee
p,
excluding the shares already owned by us. The SPA was
amended on July 31, 2023 to deal with certain matters arising after its execution.
Following the satisfaction of several customary closing conditions and regulatory approvals as defined in the
SPA, the acquisition closed on July 31, 2023.
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The total consideration to acquire the remaining InstaDeep shares, excluding the shares already owned by
BioNTech, amounts to approximately €500 million in cash, BioNTech shares, and performance-based future
milestone payments.
InstaDeep now operates as a UK-based global subsidiary and will continue to provide its services to clients
around the world in diverse industries, including in the Technology, Transport & Logistics, Industrial and Financial
Services sectors. Additionally, the acquisition is enabling the creation of a fully integrated, enterprise-wide
capability that leverages AI and ML technologies across our therapeutic platforms and operations.
H. OncoC4 Collaboration
On March 17, 2023, we and OncoC4 entered into a License and Collaboration Agreement, or the OncoC4
Agreement, for the license, development and commercialization of ONC-392 and all other monoclonal anti-
CTLA4 antibodies owned or controlled by OncoC4 (referred to as OncoC4 Licensed Compounds) as of the
execution date, including development of combinations of such antibody with other products, for use in humans
or animals, or the OncoC4 Field.
OncoC4 granted us an exclusive license under ONC-392 and OncoC4’s interest in joint intellectual property to
exploit OncoC4 Licensed Compounds and any pharmaceutical or biologic product containing OncoC4 Licensed
Compound (referred to as OncoC4 Licensed Products) in the OncoC4 Field in the entire world, which we refer to
as the OncoC4 Territory. Furthermore, OncoC4 granted us
an exclusive option that ended June 30, 2024 to
license
AI-061
, which is a biopharmaceutical composition containing as its sole active ingredients both ONC-392
and an anti-PD-1 antibody. OncoC4 retains all rights to the anti-PD-1 antibody outside of the combination with
ONC-392.
We agreed to collaborate on research, development, and commercialization of ONC-392 in the
OncoC4
Territory
and to use commercially reasonable efforts to conduct development activities of OncoC4 Licensed Compounds
and OncoC4 Licensed Products either as a monotherapy or in
combination with an anti-PD-(L)1 antibody and/or
standard of care product (which we refer to collectively as the Mono/PD-1/SOC Combinations)
in accordance
with a joint clinical development plan which is governed by a joint steering committee. All costs associated with
the joint development responsibilities are shared equally between us and OncoC4.
We are solely responsible for all development activities for the OncoC4 Licensed Compounds and OncoC4
Licensed Products in any other form or combination other than the Mono/PD-1/SOC Combinations (we refer to
such other combinations as OncoC4 Other Combinations) at our own expense and in accordance with a
research and development plan prepared by us and shared with OncoC4 through the joint steering committee.
We agreed to use commercially reasonable efforts to develop an OncoC4 Licensed Product in at least one
indication for an OncoC4 Other Combination. We agreed to first offer OncoC4 the opportunity to co-fund any
development of a PD-1 Combination prior to pursing such development independently or with a third party.
We agreed to be solely responsible, at our expense, for commercialization of OncoC4 Licensed Products
worldwide and to use commercially reasonable efforts to commercialize OncoC4 Licensed Products for each
approved indication in certain major markets.
In consideration for the rights granted to us by OncoC4, we made an upfront payment of $200 million, with a
portion of the upfront payment to be used to fund OncoC4’s share of the joint research and development costs
related to ONC-392, and agreed to make potential payments upon the achievement of specified development
and regulatory milestones and upon the achievement of specified sales milestones. We have further agreed to
pay OncoC4 double digit, tiered royalties on annual net sales of OncoC4 Licensed Products during a certain
royalty term starting from launch of product.
The OncoC4 Agreement shall continue until the last-to-expire royalty term in all countries in the OncoC4 Territory
for all OncoC4 Licensed Products. Upon the expiration of the royalty term for an OncoC4 Licensed Product in a
given country in the OncoC4 Territory, the exclusive license granted to us will become a perpetual, irrevocable,
non-exclusive, fully paid-up, and royalty-free license with respect to such OncoC4 Licensed Product in such
country. In addition to termination rights granted to each party in the case of the other party’s uncured material
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breach or insolvency, we have the right to terminate the OncoC4 Agreement in its entirety for convenience with
prior written notice to OncoC4.
I.
Pfizer
COVID-19 Vaccine
Collaboration
On April 9, 2020,
effective
as of March 17, 2020, we entered into a Collaboration Agreement with Pfizer for the
research and development of immunogenic compositions comprising RNA encoding a SARS-CoV-2 polypeptide
or fragment thereof for prophylaxis against SARS-CoV-2 in humans, which we refer to as the Pfizer Corona
Field. On January 29, 2021, effective as of March 17, 2020, we entered into an amended and restated
Collaboration Agreement with Pfizer for the research, development and commercialization of immunogenic
compositions comprising RNA in the Pfizer Corona Field, which we refer to as the Pfizer Agreement.
We and Pfizer agreed to collaborate on research, development and commercialization in the Pfizer Corona Field
worldwide (excluding the Fosun Collaboration Territory), which we refer to as the Pfizer Collaboration Territory.
The details of such activities are set forth in a research and development plan that is governed by a joint steering
committee. Each party bears its own personnel and capital expenditures costs, but the parties will share the
costs of all other agreed development activities (including the costs of manufacturing material for use in clinical
trials) evenly. Each party will, in good faith, seek funding from government funds, non-governmental
organizations and other third-party organizations to support their research and development activities. Under the
Pfizer Agreement, Pfizer is leading clinical development of and is seeking regulatory approval for any candidates
or products in the United States and we are leading clinical development of and are seeking regulatory approval
for any candidates or products in the European Union, and we will agree on a strategy for all other countries in
the Pfizer Collaboration Territory on an ongoing basis through the joint steering committees.
BioNTech can solely commercialize the vaccine in Germany and Türkiye (collectively referred to as the BioNTech
Commercialization Territory, which is a subset of the Pfizer-Collaboration Territory). We have the option to opt-out
of commercializing the vaccine in Germany and/or Türkiye, whereupon such countries will become part of the
Pfizer Commercialization Territory of the Pfizer Collaboration Territory.
Pfizer has the right to commercialize any approved COVID-19 vaccine in the rest of the Pfizer Collaboration
Territory. On a country-by-country basis in relation to the United Arab Emirates, Southeast Asia, and certain
developing countries, if we obtain funding from a third-party organization that obligates us to commercialize an
approved vaccine in such country, we are obligated to request from Pfizer in writing a decision as to whether
Pfizer wishes to commercialize or distribute such vaccine in such country in accordance with the requirements
agreed with the third-party funder. If Pfizer elects not to commercialize the vaccine in such country, then such
country shall become a part of the BioNTech Commercialization Territory.
If our Collaboration Agreement with Fosun expires or is otherwise terminated for any reason, as between us and
any international pharmaceutical group headquartered outside of China, we have granted Pfizer a right of first
negotiation to expand the Pfizer Commercialization Territory to include the Fosun Territory. See “Fosun-
COVID-19 Collaboration” below for more information on the Fosun Agreement.
We and Pfizer share responsibilities for manufacturing and supplying our
approved COVID-19 vaccines
. If there
is insufficient supply to satisfy the entire demand for vaccines in the Pfizer Collaboration Territory, we and Pfizer
have agreed to determine by mutual consent the allocation of supplies on a fair and equitable basis, subject also
to any applicable law, export controls, and taking into account any government supply obligations, or supply
obligations included in any agreement reached with a third-party funding organization.
Under the Pfizer Agreement, we have granted Pfizer an exclusive, sublicensable license in the Pfizer
Collaboration Territory under certain of our intellectual property, including our patents and know-how, relating to
uridine RNA, modified RNA and replicons in the Pfizer Corona Field as well as certain intellectual property in-
licensed by us from third parties, to use, research, develop, manufacture, commercialize and otherwise exploit
candidates and products selected under the Pfizer Agreement. We undertake to maintain in full effect all
intellectual property licenses held by us at the time we entered into the Pfizer Agreement and not to modify or
amend any such license in a manner that would adversely affect any of the rights granted to Pfizer under the
Pfizer Agreement. We are obligated to notify Pfizer of any breach of our current licenses and may be obligated to
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take steps to maintain Pfizer’s access to any intellectual property licensed under such licenses. Under the Pfizer
Agreement, we are obligated to indemnify Pfizer with respect to certain patent infringement claims that Pfizer
elects to control.
During the term of the Pfizer Agreement and a certain period thereafter, we and Pfizer have committed not to
research, develop, manufacture, commercialize or otherwise exploit immunogenic compositions comprising RNA
in the Pfizer Corona Field, or exploit vaccine candidates or products developed under the agreement for any
use, other than pursuant to the Pfizer Agreement, provided, however, that Pfizer shall have the
right to work as a
contract manufacturer for a third party
and Pfizer shall not be precluded from acquiring a third party, or being
acquired by a third party, that at the time of acquisition is active in the development or commercialization of an
immunogenic composition comprising mRNA in the Pfizer Corona Field.
On April 9, 2020, Pfizer also subscribed for $113 million of our ordinary shares under a separate investment
agreement. In addition, under the Pfizer Agreement, Pfizer made an upfront payment of $72 million and agreed
to make potential payments of up to $563 million upon the achievement of specified regulatory and commercial
milestones. We and Pfizer agreed to share development costs equally. We and Pfizer will share the gross profits
from commercializing a vaccine evenly, as well as the costs for shipping. The Pfizer Agreement continues for so
long as either at least a vaccine is being developed for use in the Pfizer Collaboration Territory or a vaccine is
being commercialized anywhere in the Pfizer Collaboration Territory. In addition to termination rights granted to
each party in the case of the other party’s uncured material breach, Pfizer may terminate the agreement (i) upon
our insolvency or (ii) on a country-by-country basis or in its entirety for convenience upon one (1) year’s prior
written notice provided that any such termination shall not become effective less than two (2) years from the first
commercial sale of an approve
d vaccine.
J.
Pfizer-Influenza Collaboration
On July 20, 2018, we and BioNTech RNA entered into a Research Collaboration and License Agreement with
Pfizer, or the Pfizer Influenza Agreement, for the research, development and Pfizer’s commercialization of
immunogenic compositions comprising modified RNA and/or replicon technology for prophylaxis against
influenza in humans, which we refer to as the Pfizer Influenza Agreement Field.
We and Pfizer agreed to collaborate on the research in the Pfizer Influenza Agreement Field for an initial period
of three years, ending in August 2021. The details of such research were set forth in a research plan that is
governed by a Joint Steering Committee, with Pfizer holding the final decision-making right. Each party will bear
its own costs under the research plan. The research term will be extended automatically by a reasonable amount
of time if the activities or deliverables under the research plan are delayed due to our material breach of our
research obligations under the research plan. In addition, Pfizer may unilaterally extend the research term by up
to a year by making an additional payment to us.
After the research term expires, Pfizer has the sole responsibility, authority and control of the development,
manufacturing and commercialization of all candidates and products. Pfizer undertakes to use commercially
reasonable efforts to seek regulatory approval for one product in the United States and in two countries out of
France, Germany, Italy, Spain, the United Kingdom and Japan, and to commercialize such product in such
countries where such product has received regulatory approval.
Under the Pfizer Influenza Agreement, we grant to Pfizer an exclusive, worldwide, sublicensable license under
certain of our intellectual property, including our patents and know-how, relating to replicons and modified RNA in
the Pfizer Influenza Agreement Field as well as certain intellectual property in-licensed by us from third parties,
to use, research, develop, manufacture, commercialize and otherwise exploit candidates and products selected
under the Pfizer Influenza Agreement. We also grant to Pfizer a non-exclusive, royalty-free, sublicensable
license under all intellectual property controlled by us or our affiliates to use, develop, manufacture,
commercialize and otherwise exploit candidates and products selected under the Pfizer Influenza Agreement in
the Pfizer Influenza Agreement Field. We undertake to maintain in full effect all intellectual property licenses held
by us at the time we entered into the agreement and to not modify or amend any such license in a manner that
would adversely affect any of the rights granted to Pfizer under the Pfizer Influenza Agreement. We are obligated
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to notify Pfizer of any breach of our current licenses and may be obligated to take steps to maintain Pfizer’s
access to any intellectual property licensed under such licenses.
We also granted Pfizer a right of first negotiation to acquire an exclusive worldwide license under certain
intellectual property controlled by us for Pfizer to develop, manufacture and commercialize immunogenic
products comprising RNA for prophylaxis against respiratory syncytial virus or
human cytomegalovirus
. The right
of first negotiation may be exercised until the end of the research term.
In consideration of the rights granted to Pfizer under the agreement, Pfizer subscribed to shares in BioNTech AG
under a separate investment agreement. In addition, under the Pfizer Influenza Agreement, Pfizer made an
upfront payment of $50 million and agreed to potential payments of up to $325 million upon the achievement of
specified development, regulatory and commercial milestones. Pfizer further agreed to a mid-single digit to very
low double-digit tiered royalty on net sales if a product is commercialized. Royalties are subject to stacking
provisions. The obligation of Pfizer to pay royalties ends, on a country-by-country and a product-by-product,
basis upon the later of (i) the expiration of the last valid licensed patent right covering such product category in
such country, (ii) 10 years after the first commercial sale of a product of such product category in such country
and (iii) the lapse of regulatory data exclusivity for the first product in such product category in such country.
There are only two product categories: one for modified RNA and a second for replicon products.
During the term of the Pfizer Influenza Agreement, we have committed not to research, develop, manufacture,
commercialize or otherwise exploit immunogenic compositions compromising RNA in the Pfizer Influenza
Agreement Field other than pursuant to the Pfizer Influenza Agreement.
The Pfizer Influenza Agreement ends on a country-by-country basis upon expiration of the last royalty term for
any product in that country. Thereafter, the licenses granted to Pfizer with respect to such product in such
country will convert into a perpetual, exclusive, fully paid-up and royalty-free license. In addition to termination
rights granted to each party in the case of the other party’s uncured material breach, Pfizer may terminate the
agreement, in whole or in part, for convenience and with or without reason at any time upon 60 days’ prior
written notice. In addition, Pfizer is entitled to terminate the agreement and initiate a technology transfer of
certain intellectual property if one of its key competitors acquires control over us
.
X
. Government Regulation
Government authorities in the
United States
at the federal, state and local levels, and in the European Union and
other countries and jurisdictions, extensively regulate, among other things, the research, development, testing,
manufacture, quality control, approval, packaging, storage, record-keeping, labeling, advertising, promotion,
distribution, marketing, post-approval monitoring and reporting and import and export of pharmaceutical
products, including biological products. In addition, some jurisdictions regulate the pricing of pharmaceutical
products. The processes for obtaining marketing approvals in the United States and in other jurisdictions, along
with subsequent compliance with applicable statutes and regulations and other requirements of regulatory
authorities, require the expenditure of substantial time and financial resources.
A. Regulation and Procedures Governing Approval of Drug and Biological Products in the United States
In the United States, the FDA regulates drugs under the Federal Food, Drug, and Cosmetic Act, or the FDCA,
and its implementing regulations and biologics under the FDCA, the Public Health Service Act, or the PHSA, and
their implementing regulations. Both drugs and biologics are subject to other federal, state and local statutes and
regulations. The process of obtaining regulatory approvals and the subsequent compliance with applicable
federal, state and local statutes and regulations requires the expenditure of substantial time and financial
resources. Failure to comply with the applicable U.S. requirements at any time during the product development
process, approval process or following approval may subject a sponsor or marketing authorization (BLA/NDA)
holder to administrative or judicial sanctions. These sanctions could include, among other actions, the FDA’s
refusal to approve pending applications, withdrawal of an approval, license revocation, clinical hold, untitled or
warning letters, voluntary or mandatory product recalls, market withdrawals, product seizures, total or partial
suspension of production or distribution, injunctions, fines, refusals of government contracts, restitution,
disgorgement and civil or criminal penalties. Any agency or judicial enforcement action could have a material
adverse effect on us.
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A sponsor seeking approval to market and distribute a new drug or biological product in the United States
generally must satisfactorily complete each of the following steps:
•
preclinical laboratory tests, animal studies and formulation studies all performed in accordance with
applicable regulations, including the FDA’s good laboratory practices, or GLP, regulations;
•
submission to the FDA of an IND application for human clinical testing, which must become effective
before human clinical trials may begin;
•
approval by the IRB representing each clinical site before each clinical trial may be initiated;
•
performance of adequate and well-controlled human clinical trials to establish the safety, potency and
purity of the product candidate for each proposed indication, in accordance applicable regulations,
including GCP;
•
preparation and submission to the FDA of a NDA for a drug product, or a BLA for a biological product
requesting marketing approval for one or more proposed indications, including submission of detailed
information on the manufacture and composition of the product in clinical development, evidence of
safety, purity and potency from preclinical testing and clinical trials, and proposed labeling;
•
review of the product by an FDA advisory committee, if applicable;
•
satisfactory completion of one or more FDA inspections of the manufacturing facility or facilities,
including those of third parties, at which the product, or components thereof, are produced to assess
compliance with current GMP requirements and to assure that the facilities, methods and controls are
adequate to preserve the product’s identity, strength, quality and purity;
•
satisfactory completion of any FDA audits of the clinical study sites to assure compliance with applicable
regulations and GCP, and the integrity of clinical data in support of the NDA or BLA;
•
payment of user fees and securing FDA approval of the NDA or BLA; and
•
compliance with applicable regulations post approval, including any post-approval requirements, such as
the potential requirement to implement a REMS and to conduct any post-approval studies required by
the FDA.
The preclinical and clinical testing and approval process requires substantial time, effort and financial resources,
and we cannot be certain that any approvals for our product candidates and any future product candidates will
be granted on a timely basis, or at all.
Preclinical Studies and Investigational New Drug Application
Before testing any drug or biological product candidate in humans, the product candidate must undergo
preclinical testing. Preclinical tests include laboratory evaluations of product chemistry, formulation and stability,
as well as animal studies to evaluate the potential for activity and toxicity. The conduct of the preclinical tests and
formulation of the compounds for testing must comply with federal regulations and requirements. The results of
the preclinical tests, together with manufacturing information, analytical data, any available clinical data or
literature and a proposed clinical protocol, are submitted to the FDA as part of an IND application. The IND
automatically becomes effective 30 days after receipt by the FDA, unless before that time the FDA raises
concerns or questions about the product or conduct of the proposed clinical trial, including concerns that patients
will be exposed to unreasonable health risks, and places the trial on a clinical hold. In that case, the IND sponsor
and the FDA must resolve any outstanding FDA concerns before the clinical trial can begin.
As a result, submission of the IND may result in the FDA not allowing the trial to commence or not be conducted
on the terms originally specified by the sponsor in the IND. If the FDA raises concerns or questions either during
this initial 30-day period, or at any time during the IND process, it may choose to impose a partial or complete
clinical hold. If the FDA imposes a clinical hold, trials may not recommence without FDA authorization and then
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only under terms authorized by the FDA. A clinical hold issued by the FDA may therefore delay either a proposed
clinical study or cause suspension of an ongoing study, until all outstanding concerns have been adequately
addressed and the FDA has notified the company that investigation may proceed. This could cause significant
difficulties in completing planned clinical trials in a timely manner.
The FDA may impose clinical holds on a product candidate at any time before or during clinical trials due to
safety concerns or non-compliance.
Human Clinical Trials in Support of an NDA or a BLA
Clinical trials involve the administration of the investigational product candidate to healthy volunteers or patients
with the disease to be treated under the supervision of qualified principal investigators, generally physicians not
employed by or under the trial sponsor’s control, in accordance with GCP requirements, which include the
requirement that all patients provide their informed consent for their participation. Clinical trials are conducted
under study protocols detailing, among other things, the objectives of the study, inclusion and exclusion criteria,
the parameters to be used in monitoring safety, dosing procedures and the effectiveness criteria to be evaluated.
A protocol for each clinical trial and any subsequent protocol amendments must be submitted to the FDA as part
of the IND.
A sponsor who wishes to conduct a clinical trial outside the United States may, but need not, obtain FDA
authorization to conduct the clinical trial under an IND. If a foreign clinical trial is not conducted under an IND, the
sponsor may submit data from the clinical trial to the FDA in support of the NDA or BLA so long as the clinical
trial is well-designed and well-conducted in accordance with GCP, including review and approval by an
independent ethics committee, and the FDA is able to validate the study data through an onsite inspection, if
necessary.
Further, each clinical trial must be reviewed and approved by an IRB either centrally or individually at each
institution at which the clinical trial will be conducted. The IRB will consider, among other things, clinical trial
design, patient informed consent, ethical factors and the safety of patients. An IRB must operate in compliance
with FDA regulations. The FDA, IRB, or the clinical trial sponsor may suspend or discontinue a clinical trial at any
time for various reasons, including a finding that the clinical trial is not being conducted in accordance with FDA
requirements or that the patients are being exposed to an unacceptable health risk. Clinical testing also must
satisfy extensive GCP rules and the requirements for informed consent. The IRB also approves the form and
content of the informed consent that must be signed by each clinical trial subject or his or her legal
representative and receive periodic reports regarding the investigation from the investigators. Additionally, some
clinical trials are overseen by an independent group of qualified experts organized by the clinical trial sponsor,
known as a data safety monitoring board or committee, or DSMB. This group may recommend continuation of
the study as planned, changes in study conduct, or cessation of the study at designated check points based on
access to certain data from the study.
Clinical trials typically are conducted in three sequential phases, but the phases may overlap or be combined.
Additional studies may be required after approval.
•
Phase 1 clinical trials (or Phase 1) are initially conducted in a limited population to test the product
candidate for safety, including adverse effects, dose tolerance, absorption, metabolism, distribution,
excretion and pharmacodynamics in healthy humans or, on occasion, in patients, such as in the case of
some products for severe or life-threatening diseases, especially when the product may be too
inherently toxic to ethically administer to healthy volunteers.
•
Phase 2 clinical trials (or Phase 2) are generally conducted in a limited patient population to identify
possible adverse effects and safety risks, preliminarily evaluate the efficacy of the product candidate for
specific targeted indications and determine dose tolerance and optimal dosage. Multiple Phase 2 clinical
trials may be conducted by the sponsor to obtain information prior to beginning larger Phase 3 clinical
trials. When a drug is intended to treat life-threatening or severely debilitating illnesses, and particularly
for rare diseases, the FDA may accept well-controlled Phase 2 clinical trials as adequate to provide
sufficient data on the drug’s safety and effectiveness to support a decision on its approvability for
marketing, in which case Phase 3 clinical trials would not be required.
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•
Phase 3 clinical trials (or Phase 3) proceed if the Phase 2 clinical trials demonstrate that a certain dose
or dose range of the product candidate is potentially effective and has an acceptable safety profile.
Phase 3 clinical trials are undertaken within an expanded patient population, often at geographically
dispersed clinical trial sites, to gather additional information about safety and effectiveness necessary to
evaluate the overall benefit-risk relationship of the product and to provide the basis for product labeling.
In some cases, the FDA may approve an NDA or a BLA for a product candidate but require the sponsor to
conduct additional clinical trials to further assess the product candidate’s safety and/or effectiveness after
approval. Such
post-approval trials
are typically referred to as Phase 4 clinical trials (or Phase 4). These studies
may be used to gain additional experience from the treatment of patients in the intended therapeutic indication
and to document a clinical benefit in the case of biologics approved under accelerated approval regulations. If
the FDA approves a product while a company has ongoing clinical trials that were not necessary for approval, a
company may be able to use the data from these clinical trials to meet all or part of any Phase 4 clinical trial
requirement or to request a change in the product labeling. Failure to exhibit due diligence with regard to
conducting required Phase 4 clinical trials or to comply with post approval commitments could result in
withdrawal of approval for products.
During all phases of clinical development, regulatory agencies require extensive monitoring and auditing of all
clinical activities, clinical data and clinical trial investigators. Annual progress reports detailing the results of the
clinical trials must be submitted to the FDA. Written IND safety reports must be promptly submitted to the FDA
and the investigators for serious and unexpected adverse events, any findings from other trials, tests in
laboratory animals or in vitro testing that suggest a significant risk for patients, or any clinically important
increase in the rate of a serious suspected adverse reaction over that listed in the protocol or investigator
brochure. The sponsor must submit an IND safety report within 15 calendar days after the sponsor determines
that the information qualifies for reporting. The sponsor also must notify the FDA of any unexpected fatal or life-
threatening suspected adverse reaction within seven calendar days after the sponsor’s initial receipt of the
information. The FDA or the sponsor or its DSMB may suspend a clinical trial at any time on various grounds,
including a finding that the patients are being exposed to an unacceptable health risk. Similarly, an IRB can
suspend or terminate approval of a clinical trial at its institution if the clinical trial is not being conducted in
accordance with the IRB’s requirements or if the new drug candidate or biological product candidate has been
associated with unexpected serious harm to patients.
There are also requirements governing the reporting of ongoing clinical trials and completed clinical trial results
to public registries. Sponsors of clinical trials of FDA-regulated products, including biologics, are required to
register and disclose certain clinical trial information, which is publicly available at www.clinicaltrials.gov.
Information related to the product, patient population, phase of investigation, trial sites and investigators, and
other aspects of the clinical trial is then made public as part of the registration. Sponsors are also obligated to
discuss the results of their clinical trials after completion. Disclosure of the results of these trials can be delayed
until the new product or new indication being studied has been approved.
Compliance with GMP Requirements
Before approving an NDA or a BLA, the FDA typically will inspect the facility or facilities where the product is
manufactured. The FDA will not approve an application unless it determines that the manufacturing processes
and facilities are in full compliance with GMP requirements and adequate to assure consistent production of the
product within required specifications. Among other things, the sponsor must develop methods for testing the
identity, strength, quality, potency and purity of the final drug or biological product. Additionally, appropriate
packaging must be selected and tested, and stability studies must be conducted to demonstrate that the drug or
biological product does not undergo unacceptable deterioration over its shelf life. In particular, the PHSA
emphasizes the importance of manufacturing control for products like biologics whose attributes cannot be
precisely defined.
Manufacturers and others involved in the manufacture and distribution of drugs and biological products must
also register their establishments with the FDA and certain state agencies. Both domestic and foreign
manufacturing establishments must register and provide additional information to the FDA upon their initial
participation in the manufacturing process.
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The manufacturing facilities may be subject to periodic announced and unannounced inspections by government
authorities to ensure compliance with GMPs and other laws. Manufacturers may have to provide, on request,
electronic or physical records regarding their establishments. Delaying, denying, limiting or refusing inspection
by the FDA may lead to a product being deemed to be
adulterated
.
Review and Approval of an NDA or a BLA
The results of product candidate development, preclinical testing and clinical trials, including negative or
ambiguous results as well as positive findings, are submitted to the FDA as part of an NDA or a BLA requesting a
license to market the product. These applications must contain extensive manufacturing information and detailed
information on the composition of the product and proposed labeling. The FDA adjusts the Prescription Drug
User Fee Act, or PDUFA, user fees on an annual basis. Fee waivers or reductions are available in certain
circumstances, including a waiver of the application fee for the first application filed by a small business.
Additionally, no user fees are assessed on NDAs or BLAs for products designated as orphan drugs, unless the
product also includes a non-orphan indication.
The FDA has 60 days after submission of the application to conduct an initial review to determine whether the
NDA or BLA is sufficient to accept for filing based on the agency’s threshold determination that it is substantially
complete so as to permit substantive review. Once the submission has been accepted for filing, the FDA begins
an in-depth review of the application. Under the goals and policies agreed to by the FDA under PDUFA, the FDA
aims to complete its initial review of a standard application and respond to the sponsor within ten months of the
60-day filing date, and for a priority review application within six months. The FDA does not always meet its
PDUFA goal dates for standard and priority NDA or BLA applications, and its review goals are subject to change
from time to time. The review process may often be significantly extended by FDA requests for additional
information or clarification. The review process and the PDUFA goal date may also be extended by three months
if the FDA requests or if the sponsor otherwise provides additional information or clarification regarding
information already provided in the submission within the last three months before the PDUFA goal date.
The FDA reviews NDA and BLA applications to determine, among other things, whether the proposed product is
safe and potent, and/or effective, for its intended use, and has an acceptable purity profile, and whether the
product is being manufactured in accordance with GMP requirements to assure and preserve the product’s
identity, safety, strength, quality, potency and purity. On the basis of the FDA’s evaluation of the application and
accompanying information, including the results of the inspection of the manufacturing facilities and any FDA
audits of clinical trial sites to assure compliance with GCPs, the FDA may issue an approval letter or a complete
response letter. An approval letter authorizes commercial marketing of the product with specific prescribing
information for specific indications. Under the FDCA, the FDA may approve an NDA if it determines that the
product is safe and effective for its intended use, the benefits of the drug outweigh any risks, and the methods
used in manufacturing the drug and the controls used to maintain the drug’s quality are adequate to preserve the
drug’s identity, strength, quality and purity. Under the PHSA, the FDA may approve a BLA if it determines that the
product is safe, pure and potent and the facility where the product will be manufactured meets standards
designed to ensure that it continues to be safe, pure and potent. If the application is not approved, the FDA may
issue a complete response letter, which will contain the conditions that must be met in order to secure final
approval of the application, and when possible will outline recommended actions the sponsor might take to
obtain approval of the application. If a complete response letter is issued, the sponsor may either resubmit the
NDA or BLA, addressing all of the deficiencies identified in the letter, or withdraw the application.
Sponsors that receive a complete response letter who elect to address the deficiencies may submit to the FDA
information that represents a complete response to the issues identified by the FDA in the response letter. Such
resubmissions are classified under PDUFA as either Class 1 or Class 2, based on the information submitted by a
sponsor in response to an action letter. Under the goals and policies agreed to by the FDA under PDUFA, the
FDA aims to review and act on a Class 1 resubmission with two months of receipt and, with respect to a Class 2
resubmission, within six months of receipt. The FDA will not approve an application until issues identified in the
complete response letter have been addressed.
The FDA may also refer the application to an Advisory Committee for review, evaluation and recommendation as
to whether the application should be approved and under what conditions. In particular, the FDA may refer
applications for novel drug or biological products or drug or biological products that present difficult questions of
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safety or efficacy to an advisory committee. Typically, an Advisory Committee is a panel of independent experts,
including clinicians and other scientific experts. The FDA is not bound by the recommendations of an Advisory
Committee, but it considers such recommendations carefully when making decisions.
If the FDA approves a new product, it may limit the approved indications for use of the product, or limit the
approval to specific dosages. It may also require that certain contraindications, warnings or precautions be
included in the product labeling. In addition, the FDA may call for post-approval studies, including Phase 4
clinical trials, to further assess the product’s safety after approval. The agency may also require testing and
surveillance programs to monitor the product after commercialization, or impose other conditions, including
distribution restrictions or other risk management mechanisms, including risk evaluation and mitigation
strategies, or REMS, to help ensure that the benefits of the product outweigh the potential risks. REMS can
include medication guides, communication plans for healthcare professionals, and elements to assure safe use,
or ETASU. ETASU can include, but are not limited to, special training or certification for prescribing or
dispensing, dispensing only under certain circumstances, special monitoring and the use of patent registries. If
the FDA concludes a REMS is needed, the sponsor of the NDA or BLA must submit a proposed REMS; the FDA
will not approve the NDA or BLA without a REMS, if required. The FDA may prevent or limit further marketing of
a product based on the results of post-marketing studies or surveillance programs. After approval, many types of
changes to the approved product, such as adding new indications, manufacturing changes and additional
labeling claims, are subject to further testing requirements and FDA review and approval.
Fast Track, Breakthrough Therapy and Priority Review Designations
The FDA may designate certain products for expedited review if they are intended to address an unmet medical
need in the treatment of a serious or life-threatening disease or condition. These programs include fast track
designation, breakthrough therapy designation and priority review designation.
The FDA may designate a product for fast track review if it is intended, whether alone or in combination with one
or more other products, for the treatment of a serious or life-threatening disease or condition, and it
demonstrates the potential to address unmet medical needs for such disease or condition. Fast track designation
applies to the combination of the product and the specific indication for which it is being studied. The sponsor of
a new drug or biologic may request that the FDA designate the drug or biologic as a fast track product at any
time during the clinical development of the product. For fast track products, sponsors may have greater
interactions with the FDA and the FDA may initiate review of sections of a fast track product’s application before
the application is complete. This rolling review may be available if the FDA determines, after preliminary
evaluation of clinical data submitted by the sponsor, that a fast track product may be effective. The sponsor must
also provide, and the FDA must approve, a schedule for the submission of the remaining information and the
sponsor must pay applicable user fees. However, the FDA’s time period goal for reviewing a fast track
application does not begin until the last section of the application is submitted. Fast track designation may be
withdrawn by the FDA if the FDA believes that the designation is no longer supported by data emerging in the
clinical trial process.
In 2012, Congress enacted the Food and Drug Administration Safety and Innovation Act, or the FDASIA. This
law established a new regulatory scheme allowing for expedited review of products designated as “breakthrough
therapies.” A product may be designated as a breakthrough therapy if it is intended, either alone or in
combination with one or more other products, to treat a serious or life-threatening disease or condition and
preliminary clinical evidence indicates that the product may demonstrate substantial improvement over existing
therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in
clinical development. The FDA may take certain actions with respect to breakthrough therapies, including holding
additional meetings with the sponsor throughout the development process; providing timely advice to the product
sponsor regarding development and approval; involving more senior staff in the review process; assigning a
cross-disciplinary project lead for the review team; and taking other steps to facilitate the design of clinical trials
in an efficient manner.
The FDA may designate a product for priority review if it is a product that treats a serious condition and, if
approved, would provide a significant improvement in safety or effectiveness. The FDA determines, on a case-
by-case basis, whether the proposed product represents a significant improvement when compared with other
available therapies. Significant improvement may be illustrated by evidence of increased effectiveness in the
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treatment of a condition, elimination or substantial reduction of a treatment-limiting product reaction, documented
enhancement of patient compliance that may lead to improvement in serious outcomes and evidence of safety
and effectiveness in a new subpopulation. A priority designation is intended to direct overall attention and
resources to the evaluation of such applications, and to shorten the FDA’s goal for
taking action
on a marketing
application to six months (compared to 10 months under standard review).
Fast track designation, priority review and breakthrough therapy designation may expedite the development or
approval process, but do not change the standards for approval.
Accelerated Approval Pathway
The FDA may grant accelerated approval to a product for a serious or life-threatening condition that provides
meaningful therapeutic advantage to patients over existing treatments based upon a determination that the
product has an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit. The FDA may
also grant accelerated approval for such a condition when the product has an effect on an intermediate clinical
endpoint that can be measured earlier than an effect on irreversible morbidity or mortality, or IMM, and that is
reasonably likely to predict an effect on IMM or other clinical benefit, taking into account the severity, rarity or
prevalence of the condition and the availability or lack of alternative treatments. Products granted accelerated
approval must meet the same statutory standards for safety and effectiveness as those granted traditional
approval.
For the purposes of accelerated approval, a surrogate endpoint is a marker, such as a laboratory measurement,
radiographic image, physical sign or other measure that is thought to predict clinical benefit, but is not itself a
measure of clinical benefit. Surrogate endpoints can often be measured more easily or more rapidly than clinical
endpoints. An intermediate clinical endpoint is a measurement of a therapeutic effect that is considered
reasonably likely to predict the clinical benefit of a product, such as an effect on IMM. The FDA has stated that
although it has limited experience with accelerated approvals based on intermediate clinical endpoints, such
endpoints generally may support accelerated approval where the therapeutic effect measured by the endpoint is
not itself a clinical benefit and basis for traditional approval, if there is a basis for concluding that the therapeutic
effect is reasonably likely to predict the ultimate clinical benefit of a product.
The accelerated approval pathway is most often used in settings in which the course of a disease is long and an
extended period of time is required to measure the intended clinical benefit of a product. Thus, accelerated
approval has been used extensively in the development and approval of products for treatment of a variety of
cancers in which the goal of therapy is generally to improve survival or decrease morbidity and the duration of
the typical disease course requires lengthy and sometimes large trials to demonstrate a clinical or survival
benefit.
The accelerated approval pathway is usually contingent on a sponsor’s agreement to conduct, in a diligent
manner, additional post-approval confirmatory studies to verify and describe the product’s clinical benefit. As a
result, a product candidate approved on this basis is subject to rigorous post-marketing compliance
requirements, including the completion of Phase 4 or post-approval clinical trials to confirm the effect on the
clinical endpoint. Failure to conduct required post-approval studies, or to confirm a clinical benefit during post-
marketing studies, may lead the FDA to withdraw the product from the market under expedited withdrawal
procedures applicable to products approved under accelerated approval. All promotional materials for product
candidates approved under accelerated regulations are subject to prior review by the FDA.
Accelerated approval pathways are available for regenerative medicine therapies that meet certain conditions.
Regenerative medicine therapies include cell therapies (both allogeneic and autologous), therapeutic tissue
engineering products, human cell and tissue products, and combination products using any such therapies or
products, except those regulated under section 361 of the PHSA. Human gene therapies, including genetically
modified cells, that lead to a sustained effect on cells or tissues, may also meet the definition of a regenerative
medicine therapy, as may xenogeneic cell products.
Regenerative medicine therapies designed to treat, modify, reverse or cure serious conditions are eligible for
FDA’s expedited programs, including fast track designation, breakthrough therapy designation, priority review
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and accelerated approval, if they meet the criteria for such programs. They may also be eligible for Regenerative
Medicine Advanced Therapy Designation, or RMAT designation.
An investigational drug is eligible for RMAT designation if it meets the definition of regenerative medicine
therapy, it is intended to treat, modify, reverse or cure a serious condition, and preliminary clinical evidence
indicates that the regenerative medicine therapy has the potential to address unmet medical needs for such
condition. An unmet medical need is a condition whose treatment or diagnosis is not addressed adequately by
available therapy.
RMAT designation confers all the benefits of the fast track and breakthrough therapy designation programs,
including early interactions with the FDA. The FDA reviews each application on a case-by-case basis to
determine whether the clinical evidence is sufficient to support RMAT designation, considering factors such as
the rigor of data collection, the consistency and persuasiveness of the outcomes, the number of patients, and the
severity, rarity or prevalence of the condition, among other factors. The FDA may decline to grant RMAT
designation if it finds the clinical evidence insufficient.
RMAT designation may expedite the development or approval process, but it does not change the standards for
approval.
Emergency Use Authorizations
The Secretary of Health and Human Services has the authority to authorize unapproved medical products,
including vaccines, to be marketed in the context of an actual or potential emergency that has been designated
by government officials. The COVID-19 pandemic has been designated such a national emergency. After an
emergency has been announced, the Secretary of Health and Human Services may authorize the issuance of,
and the FDA Commissioner may issue, Emergency Use Authorizations, or EUAs, for the use of specific products
based on criteria established by statute, including that the product at issue may be effective in diagnosing,
treating, or preventing serious or life-threatening diseases when there are no adequate, approved, and available
alternatives. An EUA is subject to additional conditions and restrictions and is product-specific. An EUA
terminates when the emergency determination underlying the EUA terminates or full approval is obtained
.
An
EUA is not a long-term alternative to obtaining FDA approval, licensure, or clearance for a product. FDA may
revoke an EUA where it is determined that the underlying health emergency no longer exists or warrants such
authorization, so it is not possible to predict how long an EUA may remain in place.
Post-Approval Regulation
If regulatory approval for marketing of a product or for a new indication for an existing product is obtained, the
sponsor will be required to comply with rigorous and extensive post-approval regulatory requirements as well as
any post-approval requirements that the FDA has imposed on the particular product as part of the approval
process. The sponsor will be required, among other things, to report certain adverse reactions and
manufacturing problems, or certain other events to the FDA, provide updated safety and efficacy information and
comply with requirements concerning advertising and promotional labeling. Manufacturers and certain of their
subcontractors are required to register their establishments with the FDA and certain state agencies, and are
subject to periodic unannounced inspections by the FDA and certain state agencies for compliance with ongoing
regulatory requirements, including GMP regulations, which impose certain procedural and documentation
requirements upon manufacturers. Accordingly, the BLA holder and its third-party manufacturers must continue
to expend time, money and effort in the areas of production and quality control to maintain compliance with GMP
regulations and other regulatory requirements. In addition, changes to the manufacturing process or facility
generally require prior FDA approval before being implemented, and other types of changes to the approved
product, such as adding new indications and additional labeling claims, are also subject to further FDA review
and approval.
Once an approval is granted, the FDA may withdraw the approval if compliance with regulatory requirements and
standards is not maintained or if problems occur after the product reaches the market. Later discovery of
previously unknown problems with a product, including adverse events of unanticipated severity or frequency, or
with manufacturing processes, or failure to comply with regulatory requirements, may result in revisions to the
approved labeling to add new safety information; imposition of post-market study requirements or clinical trial
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requirements to assess new safety risks; or imposition of distribution restrictions or other restrictions under a
REMS program. Other potential consequences include, among other things:
•
restrictions on the marketing or manufacturing of the product, complete withdrawal of the product from
the market or product recalls;
•
fines, untitled letters or warning letters or holds on post-approval clinical trials;
•
adverse publicity, including FDA statements regarding the safety of products;
•
refusal of the FDA to approve pending applications or supplements to approved applications, or
suspension or revocation of product license approvals;
•
product seizure or detention, or refusal to permit the import or export of products; or
•
injunctions, fines, debarment, disgorgement of profits or the imposition of civil or criminal penalties.
The FDA strictly regulates marketing, labeling, advertising and promotion of products that are placed on the
market. Pharmaceutical products may be promoted only for the approved indications and in accordance with the
provisions of the approved label. The FDA and other agencies actively enforce the laws and regulations
prohibiting the promotion of off-label uses, and a company that is found to have improperly promoted off-label
uses may be subject to significant liability.
Orphan Drug Designation
Orphan drug designation in the United States is designed to encourage sponsors to develop products intended
for rare diseases or conditions. In the United States, a rare disease or condition is statutorily defined as a
disease or condition that affects fewer than 200,000 individuals in the United States or that affects more than
200,000 individuals in the United States but for which there is no reasonable expectation that the cost of
developing and making available the product for the disease or condition will be recovered from sales of the
product in the United States.
Orphan drug designation qualifies a company for certain financial incentives, including tax advantages and, if the
product receives the first FDA approval for the indication for which it has orphan designation, market exclusivity
for seven years following the date of the product’s marketing approval. An application for designation as an
orphan product can be made any time prior to the filing of an application for approval to market the product.
Once a product receives orphan drug designation from the Office of Orphan Products Development at the FDA,
the product must then go through the review and approval process like any other product.
In addition, a sponsor of a product that is otherwise the same product as an already approved orphan drug may
seek and obtain orphan drug designation for the subsequent product for the same rare disease or condition if it
can present a plausible hypothesis that its product may be clinically superior to the first product. More than one
sponsor may receive orphan drug designation for the same product for the same rare disease or condition, but
each sponsor seeking orphan drug designation must file a complete request for designation.
The period of exclusivity begins on the date that the marketing application is approved by the FDA and applies
only to the indication for which the product has been designated. The FDA may approve a second application for
the same product for a different use or a second application for a clinically superior version of the product for the
same use. The FDA cannot, however, approve the same product made by another manufacturer for the same
indication during the market exclusivity period unless it has the consent of the sponsor, the manufacturer makes
a showing of clinical superiority over the product with orphan exclusivity, or the sponsor is unable to provide
sufficient quantities.
Orphan product designation does not convey any advantage in or shorten the duration of the regulatory review
and approval process.
Pediatric Studies and Exclusivity
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Under the Pediatric Research Equity Act of 2003, an NDA or a BLA or supplement thereto must contain data that
are adequate to assess the safety and effectiveness of the product for the claimed indications in all relevant
pediatric subpopulations, and to support dosing and administration for each pediatric subpopulation for which the
product is safe and effective. Sponsors who are planning to submit a marketing application for a drug or
biological product that includes a new active ingredient, new indication, new dosage form, new dosing regimen
or new route of administration must also submit pediatric study plans prior to the assessment data, and no later
than 60 calendar days following an end-of-Phase 2 meeting with the FDA or, if there is no such meeting, as early
as practicable before the initiation of the Phase 3 or Phase 2/3 study. Pediatric study plans must contain an
outline of the proposed pediatric study or studies the sponsor plans to conduct, including study objectives and
design, any deferral or waiver requests and other information required by regulation. The sponsor, the FDA, and
the FDA’s internal review committee must then review the information submitted, consult with each other and
agree upon a final plan. The FDA or the sponsor may request an amendment to the plan at any time.
The FDA may, on its own initiative or at the request of the sponsor, grant deferrals for submission of some or all
pediatric data until after approval of the product for use in adults, or full or partial waivers from the pediatric data
requirements. Additional requirements and procedures relating to deferral requests and requests for extension of
deferrals are contained in FDASIA. Unless otherwise required by regulation, the pediatric data requirements do
not apply to products with orphan designation.
Pediatric exclusivity is another type of non-patent marketing exclusivity in the United States and, if granted,
provides for the attachment of an additional six months of marketing protection to the term of any existing
regulatory exclusivity, including the non-patent and orphan exclusivity. This six-month exclusivity may be granted
if an NDA or a BLA sponsor submits pediatric data that fairly respond to a written request from the FDA for such
data. The data do not need to show the product to be effective in the pediatric population studied; rather, if the
clinical trial is deemed to fairly respond to the FDA’s request, the additional protection is granted. If reports of
requested pediatric studies are submitted to and accepted by the FDA within the statutory time limits, whatever
statutory or regulatory periods of exclusivity or patent protection cover the product are extended by six months.
This is not a patent term extension, but it effectively extends the regulatory period during which the FDA cannot
approve another application.
Biosimilars and Reference Product Exclusivity
The Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation
Act, or collectively, the ACA, signed into law in 2010, includes a subtitle called the Biologics Price Competition
and Innovation Act of 2009, or the BPCIA, which created an abbreviated approval pathway for biological
products that are biosimilar to or interchangeable with an FDA-approved reference biological product. To date, a
number of biosimilars have been licensed under the BPCIA, and numerous biosimilars have been approved in
Europe.
Under the BPCIA, an application for a biosimilar product may not be submitted to the FDA until four years
following the date that the reference product was first licensed by the FDA. In addition, the approval of a
biosimilar product may not be made effective by the FDA until 12 years from the date on which the reference
product was first licensed. During this 12-year period of exclusivity, another company may still market a
competing version of the reference product if the FDA approves a full BLA for the competing product containing
that sponsor’s own preclinical data and data from adequate and well-controlled clinical trials to demonstrate the
safety, purity and potency of its product. The BPCIA also created certain exclusivity periods for biosimilars
approved as interchangeable products. At this juncture, it is unclear whether products deemed “interchangeable”
by the FDA will, in fact, be readily substituted by pharmacies, which are governed by state pharmacy law.
The FDA has issued several guidance documents outlining an approach to review and approval of biosimilars.
Biosimilarity, which requires that there be no clinically meaningful differences between the biological product and
the reference product in terms of safety, purity and potency, can be shown through analytical studies, animal
studies, and a clinical study or studies. Interchangeability requires that a product is biosimilar to the reference
product and the product must demonstrate that it can be expected to produce the same clinical results as the
reference product in any given patient and, for products that are administered multiple times to an individual, the
biologic and the reference biologic may be alternated or switched after one has been previously administered
without increasing safety risks or risks of diminished efficacy relative to exclusive use of the reference biologic.
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Complexities associated with the larger, and often more complex, structures of biological products, as well as the
processes by which such products are manufactured, pose significant hurdles to implementation of the
abbreviated approval pathway that are still being worked out by the FDA.
The BPCIA is complex and continues to be interpreted and implemented by the FDA. In addition, recent
government proposals have sought to reduce the 12-year reference product exclusivity period. Other aspects of
the BPCIA, some of which may impact the BPCIA exclusivity provisions, have also been the subject of recent
litigation. As a result, the ultimate implementation and impact of the BPCIA is subject to significant uncertainty.
B. Regulation and Procedures Governing Approval of Medicinal Products in the European Union
The process governing approval of medicinal products, including biological medicinal products and advanced
therapy medicinal products, or ATMPs, which comprise gene therapy products, somatic cell therapy products
and tissue-engineered products, in the European Union generally follows the same lines as in the United States.
It entails satisfactory completion of pharmaceutical development, nonclinical and clinical studies to establish the
safety and efficacy of the medicinal product for each proposed indication. Moreover, an applicant must also
demonstrate the ability to manufacture the product to a suitable quality.
Clinical Trial Approval
Until recently, pursuant to the Clinical Trials Directive 2001/20/EC and the Directive 2005/28/EC on GCP, a
system for the approval of clinical trials in the European Union has been implemented through national
legislation of the member states. Under this system, a sponsor must obtain approval from the competent national
authority of a European Union member state in which the clinical trial is to be conducted or in multiple member
states if the clinical trial is to be conducted in a number of member states. Furthermore, the sponsor may only
start a clinical trial at a specific study site after the independent ethics committee has issued a favorable opinion.
In April 2014, the European Union adopted a new Clinical Trials Regulation (EU) No 536/2014, which took effect
on January 31, 2022 and replaced the Clinical Trials Directive 2001/20/EC. Commission Implementing
Regulation (EU) 2017/556 replaced the GCP Directive 2005/28/EC. The Regulation has overhauled the former
system of approvals for clinical trials in the European Union. Specifically, the Regulation, which is directly
applicable in all member states, aims to simplify and streamline the approval of clinical trials in the European
Union. For instance, Regulation (EU) No 536/2014 enables sponsors to submit one online application via a
single online platform known as the Clinical Trials Information System (CTIS) for approval to run a clinical trial in
several European countries, making it more efficient to carry out such multinational trials. It provides for strictly
defined deadlines for the assessment of clinical trial applications. This means that one national authority takes
the lead in reviewing the application and the other national authorities have only a limited involvement, although
the clinical trial approval is still granted by each national competent authority. Any substantial changes to the trial
protocol or other information submitted with the clinical trial applications must be notified to or approved by the
relevant competent authorities and ethics committees.
Pursuant to transitional provisions under Regulation (EU) No 536/2014, trials for which a request for approval
was submitted prior to January 31, 2022 could continue under the national implementations of the Directives
until January 31, 2025. In addition, until January 30, 2023, clinical trial sponsors could use CTIS to apply to run a
clinical trial under the Regulation or could choose to apply to run a trial under the Clinical Trials Directive.
However, since January 31, 2023, clinical trial sponsors have needed to use CTIS as the single-entry point to
apply to start a new clinical trial in the EU/EEA and such trials must be run under the Regulation. By January 31,
2025, any ongoing trials approved under the Clinical Trial Directive will fall under the Regulation and information
about them must be transferred to CTIS.
Under either regime, clinical trials must be conducted in accordance with European Union and national
regulations and the International Conference on Harmonization, or ICH, guidelines on GCP. Additional GCP
guidelines from the European Commission, with a focus on traceability, apply to clinical trials of ATMPs. If the
sponsor of the clinical trial is not established within the European Union, it must appoint an entity within the
European Union to act as its legal representative.
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The clinical trial application must be accompanied by a copy of the trial protocol and an investigational medicinal
product dossier with supporting information prescribed by applicable legislation as further detailed in applicable
guidance documents. Moreover, the sponsor must take out a clinical trial insurance policy, and in most European
Union countries the sponsor is liable to provide ‘no fault’ compensation to any study subject injured in the clinical
trial.
The sponsor of a clinical trial must register the clinical trial in advance, and information related to the product,
patient population, phase of investigation, study sites and investigators, and other aspects of the clinical trial will
be made public as part of the registration. The results of the clinical trial must be submitted to the competent
authorities and, with the exception of non-pediatric Phase 1 trials, will be made public at the latest within 12
months after the end of the trial.
During the development of a medicinal product, the European Medicines Agency, or EMA, and national
medicines regulators within the European Union provide the opportunity for dialogue and guidance on the
development program. At the EMA level, this is usually done in the form of scientific advice, which is given by the
Scientific Advice Working Party of the Committee for Medicinal Products for Human Use, or CHMP. A fee is
incurred with each scientific advice procedure. Advice from the EMA is typically provided based on questions
concerning, for example, quality (chemistry, manufacturing and controls testing), nonclinical testing and clinical
studies, and pharmacovigilance plans and risk-management programs. Advice is not legally binding with regard
to any future marketing authorization application of the product concerned.
Marketing Authorization
To obtain a marketing authorization for a product under the European Union regulatory system, a sponsor must
submit a marketing authorization application, or MAA, either under the centralized procedure administered by the
EMA or one of the procedures administered by competent authorities in European Union member states
(decentralized procedure, mutual recognition procedure, or if the product is to be approved in only one member
state, the national procedure).
All application procedures require an application in the common technical document, or CTD, format, which
includes the submission of detailed information about the manufacturing and quality of the product, and
nonclinical and clinical trial information. There is an increasing trend in the European Union toward greater
transparency and, while certain of the manufacturing or quality information is currently generally protected as
commercially confidential information, the EMA and national regulatory authorities are now liable to disclose
much of the nonclinical and clinical information in marketing authorization dossiers, including the full clinical
study reports, in response to freedom of information requests after the marketing authorization has been
granted. In October 2014, the EMA adopted a policy under which clinical study reports would be posted on the
agency’s website following the grant, denial or withdrawal of a MAA, subject to procedures for limited redactions
and protection against unfair commercial use. The operation of this policy has been suspended in recent years
due to priorities. However, it continues to apply the policy to COVID-19 vaccines and therapeutics. A similar
transparency requirement is contained in the Clinical Trials Regulation (EU) No 536/2014.
A marketing authorization may be granted only to a sponsor established in the European Union. Regulation (EC)
No. 1901/2006 on medicinal products for pediatric use provides that prior to obtaining a marketing authorization
in the European Union in the centralized procedure, a sponsor must demonstrate compliance with all measures
included in an EMA-approved Pediatric Investigation Plan covering all subsets of the pediatric population, unless
the EMA has granted a product-specific waiver, class waiver or deferral for one or more of the measures
included in the Pediatric Investigation Plan.
The centralized procedure provides for the grant of a single marketing authorization by the European
Commission that is valid for all European Union and European Economic Area member states. Pursuant to
Regulation (EC) No. 726/2004, the centralized procedure is compulsory for specific products, including for
medicines (including vaccines) produced by certain biotechnological processes, products designated as orphan
medicinal products, advanced therapy medicinal products and products with a new active substance indicated
for the treatment of certain diseases, including products for the treatment of cancer. For products with a new
active substance indicated for the treatment of other diseases and products that are highly innovative or for
which a centralized process is in the interest of patients, the centralized procedure is optional.
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Under the centralized procedure, the CHMP established at the EMA is responsible for conducting the
assessment of a product to define its risk/benefit profile. Under the centralized procedure, the maximum
timeframe for the evaluation of an MAA is 210 days, excluding clock stops when additional information or written
or oral explanation is to be provided by the applicant in response to questions from the CHMP. Accelerated
evaluation may be granted by the CHMP in exceptional cases, when a medicinal product is of major interest
from the point of view of public health determined by three cumulative criteria: (i) the seriousness of the disease
(e.g., heavy disabling or life-threatening diseases) to be treated, (ii) the absence or insufficiency of an
appropriate alternative therapeutic approach, and (iii) anticipation of high therapeutic benefit.
If the CHMP accepts such a request, the time limit of 210 days will be reduced to 150 days, but it is possible that
the CHMP may revert to the standard time limit for the centralized procedure if it determines that it is no longer
appropriate to conduct an accelerated assessment. The Committee for Advanced Therapies, or CAT, is
responsible in conjunction with the CHMP for the evaluation of ATMPs. The CAT is primarily responsible for the
scientific evaluation of ATMPs and prepares a draft opinion on the quality, safety and efficacy of each ATMP for
which a MAA is submitted. The CAT’s opinion is then taken into account by the CHMP when giving its final
recommendation regarding the authorization of a product in view of the balance of benefits and risks identified.
Although the CAT’s draft opinion is submitted to the CHMP for final approval, the CHMP may depart from the
draft opinion if it provides detailed scientific justification. The CHMP and CAT are also responsible for providing
guidelines on ATMPs and have published numerous guidelines, including specific guidelines on gene therapies
and cell therapies. These guidelines, which are not legally binding, provide additional guidance on the factors
that the EMA will consider in relation to the development and evaluation of ATMPs and include, inter alia, the
preclinical studies required to characterize ATMPs, the manufacturing and control information that should be
submitted in a MAA; and post-approval measures required to monitor patients and evaluate the long term
efficacy and potential adverse reactions of ATMPs.
The European Commission may grant a so-called “marketing authorization under exceptional circumstances.”
Such authorization is intended for products for which the applicant can demonstrate that it is unable to provide
comprehensive data on the efficacy and safety under normal conditions of use, because the indications for which
the product in question is intended are encountered so rarely that the applicant cannot reasonably be expected
to provide comprehensive evidence, or in the present state of scientific knowledge, comprehensive information
cannot be provided, or it would be contrary to generally accepted principles of medical ethics to collect such
information. Consequently, marketing authorization under exceptional circumstances may be granted subject to
certain specific obligations, which may include the following:
•
the applicant must complete an identified program of studies within a time period specified by the
competent authority, the results of which form the basis of a reassessment of the benefit/risk profile;
•
the medicinal product in question may be supplied on medical prescription only and may in certain cases
be administered only under strict medical supervision, possibly in a hospital, and in the case of a radio-
pharmaceutical, by an authorized person; and
•
the package leaflet and any medical information must draw the attention of the medical practitioner to
the fact that the particulars available concerning the medicinal product in question are as yet inadequate
in certain specified respects.
A marketing authorization under exceptional circumstances is subject to annual review to reassess the risk-
benefit balance in an annual re-assessment procedure. Continuation of the authorization is linked to the annual
reassessment and a negative assessment could potentially result in the marketing authorization being
suspended or revoked. The renewal of the marketing authorization of a medicinal product under exceptional
circumstances follows the same rules as a “normal” marketing authorization. After five years, the marketing
authorization will then be renewed under exceptional circumstances for an unlimited period, unless the EMA
decides, on justified grounds, to proceed with one additional five-year renewal.
The European Commission may also grant a so-called “conditional marketing authorization” prior to obtaining the
comprehensive clinical data required for an application for a full marketing authorization. Such conditional
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marketing authorizations may be granted for product candidates (including medicines designated as orphan
medicinal products and vaccines) if the CHMP finds that all the following requirements are met:
•
the benefit-risk balance of the product is positive;
•
it is likely that the applicant will be able to provide comprehensive data;
•
unmet medical needs will be fulfilled; and
•
the benefit to public health of the medicinal product’s immediate availability on the market outweighs the
risks due to need for further data.
A conditional marketing authorization will contain specific obligations to be fulfilled by the marketing authorization
holder, including obligations with respect to the completion of ongoing or new studies, manufacturing information
and with respect to the collection of pharmacovigilance data. Conditional marketing authorizations are valid for
one year, and may be renewed annually, if the risk-benefit balance remains positive, and after an assessment of
the need for additional or modified conditions and/or specific obligations. The timelines for the centralized
procedure described above also apply with respect to the review by the CHMP of applications for a conditional
marketing authorization. Once comprehensive data on the medicinal product have been obtained, the marketing
authorization may be converted into a standard marketing authorization which is no longer subject to specific
obligations. Initially, this is valid for five years, but can be renewed for unlimited validity.
During the COVID-19 pandemic, the EMA followed a “rolling review” process for COVID-19 vaccines, which is
an ad hoc procedure by which data is assessed as it becomes available with the aim of granting a conditional
marketing authorization.
The European Union medicines rules expressly permit the member states to adopt national legislation prohibiting
or restricting the sale, supply or use of any medicinal products containing, consisting of or derived from a specific
type of human or animal cell, such as embryonic stem cells.
Periods of Authorization and Renewals
A marketing authorization is valid for five years, in principle, and it may be renewed after five years on the basis
of a reevaluation of the risk benefit balance by the EMA or by the competent authority of the authorizing member
states. To that end, the marketing authorization holder must provide the EMA or the competent authority with a
consolidated version of the file in respect of quality, safety and efficacy, including all variations introduced since
the marketing authorization was granted, at least six months before the marketing authorization ceases to be
valid. Once renewed, the marketing authorization is valid for an unlimited period, unless the European
Commission or the competent authority decides, on justified grounds relating to pharmacovigilance, to proceed
with one additional five-year renewal period. Any authorization that is not followed by the placement of the
product on the European Union market (in the case of the centralized procedure) or on the market of
the
authorizing member state within three years after authorization ceases to be valid (referred to as the “sunset”
clause).
Emergency Use Distribution
The European Union medicines rules, as implemented into the national laws of the EU member states, permit
national authorities to authorize temporarily the distribution of an unapproved medicinal product in certain
emergency situations, including suspected or confirmed spread of pathogenic agents. Such an emergency use
distribution, or EUD (sometimes referred to as a “temporary exemption,” i.e., a temporary exemption from the
requirement to obtain a marketing authorization), would apply for the duration of the emergency only and would
be limited to the member state in which it has been issued. When considering whether to grant an EUD, the
relevant member state decides, which data it requires for the grant of the EUD. COVID-19 vaccines
to date
have
followed the centralized procedure, which was previously combined with a rolling review of data with a view to
granting conditional marketing
authorizations
.
Regulatory Requirements after Marketing Authorization
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Following approval, the holder of the marketing authorization is required to comply with a range of requirements
applicable to the manufacturing, marketing, promotion and sale of the medicinal product. These include
compliance with the European Union’s stringent pharmacovigilance or safety reporting rules, pursuant to which
post-authorization studies and additional monitoring obligations can be imposed. The holder of a marketing
authorization must establish and maintain a pharmacovigilance system and appoint an individual qualified
person for pharmacovigilance who is responsible for oversight of that system. Key obligations include expedited
reporting of suspected serious adverse reactions and submission of periodic safety update reports, or PSURs.
All new MAAs must include a risk management plan, or RMP, describing the risk management system that the
company will put in place and documenting measures to prevent or minimize the risks associated with the
product. The regulatory authorities may also impose specific obligations as a condition of the marketing
authorization. Such risk-minimization measures or post-authorization obligations may include additional safety
monitoring, more frequent submission of PSURs, or the conduct of additional clinical trials or post-authorization
safety or efficacy studies. RMPs and PSURs are routinely available to third parties requesting access, subject to
limited redactions.
In addition, the manufacturing of authorized products, for which a separate manufacturer’s license is mandatory,
must also be conducted in strict compliance with the EMA’s GMP requirements and comparable requirements of
other regulatory bodies in the European Union, which mandate the methods, facilities and controls used in the
manufacturing, processing and packing of products to assure their safety and identity. Specifically, medicinal
products may only be manufactured in the European Union, or imported into the European Union from another
country, by the holder of a manufacturing/import authorization from the competent national authority. The
manufacturer or importer must have a qualified person who is responsible for certifying that each batch of
product has been manufactured in accordance with European Union standards of good manufacturing practice,
or GMP, before releasing the product for commercial distribution in the European Union or for use in a clinical
trial. Manufacturing facilities are subject to periodic inspections by the competent authorities for compliance with
GMP.
Finally, the marketing and promotion of authorized products, including industry-sponsored continuing medical
education and advertising directed toward the prescribers of products and/or the general public, are strictly
regulated in the European Union. In principle, all advertising and promotional activities for the product must be
consistent with the approved summary of product characteristics, and therefore all off-label promotion is
prohibited. Direct-to-consumer advertising of prescription medicines (including vaccines) is also prohibited in the
European Union. Although general requirements for advertising and promotion of medicinal products are
established under Directive 2001/83/EC, as amended, the details and the enforcement of these rules are
governed by regulations in each member state and can differ from one country to another.
The enforcement actions and consequences for non-compliance with the EU legislation are similar to those
listed above for the United States. For centrally approved products in the EU, there is the possibility of fines for
regulatory non-compliance with certain of the legal requirements, including in relation to obligations regarding
placing the product on the market, safety monitoring and pediatric compliance.
Human Cells and Tissues
Human cells and tissues that are intended for human applications but that do not fall within the scope of rules
governing medicinal products or medical devices are not subject to premarket review and approval, nor do they
require extensive preclinical and clinical testing. However, there are European Union rules governing the
donation, procurement, testing and storage of human cells and tissues intended for human application, whether
or not they are ATMPs. These rules also cover the processing, preservation and distribution of human cell and
tissues that are not ATMPs. Establishments that conduct such activities must be licensed and are subject to
inspection by regulatory authorities. Such establishments must implement appropriate quality systems and
maintain appropriate records to ensure that cells and tissues can be traced from the donor to the recipient and
vice versa. There are also requirements to report serious adverse events and reactions linked to the quality and
safety of cells and tissues. More detailed rules may exist at the national level.
Named Patient Supplies and Compassionate Use Programs
The European Union medicines rules allow individual member states to permit the supply of a medicinal product
without a marketing authorization to fulfill special needs, where the product is supplied in response to a bona fide
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unsolicited order, formulated in accordance with the specifications of a healthcare professional and for use by an
individual patient under his direct personal responsibility. This may in certain countries also apply to products
manufactured in a country outside the European Union and imported to treat specific patients or small groups of
patients.
Some member state laws also provide for compassionate use on a “cohort” basis, subject to review and
approval of the cohort program based on the local laws in the member state.
Orphan Drug Designation and Exclusivity
Regulation (EC) No. 141/2000 and Regulation (EC) No. 847/2000 provide that a product can be designated as
an orphan drug by the European Commission if its sponsor can establish: that the product is intended for the
diagnosis, prevention or treatment of (i) a life-threatening or chronically debilitating condition affecting not more
than five in 10,000 persons in the European Union when the application is made, or (ii) a life-threatening,
seriously debilitating or serious and chronic condition in the European Union and that without incentives it is
unlikely that the marketing of the product in the European Union would generate sufficient return to justify the
necessary investment. For either of these conditions, the sponsor must demonstrate that there exists no
satisfactory method of diagnosis, prevention or treatment of the condition in question that has been authorized in
the European Union or, if such method exists, the product has to be of significant benefit compared to products
available for the condition.
An orphan drug designation provides a number of benefits, including fee reductions, regulatory assistance and
the possibility to apply for a centralized European Union marketing authorization. Marketing authorization for an
orphan drug leads to a 10-year period of orphan market exclusivity. During this orphan market exclusivity period,
neither the EMA nor the European Commission or the member states can accept an application or grant a
marketing authorization for a “similar medicinal product.” A “similar medicinal product” is defined as a medicinal
product containing a similar active substance or substances as contained in a currently authorized orphan
medicinal product, and which is intended for the same therapeutic indication. The market exclusivity period for
the authorized therapeutic indication may, however, be reduced to six years if, at the end of the fifth year, it is
established that the product no longer meets the criteria for orphan drug designation.
European Data Collection and Data Protection Laws
We are required to comply with strict data protection and privacy legislation in the jurisdictions in which we
operate, including the General Data Protection Regulation (EU) 2016/679, or GDPR. The GDPR governs our
collection and use of personal data in the European Union relating to individuals (e.g., patients). The GDPR
imposes several requirements on organizations that process such data, including: to observe core data
processing principles; to comply with various accountability measures; to provide more detailed information to
individuals about data processing activities; to establish a legal basis to process personal data (including
enhanced consent requirements); to maintain the integrity, security and confidentiality of personal data; and to
report personal data breaches. The GDPR also restricts the transfer of personal data outside of the European
Economic Area (e.g., to the United States and other countries that are not deemed to provide adequate
protection under their domestic laws). The GDPR may impose additional responsibility and liability in relation to
personal data that we process, and require us to put in place additional mechanisms ensuring compliance with
the new data protection rules. This may be onerous and adversely affect our business, financial condition, results
of operations and prospects. Failure to comply with the requirements of the GDPR and related national data
protection laws of European Union member states may result in a variety of enforcement measures, including
significant fines and other administrative measures. The GDPR has introduced substantial fines for breaches of
the data protection rules, increased powers for regulators, enhanced rights for individuals, and new rules on
judicial remedies and collective redress. We may be subject to claims by third parties, such as patients or
regulatory bodies, that we or our employees or independent contractors inadvertently or otherwise breached
GDPR and related data protection rules. Litigation may be necessary to defend against these claims. There is no
guarantee of success in defending these claims, and if we do not prevail, we could be required to pay substantial
fines and/or damages and could suffer significant reputational harm. Even if we are successful, litigation could
result in substantial cost and be a distraction to management and other employees.
C. Coverage, Pricing and Reimbursement
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Significant uncertainty exists as to the coverage and reimbursement status of any product candidates for which
we may obtain regulatory approval. Even if our product candidates are approved for marketing, sales of such
product candidates will depend, in part, on the extent to which third-party payors, including government health
programs in the United States (such as Medicare and Medicaid), commercial health insurers and managed care
organizations, provide coverage and establish adequate reimbursement levels for such product candidates. In
the United States, the member states of the European Union and markets in other countries, patients who are
prescribed treatments for their conditions and providers performing the prescribed services generally rely on
third-party payors to reimburse all or part of the associated healthcare costs. Reimbursement rules and levels
are not harmonized in the European Union and therefore differ from member state to member state. Patients are
unlikely to use any product candidates we may develop unless coverage is provided and reimbursement is
adequate to cover a significant portion of the cost of such product candidates. The process for determining
whether a payor will provide coverage for a product may be separate from the process for setting the price or
reimbursement rate that the payor will pay for the product once coverage is approved. Third-party payors are
increasingly challenging the price and examining the medical necessity and cost-effectiveness of medical
products and services and imposing controls to manage costs.
In order to secure coverage and reimbursement for any product that might be approved for sale, a company may
need to conduct expensive pharmacoeconomic studies in order to demonstrate the medical necessity and cost-
effectiveness of the product, and the cost of these studies would be in addition to the costs required to obtain
FDA or other comparable marketing approvals. Even after pharmacoeconomic studies are conducted, product
candidates may not be considered medically necessary or cost effective. A decision by a third-party payor not to
cover any product candidates we may develop could reduce physician utilization of such product candidates
once approved and have a material adverse effect on our sales, results of operations and financial condition.
Additionally, a payor’s decision to provide coverage for a product does not imply that an adequate
reimbursement rate will be approved. For example, the payor may require co-payments that patients find
unacceptably high. Further, one payor’s determination to provide coverage for a product does not assure that
such coverage will continue or that other payors will also provide coverage and reimbursement for the product,
and the level of coverage and reimbursement can differ significantly from payor to payor. Third-party
reimbursement and coverage may not be adequate to enable us to maintain price levels sufficient to realize an
appropriate return on our investment in product development. The insurance coverage and reimbursement
status of newly approved products for orphan diseases is particularly uncertain, and failure to obtain or maintain
adequate coverage and reimbursement for any such product candidates could limit a company’s ability to
generate revenue.
The containment of healthcare costs also has become a priority of U.S. federal and state and other non-U.S.
governments as well as other third-party payors such as statutory health insurance funds, and the prices of
pharmaceuticals have been a focus in this effort. Governments have shown significant interest in implementing
cost-containment programs, including price controls, restrictions on reimbursement and requirements for
substitution of generic products. Adoption of price controls and cost-containment measures, and adoption of
more restrictive policies in jurisdictions with existing controls and measures, could further limit a company’s
revenue from the sale of any approved products. Coverage policies and third-party reimbursement rates may
change at any time. Even if favorable coverage and reimbursement status is attained for one or more products
for which a company or its collaborators receive marketing approval, less favorable coverage policies and
reimbursement rates may be implemented or coverage may be ended in the future.
Outside the United States, we will face challenges in ensuring and obtaining adequate coverage and payment
for any product candidates we may develop. Pricing of prescription pharmaceuticals is subject to governmental
control in many countries, including in particular the member states of the European Union. Pricing negotiations
with governmental authorities or other third-party payors such as statutory health insurance funds can extend
well beyond the receipt of regulatory marketing approval for a product and may require us to conduct a clinical
trial or non-interventional study that compares the cost effectiveness of any product candidates we may develop
to other available therapies. The conduct of such a clinical trial or study could be expensive and result in delays
in our commercialization efforts.
In the European Union, pricing and reimbursement schemes vary widely from country to country. Some countries
provide that products may be marketed only after a reimbursement price has been agreed. Some countries may
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require the completion of additional studies that compare the cost effectiveness of a particular product candidate
to currently available therapies (so called health technology assessments) in order to obtain reimbursement or
pricing approval. The European Union recently adopted Regulation (EU) 2021/2282 on health technology
assessment, which provides a framework for member states to cooperate on health technology assessments at
the EU level. The Regulation is directly applicable in all EU member states which is in a phased period of
applicability since January 12, 2025, although pricing will still be determined nationally. Moreover, at the national
level, European Union member states may restrict the range of products for which their national health insurance
systems provide reimbursement and to control the prices of medicinal products for human use. Member states
may approve a specific price for a product or may instead adopt a system of direct or indirect controls on the
profitability of the company placing the product on the market. Other member states allow companies to fix their
own prices for products, but monitor and control prescription volumes and issue guidance to physicians to limit
prescriptions. Recently, many countries in the European Union have increased the amount of discounts required
on pharmaceuticals and these efforts could continue as countries attempt to manage healthcare expenditures,
especially in light of the severe fiscal and debt crises experienced by many countries in the European Union. The
downward pressure on health care costs in general, particularly prescription products, has become intense. As a
result, increasingly high barriers are being erected to the entry of new products in the marketplace. Political,
economic and regulatory developments may further complicate pricing negotiations, and pricing negotiations
may continue after reimbursement has been obtained. Reference pricing used by various European Union
member states and parallel trade (arbitrage between low-priced and high-priced member states) can further
reduce prices. Special pricing and reimbursement rules may apply to orphan drugs. Inclusion of orphan drugs in
reimbursement systems tend to focus on the medical usefulness, need, quality and economic benefits to patients
and the healthcare system as for any product. Acceptance of any medicinal product for reimbursement may
come with cost, use and often volume restrictions, which again can vary by country. In addition, results-based
rules of reimbursement may apply. There can be no assurance that any country that has price controls or
reimbursement limitations for pharmaceutical products will allow favorable reimbursement and pricing
arrangements for any of our products, if approved in those countries.
For COVID-19 vaccine candidates in the European Union, no pricing and reimbursement or health technology
assessments discussions have taken place with the respective health insurances and competent bodies at a
national member state level. Currently, COVID-19 vaccine candidates are supplied in the European Union based
on vaccine supply agreements with the European Commission that is acting on behalf and in the name of the
member states of the European Union.
D. United Kingdom
On June 23, 2016, in a national referendum, a majority of the electorate voted in favor of the United Kingdom
leaving the European Union (commonly referred to as “Brexit”). On March 29, 2017, the United Kingdom
Government formally notified the European Union of its intention to withdraw from the Union pursuant to Article
50 of the Treaty on the European Union. The United Kingdom formally left the European Union on January 31,
2020, with all applicable EU law, including the regulation of medicinal products, applying to and in the United
Kingdom for a transitional period, which has now expired. The United Kingdom and the European Union have
reached agreement on the terms of their future relationship in the Trade and Cooperation Agreement, or the
TCA, which formally entered into force on May 1, 2021. While the TCA governs tariff and quota free trade
between the United Kingdom and the European Union markets, it does not provide for regulatory alignment. The
regulatory framework for medicinal products in the United Kingdom is predominantly derived from European
Union law. The UK currently offers different routes to obtain a marketing authorization: (a) a national application
route with a 150-day assessment timeline, excluding clock stops or (b) an international recognition route by
which a company relies on a positive CHMP opinion or an approval granted by another reference regulator,
including the FDA and the Japanese PDMA. The international recognition procedure takes 60 days with no clock
stops for simpler applications that were approved by the reference regulator within the past two years and 110
days with the possibility of a clock stop for all other eligible applications.
Domestic United Kingdom law provided that all existing European Union law in force on December 31, 2020 was
retained in UK national law, subject to certain revisions that became necessary as a result of Brexit.
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However, the Retained EU Law (Revocation and Reform) Act 2023 came into force on January 1, 2024. This
revoked some retained EU laws (although not any relating to medicines regulation). All other retained EU laws
have been renamed as “assimilated laws” and are no longer subject to the EU principles of interpretation. Thus,
while at least initially the United Kingdom and the European Union laws relating to medicines are largely aligned,
there is the potential for further divergence in the future.
Under the terms of the Northern Ireland Protocol to the Withdrawal Agreement, European Union law governing
medicinal products continued to apply to and in Northern Ireland resulting in the potential for separate marketing
authorizations in Great Britain and Northern Ireland. In March 2023, the Northern Ireland Protocol was adjusted
by the Windsor Framework, which is another post-Brexit agreement between the EU and the UK. The Windsor
Framework aims to make it easier to move certain goods, including medicines, from Great Britain to Northern
Ireland.
Beginning January 1, 2025, medicines for supply in the UK are now authorized UK-wide by the
Medicines and Healthcare products Regulatory Agency (MHRA) only and companies can no longer apply for, or
maintain, separate licenses for Great Britain and Northern Ireland to market new medicines. Other key changes
introduced by the Windsor Framework include removing the requirements of the EU Falsified Medicines
Directive (FMD) from products intended for Northern Ireland and a requirement that all medicines placed on the
UK market be labeled “UK Only.”
E. Greater
China
Mainland China
Similar to the United States and the European Union, Mainland China has rules governing the approval for
development and commercialization of drugs, including specialized rules for vaccines. China’s drug law and
regulations require that the National Medical Products Administration’s, or NMPA’s, Center for Drug Evaluation,
or CDE, approve a clinical trial application prior to initiating a study to support the safety and effectiveness of a
drug, including a therapeutic or preventive biologic (i.e., a vaccine). This clinical trial application generally takes
approximately 60 business days but may be expedited in the case of innovative drugs studied at certain
approved sites in China.
Once approved, vaccine clinical trials must be conducted at sites that are qualified disease prevention and
control, or CDC, institutions and grade III hospitals, and the implementation of the trial must be in accordance
with China’s general drug and specialized vaccine good clinical practice regulations and related guidelines.
Other drug trials must be conducted at designated hospital sites in accordance with China’s general drug good
clinical practice rules. Furthermore, prior to the commencement of the clinical trial in China each site’s ethics
committee must approve the trial, and the National Health Commission must approve the use of human samples
containing genetic material and related genetic data. The human genetic resources, or HGR, approval requires a
joint approval or record-filing application by the Chinese and foreign parties, setting forth the parties that will
handle data and samples, the type and amount of samples that will be utilized during the study, the tests/
analysis run, and the plans for storage or destruction, and potentially the intellectual property sharing
arrangement among the parties, among other items. If the research is exploratory (i.e., not tied to a program
designed to obtain registration in China), patentable IP arising from the use of the HGR samples and data must
be jointly owned by the Chinese and foreign parties. Once approved, the HGR approval/filing may require
updates and amendments and additional procedures to transfer data to foreign parties that are not on the
approval. A final report is due at the end of the study.
Once a clinical trial in China is complete and/or foreign data is assembled, a company may submit an application
for a marketing authorization, or MA, of the drug. This procedure will include submission of clinical data,
manufacturing information and test results, among other items, and may include an onsite pre-market verification
by the NMPA. This application may be considered more quickly if the applicant qualifies for admission to various
expedited programs, including breakthrough designation for drugs that are new to the world in some respect,
treat life threatening or quality of life altering diseases and either have no comparator on the market or represent
a significant clinical advantage over existing approved therapies. Conditional approval procedures permit
approval of a drug based on earlier stage data, but subject continued marketing to the fulfillment of post-market
conditions with a designation period of time, such as the completion of additional studies. Therapeutic biologics
and small molecule drugs follow similar steps to approval for development and marketing. These steps are
similar for drugs that are imported and those that are produced domestically in China. However, domestically
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produced drugs must be produced at a facility that also obtains a drug manufacturing license based, in part, on a
pre-marketing good manufacturing practice inspection.
At both the clinical trial and MA stages, applicants for imported drugs must list a regulatory agent on the
application. The agent must be an entity in China. The imported drug MA holder must also make a filing to a
provincial level government appointing a responsible person, which is an entity that assists the marketing
authorization holder, or MAH, with fulfilling its post-market drug regulatory obligations in China. The responsible
person of the MAH is jointly liable with the MAH for these drug regulatory obligations.
Once approved, vaccines may be procured by the CDC through platforms organized by the provincial
governments. Vaccines in China must be sold and directly distributed by domestic manufacturers or general
distributors appointed to represent overseas makers to municipal level CDCs, which handle allocation and
distribution to points of vaccination in China. Distribution of other drugs occurs through procurement processes
for sales at public hospitals and sales to private hospitals or pharmacies. Distributors of all drugs must possess a
MA for the drug they are distributing or a drug distribution license.
As is the case with all drugs, once on the market, MAHs will also have post-market obligations, including
fulfillment of post-marketing commitments. In the case of vaccines, MAHs must pay compensation for injuries
caused adverse events following inoculation, or AEFIs, if the vaccine is not one required as part of the National
Inoculation Program. The government bears the cost of NIP vaccines and related AEFIs. All drug MAHs are
subject to other post-market obligations for drug marketing authorization holders, including recalls, annual
reporting, and inspections. All drug MAs must be renewed every five years, and supplemental applications,
notifications, or reports may need to be submitted for major, moderate and minor changes, respectively, to the
original registration (e.g., significant manufacturing changes).
Advertisements of prescription drugs, including vaccines, must be pre-approved and may only be placed in
approved medical journals. Other forms of “academic promotion” may be performed by medical representatives
who are authorized in writing by MAHs (or their agents) and their information filed on government designated
websites. Currently, medical representatives are permitted to provide information about the drug to health care
professionals (in accordance with certain procedural rules) and collect feedback as to drug safety, although a
proposed revision to this rule may further restrict the activities of the medical representatives.
Hong Kong and Macao
Mainland China’s drug regulatory system does not apply in Hong Kong or Macao. These administrative regions
are governed by separate laws on the development, approval, manufacturing, distribution and advertising and
promotion of drugs, including vaccines. Similar rules restricting advertising and promotional content and, in the
case of Macao, government approved advertisements, also apply.
F.
Türkiye
Other countries such as Türkiye and those in the Middle East have regulatory review processes and data
requirements for medicinal products, including vaccines, similar to those described for the European Union. The
regulatory licensing process in these countries may include local marketing authorization requirements,
manufacturing/testing facility inspections, testing of drug product upon importation and other domestic
requirements. Some countries, such as Türkiye, have introduced specific emergency authorization regimes for
COVID-19 vaccines.
G. Rest of the World Regulation
The requirements governing the conduct of clinical trials, product (including vaccine) licensing, pricing, and
reimbursement vary from country to country in markets outside the European Union and the United States. In
many markets, clinical trials must be conducted in accordance with Good Clinical Practice and applicable
regulatory requirements. Ethical standards typically follow the Declaration of Helsinki principles. In response to
the COVID-19 pandemic, some markets have granted or are considering the grant of emergency use
authorizations for vaccine candidates instead of the otherwise available regulatory approval pathways. Supply of
the COVID-19 vaccine to a number of countries outside of the United States and the European Union is similarly
governed by vaccine supply agreements with local governments.
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In Africa, there is limited harmonization of the regulation of drug and biological products across the continent,
and the functionality and regulatory capacity of national medicines regulatory authorities varies between
jurisdictions. For example, many regulators lack the technical expertise to independently assess marketing
authorization applications and instead have adopted “reliance” procedures, whereby authorization by a foreign
stringent regulatory authority or registration as a WHO pre-qualified product may be a condition for approval. The
African Union (“AU”) has issued several harmonization initiatives for medicines, including adopting the AU Model
Law on Medical Products Regulation in 2016 and establishing the African Medicines Agency, or AMA, in 2019.
The AMA’s responsibilities will include evaluating medicines for the treatment of priority diseases, among other
harmonization-related responsibilities, but has yet to issue any regulatory guidelines or procedures to date.
Failure to adhere to regulatory requirements may lead to, among others, fines, suspension or withdrawal of
regulatory authorizations or approvals, product recalls, seizure of products, restrictions or suspensions of
operations, or criminal prosecution.
H. Healthcare Law and Regulation
Healthcare providers and third-party payors play a primary role in the recommendation and prescription of
pharmaceutical products that are granted marketing approval. Our current and future arrangements with
providers, researchers, consultants, third-party payors and customers are subject to broadly applicable federal
and state fraud and abuse, anti-kickback, false claims, transparency and patient privacy laws and regulations
and other healthcare laws and regulations that may constrain our business and/or financial arrangements.
Restrictions under applicable federal and state healthcare laws and regulations in the United States and
elsewhere include, without limitation, the following:
•
the U.S. federal Anti-Kickback Statute, which prohibits, among other things, persons and entities from
knowingly and willfully soliciting, receiving, offering or paying remuneration, directly or indirectly, in-cash
or in kind, to induce or reward either the referral of an individual for, or the purchase, order or
recommendation of, any good or service, for which payment may be made, in whole or in part, under a
federal healthcare program such as Medicare and Medicaid. A person or entity does not need to have
actual knowledge of the statute or a specific intent to violate it in order to have committed a violation.
Moreover, the government may assert that a claim that includes items or services resulting from a
violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the
civil False Claims Act;
•
the U.S. federal civil and criminal false claims laws, including the civil False Claims Act, and civil
monetary penalties laws, which prohibit individuals or entities from, among other things, knowingly
presenting, or causing to be presented, to the federal government, claims for payment that are false,
fictitious, or fraudulent or knowingly making, using, or causing to be made or used a false record or
statement to avoid, decrease, or conceal an obligation to pay money to the federal government;
•
HIPAA, which created additional U.S. federal criminal laws that prohibit, among other things, knowingly
and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program or
making false statements relating to healthcare matters. Similar to the federal Anti-Kickback Statute, a
person or entity does not need to have actual knowledge of the statute or a specific intent to violate it in
order to have committed a violation;
•
HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, and
their respective implementing regulations, including the Final Omnibus Rule published in January 2013,
which impose obligations, including mandatory contractual terms, with respect to safeguarding the
privacy, security and transmission of individually identifiable health information without the appropriate
authorization by entities subject to the law, such as healthcare providers, health plans and healthcare
clearinghouses and their respective business associates;
•
the U.S. federal transparency requirements, known as the federal Physician Payments Sunshine Act,
under the ACA, which requires certain manufacturers of drugs, devices, biologics and medical supplies
to report annually to the Centers for Medicare & Medicaid Services, or CMS, within the U.S. Department
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of Health and Human Services, information related to payments and other transfers of value made by
that entity to physicians and teaching hospitals, as well as ownership and investment interests held by
physicians and their immediate family members;
•
U.S. federal consumer protection and unfair competition laws, which broadly regulate marketplace
activities and activities that potentially harm consumers;
•
U.S. federal government price reporting laws, which require us to calculate and report complex pricing
metrics to government programs and which may be used in the calculation of reimbursement and/or
discounts on marketed products;
•
the Foreign Corrupt Practices Act, a U.S. law which regulates certain financial relationships with foreign
government officials (which could include, for example, certain medical professionals);
•
the national anti-bribery laws and laws governing interactions with healthcare professionals of European
Union member states;
•
the U.K. Bribery Act 2010; and
•
analogous laws and regulations in U.S. states and other jurisdictions, such as U.S. state anti-kickback
and false claims laws, which may apply to healthcare items or services that are reimbursed by non-
governmental third-party payors, including private insurers.
Some U.S. state laws require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary
compliance guidelines and the relevant compliance guidance promulgated by the federal government in addition
to requiring pharmaceutical manufacturers to report information related to payments to physicians and other
health care providers or marketing expenditures and pricing information. Laws in U.S. states and other
jurisdictions also govern the privacy and security of health information in some circumstances, many of which
differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance
efforts.
The scope and enforcement of each of these laws is uncertain and subject to rapid change in the current
environment of healthcare reform, especially in light of the lack of applicable precedent and regulations. U.S.
federal and state enforcement bodies have recently increased their scrutiny of interactions between healthcare
companies and healthcare providers, which has led to a number of investigations, prosecutions, convictions and
settlements in the healthcare industry.
Violations of these laws can subject us to criminal, civil and administrative sanctions including monetary
penalties, damages, fines, disgorgement, individual imprisonment and exclusion from participation in
government funded healthcare programs, such as Medicare and Medicaid, additional reporting requirements and
oversight if we become subject to a corporate integrity agreement or similar agreement to resolve allegations of
non-compliance with these laws, reputational harm, and we may be required to curtail or restructure our
operations. If any of the physicians or other healthcare providers or entities with whom we expect to do business
is found to be not in compliance with applicable laws, they may be subject to similar actions, penalties, and
sanctions. Ensuring business arrangements comply with applicable healthcare laws, as well as responding to
possible investigations by government authorities, can be time- and resource-consuming and can divert a
company’s attention from the business. Moreover, we expect that there will continue to be federal and state laws
and regulations, proposed and implemented, that could impact our future operations and business.
I. Current and Future Healthcare Reform Legislation
In the United States and other jurisdictions, there have been a number of legislative and regulatory changes and
proposed changes regarding the healthcare system that could prevent or delay marketing approval of our
product candidates, restrict or regulate post-approval activities, and affect our ability to profitably sell any product
candidates for which we obtain marketing approval. We expect that current laws, as well as other healthcare
reform measures that may be adopted in the future, may result in more rigorous coverage criteria and in
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additional downward pressure on the price that we, or any collaborators, may receive for any approved products.
The incoming new United States presidential administration may seek to pursue different or additional
approaches to drug pricing and reimbursement or could seek additional legislation affecting drug pricing, either
of which could affect future profitability.
Additionally, other federal health reform measures have been proposed and adopted in the United States since
the ACA was enacted:
•
The American Taxpayer Relief Act of 2012, among other things, reduced Medicare payments to several
providers, and increased the statute of limitations period for the government to recover overpayments to
providers from three to five years.
•
The Middle Class Tax Relief and Job Creation Act of 2012 required that CMS reduce the Medicare
clinical laboratory fee schedule by 2% in 2013, which served as a base for 2014 and subsequent years.
In addition, effective January 1, 2014, CMS also began bundling the Medicare payments for certain
laboratory tests ordered while a patient received services in a hospital outpatient setting.
Further, there has been heightened governmental scrutiny in the United States and elsewhere over the manner
in which manufacturers set prices for their marketed products, which have resulted in several recent
Congressional inquiries and proposed bills designed to, among other things, bring more transparency to product
pricing, review the relationship between pricing and manufacturer patient programs, and reform government
program reimbursement methodologies for products. In addition, the U.S. federal government, state legislatures,
and other governments have shown significant interest in implementing cost containment programs, including
price-controls, restrictions on reimbursement, and requirements for substitution of generic products for branded
prescription drugs to limit the growth of government-paid health care costs. For example, the U.S. federal
government has passed legislation requiring pharmaceutical manufacturers to provide rebates and discounts to
certain entities and governmental payors to participate in federal healthcare programs. Individual states in the
United States have also become increasingly aggressive in passing legislation and implementing regulations
designed to control pharmaceutical and biological product pricing, including price or patient reimbursement
constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency
measures, and, in some cases, designed to encourage importation, from other countries and bulk purchasing.
J. Packaging and Distribution in the United States and Other Jurisdictions
If our products are made available to authorized users of the Federal Supply Schedule of the General Services
Administration, additional laws and requirements apply in the United States (and similar laws may apply in other
jurisdictions). Products must meet applicable child-resistant packaging requirements under the U.S. Poison
Prevention Packaging Act. Manufacturing, sales, promotion and other activities also are potentially subject to
federal and state consumer protection and unfair competition laws.
The distribution of pharmaceutical products is subject to additional requirements and regulations, including
extensive record-keeping, licensing, storage and security requirements intended to prevent the unauthorized
sale of pharmaceutical products.
The failure to comply with any of these laws or regulatory requirements subjects firms to possible legal or
regulatory action. Depending on the circumstances, failure to meet applicable regulatory requirements can result
in criminal prosecution, fines or other penalties, injunctions, exclusion from federal healthcare programs,
requests for recall, seizure of products, total or partial suspension of production, denial or withdrawal of product
approvals, or refusal to allow a firm to enter into supply contracts, including government contracts. Any action
against us for violation of these laws, even if we successfully defend against it, could cause us to incur
significant legal expenses and divert our management’s attention from the operation of our business.
Prohibitions or restrictions on sales or withdrawal of future products marketed by us could materially affect our
business in an adverse way.
Changes in regulations, statutes, or the interpretation of existing regulations could impact our business in the
future by requiring, for example, (i) changes to our manufacturing arrangements, (ii) additions or modifications to
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product labeling, (iii) the recall or discontinuation of our products or (iv) additional record-keeping requirements.
If any such changes were to be imposed, they could adversely affect the operation of our business.
K. Other Environmental, Health and Safety Laws and Regulations
In the United States, the European Union and other jurisdictions, we may be subject to numerous environmental,
health and safety laws and regulations, including those governing laboratory procedures and the handling, use,
storage, treatment and disposal of hazardous materials and wastes. From time to time and in the future, our
operations may involve the use of hazardous and flammable materials, including chemicals and biological
materials, and may also produce hazardous waste products. Even if we contract with third parties for the
disposal of these materials and waste products, we cannot completely eliminate the risk of contamination or
injury resulting from these materials. In the event of contamination or injury resulting from the use or disposal of
our hazardous materials, we could be held liable for any resulting damages, and any liability could exceed our
resources. We also could incur significant costs associated with civil or criminal fines and penalties for failure to
comply with such laws and regulations.
We maintain workers’ compensation employers’ liability insurance to cover us for costs and expenses we may
incur due to injuries to our employees, but this insurance may not provide adequate coverage against potential
liabilities.
In addition, we may incur substantial costs in order to comply with current or future environmental, health and
safety laws and regulations. Current or future environmental laws and regulations may impair our research,
development or production efforts. In addition, failure to comply with these laws and regulations may result in
substantial fines, penalties or other sanctions.
L. Regulation of Artificial Intelligence Systems and Models
Government authorities in the United States at the federal, state and local levels have been actively engaged in
advancing policy frameworks, guidance documents, discussion papers, standards, and proposed legislation
regarding the development and use of AI by life sciences companies and, where applicable, applying existing
regulatory frameworks (e.g., FDA regulations) to particular uses of AI. Likewise, the EU and other countries and
jurisdictions extensively regulate (or intend to extensively regulate) the development and use of AI systems and
models. The processes for monitoring emerging regulatory frameworks, evaluating how current and emerging
requirements for AI apply to our business, along with subsequent compliance with applicable requirements and
best practices, require the expenditure of substantial time and financial resources.
A biotech company could use AI in a number of different contexts. For example, it may use AI in the medicines
lifecycle for drug discovery, for non-clinical research and development, for data analysis in clinical trials and
analysis of real world data, for precision medicine (e.g., clinical decision support), for supporting clinical trial
design or assessing patient eligibility for clinical trials, for drafting medicinal product information documents, in
the manufacturing of medicinal products and in machinery, or to assist with post-authorization safety monitoring,
among other potential uses. If the AI is intended to perform a regulated activity (such as related to drug
manufacturing, release testing, or producing clinical/diagnostic outputs) or otherwise be used in operations that
are the subject of scrutiny by health authorities, the use of AI could trigger health authority oversight and, in
some cases, application of existing laws and regulations relevant to healthcare, pharmaceuticals, and/or medical
devices or sector-agnostic AI laws and regulations.
Outside the drug development and commercialization context, a biotech company may use AI for other
operational reasons. For example, a company may have plans to use automated personnel recruitment tools,
deploy facial recognition technology to ensure security of its services, use customer service chatbots, or allow its
employees to use generative AI or general-purpose AI tools to increase the efficiencies of administrative tasks.
A company will need to identify how it uses AI in its business operations, and identify the relevant applicable
regulatory regime that applies to ensure compliance. Failure to adhere to (or remain up to date with evolving)
regulatory requirements may lead to compliance actions, penalties and other risks.
United States
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In the United States, Congress, the White House, various federal agencies, and states have advanced proposed
AI legislation, policy frameworks, guidance documents, whitepapers, and governing principles to address the use
of AI, including when used in healthcare and life sciences. Of particular relevance to biotech companies, the FDA
has been adapting and applying existing regulatory frameworks to account for AI and has issued guidance,
discussion papers, and frameworks outlining FDA’s approach to regulation and oversight of health-related uses
of AI.
To
date, FDA has not issued a new regulatory framework specific to AI; rather, it has been applying its
existing regulations for drug and biologic discovery, development, clinical testing and manufacturing to
companies utilizing AI in these processes, such that companies seeking to incorporate AI into processes that are
subject to FDA oversight need to demonstrate compliance with the existing regulations for drug and biologic
sponsors. In this context, FDA issued two discussion papers on the use of AI in drug manufacturing (March
2023) and the development of drug and biological products (May 2023), and hosted a related public workshop in
August 2024. Following feedback on the discussion papers and the workshop, in January 2025, FDA issued its
first draft guidance document regarding uses of AI in drug development and other parts of the drug lifecycle,
entitled “Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and
Biological Products.” AI to support regulatory decision-making, within the scope of the draft guidance, includes AI
intended to support regulatory determinations made by FDA (e.g., with respect to safety or effectiveness of a
drug in a New Drug Application)
and
to support actions taken by sponsors in conformance with FDA’s regulatory
authority (e.g., current good manufacturing practices, post-marketing requirements, and INDs). The draft
guidance proposes a seven-step risk-based framework for assessing the risk and credibility of AI models
intended to support regulatory decision-making to determine whether the AI model is adequate for a specific use,
and describes the associated documentation FDA may expect to review in an application or during an inspection.
FDA also actively regulates some health-related AI as “software as a medical device,” or SaMD, under FDA’s
existing medical device frameworks and has issued guidance describing specific regulatory considerations that
may apply to AI-based SaMD. Most recently, FDA issued draft guidance in January 2025 on lifecycle
management and marketing submission recommendations for AI-enabled device software functions, and hosted
its inaugural Digital Health Advisory Committee meeting in November 2024 to discuss total product lifecycle
considerations for generative AI-enabled devices.
Additionally, at the executive level, the Trump Administration revoked a Biden Administration Executive Order on
the Safe, Secure, and Trustworthy Development of Artificial Intelligence that Order contained a number of
directives that would have impacted the life sciences sector, including directives to HHS to establish an AI “Task
Force” responsible for issuing guidance on a number of AI topics (such as long-term safety and real-world
performance monitoring, predictive and generative AI, equity principles, and privacy and security standards),
develop a strategy for regulating the use of AI in drug development processes, develop an “AI assurance policy”
to evaluate the performance of AI-enabled healthcare tools, and establish a common framework for capturing
clinical errors resulting from AI deployed in healthcare settings. The Trump Administration issued a new
Executive Order in January 2025 on Removing Barriers to American Leadership in Artificial Intelligence that
established a policy of “global AI dominance” and directed entities to suspend, revise, or rescind any actions
taken under the Biden Administration Executive Order that are inconsistent with this policy.
Members of Congress also have introduced a number of bills on AI regulation and frameworks for regulating AI.
For example, the Bipartisan House AI Task Force released an AI report in December 2024 and the Bipartisan
Senate AI Working Group released a roadmap for AI policy in May 2024, both of which included sections on
policy recommendations for AI in health care. Senator Bill Cassidy (R-LA), who now chairs the Senate Health,
Education, Labor, and Pensions Committee, also released a whitepaper on the “Framework for the Future of AI”
in September 2023 that disfavored a “one-size-fits-all” approach to AI regulation and instead called for a flexible
approach that takes into account the context of use and leverages existing frameworks.
U.S. state legislatures also have actively pursued AI legislation. For example, the Colorado AI Act imposes
requirements for developers and deployers of certain high-risk AI systems, and other laws will require notice or
disclosures for certain uses of generative AI or other AI systems. In addition to proposed and passed legislation,
regulators have sought to apply existing legal authorities to AI systems, including in the life sciences sector. For
example, the California Attorney General issued a legal advisory providing guidance to healthcare providers,
vendors, investors, and other healthcare entities that develop, sell, and use AI systems and similar technologies.
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The advisory advised entities on their obligations under existing California law and described certain health-
related uses of AI or marketing practices that might be unlawful.
We continue to monitor developments in the regulation of AI in drug and biologic development and
commercialization, or for more general business practices, and to assess the applicability of these evolving
frameworks and policies as well as existing legal frameworks that apply to our uses of AI. If we fail to meet
regulator expectations or comply with applicable requirements, that could impact our ability to utilize AI-related
processes or information in our development of product candidates or could subject us to delays, penalties or
other risks.
European Union
The EU Artificial Intelligence Act, or the EU AI Act, entered into force on August 1, 2024. It establishes
rules
governing certain AI systems and general-purpose AI models that apply across the EU. It applies to various
actors along the AI value chain, including “providers” and “deployers” of AI systems classified as “high-risk,”
“providers” of general-purpose AI models, and “providers” of general-purpose AI models with “systemic risk.” It
also prohibits certain AI practices and imposes transparency requirements in relation to certain AI systems and
general-purpose AI models.
The EU AI Act sets out a transition period of two years (by August 2026) for most provisions, with the following
exceptions: (i) the provisions relating to prohibited AI practices and AI literacy apply after six months (by
February 2025); (ii) the provisions relating to general-purpose AI models and the AI Act’s governance framework
apply after one year (by August 2025); and (iii) the provisions relating to high-risk AI systems that are used as
safety components of products or are themselves products regulated by certain EU harmonization legislation
(e.g., machinery, medical devices) requiring third-party conformity assessments apply after three years (by
August 2027).
The EU AI Act applies to providers, located in or outside the EU, that place on the market or put into service AI
systems in the EU, or that place on the market general-purpose AI models in the EU. It also applies to deployers
of AI systems located or established in the EU, and to providers or deployers located or established outside the
EU where the output of the system is used in the EU. Whether a biotech company incurs obligations under the
EU AI Act depends on whether it develops, offers, or uses any AI systems or general-purpose AI models;
whether it qualifies as a “provider,” “deployer,” or other regulated actor; and the jurisdiction where the system is
put into service, where the system or model is placed on the market, or where the output of a system is used.
Providers and deployers of “high-risk AI systems” will need to comply with numerous obligations that apply to
such systems. The obligations for providers and deployers differ, with the majority of obligations falling to
providers. The EU AI Act also contemplates circumstances where a deployer or other third-party must assume
the obligations of the provider, e.g., where the third-party makes a substantial modification to a high-risk AI
system that has already been placed on the market or put into service, but where the modified system remains
high risk. The EU AI Act sets out an exhaustive list of “high-risk AI systems” in Annexes I and III. The categories
of such systems that might be relevant to offerings of biotech companies include products that require a notified
body conformity assessment under the EU Medical Devices Regulation 2017/745 or EU In Vitro Diagnostic
Medical Devices Regulation 2017/746.
The EU AI Act imposes a separate set of obligations on providers of “general-purpose AI models” and an
additional set of obligations on providers of “general-purpose AI models with systemic risk.” The European
Commission will designate general-purpose AI models that have “high-impact capabilities” as models with
“systemic risk.” Providers of general-purpose AI models—with or without “systemic risk”— must comply with
certain obligations, including to draw up technical documentation about the general-purpose AI model,
implement a copyright policy to comply with EU copyright laws, and make available a summary of the content
used to train the model. Additional obligations apply to providers of general-purpose AI models with systemic
risk, including, for example, to perform model evaluation (such as adversarial testing) and to report serious
incidents to the European Commission’s AI Office. Whether these obligations apply to a biotech company will
depend on whether it develops any general-purpose AI models (or have them developed on its behalf) and
places them on the market in the EU. If so, it will need to comply with the obligations that apply to all general-
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purpose AI models and assess whether any of these models could qualify as general-purpose AI models with
systemic risk, which would require it to comply with additional obligations.
Of particular relevance to the biotech industry, the EMA has published a reflection paper on the use of AI
(September 2024), which is aimed at biopharmaceutical companies intending to use AI in the lifecycle of their
medicines, including for drug discovery, design, and development. It also covers the use of medical devices with
AI/machine-learning (ML) technology that are used to generate data or other evidence to support an EU
marketing authorization for a medicine (i.e., used within the context of clinical trials or combined with the use of a
medicine). The EMA’s view of “high patient risk” or “high regulatory impact” that AI can have differs from the
classifications used in the EU AI Act. This requires biotech companies to assess whether the use of AI could
affect patient safety (“high patient risk”) or impact regulatory decision-making (“high regulatory impact”) for the
purpose of the EU medicines rules. This means that potentially, non-high-risk AI under the EU AI Act could still
be relevant to the EMA if it impacts patient safety or evidence generation for a medicine subject to regulatory
approval. The EMA guidance puts the onus on marketing authorization applicants/marketing authorization
holders to ensure AI used during the medicines lifecycle is compliant with the medicines rules. If a biotech
company intends to use AI in the context of its medicines it will need to carry out a regulatory impact and risk
analysis and potentially discuss use cases with the EMA, including when there is no clearly written guidance
available.
Failure to adhere to (or remain up to date with evolving) EU regulatory requirements may lead to delays,
compliance risks, and penalties.
Rest of World
Outside the United States and EU, the requirements governing the use and deployment of AI may vary from
country to country, though health regulators have taken some steps toward international harmonization on AI
best practices. For example, FDA, UK MHRA, and Health Canada have issued joint guiding principles on topics
such as good machine learning practices and transparency for ML-enabled devices. A company will need to
identify how it uses AI in its business operations, and identify the relevant applicable regulatory regime that
applies to ensure compliance. Failure to adhere to (or remain up to date with evolving) regulatory requirements
may lead to delays, compliance risks, and penalties.
XI. Intellectual Property
A.
Introduction
We pursue a layered intellectual property strategy to protect our various technology platforms and their
application to the treatment of serious diseases, such as cancer and infectious diseases including COVID-19.
One focus of our intellectual property strategy is to provide protection for our platforms and products as they are
developed. We also pursue intellectual property protection for assets that may be used in future development
programs, may be of interest to our collaborators, and/or otherwise may prove valuable in the field.
Various aspects of our technology platforms and our product candidates are claimed in patent filings. We also
pursue other modalities of intellectual property protection, including trademark and trade secret protection, as
appropriate. Many of our intellectual property assets were developed and are owned solely by us, some have
been developed via collaboration and are jointly owned, and some have been acquired by acquisition and/or
licensed from third parties. We expect that we will continue to make additional patent application filings, and will
continue to pursue opportunities to acquire and license additional intellectual property assets, technologies,
platforms and/or product candidates, as developments arise or are identified.
Regardless, we cannot be certain that any of the patent filings or other intellectual property rights that we have
pursued or obtained will provide protection for any products as commercialized. The original version of our
Comirnaty
COVID-19 vaccine product, our Omicron XBB.1.5-adapted monovalent COVID-19 vaccine, our
bivalent version (Original and Omicron BA.4/BA.5), and our Omicron KP.2-adapted monovalent vaccine have
been approved by the FDA in the United States for individuals 12 and older. In addition, both the original version
of our
Comirnaty
COVID-19 vaccine product, our Omicron XBB.1.5-adapted monovalent COVID-19
vaccine,
our
bivalent vaccine, and our Omicron KP.2-adapted monovalent vaccine were also authorized by the FDA in the
United States under EUA for individuals 6 months to <12 years old. As further variants of SARS-CoV-2 arise, and
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its impact and characteristics evolve, the composition, manufacture, and use (including, e.g., dosage regimen) of
our COVID-19 vaccine products may be adjusted or modified and our filings may not protect them. Our other
product candidates are currently in clinical testing, with no certainty that they will be successful, or that significant
modification or adjustment may not be required for successful commercialization.
Our future commercial success depends, in part, on our ability to obtain and maintain patent and other
proprietary protection for commercially important technology, inventions and know-how related to our business;
defend and enforce our patents and other intellectual property; preserve the confidentiality of our trade secrets;
and operate without infringing, misappropriating or violating the valid and enforceable patents and other
intellectual property rights of third parties. Our ability to stop third parties from making, using, selling, offering to
sell or importing our products may depend on the extent to which we have rights under valid and enforceable
patents, trade secrets or other intellectual property rights that cover these activities. With respect to both our
owned and licensed intellectual property, we cannot be sure that patents will issue with respect to any of the
owned or licensed pending patent applications or with respect to any patent applications that we, our co-owners
or our licensors may file in the future, nor can we be sure that any of our owned or licensed patents or any
patents that may be issued in the future to us or our licensors will be commercially useful in protecting any
products that we ultimately attempt to commercialize or any method of making or using such products. Moreover,
we may be unable to obtain patent protection for certain of our product candidates generally as well as with
respect to certain indications. See “Risk Factors—Risks Related to our Intellectual Property” in this Annual
Report.
As of January 1, 2025
, our overall owned and in-licensed patent portfolio included more than 480 patent families,
each of which includes at least one filing in the United States or Europe, and several of which are pending or
granted in multiple jurisdictions. The patent families include at least 405 patent families that are solely or jointly
owned by BioNTech, including certain families acquired through our acquisitions and others that we have
licensed from a third party.
An issued patent provides its owner (or possibly its licensee) with a right to exclude others from making, using or
selling that which is claimed in the patent, for a specified period of time (the “term” of the patent), in the
jurisdiction in which the patent is issued. In the United States, and in many other countries, patents have a
presumptive term of 20 years from their effective filing date (which is the earliest non-provisional filing date to
which the patent claims priority). However, many jurisdictions, including the United States, require the payment
of periodic maintenance fees in order for patents to remain in force for the full 20-year term. The United States
also has provisions that require a patent term to be shortened if its claims are too similar to another patent
owned by the same party that has a shorter term. The United States and certain other jurisdictions also have
provisions that permit extension of patent term for patents that claim a drug or drug product, or its approved use,
if the patent was issued before clinical trials were completed and certain other requirements were satisfied. In
the United States, such extension is called a Patent Term Extension, or PTE, and it is limited to a period of not
more than five years, or the total patent term including the PTE cannot exceed 14 years after the date of
regulatory approval; only one patent can be extended per product approval.
We did not extend any patent for our
COVID-19 vaccine (
Comirnaty
) when it was approved by the FDA in the United States in 2021
. The United
States also offers a different form of patent term extension, known as Patent Term Adjustment, or PTA, whereby
a particular patent’s term is automatically extended beyond the 20-year date if the U.S. Patent and Trademark
Office, or the USPTO, caused delay during its examination; however, potentially available PTA is reduced by any
amount of any delay caused by the patent applicant.
Below, we provide a summary of the contours of our current patent portfolio as it relates to different aspects of
relevant technology, including noting ownership and patent terms for filings included in the portfolio that are
directed to such aspects. Particularly given our pre-commercial state of development for many product
candidates, we cannot be certain that any of the patent filings in our portfolio will provide meaningful protection
for products that we do or attempt to commercialize.
B. Patent Portfolio
The patent portfolios for our most advanced programs are summarized below. Patent prosecution is a lengthy
process, during which the scope of the claims initially submitted to the
USPTO
and similar authorities for
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examination can be significantly narrowed by the time they issue, if they issue at all. We expect this could be the
case with respect to some of our pending patent applications referred to below.
1. mRNA
The patent portfolio for our mRNA therapeutic platforms and product candidates includes patent filings directed
to features of therapeutic mRNA structures, some of which are included in our COVID-19 vaccine and in current
development candidates. Our patent portfolio also includes patent filings directed to mRNA formulations
(including their production and use), including the lipoplex formulations currently utilized with our
FixVac
and
iNeST platforms, and the lipid nanoparticles currently utilized with our mRNA,
RiboMab
and
RiboCytokine
platforms, as well as patent filings directed to mRNA manufacturing, and to uses of mRNA therapeutics. We
provide more detail below regarding the patent filings directed to these features.
mRNA Structure
Our patent portfolio includes patent filings directed to various features of mRNA structure, which may, for
example, contribute to increased immunogenicity (e.g., antigen presentation), translation efficiency, and/or
stability of mRNA constructs that include them. Such features include, for example, antigen-MHC fusions, 5’ cap
structures and related features, 3’ UTR structures, polyA tails, reduced-uracil content mRNAs, and modified
nucleoside RNAs. Filings directed to each of these features, and/or to RNA constructs that include them (singly
or in combination), or collectively, the mRNA Structure Filings, have been made in the United States and various
other jurisdictions. Some such mRNA Structure Filings are owned solely by BioNTech SE, which are referred to
collectively in this section as BioNTech, some jointly by BioNTech and one or more third parties, and some by
BioNTech licensors, such as Louisiana State University, or LSU, and the terms of the applicable agreement with
LSU, are further summarized below in “C. In-Licensing.” We have non-exclusive rights to use certain U.S. and
European patent filings owned by University of Pennsylvania and relating to RNA containing modified
nucleosides through our sublicense agreements with mRNA RiboTherapeutics, Inc. (MRT) and CellScript,
collectively, the MRT-CellScript Sublicenses, and summarized below in “C. In-Licensing”. Issued existing mRNA
Structure Filings have, and pending existing mRNA Structure Filings, if issued, would have, 20-year terms that
extend into the mid-2020s to the early-2040s.
mRNA Formulations
Our patent portfolio includes patent filings directed to various formulations for mRNA delivery, some of which are
utilized with current development candidates. For example, our portfolio includes patent filings directed to
lipoplex formulations and preparations thereof or collectively, the mRNA Lipoplex Filings. Issued mRNA Lipoplex
Filing(s) has/have, and pending existing mRNA Lipoplex Filings, if issued, would have, 20-year terms that extend
into the mid to
late-2030s or early 2040s
. Such mRNA Lipoplex Filings are solely owned by BioNTech or jointly
owned by BioNTech and TRON.
In addition, our portfolio includes U.S. and other patent filings directed to lipid nanoparticles and polyplex
technologies, which are solely owned by BioNTech or jointly owned by BioNTech and TRON, or collectively, the
mRNA Lipid Nanoparticle/Polyplex Filings. Issued mRNA Lipid Nanoparticle/Polyplex Filings have, and pending
mRNA Lipid Nanoparticle/Polyplex Filings, if issued, would have, 20 year terms that extend into the
mid- to late
2030s or early 2040s
. Some of such mRNA Lipid Nanoparticle/Polyplex Filings were granted in certain foreign
jurisdictions, and currently include U.S. issued patents. The terms of the co-ownership of such patent filings with
TRON are summarized below in “C. In-Licensing.”
mRNA Manufacturing
As discussed below, we utilize trade secret protection for many aspects of our mRNA manufacturing
technologies, including as currently utilized for production of certain of our development candidates. In addition,
our patent portfolio includes certain patent filings relevant to mRNA manufacturing, or collectively, the mRNA
Manufacturing Filings, which we believe may provide commercial value to protect product candidates and/or
support collaborations or other licensing arrangements. For example, our mRNA Manufacturing Filings include
U.S. and other patent filings relating to certain aspects of mRNA purification and production. These mRNA
Manufacturing Filings are either solely owned by BioNTech, or jointly owned by BioNTech and TRON and, if
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issued, would have 20-year terms that would extend into the mid- 2030s to early 2040s; there are patents
granted in certain foreign jurisdictions including EP, but no U.S. patent was yet issued.
mRNA Com
mercial Products and Product Candidates
Our COVID-19 vaccine. Our COVID-19 vaccine (BNT162b2), marketed as
Comirnaty
, is our most advanced
mRNA product. It
is currently sold in monovalent format (one mRNA) based on
Omicron
variants XBB.1.5, JN.1
and KP.2
. The
Omicron KP.2-adapted monovalent COVID-19 vaccine
has received full FDA approval for
individuals 12 years and older and EUA for individuals 6 months to 12 years old. Our monovalent XBB.1.5, JN.1-
and/or KP.2- adapted COVID-19 vaccines have received full and/or conditional marketing approval in various
other jurisdictions. In Europe, all three versions (XBB.1.5, JN.1- and KP.2-adapted monovalent vaccines) have
received marketing authorization for individuals 6 months and older.
Additional COVID-19 vaccine candidates, as
well as various dosing regimens and use in patient populations with certain medical conditions are being tested
in clinical trials.
Comirnaty and Other COVID-19 Vaccine mRNA Product Candidates
Both our current and previously-marketed monovalent and
bivalent
COVID-19 vaccines utilize modified-
nucleoside mRNA formulated in lipid nanoparticles and which encode an optimized SARS-CoV-2 full-length
spike protein antigen.
Our platform patent filings relevant to our COVID-19 vaccines, collectively, the “BNT162b2 Platform Filings”,
include certain mRNA Structure Filings relating to features for increasing translation efficiency and/or stability of
mRNA constructs (e.g., certain 3’ UTR structures containing a specific sequence element, interrupted polyA tails,
and certain 5’ cap/cap proximal sequence combinations), including filings that are jointly owned by BioNTech and
TRON; also relevant are certain mRNA Manufacturing Filings. Issued BNT162b2 Platform Filings have, and
pending BNT162b2 Platform Filings, if issued, would have 20-year terms extending into the late-2020s to the
early-2040s. We also have undertaken various patent filings specifically related to the BNT162b2 structure
(including as may be tailored based on particular SARS-CoV-2 variants), composition, formulation, packaging,
use and/or manufacture, collectively the BNT162b2 Filings, including filings that have arisen through
collaboration with third parties such as Pfizer. Such filings relevant to our COVID-19 vaccines, if issued, would
have 20-year terms that would extend into early 2040s.
As noted above, our MRT-CellScript Sublicenses grant us rights to use certain U.S. and European patents and
applications relating to mRNA containing modified nucleosides
, including as used in BNT162b2. We also have a
non-exclusive license from the National Institutes of Health granting us a right to use certain technology
described in U.S. and European patent filings that may relate to SARS-CoV-2 spike (S) protein mutations that
lock the S protein in an antigenically preferred prefusion conformation; such a variant is utilized in BNT162b2.
Additionally, we have obtained third-party licenses to technologies relating to certain lipids and/or lipid
nanoparticles and formulations used in BNT162b2, including a non-exclusive license from Acuitas granting use
rights relevant to proprietary lipid nanoparticles and formulations used in BNT162b2.
Additional COVID-19 vaccine mRNA product candidates are being developed and tested in clinical trials, which
share with BNT162b2 certain structural elements, and/or features of the composition, formulation, packaging,
use and/or method of manufacture. Thus, some or all of the BNT162b2 Platform Filings and/or BNT162b2
Filings, as well as the in-licensed rights discussed above with respect to BNT162b2, may be relevant to certain
of these candidates. We have also undertaken patent filings specifically related to structures and uses of certain
such additional candidates, including BNT162b4, which includes a T-cell antigen mRNA encoding SARS-CoV-2
non-spike protein antigens that are highly conserved across a broad range of SARS-CoV-2 variants and were
chosen based on our proprietary target prioritization platform and which is being assessed in combination with
our monovalent and bivalent COVID-19 vaccine products,
and
BNT162b5, a bivalent product that includes RNAs
encoding enhanced prefusion spike proteins for the SARS-CoV-2 Original strain and an Omicron variant. Such
filings specifically relevant to BNT162b4 or BNT162b5, if issued, would have 20-year terms that would extend
into the early 2040s.
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Moreover, we are currently studying safety and efficacy of our COVID-19 vaccines and vaccine candidates in
various dosing regimens (including booster doses) and/or in different age groups and/or individuals with various
medical conditions, and also in combination with other vaccines or therapies. Certain of our patent filings,
including certain BNT162b2 Filings, cover such uses being tested in clinical trials.
Oncology mRNA Product Candidates
Certain mRNA oncology product candidates are also in clinical development and involve various platforms. Our
pipeline also includes mRNA product candidates for treatment of certain infectious diseases beyond COVID-19,
and mRNA product candidates for protein replacement therapy in certain rare diseases. We currently have more
than 10 clinical oncology programs in Phase 1 or Phase 2. Our most advanced clinical oncology programs
involve our iNeST immunotherapy product candidates being developed with our collaborator, Genentech. We
also have
FixVac
product candidates in Phase 1 and Phase 2 clinical trials and have initiated Phase 1 clinical
trials of our mRNA-based intratumoral immunotherapy developed through our collaboration with Sanofi.
FixVac
Our
FixVac
product candidates share many of the structural elements involved in our iNeST product candidates.
Thus, some or all of the mRNA Structure Filings relevant to our iNeST product candidates and discussed below
are also relevant to our
FixVac
product candidates. These patent filings, or the
FixVac
Platform Filings, include
mRNA Structure Filings relating to antigen-MHC fusions, certain 5’ cap structures, 3’ UTR structures containing a
specific sequence element, and interrupted polyA tails, which are solely or jointly owned by BioNTech or
BioNTech’s licensors. Issued
FixVac
Platform Filings have, and pending
FixVac
Platform Filings, if issued, would
have, 20-year terms extending into the mid-2020s to the mid-2030s. While we have pursued or obtained patent
protection covering components of
FixVac
product candidates, manufacturing-related methods and/or
formulations, we do not currently have any claims in our owned or in-licensed issued patents that cover the
overall construct used in our
FixVac
product candidates.
Our patent portfolio further includes U.S. and other patent filings relating to combined uses of our
FixVac
and
iNeST product candidates. Such issued patent filings have, and such pending patent filings, if issued, would
have, 20-year terms that extend into 2033, and are jointly owned by BioNTech and TRON.
Our current clinical trials for
FixVac
product candidates are studying such product candidates in treatment of
various cancers. While we do not currently have any claims in our owned or in-licensed issued patents that are
directed to use of our
FixVac
product candidates in the indications of these clinical trials, certain
FixVac
Platform
Filings include specific reference to treatment of these indications, and if issued, would have 20-year terms
extending into the mid-2030s.
iNeST
Our patent filings relevant to our iNeST product candidates include mRNA Structure Filings relating to features
for increasing antigen presentation (e.g., antigen-MHC fusions) and features for increasing translation efficiency
and/or stability of mRNA constructs (e.g., certain 5’ cap structures, 3’ UTR structures containing a specific
sequence element, and polyA tails of a particular length or interrupted polyA tails); mRNA Lipoplex Filings
relating to negatively charged lipoplexes (e.g., for spleen targeting); and mRNA Manufacturing Filings, or
collectively, the iNeST mRNA Platform Filings. While we have pursued or obtained patent protection covering
components of iNeST product candidates, manufacturing-related methods and/or formulations, we do not
currently have any claims in our owned or in-licensed issued patents that cover the overall construct used in our
iNeST product candidates.
Our patent portfolio further includes U.S. and other filings directed to the process of identifying neoantigens in
patient samples and/or predicting those that will be immunoreactive in an iNeST immunotherapy product, or
collectively, the Neoantigen Filings. Certain issued Neoantigen Filings have, and certain pending Neoantigen
Filings, if issued, would have 20-year terms that extend into the 2030s. Many of the Neoantigen Filings are solely
owned by BioNTech, or jointly owned by BioNTech and TRON; our acquisition of Neon added various
Neoantigen Filings, including both BioNTech U.S.-owned and in-licensed filings.
BioNTech and TRON jointly own
issued EP patent number 2714071, whose claims recite steps relating to neoantigen selection, that were
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unsuccessfully opposed by multiple third parties. Said third parties have unsuccessfully appealed the decision to
reject such opposition and the patent was maintained as granted. In addition, related EP patent number 3473267
with claims reciting steps relating to neoantigen selection for an RNA vaccine encoding a recombinant
polyepitopic polypeptide was unsuccessfully opposed by a single third party. Said third party has instigated
appeal proceedings against this decision. Related EP patent number 3892295 from the same patent family with
claims reciting steps relating to neoantigen selection for an RNA vaccine encoding a recombinant polyepitopic
polypeptide is being opposed by a third party; claims in related U.S. cases are granted.
If we are unsuccessful
in these opposition/appeal proceedings, the patent claims for our iNeST product candidates may be narrowed, or
a patent may not issue at all. See “Risk Factors—Risks Related to our Intellectual Property” in this Annual
Report.
We are currently studying our iNeST product candidates for the treatment of metastatic melanoma, and adjuvant
pancreatic and bladder cancers in Phase 2 clinical trials.
Certain iNeST mRNA Platform Filings and Neoantigen
Filings cover treatment of each of these indications. However, we do not currently have any claims in our owned
or in-licensed issued patents that are directed to use of iNeST product candidates in the indications of these
clinical trials.
RiboMabs and RiboCytokines
We own or license a number of patent filings directed to our
RiboMab
and
RiboCytokine
programs. Many are
owned solely by us, some are jointly owned, and some have been acquired or licensed.
Patent filings relevant to our
RiboMab
and
RiboCytokine
programs include certain mRNA Structure Filings that
are also relevant to our iNeST and/or
FixVac
product candidates, including certain patent filings relating to 3’
UTR structures containing a specific sequence element, and interrupted polyA tail structures; and patent filings
under the MRT-CellScript Sublicenses relating to nucleoside-modified mRNAs as well as certain patent filings we
have licensed from Acuitas and Genevant relating to lipid or non-liposomal formulations.
I
nfectious Diseases beyond COVID-19
As is discussed elsewhere, we have collaborated with third parties, including Pfizer and UPenn, to develop
infectious disease mRNA vaccine candidates, some of which are currently in clinical trials at different phases,
including
mRNA vaccines against influenza (Phase 3)
and
HSV
(Phase 1). We are also developing our own
mRNA vaccines against malaria, which has recently entered Phase 1 clinical trial.
Certain patent filings that might be useful to our infectious disease mRNA vaccines include certain of the mRNA
Structure Filings and the mRNA Lipid Nanoparticle/Polyplex Filings as well as certain patent filings under the
MRT-CellScript Sublicenses, which include patent filings directed to nucleotide-modified mRNAs. Self-Amplifying
RNA Filings as discussed above may also be relevant. We have also undertaken and continue to undertake
filings specific to particular product candidates.
We have also licensed technologies relating to certain lipids and/or lipid nanoparticles and formulations that may
be useful for certain infectious disease mRNA vaccines.
2.
Cell Therapy
Engineered Cell Therapy
Our engineered cell therapy product class features use of chimeric antigen receptor, or CAR-, T cell or
individualized T-cell receptors for oncology therapy. Our patent filings relevant to these platforms and product
candidates, or the CAR-T/TCR Filings, are generally co-owned by BioNTech SE, BioNTech US, and TRON. For
example, the CAR-T/TCR Filings include patent filings directed to various CAR-T formats and methods of
enhancing CAR-T cells by nucleic acid vaccination, as well as patent filings directed to compositions of matter
comprising individualized T-cell receptors, for example. The CAR-T/TCR Patent Filings, if issued, would have
patent terms that would extend into the mid-2030s to early 2040s.
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Certain CAR-T programs involve CAR-T-cell product candidates that target different members of the claudin
family. Our patent portfolio includes certain patent filings specifically relevant to our claudin-specific CAR-T-cell
product candidates and are jointly owned by
BioNTech SE
and TRON, or the Claudin-Specific CAR-T Cell
Filings.
The issued Claudin-Specific CAR-T-cell filings have, and the pending Claudin-Specific CAR-T-cell filings,
if issued, would have,
20-year
terms extending into the mid-2030s. The terms of our co-ownership of such patent
filings with TRON are summarized below in “—C. In-Licensing.”
Activated T Cells
Our acquisition of Neon included technologies for using peripheral blood mononuclear cells, or PBMCs, (e.g.,
collected from apheresis material of patients) as a starting material to induce and/or expand ex vivo functional T
cells specific for therapeutically-relevant neoantigens.
Our BNT221 program, formerly Neon’s NEO-PTC-01 program, is a personalized adoptive T-cell therapy, which
uses multiple T-cell populations expanded from an individual patient’s PBMCs that together target a set of
neoantigens expressed by that patient’s tumor.
Patent filings relevant to BNT221, referred to herein as the T-cell Induction/Expansion Filings, are generally
solely owned by BioNTech US, or co-owned by BioNTech US and the Netherlands Cancer Institute (NKI). For
example, the T Cell Induction/Expansion Filings include patent filings directed to therapeutic T cell compositions
and methods of ex vivo induction and/or expansion of antigen-specific T cells. An issued subsisting T-cell
Induction/Expansion Filing in the United States has, and pending subsisting T-cell Induction/Expansion Filings, if
issued, would have, patent terms that extend into the late-2030s to early-2040s.
3.
Antibodies
Our antibodies product class features bispecific checkpoint immunomodulators for oncology therapy, which are
developed through collaboration with Genmab. Our development candidates include bispecific antibodies that
are designed to activate 4-1BB upon simultaneous binding
to
CD-40 or EpCAM
. Our patent portfolio includes
certain patent filings relevant to such bispecific antibodies, or the Bispecific Checkpoint Modulator Filings, co-
owned by us and Genmab. Such Bispecific Checkpoint Modulator Filings, if issued, would have 20-year terms
that would extend into the late 2030s.
O
ur collaboration
with Genmab also includes development of monospecific antibody candidates to address
malignant solid tumors. For example, BNT313 is a CD27 antibody based on Genmab’s proprietary HexaBody
technology platform, specifically engineered to form an antibody hexamer (a formation of six antibodies) upon
binding its target on the cell membrane of the T cells. We have also undertaken and continue to undertake filings
specific to particular product candidates.
We own patent assets acquired from MabVax Therapeutics Holding, Inc., or the MabVax Filings, that relate to
various antibodies, including certain antibodies targeting sialyl Lewis A and ganglioside GD2, as well as nucleic
acid encoding them. Issued MabVax Filings have, and the pending MabVax Filings, if issued, would have, 20-
year terms that extend into the mid-2030s.
4. Small Molecule Immunomodulators
Our small molecule therapeutics product class features oncology treatment using small molecule product
candidates that activate the immune system via TLR7 agonism. Our patent portfolio includes patent filings
relevant to these TLR7 agonists, or the TLR7 Agonist Filings. Certain TLR7 Agonist Filings are directed to
substituted imidazoquinolines, and, if issued, would have 20-year terms that would extend into the late 2030s.
C.
In-Licensing
Some of our intellectual property assets have been acquired by acquisition and/or in-licensing.
We have pursued a strategy of identifying and in-licensing third-party patents that we believe are complementary
to or otherwise interact synergistically with our own intellectual property portfolio. In addition to the agreements
described in the section “—B.X. Third-Party Collaborations” above, we have entered into material intellectual
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property licensing or option arrangements with Acuitas,
Louisiana State University, MRT-CellScript, the NIH, and
TRON
.
The key terms of these arrangements are summarized below.
Acuitas License Agreement
In April 2020, we entered into a Non-Exclusive License Agreement with Acuitas, or the Acuitas License
Agreement. Under the Acuitas License Agreement, Acuitas grants us a non-exclusive worldwide license, with the
right to sublicense (subject to certain conditions) under Acuitas’ LNP technology to develop, manufacture and
commercialize licensed products directed to the SARS-CoV-2 surface glycoprotein. We have the option to
convert the non-exclusive licenses to exclusive licenses subject to certain additional financial obligations.
Under the Acuitas License Agreement, we must pay Acuitas up to between approximately $1.6 million and $2.45
million in development milestone payments, $2.5 million and $3.75 million in regulatory milestone payments and
$2.5 million and $3.75 million in commercial milestone payments upon the occurrence of certain milestone
events. We are further required to pay Acuitas a low single-digit tiered percentage royalty on net sales of
licensed products, subject to certain potential customary reductions. Our royalty obligations continue under the
Acuitas License Agreement on a country-by-country and product-by-product basis until the later of (i) the
expiration of the last-to-expire licensed valid patent claim covering such licensed product in such country, (ii)
expiration of any data exclusivity, market exclusivity or supplemental protection certificates period for such
product in such country, and (iii) certain years following the first commercial sale of such product in such country.
The Acuitas License Agreement will continue on a product-by-product and a country-by-country basis until there
are no more payments owed to Acuitas for such product in such country. Upon expiration of the Acuitas License
Agreement, the license will become fully paid up and will remain in effect. We have the right to terminate the
Acuitas License Agreement for convenience following a certain notice period. Either party may terminate the
Acuitas License Agreement in the event of a material breach by the other party following a cure period.
Alternatively, instead of exercising our right to terminate in the event of Acuitas’ material breach, we may elect to
instead continue the license but reduce our milestone and royalty payment obligations to Acuitas by a certain
percentage. In the event of termination of the Acuitas License Agreement by us for convenience or by Acuitas for
our material breach, the licenses granted under such agreement will terminate, except that we will have the right
to sell off any remaining inventories of licensed products for a certain period of time.
LSU License Agreement
In May 2015, we entered into a Patent License Agreement with the Board of Supervisors of Louisiana State
University and Agricultural and Mechanical College, or LSU, and the University of Warsaw, or UW. The
agreement (which we refer to as the LSU Agreement) replaces and supersedes the earlier license agreement
between the parties.
Under the LSU Agreement, UW and LSU granted to us an exclusive royalty-bearing license under certain patent
rights relating to mRNA cap analogs and the synthesis and use of anti-reverse phosphorothioate analogs of the
mRNA cap in the United States, certain jurisdictions in the European Union and other countries. As consideration
for the license granted, we are obligated to pay running royalties in the low single digits on all net sales of
products utilizing the licensed patents and to pay annual maintenance fees to LSU.
We are obligated to use commercially reasonable efforts to develop one or more marketable products utilizing
the licensed patents, upon which we would owe additional milestone payments to LSU.
The LSU Agreement remains in effect until expiration of the licensed patents. We have the right to terminate the
LSU Agreement for convenience with 60 days’ prior notice, and LSU and UW may terminate for our uncured
material breach.
CellScript and mRNA Ribotherapeutics License Agreement
BioNTech RNA (now merged into BioNTech SE) entered into the two MRT-CellScript Sublicenses discussed
above. Together, the MRT-CellScript Sublicenses grant BioNTech RNA worldwide, non-exclusive sublicenses
under the Penn Modified mRNA Patent Rights (as defined in the MRT-CellScript Sublicenses) to research,
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develop, make, import, use and commercialize products for in vivo uses in humans and non-human animals,
including therapeutic and prophylactic applications, and for certain uses in the diagnostic and prognostic field of
use and certain laboratory research or screening uses. Under these sublicenses, BioNTech RNA has the right to
grant sublicenses to affiliates and third parties.
BioNTech RNA must use reasonable efforts to develop and commercialize products under the sublicenses.
Furthermore, BioNTech RNA is obliged to pay MRT and CellScript development milestone payments of up to
approximately $26 million as well as royalties in the low to mid-single digits on net sales of licensed products,
depending on the field of use.
The agreements continue until the expiration or abandonment of the last licensed patent to expire or be
abandoned. BioNTech RNA may terminate the agreement for convenience with respect to all or certain patent
rights with 60 days’ prior written notice. MRT or CellScript may terminate the respective sublicense agreement
for payment default, uncured material breach or the bankruptcy of BioNTech RNA.
NIH License Agreement
On May 27, 2020, we and the HHS, as represented by the National Institute of Allergy and Infectious Diseases,
or NIAID, of the NIH, entered into a patent license agreement to facilitate the development of a vaccine against
COVID-19, or, as amended and restated on December 20, 2024, the NIH License Agreement. P
ursuant to the
NIH License Agreement, our royalty obligation on Net Sales (as defined in the NIH License Agreement) of
Licensed Products (as defined in the NIH License Agreement, and which includes our and Pfizer’s COVID-19
vaccine) is an amount of up to a low single-digit percentage of Net Sales of Licensed Products.
The NIH License
Agreement also provides a framework for a license for use in Combination Products (as defined in the NIH
License Agreement, and which would include the COVID-19 vaccine used in combination with other active
pharmaceutical ingredients).
The NIH License Agreement remains in effect until expiration of the licensed patents. We have the right to
terminate the NIH License Agreement for convenience with 60 days’ prior notice, and NIAID may terminate for
our uncured material breach.
TRON Agreements
In 2015, we and our subsidiaries BioNTech RNA (now merged into BioNTech SE), BioNTech Diagnostics GmbH,
BioNTech Protein Therapeutics GmbH, BioNTech Cell & Gene Therapies GmbH, Eufets GmbH and JPT Peptide
Technologies GmbH entered into a Master Agreement for Research Services with TRON. Concurrently with this
Master Agreement for Research Services, or the TRON Research Agreement, we entered into a License
Agreement with Ganymed Pharmaceuticals AG, or Ganymed, TRON, Johannes Gutenberg-Universität Mainz
and Universitätsmedizin der Johannes Gutenberg-Universität Mainz, or the TRON License Agreement. The
TRON Research Agreement and TRON License Agreement together replaced and superseded our 2008
Cooperation, Purchase and Licensing Agreement with the University Mainz, or the 2008 Cooperation Agreement.
In 2015, we and our subsidiaries BioNTech RNA (now merged into BioNTech SE), BioNTech Diagnostics GmbH,
BioNTech Protein Therapeutics GmbH, BioNTech Cell & Gene Therapies GmbH, BioNTech Innovative
Manufacturing Services GmbH and JPT Peptide Technologies GmbH, entered into a Framework Collaboration
Agreement with TRON, or the TRON Collaboration Agreement.
TRON Research Agreement
Under the TRON Research Agreement, TRON from time to time performs certain services for us under work
orders, which may comprise innovative applied research projects, pre-defined research and development or
clinical research services. We and TRON meet at regular intervals, but no less than annually, to prepare an
overall non-binding project plan, which sets the scope, period and costs for the relevant projects contemplated
for that period. Individual work orders set the specific binding terms of each project or service. TRON is obligated
to render services in accordance with the scientific standards, all applicable laboratory and legal provisions and
with the care customary in the industry.
We are entitled to the exclusive rights to all inventions, methods, specifications, materials, documents, data,
know-how and other results (together, the Results) developed or discovered by TRON or by us and TRON jointly
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under the TRON Research Agreement, except to the extent they constitute improvements of the technologies
applied by TRON in the relevant projects. Under the TRON Research Agreement, TRON granted us a non-
exclusive, royalty-free license to use TRON Improvements if such TRON Improvements are necessary for the
continued development and exploitation of the Results or the manufacture or marketing of products which
contain any of the Results and are covered by a patent claiming any of the Results.
Under the TRON Research Agreement, TRON’s services rendered in the field of applied research are invoiced at
cost. For other services, fixed prices are to be set forth in the individual work orders. TRON invoices us monthly
and our payments are due no later than 10 days thereafter. Additionally, we are obligated to pay to TRON low
single-digit tiered royalties on net sales of any product developed under the TRON Research Agreement that is
covered by a patent claiming any of the Results.
The TRON Research Agreement limits each party’s liability to the other to intentional and grossly negligent
actions and, in the case of gross negligence, liability for indirect and consequential damages and lost profits is
excluded. We are obligated to indemnify TRON for all product liability claims in connection with the products and
for third-party claims asserting that the Results violate third-party intellectual property rights.
The TRON Research Agreement has an indefinite term, but may be terminated by either party on six months’
notice. If one of our subsidiaries terminates its role in the TRON Research Agreement, the agreement will survive
and continue without that subsidiary.
TRON License Agreement
The TRON License Agreement governs the ownership of and licenses under certain patents, inventions, know-
how, technologies and other knowledge (together, the Development Results) filed and created before January 1,
2015 in the course of our collaboration with TRON, Johannes Gutenberg-Universität Mainz and
Universitätsmedizin der Johannes Gutenberg-Universität Mainz (collectively, the University Parties) and
Ganymed pursuant to the 2008 Cooperation Agreement.
The TRON License Agreement sets forth the parties’ rights with respect to the Development Results, mainly
depending on which parties have contributed to such Development Results. Ownership of the Development
Results and any patents and other intellectual property in certain shares to TRON, on the one hand, and
BioNTech and/or Ganymed, on the other hand included therein is allocated. Each party may assign its share in
the co-owned Development Results to its affiliates provided that such party provide notice of the transfer and the
identity of the new co-owner to the other co-owners. However, in case of an assignment of such share to a third
party (except in case of a material asset sale), the assigning party must obligate the assignee to comply with the
terms of the TRON License Agreement and the assigning party will remain bound by the obligations of the TRON
License Agreement unless the other co-owners have consented to discharge the assigning party from such
obligations.
The parties to the TRON License Agreement grant licenses to each other under their shares in the Development
Results substantially as follows. Ganymed is exclusively entitled to use the Development Results for certain
antibodies and antibody fragments that bind to certain defined targets, or the Ganymed Field of Use. We are
exclusively entitled to use the Development Results in any other field of use (including immunological
therapeutics, small molecule compounds, small interfering RNA (siRNA)-based therapeutics, micro-proteins,
antibody based in vitro (except for those in the Ganymed Field of Use), diagnostics and therapeutics based on
long-chain RNA as well as other cell therapy applications, immune cells transgenized with recombinant directed
against certain defined targets or chimeric antigen receptors and RNA-based pharmaceuticals). The University
Parties may use the Development Results for internal research purposes only. We have an obligation to use
reasonable efforts to develop and commercialize products in our field of use worldwide.
Under the TRON License Agreement, we and Ganymed must agree on which party will have the primary role in
filing, prosecuting, maintaining and defending jointly owned patents. We and Ganymed each have the exclusive
right to enforce the Development Results in our respective fields of use, subject to certain step-in rights of the
other parties.
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We are obligated to pay to the University Parties low single-digit tiered royalties on net sales on any product that
is covered by certain of the patents including in the Development Results. If licenses are granted to third parties,
we are obligated to pay to the University Parties a mid-single-digit share of all upfront payments, milestone
payments and other remuneration we receive from such third parties in consideration for the license. Regarding
upfront payments only, the University Parties’ share will be offset against subsequent license fees on net sales.
In addition, we are obligated to pay certain development and regulatory milestones up to a low seven-figure
amount to Johannes Gutenberg-Universität Mainz.
The TRON License Agreement contains a limitation on liability as between the parties, wherein the parties will
only be liable to each other for intentional and grossly negligent actions, and, in the case of gross negligence,
liability for indirect and consequential damages and lost profits is excluded. We are obligated to indemnify the
University Parties and Ganymed for third-party claims of product liability or violation of applicable law based on
our distribution of our products or if we breach the TRON License Agreement or if we or one of our agents acts
culpably.
The TRON License Agreement will remain in effect as long as there are any obligations on us or Ganymed to
pay license fees. After expiry of the TRON License Agreement, each party will have a perpetual, non-exclusive,
royalty-free license to use the Developments Results. The TRON License Agreement may be terminated by any
party on six months’ notice. The licenses granted between the parties will survive such termination. The TRON
License Agreement also grants all parties termination rights for uncured material breaches. If only one party
terminates its role in the Agreement, the Agreement will survive and continue between the other parties.
TRON Collaboration Agreement
Under the TRON Collaboration Agreement, TRON from time to time undertakes certain projects in collaboration
with us under separate project specific agreements, comprising innovative non-clinical research and
development projects. We and TRON meet regularly to review and update project plans, and no less than
annually to agree the budget for the on-going projects for the coming calendar year. Individual project
agreements set the specific binding terms of each project. TRON is obligated to perform its obligations in
accordance with the scientific standards, all applicable technical laboratory and legal provisions and with the
care customary in the non-clinical biotechnology research industry.
Except for the results of a particular research project which has been funded exclusively by TRON, all of the
inventions, methods, specifications, materials, documents, data, know-how and other results (together, the
Results) developed or discovered by TRON or by us and TRON jointly under the TRON Collaboration Agreement
are jointly owned. Under the TRON Collaboration Agreement, TRON grants us an exclusive, worldwide,
sublicensable license under its interest in the Results to research and have researched, develop and have
developed, make and have made, use, and otherwise commercialize or have commercialized, and otherwise
commercially exploit, products in a field that is specified in the corresponding project agreement. The field of use
is either (a) the prophylaxis, diagnosis and treatment of all indications in humans and animals; or (b) the
prophylaxis, diagnosis and treatment of oncological diseases, infectious diseases and rare genetic diseases. We
are required to use our reasonable efforts to develop and commercialize products that exploit the Results.
Under the TRON Collaboration Agreement, TRON’s activities are invoiced at cost. TRON invoices us monthly
and our payments are due no later than 10 days thereafter. Additionally, we are obligated to pay to TRON low
single-digit tiered royalties on net sales of any product developed under the TRON Collaboration Agreement that
is covered by a patent claiming any of the Results or, in certain circumstances, by a patentable invention forming
part of the Results which we elect to maintain as a trade secret. If licenses under Results are granted to third
parties, we are obligated to pay to TRON a mid-single-digit share of all upfront payments, milestone payments
and other remuneration we receive from such third parties in consideration for the license. In addition, we are
obligated to pay a one-time only milestone of a low seven-figure amount to TRON the first time annual sales of a
product developed under the TRON Collaboration Agreement reach a low nine-figure number.
The TRON Collaboration Agreement limits each party’s liability to the other to cases of willful misconduct and
gross negligence and, in the case of gross negligence, liability for indirect and consequential damages and lost
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profits is excluded. We are obligated to indemnify TRON for all product liability claims in connection with the
products and for third-party claims asserting that the Results violate third-party intellectual property rights.
The TRON Collaboration Agreement came into force with retroactive effect from January 2015 and has an
indefinite term, but may be terminated by either party on nine months’ notice. If one of our subsidiaries
terminates its role in the TRON Collaboration Agreement, the agreement will survive and continue without that
subsidiary.
D.
Trademark Portfolio
Certain features of our business and our product candidates are protected by trademarks. Our trademark
portfolio includes, but is not limited to,
Comirnaty
,
BioNTainer
,
FixVac
,
RiboCytokine
,
RiboMab
,
Recon
, and
Neo-
Stim
, including logo versions of some of these trademarks.
Brand names appearing in italics throughout this report are trademarks owned by BioNTech. All other trademarks
are the property of their respective owners.
E. Trade Secret Protection
Certain of our technologies, including in particular certain proprietary manufacturing processes or technologies
and/or neoantigen prediction technologies, are protected as trade secrets.
In addition to patent protection, we rely upon unpatented trade secrets and confidential know-how and continuing
technological innovation to develop and maintain our competitive position. We protect certain of our
technologies, including, in particular, certain proprietary manufacturing processes and technologies and/or
neoantigen prediction technologies, as trade secrets. However, trade secrets and confidential know-how are
difficult to protect. We seek to protect our proprietary information, in part, by using confidentiality agreements
with any future collaborators, scientific advisors, employees and consultants, and invention assignment
agreements with our employees. We also have agreements requiring assignment of inventions with selected
consultants, scientific advisors and collaborators. These agreements may not provide meaningful protection.
These agreements may also be breached, and we may not have an adequate remedy for any such breach. In
addition, our trade secrets and/or confidential know-how may become known or be independently developed by
a third party, or misused by any collaborator to whom we disclose such information. Despite any measures taken
to protect our intellectual property, unauthorized parties may attempt to copy aspects of our products or to obtain
or use information that we regard as proprietary. Although we take steps to protect our proprietary information,
third parties may independently develop the same or similar proprietary information or may otherwise gain
access to our proprietary information. As a result, we may be unable to meaningfully protect our trade secrets
and proprietary information.
XIII. Competition
We compete in an industry characterized by rapidly advancing technologies, intense competition and a complex
intellectual property landscape. We face substantial competition from many different sources, including large and
specialty pharmaceutical and biotechnology companies, academic research institutions and governmental
agencies and public and private research institutions.
Many of our competitors and potential competitors, either alone or with their collaborators, have greater
scientific, research and product development capabilities as well as greater financial, marketing, sales and
human resources and experience than we do. In addition, smaller or early-stage companies, including
immunotherapy-focused therapeutics companies, may also prove to be significant competitors, particularly
through collaborative arrangements with large and established companies. Some of our collaborators, such as
Genmab and Pfizer, may also be competitors within the same market or other markets. Accordingly, our
competitors may be more successful than us in developing and potentially commercializing technologies and
achieving widespread market acceptance. In addition, our competitors may design technologies that are more
efficacious, safer or more effectively marketed than ours or have fewer side effects, or may obtain regulatory
approvals more quickly than we are able, which could eliminate or reduce our commercial potential. These
competitors also compete with us in recruiting and retaining qualified scientific and management personnel and
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year ended December 31, 2024
establishing clinical trial sites and patient registration for clinical trials, as well as in acquiring technologies
complementary to, or necessary for, our programs.
We anticipate that the key competitive factors affecting our technologies will be efficacy, safety, cost and
convenience, ease of distribution, storage and administration, as well as our ability to build a fully-integrated
biotechnology company. The availability of reimbursement from government and other third-party payors will also
significantly affect the pricing and competitiveness of our products. The timing of market introduction of our
products and competitive products will also affect competition among products. We expect the relative speed
with which we can develop our products, complete the clinical trials and approval processes, and supply
commercial quantities of the products to the market to be important competitive factors. Our competitors also
may obtain FDA or other regulatory approval for their products more rapidly than we may obtain approval for
ours, which could result in our competitors establishing a strong market position before we are able to enter the
market.
Specifically, our marketed monovalent and bivalent COVID-19 vaccines and any other COVID-19 vaccines we
and Pfizer develop compete with other COVID-19 vaccines that have been approved or authorized for temporary
or emergency use and a number of vaccine manufacturers, academic institutions and other organizations
currently have programs to develop COVID-19 vaccine candidates.
XIV. L
egal Proceedings
We are and may be involved in various legal proceedings, including patent litigation, product liability and other
product-related litigation, as well as other legal proceedings that arise from time to time in the
ordinary
course of
business, including, but not limited to, personal injury, consumer, off-label promotion, securities, antitrust,
employment law, tax, environmental, and/or other claims or investigations.
We currently do not believe that any of these matters will have a material adverse effect on our financial position,
and will continue to monitor the status of these and other claims that may arise. However, we could incur
judgments, enter into settlements or revise our expectations regarding the outcome of matters, which could have
a material adverse effect on our results of operations and/or our cash flows in the period in which the amounts
are accrued or paid. Our assessments, which result from a complex series of judgments about future events and
uncertainties, are based on estimates and assumptions that have been deemed reasonable by management, but
that may prove to be incomplete or inaccurate, and unanticipated events and circumstances may occur that
might cause us to change those estimates and assumptions.
Certain pending matters to which we are a party are discussed below.
For a description of the risks relating to these and other legal proceedings we face and may in the future face
and our assessments thereof, see “Risk Factors” in this Annual Report.
Alnylam Proceedings
In March 2022, Alnylam Pharmaceuticals, Inc., or Alnylam, filed a lawsuit against Pfizer and Pharmacia & Upjohn
Co. LLC in the U.S. District Court for the District of Delaware alleging that an existing patent owned by Alnylam,
U.S. Patent No. 11,246,933, or the ‘933 Patent, is infringed by the cationic lipid used in
Comirnaty
, and seeking
monetary relief, which is not specified in their filings. We filed a counterclaim to become party to the Alnylam
proceeding, and in June 2022, Alnylam added to its claims allegations that we induced infringement of the ‘933
Patent. Additionally, in July 2022, Alnylam filed a lawsuit against us, our wholly owned subsidiary, BioNTech
Manufacturing GmbH, Pfizer and Pharmacia & Upjohn Co. LLC in the U.S. District Court for the District of
Delaware alleging that we also induced infringement of a newly issued patent, U.S. Patent No. 11,382,979, or
the ‘979 Patent, which is a continuation of the ‘933 Patent. The two lawsuits were consolidated on July 28, 2022.
In May 2023, Alnylam filed a third lawsuit against Pfizer Inc. and Pharmacia & Upjohn Co. LLC in the U.S.
District Court for the District of Delaware alleging infringement of U.S. Patent Nos. 11,633,479; 11,633,480;
11,612,657; and 11,590,229, all of which are continuations of the ‘933 Patent. We filed a counterclaim to become
party to the new proceeding, and in July 2023, Alnylam added to its claims allegations that we induced
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infringement of the four new patents. All of the lawsuits have been consolidated into a single proceeding, which
is currently expected to go to trial in July 2025.
We believe we have strong defenses against the allegations claimed relative to each of the patents and intend to
vigorously defend ourselves in the proceedings mentioned above. However, our analysis of Alnylam’s claims is
ongoing and complex, and we believe the outcome of the suit remains substantially uncertain.
Taking into
account discussions with our external lawyers, we do not consider the probability of an outflow of resources to
be sufficient to recognize a provision at the balance sheet date. In our opinion, these matters constitute
contingent liabilities as of the balance sheet date. However, it is currently impractical for us to estimate with
sufficient reliability the respective contingent liabilities.
CureVac Proceedings
Infringement Proceedings – EP’122, DE’961, DE‘974, DE’575, and EP’668
In July 2022, CureVac AG (CureVac) filed a lawsuit against us and our wholly owned subsidiaries, BioNTech
Manufacturing GmbH and BioNTech Manufacturing Marburg GmbH, in the Düsseldorf Regional Court, alleging
Comirnaty
’s infringement of one European patent, EP1857122B1, or EP’122, and three Utility Models
DE202015009961U1, DE202015009974U1, and DE202021003575U1. In August 2022, CureVac AG added
European Patent EP3708668B1, or EP’668, to its German lawsuit.
On August 15, 2023, the Düsseldorf Regional Court held a hearing on infringement with respect to all five IP
rights. At the hearing, the Court suspended its infringement ruling with respect to EP’122 until December 28,
2023. On September 28, 2023, the Court issued orders suspending its infringement rulings with respect to the
remaining four IP rights (DE’961, DE’974, DE’575, and EP’668) pending validity decisions in the DE’961,
DE’974, and DE’575 cancellation proceedings before the German Patent and Trademark Office and in the
EP’668 opposition proceedings before the Opposition Division of the European Patent Office, or EPO. In the
September 28th orders, the Court explained that it was suspending its infringement rulings until validity decisions
are reached, while contemporaneously noting concerns regarding the validity of DE’961, DE’974, DE’575, and
EP’668. On December 28, 2023, the Düsseldorf Regional Court stayed the infringement proceedings as to
EP’122 until a final appellate decision is rendered as to the validity of EP’122 by the Federal Court of Justice. On
June 7, 2024, CureVac AG waived DE’575 and withdrew this utility model from the infringement proceedings. On
July 2, 2024, the EPO Opposition Division issued a preliminary opinion noting that it believes EP’668 is likely
invalid, and set an oral hearing for March 2025.
Infringement Proceedings – EP’755, DE’123, and DE’130
In July 2023, CureVac filed a second lawsuit against us and our wholly owned subsidiaries, BioNTech
Manufacturing GmbH and BioNTech Manufacturing Marburg GmbH, in the Düsseldorf Regional Court, alleging
Comirnaty
’s infringement of one European patent, EP4023755B1, or EP’755, and two Utility Models
DE202021004123U1, and DE202021004130U1. On June 7, 2024, CureVac waived DE’123 and withdrew this
utility model from the infringement proceedings. A hearing on infringement with respect to EP’755 and DE’130
that
was scheduled to occur in the Düsseldorf Regional Court on September 10, 2024 was rescheduled for July
2025 and the Court suspended its infringement ruling with respect to DE’130 until a validity decision was
reached in the co-pending cancellation proceeding before the German Patent and Trademark Office. On July 24,
2024, the EPO Opposition Division issued a prelim
inary opinion noting that it believes EP’755 is likely invalid,
and set an oral hearing for May 2025.
Nullity Proceedings – EP’122
In September 2022, we filed a nullity action in the Federal Patent Court of Germany seeking a declaration that
EP’122 is invalid. In April 2023, the Federal Patent Court of Germany issued a preliminary opinion in the EP’122
nullity action in support of the validity of EP’122. The preliminary opinion did not address any infringement of
EP’122. The preliminary opinion is a preliminary assessment by the court of the merits of a claim, and is non-
binding. On December 19, 2023, the Federal Patent Court held an oral hearing, after which it nullified EP’122.
On April 30, 2024, the Federal Patent Court issued a judgment containing its written reasons for nullifying
EP’122. On May 7, 2024, CureVac appealed the judgment, which is currently pending.
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Cancellation Proceedings – DE’961, DE‘974, and DE’575
In November 2022, we filed cancellation actions seeking the cancellation of the three German Utility Models in
the German Patent and Trademark Office. On December 27, 2023, the German Patent and Trademark Office
issued a preliminary opinion that DE’974 is likely to be cancelled. On
January 23, 2024, the German Patent and
Trademark Office issued a preliminary opinion that DE’961 is likely to be cancelled based on invalidity pursuant
to para. 1 (2) no. 5 Utility Model Act. On March 7, 2024, the German Patent and Trademark Office issued a
preliminary opinion that DE’575 is likely to be cancelled. On June 6, 2024, CureVac submitted a written
statement to the German Patent and Trademark Office waiving DE’575. On June 12, 2024, we withdrew our
request for cancellation of DE’575. On June 25 and 26, 2024, the German Patent and Trademark Office heard
oral arguments regarding DE’961 and DE’974, and at the conclusion of the hearing on June 26, 2024, confirmed
that both DE’961 and DE’974 were cancelled. In November 2024, the German Patent and Trademark Office
issued its written decisions cancelling DE’961 and DE’974. CureVac has filed an appeal in both cancellation
proceedings, which are currently pending.
Cancellation Proceedings– DE’123 and DE’130
In November 2023, we filed cancellation actions seeking the cancellation of German Utility Models DE’123 and
DE’130 in the German Patent and Trademark Office. On June 6, 2024, CureVac submitted a written statement to
the German Patent and Trademark Office waiving DE’123. On June 12, 2024, we withdrew our request for
cancellation of DE’123. On December 5, 2024, the German Patent and Trademark Office issued a preliminary
opinion that DE’130 is likely to be cancelled.
United States
In July 2022, we and Pfizer filed a complaint for a declaratory judgment in the U.S. District Court for the District
of Massachusetts, seeking a judgment of non-infringement by
Comirnaty
of U.S. Patent Nos. 11,135,312;
11,149,278; and 11,241,493. In May 2023, the action in the U.S. District Court for the District of Massachusetts
was transferred to the U.S. District Court for the Eastern District of Virginia, where CureVac filed counterclaims
asserting infringement of six additional U.S. patents, U.S. Patent Nos. 10,760,070; 11,286,492; 11,345,920;
11,471,525; 11,576,966; and 11,596,686. In July 2023, CureVac filed amended counterclaims to assert an
additional U.S. patent, U.S. Patent No. 11,667,910. In June 2024, CureVac voluntarily dismissed with prejudice
its claims of infringement with respect to the ‘493, ‘525, and ‘966 patents. Currently, a three-week jury trial is
scheduled to begin on March 3, 2025, and an one-week bench trial regarding the prosecution laches defense is
scheduled to begin on April 15, 2025.
United Kingdom
In September 2022, we and Pfizer filed a declaration of non-infringement and revocation action against EP’122
and EP’668 in the Business and Property Courts of England and Wales, in the UK High Court of Justice, or the
UK High Court. In October 2022, CureVac responded by filing a counterclaim alleging infringement of the EP’122
and EP’668 patents in the Business and Property Courts of England and Wales, in the UK High Court. On
December 18, 2023, we and Pfizer amended our pleadings to add a claim for revocation and declarations of
invalidity and non-infringement with respect to EP’755. The UK High Court held a trial on EP’668 and EP’755
between July 10, 2024 and July 24, 2024. On October 8, 2024, the UK High Court released a judgment finding
both EP’668 and EP’755 invalid. The UK High Court held a hearing on November 15, 2024, during which it
denied CureVac permission to appeal the judgment. On December 5, 2024, CureVac sought permission from the
UK Appeals Court to appeal the judgment. With respect to EP’122, on October 25, 2024, CureVac agreed to a
final and unappealable revocation of the UK designation of EP’122 and to discontinue its counterclaim for
infringement.
We believe we have strong defenses against the allegations claimed relative to each of the patents and utility
models and intend to vigorously defend ourselves in the proceedings mentioned above. However, our analysis of
CureVac’s claims is ongoing and complex, and we believe the ultimate outcomes remain substantially uncertain.
Taking into account discussions with our external lawyers, we do not consider the probability of an outflow of
resources to be sufficient to recognize a provision at the balance sheet date. In our opinion, these matters
constitute contingent liabilities as of the balance sheet date. However, it is currently impractical for us to estimate
with sufficient reliability the respective contingent liabilities.
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Moderna Proceedings
Germany
Infringement Proceedings – EP’949 and EP’565
In August 2022, Moderna filed a lawsuit against us and our wholly owned subsidiaries, BioNTech Manufacturing
GmbH, BioNTech Europe GmbH and BioNTech Manufacturing Marburg GmbH, as well as Pfizer, Pfizer
Manufacturing Belgium NV and Pfizer Ireland Pharmaceuticals in the Düsseldorf Regional Court alleging
Comirnaty
’s
infringement of two European patents, 3590949B1, or EP’949, and 3718565B1, or EP’565. On
November 7, 2023, the Opposition Division of the EPO revoked EP’565 after a one-day oral hearing, and on
December 7, 2023, it issued its written decision revoking EP’565. On December 8, 2023, the Opposition Division
issued a preliminary opinion noting that it believes EP’949 is likely invalid. As a result of those developments in
the EPO proceedings, the Düsseldorf Regional Court postponed its hearing on infringem
ent with respect to
EP’949, originally scheduled for December 12, 2023, to January 21, 2025. On February 7, 2024, Moderna
appealed the Opposition Division’s revocation decision on EP’565, and the appeal is currently pending. On May
16, 2024, the Opposition Division decided that EP’949 is valid, in amended form, and issued its written decision
regarding the same on July 8, 2024. BioNTech appealed this decision, and the appeal is currently pending.
United Kingdom
In August 2022, Moderna filed a lawsuit asserting
Comirnaty
’s infringement of EP’949 and EP’565 against us
and our wholly owned subsidiaries, BioNTech Manufacturing GmbH, BioNTech Europe GmbH and BioNTech
Manufacturing Marburg GmbH, and Pfizer Limited, Pfizer Manufacturing Belgium NV and Pfizer Inc. in the
Business and Property Courts of England and Wales, in the UK High Court. In September 2022, we and Pfizer
filed a revocation action in the Business and Property Courts of England and Wales requesting revocation of
EP’949 and EP’565.
The UK High Court held a trial between April 22, 2024, and May 21, 2024. On July 2, 2024, the UK High Court
released two judgments. The first judgment concerns the validity of EP’949 and EP’565. In this first judgment,
the UK High Court found that EP’565 is invalid and therefore not infringed, while EP’949 is valid and infringed.
The second judgment concerns whether Moderna’s October 2020 commitment not to “enforce [its] COVID-19
related patents against those making vaccines intended to combat the pandemic,” or the Patent Pledge,
amounted to a consent under UK law to carry out any acts that would otherwise amount to patent infringement.
With respect to this judgment, the UK High Court found that Moderna’s Patent Pledge amounted to consent to
carry out activities that might otherwise infringe its patents prior to March 2022, but not after March 2022.
The UK High Court held a hearing on September 25, 2024, during which it granted Pfizer and BioNTech
permission to appeal its judgment regarding the validity of EP’949, and denied Moderna permission to appeal its
judgment regarding validity of EP’565. On October 16, 2024, Moderna sought permission from the UK Appeals
Court to appeal the EP'565 judgment. On November 11, 2024, the UK Appeals Court denied Moderna’s
application to appeal; accordingly, the UK designation of EP'565 is finally revoked with no further opportunity to
appeal in the UK. No party sought permission to appeal the UK High Court’s judgment on the patent pledge.
United States
U.S. District Court Litigation
In August 2022, Moderna filed a lawsuit in the U.S. District Court for the District of Massachusetts against us and
our wholly owned subsidiaries BioNTech Manufacturing GmbH and BioNTech US Inc. and Pfizer Inc. alleging
Comirnaty
’s infringement of U.S. Patent Nos. 10,898,574; 10,702,600 and 10,933,127 and seeking monetary
relief. On April 12, 2024, the U.S. District Court for the District of Massachusetts stayed the litigation pending
resolution of the
inter partes
review of U.S. Patent Nos. 10,702,600 and 10,933,127.
Inter Partes Review
In August 2023, Pfizer and we filed petitions seeking inter partes review of U.S. Patent Nos. 10,702,600 and
10,933,127 before the United States Patent Trial and Appeal Board, or the PTAB. On March 6, 2024, the PTAB
issued decisions institutin
g
inter partes
review proceedings on all challenged claims of U.S. Patent Nos.
10,702,600 and 10,933,127. An oral hearing on the merits occurred on December 10, 2024, and a first-instance
decision by the PTAB is expected by March 2025.
184
Annual Report on Form 20-F for the
year ended December 31, 2024
Netherlands
In September 2022, Moderna filed a lawsuit against us and our wholly owned subsidiary BioNTech
Manufacturing GmbH and Pfizer B.V., Pfizer Export B.V., C.P. Pharmaceuticals International C.V. and Pfizer Inc.
in the District Court of The Hague alleging
Comirnaty
’s infringement of EP‘949 and EP’565. The District Court of
the Hague held a hearing on October 6, 2023, on infringement and validity with respect to EP’949. On December
6, 2023, the Court found EP’949 to be invalid. On March 5, 2024, Moderna appealed this decision, and the
appeal is pending. The EP’565 case has been stayed pending the outcome of Moderna’s appeal of the
Opposition Division’s revocation of EP’565.
Ireland
In May 2023, Moderna filed a lawsuit against us and our wholly owned subsidiary BioNTech Manufacturing
GmbH, Pfizer Inc., Pfizer Healthcare Ireland, Pfizer Ireland Pharmaceuticals, and C.P. Pharmaceuticals
International C.V. alleging
Comirnaty
’s infringement of EP’949 and EP’565 in the High Court of Ireland. On
February 26, 2024, the High Court of Ireland stayed the lawsuit pending the final determination of the EPO
opposition proceedings for EP’949 and EP’565 (in each case including any appeals).
Belgium
In May 2023, Moderna filed a lawsuit against us, our wholly owned subsidiary BioNTech Manufacturing GmbH,
Pfizer Inc. and Pfizer Manufacturing Belgium alleging
Comirnaty
’s infringement of EP’949 and EP’565 in the
Brussels Dutch-speaking Enterprise Court. On May 29, 2024, the parties filed a joint request to stay the
proceedings, which was entered by the Enterprise Court.
All of the above proceedings are currently pending
.
We believe we have strong defenses against the allegations claimed relative to each of the patents and intend to
vigorously defend ourselves in the proceedings mentioned above. However, our analysis of Moderna’s claims is
ongoing and complex, and we believe the outcome of the suit remains substantially uncertain.
Taking into
account discussions with our external lawyers, we do not consider the probability of an outflow of resources to
be sufficient to recognize a provision at the balance sheet date. In our opinion, these matters constitute
contingent liabilities as of the balance sheet date. However, it is currently impractical for us to estimate with
sufficient reliability the respective contingent liabilities.
Arbutus and Genevant Proceedings
In April 2023, Arbutus and Genevant filed a lawsuit against Pfizer and us in the U.S. District Court for the District
of New Jersey alleging that Pfizer and we have infringed the following patents owned by Arbutus: U.S. Patent
Nos. 9,504,651; 8,492,359; 11,141,378; 11,298,320; and 11,318,098, through the use of Genevant’s lipid
nanoparticle technology and methods for producing such lipids in
Comirnaty
, and seeking monetary relief. This
proceeding is currently pending.
We believe we have strong defenses against the allegations claimed relative to each of the patents and intend to
vigorously defend ourselves in the lawsuit mentioned above. However, our analysis of Arbutus and Genevant’s
claims is ongoing and complex, and we believe the outcome of the suit remains substantially uncertain
. Taking
into account discussions with our external lawyers, we do not consider the probability of an outflow of resources
to be sufficient to recognize a provision at the balance sheet date. In our opinion, these matters constitute
contingent liabilities as of the balance sheet date. However, it is currently impractical for us to estimate with
sufficient reliability the respective contingent liabilities.
GlaxoSmithKline Proceedings
In April 2024, GSK filed a lawsuit against Pfizer, Pharmacia & Upjohn Co. LLC, BioNTech SE, BioNTech
Manufacturing GmbH, and BioNTech US Inc. in the United States District Court for the District of Delaware
alleging that the cationic lipid used in COMIRNATY
®
infringes U.S. Patent Nos. 11,638,693; 11,638,694;
11,666,534; 11,766,401; and 11,786,467; and seeking monetary relief. On August 14, 2024, GSK filed an
amended complaint to assert infringement of three additional patents, U.S. Patent Nos. 11,759,422; 11,655,475;
and 11,851,660. This proceeding is currently pending.
185
Annual Report on Form 20-F for the
year ended December 31, 2024
We believe we have strong defenses against the allegations claimed relative to each of the patents and intend to
vigorously defend ourselves in the lawsuit mentioned above. However, our analysis of GSK’s claims is ongoing
and complex, and we believe the outcome of the suit remains substantially uncertain.
Taking into account
discussions with our external lawyers, we do not consider the probability of an outflow of resources to be
sufficient to recognize a provision at the balance sheet date. In our opinion, these matters constitute contingent
liabilities as of the balance sheet date. However, it is currently impractical for us to estimate with sufficient
reliability the respective contingent liabilities.
Ladewig Proceedings
In January 2024, we and certain of our officers and directors were named as defendants in a securities class
action complaint captioned Ladewig v. BioNTech SE filed in the U.S. District Court for the Central District of
California brought on behalf of a putative class of investors who purchased our securities from March 30, 2022
through October 13, 2023. Plaintiffs allege that we violated Sections 10(b) and 20(a) of the Exchange Act by
stating that we were “well positioned” to remain a “market leader” in vaccines for the prevention of COVID-19
and by purportedly overstating demand for Comirnaty. Plaintiffs further allege that we failed to adapt our
inventory to reflect the emergence of new COVID variants. On July 15, 2024, the case was transferred to the
U.S. District Court for the Southern District of New York.
We believe we have strong defenses against the allegations claimed and intend to vigorously defend ourselves
in the lawsuit mentioned above. We cannot reasonably estimate the maximum potential exposure or the range of
possible loss for this matter. Taking into account discussions with our external lawyers, we do not consider the
probability of an outflow of resources to be sufficient to recognize a provision at the balance sheet date. In our
opinion, these matters constitute contingent liabilities as of the balance sheet date. However, it is currently
impractical for us to estimate with sufficient reliability the respective contingent liabilities.
For additional information about events and developments since the end of the calendar year ended December
31, 2024, please see Note 22 to our consolidated financial statements included elsewhere in this Annual Report.
C. Organizational Structure
See Item 18.
D. Property, Plant and
Equipmen
t
The following is a summary of our principal owned and leased real estate. We also lease other properties in the
ordinary course of business as part of our global operations.
Germany:
Our headquarters are located in Mainz
, where we principally occupy:
•
Approximately 10,780 square meters of laboratory, GMP manufacturing, storage and office space at An
der Goldgrube 12, 55131. We have owned the building and the land on which it stands since January 1,
2023.
•
Approximately 4,000 square meters of office space at Freiligrathstraße 6, 55131 under a lease that has
been extended until December 31, 2027.
•
Approximately 8,110 square meters of office and laboratory container space, including ancillary space, at
Freiligrathstraße 6, 55131. The lease of the office container space expires on June 30, 2027. We own
the laboratory container space.
•
Approximately 1,000 square meters of office and GMP manufacturing space under a lease for part of the
building located at Kupferbergterrasse 15, 55161 that expires on March 31, 2027.
•
A 3,950-square-meter laboratory and office building at Adam-Opel-Strasse 10, 55129, which we own. On
the approximately 13,000-square-meter property, there is also an undeveloped area for a planned
186
Annual Report on Form 20-F for the
year ended December 31, 2024
laboratory and office building with a size of up to 12,000 square meters. Currently, a 2,125-square-meter
office containers are located in this area. The
containers are rented
until the end of December 2026.
•
An office building, “Haus 4,” at Hechtsheimer Straße 2c, with approximately 7,000 square meters of total
space. The building is a freehold asset.
•
Approximately 42,100 square meters of office space under a lease for two of three building parts at
Große Bleiche 54-56, 55131, under a lease that expires on December 31, 2029.
We intend to expand our capacity in Mainz as follows:
•
In January 2022, we commenced construction of a four-story building that we will own at An der
Goldgrube 10. We have planned laboratory space for research and development, offices, storage
facilities, a conference center and cafeteria. As a result, we will have an additional 2,400 square meters
of laboratory space and 4,050 square meters of office space. Completion is planned for mid-2025.
•
We also own a plot of land of approximately 8,750 square meters at Hechtsheimer Straße 2b, 55131,
where construction for a GMP manufacturing facility of approximately 18,000 square meters in total
commenced in 2021. Completion is planned for 2025. The start of operations is planned for 2026.
In Idar-Oberstein:
•
The IMFS facility (consisting of buildings A to E and J) has a total area of approximately 13,470 square
meters. This includes approximately 2,660 square meters of storage space, approximately 1,270 square
meters of development and QC laboratory space, approximately 1,650 square meters of clean rooms,
and approximately 2,540 square meters of office space. We own this facility, including the GMP-certified
manufacturing suites.
◦
We occupy approximately 575 square meters of this space, which is used primarily for storage,
under a lease that has an initial expiry date of October 1, 2021, but which we have extended
until September 30, 2026. The warehouse is in Tiefenstein.
◦
We have been renting the warehouse for GMP products since April 2022. The warehouse has
an area of 1,156 square meters. The term is 5 years with the option to extend.
◦
Rental of a plot of land with 2,916 square meters. A container facility was built on it. The office
container facility has a size of approximately 1,474 square meters. Both contracts currently run
until June 2025. We intend to extend both contracts until December 2029.
In Marburg:
Behringwerke
•
Our main manufacturing facility (H028) consists of 10,240 square meters, including 4,589 square meters
of GMP space, 2,422 square meters of technical and warehouse space, 540 square meters of laboratory
space and 2,690 square meters of office space. Effective January 1, 2025, we have also leased
additional 2,977 square meters space on the 1st and 2nd floors (H028), bringing the total leased space
to 13,217 square meters.
The lease expires on December 31, 2034.
•
Our main office building (H001) consists of 4,913 square meters of office space. The lease expires on
October 31, 2027.
Görzhausen
•
As part of our
BioNTainer
program (BioNTech Innovation Center/BIC, M102), we occupy approximately
2,040 square meters. Approximately 804 square meters are used as office space and 1,236 square
meters as GMP and technical storage space under a lease that expires on December 31, 2031.
187
Annual Report on Form 20-F for the
year ended December 31, 2024
•
Our Plasmid Production/Miami (Microbial Manufacturing, M537) comprises 3,088 square meters,
including 1,021 square meters of usable GMP and laboratory space, 1,065 square meters of usable
technical and warehouse space and 448 square meters of usable office space. The lease expires on
December 31, 2031.
In Berlin:
•
At our JPT facility, we occupy approximately 2,300 square meters of laboratories, general technical
production space, storage and offices.
•
About 2,000 square meters are occupied under a lease contract that will expire when we move into our
new building.
•
A new laboratory and office building, wholly owned by JPT, is under construction, with an expected
completion date in mid-2025.
•
We have been renting an office of approximately 1,700 square meters since April 2023. The contract
runs until December 31, 2028, and may be extended.
In Munich
, we have leased approximately 3,700 square meters in the Werksviertel. The lease is for 60 months
with options to extend.
In Neuried:
•
We occupy approximately 1,732 square meters of laboratory and office space under a lease which will
expire on November 30, 2031.
•
We leased additional space in July 2022 of approximately 1,470 square meters of laboratory, office and
storage space under a lease which will expire on August 30, 2029.
In Fussgoenheim
, we lease approximately 3,448 square meters of freezer farm space. The term ends on
December 31, 2027.
In Mutterstadt
, we occupy approximately
5,744 square meters
of freezer farm space under a rental agreement.
We also lease a further
2,160 square meters of handling space. The term ends on December 31, 2027, with a
one-year extension option.
Global locations:
In Cambridge
, Massachusetts, United States, we principally occupy:
•
Approximately 2,490 square meters of laboratory and office space under a lease for part of a building
located at 40 Erie Street. The term was extended and will expire on September 30, 2028.
•
Approximately
4,410
square meters of laboratory and office space under a lease for part of a building
located at 75 Sidney Street that has an initial term that expires on January 31, 2032.
In Gaithersburg
, Maryland, United States, we principally occupy:
•
Approximately 5,476 square meters containing office, laboratory and manufacturing space at 930 / 940
Clopper Road under a lease which will expire on July 31, 2033.
•
Approximately 1,000 square meters containing office and laboratory space at 25 West Watkins under a
lease which will expire on November 30, 2033.
In Cambridge
, United Kingdom, we principally occupy:
188
Annual Report on Form 20-F for the
year ended December 31, 2024
•
Approximately 7,400 square meters of shell and core laboratory and office space under a lease with an
initial term until October 13, 2033, including a tenant-only break option at year seven of the term. The
building is expected to be in operation during 2026.
In Vienna
, Austria, we signed a lease in September 2022 for approximately 1,300 square meters of office and
laboratory space for part of the building located at Helmut-Qualtinger-Gasse 2, 1030. The lease commenced on
April 1, 2023, with a lease term of eight years and an option to extend.
In Kigali
, Rwanda, we have leased a plot of land of approximately 35,100 square meters to develop a modular
mRNA vaccine factory for the manufacturing of bulk drug substance and bulk drug product.
In Singapore
, we own a production site. The entire area covers approximately 63,300 square meters. There is
office space of approximately 6,195 square meters, a production and technical building of approximately 20,000
square meters, and a warehouse of approximately 3,400 square meters.
In Melbourne
, Australia, we have leased a plot of land of approximately 26,100 square meters at La Trobe
University to develop a freehold modular R&D and manufacturing center.
In Paris,
France, our subsidiary InstaDeep signed a lease agreement for approximately 1,200 square meters of
office space with an initial term until December 31, 2029.
The
acquisition of Biotheus, which closed in January 2025,
is set to provide us with a significant infrastructure
component in Mainland China. The material sites are as follows:
•
A freehold manufacturing facility in Nantong, covering an area of approximately 62,000 square meters.
While most of the site is currently in a shell and core condition, it is intended to be developed further to
support additional capacity.
•
A leasehold asset in the form of the current Biotheus headquarters in Zhuhai, which comprises office,
lab, and pilot manufacturing space totaling approximately 5,500 square meters. The leases for the
building are structured between floors, with terms expiring between 2025 and 2027.
Item 4A. Unresolved Staff Comments
None.
Item
5
. Operating and Financial Review and Prospects
The following “Operating and Financial Review and Prospects” discussion should be read together with the
information in our financial statements and related notes included elsewhere in this Annual Report. The following
discussion is based on our financial information prepared in accordance with IFRS as issued by the International
Accounting Standards Board, or IASB, which may differ in material respects from generally accepted accounting
principles in other jurisdictions, including U.S. GAAP. The following discussion includes forward-looking
statements that involve risks, uncertainties and assumptions. Our actual results may differ materially from those
anticipated in these forward-looking statements as a result of many factors, including but not limited to those
described in “Risk Factors” and elsewhere in this Annual Report. Please also see “Cautionary Statement
Regarding Forward-Looking Statements.”
189
Annual Report on Form 20-F for the
year ended December 31, 2024
A.
Operating
Results
Financial Operations Overview
The following table shows our consolidated statements of profit or loss for each period
presented
:
|
Years ended
December 31,
|
|||||||||
|
(in millions €)
|
2024
|
2023
|
2022
|
||||||
|
Revenues
|
2,751.1
|
3,819.0
|
17,310.6
|
||||||
|
Cost of sales
|
(541.3)
|
(599.8)
|
(2,995.0)
|
||||||
|
Research and development expenses
|
(2,254.2)
|
(1,783.1)
|
(1,537.0)
|
||||||
|
Sales and marketing expenses
|
(67.9)
|
(62.7)
|
(59.5)
|
||||||
|
General and administrative expenses
(1)
|
(531.1)
|
(495.0)
|
(481.7)
|
||||||
|
Other operating expenses
(1)
|
(811.5)
|
(293.0)
|
(410.0)
|
||||||
|
Other operating income
|
140.6
|
105.0
|
815.3
|
||||||
|
Operating profit / (loss)
|
(1,314.3)
|
690.4
|
12,642.7
|
||||||
|
Finance income
|
664.0
|
519.6
|
330.3
|
||||||
|
Finance expenses
|
(27.4)
|
(23.9)
|
(18.9)
|
||||||
|
Profit / (Loss) before tax
|
(677.7)
|
1,186.1
|
12,954.1
|
||||||
|
Income taxes
|
12.4
|
(255.8)
|
(3,519.7)
|
||||||
|
Net profit / (loss)
|
(665.3)
|
930.3
|
9,434.4
|
||||||
|
Earnings / (Loss) per share
|
|||||||||
|
Basic earnings / (loss) per share
|
(2.77)
|
3.87
|
38.78
|
||||||
|
Diluted earnings / (loss) per share
|
(2.77)
|
3.83
|
37.77
|
||||||
(1)
Adjustments to the year 2022 figures
due to change in functional allocation of general and administrative expenses and
other operating expenses.
Comparison
of the year ended
December 31, 2024
and the year ended
December 31, 2023
Revenues
The following is a summary of revenues recognized for the periods
indicated
:
|
Years ended
December 31,
|
Change
|
|||||||||||
|
(in millions €)
|
2024
|
2023
|
€
|
%
|
||||||||
|
COVID-19 vaccine revenues
|
2,432.1
|
3,776.2
|
(1,344.1)
|
(36)
|
||||||||
|
Other revenues
|
319.0
|
42.8
|
276.2
|
645
|
||||||||
|
Total revenues
|
2,751.1
|
3,819.0
|
(1,067.9)
|
(28)
|
||||||||
COVID-19 vaccine revenues
During the
year ended December 31, 2024
, COVID-19 vaccines revenues were recognized from the supply and
sales of our COVID-19 vaccine worldwide, mainly comprising our share of the collaboration partner’s gross profit
derived from sales in the collaboration partner’s territory. During the
year ended December 31, 2024
, our
commercial revenues decreased as compared to the year ended December 31, 2023, in line with a lower
COVID-19 vaccine market demand. In addition, write-downs by our collaboration partner Pfizer, significantly
reduced our gross profit share and hence negatively influenced our revenues for the
year ended December 31,
190
Annual Report on Form 20-F for the
year ended December 31, 2024
2024
. Our COVID-19 vaccine revenues are subject to seasonal effects in the fall / winter of the northern
hemisphere.
Other revenues
During the
year ended December 31, 2024
, our other revenues were mainly derived from a pandemic
preparedness contract with the German government effectively supplemented in the three months ended March
31, 2024.
Cost of Sales
From the
year ended December 31, 2023
, to the
year ended December 31, 2024
, cost of sales
decreased
by
€58.5 million
, or
10
%, from
€599.8 million
to
€541.3 million
,
mainly due to recognizing lower cost of sales from
our decreased COVID-19 vaccine sales, which included the share of gross profit that we owe our collaboration
partner
Pfizer based on our sales.
In addition, cost of sales was impacted by expenses arising from inventory
write-downs and scrapings in the context of the launch of our variant adapted COVID-19 vaccine in the amount
of
€125.8 million
during the
year ended December 31, 2024
(
€94.5 million
for
year ended December 31, 2023
).
Research and Development Expenses
The following table summarizes our research and development expenses for the periods indicated:
|
Years ended
December 31,
|
Change
|
|||||||||||
|
(in millions €)
|
2024
|
2023
|
€
|
%
|
||||||||
|
Non-COVID-19 vaccine
|
2,018.2
|
1,470.1
|
548.1
|
37
|
||||||||
|
COVID-19 vaccine
|
236.0
|
313.0
|
(77.0)
|
(25)
|
||||||||
|
Total research and development expenses
|
2,254.2
|
1,783.1
|
471.1
|
26
|
||||||||
(1)
Break-down as per internal cost allocation logic.
From the
year ended December 31, 2023
, to the
year ended December 31, 2024
, our research and development
expenses
increased
by
€471.1 million
, or
26
%, from
€1,783.1 million
to
€2,254.2 million
,
mainly influenced by
advancing key pipeline candidates, such as our ADC antibody and individualized cancer-immunotherapy product
candidates. Further contributions to the increase came from higher personnel expenses resulting from an
increase in headcount.
Sales and Marketing Expenses
From the
year ended December 31, 2023
, to the
year ended December 31, 2024
, our sales and marketing
expenses
increased
by
€5.2 million
, or
8
%, from
€62.7 million
to
€67.9 million
,
mainly due to increased expenses
for setup and enhancement of commercial IT platforms and an increase in personnel expenses resulting from an
increase in headcount.
General and Administrative Expenses
From the
year ended December 31, 2023
,
to the
year ended December 31, 2024
, our general and administrative
expenses
increased
by
€36.1 million
, or
7
%, from
€495.0 million
to
€531.1 million
,
mainly influenced by
increased expenses for IT services as well as by an increase in personnel expenses resulting from an increase
in headcount.
Othe
r Operating Result
From
the
year ended December 31, 2023
, to the
year ended December 31, 2024
, o
ur
o
ther result
decreased
by
€482.9 million
, or
257
%, from
negative
€188.0 million
to a
negative
result of
€670.9 million
. The
decreased
other
operating result
was mainly due to the settlement of contractual disputes and related expenses to such disputes
191
Annual Report on Form 20-F for the
year ended December 31, 2024
and other litigations. The amounts shown for contractual disputes are net of the related reimbursements to be
received.
Finance Result
From
the
year ended December 31, 2023
, to the
year ended December 31, 2024
,
our total financial result
increased
by
€140.9 million
from a
positive
financial result of
€495.7 million
to a
positive
financial result of
€636.6
million
, which was driven by
interest income earned on security investments as bonds, commercial paper,
reverse repos and deposits as well as fair value adjustments in relation to our money market funds.
Income Taxes
The following table summarizes our income taxes for the periods indicated:
|
Years ended
December 31,
|
Change
|
|||||||||||
|
(in millions €)
|
2024
|
2023
|
€
|
%
|
||||||||
|
Current income taxes
|
(2.3)
|
243.1
|
(245.4)
|
(101)
|
||||||||
|
Deferred taxes
|
(10.1)
|
12.7
|
(22.8)
|
(180)
|
||||||||
|
Income taxes expenses / (income)
|
(12.4)
|
255.8
|
(268.2)
|
(105)
|
||||||||
Our current income taxes represent mainly corporate and trade taxes derived by our German tax
group. The
decrease in profit during the
year ended December 31, 2024
,
as compared to the
year ended December 31,
2023
, led t
o lower taxable income
for the
year ended December 31, 2024
, for the German tax group. Corporate
and trade tax prepayments have been made exceeding the tax charge. Refunds will become due once tax
declarations have been filed and assessed.
As of
December 31, 2024
, our accumulated tax losses comprised tax losses of German entities that were
incurred prior to the establishment of a tax group with BioNTech SE or by entities that are not within the tax
group or U.S. tax group
.
The amount of deductible temporary differences, unused tax losses, and unused tax credits for which no
deferred tax asset is recognized in the statement of financial position as of
December 31, 2024
, was
€2,028.8
million
. Thus, a
s of
December 31, 2024
, we have not recognized deferred tax assets for unused tax losses and
temporary differences in an amount
of
€332.4 million
(
December 31, 2023
:
€138.0 million
)
as the criteria of the
recognition guidance for IAS 12, which requires that no reliance should be placed on future events that cannot
be controlled and are uncertain, are not met. Unrecognized deferred tax assets are re-assessed at each
reporting date and are recognized to the extent that it has become probable that future taxable profits will allow
the deferred tax asset to be recovered.
As of
December 31, 2024
, we maintain the non-recognition of deferred tax assets for unused U.S. federal and
state tax losses and tax credits at an amount of
€30.5 million
and
€4.0 million
, respectively, as there is not
sufficient probability in terms of IAS 12 that future taxable income will be available against which these unused
tax losses and tax credits can be utilized. The material unrecognized U.S. federal and state tax losses and tax
credits will begin to expire in 2036
.
The realization of deferred tax assets is dependent upon the generation of future taxable in
come, the amount
and timing of which are subject to uncertainties. We may become subject to income tax audits and adjustments
by local tax authorities. The
asse
ssments of the recoverability
of deferred tax
assets and the nature of uncertain
tax positions are subject to significant judgment by management and subject to change
.
The group does not recognize deferred tax liabilities for taxable temporary differences associated with
investments in subsidiaries, in cases where the group is able to control the timing of the reversal of the
temporary difference and it is probable that the temporary differences will not reverse in the foreseeable future.
192
Annual Report on Form 20-F for the
year ended December 31, 2024
The aggregate amount of temporary differences associated with investments in subsidiaries, for which deferred
tax liabilities have not been recognized is
€14.5 million
.
Information about Our Operating Segments
Decisions with respect to business operations and resource allocations are made by our Management Board, as
the chief operating decision maker based on BioNTech as a whole. Accordingly, we operate and make decisions
as a single operating segment, which is also our reporting segment.
Related Party Transactions
Related party transactions that occurred during th
e
years ended December 31, 2024 and 2023
are
explained in
Item 7
.
of this Annual Report as well as in Note
21
of our consolidated financial statements included elsewhere in
this Annual Report.
Key Performance Indicators
Financial key performance indicators
The following financial performance indicators are the focus of managing our operational business development.
We use the key figures on the basis of current exchange rates (not currency-adjusted) and take into account the
effects of potential M&A activities or collaborations to the extent that they are published.
R
evenues
Total revenues mainly
comprise
expected commercial revenue, particularly in connection with our COVID-19
business as well as other revenue sources. Revenues are
heavily influenced by the volumes available under the
collaboration and the agreed upon purchase quantities
. Our revenues include our share of the collaboration
partners' gross profit and, hence, are also influenced by the incurring costs. For further information on the
composition of commercial COVID-19 vaccine sales and the components contained therein, see the comments
on revenues under Item 5. Operating Results. Our sales serve as a performance indicator of our commercial
earning power.
Research and development expenses
Research and development expenses are an indicator of our future earnings potential, as this is highly
dependent on the development of the clinical pipeline and t
he responsible use of the financial resources
generated
. This figure mainly includes expenses for the development of our clinical product candidates, early
exploratory research and research and development overhead costs.
Sales, general and administrative expenses
These costs include sales and marketing costs as well as general and administrative costs. We use this
measure to manage the costs associated with the expansion of the sales and marketing organization to ensure
the necessary infrastructure and digital capacity for future market-ready products, as well as to manage the
internal administrative and coordination functions associated with the expansion of research and development,
such as finance, human resources, or business development, with regard to the associated cost development.
In addition, we also use the following financial performance indicators:
Capital expenditures for operating activities
Capital expenditures for operating activities include expenditures for the acquisition of property, plant and
equipment as well as expenditures for the acquisition of intangible assets and rights of use, unless they are
made as part of business combinations. These mainly include expenditures for the expansion and improvement
of our research and development as well as manufacturing facilities and investments in a state-of-the-art IT
infrastructure to support the company in all digitization projects.
Non-financial key performance indicators
R&D Pipeline progress
Progress in research achievements,
s
uch as initiating registration-directed studies and advancing towards first
BLA submission
, is a key performance indicator. We are working to clinically demonstrate the benefit of
193
Annual Report on Form 20-F for the
year ended December 31, 2024
additional treatment approaches, further develop additional product candidates in the form of pivotal studies, and
continuously expand collaborations and manufacturing capabilities to offer innovative treatments to patients
around the world.
B.
Liquidity and Capital
Resources
Given our strong financial, scientific and operational accomplishments, we believe we have the resources to
diligently allocate our current capital to drive a multi-platform strategy and deliver a fully integrated global
biotechnology company. We focus our R&D, on rapidly advancing our diversified clinical oncology pipeline with
synergistic potential, developing next generation COVID-19 vaccines to maintain leadership and pandemic
preparedness, as well as broadening the label of and access to the existing vaccine. We also plan to invest
heavily to build out our global development organization, bringing in talent with clinical and regulatory expertise
needed to accelerate our pipeline development. We are also diversifying our therapeutic area footprint, which will
enable us to fully leverage the potential of all technology platforms across autoimmune diseases, inflammatory
diseases, cardiovascular disease, neurodegenerative diseases, and regenerative medicines.
In addition, we plan
to enhance capabilities through complementary acquisitions, technologies, infrastructure and manufacturing.
To
support our future trajectory, growing the organization and expanding our team is of utmost importance.
Additionally, investing in manufacturing capabilities for key technologies, deploying our global footprint in key
regions including Europe, the United States, Asia and Africa and building a targeted AI-enabled
commercialization team in key markets remain priorities for us. As a science and innovation driven company, we
will continue to focus investments on R&D and scaling the business for
commercial readiness
in oncology in
multiple countries by the end of 2025.
As of
December 31, 2024
, we had cash and cash equivalents of
€9,761.9 million
, current security investments of
€6,536.2 million
and non-current security investmen
ts of
€1,061.1 million
accumulating to
€17,359.2 million
in
cash, cash equivalents and security investments.
In general, the aim is to protect and maximize the financial
resources available for further research and development projects.
Cash and cash equivalents and financial securities are invested in accordance with our asset management and
investment policy, primarily with a focus on liquidity and capital preservation, and consist primarily of cash in
bank accounts and on hand as well as long- and short-term financial investments
.
Cash Flow
The following table summarizes the primary sources and uses of cash for each period presented:
|
Years ended
December 31,
|
||||||||
|
(in millions €)
|
2024
|
2023
|
2022
|
|||||
|
Net cash flows from / (used in):
|
||||||||
|
Operating activities
|
207.7
|
5,371.4
|
13,577.4
|
|||||
|
Investing activities
|
(2,081.2)
|
(6,954.5)
|
(35.3)
|
|||||
|
Financing activities
|
(45.9)
|
(778.6)
|
(1,419.3)
|
|||||
|
Total cash inflow / (outflow) before change in cash and cash
equivalents resulting from exchange rate differences and
other valuation effects
|
(1,919.4)
|
(2,361.7)
|
12,122.8
|
|||||
Operating Activities
We derive cash flows from operations primarily from the sale of products and services rendered. Our cash flows
from operating activities are significantly influenced by cash
we generate from our COVID-19 vaccine
194
Annual Report on Form 20-F for the
year ended December 31, 2024
collaboration under which we receive a share of our collaboration partner’s gross profit
as well as our use of
cash for operating expenses and working capital to support the business.
Cash received from our revenue streams exceeded the cash payments for our operating activities for the
year
ended December 31, 2024
, resulting in a positive cash contribution of
€184.0 million
. Additionally, the positive
cash contribution from interest and other payments related to the security investments of
€474.9 million
and
grants of
€106.0 million
were offset mainly by exercised share-based payment programs and related wage tax
payments of
€154.5 million
as well as by tax payments of
€389.2 million
. In total, the cash inflow from operating
activities was
€207.7 million
.
Net cash
generated
in operating activities for the
year ended December 31, 2023
, was
€5,371.4 million
,
comprising a profit before tax of
€1,186.1 million
,
negative
non-cash adjustments of
€393.2 million
, and a net
positive
change in assets and liabilities of
€5,574.8 million
. Non-cash items primarily included net foreign
exchange differences as well as share-based payment expenses without cash-effect. The net positive change in
assets and liabilities was primarily due to a decrease in trade receivables related to our COVID-19 collaboration
with Pfizer.
Net cash
generated
in operating activities for the
year ended December 31, 2022
, was
€13,577.4 million
,
comprising a profit before tax of
€12,954.1 million
,
positive
non-cash adjustments of
€370.9 million
, and a net
positive
change in assets and liabilities of
€4,518.5 million
. Non-cash items primarily included net foreign
exchange differences as well as share-based payment expenses without cash-effect. The net positive change in
assets and liabilities was primarily due to a decrease in trade receivables related to our COVID-19 collaboration
with Pfizer.
Investing Activities
Net cash
used
in investing activities for the
year ended December 31, 2024
, was
€2,081.2 million
. The amount
includes net inves
tments of
€1,400.1 million
spend into security investments,
€188.9 million
in equity instru
ments
and
€165.8 million
in intangibles, mainly driven from in-licensing arrangements. In addition
,
the amount for
capital expenditures supporting our operating activities amounts to
€307.1 million
whereof the majority was
related to
investments in building our laboratory and office facilities in Mainz, Germany as well as the sites in
Singapore
and
Kigali, Rwanda
.
Net cash used in investing activities for the year ended December 31, 2023, was
€6,954.5 million. The amount
includes €5,912.1 million spend into security investments, €330.6 million caused by or driven from in-licensing
arrangements as well as €336.9 million for collaborations or M&A transactions. In
addition
, the amount for capital
expenditures supporting our operating activities amounts to
€275.5 million
whereof the majority was related to
investments in building our laboratory and office facilities in Mainz, Germany.
Net cash used in investing activities for the year ended December 31, 2022, was €35.3 million, comprising the
release of €375.2 million cash deposits and compensated by €329.2 million, which was attributable to the
purchase of property, plant and equipment including the amounts spent with respect to the acquisition of the land
and laboratory as well as the office facility of our headquarter in Mainz, Germany. Intangible assets investments
amounted to €34.1 million, which was mainly attributable to certain patents and licenses. Therefore, the total
capital expenditure spent on tangible and intangible assets during the year ended December 31, 2022,
amounted to €363.3 million.
Financing Activities
Net cash
used
in financing activities for the
year ended December 31, 2024
, was
€45.9 million
, comprising
€43.6
million
used for lease payments
.
Net cash used in financing activities for the year ended December 31, 2023, was €778.6 million, comprising the
€738.5 million used for the share repurchase programs of ADS.
Net cash used in financing activities for the year ended December 31, 2022, was €1,419.3 million, comprising
the €986.4 million used for the first tranche of our $1.5 billion share repurchase program of ADS as well as the
195
Annual Report on Form 20-F for the
year ended December 31, 2024
€484.3 million special cash dividend paid in June 2022. Whereas €110.5 million cash generated was attributable
to the Pfizer equity investment as part of our HZV collaboration.
Operation and Funding Requirements
As part of our capital allocation strategy, we expect to continue to incur operating expenses for the foreseeable
future. We anticipate that our expenses will increase substantially if and as we and our collaborators:
•
continue or expand our research or development of our programs in preclinical development;
•
continue or expand the scope of our clinical trials for our product candidates;
•
initiate additional preclinical, clinical, or other trials for our product candidates, including under our
collaboration agreements;
•
continue to invest in our immunotherapy platforms to conduct research to identify novel technologies;
•
change or increase our manufacturing capacity or capability;
•
change or add additional suppliers;
•
add additional infrastructure to our quality control, quality assurance, legal, compliance and other groups
to support our operations as a public company and our product development and commercialization
efforts, including
new and expanded sites
globally
;
•
attract and retain skilled personnel;
•
seek marketing approvals and reimbursement for our product candidates;
•
devel
op our sales, marketing, and distribution infrastructure for our COVID-19 vaccine
;
•
enhance our commercial infrastructure for other product candidates for which we are seeking to obtain
marketing approval;
•
seek to identify and validate additional product candidates;
•
acquire or in-license other product candidates and technologies;
•
acquire other companies;
•
make milestone or other payments under any in-license agreements;
•
maintain, protect, defend, enforce and expand our intellectual property portfolio; and
•
experience any delays or encounter issues with any of the above.
We are a party to license and research and development agreements with universities and other third parties, as
well as patent assignment agreements, under which we have obtained rights to patents, patent applications and
know-how. We enter into contracts in the normal course of business with CROs for clinical trials and clinical and
commercial supply manufacturing, and with vendors for preclinical research studies and for other services and
products for operating purposes. We work together with CMOs who manufacture our product candidates and
products, and enter into lease agreements to lease laboratory, GMP manufacturing, storage and office spaces.
Purchase obligations under our agreements, to the extent that they are quantifiable and not cancellable, have
been considered when defining our guidance for future cash commitments. Most of the committed cash outflow
within one year is related to lease payments amounting to
€48.1 million
commitments under purchase
agreements and contractual obligations amounting to
€227.9 million
. Further, we have lease payment obligations
196
Annual Report on Form 20-F for the
year ended December 31, 2024
with an amount of
€243.0 million
and commitments under purchase agreements and contractual obligations of
€1,151.9 million
for the years 2026 and beyond.
We are subject to all of the risks related to the development and commercialization of pharmaceutical products,
and we may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that
may adversely affect our business.
Our future funding requirements, both near and long term, will depend on many factors, including, but not limited
to:
•
the initiation, progress, timing, costs, and results of preclinical or nonclinical studies and clinical trials for
our product candidates;
•
the amount and timing of revenues and associated costs from sales of our COVID-19 vaccine;
•
the results of research and our other platform activities;
•
the clinical development plans we establish for our product candidates;
•
the terms of any agreements with our current or future collaborators, and the achievement of any
milestone payments under such agreements to be paid to us or our collaborators;
•
the number and characteristics of product candidates that we develop or may in-license;
•
the outcome, timing and cost of meeting regulatory requirements established by the FDA, the EMA and
other comparable regulatory authorities;
•
the cost of filing, prosecuting, obtaining, maintaining, protecting, defending and enforcing our patent
claims and other intellectual property rights, including actions for patent and other intellectual property
infringement, misappropriation and other violations brought by third parties against us regarding our
product candidates or actions by us challenging the patent or intellectual property rights of others;
•
the effect of competing technological and market developments, including other products that may
compete with one or more of our product candidates;
•
the cost and timing of completion and further expansion of clinical and commercial scale manufacturing
activities sufficient to support all of our current and future programs;
•
the cost of establishing sales, marketing, and distribution capabilities for any product candidates for
which we may receive marketing approval and reimbursement in regions where we choose to
commercialize our products on our own; and
•
the terms of any ADS repurchases we make.
C. Research and Development, Patents and Licenses, etc.
Full details of our research and development activities and expenditures are given in Item 4 and under the
description of the “
Operating Results
” in this Item
5
within this Annual Report.
D. Trend Information
See
the description of “
Operating Results
” as well as Liquidity and Capital Resources in this Item
5
, “Business
Overview” in Item 4 and “Risk Factors” in Item 3 within this Annual Report.
197
Annual Report on Form 20-F for the
year ended December 31, 2024
E. Critical Accounting Estimates
For a discussion of our Significant Accounting Judgments, Estimates and Assumption please refer to Note
3
to
our consolidated financial statements included elsewhere in this Annual Report.
F.
Comparison
of the
year ended December 31, 2023
and the
year ended December 31, 2022
For a discussion of our operating results for the
year ended December 31, 2022
, and a comparison of the
years
ended December 31, 2023 and 2022
, please refer to Item
5
of our Annual Report on Form 20-F for the
year
ended December 31, 2023
.
Item
6
. Directors, Senior Management and Employees
A. Directors and Senior Management
Management Board (Vorstand)
In January 2024, our Supervisory Board unanimously appointed Annemarie Hanekamp to the Management
Board as our new Chief Commercial Officer (CCO), effective July 1, 2024. Annemarie Hanekamp replaced Sean
Marett, who retired as CCO and whose service contract and term of office ended prematurely by mutual
agreement. Sean Marett entered into a 12-month consultancy agreement with the Company on July 1, 2024, to
ensure a smooth transition of services.
The following table sets forth the names and functions of the current members of our Management Board, their
ages as of
December 31, 2024
, and thei
r
terms
:
|
Name
|
Age
|
Term Expires
|
Position
|
|||
|
Prof. Ugur Sahin, M.D.
|
59
|
December 31, 2026
|
Chief Executive Officer
|
|||
|
Annemarie Hanekamp
(1)
|
44
|
June 30, 2028
|
Chief Commercial Officer
|
|||
|
Jens Holstein
|
61
|
June 30, 2025
(2)
|
Chief Financial Officer
|
|||
|
Sierk Poetting, Ph.D.
|
50
|
November 30, 2026
|
Chief Operating Officer
|
|||
|
Ryan Richardson
|
45
|
December 31, 2026
|
Chief Strategy Officer
|
|||
|
James Ryan, Ph.D.
|
49
|
August 31, 2027
|
Chief Legal Officer and Chief Business Officer
|
|||
|
Prof. Özlem Türeci, M.D.
|
56
|
May 31, 2025
|
Chief Medical Officer
|
(1)
Appointed effective as of July 1, 2024. Annemarie Hanekamp replaced Sean Marett, who retired as CCO and whose
service contract and term of office ended prematurely by mutual agreement. Sean Marett entered into a 12-month
consultancy agreement with the Company on July 1, 2024, to ensure a smooth transition of services.
(2)
Jens Holstein, our Chief Financial Officer, plans to retire at the end of his term. A successor will be announced in due
course.
The business address of the members of our Management Board is the same as our business address: An der
Goldgrube 12, D-55131 Mainz, Germany.
The following is a brief summary of the business experience of the members of our Management Board
(including Sean Marett, who retired as planned from the Management Board of BioNTech as of June 30, 2024):
Prof. Ugur Sahin, M.D.,
co-founded BioNTech in 2008 and has served as our Chief Executive Officer since that
time. He is a physician, immunologist and leader in the development of novel approaches to fight cancer and
infectious diseases. Ugur Sahin is one of the world’s foremost experts on messenger ribonucleic acid (mRNA)
medicines. He has pioneered several fundamental breakthroughs enabling the development of mRNA vaccines
and other types of immunotherapies. He initiated and oversaw “Project Lightspeed”, the historic development of
the first mRNA vaccine for COVID-19, moving from lab and clinical testing to conditional approval within an
unprecedented 11-month period. He also leads BioNTech’s research and development of neoantigen specific as
well as non-neoantigen specific mRNA cancer immunotherapies, which can be individually tailored and produced
198
Annual Report on Form 20-F for the
year ended December 31, 2024
on demand according to the profile of non-synonymous mutations identified by next-generation sequencing in
patients’ tumors. Ugur Sahin is co-inventor of more than 500 filed patents applications and patents. His
academic credentials include serving as a Full Professor in Translational Oncology & Immunology at Johannes
Gutenberg University in Mainz, Germany, where he was the supervisor of more than 50 Ph.D. students. He also
holds the role of Chairman of the Scientific Management Board of the Helmholtz Institute for Translational
Oncology (HI-TRON). Based on his contributions to scientific discovery, Ugur Sahin has received numerous
awards and recognitions, including the German Sustainability Award, the Mustafa Prize, and the German Cancer
Award. He is married to Özlem Türeci.
Annemarie Hanekamp
is our Chief Commercial Officer. She joined BioNTech in 2024 and has more than 20
years of experience in the healthcare industry, including 15 years of commercial experience in companies
ranging from early-stage biotechnology companies to full-scale pharmaceutical companies. She successfully
delivered significant value in a broad range of roles: at Novartis (NYSE: NV), she led the U.S. and global teams
through a time of strategic opportunities and operational headwinds following an unprecedented strong launch
uptake of their novel treatment for prostate cancer. She was also responsible for building a new global oncology
organization following a company-wide transformation. At Bristol-Myers Squibb Co. (NYSE: BMY), she held a
pivotal role in evolving the company’s U.S. oncology strategy, resulting in significant and sustainable growth
including an expanded market access as well as product launches. Annemarie Hanekamp holds degrees in
biomedical sciences as well as organizational leadership.
Jens Holstein
is our Chief Financial Officer. Prior to joining BioNTech in 2021, Jens was CFO of dual-listed
MorphoSys AG (Nasdaq/FWB: MOR) where he was instrumental in building a fully integrated biopharmaceutical
company. Before joining MorphoSys in 2011, Jens Holstein served in multiple CFO positions as well as general
management roles within the Fresenius SE Group. He served as Regional CFO for the region EME (Europe/
Middle East) and as Managing Director of Fresenius Kabi Deutschland GmbH. From 2006 to 2010, he was
Regional CFO of Fresenius Kabi Asia Pacific Ltd., based in Hong Kong. Prior to this appointment, Jens Holstein
was Managing Director of Fresenius ProServe GmbH, and CFO and Labor Director of the company’s subsidiary
Wittgensteiner Kliniken AG. Earlier positions within Fresenius included General Manager of hospitalia care
GmbH, Commercial Manager of the Projects & Service business unit of Fresenius AG and Commercial Manager
of hospitalia international GmbH. Jens Holstein also spent several years in the consulting industry, including in
M&A with positions in Frankfurt and London. Jens Holstein holds a Diploma in Business Administration from the
University of Münster, Germany. He is also a non-executive member of the board of directors at global genomic
diagnostics company Veracyte Inc.
Sean Marett
was our
Chief Business Officer
and Chief Commercial Officer until
retiring
from the Management
Board of BioNTech with effect as of
June
30, 2024. He joined BioNTech in 2012. Prior to that, he worked in
global strategic and regional marketing and sales roles at GlaxoSmithKline (NYSE: GSK) in the United States
and Pfizer (NYSE: PFE) in Europe, before taking business development executive roles at Evotec (Nasdaq:
EVO; FWB: EVT) and Lorantis. He has successfully executed complex licensing transactions with large
pharmaceutical companies, negotiated M&A transactions and raised finance from investors. Sean Marett built
and ran a contract clinical manufacturing organization with operations across Europe and the United States for
over half a decade for the contract manufacturer NextPharma. Sean Marett has been Chairman of PHMR Ltd, a
company specializing in market access and pharmaceutical reimbursement, since 2017. He previously held non-
executive directorship of KWS BioTest Ltd (successfully sold to Charles River) from 2011 until 2018 and was a
member of the investment committee of Mann BioInvest Ltd, a fund dedicated to biotechnology and
pharmaceutical company investments from 2013 until 2016. He holds a BSc (Hons) in Biochemistry from Kings
College London and an MBA from Manchester Business School.
Sierk Poetting, Ph.D.,
is our Chief Operating Officer. He joined BioNTech in September 2014 from Novartis
(NYSE: NV), where he served in various positions from May 2012 to August 2014 as Vice President and Chief
Financial Officer for the Sandoz Division in North America. Sierk Poetting started his career as a consultant with
McKinsey & Company. A German citizen, Sierk Poetting holds a Master of Science in Optical Sciences from the
University of Arizona and a Ph.D. in Physics from the Ludwig-Maximilians University in Munich.
Ryan Richardson
is our Chief Strategy Officer. He brings more than 20 years of experience in the healthcare
and finance industries to BioNTech. Ryan joined BioNTech in 2018 as Senior Vice President, Corporate
199
Annual Report on Form 20-F for the
year ended December 31, 2024
Development & Strategy and was appointed to Chief Strategy Officer and a Member of the Management Board
in 2020. Prior to joining BioNTech, Ryan Richardson was an Executive Director in the Global Healthcare
Investment Banking team at J.P. Morgan in London, where he advised companies in the biotech and life
sciences industry on cross-border M&A, equity and debt capital financings. Earlier in his career, Ryan
Richardson worked as a Management Consultant to biopharmaceutical companies in the United States and
Europe, focusing on a wide range of strategic and operational projects in the areas of commercial strategy,
pricing and market access, new product planning, and R&D transformation. Ryan has also worked as a Health
Economist at IMS Health in London. Ryan was the recipient of the 2018 Eisenhower Zhi Xing Fellowship to
China, and the 2005-6 Robert R. Bosch Fellowship to Germany. Ryan Richardson holds an International MBA
from the University of Chicago Booth School of Business, an MSc from the London School of Economics, and a
BS in Biology from the University of Kansas.
James Ryan, Ph.D.,
is our Chief Legal Officer and Chief Business Officer. He brings nearly 20 years of global
legal and IP expertise in the pharmaceutical industry to BioNTech. James Ryan joined the Company in 2018 as
General Counsel and Senior Vice President Legal & IP and was appointed to Chief Legal Officer and a Member
of the Management Board in 2023 and to Chief Business Officer in July 2024. He has guided BioNTech through
a wide range of key business, IP and transactional activities, mergers and acquisitions, strategic collaborations
and equity capital markets transactions, including the Company’s IPO in 2019. James Ryan and his teams
played a pivotal role in the successful development of the Pfizer-BioNTech COVID-19 vaccine, supporting every
legal aspect of the program, its launch and commercialization. Prior to joining BioNTech, he established the legal
group of GW Pharmaceuticals (NASDAQ: GWPH), where he also served as Head of Legal Affairs. Earlier in his
career, James Ryan worked for a number of UK and U.S. law firms, including Special Counsel at Covington &
Burling LLP, where he specialized in commercial and strategic transactions with a focus on companies in the life
sciences sector. James has a Ph.D. in epigenetics from the University of St Andrews, is a member of the Law
Society of England & Wales, and is a member of the Law Society of Ireland.
Prof. Özlem Türeci, M.D.,
Co-founder and Chief Medical Officer of BioNTech, is a physician, immunologist, and
cancer researcher with translational and clinical experience. She has helped lead the discovery of cancer
antigens, the development of mRNA-based individualized and off-the-shelf immunotherapy candidates and other
types of immunotherapies which are currently in clinical development. Özlem Türeci leads the clinical
development of BioNTech’s “Project Lightspeed”, the company’s successful effort to develop and distribute an
mRNA-based vaccine against COVID-19, a historic achievement completed in less than one year. Özlem Türeci
previously served as CEO and Chief Medical Officer of Ganymed Pharmaceuticals AG, which she co-founded
with Ugur Sahin and Christoph Huber. She is also a professor for Personalized Immunotherapy at the University
Medical Center Mainz and the Helmholtz Institute for Translational Oncology Mainz (HI-TRON) and currently
serves as President of the Association for Cancer Immunotherapy (CIMT) in Germany. She is a recipient of the
German Sustainability Award, among other notable recognitions. Özlem Türeci is married to Ugur Sahin.
200
Annual Report on Form 20-F for the
year ended December 31, 2024
Supervisory
Board (Aufsichtsrat)
The following table sets forth the names and functions of the members of our Supervisory Board during
2024
,
their ages as of
December 31, 2024
, their terms (which expire on the date of the relevant year’s general
shareholders’ meeting) and their principal occupations outside of our
Company
:
|
Name
|
Age
|
Term
Expires
(1)
|
Principal Occupation
|
|||
|
Helmut Jeggle
(Chair Supervisory Board)
|
54
|
2026
|
Managing partner and entrepreneurial venture capital investor
of Salvia GmbH (Supervisory Board member of 4SC AG,
AiCuris AG and Tonies SE, Board Director at Bambusa
Therapeutics Inc.)
|
|||
|
Ulrich Wandschneider, Ph.D.
(Deputy Chair Supervisory Board)
|
63
|
2027
|
Managing director of beebusy capital GmbH and independent
consultant to companies in the lifescience and healthcare
sector (Supervisory Board Member at Marienhaus GmbH)
|
|||
|
Baroness Nicola Blackwood
|
45
|
2027
|
Managing Director and Chair of Oxford University Innovations
Limited (Equity Partner, ReCode Health Ventures LLC,
Trustee and Director of the Alan Turing Institute, Chair of the
Advisory Board of Genomics England Limited, Independent
NED on the RTW Biotech Opportunities Ltd.)
|
|||
|
Prof. Anja Morawietz, Ph.D.
|
47
|
2026
|
Certified Public Accountant and Management Consultant,
Professor of External Accounting and General Business
Administration at the Nuremberg University of Applied
Sciences Georg Simon Ohm
|
|||
|
Michael Motschmann
|
67
|
2027
|
Member of the Management Board and head of equity
investments of MIG Capital AG (Supervisory Board member
AFFiRiS AG, APK AG, HMW-Emissionshaus AG and HMW-
Innovations AG)
|
|||
|
Prof. Rudolf Staudigl, Ph.D.
|
70
|
2026
|
Independent consultant (member of the Supervisory Board of
TÜV Süd Aktiengesellschaft until 3 July 2024, member of the
Supervisory Board of Groz-Beckert KG (Deputy Chair))
|
(1)
Term expires as of the AGM during the years indicated.
The business address of the members of our Supervisory Board is the same as our business address: An der
Goldgrube 12, D-55131 Mainz, Germany.
The following is a brief summary of the prior business experience of the members of our Supervisory Board:
Helmut Jeggle
has been Chair of our Supervisory Board since its foundation in 2008. He has a degree in
business administration from the University of Applied Sciences in Neu-Ulm and an MBA (Master of Business
Administration) from the Stuttgart Institute of Management and Technology. From 2000 to 2007, Helmut Jeggle
held various positions at Hexal AG. From 2007 onwards, he was, among other things, in charge of Direct
Investments at ATHOS KG, the family office of the Strüngmann family, from which he
resigned as general
partner (Komplementär) in April 2021
. Since 2014, Helmut Jeggle has been Managing Director of Salvia GmbH,
where he acts as an entrepreneurial venture capital investor. He is currently a member of two other supervisory
boards of listed companies, including 4SC AG (ETR: VSC) and Tonies SE (ETR: TNIE).
Ulrich Wandschneider, Ph.D.,
has served as a member of our Supervisory Board since 2018. He has more
than 20 years of experience in the healthcare sector as a manager in the operative business and as a member
of boards and committees. He was a Partner at Arthur Andersen until 2002 and at Deloitte from 2002 to 2004 in
the healthcare and life science sector for many years. From 2004 to 2016 Ulrich Wandschneider served as Chief
Executive Officer first of Mediclin AG later of Asklepios Kliniken GmbH & Co. KGaA. In addition to BioNTech SE,
he is part of the Supervisory Board of Marienhaus GmbH, Chairman of the Board of Trustees of Oberberg GmbH
201
Annual Report on Form 20-F for the
year ended December 31, 2024
and he serves as chairman or member of various Advisory Boards, such as chairman of the Advisory Board of
Argentum Pflege Holding GmbH and Panorama Fachklinik GmbH and member of the Advisory Board of Creative
Balloons GmbH.
Baroness Nicola Blackwood
has served as a member of our Supervisory Board since May 25, 2023. She has
been Chair of Genomics England since 2020 and Chair of Oxford University Innovation since 2021. She is a
member of the House of Lords, the upper chamber of the Parliament of the United Kingdom (UK). Blackwood
was elected Member of Parliament for Oxford West and Abingdon 2010 to 2017 and served as Minister for
Innovation at the UK Department of Health and Social Care from 2016 to 2017 and 2019 to 2020 where she led
on life sciences, NHS data and digital transformation and global health security. Among other roles, she was
Chair of the technical regulator, the Human Tissue Authority, as well as a Chair of the UK House of Commons
Science and Technology Select Committee and a member of the House of Lords Science and Technology Select
Committee. Nicola Blackwood was educated at Trinity College of Music, London, St Anne’s College, Oxford, and
Emmanuel College, Cambridge.
Prof. Anja Morawietz, Ph.D.,
has served as a member of our Supervisory Board since 2022
. She has been a
professor of external accounting and general business administration at the Nuremberg University of Applied
Sciences Georg Simon Ohm since 2015. Her research areas are international and national accounting, current
developments in corporate governance and sustainability reporting. She also works as a freelance auditor,
particularly in audit-related consulting. Previously, she worked for ten years for auditing company KPMG AG,
where she conducted audits of annual and consolidated financial statements and advised clients on accounting
and regulatory issues. After training as a bank clerk at Norddeutsche Landesbank in Hanover, Anja Morawietz
studied business administration at Goethe University in Frankfurt am Main, where she also completed her
doctorate as an external doctoral candidate.
Michael Motschmann
has served as a member of our Supervisory Board since 2008. He co-founded MIG
Verwaltungs AG, or MIG, in 2004, where he serves on the Management Board and as Head of Equity
Investments. In his role with MIG, Michael Motschmann currently serves on the supervisory boards of several
private portfolio companies.
Prof. Rudolf Staudigl, Ph.D.,
has served as a member of our Supervisory Board since 2022
. He studied
chemistry at Ludwig Maximilian University of Munich, obtaining his Ph.D. (Dr. rer. nat) in 1981. After postdoctoral
research at Harvard University (Cambridge, USA) and Ludwig Maximilian University, he joined Wacker
Chemitronic in 1983. Mr. Staudigl became Vice President of Operations at Wacker Siltronic Corporation
(Portland, Oregon, USA) in 1989 and President a year later. He joined the Executive Board of Wacker
Chemitronic in 1993. In 1995, Rudolf Staudigl was appointed to the Executive Board of Wacker Chemie. In May
2008, Rudolf Staudigl was appointed President & CEO of Wacker Chemie AG. Until July 2024, he was a
member of the Supervisory Board of TÜV Süd Aktiengesellschaft. He currently serves as Deputy Chairman of
the Supervisory Board of Groz-Beckert.
B.
Compensation
Amount of Compensation of Our Supervisory Board and Management Board Members
The compensation of the members of our Supervisory Board and Management Board is disclosed below in
accordance with S
ection 162 Paragraph 1 of the
German Stock Corporation Act, or AktG,
and
in line with our
Compensation Report published on our website at
www.biontech.de
.
Compensation is considered granted if it either has been actually received or the activities to which it relates
have been performed. Compensation is considered owed if the compensation components are legally due, but
have not yet been received.
Where
the preceding definition applies, compensation is referred to only as being
“granted and owed”.
The Institute of Public Auditors in Germany, Incorporated Association (Institut der
Wirtschaftsprüfer, IDW) has provided two interpretations for the presentation. According to interpretation 1,
compensation is only shown as granted and owed in the year in which it is received (inflow principle;
Zuflussprinzip). According to interpretation 2, compensation may also be disclosed in the compensation report
for the financial year in which the activity underlying the compensation was performed (vesting principle;
Erdienungsprinzip). The Supervisory Board and the Management Board have decided to apply interpretation 2
202
Annual Report on Form 20-F for the
year ended December 31, 2024
for short-term compensation components such as fixed compensation and short-term incentives, or STI, and
interpretation 1 for share-based payments (including long-term incentives, or LTI). An approach which deviates
from interpretation 1 was chosen because it allows a fair presentation of the actual benefits, which are, for
example, subject to final underlying share price developments.
The total compensation granted or owed according to Section 162 Paragraph 1 AktG to all members of the
Supervisory Board and the Management Board for the
years ended December 31, 2024 and 2023
, is presented
in the following sections.
Compensation of Our Supervisory Board Members
The compensation of our Supervisory Board reflects the duties, time commitment and demands of the role, the
Company’s market position, the need to be able to attract suitably qualified candidates and is designed to
promote the Company’s long-term development and business strategy.
Under article 9 of the Company’s Articles of Association, our Supervisory Board receives 100% fixed
compensation. All members of the Supervisory Board are also reimbursed for their expenses.
While retaining the
system for the compensation of Supervisory Board members, the compensation of the
Supervisory Board and its
committee members
was adjusted during the year ended December 31, 2024,
to take into account the
increasing time commitment required from them in terms of their activities, responsibilities and necessary
qualifications and competencies under German stock corporation and European laws and the life sciences
industry.
The new system was approved by the Annual General Meeting, or AGM, on May 17, 2024, and was
applied on a pro rata basis upon the entry of the revised Articles of Association in our Commercial Register on
August 30, 2024. Pursuant to Section 113 Paragraph 3 AktG, as amended by the Act Implementing the Second
Shareholder Rights Directive, a listed company’s AGM must pass a resolution on the compensation of its
Supervisory Board members at least every four years.
Until August 30, 2024, each member of the Supervisory Board received annual base compensation of €70,000
(the Chair and Vice Chair received €210,000 and €105,000, respectively). The Chair of the Audit Committee
received an additional €30,000 per year. Other committee Chairs each received an additional €15,000 per year.
Each ordinary committee member received an additional €5,000 per committee.
As of August 30, 2024, the
members of the Supervisory Board receive annual base compensation of €120,000 (the Chair and Vice Chair
receive €360,000 and €180,000, respectively). The Chair of the Audit Committee receives an additional €50,000
per year. Other committee Chairs each receive an additional €30,000 per year. Each ordinary committee
member receives an additional €10,000 per committee.
Compensation is provided on a pro rata basis for individuals who are members of the Supervisory Board or a
committee for part of the financial year. In 2023, this applied to Christoph Huber, who left as of our AGM on May
23, 2023, and Nicola Blackwood, who joined on the same date. Pro rata compensation was also paid to
members of the Product Committee, which was established on October 1, 2023.
BioNTech also covers any value-added tax applicable to compensation or expense reimbursement.
Supervisory Board members are included in our D&O liability insurance and are co-insured at our expense.
203
Annual Report on Form 20-F for the
year ended December 31, 2024
The compensation granted and owed to our Supervisory Board members during the
years ended December 31,
2024 and 2023
,
is presented in the following table:
|
in thousands €
(1)
|
Helmut
Jeggle
|
Ulrich
Wandschneider,
Ph.D.
|
Baroness
Nicola
Blackwood
(2)
|
Prof.
Christoph
Huber, M.D.
(3)
|
Prof. Anja
Morawietz,
Ph.D.
|
Michael
Motschmann
|
Prof. Rudolf
Staudigl,
Ph.D.
|
|||||||
|
Chair
|
Vice Chair
|
|||||||||||||
|
Base
Compensation
|
||||||||||||||
|
2024
|
261
|
130
|
87
|
—
|
87
|
87
|
87
|
|||||||
|
2023
|
210
|
105
|
42
|
28
|
70
|
70
|
70
|
|||||||
|
Committee
Compensation
|
||||||||||||||
|
2024
|
27
|
27
|
13
|
—
|
43
|
13
|
27
|
|||||||
|
2023
|
16
|
9
|
4
|
2
|
35
|
10
|
20
|
|||||||
|
Total
|
||||||||||||||
|
2024
|
288
|
157
|
100
|
—
|
130
|
100
|
114
|
|||||||
|
2023
|
226
|
114
|
46
|
30
|
105
|
80
|
90
|
(1)
The concept of compensation being granted or owed is described in the above section “
Amount of Compensation of Our
Supervisory Board and Management Board Members
”.
(2)
Nicola Blackwood was appointed to the Supervisory Board by the AGM on May 25, 2023.
(3)
Christoph Huber retired from the Supervisory Board on May 25, 2023.
Compensation of the Members of Our Management Board
We have entered into agreements with all current members of our Management Board. We believe that the
agreements between us and the members of our Management Board provide for payments and benefits
(including upon termination of employment) that are in line with customary market practice.
Fixed compensation is primarily paid out as a salary in twelve monthly installments within a calendar year. All of
the Management Board members’ activities for BioNTech Group companies are compensated by their base
compensation of €550,000 (in the case of Ugur Sahin, €700,000), during each of the years ended December 31,
2024 and 2023. Annemarie Hanekamp’s appointment on July 1, 2024, led to an effective annual fixed
compensation of €275,000 during the year ended December 31, 2024. Due to Sean Marett’s retirement on June
30, 2024, his effective annual fixed compensation during the year ended December 31, 2024, was €275,000.
James Ryan’s effective annual fixed compensation during the year ended December 31, 2023, was €183,333
due to his appointment to the Management Board as of September 1, 2023. His compensation is partly paid in
the U.K. (in GBP) by the Company’s subsidiary, BioNTech UK Limited, and partly in Germany (in Euro).
The
Management Board’s service agreements also include an STI compensation component, which is an annual
performance-related bonus for the years of their respective service periods.
The payout amount of the short-term
incentive compensation depends on the achievement of certain financial and non-financial performance criteria
of the Group in a particular financial year, which goals are set uniformly for all members of the Management
Board. The Supervisory Board exercises reasonable discretion in determining whether such criteria have been
achieved.
50% percent of the compensation is paid following determination of the actual achievement of the
performance targets at the end of the calendar month following the date on which the Supervisory Board has
approved the consolidated financial statements of the Company for the financial year that is relevant for the
determination of the STI (first installment) and is considered granted and owed in accordance with Section 162
AktG in the same financial year
in which the activity to which the compensation relates was performed. T
he
remaining amount (second installment)
is subject to adjustments in relation to the development of the share price
between the determination date, when the STI achievement is determined, and the respective anniversary of
that date (i.e., in the event of an increase or decrease in the share price, based on the market price of ADSs
representing our ordinary shares, the payment amount is multiplied by the factor of the development of the share
204
Annual Report on Form 20-F for the
year ended December 31, 2024
price).
The second installment is also considered granted and owed
in accordance with Section 162 AktG in the
same financial year
in which the activity to which the compensation relates was performed, as the Management
Board member had already completed the activity to which it relates.
During the
year ended December 31, 2024
,
the maximum short-term incentive compensation for Ugur Sahin, Jens Holstein, Sierk Poetting, Ryan
Richardson, James Ryan and
Özlem Türeci
was
€
350,000 for Ugur Sahin a
nd
€
300,000 for the other
Management Board members
.
Based on the 2024 target achievement of 74%, the annual bonus amounts for
Ugur Sahin, Jens Holstein, Sierk Poetting, Ryan Richardson, James Ryan and Özlem Türeci for the
year ended
December 31, 2024
, amounted to €259,000; €222,000; €222,000; €222,000; €222,000; and €222,000,
respectively.
Following Sean Marett's retirement from the Management Board with effect as of June 30, 2024, his
maximum short-term incentive compensation was defined on a pro-rata basis and thus amounted to €150,000,
for the
year ended December 31, 2024
. Pursuant to
his separation agreement (see below in this section), he
was granted a guaranteed pro rata bonus in the amount of 100% of the maximum amount, that was paid out in
June 2024.
Following Annemarie Hanekamp’s appointment to the Management Board with effect as of July 1,
2024, starting for the first time in the 2025 financial year, her
maximum short-term compensation amounted
to
€275,000.
For the
year ended December 31, 2024
, she was granted a pro-rata temporis guaranteed bonus in
the amount of 50% of the maximum amount, i.e., €137,500.
The first half of the corresponding net amount is to
be paid out in April 2024 and the second half in January 2026, irrespective of the share price performance.
During the
year ended December 31, 2023
, the maximum short-term incentive compensation for Ugur Sahin,
Jens Holstein, Sean Marett, Sierk Poetting, Ryan Richardson and Özlem Türeci was €350,000 for Ugur Sahin
and €300,000 for each other Management Board member. As James Ryan was appointed to the Management
Board on September 1, 2023, his maximum short-term compensation was defined on a pro rata basis and
amounted to €100,000. Based on the 2023 target achievement of 90%, the annual bonus amounts for Ugur
Sahin, Jens Holstein, Sean Marett, Sierk Poetting, Ryan Richardson, James Ryan and Özlem Türeci for the year
ended December 31, 2023, amounted to €315,000 for Ugur Sahin, €90,000 for James Ryan and €270,000 for
each other Management Board member.
Our Management Board’s service agreements provide for long-term,
four
-year incentive compensation
(Management Board Grant - LTI) through an annual grant of options to acquire BioNTech shares at the end of
the respective waiting periods of such agreements.
The options are subject to the terms and conditions of the
respective authorizations of the AGM creating our Employee Stock Ownership Plan, or ESOP, and the applicable
option agreements
.
During the
year ended December 31, 2024
, the number of options granted to Ugur Sahin,
Jens Holstein, Sean Marett, Sierk Poetting, Ryan Richardson, James Ryan and Özlem Türeci were calculated
based on a target value of €1,050,000 for Ugur Sahin and €550,000 for each other Management Board member.
Upon Sean Marett’s resignation from the Management Board with effect as of June 30, 2024, the LTI 2024 grant
relating to the first six months of 2024 to which he was contractually entitled was immediately forfeited due to his
resignation
.
Following Annemarie Hanekamp's appointment on July 1,
2024, she received a guaranteed pro rata
LTI grant of €275,000 for the period from July 1, 2024 to December 31, 2024. This amount reflects 50% of the
annual target value and will be made available in shares or as a cash payment in 2025
. Starting January 1,
2025, Annemarie Hanekamp will participate in the LTI plan in force with a target value of €550,000.
During the
year ended December 31, 2023
, the number of options granted to Ugur Sahin, Jens Holstein, Sean
Marett, Sierk Poetting, Ryan Richardson and Özlem Türeci was calculated based on a target value of
€1,050,000 for Ugur Sahin and €550,000 for each other Management Board member. As the LTI was allocated
prior to James Ryan’s appointment to the Management Board, he received a one-time signing cash payment of
€180,000 instead
.
Taking the requirements of Section 87a Paragraph 1 AktG into account, the Supervisory Board proposed, and a
large majority of 97.33% of votes cast at the AGM on May 17, 2024 approved, a new compensation system,
which is designed to further develop the previous system while retaining its basic structure, effective as of
January 1, 2025. BioNTech has concluded new service agreements with the Management Board (also effective
as of January 1, 2025) to reflect the new compensation system. The then-current compensation system, as
approved by the AGM on June 22, 2021, is applied whenever agreements are entered into, amended or
extended and includes specific provisions with respect to benefits upon termination. Both the then-current and
the new compensation systems are available online on our website at
www.biontech.de
. The information and
205
Annual Report on Form 20-F for the
year ended December 31, 2024
other content appearing on our website are not incorporated by reference into this Annual Report and our
website address is included in this report as an inactive textual reference only.
The total compensation granted or owed to all members of the Management Board for the
years ended
December 31, 2024 and 2023
, is presented in the table below.
|
in thousands €
|
Prof.
Ugur
Sahin,
M.D.
|
Annemarie
Hanekamp
|
Jens
Holstein
|
Sean
Marett
(10)
|
Sierk
Poetting,
Ph.D.
|
Ryan
Richardson
|
James
Ryan,
Ph.D.
(2)
|
Prof.
Özlem
Türeci,
M.D.
|
|||||||||
|
Fixed compensation
(1)
|
|||||||||||||||||
|
2024
|
700
|
275
(11)
|
550
|
275
|
550
|
550
|
550
|
550
|
|||||||||
|
2023
|
700
|
—
|
550
|
550
|
550
|
550
|
183
|
550
|
|||||||||
|
Fringe benefits
(3)
|
|||||||||||||||||
|
2024
|
5
|
64
|
5
|
15
|
19
|
27
|
109
|
—
|
|||||||||
|
2023
|
6
|
—
|
5
|
12
|
5
|
26
|
—
|
—
|
|||||||||
|
Short-term incentive –
first installment
(4)
|
|||||||||||||||||
|
2024
|
130
|
69
(12)
|
111
|
150
(14)
|
111
|
111
|
111
|
111
|
|||||||||
|
2023
|
158
|
—
|
135
|
135
|
135
|
135
|
45
|
135
|
|||||||||
|
Short-term incentive –
second installment
(5)
|
|||||||||||||||||
|
2024
|
130
|
69
(12)
|
111
|
—
(14)
|
111
|
111
|
111
|
111
|
|||||||||
|
2023
|
158
|
—
|
135
|
135
|
135
|
135
|
45
|
135
|
|||||||||
|
Other variable
compensation
|
|||||||||||||||||
|
2024
|
—
|
1,250
(13)
|
—
|
—
|
—
|
—
|
—
|
—
|
|||||||||
|
2023
|
—
|
—
|
600
(7)
|
—
|
—
|
—
|
180
(6)
|
—
|
|||||||||
|
Share-based
payments (incl. long-
term incentive)
(8)
|
|||||||||||||||||
|
2024
|
|||||||||||||||||
|
Management Board
Grant - LTI
|
4,386
|
—
|
—
|
—
|
1,774
|
1,785
|
—
|
1,754
|
|||||||||
|
CEO Grant 2019
|
259,531
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|||||||||
|
2023
|
|||||||||||||||||
|
ESOP 2018
(9)
|
—
|
—
|
—
|
19,289
|
—
|
—
|
—
|
—
|
|||||||||
|
Total
|
|||||||||||||||||
|
2024
|
264,882
|
1,727
|
777
|
440
|
2,565
|
2,584
|
881
|
2,526
|
|||||||||
|
2023
|
1,022
|
—
|
1,425
|
20,121
|
825
|
846
|
453
|
820
|
(1)
For James Ryan, a part of the fixed compensation was paid by BioNTech UK Limited, a subsidiary of BioNTech SE.
Approximately 30% of his total compensation is attributable to his position as a member of the Management Board and
approximately 70% is attributable to his position as a director of BioNTech UK Limited.
(2)
James Ryan’s compensation for the year ended December 31, 2023 was granted on a pro rata basis starting as of his
appointment to the Management Board on September 1, 2023.
(3)
Includes social security, health and additional insurance, company bike and travel expenses. Other fringe benefits which
are integral to the performance of business duties, such as costs for security services, are not included in the amount.
(4)
The STI in a given year is always paid out in two installments over two years.
The first STI installment for the
year ended
December 31, 2024
,
will be paid out in April 2025, the month after the approval of the 2024 consolidated financial
206
Annual Report on Form 20-F for the
year ended December 31, 2024
statements. This installment
was considered granted and owed in 2024, the year in which the activity to which the
compensation relates was performed.
The first STI installment for the
year ended December 31, 2023
,
was considered
granted and owed in
2023
and was paid out in April
2024
.
(5)
The second STI installment for the
year ended December 31, 2024
was also considered granted and owed in 2024, as
the Management Board had already completed the activity to which it relates. It will be paid out in February 2026 (subject
to an adjustment due to the share-price development).
The second STI installment for the
year ended December 31,
2023
,
was considered granted and owed in
2023
and was paid out in February
2025
with adjustments due to the share-
price development.
The amounts ultimately paid were as follows: Ugur Sahin €183 thousand,
Jens Holstein
€157 thousand, Sean Marett €157 thousand, Sierk Poetting €157 thousand, Ryan Richardson €157 thousand, James
Ryan €52 thousand and Özlem Türeci €157 thousand.
(6)
During the year ended December 31, 2023, James Ryan received a one-time signing cash payment of €180,000 as part
of his appointment to the Management Board. The one-time signing cash payment provided compensation in lieu of
participation in the LTI 2023 program, as the awards were allocated before his appointment and a pro rata allocation for
2023 would not have been permitted under the AGM authorizations then in force. Under those authorizations, which were
modified by the May 17, 2024 AGM, ESOPs could only be issued within the first six months of each calendar year. To
further strengthen his commitment to the Company, James Ryan used £50,000 (net of costs and expenses) to purchase
BioNTech shares during the year ended December 31, 2024.
(7)
During the year ended December 31, 2023, upon the recommendation of the Compensation, Nomination and Corporate
Governance Committee, the Supervisory Board approved a special payment in the gross amount of €600,000 to Jens
Holstein, of which €150,000 (net of costs and expenses) was used to purchase 1,620 BioNTech shares during the year
ended December 31, 2023.
(8)
Explanations of our share-based payment arrangements are given in Note
16
“
Share-Based Payments
” to our
consolidated financial statements included elsewhere in this Annual Report.
The benefits from our share-based payment
arrangements (including long-term incentive) are considered granted and owed when the awards are settled
.
During the
years ended December 31, 2023 and 2024, this principle applied to the option rights granted under the ESOP 2018
Program, CEO Grant 2019 and LTI 2020 Program as a result of their exercise and settlement.
(9)
The amount shown is related to the option rights granted one-time under the ESOP 2018 Program. The table shows the
implied market value calculated using the closing price of an ADS of BioNTech on Nasdaq on the last day preceding the
exercise date converted from USD to Euro using the exchange rate published by the German Central Bank (Deutsche
Bundesbank) on the same day, as well as applying the effective exercise price and maximum cap mechanism. The
implied market value may vary from the benefit in kind.
They
are not to be seen as cash payments to the Management
Board, as the exercise was settled by delivering
ADSs
.
(10)
Sean Marett’s compensation for the year ended December 31, 2024, was granted on a pro rata basis through his
retirement with effect as of June 30, 2024.
(11)
Annemarie Hanekamp was appointed to the Management Board as Chief Commercial Officer (CCO) with effect as of July
1, 2024. Her compensation for the year ended December 31, 2024, was granted on a pro-rata basis.
(12)
For the year ended December 31, 2024, Annemarie Hanekamp was granted a guaranteed pro rata bonus in the amount
of 50% of the maximum amount, i.e., €137,500. The first half of the corresponding net amount is to be paid out in April
2024 and the second half in January 2026, irrespective of the share price performance.
(13)
The Supervisory Board granted Annemarie Hanekamp a one-time signing bonus of €1,750,000 as of her appointment.
Out of this amount, €1,250,000 was paid as a cash bonus in July 2024. The remainder of €500,000 will be granted in
shares (and considered owed) in July 2028 or, at the earliest possible date after a potential blackout period, provided she
is still a Management Board Member on June 30, 2028.
(14)
For the year ended December 31, 2024, Sean Marett was granted a guaranteed pro rata bonus in the amount of 100% of
the maximum amount pursuant to his separation agreement, that was paid out in June 2024.
For further information, see
below.
207
Annual Report on Form 20-F for the
year ended December 31, 2024
As part of Sean Marett’s retirement from the Management Board with effect as of June 30, 2024, he and the
Supervisory Board entered into a separation agreement.
Pursuant to this separation agreement, the following
payments
apply subsequently to his termination and thus as a former Management Board member
:
•
a severance payment of €275,000 payable in monthly installments equivalent to the annual base fixed
salary for the remainder of his original term of appointment until December 31, 2024;
•
an additional payment of €39,000 in respect of the 2024 STI to compensate him for the difference
between the 2024 target achievement of Management Board members of
74%
(additional payment is
already reflected in the above total compensation granted and owed table)
and
his guaranteed pro rata
STI bonus in the amount of 100% of his maximum amount pursuant to his separation agreement
;
and
•
a grant of 5,760 phantom options representing one-quarter of the 2024 LTI award, which are subject to
the same conditions and waiting period that apply to the 2024 LTI awards granted to the Management
Board; all previous granted option rights will be dealt with in accordance with the LTI terms.
In addition, to ensure a smooth transition of services, Sean Marett entered into a 12-month consultancy
agreement with the Company on July 1, 2024, resulting in a compensation of
€477,030
during the
year ended
December 31, 2024
.
208
Annual Report on Form 20-F for the
year ended December 31, 2024
Share-Based Payment Arrangements
The table below provides an overview of the share options and other share-based payment instruments
allocated to our Management Board and outstanding as of
December 31, 2024
.
|
Grant Date /
Allocation
Date
|
Number of Ordinary
Shares Underlying
Share Options /
Number of Phantom
Share Options
|
Option
Exercise
Price (€)
(11)
|
Earliest
Option
Exercise
Date
(9)
|
Option
Expiration
Date
|
Name of the
Program
|
|||||||
|
Prof. Ugur Sahin, M.D.
|
10/9/2019
(1)
|
—
|
13.74
|
10/9/2023
|
10/9/2029
|
CEO Grant 2019
|
||||||
|
2/13/2020
(2)
|
—
|
29.63
|
2/13/2024
|
2/13/2030
|
LTI 2020
(10)
|
|||||||
|
5/12/2021
(3)
|
17,780
|
178.29
|
5/12/2025
|
5/12/2031
|
LTI 2021
(10)
|
|||||||
|
5/31/2022
(4)
|
19,997
|
146.40
|
5/31/2026
|
5/31/2032
|
LTI 2022
(10)
|
|||||||
|
5/22/2023
(5)
|
38,506
|
109.67
|
5/22/2027
|
5/22/2033
|
LTI 2023
(10)
|
|||||||
|
8/26/2024
(6)
|
53,233
|
75.91
|
8/26/2028
|
8/26/2034
|
LTI 2024
(10)
|
|||||||
|
Jens Holstein
|
5/17/2021
(3)
|
6,463
|
179.83
|
5/17/2025
|
5/17/2031
|
LTI 2021
(10)
|
||||||
|
7/1/2021
(8)
|
4,246
|
n/a
(8)
|
7/1/2025
(8)
|
n/a
(8)
|
Signing Bonus
|
|||||||
|
5/31/2022
(4)
|
14,664
|
146.40
|
5/31/2026
|
5/31/2032
|
LTI 2022
(10)
|
|||||||
|
5/22/2023
(5)
|
18,416
|
109.67
|
5/22/2027
|
5/22/2033
|
LTI 2023
(10)
|
|||||||
|
8/26/2024
(6)
|
25,459
|
75.91
|
8/26/2028
|
8/26/2034
|
LTI 2024
(10)
|
|||||||
|
Sean Marett
(12)
|
2/13/2020
(2)
|
38,968
|
29.63
|
2/13/2024
|
2/13/2030
|
LTI 2020
(10)
|
||||||
|
5/12/2021
(3)
|
5,334
|
178.29
|
5/12/2025
|
5/12/2031
|
LTI 2021
(10)
|
|||||||
|
5/31/2022
(4)
|
7,332
|
146.40
|
5/31/2026
|
5/31/2032
|
LTI 2022
(10)
|
|||||||
|
5/22/2023
(5)
|
4,604
|
109.67
|
5/22/2027
|
5/22/2033
|
LTI 2023
(10)
|
|||||||
|
Sierk Poetting, Ph.D.
|
13/2/2020
(2)
|
—
|
29.63
|
2/13/2024
|
2/13/2030
|
LTI 2020
(10)
|
||||||
|
5/12/2021
(3)
|
7,112
|
178.29
|
5/12/2025
|
5/12/2031
|
LTI 2021
(10)
|
|||||||
|
5/31/2022
(4)
|
14,664
|
146.40
|
5/31/2026
|
5/31/2032
|
LTI 2022
(10)
|
|||||||
|
5/22/2023
(5)
|
18,416
|
109.67
|
5/22/2027
|
5/22/2033
|
LTI 2023
(10)
|
|||||||
|
8/26/2024
(6)
|
25,459
|
75.91
|
8/26/2028
|
8/26/2034
|
LTI 2024
(10)
|
|||||||
|
Ryan Richardson
|
2/13/2020
(2)
|
—
|
29.63
|
2/13/2024
|
2/13/2030
|
LTI 2020
(10)
|
||||||
|
5/12/2021
(3)
|
6,163
|
178.29
|
5/12/2025
|
5/12/2031
|
LTI 2021
(10)
|
|||||||
|
5/31/2022
(4)
|
7,465
|
146.40
|
5/31/2026
|
5/31/2032
|
LTI 2022
(10)
|
|||||||
|
5/22/2023
(5)
|
18,416
|
109.67
|
5/22/2027
|
5/22/2033
|
LTI 2023
(10)
|
|||||||
|
8/26/2024
(6)
|
25,459
|
75.91
|
8/26/2028
|
8/26/2034
|
LTI 2024
(10)
|
|||||||
|
James Ryan, Ph.D.
(7)
|
12/15/2020
|
1,163
|
n/a
|
12/15/2024
|
n/a
|
LTI 2020 (EEP)
|
||||||
|
12/10/2021
|
313
|
n/a
|
12/10/2025
|
n/a
|
LTI 2021 (EEP)
|
|||||||
|
12/9/2022
|
740
|
n/a
|
12/9/2026
|
n/a
|
LTI 2022 (EEP)
|
|||||||
|
12/8/2023
|
750
|
n/a
|
12/8/2027
|
n/a
|
LTI 2023 (EEP)
|
|||||||
|
8/26/2024
(6)
|
25,459
|
75.91
|
8/26/2028
|
8/26/2034
|
LTI 2024
(10)
|
|||||||
|
Prof. Özlem Türeci, M.D.
|
2/13/2020
(2)
|
—
|
29.63
|
2/13/2024
|
2/13/2030
|
LTI 2020
(10)
|
||||||
|
5/12/2021
(3)
|
7,112
|
178.29
|
5/12/2025
|
5/12/2031
|
LTI 2021
(10)
|
|||||||
|
5/31/2022
(4)
|
14,664
|
146.40
|
5/31/2026
|
5/31/2032
|
LTI 2022
(10)
|
|||||||
|
5/22/2023
(5)
|
18,416
|
109.67
|
5/22/2027
|
5/22/2033
|
LTI 2023
(10)
|
|||||||
|
8/26/2024
(6)
|
25,459
|
75.91
|
8/26/2028
|
8/26/2034
|
LTI 2024
(10)
|
(1)
Options vested in four equal installments on October 9 of 2020, 2021, 2022 and 2023. The entire award became
exercisable in 2023. The options were exercised in 2024.
(2)
Options vested in four equal installments on February 13 of 2021, 2022, 2023 and 2024, are now exercisable following
the expiry of the waiting period on February 13, 2024, and can only be exercised during defined exercise windows under
209
Annual Report on Form 20-F for the
year ended December 31, 2024
our ESOP. Apart from Sean Marett, who did not exercise the options during 2024, all other options were exercised by the
respective Management Board members.
(3)
Phantom share options were issued which vest in four equal installments on May 12 of 2022, 2023, 2024 and 2025 for all
Management Board members except Jens Holstein, and in the case of Jens Holstein, vest in four equal installments on
May 17 of the same years. The options will not become exercisable before the expiry of the waiting period on May 12,
2025 and May 17, 2025, respectively, and can only be exercised during defined exercise windows.
(4)
Phantom share options were issued which vest in four equal installments on May 31 of 2023, 2024, 2025 and 2026 for all
Management Board members. These phantom options will not become exercisable before the expiry of the waiting period
on May 31, 2026, and can only be exercised during defined exercise windows.
(5)
Options vest in four equal installments on May 22 of 2024, 2025, 2026 and 2027. The options will not become exercisable
before the expiry of the waiting period on May 22, 2027, and can only be exercised during defined exercise windows.
(6)
Options vest in four equal installments on August 26 of 2025, 2026, 2027 and 2028. The options will not become
exercisable before the expiry of the waiting period on August 26, 2028, and can only be exercised during defined exercise
windows.
(7)
As James Ryan was not part of the Management Board at the time the 2023 LTI award was allocated, he did not receive
any options under this plan. Prior to his appointment, RSUs were granted to him under the BioNTech 2020 Employee
Equity Plan (EEP). RSUs issued under the LTI 2020 (EEP), LTI 2021 (EEP), LTI 2022 (EEP) and LTI 2023 (EEP)
programs vest annually in equal installments over four years commencing in December 2021, December 2022 and
December 2023 respectively and will be settled after a waiting period of four years.
n/a = not applicable.
(8)
In connection with Jens Holstein’s appointment to the Management Board as Chief Financial Officer on July 1, 2021, the
Supervisory Board granted him a one-time signing bonus of €800,000 in the form of 4,246 phantom shares. The phantom
shares vest in four equal installments on July 1 of 2022, 2023, 2024 and June 30, 2025 but will only be settled in cash on
July 1, 2025. The cash payment is subject to an effective settlement closing price cap. This means that the settlement
closing price shall effectively be adjusted to ensure that the current price of an ADS as of the settlement date does not
exceed 800% of the cash payment, which in respect of all phantom shares shall not exceed €6.4 million.
(9)
Indicates the end of the respective waiting periods. Additional restrictions with respect to exercise windows may apply.
(10)
Management Board Grant (Long-Term Incentive) in the respective years.
(11)
All options are subject to an effective exercise price cap. This means that the exercise price shall be adjusted to ensure
that the current price of an ADS as of the exercise date does not exceed 800% of the exercise price. For the ESOP 2018
Program and the CEO Grant 2019, the maximum economic benefit receivable for any exercised option was capped at
$240.00 and the effective exercise price was capped at a Euro amount equivalent to $30.00. For the LTI 2020, the
maximum economic benefit receivable is capped at $246.24, and the effective exercise price is capped at a Euro amount
equivalent to $30.78. For the phantom share options issued under the LTI 2021 and 2022 programs and the options
issued under the LTI 2023 and 2024 programs, the maximum compensation that each member is entitled to receive,
together with other compensation components received in the respective grant year, shall not exceed €20.0 million for
Ugur Sahin and €10.0 million for all others.
(12)
Upon Sean Marett’s resignation from the Management Board with effect as of June 30, 2024, the LTI 2024 grant relating
to the first six months of 2024 to which he was contractually entitled was immediately forfeited due to his resignation. As
part of Sean Marett’s retirement from the Management Board, he and the Supervisory Board entered into a separation
agreement, details of which are outlined
in the section “
Compensation of the Members of Our Management Board
”
above.
Management
Board Grant (Long-Term Incentive)
Our Management Board’s service agreements provide for long-term,
P4Y
-year incentive compensation
(Management Board Grant - LTI) through an annual grant of options to acquire BioNTech shares at the end of
the respective waiting periods of such agreements.
The options are subject to the terms and conditions of the
respective authorizations of the AGM creating our Employee Stock Ownership Plan, or ESOP, and the applicable
option agreements
.
The allocation of options in 2020 occurred in February 2020. In May 2021 and May 2022, Management Board
members received phantom
options equivalent to the number of options they would have been entitled to
receive for 2021 and 2022
. During 2023 and 2024, options were granted in May 2023 and August 2024,
respectively.
210
Annual Report on Form 20-F for the
year ended December 31, 2024
For the awards allocated as of February 13, 2020; May 12, 2021; May 17, 2021; May 31, 2022; May 22, 2023;
and August 2024, the exercise
prices are
$30.78
(
€29.63
);
$185.23
(
€178.29
);
$186.83
(
€179.83
);
$152.10
(
€146.40
),
$113.94
(
€109.67
)
and
€75.91
r
espectively (all conversions from USD to EUR are calculated
using
the foreign exchange rate as published by the German Central Bank (Deutsche Bundesbank) as of December
31, 2024).
All options are subject to an effective exercise price cap, which means that the exercise price shall be adjusted
to ensure that the current price of an ADS as of the exercise date does not exceed
800%
of the exercise price.
For the LTI 2020, the maximum economic benefit receivable is capped at $246.24, and the effective exercise
price is capped at a Euro amount equivalent to $30.78. For the phantom share options issued under the LTI
2021 and 2022 programs and the options issued under the LTI 2023 and 2024 programs, the maximum
compensation that each member is entitled to receive, together with other compensation components received in
the respective grant year, shall not exceed
€20.0 million
for Ugur Sahin and
€10.0 million
for all others.
The options vest annually in equal installments over four years commencing on the first anniversary of the
allocation date and become exercisable four years after the allocation date.
Vested options can only be
exercised if each of the following performance criteria has been achieved: (i) at the time of exercise, the current
price is equal to or greater than the threshold amount (that is, the exercise price, provided that such amount
increases by
seven
percentage points on each anniversary of the allocation date); (ii) at the time of exercise, the
current price is at least equal to the target price (that is, (a) for the twelve-month period starting on the fourth
anniversary of the allocation date,
$8.5 billion
divided by the total number of the ordinary shares outstanding
immediately following the initial public offering (other than ordinary shares owned by BioNTech), and (b) for each
twelve-month period starting on the fifth or subsequent anniversary of the allocation date,
107%
of the target
share price applicable for the prior twelve-month period); and (iii) the closing price for the fifth trading day prior to
the start of the relevant exercise window is higher than the exercise price by at least the same percentage by
which the Nasdaq Biotechnology Index (or a comparable successor index) is higher than it was on the last
trading day before the allocation date. Following the expiry of the waiting period, option rights may be exercised
during the exercise windows set out in the ESOP agreement. Option rights can be exercised up to
ten years
after
the allocation date, after which they will be forfeited without compensation.
During the year ended December 31,
2023
, the options granted under the LTI 2020 program vested and were
almost entirely exercised in 2024, with the exception of 38,968 options held by Sean Marett. During the year
ended December 31, 2024, the options granted under the LTI 2024 program were allocated to Ugur Sahin, Jens
Holstein, Sierk Poetting, Ryan Richardson, James Ryan and Özlem Türeci. Although Sean Marett resigned from
the board as of June 30, 2024, according to his service agreement, he would have been entitled to an LTI 2024
grant within the first six months of 2024. However, upon his retirement from the Management Board, all unvested
options from the LTI 2021, LTI 2022, LTI 2023, and LTI 2024 programs were immediately forfeited. Annemarie
Hanekamp joined the Management Board on July 1, 2024, after the allocation of the LTI 2024 grant. She
received a pro rata LTI grant of €275,000 (reflects 50% of the annual target value) that will be made in shares or
as a cash payment in 2025. She will participate in the applicable LTI plan as in force starting January 1, 2025.
Chief Executive Officer Grant (CEO Grant 2019)
In September 2019, we granted Prof. Ugur Sahin, M.D., an option to purchase 4,374,963 of our shares under the
ESOP 2017/2019 program. All of these option rights vested and became exercisable in 2023, and were
exercised on August 9, 2024, with an exercise price for each option of
€13.74
(
$15.00
)
calculated using the
foreign exchange rate published by the German Central Bank (Deutsche Bundesbank) on the day before the
exercise date and by applying the effective exercise cap and the maximum cap mechanism as disclosed above.
The closing price of one ADS on Nasdaq on the settlement date converted from U.S. Dollars to Euro using the
exchange rate published by the German Central Bank (Deutsche Bundesbank) on the same day was
73.68
and
led to an intrinsic value of the exercised options of
€259.5 million
.
In August 2024, the Supervisory Board determined that the award would be settled by the delivery of treasury
shares (in the form of ADSs) equal to the net value of the exercised option rights after deduction of (i) the
exercise price and (ii) the applicable wage taxes (including solidarity surcharge and church tax, if applicable) and
social security contributions resulting from the exercise.
211
Annual Report on Form 20-F for the
year ended December 31, 2024
C.
Board Practices
Two-Tiered
Board Structure
We are a European public company with limited liability (Societas Europaea or SE) (also referred to as European
stock corporation, and in the official terminology of the European legislation referred to as European public
limited-liability company), having its seat in Germany. We have chosen to have a two-tiered SE structure. Hence,
our corporate bodies are the Management Board (
Vorstand
), the Supervisory Board (
Aufsichtsrat
) and the
shareholders’ meeting (
Hauptversammlung
). Our Management and Supervisory Boards are entirely separate,
and, as a rule, no individual may simultaneously be a member of both boards.
Our Management Board is responsible for the day-to-day management of our business in accordance with
applicable laws, our Articles of Association (
Satzung
) and the Management Board’s internal rules of procedure
(
Geschäftsordnung
). Our Management Board represents us in our dealings with third parties.
The principal function of our Supervisory Board is to supervise our Management Board. The Supervisory Board
is also responsible for appointing and removing the members of our Management Board, representing us in
connection with transactions between a current or former member of the Management Board and us, and
granting approvals for certain significant matters.
Our Management Board and our Supervisory Board are solely responsible for and manage their own areas of
competency (
Kompetenztrennung
); therefore, neither board may make decisions that, pursuant to applicable
law, our Articles of Association or the internal rules of procedure are the responsibility of the other board.
Members of both boards owe a duty of loyalty and care to us. In carrying out their duties, they are required to
exercise the standard of care of a prudent and diligent businessperson. If they fail to observe the appropriate
standard of care, they may become liable to us.
In carrying out their duties, the members of both boards must take into account a broad range of considerations
when making decisions, including our interests and the interests of our shareholders, employees, creditors and,
to a limited extent, the general public, while respecting the rights of our shareholders to be treated on equal
terms.
Additionally, the Management Board is responsible for implementing an appropriate and effective internal
control system and risk management system with regard to the scope of business activities and the risk situation
of the Company.
Our Supervisory Board has comprehensive monitoring responsibilities. To ensure that our Supervisory Board
can carry out these functions properly, our Management Board must, among other duties, regularly report to our
Supervisory Board regarding our current business operations and future business planning (including financial,
investment and personnel planning). In addition, our Supervisory Board or any of its members is entitled to
request special reports from the Management Board on all matters regarding the Company, our legal and
business relations with affiliated companies and any business transactions and matters at such affiliated
companies that may have a significant impact on our position at any time.
Under German law, our shareholders have, as a general rule, no direct recourse against the members of our
Management Board or the members of our Supervisory Board in the event that they are believed to have
breached their duty of loyalty and care to us. Apart from when we are unable to fulfill our third party obligations,
tortious conduct to board members or other special circumstances, only we have the right to claim damages
against the members of our two boards.
We may waive these claims to damages or settle these claims only if at least three years have passed since a
claim associated with any violation of a duty has arisen and only if our shareholders approve the waiver or
settlement at a shareholders’ meeting with a simple majority of the votes cast, provided that no shareholders
who in the aggregate hold one-tenth or more of our share capital oppose the waiver or settlement and have their
opposition formally recorded in the meeting’s minutes.
212
Annual Report on Form 20-F for the
year ended December 31, 2024
Supervisory Board
German law requires that the Supervisory Board consists of at least three members, while a company’s articles
of association may stipulate a certain higher number. Our Supervisory Board currently consists of six members.
As we are not subject to co-determination, the members of our Supervisory Board are all elected by the
shareholders’ meeting in accordance with the provisions of the SE Regulation and the German Stock
Corporation Act (
Aktiengesetz
). German law does not require the majority of our Supervisory Board members to
be independent and neither our Articles of Association (
Satzung
) nor the rules of procedure for our Supervisory
Board provide
otherwise.
As per our Supervisory Board’s assessment, an appropriate number of shareholder
representatives on the Supervisory Board (i.e. the entire Supervisory Board) are independent if the Supervisory
Board has two independent members. The Supervisory Board considers Helmut Jeggle and Michael
Motschmann to be independent irrespective of the fact that they will soon have been members of the
Supervisory Board for a period of
more than 14 years.
As stated in the declaration to the German Corporate
Governance Code, or the Corporate Governance Code,
(
Entsprechenserklärung
) published by the Company on
February 27, 2025
pursuant to Section 161 para. 1 of the German Stock Corporation Act (
Aktiengesetz
),
which in
accordance with the Corporate Governance Code is issued in connection with the Declaration pursuant to
Section 315d in conjunction with Section 289f of the German Commercial Code (
HGB
), the length of
membership does not give rise to any fears of material conflicts of interest on the part of the members of the
Supervisory Board and therefore does not stand in the way of their independence.
However,
the rules of
procedure for our Supervisory Board provide that the Supervisory Board should have an independent member
with expertise in the field of accounting, internal control processes and
auditing
.
Ulrich Wandschneider, Anja
Morawietz, Michael Motschmann and Rudolf Staudigl
fulfill this role.
Under European law, a member of a supervisory board of an SE may be elected for a maximum term to be
specified in the articles of association, which must not exceed six years. Re-election, including repeated re-
election, is permissible. The shareholders’ meeting may specify a term of office for individual members or all of
the members of our Supervisory Board which is shorter than the standard term of office and, subject to statutory
limits, may set different start and end dates for the terms of members of our Supervisory Board. Our Articles of
Association provide for a term of approximately five years, depending on the date of the annual general
shareholders’ meeting in the year in which the term of the relevant member is to expire.
The shareholders’ meeting may, at the same time as it elects the members of the Supervisory Board, elect one
or more substitute members. The substitute members replace members who cease to be members of our
Supervisory Board and take their place for the remainder of their respective terms of office. Currently, no
substitute members have been elected or have been proposed to be elected.
Members of our Supervisory Board may be dismissed at any time during their term of office by a resolution of the
shareholders’ meeting adopted by at least a simple majority of the votes cast. In addition, any member of our
Supervisory Board may resign at any time by giving one month’s written notice – or, in the event of cause, giving
written notice with immediate effect – of his or her resignation to the Management Board.
Our Supervisory Board elects a chairperson and a deputy chairperson from its members. The deputy
chairperson exercises the chairperson’s rights and obligations whenever the chairperson is unable to do so.
The
members of our Supervisory Board have elected Helmut Jeggle as chairperson
and Ulrich Wandschneider as
deputy chairperson, each for the term of their respective membership on our Supervisory Board.
The Supervisory Board meets at least twice each calendar half-year. Our Articles of Association provide that a
quorum of the Supervisory Board members is present if at least three of its members participate in the vote.
Members of our Supervisory Board are deemed present if they attend the meeting via telephone or other
(electronic) means of communication (including via video conference) or submit their written vote through
another member. Additionally, our Articles of Association allow for resolutions to be taken via telephone or other
(electronic) means of communications (including via video conference).
Resolutions of our Supervisory Board are passed by the vote of a simple majority of the votes cast unless
otherwise required by law, our Articles of Association or the rules of procedure of our Supervisory Board. In the
213
Annual Report on Form 20-F for the
year ended December 31, 2024
event of a tie, the chairperson of the Supervisory Board has the casting vote. Our Supervisory Board is not
permitted to make management decisions, but in accordance with European and German law and in addition to
its statutory responsibilities, it has determined that certain matters require its prior consent, including:
•
entering into certain large transactions;
•
acquiring any material interests in businesses of third parties (except group companies) or disposing of
material assets or shares of the Group (other than in relation to an internal reorganization);
•
issuing shares from authorized capital, unless the shares are issued pursuant to a redemption of stock
appreciation rights; and
•
acquiring treasury shares in return for valuable consideration.
Each member of the Supervisory Board shall disclose any conflicts of interest to the Supervisory Board,
especially those that may arise from providing advice or holding any offices or board positions at customers,
suppliers, creditors or other third parties. Material conflicts of interest that are not merely temporary and that are
specific to a particular Supervisory Board member shall result in this particular member leaving office. Our
Supervisory Board also puts in place adequate measures to limit, prevent or resolve conflicts of interest in
accordance with applicable legal requirements and the Company’s Conflicts of Interest Policy.
Our Supervisory Board conducted a self-assessment
for the
year ended December 31, 2024
.
It covered all key
aspects of the Supervisory Board’s work, including its committees, its composition, its competence profile, its
main topics and its relationship with the Management Board.
The results of the self-assessment have been
evaluated and will subsequently be presented to the Supervisory Board.
Based on the self-assessment,
the
Supervisory Board believes that it, its committees and the Management
Board continue to operate at a
professional and cooperative level
. No fundamental need for change was identified.
Supervisory Board Practices
Decisions are generally made by our Supervisory Board as a whole, however decisions on certain matters may
be delegated to committees of our Supervisory Board to the extent permitted by law. The chairperson, or if he or
she is prevented from doing so, the deputy chairperson, chairs the meetings of the Supervisory Board and
determines the order in which the agenda items are discussed, the method and order of voting, as well as any
adjournment of the discussion and passing of resolutions on individual agenda items after a due assessment of
the circumstances. Our Supervisory Board may designate further types of actions as requiring its approval.
In addition, each member of the Supervisory Board is obliged to carry out his or her duties and responsibilities
personally, and such duties and responsibilities cannot be generally and permanently delegated to third parties.
However, the Supervisory Board and its committees have the right to appoint independent experts for the review
and analysis of specific circumstances in accordance with its control and supervision duties under applicable
European and German law. We would bear the costs of any such independent experts that are retained by the
Supervisory Board or any of its committees.
Pursuant to Section 107 para. 3 of the German Stock Corporation Act (
Aktiengesetz
), the Supervisory Board
may form committees from among its members and charge them with the performance of specific tasks. The
committees’ tasks, authorizations and processes are determined by the Supervisory Board. Where permissible
by law, important powers of the Supervisory Board may also be transferred to committees.
T
he Supervisory Board has established an Audit Committee, a Compensation, Nominating, Governance
Committee, a Capital Markets Committee and a Product Committee by resolution. Set forth in the table below
are the members of the respective committees during the
year ended December 31, 2024
.
214
Annual Report on Form 20-F for the
year ended December 31, 2024
|
Name of Committee
|
Members
|
|
|
Audit Committee
|
Prof. Anja Morawietz, Ph.D. (Chair), Prof. Rudolf Staudigl,
Ph.D and Ulrich Wandschneider, Ph.D.
|
|
|
Compensation, Nominating and Corporate Governance
Committee
|
Prof. Rudolf Staudigl, Ph.D. (Chair), Baroness Nicola
Blackwood and Michael Motschmann.
|
|
|
Capital Markets Committee
|
Helmut Jeggle (Chair), Prof. Anja Morawietz, Ph.D. and
Michael Motschmann
|
|
|
Product Committee
|
Ulrich Wandschneider, Ph.D. (Chair), Baroness Nicola
Blackwood and Helmut Jeggle
|
Audit Committee
Our Audit Committee for the year ended December 31, 2024 consisted of Anja Morawietz. (Chair), Rudolf
Staudigl and Ulrich Wandschneider.
T
he Audit Committee assists the Supervisory Board in overseeing the
accuracy and integrity of our financial statements, our accounting and financial reporting processes and audits of
our financial statements, the effective functioning of our internal control system, our risk management system,
our compliance with legal and regulatory requirements, our independent auditor’s qualifications and
independence, the performance of the independent auditor and the effective functioning of our internal audit
functions, and, subject to certain limitations, adopts and implements pertinent decisions on behalf of the
Supervisory Board. The Audit Committee’s duties and responsibilities to carry out its purpose, include, among
others:
•
oversight of the Company’s accounting, sustainability reporting, financial reporting processes,
sustainability reporting processes and the audit of the annual financial statements and the consolidated
financial statements and the (group) management reports and sustainability report and the effectiveness
of the internal control system;
•
oversight of the effectiveness of the Risk Management System and the internal Audit System;
•
monitoring the independent audit, in particular the selection and independence of the auditor, the quality
of the audit and the additional services provided by the auditor;
•
making a recommendation to the Supervisory Board with respect to the proposal for the appointment of
the auditors;
•
considering the commissioning of the audit engagement, as well as the compensation, retention and
oversight of the independent auditor;
•
evaluating the qualifications, independence and quality of performance of the independent auditor;
•
reviewing and pre-approving the audit and non-audit services to be performed by the independent
auditor;
•
reviewing and discussing with the independent auditor the annual audit plan and overall auditing
strategy, the independent auditor's responsibilities and the management's responsibilities under the
auditing process, and reviewing with the independent auditor and management the critical accounting
policies and practices to be applied;
•
reviewing of alternative treatments of financial information discussed by the independent auditor and the
board, the implications of using such alternative disclosures and treatments, and the independent
auditor's preferred treatment;
215
Annual Report on Form 20-F for the
year ended December 31, 2024
•
reviewing and discussing with the independent auditor and management the adequacy and
effectiveness of our internal accounting controls and critical accounting policies;
•
reviewing and discussing with the independent auditor and management the results of our annual audit;
•
reviewing non-financial reporting;
•
reviewing the effectiveness of the compliance management system;
•
reviewing, approving and monitoring any related party transactions in accordance with SEC regulations
or German law and reviewing and monitoring potential conflict of interest situations on an ongoing basis
for compliance with our policies and procedures; and
•
overseeing procedures for the receipt, retention and treatment of complaints received regarding
accounting, internal accounting controls or auditing matters or other matters of compliance.
Within the limits of applicable European and German law, the Audit Committee shall have the resources and
authority appropriate to discharge its duties and responsibilities, including the authority to select, retain,
terminate, and approve the fees and other engagement terms of special or independent counsel, accountants or
other experts and advisors, as it deems necessary or appropriate for so discharging its duties and
responsibilities, without seeking approval of the Management Board or Supervisory Board.
All members of the Audit Committee qualify as “independent directors” as such term is defined in Rule 10A-3
under the Exchange Act and Nasdaq Rule 5605. Additionally, our Supervisory Board has determined that Anja
Morawietz, Rudolf Staudigl and Ulrich Wandschneider qualify as “audit committee financial expert” as that term
is defined under the Exchange Act.
In addition, Anja Morawietz as Chair of the Audit Committee,
Rudolf Staudigl
and Ulrich Wandschneider have the special knowledge and experience required by the German Corporate
Governance Code in the field of accounting and expertise in the field of auditing.
Compensation, Nominating and Corporate Governance Committee
Our Compensation, Nominating and Corporate Governance Committee for the
year ended December 31, 2024
consisted of Rudolf Staudigl (Chair), Nicola Blackwood and Michael Motschmann. The Compensation,
Nominating and Corporate Governance Committee’s duties and responsibilities to carry out its purpose include,
among others
:
•
preparing and discussing with management policies relating to the remuneration of the members of our
Management Board;
•
reviewing and supervising corporate goals and objectives for the remuneration of the members of the
Management Board, including evaluation of the performance of the members of the Management Board
in light of these goals and proposals to the Supervisory Board for remuneration based on such
evaluations;
•
reviewing all equity-based compensation plans and arrangements and making recommendations to the
Supervisory Board regarding such plans;
•
assisting with identifying and recruiting candidates to fill positions on the Management Board and the
Supervisory Board;
•
considering any corporate governance issue that arises and developing appropriate recommendations
for the Supervisory Board; and
•
overseeing the evaluation of the Supervisory Board and reporting on its performance and effectiveness.
Capital Markets Committee
216
Annual Report on Form 20-F for the
year ended December 31, 2024
Our Capital Markets Committee for the
year ended December 31, 2024
consisted of
Helmut Jeggle (Chair), Anja
Morawietz and Michael Motschmann.
The Capital Markets Committee advises and makes recommendations to
the Supervisory Board on issues in connection with capital measures and takeover, merger and acquisition
activities. Its responsibilities include the following tasks:
•
overseeing the activities of the Company relating to its capital structure and capital raising, including
preparation for and implementation of public offerings and share issuances; and
•
overseeing the activities of the Company relating to takeovers, mergers and acquisitions activities.
Product Committee
Our Product Committee for the
year ended December 31, 2024
consisted
of Ulrich Wandschneider (Chair),
Nicola Blackwood and Helmut Jeggle.
The Product Committee advises and makes recommendations to the
Supervisory Board with respect to our strategy and investment in research and development programs and
product launch preparations including
commercialization
.
Its responsibilities include the following tasks:
•
advising on strategy, execution and communication regarding relevant go-to-market efforts;
•
overseeing the activities relating to (a) product development, (b) launch plans and (c) their execution;
and
•
advising on market potential for products in clinical development.
Management Board
Our Supervisory Board determines the exact number of members of our Management Board, which must consist
of at least two members. Pursuant to the Articles, the Supervisory Board may also appoint a chairperson or a
spokesman of the Management Board. Ugur Sahin has been appointed the chair of the Management Board.
The members of our Management Board are appointed by our Supervisory Board for a term of up to five years.
They are eligible for reappointment or extension, including repeated re-appointment and extension, after the
completion of their term in office, in each case again for up to an additional five years. Under certain
circumstances, such as a serious breach of duty or a vote of no confidence by the shareholders in a
shareholders’ meeting, a member of the Management Board may be removed from office by our Supervisory
Board prior to the expiration of his or her term.
The members of our Management Board conduct the daily business of the Company in accordance with
applicable laws, our Articles of Association and the rules of procedure for the Management Board adopted by our
Supervisory Board. They are generally responsible for the management of our company and for handling our
daily business relations with third parties, the internal organization of our business and communications with our
shareholders.
A member of the management board of an SE governed by German law may not deal with or vote on matters
relating to proposals, arrangements or contractual agreements between himself or herself and the Company,
and a member of our Management Board may be liable to us if he or she has a material interest in any
contractual agreement between the Company and a third party which is not disclosed to and approved by our
Supervisory Board.
The rules of procedure for our Management Board provide that certain matters require a resolution of the entire
Management Board, in addition to transactions for which a resolution adopted by the entire Management Board
is required by law or required by our Articles of Association. In particular, the entire Management Board shall
decide on, among others:
•
the budget plan for the following year, which is to be presented by the Management Board to the
Supervisory Board by December 10 of each year;
217
Annual Report on Form 20-F for the
year ended December 31, 2024
•
presentation of the Company’s financial statements and consolidated financial statements and reviews
of operations of the Company and the Group;
•
reporting to the Supervisory Board;
•
all measures and transactions that require the Supervisory Board’s approval;
•
all measures and transactions that are of fundamental importance or involve an extraordinary economic
risk to us, including without limitation, establishing new lines of business or discontinuing existing ones,
acquisitions or sales of material business assets, material interests, holdings and investments and
material contracts or transactions
;
•
convening the Company’s shareholders’ meetings and proposals for resolutions by the Company’s
shareholders’ general meetings; and
•
appointment and termination of key managers in the Group.
Code of Conduct and Conflicts of Interest Policy
We have adopted a Code of Business Conduct & Ethics, or Code of Conduct, which outlines the principles of
legal and ethical business conduct under which we do business. The Code of Conduct applies to all of our
Supervisory Board members, Management Board members, directors of our subsidiaries and employees. The
full text of the Code of Conduct is available on our website at
https://www.biontech.de.
The information and other
content appearing on our website are not incorporated by reference into this Annual Report and our website
address is included in this report as an inactive textual reference only. Any amendments or waivers from the
provisions of the Code of Conduct for members of our Supervisory or Management Boards will be made only
after approval by our Supervisory Board and will be disclosed on our website promptly following the date of such
amendment or waiver.
We have also adopted a Conflicts of Interest Policy which sets forth the procedures by which we manage
potential and actual conflicts of interest. Under the Conflicts of Interest Policy, which applies to all of our
Supervisory Board members, Management Board members, directors of our subsidiaries and employees, an
actual, potential or perceived conflict of interest must be disclosed when it first arises. If the conflict is
transactional in nature and involves a member of the Management Board or the Supervisory Board, the
Management or Supervisory Board, as the case may be, with the abstention of the conflicted member, shall
decide whether to approve the transaction.
In addition, we have implemented compliance policies that describe the compliance management systems that
have been implemented for us and our subsidiaries. Our compliance policies are designed to ensure compliance
with applicable legal requirements, while at the same time implementing high ethical standards that are
mandatory for both management and each employee. The overall responsibility for the compliance management
system lies with the Management Board. The Audit Committee will receive regular reports on the operation of the
compliance management system.
D. Employees
As of
December 31, 2024
, we had
6,772
full-time equivalent employees working for us, of whom
1,282
hold a
doctoral degree or higher. The following tables provides an overview of employee full-time equivalent broken
down by function and by the regions of Europe, North America, Asia and Australia and Africa.
218
Annual Report on Form 20-F for the
year ended December 31, 2024
|
Full-time equivalents
|
Clinical
Research &
Development
|
Scientific
Research &
Development
|
Operations
|
Quality
|
Supporting
Functions
|
Commercial
& Business
Development
|
∑
|
|||||||||
|
Europe
|
597
|
1,543
|
1,075
|
419
|
1,856
|
182
|
5,672
|
|||||||||
|
North America
|
126
|
484
|
18
|
21
|
139
|
24
|
811
|
|||||||||
|
Asia and Australia
|
12
|
3
|
11
|
5
|
68
|
1
|
100
|
|||||||||
|
Africa
|
—
|
—
|
145
|
7
|
37
|
—
|
189
|
|||||||||
|
Total as of
December 31, 2024
|
735
|
2,030
|
1,249
|
452
|
2,100
|
207
|
6,772
|
|||||||||
|
Europe
|
486
|
1,555
|
1,440
|
450
|
1,184
|
185
|
5,299
|
|||||||||
|
North America
|
90
|
440
|
7
|
7
|
109
|
7
|
660
|
|||||||||
|
Asia
|
—
|
—
|
24
|
—
|
4
|
—
|
28
|
|||||||||
|
Africa
|
—
|
19
|
59
|
—
|
68
|
—
|
146
|
|||||||||
|
Total as of
December 31, 2023
|
576
|
2,014
|
1,530
|
457
|
1,365
|
192
|
6,133
|
|||||||||
|
Europe
|
243
|
1,102
|
1,300
|
384
|
924
|
140
|
4,093
|
|||||||||
|
North America
|
—
|
356
|
—
|
—
|
76
|
—
|
432
|
|||||||||
|
Asia
|
2
|
—
|
—
|
—
|
3
|
—
|
5
|
|||||||||
|
Total as of
December 31, 2022
|
245
|
1,458
|
1,300
|
384
|
1,003
|
140
|
4,530
|
None of our employees has engaged in any labor strikes. We apply the collective labor agreements of the
chemical industry and related industries at our Marburg site. We have works councils at our Idar-Oberstein,
Mainz, Marburg, Munich, Vienna and Berlin (JPT Peptide Technologies GmbH) sites as well as a group works
council (
Konzernbetriebsrat
). Further, we maintain a couple of works agreements (
Betriebsvereinbarungen
) and
group works agreements (
Konzernbetriebsvereinbarungen
) with respect to certain topics at our Idar-Oberstein,
Mainz, Marburg and Berlin (JPT Peptide Technologies GmbH) sites or the group. We consider our relationship
with our employees to be positive and have not experienced any major labor disputes.
E. Share Ownership
The share ownership information with respect to Management Board and Supervisory Board members is
presented in Item 7 below.
F. Disclosure of a Registrant’s Action to Recover Erroneously Awarded Compensation
Not applicabl
e
.
Item 7
. Major Shareholders and Related Party Transactions
A. Major Shareholders
The following table presents information, as of
December 31, 2024
,
regarding the beneficial ownership of our
ordinary shares for:
•
each person, or group of affiliated persons, known by us to own beneficially 5% or more of our
outstanding shares;
•
each member of our Supervisory Board;
•
each member of our Management Board; and
•
all members of our Supervisory Board and Management Board as a group.
219
Annual Report on Form 20-F for the
year ended December 31, 2024
The number of ordinary shares beneficially owned by each entity, person, and member of our Supervisory Board
and our Management Board is determined in accordance with the rules of the SEC, and the information is not
necessarily indicative of beneficial ownership for any other purpose. Under such rules, beneficial ownership
includes any ordinary shares over which the individual has sole or shared voting power or investment power as
well as any ordinary shares that the individual
has the right to acquire within 60 days of
December 31, 2024
,
through the exercise of any option, warrant or other right.
Except as otherwise indicated, and subject to
applicable community property laws, the persons named in the table have sole voting and investment power with
respect to all ordinary shares held by that person. All of our ordinary shares and ADSs representing our ordinary
shares vote on an equal basis.
The percentage of outstanding ordinary shares is computed on the basis of
239,970,804
ordinary shares
outstanding as of
December 31, 2024
. This amount excludes
8,581,396
shares held in treasury. Amounts
presented in this section include ordinary shares held in the form of ADSs. Unless otherwise indicated, the
address for each beneficial owner is An der Goldgrube 12, 55131 Mainz,
Germany
.
|
Name of Beneficial Owner
|
Number of
Shares
Beneficially
Owned
|
Percentage
Beneficially
Owned
|
||
|
5% shareholders
|
||||
|
AT Impf GmbH
(1)
|
101,852,563
|
42.4
%
|
||
|
Medine GmbH
(2)
|
40,432,177
|
16.9
%
|
||
|
All 5% shareholders, as a group
|
142,284,740
|
59.3
%
|
||
|
Members of the Supervisory Board and the Management Board
|
||||
|
Prof. Ugur Sahin, M.D.
(3)
|
43,207,014
|
18.0
%
|
||
|
Annemarie Hanekamp
|
—
|
—
|
||
|
Jens Holstein
|
1,620
|
(8)
|
||
|
Sierk Poetting, Ph.D.
(4)
|
767,539
|
(8)
|
||
|
Ryan Richardson
|
26,548
|
(8)
|
||
|
James Ryan, Ph.D.
|
790
|
—
|
||
|
Prof. Özlem Türeci, M.D.
|
786,999
|
(8)
|
||
|
Helmut Jeggle
(5)
|
1,425,967
|
(8)
|
||
|
Ulrich Wandschneider, Ph.D.
(6)
|
1,480
|
(8)
|
||
|
Baroness Nicola Blackwood
|
—
|
—
|
||
|
Prof. Anja Morawietz, Ph.D.
(7)
|
240
|
(8)
|
||
|
Michael Motschmann
|
—
|
—
|
||
|
Prof. Rudolf Staudigl, Ph.D.
|
400
|
(8)
|
||
|
All members of our Supervisory Board and Management Board, as a group
|
46,218,597
|
19.3
%
|
(1)
Consists of
101,852,563
ordinary shares held by AT Impf GmbH. The sole member of AT Impf GmbH is ATHOS KG, and,
as a result, ATHOS KG is deemed to be the beneficial owner of the securities held by AT Impf GmbH.
ATHOS KG via AT
Impf GmbH has de facto control over BioNTech based on its substantial shareholding, which practically enables it to
exercise the majority of voting rights to pass resolutions at our Annual General Meeting, or AGM.
As of
December 31,
2024
Thomas Maier is a general partner (
Komplementär
) of ATHOS KG and may be deemed to be beneficial owners of
the securities held by AT Impf KG. Mr. Maier disclaims beneficial ownership of such shares except to the extent of their
pecuniary interest therein.
(2)
The sole shareholder of Medine GmbH is Ugur Sahin, and, as a result, Ugur Sahin is deemed
to be the beneficial owner
of the securities held by Medine GmbH. Consists of
40,432,177
ordinary shares held by Medine GmbH, 1,320,787 of
which are held for the benefit of a former colleague pursuant to a trust arrangement.
Pursuant to this arrangement,
Medine GmbH retains voting power, but not dispositive power, over such shares for so long as such shares are held in
trust and accordingly Medine GmbH and Ugur Sahin each may be deemed beneficially to own such shares.
220
Annual Report on Form 20-F for the
year ended December 31, 2024
(3)
Consists of the shares described in note
2
above, plus 2,774
,837 ordinary shares held directly b
y Ugur Sahin
. He
is the
sole shareholder of Medine GmbH.
(4)
Consists of (a) 604,387 ordinary shares held by Tofino GmbH (Sierk Poetting is sole shareholder of Tofino GmbH), (b)
163,152 ordinary shares held directly by Sierk Poetting and
(c) 1,638 ordinary shares held by his immediate family. Mr.
Poetting disclaims beneficial ownership of the 1,638 ordinary shares held by his immediate family except to the extent of
his pecuniary interest therein
.
(5)
Consists of (a) 332,316 ordinary shares held directly by Helmut Jeggle and (b) 1,093,651 ordinary shares held by Salvia
GmbH.
(6)
Consists of
1,480
ordinary shares held by beebusy Capital GmbH. Ulrich Wandschneider is sole shareholder of beebusy
Capital GmbH.
(7)
Consists of (a) 200 ordinary shares held directly by Anja Morawietz and (b) 40 ordinary shares held by her immediate
family.
(8)
Less than one percent.
Holdings by U.S. Shareholders
Our share capital consists of ordinary shares, some of which are traded in the United States by means of
American Depositary Shares (ADSs), each representing one ordinary share. Our depositary, The Bank of New
York Mellon, is the holder of the ordinary shares underlying the ADSs. Based on the limited information available
to us and the depositary, we generally cannot determine with certainty the number of U.S. shareholders or how
many shares such shareholders own.
B.
Related Party Transactions
See Item 18.
C. Interests of Experts and Counsel
Not applicable.
Item 8. Financial Information
A. Consolidated Statements and Other Financial Information
See Item 18.
B. Significant Changes
Not applicable.
Item 9. The Offer and Listing
A. Offer and Listing Details
ADSs representing our ordinary shares have been listed on the Nasdaq Global Select Market under the symbol
“BNTX” since October 10, 2019. Prior to that date, there was no public trading market for our ADSs.
B. Plan of Distribution
Not applicable.
C.
Markets
ADSs representing our ordinary shares have been listed on the Nasdaq Global Select Market under the symbol
“BNTX” since October 10, 2019.
D. Selling Shareholders
Not applicable.
221
Annual Report on Form 20-F for the
year ended December 31, 2024
E. Dilution
Not applicable.
F. Expenses of the Issue
Not applicable.
Item 10. Additional Information
A. Share Capital
Not applicable.
B.
Memorandum and Articles of Associatio
n
General
We were incorporated as a German stock corporation (Aktiengesellschaft) with the legal name Petersberg 91. V
AG under the laws of the Federal Republic of Germany on June 2, 2008. We changed our name to BioNTech AG
on December 11, 2008. Effective as of March 8, 2019, the date on which the change of legal form and company
was registered with the commercial register (
Handelsregister
) of the local court (
Amtsgericht
) of Mainz,
Germany, we converted to a Societas Europaea with the legal name BioNTech SE. We completed our initial
public offering in October 2019. The principal legislation under which we operate and our shares are issued are
the Council Regulation (EC) No 2157/2001 of October 8, 2001 on the Statute for a European company (SE), the
German Law on the Implementation of Council Regulation (EC) No 2157/2001 of October 8, 2001 on the Statute
for a European company (SE) (
Gesetz zur Ausführung der Verordnung (EG) NR. 2157/2001 des Rates vom 8.
Oktober 2001 über das Statut der Europäischen Gesellschaft (SE) (SE-Ausführungsgesetz—SEAG)
) and the
German Stock Corporation Act (Aktiengesetz), in each case as amended.
We are registered with the commercial register (
Handelsregister
) of the local court (
Amtsgericht
) in Mainz,
Germany, under number HRB 48720. Our statutory seat is in Mainz, Germany, and our registered office is An der
Goldgrube 12, 55131 Mainz, Germany. Copies of our Articles of Association (
Satzung
) are publicly available from
the commercial register (
Handelsregister
) at the local court of Mainz, Germany, electronically at
www.unternehmensregister.de and as an exhibit to this Annual Report.
Share Capital
We have share capital registered in the commercial register (
Handelsregister
) in the amount of €
248,552,200
,
which is divided into
248,552,200
registered shares (
Namensaktien
). All shares are shares with no par value
(
Stückaktien ohne Nennbetrag
) with a notional amount attributable to each ordinary share of €1.00. Each issued
ordinary share is fully paid.
Form, Certification and Transferability of Shares
The form and contents of our share certificates, collective share certificates and global share certificates are
determined by our Management Board. A shareholder’s right to certification of its shares is excluded, to the
extent permitted by law and to the extent that certification is not required by the stock exchange on which the
shares or rights or certificates representing them are admitted to trading. We are permitted to issue collective
share certificates and global share certificates that represent multiple or all of our shares.
Our shares are freely transferable under German law.
222
Annual Report on Form 20-F for the
year ended December 31, 2024
Changes in Our Share Capital During the Last Three Financial Years
Our share capital as registered with the commercial register (
Handelsregister
) amounts to
€248,552,200
,
including an amount of
€8,581,396
relating to
8,581,396
ordinary shares held in treasury as of
December 31,
2024
.
Since January 1,
2022
, our share capital has changed as follows:
•
On March 24, 2022, our share capital as registered with the commercial register (
Handelsregister
) was
increased by issuing 497,727 shares; and
•
On May 20, 2022, our share capital as registered with the commercial register (
Handelsregister
) was
increased by issuing 1,744,392 shares.
Anti-takeover Provisions of Our Charter Documents
Our Articles of Association (
Satzung
) do not include any provisions that would have a direct effect of delaying,
deferring or preventing a change of control. However, in the event of a hostile takeover, we could use our
authorized capital to increase our share capital to issue new shares to an investor at a premium. An increase in
the number of shares outstanding could have a negative effect on a party’s ability to carry out a hostile takeover.
The provisions of German law relating to public bids and takeovers that require any such bids to be carried out in
a manner designed to safeguard equal and fair treatment to all shareholders and give them a right to be bought
out at an adequate compensation where a party acquires “control” (as such term is defined in such provisions)
over the relevant company do not apply.
Future Changes to the Share Capital
Authorized Capital
Under the relevant law, the general meeting of a European stock corporation (Societas Europaea) governed by
German law can authorize the Management Board, with the consent of the Supervisory Board, to issue shares in
a specified aggregate nominal amount of up to 50% of the issued share capital of such company at the time the
resolution becomes effective. The shareholders’ authorization becomes effective upon registration in the
commercial register (
Handelsregister
) and is valid for a maximum period of five years. Under § 4(5) of our
Articles of Association (
Satzung
), the Management Board is authorized to increase our share capital, on one or
more occasions, by a total of up to
€122,657,313
by issuing, on one or more occasions, up to 122,657,313
new,
registered shares with no par value (
Genehmigtes Kapital
) in return for cash contributions or contributions in
kind, in each case with consent of the Supervisory Board. This authorization expires on June 21, 2026.
Any new shares issued from the authorized capital will participate in the profits starting with the financial year for
which the annual financial statements have not yet been submitted to the general meeting at the time of
registration of the implementation of the capital increase. Further details of a capital increase from the authorized
capital may be specified by the Management Board.
Conditional Capital
Pursuant to § 4(6) of our Articles of Association (
Satzung
), our share capital is conditionally increased by
€4,943,452 through issuance of new registered shares with no par value, or Conditional Capital ESOP
2027/2019 (
Bedingtes Kapital ESOP 2017/2019
). The Conditional Capital ESOP 2017/2019 may only be used to
issue shares to the holders of option rights granted under the authorization for the Conditional Capital ESOP
2017/2019, or the Authorization 2017/2019.
The conditional capital increase will only be implemented to the extent that stock options under the Authorization
2017/2019 are exercised and such stock options are not serviced by our providing treasury shares or through
cash payments. Any new shares issued under the Conditional Capital ESOP 2017/2019 pursuant to § 4(6) of our
Articles of Association (
Satzung
) shall be entitled to dividends from the beginning of the previous financial year in
case they are created by the exercise of subscription rights until the start of the Annual General Meeting of the
Company and otherwise from the beginning of the financial year in which they are created as a result of the
exercise of the stock options.
223
Annual Report on Form 20-F for the
year ended December 31, 2024
Pursuant to § 4(7) of our Articles of Association (
Satzung
), our share capital is conditionally increased by
€24,855,220
through issuance of new registered shares with no par value, or Conditional Capital WSV 2024
(
Bedingtes Kapital WSV 2024
). The conditional capital may only be used to issue shares to the holders or
creditors of option rights or conversion rights or those under an obligation to convert under warrant-linked or
convertible bonds avail of their option rights or conversion rights or where they are under an obligation to
convert, to the extent they satisfy their obligation to convert, or to the extent that we exercise a right to choose to
grant our shares, in whole or in part instead of paying a monetary amount due, and to the extent cash
compensation is not granted in each relevant case or treasury shares or shares of another stock-listed company
are not utilized for servicing.
Any new shares issued under the said Conditional Capital WSV 2024 pursuant to § 4(7) of our Articles of
Association (
Satzung
) shall carry an entitlement to dividends from the beginning of the financial year in which
they are created; however, as far as the law permits, the Management Board can confer dividend rights for new
shares in derogation of the foregoing.
Pursuant to § 4(8) of our Articles of Association (
Satzung
), our share capital is conditionally increased by
€1,300,000 through issuance of new, registered shares with no par value, or Conditional Capital ESOP 2021
(
Bedingtes Kapital ESOP 2021
). The Conditional Capital ESOP 2021 serves exclusively to grant rights to the
holders of stock options issued by the Company in accordance with the authorization granted by the Annual
General Meeting on June 22, 2021 under agenda item 6 letter d) also as amended by the resolution of the
Annual General Meeting on May 17, 2024 under agenda items 12 and 13, or the Authorization 2021.
The conditional capital increase will only be implemented to the extent that stock options under our ESOP are
exercised by the holders of the stock options issued by the Company on the basis of Authorization 2021 and
such stock options are not settled by the Company with treasury shares or through cash payments. Any new
shares issued under the Conditional Capital ESOP 2021 pursuant to § 4(8) of our Articles of Association
(
Satzung
) shall participate in profits from the beginning of the preceding financial year in case they are created
by the exercise of subscription rights until the start of the annual general meeting of the Company and otherwise
from the beginning of the financial year in which they are created as a result of the exercise of the stock options.
Preemptive Rights
German law generally provides shareholders with preemptive rights when new shares convertible bonds, bonds
with warrants, profit participation rights or participating bonds are issued. This requirement, however, may also
be satisfied by way of a credit institution subscribing for the securities and then offering them to the shareholders
for purchase (
mittelbares Bezugsrecht
).
Further, it is possible for a shareholder resolution approved by three-quarters of the share capital voting on the
resolution to exclude preemptive rights both where the general meeting itself resolves that the new securities are
to be issued and in relation to the authorized capital, i.e., an authorization for the Management Board, with the
consent of the Supervisory Board, to resolve on the issuance of new securities; provided, however, that in each
case, the exclusion or the authorization to exclude preemptive rights, respectively, must be justified by specific
facts, in accordance with established case law of the German Federal Court of Justice (
BGH
). The German
Federal Court of Justice (
BGH
) considers the exclusion of subscription rights justified if it (i) serves a purpose in
the company’s interests, (ii) is suitable for attaining such purpose, and (iii) is necessary and appropriate.
Additionally, the Management Board must submit a written report to the shareholders’ meeting in which it
presents the reasons for the exclusion of the subscription rights.
Accordingly, under our Articles of Association (
Satzung
), the Management Board may, with the consent of the
Supervisory Board, exclude such preemptive rights in a capital increase from the authorized capital in the
following circumstances:
•
to exclude fractional amounts from the subscription right;
•
in the case of a capital increase against cash contributions, if the issue price of the new shares is not
significantly lower than the market price of the company’s shares already listed on the stock exchange at
224
Annual Report on Form 20-F for the
year ended December 31, 2024
the time the issue price is finally determined. However, this authorization shall only apply subject to the
provision that the shares issued excluding subscription rights in accordance with Section 186(3)
Sentence 4 AktG may not exceed a total of 10% of the share capital either at the time this authorization
takes effect or, if this amount is lower, at the time this authorization is exercised. This limit of 10% of the
share capital includes shares which are issued or disposed of during the term of this authorization until
the date of its exercise in direct or equivalent application of Section 186(3) Sentence 4 AktG. Shares
which are used to service bonds with convertible or option rights or convertible obligations are to be
offset against the 10% limit if these bonds were issued during the authorization period under exclusion of
shareholder subscription rights in accordance with Section 186(3) Sentence 4 AktG during the
entitlement period. Treasury shares are to be offset against the 10% limit, where they were disposed of
by the company during the term of this authorization with the exclusion of subscription rights pursuant to
or in analogous application of Section 186(3) Sentence 4 AktG;
•
in the case of capital increases in exchange for contributions in kind, in particular in order to be able to
offer the shares to third parties when purchasing companies, parts of companies or interests in
companies as well as licenses or industrial property rights;
•
in order to grant subscription rights to new shares to holders of conversion or option rights in respect of
bonds issued by the company or its subordinated domestic or foreign Group companies, to the extent to
which they would be entitled after exercising their conversion or option rights or after fulfilling an agreed
conversion obligation;
•
to implement a scrip dividend by which shareholders are given the option to contribute their dividend
entitlements (either in whole or part) as a contribution in kind against issuance of our new shares;
•
in case shares are to be issued to a member of our Management Board or to another person who is
employed by us or one of our affiliates. Additional restrictions with regard to the shares issued may be
agreed upon; and
•
in order to be able to satisfy an option to acquire additional ordinary shares or American Depositary
Shares that has been agreed with the issuing banks in connection with a public offering of our shares in
the form of American Depositary Shares.
The total number of new shares issued from the authorized capital and under exclusion of subscription rights
pursuant to bullets one through three above may not exceed 20% of the share capital, either at the time that the
amendment to the Articles of Association (
Satzung
), resolved upon by the general meeting of June 21, 2021,
came into effect or, if lower, at the time of utilization of the authorization. To be counted against the
aforementioned 20% limit are: (i) those shares issued or to be issued to service conversion or option rights or
conversion or option obligations or tender rights of the issuer under bonds, if the bonds have been issued during
the term of this authorization up to the time of its exercise, excluding the subscription rights of shareholders, as
well as, to a certain extent (ii) treasury shares that have been disposed under exclusion of subscription rights
during the term of this authorization (except in the case of certain exceptions of the resolution to item no. 8 of the
general meeting of August 19, 2019).
Corporate Purpose of our Company
Our business objective, as described in § 2 of our Articles of Association (
Satzung
), is to research and develop,
as well as the manufacture and marketing of immunological and RNA-based drugs and test methods for the
diagnosis, prevention and treatment of cancer, infectious diseases and other serious diseases.
Shareholders’ Meetings and Voting Rights
Pursuant to our Articles of Association (
Satzung
), shareholders’ meetings may be held in person or virtually at
our seat or in any municipality in Germany with more than 500,000 inhabitants. Generally, shareholders’
meetings are convened by our Management Board, or our Supervisory Board. Shareholders representing in the
aggregate at least five percent of our ordinary shares may, subject to certain formal prerequisites, request that a
shareholders’ meeting be convened. Shareholders representing in the aggregate at least five percent of our
225
Annual Report on Form 20-F for the
year ended December 31, 2024
ordinary shares or owning shares with an aggregate nominal value of at least €500,000 may request the addition
of one or several items to the agenda of any shareholders’ meeting. Shareholders’ meetings may be summoned
either via publication in the German Federal Gazette (
Bundesanzeiger
) or via mail or email, in each case
generally at least
30
days before the meeting.
Shareholders may participate and vote in the shareholders’ meeting if they are registered as a shareholder with
the Company’s share register. A shareholder who wishes to attend the shareholders’ meeting—either in person
or by proxy, which may also be appointed by us (
Stimmrechtsvertreter
)—must register for the meeting, which
registration must occur no later than six days before the meeting (or at a later date, if so determined by our
Management Board).
Each share carries one vote at a shareholders’ meeting. Resolutions are, in accordance with our Articles of
Association (
Satzung
), generally taken by simple majority of the votes cast. However, under applicable German
and European law, a number of resolutions must be passed by either a three-quarter majority of the votes cast or
a three-quarter majority of the share capital represented at the meeting. The fact that in these cases the quorum
is determined in relation to the share capital or shares present (as opposed to, for example, all shares eligible to
vote) means that holders of a minority of our shares could potentially control the outcome of resolutions.
Claims against Directors and Shareholders’ Derivative Actions
Under German law, generally, the company, rather than its shareholders, is the proper claimant in an action with
respect to a wrong committed against the company, or in cases where there is an irregularity in the company’s
internal management or supervision. Therefore, such claims may only be raised by the company represented by
its management board, or, in the case of a wrong committed by a member of the management board, by the
supervisory board. This concerns, in particular, claims against members of the management board or the
supervisory board.
However, pursuant to German case law, the supervisory board is obliged to pursue the company’s claims
against the management board, unless the interest of the company keeps them from doing so. Further, the
management board, or, if a claim is against a member of the management board, the supervisory board, is
obliged to pursue the company’s claims against the designated individuals if so resolved by a simple majority of
votes cast during a shareholders’ meeting. With a simple majority of votes, shareholders can also request that a
representative pursue the claim on behalf of the company. The court may appoint such a representative upon the
request of shareholders holding at least 10% of the company’s share capital or a participation of at least
€1,000,000 in the share capital.
If the company is unable to fulfill its third-party obligations, the company’s creditors may pursue the company’s
damage claims against members of the management board for certain wrongdoings.
Under certain circumstances, shareholders can bring forward damage claims of the company against its
management on their own behalf. In order to bring forward such a claim one shareholder alone or together with
other shareholders needs to hold at least 1% of the company’s share capital or a participation of €100,000 in the
share capital. Additionally, the claimant(s) must comply with special claim approval procedures conducted before
a competent court which will allow the pertinent request only if there are circumstances justifying the assumption
that damage has been afflicted on the company by improper conduct or a gross breach of the law or the articles
of association.
Dividend Rights
Under German law, distributions of dividends on shares for a given financial year are generally determined by a
process in which the management board and supervisory board submit a proposal to the company’s annual
general shareholders’ meeting held in the subsequent financial year and such annual general shareholders’
meeting adopts a resolution.
German law provides that a resolution concerning dividends and distribution thereof may be adopted only if the
company’s unconsolidated financial statements prepared in accordance with German law show net retained
profits. In determining the profit available for distribution, the result for the relevant year must be adjusted for
226
Annual Report on Form 20-F for the
year ended December 31, 2024
profits and losses brought forward from the previous year and for withdrawals from or transfers to reserves.
Certain reserves are required by law and must be deducted when calculating the profit available for distribution.
Shareholders generally participate in profit distributions in proportion to the number of shares they hold.
Dividends on shares resolved by the general shareholders’ meeting are paid annually, shortly after the general
shareholders’ meeting, in compliance with the rules of the respective clearing system. Dividend payment claims
are subject to a three-year statute of limitation in the company’s favor.
Authorization to Purchase and Sell Our Own Shares
We may not purchase our own shares unless authorized by the shareholders’ meeting or in other very limited
circumstances as set out in the AktG. The Company’s shareholders’ meeting held on May 17, 2024 authorized
the Management Board until May 16, 2029, provided it complies with the legal requirement of equal treatment, to
acquire treasury shares up to a total of 10% of the Company’s share capital at the time of the relevant resolution
or at the time the authorization is exercised. These shares held by the Company (including shares attributable to
it pursuant to the AktG) must never exceed 10% of the share capital. The shares may be purchased (i) through
the stock exchange, (ii) by means of a public offer directed to all shareholders of the Company, (iii) by means of
a public invitation to the shareholders to make a sales offer or (iv) from the Bill & Melinda Gates Foundation
under very limited circumstances as specified in the authorization. Such shares may not be purchased for
trading purposes. The Management Board is authorized to use the shares only as specified in the authorization.
Squeeze-Out of Minority Shareholders
Under German law, the shareholders’ meeting of a stock corporation may resolve, upon request of a shareholder
that holds at least 95% of the share capital, that the shares held by any remaining minority shareholders be
transferred to the majority shareholder against payment of “adequate cash compensation” (
Ausschluss von
Minderheitsaktionären
). This amount must take into account the full value of the company at the time of the
resolution, which is generally determined using the future earnings value method (
Ertragswertmethode
).
A squeeze-out in the context of a merger (
umwandlungsrechtlicher Squeeze-Out
) only requires a majority
shareholder to hold at least 90% of the share capital.
Liquidation Rights
Apart from liquidation, e.g., as a result of insolvency proceedings, we may be liquidated with a vote of the
holders of at least three-quarters of the share capital represented at the shareholders’ meeting at which such a
vote is taken. If we are liquidated, any assets remaining after all of our liabilities have been paid off would be
distributed among our shareholders in proportion to their holdings in accordance with German statutory law. The
German Stock Corporation Act provides certain protections for creditors, which must be observed in the event of
liquidation.
C. Material Contracts
Except as otherwise disclosed in this Annual Report (including the exhibits thereto), we are not currently, and
have not been in the last two years, party to any material contract, other than contracts entered into in the
ordinary course of our business.
D.
Exchange Controls
There are currently no legal restrictions in the Federal Republic of Germany on international capital movements
and foreign exchange transactions, except in limited embargo circumstances (
Teilembargo
) relating to certain
areas, entities or persons as a result of applicable resolutions adopted by the United Nations and the European
Union.
Restrictions currently exist with respect to, among others, Afghanistan, Belarus, Bosnia & Herzegovina,
Burundi, Central African Republic, China, D.R. Congo, Guatemala, Guinea, Guinea-Bissau, Haiti, Iran, Iraq,
Lebanon, Libya, Mali,
Moldova and the Transnistria region
, Montenegro, Myanmar, Nicaragua, Niger, North
Korea, Russia, Serbia, Somalia, South Sudan, Sudan, Syria, Tunisia, Türkiye, Ukraine, Venezuela, Yemen and
Zimbabwe.
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Annual Report on Form 20-F for the
year ended December 31, 2024
For statistical purposes, there are, however, limited notification requirements regarding transactions involving
cross-border monetary transfers. With some exceptions, every corporation or individual residing in the Federal
Republic of Germany must report to the German Central Bank (
Deutsche Bundesbank
) (i) any payment received
from, or made to, a non-resident corporation or individual that exceeds €50,000 (or the equivalent in a foreign
currency) and (ii) (with the exception of individuals residing in the Federal Republic of Germany) in case the sum
of claims against, or liabilities payable to, non-resident corporations or individuals exceeds €6,000,000 (or the
equivalent in a foreign currency) at the end of any calendar month. Payments include cash payments made by
means of direct debit, checks and bills, remittances denominated in euros and other currencies made through
financial institutions, as well as netting and clearing arrangements.
E.
Taxation
German Taxation
The following discussion addresses certain German tax consequences of acquiring, owning or disposing of the
ADSs. With the exception of “—Taxation of Holders Tax Resident in Germany” below, which provides an
overview of dividend taxation and of capital gains taxation with respect to holders that are residents of Germany,
this discussion applies only to U.S. treaty beneficiaries (defined below) that acquire the ADSs representing our
ordinary shares.
This discussion is based on domestic German tax laws, including, but not limited to, circulars issued by German
tax authorities, which, e.g., are not binding on the German courts, and the Treaty (defined below). It is based
upon tax laws in effect at the time of filing of this report. These laws are subject to change, possibly with
retroactive effect. For example, certain member states of the European Union are considering introducing a
financial transaction tax (
Finanztransaktionssteuer
) which, if introduced, may also be applicable on sales and/or
transfer of ADSs. There is no assurance that German tax authorities will not challenge one or more of the tax
consequences described in this section.
In addition, this discussion is based upon the assumption that each obligation in the deposit agreement and any
related agreement will be performed in accordance with its terms. It does not purport to be a comprehensive or
exhaustive description of all German tax considerations that may be of relevance in the context of acquiring,
owning and disposing of ADSs.
The tax information presented in this report is not a substitute for tax advice. Prospective holders of ADSs should
consult their own tax advisors regarding the German tax consequences of the purchase, ownership, disposition,
donation or inheritance of ADSs in light of their particular circumstances, including the effect of any state, local,
or other foreign or domestic laws or changes in tax law or interpretation. The same applies with respect to the
rules governing the refund of any German dividend withholding tax (
Kapitalertragsteuer
) withheld. Only an
individual tax consultation can appropriately account for the particular tax situation of each investor.
General
Based on the circular issued by the German Federal Ministry of Finance (
BMF-Schreiben
), dated May 24, 2013,
reference number IV C 1-S2204/12/10003, as amended by the circular dated December 18, 2018 (reference
number IV C 1 – S 2204/12/10003), in respect of the taxation of American Depositary Receipts, or ADRs, on
domestic shares, or the ADR Tax Circular, for German tax purposes, the ADSs should, in light of the ADR Tax
Circular, represent a beneficial ownership interest in the underlying shares of BioNTech and qualify as ADRs for
the purpose of the ADR Tax Circular. If the ADSs qualify as ADRs under the ADR Tax Circular, dividends would
accordingly be attributable to holders of the ADSs for German tax purposes, and not to the legal owner of the
ordinary shares (i.e., the financial institution on behalf of which the ordinary shares are stored at a domestic
depository for the ADS holders). Furthermore, holders of the ADSs should be treated as beneficial owners of the
capital of BioNTech with respect to capital gains (see below in section “—German Taxation of Capital Gains of
the U.S. Treaty Beneficiaries of the ADSs”). However, investors should note that circulars published by the
German tax authorities (including the ADR Tax Circular) are not, e.g., binding on German courts, including
German tax courts, and it is unclear whether a German court would follow the ADR Tax Circular in determining
228
Annual Report on Form 20-F for the
year ended December 31, 2024
the German tax treatment of the ADSs. For the purpose of this German tax section, it is assumed that the ADSs
qualify as ADRs within the meaning of the ADR Tax Circular.
Taxation of Holders Not Tax Resident in Germany
The following discussion describes selected German tax consequences of acquiring the ADSs, owning the ADSs
and disposing of the ADSs to a holder that is a U.S. treaty beneficiary. For purposes of this discussion, a “U.S.
treaty beneficiary” is a resident of the United States for purposes of the Convention between the Federal
Republic of Germany and United States of America for the Avoidance of Double Taxation and the Prevention of
Fiscal Evasion with respect to Taxes on Income and Capital and Certain Other Taxes of 1989, as amended by
the Protocol as of June 4, 2008 (
Abkommen zwischen der Bundesrepublik Deutschland und den Vereinigten
Staaten von Amerika zur Vermeidung der Doppelbesteuerung und zur Verhinderung der Steuerverkürzung auf
dem Gebiet der Steuern vom Einkommen und vom Vermögen und einiger anderer Steuern in der Fassung vom
4. Juni 2008
), hereinafter referred to as the “Treaty,” who is eligible for relevant benefits under the Treaty.
A holder will be a U.S. treaty beneficiary entitled to full Treaty benefits in respect of the ADSs if it is, inter alia:
•
the beneficial owner of the ADSs (and the dividends paid with respect thereto);
•
a U.S. tax resident corporation or individual;
•
not also a resident of Germany for German tax purposes; and
•
not subject to the limitation on benefits (i.e., anti-treaty shopping) article of the Treaty that applies in
limited circumstances.
Special rules apply to pension funds and certain other tax-exempt investors.
This discussion does not address the treatment of ADSs that are (i) held in connection with a permanent
establishment or fixed base through which a U.S. treaty beneficiary carries on business or performs personal
services in Germany or (ii) part of business assets for which a permanent representative in Germany has been
appointed.
General Rules for the Taxation of Holders Not Tax Resident in Germany
Non-German resident holders of ADSs are subject to German taxation with respect to German source income
(
beschränkte Steuerpflicht
). According to the ADR Tax Circular, income from the shares should be attributed to
the holder of the ADSs for German tax purposes. As a consequence, income from the ADSs should be treated
as German source income.
German Withholding Taxation of Dividends of the U.S. Treaty Beneficiaries of the ADSs
Generally, the full amount of a dividend distributed by BioNTech to a non-German resident holder, which does
not maintain a permanent establishment or other taxable presence in Germany, is subject to (final) German
withholding tax at an aggregate rate of 26.375% (that amount consists of 25% on dividends distributed plus
solidarity surcharge of 5.5% on the amount of the withholding tax). The basis for the withholding tax is generally
the dividend approved for distribution by our general shareholder’s meeting. German withholding tax is withheld
and remitted to the German tax authorities by (i) the disbursing agent (i.e., the German credit institution, financial
services institution, securities trading enterprise or securities trading bank (each as defined in the German
Banking Act (
Kreditwesengesetz
) and in each case including a German branch of a foreign enterprise, but
excluding a foreign branch of a German enterprise)) that holds or administers the underlying shares in custody
and (a) disburses or credits the dividend income from the underlying shares, (b) disburses or credits the dividend
income from the underlying shares on delivery of the dividend coupons or (c) disburses such dividend income to
a foreign agent; or (ii) the central securities depository (
Wertpapiersammelbank
) in terms of the German
Depositary Act (
Depotgesetz
) holding the underlying shares in a collective deposit, if such central securities
depository disburses the dividend income from the underlying shares to a foreign agent, regardless of whether a
holder must report the dividend for tax purposes and regardless of whether or not a holder is a resident of
Germany. Dividend payments, to the extent funded from BioNTech’s tax-recognized contribution account
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Annual Report on Form 20-F for the
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(
steuerliches Einlagekonto
), subject to certain prerequisites, do not form part of the taxable dividend income but
should lower the holder’s acquisition costs for the ADSs.
Pursuant to the Treaty, the German withholding tax may generally not exceed (i) 15% of the gross amount of the
dividends received by a U.S. treaty beneficiary other than a company holding ADSs which represent 10% or
more of the voting shares in BioNTech, and (ii) 5% of the gross amount of the dividends received by a U.S. treaty
beneficiary that is a company holding ADSs which represent 10% or more of the voting shares in BioNTech. The
excess of the total withholding tax, including the solidarity surcharge, over the maximum rate of withholding tax
permitted by the Treaty is refunded to U.S. treaty beneficiaries upon application. For example, for a declared
dividend of 100, a U.S. treaty beneficiary initially receives 73.625 (100 minus the 26.375% withholding tax
including solidarity surcharge). A U.S. treaty beneficiary other than a company holding ADSs which represent
10% or more of the voting shares in BioNTech is entitled to a partial refund from the German tax authorities in
the amount of 11.375% of the gross dividend (of 100). As a result, the U.S. treaty beneficiary ultimately receives
a total of 85 (85% of the declared dividend) following the refund of the excess withholding. However, it should be
noted that there is uncertainty as to how the German tax authorities will apply the refund process to dividends on
the ADSs with respect to non-German resident holders. Further, such refund is subject to the German anti-
avoidance treaty shopping rule (as described below in “—Withholding Tax Refund for U.S. Treaty Beneficiaries”).
German Withholding Taxation of Capital Gains of the U.S. Treaty Beneficiaries of the ADSs
The capital gains from the disposition of the ADSs realized by a non-German resident holder, which does not
maintain a permanent establishment or other taxable presence in Germany, would be treated as German source
income and be subject to German tax if the ADSs qualify as a Qualifying Participation. A Qualifying Participation
exists if a holder at any time during the five years preceding the disposition, directly or indirectly, owned at least
1% of BioNTech’s share capital, irrespective of whether through the ADSs or shares of BioNTech. If such holder
had acquired the ADSs without consideration, the previous owner’s holding period and quota would be taken into
account.
Pursuant to the Treaty, capital gains from the disposal of a Qualifying Participation realized by a U.S. treaty
beneficiary are, however, generally exempt from German taxation. Pursuant to the Treaty, U.S. treaty
beneficiaries are not subject to German tax in relation to capital gains from the disposal of a Qualifying
Participation even under the circumstances described in the preceding paragraph and therefore should not be
subject to German taxation on capital gains from the disposition of the ADSs.
German statutory law requires the disbursing agent to levy withholding tax on capital gains from the sale of
ADSs or other securities held in a custodial account in Germany. With regard to the German taxation of capital
gains, disbursing agent means a German credit institution, financial services institution, securities trading
enterprise or securities trading bank (each as defined in the German Banking Act and, in each case including a
German branch if a foreign enterprise, but excluding a foreign branch of a German enterprise) that holds the
ADSs in custody or administers the ADSs for the investor or conducts sales or other dispositions and disburses
or credits the income from the ADSs to the holder of the ADSs. The German statutory law does not explicitly
condition the obligation to withhold taxes on capital gains being subject to taxation in Germany under German
statutory law or on an applicable income tax treaty permitting Germany to tax such capital gains.
However, a circular issued by the German Federal Ministry of Finance, dated January 18, 2016, reference
number IV C 1-S2252/08/10004 :017, as most recently amended by circular dated September 16, 2019,
reference number IV C 1-S2252/08/10004 :027, provides that taxes need not be withheld when the holder of the
custody account is not a resident of Germany for tax purposes and the income is not subject to German taxation.
The circular further states that there is no obligation to withhold such tax even if the non-resident holder owns at
least 1% of the share capital of a German corporation. While circulars issued by the German Federal Ministry of
Finance are generally only to be adhered to by the German tax authorities but are, for example, not binding on
the German courts, in practice, the disbursing agents nevertheless typically rely on guidance contained in such
circulars. Therefore, a disbursing agent would only withhold tax at 26.375% on capital gains derived by a U.S.
treaty beneficiary from the sale of ADSs held in a custodial account in Germany in the event that the disbursing
agent did not follow the abovementioned guidance. In this case, the U.S. treaty beneficiary may be entitled to
claim a refund of the withholding tax from the German tax authorities under the Treaty, as described below in “—
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Annual Report on Form 20-F for the
year ended December 31, 2024
Withholding Tax Refund for U.S. Treaty Beneficiaries.” A refund of taxes withheld on capital gains from the
disposition of the ADSs which do not qualify as Qualifying Participations may also be claimed based on German
statutory domestic law.
Withholding Tax Refund for U.S. Treaty Beneficiaries
U.S. treaty beneficiaries are generally eligible for treaty benefits under the Treaty, as described above in “—
Taxation of Holders Not Tax Resident in Germany.” Accordingly, U.S. treaty beneficiaries are in general entitled
to claim a refund of (i) the portion of the otherwise applicable 26.375% German withholding tax
(
Kapitalertragsteuer
) on dividends that exceeds the applicable Treaty rate and (ii) the full amount of German
withholding tax (
Kapitalertragsteuer
) on capital gains from the disposition of ADSs. The application for such claim
is generally to be filed with the Federal Central Office of Taxation (
Bundeszentralamt für Steuern
) within four
years after the end of the calendar year in which the capital gains or dividends have been received (
bezogen
).
However, in respect of dividends, the refund described in the preceding paragraph is only possible if, due to
special rules on the restriction of withholding tax credit, the following three cumulative requirements are met: (i)
the holder must qualify as beneficial owner of the ADSs for an uninterrupted minimum holding period of 45 days
within a period starting 45 days prior to and ending 45 days after the due date of the dividends, (ii) the holder has
to bear at least 70% of the change in value risk related to the ADSs during the minimum holding period as
described under (i) of this paragraph and has not entered into (acting by itself or through a related party) hedging
transactions which lower the change in value risk by more than 30%, and (iii) the holder must not be obliged to
fully or largely compensate directly or indirectly the dividends to third parties. If these requirements are not met,
then for a holder not being tax-resident in Germany who applied for a full or partial refund of the withholding tax
pursuant to a double taxation treaty, no refund is available. This restriction generally does only apply if (a) the
German tax underlying the refund application is below a tax rate of 15% based on the gross amount of the
dividends and (b) the holder does not directly own 10% or more of the shares of BioNTech and is subject to
income taxes in its state of residence, without being tax-exempt. The restriction of the withholding tax credit does
not apply if the holder has beneficially owned the ADSs for at least one uninterrupted year until receipt (
Zufluss
)
of the dividends.
In general, as previously discussed, investors should note that it is unclear how the German tax administration
will apply the refund process to dividends on the ADSs. Further, such refund is subject to the German anti treaty
shopping rule. Generally, this rule requires that the U.S. treaty beneficiary (in case it is a non-German resident
company) maintains its own administrative substance and conducts its own business activities. In particular, a
foreign company has no right to a full or partial refund to the extent persons holding ownership interests in
BioNTech would not be entitled to the refund if they derived the income directly and the gross income realized by
the foreign company is not caused by the business activities of the foreign company, and there are either no
economic or other considerable reasons for the interposition of the foreign company, or the foreign company
does not participate in general commerce by means of a business organization with resources appropriate to its
business purpose. However, this shall not apply if the foreign company’s principal class of stock is regularly
traded in substantial volume on a recognized stock exchange, or if the foreign company is subject to the
provisions of the German Investment Tax Act (
Investmentsteuergesetz
). Whether or not and to which extent the
anti-treaty shopping rule applies to the ADSs has to be analyzed on a case by case basis taking into account all
relevant tests. In addition, the interpretation of these tests is disputed and to date no published decisions of the
German Federal Finance Court exist in this regard.
Due to the legal structure of the ADSs, only limited guidance from the German tax authorities exists on the
practical application of the refund process with respect to the ADSs and the respective limitations. Recently, the
German tax authorities have indicated that for ADR programs (which are considered comparable to ADS
programs) a collective tax certificate in connection with a withholding of tax amounts may no longer be issued by
the domestic depositary of the shares upon request of the foreign depositary agents. Rather, individual tax
certificates need to be issued which might delay a potential refund procedure. Moreover, the simplified refund
procedure based on electronic data exchange (
Datenträgerverfahren
) for claims for reimbursement based on
ADRs has been suspended temporarily by the tax authorities.
Taxation of Holders Tax Resident in Germany
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This subsection provides an overview of dividend taxation and of capital gains taxation with regard to the general
principles applicable to ADS holders that are tax resident in Germany. A holder is a German tax resident if, in
case of an individual, he or she maintains a domicile (
Wohnsitz
) or a usual residence (
gewöhnlicher Aufenthalt
)
in Germany or if, in case of a corporation, it has its place of management (
Geschäftsleitung
) or registered seat
(
Sitz
) in Germany.
The German dividend and capital gains taxation rules applicable to German tax residents require a distinction
between ADSs held as private assets (
Privatvermögen
) and ADSs held as business assets (
Betriebsvermögen
).
ADSs as Private Assets (
Privatvermögen
)
If the ADSs are held as private assets by a German tax resident, dividends and capital gains (other than capital
gains from the disposition of a Qualifying Participation) are taxed as investment income and are principally
subject to 25% German flat income tax on capital income (
Abgeltungsteuer
)
(plus a 5.5% solidarity surcharge
(
Solidaritätszuschlag
) thereon, resulting in an aggregate rate of 26.375%), which is levied in the form of
withholding tax (
Kapitalertragsteuer
). In other words, once deducted, the holder’s income tax liability on the
dividends will be settled. Dividend payments to the extent funded from BioNTech’s tax-recognized contribution
account (
steuerliches Einlagekonto
), subject to certain prerequisites, do not form part of the taxable dividend
income but should lower the holder’s acquisition costs for the ADSs.
Holders of ADSs may apply to have their capital investment income assessed in accordance with the general
rules and with an individual’s personal income tax rate if this would result in a lower tax burden in which case
actually incurred expenses are not deductible. The holder would be taxed on gross personal investment income
(including dividends or gains with respect to ADSs),
less the saver’s allowance of €1,000 for an individual or
€2,000
for a married couple and a registered civil union (
eingetragene Lebenspartnerschaft
) filing taxes jointly.
The deduction of expenses related to the investment income (including dividends or gains with respect to ADSs)
is generally not possible for private investors.
Losses resulting from the disposal of ADSs can only be offset against capital gains from the sale of any shares
(
Aktien
) and other ADSs. If, however, a holder holds a Qualifying Participation, 60% of any capital gains resulting
from the sale and transfer are taxable at the holder’s personal income tax rate (plus 5.5% solidarity surcharge
thereon). Conversely, 60% of any capital losses are recognized for tax purposes.
Since 2021, the basis for the calculation of the solidarity surcharge (
Solidaritätszuschlag
) has been reduced for
certain individual persons being subject to tax assessments (other than withholding taxes), and in certain cases,
the solidarity surcharge has been abolished. However, the abolition or reduction of the solidarity surcharge is not
applicable to corporations. In addition, the abolition or reduction of the solidarity surcharge will not affect
withholding taxes. Solidarity surcharge will still be levied at 5.5% on the full withholding tax amount and withheld
accordingly. There will not be any separate refund of such withheld solidarity surcharge (regardless of the
aforementioned exemption limits) in case the withholding tax cannot be refunded either.
Church tax generally has to be withheld, if applicable, based on an automatic data access procedure, unless the
holder of ADSs has filed a blocking notice (
Sperrvermerk
) with the Federal Central Tax Office. Where church tax
is not levied by way of withholding, it is determined by means of income tax assessment.
ADSs as Business Assets (
Betriebsvermögen
)
In case the ADSs are held as business assets, the taxation depends on the legal form of the holder (i.e., whether
the holder is a corporation or an individual).
Irrespective of the legal form of the holder, dividends are subject to the aggregate withholding tax rate of
26.375%. The withholding tax is generally creditable against the respective holder’s corporate income tax or
income tax liability. Due to special rules on the restriction of withholding tax credits in respect of dividends, a full
withholding tax credit requires that the following three cumulative requirements are met: (i) the holder must
qualify as beneficial owner of the ADSs for an uninterrupted minimum holding period of 45 days occurring within
a period starting 45 days prior to and ending 45 days after the due date of the dividends, (ii) the holder has to
bear at least 70% of the change in value risk related to the ADSs during the minimum holding period as
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Annual Report on Form 20-F for the
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described under (i) of this paragraph and has not entered into (acting by itself or through a related party) hedging
transactions which lower the change in value risk for more than 30%, and (iii) the holder must not be obliged to
fully or largely compensate directly or indirectly the dividends to third parties. If these requirements are not met,
three-fifths of the withholding tax imposed on the dividends must not be credited against the holder’s corporate
income tax or income tax liability, but may, upon application, be deducted from the holder’s tax base for the
relevant tax assessment period. A holder that is generally subject to German income tax or corporate income tax
and that has received gross dividends without any deduction of withholding tax due to a tax exemption without
qualifying for a full tax credit under the aforementioned requirements has to notify the competent local tax office
accordingly, has to file withholding tax returns for a withholding tax of 15% in accordance with statutory formal
requirements and has to make a payment in the amount of the omitted withholding tax deduction. The special
rules on the restriction of withholding tax credit (and the corresponding notification and payment obligations) do
not apply to a holder whose overall dividend earnings within an assessment period do not exceed €20,000 or
that has been the beneficial owner of the ADSs for at least one uninterrupted year until receipt (
Zufluss
) of the
dividends.
To the extent the amount withheld exceeds the income tax liability, the withholding tax will be refunded, provided
that certain requirements are met (including the aforementioned requirements).
Special rules apply to credit institutions (
Kreditinstitute
), financial services institutions
(
Finanzdienstleistungsinstitute
), financial enterprises (
Finanzunternehmen
), life insurance and health insurance
companies, and pension funds.
In principle, dividends that a corporation receives from German or foreign corporations are subject to corporate
income tax (and solidarity surcharge thereon) at a rate of 15.825% and also subject to trade tax of between 7.0%
and 19.0% depending on the multiplier applied by the relevant municipality. However, with regard to holders in
the legal form of a corporation, capital gains are in general effectively 95% tax exempt from corporate income tax
(including solidarity surcharge). Dividends are also generally 95% tax exempt from corporate income tax
(including solidarity surcharge), inter alia, if the holder held at least 10% of the registered share capital
(
Grundkapital oder Stammkapital
) of BioNTech at the beginning of the calendar year, or Qualifying Dividends.
Five percent of the capital gains and five percent of the Qualifying Dividends are treated as non-deductible
business expenses, respectively, and, as such, are subject to corporate income tax (including solidarity
surcharge); actual business expenses incurred to generate dividends may be deducted. The acquisition of a
participation of at least 10% in the course of a calendar year is deemed to have occurred at the beginning of
such calendar year for the determination of whether a dividend is a Qualifying Dividend. Participations in the
share capital of BioNTech held through a partnership, including co-entrepreneurships (
Mitunternehmerschaften
),
are attributable to the respective partner only on a pro rata basis at the ratio of its entitlement to the profits of the
partnership.
Capital gains and dividend income of a German tax resident corporation are generally subject to German trade
tax of between 7.0% and 19.0% depending on the multiplier applied by the relevant municipality. The
aforementioned 95% exemption for capital gains generally applies also for trade tax purposes. However, the
amount of any dividends after deducting business expenses related to the dividends is not subject to trade tax if
the corporation held at least 15% of BioNTech’s registered share capital at the beginning of the relevant tax
assessment period. In this case, the aforementioned exemption of 95% of the dividend income also applies for
trade tax purposes. Losses from the sale of ADSs are generally not tax deductible for corporate income tax and
trade tax purposes.
With regard to individuals holding ADSs as business assets, 60% of dividends and capital gains are taxed at the
individual’s personal income tax rate (plus 5.5% solidarity surcharge thereon). Correspondingly, only 60% of
business expenses related to the dividends and capital gains as well as losses from the sale of ADSs are
principally deductible for income tax purposes. Since 2021, the basis for the calculation of the solidarity
surcharge (
Solidaritätszuschlag
) has been reduced for certain individual persons being subject to tax
assessments (other than withholding taxes), and in certain cases, the solidarity surcharge has been abolished,
subject to the limitations described above in “—ADSs as Private Assets (
Privatvermögen
)”. The dividend income
and 60% of the capital gains are generally subject to trade tax, which is fully or partly creditable against the
individual’s personal income tax by a lump-sum method. Dividends (after deduction of business expenses
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economically related thereto) are exempt from trade tax if the holder held at least 15% of BioNTech’s registered
share capital at the beginning of the relevant tax assessment period.
German Inheritance and Gift Tax (
Erbschaft- und Schenkungsteuer
)
The transfer of ADSs to another person by inheritance or gift generally should be subject to German inheritance
and gift tax only if:
(i)
the decedent or donor or heir, beneficiary or other transferee (a) maintained his or her domicile or a usual
residence in Germany, (b) had its place of management or registered office in Germany at the time of the
transfer, (c) is a German citizen who has spent no more than five consecutive years outside of Germany
without maintaining a domicile in Germany or (d) is a German citizen who serves for a German entity
established under public law and is remunerated for his or her service from German public funds (including
family members who form part of such person’s household, if they are German citizens) and is only subject
to estate or inheritance tax in his or her country of domicile or usual residence with respect to assets
located in such country (special rules apply to certain former German citizens who neither maintain a
domicile nor have their usual residence in Germany);
(ii) at the time of the transfer, the ADSs are held by the decedent or donor as business assets forming part of a
permanent establishment in Germany or for which a permanent representative in Germany has been
appointed; or
(iii) the ADSs subject to such transfer form part of a portfolio that represents at the time of the transfer 10% or
more of the registered share capital of BioNTech and that has been held directly or indirectly by the
decedent or donor, either alone or together with related persons.
The Agreement between the Federal Republic of Germany and the United States of America for the avoidance of
double taxation with respect to taxes on inheritances and gifts as of December 21, 2000 (
Abkommen zwischen
der Bundesrepublik Deutschland und den Vereinigten Staaten von Amerika zur Vermeidung der
Doppelbesteuerung auf dem Gebiet der Nachlass-, Erbschaft- und Schenkungssteuern in der Fassung vom 21.
Dezember 2000
), hereinafter referred to as the “United States-Germany Inheritance and Gifts Tax Treaty,”
provides that the German inheritance tax or gift tax can, with certain restrictions, only be levied in the cases of (i)
and (ii) above. Special provisions apply to certain German citizens living outside of Germany and former German
citizens.
Other Taxes
No German transfer tax, value-added tax, stamp duty or similar taxes are assessed on dividend payments.
Material United States Federal Income Tax Considerations
The following discussion describes material U.S. federal income tax considerations relating to the acquisition,
ownership and disposition of ADSs by a U.S. Holder (as defined below) that acquires our ADSs and holds them
as a capital asset. This discussion is based on the tax laws of the United States, including the Internal Revenue
Code of 1986, as amended, or the Code, Treasury regulations promulgated or proposed thereunder, and
administrative and judicial interpretations thereof, all as in effect on the date hereof. These tax laws are subject
to change, possibly with retroactive effect, and subject to differing interpretations that could affect the tax
consequences described herein. This section does not address the treatment of a non-U.S. holder, nor does it
address the tax treatment under the laws of any state, local or foreign taxing jurisdiction.
For purposes of this discussion, a “U.S. Holder” is a beneficial owner of our ADSs that, for U.S. federal income
tax purposes, is:
•
an individual who is a citizen or resident of the United States;
•
a domestic corporation (or other entity taxable as a corporation);
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•
an estate the income of which is subject to U.S. federal income taxation regardless of its source; or
•
a trust if (i) a court within the United States is able to exercise primary supervision over the trust’s
administration and one or more U.S. persons have the authority to control all substantial decisions of the
trust or (ii) a valid election under the Treasury regulations is in effect for the trust to be treated as a U.S.
person.
This discussion does not address all aspects of U.S. federal income taxation that may be applicable to U.S.
Holders in light of their particular circumstances or status (including, for example, banks and other financial
institutions, insurance companies, broker and dealers in securities or currencies, traders that have elected to
mark securities to market, regulated investment companies, real estate investment trusts, partnerships or other
pass- through entities, corporations that accumulate earnings to avoid U.S. federal income tax, tax-exempt
organizations, pension plans, persons that hold our shares as part of a straddle, hedge or other integrated
investment, persons subject to alternative minimum tax or whose “functional currency” is not the U.S. dollar).
If a partnership (including any entity or arrangement treated as a partnership for U.S. federal income tax
purposes) holds our ADSs, the tax treatment of a person treated as a partner in the partnership for U.S. federal
income tax purposes generally will depend on the status of the partner and the activities of the partnership.
Partnerships (and other entities or arrangements so treated for U.S. federal income tax purposes) and their
partners should consult their own tax advisors.
In general, and taking into account the earlier assumptions, for U.S. federal income and German tax purposes, a
holder of ADSs will be treated as the owner of the shares represented by those ADSs. Exchanges of shares for
ADSs, and ADSs for shares, generally will not be subject to U.S. federal income or to German tax.
This discussion addresses only U.S. Holders and does not discuss any tax considerations other than
U.S. federal income tax considerations. Prospective investors are urged to consult their own tax
advisors regarding the U.S. federal, state and local, and foreign tax consequences of the purchase,
ownership, and disposition of ADSs.
Dividends
Under the U.S. federal income tax laws, and subject to the passive foreign investment company, or PFIC, rules
discussed below, the gross amount of any dividend we pay out of our current or accumulated earnings and
profits (as determined for U.S. federal income tax purposes) is includible in income for a U.S. Holder and subject
to U.S. federal income taxation. Dividends paid to a noncorporate U.S. Holder that constitute qualified dividend
income will be taxable at a preferential tax rate applicable to long-term capital gains, provided that the U.S.
Holder holds the ADSs for more than 60 days during the 121-day period beginning 60 days before the ex-
dividend date and meets other holding period requirements. Dividends we pay with respect to the ADSs
generally will be qualified dividend income.
A U.S. Holder must include any German tax withheld as part of the gross dividend payment, as described above
under “—German Taxation—General Rules for the Taxation of Holders Not Tax Resident in Germany,” even
though the holder does not in fact receive it. The dividend is taxable to the holder when the depositary receives
the dividend, actually or constructively. Because we are not a U.S. corporation, the dividend will not be eligible
for the dividends-received deduction generally allowed to U.S. corporations in respect of dividends received from
other U.S. corporations. The amount of the dividend distribution includible in U.S. Holder’s income will be the
U.S. dollar value of the Euro payments made, determined at the spot Euro/U.S. dollar rate on the date the
dividend distribution is includible in income, regardless of whether the payment is in fact converted into U.S.
dollars. Generally, any gain or loss resulting from currency exchange fluctuations during the period from the date
the dividend payment is included in income to the date the payment is converted into U.S. dollars will be treated
as ordinary income or loss and will not be eligible for the special tax rate applicable to qualified dividend income.
The gain or loss generally will be income or loss from sources within the United States for foreign tax credit
limitation purposes.
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To the extent a distribution with respect to ADSs exceeds our current or accumulated earnings and profits, as
determined under U.S. federal income tax principles, the distribution will be treated, first, as a tax-free return of
the U.S. Holder’s investment, up to the holder’s adjusted tax basis in its ADSs, and, thereafter, as capital gain,
which is subject to the tax treatment described below in “—Gain on Sale, Exchange or Other Taxable
Disposition.”
Subject to certain limitations, the German tax withheld in accordance with the Treaty and paid over to the
German taxing authority will be creditable or deductible against a U.S. Holder’s U.S. federal income tax liability.
To the extent a refund of the tax withheld is available to a U.S. Holder under German law or under the Treaty, the
amount of tax withheld that is refundable will not be eligible for credit against a U.S. Holder’s U.S. federal income
tax liability. See “—German Taxation—Withholding Tax Refund for U.S. Treaty Beneficiaries” above for the
procedures for obtaining a tax refund.
Gain On Sale, Exchange or Other Taxable Disposition
Subject to the PFIC rules described below under “—Passive Foreign Investment Company Considerations”, a
U.S. Holder that sells, exchanges or otherwise disposes of ADSs in a taxable disposition generally will recognize
capital gain or loss for U.S. federal income tax purposes equal to the difference between the U.S. dollar value of
the amount realized and the holder’s tax basis, determined in U.S. dollars, in the ADSs. Gain or loss recognized
on such a sale, exchange or other disposition of ADSs generally will be long-term capital gain if the U.S. Holder’s
holding period in the ADSs exceeds one year. Long-term capital gains of non-corporate U.S. Holders are taxed
generally at preferential rates. The gain or loss generally will be income or loss from sources within the United
States for foreign tax credit limitation purposes. A U.S. Holder’s ability to deduct capital losses is subject to
limitations.
Passive Foreign Investment Company Considerations
We believe that we were a PFIC for our 2024 taxable year.
Because the determination of our PFIC status is
made annually based on the factual tests described below, however, we cannot estimate with certainty at this
stage whether or not we are likely to be treated as a PFIC in the current taxable year or any future taxable years.
In particular, the total value of our asset test generally will be calculated taking into account the market price of
our ADSs or ordinary shares. This value has fluctuated considerably in the past, and may fluctuate considerably
in the future. Even if we determine that we are not a PFIC for a taxable year, there can be no assurance that the
IRS will agree with our conclusion regarding our PFIC status.
We are treated as a PFIC for any taxable year in which at least 75% of our gross income is “passive income” or
at least 50% of our gross assets during the taxable year (based on the average of the fair market values of the
assets determined at the end of each quarterly period) are assets that produce or are held for the production of
passive income. Passive income for this purpose generally includes, among other things, dividends, interest,
rents, royalties, gains from commodities and securities transactions, and gains from assets that produce passive
income. In addition, cash and short-term investment are treated as passive assets regardless of the fact that
they may not produce any income. Rents and royalties received from unrelated parties in connection with the
active conduct of a trade or business are not considered passive income for purposes of the PFIC test. In
determining whether we are a PFIC, a pro rata portion of the income and assets of each corporation in which we
own, directly or indirectly, at least a 25% interest (by value) is taken into account.
If we are classified as a PFIC in any taxable year, a U.S. Holder will be subject to special rules with respect to
distributions on and sales, exchanges and other dispositions of the ADSs. In addition, a U.S. Holder that holds
the ADSs at any time during a taxable year in which we are classified as a PFIC generally will continue to have
to treat such ADSs as ADSs in a PFIC, even if we no longer satisfy the income and asset tests described above,
unless the U.S. Holder elects to recognize gain, which will be taxed under the excess distribution rules described
below as if such ADSs had been sold on the last day of the last taxable year for which we were a PFIC.
Certain elections by a U.S. Holder, described below, generally alleviate some of the adverse consequences of
the excess distribution rules and would result in an alternative treatment of the ADSs, as described below.
236
Annual Report on Form 20-F for the
year ended December 31, 2024
A U.S. Holder of PFIC shares must generally file an annual information return on IRS Form 8621 (Information
Return by a Shareholder of a Passive Foreign Investment Company or Qualified Electing Fund) and will make
any of the elections described below such Form attached to a timely filed U.S. federal income tax return
(including available extensions). The failure to file IRS Form 8621 could result in an extension of the statute of
limitations with respect to U.S. federal income tax.
Excess Distribution Rules.
If we are a PFIC with respect to a U.S. Holder, then unless such U.S. Holder makes
one of the elections described below, a special tax regime will apply to the U.S. Holder with respect to (i) any
“excess distribution” (generally, aggregate distributions in any year that are greater than 125% of the average
annual distribution received by the holder in the shorter of the three preceding years or the holder’s holding
period for the ADSs) and (ii) any gain realized on the sale or other disposition of the ADSs. Under this regime,
any excess distribution and realized gain is treated as ordinary income and is subject to tax as if (a) the excess
distribution or gain had been realized ratably over the U.S. Holder’s holding period, (b) the amount deemed
realized in each year had been subject to tax in each year of that holding period at the highest marginal rate for
such year (other than income allocated to the current period or any taxable period before we became a PFIC,
which is subject to tax at the U.S. Holder’s regular ordinary income rate for the current year and is not subject to
the interest charge discussed below), and (c) the interest charge generally applicable to underpayments of tax
had been imposed on the taxes deemed to have been payable in those years. If we are a PFIC, this tax
treatment for U.S. Holders applies also to indirect distributions and gains deemed realized by U.S. Holders in
respect of stock of any of our subsidiaries determined to be PFICs. In addition, dividend distributions do not
qualify for the lower rates of taxation applicable to long-term capital gains discussed above under “—Taxation of
Dividends.”
Elective Alternative Treatment.
If we are a PFIC, the rules above do not apply to a U.S. Holder that makes an
election to treat ADSs as stock of a “qualified electing fund” or QEF.
We intend to provide to U.S. Holders the
required information to make a valid QEF election and expect to provide that information after April 15, 2025 and
before August 15, 2025 on our corporate website. As a result, a U.S. Holder is expected to be able to make the
QEF election with respect to its ADSs with an extension to file its U.S. federal income tax return.
A
U.S. Holder
that makes a QEF election is required to include in income its pro rata share of our ordinary earnings and net
capital gain as ordinary income and long-term capital gain, respectively, subject to a separate election to defer
payment of taxes, which deferral is subject to an interest charge. A U.S. Holder makes a QEF election generally
by attaching a completed IRS Form 8621 to a timely filed United States federal income tax return for the year
beginning with which the QEF election is to be effective (taking into account any extensions). A QEF election can
be revoked only with the consent of the IRS. We intend to annually provide or make available the information
required for a U.S. Holder to make a valid QEF election.
The rules above also do not apply to a U.S. Holder that makes a “mark-to-market” election with respect to the
ADSs. This election is available with respect to the ADSs only if they meet certain minimum trading requirements
to be considered “marketable stock” for purposes of the PFIC rules. Generally, shares or ADSs are treated as
marketable stock if they are “regularly traded” on a “qualified exchange” within the meaning of applicable U.S.
Treasury Regulations. ADSs generally will be considered regularly traded during any calendar year during which
they are traded, other than in de minimis quantities, on at least 15 days during each calendar quarter. Any trades
that have as their principal purpose meeting this requirement will be disregarded. Our ADSs will be marketable
stock as long as they remain listed on the Nasdaq Global Select Market and are traded regularly.
A U.S. Holder that makes a valid mark-to-market election for the first tax year in which the holder holds (or is
deemed to hold) ADSs and for which we are a PFIC will be required to include each year an amount equal to the
excess, if any, of the fair market value of such ADSs the holder owns as of the close of the taxable year over the
holder’s adjusted tax basis in such ADSs. The U.S. Holder will be entitled to a deduction for the excess, if any, of
the holder’s adjusted tax basis in the ADSs over the fair market value of such ADSs as of the close of the taxable
year, but only to the extent of any net mark-to-market gains with respect to such ADSs included by the U.S.
Holder under the election for prior taxable years. The U.S. Holder’s basis in such ADSs will be adjusted to reflect
the amounts included or deducted pursuant to the election. Amounts included in income pursuant to a mark-to-
market election, as well as gain on the sale, exchange or other taxable disposition of such ADSs, will be treated
as ordinary income. The deductible portion of any mark-to-market loss, as well as loss on a sale, exchange or
237
Annual Report on Form 20-F for the
year ended December 31, 2024
other disposition of ADSs to the extent that the amount of such loss does not exceed net mark-to-market gains
previously included in income, will be treated as ordinary loss.
The mark-to-market election applies to the taxable year for which the election is made and all subsequent
taxable years, unless the shares cease to be treated as marketable stock for purposes of the PFIC rules or the
IRS consents to its revocation. The excess distribution rules described above generally will not apply to a U.S.
Holder for tax years for which a mark-to-market election is in effect. However, if we are a PFIC for any year in
which the U.S. Holder owns the ADSs but before a mark-to-market election is made, the interest charge rules
described above applies to any mark-to-market gain recognized in the year the election is made.
U.S. Holders are urged to consult their tax advisors as to our status as a PFIC, and the tax
consequences to them if we were a PFIC, including the reporting requirements and the desirability of
making, and the availability of, a QEF election or a mark-to-market election with respect to the ADSs.
Medicare Tax
Non-corporate U.S. Holders that are individuals, estates or trusts and whose income exceeds certain thresholds
generally are subject to a 3.8% tax on all or a portion of their net investment income, which may include their
gross dividend income and net gains from the disposition of ADSs. A U.S. person that is an individual, estate or
trust is encouraged to consult its tax advisors regarding the applicability of this Medicare tax to its income and
gains in respect of any investment in ADSs.
Information Reporting with Respect to Foreign Financial Assets
Individual U.S. Holders may be subject to certain reporting obligations on IRS Form 8938 (Statement of
Specified Foreign Financial Assets) with respect to the ADSs for any taxable year during which the U.S. Holder’s
aggregate value of these and certain other “specified foreign financial assets” exceed a threshold amount that
varies with the filing status of the individual. This reporting obligation also applies to domestic entities formed or
availed of to hold, directly or indirectly, specified foreign financial assets, including the ADSs. Significant
penalties can apply if U.S. Holders are required to make this disclosure and fail to do so.
U.S. Holders who acquire ADSs for cash may be required to file IRS Form 926 (Return by a U.S. Transferor of
Property to a Foreign Corporation) with the IRS and to supply certain additional information to the IRS if (i)
immediately after the transfer, the U.S. Holder owns directly or indirectly (or by attribution) at least 10% of our
total voting power or value or (ii) the amount of cash transferred to us in exchange for ADSs, when aggregated
with all related transfers under applicable regulations, exceeds $100,000. Substantial penalties may be imposed
on a U.S. Holder that fails to comply with this reporting requirement.
Information Reporting and Backup Withholding
In general, information reporting, on IRS Form 1099, will apply to dividends in respect of ADSs and the proceeds
from the sale, exchange or redemption of ADSs that are paid to a holder of ADSs within the United States (and in
certain cases, outside the United States), unless such holder is an exempt recipient such as a corporation.
Backup withholding (currently at a 24% rate) may apply to such payments if a holder of ADSs fails to provide a
taxpayer identification number (generally on an IRS Form W-9) or certification of other exempt status or fails to
report in full dividend and interest income.
Backup withholding is not an additional tax. A U.S. Holder generally may obtain a refund of any amounts
withheld under the backup withholding rules that exceed the U.S. Holder’s income tax liability by filing a refund
claim with the IRS
.
F. Dividends and Paying Agents
Not applicable.
G. Statement by Experts
Not applicable.
238
Annual Report on Form 20-F for the
year ended December 31, 2024
H. Documents on Display
We are subject to the informational requirements of the Exchange Act. Accordingly, we are required to file reports
and other information with the SEC, including annual reports on Form 20-F and reports on Form 6-K. The SEC
maintains an Internet website that contains reports and other information about issuers, like us, that file
electronically with the SEC. The address of that website is www.sec.gov.
We also make available on our website, free of charge, our Annual Report and the text of our reports on Form 6-
K, including any amendments to these reports, as well as certain other SEC filings, as soon as reasonably
practicable after they are electronically filed with or furnished to the SEC. Our website address is
www.biontech.de. The information contained on our website is not incorporated by reference in this Annual
Report and our website address is included in this Annual Report as an inactive textual reference only.
Statements contained in this Annual Report regarding the contents of any contract or other document are not
necessarily complete, and, where the contract or other document is an exhibit to the Annual Report, each of
these statements is qualified in all respects by the provisions of the actual contract or other documents.
I. Subsidiary Information
Not applicable.
J. Annual Report to Security Holders
Not applicable.
Item 11. Quantitative and Qualitative Disclosures About Market Risk
We are exposed to various risks in relation to financial instruments, including counterparty risk and currency risk.
Our risk management is coordinated by our Management Board. We do not engage in the trading of financial
assets for speculative purposes. The most significant financial risks to which we are exposed include the risks
discussed below.
Counterparty Risk
In order to mitigate default risks within our asset management portfolio, we diversify our cash investments
among various counterparties and instruments that have an investment grade rating. Transactions are carried
out within the limits approved by the treasury committee.
Foreign Currency Risk
We publish our consolidated financial statements in Euro. Revenue and expenses incurred in U.S. dollars will be
translated into Euro when they are reported in our consolidated financial statements.
W
e are subject to currency
risks, as our income and expenditures are denominated in Euro and the U.S. dollar. As such, we are exposed to
exchange rate fluctuations between these currencies.
Cash inflows denominated in U.S. dollar mainly result from
generating proceeds under our collaboration agreements.
Our commercial revenues are primarily collaboration
revenues from earnings based on our partners’ gross profit, which is shared under the respective collaboration
agreements
and represents payments we receive in U.S. dollar.
Cash outflows dominated in U.S. dollar mainly
result from amounts spent on research and development activities and license obligations as well as expanding
our global footprint further. With the aim of preserving capital, surplus liquidity is mainly invested in domestic
currency investments as exchange rate fluctuations can reduce the value of our financial positions. We limit the
effects of the identified risks by means of a coordinated and consistently implemented risk strategy. Besides
applying natural hedging relationships where possible, foreign exchange forward contracts are concluded, as a
matter of principle, as instruments to mitigate foreign currency exchange risk associated with foreign currency-
denominated payments.
For further disclosures relating to foreign exchange forward contracts, see Note
12
to our consolidated financial
statements included elsewhere in this Annual Report.
239
Annual Report on Form 20-F for the
year ended December 31, 2024
Notwithstanding our efforts to mitigate some foreign currency exchange risks, there can be no assurance that
our hedging activities will adequately protect us against the risks associated with foreign currency fluctuations.
We believe the counterparties to our foreign currency forward contracts are creditworthy multinational
commercial banks. While we believe the risk of counterparty nonperformance is not material, a sustained decline
in the financial stability of financial institutions as a result of disruption in the financial markets could affect our
ability to secure creditworthy counterparties for our foreign currency hedging programs. Therefore, developments
on the financial markets are continuously monitored to enable us to respond to exceptional events at short
notice.
As a result, any substantial future appreciation or decline of the U.S. dollar against the Euro could have a
material effect on our revenue and profitability. As an example, if the U.S. dollar weakens by 5% against the
Euro, financial assets and liabilities denominated in U.S. dollar as of
December 31, 2024
would have an effect of
€12.9
million o
n our profit before tax.
For additional information about our quantitative and qualitative market risks, see Note
12
to the consolidated
financial statements.
Item 12. Description of Securities Other than Equity Securities
A. Debt Securities
Not applicable.
B. Warrants and Rights
Not applicable.
C. Other Securities
Not applicable.
D.
American Depositary Shares
Fees and Expenses
240
Annual Report on Form 20-F for the
year ended December 31, 2024
|
Persons depositing or withdrawing shares or ADS
holders must pay:
|
For:
|
|
|
$5.00 (or less) per 100 ADSs (or portion of 100 ADSs)
|
Issuance of ADSs, including issuances resulting from a
distribution of shares or rights or other property
Cancellation of ADSs for the purpose of withdrawal,
including if the deposit agreement terminates
|
|
|
$.05 (or less) per ADS
|
Any cash distribution to ADS holders
|
|
|
A fee equivalent to the fee that would be payable if
securities distributed to an ADS holder had been shares and
the shares had been deposited for issuance of ADSs
|
Distribution of securities distributed to holders of deposited
securities (including rights) that are distributed by the
depositary to ADS holders
|
|
|
$.05 (or less) per ADS per calendar year
|
Depositary services
|
|
|
Registration or transfer fees
|
Transfer and registration of shares on our share register to
or from the name of the depositary or its agent when an ADS
holder deposits or withdraws shares
|
|
|
Expenses of the depositary
|
Cable and facsimile transmissions (when expressly provided
in the deposit agreement)
Converting foreign currency to U.S. dollars
|
|
|
Taxes and other governmental charges the depositary or the
custodian has to pay on any ADSs or shares underlying
ADSs, such as stock transfer taxes, stamp duty or
withholding taxes
|
As necessary
|
|
|
Any charges incurred by the depositary or its agents for
servicing the deposited securities
|
As necessary
|
The depositary collects its fees for delivery and surrender of ADSs directly from investors depositing shares or
surrendering ADSs for the purpose of withdrawal or from intermediaries acting for them. The depositary collects
fees for making distributions to investors by deducting those fees from the amounts distributed or by selling a
portion of distributable property to pay the fees. The depositary may collect its annual fee for depositary services
by deduction from cash distributions or by directly billing investors or by charging the book-entry system
accounts of participants acting for them. The depositary may collect any of its fees by deduction from any cash
distribution payable (or by selling a portion of securities or other property distributable) to ADS holders that are
obligated to pay those fees. The depositary may generally refuse to provide fee-attracting services until its fees
for those services are paid.
From time to time, the depositary may make payments to us to reimburse us for costs and expenses generally
arising out of establishment and maintenance of the ADS program, waive fees and expenses for services
provided to us by the depositary or share revenue from the fees collected from ADS holders. In performing its
duties under the deposit agreement, the depositary may use brokers, dealers, foreign currency dealers or other
service providers that are owned by, or affiliated with, the depositary and that may earn or share fees, spreads or
commissions.
The depositary may convert currency itself or through any of its affiliates and, in those cases, acts as principal for
its own account and not as agent, advisor, broker or fiduciary on behalf of any other person and earns revenue,
including, without limitation, transaction spreads, that it will retain for its own account. The revenue is based on,
among other things, the difference between the exchange rate assigned to the currency conversion made under
the deposit agreement and the rate that the depositary or its affiliate receives when buying or selling foreign
currency for its own account. The depositary makes no representation that the exchange rate used or obtained
in any currency conversion under the deposit agreement will be the most favorable rate that could be obtained at
the time or that the method by which that rate will be determined will be the most favorable to ADS holders,
subject to the depositary’s obligations under the deposit agreement. The methodology used to determine
exchange rates used in currency conversions is available upon request.
241
Annual Report on Form 20-F for the
year ended December 31, 2024
Payment of Taxes
ADS holders will be responsible for any taxes or other governmental charges payable on their ADSs or on the
deposited securities represented by any of their ADSs. The depositary may refuse to register any transfer of ADS
holders ADSs or allow him or her to withdraw the deposited securities represented by his or her ADSs until those
taxes or other charges are paid. It may apply payments owed to you or sell deposited securities represented by
his or her ADSs to pay any taxes owed and you will remain liable for any deficiency. If the depositary sells
deposited securities, if appropriate, it will reduce the number of ADSs to reflect the sale and pay to ADS holders
any proceeds, or send to ADS holders any property, remaining after it has paid the taxes.
PART II
Item 13. Defaults, Dividend Arrearages and Delinquencies
Not applicable.
Item 14. Material Modifications to the Rights of Security Holders and Use of Proceeds
Not applicable.
Item 15. Controls and
Procedures
Disclosure Controls and Procedures
As required by Rule 13a-15 under the Exchange Act, management, including our Chief Executive Officer and our
Chief Financial Officer, has performed an evaluation of the effectiveness of our disclosure controls and
procedures. Disclosure controls and procedures refer to controls and other procedures designed to ensure that
information required to be disclosed in the reports we file or submit under the Exchange Act is recorded,
processed, summarized and reported within the time periods specified in the rules and forms of the SEC.
Disclosure controls and procedures include, without limitations, controls and procedures designed to ensure that
information required to be disclosed by us in our reports that we file or submit under the Exchange Act is
accumulated and communicated to management, including our principal executive and principal financial
officers, or persons performing similar functions, as appropriate to allow timely decisions regarding our required
disclosures.
Based on the foregoing, our CEO and CFO have concluded that, as of the end of the period covered by this
annual report, our disclosure controls and procedures were effective in ensuring that the information required to
be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed,
summarized and reported within the time periods specified in by the SEC’s rules and forms, and that the
information required to be disclosed by us in the reports that we file or submit under the Exchange Act is
accumulated and communicated to our management to allow timely decisions regarding required disclosure.
Management’s Annual Report on Internal Control over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal control over financial
reporting, as such term is defined in Exchange Act Rules 13a-15(f). Our internal control over financial reporting is
a process designed by or under the supervision of the Chief Financial Officer, to provide reasonable assurance
regarding the reliability of financial reporting and the preparation of our financial statements for external reporting
purposes in accordance with International Financial Reporting Standards as issued by the IASB.
No system of internal control over financial reporting, including one determined to be effective, may prevent or
detect all misstatements. It can provide only reasonable assurance regarding financial statement preparation
and presentation. Also, projections of the results of any evaluation of the effectiveness of internal control over
financial reporting into future periods are subject to inherent risk. The relevant controls may become inadequate
due to changes in circumstances or the degree of compliance with the underlying policies or procedures may
deteriorate.
242
Annual Report on Form 20-F for the
year ended December 31, 2024
Our management assessed the effectiveness of the Company’s internal control over financial reporting as of
December 31, 2024
. In making this assessment, it used the criteria set forth by the Committee of Sponsoring
Organizations of the Treadway Commission in “Internal Control - Integrated Framework (2013)”.
Based
on this assessment, our management has determined that the Company’s internal control over financial
reporting as of
December 31, 2024
is effective.
Attestation Report of the Registered Public Accounting Firm
The effectiveness of our internal control over financial reporting as of
December 31, 2024
has been audited by
EY GmbH & Co. KG
Wirtschaftsprüfungsgesellschaft
, an independent registered public accounting firm. Their
report is included on page F-2. EY GmbH & Co. KG
Wirtschaftsprüfungsgesellschaft
is a member of the
Chamber of Public Accountants (
Wirtschaftsprüferkammer
), Berlin, Germany.
Changes in Control over Financial Reporting
There has been no change in our internal control over financial reporting during the year ended December 31,
2024 that has materially affected, or is reasonably likely to materially affect, our internal control over financial
reporting.
Item 16. [Reserved]
Item 16A.
Audit Committee Financial Expert
Our Audit Committee for the year ended December 31, 2024 consisted of Anja Morawietz. (Chair), Rudolf
Staudigl and Ulrich Wandschneider.
All members of the Audit Committee qualify as “independent directors” as
such term is defined in Rule 10A-3 under the Exchange Act and Nasdaq Rule 5605. Additionally, our Supervisory
Board has determined that Anja Morawietz, Rudolf Staudigl and Ulrich Wandschneider qualify as “audit
committee financial expert” as that term is defined under the Exchange Act.
Item 16B. Code of Ethics
We have adopted a Code of Ethics & Business Integrity, or Code of Ethics, which outlines the principles of legal
and ethical business conduct under which we do business. The Code of Ethics applies to all of our Supervisory
Board members, Management Board members, directors of our subsidiaries and employees. The full text of the
Code of Ethics is available on our website at h
ttps://www.biontech.de
. The information and other content
appearing on our website are not part of this Annual Report and our website address is included in this Annual
Report as an inactive textual reference only. Any amendments or waivers from the provisions of the Code of
Ethics for members of our Supervisory or Management Boards will be made only after approval by our
Supervisory Board and will be disclosed on our website promptly following the date of such amendment or
waiver.
Item 16C.
Principal Accountant Fees and Services
EY GmbH & Co. KG Wirtschaftsprüfungsgesellschaft
, or EY, has served as our independent registered public
accounting firm for the years ended
December 31, 2024
,
December 31, 2023
,
December 31, 2022
for which
audited financial statements appear in this Annual Report.
The
following
table sets out the aggregate fees for professional audit services and other services rendered by
EY in the periods indicated:
243
Annual Report on Form 20-F for the
year ended December 31, 2024
|
Years ended
December 31,
|
||||||
|
(in millions €)
|
2024
|
2023
|
||||
|
Audit fees
|
2.8
|
3.2
|
||||
|
Audit-related fees
|
—
|
0.3
|
||||
|
Tax fees
|
0.6
|
0.1
|
||||
|
Total fees for professional audit services and other services
|
3.4
|
3.6
|
||||
In the
year ended December 31, 2024
, audit fees related to professional services associated with the integrated
audit of our consolidated financial statements and our internal control over financial reporting as set out in this
Annual Report, professional services associated with interim reviews, audit fees related to the remuneration
report and professional services related to our statutory and regulatory filings for
our subsidiaries.
Due to
additional procedures related to the acquisition of InstaDeep and to an implementation of IT-systems in the
year
ended December 31, 2023
, the expenses were lower during
year ended December 31, 2024
. In the
year ended
December 31, 2023
, audit fees related to professional services associated with the integrated audit of our
consolidated financial statements and our internal control over financial reporting, professional services
associated with interim reviews, audit fees related to the remuneration report and professional services related to
our statutory and regulatory filings for our subsidiaries.
In the
year ended December 31, 2024
, no audit-related services have been received
.
In the
year ended
December 31, 2023
, audit-related fees were attributable to assurance and related services including attest
related services and accounting consultations
.
In the
year ended December 31, 2024
, tax service fees were billed for services in conjunction with transactions,
especially with our
financing
and deal transactions. In the
year ended December 31, 2023
, tax service fees billed
for services in conjunction with transactions, especially with our financing and
deal transactions
.
The Audit Committee evaluates the qualifications, independence and performance of the independent auditor as
well as pre-approves and reviews the audit and non-audit services to be performed by the independent auditor.
The external audit plan and fees for professional audit services and other services rendered by EY for the years
ended
December 31, 2024
and
2023
,
were approved by the Audit Committee. The Audit Committee monitors
compliance with the German and U.S. rules on non-audit services provided by an independent registered public
accounting firm.
Item 16D. Exemptions from the Listing Standards for Audit Committees
Please see “Board Practices—Supervisory Board Practices—Audit Committee” in Item 6C of this Annual Report
for the information required by this Item 16D.
Item 16E. Purchases of Equity Securities by the Issuer and Affiliated Purchasers
Not applicable.
Item 16F. Change in Registrant’s Certifying Accountant
Not applicable.
Item 16G. Corporate Governance
German Corporate Governance Code
The German Corporate Governance Code, or the Corporate Governance Code, was originally published by the
German Federal Ministry of Justice (
Bundesministerium der Justiz
) in 2002. The version currently in effect, dated
April 28, 2022
, was published in the German Federal Gazette (
Bundesanzeiger
) on June 27, 2022. The
Corporate Governance Code contains principles (
Grundsätze
), recommendations (
Empfehlungen
) and
244
Annual Report on Form 20-F for the
year ended December 31, 2024
suggestions (
Anregungen
) relating to the management and supervision of German companies that are listed on
a stock exchange. It follows internationally and nationally recognized standards for good and responsible
corporate governance. The purpose of the Corporate Governance Code is to make the German system of
corporate governance transparent for investors. The Corporate Governance Code includes corporate
governance principles, recommendations and suggestions with respect to shareholders and shareholders’
meetings, the management and supervisory boards, transparency, accounting policies and auditing.
There is no obligation to comply with the recommendations or suggestions of the Corporate Governance Code.
The German Stock Corporation Act (
Aktiengesetz
) requires only that the management board and supervisory
board of a German company listed on a trading facility (such as a stock exchange) which is regulated and
supervised by government authorities issue an annual declaration that either (i) states that the company has
complied with the recommendations of the Corporate Governance Code or (ii) lists the recommendations that
the company has not complied with and explains its reasons for deviating from the recommendations of the
Corporate Governance Code (
Entsprechenserklärung
). In addition, a listed company is also required to state in
this annual declaration whether it intends to comply with the recommendations or list the recommendations it
does not plan to comply with in the future. These declarations must be made accessible to shareholders at all
times. If the company changes its policy on certain recommendations between such annual declarations, it must
disclose this fact and explain its reasons for deviating from the recommendations. Non-compliance with
suggestions contained in the Corporate Governance Code need not be disclosed.
As a listed company, o
ur Management Board and Supervisory Board comply with the Corporate Governance
Code except for such provisions which are listed explicitly in the annual declaration and for which they provide
an explanation of non-compliance.
Differences in Corporate Law
The applicable provisions of the SE Regulation in conjunction with the German Stock Corporation Act as applied
to a European stock corporation that has its legal seat in Germany differ from laws applicable to U.S.
corporations and their shareholders. Set forth below is a summary of certain differences between the provisions
of the SE Regulation in conjunction with the German Stock Corporation Act applicable to us and the General
Corporation Law of the State of Delaware relating to shareholders’ rights and protections. This summary is not
intended to be a complete discussion of the respective rights and it is qualified in its entirety by reference to
Delaware law and European and German law.
|
European Union/Federal Republic
of Germany
|
Delaware
|
|||
|
Board System
|
A European stock corporation may choose to
have a two-tier board structure composed of
the Management Board (Vorstand) and the
Supervisory Board (Aufsichtsrat). We have
chosen this structure.
The Management Board is responsible for
running the company’s affairs and
representing the company in dealings with
third parties.
The Supervisory Board of a European stock
corporation under German law has a control
and supervisory function. The Supervisory
Board does not actively manage the company
but certain Management Board actions
require the approval of the Supervisory Board.
|
Under Delaware law, a corporation has a
unitary board structure, and it is the
responsibility of the board of directors to
appoint and oversee the management of the
corporation on behalf of and in the best
interests of the stockholders of the
corporation.
Management is responsible for running the
corporation and overseeing its day-to-day
operations.
|
245
Annual Report on Form 20-F for the
year ended December 31, 2024
|
Appointment and
Number of Directors
|
Under applicable European and German law,
a European stock corporation governed by
German law with a share capital of at least €3
million generally must have at least two
members on its Management Board and the
number of members shall be determined by or
in the manner provided in the company’s
articles of association.
The Supervisory Board must consist of at
least three but—depending on the share
capital—no more than 21 Supervisory Board
members, whereby the number of Supervisory
Board members must be divisible by three if
this is necessary for the fulfilment of co-
determination requirements. The articles of
association of the company must specify if the
Supervisory Board has more than three
members.
Supervisory Board members are either
appointed by the shareholders’ meeting or
delegated by one or more individual
shareholders if so provided for in the
company’s articles of association. If the
Supervisory Board consists of fewer members
than is required to meet the quorum for
resolutions (either statutory or pursuant to the
company’s articles of association), a
competent court may appoint additional
members as needed to meet the quorum. The
provisions of German law in relation to
employees’ co-determination do not apply to
the Company.
|
Under Delaware law, a corporation must have
at least one director and the number of
directors shall be fixed by or in the manner
provided in the bylaws.
|
246
Annual Report on Form 20-F for the
year ended December 31, 2024
|
Removal of Directors
|
Members of the Management Board of a
European stock corporation are appointed by
the Supervisory Board for a maximum period
of six years with an opportunity to be
reelected. The articles of association may
provide for a shorter term which in our case is
up to five years. The members of the
Management Board may be reelected, even
repeatedly. The Supervisory Board may
remove a member of the Management Board
prior to the expiration of his or her term only
for cause, such as gross breach of duties
(
grobe Pflichtverletzung
), the inability to
manage the business properly (
Unfähigkeit
zur ordnungsgemäßen Pflichtausübung
) or a
vote of no-confidence during the
shareholders’ meeting (
Vertrauensentzug
).
The shareholders themselves are not entitled
to appoint or dismiss the members of the
Management Board.
Under European law, a member of the
Supervisory Board of a company may be
elected for a term of up to six years. The
articles of association may provide for a
shorter term. Our Supervisory Board
members are, if the general meeting does not
resolve on a shorter term, elected for a period
up to the end of the general meeting deciding
on the discharge for the fourth financial year
after the election. Reelection, including
repeated reelection, is permissible. Members
of the Supervisory Board may be removed
with or without cause by way of a general
meeting resolution, with the applicable
majority requirement depending on the
relevant company’s articles of association.
|
Under Delaware law, any director or the entire
board of directors may be removed, with or
without cause, by the holders of a majority of
the shares then entitled to vote at an election
of directors, except (i) unless the certificate of
incorporation provides otherwise, in the case
of a corporation whose board of directors is
classified, stockholders may effect such
removal only for cause; or (ii) in the case of a
corporation having cumulative voting, if less
than the entire board of directors is to be
removed, no director may be removed without
cause if the votes cast against his removal
would be sufficient to elect him if then
cumulatively voted at an election of the entire
board of directors, or, if there are classes of
directors, at an election of the class of
directors of which he is a part.
|
||
|
Vacancies on the Board
of Directors
|
Under the law, vacant positions on the
Management Board are filled by the
Supervisory Board in accordance with the
general rules of appointment, which provide
that vacancies are filled by the simple majority
of votes of Supervisory Board members
present or represented by proxy at the vote
(with, under certain circumstances, the
chairman having a casting vote), unless
otherwise provided by the company’s articles
of association. In case of emergencies, a
vacant position on the Management Board
may be filled by an individual appointed by the
court. Vacant positions on the Supervisory
Board are filled in accordance with the
general rules of appointment.
|
Under Delaware law, vacancies and newly
created directorships may be filled by a
majority of the directors then in office (even
though less than a quorum) or by a sole
remaining director unless (i) otherwise
provided in the certificate of incorporation or
by-laws of the corporation or (ii) the certificate
of incorporation directs that a particular class
of stock is to elect such director, in which
case a majority of the other directors elected
by such class, or a sole remaining director
elected by such class, will fill such vacancy.
|
247
Annual Report on Form 20-F for the
year ended December 31, 2024
|
Annual General Meeting
|
A European stock corporation, which is
governed by German law, must hold an
annual shareholders’ meeting within six
months of the end of its fiscal year. The
annual shareholders’ meeting must be held at
a location determined by the articles of
association. If the articles of association do
not provide for a specific location, the
shareholders’ meeting shall be held at the
company’s seat or, if applicable, at the venue
(in Germany) where its shares are listed.
Under the articles of association, the
Management Board is authorized to provide
for the Annual General Meeting to be held
without the physical presence of the
shareholders or their proxies at the location of
the Annual General Meeting (virtual Annual
General Meeting).
|
Under Delaware law, the annual meeting of
stockholders shall be held at such place, on
such date and at such time as may be
designated from time to time by the board of
directors or as provided in the certificate of
incorporation or by the bylaws.
|
||
|
General Meeting
|
Under the law, extraordinary shareholders’
meetings, in addition to the annual
shareholders’ meetings, may be called either
by the Management Board, or the Supervisory
Board. Shareholders holding at least 5% of
the company’s share capital are entitled to
request that an extraordinary shareholders’
meeting be convened. In the event that the
meeting is not then so convened, a competent
court may order that the meeting be convened
or authorize the shareholders or their
representative to convene the meeting
themselves.
|
Under Delaware law, special meetings of the
stockholders may be called by the board of
directors or by such person or persons as
may be authorized by the certificate of
incorporation or by the bylaws.
|
||
|
Notice of General
Meetings
|
Under applicable European and German law,
unless a longer period is otherwise provided
for in the articles of association or applies
because of registration requirements
stipulated in the articles of association, the
shareholders must be given at least 30 days’
advance notice of the shareholders’ meeting.
Such notices must at least specify the name
of the company, the statutory seat of the
company, and the location, date and time of
the shareholders’ meeting. In addition, the
invitation must contain the agenda items as
well as the Management Board’s and the
Supervisory Board’s voting proposal for each
agenda item and, depending on the
circumstances, certain further information.
If all shareholders entitled to attend the
shareholders’ meeting are present or
represented and do not object to the meeting
being held, the formalities of calling and
holding of a shareholders’ meeting do not
apply.
|
Under Delaware law, unless otherwise
provided in the certificate of incorporation or
bylaws, written notice of any meeting of the
stockholders must be given to each
stockholder entitled to vote at the meeting not
less than ten nor more than 60 days before
the date of the meeting and shall specify the
place, date, hour, and purpose or purposes of
the meeting.
|
248
Annual Report on Form 20-F for the
year ended December 31, 2024
|
Proxy
|
A shareholder may designate another person
to attend, speak and vote at a shareholders’
meeting of the company on such
shareholder’s behalf by proxy.
With respect to Management Board meetings,
a Management Board member may transmit
its (written or verbal) vote via another
Management Board member.
With respect to Supervisory Board meetings,
a Supervisory Board member may participate
in voting by issuing a written vote to another
Supervisory Board member or any third party
entitled to attend the Supervisory Board
meeting.
|
Under Delaware law, at any meeting of
stockholders, a stockholder may designate
another person to act for such stockholder by
proxy, but no such proxy shall be voted or
acted upon after three years from its date,
unless the proxy provides for a longer period.
A director of a Delaware corporation may not
issue a proxy representing the director’s
voting rights as a director.
|
||
|
Preemptive Rights
|
Under the law applicable to European stock
corporations governed by German law,
existing shareholders have a statutory
subscription right for any additional issue of
shares or any security convertible into shares
pro rata to the nominal value of their
respective holdings in the company, unless (i)
shareholders representing three-quarters of
the registered share capital present at the
shareholders’ meeting have resolved upon the
whole or partial exclusion of the subscription
right and (ii) there exists good and objective
cause for such exclusion. No separate
resolution on the exclusion of subscription
rights is required if all shareholders waive
their statutory subscription rights.
|
Under Delaware law, stockholders have no
preemptive rights to subscribe to additional
issues of stock or to any security convertible
into such stock unless, and except to the
extent that, such rights are expressly provided
for in the certificate of incorporation.
|
||
|
Authority to Allot
|
Under applicable European and German law,
the Management Board may not allot shares,
grant rights to subscribe for or to convert any
security into shares unless a shareholder
resolution to that effect has been passed at
the company’s shareholders’ meeting granting
the Management Board with such authority—
subject to the approval of the Supervisory
Board—in each case in accordance with the
provisions of the German Stock Corporation
Act.
|
Under Delaware law, if the corporation’s
certificate of incorporation so provides, the
board of directors has the power to authorize
the issuance of stock. It may authorize capital
stock to be issued for consideration consisting
of cash, any tangible or intangible property or
any benefit to the corporation or any
combination thereof. It may determine the
amount of such consideration by approving a
formula. In the absence of actual fraud in the
transaction, the judgment of the directors as
to the value of such consideration is
conclusive.
|
249
Annual Report on Form 20-F for the
year ended December 31, 2024
|
Liability of Directors and
Officers
|
Under German law, any provision, whether
contained in the company’s articles of
association or any contract or otherwise, that
purports to exempt a Management or
Supervisory Board member from any liability
that would otherwise attach to such board
member in connection with any negligence,
default, breach of duty or breach of trust in
relation to the company is void.
Under German law, members of both the
Management Board and members of the
Supervisory Board are liable to the company,
and in certain cases to third parties or
shareholders, for any damage caused to them
due to a breach of such member’s duty of
care. Apart from insolvency or special
circumstances, only the company has the
right to claim damages from members of
either board. The company may waive or
settle claims for damages against a negligent
Management or Supervisory Board member
only after the expiry of three years and only if
the company’s shareholder meeting approves
thereof and no minority holding at least 10%
of the capital stock raises an objection. In
case a third party raises claims directly
against members of the Management Board
or of the Supervisory Board, such members
may claim from the company under additional
requirements indemnification regarding
liabilities arising out of or in connection with
their services to the company.
|
Under Delaware law, a corporation’s
certificate of incorporation may include a
provision eliminating or limiting the personal
liability of a director to the corporation and its
stockholders for damages arising from a
breach of fiduciary duty as a director.
However, no provision can limit the liability of
a director for:
• any breach of the director’s duty of loyalty
to the corporation or its stockholders;
• acts or omissions not in good faith or that
involve intentional misconduct or a knowing
violation of law;
• intentional or negligent payment of unlawful
dividends or stock purchases or redemptions;
or
• any transaction from which the director
derives an improper personal benefit.
|
||
|
Voting Rights
|
Under the relevant European and German
law, each share, except for statutory non-
voting preferred shares (
nicht
stimmberechtigte Vorzugsaktien
), entitles its
holder to vote at the shareholders’ meeting
with, in the case of no-par value shares, each
share conferring one vote. While German law
does not provide for a minimum attendance
quorum for shareholders’ meetings, the
company’s articles of association may so
provide. In general, resolutions adopted at a
shareholders’ meeting may be passed by a
simple majority of votes cast, unless a higher
majority is required by law or under the
company’s articles of association.
|
Delaware law provides that, unless otherwise
provided in the certificate of incorporation,
each stockholder is entitled to one vote for
each share of capital stock held by such
stockholder.
|
250
Annual Report on Form 20-F for the
year ended December 31, 2024
|
Shareholder Vote on
Certain Transactions
|
Under applicable European and German law,
certain shareholders’ resolutions of
fundamental importance require the vote of at
least three-quarters of the share capital
present or represented in the voting at the
time of adoption of the resolution. Resolutions
of fundamental importance include, in
particular, capital increases with exclusion of
subscription rights, capital decreases, the
creation of authorized or conditional share
capital, the dissolution of a company, a
merger into or with another company, split-offs
and split-ups, the conclusion of inter-company
agreements (
Unternehmensverträge
), in
particular domination agreements
(
Beherrschungsverträge
) and profit and loss
transfer agreements
(
Ergebnisabführungsverträge
).
|
Generally, under Delaware law, unless the
certificate of incorporation provides for the
vote of a larger portion of the stock,
completion of a merger, consolidation, sale,
lease or exchange of all or substantially all of
a corporation’s assets or dissolution requires:
• the approval of the board of directors; and
• approval by the vote of the holders of a
majority of the outstanding stock or, if the
certificate of incorporation provides for more
or less than one vote per share, a majority of
the votes of the outstanding stock of a
corporation entitled to vote on the matter.
|
251
Annual Report on Form 20-F for the
year ended December 31, 2024
|
Standard of Conduct for
Directors
|
Under applicable European and German law,
both Management and Supervisory Board
members must conduct their affairs with “the
care and diligence of a prudent business man”
and act in the best interest of the company.
The scope of the fiduciary duties of
Management and Supervisory Board
members is generally determined by
European and German legislation and by the
courts.
Statutory and fiduciary duties of members of
the Management Board to the company
include, among others:
• to act in accordance with the law, the
company’s articles of association and the
rules of procedure for the Management Board,
if any;
• to report to the Supervisory Board on a
regular basis as well as on certain important
occasions;
• to exercise reasonable care, skill and
diligence;
• to maintain a proper accounting system;
• to not compete, directly or indirectly, with the
company without permission by the
supervisory board; and
• to secure that no further transactions are
made in case of insolvency.
Statutory and fiduciary duties of members of
the Supervisory Board to the company
include, among others:
• to effectively supervise the Management
Board’s handling of the company’s affairs;
• to evaluate and issue a resolution on certain
transactions which can only be conducted by
the Management Board after approval of the
Supervisory Board;
• to approve the company’s financial
statements;
• to appoint the Management Board members
and to represent the company in transactions
between the company and members of the
Management Board; and
• to approve service contracts between
individual members of the Management Board
and the company.
|
Delaware law does not contain specific
provisions setting forth the standard of
conduct of a director. The scope of the
fiduciary duties of directors is generally
determined by the courts of the State of
Delaware. In general, directors have a duty to
act without self-interest, on a well- informed
basis and in a manner they reasonably
believe to be in the best interest of the
stockholders.
Directors of a Delaware corporation owe
fiduciary duties of care and loyalty to the
corporation and to its stockholders. The duty
of care generally requires that a director act in
good faith, with the care that an ordinarily
prudent person would exercise under similar
circumstances. Under this duty, a director
must inform himself of all material information
reasonably available regarding a significant
transaction. The duty of loyalty requires that a
director act in a manner he reasonably
believes to be in the best interests of the
corporation. He must not use his corporate
position for personal gain or advantage. In
general, but subject to certain exceptions,
actions of a director are presumed to have
been made on an informed basis, in good
faith and in the honest belief that the action
taken was in the best interests of the
corporation. However, this presumption may
be rebutted by evidence of a breach of one of
the fiduciary duties. Delaware courts have
also imposed a heightened standard of
conduct upon directors of a Delaware
corporation who take any action designed to
defeat a threatened change in control of the
corporation.
In addition, under Delaware law, when the
board of directors of a Delaware corporation
approves the sale or break-up of a
corporation, the board of directors may, in
certain circumstances, have a duty to obtain
the highest value reasonably available to the
stockholders.
|
252
Annual Report on Form 20-F for the
year ended December 31, 2024
|
Stockholder Actions
|
Under German law, generally, the company,
rather than its shareholders, is the proper
claimant in an action with respect to a wrong
committed against the company, or in cases
where there is an irregularity in the company’s
internal management or supervision.
Therefore, such claims may only be raised by
the company represented by its Management
Board, or, in the case of a wrong committed
by a member of the Management Board, by
the Supervisory Board.
Additionally, pursuant to German case law,
the Supervisory Board is obliged to pursue the
company’s claims against the Management
Board, unless the interest of the company
keeps them from doing so.
The Management Board, or, if a claim is
against a member of the Management Board,
the Supervisory Board, is obliged to pursue
the company’s claims against the designated
individuals if so resolved by a simple majority
of votes cast during a shareholders’ meeting.
With a simple majority of votes, shareholders
can request that a representative pursues the
claim on behalf of the company.
If the company is unable to fulfill its third-
party obligations, the company’s creditors
may pursue the company’s damage claims
against members of the Management Board
for certain wrongdoings.
Under certain circumstances, shareholders
can bring forward damage claims of the
company against its management on their
own behalf. In order to bring forward such a
claim one shareholder alone or together with
other shareholders needs to hold at least one
percent of the company’s share capital or a
participation of €100,000 in the share capital.
Additionally, the claimant(s) need(s) to pass
through special claim approval procedures.
|
Under Delaware law, a stockholder may
initiate a derivative action to enforce a right of
a corporation if the corporation fails to enforce
the right itself. The complaint must:
• state that the plaintiff was a stockholder at
the time of the transaction of which the
plaintiff complains or that the plaintiffs shares
thereafter devolved on the plaintiff by
operation of law; and
• either (i) allege with particularity the efforts
made by the plaintiff to obtain the action the
plaintiff desires from the directors and the
reasons for the plaintiff’s failure to obtain the
action, or (ii) or state the reasons for not
making the effort.
Additionally, the plaintiff must remain a
stockholder through the duration of the
derivative suit. The action will not be
dismissed or compromised without the
approval of the Delaware Court of Chancery.
|
Foreign Private Issuer Exemptions
As a “foreign private issuer,” as defined by the SEC, although we are permitted to follow certain corporate
governance practices of the Federal Republic of Germany, instead of those otherwise required under the rules of
the Nasdaq Stock Market LLC, or Nasdaq, for domestic issuers, we follow the Nasdaq corporate governance
rules applicable to foreign private issuers. While we voluntarily follow most Nasdaq corporate governance rules,
we intend to take advantage of the following limited exemptions:
•
exemption from filing quarterly reports on Form 10-Q and providing current reports on Form 8-K
disclosing significant events within four days of their occurrence (however, we intend to furnish quarterly
financial information under cover of Form 6-K);
•
exemption from compliance with Regulation FD, which generally requires that when a company
intentionally discloses material non-public information, it do so through a public disclosure that is broadly
available to all members of the public at the same time. However, we do furnish quarterly financial
information and other information on a more frequent basis under cover of Form 6-K, and intend to
continue doing so. Moreover, we comply with other securities laws, such as rule 10b-5 (rule targeting
securities fraud), among others;
253
Annual Report on Form 20-F for the
year ended December 31, 2024
•
exemption from Section 16 rules regarding sales of ordinary shares by insiders, which will provide less
data in this regard than the data provided to shareholders of U.S. companies that are subject to the
Exchange Act; and
•
exemption from the Nasdaq rules applicable to domestic issuers requiring disclosure within four
business days of any determination to grant a waiver of the code of business conduct and ethics to
directors and officers. Although we will require board approval of any such waiver, we may choose not to
disclose the waiver in the manner set forth in the Nasdaq rules, as permitted by the foreign private issuer
exemption.
Furthermore, Nasdaq Rule 5615(a)(3) provides that, as a foreign private issuer, we may rely on home country
corporate governance practices in lieu of certain of the rules in the Nasdaq Rule 5600 Series and Rule 5250(d),
provided that we nevertheless comply with Nasdaq’s Notification of Noncompliance requirement (Rule 5625) and
the Voting Rights requirement (Rule 5640) and that we have an audit committee that satisfies Rule 5605(c)(3),
consisting of committee members that meet the independence requirements of Rule 5605(c)(2)(A)(ii). Although
we are permitted to follow certain corporate governance rules that conform to German requirements in lieu of
many of the Nasdaq corporate governance rules, we comply with the Nasdaq corporate governance rules
applicable to foreign private issuers. We may utilize these exemptions for as long as we continue to qualify as a
foreign private issuer.
Item 16H. Mine Safety Disclosure
Not applicable.
Item 16I. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections
Not applicable.
Item 16J. Insider Trading Policies
We have
adopted
an insider trading policy that is reasonably designed to promote compliance with applicable
insider trading laws, rules and regulations, and any listing standards applicable to us. A copy is included as an
exhibit to this Annual Report.
Item
16K.
Cybersecurity
Risk Management and Strategy
and people. From a business perspective, this means protecting key information assets and complying with
applicable international and national privacy laws, information security policies and contractual obligations.
principles, and our Data Privacy Policy, effective since 2021, provides for a consistent level of company-wide
data privacy and data protection. In addition, our Information Classification Policy, introduced internally during
the year ended December 31, 2023, provides a system for classifying and protecting our physical and digital
assets. These policies are applicable to BioNTech SE and its affiliates, including all Supervisory Board and
Management Board members, as well as all other officers and employees, and are part of our overall Information
Security Management System, or ISMS,
that became effective in 2024 as part of the preparation for the ISO
The ISMS enables us to systematically manage information security through defined processes and structures.
This helps to reduce the risks of business interruptions, disclosure of sensitive data or intellectual property, and
other damages caused by IT security incidents. Additionally, as an operator of an essential service, we are
regulated by the IT Security Act and must comply with legislative requirements, including the implementation of
security measures to reduce the information security risks.
254
Annual Report on Form 20-F for the
year ended December 31, 2024
We aim to prevent the implementation of overly complicated and time-consuming procedures that may lead to an
unnecessary increase in effort. We are striving to align the protection of data and the provision of essential
service with our organizational context and economic approach. We aim to create an ISMS that is not limited to
documentation but is fully integrated into daily practice.
into our overall enterprise risk management system, which was developed with input from internal and
external
To achieve and preserve information security, we strive for the orderly planning, implementation, control, and
optimization of all activities required for the protection of data privacy and the detection, response and recovery
of data privacy risks. We are committed to the continual improvement of our ISMS based on the results of the
performance evaluation. We will initially seek certifications for our main manufacturing facility and an R&D site in
addition to the cybersecurity organization.
We take responsibility for the transparent communication and proper processing of personal data. This includes
the storage, access, retention, and security of all personal data when engaging with patients, employees,
customers, business partners, and vendors. We communicate our practices in a data privacy statement on our
corporate website. We require the third parties with which we contract to adhere to contractual privacy and
security provisions, and we request specific information from major vendors about their practices in protecting
data privacy.
When processing personal data, we are responsible for ensuring that we comply with applicable data protection
laws. These include the European Union’s General Data Protection Regulation (
GDPR
), the
German
Commercial Code (
HGB
)
, the German Federal Data P
rotection Act (
BDSG
),
the German IT Security Act 2.0 (IT-
SiG 2.0), the German Federal Office for Information Security Act (
BSIG
), and other privacy and data security
laws in the jurisdictions where we operate. In April 2023, we were designated as a part of Germany’s critical
infrastructure (
KRITIS
) under the BSIG, which has resulted in heightened reporting and verification obligations.
We are in the process of implementing a global data privacy framework that sets out the requirements and
standards applicable to processing personal data. The framework is being designed to foster compliance with
the applicable regulations and sets minimum standards for the Company. As part of our global strategy, privacy-
related documents, such as informed consent forms for clinical trials, are being standardized company-wide. The
forms facilitate the user-friendly implementation of the standards we have established and provide transparency
on how and why we process personal data.
losses of personal data such as patient or customer data. Contracts and confidentiality agreements with clinical
trial sites were compliant with relevant regulations. We do not believe that any cybersecurity threats in 2024,
including as a result of any previous cybersecurity incidents, have materially affected or are reasonably likely to
materially affect us, including our business strategy, results of operations, or financial condition. For a discussion
of cybersecurity and data privacy-related risks and uncertainties, see Item 3.D, “Risk Factors,” of this Annual
Report on Form 20-F.
Governance
across entities and locations. Our overarching strategy was developed in 2021 by the Chief Operating Officer, or
COO, and Chief Information Security Officer, or CISO, in alignment with the Data Protection Officer and Head of
Global Security and Protection, and is regularly updated. The ISMS was implemented in 2024.
•
The ISMS a
udit committee (the Committee)
is comprised of three people from the supervisory board and
the CFO. The Committee supports the ISMS and approves related policies and IT security protection
255
Annual Report on Form 20-F for the
year ended December 31, 2024
measures. They are informed about the implementation progress and functioning of the ISMS and
determine the risk appetite as well as our risk strategy. The progress of the ISMS, along with related Key
Performance Indicators, is presented to the Committee on an annual basis. The Committee also informs
the entire Management Board about the outcome of its review.
material risks from cybersecurity threats. His ambit includes reviewing our information security capabilities,
or ISO, in obtaining the resources it needs.
The COO’s extensive experience in risk management, operations
and corporate governance, with over 11 years of experience in the pharmaceutical industry in particular, are
critical to the management of cyber and information security at the Company.
•
The COO is supported by the
CISO, who leads the ISO and is accountable for security strategy,
operations, and policy development and implementation. Our CISO, Raimond Jähn, was the department
lead of our IT security team starting in 2016, has led the cyber and information security transformation
program towards a new operating model since 2021, and was formally designated as CISO by the COO
in 2023. Our Head of Cyber and Information Security, Data Protection Officer, and Head of Global
•
Data privacy matters fall under the purview of our
Chief Legal Officer
,
or CLO, and Management Board
member, James Ryan, who is supported by our Senior Director, Data Privacy. Dr. Ryan’s qualifications
include close to twenty years of expertise in legal and intellectual property matters, both within the
pharmaceutical industry as well as as an outside counsel with a focus on strategic life sciences
transactions. Together with his deep familiarity with the Company’s history, operations, and processes,
James Ryan is uniquely positioned to advise on data privacy matters.
For additional information on Sierk Poetting’s and James Ryan’s experience, see Item 6.A, “Directors and Senior
Management”.
PART III
Item 17. Financial Statements
See Item 18.
Item 18. Financial Statements
The financial statements are filed as part of this Annual Report beginning on page
F-1
.
Item 19. Exhibits
|
Exhibit
Number
|
Description
|
|
|
1.1
|
||
|
2.1
|
||
|
2.2
|
||
|
2.3
|
||
|
2.4*
|
256
Annual Report on Form 20-F for the
year ended December 31, 2024
|
4.1†
|
|
|
|
4.2†
|
||
|
4.3†
|
||
|
4.4†
|
||
|
4.5†
|
|
|
|
4.6†
|
|
|
|
4.7†
|
|
|
|
4.8†
|
|
|
|
4.9†
|
|
|
|
4.10
|
||
|
4.11†
|
|
|
|
4.12†
|
257
Annual Report on Form 20-F for the
year ended December 31, 2024
|
4.13†
|
|
|
|
4.14†
|
||
|
4.15†
|
|
|
|
4.16†
|
|
|
|
4.17†
|
|
|
|
4.18†
|
||
|
4.19†
|
||
|
4.20†
|
||
|
4.21†
|
||
|
4.22†
|
||
|
4.23†
|
||
|
4.24†
|
||
|
4.25†
|
||
|
4.26†
|
||
|
4.27†
|
||
|
4.28†
|
||
|
4.29†
|
258
Annual Report on Form 20-F for the
year ended December 31, 2024
|
4.30†
|
||
|
4.31†
|
||
|
4.32†
|
||
|
4.33†
|
|
|
|
4.34†
|
|
|
|
4.35†
|
|
|
|
4.36†
|
||
|
4.37†
|
||
|
4.38†
|
||
|
4.39†
|
||
|
4.40†
|
||
|
4.41†
|
|
|
|
4.42†
|
||
|
4.43†
|
|
|
|
4.44†
|
|
|
|
4.45†
|
|
|
|
4.46†
|
|
259
Annual Report on Form 20-F for the
year ended December 31, 2024
|
4.47†
|
|
|
|
4.48†
|
||
|
4.49†
|
||
|
4.50†
|
||
|
4.51†
|
||
|
4.52†
|
||
|
4.53†
|
||
|
4.54*†
|
||
|
4.55*†
|
||
|
4.56*†
|
||
|
8*
|
||
|
11.1*†
|
||
|
12.1*
|
||
|
12.2*
|
||
|
13.1*
|
||
|
13.2*
|
||
|
15.1*
|
||
|
97
|
Compensation Clawback Policy
(incorporated herein by reference to Exhibit 97 to the Registrant’s Annual
Report on Form 20-F (File No. 001-39081), filed with the SEC on March 20, 2024)
|
|
|
101.INS
|
XBRL Instance Document
|
|
|
101.SCH
|
XBRL Taxonomy Extension Schema Document
|
|
|
101.CAL
|
XBRL Taxonomy Extension Calculation Linkbase Document
|
|
|
101.DEF
|
XBRL Taxonomy Extension Definition Linkbase Document
|
|
|
101.LAB
|
XBRL Taxonomy Extension Label Linkbase Document
|
|
|
101.PRE
|
XBRL Taxonomy Extension Presentation Linkbase Document
|
*
Filed herewith.
†
Certain information has been excluded from the exhibit because it is both (i) not material and (ii) the type of
information that the Registrant treats as private or confidential.
260
Annual Report on Form 20-F for the
year ended December 31, 2024
SIGNATURES
The Registrant hereby certifies that it meets all of the requirements for filing on Form 20-F and that it has duly
caused and authorized the undersigned to sign this Annual Report on Form 20-F on its behalf.
|
BioNTech SE
|
||||
|
Date: March 10, 2025
|
By:
|
/s/ Prof. Ugur Sahin, M.D.
|
||
|
Prof. Ugur Sahin, M.D.
|
||||
|
Chief Executive Officer
|
||||
|
Date: March 10, 2025
|
By:
|
/s/ Jens Holstein
|
||
|
Jens Holstein
|
||||
|
Chief Financial Officer
|
||||
F-1
Annual Report on Form 20-F for the
year ended December 31, 2024
F-2
Annual Report on Form 20-F for the
year ended December 31, 2024
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING
FIRM
To the Shareholders and Supervisory Board of BioNTech SE.
Opinion on the Financial Statements
We have audited the accompanying consolidated statements of financial position of BioNTech SE (the
Company) as of December 31, 2024 and 2023, the related consolidated statements of profit or loss,
comprehensive income, changes in stockholders’ equity and cash flows for each of the three years in the period
ended December 31, 2024, and the related notes (collectively referred to as the “consolidated financial
statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the
financial position of the Company at December 31, 2024 and 2023, and the results of its operations and its cash
flows for each of the three years in the period ended December 31, 2024, in conformity with International
Financial Reporting Standards (IFRS) as issued by the International Accounting Standard Board.
We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board
(United States) (PCAOB), the Company's internal control over financial reporting as of December 31, 2024,
based on criteria established in Internal Control-Integrated Framework issued by the Committee of Sponsoring
Organizations of the Treadway Commission “(2013 framework),” and our report dated March 10, 2025,
expressed an unqualified opinion thereon.
Basis for Opinion
These financial statements are the responsibility of the Company's management. Our responsibility is to express
an opinion on the Company’s financial statements based on our audits. We are a public accounting firm
registered with the PCAOB and are required to be independent with respect to the Company in accordance with
the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange
Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan
and perform the audit to obtain reasonable assurance about whether the financial statements are free of material
misstatement, whether due to error or fraud. Our audits included performing procedures to assess the risks of
material misstatement of the financial statements, whether due to error or fraud, and performing procedures that
respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts
and disclosures in the financial statements. Our audits also included evaluating the accounting principles used
and significant estimates made by management, as well as evaluating the overall presentation of the financial
statements. We believe that our audits provide a reasonable basis for our opinion.
Critical Audit Matters
The critical audit matters communicated below are matters arising from the current period audit of the financial
statements that were communicated or required to be communicated to the audit committee and that: (1) relate
to accounts or disclosures that are material to the financial statements and (2) involved our especially
challenging, subjective, or complex judgments. The communication of critical audit matters does not alter in any
way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating
the critical audit matters below, providing separate opinions on the critical audit matters or on the accounts or
disclosures to which they relate.
F-3
Annual Report on Form 20-F for the
year ended December 31, 2024
|
Revenue recognition from collaboration partner’s COVID-19 vaccine sales
|
|
|
|
|
|
Description of
the Matter
|
As described in more detail in Note 6 to the consolidated financial statements, the Company
recognizes revenues associated with COVID-19 vaccine sales in a total amount of €2.4
billion. This includes €1.8 billion from the Company’s share of its collaboration partner´s gross
profit.
The Company is contractually eligible to receive a share of the collaboration partner’s gross
profit from vaccine sales in the collaboration partner’s territories. Such gross profit share is
recognized as collaboration revenue. In order to determine the gross profit share, the
Company uses certain information from the collaboration partner, including vaccine sales
outside of the United States and associated production costs, some of which is based on
preliminary data shared by the partner and might differ once final data is available.
Auditing revenue recognition specific to the gross profit share was complex due to the
significant estimation uncertainty in inputs to the calculation. Specifically, the collaboration
partner’s vaccine sales outside of the United States and associated manufacturing and
shipping costs are partially estimated for the last month in the period based on historical
information and could change based on the actual vaccine sales and costs incurred.
|
|
|
|
|
How We
Addressed the
Matter in Our
Audit
|
We obtained an understanding, evaluated the design and tested the operating effectiveness
of the Company’s controls related to revenue recognition from the collaboration partner’s
vaccine sales outside of the United States. For example, we tested controls over
management’s review of the significant assumptions used to determine the gross profit share
the Company is eligible to receive.
Our audit procedures included, among others, reading the contract with the collaboration
partner to understand key terms and obtaining an understanding of management’s
methodology and assumptions used to calculate the gross profit share. We performed a
hindsight analysis to assess management’s accuracy in estimating the collaboration partner’s
vaccine sales outside of the United States and manufacturing and shipping costs. We
obtained a confirmation directly from the collaboration partner regarding vaccine sales and
cost inputs used to estimate the profit share. We performed a sensitivity analysis of the
significant assumptions to evaluate the change in the gross profit share resulting from
changing the assumptions, as well as an analysis of previous estimation compared to the
actual payments obtained to date. We tested the completeness and accuracy of the
Company’s gross profit share calculation. We evaluated the Company’s related disclosures in
the consolidated financial statements.
|
F-4
Annual Report on Form 20-F for the
year ended December 31, 2024
|
Claims and legal contingencies
|
|
|
Description of
the Matter
|
As described in more detail in Note 18 to the consolidated financial statements, the Company
is involved in various claims and litigations specifically related to patent infringements and
product liability matters. The Company, assisted by their internal and external legal counsel,
assesses the need to record a provision or disclose a contingency on a case-by-case basis
considering the underlying facts of each matter. The Company discloses contingent liabilities
in circumstances where a cash outflow is probable, but management is unable to make a
reasonable estimate of the expected financial effect that will result from ultimate resolution of
the proceeding, or a cash outflow is reasonably possible. A provision is recorded when a cash
outflow is deemed probable and reasonably estimable.
Auditing management's determination of whether a cash outflow of such patent or product
liability matters is probable and reasonably estimable, reasonably possible or remote, and the
related disclosures, is highly subjective and requires significant judgement.
|
|
How We
Addressed the
Matter in Our
Audit
|
We obtained an understanding, evaluated the design and tested the operating effectiveness
of the Company’s controls in assessing the completeness, valuation, presentation and
disclosures with respect to such claims and legal proceedings. For example, this included
testing controls related to the Company’s process for identification, recognition, measurement
and disclosure of claims and legal contingencies.
We assessed the fact patterns related to the claims and legal proceedings subject to
evaluation by the Company and assessed their determination of the probability of their
outcomes through review of presentations for board meetings and inspection of responses to
inquiry letters received from both internal and external legal counsels. Further, we held
discussions with internal legal counsel and external legal counsels to confirm our
understanding of the allegations, reviewed legal expenses incurred, evaluated resolutions of
claims already concluded against management’s assessment and obtained written
representations from executives of the Company confirming the completeness and accuracy
of the information provided.
We evaluated the adequacy of the Company’s disclosures in relation to these matters
|
/s/
EY GmbH & Co. KG Wirtschaftsprüfungsgesellschaft
We have served as the Company’s auditor since 2018
March 10, 2025
F-5
Annual Report on Form 20-F for the
year ended December 31, 2024
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING
FIRM
To the Shareholders and Supervisory Board of BioNTech SE.
Opinion on Internal Control Over Financial Reporting
We have audited BioNTech SE’s internal control over financial reporting as of December 31, 2024, based on
criteria established in Internal Control—Integrated Framework issued by the Committee of Sponsoring
Organizations of the Treadway Commission “(2013 framework),” (the COSO criteria). In our opinion, BioNTech
SE (the Company) maintained, in all material respects, effective internal control over financial reporting as of
December 31, 2024, based on the COSO criteria.
We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board
(United States) (PCAOB), the consolidated statements of financial position of the Company as of December 31,
2024 and 2023, the related consolidated statements of profit or loss, comprehensive income, changes in
stockholders’ equity and cash flows for each of the three years in the period ended December 31, 2024, and the
related notes and our report dated March 10, 2025 expressed an unqualified opinion thereon.
Basis for Opinion
The Company’s management is responsible for maintaining effective internal control over financial reporting and
for its assessment of the effectiveness of internal control over financial reporting included in the accompanying
Management’s Annual Report on Internal Control over Financial Reporting. Our responsibility is to express an
opinion on the Company’s internal control over financial reporting based on our audit. We are a public
accounting firm registered with the PCAOB and are required to be independent with respect to the Company in
accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and
Exchange Commission and the PCAOB.
We conducted our audit in accordance with the standards of the PCAOB. Those standards require that we plan
and perform the audit to obtain reasonable assurance about whether effective internal control over financial
reporting was maintained in all material respects.
Our audit included obtaining an understanding of internal control over financial reporting, assessing the risk that
a material weakness exists, testing and evaluating the design and operating effectiveness of internal control
based on the assessed risk, and performing such other procedures as we considered necessary in the
circumstances. We believe that our audit provides a reasonable basis for our opinion.
Definition and Limitations of Internal Control Over Financial Reporting
A company’s internal control over financial reporting is a process designed to provide reasonable assurance
regarding the reliability of financial reporting and the preparation of financial statements for external purposes in
accordance with generally accepted accounting principles. A company’s internal control over financial reporting
includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail,
accurately and fairly reflect the transactions and dispositions of the assets of the company; (2) provide
reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements
in accordance with generally accepted accounting principles, and that receipts and expenditures of the company
are being made only in accordance with authorizations of management and directors of the company; and (3)
provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or
disposition of the company’s assets that could have a material effect on the financial statements.
Because of its inherent limitations, internal control over financial reporting may not prevent or detect
misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that
F-6
Annual Report on Form 20-F for the
year ended December 31, 2024
controls may become inadequate because of changes in conditions, or that the degree of compliance with the
policies or procedures may deteriorate.
/s/
EY GmbH & Co. KG Wirtschaftsprüfungsgesellschaft
Cologne, Germany
March 10, 2025
F-7
Annual Report on Form 20-F for the
year ended December 31, 2024
Consolidated
Statements of
Profit
or Loss
|
Years ended
December 31,
|
||||||||||
|
(in millions €, except per share data)
|
Note
|
2024
|
2023
|
2022
|
||||||
|
Revenues
|
6
|
|
|
|
||||||
|
Cost of sales
|
7.1
|
(
|
(
|
(
|
||||||
|
Research and development expenses
|
7.1
|
(
|
(
|
(
|
||||||
|
Sales and marketing expenses
|
7.1
|
(
|
(
|
(
|
||||||
|
General and administrative expenses
(1)
|
7.1
|
(
|
(
|
(
|
||||||
|
Other operating expenses
(1)
|
7.2
|
(
|
(
|
(
|
||||||
|
Other operating income
|
7.2
|
|
|
|
||||||
|
Operating profit / (loss)
|
(
|
|
|
|||||||
|
Finance income
|
7.3
|
|
|
|
||||||
|
Finance expenses
|
7.3
|
(
|
(
|
(
|
||||||
|
Profit / (Loss) before tax
|
(
|
|
|
|||||||
|
Income taxes
|
8
|
|
(
|
(
|
||||||
|
Net profit / (loss)
|
(
|
|
|
|||||||
|
Earnings / (Loss) per share
|
||||||||||
|
Basic earnings / (loss) per share
|
9
|
(
|
|
|
||||||
|
Diluted earnings / (loss) per share
|
9
|
(
|
|
|
||||||
(1)
Adjustments
to
the year 2022 figures
d
ue to change in functional allocation of general and administrative expenses and
other operating expenses (see Note
7.2
).
The accompanying notes form an integral part of these consolidated financial statements.
F-8
Annual Report on Form 20-F for the
year ended December 31, 2024
Consolidated Statements of Comprehensive Income
|
Years ended
December 31,
|
||||||||||
|
(in millions €)
|
Note
|
2024
|
2023
|
2022
|
||||||
|
Net profit / (loss)
|
(
|
|
|
|||||||
|
Other comprehensive income
|
||||||||||
|
Other comprehensive income that may be reclassified to
profit or loss in subsequent periods, net of tax
|
||||||||||
|
Exchange differences on translation of foreign operations
|
|
(
|
|
|||||||
|
Net other comprehensive income / (loss) that may be
reclassified to profit or loss in subsequent periods
|
|
(
|
|
|||||||
|
Other comprehensive loss that will not be reclassified to
profit or loss in subsequent periods, net of tax
|
||||||||||
|
Net gain / (loss) on equity instruments designated at fair
value through other comprehensive income
|
12
|
(
|
|
|
||||||
|
Remeasurement gain / (loss) on defined benefit plans
|
|
|
|
|||||||
|
Net other comprehensive income / (loss) that will not be
reclassified to profit or loss in subsequent periods
|
(
|
|
|
|||||||
|
Other comprehensive income / (loss), net of tax
|
(
|
(
|
|
|||||||
|
Comprehensive income / (loss), net of tax
|
(
|
|
|
|||||||
The accompanying notes form an integral part of these consolidated financial statements.
F-9
Annual Report on Form 20-F for the
year ended December 31, 2024
Consolidated Statements of
Financial
Position
|
(in millions €)
|
December 31,
|
December 31,
|
||||||
|
Assets
|
Note
|
2024
|
2023
|
|||||
|
Non-current assets
|
||||||||
|
Goodwill
|
10
|
|
|
|||||
|
Other intangible assets
|
10
|
|
|
|||||
|
Property, plant and equipment
|
11
|
|
|
|||||
|
Right-of-use assets
|
20
|
|
|
|||||
|
Contract assets
|
6
|
|
|
|||||
|
Other financial assets
|
12
|
|
|
|||||
|
Other non-financial assets
|
14
|
|
|
|||||
|
Deferred tax assets
|
8
|
|
|
|||||
|
Total non-current assets
|
|
|
||||||
|
Current assets
|
||||||||
|
Inventories
|
13
|
|
|
|||||
|
Trade and other receivables
|
12
|
|
|
|||||
|
Contract assets
|
6
|
|
|
|||||
|
Other financial assets
|
12
|
|
|
|||||
|
Other non-financial assets
|
14
|
|
|
|||||
|
Income tax assets
|
8
|
|
|
|||||
|
Cash and cash equivalents
|
12
|
|
|
|||||
|
Total current assets
|
|
|
||||||
|
Total assets
|
|
|
||||||
|
Equity and liabilities
|
||||||||
|
Equity
|
||||||||
|
Share capital
|
15
|
|
|
|||||
|
Capital reserve
|
|
|
||||||
|
Treasury shares
|
15
|
(
|
(
|
|||||
|
Retained earnings
|
|
|
||||||
|
Other reserves
|
16
|
(
|
(
|
|||||
|
Total equity
|
|
|
||||||
|
Non-current liabilities
|
||||||||
|
Lease liabilities, loans and borrowings
|
12
|
|
|
|||||
|
Other financial liabilities
|
12
|
|
|
|||||
|
Provisions
|
17
|
|
|
|||||
|
Contract liabilities
|
6
|
|
|
|||||
|
Other non-financial liabilities
|
19
|
|
|
|||||
|
Deferred tax liabilities
|
8
|
|
|
|||||
|
Total non-current liabilities
|
|
|
||||||
|
Current liabilities
|
||||||||
|
Lease liabilities, loans and borrowings
|
12
|
|
|
|||||
|
Trade payables and other payables
|
12
|
|
|
|||||
|
Other financial liabilities
|
12
|
|
|
|||||
|
Income tax liabilities
|
8
|
|
|
|||||
|
Provisions
|
17
|
|
|
|||||
|
Contract liabilities
|
6
|
|
|
|||||
|
Other non-financial liabilities
|
19
|
|
|
|||||
|
Total current liabilities
|
|
|
||||||
|
Total liabilities
|
|
|
||||||
|
Total equity and liabilities
|
|
|
The accompanying notes form an integral part of these consolidated financial statements.
F-10
Annual Report on Form 20-F for the
year ended December 31, 2024
Consolidated Statements of Changes in Stockholders’
Equity
|
Equity attributable to equity holders of the parent
|
||||||||||||||||
|
(in millions €)
|
Note
|
Share
capital
|
Capital
reserve
|
Treasury
shares
|
Retained
earnings
|
Other
reserves
|
Total equity
|
|||||||||
|
As of January 1, 2022
|
|
|
(
|
|
|
|
||||||||||
|
Net profit
|
—
|
—
|
—
|
|
—
|
|
||||||||||
|
Other comprehensive income
|
—
|
—
|
—
|
—
|
|
|
||||||||||
|
Total comprehensive income
|
—
|
—
|
—
|
|
|
|
||||||||||
|
Issuance of share capital
|
15
|
|
|
|
—
|
—
|
|
|||||||||
|
Redemption of convertible note
|
|
|
—
|
—
|
—
|
|
||||||||||
|
Share repurchase program
|
16
|
—
|
(
|
(
|
—
|
—
|
(
|
|||||||||
|
Transaction costs
|
16
|
—
|
(
|
—
|
—
|
—
|
(
|
|||||||||
|
Dividends
|
16
|
—
|
—
|
—
|
(
|
—
|
(
|
|||||||||
|
Share-based payments
|
16
|
—
|
|
|
—
|
(
|
(
|
|||||||||
|
Deferred tax assets
|
16
|
—
|
—
|
—
|
—
|
|
|
|||||||||
|
As of December 31, 2022
|
|
|
(
|
|
(
|
|
||||||||||
|
Net profit
|
—
|
—
|
—
|
|
—
|
|
||||||||||
|
Other comprehensive loss
|
—
|
—
|
—
|
—
|
(
|
(
|
||||||||||
|
Total comprehensive income / (loss)
|
—
|
—
|
—
|
|
(
|
|
||||||||||
|
Treasury shares used for acquisition of business
combination
|
—
|
|
|
—
|
—
|
|
||||||||||
|
Share repurchase program
|
—
|
(
|
(
|
—
|
—
|
(
|
||||||||||
|
Share-based payments
|
16
|
—
|
|
|
—
|
(
|
|
|||||||||
|
Current and deferred taxes
|
—
|
—
|
—
|
—
|
(
|
(
|
||||||||||
|
As of December 31, 2023
|
|
|
(
|
|
(
|
|
||||||||||
|
Net loss
|
—
|
—
|
—
|
(
|
—
|
(
|
||||||||||
|
Other comprehensive loss
|
—
|
—
|
—
|
—
|
(
|
(
|
||||||||||
|
Total comprehensive loss
|
—
|
—
|
—
|
(
|
(
|
(
|
||||||||||
|
Share-based payments
|
16
|
—
|
|
|
—
|
(
|
(
|
|||||||||
|
As of December 31, 2024
|
|
|
(
|
|
(
|
|
||||||||||
F-11
Annual Report on Form 20-F for the
year ended December 31, 2024
Consolidated Statements of Cash
Flows
|
Years ended
December 31,
|
||||||||
|
(in millions €)
|
2024
|
2023
|
2022
|
|||||
|
Operating activities
|
||||||||
|
Net profit / (loss)
|
(
|
|
|
|||||
|
Income taxes
|
(
|
|
|
|||||
|
Profit / (Loss) before tax
|
(
|
|
|
|||||
|
Adjustments to reconcile profit before tax to net cash flows:
|
||||||||
|
Depreciation and amortization of property, plant, equipment, intangible assets and
right-of-use assets
|
|
|
|
|||||
|
Share-based payment expenses
|
|
|
|
|||||
|
Net foreign exchange differences
|
(
|
(
|
|
|||||
|
(Gain) / Loss on disposal of property, plant and equipment
|
(
|
|
|
|||||
|
Finance income excluding foreign exchange differences
|
(
|
(
|
(
|
|||||
|
Finance expense excluding foreign exchange differences
|
|
|
|
|||||
|
Government grants
|
(
|
|
|
|||||
|
Unrealized (gain) / loss on derivative instruments at fair value through profit or loss
|
|
|
(
|
|||||
|
Working capital adjustments:
|
||||||||
|
Decrease in trade and other receivables, contract assets and other assets
|
|
|
|
|||||
|
Decrease in inventories
|
|
|
|
|||||
|
Increase in trade payables, other financial liabilities, other liabilities, contract
liabilities, refund liabilities and provisions
|
|
|
|
|||||
|
Interest received and realized gains from cash and cash equivalents
|
|
|
|
|||||
|
Interest paid and realized losses from cash and cash equivalents
|
(
|
(
|
(
|
|||||
|
Income tax paid
|
(
|
(
|
(
|
|||||
|
Share-based payments
|
(
|
(
|
(
|
|||||
|
Government grants received
|
|
|
|
|||||
|
Net cash flows from operating activities
|
|
|
|
|||||
|
Investing activities
|
||||||||
|
Purchase of property, plant and equipment
|
(
|
(
|
(
|
|||||
|
Proceeds from sale of property, plant and equipment
|
|
(
|
|
|||||
|
Purchase of intangible assets and right-of-use assets
|
(
|
(
|
(
|
|||||
|
Acquisition of subsidiaries and businesses, net of cash acquired
|
|
(
|
|
|||||
|
Investment in other financial assets
|
(
|
(
|
(
|
|||||
|
Proceeds from maturity of other financial assets
|
|
|
|
|||||
|
Net cash flows used in investing activities
|
(
|
(
|
(
|
|||||
|
Financing activities
|
||||||||
|
Proceeds from issuance of share capital and treasury shares, net of costs
|
|
|
|
|||||
|
Proceeds from loans and borrowings
|
|
|
|
|||||
|
Repayment of loans and borrowings
|
(
|
(
|
(
|
|||||
|
Payments related to lease liabilities
|
(
|
(
|
(
|
|||||
|
Share repurchase program
|
|
(
|
(
|
|||||
|
Dividends
|
|
|
(
|
|||||
|
Net cash flows used in financing activities
|
(
|
(
|
(
|
|||||
|
Net increase / (decrease) in cash and cash equivalents
|
(
|
(
|
|
|||||
|
Change in cash and cash equivalents resulting from exchange rate differences
|
|
(
|
|
|||||
|
Change in cash and cash equivalents resulting from other valuation effects
|
|
|
(
|
|||||
|
Cash and cash equivalents at the beginning of the period
|
|
|
|
|||||
|
Cash and cash equivalents as of December 31
|
|
|
|
|||||
The accompanying notes form an integral part of these consolidated financial statements.
F-12
Annual Report on Form 20-F for the
year ended December 31, 2024
Notes to the Consolidated Financial Statements
1
Corporate Information
BioNTech SE is a limited company incorporated and domiciled in Germany. American Depositary Shares (ADS)
representing BioNTech SE’s ordinary shares have been publicly traded on the Nasdaq Global Select Market
since October 10, 2019. The registered office is located in Mainz, Germany (An der Goldgrube 12, 55131
Mainz). BioNTech SE is registered in the commercial register B of the Mainz Local Court under the number
HRB 48720. The accompanying consolidated financial statements, which were prepared in accordance with
International Financial Reporting Standards (IFRS), present the financial position and the results of operations of
BioNTech SE and its subsidiaries, hereinafter also referred to as “BioNTech,” the “Group,” “we” or “us.”
Our consolidated financial statements for the
year ended December 31, 2024
, were authorized for issue in
accordance with a
resolution of the Supervisory Board
on
March 7, 2025
.
2
Significant Accounting Policies
2.1
Basis of
Preparation
General
The consolidated financial statemen
ts have been prepared in accordance with the
IFRS Accoun
ting
Standards
as issued by the International Accounting Standards Board (IASB)
.
We prepare and publish our consolidated financial statements in Euros and round numbers to
t
housands
or
millions of Euros
, respectively. Accordingly, numerical figures shown as totals in some tables may not be exact
arithmetic aggregations of the figures that preceded them and figures presented in the explanatory notes may
not add up to the rounded arithmetic aggregations. Rounding applied may differ from rounding published in
Decisions with respect to business operations and resource allocations are made by our Management Board, as
the chief operating decision maker based on BioNTech as a whole. Accordingly, we operate and make decisions
2.2
Basis of Consolidation
The consolidated financial statements comprise the financial statements of BioNTech SE and its controlled
investees (subsidiaries).
The Group controls an investee if, and only if, the Group has
•
power over the investee (i.e., existing rights that give it the current ability to direct the relevant activities
of the investee);
•
exposure, or rights, to variable returns from its involvement with the investee; and
•
the ability to use its power over the investee to affect its returns.
Generally, there is a presumption that a majority of voting rights results in control.
Whether an investee is controlled is re-assessed if facts and circumstances indicate that there are changes to
one or more of the three elements of control. Consolidation of a subsidiary begins when control is obtained over
the subsidiary and ceases when control over the subsidiary is lost.
The profit / (loss) and each component of other comprehensive income / (loss) for the period are attributed to the
equity holders of the parent of the Group and to the non-controlling interests, even if this results in the non-
F-13
Annual Report on Form 20-F for the
year ended December 31, 2024
controlling interests having a deficit balance. When necessary, adjustments are made to the consolidated
financial statements of subsidiaries to bring their accounting policies in line with the Group’s accounting policies.
All intra-group assets and liabilities, equity, income, expenses and cash flows relating to transactions between
members of the Group are eliminated on consolidation.
A change in the ownership interest of a subsidiary, without a loss of control, is accounted for as an equity
transaction.
If control over a subsidiary is lost, the related assets (including goodwill), liabilities, non-controlling interests and
other components of equity are derecognized, while any resultant gain or loss is recognized in the consolidated
statements of profit or loss. Any investment retained is recognized at fair value.
2.3.1
Foreign Currencies
Our consolidated financial statements are presented in Euros, which is also our functional currency. For each
entity, the Group determines the functional currency, and items included in the consolidated financial statements
of such entities are measured using that functional currency. We use the direct method of consolidation and, on
disposal of a foreign operation, the gain or loss that is reclassified to the consolidated statements of profit or loss
reflects the amount that arises from using this method.
Transactions and Balances
Transactions in foreign currencies are initially recorded by the Group’s entities at their respective functional
currency spot rates at the date the transaction first qualifies for recognition.
Monetary assets and liabilities denominated in foreign currencies are translated at the functional currency spot
rates of exchange at the reporting date.
Non-monetary items that are measured in terms of historical cost in a foreign currency are translated using the
exchange rates at the dates of the initial transactions.
In determining the spot exchange rate to use on initial recognition of the related asset, expense or income (or
part of it) on the derecognition of a non-monetary asset or non-monetary liability relating to advance
consideration, the date of the transaction is the date on which the Group initially recognizes the non-monetary
asset or non-monetary liability arising from the advance consideration. If there are multiple payments or receipts
in advance, the Group determines the transaction date for each payment or receipt of advance consideration.
Foreign Currency Translation
Foreign currency translation effects from the translation of
operating
activities include foreign exchange
differences arising on operating items such as trade receivables and trade payables and are either shown as
other operating income or expenses on a cumulative basis. Foreign currency translation effects presented within
finance income and expenses include foreign exchange differences arising on financing items such as loans and
borrowings as well as foreign exchange differences arising on cash and cash equivalents and are either shown
as finance income or expenses on a cumulative basis.
Foreign Currency Translation on Consolidation
Upon consolidation, the assets and liabilities of foreign operations are translated into Euros at the rate of
exchange prevailing at the reporting date and the transactions recorded in their consolidated statements of profit
or loss are translated at exchange rates prevailing at the dates of the transactions.
The exchange differences arising on translation for consolidation are recognized in other comprehensive
income. On disposal of a foreign operation, the component of other comprehensive income relating to that
particular foreign operation is reclassified to profit or loss.
F-14
Annual Report on Form 20-F for the
year ended December 31, 2024
Any goodwill arising on the acquisition of a foreign operation and any fair value adjustments to the carrying
amounts of assets and liabilities arising upon the acquisition are treated as assets and liabilities of the foreign
operation and translated at the spot rate of exchange at the reporting date.
2.3.2
Current versus Non-Current Classifications
Assets and liabilities in the consolidated statements of financial position are presented based on current or non-
current classification.
An asset is current when it is either: (i) expected to be realized or intended to be sold or consumed in the normal
operating cycle, (ii) held primarily for the purpose of trading, (iii) expected to be realized within twelve months
after the reporting period, or (iv) cash or cash equivalents, unless it is restricted from being exchanged or used to
settle a liability for at least twelve months after the reporting period. All other assets are classified as non-current.
A liability is current when it is either: (i) expected to be settled in the normal operating cycle, (ii) held primarily for
the purpose of trading, (iii) due to be settled within twelve months after the reporting period, or (iv) there is no
unconditional right to defer the settlement of the liability for at least twelve months after the reporting period.
The
terms of the liability that could, at the option of the counterparty, result in its settlement by the issue of equity
instruments do not affect its classification. The Group classifies all other liabilities as non-current.
Deferred tax assets and liabilities are classified as non-current assets and liabilities, respectively.
2.3.3
Revenue from Contracts with Customers
Revenue
Identification of the Contract
We generate revenues from collaboration and license agreements, which contain multiple elements, including
licenses to use, research, develop, manufacture and commercialize candidates and products, research and
development services as well as obligations to develop and manufacture preclinical and clinical material and
products. We determined that those collaboration and license agreements qualify as contracts with customers. A
contract is an agreement between two or more parties that establishes enforceable rights and obligations.
Identification of Performance Obligations
Our customer contracts often include bundles of licenses, goods and services. If the granting of a license is
bundled together with delivering of goods and or the rendering of services, it is assessed whether these
agreements are comprised of more than one performance obligation. A performance obligation is only accounted
for as the grant of a license if the grant of a license is the sole or the predominant promise of the performance
obligation.
Determining Transaction Prices
We apply judgment when determining the consideration that is expected to be received. If the consideration in
an agreement includes a variable amount, we estimate the amount of consideration to which we will be entitled
in exchange for transferring the goods to the customer. At contract inception, the variable consideration is
estimated based on the most likely amount of consideration expected from the transaction and constrained until
it is highly probable that a significant revenues reversal in the amount of cumulative revenues recognized will not
occur when the associated uncertainty with respect to the variable consideration is subsequently resolved.
The
estimated revenues are updated at each reporting date to reflect the current facts and circumstances.
Allocation of Transaction Prices
If a contract with a customer contains more than one performance obligation, the transaction price is allocated to
each performance obligation based on
relative standalone selling prices. We have established the following
hierarchy to determine the standalone selling prices.
•
Where standalone selling prices for offered licenses, goods or services are observable and reasonably
consistent across customers, our standalone selling price estimates are derived from our respective
F-15
Annual Report on Form 20-F for the
year ended December 31, 2024
pricing history. However, due to the limited number of customers and the limited company history, this
approach can rarely be used.
•
Where sales prices for an offering are not directly observable or highly variable across customers, we
follow a cost-plus-margin approach.
•
For offerings that have highly variable pricing and lack substantial direct costs to estimate based on a
cost-plus-margin approach, we allocate the transaction price by applying a residual approach.
Judgment is required when estimating standalone selling prices.
Recognition of Revenues
For each separate performance obligation, it is evaluated whether control is transferred either at a point in time
or over time. For performance obligations that are satisfied over time, revenues are recognized based on a
measure of progress, which depicts the performance in transferring control to the customer.
Under the terms of
our licensing arrangements, when we provide the licensee with a research and development license, which
represents a right to access our intellectual property as it exists throughout the license period (as our intellectual
property is still subject to further research)
,
the promise to grant a license is accounted for as a performance
obligation satisfied over time as our customers simultaneously receive and consume the benefits from our
performance
.
Revenues based on the collaboration partners’ gross profit, which is shared under the respective collaboration
agreements, are recognized based on the sales-based or usage-based royalty exemption; i.e
.,
when
the
underlying sales occur, which is when the performance obligation has been satisfied.
As described further in
Note
3
, judgment is applied to
certain aspects when accounting for the collaboration agreements.
Revenue arrangements
that involve two or more partners who contribute to the provision of a specific good or
service to a customer are assessed in terms of principal-agent considerations
in order to determine the
appropriate treatment for the transactions between us and the collaborator and the transactions between us and
other third parties. The classification of transactions under such arrangements is determined based on the
nature and contractual terms of the arrangement along with the nature of the operations of the participants. Any
consideration related to activities in which we are considered the principal, which includes being in control of the
good or service before such good or service is transferred to the customer, is accounted for as gross revenues.
Any consideration related to activities in which we are considered the agent is accounted for as net revenues.
Revenues from the sale of pharmaceutical and medical products (e.g., COVID-19 vaccine sales and other sales
of peptides and retroviral vectors for clinical supply) are recognized when we transfer control of the product to
the customer. Control of the product normally transfers when the customer gains physical possession and we
have not retained any significant risks of ownership or future obligations with respect to the product. In general,
Pfizer Inc., or Pfizer, there is a significant time lag between when revenues are recognized and the payments are
received.
The contractual settlement of the gross profit share has a temporal offset of more than one calendar
quarter. As Pfizer’s financial quarter for subsidiaries outside the United States differs from ours, it creates an
additional time lag between the recognition of revenues and the payment receipt.
For certain contracts, the finished product may temporarily be stored at our location
under a
bill-and-hold
arrangement
.
Revenues from bill-and-hold arrangements are recognized at the point in time when the customer
obtains control of the product and all of the following criteria have been met: (i) the arrangement is substantive;
(ii) the product is identified separately as belonging to the customer; (iii) the product is ready for physical transfer
to the customer; and (iv) we do not have the ability to use the product or direct it to another customer. In
determining when the customer obtains control of the product, we consider certain indicators, including whether
title and significant risks and rewards of ownership have transferred to the customer and whether customer
acceptance has been received.
F-16
Annual Report on Form 20-F for the
year ended December 31, 2024
Contract Balances
Contract Assets
A contract asset is the right to consideration in exchange for goods or services transferred to the customer. If we
transfer goods or services to a customer before the customer pays the respective consideration or before
payment is due, a contract asset is recognized for the earned consideration that is conditional.
Trade Receivables
A receivable represents our right to an amount of consideration that is unconditional (i.e., only the passage of
time is required before payment of the consideration is due).
Contract Liabilities
A contract liability is the obligation to transfer goods or services to a customer for which we have received
consideration (or an amount of consideration is due) from the customer. If a customer pays consideration before
we transfer goods or services to the customer, a contract liability is recognized when the payment is made or
when the payment is due (whichever is earlier). Contract liabilities are recognized as revenue when we fulfill our
performance obligations under the
contract.
2.3.4
Research and Development Expenses
Research and development costs are expensed in the period in which they are incurred.
Regarding internal
projects, we
consider that regulatory approval and other uncertainties inherent in the development of new
products preclude the capitalization of internal development expenses as an intangible asset until marketing
approval from a regulatory authority is obtained.
Payments made to third parties, such as contract research and
development organizations as compensation for subcontracted research and development, that are deemed not
to transfer intellectual property are expensed as internal research and development expenses in the period in
which they are incurred. Such payments are only capitalized
if they meet the criteria for recognition of an
internally generated intangible asset, usually when marketing approval has been received from a regulatory
authority.
We have entered into agreements under which third parties grant licenses to us, which are known as
in-license agreements. If in-licensing results in consideration for the acquisition of intellectual property that meets
the definition of an identifiable asset, this is capitalized as an intangible asset
unless the respective intellectual
property is mainly used as part of our general ongoing research and development activities without any intent to
market the respective product as such
.
If the transaction also includes research and development services to be
provided by the licensor, the share of consideration attributable to these services is recognized in research and
development expenses in line with the performance of the services. Sales-based milestone or royalty payments
incurred under license agreements after the approval date of the respective pharmaceutical product are
recognized as expenses in cost of sales as incurred.
Subsequent internal research and development costs in relation to intellectual property rights are expensed
because the technical feasibility of the internal research and development activity can only be demonstrated by
the receipt of marketing approval for a related product from a regulatory authority in a major market.
Prior to the second quarter of 2023
, we had assessed that inventory produced prior to successful regulatory
approval did not meet the criteria for capitalization as an asset, and accordingly expensed the costs of pre-
launch inventory as research and development costs. Based on the experience of the past years and the
developments since our COVID-19 vaccine was first authorized or approved for emergency or temporary use,
our assessment regarding the potential to produce economic benefits changed.
Beginning
with the second
quarter of 2023,
pre-launch products from the
Comirnaty
product family with their potential for economic benefit
fulfill the recognition criteria for an asset under the IFRS Conceptual Framework.
At each reporting date, the
respective inventory is measured at the lower of cost and net realizable value. However,
because it is
not
probable until regulatory approval is obtained, we consider the net realizable value to be
zero
, as this is the
probable amount expected to be realized from its sale until approval is obtained. The write-down is recognized in
the statements of profit or loss as research and development expenses. If regulatory approval for a product
candidate is obtained, the relevant write-down would be reversed to a maximum of the original cost.
Subsequently, inventory is recognized as cost of sales.
F-17
Annual Report on Form 20-F for the
year ended December 31, 2024
2.3.5
Government Grants
Government grants and similar grants which are accounted for in accordance with IAS 20 are recognized where
there is reasonable assurance that the grant will be received and all attached conditions will be complied with.
When the grant relates to an expense item, it is recognized as other income on a systematic basis over the
periods that the related costs for which the grant is intended to compensate are expensed. When the grant
relates to an asset, it is recognized as deferred income within the consolidated statements of financial position.
Other income is subsequently recognized in our consolidated statements of profit or loss over the useful life of
2.3.6
Taxes
Current Income Tax
Current income tax assets and liabilities are measured at the amount expected to be recovered from or paid to
the taxation authorities. The tax rates and tax laws used to compute the amount are those that are enacted or
substantively enacted at the reporting date in the countries where the Group operates and generates taxable
income.
In addition, current income taxes presented for the period include adjustments for uncertain tax payments or tax
refunds for periods not yet finally assessed
by tax authorities
, excluding interest expenses and penalties on the
underpayment of taxes. In the event that amounts included in the tax return are considered unlikely to be
accepted by the tax authorities (uncertain tax positions), a provision for income taxes is recognized.
Management periodically evaluates positions taken in the tax returns with respect to situations in which
applicable tax regulations are subject to interpretation and establishes provisions where appropriate.
Deferred Tax
Deferred tax is provided using the liability method on temporary differences between the tax bases of assets and
liabilities and their carrying amounts for financial reporting purposes at the reporting date.
Deferred tax liabilities are recognized for all taxable temporary differences, except:
•
when the deferred tax liability arises from the initial recognition of goodwill or an asset or liability in a
transaction that is not a business combination and, at the time of the transaction, affects neither the
accounting profit nor taxable profit or loss; or
•
in respect of taxable temporary differences associated with investments in subsidiaries, when the timing
of the reversal of the temporary differences can be controlled and it is probable that the temporary
differences will not reverse in the foreseeable future.
Deferred tax assets are recognized for all deductible temporary differences, the carry forward of unused tax
credits and any unused tax losses. Deferred tax assets are recognized to the extent that it is probable that
taxable profit will be available against which the deductible temporary differences, the carry forward of unused
tax credits and unused tax losses can be utilized, except:
•
when the deferred tax asset relating to the deductible temporary difference arises from the initial
recognition of an asset or liability in a transaction that is not a business combination and, at the time of
the transaction, affects neither the accounting profit nor taxable profit or loss; or
•
in respect of deductible temporary differences associated with investments in subsidiaries, deferred tax
assets are recognized only to the extent that it is probable that the temporary differences will reverse in
the foreseeable future and taxable profit will be available against which the temporary differences can be
utilized.
F-18
Annual Report on Form 20-F for the
year ended December 31, 2024
Deferred tax assets and liabilities are measured at the tax rates that are expected to apply in the year in which
the asset is realized, or the liability is settled, based on tax rates (and tax laws) that have been enacted or
substantively enacted at the reporting date.
Unrecognized deferred tax assets are re-assessed at each reporting date and are recognized to the extent that it
has become probable that future taxable profits
will allow the deferred tax asset to be recovered
.
Recognition of Taxes
Current and deferred tax items are recognized similarly to the underlying transaction either in profit or loss, other
comprehensive income or directly in equity.
Current tax assets and current tax liabilities are offset if, and only if, we have a legally enforceable right to set off
the recognized amounts and intend either to settle on a net basis, or to realize the asset and settle the liability
simultaneously. Deferred tax assets and deferred tax liabilities are only offset when we have a legally
enforceable right to set off current tax assets and current tax liabilities and the deferred tax assets and deferred
tax liabilities relate to income taxes levied by the same taxation authority on either (i) the same taxable entity or
(ii) different taxable entities, which intend either to settle current tax liabilities and assets on a net basis, or to
realize the assets and settle the liabilities simultaneously, in each future period in which significant amounts of
deferred tax liabilities or assets are expected to be settled or recovered.
Sales Tax
Expenses and assets are recognized net of sales tax, except when the sales tax incurred on a purchase of
assets or services is not recoverable from the taxation authority.
The net amount of sales tax recoverable from, or payable to, the taxation authority is included as part of
receivables or payables in the consolidated statements of financial position.
Global Minimum Taxation
Based on the Organisation for Economic Co-operation and Development (OECD) Base Erosion and Profit
Shifting (BEPS) project to tackle tax avoidance, the OECD/G20 Inclusive Framework (an association of about
140 countries) decided to introduce a global minimum taxation for large multinational groups (known as Pillar 2).
The Global Anti-Base Erosion Rules are intended to ensure that large multinational groups pay a minimum level
of tax on the income arising in each jurisdiction where they operate. In December 2021, the OECD published its
Model Rules, which serve as a draft bill for implementation into national domestic law, followed by guidelines and
commentaries published in March 2022. In December 2022, the EU adopted a corresponding directive (EU
2022/2523) that obliges EU member states to transpose the rules into national domestic law.
If the effective tax
rate in any jurisdiction is below the minimum rate (
15
%
), the Group may be subject to the so-called top-up tax or
a so-called qualified domestic minimum top-up tax.
Several jurisdictions in which the Group operates have transposed the OECD Model Rules into national
domestic law and brought them into force. In addition, the Group is closely following the progress of the
legislative process in each country in which the Group operates. As of the balance sheet date, the BEPS Pillar 2
regulations (
MinBestRL UmsG
) had already been transposed into German law (
MinStG
). The date of application
of the law in Germany is for
financial
years beginning after December 30, 2023. Subsequently, as the OECD
Model Rules have entered into force in Germany,
the Group is obliged to file top-up tax information returns for all
entities which are part of the Group, beginning in financial year 2024.
The Group falls within the scope of these
regulations.
The Group carried out an analysis as of the reporting date to determine the fundamental impact and
the jurisdictions in which the Group is exposed to possible effects in connection with a Pillar 2 top-up tax.
Business combinations are accounted for using the acquisition method. The cost of an acquisition is measured
as the aggregate of the consideration transferred, which is measured at acquisition date fair value, and the
amount of any non-controlling interests in the acquiree.
F-19
Annual Report on Form 20-F for the
year ended December 31, 2024
Goodwill is initially measured at cost as the excess of the aggregate of the consideration transferred and the
amount recognized for non-controlling interests and any previous interest held over the net identifiable assets
acquired and liabilities assumed.
Costs related to executing business combinations are recognized when they are incurred and are classified as
general and administrative
expenses.
After initial recognition, goodwill is tested at least annually or when there is an indication for impairment. See
Note
2.3.10
. For the purpose of impairment testing, goodwill acquired in a business combination is, from the
acquisition date, allocated to each of the cash-generating units that are expected to benefit from the
2.3.8
Intangible Assets
Intangible assets acquired separately are measured on initial recognition at cost. The cost of intangible assets
acquired in a business combination is their fair value at the date of acquisition. Following initial recognition,
intangible assets are carried at cost less any accumulated amortization and accumulated impairment losses.
The portion of the consideration paid by us in
in-licensing agreements
to acquire rights to
i
ntellectual propert
y
is
recognized as an intangible asset, referred to as In-process R&D. If an in-licensing agreement includes research
and development services, the share of consideration attributable to these services is deferred and recognized in
research and development expenses as goods or services are received. Payments depending on the
achievement of specific milestones as part of the purchase of intangible assets, except for intangible assets
acquired in a business combination, are
recognized as subsequent acquisition cost of the intangible asset
and
as a financial liability once the milestone is reached.
The useful lives of intangible assets are assessed as either finite or indefinite.
Intangible assets with finite lives are amortized generally on a straight-line basis over the useful life and
assessed for impairment whenever there is an indication that the intangible asset may be impaired. The
amortization period and the amortization method for an intangible asset with a finite useful life are reviewed at
the end of each reporting period at the least. The amortization expense on intangible assets with finite lives is
recognized in the consolidated statements of profit or loss in the expense category that is consistent with the
function of the intangible assets.
|
Intangible assets
|
Useful life (years)
|
|
|
Intellectual property rights
|
|
|
|
Licenses
|
|
|
|
Software
|
|
Intangible assets with indefinite useful lives are tested for impairment at least annually, or when there is an
indication for impairment, either individually or at the level of a cash-generating unit (see Note
2.3.10
for further
details). In the case of intangible assets not yet available for use, the point in time from which a capitalized asset
can be expected to generate economic benefit for the Group cannot be determined. Such assets are not
amortized, and therefore classified as having an indefinite useful life.
The intangible assets not yet available for
use are tested for impairment annually, or when there is an indication for impairment on an individual basis. The
assessment of indefinite life is reviewed annually to determine whether the indefinite life continues to be
supportable. If not, the change in useful life from indefinite to finite is made on a prospective basis.
We have classified advanced payments on intangible assets as intangible assets that are not yet ready for use.
Advanced payments on intangible assets are tested for impairment on an annual basis
.
F-20
An intangible asset is derecognized upon disposal (i.e., at the date the recipient obtains control) or when no
future economic benefits are expected from its use or disposal. Any gain or loss arising upon derecognition of
the asset (calculated as the difference between the net disposal proceeds and the carrying amount of the asset)
is included in the consolidated statements of profit or loss.
See Note
2.3.4
for further details in connection with our accounting of internally generated intangible assets.
2.3.9
Property, Plant and Equipment
Construction in progress is stated at cost. Property, plant and equipment are stated at cost, net of accumulated
depreciation and accumulated impairment losses, if any. Such cost includes the cost of replacing part of the
property, plant and equipment if the recognition criteria are met. All other repair and maintenance costs are
expensed as incurred.
|
Property, plant and equipment
|
Useful life (years)
|
|
|
Buildings
|
|
|
|
Equipment, tools and installations
|
|
Operating and business equipment
has
a useful life of
1
-
10
years
and is reported under equipment, tools and
installations due to
immateriality
. Leasehold improvements disclosed in buildings have a useful life of the shorter
period of the underlying lease term or the economic useful live (see Note
2.3.16
).
An item of property, plant and equipment initially recognized is derecognized upon disposal (i.e., at the date the
recipient obtains control) or when no future economic benefits are expected from its use or disposal. Any gain or
loss arising on derecognition of the asset (calculated as the difference between the net disposal proceeds and
the carrying amount of the asset) is included in the consolidated statements of profit or loss when the asset is
derecognized.
The residual values, useful lives and methods of depreciation of property, plant and equipment are reviewed at
each financial year-end and adjusted prospectively, if appropriate.
2.3.10
Impairment of Non-Financial Assets
At each reporting date, we assess whether there is an indication that a non-financial asset may be impaired.
Goodwill is tested for impairment at least annually. Impairment is determined for goodwill by assessing the
recoverable amount of each cash-generating unit (or group of CGUs) to which the goodwill relates. If any
indication exists, or when annual impairment testing is performed, we estimate the asset’s or CGU’s recoverable
amount. The recoverable amount is the higher of an asset’s or CGU’s fair value less costs of disposal and its
value in use. The recoverable amount is determined for an individual asset, unless the asset does not generate
cash inflows that are largely independent of those from other assets or groups of assets. If the asset does not
generate independent cash inflows, the impairment test is performed for the smallest group of assets that
generate largely independent cash inflows from other assets (CGU). When the carrying amount of an asset or
cash-generating unit exceeds its recoverable amount, the asset or the non-current assets of the CGU are
considered impaired and written down to their recoverable amount.
Impairment losses are recognized in the consolidated statements of profit or loss in expense categories
consistent with the function of the impaired asset.
Intangible assets with an indefinite useful life are tested for impairment annually at the CGU level, as
appropriate, and when circumstances indicate that the carrying value may be impaired.
Intangible assets not yet available for use are not amortized, but rather tested for impairment when a triggering
event arises or at least once a year
.
The identification of triggering events takes place on a quarterly or on an ad
F-21
Annual Report on Form 20-F for the
year ended December 31, 2024
hoc basis with the involvement of the responsible departments, taking internal and external information sources
into consideration.
The impairment test is performed annually or if there are indications of impairment by
determining the asset’s value in use.
In assessing value in use, the estimated discounted future cash flows are
based on long-term forecast calculations reflecting the asset’s estimated product life cycles. The assumptions
are based on internal estimates along with external market studies. The result of the valuation depends to a
large extent on the estimates by the management of the future cash flows of the assets and the discount rate
applied, and is therefore subject to uncertainty.
Any expense resulting from an impairment of intangible assets
with finite lives is recognized in the consolidated statements of profit or loss in the expense category that is
2.3.11
Financial Instruments
A financial instrument is any contract that gives rise to a financial asset of one entity and a financial liability or
equity instrument of another entity.
i) Financial Assets
Initial Recognition and Measurement
Financial assets are initially measured at fair value
as of the trade date
and – depending on their classification –
subsequently measured at amortized cost, fair value through other comprehensive income (OCI) or fair value
through profit or loss.
Subsequent Measurement
The measurement of financial assets depends on their classification, as described below.
Financial Assets Measured at Amortized Cost
Financial assets measured at amortized cost include trade receivables and other financial assets that are
generally measured using the effective interest rate (EIR) method. With respect to trade receivables, we applied
the practical expedient, which means that they are measured at the transaction price determined in accordance
with IFRS 15. Refer to the accounting policies in Note
2.3.3
. Other financial assets measured at amortized cost
are held to collect contractual cash flows, which are solely payments of principal and interest. Gains and losses
are recognized in our consolidated statements of profit or loss when the financial asset is derecognized, modified
or impaired.
Financial Assets Designated at Fair Value through OCI (Equity Instruments)
Upon initial recognition, we can irrevocably elect to classify equity investments as equity instruments designated
at fair value through OCI if they meet the definition of equity under IAS 32 and are not held for trading. The
classification is determined on an instrument-by-instrument basis. Gains and losses on these financial assets are
never recycled to profit o
r loss.
Dividends are recognized as other income in the consolidated statements of
profit or loss when the right of payment has been established. I
f dividends clearly represent a recovery of part of
the cost of the investment they are recognized in the OCI
.
Equity instru
ments designated at fair value through
OCI are not subject to impairment assessment. We elected to irrevocably classify our non-listed and listed equity
investments under this category. They are recognized using trade date accounting.
Financial Assets at Fair Value through Profit or Loss
When we acquire contractual rights to cash flows from the sale of patent-protected biopharmaceutical products
by unrelated biopharmaceutical companies as royalty assets and do not own the intellectual property or have the
right to commercialize the underlying products, royalty assets are recognized as financial assets measured at
fair value through profit and loss. We recognize day one gains and losses only when the fair value is evidenced
by a quoted price in an active market for the same instrument or is based on a valuation technique that only uses
data from observable markets. In all other cases, we defer the difference between the fair value at initial
recognition and the transaction price. After initial recognition, we recognize that deferred difference as a gain or
loss only to the extent that it arises from a change in a factor that market participants would take into account
when pricing the asset or liability.
F-22
Annual Report on Form 20-F for the
year ended December 31, 2024
Derivatives not designated as hedging instruments are measured at fair value through profit or loss. A financial
asset exists if the
derivative
has a positive fair value.
Derecognition
A financial asset (or, where applicable, a part of a financial asset or part of a group of similar financial assets) is
primarily derecognized (i.e., removed from the consolidated statements of financial position) when the rights to
receive cash flows from the asset have expired or have been transferred in terms of fulfilling the derecognition
criteria.
Impairment of Financial Assets
An allowance for expected credit losses (ECLs) is considered for all non-derivative financial debt investments,
including cash
,
time deposits and debt securities of the Group. ECLs are based on the difference between the
contractual cash flows due in accordance with the contract and all of the cash flows that the Group expects to
receive, discounted at an approximation of the original effective interest rate. The expected cash flows will
include cash flows from the sale of collateral held or other credit enhancements that are integral to the
contractual terms.
Since our financial debt investments are considered to be investments with low risk,
the expected credit loss in
the upcoming twelve months is used to determine the impairment loss. Wherever a considerable increase in the
default risk is assumed, the lifetime expected credit loss of the financial asset is considered.
For trade receivables and contract assets the Group applies a simplified approach in calculating ECLs. This
means that the Group does not track changes in credit risk, but instead recognizes a loss allowance based on
lifetime ECLs at each reporting date. We have established
an
ECL model that is
based on the probability of
default (PD),
considers
the respective country default probabilities
and takes the maturities into account. In order
to determine the PD of companies, we use the maturities of the trade receivables and the score of the
companies.
If there is objective evidence that certain
trade receivable
s or contract assets are fully or partially impaired,
additional loss allowances are recognized to account for expected credit losses. A debtor’s creditworthiness is
assumed to be impaired if there are objective indications that the debtor is in financial difficulties, such as the
disappearance of an active market for its products or impending insolvency.
ii)
Financial Liabilities
Financial liabilities are generally measured at amortized cost using the
effective interest
rate (EIR) method.
Derivatives with negative fair values not designated as hedging instruments and liabilities for contingent
consideration in business combinations are measured at fair value.
All financial liabilities are recognized initially at fair value and, in the case of loans and borrowings and payables,
net of directly attributable transaction costs.
Financial liabilities measured at amortized cost include loans and borrowings, trade payables and other financial
liabilities. They are measured at amortized cost using the EIR method. Gains and losses are recognized in the
consolidated statements of profit or loss when the liabilities are derecognized as well as through the EIR
amortization process.
Amortized cost is calculated by taking into account any discount or premium on acquisition and fees or costs that
are an integral part of the EIR. The EIR amortization is included as finance costs in the consolidated statements
of profit or loss.
Derecognition
A financial liability is derecognized when the obligation under the liability is discharged or cancelled or expires.
When an existing financial liability is replaced by another from the same lender on substantially different terms,
or the terms of an existing liability are substantially modified, such an exchange or modification is treated as the
F-23
Annual Report on Form 20-F for the
year ended December 31, 2024
derecognition of the original liability and the recognition of a new liability. The difference in the respective
carrying amounts is recognized in the consolidated statements of profit or loss.
iii) Expenses and Income from Exchange Forward Contracts
Effects from foreign exchange forward contracts, which are measured at fair value through profit or loss, are
shown as either other operating income or other operating expenses on a cumulative basis and might switch
between those two items during the year-to-date reporting periods.
Fair value is a market-based measurement. For some assets and liabilities, observable market transactions or
market information is available. For other assets and liabilities, observable market transactions or market
information might not be available. When a price for an identical asset or liability is not observable, another
valuation technique is used. To increase consistency and comparability in fair value measurements, there are
three levels of the fair value hierarchy:
•
Level 1 contains the use of quoted prices in active markets for identical assets or liabilities.
•
Level 2 inputs are inputs other than quoted prices included within Level 1 that are observable for the
asset or liability either directly or indirectly.
•
Level 3 inputs are unobservable.
Within this hierarchy, estimated values are made by management based on reasonable assumptions, including
other fair value methods.
For assets and liabilities that are recognized in the financial statements at fair value on a recurring basis, we
determine whether transfers have occurred between levels in the fair value hierarchy by re-assessing
categorization (based on the lowest level input that is significant to the fair value measurement as a whole) at the
end of each reporting period.
For the purpose of fair value disclosures, classes of assets and liabilities have been determined on the basis of
the nature, characteristics and risks of the asset or liability and the level of the fair value hierarchy, as explained
above.
Inventories are valued at the lower of cost and net realizable value.
Costs incurred in bringing each product to its present location and condition are accounted for as follows:
•
raw materials and supplies: purchase cost on a
first-in / first-out basis
; or
•
unfinished goods and finished goods: cost of direct materials and labor, including both internal
manufacturing and third-party contract manufacturing organizations, or CMOs, and a proportion of
manufacturing overheads based on the normal operating capacity, but excluding borrowing costs.
Net realizable value is the estimated selling price in the ordinary course of business less estimated costs of
completion and the estimated costs necessary to make the sale.
Write-offs are recorded if i
nventories are
expected to
be unsaleable
, do not fulfill the specification defined by our quality standards or if their shelf-life has
expired.
For our inventories subject to
the collaboration partners’ gross profit share mechanism, we consider
the
contractual compensation payments in the estimate of the net realizable value.
Beginning with the second quarter of 2023, pre-launch products from the
Comirnaty
product family with their
potential for economic benefit fulfill the recognition criteria for an asset under the IFRS Conceptual Framework.
At each reporting date, the respective inventory is measured at the lower of cost and net realizable value.
F-24
Annual Report on Form 20-F for the
year ended December 31, 2024
However, because
is
not probable until regulatory approval is obtained, we consider the net realizable value to
2.3.14
Cash and Cash Equivalents
Cash and cash equivalents comprise cash at banks and on hand and short-term investments that we consider to
be highly liquid
(including deposits, money market funds and reverse repos)
with an original maturity of three
months or less that are readily convertible to a known amount of cash and subject to an insignificant risk of
changes in value. Deposits with an original maturity of more than three months are recognized as other financial
We apply the par value method to our repurchases of outstanding American Depositary Shares, or ADSs.
Accordingly,
t
he nominal value of acquired treasury shares is deducted from equity and shown in the separate
item “Treasury shares”. Any premium paid in excess of the nominal value of a repurchased ADS is deducted
from
the capital reserve
. On the trade date, we recognize a liability, and on the settlement date, we settle in cash.
We recognize the foreign exchange differences that may occur between the trade and settlement date as profit
or loss.
2.3.16
Leases
At the inception of a contract, we assess whether the contract is, or contains, a lease. A contract is, or contains,
a lease if the contract conveys the right to control the use of an identified asset for a period of time in exchange
for consideration.
At inception or on reassessment of a contract that contains a lease component, the consideration in the contract
is allocated to each lease component on the basis of their relative standalone prices. However, for leases of land
and buildings in which we are a lessee, we have elected not to separate non-lease components, and instead
account for the lease and non-lease components as a single lease component.
We reco
gnize a right-of-use asset and a lease liability at the lease commencement date.
The right-of-use asset is initially measured at cost.
the assets or shorter lease term, as follows:
|
Right-of-use assets
|
Useful life or shorter
lease term (years)
|
|
|
Buildings
|
|
|
|
Equipment, tools and installations
|
|
|
|
Production facilities
|
|
|
|
Automobiles
|
|
The lease liability is initially measured at the present value of the lease payments that are not paid at the
commencement date, discounted using the incremental borrowing interest rate implicit in the lease or, if that rate
cannot be readily determined, the Group’s incremental borrowing rate. Generally, the incremental borrowing rate
is used as the discount rate.
The lease liability is subsequently measured at amortized cost using the EIR
method
. It is remeasured when
there is a change in future lease payments arising from a change in an index or rate, if there is a change in the
estimate of the amount expected to be payable under a residual value guarantee, or if we change our
assessment of whether we will exercise a purchase, extension or termination option. When the lease liability is
remeasured, a corresponding adjustment is made to the carrying amount of the right-of-use asset or is recorded
F-25
Annual Report on Form 20-F for the
year ended December 31, 2024
in the consolidated statements of profit or loss if the carrying amount of the right-of-use asset has been reduced
to zero.
Right-of-use assets are presented separately and lease liabilities are presented under “Financial liabilities” in the
consolidated statements of financial position.
Short-Term Leases and Leases of Low-Value Assets
We have elected not to recognize right-of-use assets and lease liabilities for short-term leases of machinery that
have a lease term of 12 months or less or leases of low-value assets. We recognize the lease payments
associated with these leases as an expense in the consolidated statements of profit or loss on a straight-line
basis over the lease term.
2.3.17
Provisions
Provisions are recognized when there is a present obligation (legal or constructive) as a result of a past event, it
is probable that an outflow of resources embodying economic benefits will be required to settle the obligation
and a reliable estimate can be made of the amount of the
obligation
. When we expect some or all of a provision
to be reimbursed, for example, under an insurance contract, the reimbursement is recognized as a separate
asset, but only when the reimbursement is virtually certain.
A provision is also recognized for certain contracts with suppliers for which the unavoidable costs of meeting the
obligations exceed the economic benefits expected to be received. The economic benefits considered in the
assessment comprise the future benefits we are directly entitled to under the contract as well as the anticipated
future benefits that are the economic consequence of the contract if these benefits can be reliably determined.
T
he expense relating to a provision is presented in the consolidated statements of profit or loss net of
any
Employees (and others providing similar services) receive remuneration in the form of share-based payments,
which are settled in equity instruments (equity-settled transactions) or in cash (cash-settled transactions).
In accordance with IFRS 2, share-based payments are generally divided into cash-settled and equity-settled.
Both types of payment transactions are measured
initially
at their fair value as of the grant date. The fair value is
determined using an appropriate valuation model, further details of which are given in Note
16
. Rights granted
under cash-settled transactions are remeasured at fair value at the end of each reporting period until the
settlement date. The cost of share-based payment awards is recognized over the relevant service period,
applying either the straight-line method or the graded vesting method, where applicable.
These costs are recognized in cost of sales, research and development expenses, sales and marketing
expenses or general and administrative expenses, together with a corresponding increase in equity (other
reserves) or other liabilities, over the period in which the service is provided (the vesting period). The cumulative
expense recognized for cash- and equity-settled transactions at each reporting date until the vesting date
reflects the extent to which the vesting period has expired, and also reflects the best estimate of the number of
equity instruments expected to ultimately vest.
Service and non-market performance conditions are not taken into account when determining the grant date fair
value of awards, but the likelihood of the conditions being met is assessed as part of our best estimate of the
number of equity instruments that will ultimately vest. Market performance conditions are reflected within the
grant date fair value. Any other conditions attached to an award, but without an associated service requirement,
are considered to be non-vesting conditions. Non-vesting conditions are reflected in the fair value of an award
and lead to an immediate expensing of an award unless there are also service and/or performance conditions.
If we have a choice of settling either in cash or by providing equity instruments, the rights granted are accounted
for as an equity-settled transaction, unless there is a present obligation to settle in cash.
F-26
Annual Report on Form 20-F for the
year ended December 31, 2024
If, due to local tax regulations, an amount is withheld for the employee’s tax obligations and paid directly to the
tax authorities in cash on the employee’s behalf, the entire
share-
based payment program remains an equity-
settled plan based on the IFRS 2 classification. Accordingly, t
he amount withheld for the employee’s tax
obligations expected to be paid directly to the tax authorities is reclassified from “Other reserves” to “Other non-
financial liabilities”.
2.3.19
Cash Dividend
We recognize a liability to pay a dividend when the distribution is authorized. As per the corporate laws of
Germany, a distribution is authorized when it is approved by the general shareholder meeting. A corresponding
amount is recognized directly in equity.
2.4
Standards Applied for the First Time
d
id
n
ot have a material impact
on our consolidated financial
statements:
|
Standards / Interpretations
|
Date of application
|
|
|
Amendments to IFRS 16 Leases: Lease Liability in a Sale and Leaseback
|
January 1, 2024
|
|
|
Amendments to IAS 7 Statement of Cash Flows and IFRS 7 Financial Instruments: Disclosures:
Supplier Finance Arrangements
|
January 1, 2024
|
|
|
Amendments to IAS 1 Presentation of Financial Statements: Classification of Liabilities as Current
or Non-Current
|
January 1, 2024
|
|
|
Amendments to IAS 1 Presentation of Financial Statements: Non-current Liabilities with Covenants
|
January 1, 2024
|
2.5
Standards Issued but Not Yet Effective
of the financial statements and that might have an impact on our financial statements are disclosed below. We
have not adopted any standards early and intend to adopt these new and amended standards and
interpretations, if applicable, when they become
effective
.
|
Standards / Interpretations
|
Date of application
|
||
|
Amendments to IAS 21 The Effects of Changes in Foreign Exchange Rates: Lack of Exchangeability
|
January 1, 2025
|
||
|
Amendments to the Classification and Measurement of Financial Instruments:
– Amendments to IFRS 9 and IFRS 7
|
January 1, 2026
|
||
|
Annual Improvements Volume 11
|
January 1, 2026
|
||
|
Contracts Referencing Nature-dependent Electricity – Amendments to IFRS 9 and IFRS 7
|
January 1, 2026
|
||
|
IFRS 18 Presentation and Disclosure in Financial Statements
|
January 1, 2027
|
||
|
IFRS 19 Subsidiaries without Public Accountability: Disclosures
|
January 1, 2027
|
||
An analysis of the effects of IFRS 18 on us with regard to the presentation and disclosures in the financial
statements has
been started and is ongoing.
IFRS 18 requires additional defined subtotals (operating, investing,
financing) in the statement of profit and loss and disclosures about management performance measures, and
adds new principles for aggregating and disaggregating information. With regard to the first-time application of
the other standards and interpretations listed in the table and other standards amended in the annual
improvements, it is currently estimated that there will be no material impact on our consolidated financial
statements.
3
Sig
nificant Accounting
Judgements
,
Estimates and
Assumptions
The preparation of the consolidated financial statements requires management to make judgments, estimates
and assumptions that affect the reported amounts of revenues, expenses, assets and liabilities, the
F-27
Annual Report on Form 20-F for the
year ended December 31, 2024
accompanying disclosures and the disclosure of contingent liabilities. Uncertainty about these assumptions and
estimates could result in outcomes that require a material adjustment to the carrying amount of assets or
liabilities affected in future periods.
Significant accounting judgments,
as
well as k
ey assumptions concerning the future and other key sources of
estimation uncertainty at
the reporting date that have a significant risk of causing a material adjustment to the
carrying amounts of assets and liabilities within the next financial year, are described below.
We based our
assumptions and estimates on parameters available when the consolidated financial statements were prepared.
Existing circumstances and assumptions about future developments, however, may change due to market
changes or circumstances arising that are beyond the control of the Group. Such changes are reflected in the
assumptions when they occur.
Revenues from Contracts with Customers
We applied the following judgments, estimates and assumptions that significantly affect the determination of the
amount and timing of revenues from contracts with
customers
:
Identification and Determination of Performance Obligations
We generate revenues from collaboration and license agreements, which contain multiple elements, including
licenses to use, research, develop, manufacture and commercialize candidates and products, research and
development services as well as obligations to develop and manufacture preclinical and clinical material and
products.
We determined that those collaboration and license agreements qualify as contracts with customers.
A
contract is an agreement between two or more parties that establishes enforceable rights and obligations.
At
inception of each agreement, we apply judgment when determining which promises represent distinct
performance obligations. If promises are not distinct, they are combined until the bundle of promised goods and
services is distinct.
For some agreement
s, this results in accounting for goods and services promised in a
collaboration and license agreement as a single performance obligation with a single measure of progress. For
these combined performance obligations, we assess which of these promises is the predominant promise to
determine the nature of the performance obligation.
When licenses are granted, we determined that the grant of
the license is the predominant promise within the combined performance obligations.
In our view, we grant our
customers a right to access or a right to use our intellectual property due to the collaboration and license
agreements.
Measurement of the Transaction Price
Our collaboration and license agreements often include variable
considerati
on
, which is contingent on the
occurrence or non-occurrence of a future event (i.e., reaching a certain milestone). When determining deferred
revenues from a collaboration and license agreement, we need to estimate the amount of consideration to which
we will be entitled in exchange for transferring the promised goods or services to our customers.
As there are usually only two possible outcomes (i.e., milestone is reached or not), we have assessed that the
method of the most likely amount is the best method to predict the amount of consideration to which we will be
entitled. At contract inception, the most likely amount for milestone payments is estimated to be
zero
.
We have
assessed that the likelihood of achieving the respective milestone decreases depending on how far the expected
date of achieving the milestone lies in the future. At each reporting date, we use judgment to determine when to
include variable consideration in the transaction price in such a way that it is highly probable that a significant
revenue reversal in the amount of cumulative revenue recognized will not occur when the associated uncertainty
with respect to the variable consideration is subsequently resolved. We have concluded that future milestone
payments are fully constrained at the end of the current financial year.
Future milestone payments would become unconstrained upon the satisfaction of the milestone event,
specifically a development event, regulatory approval or achievement of a sales milestone.
F-28
Annual Report on Form 20-F for the
year ended December 31, 2024
Allocation of the Transaction Price to Performance Obligations and Revenue Recognition as Performance
Obligations are Satisfied
We allocate the transaction price to performance obligations based on their relative standalone selling prices,
which are generally based on our best estimates and interpretations of facts and circumstances of each
contractual agreement and may require significant judgment to determine appropriate allocation.
Upfront payments and reimbursement for expenses are initially deferred on our consolidated statements of
financial position. We assessed that no significant financing component exists within our collaboration
agreements since the overall business purpose of advanced payments is to support the payment structure rather
than to provide a significant benefit of financing. For performance obligations in which the costs vary based on
progress, an input-based measure that takes into account cost incurred is the most reliable indicator of the
progress of the related research activities. In other cases, revenue recognition on a straight-line basis may be
the most reliable indicator of our performance toward complete satisfaction. If the contractual activities progress,
the achievement of development milestones will be used to measure the progress toward complete satisfaction.
We evaluate the measure of progress in each reporting period and, if necessary, adjust the measure of
performance and related revenue recognition. Any such adjustments are recorded on a cumulative catch-up
basis, which would affect revenues and net profit or loss in the period of adjustment.
Upon successfully commercializing a pharmaceutical product, the collaboration and license agreements also
provide for additional profit-sharing or tiered royalties earned when customers recognize net sales of licensed
products as well as sales milestone payments. Revenue is recognized based on the sales-based or usage-
based royalty exemption; i.e., when, or as, the underlying sales occur, which is when the performance obligation
has been satisfied.
Principal-Agent Considerations
Collaboration agreements
that involve two or more partners who contribute to the provision of a specific good or
service to a customer are assessed in terms of principal-agent considerations
. Under our current collaboration
agreements, the allocation of marketing and distribution rights defines territories in which the collaboration
partner acts as a principal in each case. We recognize revenue net based on the collaboration partners’ gross
profit in territories where the partner is responsible for supply, and on a gross basis when directly supplying our
customers in our territories when control has been transferred. Amounts paid to collaboration partners for their
share of our profits earned where we are the principal in the transaction are recorded as cost of sales.
Pfizer Agreement Characteristics
With respect to our collaboration with Pfizer, commercial revenues are recognized based on our collaboration
partner’s
gross profit from COVID-19 vaccine sales, which is shared under the respective collaboration
agreement. In determining commercial revenues pursuant to this collaboration agreement, we are reliant on our
collaboration partner for details regarding its gross profit for the period at hand. Some of the information which
our collaboration partner provides us with to identify the gross profit is, by necessity, preliminary and subject to
change.
Pfizer’s gross profit share is calculated based on sales and takes into account transfer prices. The latter include
manufacturing and shipping costs, which represent standard prices and include mark-ups on manufacturing
costs as specified by the terms of the agreement. Manufacturing and shipping cost variances were considered
as far as those have
been identified
. Nevertheless, those input parameters may be adjusted once actual costs
are determined. The sales as reported by Pfizer
have been
used to estimate license obligations in terms of
royalties and sales milestones. Sales milestones and royalties are recognized as they are earned by the
partners. Sales milestones are shared equally, while royalty payments are borne by the partners on the basis of
revenues in the territories for which the partners are responsible and
subsequently deducted as cost under the
gross profit shared.
The estimated royalty fees applied to net sales reflect the license obligations to the extent
currently identified from third-party contractual arrangements. Changes in estimates are accounted for
prospectively, when determined.
F-29
Annual Report on Form 20-F for the
year ended December 31, 2024
Manufacturing cost variances include among others
expenses from unused contract manufacturing capacities
and
overstock inventories finally scrapped.
As only
materialized
costs – which for example means manufacturing
capacities finally lapsed or inventories finally scrapped – are shared with the partner in a cash-effective manner,
the gross profit share impact is anticipated once assessed as being
highly probable
to occur
.
Any changes to this
assessment will be recognized prospectively.
Pfizer’s determination of manufacturing and shipping costs also affects the transfer prices that have been
charged to COVID-19 vaccine supplies that it manufactures and supplies to us and may be subject to adjustment
whenever manufacturing and shipping cost variances are identified. Likewise, our own cost of sales and the
respective gross profit share owed to our partner may be adjusted prospectively, when changes are determined.
For contract balances related to the Pfizer
agreement
,
see
Note
6
.
Judgment is required in determining whether
a right to consideration is unconditional and thus qualifies as a receivable.
Intangible Assets
Significant assumptions and estimates are required for the identification of a potential need to recognize an
impairment loss. These estimates include management’s assumptions regarding future cash flow projections and
economic risks that require significant judgment and assumptions about future developments. T
hey can be
affected by a variety of factors, including, but not limited to, changes in business strategy, assumptions regarding
funding ability of expected R&D expenses, assumptions regarding the size of addressable markets and number
of addressable indications as well as the time and probability to reach market.
Changes to the assumptions underlying our assessment of the impairment of goodwill and intangible assets
could require material adjustments to the carrying amount of our recognized goodwill and intangible assets, as
well as to the amounts of impairment charges recognized in profit or loss.
Significant assumptions and estimates are also required to determine the appropriate amount of amortization of
intangible assets. They relate in particular to the determination of the underlying useful life. The useful life of an
intangible asset is based on our estimates regarding the period over which the intangible asset is expected to
generate economic benefits for us.
Contingencies
Disclosures in respect of third-party claims and litigation for which no provisions have been recognized
disclosures are made in the form of contingent liabilities
, unless a potential outflow of resources is considered
remote.
It is not practicable to estimate the financial impact of our contingent liabilities
due to the uncertainties
around lawsuits and claims as outlined above.
For further disclosures relating to contingencies see Note
18
.
Research and Development Expenses
The nature of our business and primary focus of our activities, including development of our platforms and
manufacturing technologies, generate a significant amount of research and development expenses.
Research
costs are expensed as incurred. Development expenditures on an individual project are recognized as an
intangible asset if, and only if, the capitalization criteria are met. Based on our assessment, we have concluded
that, d
ue to the inherent risk of failure in pharmaceutical development and the uncertainty of approval, these
criteria are usually not met before regulatory approval is achieved
. The related expenditure is reflected in the
consolidated statements of profit or loss in the period in which the expenditure is incurred. We have entered into
agreements under which third parties grant licenses to us, which are known as in-license agreements. If in-
licensing results in consideration for the acquisition of intellectual property that meets the definition of an
identifiable asset,
this is capitalized as an intangible asset.
If the transaction also includes research and
development services to be provided by the licensor, the share of consideration attributable to these services is
recognized in research and development expenses in line with the performance of the services.
The allocation of
consideration attributable to the acquisition of intellectual property and consideration attributable to the research
and development services provided by the licensor requires management to make judgements and assumptions
.
F-30
Annual Report on Form 20-F for the
year ended December 31, 2024
These judgments and assumptions need to be applied on a case-by-case basis and can materially affect our
research and development expenses.
Business Combinations
In our accounting for business combinations, judgment is required in determining whether an intangible asset is
identifiable and whether it should be recorded separately from goodwill. Additionally, estimating the acquisition-
date fair values in conjunction with purchase price allocation involves estimation uncertainty and discretionary
decisions. The necessary measurements are based on information available on the acquisition date and on
expectations and assumptions that have been deemed reasonable by management. These judgments,
estimates and assumptions can materially affect our financial position and profit.
Share-Based Payments
Determining the fair value of share-based
payment
transactions requires the most appropriate valuation for the
specific program, which depends on the underlying terms and conditions. We used valuation models such as a
binomial or Monte Carlo simulation model for the measurement of the cash- and equity-settled transactions’ fair
value, taking into account certain assumptions relating to a number of factors, including the volatility of the stock
price, the determination of an appropriate risk-free interest rate, expected dividends and the probability of
reaching a minimum hurdle to exercise the relevant options. For awards which were granted prior to the initial
public offering, at a time where no quoted market prices existed, the valuation model assumptions included the
option’s underlying share price. For awards which were granted after the initial public offering, the grant date’s
share prices on the Nasdaq Global Select Market were included in the valuation.
A fluctuation assumption is applied when estimating the number of equity instruments for which service
conditions are expected to be satisfied and will be revised if material differences arise. Ultimately, a true-up to
the number satisfied by the settlement date will be recorded.
For further disclosures relating to share-based payments, see Note
16
.
Income Taxes
We are subject to income taxes in more than one tax jurisdiction. Due to the increasing complexity of tax laws
and the corresponding uncertainty regarding the legal interpretation by the fiscal authorities, tax calculations are
generally subject to an elevated amount of uncertainty. To the extent necessary, possible tax risks are taken into
account in the form of provisions.
We do not recognize or we would
i
mpair
deferred tax assets if it is unlikely that a corresponding amount of future
taxable profit will be available against which the deductible temporary differences, tax loss carry forwards and
tax credits can be utilized. The assessment whether a deferred tax asset can be recognized or is impaired
requires significant judgment, as we need to estimate future taxable profits to determine whether the utilization of
the deferred tax asset is probable. In evaluating our ability to utilize our deferred tax assets, we consider all
available positive and negative evidence, including the level of historical taxable income and projections for
future taxable income over the periods in which the deferred tax assets are recoverable. Based on the
requirements in IAS 12, to not place reliance on future events that are uncertain as they for example cannot be
controlled,
managements a
ssessment takes particular into account the fact that there is an inherent risk of failure
in pharmaceutical development and an uncertainty of approval which is dependent on external regulatory
agencies’ opinions. This also includes management’s assessment on the character and amounts of taxable
future profits, the periods in which those profits are expected to occur, and the availability of tax planning
opportunities.
Our management continued to take the view that deferred tax assets on tax losses carried forward that relate to
subsidiaries which have a loss-making history cannot be recognized. This includes the assessment that those
subsidiaries have neither any taxable temporary differences nor any tax planning opportunities available that
could support the recognition of deferred tax assets.
For further disclosures relating to deferred taxes, see Note
8
.
F-31
Annual Report on Form 20-F for the
year ended December 31, 2024
4
Group
Information
Information about Subsidiaries
|
% equity interest
|
||||||||||
|
Name
|
Country of
incorporation
|
Registered
office
|
December
31, 2024
|
December
31, 2023
|
||||||
|
BioNTech BioNTainer Holding GmbH
|
Germany
|
Mainz
|
|
|
||||||
|
BioNTech Cell & Gene Therapies GmbH
|
Germany
|
Mainz
|
|
|
||||||
|
BioNTech Collaborations GmbH
|
Germany
|
Mainz
|
|
n/a
(1)
|
||||||
|
BioNTech Delivery Technologies GmbH
|
Germany
|
Halle
|
|
|
||||||
|
BioNTech Diagnostics GmbH
|
Germany
|
Mainz
|
|
|
||||||
|
BioNTech Europe GmbH
|
Germany
|
Mainz
|
|
|
||||||
|
BioNTech Idar-Oberstein Services GmbH
|
Germany
|
Idar-Oberstein
|
|
|
||||||
|
BioNTech Individualized mRNA Manufacturing GmbH
|
Germany
|
Mainz
|
|
|
||||||
|
BioNTech Innovation and Services Marburg GmbH
|
Germany
|
Marburg
|
|
|
||||||
|
BioNTech Innovation GmbH
|
Germany
|
Mainz
|
|
|
||||||
|
BioNTech Innovative Manufacturing Services GmbH
|
Germany
|
Idar-Oberstein
|
|
|
||||||
|
BioNTech Manufacturing GmbH
|
Germany
|
Mainz
|
|
|
||||||
|
BioNTech Manufacturing Marburg GmbH
|
Germany
|
Marburg
|
|
|
||||||
|
BioNTech Real Estate Holding GmbH
|
Germany
|
Holzkirchen
|
|
|
||||||
|
InstaDeep DE GmbH
|
Germany
|
Berlin
|
|
|
||||||
|
JPT Peptide Technologies GmbH
|
Germany
|
Berlin
|
|
|
||||||
|
NT Security and Services GmbH
|
Germany
|
Mainz
|
|
|
||||||
|
reSano GmbH
|
Germany
|
Mainz
|
|
|
||||||
|
BioNTech Australia Pty Ltd.
|
Australia
|
Melbourne
|
|
|
||||||
|
BioNTech R&D (Austria) GmbH
|
Austria
|
Vienna
|
|
|
||||||
|
Simba Merger Sub
|
Cayman Islands
|
George Town
|
|
n/a
(1)
|
||||||
|
BioNTech (Shanghai) Pharmaceuticals Co. Ltd.
|
China
|
Shanghai
|
|
|
||||||
|
InstaDeep France SAS
|
France
|
Paris
|
|
|
||||||
|
Biopharma BioNTech Israel Ltd.
|
Israel
|
Tel Aviv
|
|
|
||||||
|
New Technologies Re
|
Luxembourg
|
Luxembourg
|
|
|
||||||
|
InstaDeep Nigeria Limited
|
Nigeria
|
Lagos
|
|
|
||||||
|
BioNTech Rwanda Ltd.
|
Rwanda
|
Kigali
|
|
|
||||||
|
BioNTech Pharmaceuticals Asia Pacific Pte. Ltd.
|
Singapore
|
Singapore
|
|
|
||||||
|
BioNTech Pharmaceuticals Spain S.L
|
Spain
|
Barcelona
|
|
|
||||||
|
BioNTech Switzerland GmbH
|
Switzerland
|
Basel
|
|
|
||||||
|
BioNTech Taiwan Co. Ltd.
|
Taiwan
|
Taipei
|
|
|
||||||
|
InstaDeep Tunisia SARL
|
Tunisia
|
Tunis
|
|
|
||||||
|
BioNTech Turkey Tıbbi Ürünler Ve Klinik Araştirma
Ticaret Anonim Şirketi
|
Turkey
|
Istanbul
|
|
|
||||||
|
BioNTech UK Ltd.
|
United Kingdom
|
London
|
|
|
||||||
|
InstaDeep Ltd.
|
United Kingdom
|
London
|
|
|
||||||
|
BioNTech Research and Development, Inc.
|
United States
|
Cambridge
|
|
|
||||||
|
BioNTech USA Holding, LLC
|
United States
|
Cambridge
|
|
|
||||||
|
BioNTech US Inc.
|
United States
|
Cambridge
|
|
|
||||||
|
BioNTech Delivery Technologies (US), LLC
|
United States
|
Cambridge
|
|
|
||||||
|
InstaDeep LLC
|
United States
|
Dover
|
|
|
||||||
|
JPT Peptide Technologies Inc.
|
United States
|
Cambridge
|
|
|
||||||
(1)
Included during the
year ended December 31, 2024
.
F-32
Annual Report on Form 20-F for the
year ended December 31, 2024
All entities listed above are included in our consolidated financial statements.
Parent Company
owner of the following percentage of ordinary shares in BioNTech at the dates as indicated.
ATHOS KG via AT
Impf GmbH has de facto control over BioNTech based on its substantial shareholding,
which
practically
enables
it to exercise the majority of voting rights to pass resolutions at our Annual General Meeting, or AGM.
|
Ownership of ordinary shares in
BioNTech (in %)
|
||||||||||
|
Name
|
Country of
incorporation
|
Registered
office
|
December 31,
2024
|
December 31,
2023
|
||||||
|
AT Impf GmbH
|
Germany
|
Munich
|
|
|
||||||
Entity
with Significant Influence over the Group
dates as indicated:
|
Ownership of ordinary shares in
BioNTech (in %)
|
||||||||||
|
Name
|
Country of
incorporation
|
Registered
office
|
December 31,
2024
|
December 31,
2023
|
||||||
|
Medine GmbH
|
Germany
|
Mainz
|
|
|
||||||
5
Bu
sin
ess Combinations
Acquisition of Biotheus
On November 13, 2024, our subsidiary, BioNTech Collaborations GmbH, entered into an agreement and plan of
merger, or the Merger Agreement, with Biotheus, a clinical-stage biotechnology company dedicated to the
discovery and development of novel antibodies to address unmet medical needs of patients with oncological or
inflammatory diseases. The acquisition supports the global execution of our oncology strategy and provides full
global rights to BNT327/PM8002, an investigational PD-L1 x VEGF-A bispecific antibody, with potential to
replace current checkpoint inhibitor standard of care treatments for solid tumors.
Following the satisfaction of several customary closing conditions and regulatory approvals as defined in the
Merger Agreement, the acquisition closed on January 31, 2025.
Upon closing and under the terms of the agreement, we paid Biotheus shareholders upfront of approximately
$
850.0
million
, predominantly in cash, with a small portion in ADSs, to acquire
100
%
of the issued share capital
of Biotheus, subject to customary purchase price adjustments, and agreed to pay additional performance-based
contingent payments of up to
$
150.0
million
if certain milestones are met.
By closing the acquisition, we gained full rights to Biotheus’s pipeline candidates and its in-house bispecific
antibody drug conjugate capability. The acquisition has expanded our footprint in China, adding a local research
and development hub to conduct clinical trials. In addition, we have gained a biologics manufacturing facility to
contribute to our future global manufacturing and supply, and more than 300 Biotheus employees in R&D,
manufacturing and enabling functions have joined the BioNTech workforce.
F-33
Annual Report on Form 20-F for the
year ended December 31, 2024
We are in the process of performing a preliminary allocation of the total consideration and the underlying assets
acquired and liabilities assumed based on their estimated fair value as of the acquisition date in accordance with
IFRS 3.
Based on our initial assessment, the purchase price will be mainly allocated to amounts related to the
settlement
of the pre-existing relationship in connection with
the License and Collaboration Agreement with Biotheus a
s of
November 2023, which comprised the development, manufacturing and commercialization of BNT327 ex-
Greater
China
.
The amount related to the settlement of the pre-existing relationship i
s
identified based on the fair value of the
settled rights of Biotheus in connection with contingent payments in relation to the License and Collaboration
Agreement and will be separated from the remaining consideration to be transferred for the acquired business of
Biotheus. The consideration for the acquired business of Biotheus will be allocated to net assets acquired, which
include identified intangible assets in connection with Biotheus’ BNT327 Greater China rights and other clinical
pipeline candidates, property, plant and equipment, cash, financial liabilities, deferred tax liabilities and if
applicable
goodwill as residual
.
The assessment is preliminary as the accounting for the settlement of the pre-existing relationship and business
combination is still in progress.
F-34
Annual Report on Form 20-F for the
year ended December 31, 2024
6
Revenues from Contracts with Customers
|
Years ended December 31,
|
||||||||||||||
|
(in millions €)
|
2024
|
2023
|
2022
|
|||||||||||
|
COVID-19 vaccine revenues
|
|
|
|
|
|
|
||||||||
|
Other revenues
|
|
|
|
|
|
|
||||||||
|
Total
|
|
|
|
|
|
|
||||||||
|
(in millions €)
|
Years ended December 31,
|
|||||||||||||
|
Revenues by customers
|
2024
|
2023
|
2022
|
|||||||||||
|
Pfizer
|
|
|
|
|
|
|
||||||||
|
German Federal Ministry of Health
|
|
|
|
|
|
|
||||||||
|
Other customers
|
|
|
|
|
|
|
||||||||
|
Total
|
|
|
|
|
|
|
||||||||
|
(in millions €)
|
Years ended December 31,
|
|||||||||||||
|
Revenues by countries
|
2024
|
2023
|
2022
|
|||||||||||
|
United States
|
|
|
|
|
|
|
||||||||
|
Germany
|
|
|
|
|
|
|
||||||||
|
Rest of the World
|
|
|
|
|
|
|
||||||||
|
Total
|
|
|
|
|
|
|
||||||||
COVID-19 vaccine revenues
During the
year ended December 31, 2024
, COVID-19 vaccines revenues were recognized from the supply and
sales of our COVID-19 vaccine worldwide, mainly comprising our share of the collaboration partner’s gross profit
derived from sales in the collaboration partner’s territory. During the
year ended December 31, 2024
, our
commercial revenues
decreased as compared to the year ended December 31, 2023, in line with a lower
COVID-19 vaccine market demand.
In addition, write-downs by our collaboration partner Pfizer,
significantly
reduced our gross profit share and hence negatively influenced our revenues for the
year ended December 31,
2024
.
Our COVID-19 vaccine revenues are subject to seasonal effects in the fall / winter of the northern
hemisphere.
Other revenues
During the
year ended December 31, 2024
, our other revenues were mainly derived from a pandemic
preparedness contract with the German government effectively supplemented in the three months ended M
arch
31, 2024.
F-35
Annual Report on Form 20-F for the
year ended December 31, 2024
|
Years ended December 31,
|
||||||||
|
(in millions €)
|
2024
|
2023
|
2022
|
|||||
|
Timing of revenue recognition
|
||||||||
|
Goods and services transferred at a point in time
|
|
|
|
|||||
|
Goods and services transferred over time
|
|
|
|
|||||
|
Revenue recognition applying the sales-based or usage-based
royalty recognition constraint model
(1)
|
|
|
|
|||||
|
Total
|
|
|
|
|||||
(1)
Represents sales based on the share of the collaboration partners’ gross profit and sales milestones.
|
2024
|
2023
|
|||||||||||||
|
(in millions €)
|
Current
|
Non-
current
|
Total
|
Current
|
Non-
current
|
Total
|
||||||||
|
As of January 1
|
|
|
|
|
|
|
||||||||
|
Additions
|
|
|
|
|
|
|
||||||||
|
thereof: attributable to performance
obligations satisfied in prior periods
|
|
|
|
|
|
|
||||||||
|
Reclassification to trade accounts receivables
|
(
|
|
(
|
|
|
|
||||||||
|
Reclassification from non-current to current
|
|
(
|
|
|
|
|
||||||||
|
Changes in scope of consolidation
|
|
|
|
|
|
|
||||||||
|
As of December 31
|
|
|
|
|
|
|
||||||||
During the
year ended December 31, 2024
, the contract assets were significantly influenced by the rendering of
F-36
Annual Report on Form 20-F for the
year ended December 31, 2024
6.3
Contract Liabilities
|
2024
|
2023
|
|||||||||||||
|
(in millions €)
|
Current
|
Non-
current
|
Total
|
Current
|
Non-
current
|
Total
|
||||||||
|
As of January 1
|
|
|
|
|
|
|
||||||||
|
Additions
|
|
|
|
|
|
|
||||||||
|
Recognition as revenues
|
(
|
|
(
|
(
|
|
(
|
||||||||
|
Reclassification from non-current to current
|
|
(
|
|
|
(
|
|
||||||||
|
Currency effects
|
(
|
|
(
|
(
|
|
(
|
||||||||
|
As of December 31
|
|
|
|
|
|
|
||||||||
Contract liabilities significantly decreased compared to the previous year as advance payments in connection
with the amendment of the COVID-19 vaccine purchase agreem
ent with the European Commission, or EC, were
consumed. As of
December 31, 2024
, the
contract liabilities included
€
416.2
million
of such payments
and
€
61.1
million
of remaining upfront fees fro
m our collaboration agreement with Pfizer (Zoster) (as of
December 31, 2023
:
€
688.7
million
payments under our COVID
-19 vaccine purchase agreement with the
European Commission and
€
62.3
million
of remaining upfront fees from our collaboration agreement with Pfizer
(Zos
ter)).
|
Years ended December 31,
|
||||||||
|
(in millions €)
|
2024
|
2023
|
2022
|
|||||
|
Amounts included in contract liabilities at the beginning of the year
|
|
|
|
|||||
7
Income
and
Expenses
Cost of Sales
From the
year ended December 31, 2023
, to the
year ended December 31, 2024
, cost of sales
decreased
by
€
58.5
million
, or
10
%, from
€
599.8
million
to
€
541.3
million
,
m
ainly due to recognizing lower cost of sales from
our decreased COVID-19 vaccine sales, which included the share of gross profit that we owe our collaboration
partner
Pfizer based on our sales.
The same reasoning applies to the change while comparing the
years ended
December 31, 2023 and 2022
, which
decreased
by
€
2,395.2
million
, or
80
%
, from
€
2,995.0
million
to
€
599.8
million
.
In addition, cost of sales was impacted by expenses
arising from
inventory
write-downs and scrapings
in
the context of the launch of our variant adapted COVID-19 vaccine in the amount o
f
€
125.8
million
during the
year ended December 31, 2024
(
€
94.5
million
for
year ended December 31, 2023
, and
nil
for
year ended
December 31, 2022
).
Research
and Development Expenses
From the
year ended December 31, 2023
to the
year ended December 31, 2024
, our research and development
expenses
increased
by
€
471.1
million
, or
26
%
, from
€
1,783.1
million
to
€
2,254.2
million
,
mainly influenced
by
advancing key pipeline candidates, such as our ADC antibody and individualized cancer-immunotherapy product
candidates. Further contributions to the increase came from higher personnel expenses resulting from an
increase in headcount.
The same reasoning applies to the change in our research and development expenses
while comparing the
years ended December 31, 2023 and 2022
, which
increased
by
€
246.1
million
, or
16
%
,
from
€
1,537.0
million
to
€
1,783.1
million
.
F-37
Annual Report on Form 20-F for the
year ended December 31, 2024
Sales and Marketing Expenses
From the
year ended December 31, 2023
, to the
year ended December 31, 2024
, our sales and marketing
expenses
increased
by
€
5.2
million
, or
8
%, from
€
62.7
million
to
€
67.9
million
,
mainly due to increased expenses
for setup and enhancement of commercial IT platforms and an increase in personnel expenses resulting from an
increase in headcount.
The same reasoning applies to the change in sales and marketing expenses while
comparing the
years ended December 31, 2023 and 2022
, which
increased
by
€
3.2
million
, or
5
%
, from
€
59.5
million
to
€
62.7
million
.
General and Administrative Expenses
From the
year ended December 31, 2023
to the
year ended December 31, 2024
, our general and administrative
expenses
increased
by
€
36.1
million
, or
7
%, from
€
495.0
million
to
€
531.1
million
,
mainly influenced by
increased expenses for IT services as well as by an increase in personnel
expenses
resulting from an increase
in headcount.
The same reasoning applies to the change in general and administrative expenses while
comparing the
years ended December 31, 2023 and 2022
, which
increased
by
€
13.3
million
, or
3
%
, from
€
481.7
million
to
€
495.0
million
.
|
Years ended
December 31,
|
||||||||
|
(in millions €)
|
2024
|
2023
|
2022
|
|||||
|
Other operating result
|
||||||||
|
Other operating income
|
|
|
|
|||||
|
Gain on derivative instruments at fair value through profit or loss
|
|
|
|
|||||
|
Grants
|
|
|
|
|||||
|
Foreign exchange differences, net
|
|
|
|
|||||
|
Other
|
|
|
|
|||||
|
Other operating expenses
|
(
|
(
|
(
|
|||||
|
Contractual disputes / settlements
|
(
|
|
|
|||||
|
Litigation costs
(1)
|
(
|
(
|
(
|
|||||
|
Loss on derivative instruments at fair value through profit or loss
|
(
|
|
(
|
|||||
|
Foreign exchange differences, net
|
|
(
|
|
|||||
|
Other
|
(
|
(
|
(
|
|||||
|
Total other operating result
|
(
|
(
|
|
|||||
(1)
Adjustments to the year 2022 figures
relate to reclassifying legal costs in connection with certain litigation as other
operating expenses, rather than general and administrative expenses, to reflect changes in reporting.
During the
year ended December 31, 2024
, the other operating income
increased
compared to the
year ended
December 31, 2023
, as foreign exchange differences arising on operating items changed from a negative effect
to a positive effect.
Comparing the
year ended December 31, 2023
, to the
year ended December 31, 2022
, we
had a negative effect from exchange differences.
During the
year ended December 31, 2024
, the other expenses
increased
compared to the
year ended
December 31, 2023
,
which
was mainly due to the settlement of contractual disputes and related expenses to
such disputes and other litigations. The amounts shown for contractual disputes are net of the related
reimbursements to be received.
For further information see Note
12.2
.
During the
year ended December 31,
2023
, the other operating expenses
decreased
compared to the
year ended December 31, 2022
, as the fair
F-38
Annual Report on Form 20-F for the
year ended December 31, 2024
|
Years ended
December 31,
|
||||||||
|
(in millions €)
|
2024
|
2023
|
2022
|
|||||
|
Finance result
|
||||||||
|
Finance income
|
|
|
|
|||||
|
Gains from financial instruments measured at amortized cost
|
|
|
|
|||||
|
Gains from financial instruments measured at fair value
|
|
|
|
|||||
|
Foreign exchange differences, net
|
|
|
|
|||||
|
Finance expenses
|
(
|
(
|
(
|
|||||
|
Loss from financial instruments measured at fair value
|
(
|
|
|
|||||
|
Loss from financial instruments measured at amortized cost
without expected credit losses
|
(
|
|
|
|||||
|
Loss from financial instruments measured at amortized cost,
expected credit losses
|
(
|
|
|
|||||
|
Foreign exchange differences, net
|
|
(
|
|
|||||
|
Other
|
(
|
(
|
(
|
|||||
|
Total finance result
|
|
|
|
|||||
During the
year ended December 31, 2024
, the finance income
increased
compared to the
year ended
December 31, 2023
, mainly due to
interest income earned on security investments as bonds, commercial paper,
reverse repos and deposits as well as fair value adjustments
in relation
to our money market funds.
The same
effect applies for the
year ended December 31, 2023
, compared to the
year ended December 31, 2022
.
During the
year ended December 31, 2024
, the finance expenses
increased
compared to the
year ended
December 31, 2023
,
mainly due to interest expenses for financial liabilities that have been discounted at
inception date, interests on leases and tax liabilities and impairments
for expected credit losses
of financial
assets. This was partially compensated by positive exchange rate effects
. During the
year ended December 31,
2023
, the other finance income increased compared to the
year ended December 31, 2022
.
|
Years ended
December 31,
|
||||||||
|
(in millions €)
|
2024
|
2023
|
2022
|
|||||
|
Wages and salaries
|
|
|
|
|||||
|
Social security costs
|
|
|
|
|||||
|
Pension costs
|
|
|
|
|||||
|
Total
|
|
|
|
|||||
Wages and salaries include,
among other things,
expenses for share-based payments. The increase is mainly
due to an increase in headcount between the
years ended December 31, 2024 and 2023
.
8
In
come Tax
Income tax for t
he years ended
December 31, 2024
,
December 31, 2023
, and
December 31, 2022
, comprised
current income taxes, other taxes and deferred taxes. We are subject to corporate taxes, the solidarity surcharge
and trade taxes. Our corporate tax rate in the reporting year remained unchanged (
15.0
%
) as did the solidarity
surcharge (
5.5
%
) whereas the average trade tax rate changed resulting in a combined income tax rate of
27.6
%
F-39
Annual Report on Form 20-F for the
year ended December 31, 2024
in the
year ended December 31, 2024
(during the years ended
December 31, 2023
and
2022
:
27.1
%
and
27.2
%
,
respectively).
Deferred taxes are calculated at a rate of
30.8
%
.
BioNTech USA Holding,
LLC is subject to Federal
Corporate Income Tax (
21.0
%
) as well as State Income Tax in various state jurisdictions (effective rate of
3.4
%
).
The deferred tax rates calculations basis remained unchanged compared to the previous period.
|
Years ended
December 31,
|
||||||||
|
(in millions €)
|
2024
|
2023
|
2022
|
|||||
|
Current income taxes
|
(
|
|
|
|||||
|
Deferred taxes
|
(
|
|
(
|
|||||
|
Income taxes expenses / (income)
|
(
|
|
|
|||||
taxes were calculated using the combined income tax rate of BioNTech SE applicable to the Group and
mentioned above which was applied to profit before taxes to calculate the expected income
taxes
.
|
Years ended
December 31,
|
||||||||
|
(in millions €)
|
2024
|
2023
|
2022
|
|||||
|
Profit / (Loss) before tax
|
(
|
|
|
|||||
|
Expected tax credit
|
(
|
|
|
|||||
|
Effects
|
||||||||
|
Deviation due to local tax basis
|
|
|
|
|||||
|
Deviation due to deviating income tax rate (Germany and
foreign countries)
|
|
(
|
|
|||||
|
Change in valuation allowance
|
(
|
(
|
|
|||||
|
Effects from tax losses and tax credits
|
|
(
|
|
|||||
|
Change in deferred taxes due to tax rate change
|
|
(
|
(
|
|||||
|
Non-deductible expenses
|
(
|
|
|
|||||
|
Non tax-effective income
|
(
|
(
|
(
|
|||||
|
Non tax-effective share-based payment expenses
|
(
|
|
|
|||||
|
Tax-effective equity transaction costs
|
|
|
|
|||||
|
Adjustment prior year taxes
|
|
|
(
|
|||||
|
Non-tax effective bargain purchase
|
|
|
|
|||||
|
Other effects
|
|
(
|
|
|||||
|
Income taxes
|
(
|
|
|
|||||
|
Effective tax rate
|
|
|
|
|||||
Taxes
F-40
Annual Report on Form 20-F for the
year ended December 31, 2024
|
Year ended December 31, 2024
|
||||||||||||
|
(in millions €)
|
January 1,
2024
|
Recognized
in P&L
|
Recognized
in OCI
|
Recognized
directly in
equity
|
December 31,
2024
|
|||||||
|
Fixed assets
|
(
|
|
|
|
|
|||||||
|
Right-of-use assets
|
(
|
(
|
|
|
(
|
|||||||
|
Inventories
|
|
(
|
|
|
|
|||||||
|
Trade and other receivables
|
(
|
(
|
|
|
(
|
|||||||
|
Lease liabilities
|
|
|
|
|
|
|||||||
|
Contract liabilities
|
(
|
(
|
|
|
(
|
|||||||
|
Loans and borrowings
|
|
|
|
|
|
|||||||
|
Net employee defined benefit liabilities
|
|
|
|
|
|
|||||||
|
Share-based payments
|
|
|
|
(
|
|
|||||||
|
Other provisions
|
|
|
|
|
|
|||||||
|
Other (incl. deferred expenses)
|
(
|
|
|
|
|
|||||||
|
Tax losses / tax credits
|
|
|
|
|
|
|||||||
|
Deferred tax assets net (before
valuation adjustment)
|
|
|
|
(
|
|
|||||||
|
Valuation adjustment
|
(
|
(
|
(
|
|
(
|
|||||||
|
Deferred tax assets / (liabilities), net
(after valuation adjustment)
|
|
|
|
(
|
|
|||||||
|
Thereof deferred tax assets
|
|
|
|
(
|
|
|||||||
|
Thereof deferred tax liability
|
(
|
(
|
|
|
(
|
F-41
Annual Report on Form 20-F for the
year ended December 31, 2024
|
Year ended December 31, 2023
|
||||||||||||
|
(in millions €)
|
January 1,
2023
|
Recognized
in P&L
|
Recognized
in OCI
|
Recognized
directly in
equity
|
December 31,
2023
|
|||||||
|
Fixed assets
|
|
|
|
(
|
(
|
|||||||
|
Right-of-use assets
|
(
|
(
|
|
|
(
|
|||||||
|
Inventories
|
|
(
|
|
|
|
|||||||
|
Trade and other receivables
|
(
|
|
|
|
(
|
|||||||
|
Lease liabilities
|
|
|
|
|
|
|||||||
|
Loans and borrowings
|
|
(
|
|
|
|
|||||||
|
Contract liabilities
|
(
|
(
|
|
|
(
|
|||||||
|
Net employee defined benefit liabilities
|
|
(
|
|
|
|
|||||||
|
Other provisions
|
|
(
|
|
|
|
|||||||
|
Share-based payments
|
|
|
|
(
|
|
|||||||
|
Other (incl. deferred expenses)
|
|
(
|
|
|
(
|
|||||||
|
Tax losses / tax credits
|
|
(
|
|
|
|
|||||||
|
Deferred tax assets net (before
valuation adjustment)
|
|
(
|
|
(
|
|
|||||||
|
Valuation adjustment
|
(
|
|
|
(
|
(
|
|||||||
|
Deferred tax assets / (liabilities), net
(after valuation adjustment)
|
|
(
|
|
(
|
|
|||||||
|
Thereof deferred tax assets
|
|
|
|
(
|
|
|||||||
|
Thereof deferred tax liability
|
(
|
(
|
|
|
(
|
As of
December 31, 2024
, our accumulated tax losses comprised tax losses of German entities that were
incurred prior to the establishment of a tax group with BioNTech SE or by entities that are not within the tax
group or U.S. tax group
.
Up until the year ended
December 31, 2024
, our accumulated tax losses also
comprised those of the German tax group.
Our accumulated tax losses
for the periods indicated amounted to the
following:
|
Years ended
December 31,
|
||||||||
|
(in millions €)
|
2024
|
2023
|
2022
|
|||||
|
Corporate tax
|
|
|
|
|||||
|
Trade tax
|
|
|
|
|||||
|
Years ended
December 31,
|
||||||||
|
(in millions €)
|
2024
|
2023
|
2022
|
|||||
|
Federal tax credits
|
|
|
|
|||||
|
State tax credits
|
|
|
|
|||||
Up until the year ended
December 31, 2024
,
deferred tax assets on tax losses were
only partially
recognized, as
there was not sufficient probability in terms of IAS 12 that future taxable profits would have been available
against which all the unused tax losses could have been utilized.
F-42
Annual Report on Form 20-F for the
year ended December 31, 2024
The amount of deductible temporary differences, unused tax losses, and unused tax credits for which no
deferred tax asset is recognized in the statement of financial position as of
December 31, 2024
, is
€
2,028.8
million
. Therefore, as of
December 31, 2024
, we have not recognized deferred tax assets for unused tax losses
and temporary differences in an amount of
€
332.4
million
(
December 31, 2023
:
€
138.0
million
,
December 31,
2022
:
€
136.7
million
).
As of
December 31, 2024
, we maintain the
partial
non-recognition of deferred tax assets for unused U.S. federal
and state tax losses and tax credits at an amount of
€
30.5
million
and
€
4.0
million
, respectively, as there is not
sufficient probability in terms of IAS 12 that future taxable income will be available against which these unused
tax losses and tax credits can be utilized. The material unrecognized U.S. federal and state tax losses and tax
credits will begin to expire in 2036.
We do not recognize deferred tax liabilities for taxable temporary differences associated with investments in
subsidiaries, in cases where we are able to control the timing of the reversal of the temporary difference and it is
probable that the temporary differences will not reverse in the foreseeable future.
The aggregate amount of
temporary differences associated with investments in subsidiaries, for which deferred tax liabilities have not been
recognized,
is
€
14.5
million
.
The global minimum taxation for large multinational groups (known as The Pillar Two regulations) based on Base
Erosion and Profit Shifting (BEPS) project by the Organization for Economic Co-operation and Development
(OECD) were transposed into German law at the end of 2023 (MinStG) and came into force on January 1
st
,
2024. We do fall within the scope of these regulations. As of December 31, 2024 we carried out an analysis to
determine the impact and jurisdictions from which we are exposed to potential effects in connection with a Pillar
Two top-up tax. It was checked whether the CbCR Safe Harbor Regulations were fulfilled. In Jurisdictions where
the CbCR Regulations do not apply, the effective tax rate was calculated on a simplified basis. Since our relevant
effective tax rate calculated for Pillar Two purposes is mainly above 15% in all jurisdictions in which it operates, it
has been determined that we are not materially subject to Pillar Two top-up taxes. We apply the exception in IAS
12, according to which no deferred tax assets and liabilities are recognized in connection with the second pillar
(Pillar Two) income taxes of the OECD and no disclosures are made in this regard. We closely monitor the
progress of the legislative process in each country in which we operate.
9
Earnings per Share
Basic earnings per share (EPS) is calculated by dividing the profit for the year attributable to ordinary equity
holders of the parent by the weighted average number of ordinary shares outstanding during the year.
Diluted EPS is calculated by dividing the profit attributable to ordinary equity holders of the parent by the
weighted average number of ordinary shares outstanding during the year, plus the weighted average number of
ordinary shares that would be issued on conversion of all the dilutive potential ordinary shares into ordinary
shares.
F-43
Annual Report on Form 20-F for the
year ended December 31, 2024
|
Years ended
December 31,
|
||||||||
|
(in millions €, except per share data)
|
2024
|
2023
|
2022
|
|||||
|
Profit attributable to ordinary equity holders of the parent for
basic earnings
|
(
|
|
|
|||||
|
Weighted average number of ordinary shares outstanding
for basic EPS
|
|
|
|
|||||
|
Effects of dilution from share options
|
|
|
|
|||||
|
Weighted average number of ordinary shares outstanding
adjusted for the effect of dilution
|
|
|
|
|||||
|
Earnings / (Loss) per share
|
||||||||
|
Basic earnings / (loss) per share
|
(
|
|
|
|||||
|
Diluted earnings / (loss) per share
|
(
|
|
|
|||||
10
Other
Intangible
Assets and
Goodwill
Goodwill
|
(in millions €)
|
Goodwill
|
|||
|
Acquisition costs
|
||||
|
As of January 1, 2023
|
|
|||
|
Currency differences
|
(
|
|||
|
Acquisition of subsidiaries and businesses
|
|
|||
|
As of December 31, 2023
|
|
|||
|
Acquisition of subsidiaries and businesses
|
|
|||
|
Currency differences
|
|
|||
|
As of December 31, 2024
|
|
Intangible Assets with I
ndefinite Useful Lives
|
CGU Immunotherapies
|
CGU External Product
Sales of JPT
|
CGU External Business
of InstaDeep
|
Total
|
|||||||||||||||||||||
|
(in millions €)
|
As of
December
31, 2024
|
As of
December
31, 2023
|
As of
December
31, 2024
|
As of
December
31, 2023
|
As of
December
31, 2024
|
As of
December
31, 2023
|
As of
December
31, 2024
|
As of
December
31, 2023
|
||||||||||||||||
|
Goodwill
|
|
|
|
|
|
|
|
|
||||||||||||||||
|
Intangible assets
with indefinite
useful life
|
|
|
|
|
|
|
|
|
||||||||||||||||
|
Total
|
|
|
|
|
|
|
|
|
||||||||||||||||
For the
year ended December 31, 2024
, our
goodwill
relates
almost completely
to the CGU Immunotherapies.
The CGU Immunotherapies focuses on
the development of therapies in the field of oncology and
infectious
diseases
and comprises our broad pipeline that includes mRNA-based immune activators, antigen-targeting
T cells and antibodies and defined immunomodulators of various immune cell mechanisms
.
F-44
Annual Report on Form 20-F for the
year ended December 31, 2024
We performed our annual Goodwill impairment test in October
2024
.
The recoverable amount of the CGU Immunotherapies
has been determined based on a fair value less cost of
disposal (FVLCD), which we derived based on our market capitalization as an observable input parameter.
The recoverable amounts of the CGU External Product Sales of JPT and the CGU External Business of
InstaDeep have been determined based on their value in use. In assessing value in use, the estimated future
cash flows, which are derived based on a bottom-up business plan provided by the management of the
respective entities, are discounted to t
heir present value using a pre-tax discount rate
that reflects current market
assessments of the time value of money and the risks specific to the assets.
A l
ong-term growth rate of
1.5
%
is
applied to project future cash flows after the last year of the detailed planning period.
As a result of the analysis in October 2024, we did not identify an impairment for these CGUs.
Even if our market
capitalization had been approximately 10% lower, FVLCD
would have still been above
t
he respective carrying
amount of the CGU Immunotherapies.
Intangible assets with indefinite useful lives mainly comprised acquired
intangible
assets not yet available for
use, or
In-process R&D
,
of
€
485.5
million
(as of
December 31, 2023
:
€
443.5
million
)
. Such assets are not
amortized and
therefore reviewed for impairment annually
.
The annual impairment test was performed on an
individual basis of the assets during the
three months ended December 31, 2024
.
The recoverable amounts
were
determined based on the value in use.
The results gave rise to impairment losses in total of
€
55.1
million
that were
related to the CGU Immunotherapies
. The impairment losses were recorded under R&D expenses in
the consolidated statements of profit or loss. The impairments resulted from revised prioritization of product
candidates in
the overall portfolio.
We
examine the existence of indications of impairment using various factors, particularly deviations from sales
forecasts and the analysis of changes in medium-term planning. The identification of indications of impairment
takes place with the involvement of the responsible departments, taking external and internal information
sources into consideration.
During the three
months ended June 30,
2024
,
we identified a
triggering event in connection with the asset
related to the product candidate BNT326/YL202 due to the partial clinical hold placed on
the Phase 1 trial of our
partner, MediLink Therapeutics (Suzhou) Co., Ltd, or MediLink
by the
U.S. Food and Drug Administration, or
FDA. The impairment test performed did not reveal any impairment loss.
Further triggering events were identified
in connection with the asset related to the product candidate BNT316/ONC-392.
During the three months ended
September 30,
2024
,
a triggering event was identified based on the operational hold of the trial. During the
three
months ended December 31, 2024
, the trial was then placed on partial clinical hold. The FDA subsequently lifted
the partial clinical holds related to both product candidates.
During the
three months ended December 31, 2024
,
we identified a triggering event based on our analysis of changes in medium-term planning. We have performed
impairment tests in connection with the identified triggering events which did not give rise to any impairment loss.
A sensitivity analysis of
t
he key assumptions
, future cash flows and weighted average cost of capital, was
performed as part of the
scheduled
impairment testing of the intangible assets not yet available for use. For
those assets that have not been impaired, the sensitivity analysis did not give rise to any impairment loss, either
for a reduction o
f
10
%
in future cash flows or for a
10
%
increase in the weighted average cost of capital.
F-45
Annual Report on Form 20-F for the
year ended December 31, 2024
Other Intangible Assets
|
(in millions €)
|
In-process
R&D
|
Concessions,
licenses and
similar rights
|
Advance
payments
|
Total
|
||||||
|
Acquisition costs
|
||||||||||
|
As of January 1, 2023
|
|
|
|
|
||||||
|
Additions
|
|
|
|
|
||||||
|
Disposals
|
|
(
|
(
|
(
|
||||||
|
Reclassifications
|
|
|
(
|
|
||||||
|
Currency differences
|
|
(
|
|
(
|
||||||
|
Acquisition of subsidiaries and businesses
|
|
|
|
|
||||||
|
As of December 31, 2023
|
|
|
|
|
||||||
|
Additions
|
|
|
|
|
||||||
|
Disposals
|
|
(
|
|
(
|
||||||
|
Reclassifications
|
|
|
(
|
|
||||||
|
Currency differences
|
|
|
|
|
||||||
|
As of December 31, 2024
|
|
|
|
|
|
(in millions €)
|
In-process
R&D
|
Concessions,
licenses and
similar rights
|
Advance
payments
|
Total
|
||||||
|
Cumulative amortization and impairment
charges
|
||||||||||
|
As of January 1, 2023
|
|
|
|
|
||||||
|
Amortization
|
|
|
|
|
||||||
|
Disposals
|
|
(
|
|
(
|
||||||
|
Currency differences
|
|
(
|
|
(
|
||||||
|
As of December 31, 2023
|
|
|
|
|
||||||
|
Amortization
|
|
|
|
|
||||||
|
Impairment
|
|
|
|
|
||||||
|
Disposals
|
|
(
|
|
(
|
||||||
|
Currency differences
|
|
|
|
|
||||||
|
As of December 31, 2024
|
|
|
|
|
|
(in millions €)
|
In-process
R&D
|
Concessions,
licenses and
similar rights
|
Advance
payments
|
Total
|
|||||
|
Carrying amount
|
|||||||||
|
As of December 31, 2023
|
|
|
|
|
|||||
|
As of December 31, 2024
|
|
|
|
|
The intangible assets resulting from licensing and collaboration agreements are combined into one class of
assets, In-process R&D, due to their similar nature and use in our operations and are attributed to the CGU
Immunotherapies.
F-46
Annual Report on Form 20-F for the
year ended December 31, 2024
The amortization of the concessions, licenses and similar rights during the
year ended December 31, 2024
,
has
been mainly recorded under R&D expenses in the consolidated statements of profit or loss.
During the
year ended December 31, 2024
, triggering events with respect to two intangible assets with definite
useful life occurred.
We performed impairment tests based on decisions to stop the development of the
compounds
that were acquired as part of
bus
iness combinations
in the past
. The recoverable amounts were
determined based on the value in use.
The impairment tests gave rise to the full impairme
nt of the compounds in
the amount of
€
26.4
million
.
The remaining insignificant impairments relate to intangibles which are not
significant for the group.
The majority of these impairment losses were recorded under R&D expenses in the
consolidated statements of profit or loss.
The decrease in other intangible assets by
€
13.7
million
from December 31,
2023
, to
December 31, 2024
, was
mainly related t
o
impairment losses of
€
83.3
million
in total (as of
December 31, 2023
:
nil
)
.
This was partially
offset by the payments made in connection with the purchase of intangible assets. We entered into license and
collaboration agreements in which we work together with partners to develop pharmaceutical products and,
provided regulatory approval is granted, commercialize them. Thereof
€
9.4
million
(as of
December 31, 2023
:
€
443.5
million
) was related to upfront payments and
€
87.7
million
(as of
December 31, 2023
:
nil
)
was related to
milestone payments as part of the purchase of intangible assets that were recognized as subsequent acquisition
cost of the intangible assets acquired.
The payments
in connection with the license and collaboration
F-47
Annual Report on Form 20-F for the
year ended December 31, 2024
11
Property, Pla
nt and Equipment
|
(in millions €)
|
Land and
buildings
|
Equipment,
tools and
installations
|
Construction
in progress
and advance
payments
|
Total
|
||||||
|
Acquisition and production costs
|
||||||||||
|
As of January 1, 2023
|
|
|
|
|
||||||
|
Additions
|
|
|
|
|
||||||
|
Disposals
|
|
(
|
(
|
(
|
||||||
|
Reclassifications
|
|
|
(
|
|
||||||
|
Currency differences
|
(
|
(
|
(
|
(
|
||||||
|
Acquisition of subsidiaries and businesses
|
|
|
|
|
||||||
|
As of December 31, 2023
|
|
|
|
|
||||||
|
Additions
|
|
|
|
|
||||||
|
Disposals
|
(
|
(
|
|
(
|
||||||
|
Reclassifications
|
|
|
(
|
|
||||||
|
Currency differences
|
|
|
|
|
||||||
|
As of December 31, 2024
|
|
|
|
|
|
(in millions €)
|
Land and
buildings
|
Equipment,
tools and
installations
|
Construction
in progress
and advance
payments
|
Total
|
||||||
|
Cumulative depreciation and impairment
charges
|
||||||||||
|
As of January 1, 2023
|
|
|
|
|
||||||
|
Depreciation
|
|
|
|
|
||||||
|
Disposals
|
|
(
|
|
(
|
||||||
|
Currency differences
|
(
|
(
|
|
(
|
||||||
|
As of December 31, 2023
|
|
|
|
|
||||||
|
Depreciation
|
|
|
|
|
||||||
|
Impairment
|
|
|
|
|
||||||
|
Disposals
|
(
|
(
|
|
(
|
||||||
|
Currency differences
|
|
|
|
|
||||||
|
As of December 31, 2024
|
|
|
|
|
|
(in millions €)
|
Land and
buildings
|
Equipment,
tools and
installations
|
Construction
in progress
and advance
payments
|
Total
|
|||||
|
Carrying amount
|
|||||||||
|
As of December 31, 2023
|
|
|
|
|
|||||
|
As of December 31, 2024
|
|
|
|
|
F-48
Annual Report on Form 20-F for the
year ended December 31, 2024
Non-Current Assets by Region
As of
December 31, 2024
, non-current assets comprised
€
177.6
million
in other intangible assets, goodwill,
property, plant and equipment, right-of-use assets and other assets of our subsidiaries incorporated in the United
States (as of
December 31, 2023
:
€
158.2
million
) as well as
€
529.6
million
in the United Kingdom (as of
December 31, 2023
:
€
511.7
million
), respectively.
The
remaining non-current assets of
€
1,683.3
million
(as of
December 31, 2023
:
€
1,469.0
million
)
mainly relate to entities inco
rporated in Germany.
12
Financial Assets and Financial
Liabilities
Our capital management objectives are designed primarily to finance our growth strategy.
Our treasury committee reviews the total amount of
cash and cash equivalents
on a regular basis. As part of this
review, the committee considers total cash and cash equivalents, cash outflow, currency translation differences
and refinancing activities.
We monitor cash using a burn rate.
The cash burn rate is defined as the average
monthly net cash flow from operating and investing activities during a financial year.
|
(in millions €)
|
December 31, 2024
|
December 31, 2023
|
||||
|
Cash at banks and on hand
|
|
|
||||
|
Security investments disclosed as cash and cash equivalents
|
|
|
||||
|
Bank deposits
|
|
|
||||
|
Money market funds
|
|
|
||||
|
Reverse Repo
|
|
|
||||
|
Total
|
|
|
I
n general, the aim is to
protect and
maximize the financial resources available for further research and
development projects.
Since
December 2021, we have had an investment and asset management policy in place that contains policies
and processes for managing cash and cash equivalents. Under this policy, our investment portfolio is to be
maintained in a manner that minimizes risks to the invested capital. These risks include mainly credit risk and
concentration risk. The portfolio must provide liquidity in a timely manner to accommodate operational and
capital needs. The portfolio is managed by the Treasury department.
We are not subject to externally imposed capital requirements.
Our capital management objectives were
achieved in
the
years ended December 31, 2024 and 2023
.
F-49
Annual Report on Form 20-F for the
year ended December 31, 2024
Financial Assets and Liabilities at Amortized Cost and at Fair Value through OCI and Profit or Loss
profit or loss, as of the dates indicated:
|
December 31, 2024
|
||||||||||||||||||||||
|
Carrying amount
|
Fair value
|
|||||||||||||||||||||
|
(in millions €)
|
Current
|
Non-
current
|
Total
|
Level 1
(Fair value)
|
Level 2
(Fair value)
|
Level 3
(Fair value)
|
Total
|
|||||||||||||||
|
Financial assets subsequently measured at fair
value through profit or loss
|
||||||||||||||||||||||
|
Foreign exchange forward contracts
|
|
|
|
|
|
|
|
|||||||||||||||
|
Security investments disclosed as cash and cash
equivalents
|
|
|
|
|
|
|
|
|||||||||||||||
|
Other financial assets
|
|
|
|
|
|
|
|
|||||||||||||||
|
Financial assets subsequently measured at fair
value through OCI
|
||||||||||||||||||||||
|
Non-listed equity investments
|
|
|
|
|
|
|
|
|||||||||||||||
|
Listed equity investments
|
|
|
|
|
|
|
|
|||||||||||||||
|
Financial assets subsequently measured at
amortized costs
(1)
|
||||||||||||||||||||||
|
Security investments disclosed as other financial
assets
|
|
|
|
|
|
|
|
|||||||||||||||
|
Security investments disclosed as cash and cash
equivalents
|
|
|
|
|
|
|
|
|||||||||||||||
|
Cash at banks and on hand
|
|
|
|
|
|
|
|
|||||||||||||||
|
Trade and other receivables
|
|
|
|
|
|
|
|
|||||||||||||||
|
Reimbursement asset
|
|
|
|
|
|
|
|
|||||||||||||||
|
Other financial assets
|
|
|
|
|
|
|
|
|||||||||||||||
|
Financial liabilities subsequently measured at
fair value
|
||||||||||||||||||||||
|
Foreign exchange forward contracts
|
|
|
|
|
|
|
|
|||||||||||||||
|
Contingent consideration
|
|
|
|
|
|
|
|
|||||||||||||||
|
Financial liabilities subsequently measured at
amortized costs
(1)
|
||||||||||||||||||||||
|
Loans and borrowings
|
|
|
|
—
|
|
|
|
|||||||||||||||
|
Trade payables and other payables
|
|
|
|
—
|
|
|
|
|||||||||||||||
|
Other financial liabilities
|
|
|
|
—
|
|
|
|
|||||||||||||||
|
Financial liabilities subsequently not measured
according to IFRS 9
|
||||||||||||||||||||||
|
Lease liabilities
|
|
|
|
—
|
|
|
|
|||||||||||||||
(1)
Fair values for financial assets and liabilities at amortized costs are not disclosed as the book values represent a
reasonable approximation.
F-50
Annual Report on Form 20-F for the
year ended December 31, 2024
|
December 31, 2023
|
|||||||||||||||||||||
|
Carrying amount
|
Fair value
|
||||||||||||||||||||
|
(in millions €)
|
Current
|
Non-
current
|
Total
|
Level 1
(Fair value)
|
Level 2
(Fair value)
|
Level 3
(Fair value)
|
Total
|
||||||||||||||
|
Financial assets subsequently measured at fair
value through profit or loss
|
|||||||||||||||||||||
|
Security investments disclosed as cash and cash
equivalents
|
|
|
|
|
|
|
|
||||||||||||||
|
Financial assets subsequently measured at fair
value through OCI
|
|||||||||||||||||||||
|
Non-listed equity investments
|
|
|
|
|
|
|
|
||||||||||||||
|
Listed equity investments
|
|
|
|
|
|
|
|
||||||||||||||
|
Financial assets subsequently measured at
amortized costs
(1)
|
|||||||||||||||||||||
|
Security investments disclosed as other financial
assets
|
|
|
|
|
|
|
|
||||||||||||||
|
Security investments disclosed as cash and cash
equivalents
|
|
|
|
|
|
|
|
||||||||||||||
|
Cash at banks and on hand
|
|
|
|
|
|
|
|
||||||||||||||
|
Trade and other receivables
|
|
|
|
|
|
|
|
||||||||||||||
|
Other financial assets
|
|
|
|
|
|
|
|
||||||||||||||
|
Financial liabilities subsequently measured at fair
value
|
|||||||||||||||||||||
|
Foreign exchange forward contracts
|
|
|
|
|
|
|
|
||||||||||||||
|
Contingent consideration
|
|
|
|
|
|
|
|
||||||||||||||
|
Financial liabilities subsequently measured at
amortized costs
(1)
|
|||||||||||||||||||||
|
Loans and borrowings
|
|
|
|
—
|
|
|
|
||||||||||||||
|
Trade payables and other payables
|
|
|
|
—
|
|
|
|
||||||||||||||
|
Other financial liabilities
|
|
|
|
—
|
|
|
|
||||||||||||||
|
Financial liabilities subsequently not measured
according to IFRS 9
|
|||||||||||||||||||||
|
Lease liabilities
|
|
|
|
—
|
|
|
|
||||||||||||||
(1)
Fair values for financial assets and liabilities at amortized costs are not disclosed as the book values represent a
reasonable approximation.
Trade and other receivables
Trade and other receivables significantly decreased compared to the previous year and predominantly comprise
trade receivables from our COVID-19 collaboration with Pfizer as well as our direct product sales to customers in
our territory.
The contractual settlement of the gross profit share has a temporal offset of more than one calendar
quarter. As Pfizer’s financial quarter for subsidiaries outside the United States differs from ours, it creates an
additional time lag between the recognition of revenues and the payment receipt.
Consequently, as of
December 31, 2024
,
our trade receivables included, in addition to the profit share for the fourth quarter of 2024,
trade receivables which related to the gross profit share for the third quarter of 2024.
Reimbursement asset
For the
year ended December 31, 2024
, we recognized a reimbursement asset in the amount of
€
514.5
million
,
derived from the settlement as described below
under other financial liabilities
.
In connection with the Settlement Agreement with the
National Institutes of Health, or the
NIH
, Pfizer has agreed
to reimburse us for
$
364.5
million
(as of
December 31, 2024
, amounted to
€
350.9
million
)
of the claimed
royalties paid to the NIH for 2020-2023 sales under the Settlement Agreement.
In connection with the Term Sheet and the proposed Settlement Agreement with the
University of Pennsylvania,
or UPenn
, Pfizer has agreed to reimburse us for up to
$
170.0
million
(as of
December 31, 2024
, amounts to
F-51
Annual Report on Form 20-F for the
year ended December 31, 2024
€
163.6
million
) of the claimed royalties payable to UPenn for 2020-2023 sales in connection with the proposed
Settlement Agreement.
Other financial liabilities
During the
year ended December 31, 2024
, the other financial liabilities increased compared to the
year ended
December 31, 2023
, which is essentially related to the settlement of the contractual disputes with the NIH and
UPenn in the amount of
€
1,146.9
million
.
On December 20, 2024, we entered into a Settlement Agreement with the NIH. Under the terms of the
Settlement Agreement, we will,
among other things
, pay
$
791.5
million
(as of
December 31, 2024
, amounts to
€
761.9
million
) to the
NIH
.
On December 23, 2024, we entered into a binding Term Sheet with UPenn to provide terms on which we retain
license rights under certain UPenn patent rights in order to allow it to continue to pursue development and
commercialization of Licensed Products. Under the terms of the Term Sheet, we and
UPenn intend to enter into
a Settlement Agreement, pursuant to which we
would,
among other things
,
pay
$
400.0
million
(as of
December 31, 2024
, amounts to
€
385.0
million
) as
royalties for
calendar years 2020-2023 to UPe
nn as well as
$
52.0
million
as a contribution to a research and development investment fund to be jointly managed by us and
UPenn.
Equity investments designated at
Fair Value through OCI
the following effect
s
:
|
Years ended
December 31,
|
|||||||||
|
(in millions €)
|
2024
|
2023
|
2022
|
||||||
|
Net gain / (loss) on equity instruments designated at fair value through other
comprehensive income
|
(
|
|
|
||||||
|
Total
|
(
|
|
|
||||||
During the year ended
December 31, 2024
, the
non-listed and listed equity investments
increased by
€41.1 million
compared to year-end 2023 mainly due to our
investment in Autolus Therapeutics plc
in February
2024 and offsetting subsequent fair value changes amounting to
€
146.6
million
during the year ended
December 31, 2024
.
F-52
Annual Report on Form 20-F for the
year ended December 31, 2024
Measurement of fair values
consolidated statements of financial position, as well as the significant unobservable inputs used.
|
Type
|
Valuation technique
|
Significant unobservable inputs
|
||
|
Forward exchange contracts
|
Discounted cash flow using par method.
Expected future cash flows based on foreign
exchange forwards discounted over the
respective remaining term of the contracts
using the respective deposit interest rates
and spot rates.
|
n/a
|
||
|
Non-listed equity
investments
|
Quantitative and qualitative factors such as
actual and forecasted results, cash position
and financing round valuations.
|
–
Actual and forecasted results
–
Net Asset Value
–
Cash position
–
Nature and pricing indication of latest
financing round
|
||
|
Listed equity investments
|
Stock prices of the listed companies and
applicable exchange rates, if the listing is in
a foreign currency.
|
n/a
|
||
|
Money market funds
|
Quoted prices on an active market.
|
n/a
|
||
|
Contingent consideration
|
Present value of expected future payments
and reflecting changes in expected
achievement of underlying performance
parameters and compounding effects.
|
–
Expected future payments
–
Applied cost of capital
|
||
|
Royalty assets
|
Present value of expected future cash flows.
|
–
Expected future cash flows
–
Applied cost of capital
|
assets
as well as contingent considerations
and the effect of the measurements on our consolidated statements
of profit or loss for the current period.
|
Financial assets
|
Financial liabilities
|
||||||
|
(in millions €)
|
Other financial assets
|
Contingent
consideration
|
|||||
|
As of January 1, 2023
|
|
(
|
|||||
|
Additions
|
|
(
|
|||||
|
Net effect on profit or loss - Finance income / (expense)
|
|||||||
|
Net change in fair value
|
|
(
|
|||||
|
As of December 31, 2023
|
|
(
|
|||||
|
As of January 1, 2024
|
|
(
|
|||||
|
Additions
|
|
|
|||||
|
Disposals
|
|
|
|||||
|
Net effect on profit or loss - Finance income / (expense)
|
|||||||
|
Net change in fair value
|
(
|
(
|
|||||
|
As of December 31, 2024
|
|
(
|
F-53
Annual Report on Form 20-F for the
year ended December 31, 2024
variable input factors, with all other factors remaining constant, is shown in the following table:
Contingent consideration
|
Input factor
|
Change in
assumptions
|
Change in fair value with
increasing input factor
(in millions €)
|
Change in fair value with
decreasing input factor
(in millions €)
|
||||||
|
Cash flow projections
|
|
|
(
|
||||||
|
Discount rate
|
|
(
|
|
unobservable, variable input factors, with all other factors remaining constant, is shown in the following table:
Royalty assets
|
Input factor
|
Change in
assumptions
|
Change in fair value with
increasing input factor
(in millions €)
|
Change in fair value with
decreasing input factor
(in millions €)
|
||||||
|
Cash flow projections
|
|
|
(
|
||||||
|
Discount rate
|
|
(
|
|
The estimated fair value of non-listed equity investments would, for example, increase (decrease) if the price of
the latest financing round of the respective investment were to increase (decrease) and the overall company
value were higher (lower).
Our financial liabilities mainly comprise obligations derived from other financial liabilities such as obligation from
transactions with li
censors,
trade and other payables,
lease liabilities, contingent
consideration
, liabilities from
exchanges forward contracts
.
The main purpose of these financial liabilities is to enable our operations. Our
principal financial assets include mainly cash, security investments, trade receivables and reimbursement assets
that derive directly from our operations.
We are exposed to market risk, credit risk and liquidity risk. Our Management Board oversees the management
of these risks.
The treasury committee provides assurance to our Management Board that our financial risk activities are
governed by appropriate policies and procedures and that financial risks are identified, measured and managed
in accordance with our policies and risk objectives.
The Management Board reviews and agrees policies for
managing each of these risks, which are summarized below.
Market risks address the risks that the fair value or future cash flows of a financial instrument will fluctuate due to
changes in market prices. Market risks comprise three types of risk: interest risks, foreign currency risks and
other price risks. Financial instruments affected by market risks include financial assets such as security
investments, trade and other receivables, cash and cash equivalents as well as financial liabilities such as trade
payables and other financial liabilities.
We do not consider interest risks as well as other price risks as material
risks to us.
There were no material changes in the way the risks were managed and valued during the
years ended
December 31, 2024 and 2023
.
F-54
Annual Report on Form 20-F for the
year ended December 31, 2024
Foreign Currency Risks
Foreign currency risks address the risks that the fair value or future cash flows of an exposure will fluctuate
because of changes in foreign exchange rates.
We are subject to currency risks, as our income and
expenditures are denominated in Euro and the U.S. dollar. As such, we are exposed to exchange rate
fluctuations between these currencies.
Cash inflows denominated in U.S. dollar mainly result from generating
proceeds under our collaboration agreements.
Our commercial revenues are primarily collaboration revenues
from earnings based on our partners’ gross profit, which is shared under the respective collaboration agreements
and represents payments we receive in U.S. dollar.
Cash outflows dominated in U.S. dollar mainly result from
amounts spent on research and development activities and license obligations as well as expanding our global
footprint further. With the aim of preserving capital, surplus liquidity is mainly invested in domestic currency
investments as exchange rate fluctuations can reduce the value of our financial positions. We limit the effects of
the identified risks by means of a coordinated and consistently implemented risk strategy. Besides applying
natural hedging relationships where possible, foreign exchange forward contracts are concluded, as a matter of
principle, as instruments to mitigate foreign currency exchange risk associated with foreign currency-
denominated payments.
However
, t
he foreign exchange forward contracts which we entered into were not
designated as hedging instruments under IFRS.
as follows:
|
(in millions €)
|
December 31, 2024
|
December 31, 2023
|
||||
|
Cash and cash equivalents in U.S. dollar
|
|
|
||||
|
Monetary assets in U.S. dollar
|
|
|
||||
|
Monetary liabilities and provisions in U.S. dollar
|
|
|
||||
|
Total
|
|
|
or U.S. dollar forward rates, with all other variables held constant. The impact on our profit before tax is due to
changes in the fair value of monetary assets and liabilities. The exposure to foreign currency changes for all
other currencies is not material.
|
1 € =
|
Closing rate
|
Average rate
|
|||||||||||||
|
Currency
|
Country
|
2024
|
2023
|
2024
|
2023
|
||||||||||
|
U.S. dollar
|
United States
|
|
|
|
|
||||||||||
|
(in millions €)
|
Change in U.S.
dollar rate
|
Effect on profit /
(loss) before tax
|
Effect on pre-tax
equity
|
||||
|
2024
|
+5 %
|
(
|
(
|
||||
|
-5 %
|
|
|
|||||
|
2023
|
+5 %
|
(
|
(
|
||||
|
-5 %
|
|
|
Credit risks address the risks that a counterparty will not meet its obligations under a financial instrument or
customer contract, leading to a financial loss. We are exposed to credit risks from our operating activities,
including security investments, bank deposits, reverse repos, foreign exchange transactions, trade and other
receivables and
cash at bank
s. The maximum exposure to credit risk for the components of the consolidated
F-55
Annual Report on Form 20-F for the
year ended December 31, 2024
statements of financial position as of
December 31, 2024
, and
December 31, 2023
, are the carrying amounts as
illustrated in Note
12.1
and Note
12.2
.
Security Investments,
Bank Deposits, Reverse Repos
and
Cash
at banks
Our financial management is dedicated predominantly to the goal of capital preservation. Thus, all our financial
activities are focused towards avoiding risks and, where they cannot be avoided, actively managing and
minimizing them.
Credit risks from balances with security investments, bank deposits, reverse repos and cash at
banks are managed by our Treasury department in accordance with our investment and asset management
policy.
Our security investments are solely invested in the highest-quality liquid assets (e.g. core European sovereign,
supranational and agency bonds) and bank deposits with a maturity of more than 3 months (held at selected
banks, exclusively rated as investment grade). They do not bear any currency risks or material credit risks. The
bank deposits are held at selected banks, exclusively rated as investment grade. We limit our investment
engagements individually and track each credit risk continuously. For reverse repos, only investment-grade
counterparties qualify as our business partners and secured investments are solely collateralized by high-quality
liquid assets.
Accordingly,
credit risks from these financial assets are limited. Before entering into new business relationships
and during ongoing business relationships, we evaluate our business partners with regard to their individual
default risk. Therefore, we do not presume an increased credit risk as of the balance sheet date and determine
the impairment loss based on the upcoming twelve months.
The calculated expected credit losses
were
not material as of
December 31, 2024
, and
December 31, 2023
.
Trade and Other Receivables
Our exposure to credit risks of trade a
nd other
receivables is primarily related to transactions with corporate
customers in the biopharma / biotech industry that operate in the United States or Germany,
as well as
governments which are customers
, in connection with fulfilling our commercial obligations in our territories as
defined in our contracts with customers.
An analysis of the aging of receivables
and the creditworthiness of
customers is used to evaluate this risk at each reporting date. We follow risk control procedures to assess the
credit quality of our customers taking into account their financial position, past experience and other factors.
As of
December 31, 2024
, outstanding trade and other receivables were mainly due from our collaboration
partner Pfizer. Besides well-established pharmaceutical companies and governmental institutions, our other
customers – to a smaller extent – are medical universities, other public institutions and peers in the biopharma
industry. The balances with those customers are not material
.
Due to this customer portfolio, the credit risk on
trade and other receivables is generally very low. We have not incurred material bad debt expense and do not
expect that this will change with respect to the trade and other receivables outstanding as of
December 31,
2024
.
The expected credit risk on trade
and other receivables and contract assets
derived from a
pplying the simplified
approach in
calculating expected credit losses
was not materia
l
as of
December 31, 2024
, and
December 31,
We plan to invest heavily in R&D as we make a strong drive to build out our global development organization
and diversify our therapeutic area footprint. Additionally, we plan to enhance capabilities through complementary
acquisitions, technologies, infrastructure and manufacturing.
Our liquidity management ensures the availability of
c
ash and cash equivalent
s, short term financial instruments for operational activities and further investments
through appropriate budget planning. In addition, a sufficient level of cash and cash equivalents, which are
managed centrally, is always maintained to finance the operational activities.
We monitor liquidity risks using a liquidity planning tool.
F-56
Annual Report on Form 20-F for the
year ended December 31, 2024
Ultimately, the responsibility for liquidity risk management lies with our Management Board, which has
established an appropriate approach to managing short-, medium- and long-term financing and liquidity
requirements. We manage
l
iquidity risks by holding appropriate reserves based on our COVID-19 sales
,
as well
as by monitoring forecasted and actual cash flows and reconciling the maturity profiles of financial assets and
liabilities. Significant reserves currently exist and were generated during the Covid-19 pandemic.
Risk Concentration
Concentrations arise when the number of
counterparties is small or when a larger number of counterparties is
engaged in similar business activities, or activities in the same geographical region, or has economic features
that would cause their ability to meet contractual obligations to be affected similarly by changes in economic,
political or other conditions. Concentrations indicate the relative sensitivity of our performance to developments
affecting a particular industry. We only have a limited number of customers mainly comprising pharmaceutical
companies and governmental institutions.
follows:
|
Year ended December 31, 2024
|
||||||||
|
(in millions €)
|
Less than
1 year
|
1 to 5
years
|
More than
5 years
|
Total
|
||||
|
Trade and other payables
|
|
|
|
|
||||
|
Lease liabilities
|
|
|
|
|
||||
|
Contingent consideration
|
|
|
|
|
||||
|
Foreign exchange forward contracts
|
|
|
|
|
||||
|
Other financial liabilities
|
|
|
|
|
||||
|
Total
|
|
|
|
|
||||
|
Year ended December 31, 2023
|
||||||||
|
(in millions €)
|
Less than
1 year
|
1 to 5
years
|
More than
5 years
|
Total
|
||||
|
Loans and borrowings
|
|
|
|
|
||||
|
Trade and other payables
|
|
|
|
|
||||
|
Lease liabilities
|
|
|
|
|
||||
|
Contingent consideration
|
|
|
|
|
||||
|
Foreign exchange forward contracts
|
|
|
|
|
||||
|
Other financial liabilities
|
|
|
|
|
||||
|
Total
|
|
|
|
|
F-57
Annual Report on Form 20-F for the
year ended December 31, 2024
|
Year ended December 31, 2024
|
||||||||||||||
|
(in millions €)
|
January 1,
2024
|
Cash flows
|
New leases
and
disposals
|
Reclassifi-
cation
|
Other
|
December
31, 2024
|
||||||||
|
Current obligations under
lease contracts
|
|
(
|
|
|
|
|
||||||||
|
Non-current obligations
under lease contracts
|
|
|
|
(
|
|
|
||||||||
|
Loans and borrowings
|
|
(
|
|
|
|
|
||||||||
|
Total
|
|
(
|
|
|
|
|
||||||||
|
Year ended December 31, 2023
|
|||||||||||||
|
(in millions €)
|
January 1,
2023
|
Cash flows
|
New leases
and
disposals
|
Reclassifi-
cation
|
Other
|
December
31, 2023
|
|||||||
|
Current obligations under
lease contracts
|
|
(
|
(
|
|
(
|
|
|||||||
|
Non-current obligations
under lease contracts
|
|
|
|
(
|
(
|
|
|||||||
|
Loans and borrowings
|
|
|
|
|
|
|
|||||||
|
Total
|
|
(
|
|
|
(
|
|
|||||||
13
Inventories
|
(in millions €)
|
December 31, 2024
|
December 31, 2023
|
||||
|
Raw materials and supplies
|
|
|
||||
|
Unfinished goods
|
|
|
||||
|
Finished goods
|
|
|
||||
|
Total
|
|
|
During
the
year ended December 31, 2024
,
expenses from inventory write-downs to net realizable value and
scrapings due to inventories expected to be unsellable, not fulfilling the specification defined by our quality
standards and shelf-life expiry resulted
in
€
125.8
million
, compared to
€
94.5
million
in the previous period.
The
inventories valued at net realizable value in our consolidated statements of financial position as of
December 31,
2024
, take contractual c
ompensation payments into consideration.
We have not pledged any inventories as
securities for liabilities.
During the
years ended December 31, 2024 and 2023
, inventories in the amount of
F-58
Annual Report on Form 20-F for the
year ended December 31, 2024
14
Other Non-Financial Assets
|
(in millions €)
|
December 31, 2024
|
December 31, 2023
|
||||
|
Deferred expenses
|
|
|
||||
|
Prepayments related to service contracts
|
|
|
||||
|
Other
|
|
|
||||
|
Total
|
|
|
||||
|
Total current
|
|
|
||||
|
Total non-current
|
|
|
Deferred expenses mainly comprise prepayments for future expenses of
€
83.1
million
(
€
151.1
million
as of
December 31, 2023
) for the
settlement fee of the European Commission to our collaboration partne
r and
prepayments for our collaborations with
Ryvu Therapeutics S.A., Krakow, Poland,
€
8.5
million
(
€
15.7
million
as
of
December 31, 2023
) and MediLink Therapeutics Co., Ltd, Suzhou, China,
€
17.7
million
(
nil
as of
December 31, 2023
). T
he remaining deferred expenses mainly comprise insurance obligations o
f
€
18.2
million
15
Issued Capital and
Reserves
As of
December 31, 2024
, the number of shares outstanding was
239,970,804
. This amount excludes
F-59
Annual Report on Form 20-F for the
year ended December 31, 2024
16
S
hare-Based
Payments
following
expense
s
:
|
Years ended
December 31,
|
||||||||||
|
(in millions €)
|
Note
|
2024
|
2023
|
2022
|
||||||
|
Expense arising from equity-settled share-based
payment arrangements
|
|
|
|
|||||||
|
Employee Stock Ownership Plan
|
16.5
|
|
|
|
||||||
|
Chief Executive Officer Grant
|
16.4
|
|
|
|
||||||
|
Management Board Grant
(1)
|
16.3
|
|
|
|
||||||
|
BioNTech 2020 Employee Equity Plan for
Employees Based Outside North America
|
16.1
|
|
|
|
||||||
|
InstaDeep Employee Incentive Plan
(2)
|
16.1, 16.5
|
|
|
|
||||||
|
2024 North America Employee Participation Plan
|
16.1
|
|
|
|
||||||
|
Expense / (Income) arising from cash-settled
share-based payment arrangements
|
|
|
|
|||||||
|
Employee Stock Ownership Plan
|
16.5
|
|
(
|
|
||||||
|
Management Board Grant
(1)
|
16.2, 16.3
|
|
(
|
|
||||||
|
BioNTech 2020 Restricted Stock Unit Plan for North
America Employees
|
16.1
|
|
|
|
||||||
|
Total
|
|
|
|
|||||||
|
Cost of sales
|
|
|
|
|||||||
|
Research and development expenses
|
|
|
|
|||||||
|
Sales and marketing expenses
|
|
|
|
|||||||
|
General and administrative expenses
|
|
|
|
|||||||
|
Total
|
|
|
|
|||||||
(1)
In May 2022, phantom options were granted under the Management Board Grant for the year 2022 which led to a
modification from an equity-settled to cash-set
tled share-based payment arrangement and a reclassification of
€
3.3
million
between equity and non-current other liabilities, respectively. Expenses incurred before and after the
modification dates have been disclosed as equity-settled or cash-settled share-based payment arrangement,
respectively.
The amount includes expenses incurred with respect to a one-time signing bonus granted to Jens Holstein
and Annemarie Hanekamp as of their appointment to the Management Board (see Note
21.2
).
(2)
The first tranche of
40,249
RSUs vested in July 2024 and was settled in the
three months ended December 31, 2024
, in
cash.
During the years ended
December 31, 2024
,
2023
and
2022
, our share-based payment arrangements led to a
cash outflow of
€
154.5
million
,
€
766.2
million
and
€
51.8
million
, respectively. We expect to settle the equity-
settled share-based payment arrangements remaining from our
2020 Management Board Grant (see Note
16.3
)
and the Employee Stock Ownership Plan (see Note
16.5
)
on a net basis by delivering to the participant a
number of ADSs equal to the net value of the exercised option rights after deduction of (i) the exercise price and
(ii) the applicable wage taxes (including solidarity surcharge thereon and church tax, if applicable) and social
security contributions resulting from such exercise.
This reduces the dilutive impact of the respective rights
compared to an all-equity settlement.
If all of the equity-settled rights outstanding as of
December 31, 2024
,
were to be exercised accordingly,
the cash outflow to the tax authority in
2025
would amount to approximately
€
9.9
million
(based
on the share price as of
December 31, 2024
).
F-60
Annual Report on Form 20-F for the
year ended December 31, 2024
BioNTech 2020 Employee Equity Plan for Employees Based Outside North America (Equity-Settled)
In December 2020, we approved
the BioNTech 2020 Employee Equity Plan for employees based outside North
America, or the European Plan.
Under the European Plan, Restricted Stock Units,
or
RSUs
, ar
e offered to our
employees.
Award agreements were entered as of the respective grant dates in February 2021 (LTI 2020), January 2022
(LTI 2021 program), December 2022 (LTI 2022 program) and January 2024 (LTI 2023).
RSUs
issued under the
LTI 2020, LTI 2021, LTI 2022 and LTI 2023 programs vest annually in equal installments over respective waiting
periods of
four years
,
commencing in December 2020, December 2021, December 2022 and December 2023,
respectively. All programs were classified as equity-settled as we have the ability to determine the method of
settlement.
The fair values of the awards issued under the European Plan were based upon the price of our ADSs
representing ordinary shares at the grant
date
.
|
LTI 2020 program
|
LTI 2021 program
|
LTI 2022 program
|
LTI 2023 program
|
|||||||
|
Weighted average fair value
|
€
|
€
|
€
|
€97.99
|
||||||
|
Waiting period (in years)
|
|
|
|
4.0
|
The RSUs outstanding as of the respective dates are presented in the table below.
|
LTI 2020 program
|
LTI 2021 program
|
LTI 2022 program
|
LTI 2023 program
|
|||||||
|
As of January 1, 2023
|
|
|
|
—
|
||||||
|
Forfeited / Modified
|
(
|
(
|
(
|
—
|
||||||
|
As of December 31, 2023
|
|
|
|
—
|
||||||
|
As of January 1, 2024
|
|
|
|
—
|
||||||
|
Granted / Allocated
|
|
|
|
834,211
|
||||||
|
Settled
|
(
|
|
|
—
|
||||||
|
Forfeited / Modified
|
(
|
(
|
(
|
(62,902)
|
||||||
|
As of December 31, 2024
|
|
|
|
771,309
|
||||||
|
thereof vested
|
|
|
|
194,636
|
||||||
|
thereof unvested
|
|
|
|
576,673
|
(1)
The closing price of an American Depositary Share of BioNTech on Nasdaq o
n December 13, 2024, the last trading day
before the settlement date, converted from USD to Euro using the exchange rate published by the German Central Bank
(
Deutsche Bundesbank
) on the same day was
€114.45
.
BioNTech
2024 North America Employee Participation Plan
(Equity-Settled)
During the
year ended December 31, 2024
, a new long-term incentive program for employees resident in North
America was established. Within this plan, BioNTech SE has granted RSUs and Performance-RSUs (for
individuals at the Job Level Vice President or above) with an equity-based LTI program to all of their employees.
The number of RSUs granted to each participant is determined by multiplying the eligible earnings by a
percentage within the applicable range for such individual’s BioNTech Job Level and dividing such amount by the
Share Price at
Grant
, rounding the result down to the nearest whole number. The number of PRSUs is subject to
adjustments based on the performance of BioNTech ADSs against the Nasdaq Biotechn
ology Index (Index). In
May 2024,
356,757
RSUs and
34,481
PRSUs were granted to the participants. In December 2024,
47,115
further RSUs were granted to New-Joiners. The weighted average fair value at grant dates was
€
93.00
. Between
F-61
Annual Report on Form 20-F for the
year ended December 31, 2024
the grant date in May and December 31, 2024,
24,284
RSUs and
2,915
PRSUs were forfeited.
As of
December 31, 2024
,
379,588
RSUs and
31,566
PRSUs
are outstanding.
All RSUs, except the PRSUs, shall vest with annually in equal tranches of
25
%
over a period of
4
years
, starting
from the date of the grant. In contrast to the German LTI employee programs 2020-2023, there is no 4-year
waiting period.
InstaDeep RSU Program Employees (
Partly Equity-Settled, Partly Cash-Settled
)
As part of the acquisition of InstaDeep in
2023
, it was agreed to issue a long-term RSU award with a total target
incentive value of
£
15.0
million
. The start of the vesting period was July
2023
. The
160,997
RSUs
granted
under
this award vest annually in equal tranches of
25
%
over a period of
4
years
. There is no waiting period and each
tranche will be settled with vesting. The weighted average fair value at grant date was
€
92.08
.
The first tranche of
40,249
RSUs vested in July 2024 and was settled in the three months ended December 31,
2024, in cash. As of
December 31, 2024
,
120,748
RSUs were outstanding. The gross payout amount of the
settlement of the first tranche was
€
2.1
million
. The program is accounted for as equity-settled and it is at the
discretion of the company whether the following three tranches will be settled in equity or in cash in the years
2025-2027.
BioNTech 2020 Restricted Stock Unit Plan for North America Employees (Cash-Settled)
In December 2020, we approved
the BioNTech 2020 Restricted Stock Unit Plan for North America Employees, or
the North American Plan. Under the North American Plan, RSUs are offered to our employees. These RSUs vest
over
four years
, with
25
%
vesting one year after the service commencement date and the remainder vesting in
equal quarterly installments thereafter. The first awards under the North American Plan were granted in February
2021
. The service date for these awards is the date as of which the employee became employed by BioNTech
US. As these RSUs are intended to be cash-settled upon vesting, the awards were defined as a cash-settled
share-based payment arrangement. During the years ended
December 31, 2024
,
2023
and
2022
,
the settlement
of RSUs resulted in a cash outflow o
f
€
13.9
million
,
€
10.0
million
and
€
9.4
million
,
r
espectively.
As of
December 31, 2024
, the liability related to these awards amounted to
€
11.2
million
(
€
14.4
million
as of
Management Board’s service agreements also include an STI compensation component, which is an annual
performance-related bonus for the years of their respective service periods.
Supervisory Board has approved the consolidated financial statements of the Company for the financial / bonus
year that is relevant for the determination of the STI (first installment). The remaining
50
%
of each annual
award
is paid out one year after the achievement of the performance targets for the respective bonus year has been
determined, subject to an adjustment relative to the performance of the price of the American Depositary Shares
representing our ordinary shares during that year (
second
installment). The second installments represent
cash-
settled share-based payment arrangements. The fair values of the liabilities are recognized over the awards’
vesting periods beginning when entering or renewing service agreements, i.e., the service commencement date,
until each separate determination date and are remeasured until the settlement date.
As of
December 31, 2024
,
Our Management Board’s service agreements provide for long-term,
four
-year incentive compensation
(Management Board Grant - LTI) through an annual grant of options to acquire BioNTech shares at the end of
the respective waiting periods of such agreements.
The options are subject to the terms and conditions of the
respective authorizations of the AGM creating our Employee Stock Ownership Plan, or ESOP, and the applicable
option agreements
.
F-62
Annual Report on Form 20-F for the
year ended December 31, 2024
The options vest annually in equal installments over
four years
commencing on the first anniversary of the
allocation date and are exercisable
four years
after the allocation date.
Vested options can only be exercised if
each of the following performance criteria has been achieved: (i) at the time of exercise, the current price is
equal to or greater than the threshold amount (that is, the exercise price, provided that such amount increases
by
seven
percentage points on each anniversary of the allocation date); (ii) at the time of exercise, the current
price is at least equal to the target price (that is, (a) for the twelve-month period starting on the fourth anniversary
of the allocation date,
$
8.5
billion
divided by the total number of the ordinary shares outstanding immediately
following the initial public offering (other than ordinary shares owned by BioNTech), and (b) for each twelve-
month period starting on the fifth or subsequent anniversary of the allocation date,
107
%
of the target share price
applicable for the prior twelve-month period); and (iii) the closing price for the fifth trading day prior to the start of
the relevant exercise window is higher than the exercise price by at least the same percentage by which the
Nasdaq Biotechnology Index (or a comparable successor index) is higher than it was on the last trading day
before the allocation date. Following the expiry of the waiting period, option rights may be exercised during the
exercise windows set out in the ESOP agreement. Option rights can be exercised up to
ten years
after the
allocation date, after which they will be forfeited without compensation.
The right to receive options generally represents an equity-settled share-based payment arrangement.
The
allocation of options in 2020 occurred in February 2020. In May 2021 and May 2022, Management Board
members received phantom options equivalent to the number of options they would have been entitled to
receive for 2021 and 2022
,
which led to a
modificatio
n from equity-settled to cash-settled share-based payment
arrangement and a reclassification of
€
1.1
million
and
€
3.3
million
between equity and non-current other
liabilities as of the respective allocation dates
. During 2023 and 2024, options were granted in May 2023 and
August 2024, respectively.
A Monte-Carlo simulation model has been used to measure the fair values at the (estimated) allocation dates of
the Management Board Grant. This model incorporates the impact of the performance criteria regarding share
price and index development described above.
The parameters used for measuring the fair values as of the
respective (estimated) allocation
dates were as
follows
:
|
Allocation date
February 2020
|
Allocation date
May 12, 2021
(1)
|
Allocation date
May 17, 2021
(1)
|
Allocation date
May 2022
(1)
|
Allocation date
May 2023
|
Allocation date
August 2024
|
|||||||||
|
Weighted average
fair value
|
€
|
€
|
€
|
€
|
€
|
€
|
||||||||
|
Weighted average
share price
|
€
|
€
|
€
|
€
|
€
|
€
|
||||||||
|
Exercise price
(2)
|
€
|
€
|
€
|
€
|
€
|
€
|
||||||||
|
Expected volatility
|
|
|
|
|
|
|
||||||||
|
Expected life (years)
|
|
|
|
|
|
|
||||||||
|
Risk-free interest
rate
|
|
|
|
|
|
|
(1)
Classified as cash-settled share-based payment arrangement; all other share-based payment arrangements are
classified as equity-settled.
(2)
The share options allocated as of February 2020 and May 2023 as well as the phantom share options allocated as of
May 2021 and 2022 are subject to an effective exercise price cap.
For the awards with estimated allocation dates, the exercise prices of options expected to be allocated have
been derived from the Monte-Carlo simulation model. Those will be adjusted until the actual allocation has
occurred and the exercise price has ultimately been determined.
F-63
Annual Report on Form 20-F for the
year ended December 31, 2024
|
Estimated allocation
date 2025
|
Estimated allocation
date 2026
|
Estimated allocation
date 2027
|
Estimated allocation
date 2028
|
|||||||
|
Weighted average fair value
(1)
|
€
|
€
|
€
|
|
||||||
|
Weighted average share price
(1)
|
€
|
€
|
€
|
€
|
||||||
|
Exercise price
(1)
|
€
|
€
|
€
|
€
|
||||||
|
Expected volatility
|
|
|
|
|
||||||
|
Expected life (years)
(1)
|
|
|
|
|
||||||
|
Risk-free interest rate
|
|
|
|
|
(1)
Valuation parameter for estimated allocation dates derived from the Monte-Carlo simulation model.
All options are subject to an effective exercise price cap, which means that the exercise price shall be adjusted
to ensure that the current price of an ADS as of the exercise date does not exceed
800
%
of the exercise price.
For the LTI 2020, the maximum economic benefit receivable is capped at
$
246.24
, and the effective exercise
price is capped at a Euro amount equivalent to
$
30.78
. For the phantom share options issued under the LTI
2021 and 2022 programs and the options issued under the LTI 2023 and 2024 programs, the maximum
compensation that each member is entitled to receive, together with other compensation components received in
the respective grant year, shall not exceed
€
20.0
million
for Ugur Sahin and
€
10.0
million
for all others.
Expected volatility was based on an evaluation of the historical volatilities of comparable companies over the
historical period commensurate with the expected option term. The expected term was based on general option
holder behavior for employee options.
indicated are presented in the table below.
|
Allocation
date
February
2020
|
Allocation
date May 12,
2021
(1)
|
Allocation
date May 17,
2021
(1)
|
Allocation
date May
2022
(1)
|
Allocation
date May
2023
|
Allocation
date August
2024
|
|||||||||
|
(Phantom) share options outstanding
as of January 1, 2023
|
|
|
|
|
|
|
||||||||
|
Granted / Allocated
|
|
|
|
|
|
|
||||||||
|
(Phantom) share options outstanding
as of December 31, 2023
|
|
|
|
|
|
|
||||||||
|
(Phantom) share options outstanding
as of January 1, 2024
|
|
|
|
|
|
|
||||||||
|
Granted / Allocated
|
|
|
|
|
|
|
||||||||
|
Exercised
(2)
|
(
|
|
|
|
|
|
||||||||
|
Forfeited / Modified
|
|
(
|
|
(
|
(
|
(
|
||||||||
|
(Phantom) share options outstanding
as of December 31, 2024
|
|
|
|
|
|
|
||||||||
|
thereof allocated and vested but
subject to performance and/or waiting
requirements
|
|
|
|
|
|
|
||||||||
|
thereof allocated and unvested
|
|
|
|
|
|
|
(1)
Classified as cash-settled share-based payment arrangement; all other share-based payment arrangements are
classified as equity-settled.
(2)
The average closing price of an American Depositary Share of BioNTech on Nasdaq weighted over the various dates
immediately preceding the settlement dates, converted from USD to Euro using the exchange rate published by the
German Central Bank (Deutsche Bundesbank) on the same days was
€75.00
for all options exercised in 2024.
F-64
Annual Report on Form 20-F for the
year ended December 31, 2024
For the awards with estimated allocation dates, the numbers of options expected to be allocated have been
derived from a Monte-Carlo simulation model. Those will be adjusted until the actual allocation has occurred and
the number of options granted has ultimately been determined.
The share options expected to be allocated to our Management Board as of the dates indicated are presented in
the table below.
|
Estimated
allocation date
2025
(1)
|
Estimated
allocation date
2026
(1)
|
Estimated
allocation date
2027
(1)
|
Estimated
allocation date
2028
(1)
|
|||||||
|
Share options estimated to be allocated
|
|
|
|
|
As of
December 31, 2024
, the share options allocated and expected to be
allocated under our equity-settled
share-based payment arrangements had
a remaining weighted average
expected
life
o
f
5.0
years
(as of
December 31, 2023
:
4.1
years
)
.
As of
December 31, 2024
, the
liability related to the phantom option awards amounted to
€
5.1
million
(
€
3.6
In September 2019, we granted Prof. Ugur Sahin, M.D., an option to purchase
4,374,963
of our shares under the
ESOP 2017/2019 program. All of these option rights vested and became exercisable in 2023, and were
exercised on August 9, 2024, with an exercise price for each option of
€
13.74
(
$15.00
)
calculated using the
foreign exchange rate published by the German Central Bank (Deutsche Bundesbank) on the day before the
exercise date and by applying the effective exercise cap and the maximum cap mechanism as disclosed above.
The closing price of one ADS on Nasdaq on the settlement date converted from U.S. Dollars to Euro using the
exchange rate published by the German Central Bank (Deutsche Bundesbank) on the same day was
€
73.68
and
led to an intrinsic value of the exercised options of
€
259.5
million
.
In August 2024, the Supervisory Board determined that the award would be settled by the delivery of treasury
shares (in the form of ADSs) equal to the net value of the exercised option rights after deduction of (i) the
exercise price and (ii) the applicable wage taxes (including solidarity surcharge and church tax, if applicable) and
social security contributions resulting from the exercise. The applicable taxes and social security contributions
resulting from and withheld upon the exercise amounted to
€
123.2
million
and were paid by us in September
2024 in cash directly to the respective authorities. The settlement mechanism decision changed neither the
rights nor the classification of the grant as equity-settled. As a result of the settlement, no additional share-based
payments under IFRS 2 were recorded during the year ended December 31, 2024.
Employee Stock Ownership Plan
(Equity-Settled)
Based on an authorization of the general meeting on August 18, 2017, we established a share option program
under which we granted selected employees options to receive our shares. The program is designed as an
Employee Stock Ownership Plan, or ESOP. We offered participants a certain number of option rights by their
explicit acceptance of an option rights agreement. The exercise of option rights in accordance with the
agreement gives the participants the right to obtain shares against payment of the exercise price. With respect to
the Management Board members serving at the time of allocation, the options are subject to the effective
exercise price cap and maximum cap mechanisms. Under the exercise price cap, the exercise price shall be
adjusted to ensure that the current price of an ADS as of the exercise date does not exceed
800
%
of the
exercise price. Under the maximum cap mechanism, the maximum economic benefit receivable in respect of any
exercised option, was capped at
$
240.00
, with the effective exercise price being capped at a Euro amount
equivalent to
$
30.00
. Under the ESOP, the option rights (other than Özlem Türeci’s, and Ryan Richardson’s
options) fully vest after
four years
and can be exercised if: (i) the waiting period of
four years
has elapsed; and
F-65
Annual Report on Form 20-F for the
year ended December 31, 2024
(ii) at the time of exercise, the average closing price of the shares of the Company or the average closing price
of the right or certificate to be converted into an amount per share on the previous ten trading days preceding the
exercise of the option right exceeds the strike price by a minimum of
32
%
, with this percentage increasing by
anniversary date.
Following the expiry of the waiting period, option rights may be exercised within a period of
four weeks from the date of the Annual General Meeting or the publication of the annual financial statements, the
semi-annual report or our most recent quarterly report or interim report (exercise windows).
The option rights can
be exercised up to eight years after the allocation date. If they have not been exercised by that date, they will be
forfeited without compensation.
By way of a shareholders’ resolution of the general meeting on August 19, 2019, the authorization to issue such
option rights was amended such that, in order for the options to be exercisable, the average closing price of the
Company’s shares or the average closing price of the right or certificate to be converted into an amount per
share on the ten trading days immediately preceding the exercise must exceed the strike price by a minimum of
as of each subsequent anniversary date. Furthermore, in addition to the aforementioned requirements, the
exercise is only possible if the share price (calculated by reference to the price of the ordinary share underlying
the ADS) has performed similar to or better than the Nasdaq Biotechnology Index. The changes made do not
affect option rights already issued.
The fair value of the ESOP has been measured using a binomial model. Service conditions attached to the
arrangement were not taken into account in measuring the fair value.
The share options can only be exercised by the grantee if the price of the share is equal or greater to the
threshold amount as defined in the ESOP agreement. Moreover, the option rights can only be exercised if the
IPO has occurred. Both conditions have been incorporated into the fair value at the grant date.
|
Grant date
November 15, 2018
|
Grant dates between
February 21 and
April 3, 2019
|
|||||
|
Weighted average fair value
|
€
|
€
|
||||
|
Weighted average share price
|
€
|
€
|
||||
|
Exercise price
(1)
|
€
|
€
|
||||
|
Expected volatility
|
|
|
||||
|
Expected life (years)
|
|
|
||||
|
Risk-free interest rate
|
|
|
(1)
With respect to the Management Board members appointed as such at the time the options were granted, the options are
subject to the effective exercise price cap as well as the maximum cap mechanism.
Expected volatility has been based on an evaluation of the historical and the implied volatilities of comparable
companies over the historical period commensurate with the expected term. The expected term has been based
on general option holder behavior for employee options.
F-66
Annual Report on Form 20-F for the
year ended December 31, 2024
these options that occurred during the periods
indicated
:
|
Share options
outstanding
|
Number of ordinary
shares underlying
options
|
Weighted average
exercise price (€)
(1)
|
||||||
|
As of January 1, 2023
|
|
|
|
|||||
|
Exercised
(2)
|
(
|
(
|
|
|||||
|
As of December 31, 2023
|
|
|
|
|||||
|
As of January 1, 2024
|
|
|
|
|||||
|
Exercised
(2)
|
(
|
(
|
|
|||||
|
As of December 31, 2024
|
|
|
|
|||||
|
thereof vested
|
|
|
|
|||||
|
thereof unvested
|
|
|
|
(1)
With respect to the Management Board members appointed as such at the time the options were granted, the options are
subject to the effective exercise price cap as well as the maximum cap mechanism.
(2)
The average closing pric
e
of an American Depositary Share of BioNTech on Nasdaq weighted over the various dates
immediately preceding the settlement dates, converted from USD to Euro using the exchange rate published by the
German Central Bank (Deutsche Bundesbank) on the same days was
€
83.45
and
€
96.49
for all settlements during the
years ended December 31, 2024 and 2023
, respectively.
In September 2022, the Supervisory Board determined the ESOP settlement by the delivery of treasury shares
(in the form of ADSs) equal to the net value of the exercised option rights after deduction of (i) the exercise price
and (ii) the applicable wage taxes (including solidarity surcharge thereon and church tax, if applicable) and social
security contributions resulting from such exercise. The settlement was applied during the exercise windows in
2024 and 2023.
As of
December 31, 2024
, the share options
outstanding under our equity-settled share-based payment
arrangements had
a remaining weighted average expected life of
0.1
years (as of
December 31, 2023
:
0.8
years).
InstaDeep Employee Stock Ownership
Awards
(Equity-Settled)
As part of the acquisition of InstaDeep in 2023, we agreed to issue long-term ESOP awards with a total target
incentive value of
£15.0 million
. With this award,
398,013
options were granted to the InstaDeep employees. The
awards are subject to a 4-year cliff vesting and will vest and become exercisable in July 2027. The exercise price
is
$94.47
for all InstaDeep employees located in France and Rest of World and
$100.34
for two employees
located in the US. As of
December 31, 2024
,
398,013
options are outstanding.
The fair value of the ESOP awards has been measured using a Monte Carlo simulation. For the ESOPs granted
under the InstaDeep Employee Stock Ownership awards, the same performance requirements that allow the
ESOPs to be exercised apply as for the BioNTech Employee Stock Ownership Plan.
Employee Stock Ownership Plan
(Cash-Settled)
Phantom options which were granted under the ESOP mainly during the
year ended December 31, 2022
, each
give the participants the right to receive a cash payment equal to the difference between an exercise closing
price (average closing price of an American Depositary Share of BioNTech on Nasdaq over the last ten trading
days preceding the exercise date) and the exercise price.
The phantom options can only be exercised by the
grantee if the price of the share is equal or greater to the threshold amount as defined in the ESOP agreement.
The majority of options have an exercise price of
€
10.14
. During the
years ended December 31, 2024 and 2023
,
€
3.8
million
and
€4.5 million
, respectively. The average 10-day closing prices of an American Depositary Share
of BioNTech on Nasdaq weighted over the various settlement dates converted from USD to Euro
using the
F-67
Annual Report on Form 20-F for the
year ended December 31, 2024
exchange rate published by the German Central Bank (
Deutsche Bundesbank
) on the same da
ys
w
as
€
92.70
and
€96.25
.
As
of
December 31, 2024
,
58,903
cash-settled option rights remained outstanding.
As of
December 31, 2024
, the liability related to cash-settled share-based payment option rights amounted to
€
5.0
million
(
€
8.5
million
as of
December 31, 2023
).
The liability is based on the fair value of the respective
rights. The fair value is measured using a binomial model consistent with the grant date fair value measurement
17
Provisions
|
(in millions €)
|
December 31, 2024
|
December 31, 2023
|
||||
|
Contractual disputes / settlements
|
|
|
||||
|
Obligations from onerous CMO contracts
|
|
|
||||
|
Other
|
|
|
||||
|
Total
|
|
|
||||
|
Total current
|
|
|
||||
|
Total non-current
|
|
|
As of
December 31, 2024
, our current provisions included
€
85.7
million
in contractual disputes mainly related to
collaborators regarding, among other things, the interpretation of each party’s obligations or the amounts
payable under the respective agreements
(
€
118.2
million
as of
December 31, 2023
).
Acknowledging a decrease
in obligations identified as contractual
disputes
, the change
of
€
32.5
million
compared to the previous period
related entirely to
consumption
.
As of
December 31, 2024
, our current provisions included
€
50.7
million
(
€
80.2
million
as of
December 31, 2023
)
of obligations for production capacities derived from contracts with Contract Manufacturing Organizations, or
CMOs, that became redundant. The change of
€
29.5
million
compared to
December 31, 2023
, related entirely to
release of provision.
As of
December 31, 2024
, our current provisions included
€
29.3
million
in other obligations mainly comprising
employee related obligations
(
€
79.7
million
as of
December 31, 2023
, mainly comprising inventor remunerations
as well as customs and duties).
The change of
€
50.4
million
compared to the previous period related mainly to
consumption.
18
Contingent Liabilities and Other Financial Commitments
Contingent Liabilities
Our contingent liabilities include, but are not limited to, intellectual property disputes and contractual disputes
regarding, among other things, the interpretation of each party’s obligations or the amounts payable under the
respective agreements, product-related disputes and actions by or on behalf of our shareholders.
From time to time, in the normal course and conduct of our business, we may be involved in proceedings with
third parties about considering, for example, the use and/or remuneration for use of such third party’s intellectual
property. As of
December 31, 2024
, none of the intellectual property-related considerations outlined below, of
which we have either been notified, or for which potential claims could be brought against us or our subsidiaries
in the future, fulfill the criteria for recording a provision.
We are subject to an increasing number of product-related disputes. Our product liability claims often involve
highly complex issues related to medical causation, correctness and completeness of product information
(Summary of Product Characteristics/package leaflet) as well as label warnings and reliance thereon, scientific
evidence and findings, actual and provable defectiveness and injury, and other matters. These complexities vary
from matter to matter. As of
December 31, 2024
, none of these claims fulfill the criteria for recording a provision.
F-68
Annual Report on Form 20-F for the
year ended December 31, 2024
We are currently subject to certain claims by or on behalf of our shareholders. As of
December 31, 2024
, these
claims do not fulfill the criteria for recording a provision.
Substantially all of our contingent liabilities are subject to significant uncertainties and, therefore, determining the
likelihood of a loss and/or the measurement of any loss can be complex. Consequently, we are unable to
estimate the range of reasonably possible loss. Our assessments, which result from a complex series of
judgments about future events and uncertainties, are based on estimates and assumptions that have been
deemed reasonable by management, but that may prove to be incomplete or inaccurate, and unanticipated
events and circumstances may occur that might cause us to change those estimates and assumptions. We
currently do not believe that any of these matters will have a material adverse effect on our financial position,
and will continue to monitor the status of these and other claims that may arise. However, we could incur
judgments, enter into settlements or revise our expectations regarding the outcome of matters, which could have
a material adverse effect on our results of operations and/or our cash flows in the period in which the amounts
are accrued or paid. We will continue to evaluate whether, if circumstances were to change in the future, the
recording of a provision may be needed and whether potential indemnification entitlements exist against any
such claim.
Certain pending matters to which we are a party are discussed below.
Alnylam Proceedings
In March 2022, Alnylam Pharmaceuticals, Inc., or Alnylam, filed a lawsuit against Pfizer and Pharmacia & Upjohn
Co. LLC in the U.S. District Court for the District of Delaware alleging that an existing patent owned by Alnylam,
U.S. Patent No. 11,246,933, or the ‘933 Patent, is infringed by the cationic lipid used in
Comirnaty
, and seeking
monetary relief, which is not specified in their filings. We filed a counterclaim to become party to the Alnylam
proceeding, and in June 2022, Alnylam added to its claims allegations that we induced infringement of the ‘933
Patent. Additionally, in July 2022, Alnylam filed a lawsuit against us, our wholly owned subsidiary, BioNTech
Manufacturing GmbH, Pfizer and Pharmacia & Upjohn Co. LLC in the U.S. District Court for the District of
Delaware alleging that we also induced infringement of a newly issued patent, U.S. Patent No. 11,382,979, or
the ‘979 Patent, which is a continuation of the ‘933 Patent. The two lawsuits were consolidated on July 28, 2022.
In May 2023, Alnylam filed a third lawsuit against Pfizer Inc. and Pharmacia & Upjohn Co. LLC in the U.S.
District Court for the District of Delaware alleging infringement of U.S. Patent Nos. 11,633,479; 11,633,480;
11,612,657; and 11,590,229, all of which are continuations of the ‘933 Patent. We filed a counterclaim to become
party to the new proceeding, and in July 2023, Alnylam added to its claims allegations that we induced
infringement of the four new patents. All of the lawsuits have been consolidated into a single proceeding, which
is currently expected to go to trial in July 2025.
We believe we have strong defenses against the allegations claimed relative to each of the patents and intend to
vigorously defend ourselves in the proceedings mentioned above. However, our analysis of Alnylam’s claims is
ongoing and complex, and we believe the outcome of the suit remains substantially uncertain.
Taking into
account discussions with our external lawyers, we do not consider the probability of an outflow of resources to
be sufficient to recognize a provision at the balance sheet date. In our opinion, these matters constitute
contingent liabilities as of the balance sheet date. However, it is currently impractical for us to estimate with
sufficient reliability the respective contingent liabilities.
CureVac Proceedings
Infringement Proceedings – EP’122, DE’961, DE‘974, DE’575, and EP’668
In July 2022, CureVac AG (CureVac) filed a lawsuit against us and our wholly owned subsidiaries, BioNTech
Manufacturing GmbH and BioNTech Manufacturing Marburg GmbH, in the Düsseldorf Regional Court, alleging
Comirnaty
’s infringement of one European patent, EP1857122B1, or EP’122, and three Utility Models
DE202015009961U1, DE202015009974U1, and DE202021003575U1. In August 2022, CureVac AG added
European Patent EP3708668B1, or EP’668, to its German lawsuit.
On August 15, 2023, the Düsseldorf Regional Court held a hearing on infringement with respect to all five IP
rights. At the hearing, the Court suspended its infringement ruling with respect to EP’122 until December 28,
F-69
Annual Report on Form 20-F for the
year ended December 31, 2024
2023. On September 28, 2023, the Court issued orders suspending its infringement rulings with respect to the
remaining four IP rights (DE’961, DE’974, DE’575, and EP’668) pending validity decisions in the DE’961,
DE’974, and DE’575 cancellation proceedings before the German Patent and Trademark Office and in the
EP’668 opposition proceedings before the Opposition Division of the European Patent Office, or EPO. In the
September 28th orders, the Court explained that it was suspending its infringement rulings until validity decisions
are reached, while contemporaneously noting concerns regarding the validity of DE’961, DE’974, DE’575, and
EP’668. On December 28, 2023, the Düsseldorf Regional Court stayed the infringement proceedings as to
EP’122 until a final appellate decision is rendered as to the validity of EP’122 by the Federal Court of Justice. On
June 7, 2024, CureVac AG waived DE’575 and withdrew this utility model from the infringement proceedings. On
July 2, 2024, the EPO Opposition Division issued a preliminary opinion noting that it believes EP’668 is likely
invalid, and set an oral hearing for March 2025.
Infringement Proceedings – EP’755, DE’123, and DE’130
In July 2023, CureVac filed a second lawsuit against us and our wholly owned subsidiaries, BioNTech
Manufacturing GmbH and BioNTech Manufacturing Marburg GmbH, in the Düsseldorf Regional Court, alleging
Comirnaty
’s infringement of one European patent, EP4023755B1, or EP’755, and two Utility Models
DE202021004123U1, and DE202021004130U1. On June 7, 2024, CureVac waived DE’123 and withdrew this
utility model from the infringement proceedings. A hearing on infringement with respect to EP’755 and DE’130
that
was scheduled to occur in the Düsseldorf Regional Court on September 10, 2024 was rescheduled for July
2025 and the Court suspended its infringement ruling with respect to DE’130 until a validity decision was
reached in the co-pending cancellation proceeding before the German Patent and Trademark Office. On July 24,
2024, the EPO Opposition Division issued a prelim
inary opinion noting that it believes EP’755 is likely invalid,
and set an oral hearing for May 2025.
Nullity Proceedings – EP’122
In September 2022, we filed a nullity action in the Federal Patent Court of Germany seeking a declaration that
EP’122 is invalid. In April 2023, the Federal Patent Court of Germany issued a preliminary opinion in the EP’122
nullity action in support of the validity of EP’122. The preliminary opinion did not address any infringement of
EP’122. The preliminary opinion is a preliminary assessment by the court of the merits of a claim, and is non-
binding. On December 19, 2023, the Federal Patent Court held an oral hearing, after which it nullified EP’122.
On April 30, 2024, the Federal Patent Court issued a judgment containing its written reasons for nullifying
EP’122. On May 7, 2024, CureVac appealed the judgment, which is currently pending.
Cancellation Proceedings – DE’961, DE‘974, and DE’575
In November 2022, we filed cancellation actions seeking the cancellation of the three German Utility Models in
the German Patent and Trademark Office. On December 27, 2023, the German Patent and Trademark Office
issued a preliminary opinion that DE’974 is likely to be cancelled. On
January 23, 2024
, the German Patent and
Trademark Office issued a preliminary opinion that DE’961 is likely to be cancelled based on invalidity pursuant
to para. 1 (2) no. 5 Utility Model Act. On March 7, 2024, the German Patent and Trademark Office issued a
preliminary opinion that DE’575 is likely to be cancelled. On June 6, 2024, CureVac submitted a written
statement to the German Patent and Trademark Office waiving DE’575. On June 12, 2024, we withdrew our
request for cancellation of DE’575. On June 25 and 26, 2024, the German Patent and Trademark Office heard
oral arguments regarding DE’961 and DE’974, and at the conclusion of the hearing on June 26, 2024, confirmed
that both DE’961 and DE’974 were cancelled. In November 2024, the German Patent and Trademark Office
issued its written decisions cancelling DE’961 and DE’974. CureVac has filed an appeal in both cancellation
proceedings, which are currently pending.
Cancellation Proceedings– DE’123 and DE’130
In November 2023, we filed cancellation actions seeking the cancellation of German Utility Models DE’123 and
DE’130 in the German Patent and Trademark Office. On June 6, 2024, CureVac submitted a written statement to
the German Patent and Trademark Office waiving DE’123. On June 12, 2024, we withdrew our request for
cancellation of DE’123. On December 5, 2024, the German Patent and Trademark Office issued a preliminary
opinion that DE’130 is likely to be cancelled.
United States
F-70
Annual Report on Form 20-F for the
year ended December 31, 2024
In July 2022, we and Pfizer filed a complaint for a declaratory judgment in the U.S. District Court for the District
of Massachusetts, seeking a judgment of non-infringement by
Comirnaty
of U.S. Patent Nos. 11,135,312;
11,149,278; and 11,241,493. In May 2023, the action in the U.S. District Court for the District of Massachusetts
was transferred to the U.S. District Court for the Eastern District of Virginia, where CureVac filed counterclaims
asserting infringement of six additional U.S. patents, U.S. Patent Nos. 10,760,070; 11,286,492; 11,345,920;
11,471,525; 11,576,966; and 11,596,686. In July 2023, CureVac filed amended counterclaims to assert an
additional U.S. patent, U.S. Patent No. 11,667,910. In June 2024, CureVac voluntarily dismissed with prejudice
its claims of infringement with respect to the ‘493, ‘525, and ‘966 patents.
Currently,
a three-week jury trial is
scheduled to begin on March 3, 2025
, and an one-week bench trial regarding the prosecution
laches
defense is
scheduled to begin on April 15, 2025.
United Kingdom
In September 2022, we and Pfizer filed a declaration of non-infringement and revocation action against EP’122
and EP’668 in the Business and Property Courts of England and Wales, in the UK High Court of Justice, or the
UK High Court. In October 2022, CureVac responded by filing a counterclaim alleging infringement of the EP’122
and EP’668 patents in the Business and Property Courts of England and Wales, in the UK High Court. On
December 18, 2023, we and Pfizer amended our pleadings to add a claim for revocation and declarations of
invalidity and non-infringement with respect to EP’755. The UK High Court held a trial on EP’668 and EP’755
between July 10, 2024 and July 24, 2024. On October 8, 2024, the UK High Court released a judgment finding
both EP’668 and EP’755 invalid. The UK High Court held a hearing on November 15, 2024, during which it
denied CureVac permission to appeal the judgment. On December 5, 2024, CureVac sought permission from the
UK Appeals Court to appeal the judgment. With respect to EP’122, o
n October 25, 2024, CureVac agreed to a
final and unappealable revocation of the UK designation of EP’122 and to discontinue its counterclaim for
infringement.
We believe we have strong defenses against the allegations claimed relative to each of the patents and utility
models and intend to vigorously defend ourselves in the proceedings mentioned above. However, our analysis of
CureVac’s claims is ongoing and complex, and we believe the ultimate outcomes remain substantially uncertain.
Taking into account discussions with our external lawyers, we do not consider the probability of an outflow of
resources to be sufficient to recognize a provision at the balance sheet date. In our opinion, these matters
constitute contingent liabilities as of the balance sheet date. However, it is currently impractical for us to estimate
with sufficient reliability the respective contingent liabilities.
Moderna Proceedings
Germany
Infringement Proceedings – EP’949 and EP’565
In August 2022, Moderna filed a lawsuit against us and our wholly owned subsidiaries, BioNTech Manufacturing
GmbH, BioNTech Europe GmbH and BioNTech Manufacturing Marburg GmbH, as well as Pfizer,
Pfizer
Manufacturing Belgium NV and Pfizer Ireland Pharmaceuticals
in the Düsseldorf Regional Court alleging
Comirnaty
’s
infringement of two European patents, 3590949B1, or EP’949, and 3718565B1, or EP’565. On
November 7, 2023, the Opposition Division of the EPO revoked EP’565 after a one-day oral hearing, and on
December 7, 2023, it issued its written decision revoking EP’565. On December 8, 2023, the Opposition Division
issued a preliminary opinion noting that it believes EP’949 is likely invalid. As a result of those developments in
the EPO proceedings, the Düsseldorf Regional Court postponed its hearing on infringem
ent with respect to
EP’949, originally scheduled for December 12, 2023, t
o January 21, 2025.
On February 7, 2024, Moderna
appealed the Opposition Division’s revocation decision on EP’565, and the appeal is currently pending. On May
16, 2024, the Opposition Division decided that EP’949 is valid, in amended form, and issued its written decision
regarding the same on July 8, 2024. BioNTech appealed this decision, and the appeal is currently pending.
United Kingdom
In August 2022, Moderna filed a lawsuit asserting
Comirnaty
’s infringement of EP’949 and EP’565 against us
and our wholly owned subsidiaries, BioNTech Manufacturing GmbH, BioNTech Europe GmbH and BioNTech
Manufacturing Marburg GmbH, and Pfizer Limited, Pfizer Manufacturing Belgium NV and Pfizer Inc. in the
Business and Property Courts of England and Wales, in the UK High Court. In September 2022, we and Pfizer
F-71
Annual Report on Form 20-F for the
year ended December 31, 2024
filed a revocation action in the Business and Property Courts of England and Wales requesting revocation of
EP’949 and EP’565.
The UK High Court held a trial between April 22, 2024, and May 21, 2024. On July 2, 2024, the UK High Court
released two judgments. The first judgment concerns the validity of EP’949 and EP’565. In this first judgment,
the UK High Court found that EP’565 is invalid and therefore not infringed, while EP’949 is valid and infringed.
The second judgment concerns whether Moderna’s October 2020 commitment not to “enforce [its] COVID-19
related patents against those making vaccines intended to combat the pandemic,” or the Patent Pledge,
amounted to a consent under UK law to carry out any acts that would otherwise amount to patent infringement.
With respect to this judgment, the UK High Court found that Moderna’s Patent Pledge amounted to consent to
carry out activities that might otherwise infringe its patents prior to March 2022, but not after March 2022.
The UK High Court held a hearing on September 25, 2024, during which it granted Pfizer and BioNTech
permission to appeal its judgment regarding the validity of EP’949, and denied Moderna permission to appeal its
judgment regarding validity of EP’565. On October 16, 2024, Moderna sought permission from the UK Appeals
Court to appeal the EP'565 judgment. On November 11, 2024, the UK Appeals Court denied Moderna’s
application to appeal; accordingly, the UK designation of EP'565 is finally revoked with no further opportunity to
appeal in the UK. No party sought permission to appeal the UK High Court’s judgment on the patent pledge.
United States
U.S. District Court Litigation
In August 2022, Moderna filed a lawsuit in the U.S. District Court for the District of Massachusetts against us and
our wholly owned subsidiaries BioNTech Manufacturing GmbH and BioNTech US Inc. and Pfizer Inc. alleging
Comirnaty
’s infringement of U.S. Patent Nos. 10,898,574; 10,702,600 and 10,933,127 and seeking monetary
relief. On April 12, 2024, the U.S. District Court for the District of Massachusetts stayed the litigation pending
resolution of the
inter partes
review of U.S. Patent Nos. 10,702,600 and 10,933,127.
Inter Partes Review
In August 2023, Pfizer and we filed petitions seeking inter partes review of U.S. Patent Nos. 10,702,600 and
10,933,127 before the United States Patent Trial and Appeal Board, or the PTAB. On March 6, 2024, the PTAB
issued decisions institutin
g
inter partes
review proceedings on all challenged claims of U.S. Patent Nos.
10,702,600 and 10,933,127. An oral hearing on the merits occurred on December 10, 2024, and a first-instance
decision by the PTAB is expected by March 2025.
Netherlands
In September 2022, Moderna filed a lawsuit against us and our wholly owned subsidiary BioNTech
Manufacturing GmbH and Pfizer B.V., Pfizer Export B.V., C.P. Pharmaceuticals International C.V. and Pfizer Inc.
in the District Court of The Hague alleging
Comirnaty
’s infringement of EP‘949 and EP’565. The District Court of
the Hague held a hearing on October 6, 2023, on infringement and validity with respect to EP’949. On December
6, 2023, the Court found EP’949 to be invalid. On March 5, 2024, Moderna appealed this decision, and the
appeal is pending. The EP’565 case has been stayed pending the outcome of Moderna’s appeal of the
Opposition Division’s revocation of EP’565.
Ireland
In May 2023, Moderna filed a lawsuit against us and our wholly owned subsidiary BioNTech Manufacturing
GmbH, Pfizer Inc., Pfizer Healthcare Ireland, Pfizer Ireland Pharmaceuticals, and C.P. Pharmaceuticals
International C.V. alleging
Comirnaty
’s infringement of EP’949 and EP’565 in the High Court of Ireland. On
February 26, 2024, the High Court of Ireland stayed the lawsuit pending the final determination of the EPO
opposition proceedings for EP’949 and EP’565 (in each case including any appeals).
Belgium
In May 2023, Moderna filed a lawsuit against us, our wholly owned subsidiary BioNTech Manufacturing GmbH,
Pfizer Inc. and Pfizer Manufacturing Belgium alleging
Comirnaty
’s infringement of EP’949 and EP’565 in the
F-72
Annual Report on Form 20-F for the
year ended December 31, 2024
Brussels Dutch-speaking Enterprise Court. On May 29, 2024, the parties filed a joint request to stay the
proceedings, which was entered by the Enterprise Court.
All of the above proceedings are currently pending
.
We believe we have strong defenses against the allegations claimed relative to each of the patents and intend to
vigorously defend ourselves in the proceedings mentioned above. However, our analysis of Moderna’s claims is
ongoing and complex, and we believe the outcome of the suit remains substantially uncertain.
Taking into
account discussions with our external lawyers, we do not consider the probability of an outflow of resources to
be sufficient to recognize a provision at the balance sheet date. In our opinion, these matters constitute
contingent liabilities as of the balance sheet date. However, it is currently impractical for us to estimate with
sufficient reliability the respective contingent liabilities.
Arbutus and Genevant Proceedings
In April 2023, Arbutus and Genevant filed a lawsuit against Pfizer and us in the U.S. District Court for the District
of New Jersey alleging that Pfizer and we have infringed the following patents owned by Arbutus: U.S. Patent
Nos. 9,504,651; 8,492,359; 11,141,378; 11,298,320; and 11,318,098, through the use of Genevant’s lipid
nanoparticle technology and methods for producing such lipids in
Comirnaty
, and seeking monetary relief. This
proceeding is currently pending.
We believe we have strong defenses against the allegations claimed relative to each of the patents and intend to
vigorously defend ourselves in the lawsuit mentioned above. However, our analysis of Arbutus and Genevant’s
claims is ongoing and complex, and we believe the outcome of the suit remains substantially uncertain
. Taking
into account discussions with our external lawyers, we do not consider the probability of an outflow of resources
to be sufficient to recognize a provision at the balance sheet date. In our opinion, these matters constitute
contingent liabilities as of the balance sheet date. However, it is currently impractical for us to estimate with
sufficient reliability the respective contingent liabilities.
GlaxoSmithKline Proceedings
In April 2024, GSK filed a lawsuit against Pfizer, Pharmacia & Upjohn Co. LLC, BioNTech SE, BioNTech
Manufacturing GmbH, and BioNTech US Inc. in the United States District Court for the District of Delaware
alleging that the cationic lipid used in COMIRNATY
®
infringes U.S. Patent Nos. 11,638,693; 11,638,694;
11,666,534; 11,766,401; and 11,786,467; and seeking monetary relief. On August 14, 2024, GSK filed an
amended complaint to assert infringement of three additional patents, U.S. Patent Nos. 11,759,422; 11,655,475;
and 11,851,660. This proceeding is currently pending.
We believe we have strong defenses against the allegations claimed relative to each of the patents and intend to
vigorously defend ourselves in the lawsuit mentioned above. However, our analysis of GSK’s claims is ongoing
and complex, and we believe the outcome of the suit remains substantially uncertain.
Taking into account
discussions with our external lawyers, we do not consider the probability of an outflow of resources to be
sufficient to recognize a provision at the balance sheet date. In our opinion, these matters constitute contingent
liabilities as of the balance sheet date. However, it is currently impractical for us to estimate with sufficient
reliability the respective contingent liabilities.
Ladewig Proceedings
In January 2024, we and certain of our officers and directors were named as defendants in a securities class
action complaint captioned Ladewig v. BioNTech SE filed in the U.S. District Court for the Central District of
California brought on behalf of a putative class of investors who purchased our securities from March 30, 2022
through October 13, 2023. Plaintiffs allege that we violated Sections 10(b) and 20(a) of the Exchange Act by
stating that we were “well positioned” to remain a “market leader” in vaccines for the prevention of COVID-19
and by purportedly overstating demand for Comirnaty. Plaintiffs further allege that we failed to adapt our
inventory to reflect the emergence of new COVID variants. On July 15, 2024, the case was transferred to the
U.S. District Court for the Southern District of New York.
F-73
Annual Report on Form 20-F for the
year ended December 31, 2024
We believe we have strong defenses against the allegations claimed and intend to vigorously defend ourselves
in the lawsuit mentioned above.
We cannot reasonably estimate the maximum potential exposure or the range of
possible loss for this matter. Taking into account discussions with our external lawyers, we do not consider the
probability of an outflow of resources to be sufficient to recognize a provision at the balance sheet date. In our
opinion, these matters constitute contingent liabilities as of the balance sheet date. However, it is currently
impractical for us to estimate with sufficient reliability the respective contingent liabilities.
Other Financial Commitments
|
(in millions €)
|
December 31, 2024
|
December 31, 2023
|
||||
|
Commitments under purchase agreements for property, plant and equipment
|
|
|
||||
|
Contractual obligation to acquire intangible assets
|
|
|
||||
|
Total
|
|
|
Contractual obligations to acquire intangible assets exist in connection with in-licensing and research and
development collaborations. We have entered into obligations to make milestone payments once specific targets
have been reached. P
rovided that all of the
milestone
events are achieved, we would be obligated to pay up to
€
1,193.1
million
as of
December 31, 2024
, (
€
1,721.1
million
as of
December 31, 2023
) in connection with the
acquisition of intangible assets
. The amounts shown represent the maximum payments to be made, and it is
unlikely that they will all fall due. We have excluded any milestone payments subject to in-licensing agreements
with Biotheus as such payments are treated as intra-group transactions
following the acquisition of Biotheus,
which closed in January 2025
. Commitments from the acquisition of Biotheus are disclosed under Note 5
Business Combinations. The amounts and the dates of the actual payments may both vary considerably from
those stated in the table, since the achievement of the conditions for payment is possible but uncertain. Other
financial obligations from possible future sales-based milestone and license payments were not included in the
table above.
and contractual obligations to acquire intangible assets are as follows:
|
Year ended December 31, 2024
|
||||||||||
|
(in millions €)
|
Less than
1 year
|
1 to 5
years
|
More than
5 years
|
Total
|
||||||
|
Commitments under purchase agreements for property, plant
and equipment
|
|
|
|
|
||||||
|
Contractual obligation to acquire intangible assets
|
|
|
|
|
||||||
|
Total
|
|
|
|
|
||||||
Other financial obligations were recognized at nominal value.
F-74
Annual Report on Form 20-F for the
year ended December 31, 2024
19
Other Non-Financial Liabilities
|
(in millions €)
|
December 31, 2024
|
December 31, 2023
|
||||
|
Liabilities to employees
|
|
|
||||
|
Liabilities from share-based payment arrangements
|
|
|
||||
|
Liabilities from wage taxes and social securities expenses
|
|
|
||||
|
Grants
|
|
|
||||
|
Other
|
|
|
||||
|
Total
|
|
|
||||
|
Total current
|
|
|
||||
|
Total non-current
|
|
|
Other Non-Financial Liabilities related to funds received based on government grants and similar grants with a
total nominal amount of
€
326.8
million
. The received funds for which no related expense has been recognized
during the
year ended December 31, 2024
, were deferred and recognized in the Other Non-Financial Liabilities.
The government grants and similar grants are mainly related to assets such as buildings and equipment.
The
funding will be recognized in profit or loss within other operating income over the respective useful life of the
underlying assets, see Note
2.3.9
. The grants are related to conditions such as construction milestones
.
20
Leases
Right-of-Use Assets
position as of the dates
indicated
:
|
(in millions €)
|
December 31, 2024
|
December 31, 2023
|
||||
|
Buildings
|
|
|
||||
|
Production facilities
|
|
|
||||
|
Other operating equipment
|
|
|
||||
|
Total
|
|
|
Additions to the right-of-use assets during the
year ended December 31, 2024
, were
€
74.4
million
(during the
year ended December 31, 2023
:
€
66.4
million
)
.
Lease Liability
|
(in millions €)
|
December 31, 2024
|
December 31, 2023
|
||||
|
Current
|
|
|
||||
|
Non-current
|
|
|
||||
|
Total
|
|
|
F-75
Annual Report on Form 20-F for the
year ended December 31, 2024
|
Years ended
December 31,
|
||||||||
|
(in millions €)
|
2024
|
2023
|
2022
|
|||||
|
Buildings
|
|
|
|
|||||
|
Production facilities
|
|
|
|
|||||
|
Other operating equipment
|
|
|
|
|||||
|
Total depreciation charge
|
|
|
|
|||||
|
Interest on lease liabilities
|
|
|
|
|||||
|
Expense related to short-term leases and leases of low-value assets
|
|
|
|
|||||
|
Total amounts recognized in profit or loss
|
|
|
|
|||||
During the
year ended December 31, 2024
, the total cash outflow for leases amounted to
€
43.6
million
(during
the
year ended December 31, 2023
:
€
46.0
million
; during the
year ended December 31, 2022
:
€
46.2
million
).
We have
several lease contracts that include extension options. These options are negotiated by management
to provide flexibility in managing the leased asset portfolio and align with the need of the business. Management
exercises judgment in determining whether these extension options are reasonably certain to be exercised. The
undiscounted potential future lease payments, which relate to periods after the exercise date of renewal options
and are not included in lease liabilities, amount to up to
€
152.1
million
as of
December 31, 2024
, considering
terms up until
2049
(as of
December 31, 2023
:
€
157.2
million
considering terms up until
2049
)
.
21
Related Party Disclosures
ATHOS KG,
H
olzkirchen, Germany is the sole shareholder of AT Impf GmbH, Munich, Germany and beneficial
owner of our ordinary shares.
ATHOS KG via AT Impf GmbH has de facto control over BioNTech based on its
substantial shareholding, which practically enables it to exercise the majority of voting rights to pass resolutions
at our Annual General Meeting, or AGM.
F-76
Annual Report on Form 20-F for the
year ended December 31, 2024
Supervisory Board. Key management personnel compensation is comprised of the
following
:
|
Years ended
December 31,
|
||||||||
|
(in millions €)
|
2024
|
2023
|
2022
|
|||||
|
Management Board
(1)
|
|
|
|
|||||
|
Fixed compensation
|
|
|
|
|||||
|
Fringe benefits
|
|
|
|
|||||
|
Short-term incentive – first installment
|
|
|
|
|||||
|
Short-term incentive – second installment
(2)
|
|
|
|
|||||
|
Other variable compensation
(3)
|
|
|
|
|||||
|
Share-based payments (incl. long-term incentive)
(4)
|
|
|
|
|||||
|
Supervisory Board
|
|
|
|
|||||
|
Total compensation of key management personnel
|
|
|
|
|||||
(1)
During the
year ended December 31, 2024
, Sean Marett retired from the Management Board with effect as of July 1,
2024. Therefore, his compensation until his departure date is presented on a pro-rata basis in this table. The following
compensation pursuant to his separation agreement subsequent to his departure date and thus as former Management
Board member are not included in this table: a severance payment of
€
275,000
, an additional payment of
€
39,000
in
respect of the 2024 STI, a grant of
5,760
phantom options in respect of the 2024 LTI and a payment of
€
477,030
in
relation to his 12-months consultancy agreement.
(2)
The fair value of the second installment of the short-term incentive compensation which has been classified as a cash-
settled share-based payment arrangement was determined pursuant to the regulations of IFRS 2 “Share-based
Payments”. This table shows the pro-rata share of personnel expenses for the respective financial year, which are
recognized over the award’s vesting period beginning as of the service commencement date (date when entering or
renewing service agreements) until each separate determination date and are remeasured until settlement date.
(3)
Represents for the financial year 2024 the cash payment related to the one-time signing bonus granted to Annemarie
Hanekamp as part of her appointment to the Management Board, designed to compensate
her for lower bonus payments
that she would receive as part
of
her compensation package with BioNTech and to recognize and appreciate her move to
BioNTech.
For 2023, the amount represents the one-time signing cash payment related to James Ryan’s appointment to
the Management Board to provided compensation in lieu of participation in the LTI 2023 program and the one-time
special cash payment related to Jens Holstein to honor his contribution to BioNTech’s extraordinary financial
performance. For 2022, the amount i
ncludes a one-time signing and retention cash payment agreed when renewing the
service agreement agreed with Sean Marett in 2022.
(4)
The fair value of the share-based payments was determined pursuant to the regulations of IFRS 2 “Stock-based
Payments”. This table shows the pro-rata share of personnel expenses resulting from stock-based compensation for the
respective financial year.
During the years ended
December 31, 2024
,
2023
and
2022
, the amounts included expenses
derived from a one-time signing bonus granted to Jens Holstein as of his appointment to the Management Board in the
form of
4,246
phantom shares
as well as expenses derived from the one-time signing bonus granted to Annemarie
Hanekamp as of her appointment to the Management Board in the form of shares in the amount of
€
500,000
.
The amounts disclosed in the table are the amounts recognized as an expense during the period.
Management Board members participated in our ESOP program (see Note
16
). Out of the
5,152,410
option
rights granted to our Management Board under the ESOP 2018 program,
4,921,630
options were exercised
during the year ended December 31, 2022. The remaining
230,780
option rights were exercised by Sean Marett
in May 2023. During the year ended December 31, 2024, our CEO Prof. Ugur Sahin, M.D.,
exercised
all
participated in the LTI 2020 Board Program, exercised
209,128
options in August 2024 while
38,968
options are
outstanding as of December 31, 2024 (see Note
16
).
For further information regarding outstanding options for
each Management Board member from LTI 2021-2024 Board Programs, see Note
16
.
F-77
Annual Report on Form 20-F for the
year ended December 31, 2024
indicated
:
|
Years ended
December 31,
|
||||||||
|
(in millions €)
|
2024
|
2023
|
2022
|
|||||
|
Purchases of various goods and services from entities controlled
by ATHOS KG
|
|
|
|
|||||
|
Purchases of property and other assets from entities controlled
by ATHOS KG
|
|
|
|
|||||
|
Total
|
|
|
|
|||||
The amounts disclosed in the table are the amounts recognized as an expense during the period.
On December 22, 2022, we entered into a purchase agreement with Santo Service GmbH, pursuant to which we
acquired the real estate property An der Goldgrube 12 and the existing laboratory and office building including
any movable assets for a
total consideration of
€
62.5
million
. The purchase price was paid during the year ended
December 31, 2022. Santo Service GmbH is wholly owned by AT Impf GmbH, that is controlled by ATHOS KG.
periods indicated:
|
(in millions €)
|
December 31, 2024
|
December 31, 2023
|
||||
|
ATHOS KG
|
|
|
||||
|
Total
|
|
|
by related parties.
A number of individuals in key positions can control or exercise significant influence over BioNTech SE. There
were no business relationships with individuals in key positions during the year ended
December 31, 2024
.
22
Events After the Reporting Period
Business Combinations
Acquisition of Biotheus
Our subsidiary, BioNTech Collaborations GmbH, entered into an agreement and plan of merger, or the merger
agreement, with Biotheus on November 13, 2024. Following the satisfaction of several customary closing
conditions and regulatory approvals as provided in the merger agreement, the acquisition of Biotheus closed on
January 31, 2025. For further information, please refer to the description of this acquisition in N
ote
5
.
Contingent Liabilities
and Other Financial Commitments
Promosome
In January 2025, Promosome LLC filed a lawsuit against us and Pfizer in the Unified Patent Court, or the UPC,
Munich Division, alleging that Comirnaty infringes EP 2 401 365 and seeking monetary relief. This proceeding is
currently pending.
F-78
Annual Report on Form 20-F for the
year ended December 31, 2024
CureVac Proceedings - United Kingdom
On January 27, 2025, the UK Appeals Court denied CureVac’s application to appeal; accordingly, the UK
designations of EP’668 and EP’755 are finally revoked with no further opportunity to appeal in the UK.
Moderna Proceedings - Germany
On January 21, 2025, the Düsseldorf Regional Court held a hearing on infringement with respect to EP’949. On
March 5, 2025, the Court issued a first-instance decision declining to stay the infringement proceedings and
finding infringement of EP’949 by BioNTech and Pfizer. BioNTech and Pfizer intend to appeal the Düsseldorf
Regional Court’s infringement decision. The court has not ruled on the invalidity of EP’949 which will be decided
in a next step by the EPO in the opposition appeal proceedings. The Opposition Division of the EPO found
EP’949 to be valid in 2024; BioNTech appealed this decision, and the appeal is currently pending. Should
Moderna nevertheless decide to enforce the Düsseldorf Regional Court’s first instance-decision on a preliminary
basis, BioNTech and Pfizer will need to provide information and render accounts on relevant acts in Germany. A
determination of compensation and damages will then follow in separate proceedings. The EPO’s decision as to
the invalidity of EP’949 is expected before any determination of compensation and damages will take place.
Moderna Proceedings - US
With respect to Pfizer and our inter partes proceedings against Moderna, on March 5, 2025, the United States
Patent Trial and Appeal Board found all challenged claims of Moderna's US Patent Nos. 10,933,127 and
10,702,600 to be unpatentable and thus invalid. Moderna may appeal this decision.
Our assessment stated in Note 18 remains unchanged: None of these claims fulfill the criteria for recording a
provision but represent contingent liabilities. These contingent liabilities are subject to significant uncertainties
and, therefore, determining the likelihood of a loss and/or the measurement of any loss can be complex.
Consequently, we are unable to estimate the range of reasonably possible loss. Our assessments, which result
from a complex series of judgments about future events and uncertainties, are based on estimates and
assumptions that have been deemed reasonable by management, but that may prove to be incomplete or
inaccurate, and unanticipated events and circumstances may occur that might cause us to change those
estimates and assumptions. We currently do not believe that any of these matters will have a material adverse
effect on our financial position, and will continue to monitor the status of these and other claims that may arise.
However, we could incur judgments, enter into settlements or revise our expectations regarding the outcome of
matters, which could have a material adverse effect on our results of operations and/or our cash flows in the
period in which the amounts are accrued or paid. We will continue to evaluate whether, if circumstances were to
change in the future, the recording of a provision may be needed and whether potential indemnification
entitlements exist against any such claim.
Jens Holstein - retirement
Jens Holstein, our Chief Financial Officer, plans to retire at the end of his term. A successor will be announced in
due course.
TABLE OF CONTENTS
Part IItem 1. Identity Of Directors, Senior Management and AdvisersItem 2. Offer Statistics and Expected TimetableItem 3. Key InformationPart on Our Ability To Acquire, In-license Or Use Such Intellectual Property and Proprietary Rights. in Addition, OurItem 4. Information on The CompanyPart A Is A Non-randomized Run-in Portion Designed To Demonstrate The Safety Of The Combination Of Bnt113 andPart 2 Is Currently Investigating The Combination Treatment OfItem 4A. Unresolved Staff CommentsItem 5. Operating and Financial Review and ProspectsItem 7. Of This Annual Report As Well As in Note 21 Of Our Consolidated Financial Statements Included Elsewhere inItem 6. Directors, Senior Management and EmployeesItem 7. Major Shareholders and Related Party TransactionsItem 8. Financial InformationItem 9. The Offer and ListingItem 10. Additional InformationItem 11. Quantitative and Qualitative Disclosures About Market RiskItem 12. Description Of Securities Other Than Equity SecuritiesPart IIItem 13. Defaults, Dividend Arrearages and DelinquenciesItem 14. Material Modifications To The Rights Of Security Holders and Use Of ProceedsItem 15. Controls and ProceduresItem 15. Controls andItem 16. [reserved]Item 16A. Audit Committee Financial ExpertItem 16B. Code Of EthicsItem 16C. Principal Accountant Fees and ServicesItem 16D. Exemptions From The Listing Standards For Audit CommitteesItem 16E. Purchases Of Equity Securities By The Issuer and Affiliated PurchasersItem 16F. Change in Registrant S Certifying AccountantItem 16G. Corporate GovernanceItem 16H. Mine Safety DisclosureItem 16I. Disclosure Regarding Foreign Jurisdictions That Prevent InspectionsItem 16J. Insider Trading PoliciesItem 16K. CybersecurityPart IIIItem 17. Financial StatementsItem 18. Financial StatementsItem 19. ExhibitsNote 3, Judgment Is Applied To Certain Aspects When Accounting For The Collaboration AgreementsNote 2. 3.10. For The Purpose Of Impairment Testing, Goodwill Acquired in A Business Combination Is, From TheItem Treasury Shares . Any Premium Paid in Excess Of The Nominal Value Of A Repurchased Ads Is Deducted