SNY 20-F Report ended Dec. 31, 2024
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
_________________________
FORM
20-F
(Mark One)
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REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934
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Or
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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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For the fiscal year ended
December 31
,
2024
Or
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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Or
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SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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Date of event requiring this shell company report
For the transition period from to
Commission File Number:
001-31368
_______________________________
(Exact name of registrant as specified in its charter)
N/A
(Translation of registrant’s name into English)
(Jurisdiction of incorporation or organization)
(Address of principal executive offices)
________________________
(Name, Telephone, E-mail and/or Facsimile number and Address of Company Contact Person)
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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
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Name of each exchange on which registered:
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American Depositary Shares, each representing one half
of one ordinary share, par value €2 per share
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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
The number of outstanding shares of each of the issuer’s classes of capital or common stock as of December 31,
2024
was:
Ordinary shares
:
1,263,122,721
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).
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
definition of “large accelerated filer”, “accelerated filer” or “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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Non-accelerated filer
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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
(1)
provided pursuant to Section 13(a) of the
Exchange Act. ☐
(1) The term “new or revised financial accounting standard” refers to any update issued by the Financial Accounting Standards Board to its Accounting
Standards Codification after April 5, 2012.
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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as issued by the International 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
☒
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*
Not for trading but only in connection with the registration of American Depositary Shares representing such ordinary shares.
Presentation of financial
and other information
The consolidated financial statements contained in this annual report on Form 20-F have been prepared in accordance with
International Financial Reporting Standards (IFRS) as issued by the International Accounting Standards Board (IASB) and with
IFRS as endorsed by the European Union, as of December 31,
2024
.
Unless otherwise indicated or the context requires otherwise, the terms “Sanofi,” the “Company,” the “Group,” “we,” “our,” or “us”
refer to Sanofi and its consolidated subsidiaries.
All references herein to “United States” or “US” are to the United States of America, references to “dollars” or “$” are to the
currency of the United States, references to “France” are to the Republic of France, and references to “euro” and “€” are to the
currency of the European Union member states (including France) participating in the European Monetary Union.
As of the date of this report on Form 20-F, all commercial trademarks mentioned here are protected, and are trademarks of
Sanofi and/or its subsidiaries, with the exception of:
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trademarks used or that may be or have been used under license by Sanofi and/or its affiliates, such as Aldurazyme, a
trademark of the Biomarin/Genzyme LLC Joint Venture; Alprolix, a trademark of Swedish Orphan Biovitrum AB in Europe;
ALTUVIIIO
, a trademark of Sobi in Europe and in Africa; Anket, a trademark of Innate Pharma; Atomnet, a trademark of
Atomwise, Inc.;
Cialis, a trademark of Eli Lilly; Eloctate, a trademark of Swedish Orphan Biovitrum AB in Europe; Stamaril, a
trademark of the
Institut Pasteur;
Tamiflu, a trademark of Hoffmann-La Roche; Vaxelis, a trademark of MSP Vaccine Company
(US) and MCM Vaccine B.V. (Netherlands); Zaltrap, a trademark of Regeneron in the United States;
•
trademarks sold by Sanofi and/or its affiliates to a third party, such as Altace, a trademark of King Pharmaceuticals in the
United States; Libtayo, a trademark of Regeneron; Praluent, a trademark of Regeneron in the United States; and
•
other third party trademarks such as Stoxx, a trademark of Stoxx Ltd; and Zantac, a trademark of Glaxo Group Limited (except
in the US and Canada).
Not all trademarks related to products under development have been authorized as of the date of this annual report by the
relevant health authorities.
The data relating to market shares and ranking information for medicines and vaccines, in particular as presented
in “Item 4. Information on the Company — B. Business Overview — B.5. Markets — B.5.1. Marketing and distribution,” are based
primarily on sales data excluding vaccines and in constant euros (unless otherwise indicated) on a September
2024
moving
annual total (MAT) basis. The data are primarily from a IQVIA local sales audit, supplemented by country-specific sources.
Product indications described in this annual report are composite summaries of the major indications
approved
in the product’s
principal markets. Not all indications are necessarily available in each of the markets in which the products are approved. The
summaries presented herein for the purpose of financial reporting do not substitute for careful consideration of the full labeling
approved in each market.
Cautionary statement regarding
forward-looking statements
This annual report contains certain forward-looking statements within the meaning of applicable federal securities law, including
the Private Securities Litigation Reform Act of 1995, as amended. We may also make written or oral forward-looking statements in
our periodic reports to the Securities and Exchange Commission on Form 6-K, in our annual report to shareholders, in our offering
circulars and prospectuses, in press releases and other written materials and in oral statements made by our officers, directors or
employees to third parties. Examples of such forward-looking statements include:
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projections of operating revenues, net income, business net income, earnings per share, business earnings per share, capital
expenditures, cost savings, restructuring costs, positive or negative synergies, dividends, capital structure or other financial
items or ratios;
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statements of our profit forecasts, trends, business strategies, plans, objectives or goals, including those relating to products,
clinical studies, regulatory approvals and competition; and
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statements about our future events and economic performance or that of France, the United States or any other countries in
which we operate.
Words such as “believe,” “anticipate,” “can,” “contemplate,” “could,” “plan,” “expect,” “intend,” “is designed to,” “may,” “might,”
“plan,” “potential,” “objective,” “target,” “estimate,” “project,” “predict,” “forecast,” “ambition,” “guideline,” "seek," “should,” “will,”
"goal," or the negative of these and similar expressions are intended to identify forward-looking statements but are not the
exclusive means of identifying such statements.
Forward-looking statements involve inherent, known and unknown risks, uncertainties and assumptions associated with the
regulatory, economic, financial and competitive environment, and other factors that could cause actual future results to differ
materially from those expressed or implied in the forward-looking statements.
These risks, uncertainties and assumptions include risk factors, which could also affect future results and cause actual results to
differ materially from those contained in any forward-looking statements, and which include those discussed under “Item 3. Key
Information — D. Risk Factors.” Additional risks, not currently known or that are currently considered immaterial by the Group,
may have the same unfavorable effect and investors may lose all or part of their investment.
As a result of these factors, we cannot assure you that the forward-looking statements in this annual report will prove to be
accurate. Furthermore, if our forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the
significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or
warranty by us or any other person that we will achieve our objectives and plans in any specified time frame or at all. Moreover,
forward-looking statements speak only as of the date they are made. Other than required by law, we do not undertake any
obligation to update them in light of new information, future developments or otherwise, except as required by law. These
forward-looking statements are based upon information, assumptions and estimates available to us as of the date of this annual
report, and while we believe such information forms a reasonable basis for such statements, such information may be limited or
incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all
potentially available relevant information. In light of these risks,uncertainties and assumptions, you should not place undue
reliance on any forward looking statements contained herein.
You should read this annual report and the documents that we reference in this annual report and have filed as exhibits
completely and with the understanding that our actual future results may be materially different from what we expect. We qualify
all of our forward-looking statements by these statements.
Abbreviations
Principal abbreviations used in the Annual Report on Form 20-F
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ADR
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American Depositary Receipt
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ADS
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American Depositary Share
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AFEP
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Association française des entreprises privées (French
Association of Large Companies)
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AMF
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Autorité des marchés financiers (the French market
regulator)
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ANDA
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Abbreviated New Drug Application
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BLA
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Biologic License Application
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BMS
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Bristol-Myers Squibb
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CEO
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Chief Executive Officer
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CER
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Constant exchange rates
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CGU
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Cash generating unit
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CHC
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Consumer Healthcare, Opella
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CHMP
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Committee for Medicinal Products for Human Use
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COVALIS
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Sanofi committee for internal occupational exposure
limits (Comité des Valeurs Limites Internes Sanofi)
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CSR
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Corporate Social Responsibility
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CVR
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Contingent value right
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EFPIA
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European Federation of Pharmaceutical Industries and
Associations
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EMA
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European Medicines Agency
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EU
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European Union
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FCF
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Free cash flow
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FDA
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US Food and Drug Administration
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GAVI
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Global Alliance for Vaccines and Immunisation
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GBU
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Global Business Unit
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GERS
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Groupement pour l'Élaboration et la Réalisation de
Statistiques (French pharmaceutical industry statistics
partnership)
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GCP
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Good clinical practices
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GDP
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Good distribution practices
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GHG
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Greenhouse gas
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GLP
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Good laboratory practices
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GLP-1
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Glucagon-like peptide-1
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GMP
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Good manufacturing practices
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GRI
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Global Reporting Initiative
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Hib
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Haemophilus influenzae type b
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HSE
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Health, Safety and Environment
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IASB
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International Accounting Standards Board
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ICH
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International Council for Harmonization
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IFPMA
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International Federation of Pharmaceutical
Manufacturers & Associations
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IFRIC
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International Financial Reporting Interpretations
Committee
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IFRS
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International Financial Reporting Standards
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IPV
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Inactivated polio vaccine
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ISIN
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International Securities Identification Number
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J-MHLW
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Japanese Ministry of Health, Labor and Welfare
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LoE
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Loss of Exclusivity
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LSD
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Lysosomal storage disorder
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MEDEF
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Mouvement des entreprises de France (French business
confederation)
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mRNA
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messenger RNA
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MS
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Multiple sclerosis
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NASDAQ
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National Association of Securities Dealers Automated
Quotations
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NDA
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New Drug Application
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NHI
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National Health Insurance (Japan)
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NYSE
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New York Stock Exchange
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OECD
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Organisation for Economic Co-operation and
Development
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OPV
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Oral polio vaccine
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OTC
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Over the counter
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PhRMA
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Pharmaceutical Research and Manufacturers of America
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PMDA
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Pharmaceuticals and Medical Devices Agency (Japan)
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PRV
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Priority Review Voucher
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PTE
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Patent Term Extension
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QIV
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Quadrivalent influenza vaccine
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R&D
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Research and development
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SA
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Société anonyme (French public limited corporation)
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SEC
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US Securities and Exchange Commission
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SPC
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Supplementary Protection Certificate
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TRIBIO
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Sanofi Committee for Biological Risk Prevention
(Biosafety, Biosecurity, Biosurveillance)
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TSR
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Total shareholder return
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UNICEF
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United Nations Children’s Emergency Fund
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US
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United States of America
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WHO
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World Health Organization
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[THIS PAGE HAS BEEN INTENTIONALLY LEFT BLANK]
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TABLE OF CONTENTS
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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 4.A
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Item 5.
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D. Trend information
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E. Critical accounting estimates
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Item 6.
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Item 7.
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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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Item 13.
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Item 14.
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Item 15.
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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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Item 16G.
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Item 16H.
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Item 16I.
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Item 16J.
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Item 16K.
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Item 17.
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Item 18.
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Item 19.
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SANOFI
FORM 20-F
2024
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1
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PART I
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ITEM 1. Identity of Directors, Senior Management and Advisers
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Part I
Item 1. Identity of Directors, Senior Management and Advisers
N/A
Item 2. Offer Statistics and Expected Timetable
N/A
Item 3. Key Information
A. Selected financial data
N/A
B. Capitalization and indebtedness
N/A
C. Reasons for offer and use of proceeds
N/A
D. Risk factors
Important factors that could cause actual financial, business, research, or operating results to differ materially from expectations
are disclosed in this annual report, including without limitation the following risk factors. Investors should carefully consider all the
information set forth in the following risk factors and elsewhere in this document before deciding to invest in any of the
Company’s securities. In addition to the risks listed below, we may be subject to other material risks that as of the date of this
report are not currently known to us or that we deem immaterial at this time.
Risks relating to legal and regulatory matters
Product liability claims could adversely affect our business, results of operations and financial condition
Product liability is a significant risk for any pharmaceutical company, given that liability claims relating to our industry are
unforeseeable by nature. The evolving regulatory environment worldwide (the ever-more stringent regulatory requirements
applicable to the pharmaceutical industry, plus more stringent data, quality, and supply obligations) clearly impacts our potential
liability, and we may incur different liability claims to what we have handled in the past, regarding their nature, scope, and level.
For a detailed analysis of the regulatory environment in which we operate, refer to “Item 4. Information on the Company - B.
Business Overview - B.5.3. Regulatory framework.” Substantial damages have been awarded by some jurisdictions and/or
settlements agreed – notably in the United States and other common law jurisdictions – against pharmaceutical companies
based on claims for injuries allegedly caused using their products. Such claims can also lead to product recalls, withdrawals, or
declining sales, and/or be accompanied by consumer fraud claims by customers, third-party payers seeking reimbursement of
the cost of the product and/or other claims, including potential civil or criminal governmental actions.
We are currently defending several product liability claims (see Note D.22.a. to the consolidated financial statements included at
Item 18. of this annual report) notably with respect to Taxotere, Zantac, Depakine and Gold Bond, and there can be no assurance
that we will be successful in defending these claims, or that we will not face additional claims in the future.
Establishing the full side effect profile of a pharmaceutical drug goes beyond data derived from preapproval clinical studies
which may only involve several hundred to several thousand patients. Routine review and analysis of the continually growing
body of post-marketing safety data and clinical studies provide additional information – for example, potential evidence of rare,
population-specific, or long-term adverse events or of drug interactions that were not observed in preapproval clinical studies.
This causes product labeling to evolve over time following interactions with regulatory authorities, which may include restrictions
of therapeutic indications, new contraindications, warnings, or precautions and occasionally even the suspension or withdrawal
of a product marketing authorization. Following any of these events, pharmaceutical companies can face significant product
liability claims (see Note D.22.a. to the consolidated financial statements included at Item 18. of this annual report).
Furthermore, we commercialize several devices (some of which use new technologies) which, if they malfunction, could cause
unexpected damage and lead to product liability claims (see “Breaches of data security, disruptions of information technology
systems and cyber threats could result in financial, legal, competitive, operational, business or reputational harm” below).
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2
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SANOFI
FORM 20-F
2024
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PART I
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ITEM 3. Key Information
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Although we continue to insure a portion of our product liability with third-party carriers, product liability coverage is increasingly
difficult and costly to obtain, particularly in the United States. In the future, it is possible that self-insurance may become the sole
commercially reasonable means available for managing the financial risk associated with product liability in our pharmaceuticals
and vaccines businesses (see “Item 4. Information on the Company — B. Business Overview — B.8. Insurance and risk coverage”).
In cases where we self-insure, the legal costs that we would bear for handling such claims, and potential damage awards to be
paid to claimants, could have a negative impact on our financial condition. Due to insurance conditions, even when we have
insurance coverage, recoveries from insurers may not be totally successful due to market-driven insurance limitations and
exclusions. Moreover, insolvency of an insurer could affect our ability to recover claims on policies for which we have already paid
a premium.
Product liability claims, regardless of their merits or the ultimate success of our defense, are costly, divert management’s
attention, may harm our reputation, and can impact the demand for our products and generate speculative news flows and/or
rumors relating to such claims. Substantial product liability claims could materially adversely affect our business, results of
operations and financial condition, and/or may have an impact on market perception of our company and negatively affect our
stock price.
Claims and investigations relating to ethics and business integrity, competition law, marketing practices,
pricing, human rights of workers and other legal matters could adversely affect our business,
results of operations and financial condition
Our industry is heavily regulated and legal requirements vary from country to country, and new requirements are imposed on our
industry from time to time. Governments and regulatory authorities around the world have been strengthening implementation
and enforcement activities in recent years, including in relation to anti-bribery, anti-corruption, and ethical requirements with
respect to medical and scientific research, interactions with healthcare professionals and payers, and respect for the human
rights of workers.
We have adopted a Code of Conduct that requires employees to comply with applicable laws and regulations, as well as the
specific principles and rules of conduct set forth in the Code. We also have policies and procedures designed to help ensure that
we, our officers, employees, agents, intermediaries and other third parties comply with applicable laws and regulations (including
but not limited to the US Foreign Corrupt Practices Act (FCPA), the UK Bribery Act, the OECD Anti-Bribery Convention, the
French Anti-Corruption measures law (Sapin II), the French duty of vigilance law and other anti-bribery laws and regulations).
Notwithstanding these efforts, failure to comply with laws and regulations (including as a result of a business partner’s breach)
may occur and could result in liabilities for us and/or our management.
Sanofi and certain of its subsidiaries could become the subject of investigations or proceedings by various government entities or
could face audits and/or litigation, including allegations of corruption, claims related to employment matters, patent and
intellectual property disputes, consumer law claims and/or competition law and tax audits. We are currently the target of a
number of lawsuits relating to pricing and marketing practices (including, for example, “whistleblower” litigation in the United
States), which we are vigorously defending. With respect to tax issues, the complexity of the fiscal environment is such that the
ultimate resolution of any tax matter may result in payments that are greater or less than the provisions we have booked. See
“Item 8. Financial Information — A. Consolidated Financial Statements and Other Financial Information — Information on Legal or
Arbitration Proceedings” and Note D.22. to our consolidated financial statements included at Item 18. of this annual report. In
addition, responding to such investigations is costly and may divert management’s attention from our business.
Unfavorable outcomes in any of these matters, or in similar matters that may arise in the future, could preclude the
commercialization of our products, harm our reputation, negatively affect the profitability of existing products and subject us to
substantial fines, punitive damages, penalties and injunctive or administrative remedies, potentially leading to the imposition of
additional regulatory controls, monitoring or self-reporting obligations, or exclusion from government reimbursement programs
or markets, all of which could have a material adverse effect on our business, results of operations or financial condition.
The unpredictability of these proceedings could lead Sanofi, after consideration of all relevant factors, to enter into settlement
agreements to settle certain claims. Such settlements may involve significant monetary payments and/or potential criminal
penalties, may include admissions of wrongdoing and may require entering into a Corporate Integrity Agreement (CIA) or a
Deferred Prosecution Agreement (in the United States), which is intended to regulate company behavior for a specified number
of years. For example, on February 28, 2020, Sanofi US entered into a civil settlement with the United States Department of
Justice and agreed to pay approximately $11.85 million to resolve allegations regarding certain charitable donations Sanofi US
made to an independent patient assistance foundation that assisted patients being treated for multiple sclerosis. In connection
with this settlement, Sanofi US also entered into a CIA with the Office of the Inspector General for the United States Department
of Health and Human Services effective the same day, which will require us to meet and maintain certain compliance
requirements in the United States.
Our activities (including our products and manufacturing activities) are subject to significant
government regulations and regulatory approvals, which are often costly and could result in adverse
consequences to our business if we fail to anticipate the regulations, comply with them, maintain
the required approvals, and/or adapt to changes in applicable regulations
Obtaining a marketing authorization for a product is a long and highly regulated process requiring us to present extensive
documentation and data to the relevant regulatory authorities either at the time of the filing of the application for a marketing
authorization or later during its review. Each regulatory authority may impose its own requirements which can evolve over time.
Each regulatory authority may also delay or refuse to grant approval even though a product has already been approved in
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SANOFI
FORM 20-F
2024
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3
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PART I
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ITEM 3. Key Information
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another country. Regulatory authorities are increasingly strengthening their requirements on product safety and risk/benefit
profiles. All these requirements, including post-marketing requirements, have increased the costs associated with maintaining
marketing authorizations (see “Item 4. Information on the Company — B. Business Overview — B.5. Markets — B.5.3. Regulatory
framework”).
Moreover, to monitor our compliance with applicable regulations, the FDA, EMA, WHO and comparable national agencies in other
jurisdictions routinely conduct regulatory inspections of our facilities, distribution centers, commercial activities and development
centers (including hospitals), and may identify potential deficiencies which we must adequately address. More generally, if we fail
to adequately respond to regulatory inspection observations identified during an inspection or fail to comply with applicable
regulatory requirements at all or within the targeted timeline, we could be subject to enforcement, remedial and/or punitive
actions by the FDA (such as a Warning Letter, injunction, seizure or cease and desist order), the EMA or other regulatory
authorities.
For example,
in January 2025
, the FDA issued a warning letter related to certain GMP practices at our Framingham
facility.
In addition, we have an obligation to monitor and report adverse events and safety signals. To comply with these duties,
we must regularly train our employees and certain third parties (such as external sales forces and distributor employees) on
regulatory matters, including on pharmacovigilance. If we fail to train these people, or fail to train them appropriately, or if they do
not comply with contractual requirements, we may be exposed to the risk that safety events are not reported or not reported in a
timely manner in breach of our reporting obligations.
Due to regulatory or geopolitical constraints, we may face delays in our clinical studies due, for example, to the new EU Clinical
Trials Regulation review process for approvals of new studies or for the transition of ongoing studies under such new regulation,
and/or restrictions imposed on clinical study sites, and/or delays in the supply chain for investigational products and/or the
initiation and enrollment of patients in our clinical studies, and/or disruptions related to regulatory approvals, for instance due to
the inability of health authorities to perform inspections in other countries and/or delays in label expansions for existing products,
and/or delays due to the complexities of the review processes for clinical studies which involve an investigational device or
diagnostic combined with the investigational product. We may not be able to fully mitigate these delays, which could negatively
impact the timing of our pipeline development programs and may have a negative impact on our product development and
launches and hence on future product sales, business, and results of operations.
In addition, all aspects of our business, including research and development, manufacturing, marketing, reimbursement, pricing,
and sales, are subject to extensive legislation and governmental regulation. Changes in applicable laws and the costs of
compliance with such laws and regulations could have an adverse effect on our business.
For example, the pharmaceutical industry has experienced challenges due to the implementation of the new European Union
regulations for Medical Devices (EU MDR) and for In-Vitro Diagnostic Devices (IVDR), which entered into force in May 2021 and
May 2022, respectively. In October 2024, the European Parliament adopted a resolution for a revision of these regulations with a
view to addressing challenges, in particular obstacles associated with the implementation of the EU MDR and IVDR; however, the
outcome of that resolution is uncertain at this stage. The FDA's recent rulemaking on laboratory-developed tests (LDTs),
implemented in May 2024, introduces significant regulatory uncertainty and potential delays in product availability as clinical
testing laboratories in the US adapt to new requirements; this poses a risk to Sanofi clinical study timelines and the availability of
testing to support commercial products given that LDTs are used for patient selection, product dose decisions, treatment
monitoring and clinical study endpoints.
For information about risks related to changes (i)
in proprietary rights rules and regulations, see “– We rely on our patents and
other proprietary rights to provide exclusive rights to market certain of our products. If such patents and other rights were
limited, invalidated, or circumvented, our financial results could be adversely affected” below; and (ii) in environmental rules and
regulations, see “– Management of the historical contamination related to our past industrial activities could adversely impact our
results of operations and reputation” below.
In addition, changes in tax laws or regulations or their interpretation or exposures to additional tax liabilities around the world
could negatively impact our operating results. Changes to tax laws or regulations may occur at any time, and any related expense
or benefit recorded may be material to the fiscal quarter and year in which the law change is enacted. As a result of the 2024
presidential and legislative elections in the United States, changes to applicable laws and regulations that have been announced,
proposed, and/or adopted, or could be made or expanded in the future, may result in new or expanded trade restrictions by the
United States and/or other countries, including, but not limited to, tariffs or import taxes being applied to imported goods and
services which could affect our operations and our exports into the United States. Other countries may implement trade
restrictions and/or retaliatory measures as well. Any such trade restrictions or measures could affect our operations, our exports
into the United States and other countries and/or our supply chains. Significant modifications to tax legislation are also expected
in some of the markets where we operate, such as France and the United States. All these elements could negatively impact our
business and operating results.
Furthermore, most of the jurisdictions in which we operate have double tax treaties with other foreign jurisdictions, which provide
a framework for mitigating the impact of double taxation on our revenues and capital gains. However, the outcome of those
mechanisms developed to resolve such conflicting claims can in some circumstances be
uncertain
and can be expected to be
very lengthy. Provisions for tax contingencies are made based on experience, interpretations of tax law, and judgments about
potential actions by tax authorities. However, due to the complexity of tax contingencies, the ultimate resolution of any tax
matter may result in payments materially different from the amounts accrued.
|
4
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SANOFI
FORM 20-F
2024
|
|
PART I
|
|
ITEM 3. Key Information
|
We rely on our patents and other proprietary rights to provide exclusive rights to market certain
of our products. If such patents and other rights were limited, invalidated, or circumvented,
our financial results could be adversely affected
Through patent and other proprietary rights, such as data exclusivity or supplementary protection certificates in Europe, we hold
exclusivity rights for several of our research-based products. However, the protection that we are able to obtain varies in its
duration and scope. Furthermore, patents and other proprietary rights do not always provide effective protection for our
products. We cannot be certain that we will obtain adequate patent protection for new products and technologies in important
markets or that such protections, once granted, will last as long as originally anticipated.
For example, governmental authorities are increasingly looking to facilitate generic and biosimilar competition for existing
products through new regulatory proposals intended to achieve, or resulting in, changes to the scope of patent or data
exclusivity rights and using accelerated regulatory pathways for generic and biosimilar drug approvals. At the EU level, the
proposed wide-ranging revision of the general pharmaceutical legislation may pose downside risks to innovation and
competitiveness in Europe, primarily due to the reduction of intellectual property (IP) protections and a stricter incentives
framework for orphan medicinal products (OMPs). Such regulatory proposals could make patent prosecution for new products
more difficult and time consuming or could adversely affect the exclusivity period for our products.
Moreover, manufacturers of generic products or biosimilars are increasingly seeking to challenge patent validity or coverage
before the patents expire, and manufacturers of biosimilars or interchangeable versions of the products are seeking to have their
version of the product approved before the exclusivity period ends. Furthermore, in an infringement suit against a third party, we
may not prevail, and the decision rendered may not conclude that our patent or other proprietary rights are valid, enforceable, or
infringed. Our competitors may also successfully avoid our patents. Even in cases where we ultimately prevail in an infringement
claim, legal remedies available for harm caused to us by infringing products may be inadequate to make us whole. Moreover, a
successful result against a competing product for a given patent or in a specific country is not necessarily predictive of our future
success against another competing product or in another country because of local variations in the patents and patent laws.
In addition, if we lose patent protection because of an adverse court decision or a settlement, we face the risk that government
and private third-party payers and purchasers of pharmaceutical products may claim damages alleging they have over-
reimbursed or overpaid for a drug.
We also rely on unpatented proprietary technology, know-how, trade secrets and other confidential information, which we seek
to protect through various measures, including confidentiality agreements with licensees, employees, third-party collaborators,
and consultants who may have access to such information. If these agreements are breached or our other protective measures
should fail, then our contractual or other remedies may not be adequate to cover our losses.
In certain cases, to terminate or avoid patent litigation we or our collaboration partners may be required to obtain licenses from
the holders of third-party intellectual property rights. Any payments under these licenses may reduce our profits from such
products and we may not be able to obtain these licenses on favorable terms or at all.
Third parties may also request a preliminary or permanent injunction in a country from a court of law to prevent us from marketing
a product if they consider that we infringe their patent rights in that country. If third parties obtain a preliminary or permanent
injunction or if we fail to obtain a required license for a country where valid third-party intellectual property rights as confirmed by
a court of law exist, or if we are unable to alter the design of our technology to fall outside the scope of third-party intellectual
property rights, we may be unable to market some of our products in certain countries, which may limit our profitability.
In addition, the pursuit of valid business opportunities may require us to challenge intellectual property rights held by others that
we believe were improperly granted, including through negotiation and litigation, and such challenges may not always be
successful. Third parties may claim that our products infringe one or more patents owned or controlled by them. Claims of
intellectual property infringement can be costly and time-consuming to resolve, may delay or prevent product launches, and may
result in significant royalty payments or damages.
Furthermore, some countries may consider granting a compulsory license to a third party to use patents protecting an
innovator’s product, which limits the value of the patent protection granted to such products.
We have increased the proportion of biological therapeutics in our pipeline relative to traditional small molecule pharmaceutical
products. Typically, the development, manufacture, sale, and distribution of biological therapeutics is complicated by third-party
intellectual property rights (otherwise known as freedom to operate (FTO) issues), to a greater extent than for the small molecule
therapeutics, because of the types of patents allowed by national patent offices. Further, our ability to successfully challenge
third-party patent rights is dependent on the legal interpretation and case law of national courts. In addition, we expect to face
increasing competition from biosimilars in the future. With the accelerated regulatory pathways provided in the United States
and Europe for biosimilar drug approval, biosimilars can be a threat to the exclusivity of any biological therapeutics we sell or may
market in the future and can pose the same issues as the small molecule generic threat described above. If a biosimilar version of
one of our products were to be approved, it could reduce our sales and/or profitability of that product.
We currently hold trademark registrations and have trademark applications pending in many jurisdictions, any of which may be
the subject of a governmental or third-party objection, which could prevent the maintenance or issuance of the trademark. As
our products mature, our reliance on our trademarks and trade dress to differentiate us from our competitors increases and, as a
result, our business could be adversely affected if we are unable to prevent third parties from adopting, registering, or using
trademarks and trade dress that infringe, dilute, or otherwise violate our rights.
If our patents and/or proprietary rights to our products were limited or circumvented, our financial results could be adversely
affected.
|
SANOFI
FORM 20-F
2024
|
5
|
|
PART I
|
|
ITEM 3. Key Information
|
Failure to comply with data ethics and privacy regulations could adversely affect our business
and reputation
We operate in an environment that relies on the collection, processing, analysis, and interpretation of large sets of patients’ and
other individuals’ personal data, and the operation of our business requires data to flow freely across borders of numerous countries.
The legal and regulatory environment of data privacy is diversified, with regional legislation such as the General Data Protection
Regulation (GDPR) in Europe, the Personal Information Protection Law (PIPL) in China, and other significant privacy legislation,
including the California Consumer Privacy Act (CCPA) in the United States. As the framework continues to evolve, some
uncertainty remains with respect to absence of clear guidance or case law.
Such uncertainty could result in an operational risk limiting or preventing the transfer of data across borders, which may have an
impact on our activities (e.g., on clinical studies). Breach of the regulations described above could also carry financial sanctions
and may harm our reputation and those of our activities that rely on personal data processing.
Furthermore, the increasing volume of data processed and advances in new technologies, such as artificial intelligence, have
resulted in a greater focus on data governance and the ethical use of personal data. Failure in our data governance and ethical
use of personal data could affect our business and reputation.
Risks relating to our business
The pricing and reimbursement of our products is negatively affected by increasing cost containment
pressures and decisions of governmental authorities and other third parties
The commercial success of our existing products and our product candidates depends in part on their pricing and reimbursement
conditions. Our products are negatively affected by continued downward pricing pressure and scrutiny due, inter alia, to:
•
stricter price and access controls imposed by governments and other payers around the world:
–
requirements for greater transparency around drug pricing and drug development costs,
–
widespread use of international reference pricing and therapeutic reference pricing, among other pricing methodologies
and caps,
–
mandatory price cuts, renegotiations, industry payback and rebates,
–
delisting from reimbursement and restrictions on the label population,
–
access restrictions for high-priced innovative medicines,
–
prescribing guidelines and binding medicine utilization controls,
–
Medicare drug price negotiations under the US Inflation Reduction Act (IRA),
–
greater use of tendering and centralized procurement (national/regional/class-wide level),
–
cross-country cooperation in price negotiations, contracting or procurement, which is already occurring to some extent,
such as the Vaccine Alliance (GAVI), the BeNeLuxA alliance in Europe, and the Pan American Health Organization (PAHO),
–
shifting of the payment burden to US patients and access disruptions through
copay
accumulator and maximizer programs
as well as alternative funding programs,
–
more aggressive formulary utilization management controls (including stepped therapy, strict prior authorization criteria,
formulary exclusions) by US insurers and pharmacy benefits managers (PBMs), and
–
discriminatory and non-transparent pricing and procurement policies (e.g. government procurement restrictions, import
bans) in favor of domestic pharmaceutical companies,
–
widespread
use of health technology assessment (HTA) to inform coverage and reimbursement decisions, and
–
more stringent evidence and value requirements (e.g. comparative effectiveness, patient preferences, real-word evidence,
health economic modelling) by payers and HTA authorities, raising the bar for market entry,
•
u
nreasonable thresholds for cost-effectiveness :
–
increasingly restrictive HTA decisions with significant variation across markets; increased generic and biosimilar
competition, accelerating price erosion, and
–
next generation biosimilars coming to the market across major therapeutic areas; and
•
potential savings from increased biosimilar use, which are
expected to be a cumulative $290 billion globally from 2023 to 2027
and could reach $383 billion according to the IQVIA Institute's recent Global Use of Medicines report:
–
evolving regulatory landscapes to support interchangeability (e.g., in the US and EU) and pharmacy substitution (e.g. in the
EU Nordic countries, Germany and France).
In the United States, which accounted for
48.7%
of our net sales in 2024, the Inflation Reduction Act (IRA) was enacted in
August 2022. The law includes three core drug pricing provisions (Medicare negotiation, Part D redesign, and Medicare inflation
penalties). Significant uncertainties remain on the process and methods of Medicare negotiation. While no Sanofi product was
among the first ten drugs to face Medicare price negotiations in 2024, the new legislation
may likely
have a negative impact on
our revenue growth and will influence our portfolio strategy in the mid- to longer term. However, recent election results in the US
may spark uncertainty for the IRA.
Although a full repeal of the IRA may be unlikely due to budgetary impact, the new US
administration could change some of the IRA provisions, including Medicare drug price negotiations.
Furthermore, we face increasing pricing pressure and gross-to-net (GTN) erosion from continuing vertical integration and
consolidation of the US health insurance market,
as well as political scrutiny over insulin prices, which resulted in the list price of
Lantus being lowered by 78% effective January 1, 2024.
With the three largest pharmacy benefit manager group purchasing
organizations (PBM GPOs) (Ascent, Zinc and Emisar) now covering over 85% of prescription drug claims, consolidation has led to
increased utilization management and restrictive formularies, increasing the negotiating power of PBMs over drug manufacturers
and thereby adversely impacting our sales
.
|
6
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SANOFI
FORM 20-F
2024
|
|
PART I
|
|
ITEM 3. Key Information
|
Under the new US
administration
we could face unpredictable drug pricing policies, an increasing focus on price transparency,
persistent supply chain challenges due to high dependency on
active pharmaceutical ingredient
imports, an ‘America First’
protectionist policy, and explosive growth of the federal 340B drug pricing program.
In China, high pricing pressure and intensifying local competition are expected to continue as a growing number of our products
are subject to national reimbursement drug list (NRDL) negotiations and national volume-based procurement (VBP) tenders,
giving priority to the lowest prices with limited acceptability of value based-pricing
.
At market entry, new drugs listed on the
NRDL had an average
price cut of 60.1%
over the past five years. Further expansion of the (VBP) policy to biologics and
biosimilars also poses a growing threat to our key established
products and our biologics portfolio
, with over 500 drugs targeted
for inclusion by 2025.
Several factors may hinder or delay our research and development efforts to renew our portfolio
of medicines and vaccines
Discovering and developing a new medicine or vaccine is a costly, lengthy, and uncertain process. To be successful in the highly
competitive biopharmaceutical industry, we must commit substantial resources each year to research and development in order
to develop new medicines and vaccines to compensate for decreasing sales of medicines and vaccines facing patent expiration
and termination of regulatory data exclusivity, introduction of lower-priced generics and biosimilars, or competition from new
product launches by competitors that are perceived as being equivalent or superior to our therapies. We must pursue
both
research
and early- and late-stage development to achieve a sustainable and well-balanced portfolio. In 2024, we spent
€
7,394
million on research and development, amounting to
18.0%
of our net sales. As part of an update
on our Play to Win
strategy
, we announced in October 2023 our intent to increase our research and development spend. Failure to invest in the
right technology platforms, disease areas, medicine or vaccine classes, geographic markets, and licensing or acquisition
opportunities could adversely impact the productivity of our internal pipeline.
We are pursuing a pipeline-driven transformation, including potential multi-indication opportunities such as amlitelimab,
frexalimab, and the oral TNFR1si, intended to address unmet medical needs in markets with a low penetration of novel therapies,
or where there is no current effective therapy approved. We focus our R&D strategy on therapeutics in immunology, rare
diseases, neurology, and selectively in oncology. In 2021, Sanofi acquired Translate Bio to accelerate the deployment of mRNA
technology for the development of new vaccines, including for seasonal influenza, and beyond vaccines, therapeutics where
there is a strong unmet medical need. However, mRNA technology is still in its early days and the ability of this technology to
produce strong results with an acceptable safety profile remains to be fully asserted. We may fail to improve our development
productivity sufficiently to sustain our pipeline (see also “— We may fail to successfully identify external business opportunities
or realize the anticipated benefits from our strategic investments or divestments” below).
The competitive landscape includes a high level of uncertainty as numerous companies are working on or may be evaluating
similar targets to us. A medicine or vaccine considered as promising at the beginning of its development may become less
attractive if a competitor addressing the same unmet need reaches the market earlier. There can be no assurance that any of
our pipeline candidates will be proven safe or effective (see “Item 4. Information on the Company — B. Business Overview
— B.4. Global research & development”). Over these research and development cycles, usually spanning several years, there is a
substantial risk at each stage of development – including pre-clinical activities and clinical studies – that we will not achieve our
goals of safety and/or efficacy and that we will have to abandon a medicine or vaccine in which we have invested substantial
amounts of money and human resources. For instance, the global clinical development program of amcenestrant for breast
cancer was discontinued in August 2022 following the outcome of the prespecified interim analysis of a Phase 3 study. As
another example, in late 2023, based on the outcome of a prespecified interim analysis of a Phase 3 study, the global clinical
development program for tusamitamab ravtansine was discontinued after the Independent Data Monitoring Committee found
that the compound, as a monotherapy, did not meet its dual primary endpoints. Studies are increasingly designed with clinical
endpoints of superiority, which means that failure to achieve those endpoints could damage the medicine or vaccine’s outlook
and our overall development program.
Decisions concerning the studies to be carried out can have a significant impact on the marketing strategy for a given medicine
or vaccine. Multiple in-depth studies can demonstrate that a medicine or vaccine has additional benefits, facilitating the
marketing, but such studies are expensive and time consuming and may delay the medicine or vaccine’s submission to
regulatory authorities for approval.
In addition, following (or in some cases in parallel with) the marketing authorization, a dossier is also submitted to governmental
agencies and/or national or regional third-party payers for review. These
Health Technology Assessment
(HTA) bodies evaluate
evidence on the value of the new medicine or vaccine, assess the medical need it serves, and provide recommendations on the
corresponding reimbursement. Such analyses may require additional studies, including comparative studies, which may
effectively delay marketing, change the population which the new medicine or vaccine treats, and add costs to the
development. Our continuous investments in our research and development pipeline, and in launches of newly registered
molecules, could therefore result in increased costs without a proportionate increase in revenues, which would negatively affect
our operating results and profitability.
Furthermore, there can be no assurance that all medicines or vaccines approved or launched will generally achieve commercial
success.
Finally, even after a medicine or vaccine reaches the market, certain developments following regulatory approval may reduce
demand for them. Clinical studies and post-marketing surveillance of certain marketed medicines and vaccines have the
potential to raise concerns among some prescribers and patients relating to the safety, efficacy, or tolerability of
pharmaceuticals in general, which could negatively affect sales or lead to increased volatility in market reaction.
|
SANOFI
FORM 20-F
2024
|
7
|
|
PART I
|
|
ITEM 3. Key Information
|
Breaches of data security, disruptions of information technology systems and cyber threats could result
in financial, legal, competitive, operational, business, or reputational harm
Our business depends heavily on the use of interdependent information technology systems, including Internet-based systems
and digital tools. Certain key areas such as research and development, production and sales are largely dependent on our
information systems (including cloud-based computing) or those of third-party providers (including for the storage and transfer
of critical, confidential, sensitive, or personal information regarding our patients, clinical studies, vendors, customers, employees,
collaborators and others). We are therefore vulnerable to cybersecurity attacks and incidents and misuse or manipulation of any
of these IT systems could result in exposure of confidential information or the modification of critical data.
We and our third-party service providers, suppliers, contract manufacturers, distributors or other contracting third parties use, to
the best of our ability, secure information technology systems for the protection of data and threat detection. Like many
companies, we may experience certain of the following events which pose a risk to the security and availability of these systems
and networks, and the confidentiality, integrity, and availability of our sensitive data: breakdown, outages, service disruption or
impairment, data loss or deterioration in the event of a system malfunction or increasing threat of data theft or corruption in the
event of a cyber-attack, security breach, industrial espionage attacks, insider threat attacks, cybercrimes, including state-
sponsored cybercrimes, malware, misplaced or lost data, programming or human errors or other similar events. Also, in the event
of an attack, US and European legislation related to the financing of terrorism imposes increasing restrictions on payments of
ransom. As a result, our ability to recover the data might be limited. Therefore, our business continuity could be at risk if we are
unable to recover data through back-ups and restorations. In addition, in the EU, a number of existing and forthcoming rules and
laws – including NIS2, the European Health Data Space (EHDS), the Data Act, the Cyber Resilience Act and the AI Act – are
changing privacy and cybersecurity compliance requirements, and creating new potential enforcement risks.
We are increasingly using generative artificial intelligence (AI) to enhance our business processes. Although we have set up a
governance body to control the AI initiatives taken on a company-wide scale and have made a generative AI charter available to
all our employees, this new technology, like other AI technology, entails risks linked to transparency, fairness, data privacy and
confidentiality, eco-responsibility, and cybersecurity. These risks could result in unintended consequences such as unethical
practices, business and reputational harm, cyber-attacks, and security breaches (see “— We may fail to develop or take
advantage of digitalization and prioritizing data as an organizational asset” below). There is a global trend towards more
comprehensive regulation of AI that may require us to modify existing or adopt new compliance procedures or developments.
Each of these events could negatively impact important processes, such as scientific research and clinical studies, the submission
of outcomes to health authorities for marketing authorizations, the functioning of production processes and the supply chain,
compliance with legal requirements, trade secrets, security strategies and other key activities, including Sanofi’s employees’
ability to communicate between themselves as well as with third parties (see also “— Product liability claims could adversely
affect our business, results of operations and financial condition” above). This could result in material financial, legal, competitive,
operational, business, or reputational harm.
Although we maintain relevant insurance coverage, this insurance may not be sufficiently available in the future to cover the
financial, business, or reputational losses that may result from an interruption or breach of our systems. For example, certain types
of cyber-attacks could be considered as an act of war subject to insurance exclusion.
The manufacture of our products is technically complex, and supply interruptions, product recalls or
inventory losses caused by unforeseen events may reduce sales, adversely affect our operating results
and financial condition, delay the launch of new products, and negatively impact our image
Many of our products are manufactured using technically complex processes with production constraints, including the need for
specialized facilities, trained and certified employees, and highly specific raw materials. We must ensure that all manufacturing
processes comply with (i) current Good Manufacturing Practices (cGMP), (ii) other applicable regulations issued by governmental
health authorities around the world, as well as (iii) our own quality standards. Third parties supply us with a portion of our raw
materials, active ingredients, and medical devices, which exposes us to the risk of a supply shortage or interruption especially if
these suppliers are unable to manufacture our products in line with quality standards or if they experience financial difficulties.
Epidemics and other public health crises, such as the COVID-19 pandemic, expose us to risks of a slowdown or temporary
suspension in the production of our active pharmaceutical ingredients, raw materials, and some of our products. Any prolonged
restrictive measures put in place to control an outbreak of contagious disease or other adverse public health development, in a
country, state or region in which any of our principal production sites are located, may have a material and adverse effect on our
manufacturing operations. Any of these factors could adversely affect our business, operating results, or financial condition (see
“Item 4. Information on the Company — B. Business Overview — B.7. Production and raw materials” for a description of these
outsourcing arrangements and “A failure in our crisis and business continuity management processes in case of unpredictable
events could have negative consequences for our business, operations and reputation” below).
Our business may require the transformation and adaptation of our plants to ensure the continuity of production of our products
in sufficient quantities to satisfy demand. This may be necessary to meet the need to produce new products, including biologics,
or to ensure the scaling up production of products under development once approved. This need may also result from new
regulatory requirements. Furthermore, our biological products are subject to the risk of manufacturing stoppages or the risk of
loss of inventory because of the difficulties inherent in the processing of biological materials and the potential difficulties in
accessing adequate amounts of raw materials meeting required standards. In addition, specific storage and distribution
conditions are required for many biological products (for example, cold storage is required for certain vaccines, insulin-based
products, and some hemophilia products). These production difficulties may also be encountered during testing, which is a
mandatory requirement prior to drug products being released.
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8
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SANOFI
FORM 20-F
2024
|
|
PART I
|
|
ITEM 3. Key Information
|
The complexity of our production processes, as well as standards required for the manufacture of our products, subject us to
risks because the investigation and remediation of any identified or suspected problems can cause production delays,
substantial expense, product recalls or lost sales and inventories, and delay the launch of new products; this could adversely
affect our operating results and financial condition, and cause reputational damage and the risk of product liability (see
“— Product liability claims could adversely affect our business, results of operations and financial condition” above). In addition,
some of our production sites, and some of our suppliers’ and/or contractors’ sites, are in areas exposed to natural disasters such
as floods, earthquakes, and hurricanes (see “— Climate change or legal, regulatory or market measures to address climate
change may negatively affect our business and results of operations” below). Such disasters could be exacerbated by climate
change. In the event of a major disaster, we could experience severe destruction or interruption of our operations and
production capacity at these sites.
When manufacturing disruptions occur, we may not have alternate manufacturing capacity, particularly for certain biologics. In
the event of manufacturing disruptions, our ability to use backup facilities or set up new facilities is more limited because
biologics are more complex to manufacture and generally require dedicated facilities. Even though we aim to have backup
sources of supply whenever possible, including by manufacturing backup supplies of our principal active ingredients at
additional facilities when practicable, we cannot be certain they will be sufficient if our principal sources become unavailable.
Switching sources and manufacturing facilities requires significant time and prior approval by health authorities.
Supply shortages generate even greater negative reactions when they occur with respect to life saving medicines with limited
or no viable therapeutic alternatives. Shortages of specific products can have a negative impact on the confidence of patients,
customers and professional healthcare providers and the image of Sanofi and may lead to lower product revenues.
A substantial share of the revenue and income of Sanofi depends on the performance of certain
flagship products
Our strategy, as presented in December 2019 and completed as part of our R&D Day presentation in December 2023, focuses
on key growth drivers including (but not limited to) Dupixent, Vaccines, and key therapeutic areas in immunology. Nevertheless,
market expansion and new launches of medicines and vaccines may not deliver the anticipated benefits. We may also
encounter delays or failures in our launch strategy (in terms of timing, pricing, market access, marketing efforts, and dedicated
sales forces), such that our products may not deliver the expected benefits. The competitive environment for a given medicine
or vaccine may also have changed by the time of the actual launch, modifying our initial forecasts. The need to prioritize the
allocation of resources may also cause delays in or hamper the launch or expansion of certain medicines or vaccines.
Also, we currently generate a substantial share of our net sales from certain key products (see “Item 5. Operating and
Financial Review and Prospects — A.2.1. Net sales — 3/Net Sales – Biopharma segment”). For example, Dupixent generated net
sales of
€13,072
million in 2024 representing
31.8%
of our net sales for the year and is Sanofi’s biggest product in terms of sales.
Among our flagship products, Lantus, Lovenox, Plavix, Jevtana and Aubagio
already face generic competition on the market. In
2024, Lantus was one of Sanofi’s leading products with net sales of €
1,628
million. With respect to influenza, which represented
30.8%
of vaccines net sales in 2024, we may face potential challenges. The influenza market is expected to have several new
competitive entrants, both from standalone flu mRNA and COVID-flu combinations, who could be on the market ahead of us.
Additionally, the influenza market globally is subject to intense pricing pressure, as well as a decrease in vaccination coverage.
The combination of such factors could result in a lowering of revenue from sales of influenza vaccines. Beyfortus, which
represented
20.3%
of our vaccines net sales in 2024, may also face competition from another monoclonal antibody in the
coming years, which could negatively impact our revenue in this area.
More generally, expiration of effective intellectual property protections for our products typically results in the market entry of
one or more lower-priced generic competitors, often leading to a rapid and significant decline in revenues from those products
(for information regarding ongoing patent litigation see Note D.22.b. to the consolidated financial statements included at
Item 18. of this annual report).
The introduction of a generic product results in adverse price and volume effects for our branded or genericized products. For
example, although we do not believe it is possible to state with certainty what level of net sales would have been achieved in the
absence of generic competition, a comparison of our consolidated net sales for 2024 and 2023 for the main products affected
by generic and biosimilar competition shows a loss of €
794
million of net sales on a reported basis (see “Item 5. Operating and
Financial Review and Prospects — A.1.2. Impacts of Competition from generics and biosimilars”). However, other parameters
may have contributed to the loss of sales, such as a fall in the average price of certain products (e.g., Lantus).
Furthermore, in general, if one or more of our flagship products were to encounter problems (such as material product liability
litigation, unexpected side effects, product recalls, non-approval by the health authorities of a new indication for a marketed
product, pricing pressure and manufacturing or supply issues), the adverse impact on our business, results of operations and
financial condition could be significant.
(1)
The information in this section supplements the disclosures required under IFRS 7 as presented in Notes B.8.7., D.10. and D.34. to our consolidated
financial statements, provided at Item 18. of this annual report.
|
SANOFI
FORM 20-F
2024
|
9
|
|
PART I
|
|
ITEM 3. Key Information
|
We rely on third parties for the discovery, manufacture, marketing, and distribution of some
of our products
Our industry is both highly collaborative and competitive, whether in the discovery and development of new products, in-
licensing, the marketing and distribution of approved products, or manufacturing activities. We expect that we will continue to
rely on third parties for key aspects of our business and we need to ensure our attractiveness as a potential partner.
We conduct several significant
research and development programs and market some of our products in collaboration with
other biotechnology and pharmaceutical companies. For example, we currently have a global strategic collaboration with
Regeneron on monoclonal antibodies for the development and commercialization of Dupixent, Kevzara (sarilumab) and
SAR440340 (REGN3500- itepekimab) (see “Item 5. Operating and Financial Review and Prospects — A.1.7. Financial
Presentation of Alliances — 1/ Alliance Arrangements with Regeneron Pharmaceuticals Inc.”). We rely upon Regeneron to
successfully carry out their responsibilities regarding the manufacture and supply of these collaboration antibodies
(see “Item 4. Information on the Company — B. Business Overview”). In May 2024, we announced a co-exclusive licensing
agreement to develop novel flu-COVID-19 combination vaccines with Novavax (see above —“Several factors may hinder or
delay our research and development efforts to renew our portfolio of medicines and vaccines”). We may also rely on partners to
design and manufacture medical devices, in particular for the administration of our products. Finally, we may rely on partners for
the development and commercialization of in-vitro diagnostic tests used in clinical studies, and in-vitro diagnostic tests
specified in the labeling of our products as necessary or useful for the management of patients taking our products. As regards
some products launched or under development for which we have a collaboration agreement with partners, the terms of the
applicable alliance agreement may require us to share profits and losses arising from commercialization of such products with
our partners. This differs from the treatment of revenue and costs generated by other products for which we have no alliance
agreement, and such profit sharing may deliver a lower contribution to our financial results.
We could also be subject to the risk that we may not properly manage the decision-making process with our partners. Decisions
may be controlled by, or subject to the approval of our collaboration partners, who may have views that differ from ours. We are
also subject to the risk that our partners may not perform effectively, which could have a detrimental effect when our
collaboration partners are responsible for the performance of certain key tasks or functions, for example related to
manufacturing or distribution. This risk is further increased by the growing number of distribution centers divested by Sanofi as
part of its global strategy and by the resulting growing externalization of distribution tasks and functions.
Any failures in the development process or differing priorities may adversely affect our business, including the activities
conducted through our collaboration arrangements. We also cannot guarantee that third-party manufacturers will be able to
meet our near-term or long-term manufacturing requirements, for internal reasons (e.g. in case of financial difficulties), reasons
directly related to their contractual relationship with Sanofi, or external reasons (e.g. in the event of a health crisis). Thereby,
following the completion of the spin-off of EUROAPI in May 2022, EUROAPI became a third-party manufacturer and continues
to manufacture a certain number of active pharmaceutical ingredients for Sanofi. We are also subject to the risk that contract
research organizations or other vendors (for instance regarding digital activities) retained by us, or our collaboration partners
may not perform effectively.
Any conflicts, difficulties or litigation with our partners during these agreements or at the time of their renewal or renegotiation,
or any disruption in the relationships with our partners, may affect the development, manufacturing, launch and/or marketing of
certain of our products or product candidates and may cause a decline in our revenues or otherwise negatively affect our results
of operations.
We are subject to the risk of non-payment by our customers
(1)
Our customers, which consist principally of wholesalers, distributors, pharmacies, hospitals, clinics, and government agencies,
present risks related to delayed payments or even non-payment. This risk is accentuated by recent concentrations among
distributors and retailers, as well as by ongoing uncertainties in global credit markets and economic conditions, in particular in
emerging markets. As a result, we may be affected by fluctuations in the buying patterns of such customers. The United States
presents specific customer credit risk issues because of the concentrated pharmaceutical distribution system: in 2024 our three
main customers represented respectively
15%
,
11%
and
8%
of our consolidated net sales, respectively. We are also exposed to
large wholesalers in other regions, particularly in Europe. An inability of one or more of these wholesalers to honor their debts to
us could adversely affect our financial condition (see Note D.34. to our consolidated financial statements included at Item 18. of
this annual report).
In certain countries, some of our customers are public or subsidized health systems. The economic and credit conditions in
these countries could further extend the average collection period for accounts receivable, putting additional strain on our
working capital.
(2)
The information in this section supplements the disclosures required under IFRS 7 as presented in Note B.8.7. to our consolidated financial statements,
provided at Item 18. of this annual report.
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10
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SANOFI
FORM 20-F
2024
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PART I
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ITEM 3. Key Information
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Global economic conditions and an unfavorable financial environment could have negative
consequences for our business
(2)
Over the past several years, growth of the global pharmaceutical market has increasingly been tied to global economic trends. In
this context, a substantial and lasting slowdown or instability of the global economy, major national economies or emerging
markets could negatively affect the global pharmaceutical market's growth and, as a result, adversely affect our business. For
example, unpredictable geopolitical conditions that currently exist in various parts of the world could have a material negative
impact on our business, in particular the armed conflict between Russia and Ukraine, and the escalation of violence and potential
further conflicts in the Middle East. The consequences of these conflicts remain uncertain, and will depend on developments
outside Sanofi’s control, including, but not limited to the duration and severity of the conflicts, and the consequences of the
ongoing and additional financial and economic sanctions imposed by governments in response. Sanofi faces rising tensions
between the US and China, two of our key markets. Trade, economic, technological and military conflicts could disrupt supply
chains, raise raw material costs, and affect clinical and manufacturing operations and business strategy. Other related issues have
arisen or are arising such as regional instability; geopolitical uncertainties; adverse effects on fuel and energy costs, supply chains,
macroeconomic conditions, inflation, and currency exchange rates in various regions of the world and exposure of third parties to
gas shortages. Collectively, such unstable conditions could, among other things, disturb the international flow of goods and
increase the costs and difficulties associated with international transactions.
Unfavorable economic conditions have reduced the sources of funding for national social security systems, leading to austerity
measures including heightened pressure on drug prices, increased substitution of generic drugs, and the exclusion of certain
products from formularies among others (see “— The pricing and reimbursement of our products is negatively affected by
increasing cost containment pressures and decisions of
governmental
authorities and other third parties” above).
The challenging economic environment could also negatively impact our net sales. In regions with high unemployment, rising
inflation, or limited third-party payer systems, patients may turn to more affordable generic alternatives, delay treatments, or
reduce observance to cut costs. In the United States there has been a significant increase in the number of beneficiaries in the
Medicaid program, under which sales of pharmaceuticals are subject to substantial rebates and, in many US states, to formulary
restrictions limiting access to brand-name drugs, including ours. Additionally, rising healthcare costs have prompted some
employers to transfer a greater share of these costs to their employees, which further decreases demand for brand-name
pharmaceuticals and intensifies downward pressure on prices.
Our Opella business (which is classified in “discontinued operations” in Sanofi’s income statement following the announcement of
exclusive negotiations for the sale of a 50% controlling stake to CD&R, with the transaction expected to close at the earliest in
second quarter 2025, see generally “Item 5. Operating and Financial Review and Prospects”) could also be adversely impacted by
deteriorating economic conditions, as consumers may have reduced purchasing power, prompting them to opt for lower-cost
alternatives.
Should global economic conditions worsen, or in the event of default or failure of major players including wholesalers or public
sector buyers financed by insolvent states, Sanofi's financial situation, profitability, operational results, and distribution channels
of products could be adversely affected. See also “— We are subject to the risk of non-payment by our customers” above.
A failure in our crisis and business continuity management processes in case of unpredictable events
could have negative consequences for our business, operations, and reputation
We have increased crisis preparedness and response in recent years due in particular to crises such as the COVID-19 pandemic
and ongoing war in Ukraine and conflicts in the Middle East. Nevertheless, unpredictable and extraordinary internal or external
events, or a combination of escalating events that may occur as a result of a large scale cyber-attack (see also “— Breaches of
data security, disruptions of information technology systems and cyber threats could result in financial, legal, competitive,
operational, business or reputational harm” above), a pandemic or natural disasters, could result in the failure of critical processes
within Sanofi or a third party on whom we rely. Moreover, lack of resources and/or low maturity level in crisis management of our
service providers faced with an increasing number of major international crises may hamper our ability to implement our business
continuity plans. Such failure or limited implementation of our business continuity plans may adversely impact our business,
operations, and reputation.
The occurrence of these unforeseen events may also heighten other risks such as a disruption or temporary suspension in
production of active pharmaceutical ingredients, raw materials and some of other products and/or lead to manufacturing delays
or disruptions and supply chain interruptions (including to the extent those measures apply to our third-party suppliers) and may
have an adverse effect on our business (see “— The manufacture of our products is technically complex, and supply interruptions,
product recalls or inventory losses caused by unforeseen events may reduce sales, adversely affect our operating results and
financial condition, delay the launch of new products and negatively impact our image” above). Also, a sudden increase in
demand for selected medicinal products in the event of a crisis can result in short-term unavailability or shortages of raw
materials.
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SANOFI
FORM 20-F
2024
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11
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PART I
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ITEM 3. Key Information
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Climate change or legal, regulatory or market measures to address climate change may negatively affect
our business and results of operations
Climate change resulting from increased concentrations of carbon dioxide and other greenhouse gases in the atmosphere could
present both physical and transition risks to our operations.
Physical risks include adverse impacts on global temperatures, weather patterns and the frequency and severity of extreme
weather and natural disasters.
Natural disasters and extreme weather conditions, such as a hurricane, tornado, earthquake,
wildfire, or flooding, may pose physical risks to our facilities and disrupt the operation of our supply chain. The impacts of the
changing climate on water resources may result in water scarcity, limiting our ability to access sufficient high-quality water in
certain locations, which may increase operational costs. For example, in 2023 and 2024, our sites located in North Africa were
exposed to intermittent shortages of drinking water distribution following severe episodes of water scarcity and maintenance
issues of municipal utilities systems.
Concern over climate change may also result in new or additional legal or regulatory requirements, designed to reduce
greenhouse gas emissions and/or mitigate the effects of climate change on the environment. If such laws or regulations were to
be more stringent than current legal or regulatory obligations (e.g., increased carbon taxation risk), we may experience disruption
in, or an increase in the costs associated with sourcing, manufacturing, and distribution of our products, which may adversely
affect our business, results of operations or financial condition.
The increasing use of social media platforms and new technologies present risks and challenges
for our business and reputation
We increasingly rely on social media, new technologies and digital tools to communicate about our products and about diseases
or to provide health services. The use of these media requires specific attention, monitoring programs and moderation of
comments. Political and market pressures may be generated by social media because of rapid news cycles. This may result in
commercial harm, overly restrictive regulatory actions, and erratic share price performance. In addition, unauthorized
communications, such as press releases or posts on social media, purported to be issued by Sanofi, may contain information that
is false or otherwise damaging and could have an adverse impact on our image and reputation and on our stock price. Negative
or inaccurate posts or comments about Sanofi, our business, directors, or officers on any social networking website could
seriously damage our reputation. In addition, our employees and partners may use social media and mobile technologies
inappropriately, which may give rise to liability for Sanofi, or which could lead to breaches of data security, loss of trade secrets or
other intellectual property or public disclosure of sensitive information. Such uses of social media and mobile technologies could
have an adverse effect on our reputation, business, financial condition, and results of operations.
Risks relating to Sanofi’s structure and strategy
We may fail to successfully identify external business opportunities or realize the anticipated benefits
from our strategic investments or divestments
We pursue a strategy of selective acquisitions, in-licensing, and collaborations to reinforce our pipeline and portfolio. We are also
proceeding to selective divestments to focus on key business areas. The implementation of this strategy depends on our ability to
identify transaction opportunities, mobilize the appropriate resources to enter into agreements in a timely manner, and execute
these transactions on acceptable economic terms. Moreover, entering into in-licensing or collaboration agreements generally
requires the payment of significant “milestones” well before the relevant products reach the market, without any assurance that
such investments will ultimately become profitable in the long term (see Note C. to the consolidated financial statements
included at Item 18. of this annual report and “— We rely on third parties for the discovery, manufacture, marketing, and
distribution of some of our products” above). Once a strategic transaction is agreed upon with a third party, we may not be able
to complete the transaction in a timely manner or at all.
For example, our planned separation of Opella may not be completed on
the terms or timeline currently contemplated, if at all, and may not achieve the expected results (see “—Completion of the
separation of Opella is subject to conditions that may not be satisfied and we may fail to realize any or all of the anticipated
benefits of the separation and/or face unintended adverse impacts on our business” below).
For newly acquired activities or businesses, our growth objectives could be delayed or ultimately not realized, and expected
synergies could be adversely impacted if, for example:
we are unable to integrate those activities or businesses quickly or
efficiently; key employees leave; or we have higher than anticipated integration costs.
The Translate Bio acquisition (see in “— Several factors may hinder or delay our research and development efforts to renew our
portfolio of medicines and vaccines” above) which was completed in 2021 may not generate the expected results in terms of
developing new mRNA-based products to meet existing or future needs, and the potential of Translate Bio’s mRNA platform may
not be realized to its full extent because of the difficulty of integrating the activity quickly and efficiently into the Group.
We may also miscalculate the risks associated with business development transactions at the time they are made or may lack the
resources or ability to access all the relevant information to evaluate such risks properly, including regarding the potential of
research and development pipelines, manufacturing issues, tax or accounting issues, compliance issues, or the outcome of
ongoing legal and other proceedings. It may also take a considerable amount of time and be difficult to implement a risk analysis
and risk mitigation plan after the acquisition of an activity or business is completed due to lack of historical data. Acquired
businesses may not always be in full compliance with legal, regulatory or Sanofi standards, including, for example, current Good
Manufacturing Practices (cGMP), which can be costly and time consuming to remedy. As a result, risk management and coverage
of such risks, particularly through insurance policies, may prove to be insufficient or ill-adapted.
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12
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SANOFI
FORM 20-F
2024
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PART I
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ITEM 3. Key Information
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With respect to divestments, their financial benefit could be impacted if we face significant financial claims or significant post-
closing price adjustments. Furthermore, the value of the assets to be divested may deteriorate while we are in the process of
executing our divestment strategy, with the risk that we do not realize the anticipated benefits.
Because of the active competition among pharmaceutical groups for business development opportunities, there can be no
assurance of our success in completing these transactions when such opportunities are identified.
Completion of the separation of Opella is subject to conditions that may not be satisfied and we may fail
to realize any or all of the anticipated benefits of the separation and/or face unintended adverse impacts
on our business
In October 2024, we announced that we had entered into exclusive negotiations with CD&R for the potential sale and purchase
of a 50% controlling stake in Opella and that we would remain a significant shareholder in Opella. This intended separation aims at
paving the way for Opella to become a new, standalone leader in Consumer Healthcare, while supporting our strategy and
increased focus on innovative medicines and vaccines.
This intended separation may not be completed on the expected terms or may be delayed or may not be completed at all. In
particular, completion of the separation will be subject to obtaining regulatory approvals from the competent authorities. There
can be no assurance that any or all of these conditions will be satisfied. There can also be no assurance regarding the ultimate
timing of the planned separation. Unanticipated developments could delay, prevent or otherwise adversely affect the planned
separation, including disruptions in general or financial market conditions, the political and geopolitical situations, and potential
problems or delays in obtaining various regulatory approvals or clearances.
Failure to complete the separation would result in the potential benefits of the separation not being realized and could have a
material adverse effect on the success of Sanofi
as a whole
, including our results of operations and financial condition. In addition,
if completion of the separation does not occur, the Opella business will remain part of Sanofi, which could (i) have an adverse
effect on our strategy, including but not limited to the allocation of resources to the Biopharma segment, where value-creating
opportunities and longer-term operational changes have been identified to support our intended accelerated R&D expenditure;
(ii) cause potential delay in the execution of the strategic objectives of Sanofi and the Opella business; and (iii) have a disruptive
effect on management and employees of Sanofi and/or the Opella business. Moreover, failure to complete the separation could
have an adverse effect on our reputation and on external perception of our ability to implement large scale projects successfully,
even where due to factors outside our control. There are also costs associated with the separation that we would still be required
to pay even if the separation is not completed.
Completion of the planned separation, for which we have incurred and are expected to incur significant costs, may not achieve
the expected benefits in full or in part and there is no guarantee as to the timing of when or if any such benefits may be realized.
The success of the operation and its expected benefits will depend on several factors, including many factors outside of our
control, and a number of assumptions that may prove incorrect.
Post-separation, we may face a number of challenges relating to the implementation of the separation and to operating without
the Opella business. There may be adverse financial, operational, regulatory, consumer, patient and reputational implications if
we fail (either wholly or in part) to meet such challenges. Such adverse implications could impact our financial condition, results of
operations and/or prospects. For example, our business will be smaller and less diversified than currently, and will be more
susceptible to adverse developments in the remaining business and markets in which we operate. Accordingly, should any part of
our remaining business underperform, this could have a greater adverse impact on our results or financial conditions following
separation than would have been the case prior to the separation. In addition, post-separation we will have greater relative
exposure to the global pharmaceuticals and vaccines markets and the associated risks and will no longer benefit from exposure to
the Consumer Healthcare market we had prior to separation from the Opella business, which would make us more reliant on the
R&D process (see “—Several factors may hinder or delay our research and development efforts to renew our portfolio of
medicines and vaccines).
Finally, as we will retain a holding in Opella of up to 48% with veto rights only on certain matters, we will not control operational
decisions and Opella’s success will depend on its ability to retain talent and skilled professionals and take advantage of the
opportunities that lie ahead in its segment. Therefore, our remaining holding in Opella may fall in value if Opella’s strategy does
not deliver the expected benefits.
The globalization of our business exposes us to increased risks in specific areas
As part of the presentation of our strategy in December 2019, we identified our strong presence in China among our core drivers,
with revenue amounting to
6.5%
of our net sales in 2024.
The difficulties in operating in emerging markets, a significant decline in the anticipated growth rate or an unfavorable movement
of the exchange rates of currencies against the euro could impair our ability to take advantage of growth opportunities and could
adversely affect our business, results of operations or financial condition. For instance, if a long-lasting epidemic and prolonged
or repeated restrictive measures to control the outbreak were to result in an economic slowdown in any of our targeted markets,
it would reduce our sales due to lower healthcare spending on other diseases and fewer promotional activities, and could
significantly impact our business operations. Furthermore, it is not possible to predict if or how such
health crisis
would impact
any affected jurisdiction, or to what extent (see also “— Global economic conditions and an unfavorable financial environment
could have negative consequences for our business” above).
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SANOFI
FORM 20-F
2024
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13
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PART I
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ITEM 3. Key Information
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Emerging markets also expose us to more volatile economic conditions; legal, regulatory and political instability, both globally and
locally (including a backlash in certain areas against free trade); competition from multinational or locally based companies that
are already well established in these markets; the inability to adequately respond to the unique characteristics of emerging
markets (particularly with respect to their underdeveloped judicial systems and regulatory frameworks); difficulties in recruiting
qualified personnel or maintaining the necessary internal control systems;
difficulties that may adversely affect our ability to
supply our products,
potential exchange controls; weaker intellectual property protection; higher crime levels (particularly with
respect to counterfeit products); and compliance issues including corruption and fraud (see particularly “— Claims and
investigations relating to ethics and business integrity, competition law, marketing practices, pricing, human rights of workers,
and other legal matters could adversely affect our business, results of operations and financial condition” above).
Given the increasing
globalization of our business, if relations between the United States, European Union countries and other
governments deteriorate, our business and investments in such markets may also be adversely affected.
For example, the
BIOSECURE Act in the United States, which would prohibit federal agencies from entering into certain contracts with or
expenditures related to companies that have specified commercial connections with “biotechnology companies of
concern” (the identification criteria for which have not been determined, and the list of which has not been defined and could
be very extensive, including companies in China), has been proposed in the US Congress, and, if enacted, could restrict our
ability to contract or collaborate with such biotechnology companies. This, in turn, could materially and adversely affect our or
our collaboration partners’ ability to manufacture or supply marketed products and product candidates, or to advance our or
our collaboration partners’ preclinical research, which could materially and adversely affect our business and future prospects.
We may fail to develop or take advantage of digitalization and prioritizing data as an organizational
asset
We have undertaken several digital initiatives, such as the implementation of artificial intelligence (AI) across our business. For
example, in research and development, we have built multiple AI programs to reduce research times through improved
predictive modelling. We are also seeking to automate time-consuming activities, enabling research and development teams to
scale and accelerate research processes and improve potential target identification in therapeutic areas such as immunology,
oncology and neurology. In manufacturing and supply, we have developed an in-house AI-enabled yield optimization solution
that delivers higher yield levels and optimizes usage of raw materials.
Our success in these efforts will depend on many factors including data availability; entering into successful partnerships and
alliances with technology companies (such as the AI collaboration with Formation Bio and OpenAI announced in May 2024,
aimed at building AI-powered software to accelerate drug development ); a profound transformation of our organization; a
cultural change among our employees, and the development of relevant skills; our ability to adopt AI agents; attracting and
retaining employees with appropriate skills and mindsets in a tight labor market; and successfully innovating across a variety of
technology fields, while seeking to comply with evolving external regulations. In recent years, we have accelerated our digital
transformation, including in the ways we engage and interact with our stakeholders. However, there is no guarantee that our
efforts towards digital transformation will succeed. More generally, we may fail to capture the benefits of AI, digitalization and
valuing data as an enterprise asset at an appropriate cost and/or in a timely manner, and/or enter into appropriate partnerships.
Competitors, including new entrants such as tech companies, may outpace us in this fast-moving area. If we fail to adequately
integrate digital capabilities into our organization and business model, we could lose patients and market share. This could have
an adverse impact on our business, prospects, and results of operations. Because AI is an emerging technology, it is possible
that our use of AI technologies may not have the intended effects or benefits, such as increasing efficiency. In addition, the use
of AI technologies presents certain risks, including the use of personal data as described above (see “— Failure to comply with
data ethics and privacy regulations could adversely affect our business and reputation" above).
The success of digital initiatives will also depend on our ability to shift our culture to a data-driven culture and to transform the
architecture of our business process designs to integrate AI. This calls for management of data as an asset and the definition of
a robust life-cycle management process for data that is applied consistently across Sanofi. Misuse of such technologies could
negatively affect our reputation, disrupt our operations, or otherwise have a material adverse impact on our financial results and
could also subject us to legal and reputational risks.
We may fail to accelerate our operational efficiency and perform our transformation program
As part of the presentation of the next chapter of our Play to Win strategy in October 2023, we announced our intent to
improve our operating efficiencies to fund growth. We also announced savings of a total of up to €2 billion from 2024 to the
end of 2025, most of which will be reallocated to fund innovation and growth drivers. We also announced our intent to separate
Opella, with an anticipated closing date of the transaction at the earliest in the second quarter 2025, subject to obtaining
regulatory approvals from the competent authorities. (See also “— Completion of the separation of Opella is subject to
conditions that may not be satisfied and we may fail to realize any or all of the anticipated benefits of the separation and/or face
unintended adverse impacts on our business”). To deploy our strategy, we must also disrupt our normal course of business and
transform our operations. Nevertheless, we may not succeed in federating employees behind the transformation program,
which may hamper our ability to execute such organizational changes. Besides, there is no guarantee that we will be able to fully
deliver these operating efficiencies or separate the Opella business within the targeted timeline, or at all, or generate the
expected benefits.
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14
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SANOFI
FORM 20-F
2024
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PART I
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ITEM 3. Key Information
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Unsuccessful management of sustainability (environmental, social and governance) matters
could adversely affect our reputation and we may experience difficulties meeting the expectations
of our stakeholders
Companies are increasingly expected to behave in a responsible manner on a variety of sustainability matters, by governmental
and regulatory authorities, counterparties such as vendors and suppliers, customers, investors, the public at large and others. This
context, driven in part by a rapidly changing regulatory framework in the US and in Europe, including the EU’s Corporate
Sustainability Reporting Directive (CSRD), is raising new challenges and influencing strategic decisions that companies must take
if they wish to optimize their positive impact and mitigate their negative impact on sustainability matters. These evolving
regulatory requirements are also likely to result in increased costs and complexities of compliance in order to collect, measure and
report on the relevant ESG-related information, and may expose us to additional regulatory, litigation and reputational risk. Given
recent political and geopolitical pressures, there is also the possibility that some or part of these rules or regulations are rolled
back or amended, in which case we would face additional compliance costs and, depending on such changes, we may face other
adverse effects described below.
We have adopted a sustainability strategy that aims at ensuring global access and affordability, addressing unmet needs with
transformative therapies, and minimizing the impact of our activities and products on the climate and the environment. The
strategy includes leveraging our personnel’s experience and making societal impact a key driver of our employees’ engagement.
However, despite our ambitions we could be unable to meet our sustainability or other strategic objectives in an efficient and
timely manner, or at all.
Furthermore, statements about our ESG-related initiatives and goals, and progress against those goals, may be based on
standards for measuring progress that are still developing, internal controls and processes that continue to evolve and
assumptions that are subject to change in the future.
We may also be unable to meet the ever more demanding criteria used by rating agencies in their sustainability assessments
process, leading to a downgrading in our rating. Financial investments in companies which perform well in sustainability
assessments are increasingly popular, and major institutional investors have made known their interest in investing in such
companies.
Depending on sustainability assessments, our ability to fulfill our sustainability strategy, and on the rapidly changing views on
acceptable levels of action across a range of sustainability topics from investors, we may be unable to meet society’s or investors’
expectations or the targets or goals contained in our sustainability strategy, in which case, our reputation may be harmed; we
may face increased compliance or other costs; and interest in subscribing to securities issued by us, and our ability to participate
in the debt and equity markets, may decrease. In addition, we could be criticized for the scope or nature of such initiatives or
goals, or for any revisions to these goals.
In addition, in recent years “anti-ESG” sentiment has gained momentum across the US, with several states and Congress having
proposed or enacted “anti-ESG” policies, legislation, or initiatives or issued related legal opinions, and the US President having
recently issued an executive order opposing diversity equity and inclusion (“DEI”) initiatives in the private sector. Such anti-ESG
and anti-DEI-related policies, legislation, initiatives, litigation, scrutiny and other actions could result in additional compliance
obligations, Sanofi becoming the subject of investigations and enforcement actions, or otherwise suffering reputational harm.
Our success depends in part on our senior management team and other key employees and our ability to
attract, integrate and retain key personnel and qualified individuals in the face of intense competition
Our success depends on the expertise of our senior management team and other key employees. In 2024, there
were
2,282
“Senior Leaders” within Sanofi. In addition, we rely heavily on recruiting and retaining talented people to help us meet
our strategic objectives. We face intense competition for qualified individuals for senior management positions, or in specific
geographic regions or in specialized fields such as clinical development, biosciences and devices, or digital and artificial
intelligence. Our ability to hire qualified personnel also depends in part on our ability to reward performance, incentivize our
employees and pay competitive compensation. The inability to attract, integrate and/or retain highly skilled personnel, in
particular those in leadership positions, may weaken our succession plans, may materially adversely affect the implementation of
our strategy and our ability to meet our strategic objectives, and could ultimately adversely impact our business or results of
operations.
Environmental and safety risks of our industrial activities
Risks from manufacturing activities and the handling of hazardous materials could adversely affect
our results of operations and reputation
Manufacturing activities, such as the chemical manufacturing of the active ingredients in our products and the related storage
and transportation of raw materials, products and waste, expose us to risks of industrial accidents that may lead to discharges or
releases of toxic or pathogenic substances or other events that can cause personal injury, property damage and environmental
contamination, and may result in additional operational constraints, including the shutdown of affected facilities and/or the
imposition of civil, administrative, criminal penalties and/or civil damages, and affect Sanofi’s reputation.
The occurrence of an industrial accident may significantly reduce the productivity and profitability of a particular manufacturing
facility and adversely affect our operating results and reputation. Although we maintain property damage, business interruption
and casualty insurance that we believe is in accordance with customary industry practices, this insurance may not be adequate to
fully cover all potential hazards incidental to our business.
(3)
The information in this section supplements the disclosures required under IFRS 7 as presented in Note B.8.7. to our consolidated financial statements,
provided at Item 18. of this annual report.
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SANOFI
FORM 20-F
2024
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15
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PART I
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ITEM 3. Key Information
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Management of the historical contamination related to our past industrial activities could adversely
impact our results of operations and reputation
The environmental laws of various jurisdictions impose actual and potential obligations on our Company to manage and/or
remediate contaminated sites. These obligations may relate to sites (i)
that we currently own or operate; (ii) that we formerly
owned or operated; or (iii) where waste from our operations was disposed.
These environmental remediation obligations could reduce our operating results. Sanofi accrues provisions for remediation when
our management believes the need is probable and that it is reasonably possible to estimate the cost (see Note D.22 to the
consolidated financial statements included at Item 18. of this annual report). Our provisions for these obligations may be
insufficient if the assumptions underlying these provisions prove incorrect or if we are held responsible for additional, currently
undiscovered contamination. These judgments and estimates may later prove inaccurate, and any shortfalls could have an
adverse effect on our results of operations and financial condition. For more detailed information on environmental policies and
issues, see “Item 4. Information on the Company — B. Business Overview — B.9. Health, Safety and Environment" and
Notes "B.12. Provisions for risks" and "D.19.3. Other provisions" to the consolidated financial statements included at Item 18. of this
annual report.
We are or may become involved in claims, lawsuits and administrative proceedings relating to environmental matters.
Some current and former Sanofi subsidiaries have been named as “potentially responsible parties” or the equivalent under
the US Comprehensive Environmental Response, Compensation and Liability Act of 1980, as amended (CERCLA, also known
as “Superfund”), and similar statutes or obligations in France, Germany, Italy, Brazil and elsewhere. As a matter of statutory or
contractual obligations, we and/or our subsidiaries may retain responsibility for environmental liabilities at some of the sites of our
predecessor companies, or of subsidiaries that we demerged, divested, or may divest. We have disputes outstanding regarding
certain sites no longer owned or operated by the Company. An adverse outcome in such disputes might have an adverse effect
on our operating results. See Note D.22.d to the consolidated financial statements included at Item 18. of this annual report and
“Item 8. Financial Information — A. Consolidated Financial Statements and Other Financial Information — Information on Legal or
Arbitration Proceedings”.
Environmental regulations are evolving
.
For example, in Europe, new or evolving regulatory regimes include the Registration,
Evaluation, Authorization and Restriction of Chemicals Regulation (which may include, in the future, a restriction on per- and
polyfluoroalkyl substances (PFAS) based on a recent draft released by the European Chemicals Agency (ECHA)); the
Classification and Labelling regulations applicable to hazardous chemicals; directives related to the control of major-accident
hazards (the “Seveso” directives); the Industrial Emission regulations; the Waste Framework
Directive; the Emission Trading
Scheme Directive; the Water
Framework Directive; the Directive on Taxation of Energy Products and
Electricity; and the recently
adopted Urban Wastewater Treatment Directive, as well as other regulations aimed at protecting public health or preventing
climate change. Stricter environmental, safety and health laws and enforcement policies could result in substantial costs and
liabilities to our Company and could subject our handling, manufacture, use, reuse or disposal of substances or pollutants, site
restoration and compliance to more rigorous scrutiny than is currently the case. Consequently, compliance with these laws could
result in capital expenditures as well as other costs and liabilities, thereby adversely affecting our business, results of operations or
financial condition.
Risks related to financial markets
(3)
Fluctuations in currency exchange rates could adversely affect our results of operations
and financial condition
Because we sell our products in numerous countries, our results of operations and financial condition could be adversely affected
by fluctuations in currency exchange rates. We are particularly sensitive to movements in exchange rates between the euro and
the US dollar, the Japanese yen, the Chinese yuan, and currencies in emerging markets. In
2024
,
48.7%
of our net sales were
generated in the United States,
22.0%
in Europe, and
29.4%
in the Rest of the World region (see the definition in
“Item 5. Operating and Financial Review and Prospects — A. Operating results”), including countries that are, or may in future
become, subject to exchange controls (including
6.5%
in China and
3.4%
in Japan). While we incur expenses in those currencies,
the impact of currency exchange rates on these expenses does not fully offset the impact of currency exchange rates on our
revenues. As a result, currency exchange rate movements can have a considerable impact on our earnings. When deemed
appropriate and when technically feasible, we enter into transactions to hedge our exposure to foreign exchange risks. These
efforts, when undertaken, may fail to offset the effect of adverse currency exchange rate fluctuations on our results of operations
or financial condition. For more information concerning our exchange rate exposure, see “Item 11. Quantitative and Qualitative
Disclosures about Market Risk.”
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Risks relating to an investment in our shares or ADSs
Foreign exchange fluctuations may adversely affect the US dollar value of our ADSs and dividends
(if any) regardless of our operating performance
H
olders of American depositary shares (ADSs) face exchange rate risks. Our ADSs trade in US dollars and our shares trade in
euros. The value of the ADSs and our shares could fluctuate substantially as the exchange rates between these currencies
fluctuate. If and when we pay dividends, they would be denominated in euros. Fluctuations in the exchange rate between the
euro and the US dollar will affect the US dollar amounts received by owners of ADSs upon conversion by the depositary of cash
dividends, if any. Moreover, these fluctuations may affect the US dollar price of the ADSs on the NASDAQ Global Select Market
(NASDAQ) whether we pay dividends, in addition to any amounts that a holder would receive upon our liquidation or in the
event of a sale of assets, merger, tender offer or similar transaction denominated in euros or any foreign currency other than
US dollars.
Persons holding ADSs rather than shares may have difficulty exercising certain rights as a shareholder
Holders of ADSs may have more difficulty exercising their rights as a shareholder than if they directly held shares. For example, if
we issue new shares and existing shareholders have the right to subscribe for a pro rata portion of the new issuance, the
depositary is allowed, at its own discretion, to sell this right to subscribe for new shares for the benefit of the ADS holders instead
of making that right available to such holders. In that case, ADS holders could be substantially diluted. Holders of ADSs must also
instruct the depositary how to vote their shares. Because of this additional procedural step involving the depositary, the process
for exercising voting rights will take longer for holders of ADSs than for holders of shares. ADSs for which the depositary does not
receive timely voting instructions will not be voted at any meeting. US investors may have difficulty in serving process or
enforcing a judgment against us or our directors or executive officers.
Sales of our shares may cause the market price of our shares or ADSs to decline
Sales of large numbers of our shares, or a perception that such sales may occur, could adversely affect the market price for our
shares and ADSs. L’Oréal, our largest shareholder, is not subject to any contractual restrictions on the sale of the shares it holds in
our Company. L’Oréal does not consider its stake in our Company as strategic and completed an off-market block trade of which
2.3% was bought back by Sanofi in February 2025. See “Item 7. Major Shareholders and Related Party Transactions" below.
Our largest shareholder owns a significant percentage of the share capital and voting rights of Sanofi
Following the buy-back we made of a block of shares from L'Oréal in February 2025, and after cancellation of said shares, L'Oréal
will own (excluding treasury shares) 7.2% of our share capital and 13.1% of our voting rights. See “Item 7. Major Shareholders and
Related Party Transactions — A. Major Shareholders”. Affiliates of L’Oréal currently serve on our Board of Directors. To the extent
L’Oréal continues to hold a large percentage of our share capital and voting rights, it will remain in a position to exert greater
influence in the appointment of the directors and officers of Sanofi and in other corporate actions that require shareholders’
approval.
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Item 4. Information on the Company
Introduction
Sanofi is a leading global healthcare company, focused on patient needs and engaged in the research, development,
manufacture and marketing of therapeutic solutions.
In the remainder of this section, a product is referred to either by its international non-proprietary name (INN) or its brand name,
which is generally exclusive to the company that markets it. In most cases, the brand names of our products, which may vary from
country to country, are protected by specific registrations. In this document, products are identified by their brand names used in
France and/or in the US.
Sanofi reports segment information for the Biopharma operating segment, further to the opening of exclusive negotiations
between Sanofi and Clayton, Dubilier & Rice (CD&R) on October 21, 2024 with a view to selling an equity interest in Opella,
which would lead to loss of control over Opella on the effective closing date, scheduled for the second quarter of 2025 at the
earliest.
Prior to the opening of those exclusive negotiations, Opella (formerly Consumer Healthcare) was an operating segment of
Sanofi. As a result of the announcement of the Proposed Opella Transaction (as defined in Note D.1.1.2. Project to divest a
controlling interest in Opella), as of the fourth quarter of 2024 Opella meets the criteria for a discontinued operation under
IFRS 5 (see Note B.7.), and the net income from this business is now presented separately within the line item
Net income from
discontinued operations
in the consolidated income statement. This presentation in a separate line item in the income
statement applies to results of operations for the current period, and for the comparative periods presented. With effect from
that date, Sanofi became a dedicated Biopharma company of which the performance, based on internal management
reporting, is subject to regular review by the Chief Executive Officer, Sanofi's chief operating decision-maker.
The Biopharma operating segment comprises commercial operations and research, development and production activities
relating to the Specialty Care, General Medicines and Vaccines franchises plus support and corporate functions, for all
geographical territories. It also includes revenues generated by legal entities within the Biopharma segment (and included in
the scope of continuing operations) from the manufacture of Consumer Healthcare products on behalf of legal entities within
Opella; those revenues are presented within
Other Revenues
in the income statement. The Biopharma operating segment also
includes the the purchase price of Biopharma products manufactured by legal entities within the Opella scope.
The “Other” category comprises primarily, but not exclusively, Consumer Healthcare activities that will not be transferred on
the effective date of loss of control of Opella. These are primarily (i) hospital sales of Opella products in China, the transfer of
which will be finalized no earlier than 2028 after a transitional period required to complete the transfer plan agreed with Sanofi
in the context of public tendering arrangements ; (ii) sales made by the dedicated entity Opella Russie, the equity interests in
which will be retained by Sanofi. Sanofi will continue to distribute Opella products in Russian territory under the distribution
agreement signed in connection with the separation, the parties reserving the right to discuss the transfer of this retained
interest during the distribution agreement term ; and (iii) sales of the Gold Bond product range, which are continuing in the
United States through the retained subsidiary Gold Bond LLC (holder of the associated worldwide property rights).
Figures for comparative periods (2023 and 2022) have been re-presented on a consistent basis to reflect the classification of
Opella as a discontinued operation.
A. History and development of the Company
The current Sanofi corporation was incorporated under the laws of France in 1994 as a
société anonyme
, a form of limited liability
company, for a term of 99 years. Since May 2011, we have operated under the commercial name “Sanofi” (formerly known as
Sanofi-Aventis). Our registered office is located at
46, avenue de la Grande Armée
–
75017
Paris
–
France
, our main telephone
number is +33 1 53 77 40 00, and our website (which contains information about the company and information filed with and
provided to the SEC) is www.sanofi.com. Our principal US subsidiary’s office is located at 55 Corporate Drive, Bridgewater,
NJ 08807; telephone: +1 (908) 981 5000.
The SEC maintains a website at http://www.sec.gov that contains reports, proxy and information statements, and other
information regarding issuers that file electronically with the SEC.
Main events over the last three years
On February 8, 2022, Sanofi acquired the entire share capital of the immuno-oncology company
Amunix Pharmaceuticals, Inc.
(Amunix), thereby gaining access to Amunix’s innovative ProXTen technology and a promising pipeline of immunotherapies.
On May 3, 2022, Sanofi’s General Meeting of Shareholders approved the decision to distribute approximately 58% of the
share capital of
EUROAPI
, a European leader in the development, manufacture, marketing and distribution of active
pharmaceutical ingredients (APIs), in the form of an exceptional dividend in kind to Sanofi shareholders. On the dividend
payment date of May 10, 2022 (further to the admission of EUROAPI shares to listing on the regulated market of Euronext Paris
on May 6, 2022), Sanofi divested control over EUROAPI and its subsidiaries, resulting in their deconsolidation from the Sanofi
consolidated financial statements as of that date.
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On March 13, 2023, Sanofi and
Provention Bio, Inc.
(Provention), a US-based publicly-traded biopharmaceutical company
developing therapies to prevent and intercept immune-mediated diseases including type 1 diabetes, entered into an agreement
under which Sanofi acquired the outstanding shares of Provention common stock for $25.00 per share in an all-cash
transaction valued at approximately $2.8 billion. On April 27, 2023, Sanofi announced the completion of its acquisition of
Provention. The acquisition added
Tzield
(teplizumab-mzwv), a therapy for type 1 diabetes, to Sanofi’s core General Medicines
medicine portfolio.
On July 28, 2023, Sanofi announced that it had entered into a definitive agreement to acquire ownership of
Qunol
, a market-
leading US-based health & wellness brand. This transaction was intended to strengthen Opella in the Vitamin, Mineral and
Supplements (VMS) category, one of the largest and fastest-growing consumer health categories in the US, focused on the
dynamic healthy aging segment. Sanofi’s
acquisition of QRIB Intermediate Holdings, LLC was completed on September 29,
2023, at a purchase price of $1,419 million.
On May 30, 2024, Sanofi announced that it had completed the acquisition of
Inhibrx, Inc
(Inhibrx), a publicly-traded, clinical-
stage biopharmaceutical company focused on developing a pipeline of novel biologic therapeutic candidates in oncology and
orphan diseases. The acquisition added SAR447537 (formerly INBRX-101) to Sanofi’s rare disease development portfolio. Under
the terms of the merger agreement, Sanofi agreed to (i) pay Inhibrx stockholders $30 per share of Inhibrx common stock on
closing of the merger (approximately $1.7 billion) and issue one non-transferable contingent value right (CVR) per share of
Inhibrx common stock, entitling its holder to receive a deferred cash payment of $5, contingent upon the achievement of
certain regulatory milestones (approximately $0.3 billion, if those milestones are achieved); (ii) pay off Inhibrx’s outstanding
third-party debt (approximately $0.2 billion); and (iii) contribute capital to a new publicly traded company (New Inhibrx) (at least
$0.2 billion). Since the closing of the merger, Inhibrx has become a wholly owned subsidiary of Sanofi. Additionally, Sanofi retains
a minority stake (approximately 8%) in New Inhibrx.
On October 21, 2024, Sanofi and Clayton, Dubilier & Rice (CD&R) announced that they had entered exclusive negotiations for
the Proposed Opella Transaction as defined under "Item 4 –B.3. Opella." The opening of the exclusive negotiations relating to
the Proposed Opella Transaction, and the signature of a put option agreement as of that date (leading to loss of the control
previously exercised by Sanofi over Opella), triggered the reclassification of the Opella business as a discontinued operation for
the 2024 financial year. Opella meets the criteria for a discontinued operation under IFRS 5, and the post-tax profit or loss from
Opella is now presented separately within the line item
Net income/(loss) from discontinued operations
in Sanofi's
consolidated income statement. This presentation in a separate line item of the income statement applies to operations for the
year ended December 31, 2024 and for the comparative periods presented. Sanofi has exercised the put option, pursuant to
which Sanofi is contemplating entering into an agreed form share purchase agreement; that agreement, once entered into by
the parties, will govern the terms for the sale and purchase of the share capital of Opella. Sanofi expects to receive a cash
payment during 2025, which may reach several billion euros, upon closing of the Proposed Opella Transaction, expected in the
second quarter of 2025 at the earliest, while retaining an indirect stake of around 50% in Opella. The proceeds would be used in
line with Sanofi’s existing capital allocation priorities, including shareholder returns.
On November 29, 2024, Sanofi entered into a definitive agreement with
Recordati
for the sale of Sanofi's global rights to
Enjaymo. Under this agreement, Sanofi received an upfront payment of $825 million and will be eligible for milestone payments of
up to $250 million based on sales. This divestment is part of Sanofi's strategy to streamline its portfolio and focus on core
biopharmaceutical innovations.
More detailed information about these changes is provided in Note D.1. to our consolidated financial statements, included at
Item 18. of this annual report.
B. Business overview
Sanofi’s activities are organized around the following categories: Immunology & Inflammation, Rare Diseases, Neurology, Oncology,
Other Medicines, Vaccines, and Opella. Except for Opella, which is a held-for-sale operation and therefore presented as a
discontinued operation in 2024 in accordance with IFRS 5, all of Sanofi's activities fall within the Biopharma operating segment.
B.1.
Strategy
The market context for Sanofi
Several fundamental trends continue to point to a positive outlook for the pharmaceutical industry. The global population is
growing and aging, and unmet medical needs remain high. Health needs have further increased, strengthening the key roles of
innovation in R&D activities and cutting-edge manufacturing. The industry has taken steps to increase R&D productivity, with the
objective of launching a higher number of innovative medicines and vaccines. Patients around the world – including a rising
middle class in emerging markets – are demanding better healthcare, empowered by access to more and more information.
It is a
challenging time scientifically and technologically: the promise of artificial intelligence (AI) is generating new insights into how to
diagnose and treat diseases, and Immunology remains a key therapeutic area with high unmet needs.
Digital technologies and
advanced data analytics are having a transformative effect across sales and marketing activities, R&D and manufacturing, and
are acting as enablers for new businesses.
At the same time, increased geopolitical uncertainties, inflation, supply shortages, and issues around budget tightening will
continue to put pressure on healthcare costs, and on the entire healthcare value chain. Although we believe that pharmaceuticals
and vaccines will remain a fundamentally attractive business within that value chain, the bar for innovation will most likely
continue to rise. Payers will continue to put scrutiny on prices and reimbursement criteria, and demand demonstration of real-life
(1)
In partnership with Regeneron.
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outcomes to confirm the efficacy of medicines and vaccines. This will be coupled with more innovative pricing and contracting
practices, and more transparent policies. In view of growing concerns over increasing healthcare costs across global markets, the
pharmaceutical industry will be increasingly judged by its contribution to improved access for patients and to the development of
innovative, highly cost-effective medicines.
Strategic framework
The Sanofi “Play to Win” strategy is organized around four key priorities: 1) focus on growth; 2) lead with innovation; 3) accelerate
efficiency; and 4) reinvent how we work to drive innovation and growth.
In October 2023, we announced that we had entered the next chapter of our Play to Win Strategy and:
•
increased investments in our pipeline to fully realize long-term growth potential, bolstered by successful launches and R&D
progress;
•
launched strategic cost initiatives, with most of the savings to be reallocated to fund innovation and growth drivers;
•
announced our intention to separate the Consumer Healthcare Business ; and
•
reiterated our capital allocation policy.
1) Focus on growth
•
Dupixent (dupilumab)
(1)
– By leveraging the product’s unique mechanism of action targeting the type 2 inflammation pathway
and its favorable safety profile, we have raised our ambition for peak sales of Dupixent. In September 2024, Dupixent was
approved in the US by the FDA as the first-ever biologic medicine for patients with Chronic Obstructive Pulmonary Disease
(COPD).
•
Vaccines – Sanofi has progressed to continued strong growth, driven by four core franchises: Influenza; Meningitis;
Polio,
Pertussis a Hib (PPH)
& Boosters; and Respiratory syncytial virus (RSV).
•
Pipeline – We are focusing our investments on projects in immunology, rare diseases, neurology and vaccines.
2) Lead with innovation
We have been able to shift from a priority medicine list to a steady flow of medicines in a refocused, consistent pipeline. Our
pipeline is showing potential opportunities for market-leading products.
To continue fueling our promising pipeline and enhance our position in our core therapeutic areas, we have:
i.
acquired Inhibrx, Inc,. adding a potential best-in-class rare disease medicine for Alpha-1 Antitrypsin Deficiency to the pipeline;
ii.
entered into a strategic collaboration with Synthekine to develop and commercialize IL-10 receptor agonists for the
treatment of inflammatory diseases;
iii.
established a strategic collaboration with Belharra to advance the discovery of novel small molecule therapeutics for
immunological diseases;
iv.
established a co-exclusive licensing agreement with Novavax to co-commercialize a COVID-19 vaccine and develop novel flu-
COVID-19 combination vaccines;
v.
entered into an exclusive worldwide out-licensing agreement with Vir Biotechnology for three clinical-stage masked T-cell
engagers and exclusive use of the protease-cleavable masking platform for oncology and infectious diseases, medicines
previously acquired by Sanofi from Amunix Pharmaceuticals;
vi.
entered into a three-way collaboration with Formation Bio and OpenAI to build AI-powered software to accelerate drug
development and bring new medicines to patients more efficiently;
vii.
secured rights to develop a CD73 inhibitor(uliledlimab) in China, from VJ Pharma, a company spun out from I-Mab; and
viii.
entered into an exclusive licensing agreement (i) with RadioMedix to develop radiopharmaceuticals for PET imaging and
targeted alpha therapy (TAT) to respond to unmet medical needs in cancer, and (ii) with Orano Med to develop lead-212
(212Pb) radioligand therapies (RLTs) for cancer.
3) Accelerate efficiency
In October 2023, we announced new Strategic Costs Initiatives. We are improving our cost structure, launching efficiency
initiatives across our Biopharma business to free operational resources to support R&D investment and unlock value-creation
opportunities. This includes prioritizing our investments in R&D and modernizing our approach to commercial delivery.
To transform the practice of medicine,
we are developing and deploying AI-powered solutions across all business units at all
levels of Sanofi, not only to increase automation and efficiency, but also to fundamentally change the way we work and think.
We
are investing in computational tools and AI to become the leading digital healthcare platform for employees, patients and
providers.
AI and data science are already supporting our teams in areas such as accelerating drug discovery, improving clinical
trial design, and streamlining the manufacture and supply of drugs and vaccines. We are driving a company-wide culture shift
that embeds digital DNA into the fabric of our organization.
O
ur R&D teams are already accelerating their work: our Target Discovery engines have delivered seven novel drug targets in just
one year, while our mRNA modelling solution has cut mRNA design time in half.
Our Manufacturing & Supply (M&S) teams are
saving time on time-consuming tasks and spending more time taking action based on data insights. By assessing data trends and
identifying production outliers, we help our teams optimize the use of raw materials and resources as they manufacture and
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distribute life-changing therapies to patients around the globe.
Our Portfolio Strategy teams are using AI to leverage data such as
internal clinical-trial and commercial data, as well as external information like competitor news flow, to predict value drivers such
as R&D costs, trial enrollment, and a program’s probability of success.
In 2024, we achieved key AI milestones across the business:
•
in partnership with Aily Labs, we
deployed the internal application
plai
.
Plai
aggregates internal data across all functions and
harnesses the power of AI to provide timely insights and personalized
“
what if
”
development scenarios to support informed
decision-making. We also hosted
our inaugural global hackathon, enabling over 31,000 Sanofi employees to learn about the AI
Agents used in Sanofi operations;
•
the expansion of our accelerators continued with the launch of two additional accelerators: a digital R&D accelerator, followed
by a digital M&S accelerator in 2024;
•
in Research, we have built multiple AI programs to reduce research times through improved predictive modelling and
automated time-sink activities. As a result, AI enables R&D teams to scale and accelerate research processes and improve
potential target identification in therapeutic areas like immunology, oncology or neurology by 20 to 30%;
•
in Manufacturing & Supply, we have developed an in-house AI-enabled yield optimization solution which learns from past and
current batch performance in an effort to enable consistently higher yield levels. This optimizes usage of raw materials,
supports our environmental efforts and supports improved cost efficiency; and
•
we have partnered with FormationBio and OpenAI to develop AI-powered software to accelerate drug development, create
custom drug development lifecycle solutions and bring new medicines to patients more efficiently:
–
in 2024 we focused on unifying Sanofi’s approach to data and AI, standardizing our approach to unlock value through
shared tools and assets,
–
Sanofi's internal GenAI tools are maturing rapidly, with Concierge (launched October 2024) and a successful M365 Copilot
pilot completed,
–
over 2,000 new users, across verticals, were trained on GenAI tooling delivered from GenAI Board-approved use cases in
2024,
–
approximately 7,000 Sanofi employees received training throughout Gen AI courses on
SanofiU, our in-house learning
platform
.
4) Reinvent how we work
Transformation and simplification have started, with the aim of increasing empowerment and accountability. To drive
implementation of our new culture built on stronger focus, diversity and teamwork, we have streamlined our executive leadership
team around 13 members. Three new members were appointed to our Executive Committee in 2024: Brian Foard as Head of the
Specialty Care Global Business Unit (succeeding Bill Sibold); François Roger as Chief Financial Officer (succeeding Jean-Baptiste
de Chatillon); and Audrey Duval as Global Head of Corporate Affairs.
The complete Sanofi Executive Committee now includes the
four managers who head up
our Global Business Units (Specialty Care, General Medicines, Vaccines, and Opella
)
as well as the
heads of each of the following support functions: Research and Development; Manufacturing & Supply; Finance; People &
Culture; Digital, Legal, Business Integrity & Global Security; Corporate Affairs; Ethics and Business Operations.
In 2024, we progressed further in building and simplifying our standalone Opella organization. We have further reduced our
portfolio, mainly through divestments, to approximately 100 brands (15% fewer than in 2023).
In October 2024, in line with our strategy of increased focus on innovative medicines and vaccines, we announced that we had
entered into exclusive negotiations with CD&R for the potential sale and purchase of a controlling stake
of approximately 50% in
Opella.
For more information on this potential transaction, see “— B.3 Opella.”
Our Corporate Social Responsibility (CSR) strategy aims to build a healthier, more resilient world by ensuring access to healthcare
for the world’s poorest people and bringing focus to addressing broader unmet needs. Our commitment to society also aims to
accelerate our goal of reducing the environmental impact of our products and of our worldwide operations. Key to tackling the
global challenges that face our company are our people, who each have a role to play in building a diverse and inclusive workplace.
Our CSR Strategy focuses on four building blocks integrated into our Play to Win core business strategy:
•
affordable access – to ensure affordable global access to health, while helping healthcare systems to remain sustainable;
•
R&D for unmet needs – to be at the cutting edge of R&D innovation, to help people live fully and drive growth;
•
Planet Care – to minimize the environmental impact of our business through environmental sustainability; and
•
in & beyond the workplace – to give all Sanofi colleagues the chance to become a leader of change, unlocking the potential of
our diverse teams.
Building on the existing strategy, an evolution of the CSR strategy was presented to and validated by the Board in late 2024. The
CSR strategy will be unveiled internally and externally in early 2025 and implemented thereafter.
Capital allocation policy
We will continue to pursue our focused and disciplined capital allocation policy. Our priorities in deploying the cash generated
from our operations are, in the following order: (i) investment in organic growth; (ii) business development and merger &
acquisition activities, focusing on bolt-on, value-enhancing opportunities to drive scientific and commercial leadership in core
therapeutic areas; (iii) growing the annual dividend; and (iv) anti-dilutive share buybacks. We also have the potential to raise
capital through asset disposals, including streamlining “tail” brands in our Established Products business.
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B.2. Biopharma segment
The sections below provide additional information on our main medicines. Our intellectual property rights over our biopharma
medicines are material to our operations and are described at “B.6. Patents, Intellectual Property and Other Rights” below. As
disclosed in “Item 8. Financial Information — A. Consolidated Financial Statements and Other Financial Information — Patents” of
this annual report, we are involved in significant litigation concerning the patent protection of a number of these medicines. For
more information on sales performance, see “Item 5. Operating and Financial Review and Prospects — A. Operating Results.”
Immunology & Inflammation
Dupixent
Dupixent (dupilumab) is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13
(IL-13) pathways and is not an immunosuppressant. Dupilumab is jointly developed by Sanofi and Regeneron under a global
collaboration agreement. To date, dupilumab has been studied across more than 59 completed studies and 23 ongoing studies,
involving more than 12,000 patients with various chronic diseases driven in part by type 2 inflammation. The dupilumab
development program has shown significant clinical benefit and a decrease in type 2 inflammation in Phase 3 studies,
establishing that IL-4 and IL-13 are key and central drivers of the type 2 inflammation that plays a major role in multiple
inflammatory diseases such as atopic dermatitis (AD), asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis
and prurigo nodularis. Dupixent comes in either a pre-filled syringe for use in a clinic or at home by self-administration as a
subcutaneous injection or in a pre-filled pen for at-home administration, providing patients with a more convenient option.
Dupixent is available in all major markets including the US (since April 2017), most European Union countries (the first launch was
in Germany in December 2017), Japan (since April 2018), and China (since June 2020).
Atopic dermatitis (AD)
Moderate-to-severe AD, a form of eczema and a chronic inflammatory disease, is characterized by rashes that sometimes cover
much of the body and can include intense, persistent itching and skin dryness, cracking, redness, crusting and oozing. Eighty-five
to ninety percent of patients first develop symptoms before five years of age, which can often continue through adulthood.
In 2014, the FDA also granted Dupixent
Breakthrough Therapy
designation, and after a Priority Review evaluation, it granted
Dupixent marketing authorization in March 2017 for the treatment of adults with moderate-to-severe AD whose disease is not
adequately controlled with topical prescription therapies, or when those therapies are not advisable. In 2016, the FDA granted
Dupixent
Breakthrough Therapy
designation for adolescent patients aged 12 to 17 years and in March 2019, the FDA extended the
marketing authorization to cover this age group.
In 2016, the FDA granted Breakthrough Therapy designation for Dupixent for the treatment of severe AD in children aged
six months to 11 years. On May 26, 2020, Dupixent was approved as the first biologic medicine for children aged six to 11 years with
moderate-to-severe AD. Having accepted Dupixent for Priority Review in February 2022, the FDA approved Dupixent on June 7,
2022 for children aged six months to five years with moderate-to-severe AD whose disease is not adequately controlled with
topical prescription therapies or when those therapies are not advisable, making Dupixent the first biologic medicine to
significantly reduce signs and symptoms in children as young as six months.
The EC approved Dupixent in September 2017 for use in adults with moderate-to-severe AD who are candidates for systemic
therapy, and extended the marketing authorization in August 2019 to include adolescents aged 12 to 17 years. On November 30,
2020, the EC extended the marketing authorization to children aged six to 11 years with severe AD and on June 28, 2021, the
Dupixent label was updated with long-term data for up to three years, reinforcing the medicine’s well-established safety profile in
adults with moderate-to-severe AD. On January 27, 2023 the CHMP adopted a positive opinion for Dupixent, recommending
expanded approval in the EU to treat severe AD in children aged six months to five years who are candidates for systemic
therapy. In March 2023, Dupixent was approved by the EC as the first and only targeted medicine for children as young as six
months old with severe AD.
On January 22, 2018, the Ministry of Health, Labor and Welfare (MHLW) in Japan granted marketing and manufacturing
authorization for Dupixent for the treatment of AD in adults not adequately controlled with existing therapies. More recently, on
September 25, 2023 Dupixent
was approved in Japan to treat patients aged six months and older with moderate-to-severe AD.
On June 19, 2020, the National Medical Products Administration (NMPA) in China approved Dupixent for adults for the treatment
of moderate-to-severe AD after identifying dupilumab as an overseas medicine regarded as urgently needed in clinical practice,
leading to an expedited review and approval process. On December 28, 2020, the National Healthcare Security Administration
(NHSA) officially announced the results of the 2020 National Reimbursement Drug List (NRDL) negotiations, with Dupixent
300 mg included in the updated NRDL effective March 1, 2021. Dupixent was approved in China in September 2021 for
adolescents aged 12-17 years with moderate-to-severe AD. The indication for children aged six years and over, along with
the adolescent and adult AD indications, was included in the current NRDL reimbursement scope, which was reviewed during
the Dupixent NRDL renewal in 2022 in accordance with the two-year cycle for the China access process. In May 2023, Dupixent
was approved in China to treat moderate to severe AD in infants and children aged six months and older.
In April 2023, new abstract data from a long-term efficacy open-label study presented at the Revolutionizing Atopic Dermatitis
(RAD) 2023 Spring Conference in Washington, DC showed that Dupixent demonstrated robust and sustained efficacy with
progressive improvement of AD signs and symptoms in patients with moderate-to-severe AD who completed up to five years of
treatment: the longest duration of data for any biologic medicine in this disease. Additionally, the long-term safety data from a
52-week open-label extension study in children aged six months to five years reinforced the well-established safety profile of
Dupixent observed across all other approved age groups. These data build on the existing evidence supporting the selective way
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Dupixent inhibits IL4/IL-13 pathways, both key and central drivers of type 2 inflammation, thereby significantly improving
itching and skin lesions and other important measures that impact a patient’s quality of life. The inclusion of the results from the
five-year OLE study for adults in the Dupixent label was approved in Europe in June 2023, and in the US by the FDA in
October 2023.
In March 2023, positive results from the clinical study assessing Dupixent in adults and adolescents with uncontrolled moderate-
to-severe atopic hand and foot dermatitis were presented in a late-breaking session, one of more than 20 Dupixent scientific
presentations, at the American Academy of Dermatology (AAD) 2023 Annual Meeting. The study, evaluating a biologic for this
difficult-to-treat population, met its primary and key secondary endpoints. In August 2023, the clinical section of the Dupixent
label in Europe was updated to include the hand and foot dermatitis population. In January 2024, the Dupixent US label was
updated with data further supporting use in AD with moderate-to-severe hand and foot involvement.
These Phase 3 data are from the first and only study evaluating a biologic specifically for this difficult-to-treat population and
have also been added to the Dupixent label in the European Union, with regulatory submissions under way in additional
countries.
Asthma
Dupixent was granted marketing authorization by the FDA in October 2018 as an add-on maintenance therapy in patients with
moderate-to-severe asthma aged 12 years and older with an eosinophilic phenotype or with oral corticosteroid-dependent
asthma. In May 2019, the EC approved Dupixent for use as an add-on maintenance treatment in severe asthma patients aged
12 years and older with type 2 inflammation whose symptoms are inadequately reduced by other treatments.
In September 2020, new long-term data from a Phase 3 open-label extension study showed sustained improvement in lung
function and reduction in severe exacerbations in adults and adolescents with moderate-to-severe asthma. On May 17, 2021,
detailed results from a Phase 3 study showed Dupixent significantly
reduced severe asthma attacks, and within two weeks rapidly
improved lung function in children aged six to 11 years with uncontrolled moderate-to-severe asthma with evidence of type 2
inflammation. Moreover, Dupixent
significantly improved overall asthma symptom control and reduced an airway biomarker of
type 2 inflammation, called fractional exhaled nitric oxide (FeNO), that plays a major role in asthma.
In October 2021, the FDA approved Dupixent as an add-on maintenance treatment for patients aged six to 11 years with
moderate-to-severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid-dependent asthma, thereby
bringing a new treatment for children who may be suffering from life-threatening asthma attacks and poor lung function
affecting their ability to breathe, which could potentially continue into adulthood. On April 7, 2022, the EC approved Dupixent for
use in children aged six to 11 years as an add-on maintenance treatment for severe asthma with type 2 inflammation
characterized by raised blood eosinophils and/or raised FeNO, whose symptoms are inadequately reduced with medium to high
dose inhaled corticosteroids (ICS) plus another medicine for maintenance treatment.
In March 2019, Dupixent
was approved in Japan for treating patients aged 12 years and over with severe or refractory asthma
whose symptoms are inadequately controlled with existing therapies. In November 2023, Dupixent
received approval in China for
treatment of moderate to severe asthma patients aged 12 years and over with type 2
inflammation
.
I
n February 2024
, topline results from the VESTIGE Phase 4 clinical study were presented at the 2024 American Academy of
Allergy, Asthma, and Immunology Annual Meeting. This study evaluated the effects of Dupixent on airway remodeling in adults
with uncontrolled moderate-to-severe asthma characterized by an eosinophilic phenotype or those dependent on oral
corticosteroids.
In 2024, Sanofi initiated a Phase 3 study for children aged 2 to 6 years suffering from asthma. This parallel, two-arm Phase 3 study
aims to evaluate the efficacy and long-term safety of dupilumab treatment in children with uncontrolled asthma and/or recurrent
severe asthmatic wheeze.
Chronic rhinosinusitis with nasal polyposis (CRSwNP)
CRSwNP is a chronic disease of the upper airway that obstructs the sinuses and nasal passages. It can lead to breathing
difficulties, nasal congestion and discharge, reduced or loss of sense of smell and taste, and facial pressure.
In June 2019, the FDA approved Dupixent for use with other medicines to treat CRSwNP in adults whose disease is not controlled.
In October 2019, the EC approved Dupixent for use as an add-on therapy with intranasal corticosteroids in adults with severe
CRSwNP for whom therapy with systemic corticosteroids and/or surgery do not provide adequate disease control. In
March 2020, the Japanese Pharmaceuticals and Medical Devices Agency approved Dupixent
as add-on maintenance treatment
for adults with inadequately controlled CRSwNP.
I
n
September 2024, the FDA approved Dupixent (dupilumab) as an add-on maintenance treatment for adolescent patients aged
12 to 17 years with inadequately controlled CRSwNP), expanding the initial FDA approval in CRSwNP from June 2019 for patients
aged 18 years and older. The FDA evaluated Dupixent for this expanded indication under Priority Review, which is reserved for
medicines that represent potentially significant improvements in efficacy or safety in treating serious conditions.
Eosinophilic esophagitis (EoE)
EoE is a chronic and progressive inflammatory disease that damages the esophagus and prevents it from working properly;
swallowing even small amounts of food can be a painful and worrisome choking experience. In severe cases, a feeding tube may
be the only option to ensure proper calorific intake and adequate nutrition. As the disease progresses, patients may continue to
experience symptoms despite multiple treatments.
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On September 14, 2020, the FDA granted Breakthrough Therapy designation to Dupixent for the treatment of patients aged
12 years and older with EoE, and subsequently accepted the file for Priority Review on April 4, 2022. On May 20, 2022, the FDA
approved Dupixent to treat patients with EoE aged 12 years and older. With this approval, Dupixent became the first and only
medicine specifically indicated to treat EoE in the US.
On December 16, 2022, the EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion,
recommending the approval of dupilumab in the EU to treat adults and adolescents with EoE. On January 30, 2023, the EC
expanded the marketing authorization for Dupixent in the EU to include the treatment of EoE in adults and adolescents aged
12 years and older.
On July 14, 2022, a Dupixent Phase 3 study showed positive results in children aged one to 11 years with EoE, making this the fifth
pediatric pivotal study across three type 2 inflammatory diseases to reinforce the well-established efficacy and safety profile of
Dupixent. In January 2024, Dupixent was approved by the FDA for the treatment of adult and pediatric patients aged one year or
older, weighting at least 15 kilograms, with EoE. The EoE pediatric indication was approved in the EU in November 2024
Prurigo nodularis (PN)
Prurigo nodularis is a chronic,
debilitating skin disease with underlying type 2 inflammation and has one of the highest impacts on
a patient’s quality of life among inflammatory skin diseases due to the extreme itching it causes.
People
with PN experience
intense, persistent itching, with thick skin lesions (called nodules) that can cover most of the body. The disease is often painful –
with burning, stinging and tingling of the skin – and can negatively affect mental health, daily living activities and social
interactions. High-potency topical steroids are commonly prescribed but are associated with safety risks if used long-term.
The FDA evaluated the Dupixent application for PN under Priority Review on May 31, 2022. On September 29, 2022, the FDA
approved Dupixent for the treatment of adult patients with PN. With this approval, Dupixent became the first and only medicine
specifically indicated to treat PN in the US.
The FDA approval was based on data from two Phase 3 studies evaluating the efficacy
and safety of Dupixent in adults with PN. Efficacy in these studies assessed the proportion of subjects with clinically meaningful
reduction in itching, clearing of skin, or both. On December 15, 2022, the EC expanded the marketing authorization for Dupixent
in the EU to treat adults with moderate-to-severe PN who are candidates for systemic therapy, after the previous positive
recommendation on November 11, 2022.
The Dupixent
PN indication was approved in Japan on June 26, 2023, and in China on September 22, 2023.
Chronic spontaneous urticaria
(CSU)
CSU is a chronic inflammatory skin disease characterized by the sudden onset of hives on the skin and/or swelling deep under
the skin. Despite standard-of-care treatment, people with CSU often experience symptoms including a persistent itching or
burning sensation, which can be debilitating and significantly impact quality of life. Swelling often occurs on the face, hands and
feet, but can also affect the throat and upper airways. On July 29, 2021 a pivotal Phase 3 study evaluating Dupixent in patients
with moderate-to-severe CSU met its primary endpoints and all key secondary endpoints at 24 weeks. Adding Dupixent to
standard-of-care antihistamines significantly reduced itching and hives for biologic-naive pa
tients, compared to those treated
with antihistamines alone (placebo) in Study A (the first of three studies) of the LIBERTY CUPID clinical program.
Study B of the clinical study evaluated Dupixent in adults and adolescents who remain symptomatic despite standard-of-care
treatment and are intolerant or incomplete responders to an anti-IgE therapeutic (omalizumab). Although positive numerical
trends
in reducing itching and hives were observed, the study was stopped due to futility based on a pre-specified interim
analysis. Further analysis demonstrated that Dupixent met the EU primary endpoint (UAS7 at week 24). Th
e safety data were
generally consistent with the known safety profile of Dupixent in its approved indications. In December 2022, Dupixent was
submitted to the FDA for the CSU indication. In October 2023, the FDA issued a Complete Response Letter (CRL) stating that
additional efficacy data were required to support approval; it did not identify any issues with safety or manufacturing.
Accordingly, a third clinical study (Study C) was initiated to provide additional efficacy data.
In September 2024, the Dupixent confirmatory Phase 3 study (LIBERTY-CUPID Study C) met the primary and key secondary
endpoints for the investigational treatment of patients with uncontrolled, biologic-naive CSU receiving background therapy with
antihistamines. This positive study confirmed results from Study A, the first Phase 3 study of Dupixent in this setting. Earlier in
2024, Japan was the first country in the world to approve and launch Dupixent for adult and adolescent CSU patients based on
the results from Study A (February 2024), followed by approvals in the United Arab Emirates (UAE) (September 2024) and Brazil
(November 2024).
Chronic obstructive pulmonary disease
(COPD)
COPD is a progressive respiratory disorder that damages the lungs and reduces lung function, making it the fourth leading cause
of death worldwide. Key symptoms include persistent coughing, excessive mucus production, and shortness of breath, which can
significantly affect daily activities and contribute to sleep disturbances, anxiety, and depression. COPD also imposes a major
health and economic burden due to frequent acute exacerbations, often requiring treatment with systemic corticosteroids and/
or antibiotics. While smoking and exposure to harmful particles are primary risk factors, the disease may still progress in those
who have quit smoking.
Around 50% of COPD patients continue to experience exacerbations despite receiving triple inhaled therapy. In the US,
approximately 300,000 individuals have inadequately controlled COPD with an eosinophilic phenotype, a subgroup prone to a
30% increase in exacerbations and a higher risk of COPD-related hospital readmissions within a year.
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On July 3, 2024, following a positive review by the EMA, the EC approved Dupixent as an add-on maintenance treatment for
adults with uncontrolled COPD characterized by elevated blood eosinophils. This approval covers patients already on a
combination of an inhaled corticosteroid (ICS), a long-acting beta2-agonist (LABA), and a long-acting muscarinic antagonist
(LAMA), or those on a LABA/LAMA combination if ICS is unsuitable. The EC was the first regulatory agency worldwide to grant
approval for Dupixent in COPD patients.
On September 10, 2024, a pooled analysis from the BOREAS and NOTUS Phase 3 studies showed that Dupixent reduced
exacerbations and improved lung function compared to placebo in adults with uncontrolled COPD and evidence of type 2
inflammation (i.e. raised blood eosinophils). The results were presented for the first time, in collaboration with Regeneron, at the
2024 European Respiratory Society (ERS) International Congress.
On September 27, 2024, the National Medical Products Administration (NMPA) in China also approved Dupixent as an add-on
treatment for adults with uncontrolled COPD and raised blood eosinophils. This approval similarly covers patients on
combinations of ICS, LABA, and LAMA, or LABA and LAMA if ICS is not appropriate. Dupixent has now been approved for the
treatment of COPD in over 30 countries, including the 27 EU member states.
On September 27, 2024, the FDA approved Dupixent as the first biologic treatment for COPD in the United States. This approval,
which applies to adults with inadequately controlled COPD and an eosinophilic phenotype, was based on two pivotal Phase 3
studies showing significant reductions in exacerbations and improvements in lung function and quality of life compared to
placebo. Dupixent has become the leading biologic in new-to-brand prescriptions across all its FDA-approved indications and is
the most prescribed biologic by US pulmonologists.
Life cycle management
Dupixent is currently being evaluated in clinical development programs for diseases that are driven by type 2 inflammation. These
include bullous pemphigoid (BP), chronic pruritis of unknown origin (CPUO), eosinophilic gastroenteritis (EoG), ulcerative colitis
(UC) and Lichen Simplex Chronicus (LSC) See “— B.4. Global research & development”.
In September 2024,
Dupixent became the first and only biologic to achieve significant improvements in disease remission and
symptoms in bullous pemphigoid, based on positive results from a pivotal study.
Dupixent is developed and commercialized in collaboration with Regeneron. For additional information on the collaboration,
see “Item 5. Operating and Financial Review and Prospects — A.1.7. Financial Presentation of Alliances — Alliance Arrangements
with Regeneron Pharmaceuticals Inc. (Regeneron).”
Kevzara
Kevzara (sarilumab) is a human monoclonal antibody that binds to the interleukin-6 receptor (IL-6R) and has been shown to
inhibit IL-6R mediated signaling. IL-6 is a cytokine in the body that, in excess and over time, can contribute to the inflammation
associated with rheumatoid arthritis (RA). Kevzara is available in 20 countries, including the US.
Kevzara is developed and commercialized in collaboration with Regeneron. For additional information, see “Item 5. Operating and
Financial Review and Prospects — A.1.7. Financial Presentation of Alliances — Alliance Arrangements with Regeneron
Pharmaceuticals Inc. (Regeneron).”
Rheumatoid arthritis (RA)
RA is a chronic inflammatory autoimmune disease causing inflammation, pain, and eventually joint damage and disability.
In May 2017, the FDA approved Kevzara for the treatment of adult patients with moderately to severely active RA who have had
an inadequate response or intolerance to one or more disease modifying anti-rheumatic drugs (DMARDs), such as methotrexate.
In June 2017, the EC granted marketing authorization for Kevzara in combination with methotrexate for the treatment of
moderately to severely active RA in adult patients who have responded inadequately to – or who are intolerant to – one or
more DMARDs, such as methotrexate. In September 2017, Kevzara obtained manufacturing and marketing approval in Japan as a
treatment for RA not responding well to conventional treatments. In February 2023, the FDA approved Kevzara for the treatment
of adult patients with
polymyalgia rheumatica (PMR) who have had an inadequate response to corticosteroids or who cannot
tolerate a corticosteroid taper. In June 2024, the FDA approved Kevzara for the treatment of polyarticular Juvenile Idiopathic
Arthritis. Lastly, in November 2024, the EC granted marketing authorization for Kevzara for the treatment of PMR in adult
patients who have had an inadequate response to corticosteriods, or who experience a relapse on a corticosteroid taper.
Polymyalgia rheumatica (PMR)
PMR
is a rheumatic inflammatory disorder characterized by pain and stiffness around the neck, shoulder and hip areas that leads
to significant decline in quality of lif
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Rare diseases
Cerezyme
Cerezyme (imiglucerase) is an ERT used to treat Gaucher disease, a chronic, inherited, progressive and potentially life-
threatening lysossomal storage disorders (LSD). Gaucher disease is caused by a deficiency of the enzyme glucocerebrosidase;
this causes a fatty substance called glucosylceramide (also called GL-1) to build up in certain areas of the body including the
spleen, liver, and bone. Gaucher disease exhibits diverse manifestations, a broad range of onset of symptoms, and a wide clinical
spectrum of disease severity. It is estimated that Gaucher disease occurs in approximately one in 120,000 newborns in the
general population and one in 850 in the Ashkenazi Jewish population worldwide, but incidence and patient severity vary among
regions. Cerezyme has been marketed in the US since 1994, in the EU since 1997, in Japan since 1998 and in China since 2008,
and is approved to treat type 1 Gaucher disease in more than 85 countries. It has also been approved to treat the systemic
symptoms of type 3 Gaucher disease in most non-US markets, including the EU and Japan.
Cerdelga
Cerdelga (eliglustat) is the first and only first-line oral therapy for Gaucher disease type 1 adult patients. A potent, highly specific
ceramide analog inhibitor of GL-1 synthesis with broad tissue distribution, Cerdelga has demonstrated efficacy in the treatment
of naive Gaucher disease patients and in patients who switch from enzyme replacement therapy. Cerdelga has been approved to
treat type 1 Gaucher disease in the US (2014), and in the EU and Japan (2015). It is also in development for the treatment of type 1
Gaucher disease in pediatric patients. See “— B.4. Global Research & Development.”
Myozyme and Lumizyme
Myozyme (alglucosidase alfa) is an ERT used to treat both Infantile Onset and Late Onset Pompe disease (IOPD and LOPD).
Pompe disease is an inherited, progressive and often fatal neuromuscular disease, caused by a genetic deficiency or
dysfunction of the lysosomal enzyme acid alpha-glucosidase (GAA) that results in the build-up of glycogen in the muscles’
cells. For IOPD, symptoms begin within a few months of birth and there are impacts on the heart in addition to causing skeletal
muscle weakness. Other symptoms include difficulties breathing, frequent chest infections, problems feeding that result in
failure to gain weight as expected, and failure to meet certain developmental milestones. Patients with LOPD typically present
symptoms any time after the first year of life to late adulthood and rarely manifest cardiac problems. The hallmark symptom of
LOPD is skeletal muscle weakness, which often leads to walking disability and reduced respiratory function. Patients often
require wheelchairs to assist with mobility and may require mechanical ventilation to help with breathing. Pompe disease
occurs in approximately one in 40,000 newborns worldwide, but incidence and patient severity vary among regions.
Myozyme was first approved in 2006 in the EU and has since been approved in more than 80 countries. In the US, alglucosidase
alfa has been marketed as Lumizyme since 2010.
Nexviazyme/Nexviadyme
Nexviazyme / Nexviadyme (avalglucosidase alfa-ngpt) is a novel mannose-6-phosphate (M6P) enriched enzyme replacement
therapy (ERT) treatment designed as a monotherapy for the entire spectrum of infantile-onset and late-onset Pompe disease
(IOPD, LOPD), including patients who have changed treatments and naive patients, who have not received treatment
previously. Nexviazyme/Nexviadyme is scientifically designed to specifically target the M6P receptor, the key pathway for ERT,
to effectively clear glycogen build-up in muscle cells. It helps replace the GAA enzyme for people whose bodies do not
produce enough. Investment in the clinical development of Nexviazyme is continuing, with an ongoing Phase 3 study in
treatment-naive IOPD patients aged less than 12 months. Nexviazyme/Nexviadyme is administered as a monotherapy ERT
every two weeks.
Nexviazyme was first approved in the US by the FDA on August 6, 2021 for LOPD patients aged one year and older. On June 24,
2022, the EC granted marketing authorization for Nexviadyme as a potential new standard of care for the long-term treatment of
both LOPD and IOPD. Nexviazyme/Nexviadyme has been approved in more than 59 countries and successfully launched in
32 countries including the US, Germany, the UK, other European markets, Japan and Australia. In all launched markets, the vast
majority of eligible patients are currently being treated with Nexviazyme/Nexviadyme.
Fabrazyme
Fabrazyme (agalsidase beta) is an ERT used to treat Fabry disease (FD). FD is a multisystemic, progressive, X-linked inherited
disorder of glycosphingolipid metabolism due to deficient or absent lysosomal α-galactosidase A activity resulting in progressive
globotriaosylceramide (GL-3) accumulation in the lysosomes of various tissues. FD affects both
genders
. With age, progressive
organ damage develops, leading to potentially life-threatening renal, cardiac and/or cerebrovascular complications. FD is
characterized by different symptom severities and rates of progression, ranging from classic disease with early symptom onset to
non-classic disease with cardiac and/or renal complications later in life.
FD is seen in all racial and ethnic groups and is an under-
diagnosed condition. Prevalence estimates vary across regions. Classic FD mutations are estimated to be approximately 1:40,000
in males with more wide-ranging estimates for non-classic in both males and females
. Fabrazyme has been marketed in the EU
since 2001 and in the US since 2003 and is approved in more than 70 countries.
Aldurazyme
Aldurazyme (laronidase) is the only approved ERT for mucopolysaccharidosis type 1 (MPS I), an inherited lysosomal storage
disorder caused by a deficiency of alpha-L-iduronidase, a lysosomal enzyme normally required for the breakdown of certain
complex carbohydrates known as glycosaminoglycans (GAGs). MPS I is multi-systemic, and children with MPS I are described as
having either a severe or attenuated form of the disorder based on age of onset, severity of symptoms, rate of disease
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progression and whether there is early and direct involvement of the brain. MPS I occurs in approximately one per 100,000 live
births worldwide, but incidence and patient severity vary among regions. Sanofi markets Aldurazyme in the EU and the US (since
2003) and in more than 75 other countries.
Xenpozyme
Xenpozyme
(olipudase alfa) is an ERT designed to replace deficient or defective acid sphingomyelinase (ASMD), an enzyme that
allows for the breakdown of the lipid sphingomyelin. In individuals with ASMD, an insufficiency of the ASM enzyme means
sphingomyelin is poorly metabolized, potentially leading to lifelong accumulation in and damage to multiple organs.
The significance of the unmet need that Xenpozyme
addresses has been recognized by Japan’s PMDA with Sakigake designation,
by the EU with PRIME designation, and by the FDA with Breakthrough designation.
Xenpozyme was approved first in Japan on March 28, 2022, followed by Europe on June 24, 2022 and the US on August 31, 2022.
Xenpozyme
is the first and only ERT for the treatment of non-central nervous system manifestations of ASMD, with demonstrated
improvements in hepatosplenomegaly, pulmonary, liver and hematologic function, dyslipidemia, and growth (children only) in
clinical studies of adults and children with ASMD. Xenpozyme is given as an intravenous infusion once every two weeks, and the
dose is based on body weight.
Xenpozyme has to date been commercialized in 25 countries, however only 15 of those have full reimbursement by payers. By
2030, it is anticipated that Xenpozyme
will have been launched in many additional markets worldwide.
ALTUVIIIO
ALTUVIIIO (Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein) is a first-in-class high-sustained factor VIII therapy
that is designed to extend protection from bleeds with once-weekly prophylactic dosing for adults and children with hemophilia A.
Hemophilia A is a rare, x-linked genetic bleeding disorder characterized by a deficiency of functional coagulation factor VIII, resulting
in a prolonged patient plasma-clotting time. As a consequence, people with hemophilia A bleed for a longer time than normal.
ALTUVIIIO temporarily replaces the missing coagulation factor VIII by intravenous injection. In adults and adolescents, it is the
first factor VIII therapy that has been shown to break through the von Willebrand factor ceiling, which imposes a half-life
limitation on earlier generation factor VIII therapies. ALTUVIIIO builds on innovative Fc fusion technology by adding a region of
von Willebrand factor and XTEN polypeptides to extend its time in circulation.
ALTUVIIIO was first approved in February 2023 by the FDA, which had previously granted Breakthrough Therapy designation in
May 2022 (the first factor VIII therapy to receive this designation); fast-track designation in February 2021; and Orphan Drug
designation in 2017. ALTUVIIIO has since been approved the by regulatory authorities in Japan, Taiwan, Macau and Hong Kong,
and has been commercialized in Japan and Taiwan.The European Commission (EC) granted Orphan Drug designation in June
2019, and a marketing authorization application was filed with the European Medicines Agency (EMA) in May 2023. ALTUVOCT
(the brand name of ALTUVIIIO in Europe) received EC marketing authorization in June 2024.
ALTUVIIIO is developed and commercialized in collaboration with Swedish Orphan Biovitrum AB (Sobi), whose territories include
Europe, Russia, the Middle East, and some countries in North Africa.
Eloctate
Eloctate (antihemophilic factor (recombinant), Fc fusion protein) is an extended half-life factor VIII therapy clotting-factor
therapy to control and prevent bleeding episodes in adults and children with hemophilia A. In the US, it is indicated for use in
adults and children with hemophilia A for on-demand treatment and control of bleeding episodes, perioperative management of
bleeding, and routine prophylaxis to reduce the frequency of bleeding episodes.
Hemophilia A is a rare, x-linked genetic bleeding disorder characterized by a deficiency of functional coagulation Factor VIII,
resulting in a prolonged patient plasma-clotting time. As a consequence, people with hemophilia A bleed for a longer time than
normal. Eloctate temporarily replaces the missing coagulation Factor VIII by intravenous injection.
We market Eloctate primarily in the US (since 2014), Japan, Canada, Australia, South Korea, Taiwan and Hong Kong / Macau.
Eloctate is developed and commercialized in collaboration with Swedish Orphan Biovitrum AB (Sobi), whose territories include
Europe, Russia, the Middle East, and some countries in North Africa.
Alprolix
Alprolix (coagulation Factor IX (recombinant), Fc fusion protein) is an extended half-life factor IX clotting-factor therapy to
control and prevent bleeding episodes in adults and children with hemophilia B. In the US, it is indicated for use in adults and
children with hemophilia B for on-demand treatment and control of bleeding episodes, perioperative management of bleeding,
and routine prophylaxis to reduce the frequency of bleeding episodes.
Hemophilia B is a rare, x-linked genetic bleeding disorder characterized by a deficiency of functional coagulation Factor IX,
resulting in a prolonged patient plasma-clotting time. As a consequence, people with hemophilia B bleed for a longer time than
normal. Alprolix temporarily replaces the missing coagulation Factor IX by intravenous injection.
We market Alprolix primarily in the US (since 2014), Japan, Canada, Australia, New Zealand, South Korea, Taiwan and Hong Kong /
Macau.
Alprolix is developed and commercialized in collaboration with Swedish Orphan Biovitrum AB (Sobi), whose territories include
Europe, Russia, the Middle East, and some countries in North Africa.
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Cablivi
Cablivi (caplacizumab) is a bivalent anti-von Willebrand Factor (vWF) NANOBODY
®
VHH for the treatment of adults experiencing
an episode of acquired thrombotic thrombocytopenic purpura (aTTP). Cablivi is the first therapeutic specifically indicated for the
treatment of aTTP.
Acquired thrombotic thrombocytopenic purpura is an ultra-rare (3.5-4.5 episodes per million of population), life-threatening,
autoimmune-based blood clotting disorder characterized by extensive clot formation in small blood vessels throughout the body,
leading to severe thrombocytopenia (very low platelet count); microangiopathic hemolytic anemia (loss of red blood cells through
destruction); ischemia (restricted blood supply to parts of the body); and widespread organ damage, especially in the brain and
heart. Cablivi has an immediate effect on platelet adhesion and the ensuing formation and accumulation of the micro-clots.
Cablivi was granted marketing authorization in Europe by the EC in September 2018; in the US by the FDA in February 2019; and
in Japan by the Japanese Pharmaceutical and Medical Devices Agency (PMDA) in September 2022. Cablivi is currently available
in 26 countries including the US, the majority of European countries (17), Brazil, Colombia, Japan and five Greater Gulf region
states. Additional commercial launches are ongoing.
Cablivi was developed by Ablynx, a Sanofi company since mid-2018.
Enjaymo
Enjaymo (sutimlimab; formerly known as BIVV009) is a monoclonal antibody targeting the classical complement pathway (CP)
specific serine protease (C1s), thereby inhibiting CP activity which is associated with a variety of immune disorders involving the
presence of autoantibodies. Enjaymo is the first-and-only approved therapeutic option approved for hemolytic anemia in adult
patients with cold agglutinin disease (CAD).
CAD is a rare, serious, and chronic autoimmune hemolytic anemia, where the body’s immune system mistakenly attacks healthy
red blood cells and causes their rupture, known as hemolysis. The disease impacts the lives of an estimated 12,000 people in
the US, Europe, and Japan and is associated with profound fatigue and increased risk of thromboembolic events and mortality.
Enjaymo has previously received Breakthrough Therapy Designation and Orphan Drug Designations from the FDA, and orphan
medicine designation from the EMA. After priority review, the medicine was approved in February 2022, in the US as the first
treatment in adult patients with CAD. Enjaymo was approved by the Japanese Ministry of Health, Labor and Welfare in
June 2022 and granted marketing authorization by the EC in November 2022. Swissmedic, the Korean MFDS and the Israeli
Ministry of Health granted marketing approval for Enjaymo in June 2023, July 2023 and October 2023, respectively.
Enjaymo is currently available in the US, Japan, Germany, Austria and the Netherlands. Additional commercial launches are
ongoing.
On November 29, 2024, Sanofi sold Enjaymo (sutimlimab) to Recordati, which acquired the global rights to the product and will
be responsible for all activities after acquiring marketing authorization holder (MAH) status across all markets.
Neurology
Aubagio
Aubagio (teriflunomide)
is used to help manage multiple sclerosis (MS). This small molecule agent, taken once daily, works by
reducing inflammation and modulating the immune system to prevent the immune attacks that cause MS symptoms
.
Aubagio is approved in more than 80 countries around the world including the US (since September 2012) for the treatment of
patients with relapsing forms of MS; the EU (since August 2013) for the treatment of adult patients with relapsing remitting MS;
and China (since July 2018). In June 2021, the EC approved Aubagio for the treatment of pediatric patients aged 10 to 17 years
with relapsing-remitting multiple sclerosis (RRMS).
In 2017, Sanofi reached settlement with all 20 generic Aubagio ANDA first filers, granting each a royalty-free license to enter the
US market on March 12, 2023. In the EU, the first generic competitors to Aubagio became available in September 2023.
Oncology
Sarclisa
Sarclisa (isatuximab) is a monoclonal antibody that binds a specific epitope on the human CD38 receptor and has antitumor
activity via multiple mechanisms of action. It was first approved in the US in March 2020 in combination with pomalidomide and
dexamethasone for the treatment of adults with relapsed refractory multiple myeloma (RRMM) who have received at least two
prior therapies including lenalidomide and a proteasome inhibitor, and in Europe by the EC in May 2020 in combination with
pomalidomide and dexamethasone for the treatment of adult patients with RRMM who have received at least two prior therapies
including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on the last therapy. Sarclisa is
now approved for this indication in more than 50 countries. In early 2025 Sarclisa, in combination with pomalidomide and
dexamethasone,
was approved by the NMPA (National Medical Products Administration) in China for the treatment of adult
patients with multiple myeloma (MM) who have received at least one prior line including lenalidomide and proteasome inhibitor.
This is the first indication of Sarclisa to be approved in China.
Sarclisa was approved in the US in March 2021 for a label extension in combination with carfilzomib and dexamethasone for the
treatment of adults with RRMM who have received one to three prior lines of therapy, and in Europe in April 2021 by the EC for
the treatment of adult patients with MM who have received at least one prior therapy. The Japanese Ministry of Health, Labor
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and Welfare (MHLW) granted approval for Sarclisa in November 2021 in combination with carfilzomib and dexamethasone, in
combination with dexamethasone, and as monotherapy for RRMM patients.
Sarclisa was approved in the US in September 2024, in Europe in January 2025, and (as the second indication) in China in January
2025 in combination with bortezomib, lenalinomide and dexamethasone for the treatment of adults with newly diagnosed MM
who are not eligible for autologous stem cell transplant (ASCT).
ANVISA, the Brazilian healthcare authority, also approved Sarclisa in the same combination for the treatment of adult patients
with newly diagnosed MM who are not eligible for ASCT or with no intent for ASCT as initial therapy.
This additional label has also
been submitted to other regulatory authorities, and is currently being reviewed. In addition, the Phase 3 IRAKLIA study
investigating the development of a new subcutaneous formulation with an on-body device system, which w
as initiated in the
second half of 2022 in over 20 countries, reported positive read-outs having reached its co-primary end points.
Sarclisa is also being investigated with several innovative agents in MM in an umbrella Phase 1/2 study.
Jevtana
Jevtana (cabazitaxel), a chemotherapy drug and cytotoxic agent, is a semi-synthetic second-generation taxane that prevents
many cancer cells from dividing, which ultimately results in destroying many such cells. It is approved in combination with
prednisone for the treatment of patients with metastatic castration resistant prostate cancer previously treated with a docetaxel-
containing treatment regimen. Jevtana was granted marketing authorization by the FDA in June 2010, by the EC in March 2011,
and in Japan in July 2014. The medicine is marketed in over 75 countries. In Europe, generic competition started for Jevtana from
the end of March 2021. In the US, the Jevtana composition of matter patent expired in September 2021. Sanofi has filed patent
infringement suits under the US Hatch-Waxman Act against generic manufacturers for cabazitaxel in the US District Court for the
District of Delaware asserting three Orange Book listed US patents for Jevtana. Sanofi entered into settlement agreements with
most of the defendants and went to trial against the remaining defendant, Sandoz, on one of the patents in January 2023; see
Note D.22.b. to the consolidated financial statements, included at Item 18. of this annual report.
The
district court issued a final
judgment in favor of Sanofi in connection with the Jevtana patent litigation against Sandoz in June 2023, and on August 2, 2023,
Sandoz appealed to the Court of Appeals for the Federal Circuit. On October 5, 2023, Sanofi and Sandoz filed a joint stipulation
voluntarily dismissing Sandoz’s Appeal, bringing this matter to conclusion.
Fasturtec/Elitek
Fasturtec/Elitek is used for the management of plasma uric levels in patients with leukemia, lymphoma, and solid tumor
malignancies receiving anticancer therapies.
Other medicines
Lantus
Lantus (insulin glargine 100 units/mL) is a long-acting analog of human insulin, indicated for once-daily administration for the
treatment of diabetes mellitus in adults, adolescents and children aged two years and above. Lantus relies on more than 20 years
of clinical evidence in diabetes treatment and a well-established safety profile. Approved in the US and the EU in 2000 and in
Japan in 2008, Lantus is available in over 130 countries worldwide.
Two insulin glargine biosimilars are available in the US,
two in
European markets
, and two in Japan.
Toujeo
Toujeo (insulin glargine 300 units/mL) is a long-acting analog of human insulin, indicated for the treatment of diabetes mellitus in
adults. Toujeo has been granted marketing authorization by the FDA (February 2015), the EC (April 2015), and the Ministry of
Health, Labor and Welfare (J-MHLW) in Japan, where its approved brand name is Lantus XR (July 2015). Toujeo has now been
launched in more than 60 countries, including China since the end of 2020. In January 2020, the EC approved an expansion of
the indication to include the treatment of diabetes in adolescents and children (aged six years and above).
Toujeo is available in Toujeo Solostar, a disposable prefilled pen which contains 450 units of insulin glargine and requires one-
third of the injection volume to deliver the same number of insulin units as Lantus
Solostar. In the US (since 2018) and the EU
(since 2019), Toujeo is also available in a disposable prefilled pen which contains 900 units of insulin glargine. In India, Toujeo is
also available in a dedicated 450-unit cartridge in combination with a dedicated reusable pen (TouStar).
Lovenox/Clexane
Lovenox or Clexane (enoxaparin sodium) is a low molecular weight heparin (LMWH) indicated for the prophylaxis and treatment
of venous thromboembolism and in the treatment of acute coronary syndrome. In the US, enoxaparin generics are available, while
biosimilar enoxaparin medicines have gradually become available across various European countries and in a growing number of
international markets, including China. Lovenox or Clexane is marketed in more than 100 countries.
Plavix/Iscover
Plavix or Iscover (clopidogrel bisulfate) is a platelet adenosine diphosphate (ADP) receptor antagonist. It is indicated for the
prevention of atherothrombotic events in patients with a history of recent myocardial infarction (MI), recent ischemic stroke or
established peripheral arterial disease (PAD), and for patients with acute coronary syndrome (ACS). Plavix is also indicated in
combination with acetylsalicylic acid (ASA) for the prevention of atherothrombotic and thromboembolic events in atrial
fibrillation, including stroke.
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CoPlavix/DuoPlavin, a fixed-dose combination of clopidogrel bisulfate and ASA, is indicated for the prevention of
atherothrombotic events in adult patients with acute coronary syndrome who are already taking both clopidogrel and ASA.
Several clopidogrel bisulfate generics have been launched in most markets. Plavix or Iscover are available in more than
110 countries.
Sanofi is involved in two Plavix medicine lawsuits. See Note D.22.c) to our consolidated financial statements, included at Item 18.
of this annual report.
Rezurock
Rezurock (belumosudil) is a first-in-class selective ROCK2 (rho-associated coiled-coil–containing protein kinase-2) inhibitor. It was
approved in July 2021 by the FDA for the treatment of adult and pediatric patients aged 12 years and older with chronic graft-
versus-host disease (chronic GVHD) after failure of at least two prior lines of systemic therapy. In addition to robust adoption in the
United States, Rezurock has been launched in 10 countries including Canada, the United Kingdom, China, Japan and South Korea
(marketed in Japan and South Korea by partner Romeck Pharma). Early access or managed access programs are available in 28
countries, including European Union countries and Turkey. On November 28, 2024, Sanofi achieved the inclusion of Rezurock on
the new National Reimbursement Drug List in China, via a thorough process recognizing the clinical and pharma-economic value
of the medicine. The new list became effective on January 1, 2025. Rezurock’s favorable market adoption, longer durability of
response, and recent three-year safety publication, especially in US patients, are a reflection of its clinical profile. Sanofi is currently
developing an oral suspension to support pediatric studies. Two belumosudil Phase 3 clinical studies are currently enrolling patients
for the treatment of (i) newly diagnosed cGVHD patients and (ii) chronic lung allograft dysfunction (CLAD) post bilateral lung
transplant. Currently, there are no approved targeted therapies for either newly diagnosed cGVHD or CLAD.
Praluent
Praluent (alirocumab) is a human monoclonal antibody (mAb) for self-administered injection every two weeks or once-monthly. It
blocks the interaction of proprotein convertase subtilisin/kexin type 9 (PCSK9) with low-density lipoprotein (LDL) receptors,
increasing the recycling of LDL receptors and reducing LDL cholesterol levels. Praluent
is indicated
as an adjunct to diet and
maximally tolerated statin therapy in certain adult patients and in pediatric patients eight years of age and older with
heterozygous familial hypercholesterolaemia (HeFH) with uncontrolled LDL cholesterol. Praluent has been approved in more than
60 countries worldwide, including the US (in 2015), Canada and Switzerland, as well as in the European Union (in 2015). In 2018,
the FDA approved a Praluent label update for patients currently requiring LDL apheresis therapy. In March 2019 in the EU and in
April 2019 in the US, Praluent was approved for use in patients with established cardiovascular disease to reduce the risk of
cardiovascular events. In November 2023, following positive review by EMA, the EC approved a Praluent label update for
pediatric HeFh patients aged eight years and older. In December 2019, Praluent was approved in China, where it started to be
commercialized in May 2020. Since April 2020, Regeneron has been responsible for commercialization of Praluent in the US, and
Sanofi has been responsible for all other markets outside the US. For additional information on the commercialization of this
medicine, see “Item 5. Operating and Financial Review and Prospects — A.1.7. Financial Presentation of Alliances — Alliance
Arrangements with Regeneron Pharmaceuticals Inc. (Regeneron).”
Thymoglobulin
Thymoglobulin (anti-thymocyte globulin) is a polyclonal anti-human thymocyte antibody preparation that acts as a broad
immunosuppressive and immunomodulating agent. In the US, Thymoglobulin is indicated for the prophylaxis
and/or
treatment
of acute rejection in patients receiving a kidney transplant, used in conjunction with concomitant immunosuppression. Outside
the US, depending on the country, Thymoglobulin is indicated for the treatment and/or prevention of acute rejection in organ
transplantation; immunosuppressive therapy in aplastic anemia; and the treatment and/or prevention of Graft-versus-Host
Disease (GvHD) after allogeneic hematopoietic stem cell transplantation. Thymoglobulin is currently marketed in over 65 countries.
Aprovel/Avapro/Karvea
Aprovel, also known as Avapro or Karvea (irbesartan), is an angiotensin II receptor antagonist indicated in the treatment of
hypertension and for the treatment of renal disease in patients with hypertension and type 2 diabetes. Sanofi also markets
CoAprovel/Avalide/Karvezide, a combination of irbesartan and the diuretic hydrochlorothiazide. A combination with amlodipine
(Aprovasc, Aprexevo, Aproxxamlo) has been launched in several countries.
A number of irbesartan generics have been launched in most markets. Aprovel and CoAprovel are marketed in more than
80 countries. In Japan, the medicine is licensed to Shionogi Co. Ltd and BMS KK. BMS KK has sublicensed the agreement to
Dainippon Pharma Co. Ltd.
Multaq
Multaq (dronedarone) is an oral multichannel blocker with anti-arrhythmic properties for prevention of atrial fibrillation
recurrences in certain patients with a history of paroxysmal or persistent atrial fibrillation. Multaq was approved in the US and in
the EU in 2009. Multaq is available in approximately 35 countries.
Soliqua – Suliqua
Soliqua 100/33 or Suliqua is a once-daily fixed-ratio combination of insulin glargine 100 Units/mL, a long-acting analog of human
insulin, and lixisenatide, a GLP-1 receptor agonist. The FDA approved Soliqua 100/33 in November 2016 for the treatment of
adults with type 2 diabetes inadequately controlled on basal insulin (less than 60 units daily) or lixisenatide; and in February 2019
for patients uncontrolled on oral antidiabetic medicines. In January 2017, Suliqua (the medicine’s brand name in Europe) was
approved for use in combination with metformin with or without SGLT-2 inhibitors for the treatment of adults with type 2
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diabetes to improve glycemic control, when this had not been provided either by metformin alone or by metformin combined
with another oral glucose-lowering medicine or with basal insulin. In Japan, Soliqua was approved in May 2020 for type 2
diabetes mellitus, where treatment with insulin is required. In China, Soliqua was approved in January 2023 for the treatment of
adults with insufficiently controlled type 2 diabetes mellitus to improve glycemic control as an adjunct to diet and exercise in
addition to other oral antidiabetic drugs. Soliqua received National Reimbursement Drug List (NRDL) status in China in
December 2023. Suliqua is available in over 40 countries. Soliqua is approved in over 80 countries.
Mozobil
Mozobil (plerixafor injection) is a hematopoietic stem cell mobilizer. It is indicated in combination with granulocyte-colony
stimulating factor (G-CSF) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous
transplantation in patients with non-Hodgkin’s lymphoma (NHL) and MM. Mozobil is marketed in over 65 countries. Generic
Mozobil has been available in the US since the end of 2023, and in Europe since 2024.
Tzield
Tzield (Teplizumab) is a CD3-directed antibody (CD3 is a cell surface antigen present on T lymphocytes). It was approved by the
FDA in November 2022 to delay the onset of Stage 3 type 1 diabetes (T1D) in adults and pediatric patients aged eight years and
older with Stage 2 type 1 diabetes. The medicine is currently marketed in the United States, and approved in Israel and the United
Arab Emirates in this indication, with plans for pursuing regulatory approval in other regions such as the EU, China and Japan. The
medicine is currently in development for further indications for the treatment of patients already in Stage 3 (clinical onset) type 1
diabetes, as well as for pediatric patients ages 0-7 at Stages 2 and 3 type 1 diabetes.
Early access programs and Managed Access
Programs
are available in France, Germany, Israel, Spain, the UK and China.
Vaccines
The Vaccines division of Sanofi is a world leader in the vaccine industry and a key supplier of life-saving vaccines all over the
world and for publicly funded international stakeholders such as UNICEF, the Pan American Health Organization (PAHO) and the
Global Alliance for Vaccines and Immunization (GAVI).
The Vaccines portfolio includes the following products:
Influenza vaccines
Sanofi is a world leader in the production and marketing of influenza vaccines, offering several distinct influenza vaccines that are
sold globally.
As influenza strains vary from one season to the next, the World Health Organization (WHO) selects the strains to be included in
influenza vaccines for each season. In 2024, the WHO decided to move from quadrivalent influenza vaccines including two A
strains and two B strains back to trivalent influenza vaccines including two A strains and one B strain, as it was considered that
the B Yamagata strains were not responsible for a significant burden in past seasons. All manufacturers will therefore
progressively move back from quadrivalent to trivalent influenza vaccines in the coming seasons. In 2024, Sanofi commercialized
trivalent influenza vaccines in the US, and quadrivalent influenza vaccines in all other countries. The switch to trivalent will happen
in all other countries in the upcoming seasons.
Fluzone Quadrivalent is a quadrivalent inactivated influenza vaccine, produced in the US, containing two type A antigens and two
type B antigens in order to provide increased protection against more circulating strains of influenza viruses. Fluzone
Quadrivalent/FluQuadri is
available in seven countries (including the US) for children aged over six months, adolescents and
adults. Fluzone 0.5 ml QIV is the currently-licensed standard dose (15 µg/strain)
quadrivalent
influenza vaccine for ages six
months and older. Fluzone trivalent is the same vaccine but includes two A strains and only one B strain.
Fluzone High-Dose Quadrivalent, designed specifically to provide greater protection against influenza for people aged 65 years
and older, was approved by the FDA in November 2019. Fluzone High-Dose Quadrivalent was approved in the EU in the second
quarter of 2020, under the name Efluelda, indicated for adults aged 60 years and above. Both Fluzone High-Dose Quadrivalent
and Efluelda have been available since the 2020/21 influenza season. To date, this vaccine has been distributed to more than
25 countries worldwide. Fluzone HD/Efluelda trivalent is the same vaccine but includes two A strains and only one B strain.
Flublok is a quadrivalent recombinant
protein-based
influenza vaccine indicated for adults aged 18 and older. Flublok is currently
licensed in the US, Hong Kong and Australia. This same recombinant protein-based influenza vaccine is also licensed under the
brand name Supemtek in Canada, the United Kingdom, the European Union and Switzerland. Flublok will also switch to trivalent
following the new WHO recommendation.
Vaxigrip
is a trivalent influenza vaccine, containing two antigens against type A influenza viruses and one antigen against type B
influenza viruses.
VaxigripTetra is the quadrivalent (QIV) version of Vaxigrip, including two antigens against A strains of influenza viruses and two
antigens against B strains, and is produced in France. Vaxigrip Tetra was licensed in 2016 and has been approved in 95 countries.
It is not licensed in the US where Fluzone Quadrivalent, which is produced in the US, is distributed. Following the new WHO
recommendations, countries will switch back to Vaxigrip (trivalent) in the coming seasons.
COVID Vaccine
From 2025 onwards, Sanofi will commercialize the recombinant adjuvanted COVID-19 vaccine from Novavax.
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Poliomyelitis, pertussis and Haemophilus influenzae type b (Hib) pediatric vaccines
Sanofi is one of the key players in pediatric vaccines in both developed and emerging markets, with a broad portfolio of
standalone and combination vaccines protecting against up to six diseases in a single injection. Due to the diversity of
immunization schedules throughout the world, vaccines can be either quadrivalent, pentavalent, or hexavalent according to
regional specificities.
Tetraxim, a pediatric combination vaccine protecting against diphtheria, tetanus, pertussis and poliomyelitis (polio), was first
marketed in 1998. To date, the vaccine has been launched in close to 100 countries (this vaccine is not marketed in the US).
Pentaxim, a pediatric combination vaccine protecting against diphtheria, tetanus, pertussis, polio and Hemophilus influenzae
type b (Hib), was first marketed in 1997. To date, the vaccine has been launched in more than 90 countries (this vaccine is not
marketed in the US). In most European, Latin American, Asian and Middle Eastern markets, Pentaxim is being gradually replaced
by Hexaxim.
Hexaxim/Hexyon/Hexacima is a fully liquid, ready-to-use 6-in-1 (hexavalent) pediatric combination vaccine that provides
protection against diphtheria, tetanus, pertussis, polio, Hib and hepatitis B. Hexaxim is the only combination vaccine including
acellular pertussis (acP) and inactivated polio vaccines (IPV) currently prequalified by the WHO.
First marketed in 2013
, Hexaxim is
now available in more than 100 countries outside the US.
Pentacel, a pediatric combination vaccine protecting against diphtheria, tetanus, pertussis, polio and Haemophilus influenzae
type b (Hib), was launched in the US in 2008.
Quadracel is a vaccine indicated for active immunization against diphtheria, tetanus, pertussis and poliomyelitis, used in children
aged four through six years as a fifth dose in the diphtheria, tetanus, pertussis vaccination (DTaP) series, and as a fourth or fifth
dose in the IPV series. It was launched in the US in 2017.
ACT-HIB is a standalone vaccine protecting against Hib, and is mainly distributed in the US and in Japan in conjunction with
pertussis combination vaccines that do not contain the Hib valence.
Sanofi is a leading provider of polio vaccines and has been a partner of the Global Polio Eradication Initiative (GPEI) for over
30 years. Since Sanofi launched its first IPV, more than 1.5 billion doses have been distributed worldwide.
Vaxelis
Vaxelis is a hexavalent combination vaccine protecting against diphtheria, tetanus, pertussis, polio, Hib and hepatitis B. This
vaccine (developed and distributed in partnership with Merck) was approved in 2016 by the EC and is distributed in various EU
countries. Vaxelis was approved by the FDA in December 2018, becoming the first hexavalent vaccine to be approved in the US,
and launched in this country in June 2021.
Sales of Vaxelis in the US are recognized by the Merck Sanofi Pasteur joint venture and credited equally to Merck and Sanofi as
income from equity affiliates. Consequently, these sales are not reported separately in each joint venture partner’s net sales.
Sanofi recognizes 50% of the joint venture's profits within the line item
Share of profit/(loss) from investments accounted for
using the equity method
.
Booster vaccines
Adacel is the leading trivalent booster vaccine offering protection against diphtheria, tetanus and pertussis. The vaccine can be
used from four years of age following primary immunization and is the first Tdap vaccine indicated for use during pregnancy for
protection against pertussis in newborns. It is available in 71 countries including the US and other countries mostly in Europe, Asia
and Latin America. Recently, Adacel has been introduced in additional countries that are implementing new vaccination
programs, particularly focusing on maternal immunization.
Repevax/Adacel-Polio is a combination vaccine that provides protection against diphtheria, tetanus, pertussis and polio. It is the
first Tdap-IPV vaccine indicated for use during pregnancy for protection against pertussis in newborns. It is currently marketed in
25 countries outside the US, with a strong focus on European markets (such as France and Germany).
Respiratory syncytial virus (RSV) protection
In 2023, Sanofi launched Beyfortus (nirsevimab-alip), a long-acting monoclonal antibody designed to protect against RSV. It is
indicated for the protection of neonates and infants born during or entering their first RSV season, and for children up to
24
months who
remain particularly vulnerable to severe RSV in their second RSV season.
Beyfortus is licensed in numerous countries and has now been launched in more than 20 countries, including in North America,
Europe, China and Japan. Real world data from countries such as the US, Spain and France have confirmed and even surpassed
the outstanding efficacy data generated during the clinical development of this monoclonal antibody. Many more countries are
expected to implement all-infant protection in the future. Sanofi and AstraZeneca entered into an agreement in 2017 to develop
and commercialize Beyfortus, under which AstraZeneca leads development and manufacturing activities and Sanofi leads
commercialization activities and records revenues. Sanofi will continue to expand Beyfortus in new geographies across Europe,
Asia and Latin America.
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Meningitis and travel & endemic vaccines
Menactra, the first quadrivalent conjugate vaccine against meningococcal meningitis (serogroups: A, C, Y, and W-135), one of the
deadliest forms of meningitis, is indicated for people aged nine months through 55 years. Since launch, it has become a strong
leader in the meningitis quadrivalent market. It is commercialized in a large number of countries (excluding Europe). Menactra was
the first fully liquid (no reconstitution needed) meningitis quadrivalent conjugated vaccine, and more than 100 million doses of
this vaccine have been distributed since launch.
MenQuadfi is a novel fully-liquid meningococcal quadrivalent conjugated vaccine expected to have a broad age indication from
infants (six weeks) to the elderly, with flexible dosing schedules. MenQuadfi is the first and only quadrivalent ACWY vaccine to
demonstrate superior immune response against serogroup C in toddlers compared to a monovalent serogroup C vaccine
(standard-of-care in multiple markets in Europe and internationally). MenQuadfi will progressively fully replace Menactra. It is
already available in the US (for people over two years of age), and in Australia, Canada, Europe, Japan, Argentina, Brazil, and Chile
for people aged 12 months and above. Marketing authorization is also pending in numerous other countries. Extension of the age
indication down to six weeks of age will follow submission of additional Phase 3 data.
Sanofi provides a wide range of travel and endemic vaccines including yellow fever, rabies, typhoid and hepatitis A vaccines. These
vaccines are used in endemic settings in the developing world and are the foundation for important partnerships with governments and
organizations such as UNICEF. They are also used by travelers and military personnel in industrialized countries and in endemic areas.
B.3. Opella
The implementation and simplification of Sanofi's autonomous Opella business unit continued in 2024. Mainly as a result of
divestments, the portfolio was further reduced to approximately 100 brands by the end of the year.
Opella operates in 100 countries and manages 13 strategic state-of-the-art production sites as well as four research and
innovation centers, with a portfolio of leading brands.
In October 2024, in line with its strategy of focusing on innovative medicines and vaccines, Sanofi announced that it had entered
into exclusive negotiations for the sale of a controlling stake of around 50% in Opella. The agreements in connection with the
potential sale and purchase of a 50% controlling stake in Opella are described as follows:
•
Share Purchase Agreement
In connection with the potential sale of a 50% controlling stake in Opella Healthcare SAS (“Opella”) to Clayton, Dubilier & Rice
(CD&R) (the “Proposed Opella Transaction”), Sanofi has exercised on February 3, 2025 its put option pursuant to the put option
agreement entered into with Opal Bidco SAS (“Bidco”) on October 21, 2024. The put option agreement appends an agreed form
share purchase agreement (the “SPA”), which will govern the terms of the sale and purchase of the share capital of Opella once
entered into by the parties. Pursuant to the exercise of its put option, Sanofi contemplates entering into the SPA, in accordance
with the put option agreement. The purchase price for the acquisition of Opella will be determined and paid at closing of the
Proposed Opella Transaction (“Closing”), based on an enterprise value of approximately €16 billion.
The transaction is expected to close in the second quarter of 2025 at the earliest, subject to obtaining customary regulatory
approvals from the competent authorities. The SPA may be terminated by either party if the conditions are not satisfied and
Closing has not occurred by an agreed long stop date or such other date as the parties otherwise agree.
Pursuant to the SPA, Sanofi and Bidco have made certain customary representations and warranties and have agreed to certain
customary covenants. Specifically, before the Closing, Sanofi is subject to certain business conduct restrictions with respect to
the Opella business.
Sanofi has also agreed to enter into a shareholders’ agreement (the “Shareholders’ Agreement”) with CD&R (and certain co-
investors) to govern from Closing their respective shareholding and management of a joint venture company (“JV Co”) to be
formed at or prior to Closing with CD&R that is contemplated to, following the Closing, indirectly wholly own Opella. It is
anticipated that Bpifrance will ultimately take an approximately 2 % stake in JV Co but the terms of Bpifrance’s investment are
subject to ongoing negotiation.
The Shareholders’ Agreement will provide for a lock-up period during which Sanofi is only permitted to carry out certain types of
direct or indirect transfers of its securities in JV Co.
•
Separation Agreement
In connection with the separation of the Opella business, Sanofi entered into a Separation Agreement and certain other
agreements with Opella on July 22, 2024 (to be amended on or around the date of the SPA) to effect the separation of the Opella
business and provide a framework for their ongoing relationship.
The Separation Agreement sets out the rights and obligations of the parties with respect to the separation, including the terms
and conditions governing the transfer of assets to, and assumption of liabilities by, each of the Opella group and the Sanofi
group. In particular, Sanofi has agreed to retain Gold Bond Co LLC and its business.
The Sanofi group and the Opella group have each agreed, subject to certain exceptions, to release and indemnify the other party
and each of their respective past, present and future directors, officers, managers, agents and employees and each of the heirs,
executors, administrators, successors and assigns of any of the foregoing from any and all claims against any of them that arise
out of or relate to their respective businesses.
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The Sanofi group has agreed to indemnify the Opella group in respect of all liabilities relating to, arising out of or resulting from
among other things, Sanofi’s retained businesses including environmental liabilities, whether arising before or after the Closing,
and certain liabilities relating to (i) the commercialization of any Zantac branded products (i.e., products containing ranitidine as
its active pharmaceutical ingredient) prior to Closing, including certain product liability claims, and (ii) all personal injury claims
resulting from the manufacturing or handling of Zantac prior to Closing (see Note D.22.a to the consolidated financial statements
included at Item 18. of this annual report).
B.4. Global research & development
The ambition of Sanofi Research & Development (R&D) is to develop first-in-class or best-in-class medicines that respond to the
urgent needs of patients, leveraging our leadership in immunology across all other therapeutic areas. This ambition is reflected in
our R&D pipeline, which is presented in “— B.4.1. Biopharma pipeline” below.
Discovering and developing new medicines is a costly, lengthy, and uncertain process and our continuous investments in R&D for
future products and for the launches of newly registered medicines could result in increased costs without a proportionate
increase in revenues. See “Item 3. Key Information — D. Risk Factors” for further information.
B.4.1. Biopharma pipeline
For
2024, the main changes related to our medicines and vaccines pipeline were:
|
Medicines and vaccines
|
Indication
|
Change
|
Reason
|
|
SAR447537 - AAT fusion protein
|
Alpha-1 antitrypsin deficiency
|
Added
|
Acquired from Inhibrx Inc.
|
|
SAR447873 - SSTR targeting alpha-emitter therapy
|
Gastroenteropancreatic neuroendocrine tumors
|
Added
|
Co-developed with RadioMedix
and Orano Med
|
|
SAR446959 - MMP13 x ADAMTS5 x CAP NANOBODY
®
VHH
|
Knee osteoarthritis
|
Added
|
Entered confirmatory
development
|
|
SP0237 - mRNA vaccine
|
Flu
|
Added
|
Entered confirmatory
development
|
|
SP0268 - mRNA vaccine
|
Acne
|
Added
|
Entered confirmatory
development
|
|
SP0287 - Fluzone HD + Nuvaxovid combination vaccine
|
Flu + COVID-19
|
Added
|
Entered confirmatory
development
|
|
SP0287 - Flublok + Nuvaxovid combination vaccine
|
Flu + COVID-19
|
Added
|
Entered confirmatory
development
|
|
SP0289 - mRNA vaccine
|
Flu (H5 pandemic)
|
Added
|
Entered confirmatory
development
|
|
SP0291 - mRNA vaccine
|
RSV+hMPV+PIV3 (older adults)
|
Added
|
Entered confirmatory
development
|
|
SP0335 - Inactivated adjuvanted vaccine
|
Flu (H5 pandemic)
|
Added
|
Entered confirmatory
development
|
|
Kevzara - IL-6R mAb
|
Polyarticular juvenile idiopathic arthritis
|
Removed
|
Commercialized
|
|
SAR439459 - TGFb mAb
|
Osteogenesis imperfecta
|
Removed
|
Development discontinued
|
|
SAR442501 - FGFR3 antibody
|
Achondroplasia
|
Removed
|
Development discontinued
|
|
SAR443809 - Factor Bb mAb
|
Rare renal diseases
|
Removed
|
Development discontinued
|
|
SAR443820 - RIPK1 inhibitor
|
Amyotrophic lateral sclerosis, Multiple sclerosis
|
Removed
|
Development discontinued
|
|
SAR444200 - GPC3 x TCR NANOBODY
®
VH
|
Solid tumors
|
Removed
|
Development discontinued
|
|
SAR444245 - pegenzileukin
|
Solid tumors
|
Removed
|
Development discontinued
|
|
SAR444559 - CD38 mAb Next generation
|
Inflammatory indication
|
Removed
|
Development discontinued
|
|
SAR444836 - PAH replacement AAV-based gene therapy
|
Phenylketonuria
|
Removed
|
Development discontinued
|
|
SAR445419 - NK cell-based immunotherapy
|
Acute myeloid leukemia
|
Removed
|
Development discontinued
|
|
SAR445611 - CX3CR1 NANOBODY
®
VHH
|
Inflammatory indication
|
Removed
|
Development discontinued
|
|
SAR446309 - HER2 T cell engager
|
Solid tumors
|
Removed
|
Development discontinued
|
|
losmapimod - p38a/b MAPK inhibitor
|
Facioscapulohumeral muscular dystrophy
|
Removed
|
Development discontinued
(1)
|
|
SP0282 - E. coli sepsis vaccine
|
E. coli sepsis
|
Removed
|
Development discontinued
(2)
|
|
SP0273 - mRNA QIV
|
Flu
|
Removed
|
Development discontinued
|
Abbreviations are explained in “— B.4.1.1. Products in development” and “— B.4.1.2. Line extensions” below.
(1)
in-licensed from Fulcrum Therapeutics outside of the United States.
(2)
discontinued in February 2025; partnered with Janssen Pharmaceuticals Inc., a Johnson and Johnson company
The portfolio of products in clinical development (from Phase 1 to Phase 3) and in registration as
of
December 31, 2024
is
described in “—E. R&D Appendix.”
Phase 1 studies are the first studies performed in humans, who are mainly healthy volunteers, except for studies in oncology
where Phase 1 studies are performed in patients. Their main objective is to assess the tolerability, the pharmacokinetic profile (the
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way the product is distributed and metabolized in the body and how it is eliminated) and where possible the pharmacodynamic
profiles of the new drug (i.e. how the product may react on some receptors).
Phase 2 studies are early controlled studies in a limited number of patients under closely monitored conditions to show efficacy
and short-term safety, and to determine the dose and regimen for Phase 3 studies.
Phase 3 studies have the primary objective of demonstrating or confirming the therapeutic benefit and safety of the new drug in
the intended indication and population. They are designed to provide an adequate basis for registration.
B.4.1.1. Products in development
The pipeline of products in clinical development is focused on medicines and vaccines seen as potential market leading
opportunities, among which amlitelimab, frexalimab and balinatunfib are ‘pipeline-in-a-product’ medicines and vaccines, as
summarized below:
|
‘Pipeline-in-a-product’ medicines
|
Indications
|
Development phase
|
|
amlitelimab
(OX40L mAb)
|
Atopic dermatitis
Asthma
Hidradenitis suppurativa
Celiac disease
Alopecia areata
Systemic sclerosis
|
Phase 3
Phase 2
Phase 2
Phase 2
Phase 2
Phase 2
|
|
frexalimab
(CD40L mAb)
|
RMS
nrSPMS
Systemic lupus erythematosus
Type 1 diabetes
|
Phase 3
Phase 3
Phase 2
Phase 2
|
|
balinatunfib
(Oral TNFR1si)
|
Rheumatoid arthritis
Psoriasis
Crohn’s disease
|
Phase 2
Phase 2
Phase 2
|
|
Pipeline medicines and vaccines
|
Indications
|
Development phase
|
|
tolebrutinib
(BTKi
|
nrSPMS
PPMS
|
Phase 3
(1)
Phase 3
|
|
rilzabrutinib
(BTKi)
|
ITP
CSU
Asthma
IgG4-related disease
Warm autoimmune hemolytic anemia
|
Regulatory
Phase 2
Phase 2
Phase 2
Phase 2
|
|
itepekimab
(IL33 mAb)
|
COPD
Bronchiectasis
|
Phase 3
Phase 2
|
|
lunsekimig
(IL13xTSLP NANOBODY
®
VHH)
|
Moderate to severe asthma
High-risk asthma
CRSwNP
|
Phase 2
Phase 2
Phase 2
|
|
IRAK4 degrader
(SAR444656)
|
Atopic dermatitis
Hidradenitis suppurativa
|
Phase 2
Phase 2
|
|
duvakitug
(TL1A mAb)
|
Ulcerative colitis
Crohn’s disease
|
Phase 2b
Phase 2b
|
|
RSV mRNA vaccine
(SP0256)
|
RSV older adult
|
Phase 2
|
|
Acne mRNA vaccine
(SP0268)
|
Acne
|
Phase 1
|
(1)
Awaiting submission acceptance in the US.
a) Immunology & Inflammation
a
mlitelimab
(SAR445229
)
, a human monoclonal antibody blocking OX40L pathway, is a ‘pipeline-in-a-product’ asset currently
being assessed in clinical programs for the treatment of a range of immune diseases.
In AD, the dosing of once every 12 weeks is being assessed in a large Phase 3 clinical program (OCEANA). Enrollment of the four
main AD studies designed to evaluate on- and off-treatment efficacy and safety in adults and adolescents continued in 2024,
with results supporting subsequent regulatory submission (expected in 2026).
The proof-of concept Phase 2 study (TIDE-Asthma) assessing amlitelimab in moderate-to-severe asthma has a 60-week double-
blind placebo-controlled period, in which patients are dosed once every four weeks during the initial 24 weeks and once every
12 weeks for the subsequent 36 weeks. Sanofi anticipates results for the full and completed 60-week treatment and follow-up
period will be available in the first half of 2025.
The Phase 2 study of amlitelimab in hidradenitis suppurativa (HS) recruited its last patient in 2024; results are expected in the first
half of 2025.
In 2024, additional Phase 2 studies assessing the efficacy and safety of subcutaneous injections of amlitelimab enrolled their first
patients in adults with non-responsive celiac disease, severe alopecia areata and systemic sclerosis, respectively.
frexalimab (SAR441344)
is a second generation anti-CD40L monoclonal antibody that blocks the costimulatory CD40/CD40L
pathway, which is important for the activation and function of adaptive (T and B cells) and innate (macrophages/microglia and
dendritic cells) immunity. Sanofi is developing frexalimab under an exclusive license from ImmuNext Inc.
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Frexalimab is a ‘pipeline-in-a-product’ asset being evaluated in Phase 3 studies for the treatment of MS (see details in “— c
)
Neurology
”) below, and in Phase 2 studies for the treatment of systemic lupus erythematosus and adults and adolescents with
newly diagnosed type 1 diabetes. In 2024, the clinical development of frexalimab in Sjogren’s syndrome was discontinued based
on results from the Phase 2 study; the data confirmed pharmacological activity and a well-tolerated safety profile, but not the
necessary efficacy outcomes to continue to move the development forward in this indication.
balinatunfib (
SAR441566
) the first small molecule TNFR1 signaling inhibitor, is intended to provide patients with an oral alternative
to anti-TNFa monoclonal antibodies in the range of inflammatory indications where these have been approved. Balinatunfib is a
‘pipeline-in-a-product’ asset currently being evaluated in two Phase 2b clinical studies for the treatment of psoriasis and RA,
respectively. In these two indications, results are expected in the first and second half of 2025, respectively. In 2024, a Phase 2
study was initiated to assess balinatunfib in adults with moderate-to-severe Crohn’s disease.
itepekimab (SAR440340)
is a human anti-IL33 monoclonal antibody co-developed with Regeneron. A Phase 3 clinical program is
evaluating itepekimab for the treatment of COPD in former smokers (AERIFY-1 and AERIFY-2 studies) and in current smokers
(AERIFY-2); results are expected in the second half of 2025. In addition, an exploratory Phase 2a study (AERIFY-3) is evaluating
the mechanism of action of itepekimab and its impact on airway inflammation in former and current smokers with COPD.
Itepekimab has FDA fast-track designation for the treatment of COPD. In 2024, an additional Phase 2 study evaluating
itepekimab for the treatment of patients with bronchiectasis was initiated.
rilzabrutinib (SAR444671)
is a covalent and reversible inhibitor of Bruton’s tyrosine kinase under evaluation in multiple clinical
studies across a range of autoimmune/inflammatory indications.
Positive results were obtained in 2024 from the RILECSU Phase 2 study, showing that rilzabrutinib significantly improved itch,
hives and urticaria in adults with moderate-to-severe CSU whose symptoms are not adequately controlled by H1-antihistamines;
the indication will be further investigated in Phase 3
.
Encouraging results from a Phase 2 study showed that treatment with rilzabrutinib at both high and low doses led to a numerical
reduction in loss of asthma control events (the primary endpoint) and improvements in symptoms in adults with uncontrolled
moderate-to-severe asthma.
In the last quarter of 2024, the 52-week open-label two-cohort Phase 2 study of rilzabrutinib in IgG4-related disease showed
considerable outcomes on flare-free, steroid-free disease rates.
In addition, rilzabrutinib is being evaluated for the treatment of immune thrombocytopenia and
warm autoimmune hemolytic
anemia
(see details in “— b
) Rare diseases
” below
).
lunsekimig (SAR443765)
is a bispecific NANOBODY
®
VHH which blocks both TSLP and IL-13, key upstream and downstream
mediators (respectively) of asthma. A Phase 2b study (AIRCULES) is assessing the efficacy, safety, and tolerability of add-on
therapy with lunsekimig in adults with moderate-to-severe asthma. In 2024, two additional Phase 2 studies were initiated to
assess lunsekimig (i) in adults with asthma who are not eligible for biologic treatments (high-risk asthma), and (ii) in adults with
CRSwNP.
SAR444656
is a selective, orally administered small molecule targeting Interleukin-1 Receptor Associated Kinase 4 (IRAK4), which
is necessary for proinflammatory signaling and cytokine production. SAR444656 is developed in partnership with Kymera
Therapeutics. Two Phase 2 studies are currently evaluating SAR444656 for the treatment of AD and hidradenitis suppurativa
(HS), respectively.
duvakitug
(
SAR447189
, also known as TEV-48574) is an anti-TL1A monoclonal antibody co-developed with Teva
Pharmaceuticals. In 2024, the companies announced that the RELIEVE UCCD Phase 2b study had met its primary endpoints in
patients with ulcerative colitis (UC) and Crohn’s disease, the two main types of inflammatory bowel disease (IBD). Sanofi and Teva
plan to initiate Phase 3 development in IBD, pending regulatory discussions.
eclitasertib (SAR443122)
is a small molecule targeting the receptor-interacting serine/threonine-protein kinase 1 (RIPK1), which is
being co-developed with Denali. The Phase 2 RESOLUTE study evaluating eclitasertib in patients with moderate to severe UC is
ongoing.
riliprubart (SAR445088)
is a humanized IgG4 monoclonal antibody that binds to and inhibits C1s, thereby inhibiting classical
pathway (CP) of complement activity. Activation of the CP of complement is associated with a variety of immune disorders
involving the presence of autoantibodies. The asset is under clinical development in various indications (see details in
“—
c) Neurology”
and
“— b) Rare diseases”
below). A Phase 2 study is currently evaluating the efficacy of riliprubart in prevention of
antibody-mediated rejection (AMR) or treatment of active AMR.
brivekimig (SAR442970)
is a bispecific NANOBODY
®
molecule that combines blockades of TNFa and of the immune co-
stimulatory regulator OX40L. A Phase 2 study is assessing brivekimig in adults with moderate to severe HS; results are expected in
the first half of 2025.
Other assets are currently being evaluated in Phase 1 clinical studies for subsequent development in inflammatory indications:
•
SAR444336
, a non-beta IL2 Synthorin™ molecule designed to selectively engage CD4+ regulatory T cells (and not on effector
T or NK cells).
•
SAR445399
, a monoclonal antibody targeting IL1R3.
•
SAR446422
, a bispecific antibody targeting CD28 and OX40.
•
SAR446959
, a NANOBODY
®
molecule targeting Matrix Metallopeptidase 13 (MMP13), A Disintegrin And Metalloproteinase with
Thrombospondin Motifs 5
(ADAMTS5) and a cartilage anchoring protein (CAP).
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b) Rare Diseases
fitusiran (SAR439774)
is a first-in-class, subcutaneously administered antithrombin siRNA therapy. The FDA granted fitusiran
breakthrough therapy and fast-track designations for hemophilia A/B. Fitusiran also obtained orphan drug designation in the US
and in Europe. In 2024, regulatory submissions for the treatment of hemophilia A or B in adults and adolescents with or without
inhibitors were completed in several regions, including the US with a prescription drug user fee act (PDUFA) date of March 28,
2025. In addition, Sanofi’s collaboration partner Siemens Healthineers submitted the INNOVANCE
®
Antithrombin Assay for FDA
review as a companion diagnostic that will measure antithrombin levels in people living with hemophilia who are prescribed
fitusiran.
rilzabrutinib (SAR444671)
is a Bruton’s tyrosine kinase inhibitor (see details in section
“— a) Immunology & Inflammation”
above)
developed for the treatment of immune thrombocytopenia (ITP), for which the FDA has granted fast-track designation. The asset
has also obtained orphan drug designation in the US, Europe, and Japan. The primary endpoint of durable platelet response was
met in the rilzabrutinib Phase 3 study LUNA 3 in adult patients with persistent or chronic ITP. Other key secondary endpoints
were met including reduced bleeding, number of weeks with platelet response, the need for rescue therapy use, and improved
physical fatigue and quality of life measures. The safety profile of rilzabrutinib was favorable and consistent with that reported in
previous studies. Rilzabrutinib is under regulatory review in the EU, China, and the US with a target date to receive an FDA
decision on August 29, 2025.
In 2024, a Phase 2 study in warm autoimmune hemolytic anemia read out positively with clinically meaningful outcomes on
response rate and additional disease markers.
The results of this study build on the successful Phase 3 study of rilzabrutinib in ITP
and reinforce its efficacy in autoimmune cytopenias
.
venglustat (GZ402671)
is an orally administered brain penetrant glucosylceramide synthase (GCS) inhibitor that blocks the
conversion of ceramide to glucosylceramide (GL-1). In 2024, the AMETHIST Phase 3 study of venglustat for the treatment of GM2
gangliosidosis was discontinued based on the absence of positive trends on clinical endpoints. The data reinforced the favorable
safety profile and do not impact the other two indications, FD and Gaucher disease type 3, in which venglustat is currently being
evaluated in Phase 3 studies. Results in these two indications are expected in the second half of 2025. Orphan drug designation
has been granted in the US, Europe, and Japan for FD and Gaucher disease type 3, and the FDA has granted venglustat fast-
track designation for FD.
SAR447537 (formerly INBRX-101):
in May 2024, the acquisition of Inhibrx, Inc. closed, adding SAR447537 to Sanofi’s rare disease
Phase 2 pipeline. SAR447537 is a human recombinant protein that holds the promise of allowing alpha-1 antitrypsin deficiency
(AATD) patients to achieve normalization of serum AAT levels with less frequent dosing. AATD is an inherited rare disease
characterized by low levels of AAT protein, predominantly affecting the lung with progressive deterioration of the tissue. Results
from the ongoing Phase 2 study (ELEVAATE) are expected in the second half of 2025. The FDA has granted SAR447537 fast-
track designation for AATD.
In 2024, the
decision was taken
to discontinue the development of
riliprubart
(see details in
“— a) Immunology & Inflammation”
above) in cold agglutinin disease, a rare autoimmune disorder characterized by the premature destruction of red blood cells
(hemolysis), due to prioritization of other projects. As of now, the data confirmed pharmacological activity and a well-tolerated
safety profile, as in other indications.
c) Neurology
tolebrutinib (SAR442168)
is an oral investigational brain-penetrant and bioactive Bruton’s tyrosine kinase (BTK) inhibitor, which
achieves cerebrospinal fluid concentrations that are predicted to modulate B lymphocytes and microglial cells.
Positive results from the HERCULES Phase 3 study showed that tolebrutinib met the primary endpoint of improvement over placebo
in delay
ing time to onset of confirmed disability progression in subjects with non-relapsing secondary progressive multiple sclerosis
(nrSPMS). Preliminary analysis of liver safety was consistent with previous tolebrutinib studies. In December, the FDA granted
breakthr
ough therapy designation to tolebrutinib for the treatment of adults with nrSPMS. Sanofi expects to receive regulatory
submission acceptance in the US during the first half of 2025; EU submission is also anticipated during the first half of 2025.
Results from the GEMINI 1 and 2 Phase 3 studies evaluating tolebrutinib did not meet the primary endpoint of reducing annualized
relapse rate, compared to Aubagio, a standard of care treatment, in people with relapsing MS (RMS). However, analysis of the key
secondary endpoint of pooled 6-month CDW data showed a considerable delay in time to onset, which supports the CDP data
observed in HERCULES.
A Phase 3 study (PERSEUS) is currently ongoing to determine the efficacy of tolebrutinib in delaying disability progression in
primary progressive multiple sclerosis (PPMS); results are expected in the second half of 2025 with subsequent submissions
anticipated in 2026.
frexalimab (SAR441344)
is a monoclonal antibody targeting CD40L (see
“— a) Immunology & Inflammation”
above) that has the
potential to address both acute and chronic neuroinflammation in MS through its unique upstream mechanism of action. In 2024,
new efficacy and safety data at 18 months from the Phase 2 study for the treatment of RMS demonstrated sustained reduction of
disease activity, with stable clinical surrogate endpoints, and good tolerance, with no new safety signals. These results support
the ongoing Phase 3 clinical program, with two studies in RMS and nrSPMS.
riliprubart (SAR445088)
is a complement C1s inhibitor (see details in
“— a) Immunology & Inflammation”
above) that is being
assessed in patients with chronic inflammatory demyelinating polyneuropathy (CIDP), for which orphan drug designation was
granted in the US and in Europe. In 2024, new data from a Phase 2 study showed encouraging efficacy and safety for patients
with CIDP. In part A results at 24 weeks, riliprubart showed promising disease-controlling benefits, with most study patients
improving or remaining stable, including those who experienced failure or inadequate response to standard-of-care treatment
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(SOC-refractory), and those having residual disability despite treatment with SOC (IVIg-treated). In part B, after approximately
one year of treatment, riliprubart continued to show promising disease-controlling benefits across all enrolled cohorts. Additional
results indicated that riliprubart may improve patient-reported fatigue and quality-of-life measurements as well as biomarkers
associated with CIDP disease progression. Supported by the Phase 2 data, two Phase 3 studies evaluating riliprubart in SOC-
refractory CIDP (MOBILIZE) and IVIg-treated CIDP (VITALIZE) were initiated.
SAR446159
, a bispecific antibody targeting alpha-synuclein and insulin-like growth factor 1 receptor (IGF1R) developed in
collaboration with ABL Bio for the treatment of Parkinson’s disease, is under evaluation in a Phase 1 study.
d) Oncology
SAR443579
is a trifunctional anti-CD123 NK cell engager developed in partnership with Innate Pharma. The asset is being
investigated in a Sanofi-sponsored Phase 1/2 clinical study in various hematological malignancies, including acute myeloid
leukemia for which FDA fast-track designation was obtained. In 2024, SAR443579 progressed to the Phase 2 dose expansion part
of the study.
SAR447873
is a somatostatin receptor (SSTR)-targeting alpha-emitter therapy that entered Sanofi’s pipeline in 2024 through
partnership with RadioMedix and OranoMed. The AlphaMedix02 Phase 2 study is currently evaluating SAR447873 in subjects with
SSTR-expressing neuroendocrine tumors; results from this study are expected in the first half of 2025. The asset was granted
breakthrough therapy designation in gastroenteropancreatic neuroendocrine tumors from the FDA for patients who are naive to
peptide-receptor radionuclide therapy.
In addition, Sanofi’s clinical pipeline includes several assets being evaluated in Phase 1 for the treatment of various cancer
settings:
•
SAR444881, a monoclonal antibody targeting the Ig-like transcript 2 (ILT2) receptor, co-developed with Biond Biologics for
the treatment of solid tumors.
•
SAR445877, an anti-PD1xIL15 fusion protein under assessment in patients with solid tumors.
•
SAR445514, a trifunctional anti-BCMA NK cell engager, developed in partnership with Innate Pharma for the treatment of
relapsed or refractory multiple myeloma.
•
SAR445953, an antibody drug conjugate that binds to human CEACAM-5 under evaluation for the treatment of colorectal
cancer or other solid tumors. SAR445953 is developed in collaboration with Pfizer.
e) Vaccines
SP0087
is a purified human rabies vaccine aimed at replacing Sanofi’s commercialized rabies vaccines (Imovax and Verorab). This
next generation rabies vaccine is cultured on Vero cells and is free from animal or human material. The asset is currently under
evaluation in a Phase 3 study for pre- and post-exposure prophylaxis in all age groups; results from this pivotal study are
expected in the first half of 2025. The FDA has granted SP0087 fast-track designation.
SP0125
is a live attenuated vaccine intended to expand protection against RSV to all toddlers, from the second season onwards
(all infants can indeed be protected against RSV during their first season with Beyfortus, which is available in the US and several
other countries; s
ee
“—
B.2. Main Biopharma medicines and vaccines”
). In 2024, a Phase 3 study (PEARL) was initiated to evaluate
SP0125 for the prevention of RSV in toddlers; the study is being conducted in approximately 6,300 children aged six months to
less than 22 months. SP0125 has been granted fast-track designation by the FDA and PRIME designation by the EU.
SP0202
is a 21-valent conjugate vaccine intended to provide expanded protection against pneumococcal disease, developed in
collaboration with
SK bioscience.
In 2024, a Phase 3 program was initiated for SP0202, which is the first pneumococcal conjugate
vaccine candidate with more than 20 serotypes to enter this clinical stage in infants and toddlers. The Phase 3 program will
include more than 7,700 infants, toddlers, young children, and adolescents across multiple geographies, including the US,
Europe, Australia, Asia, and Latin America. The FDA has granted SP0202 fast-track designation.
SP0256
is an mRNA vaccine candidate intended to prevent RSV and human metapneumovirus (hMPV) infections in the older
adult population. A Phase 1/2 study is ongoing to evaluate this combination vaccine, for which the FDA has granted fast-track
designation to prevent RSV and hMPV infections in people aged 60 to 75 years.
SP0218
is a live attenuated yellow fever vaccine (freeze-dried and produced in Vero cells), for subcutaneous and intra-muscular
administration in people aged nine months and older. This next generation vaccine aims at replacing Stamaril (licensed in 1983)
and YF-VAX (licensed in 1970), thereby securing a sustainable and consistent worldwide supply with a single product. Positive
Phase 2 results served as the basis for the initiation of a Phase 3 study that is expected to enroll participants early 2025.
SP0230
is a pentavalent vaccine against meningitis caused by serogroups ABCWY in adults and adolescents. In 2024, a Phase 1/2
study enrolled the first participants; results are expected in the second half of 2025.
SP0237
is a flu mRNA vaccine that is part of our efforts to develop a next generation, enhanced flu vaccine containing
hemagglutinin and neuraminidase designed to offer improved efficacy and provide protection beyond flu. In 2024, a Phase 1/2
study with an enhanced mRNA formulation against flu enrolled the first participants.
SP0268
,
an acne mRNA vaccine designed for adolescents and adults with moderate to severe acne, is the most advanced
therapeutic vaccine for acne in development. In 2024, a Phase 1/2 study evaluating SP0268 enrolled the first participants.
Two combination vaccine candidates for prevention of influenza and COVID-19
infections in individuals 50 years of age and older
(
SP0287
)
, which were granted fast-track designation in the US, had their respective Phase 1/2 studies initiated in 2024. The first
combination vaccine candidate consists of the influenza protein-based trivalent vaccine
Fluzone HD
combined with the
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2024
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adjuvanted recombinant Novavax COVID-19 vaccine. The second candidate combines the influenza recombinant protein-based
trivalent vaccine
Flublok
with the Novavax COVID-19 vaccine.
Additional vaccine
candidates entered clinical development with Phase 1/2 or Phase 2 clinical trials initiated in 2024, respectively
for the prevention of pandemic flu (
SP0289,
a flu mRNA vaccine and
SP0335,
a flu H5 inactivated adjuvanted vaccine) and of
RSV, hMPV, and parainfluenza virus type 3 (PIV3) infections in the older adult (
SP0291
, an RSV+hMPV+PIV3 mRNA vaccine).
B.4.1.2. Line extensions
The main R&D activities supporting line extensions for our marketed products are summarized below. For more information on
marketed products
s
ee also
“
—
B.2. Main Biopharma medicines and vaccines
”.
Dupixent
is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13)
pathways, jointly developed with Regeneron. Dupixent has received regulatory approvals in several countries for multiple
indications. Details about clinical and regulatory activities for Dupixent during 2024 for the treatment of respiratory, dermatology
and gastrointestinal diseases are provided below:
a.
The FDA approved Dupixent as an add-on maintenance treatment of adults with COPD and an eosinophilic phenotype.
Dupixent is the first biologic medicine approved in the US to treat these patients. The National Medical Products
Administration in China approved Dupixent as an add-on maintenance treatment for adults with uncontrolled COPD
characterized by raised blood eosinophils. Specifically, the approval covers patients already on a combination of an inhaled
corticosteroid (ICS), a long-acting beta2-agonist (LABA) and a long-acting muscarinic antagonist (LAMA), or on a combination
of a LABA and a LAMA if ICS is not appropriate. Dupixent has now been approved for the treatment of COPD in more than
30 countries worldwide, including the 27 countries in the EU. In Japan, approval is expected in the first half of 2025.
b.
CSU is a chronic skin condition that causes sudden and debilitating hives and persistent itch, which can impact quality of life.
LIBERTY-CUPID Study C, a confirmatory Phase 3 study, met the primary and key secondary endpoints for the treatment of
patients with uncontrolled, biologic-naive CSU receiving background therapy with antihistamines. The new Study C data
supported regulatory resubmission of the supplemental biologics license application (sBLA) for Dupixent in the US in October
2024, with a target action date for the FDA decision of April 18, 2025. This positive study confirmed results from Study A, the
first Phase 3 study of Dupixent in this setting. In early in 2024, Japan was the first country to approve Dupixent for adult and
adolescent CSU patients based on the results from Study A. The indication is also under review in the EU based on results from
Study A and Study B (patients uncontrolled on standard-of-care H1 antihistamines and refractory to omalizumab).
c.
Dupixent’s pivotal LIBERTY-BP Phase 3 study in bullous pemphigoid (BP) met the primary and all key secondary endpoints
evaluating its use in adults with moderate-to-severe disease. Dupixent had previously been granted orphan drug designation
by the FDA for this chronic and relapsing disease, characterized by intense itch and blisters, reddening of the skin, and painful
chronic lesions. The blisters and rash can form over much of the body and cause the skin to bleed and crust, resulting in
patients being more prone to infection and affecting their daily functioning. Results of the LIBERTY-BP study served as the
basis for the submission of the sBLA of Dupixent for the treatment of adults with moderate-to-severe BP.
d.
The LIBERTY-CPUO-CHIC Study A Phase 3 study evaluating Dupixent in adults with uncontrolled and severe chronic pruritus
of unknown origin (CPUO) did not achieve statistical significance in its primary itch responder endpoint (despite favorable
numerical improvements) but showed nominally significant improvements in all other itch endpoints. The Dupixent Phase 3
study program in CPUO consists of Study A and Study B. Study B is intended to be initiated as a subsequent pivotal study.
e.
A Regeneron-sponsored Phase 2/3 study evaluating Dupixent in adult and adolescent patients with eosinophilic gastritis with
or without eosinophilic duodenitis is ongoing.
f.
A Phase 3 program to evaluate Dupixent in adults with lichen simplex chronicus was initiated in 2024.
g.
Finallly, a Phase 2 clinical study is ongoing for the treatment of patients with ulcerative colitis.
Kevzara
, a monoclonal antibody against the IL-6 receptor developed with Regeneron, is already marketed for the treatment of
moderate to severe rheumatoid arthritis and polymyalgia rheumatica.
In 2024, the FDA approved Kevzara for the treatment of patients weighing 63 kilograms or greater with active polyarticular
juvenile idiopathic arthritis (pJIA), a form of arthritis that impacts multiple joints at a time. The approval in this patient population
was supported by evidence from adequate and well-controlled studies and pharmacokinetic data from adults with rheumatoid
arthritis as well as a pharmacokinetic, pharmacodynamic, dose finding and safety study in pediatric patients with pJIA. Approval
in Europe for the treatment of patients with
pJIA
was obtained in January 2025
.
Tzield
, a CD3-directed monoclonal antibody, is the first and only disease modifying therapy in type 1 diabetes (T1D), a chronic
autoimmune condition where the body’s ability to regulate blood sugar levels is impacted due to the gradual destruction of
insulin producing beta cells by one’s own immune system. The product is approved by the FDA to delay the onset of Stage 3 T1D
in adults and children eight years and older diagnosed with Stage 2 T1D. In addition, the potential of Tzield to slow the
progression of Stage 3 T1D in newly diagnosed children and adolescents is currently being evaluated in a Phase 3 clinical
program. In 2024, the EMA accepted for review the regulatory submission for Tzield in children and adolescents to delay the
onset of stage 3 T1D, as well as for early intervention in stage 3 T1D.
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2024
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Rezurock
is a selective ROCK2 (rho-associated coiled-coil–containing protein kinase-2) inhibitor that was first approved by the
FDA for the treatment of adult and pediatric patients aged 12 years and older with chronic graft-versus-host disease (chronic
GVHD) after failure of at least two prior lines of systemic therapy.
Rezurock is now approved in multiple countries, including
China, the UK and Canada.
In 2024, the EMA accepted for review the regulatory submission of Rezurock for the third line
treatment of chronic GVHD. The EMA granted an orphan designation in 2019 for this indication.
A Phase 3 study is evaluating Rezurock on top of azithromycin and standard-of-care regimen of immunosuppression in adult
participants who have evidence of progressive chronic lung allograft dysfunction despite azithromycin therapy.
Nexviazyme
is a long-term enzyme replacement therapy targeting the mannose-6-phosphate receptor to effectively clear
glycogen build-up in muscle cells. This enzyme replacement therapy is approved for the treatment of patients with Pompe
disease, a rare disease caused by a deficiency of the enzyme acid alpha-glucosidase (GAA)
.
In Europe, the treatment is marketed
under the brand name Nexviadyme.
In 2024, new data from the Mini-COMET Phase 2 long-term extension study in pediatric patients with infantile-onset Pompe
disease (IOPD) suggested that Nexviazyme meaningfully improved ptosis, or drooping eyelid, over nearly three years.
Additionally, positive safety debut data were obtained from the Baby-COMET Phase 3 study, the first study in over 20 years of
any treatment in naive IOPD patients.
This Phase 3 study is currently ongoing and is expected to read out in 2026.
Sarclisa
is a monoclonal antibody designed to selectively bind to CD38, a cell surface antigen expressed in MM cancer cells and
other hematological malignancies. Sarclisa is approved in several countries in combination settings for the treatment of adults
with relapsed refractory multiple myeloma (RRMM). Sarclisa is under evaluation in combination with current standard and novel
treatments across the MM treatment continuum.
Sarclisa in combination with bortezomib, lenalidomide, and dexamethasone (VRd) as a first-line treatment option for adult
patients with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplant was approved by the
FDA in September 2024 and in the EU and in China in January 2025. The regulatory submission in this indication for Sarclisa is
currently under review in Japan, supported by the IMROZ Phase 3 study. This study demonstrated that Sarclisa in combination
with standard-of-care VRd, followed by Sarclisa-Rd, improved progression-free survival (PFS) and led to a rapid and greater
depth of response compared to VRd alone, as shown by minimal residual disease (MRD) negativity rate over time, in transplant-
ineligible patients with newly diagnosed MM.
New results from the German-speaking Myeloma Multicenter Group (GMMG)-HD7 Phase 3 study showed that Sarclisa in
combination with lenalidomide, bortezomib and dexamethasone (RVd) during induction therapy in NDMM, transplant-eligible,
significantly prolonged PFS from first randomization, resulting in a statistically significant and clinically meaningful reduction in
disease progression or death, compared to RVd induction regardless of the maintenance regimen. The study results supported
the regulatory submission that is currently under review by the EMA.
The development of a new subcutaneous formulation of Sarclisa at a fixed dose in combination with pomalidomide and
dexamethasone (Pd) in RRMM patients who have received at least one prior line of therapy is under evaluation in a Phase 3 study
(IRAKLIA); in this program, Sarclisa is administered subcutaneously using Enable Injections’ enFuse hands-free on-body device
delivery system. The co-primary endpoints of this study were met, supporting regulatory submissions in the US and in the EU that
are planned during the first half of 2025.
Sarclisa is also assessed in a Phase 3 study in combination with lenalidomide and dexamethasone versus lenalidomide and
dexamethasone in patients with high-risk smoldering MM, and in a Phase 2 study in new combinations with emerging novel
mechanisms of action for the treatment of patients with RRMM or newly diagnosed MM patients.
Fluzone HD
is a high-dose quadrivalent influenza vaccine licensed in the US and in Europe for the elderly population, who do not
respond as well to standard-dose influenza vaccines due to aging of the immune system (immuno-senescence). A Phase 3 study
to evaluate immunogenicity and safety of Fluzone HD in participants 50 through 64 years of age was initiated in 2024.
MenQuadfi
: Sanofi’s Men ACYW-TT vaccine is our latest advance in meningococcal quadrivalent conjugate vaccination, designed
to help protect an expanded patient group including infants and adolescents through older adults. MenQuadfi is already licensed
in the US (for people aged two years and over), and in Europe and several other countries (for people aged 12 months and over).
MenQuadfi has also received WHO pre-qualification for people aged 12 months and above. In 2024, positive safety and
immunogenicity results from a Phase 3 study of MenQuadfi to protect infants from six weeks of age against invasive
meningococcal disease caused by serogroups ACWY, supported regulatory submission in the US. The FDA accepted for review
the supplemental biologics license application for the potential extension of the indication to include children aged six weeks to
23 months through active immunization for the prevention of invasive meningococcal disease caused by Neisseria meningitidis
serogroups A, C, W, and Y. The target action date for the FDA decision is May 23, 2025.
B.4.2. R&D Expenditures for late stage development
Expenditures on research and development amounted to €
7,394
million in
2024
(€
6,507
million in
2023
). Research and
development expenditures represented approximately
18.0
% of our net sales in
2024
, compared with
17.2
% in
2023
. The
acceleration in R&D spend was focused mainly on key projects in immunology, rare diseases, neurology and vaccines, and also
reflects the acquisitions and in-licensing agreements carried out in 2024; by contrast, expenditures in oncology have been
reduced. Expenditures in Medical Affairs and R&D Support Functions reached €2,091 million in 2024 (€2,035 million in 2023 CER),
driven by continued investment in digital R&D. In addition, a reimbursement of R&D expenses of approximately €200 million was
received from Sobi in 2024 following the registration of ALTUVIIIO in Europe, and credited to R&D expenses.
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2024
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B.5. Markets
A breakdown of revenues by segment and by geographical region for
2024
,
2023
, and
2022
can be found at Note D.34. to our
consolidated financial statements, included at Item 18. of this annual report.
The following market shares and ranking information are based on consolidated national pharmaceutical sales data (excluding
vaccines), in constant euros, on a September
2024
Moving Annual Total (MAT) basis. The data are mainly from IQVIA MIDAS local
sales audit supplemented by various other country-specific sources including Knobloch (Mexico), GERS (France) and HMR
(Portugal).
B.5.1. Marketing and distribution
We have business operations in approximately
63
countries and our products are available in more than
160
countries.
A breakdown of our aggregate net sales by geographical region is presented in “Item 5. Operating and Financial Review and
Prospects — Results of Operations — Year Ended
December 31, 2024
Compared with Year Ended
December 31, 2023
.” Sanofi is
the tenth largest pharmaceutical company globally by sales. Our main markets in terms of net sales are respectively:
•
United States: we rank fifteenth with a market share of 2.1%;
•
Europe: we are the fifth largest pharmaceutical company in France where our market share is 4.0%, and we rank fourth in
Germany with a 4.0% market share; and
•
other countries: we are ranked twelfth in Japan with a market share of 2.3%, and ninth in China with a market share of 1.5%.
Although
specific distribution patterns vary by country, we sell prescription drugs primarily to wholesale drug distributors,
independent and chain retail drug outlets, hospitals, clinics, managed-care organizations and government institutions. Some
products in Rare Diseases and Oncology may also be sold directly to physicians. With the exception of Opella products, our drugs
are ordinarily dispensed to patients by pharmacies upon presentation of a doctor’s prescription. Our vaccines are sold and
distributed through multiple channels including physicians, pharmacies, hospitals, private companies and distributors in the
private sector, and governmental entities and non-governmental organizations in the public and international donor markets.
We
use a range of channels from in-person to digital to disseminate information about and promote our products among
healthcare professionals, ensuring that the channels not only cover our latest therapeutic advances but also our established
prescription products, which satisfy patient needs in some therapy areas. In some countries, products are also marketed directly
to patients by way of television, radio, newspapers and magazines, and digital channels (such as the internet), in accordance with
local regulations. National education and prevention campaigns can be used to improve patients’ knowledge of their conditions.
We regularly exhibit at major medical congresses.
Our
sales representatives, who work closely with healthcare professionals, use their expertise to promote and provide scientific
information on our drugs, and to inform healthcare professionals when necessary about alternative access to our drugs for their
patients. They represent our values on a day-to-day basis and are required to adhere to a code of conduct and to internal
policies on which they receive training.
Sanofi markets most of its products through its own own sales forces. Nevertheless, Sanofi has entered into and continues to
form alliances to promote/market or co-promote/co-market certain products in specific geographical areas. Our major alliances
are detailed at “Item 5. Operating and Financial Review and Prospects — A.1.7. Financial Presentation of Alliances.” See also
“Item 3. Key Information — D. Risk Factors — We rely on third parties for the discovery, manufacture and marketing of some of
our products.”
B.5.2. Competition
The pharmaceutical industry continues to experience significant changes in its competitive environment.
There are four primary types of competition in the prescription pharmaceutical market:
•
competition among pharmaceutical companies to research and develop new patented products or address unmet medical
needs;
•
competition among different patented pharmaceutical products for the same therapeutic indication, including competition
for market access, as is currently being observed in particular in the US (but also in other markets around the world). The
number of drugs excluded from leading pharmacy benefit managers’ formularies has increased dramatically over the past five
years in the US commercial health insurance market, mostly in crowded therapeutic areas. For 2024, the three largest
pharmacy benefit managers (PBMs) - Caremark (CVS Health), Express Scripts (Cigna), and OptumRx (United Health Group) -
have again each excluded 600 or more drugs from their standard formularies. Formulary exclusions and utilization
management are tools used by payers to manage prescription drug costs and leverage their negotiating power with
manufacturers;
•
competition among original and generic products or original biological products and biosimilars, at the end of regulatory
exclusivity or patent protection; and
•
competition among generic or biosimilar products.
Generics
manufacturers who have received all necessary regulatory approvals for a product may decide to launch a generic
version before the patent expiry date, even in cases where the owner of the original product has already commenced patent
infringement litigation against the generics manufacturer. Such launches are said to be “at risk” for the owner and the promoter
of the generic product because it may be required to pay damages to the owner of the original product in the context of patent
infringement litigation; however, such launches may also significantly impair the profitability of the pharmaceutical company
whose product is challenged.
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Drug manufacturers also face intra-product competition through parallel trade, where legally permitted. This refers to the
practice whereby parallel traders or importers purchase drugs in one country and sell them in another country without the
authorization of the original drug manufacturer. This usually occurs in markets where price differences exist due to factors like
varying regulations, taxes or exchange rates. The parallel trader or importer will repackage or resize the original product with
leaflets in the local language and sell it through an alternative channel at a higher price. This situation is of particular relevance in
the European Union single market, where such practices have been encouraged by the current regulatory framework. Some of
the risks arising from parallel trade include quality and safety concerns, breach of intellectual property rights and supply chain
disruptions (see “Item 3. Key Information — D. Risk Factors”).
The industry is also facing a proliferation of falsified and substandard medicines, a problem particularly widespread in low- and
middle-income countries. The WHO estimates that 10% of medicines in these regions are falsified, affecting all therapeutic areas
including vaccines. Worldwide, falsified products are an issue, due in part to an exponential rise in internet connectivity of those
engaged in the manufacture, distribution and supply of substandard and falsified medical products. Similar types of competition
apply to Opella.
In
Vaccines, there are two primary types of competition:
•
competition
for innovation in the development of new vaccines, including breakthrough technologies (such as mRNA vaccines
introduced against COVID-19)
or address unmet medical needs; and
•
competition among different patented (or non-patented) vaccine products marketed for the same therapeutic indication.
In contrast, generics and biosimilars do not directly affect vaccines, which rely on proprietary viral or bacterial strains.
Competition from parallel importers remains limited due to the specific requirements for vaccines, such as the cold chain and the
need for administration by healthcare professionals.
B.5.3. Regulatory
framework
The pharmaceutical and health-related biotechnology sectors are highly regulated. National and supranational health authorities
administer a vast array of legal and regulatory requirements that dictate pre-approval testing (including testing in human
subjects) and quality standards to maximize the safety and efficacy of a new medical product. These authorities also regulate
product labeling, manufacturing, importation/exportation, safety reporting and marketing, as well as mandatory post-approval
requirements and commitments.
The submission of an application to a regulatory authority does not guarantee that a license or approval to market will be
granted. Furthermore, each regulatory authority may impose its own requirements during product development or during the
application review. It may refuse to grant approval or require additional data before granting approval, even in circumstances in
which the same product has already been approved in other countries. Regulatory authorities also have the authority to request
product recalls and product withdrawals, to impose penalties for violations of regulations, and ultimately the ability to revoke
product licensure or approval.
Product review and approval can vary from six months or less to several years from the date of application submission depending
upon the country and regulatory jurisdiction. Factors such as the quality of data and evidence, the review procedures, the nature
of the product and the condition to be treated, play a major role in the length of time a product is under review, and whether or
not the product is ultimately licensed or approved.
In the EU
, there are three main procedures for applying for marketing authorization:
•
the centralized procedure is mandatory for drugs derived from biotechnologies; new active substances designed for human
use to treat HIV, viral diseases, cancer, neurodegenerative diseases, diabetes and auto-immune diseases; orphan drugs; and
innovative products for veterinary use. When an application for human use is submitted to the EMA, the scientific evaluation of
the application is carried out by the EMA’s CHMP and a scientific opinion is prepared. This opinion is sent to the EC, which
adopts the final decision and grants an EU marketing authorization. Such a marketing authorization is valid throughout the EU,
and the drug may be marketed within all EU Member States;
•
if a company is seeking a national marketing authorization in more than one Member State, two procedures are available to
facilitate the granting of harmonized national authorizations across Member States: the mutual recognition procedure or the
decentralized procedure. Both procedures are based on the recognition by national competent authorities of a first
assessment performed by the regulatory authority of one Member State; and
•
national authorizations are still possible, but are only for products intended for commercialization in a single EU Member State
or for line extensions to existing national product licenses.
In the EU, vaccines are treated as pharmaceutical products, and therefore have to obtain marketing authorization under the
centralized procedures described above.
Generic products are subject to the same marketing authorization procedures. A generic product must contain the same active
medicinal substance as a reference product approved in the EU. Generic applications are abridged: generic manufacturers only
need to submit quality data and demonstrate that the generic drug is “bioequivalent” to the originator product (i.e. performs in
the same manner in the patient’s body), but do not need to submit safety or efficacy data since regulatory authorities can refer to
the reference product’s dossier.
Another relevant aspect in the EU regulatory framework is the “sunset clause” under which any marketing authorization ceases to
be valid if it is not followed by marketing within three years, or if marketing is interrupted for a period of three consecutive years.
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In the US
, the FDA has broad regulatory jurisdiction over all pharmaceutical and biological products that are intended for sale and
marketing in the US. To commercialize a new drug or biologic in the US, an applicant must submit to the FDA a New Drug
Application (NDA) under the Food, Drug and Cosmetic (FD&C) Act or a Biologics License Application (BLA) under the Public
Health Service (PHS) Act, respectively, for filing and pre-market review. Specifically, the FDA must decide whether the product is
safe and effective for its proposed use; if the benefits of the product outweigh its risks; whether the product labeling is adequate;
and if the manufacturing of the product and the controls used for maintaining quality are adequate to preserve the product’s
identity, strength, quality and purity. Based upon this review, the FDA can stipulate post-approval commitments and
requirements. Changes to an approved product, including but not limited to a new indication, require submission of a
supplemental NDA (sNDA) for a drug or a sBLA for a biological product.
The FD&C Act provides another option for NDA product approval via the 505(b)(2) pathway. This 505(b)(2) application contains
full reports of investigations of safety and effectiveness but at least some of the information required for approval comes from
studies not conducted by or for the applicant and for which the applicant has not obtained a right of reference. For example,
under the 505(b)(2) pathway an applicant may seek to rely on literature or earlier FDA findings of safety and effectiveness for
approved drugs.
Sponsors wishing to market a generic drug or biosimilar product can file an Abbreviated NDA (ANDA) under 505(j) of the FD&C
Act or abbreviated BLA (aBLA) under 351(k) of the PHS Act, respectively.
•
ANDA applications are “abbreviated” because they are generally not required to include data to establish safety and efficacy
but need to demonstrate that their product is bioequivalent (i.e., performs in humans in the same manner as the originator’s
product) to a reference listed drug. Consequently, the length of time and cost required for development of generics can be
considerably less than for the innovator’s drug. The ANDA pathway in the US can only be used for generics of drugs that can
be referenced as having been approved under the FD&C Act.
•
aBLA applications contain evidence that the potential product is biosimilar to a reference product already approved by the
FDA. A biosimilar is highly similar to and has no clinically meaningful differences in terms of safety, purity, and potency (i.e.
safety and effectiveness) from an FDA-licensed reference product. The abbreviated approval pathway for biosimilars was
created to help reduce the time and cost of development of biologics without compromising safety and effectiveness.
Consequently, the length of time and cost required for development of biosimilars may be less than for the innovator’s
reference product.
In Japan
, the entire process of approval review from review-related inspections and clinical study consultation to review for the
drugs approved by the Ministry of Health, Labour and Welfare (MHLW) is undertaken by the PMDA. The PMDA conducts a first
scientific review of the NDA submitted, assessing particularly the safety, efficacy and quality of the product or medical device
proposed. Results of this primary evaluation are then submitted to the PMDA’s external experts. After a second evaluation based
on the external experts’ feedback, a report is provided; the Pharmaceutical Affairs and Foods Sanitation Council (PAFSC) – one of
the councils organized under the MHLW as advisory commission – is consulted, and advises the MHLW on final approvability.
For Japanese registrations, in principle, clinical data for Japanese patients are necessary. The regulatory authorities can require
local clinical studies, though they now strongly recommend and also accept multi-regional studies including Japan. In some
cases, bridging studies have been conducted to verify extrapolability of foreign clinical data to Japanese patients and to obtain
data to determine the appropriateness of the dosages for Japanese patients.
The MHLW may require additional post-approval studies (Phase 4) for some specific cases, to further evaluate safety and/or to
gather information on the use of the product under specified conditions. In approval of new drugs, new indications, new dosages
or new administrations, the re-examination period is determined by the MHLW. Post-marketing information on a drug for the
predetermined period after approval is collected to reconfirm its efficacy, safety and quality at the end of the period. This
collection process involves both post-marketing surveillance (PMS), which is a non-interventional study, and post-marketing
clinical studies.
For generic products, the data necessary for filing are similar to EU and US requirements. Companies only need to submit quality
data, and data demonstrating bioequivalence to the originator product, unless the drug is biopharmaceutical. Common Technical
Document (CTD) submission for generics has been mandatory since March 2017.
The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) was created
in 1990 and reformed in 2015.
The ICH currently includes
23
Members and
38
Observers. Harmonization is achieved through the development of ICH Guidelines
via a process of scientific consensus with regulatory and industry experts working side-by-side.
In addition to the joint efforts, Free Trade Agreements (FTAs) have proven to be one of the best ways to open up foreign markets to
exporters and to allow for discussions on harmonization topics for regulatory authorities. Some agreements, such as the Agreement
on Trade Related Aspects of Intellectual Property Rights (TRIPS), are international in nature, while others are between specific
countries. The requirements of many countries (including Japan and several EU Member States) to negotiate selling prices or
reimbursement rates for pharmaceutical products with government regulators significantly extend the time to market entry beyond
the initial marketing approval. While marketing authorizations for new pharmaceutical products in the EU have been largely
centralized within the EC in collaboration with the EMA, pricing and reimbursement remain a matter of national competence.
For a description of risks relating to the regulatory environment in which we operate, refer to “— Item 3.D. Risk Factors
— Product liability claims could adversely affect our business, results of operations and financial condition.”
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B.5.4. Pricing & reimbursement
We are operating in a
highly volatile and competitive
market access and launch environment globally.
Faced with mounting budget pressure, governments and payers are using several
drug price control policies
such as price
referencing for imported drugs, increased patient co-payments, restrictive formularies, prescribing guidelines, tendering
procedures, generic and biosimilar substitution, and medico-economic evaluations of healthcare products.
In addition, the industry faces growing pressure to demonstrate the value and cost-effectiveness of products throughout their
life cycle (e.g. comparative efficacy studies, real-world patient data, budget modelling) to meet
diverse and stringent payer
evidence requirements
, raising the bar for market entry in many countries.
Despite numerous pricing and reimbursement challenges, payers and regulators remain committed to providing
access to new
innovative therapies
, with greater emphasis on real-world evidence (RWE).
These trends are likely to
continue in the coming year amid economic, political
and geopolitical headwinds
.
United States
The US health insurance system is comprised of commercial insurance and government-provided insurance. Commercial
insurance is offered widely as part of employee benefit packages and is the main source of employee access to subsidized
healthcare. Some individuals purchase private health plans directly or through marketplaces established under the Affordable
Care Act, while publicly subsidized programs provide coverage for retirees, the indigent, the disabled, uninsured children, and
active or retired military personnel. Double coverage can occur.
Commercial insurance includes:
•
Managed Care Organizations (MCOs), which combine the functions of health insurance, delivery of care, and administration.
MCOs use specific provider networks and specific services and products. There are four primary types of managed care plans:
Health Maintenance Organizations (HMOs), Preferred Provider Organizations (PPOs), Exclusive Provider Organizations (EPOs),
and Point of Service (POS) plans; and
•
Pharmacy Benefit Managers (PBMs), which serve as intermediaries between insurance companies, pharmacies and
manufacturers to negotiate rebates and discounts on formulary placement for commercial health plans, self-insured employer
plans, Medicare Part D plans, and federal and state government employee plans.
Government insurance includes:
•
Medicare
, which provides health insurance for retirees and for people with permanent disabilities. The original Medicare
program covers inpatient services through Part A, and outpatient items and services through Part B, and the vast majority of
retirees purchase additional coverage through some or all of Part B (outpatient items and services). Beneficiaries may choose
to enroll in a Medicare Advantage program under Part C in lieu of original Medicare Parts A and B. Beneficiaries under both
original Medicare and Part C may also opt to enroll in a Part D plan to obtain outpatient drug coverage. Almost two-thirds of all
Medicare beneficiaries have enrolled in Part D plans;
•
Medicaid
, which provides health insurance for low-income families, certain qualified pregnant people and children, individuals
receiving supplemental security income, and other eligible persons determined on a state-by-state basis; and
•
TRICARE
, which provides health insurance for uniformed service members, retirees, and their families including
comprehensive healthcare, prescription and dental coverage.
The US is still the largest pharmaceutical market in the world and is expected to grow to nearly $1.09 trillion by 2028.
The US landscape is likely to be driven by two major market dynamics over the next decade: shorter economic lifecycles of eight
years for small molecules and 12 years for biologics, and more restrictive formulary management.
However, the recent change in administration in the US may spark uncertainty for the regulatory landscape, in particular the
Inflation Reduction Act (IRA).
The passage of the IRA, signed into law in August 2022, will exert increased price pressure at launch and throughout the lifecycle
of drugs. The legislation contains three main drug pricing policies which are to be phased between 2022 and 2026: Medicare
drug price negotiation, inflation penalties on list price increases, and Medicare Part D redesign. Importantly, all of the policy
changes enacted under the IRA apply to the coverage of drugs under applicable Medicare Programs: Part B (for physician-
administered outpatient medicines) and Part D (for self-administered medicines), as well as such coverage for beneficiaries
enrolled in Part C.
The most impactful provision in the IRA is the introduction of Medicare price negotiations affecting the prices of drugs with high
budget impact on Medicare Part B and Part D, starting with 10 drugs with high Part D expenditures whose negotiated pricing will
take effect in 2026, up to 15 additional high-expenditure Part D drugs whose pricing will take effect in 2027, and up to 15 more
drugs with high expenditures under Parts Part B and/or Part D whose negotiated pricing will take effect in 2028. From 2029 and
beyond, up to 20 more drugs with high Part B and/or Part D expenditures will be selected for negotiated pricing taking effect
each year. No Sanofi product was selected for the first round of price negotiations which resulted in steep discounts ranging from
60% to 80% of the list price on the selected drugs.
The IRA also imposes inflation penalties applied to Medicare volumes in Medicare Part B and D if prices rise faster than inflation
(based on the consumer price index, CPI), beginning in October 2022 for Part D and January 2023 for Part B.
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Other measures of the IRA redesign the Medicare Part D benefit, including a monthly $35 insulin cap in 2023 and an annual
$2,000 out-of-pocket (OOP) spending cap in 2025 for Medicare beneficiaries.
Altogether, the IRA was initially expected to reduce federal drug spending by about $290 billion through 2031 according to
estimates from the Congressional Budget Office (CBO). The legislation is also likely to have a negative impact on industry revenue
growth and future innovation, although significant uncertainties remain over the process and methods of Medicare price
negotiations.
In addition to the IRA, the industry is exposed to increased price pressure from continuing vertical integration and consolidation
wit
hin the US health insurance market
. With the three largest PBM-owned group purchasing organizations (GPOs) Ascent, Zinc
and Emisar now covering over 85% of US prescription drug claims, consolidation has increased payers’ bargaining power when
negotiating discounted prices, leading to stricter formulary management and a dramatic increase in product exclusions over the
past five years.
Europe
In Europe, economic pressures stemming from rising inflation and slow economic growth are resulting in a heightened focus on
cost-containment across healthcare systems and a growing tension between affordability and innovation.
On April 26 2023, the EC adopted a proposal for a new directive and a new regulation, which represent the largest
pharmaceutical reform in the EU in over 20 years.The revision aims to achieve greater equity of access and use of medicines
across the EU. The package is still under tripartite discussions between the EC, the Parliament and the Council of Member States,
and adoption is unlikely until 2028. The new legislation contains a few components with direct impact on access. The most
concerning draft proposals relate to modulated regulatory data protection and orphan market exclusivity periods; greater
transparency in R&D costs; faster availability of generics and biosimilars; and more stringent obligations for the supply of
medicines. The industry is deeply concerned by the potential detrimental impact of the package on innovation, competitiveness
and patient access across Europe because of weakened intellectual property protection.
Harmonization of EU health technology assessment (HTA) is also intended to address patient access inequalities in Europe, with
official implementation in January 2025. To achieve this, a joint EU HTA process is being implemented in phases, starting with
oncology medicines and advanced therapy medicinal products (ATMPs) from 2025, before expanding to orphan drugs in 2028
and other products in 2030. It will introduce EU-level joint scientific consultations (JSCs) and joint clinical assessments (JCAs)
that will serve as the basis for national value assessments and price negotiations. 25 JCAs are planned to be conducted by the EU
HTA Coordination Group (HTACG) in 2025. While preparations gathered pace in 2024, there are short-term risks and
uncertainties related to the new JCA framework, especially as regards methodologies (i.e. comparators and endpoints), potential
delayed assessments, and the disruption caused to national HTA processes in adopting EU HTA without additional resources. In
addition, the new EU HTA regulation will trigger increased workload and higher evidence requirements at launch, requiring Sanofi
and other manufacturers to adapt their operating models. As countries and companies transition to the new processes, EU-wide
coordination on HTA is anticipated to gain momentum, albeit slower than initially expected.
Another priority of the EC is to secure the uninterrupted supply of medicines in Europe. In 2024 it launched the Critical Medicines
Alliance, paving the way for a possible Critical Medicines Act in the future. To mitigate drug shortages, the EC is pursuing several
actions including reshoring of generics production, compulsory stockpiling, and joint procurement of the most critical medicines.
China
China is pursuing reforms towards "Healthy China 2030".
Healthcare is one of the growth priorities with policies aimed at
addressing a large and increasing burden of disease (especially cancer, diabetes and cardiovascular diseases), while balancing
access to innovation and costs.
China also continues to improve regulatory timelines
. For example, Dupixent received approval for the treatment of adults with
moderate-to-severe AD in June 2020, within six months of filing through an accelerated review process.
Pricing pressure is expected to remain at a high level
as a growing number of products are subject to National Reimbursement
Drug List (NRDL) price negotiations and volume-based procurement (VBP) tenders, with the lowest price prevailing to compete
with local champions.
Access to innovative therapies has been accelerating in the last five years, fueled by annual NRDL updates, albeit with steep price
cuts across therapy areas. According to the National Healthcare Security Administration (NHSA), 91 new drugs were added to the
National Reimbursement Drug List (NRDL) in December 2024, with an average price cut of 63%, the highest level since NRDL
updates began in 2017. More than 70% of successful medicines were developed by Chinese companies, continuing the recent
growth in domestic manufacturers’ share of new entries to the NRDL. Additionally, 38 of the 91 new entries to the NRDL are in
Class 1 where China is the global first-launch market.
Further expansion of the VBP policy will pursue aggressive price cutting of a growing number of products, including biologics,
with more than 500 drugs targeted for inclusion in 2025.
B.6. Patents, intellectual property and other rights
Intellectual property rights are essential to our business because they protect our innovations and investments in research and
development, manufacturing and marketing of our products. Intellectual property rights include patents, trademarks, copyrights,
know‑how, trade secrets and regulatory-based protection.
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Patent protection
We own a broad portfolio of patents, patent applications and patent licenses worldwide. These patents are of various types and
may cover: active ingredients; pharmaceutical formulations; product manufacturing processes; intermediate chemical
compounds; therapeutic indications/methods of use; technology platforms; delivery systems; digital applications; and enabling
technologies, such as assays. Patent protection is considered, in the aggregate, to be of material importance to the marketing
and sales of our products.
Patent protection for individual products typically extends for 20 years from the patent filing date in countries where we seek
patent protection. A substantial part of the 20-year life span of a patent on a new molecule (small molecule or biologic) has
generally already passed by the time the related product obtains marketing authorization. As a result, the effective period of
patent protection for an approved product’s active ingredient is significantly shorter than 20 years. In some cases, the period of
effective protection may be extended by procedures established to compensate regulatory delay in Europe (via Supplementary
Protection Certificate or SPC), in the US (via Patent Term Extension or PTE), and in Japan (PTE).
The protection a patent provides to the related product depends upon the type of patent and its scope of coverage, and may
also vary from country to country.
In Europe, applications for new patents may be submitted to the European Patent Office (EPO). In the US, applications for new
patents may be submitted to the United States Patent and Trademark Office (USPTO).
We monitor our competitors and vigorously seek to challenge patent infringers when such infringement would negatively impact
our business objectives. See “Item 8. — A. Consolidated Financial Statements and Other Financial Information —
Information on
Legal or Arbitration Proceedings — Patents
” of this annual report.
The expiration or loss of a patent covering a new molecule, typically referred to as a compound patent, may result in significant
competition from generic or biosimilar products and can result in a dramatic reduction in sales of the original branded product
(see “Item 3. Key Information — D. Risk Factors”). In some cases, it is possible to continue to benefit from a commercial
advantage through product manufacturing trade secrets or other types of patents. Certain categories of products, such as
traditional vaccines and insulin, were historically relatively less reliant on patent protection and may in many cases have no patent
coverage. It is increasingly frequent for novel vaccines also to be patent protected.
Regulatory exclusivity
In some markets, including the EU and the US, many of our pharmaceutical products may also benefit from multi-year regulatory
exclusivity periods, during which a generic or biosimilar competitor may not rely on our clinical study and safety data in its drug
application. This exclusivity operates independently of patent protection and may protect the product from generic or biosimilar
competition even if there is no patent covering the product.
United States
•
The FDA may not grant final marketing authorization to a generic competitor for a New Chemical Entity (NCE) until the
expiration of the regulatory exclusivity period (five years) that commences upon the first marketing authorization of the
reference listed drug.
•
Significant new uses of existing NCEs, including new indications, may qualify for an additional three years of regulatory
exclusivity if certain conditions are met.
•
For biological drugs, the FDA may not approve a biosimilar application until 12 years after the date on which the reference
product was first licensed.
•
Pediatric extensions are available under certain conditions of the Hatch-Waxman Act by providing data on pediatric studies.
Under such cases the FDA allows for an extension of regulatory exclusivity and patent life by six months, to the extent these
protections have not already expired (the so-called “pediatric exclusivity”).
•
Orphan drug exclusivity may be under certain circumstances to drugs intended to treat rare diseases or conditions.
European Union
•
Regulatory exclusivity is available in two forms: data exclusivity and marketing exclusivity.
•
Generic or biosimilar drug applications will not be accepted for review until eight years after the first marketing authorization
(data exclusivity). This eight-year period is followed by a two-year period during which generics or biosimilars cannot be
marketed (marketing exclusivity).
•
The marketing exclusivity period can be extended to three years if, during the first eight-year period, the marketing
authorization holder obtains an authorization for one or more new therapeutic indications which are deemed to provide a
significant clinical benefit over existing therapies. This is known as the “8+2+1” rule.
•
Pediatric extensions - A regulation on pediatric medicines provides for pediatric research obligations with potential associated
rewards including extension of supplementary patent protection and six-month regulatory exclusivity for pediatric marketing
authorization (for off-patent medicinal products).
•
Orphan drug exclusivities also exist in the EU.
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Japan
•
The regulatory exclusivity period varies, but is generally four to six years for drugs for a specific use, and for medicinal products
with new indications or with new dosages; eight years for drugs containing a new chemical entity; ten years for orphan drugs,
and for new drugs requiring pharmaco-epidemiological study; six to eight years for innovative drugs (“SAKIGAKE” products),
and for orphan drugs with a new ethical combination or new mode of administration; and six years for other medicinal
products, such as new prescription combination drugs or drugs requiring a new mode of administration.
•
There is no pediatric research extension of patent protection for patented medicinal products. However, regulatory exclusivity
may be extended from eight to ten years.
Emerging markets
One of the main limitations on our operations in emerging market countries is the lack of effective intellectual property protection
or enforcement for our products, which frequently do not provide non-patent exclusivity for innovative products. While the
situation has gradually improved, the lack of protection for intellectual property rights or the lack of robust enforcement poses
difficulties in certain countries. Additionally, in recent years a number of countries have waived or threatened to waive intellectual
property protection for specific products, for example through compulsory licensing of generics. See “Item 3. Key Information —
D. Risk Factors — Risks Relating to Sanofi’s Structure and Strategy — The globalization of our business exposes us to increased
risks in specific areas”.
Product and patent overview
We summarize in the table below the intellectual property coverage (in some cases through licenses) of our most significant
marketed products in terms of sales, in our major markets. In the discussion of patents below, we focus on active ingredient
patents (compound patents) and, in the case of NCEs, on any later filed patents listed as applicable in the FDA’s list of Approved
Drug Products with Therapeutic Equivalence Evaluations (the “Orange Book”) or in its foreign equivalents. For biologics, the
Orange Book listing does not apply.
The table provides a list of expiration dates, which include six-month pediatric extensions when applicable, and when indicated,
extensions due to Patent Term Adjustment (PTA) or other regulatory delays. Where patent terms have expired we indicate such
information and mention whether generics or biosimilars are on the market.
We do not provide later filed patent information relating to formulations already available as an unlicensed generic. References
below to patent protection in Europe indicate the existence of relevant patents in most major markets in the EU. Specific
situations may vary by country.
We additionally set out any regulatory exclusivity from which these products continue to benefit in the EU, US or Japan.
Regulatory exclusivities presented below incorporate any pediatric extensions obtained. While EU regulatory exclusivity is
intended to be applied throughout the EU, in some cases Member States have taken positions prejudicial to our exclusivity rights.
|
United States
|
European Union
|
Japan
|
|
|
Dupixent
|
Compound: March 2031 with PTE*
|
Compound: September 2032 with SPC*
(March 2033 with pediatric extension of
SPC* in process of being granted across
EU countries)
|
Compound: May 2034 with PTE*
|
|
Later filed patents: coverage ranging
through March 2044 (pending)
|
Later filed patents: coverage ranging
through December 2043 (pending)
|
Later filed patents: coverage ranging
through October 2042 (pending)
|
|
|
Regulatory exclusivity: March 2029
|
Regulatory exclusivity: September 2028
|
Regulatory exclusivity: January 2026
|
|
|
Toujeo
|
Compound: expired
|
Compound: expired
|
Compound: expired
|
|
Later filed patents: coverage ranging
through May 2031
|
Later filed patents: coverage ranging
through May 2031
|
Later filed patents: coverage ranging
through July 2033 with PTE*
|
|
|
Lantus
|
Compound: expired
|
Compound: expired
|
Compound: expired
|
|
Generics/biosimilars on the market
|
Generics/biosimilars on the market
|
Generics/biosimilars on the market
|
|
|
Lovenox
|
Compound: expired
|
Compound: expired
|
Compound: expired
|
|
Generics on the market
|
Biosimilars on the market
|
||
|
Plavix
|
Compound: expired
|
Compound: expired
|
Compound: expired
|
|
Generics on the market
|
Generics on the market
|
Generics on the market
|
|
|
Fabrazyme
|
Patent: expired
|
Patent: expired
|
Patent: expired
|
|
Regulatory exclusivity: March 2028
pediatric indication (ages 2-8 with
confirmed Fabry disease)
|
Generics/biosimilars on the market
|
||
|
Myozyme
|
Compound: expired
|
Compound: expired
|
Compound: expired
|
|
Alprolix
|
Use: December 2027 with PTE*
|
Compound: May 2029 with SPC* in most
EU countries
|
Compound: February 2026 with PTE*
|
|
Later filed patents: coverage ranging
through April 2039 (pending)
|
Later filed patents: coverage ranging
through December 2037 (pending)
|
Later filed patents: coverage ranging
through December 2037 (pending)
|
|
|
Regulatory exclusivity: March 2026
|
Regulatory exclusivity: May 2028
|
||
|
Cerezyme
|
Patent: expired
|
Patent: expired
|
Patent: expired
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United States
|
European Union
|
Japan
|
|
|
Aubagio
|
Compound: expired
|
Compound: expired
|
Compound: expired
|
|
Later filed patent: coverage ranging
through April 2027 with SPC*
|
|||
|
Generics on the market
|
Generics on the market
|
||
|
NEW LAUNCHES
|
|||
|
Nexviazyme/
Nexviadyme
|
Compound: March 2030 with PTA* (PTE*
pending)
|
Compound: January 2028 (SPC* in process
of being granted across EU countries)
|
Compound: December 2032 with PTE*
|
|
Later filed patents: coverage ranging
through May 2032
|
Later filed patents: coverage ranging
through May 2032
|
Later filed patents: coverage ranging
through December 2029
|
|
|
Regulatory exclusivity: pending
|
Regulatory exclusivity: no (a)
|
Regulatory exclusivity: September 2031
|
|
|
Sarclisa
|
Compound: October 2032 with PTA* and
PTE*
|
Compound: October 2032 with SPC*
|
Compound: October 2032 with PTE*
|
|
Later filed patents: coverage ranging
through November 2041 (pending)
|
Later filed patents: coverage ranging
through November 2041 (pending)
|
Later filed patents: coverage ranging
through November 2041 (pending)
|
|
|
Regulatory exclusivity: March 2032
|
Regulatory exclusivity: May 2030
|
Regulatory exclusivity: June 2028
|
|
|
ALTUVIIIO
|
Compound: February 2037 with PTA*
(PTE* pending)
|
Compound: January 9, 2035 (SPC*
pending)
|
Compound: January 9, 2035 (PTE*
pending)
|
|
Later filed patents: coverage ranging
through March 2043 (pending)
|
Later filed patents: coverage ranging
through March 2043 (pending)
|
Later filed patents: coverage ranging
through March 2043 (pending)
|
|
|
Regulatory exclusivity: February 2035
|
Regulatory exclusivity: June 2034
|
Regulatory exclusivity: September 2031
|
|
|
Rezurock
|
Compound : October 2029 with PTA*
(PTE* pending)
|
N/A
|
Compound : March 2026 (PTE* pending)
|
|
Later filed patents : coverage ranging
through July 2042
|
Later filed patents : October 2033 (PTE*
pending)
|
||
|
Regulatory exclusivity: July 2028
|
Regulatory exclusivity: March 2034
|
||
|
Cablivi
|
Compound: August 2027 with PTA* (PTE*
pending)
|
Compound: May 2031 with SPC* in most
EU countries
|
Compound: May 2031 with PTE*
|
|
Later filed patents: coverage ranging
through 2039
|
Later filed patents: coverage ranging
through 2039 (pending)
|
Later filed patents: coverage ranging
through 2039 (pending)
|
|
|
Regulatory exclusivity: Feb. 2031
|
Regulatory exclusivity: Sep. 2030
|
Regulatory exclusivity: Sep. 2032
|
|
|
Xenpozyme
|
Use: March 2031 with PTA* (PTE* pending)
|
Use: August 2030 (SPC* in process of
being granted across EU countries)
|
Use: August 2030 (PTE* pending)
|
|
Later filed patents: coverage ranging
through 2043 (pending)
|
Later filed patents: coverage ranging
through 2043 (pending)
|
Later filed patents: coverage ranging
through 2043 (pending)
|
|
|
Regulatory exclusivity: August 2034
|
Regulatory exclusivity: June 2032
|
Regulatory exclusivity: March 2030
|
|
|
Tzield
|
Compound : Expired
|
N/A
|
N/A
|
|
Later filed patents : coverage ranging
through May 2043 (pending)
|
|||
|
Regulatory exclusivity: November 2034
|
|||
|
Beyfortus
|
Compound: January 2035 (PTE* pending)
|
Compound: January 2035 (SPC* in process
of being granted across EU countries)
|
Compound: January 2035 (PTE* pending)
|
|
Later filed patent: coverage ranging
through September 2042 (pending)
|
Later filed patent: coverage ranging
through September 2042 (pending)
|
Later filed patent: coverage ranging
through September 2042 (pending)
|
|
|
Regulatory exclusivity: July 2035
|
Regulatory exclusivity: November 2032
|
Regulatory exclusivity: March 2032
|
|
*
PTE: Patent Term Extension. – SPC: Supplementary Protection Certificate. – PTA: Patent Term Adjustment.
(a)
Subject to legal challenge before EU General Court.
Third-party patents and challenges to intellectual property
Patents held or licensed by Sanofi do not in all cases provide effective protection against a competitor’s generic or biosimilar
version of our products. For example, notwithstanding the presence of unexpired patents, competitors launched generic versions
of Allegra in the US (prior to the product being switched to over-the-counter status) and Multaq in the EU.
We caution the reader that there can be no assurance that we will prevail when we assert a patent in litigation and that there may be
instances in which Sanofi determines that it does not have a sufficient basis to assert one or more of the patents mentioned in this
report, for example in cases where a competitor proposes a formulation not appearing to fall within the claims of our formulation
patent; a salt or crystalline form not claimed by our composition of matter patent; or an indication not covered by our method of use
patent. See “Item 3. Key Information — D. Risk Factors — Risks Relating to Legal and Regulatory Matters — We rely on our patents
and other proprietary rights to provide exclusive rights to market certain of our products, and if such patents and other rights were
limited, invalidated or circumvented, our financial results could be materially and adversely affected.” As disclosed in Item 8. of this
annual report, we are involved in significant litigation concerning the patent protection of a number of our products.
In addition to directly challenging our intellectual property rights, in some circumstances a competitor may be able to market a
generic version of one of our products.
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In the US, competitor generic companies can challenge patents by filing Abbreviated New Drug Applications (ANDAs) to receive
authority to market a generic version of our approved products, by demonstrating that the purportedly generic version has the
same properties (safety and other technical data) as the original approved product. Our products and patents are also subject to
challenge by under section 505(b)(2) of the US Federal Food, Drug, and Cosmetic Act, which allows for approval for a wide range
of products, especially for those products that represent only a limited change from an existing approved drug.
Similarly, entities wishing to market a generic biologic can utilize an abbreviated approval pathway established in the PHS Act.
This §351(k) pathway enables an applicant to rely on a reference product sponsor’s data when seeking approval of a biological
product shown to be biosimilar (highly similar with no clinically meaningful differences) or interchangeable with an FDA-licensed
reference BLA product. See also “— B.5.3. Regulatory Framework” above.
In the EU, a generic drug manufacturer may only reference the data of the regulatory file for the original approved product after
data exclusivity has expired. Generic products may be approved for marketing following the expiration of marketing exclusivity
without regard to the patent holder’s rights. Nevertheless, in most of these jurisdictions once the competing product is launched,
and in some jurisdictions even prior to launch (once launch is imminent), the patent holder may seek an injunction against such
marketing if it believes its patents are infringed. See Item 8. of this annual report.
We seek to defend our patent rights vigorously in these cases. Success or failure in the assertion of a given patent against a
competing product is not necessarily predictive of the future success or failure in the assertion of the same patent. See “Item 3.
Key Information — D. Risk Factors — Risks Relating to Legal and Regulatory Matters — We rely on our patents and other
proprietary rights to provide exclusive rights to market certain of our products, and if such patents and other rights were limited,
invalidated or circumvented, our financial results could be materially and adversely affected.”
B.7. Production and raw materials
We have opted to manufacture the majority of our products in-house. There are three principal stages in our production process:
the manufacture of active ingredients, the transformation of those ingredients into drug products or vaccines, and the final
packaging.
Our general policy is to produce our key active ingredients and main drug products at our own plants
in order to reduce our
dependence on external suppliers. We also rely on third parties for the manufacture and supply of specific active ingredients,
drug products and medical devices. Active ingredients are manufactured using raw materials sourced from suppliers who have
been subject to rigorous selection and approval procedures, in accordance with international standards and our own internal
directives. We have outsourced some of our production under supply contracts associated with acquisitions of products or
businesses or with Sanofi plant divestitures, or to establish a local presence to capitalize on growth in emerging markets. Our
pharmaceutical subcontractors follow our general quality and logistics policies, as well as meeting other criteria.
Our manufacturing activities require significant amounts of energy, the costs of which increased in
2022 and 2023
as a result of
inflationary pressures and supply constraints due to the war in Ukraine. The Group uses supply contracts and hedging to mitigate
those risks and costs. See “Item 3. Key Information — D. Risk Factors — Risks Relating to Our Business.”
We also obtain active ingredients from third parties under collaboration agreements. This applies in particular to the monoclonal
antibodies developed with
Regeneron
.
Our production sites are divided into three categories:
•
global sites, which serve all markets: located mainly in Europe, these facilities are dedicated to the manufacture of our
active
ingredients
, injectable products, and a number of our main solid-form products;
•
regional sites, which serve markets at regional level, giving us a strong industrial presence in emerging markets; and
•
local sites, which serve their domestic market only.
Vaccines produces vaccines at various sites, with the main locations situated in France, the United States, Canada, India, Mexico
and China. The pharmaceutical site at Le Trait (France) also contributes to Vaccines’ industrial operations by making its sterile
filling facilities available for vaccine manufacturing.
All of our production facilities are good manufacturing practice (GMP) compliant, in line with international regulations.
Our main sites are approved by the FDA:
•
the Specialty Care facilities in the United States (Framingham MA and Northborough MA), France (Lyon Gerland, Vitry-sur-
Seine, Le Trait), Germany (Frankfurt), Ireland (Waterford) and Belgium (Geel);
•
the General Medicines facilities in Germany (Frankfurt), France (Aramon, Sisteron, Ploermel, Ambarès and Tours), Italy (Anagni
and Scoppito), Singapore (Jurong) and the United States (Ridgefield NJ);
•
the Vaccines facilities in France (Marcy l’Étoile, Le Trait, Val-de-Reuil and Neuville-sur-Saône), the United States (Swiftwater
PA) and Canada (Toronto); and
•
the Opella facilities in France (Compiègne) and the United States (Chattanooga TN).
Wherever possible, we seek to have multiple plants approved for the production of key active ingredients and our strategic
finished products (this is the case with Lovenox and Dupixent, for example).
More details about our manufacturing sites are given below at section “— D. Property, Plant and Equipment”.
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B.8. Insurance and risk coverage
We are protected by five main insurance programs, relying not only on the traditional corporate insurance and reinsurance
market but also on our direct insurance company, Carraig Insurance DAC (Carraig).
These five key programs cover Property & Business Interruption; General & Product Liability; Stock & Transit; loss and liability
arising from cyber and digital risks; and Directors & Officers Liability.
Carraig participates in our coverage for various lines of insurance including Property, Stock & Transit, Cyber/Digital, and General
& Product Liability. Carraig is run under the supervision of the Irish and European regulatory authorities, is wholly owned by
Sanofi, and has sufficient resources to meet those portions of our risks that it has agreed to cover.
Carraig sets premiums for our entities at market rates. Claims are assessed using the traditional models applied by insurance and
reinsurance companies, and Sanofi's reserves are regularly verified and confirmed by independent actuaries.
Our Property & Business Interruption program covers all our entities worldwide, in all territories where it is possible to use a
centralized program operated by Carraig. By sharing risk between our entities, this approach enables us to set deductibles and
cover appropriate to the needs of local entities before the market attachment point. It also incorporates a prevention program,
including a comprehensive site visit schedule covering our production, storage, research and distribution facilities and
standardized repair and maintenance procedures across all sites.
The Stock & Transit program protects all goods owned by Sanofi while they are in transit nationally or internationally, whatever
the means of transport, and all our inventories wherever they are located. Sharing risk between our entities through Carraig
means that we can set deductibles at appropriate levels, for instance differentiating between goods that require temperature
controlled distribution and those that do not. We have developed a prevention program with assistance from experts,
implementing best practices in this area at our distribution sites.
Our Cyber/Digital insurance program protects our operations against loss originating from various sources, and against liability in
respect of data security. Centralized through Carraig, the program enables us to set deductibles and cover appropriate to the
needs of local entities before the market attachment point.
Our General & Product Liability program was renewed in 2024 for all our subsidiaries worldwide in all territories where it was
possible to do so. For several years, insurers have been reducing product liability coverage because of the difficulty of
transferring risk for some products that have been subject to numerous claims.
The principal risk exposure for our pharmaceutical products is covered with low deductibles at country level, with a greater
proportion of risk being retained. The level of risk self-insured by Sanofi (including via Carraig) before the market attachment
point enables us to retain control over the management and prevention of risk. Our negotiations with third-party insurers and
reinsurers are tailored to our specific risks. In particular, they allow for differential treatment of products in the development
phase, for discrepancies in risk exposure between European countries and the United States and for specific issues arising in
certain jurisdictions. Coverage is adjusted every year to take account of the relative weight of new product liability risks such as
those arising out of biotechnologies and new technology platforms.
Our coverage for risks that are not specific to the pharma-biotech industry (general liability) is designed to address the potential
impacts of our operations.
For all the insurance programs handled by Carraig, outstanding claims are covered by provisions for the estimated cost of settling
all claims incurred but not paid at the balance sheet date, whether reported or not, together with all related claims handling
expenses. Where there is sufficient data history from Sanofi or from the market for claims made and settled, management – with
assistance from independent actuaries – prepares an actuarial estimate of our exposure to unreported claims for the risks
covered. The actuaries perform an actuarial valuation of the company’s Incurred But Not Reported (IBNR) and Allocated Loss
Adjustment Expense (ALAE) liabilities at year end. Two ultimate loss projections (based upon reported losses and paid losses,
respectively) are computed each year using various actuarial methods including the Bornhuetter-Ferguson method; those
projections form the basis for the provisions set.
The Directors & Officers Liability program protects all legal entities under our control, and their directors and officers. Carraig is
not involved in this program.
We also operate other insurance programs, but these are of much lesser importance than those described above.
All our insurance programs are backed by highly-rated insurers and reinsurers and are intended to be designed in such a way that
we can integrate most newly acquired businesses without interruption of cover. Our insurance coverage has been designed to
reflect our risk profile and the capacity available in the insurance market. By centralizing our major programs, we are able to
provide what we believe to be excellent, cost effective protection
.
B.9. Health, Safety and Environment
Our manufacturing and research operations are subject to increasingly stringent health, safety and environmental (HSE) laws and
regulations. These laws and regulations are complex and rapidly changing, and Sanofi invests the necessary sums in order to
comply with them. This investment, which aims to respect HSE matters, varies from year to year.
Applicable environmental laws and regulations may require us to eliminate or reduce the effects of chemical substance discharge
at our various sites. The sites in question may belong to Sanofi, and may be currently operational, or may have been owned or
operational in the past. In this regard, Sanofi may be held liable for the costs of removal or remediation of hazardous substances
on, under or in the sites concerned, or on sites where waste from activities has been stored, without regard to whether the owner
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or operator knew of or under certain circumstances caused the presence of the contaminants, or at the time site operations
occurred the discharge of those substances was authorized.
As is the case for a number of companies in the pharmaceutical, chemical and intense agrochemical industries, soil and
groundwater contamination has occurred at some of our sites in the past, and may still occur or be discovered at others. In
Sanofi’s case, such sites are mainly located in the United States, Germany and France. As part of a program of environmental
surveys conducted over the last few years, detailed assessments of the risk of soil and groundwater contamination have been
carried out at current and former Sanofi sites. In cooperation with national and local authorities, Sanofi regularly assesses the
rehabilitation work required and carries out such work when appropriate. Remediation works have just been completed at
Neuville in France. Long-term rehabilitation work is in progress or planned in Mount Pleasant, Portland in the United States;
Frankfurt in Germany; Valernes, Septèmes and Limay in France; and on a number of sites divested to third parties and covered by
contractual environmental guarantees granted by Sanofi.
We may also have potential liability for investigation and cleanup at several other sites. We have established provisions for the
sites already identified and to cover contractual guarantees for environmental liabilities for sites that have been divested. In
France specifically, we have provided the financial guarantees to the authorities as required under French regulations for
environmental protection in connection with the operation of activities on French sites.
Potential environmental contingencies arising from certain business divestitures are described in Note D.22.d. to the consolidated
financial statements. In
2024
, Sanofi spent €35 million on rehabilitating sites previously contaminated by soil or groundwater
pollution.
Due to changes in environmental regulations governing site remediation, our provisions for remediation obligations may not be
adequate due to the multiple factors involved, such as the complexity of operational or previously operational sites, the nature of
claims received, the remediation techniques involved, the planned timetable for rehabilitation, and the outcome of discussions
with national regulatory authorities or other potentially responsible parties, as in the case of multiparty sites. Given the long
industrial history of some of our sites and the legacy obligations arising from the past involvement of Aventis in the chemical and
agrochemical industries, it is impossible to quantify the future impact of these laws and regulations with precision.
See “Item 3.D. Risk Factors — Environmental and safety risks of Our Industrial Activities.”
We have established, in accordance with our current knowledge and projections, provisions for cases already identified and to
cover contractual guarantees for environmental liabilities relating to sites that have been divested. In accordance with
Sanofi standards, a comprehensive review is carried out once a year on the legacy of environmental pollution. In light of
data collected during this review, we adjusted our provisions to €
474
million as of
December 31, 2024
versus €
493
million as
of
December 31, 2023
. The terms of certain business divestitures, and the environmental obligations and retained environmental
liabilities relating thereto, are described in Note D.22. to our consolidated financial statements.
To our knowledge, Sanofi did not incur any liability in
2024
for non-compliance with current HSE laws and regulations that could
be expected to significantly jeopardize its activities, financial situation or operating income. We also believe that we are in
substantial compliance with current HSE laws and regulations and that all the environmental permits required to operate our
facilities have been obtained.
Regular HSE audits are carried out by Sanofi in order to assess compliance with standards (which implies compliance with
regulations) and to initiate corrective measures (19 internal audits performed in
2024
). Moreover, more than 100 specific visits
were performed jointly with experts representing our insurers.
Sanofi has implemented a worldwide master policy on HSE to promote the health and well-being of the employees and
contractors working on its sites and respect for the environment. We consider this master policy to be an integral part of our
commitment to social responsibility. In order to implement this master policy, Sanofi key requirements have been drawn up in the
key fields of HSE management, HSE leadership, safety in the workplace, process safety, occupational hygiene, health in the
workplace and protection of the environment. However, despite these efforts, Sanofi may be unsuccessful in the implementation
of its policy to reduce and mitigate the harmful effects of its activities on the health and safety of its employees, customers or the
general public and on the environment more generally. See “Item 3. Key information — D. Risk Factors” for further information.
Health
From the development of compounds to the commercial launch of new drugs, Sanofi research scientists continuously assess the
effect of products on human health. This expertise is made available to employees through two committees responsible for
chemical and biological risk assessment. Sanofi’s COVALIS
(Comité des Valeurs Limites Internes Sanofi)
Committee is responsible
for the hazard determination and classification of all API and synthesis intermediates handled at Sanofi facilities. This covers all
active ingredients handled in production at company sites or in processes sub-contracted for manufacture. Any important issues
involving raw materials or other substances that lack established occupational exposure limits may also be reviewed. The
COVALIS Committee determines the occupational exposure limits required within Sanofi. Our TRIBIO Committee is responsible
for classifying all biological agents according to their degree of pathogenicity, and applies rules for their containment and the
preventive measures to be respected throughout Sanofi. See “Item 3. Key Information — D. Risk Factors — Environmental and
safety risks of our industrial activities — Risks from manufacturing activities and the handling of hazardous materials could
adversely affect our results of operations and reputation.”
Appropriate occupational hygiene practices and programs are defined and implemented in each site. These practices consist
essentially of containment measures for collective and individual protection against chemical and biological exposure in all
workplaces where chemical substances or biological agents are handled. All personnel are monitored with an appropriate medical
surveillance program, based on the results of professional risk evaluations linked to their duties.
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In addition, dedicated resources have been created to implement the European Regulation on Registration, Evaluation,
Authorization and Restriction of Chemicals (REACH) and the European Regulation on Classification, Labeling and Packaging of
chemicals (CLP). To fully comply with REACH, Sanofi has registered the relevant hazardous chemical substances with the
European Chemicals Agency (ECHA).
While these measures focus on managing chemical and biological risks, Sanofi's commitment to employee well-being extends
beyond safety protocols. Through the All Well program, Sanofi offers comprehensive health and wellbeing support to all its
employees. This program provides various global and local resources to promote healthy nutrition, physical activity, vaccination,
and health checkups, as well as a Global Employee Assistance Program, ensuring a holistic approach to employee health and
safety.
Safety
Sanofi has rigorous policies to identify and evaluate safety risks and to develop preventive safety measures, and methods for
checking their efficacy. Additionally, Sanofi invests in training that is designed to instill in all employees a sense of concern for
safety, regardless of their duties. These policies are implemented on a worldwide scale to ensure the safety of all employees and
to protect their health. Each project, whether in research, development or manufacturing, is subject to evaluation procedures,
incorporating the chemical substance and process data communicated by the COVALIS and TRIBIO Committees described
above. The preventive measures are designed primarily to reduce the number and seriousness of work accidents and to minimize
exposures involving permanent and temporary Sanofi employees as well as our sub-contractors.
The French chemical manufacturing sites in Aramon and Sisteron are listed Seveso III (from the name of the European directive
that deals with potentially dangerous establishments where dangerous substances may be present in quantities exceeding
certain thresholds to prevent major accidents and limit their consequences). In accordance with French law on technological risk
prevention, the French sites are also subject to heightened security inspections due to the toxic or flammable materials stored on
the sites and used in the operating processes.
Risk assessments of processes and installations are drawn up according to standards and internal guidelines incorporating the
best state of the art benchmarks for the industry. These assessments are used to fulfill regulatory requirements and are regularly
updated. Particular attention is paid to any risk-generating changes such as process or installation changes, as well as changes in
production scale and transfers between industrial or research units.
We are using specialized process safety-testing laboratories that
are fully integrated into our chemical development activities
,
apply methods to obtain the physico-chemical parameters of manufactured chemical substances (intermediate chemical
compounds) and apply models to measure the effect of potentially leachable substances in the event of a major accident. In
these laboratories the parameters for qualifying hazardous reactions are also determined, in order to define scale-up process
conditions while transferring from development stage to industrial scale. We use these data to enhance the relevance of our risk
assessments.
We believe that the safety management systems implemented at each site, the hazard studies carried out and the risk
management methods implemented, as well as our third-party property insurance policies covering any third-party physical
damage, are consistent with legal requirements and the best practices in the industry, although no guarantee can be given that
they will prevent accidents of various kinds.
We have also designed
a new Global Safety Culture program — “Leading Safety” — to help protect the health and safety of our
employees, contractors and communities. It is based on five positive performance drivers: strengthen safety leadership; focus on
key risks; increase managerial skills; improve safety barriers and the effectiveness of controls; and increase reports of unsafe acts
& hazardous conditions.
Environment
Beyond healthcare, we have taken steps to address the environmental impacts of our products and activities and to help
strengthen our resilience in the face of environmental changes. We have identified six major environmental challenges relating to
our businesses: greenhouse gas emissions and climate disruption; eco-design; water; pharmaceuticals in the environment; waste;
and biodiversity.
We have been implementing environmental initiatives since 2010. More recently, we established the Planet Care program, which
seeks to address environmental impacts across the value chain.
We have also taken measures to seek to reduce our greenhouse gas emissions and pursue more sustainable water resource
management, especially at sites which are under hydric stress, and have set both medium-term and long-term targets. See
“Cautionary statement regarding forward-looking statements” and “Item 3.D. Risk Factors.”
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ITEM 4. Information on the Company
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C. Organizational Structure
C.1. Significant Subsidiaries
Sanofi is the holding company of a consolidated group consisting of almost
260
companies.
The principal companies in the
Sanofi group as of
December 31, 2024
is provided in Note F. to our consolidated financial statements, included in Item 18. of this
annual report.
Since 2009, we have transformed Sanofi through numerous acquisitions and divestments, in particular the acquisitions of
Genzyme in April 2011, Boehringer Ingelheim (BI) Consumer Healthcare in January 2017
(mainly through an asset purchase)
,
Bioverativ in March 2018, Ablynx in June 2018, Synthorx in January 2020, Principia in September 2020, Kymab in April 2021,
Translate Bio in September 2021, and Amunix Pharmaceuticals, Inc in February 2022; the deconsolidation of EUROAPI in
May 2022, the acquisitions of Provention Bio, Inc. QRIB Intermediate Holdings, LLC. in 2023; and the acquisitions of Inhibrx, Inc in
2024; and the sale of Opella, expected to close in the second quarter of 2025 at the earliest (
for a description of the main such
events over the past three years, refer to “A. History and Development of the Company” above)
.
In certain countries, we carry on some of our business operations through joint ventures with local partners. In addition, we have
entered into worldwide collaboration agreements, in particular with Regeneron on Dupixent and Kevzara
and with AztraZeneca
on Beyfortus. For further information, refer to Note C. “Principal Alliances” to our consolidated financial statements, included at
Item 18. of this annual report.
C.2. Internal organization of activities
Sanofi and its subsidiaries collectively form a group organized around a Biopharma operating segment (Immunology &
Inflammation, Rare diseases, Neurology, Oncology, Other medicines, Vaccines). Opella, our former Consumer Healthcare
operating segment, is now classified as a discontinued operation in accordance with IFRS 5. See “Item 5. Operating and Financial
Review and Prospects — A.1.1. 2024 Overview”.
Within Sanofi, responsibility for R&D rests with Sanofi and Genzyme Corporation for medicines, and with Sanofi Pasteur and
Sanofi Pasteur, Inc.
for vaccines
.
However, within our integrated R&D organization, strategic priorities are set and R&D efforts
coordinated on a worldwide scale. In fulfilling their role in R&D, the aforementioned companies subcontract R&D to those of their
subsidiaries that have the necessary resources. They also license patents, manufacturing know-how and trademarks to certain of
their French and foreign subsidiaries. Those licensee subsidiaries manufacture, commercialize and distribute the majority of our
products, either directly or via local distribution entities.
Our industrial property rights, patents and trademarks are mainly held by the following companies:
•
Biopharma: Sanofi, Sanofi Mature IP, Sanofi Biotechnology SAS (France), Sanofi-Aventis Deutschland GmbH (Germany),
Ablynx (Belgium), Genzyme Corporation, Bioverativ Inc., Kadmon
Corporation LLC
, Amunix Pharmaceuticals, Inc., Kymab Ltd,
Principia Biopharma Inc., Sanofi Pasteur (France), Sanofi Pasteur, Inc. (US),
Sanofi Pasteur Vaxdesign Corp.,
Translate Bio (US),
Synthorx, Inc., Aventis Pharma SA
and
Provention Bio, Inc.
;
•
Opella: A. Nattermann Cie & GmbH (Germany), Chattem Inc. (US), Opella Healthcare and SSP Co. Ltd (Japan), which are now
part of Sanofi’s discontinued operations (see “Item 5. Operating and Financial Review and Prospects — A.1.1. 2024 Overview”).
For a description of our principal items of property, plant and equipment, see “— D. Property, Plant and Equipment” below. Our
property, plant and equipment is held mainly by the following companies:
•
in France: Sanofi Pasteur SA, Sanofi Winthrop Industrie, Opella Healthcare International SAS and Sanofi-Aventis Recherche &
Développement;
•
in the United States: Sanofi Pasteur, Inc., Genzyme Therapeutics Products LP, Genzyme Corporation and Translate Bio;
•
in Germany: Sanofi-Aventis Deutschland GmbH;
•
in Canada: Sanofi Pasteur Limited;
•
in Belgium: Genzyme Flanders BVBA; and
•
in Ireland: Genzyme Ireland Limited.
C.3. Financing and financial relationships between group companies
The Sanofi parent company raises the bulk of the Company’s external financing and uses the funds raised to meet, directly or
indirectly, the financing needs of its subsidiaries. The parent company operates a cash pooling arrangement under which any
surplus cash held by subsidiaries is managed centrally. There is also a centralized foreign exchange risk management system in
place, whereby the parent company contracts hedges to meet the needs of its principal subsidiaries.
Consequently, at
December 31, 2024
, the Sanofi parent company held 91% of our external financing and 77% of our surplus cash.
In addition, the Sanofi parent company, plus the wholly-owned Sanofi subsidiaries Sanofi European Treasury Center SA (SETC)
and/or Genzyme Ireland Limited, provide financing and certain financial services to Sanofi subsidiaries.
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D. Property, Plant and Equipment
D.1. Overview
Our headquarters are located in Paris, France.
We operate our business through office premises and research, production and logistics facilities in approximately
70
countries
around the world. Our office premises house all of our support functions, plus operational representatives from our subsidiaries
and the Company.
A breakdown of our sites by use and by ownership status (owned versus leasehold) is provided below. This breakdown is based on
surface area. All surface area figures are unaudited.
|
Breakdown of sites by use
|
Breakdown of sites by ownership status
|
|||
|
Industrial
|
59%
|
Leasehold
|
26%
|
|
|
Research
|
13%
|
Owned
|
74%
|
|
|
Offices
|
13%
|
|||
|
Logistics
|
9%
|
|||
|
Other
|
6%
|
|||
D.2. Description of our sites
Sanofi industrial sites
As part of the process of transforming Sanofi and creating Global Business Units, we are continuing to adapt the organization of
the Manufacturing & Supply department in support of our new business model.
The Manufacturing & Supply department focuses on customer needs and service quality; the sharing of “Sanofi Manufacturing
System” good manufacturing practices; and the development of a common culture committed to quality.
The organizational structure of Manufacturing & Supply is aligned on our corporate structure and our four Global Business Units:
Specialty Care, General Medicines, Vaccines and Opella, which is now part of Sanofi’s discontinued operations (see “Item 5.
Operating and Financial Review and Prospects — A.1.1. 2024 Overview”).
The Manufacturing & Supply department is also responsible for Sanofi Global HSE and Global Supply Chain.
At the end of
2024
, we were carrying out industrial production at
52
sites in
24
countries:
•
8
sites for our Specialty Care operations;
•
21
sites for our General Medicines operations;
•
9
sites for the industrial operations of Vaccines; and
•
13
sites for our Opella operations, which are now part of Sanofi’s discontinued operations (see “Item 5. Operating and Financial
Review and Prospects — A.1.1. 2024 Overview”).
The quantity of units sold in
2024
, including in-house and outsourced production, was
4.2
billion. This comprised:
•
Biopharma:
2.1
billion units; and
•
Opella:
2.1
billion units.
We believe that our production facilities are in compliance with all material regulatory requirements, are properly maintained and
are generally suitable for future needs. We regularly inspect and evaluate those facilities with regard to environmental, health,
safety and security matters, quality compliance and capacity utilization. For more information about our property, plant and
equipment, see Note D.3. to our consolidated financial statements, included at Item 18. of this annual report, and
section “B.7. Production and Raw Materials” above.
Our main production sites by volume are:
•
Le Trait (France), Frankfurt (Germany), Waterford (Ireland), Geel (Belgium) and Framingham (United States) for Specialty Care;
•
Aramon, Sisteron and Ambarès (France), Frankfurt (Germany), Csanyikvölgy (Hungary), Lüleburgaz (Turkey), Campinas (Brazil),
Jurong (Singapore) and Hangzhou (China) for General Medicines products;
•
Marcy-l’Étoile and Val-de-Reuil (France), Toronto (Canada) and Swiftwater (United States) for vaccines; and
•
Compiègne and Lisieux (France), Cologne (Germany), Origgio (Italy), Chattanooga (United States) and Ocoyoacac (Mexico) for
Opella products, now part of Sanofi’s discontinued operations (see “Item 5. Operating and Financial Review and Prospects —
A.1.1. 2024 Overview”).
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Research & Development sites
In Pharmaceuticals, research and development activities are conducted at the following sites:
•
two operational sites in France: Montpellier and Vitry-sur-Seine/Alfortville;
•
two sites in the rest of Europe (Germany and Belgium), the larger of which is in Frankfurt (Germany);
•
three sites in the United States: Bridgewater, Cambridge and Framingham/Waltham ; and
•
three sites in China (Beijing, Shanghai and Chengdu).
In Vaccines, research and development activities are conducted at the following sites :
•
Swiftwater, Cambridge and Orlando (United States);
•
Marcy-l’Étoile/Lyon (France); and
•
Toronto (Canada).
D.3. Acquisitions, capital expenditures and divestitures
The carrying amount of our property, plant and equipment at
December 31, 2024
was €
10,091
million. During
2024
, we
invested €
1,717
million (see Note D.3. to our consolidated financial statements, included at Item 18. of this annual report), mainly
in increasing capacity and improving productivity at our various production and R&D sites.
Our principal acquisitions, capital expenditures and divestitures in
2022
,
2023
and
2024
are described in Notes D.1. & D.2.
(“Changes in the scope of consolidation”), D.3. (“Property, plant and equipment”) and D.4. (“Goodwill and other intangible
assets”) to our consolidated financial statements, included at Item 18. of this annual report. For associated commitments, and
in particular future contingent milestone payments, refer to Notes D.18 and D.21. to our consolidated financial statements,
which provide disclosures about liabilities related to business combinations and our principal research and development
collaboration agreements, respectively.
As of
December 31, 2024
, our firm commitments in respect of future capital expenditures amounted to €
422
million. The
principal locations involved are: for medicines, the industrial facilities at Frankfurt (Germany); Le Trait, Maisons-Alfort,
Compiègne, and Ambares (France); Cambridge (United States); Geel (Belgium); Origgio, Anagni, Brindisi and Scoppito (Italy);
and for vaccines, the facilities at Swiftwater (United States); Toronto (Canada); Marcy-l’Étoile, Neuville-sur-Saône and Val-de-
Reuil (France); and Singapore.
In the medium term and assuming no changes in the scope of consolidation, we expect to invest on average approximately
€1.5 billion a year in property, plant and equipment. We believe that our own cash resources and the undrawn portion of our
existing credit facilities will be sufficient to fund these expenditures.
Our principal ongoing capital expenditures are described below.
Medicines
Our Medicines industrial operations are organized through end-to-end clusters.
We have four dedicated biotechnology hubs: Paris/Lyon (France), Frankfurt (Germany), Geel (Belgium) and the Boston Area
(United States). Exploiting innovative techniques, including cell and microbiological culture and the development of viral
vectors, our biotechnology operations call for highly specific knowledge and expertise backed by dedicated production
platforms to support global product launches.
In May 2024, Sanofi announced plans for major investment to increase the
production capabilities of our facility at Vitry-sur-Seine (France).
We also have end-to-end clusters with chemistry, pharmaceutical and injectable sites organized through a network of regional
and local industrial sites, supporting growth in those markets. A dedicated Launch Sites cluster has been implemented, from
API manufacturing to finished goods packaging (Sisteron, Aramon, Ambarès, Scoppito).
The Frankfurt facility is our principal
site for the manufacture of diabetes treatments. Also in 2024, we announced major investments in the production of insulin
APIs, at new facilities in Frankfurt (Germany) and Beijing (China).
Vaccines
The industrial operations of our Vaccines business are in a major investment phase, preparing for the upcoming growth of our
influenza and Polio/Pertussis/Hib franchises, plus the mid-term growth linked to our mRNA roadmap and New Vaccines
pipeline.
Major investments
were announced in 2020 and 2021
with a new Evolutive Facility in France (Neuville-Sur-Saone) and
a new facility in Singapore for our New Vaccines pipeline
. Other major investments are under way in France (including
construction of a new influenza vaccine building at Val-de-Reuil), Canada (a new pertussis vaccine building), the US and
Mexico.
Opella
The pharmaceutical industrial operations of our Opella business are spread across a dedicated network. Global markets are
supplied from our facilities at Compiègne (France), Cologne (Germany) and Origgio (Italy). We have recently invested in new
production capacities in Narita (Japan), Origgio (Italy) and Lisieux (France). All of these operations are part of Sanofi’s
discontinued operations (see Note D.36. to our consolidated financial statements, included at Item 18 of this Annual Report on
Form 20-F).
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2024
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55
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PART I
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|
ITEM 4. Information on the Company
|
Innovation and culture of industrial excellence
The ambition of our Manufacturing & Supply department is to continue to raise safety, quality and operating standards in Sanofi’s
production activities, and to remain a world leader and a benchmark in the global pharmaceutical industry. To achieve this goal,
all our activities share a common culture of industrial excellence, enshrined in the Sanofi Manufacturing System. This sets out a
series of priorities (such as customer service, constant improvement, site network optimization and transverse optimization) that
constitute our industrial vision and will be crucial to our mutual success.
In terms of operational excellence, we continue to build on our Top Decile performance program, focused on core sites and fully
leveraging digital opportunities and technology innovations. We are also reinforcing the Sanofi Manufacturing System to drive
more improvement directly from the sites and reach our performance goals, while creating a culture of best practices shared
across the industrial network.
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PART I
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|
ITEM 4. Information on the Company
|
E. R&D
Appendix
R&D Pipeline
|
Registration
|
||
|
Name
|
Description
|
Indication
|
|
Dupixent
(a)
|
IL4xIL13 mAb
|
Chronic obstructive pulmonary disease (JP)
Chronic spontaneous urticaria (US, EU)
|
|
fitusiran
|
RNAi targeting anti-thrombin
|
Hemophilia A and B (US, CN)
(1)
|
|
rilzabrutinib
|
BTK inhibitor
|
Immune thrombocytopenia (US, EU, CN)
|
|
Sarclisa
|
CD38 mAb
|
NDMM, TI (IMROZ) (JP)
NDMM, TE (HD7) (EU)
|
|
MenQuadfi
|
4-valent (ACWY) conjugate vaccine
|
Meningitis (six weeks+) (US)
(1)
|
|
Phase 3
|
||||||
|
Name
|
Description
|
Indication
|
Name
|
Description
|
Indication
|
|
|
Immunology
|
Neurology
|
|||||
|
Dupixent
(a)
|
IL4xIL13 mAb
|
Bullous pemphigoid
(2)
Chronic pruritus of
unknown origin
Eosinophilic gastritis
Lichen simplex chronicus
|
tolebrutinib
|
BTK inhibitor
|
Non-relapsing secondary
progressive MS
(2)
Primary progressive MS
|
|
|
itepekimab
(a)
|
IL33 mAb
|
Chronic obstructive
pulmonary disease
|
frexalimab
(b)
|
CD40L mAb
|
Relapsing MS
Non-relapsing secondary
progressive MS
|
|
|
amlitelimab
|
OX40L mAb
|
Atopic dermatitis
|
riliprubart
|
C1s inhibitor
|
SOC-refractory CIDP
IVIg-treated CIDP
|
|
|
Rezurock
|
ROCK2 inhibitor
|
Chronic lung allograft
dysfunction
Chronic graft-versus-host
disease, 1L
|
Oncology
|
|||
|
Tzield
|
CD3 mAb
|
Type 1 diabetes
|
Sarclisa
|
CD38 mAb
|
NDMM, TE (HD7) (US)
NDMM, TE (IsKia)
Smoldering MM (ITHACA)
|
|
|
Rare diseases
|
CD38 mAb
subcutaneous
|
Relapsed/refractory MM
(IRAKLIA)
|
||||
|
Nexviazyme
|
E
nzyme replacement
therapy
|
Pompe disease infantile
onset (US)
|
Vaccines
|
|||
|
venglustat
|
Oral GCS inhibitor
|
Fabry disease
Gaucher disease type 3
|
SP0087
|
Vero cell vaccine
|
Rabies
|
|
|
SP0125
|
Live attenuated
vaccine
|
RSV (toddlers)
|
||||
|
Fluzone HD
|
Multivalent inactivated
vaccine
|
Flu (50 years+)
|
||||
|
SP0202
(c)
|
21-valent conjugate
vaccine
|
Pneumococcal disease
|
||||
(1) Currently in Phase 3 in EU -
(2) Awaiting regulatory acceptance in the US
Collaborations:
(a) Regeneron - (b) ImmuNext - (c) SK bioscience
Abbreviations:
1L: 1
st
line - BTK: Bruton’s tyrosine kinase - CD: Cluster of differentiation - C1s: Complement component 1s - CIDP: Chronic inflammatory demyelinating polyneuropathy -
CN: China - EU: Europe - GCS: Glucosylceramide synthase - HD: High dose - IL: Interleukin - IVIg: Intravenous immunoglobulin - JP: Japan - mAb: Monoclonal antibody -
MM: Multiple myeloma - MS: Multiple sclerosis - NDMM: Newly diagnosed multiple myeloma - RNAi: RNA interference - ROCK2: Rho Associated coiled-coil containing
protein kinase 2 - RSV: Respiratory syncytial virus - SOC: Standard of care - TE: Transplant eligible - TI: Transplant ineligible - US: United States of America
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2024
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57
|
|
PART I
|
|
ITEM 4. Information on the Company
|
|
Phase 2
|
||||||
|
Name
|
Description
|
Indication
|
Name
|
Description
|
Indication
|
|
|
Immunology
|
Rare diseases
|
|||||
|
Dupixent
(a)
|
IL4xIL13 mAb
|
Ulcerative colitis
|
rilzabrutinib
|
BTK inhibitor
|
Warm autoimmune
hemolytic anemia
|
|
|
itepekimab
(a)
|
IL33 mAb
|
Bronchiectasis
|
SAR447537
|
AAT fusion protein
|
Alpha-1 antitrypsin
deficiency
|
|
|
amlitelimab
|
OX40L mAb
|
Alopecia areata
Asthma
Celiac disease
Hidradenitis suppurativa
Systemic sclerosis
|
Oncology
|
|||
|
rilzabrutinib
|
BTK inhibitor
|
Asthma
Chronic spontaneous
urticaria
IgG4-related disease
|
Sarclisa
|
CD38 mAb
|
Relapsed/refractory MM
|
|
|
frexalimab
(b)
|
CD40L mAb
|
Systemic lupus
erythematosus
Type 1 diabetes
|
SAR443579
(f)
|
Trifunctional anti-
CD123 NK cell engager
|
Acute myeloid leukemia
|
|
|
balinatunfib
|
Oral TNFR1 signaling
inhibitor
|
Psoriasis
Rheumatoid arthritis
Crohn’s disease
|
SAR447873
(g)
|
SSTR targeting alpha-
emitter therapy
|
Gastroenteropancreatic
neuroendocrine tumors
|
|
|
lunsekimig
|
IL13xTSLP
NANOBODY
®
VHH
|
Asthma
High-risk asthma
Chronic rhinosinusitis with
nasal polyps
|
Vaccines
|
|||
|
eclitasertib
(c)
|
RIPK1 inhibitor
|
Ulcerative colitis
|
SP0218
|
Vero cell vaccine
|
Yellow fever
|
|
|
SAR44656
(d)
|
IRAK4 degrader
|
Atopic dermatitis
Hidradenitis suppurativa
|
SP230
|
5-valent (ABCYW)
vaccine
|
Meningitis
|
|
|
brivekimig
|
TNFaxOX40L
NANOBODY
®
VHH
|
Hidradenitis suppurativa
|
SP0256
|
mRNA vaccine
|
RSV (older adults)
|
|
|
duvakitug
(e)
|
TL1A mAb
|
Crohn’s disease
Ulcerative colitis
|
SP0335
|
Inactivated adjuvanted
vaccine
|
Flu (H5 pandemic)
|
|
|
riliprubart
|
C1s inhibitor
|
Antibody-mediated
rejection
|
||||
|
Phase 1
|
||||||
|
Name
|
Description
|
Indication
|
Name
|
Description
|
Indication
|
|
|
Immunology
|
Oncology
|
|||||
|
SAR444336
|
Non-beta IL2
Synthorin
TM
|
Inflammatory indication
|
SAR444881
(i)
|
ILT2 mAb
|
Solid tumors
|
|
|
SAR445399
(1)
|
IL1R3 mAb
|
Inflammatory indication
|
SAR445877
|
PD1xIL15 fusion protein
|
Solid tumors
|
|
|
SAR446422
|
CD28xOX40 bispecific
Ab
|
Inflammatory indication
|
SAR445514
(f)
|
Trifunctional anti-
BCMA NK cell engager
|
Relapsed/refractory MM
|
|
|
SAR446959
|
MMP13xADAMTS5xCAP
NANOBODY
®
VHH
|
Knee osteoarthritis
|
SAR445953
(j)
|
CEACAM5-Topo1 ADC
|
Colorectal cancer
|
|
|
Neurology
|
Vaccines
|
|||||
|
SAR446159
(h)
|
SynucleinxIGF1R mAb
|
Parkinson’s disease
|
SP0237
|
mRNA vaccine
|
Flu
|
|
|
SP0268
|
mRNA vaccine
|
Acne
|
||||
|
SP0287
|
Fluzone HD+Nuvaxovid
|
Flu+COVID-19
|
||||
|
SP0287
|
Flublok+Nuvaxovid
|
Flu+COVID-19
|
||||
|
SP0289
|
mRNA vaccine
|
Flu (H5 pandemic)
|
||||
|
SP0256
|
mRNA vaccine
|
RSV+hMPV (older adults)
|
||||
|
SP0291
|
mRNA vaccine
|
RSV+hMPV+PIV3 (older
adults)
|
||||
(1) Also known as MAB212, in-licensed from MAB Discovery
Collaborations:
(a) Regeneron - (b) ImmuNext - (c) Denali - (d) Kymera - (e) Teva Pharmaceuticals - (f) Innate Pharma - (g) RadioMedix and Orano Med - (h) ABL Bio - (i) Biond Biologics -
(j) Pfizer
Abbreviations:
AAT: Alpha-1 antitrypsin - Ab: Antibody - ADAMTS5: A Disintegrin And Metalloproteinase with Thrombospondin Motifs 5 - ADC: Antibody-drug conjugate - BCMA: B-Cell
maturation antigen - BTK: Bruton’s tyrosine kinase - C1s: Complement component 1s - CAP: Cartilge anchoring protein - CD: Cluster of differentiation - CEACAM5:
Carcinoembryonic antigen cell adhesion molecule 5 - H5: hemagglutinin 5 - hMPV: human Metapneumovirus - IGF1R: Insulin-like growth factor 1 receptor - IgG4:
Immunoglobulin G4 - IL: Interleukin - IL1R3: Interleukin-1 receptor 3 - ILT2: Ig-like transcript 2 - IRAK4: Interleukin 1 receptor associated kinase 4 - mAb: Monoclonal antibody
- MM: Multiple myeloma - MMP13: Matrix metallopeptidase 13 - mRNA: messenger RNA - NK: Natural killer - PD1: Programmed death protein 1 – PIV3: Parainfluenza virus
type 3 - RIPK1: Receptor-interacting serine/threonine protein kinase 1 - RSV: Respiratory syncytial virus - SSTR: Somatostatin receptor - TL1A: Tumor necrosis factor-like
cytokine 1A - TNFa: Tumor necrosis factor alpha - TNFR1: Tumor necrosis factor receptor 1 - Topo1: Topoisomerase - TSLP: Thymic stromal lymphopoietin
|
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SANOFI
FORM 20-F
2024
|
|
PART I
|
|
ITEM 4A. Unresolved Staff Comments
|
Item 4A. Unresolved Staff Comments
N/A
Item 5. Operating and Financial Review and Prospects
You should read the following discussion in conjunction with our consolidated financial statements and the notes thereto
included in this annual report at Item 18.
Our consolidated financial statements have been prepared in accordance with International Financial Reporting Standards
(IFRS) as issued by the International Accounting Standards Board (IASB) and with IFRS endorsed by the European Union as
of
December 31, 2024
.
The following discussion contains forward-looking statements that involve inherent risks and uncertainties. Actual results may
differ materially from those contained in such forward-looking statements. See “Cautionary Statement Regarding Forward-
Looking Statements” at the beginning of this document.
Unless otherwise stated, all financial variations in this item are given on a reported bas
is.
A. Operating results
A.1. Significant operating information
A.1.1.
2024
Overview
2024 Business Developments
During
2024
, Sanofi continued to implement its “Play to Win” strategy, initiating the second phase which aims to launch major
innovations, redeploy resources and develop leading innovative R&D. For further information about our strategy, refer to
“Item 4. Information on the Company — B. Business Overview — B.1. Strategy.” Other significant events of the year are
described below.
On May 10,
2024
, Sanofi entered into a co-exclusive licensing agreement with
Novavax
. The terms of the agreement include (i) a
co-exclusive license to co-commercialize Novavax’s current stand-alone adjuvanted COVID-19 vaccine worldwide (except in
countries with existing Advance Purchase Agreements and in India, Japan, and South Korea, where Novavax has existing
partnership agreements); (ii) an exclusive license to Novavax’s adjuvanted COVID-19 vaccine for use in combination with Sanofi’s
flu vaccines; and (iii) a non-exclusive license to use the Matrix-M adjuvant in vaccine products. Novavax received an upfront
payment of $
500
million and could receive up to $
700
million contingent on the attainment of development, regulatory and
commercialization milestones, representing up to
$1.2 billion
in total. Starting in 2025, Sanofi will recognize sales of Novavax’s
adjuvanted COVID-19 vaccine and will bear certain R&D, regulatory, and commercialization expenses. Novavax will receive
double-digit tiered royalties on Sanofi sales of COVID-19 vaccines and combined influenza/COVID-19 vaccines. Novavax is also
entitled to additional launch and sales milestone payments of up to $
200
million, plus single-digit royalties for each additional
Sanofi vaccine product developed under a non-exclusive license using Novavax’s Matrix-M adjuvant technology. In addition,
Sanofi took a minority equity interest of less than 5% in Novavax. Outside of the collaboration, each party may develop and
commercialize their own flu and COVID-19 vaccines and their own adjuvanted products at their own cost.
On May 13,
2024
, Sanofi announced plans for an investment in
major industrial projects
of more than €1.1 billion, to create new
bioproduction capacity at its sites in Vitry-sur-Seine (Val de Marne), Le Trait (Seine-Maritime) and Lyon Gerland (Rhône). This plan
brings to more than €3.5 billion the amount committed by Sanofi since the COVID-19 pandemic to major projects to keep
production of medicines and vaccines in France for patients around the world.
On May 30, 2024, Sanofi announced that it had completed the acquisition of
Inhibrx, Inc
(Inhibrx), a publicly-traded, clinical-
stage biopharmaceutical company focused on developing a pipeline of novel biologic therapeutic candidates in oncology and
orphan diseases. The acquisition added SAR447537 (formerly INBRX-101) to Sanofi’s rare disease development portfolio. Under
the terms of the merger agreement, Sanofi agreed to (i) pay Inhibrx stockholders $30 per share of Inhibrx common stock on
closing of the merger (approximately $1.7 billion) and issue one non-transferable contingent value right (CVR) per share of Inhibrx
common stock, entitling its holder to receive a deferred cash payment of $5, contingent upon the achievement of certain
regulatory milestones (approximately $0.3 billion, if those milestones are achieved); (ii) pay off Inhibrx’s outstanding third-party
debt (approximately $0.2 billion); and (iii) contribute capital to a new publicly traded company (New Inhibrx) (at least $0.2 billion).
Since the closing of the merger, Inhibrx has become a wholly owned subsidiary of Sanofi. Additionally, Sanofi retains a minority
stake (approximately 8%) in New Inhibrx.
On September 10, 2024, in the presence of President Macron, Sanofi broke ground on a new production unit in Neuville-sur-
Saône (Rhône-Alpes), named
Modulus
, to produce upcoming vaccines and biological drugs. Modulus has the unique capability of
adapting to produce up to four vaccines or biopharmaceuticals simultaneously and can be reconfigured within days or weeks to
switch technological platforms (live attenuated viral vaccines, recombinant protein vaccines, or mRNA-based vaccines, as well as
biotechnology-derived treatments like enzymes or monoclonal antibodies), whereas such changes typically take several months
(1)
Non-IFRS financial measure: see definition in “— Presentation of Net Sales” below.
(2)
Non-IFRS financial measure: see definition in “— Segment Information — Business Net Income” below.
|
SANOFI
FORM 20-F
2024
|
59
|
|
PART I
|
|
ITEM 5. Operating and Financial Review and Prospects
|
or even years in conventional factories. Sanofi invested nearly €500 million in Modulus, which is expected to be operational by
the end of 2025, following certification of the facilities and validation of manufacturing processes. Sanofi plans to produce some
of its future biopharmaceuticals and vaccines there.
On October 21, 2024, Sanofi and Clayton, Dubilier & Rice (CD&R) announced that they had entered exclusive negotiations for
the
Proposed Opella Transaction as defined under
"Item 4 –B.3. Opella." The opening of the exclusive negotiations relating to
the Proposed Opella Transaction, and the signature of a put option agreement as of that date (leading to loss of the control
previously exercised by Sanofi over Opella), triggered the reclassification of the Opella business as a discontinued operation
for the 2024 financial year. Opella meets the criteria for a discontinued operation under IFRS 5, and the post-tax profit or loss
from Opella is now presented separately within the line item
Net income/(loss) from discontinued operations
in Sanofi's
consolidated income statement. This presentation in a separate line item of the income statement applies to operations for
the year ended December 31, 2024 and for the comparative periods presented.
Sanofi has exercised the put option, pursuant
to which Sanofi is contemplating entering into an agreed form share purchase agreement; that agreement, once entered into
by the parties, will govern the terms for the sale and purchase of the share capital of Opella. Sanofi expects to receive a cash
payment during 2025, which may reach several billion euros,
upon closing of the Proposed Opella Transaction, expected in
the second quarter of 2025 at the earliest, while retaining an indirect stake of around 50% in Opella. The proceeds would be
used in line with Sanofi’s existing capital allocation priorities, including shareholder returns.
2024 Financial results
For further information about the biopharma products we sell, and about our research and development portfolio, refer
to “Item 4. Information on the Company — B. Business Overview.”
Our net sales for
2024
amounted to €
41,081
million, an increase of
8.6
% from
2023
. At constant exchange rates (CER)
(1)
, net sales
rose by
11.3
%, driven mainly by strong performances for Dupixent and increased sales of ALTUVIIIO, Lantus and Beyfortus.
Net income attributable to equity holders
of Sanofi amounted to €
5,560
million for
2024
, compared with €
5,400
million in
2023
, a €
160
million increase. Earnings per share was €
4.44
in
2024
, compared with €
4.31
in
2023
. Business net income
(2)
was €
8,912
million, down
1.8%
on
2023
, while business earnings per share (business EPS
(2)
) was
1.8%
lower than in
2023
at €
7.12
.
At the Annual General Meeting on April 30, 2025, we will ask our shareholders to approve a dividend of €
3.92
per share for the
2024
financial year, representing a payout of
55.0
% of our Business net income per share (see “— B.2. Consolidated balance
sheet and debt.”).
A.1.2. Impacts of competition from generics and biosimilars
Some of our flagship products continued to suffer sales erosion in
2024
under the impact of competition from generics and
biosimilars. We do not believe it is possible to state with certainty what level of net sales would have been achieved in the
absence of generic competition. A comparison of our consolidated net sales for the years ended
December 31, 2024
and
2023
(see “— Results of Operations — Year Ended
December 31, 2024
Compared with Year Ended
December 31, 2023
” below) for
the main products affected by generic and biosimilar competition shows a loss of €
794
million of net sales on a reported basis.
However, other parameters can also contribute to the loss of sales, such as a fall in the average selling price of certain
products.
The table below sets forth the change by product.
|
(€ million)
|
2024
|
2023
|
Change on a
reported basis
|
Change on a
reported basis
(%)
|
|
Aprovel Europe
|
73
|
78
|
(5)
|
-6.4
%
|
|
Lantus Europe
|
340
|
357
|
(17)
|
-4.8
%
|
|
Lovenox Europe
|
567
|
622
|
(55)
|
-8.8
%
|
|
Plavix Europe
|
91
|
96
|
(5)
|
-5.2
%
|
|
Aubagio Europe
|
152
|
437
|
(285)
|
-65.2
%
|
|
Mozobil Europe
|
39
|
70
|
(31)
|
-44.3
%
|
|
Aubagio United States
|
187
|
460
|
(273)
|
-59.3
%
|
|
Mozobil United States
|
12
|
119
|
(107)
|
-89.9
%
|
|
Aprovel Japan
|
11
|
16
|
(5)
|
-31.3
%
|
|
Plavix
Japan
|
22
|
33
|
(11)
|
-33.3
%
|
|
Total
|
1,494
|
2,288
|
(794)
|
-34.7
%
|
We expect the erosion caused by generic competition to continue in
2025
, with a negative impact on our net income. The
products likely to be impacted in
2025
include those that already faced generic competit
ion in
2024
, but whose sales can
reasonably be expected to be subject to further sales erosion in
2025
(see products listed in the table above). In addition, we
have experienced generic competition for Aubagio in the United States since March 2023 and in Europe since October 2023,
with a greater impact in 2024. The same pattern occurred for Mozobil with generic competition in United States since July 2023,
and in Europe since early 2024.
(1)
From 2024,
Net sales
excludes sales of Consumer Healthcare products, reclassified within
Net income from discontinued operations
for the three years
presented.
|
60
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SANOFI
FORM 20-F
2024
|
|
PART I
|
|
ITEM 5. Operating and Financial Review and Prospects
|
In
2024
, aggregate consolidated net sales of those products in Europe, the United States and Japan amounted to €
1,494
million;
this comprised €
1,262
million in Europe, €
187
million in the United States and €
33
million in Japan. The negative impact on our
2025
net sales is likely to represent a substantial portion of those sales, but the actual impact will depend on a number of factors,
such as the impact of generics and biosimilars on sales of our molecules, but also the market entry of generics of other molecules
that are in competition with our products.
In China, the authorities have
implemented a range of healthcare cost containment measures, including the Volume Based
Procurement (VBP) reverse auction that particularly impacts our insulin-based products, Plavix, Aprovel, and Lovenox (see also
“Item 4. Information on the Company — B. Business Overview — B.5.4. Pricing & Reimbursement”). A large number of molecules
were selected to submit tenders under successive waves of the VBP program, with the successful bidders being awarded a high
level of market share in return for offering lower prices. The recent tenth round of VBP results was very unfavorable to multinational
companies like Sanofi. Domestic generic companies won almost 100% of the bids due to further aggressive price reductions.
A.1.3. Purchase accounting effects
Our results of operations and financial condition for the years ended December 31,
2024
,
2023
and 2022, have been significantly
affected by our past acquisitions (acquisition of Genzyme in April 2011, exchange of our Animal Health business (Merial) for
Boehringer Ingelheim’s CHC business in January 2017, acquisition of Bioverativ in 2018, and certain o
ther transactions)
. See “—
A.1.11. Critical accounting and reporting policies — 2/ Business combinations” below for an explanation of the impact of business
combinations on our results of operations.
The Genzyme business combination has generated significant amortization of intangible assets (€152 million in
2024
, €405 million in
2023
and €513 million in 2022). The exchange of Merial for Boehringer Ingelheim’s CHC business has
generated amortization of intangible assets (€179 million in
2024
, €184 million in
2023
and €188 million in 2022). The Bioverativ
business combination has generated significant amortization of intangible assets (€630 million in
2024
, €633 million in
2023
and
€375 million in 2022). The Kadmon acquisition has generated amortization of intangible assets (€164 million in
2024
, €156 million
in
2023
and €160 million in 2022). The Provention Bio, Inc. acquisition has generated amortization of intangible assets
(€214 million in
2024
and €144 million in 2023).
In order to isolate the purchase accounting effects of all acquisitions and certain other items, we use a non-IFRS financial
measure that we refer to as “business net income” (see definition and discussion of reconciliation to the IFRS financial measure
Operating income
in “— A.1.5. Segment Information and Business Net Income —Business Net Income” below).
A.1.4. Sources of revenues and expenses
Revenues.
Revenue arising from the sale of goods is presented in the income statement within
Net sales
. Net sales comprise
revenue from sales of medicines, vaccines
and active ingredients
(1)
,
net of sales returns, of customer incentives and discounts,
and of certain sales-based payments paid or payable to the healthcare authorities. Returns, discounts, incentives and rebates are
recognized in the period in which the underlying sales are recognized, as a reduction of sales revenue. See Note B.13.1. to our
consolidated financial statements included at Item 18. of this annual report. We sell biopharma products directly, through
alliances, and by licensing arrangements throughout the world. When we sell products directly, we record sales revenues as part
of our consolidated net sales. When we sell products through alliances, the revenues reflected in our consolidated financial
statements are based on the contractual arrangements governing those alliances. For more information about our alliances,
see “— A.1.7. Financial Presentation of Alliances” below.
Other revenues:
all revenue that falls within the scope of IFRS 15 but does not relate to sales of Sanofi products is shown in this
line item. It mainly comprises (i) royalties received from licensing intellectual property rights to third parties; (ii) VaxServe sales of
products sourced from third-party manufacturers; and (iii) revenue received under agreements for Sanofi to provide
manufacturing services to third parties. Royalties received under licensing arrangements are recognized over the period during
which the underlying sales are recognized. VaxServe's operations include the distribution within the United States of vaccines and
other products manufactured by third parties.
Other revenues
is also used to recognize revenues arising from the manufacturing of Consumer Healthcare products by legal
entities within the scope of continuing operations on behalf of legal entities within the scope of discontinued operations (see
Note B.7.).
Other revenues
includes revenues associated with Consumer Healthcare operations not transferred on the effective date of loss
of control of Opella. These comprise primarily, but not exclusively, Consumer Healthcare activities that will not be transferred on
the effective date of loss of control of Opella, primarily (i) hospital sales of Opella products in China, the transfer of which will be
finalized no earlier than 2028 after a transitional period required to complete the transfer plan agreed with Sanofi in the context
of public tendering arrangements ; (ii) sales made by the dedicated entity Opella Russie, the equity interests in which will be
retained by Sanofi. Sanofi will continue to distribute Opella products in Russian territory under the distribution agreement signed
in connection with the separation, the parties reserving the right to discuss the transfer of this retained interest during the
distribution agreement term ; and (iii) sales of the Gold Bond product range, which are continuing in the United States through
the retained subsidiary Gold Bond LLC (holder of the associated worldwide property rights).
Cost of Sales
.
Our cost of sales consists primarily of the cost of purchasing raw materials and active ingredients, labor and other
costs relating to our manufacturing activities, packaging materials, payments made under licensing agreements and distribution
costs. We have license agreements under which we manufacture, sell and distribute products that are patented by other
companies. When we pay royalties, we record them in
Cost of sales
.
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Operating Income
.
Our operating income reflects our revenues, our cost of sales and the remainder of our operating expenses,
the most significant of which are research and development expenses and selling and general expenses. For our operating
segment, we also measure our results of operations through an indicator referred to as “Business Operating Income,” which we
describe below under “— A.1.5. Segment Information and Business Net Income — Business Operating Income.”
A.1.5. Segment information and Business net income
1/ Segment information
In accordance with IFRS 8 (Operating Segments), the segment information reported by Sanofi is prepared on the basis of internal
management data provided to our Chief Executive Officer, who is the chief operating decision maker of Sanofi. The operating
segment disclosures required under IFRS 8 are provided in Notes B.26. and D.35. to the consolidated financial statements
included at Item 18. of this annual report.
Sanofi reports segment information for the Biopharma operating segment, further to the opening of exclusive negotiations
between Sanofi and Clayton, Dubilier & Rice (CD&R) on October 21, 2024 with a view to selling an equity interest in Opella, which
would lead to loss of control over Opella on the effective closing date, scheduled for the second quarter of 2025 at the earliest.
Prior to the opening of those exclusive negotiations, Opella (formerly Consumer Healthcare) was an operating segment of Sanofi.
As a result of the announcement of the Proposed Opella Transaction (as defined in Note D.1.1.2. Project to divest a controlling
interest in Opella), as of the fourth quarter of 2024 Opella meets the criteria for a discontinued operation under IFRS 5 (see Note
B.7.), and the net income from this business is now presented separately within the line item
Net income from discontinued
operations
in the consolidated income statement. This presentation in a separate line item in the income statement applies to
results of operations for the current period, and for the comparative periods presented. With effect from that date, Sanofi
became a dedicated Biopharma company of which the performance, based on internal management reporting, is subject to
regular review by the Chief Executive Officer, Sanofi's chief operating decision-maker.
The Biopharma operating segment comprises commercial operations and research, development and production activities
relating to the Specialty Care, General Medicines and Vaccines franchises plus support and corporate functions, for all
geographical territories. It also includes revenues generated by legal entities within the Biopharma segment (and included in the
scope of continuing operations) from the manufacture of Consumer Healthcare products on behalf of legal entities within Opella;
those revenues are presented within
Other Revenues
in the income statement. The Biopharma operating segment also includes
the the purchase price of Biopharma products manufactured by legal entities within the Opella scope.
The “Other” category comprises primarily, but not exclusively, Consumer Healthcare activities that will not be transferred on the
effective date of loss of control of Opella. These are primarily (i) hospital sales of Opella products in China, the transfer of which
will be finalized no earlier than 2028 after a transitional period required to complete the transfer plan agreed with Sanofi in the
context of public tendering arrangements ; (ii) sales made by the dedicated entity Opella Russie, the equity interests in which will
be retained by Sanofi. Sanofi will continue to distribute Opella products in Russian territory under the distribution agreement
signed in connection with the separation, the parties reserving the right to discuss the transfer of this retained interest during the
distribution agreement term ; and (iii) sales of the Gold Bond product range, which are continuing in the United States through
the retained subsidiary Gold Bond LLC (holder of the associated worldwide property rights).
Figures for comparative periods (2023 and 2022) have been re-presented on a consistent basis to reflect the classification of
Opella as a discontinued operation.
2/ Business operating income (non-IFRS financial measure)
We report segment results on the basis of “Business operating income.” This non-IFRS indicator is used internally by Sanofi’s chief
operating decision maker to measure the performance of
our operating segmen
t and to allocate resources. For a definition of
“Business operating income,” and a reconciliation between that indicator and IFRS
Income before tax and investments
accounted for using the equity method
, refer to Note D.35. to our consolidated financial statements included at Item 18. of this
annual report.
“Business operating income” is a non-IFRS financial measure and is reconciled with IFRS
Operating income
. IFRS
Operating
income
for
2024
amounted to
€7,252
million, versus
€6,960
million for
2023
and €
10,162
million for 2022;
refer to Note D.35. to
our consolidated financial statements included at Item 18. of this annual report
.
Our “Business operating income” for
2024
amounted to €
11,343
million, versus €
11,178
million in
2023
and €
12,793
million in 2022.
Because our “Business operating income” is not a standardized measure, it may not be directly comparable with the non-IFRS
financial measures of other companies using the same or similar non-IFRS financial measures. Although management uses this
non-IFRS measure to set goals and measure performance, it has no standardized meaning prescribed by IFRS. This non-IFRS
measure is presented solely to permit investors to more fully understand how Sanofi’s management assesses underlying
performance. This non-IFRS measure is not, and should not be viewed as, a substitute for IFRS measures, and should be viewed in
conjunction with IFRS measures of our performance and financial position. Consequently, there may be limitations on the
usefulness of this measure to investors.
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3/ Business net income (non-IFRS financial measure)
Sanofi also presents "Business net income", a non-GAAP financial measure that is not included in our financial statements. We
believe that reporting this indicator enhances understanding of our operational performance by our management and investors.
“Business net income” represents “Business operating income,” less (i) net financial expenses (except those related to financial
liabilities accounted for at amortized cost and subject to periodic remeasurement in accordance with paragraph B5.4.6 of IFRS 9)
and (ii) income tax expense related to “Business operating income”.
“Business net income” is a non-IFRS financial measure; it is reconciled with IFRS
Net income attributable to equity holders of
Sanofi
, which amounted to €
5,560
million for
2024
versus €
5,400
million for
2023
and €
8,371
million for 2022.
Our “Business net
income” for
2024
was
€8,912
million,
1.8
% lower than in
2023
(
€9,076
million).
That represents
21.7%
of our net sales, compared
with
24.0%
in
2023
and
26.8%
in 2022.
The table below reconciles
Net income attributable to equity holders of Sanofi
to our “Business net income”:
|
(€ million)
|
2024
|
2023(g)
|
2022(g)
|
|
Net income attributable to equity holders of Sanofi (IFRS)
|
5,560
|
5,400
|
8,371
|
|
Net income from discontinued operations
|
(64)
|
(338)
|
(401)
|
|
Amortization of intangible assets
|
1,749
|
1,911
|
1,804
|
|
Impairment of intangible assets
(a)
|
248
|
896
|
(429)
|
|
Fair value remeasurement of contingent consideration
(b)
|
127
|
93
|
53
|
|
Expenses arising from the impact of acquisitions on inventories
|
10
|
9
|
3
|
|
Restructuring costs and similar items
|
1,396
|
1,030
|
1,077
|
|
Other gains and losses, and litigation
(c)
|
470
|
196
|
143
|
|
Financial (income)/expenses relating to financial liabilities accounted for at amortized
cost and subject to periodic remeasurement
(d)
|
291
|
541
|
—
|
|
Tax effects of the items listed above:
|
(883)
|
(940)
|
(560)
|
|
•
amortization and impairment of intangible assets
|
(359)
|
(433)
|
(206)
|
|
•
fair value remeasurement of contingent consideration
|
(25)
|
(13)
|
(9)
|
|
•
restructuring costs and similar items
|
(320)
|
(278)
|
(175)
|
|
•
other items
|
(179)
|
(216)
|
(144)
|
|
Other tax effects
|
(81)
|
23
|
—
|
|
Other items
(e)
|
89
|
255
|
—
|
|
Business net income (non-IFRS)
|
8,912
|
9,076
|
10,099
|
|
Average number of shares outstanding (million)
|
1,251.4
|
1,251.7
|
1,251.9
|
|
Basic earnings per share (IFRS) (€)
|
4.44
|
4.31
|
6.69
|
|
Reconciling items per share (€)
(f)
|
2.68
|
2.94
|
1.38
|
|
Business earnings per share (non-IFRS) (€)
|
7.12
|
7.25
|
8.07
|
(a)
For 2024, this line corresponds to (i) an impairment loss of
€640 million
in connection with various research and development projects – including a
€239 million loss resulting from the decision taken in February 2025 to discontinue a phase 3 clinical study investigating of a vaccine candidate to
prevent invasive E.coli disease - and (ii) an impairment reversal of €392 million recognized in connection with the disposals of the ProXTen technology
platform and of Enjaymo, a commercialized product.
For 2023, this amount mainly comprises an impairment loss of €833 million, reflecting the impact of the strategic decision to de-prioritize certain R&D
programs, in particular those related to the NK Cell and ProXTen technology platforms.
For 2022, this line includes a reversal of €2,154 million on Eloctate franchise products following FDA approval of ALTUVIIIO on February 22, 2023, partly
offset by an impairment loss of €1,586 million on intangible assets relating to SAR444245 (non-alpha interleukin-2) based on revised cash flow
projections reflecting unfavorable developments in the launch schedule in key indications.
(b)
This line includes an impact attributable to non-controlling interests, related to a remeasurement of contingent consideration within a subsidiary of
Sanofi: €31 million expense in 2024, not material in 2023 and €80 million expense in 2022.
(c)
Other gains and losses, and litigation for
2024
represent a charge of €
470
millio
n, mainly comprising a provision recognized in respect of the litigation
related to Plavix (clopidogrel) in the US state of Hawaii (see Note D.22.)
(d)
This line corresponds to the financial expense arising from remeasurement of the financial liability recognized in the balance sheet to reflect estimated
future royalties on sales of Beyfortus in the United States.
(e)
This line includes the share of profits/losses arising from the equity-accounted investment in EUROAPI, including an impairment loss taken against the
equity interests based on the quoted market price: €2.88 as of December 31, 2024 and €
5.73
as of December 31, 2023.
(f)
Corresponds to the reconciliation between basic earnings per Share (IFRS) and business earnings per share (non-IFRS): sum total of reconciling items
divided by the weighted average number of shares outstanding.
(g)
Figures for comparative periods (2023 and 2022) have been re-presented on a consistent basis to reflect the classification of Opella as a discontinued
operation.
2022 business net income has been recast from the amount previously reported to include the one-time income of €952 million from the Libtayo
transaction (€706 million net of tax).
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We define “Business net income” as
Net income attributable to equity holders of Sanofi
determined under IFRS, excluding the
following items:
•
net income from discontinued operations, including Opella;
•
amortization and impairment losses charged against intangible assets (other than software and other rights of an industrial or
operational nature);
•
fair value remeasurements of contingent consideration relating to business combinations (IFRS 3), or to divestments of
operations meeting the definition of a business;
•
expenses arising from the remeasurement of inventories following business combinations (IFRS 3) or acquisitions of groups of
assets that do not constitute a business within the meaning of paragraph 2b of IFRS 3;
•
restructuring costs and similar items (presented within the line item
Restructuring costs and similar items
)
;
•
other gains and losses (including gains and losses on major divestments), presented within the line item
Other gains and
losses, and litigation
;
•
other costs and provisions related to litigation (presented within the line item
Other gains and losses, and litigation
);
•
(income)/expenses related to financial liabilities accounted for at amortized cost and subject to periodic remeasurement in
accordance with paragraph B5.4.6 of IFRS 9 (Financial Instruments);
•
tax effects related to the items listed above as well as effects of major tax disputes;
•
the share of profits/losses from investments accounted for using the equity method, except for joint ventures and associates
with which Sanofi has a strategic alliance; and
•
the portion attributable to non-controlling interests of the items listed above.
We also report “Business earnings per share” (“Business EPS”), a non-IFRS financial measure we define as “Business net income”
divided by the weighted average number of shares outstanding. “Business EPS” was
€7.12
for
2024
, compared with
€7.25
for
2023 (down
1.8
%) and €
8.07
for 2022, based on an average number of shares outstanding of
1,251.4
million for
2024
,
1,251.7
million for
2023
and
1,251.9
million for 2022.
The table below reconciles our “Business operating income” to our “Business net income”:
|
(€ million)
(a)
|
December 31,
2024
|
December 31,
2023
|
December 31,
2022
(b)
|
|
Business operating income
|
11,343
|
11,178
|
12,793
|
|
Financial income and expenses (except those related to financial liabilities accounted for at
amortized cost and subject to periodic remeasurement in accordance with
paragraph B5.4.6 of IFRS 9)
|
(263)
|
(168)
|
(225)
|
|
Income tax expense on business operating income
|
(2,168)
|
(1,934)
|
(2,469)
|
|
Business net income
|
8,912
|
9,076
|
10,099
|
(a)
Figures for comparative periods (2023 and 2022) have been re-presented on a consistent basis to reflect the classification of Opella as a discontinued
operation.
(b)
2022 business operating income has been recast from the amount previously reported to include the one-time income of €952 million from the Libtayo
transaction (€706 million net of tax).
The most significant reconciling items between “Business net income” and
Net income attributable to equity holders of Sanofi
relate to (i) the purchase accounting effects of our acquisitions of groups of assets and business combinations, particularly the
amortization and impairment of intangible assets (other than software and other rights of an industrial or operational nature);
(ii) the impacts of restructurings or transactions regarded as non-recurring, where the amounts involved are particularly
significant; (iii) remeasurements recognized through profit or loss in respect of (a) amounts receivable in respect of business
divestments and accounted for at fair value, (b) liabilities arising from business combinations (IFRS 3) and accounted for at fair
value, (c) liabilities accounted for at amortized cost and subject to periodic remeasurement under IFRS 9; and (iv) net income from
discontinued operations, including Opella. We believe that excluding those impacts enhances an investor’s understanding of our
underlying economic performance, because it gives a better representation of our recurring operating performance.
We believe that eliminating charges related to the purchase accounting effects of our acquisitions and business combinations
(particularly amortization and impairment of some intangible assets) enhances comparability of our ongoing operating
performance relative to our peers. Those intangible assets (principally rights relating to research and development, technology
platforms and commercialization of products) are accounted for in accordance with IAS 38 (Intangible Assets) and IFRS 3
(Business Combinations).
We also believe that eliminating the other effects of business combinations (such as the incremental cost of sales arising from the
workdown of acquired inventories remeasured at fair value in business combinations) gives a better understanding of our
recurring operating performance.
Eliminating restructuring costs and similar items enhances comparability with our peers because those costs are incurred in
connection with reorganization and transformation processes intended to optimize our operations.
We believe that eliminating the effects of transactions that we regard as non-recurring and that involve particularly significant
amounts (such as major gains and losses on disposals, and costs and provisions associated with major litigation and other major
non-recurring items) improves comparability from one period to the next.
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Finally, remeasurements recognized in profit or loss during the period in respect of (i) assets or liabilities accounted for at fair
value and recognized in the balance sheet in connection with business acquisitions or divestments or (ii) liabilities accounted for
at amortized cost and subject to periodic remeasurement, generally determined on the basis of revised sales forecasts, are not
reflective of our operating performance.
In addition to the items mentioned above relating to our continuing operations, “Business net income” excludes net income from
the Opella discontinued operation, the results of which have been presented separately in the consolidated income statement
since October 2024 (comparative figures have been re-presented on a consistent basis). Under IFRS 5 (Non-Current Assets Held
for Sale and Discontinued Operations), a discontinued operation is defined as a component of an entity that has been disposed of
or is classified as held for sale, and represents a separate major line of business. With effect from October 2024, “Business net
income” from continuing operations is used by management to measure Sanofi’s financial performance on an ongoing basis. We
believe that providing a performance measure aligned with our management approach is useful for investors and analysts.
We remind investors, however, that “Business net income” should not be considered in isolation from, or as a substitute for,
Net
income attributable to equity holders
of Sanofi
reported in accordance with IFRS. In addition, we strongly encourage investors
and potential investors not to rely on any single financial measure but to review our financial statements, including the notes
thereto, carefully and in their entirety.
We compensate for the material limitations described above by using “Business net income” only to supplement our IFRS
financial reporting and by ensuring that our disclosures provide sufficient information for a full understanding of all adjustments
included in “Business net income.”
Because our “Business net income” and “Business EPS” are not standardized measures, they may not be directly comparable with
the non-IFRS financial measures of other companies using the same or similar non-IFRS financial measures.
A.1.6. Presentation of net sales
In the discussion below, we present our consolidated net sales for
2024
,
2023
and 2022. We analyze our net sales by various
categories including medicines, vaccines, business, and geographical region. In addition to reported net sales, we analyze non-
IFRS financial measures designed to isolate the impact on our net sales of currency exchange rates and changes in the structure
of our group.
When we refer to changes in our net sales at constant exchange rates (CER), that means that we have excluded the effect of
exchange rates by recalculating net sales for the relevant period using the exchange rates that were used for the previous peri
od.
A
.1.7. Financial presentation of alliances
We have entered into a number of alliances for the development, co-promotion and/or co-marketing of our products. We believe
that a presentation of our two principal alliances is useful to an understanding of our financial statements.
1. Alliance arrangements with Regeneron Pharmaceuticals, Inc. (Regeneron)
Collaboration agreements on human therapeutic antibodies
In November 2007, Sanofi and Regeneron signed
two
agreements (amended in November 2009) relating to human therapeutic
antibodies: (i) the Discovery and Preclinical Development Agreement, and (ii) the License and Collaboration Agreement, relating
to clinical development and commercialization. Under the License and Collaboration Agreement, Sanofi had an option to develop
and commercialize antibodies discovered by Regeneron under the Discovery and Preclinical Development Agreement.
Discovery and development
Because Sanofi decided not to exercise its option to extend the Discovery and Preclinical Development Agreement, that
agreement expired on December 31, 2017.
As a result of Sanofi’s exercise of an option with respect to an antibody under the Discovery and Preclinical Development
Agreement, such antibody became a “Licensed Product” under the License and Collaboration Agreement, pursuant to which
Sanofi and Regeneron co-develop the antibody with Sanofi initially being wholly responsible for funding the development
program. On receipt of the first positive Phase 3 study results for any antibody being developed under the License and
Collaboration Agreement, the subsequent development costs for that antibody are split
80%
Sanofi,
20%
Regeneron. Amounts
received from Regeneron under the License and Collaboration Agreement are recognized by Sanofi as a reduction in the line
item
Research and development expenses
. Co-development with Regeneron of the antibodies Dupixent, Kevzara and
REGN3500 (SAR440340 - itepekimab) is ongoing under the License and Collaboration Agreement as of December 31, 2024.
Once a product begins to be commercialized, and provided that the share of quarterly results under the agreement represents a
profit, Sanofi is entitled to an additional portion of Regeneron’s profit-share (capped at
20%
of Regeneron’s share of quarterly
profits since April 1, 2022, and at
10%
until March 31, 2022) until Regeneron has paid
50%
of the cumulative development costs
incurred by the parties in the collaboration (see Note D.21.1.).
On the later of (i)
24 months
before the scheduled launch date or (ii) the first positive Phase 3 study results, Sanofi and Regeneron
share the commercial expenses of the antibodies co-developed under the License and Collaboration Agreement.
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Commercialization
Sanofi is the lead party with respect to the commercialization of all co-developed antibodies, and Regeneron has certain option
rights to co-promote the antibodies. Regeneron has exercised its co-promotion rights in the United States and in certain other
countries. Sanofi recognizes all sales of the antibodies. Profits and losses arising from commercial operations in the United States are
split
50
/50. Outside the United States, Sanofi is entitled to between
55%
and
65%
of profits depending on sales of the antibodies,
and bears
55%
of any losses. The share of profits and losses due to or from Regeneron under the agreement is recognized within the
line items
Other operating income
or
Other operating expenses
, which are components of
Operating income
.
In addition, Regeneron is entitled to receive payments contingent on the attainment of specified levels of aggregate sales on all
antibodies outside the United States, on a rolling twelve-month basis. The opposite entry for that liability is capitalized within
Other
intangible assets
on the balance sheet.
Two
payments of
$50 million
each were made in 2022, following attainment first of
$2.0 billion
and then of
$2.5 billion
in sales of all antibodies outside the United States on a rolling twelve-month basis. The final
milestone payment of
$50 million
, payable to Regeneron in the event that
$3.0 billion
in sales on a rolling twelve-month basis is
attained, was made in 2023
.
Amendments to the collaboration agreements
In January 2018, Sanofi and Regeneron signed a set of amendments to their collaboration agreements, including an amendment
that allowed for the funding of additional programs on Dupixent and REGN3500 (SAR440340 – itepekimab) with an intended
focus on extending the current range of indications, finding new indications, and improving co-morbidity between multiple
pathologies.
Effective April 1, 2020, Sanofi and Regeneron signed a Cross License and Commercialization Agreement for Praluent, whereby
Sanofi obtained sole ex-US rights to Praluent, and Regeneron obtained sole US rights to Praluent along with a right to
5%
royalties on Sanofi’s sales of Praluent outside the United States. Each party is solely responsible for funding the development,
manufacturing and commercialization of Praluent in their respective territories. Although each party has sole responsibility for
supplying Praluent in its respective territory, Sanofi and Regeneron entered into agreements to support manufacturing needs for
each other.
Effective September 30, 2021, Sanofi and Regeneron signed an amendment to their collaboration agreement in order to specify
allocations of responsibilities and associated resources between the two parties in connection with the co-promotion of Dupixent
in certain countries. The terms of the collaboration relating to REGN3500 (SAR440340 – itepekimab) are unchanged.
Effective July 1, 2022, Sanofi and Regeneron signed an amendment to their collaboration agreement in order to increase the
additional portion of Regeneron’s quarterly profit-share attributable to Sanofi from
10%
to
20%
with retroactive impact as of
April 1, 2022.
Immuno-oncology (IO) collaboration agreements
On July 1, 2015, Sanofi and Regeneron signed
two
agreements – the IO Discovery and Development Agreement and the IO
License and Collaboration Agreement (IO LCA) – relating to new antibody cancer treatments in the field of immuno-oncology.
The Amended IO Discovery Agreement, effective from December 31, 2018, was terminated through a Letter Amendment dated
March 16, 2021 in which Sanofi formalized its opt-out from the BCMAxCD3 and MUC16xCD3 programs.
LIBTAYO
(cemiplimab)
Under the 2015 IO LCA as amended in January 2018, Sanofi and Regeneron committed funding of no more than
$1,640 million
,
split on a
50
/50 basis (
$820 million
per company), for the development of REGN2810 (cemiplimab, trademark Libtayo), a PD-1
inhibitor antibody. The funding was raised to
$1,840 million
by way of amendment effective on September 30, 2021. Regeneron
was responsible for the commercialization of Libtayo in the United States, and Sanofi in all other territories. Sanofi has exercised
its option to co-promote Libtayo in the United States. In 2021, Regeneron exercised its option to co-promote Libtayo in certain
other countries.
The IO LCA also provided for a one-time milestone payment of
$375 million
by Sanofi to Regeneron in the event that sales of a
PD-1 product were to exceed, in the aggregate,
$2 billion
in any consecutive 12-month period.
Under the IO LCA Sanofi and Regeneron shared equally in profits and losses generated by the commercialization of collaboration
products, except that Sanofi was entitled to an additional portion of Regeneron’s profit-share (capped at
10%
of Regeneron’s
share of quarterly profits) until Regeneron had paid
50%
of the cumulative development costs incurred by the parties under the
IO Discovery Agreement, as amended.
In June 2022, Sanofi and Regeneron restructured their IO LCA. Under the terms of the Amended and Restated IO LCA,
Regeneron holds exclusive worldwide licensing rights to Libtayo with effect from July 1, 2022.
In July 2022, Sanofi received as consideration an upfront payment of
$900 million
(
€856 million
), which was recognized within
Other operating income
on the date of receipt. The same line item also includes a regulatory milestone payment of
$100 million
(
€96 million
) following the US FDA approval in November 2022 of Libtayo in combination with chemotherapy as a first line
treatment for NSCLC (non-small cell lung cancer). In addition, Sanofi is entitled to royalties of
11%
and to milestone payments
(
€116 million
in 2023,
€111 million
in 2022) linked to global net sales of Libtayo; those royalties are recognized within
Other
operating income
in line with the pattern of sales
. All of the cash inflows relating to the above items (
€117 million
in 2024,
€196 million
in 2023,
€952 million
in 2022) are presented within
Net cash provided by/(used in) operating activities
in the
consolidated statement of cash flows.
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The amendment to the terms of the IO LCA resulted in Sanofi recognizing an accelerated amortization charge of
€226 million
in 2022
; this was allocated to the Libtayo product rights included within the residual carrying amount of the intangible asset
recognized in July 2015 to reflect rights to an antibody targeting the immune checkpoint receptor PD-1 (programmed cell death
protein-1) under the Sanofi/Regeneron alliance.
The transaction also includes time-limited transitional services agreements with Regeneron which include manufacturing,
distribution (for which Sanofi acts as agent), and promotion.
Investor agreement
In 2014 and 2020, Sanofi and Regeneron amended the investor agreement entered into by the two companies in 2007. Under
the terms of the amendments, Sanofi accepted various restrictions, including “standstill” provisions that contractually prohibit
Sanofi from seeking to directly or indirectly exert control of Regeneron or acquiring more than
30%
of Regeneron’s capital stock
(consisting of the outstanding shares of common stock and the shares of Class A stock). This prohibition remains in place until the
earlier of (i) the later of the fifth anniversaries of the expiration or earlier termination of the Zaltrap collaboration agreement with
Regeneron (related to the development and commercialization of Zaltrap) or the collaboration agreement with Regeneron on
monoclonal antibodies (see “Collaboration agreements on human therapeutic antibodies” above), each as amended or (ii) other
specified events.
Starting in 2018 Sanofi began to sell shares of Regeneron stock and announced on May 29, 2020 the closing of its sale of
13 million
shares of Regeneron common stock in a registered offering and a private sale to Regeneron (see Note D.1.).
Pursuant to subsequent sales in 2022, Sanofi no longer holds any shares of Regeneron stock, as of December 31, 2024.
2. Agreements on the commercialization of Beyfortus (nirsevimab, previously MEDI8897) in the US
On March 1, 2017, Sanofi and AstraZeneca entered into an agreement to develop and commercialize a monoclonal antibody
(MEDI8897, nirsevimab) for the prevention of Respiratory Syncytial Virus (RSV) associated illness in newborns and infants.
Under the terms of the agreement, Sanofi made an upfront payment of
€
120 million
in March 2017, a development milestone
payment of
€
30 million
in the third quarter of 2019, a regulatory milestone payment of
€25 million
associated with the approval of
Beyfortus (nirsevimab) by the EMA in Europe in November 2022, and a regulatory milestone payment of
€65 million
associated
with the approval of Beyfortus (nirsevimab) by the US FDA in July 2023.
In addition, Sanofi could pay AstraZeneca up to
€375 million
if sales objectives are met. Those amounts are recognized as a
component of the value of the intangible asset when payment becomes probable. In 2024, payments of
€25 million
and of
€
50 million
were made, and an amount of €
100 million
was recognized as an accrued expense further to a contractual threshold
being met.
The agreement also specifies that AstraZeneca is responsible for development and manufacturing, and Sanofi for
commercialization. Sanofi recognizes the sales and cost of sales (purchases of finished products from AstraZeneca) and shares
the Alliance’s commercial profits (i) 50
/50 in major territories and (ii) based on
25%
of net sales in other territories. The share of
commercial profits and losses due to or from AstraZeneca is recognized as a component of operating income, within the line
items
Other operating income
or
Other operating expenses
. In addition, Sanofi and AstraZeneca share development costs
50
/50, with Sanofi’s portion recognized within the income statement line item
Research and development expenses
.
On April 9, 2023, Sanofi and AstraZeneca simplified their contractual agreements for the development and commercialization of
Beyfortus (nirsevimab) in the US. Sanofi thereby obtained control of all commercial rights to Beyfortus (nirsevimab) in the US, and
ended the sharing of commercial profits between the two partners in that territory. In line with the terms of the revised
agreements and in accordance with IAS 38, Sanofi recognized an intangible asset of
€1.6 billion
for the fair value of the additional
US rights. On the same date, AstraZeneca and Sobi ended their participation agreement, signed in 2018, which transferred the
economic rights for the US territory to Sobi.
Sanofi simultaneously entered into an agreement with Sobi relating to direct royalties on US net sales of Beyfortus (nirsevimab). In
line with the terms of that agreement, on April 9, 2023 Sanofi recognized a financial liability amounting to
€1.6 billion
. That liability
is classified as a financial liability at amortized cost under IFRS 9. Other than royalty payments, subsequent movements in the
liability comprise (i) the unwinding of discount and (ii) changes in estimates of future cash outflows for royalty payments. Those
movements will be recognized in the income statement within
Net financial income/(expenses)
in accordance with paragraph
B.5.4.6 of IFRS 9.
As of December 31, 2024 the liability was remeasured by an amount of €
291 million
.
As of December 31, 2023 the liability was
remeasured by an amount of
€541 million
, reflecting the strong success of the US launch of Beyfortus, which led to sales
forecasts being revised upward from the initial estimate. The resulting adjustment was recognized within
Financial expenses
.
For territories other than the US (except for China, which is now considered a “major market,” with profits/losses shared
50
/50
with AstraZeneca), the existing agreement between AstraZeneca and Sanofi continues to govern the principal terms of the
collaboration: Sanofi recognizes the sales and cost of sales and shares the Alliance’s commercial profits with AstraZeneca.
In May 2023, data from the HARMONIE Phase 3b study confirmed that nirsevimab prevents infant hospitalizations due to RSV
with consistent and high efficacy.
Beyfortus was approved in Europe in November 2022, in the United States in July 2023, and in a number of other countries
(including China and Japan) in 2024.
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A.1.8. Impact of exchange rates
We report our consolidated financial statements in euros. Because we earn a significant portion of our revenues in countries
where the euro is not the local currency, our results of operations can be significantly affected by exchange rate movements
between the euro and other currencies.
We experience these effects even though certain of these countries do not account for a large portion of our net sales. In
2024
,
we earned
48.7%
of our net sales in the United States. An increase in the value of the US dollar against the euro has a positive
impact on both our revenues and our operating income. A decrease in the value of the US dollar against the euro has a negative
impact on our revenues, which is not offset by an equal reduction in our costs and therefore negatively affects our operating
income. A variation in the value of the US dollar has a particularly significant impact on our operating income, which is higher in
the United States than elsewhere.
For a description of arrangements entered into to manage operating foreign exchange risks as well as our hedging policy,
see “Item 11. Quantitative and Qualitative Disclosures about Market Risk,” and “Item 3. Key Information — D. Risk Factors — Risks
Related to Financial Markets — Fluctuations in currency exchange rates could adversely affect our results of operations and
financial condition.”
A.1.9. Divestments
On November 29, 2024, Sanofi entered into a definitive agreement with
Recordati
for the sale of Sanofi's global rights to Enjaymo
and the transfer of specific employees. Under this agreement, Sanofi received an upfront payment of $825 million and will be
eligible for milestone payments of up to $250 million based on sales.
There were no material divestments in 2023.
On May 3, 2022, Sanofi's General Meeting of Shareholders approved the decision to distribute approximately 58% of the
share capital of
EUROAPI
, a European leader in the development, manufacture, marketing and distribution of Active
Pharmaceutical Ingredients (APIs), in the form of an exceptional dividend in kind to Sanofi shareholders. On the dividend payment
date of May 10, 2022 (further to the admission of EUROAPI shares to listing on the regulated market of Euronext Paris on
May 6, 2022), Sanofi divested control over EUROAPI and its subsidiaries, resulting in their deconsolidation from the Sanofi
consolidated financial statements as of that date. The cash impact of the deconsolidation of EUROAPI, presented within the line
item
Disposals of consolidated undertakings and investments accounted for using the equity method
in the statement of
cash flows, was a net cash inflow of
€101
million.
For further details about the divestments mentioned above, see Note D.1. to our consolidated financial statements included
at Item 18. of this annual report.
A.1.10. Acquisitions
On
May 30, 2024
, Sanofi completed the acquisition of
Inhibrx, Inc
(
Inhibrx), adding
SAR447537 (formerly INBRX-101) to Sanofi’s
rare disease pipeline. The transaction did not meet the criteria for a business combination under IFRS 3, and consequently was
accounted for as an acquisition of a group of assets.
The acquisition price was
$2,035 million
. Of that amount (plus acquisition-related costs),
$1,885 million
was allocated to in-
process development in respect of SAR447537, and recognized within
Other intangible assets
in accordance with IAS 38. The
difference between that amount and the acquisition price corresponds to the other assets acquired and liabilities assumed in the
transaction.
In addition, Sanofi awarded the former shareholders of Inhibrx an unquoted, non-transferable CVR certificate that entitles them
to a deferred cash payment of
$5.00
per Inhibrx share, subject to attainment of
a specified
regulatory milestone before June 30,
2027. The nominal value of that off balance sheet commitment is
$300 million
.
The impact of this acquisition, as reflected within the line item
Acquisitions of consolidated undertakings and investments
accounted for using the equity method
in the consolidated statement of cash flows, is a net cash outflow of
$2,035 million
.
On July 28, 2023, Sanofi agreed to acquire
QRIB Intermediate Holdings, LLC
(QRIB), the owner of Qunol, a market-leading US-
based health & wellness brand. The acquisition strengthened Opella's operations in the Vitamin, Mineral and Supplements (VMS)
category. The acquisition of QRIB by Sanofi was completed on September 29, 2023, at a purchase price of $1,419 million. The
impact of this acquisition is reflected in
Acquisitions of consolidated undertakings and investments accounted for using the
equity method
in the consolidated statement of cash flows and represents a net cash outflow of $1,410 million.
On March 13, 2023, Sanofi entered into a merger agreement with
Provention Bio, Inc.
(Provention), a US-based publicly traded
biopharmaceutical company developing therapies to prevent and intercept immune-mediated diseases including type 1 diabetes.
Under the terms of the agreement, Sanofi acquired the outstanding shares of Provention common stock for $25.00 per share in
an all-cash transaction valued at approximately $2.8 billion. The acquisition of Provention was completed on April 27, 2023, with
Sanofi holding all of the shares of Provention on expiration of the tender offer. The impact of this acquisition as reflected within
the line item
Acquisitions of consolidated undertakings and investments accounted for using the equity method
in the
consolidated statement of cash flows is a net cash outflow of $2,722 million.
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On February 8, 2022, Sanofi acquired the entire share capital of the immuno-oncology company
Amunix Pharmaceuticals, Inc.
(Amunix), thereby gaining access to Amunix’s innovative ProXTen technology and a promising pipeline of immunotherapies. The
acquisition price of Amunix comprised a fixed payment of
€970 million
, plus contingent consideration in the form of milestone
payments based on attainment of certain future development objectives of up to
$225 million
, the fair value of which as of the
acquisition date was
€156 million
. The impact of this acquisition was reflected within the line item
Acquisitions of consolidated
undertakings and investments accounted for using the equity method
in the consolidated statement of cash flows is a net
cash outflow of
€852 million
. The license agreement entered into with Vir Biotechnology, Inc. in September 2024 led to the
derecognition of the ProXTen intangible asset.
For further information about the acquisitions mentioned above, see Note D.1. to our consolidated financial statements included
at Item 18. of this annual report.
A.1.11.
Critical accounting and reporting policies
Our consolidated financial statements are affected by the accounting and reporting policies that we use. Certain of our
accounting and reporting policies are critical to an understanding of our results of operations and financial condition, and in some
cases the application of these critical policies can be significantly affected by the estimates, judgments and assumptions made
by management during the preparation of our consolidated financial statements. The accounting and reporting policies that we
have identified as critical to a full understanding of our results of operations and financial condition are the following:
1/ Revenue recognition
Our policies with respect to revenue recognition are discussed in Note B.13. to our consolidated financial statements included
at Item 18. of this annual report. Revenue arising from the sale of goods is presented in the income statement within
Net sales
.
Net sales
comprise revenue from sales of medicines, vaccines, and
active ingredients
, net of sales returns, of customer incentives
and discounts, and of certain sales-based payments paid or payable to the healthcare authorities. In accordance with IFRS 15
(Revenue from Contracts with Customers), such revenue is recognized when Sanofi transfers control over the product to the
customer. Control refers to the ability to direct the use of, and obtain substantially all of the remaining benefits from, the
products. For the vast majority of contracts, revenue is recognized when the product is physically transferred, in accordance with
the delivery and acceptance terms agreed with the customer.
For contracts entered into by our vaccines business, transfer of control is usually determined by reference to the terms of release
(immediate or deferred) and acceptance of batches of vaccine.
As regards contracts with distributors, Sanofi does not recognize revenue when the product is physically transferred to the
distributor in case of products sold on consignment, or if the distributor acts as an agent. In such cases, revenue is recognized
when control is transferred to the end customer, and the distributor’s commission is presented within the line item
Selling and
general expenses
in the income statement.
We offer various types of price reductions on our products. In particular, products sold in the United States are covered by
various programs (such as Medicare and Medicaid) under which products are sold at a discount. Rebates are granted to
healthcare authorities, and under contractual arrangements with certain customers. Some wholesalers are entitled to chargeback
incentives based on the selling price to the end customer, under specific contractual arrangements. Cash discounts may also be
granted for prompt payment. The discounts, incentives and rebates described above are estimated on the basis of specific
contractual arrangements with our customers or of specific terms of the relevant regulations and/or agreements applicable for
transactions with healthcare authorities, and of assumptions about the attainment of sales targets. We also estimate the amount
of sales returns, on the basis of contractual sales terms and reliable historical data. Discounts, incentives, rebates and sales
returns are recognized in the period in which the underlying sales are recognized within
Net Sales
, as a reduction of gross sales.
For additional details regarding the financial impact of discounts, incentives, rebates and sales returns, see Note D.23. to our
consolidated financial statements included at Item 18. of this annual report.
Revenues from non-Sanofi products, mainly comprising royalty income from license arrangements and sales of non-Sanofi
products by our US-based entity VaxServe, are presented within
Other revenues
. This line item also includes revenues arising
from the distribution of Eloctate and Alprolix under Sanofi’s agreements with Swedish Orphan Biovitrum AB (Sobi) and revenue
received under agreements for Sanofi to provide manufacturing services to third parties.
Other revenues
is also used to
recognize revenues arising from the manufacturing of Consumer Healthcare products by legal entities within the scope of
continuing operations on behalf of legal entities within the scope of discontinued operations (see Note B.7.). Finally, in the
interests of consistency,
Other Revenues
includes revenues associated with Consumer Healthcare operations that will not be
transferred on the effective date of loss of control of Opella. These are primarily, but not exclusively, Consumer Healthcare
activities that will not be transferred on the effective date of loss of control of Opella. These are primarily (i) hospital sales of
Opella products in China, the transfer of which will be finalized no earlier than 2028 after a transitional period required to
complete the transfer plan agreed with Sanofi in the context of public tendering arrangements ; (ii) sales made by the dedicated
entity Opella Russie, the equity interests in which will be retained by Sanofi. Sanofi will continue to distribute Opella products in
Russian territory under the distribution agreement signed in connection with the separation, the parties reserving the right to
discuss the transfer of this retained interest during the distribution agreement term; and (iii) sales of the Gold Bond product
range, which are continuing in the United States through the retained subsidiary Gold Bond LLC (holder of the associated
worldwide property rights).
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2/ Business combinations
As discussed in Note B.3. “Business combinations and transactions with non-controlling interests” to our consolidated financial
statements included at Item 18. of this annual report, business combinations are accounted for by the acquisition method.
The acquiree’s identifiable assets and liabilities that satisfy the recognition criteria of IFRS 3 (Business Combinations) are
measured initially at their fair values as at the acquisition date, except for (i) non-current assets classified as held for sale, which
are measured at fair value less costs to sell and (ii) assets and liabilities that fall within the scope of IAS 12 (Income Taxes)
and IAS 19 (Employee Benefits). Business combinations completed on or after January 1, 2010 are accounted for in accordance
with the revised IFRS 3 and IFRS 10 (Consolidated Financial Statements). In particular, contingent consideration payable to former
owners agreed in a business combination, e.g. in the form of payments upon the achievement of certain R&D milestones, is
recognized as a liability at fair value as of the acquisition date irrespective of the probability of payment. If the contingent
consideration was originally recognized as a liability, subsequent adjustments to the liability are recognized in profit or loss
(see Note D.18. “Liabilities related to business combinations and non-controlling interests” to our consolidated financial
statements included at Item 18. of this annual report).
3/ Impairment of goodwill and intangible assets
As discussed in Note B.6. “Impairment of property, plant and equipment, intangible assets, and investments accounted for using
the equity method” and in Note D.5. “Impairment of intangible assets and property, plant and equipment” to our consolidated
financial statements included at Item 18. of this annual report, we test our intangible assets for impairment periodically or when
there is any internal or external indication of impairment. Such indicators could include primarily but not exclusively (i) increased
market competition resulting from (for example) the introduction of a competitor’s product; (ii) earlier than expected loss of
exclusivity; (iii) increased pricing pressure; (iv) restrictions imposed by regulatory authorities on the manufacture or sale of a
product; (v) delay in the projected launch of a product; (vi) different from expected clinical study results; (vii) higher than
expected development costs or (viii) lower than expected economic performance.
We test for impairment on the basis of the same objective criteria that were used for the initial valuation. Our initial valuation and
ongoing tests are based on the relationship of the value of our projected future cash flows associated with the asset to either the
purchase price of the asset (for its initial valuation) or the carrying amount of the asset (for ongoing tests for impairment).
Significant underlying assumptions requiring the exercise of considerable judgement are applied in the future cash flow
projections used to determine the recoverability of intangible assets, including primarily but not exclusively (i) therapeutic class
market growth drivers; (ii) expected impacts from competing products (including but not exclusively generics and biosimilars);
(iii) projected pricing and operating margin levels; (iv) likely changes in the regulatory, legal or tax environment; and
(v) management’s estimates of terminal growth or attrition rates.
The recoverable amounts of intangible assets related to research and development projects are determined based on future net
cash flows, which reflect the development stage of the project and the associated probability of success of marketization of the
compound.
The projected cash flows are discounted to present value using a discount rate, which factors in the risks inherent in cash flow
projections.
Changes in facts and circumstances, assumptions and/or estimates may lead to future additional impairment losses or reversal of
impairment previously recorded.
Key assumptions relating to goodwill impairment are the perpetual growth rate and the post-tax discount rate. A sensitivity
analysis to the key assumptions is disclosed in Note D.5. “Impairment of intangible assets and property, plant and equipment” to
our consolidated financial statements included at Item 18. of this annual report.
4/ Pensions and post-retirement benefits
As described in Note B.23. “Employee benefit obligations” to our consolidated financial statements included at Item 18. of this
annual report, we recognize our pension and retirement benefit commitments as liabilities on the basis of an actuarial estimate of
the rights vested in employees and retirees at the end of the reporting period, net of the fair value of plan assets held to meet
those obligations. We prepare this estimate at least on an annual basis taking into account financial assumptions (such as
discount rates) and demographic assumptions (such as life expectancy, retirement age, employee turnover, and the rate of salary
increases).
We recognize all actuarial gains and losses (including the impact of a change in discount rate) immediately through equity.
Depending on the key assumptions used, the pension and post-retirement benefit expense could vary within a range of
outcomes and have a material effect on reported earnings. A sensitivity analysis to these key assumptions is set forth
in Note D.19.1. “Provisions for pensions and other benefits” to our consolidated financial statements included at Item 18. of this
annual report.
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5/ Taxes
As discussed in Note B.22. “Income tax expense” to our consolidated financial statements included at Item 18. of this annual
report, we recognize deferred income taxes on tax loss carry-forwards and on temporary differences between the tax base and
carrying amount of assets and liabilities. We calculate our deferred tax assets and liabilities using enacted tax rates applicable for
the years during which we estimate that the temporary differences are expected to reverse. We do not recognize deferred tax
assets when it is more likely than not that the deferred tax assets will not be realized. The recognition of deferred tax assets is
determined on the basis of profit forecasts for each tax group, and of the tax consequences of the strategic opportunities
available to Sanofi.
The positions adopted by Sanofi in tax matters are based on its interpretation of tax laws and regulations. Some of those positions
may be subject to uncertainty. In such cases, Sanofi assesses the amount of the tax liability on the basis of the following
assumptions: that its position will be examined by one or more tax authorities on the basis of all relevant information; that a
technical assessment is carried out with reference to legislation, case law, regulations, and established practice; and that each
position is assessed individually (or collectively where appropriate), with no offset or aggregation between positions. Those
assumptions are assessed on the basis of facts and circumstances existing at the end of the reporting period. When an uncertain
tax liability is regarded as probable, it is measured on the basis of Sanofi’s best estimate and recognized as a liability; uncertain tax
assets are not recognized.
6/ Provisions for risks
Sanofi and its subsidiaries and affiliates may be involved in litigation, arbitration or other legal proceedings. These proceedings
typically are related to product liability claims, intellectual property rights, compliance and trade practices, commercial claims,
employment and wrongful discharge claims, tax assessment claims, waste disposal and pollution claims, and claims under
warranties or indemnification arrangements relating to business divestitures. As discussed in Note B.12. “Provisions for risks” to
our consolidated financial statements included at Item 18. of this annual report, we record a provision where we have a present
obligation, whether 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 outflow of
resources. We also disclose a contingent liability in circumstances where we are unable to make a reasonable estimate of the
expected financial effect that will result from the ultimate resolution of the proceeding, or a cash outflow is not probable.
For additional details regarding the financial impact of provisions for risks see Notes D.19.3. “Other provisions” and D.22. “Legal
and Arbitral Proceedings” to our consolidated financial statements included at Item 18. of this annual report.
7/ Provisions for restructuring costs
Provisions for restructuring costs include collective redundancy or early retirement benefits, compensation for early termination
of contracts, and rationalization costs relating to restructured sites. Refer to Note D.19.2. to our consolidated financial statements
included at Item 18. of this annual report.
Provisions are estimated on the basis of events and circumstances related to present obligations at the end of the reporting
period and of past experience, and to the best of management’s knowledge at the date of preparation of the financial
statements. The assessment of provisions can involve a series of complex judgments about future events and can rely heavily on
estimates and assumptions. Given the inherent uncertainties related to these estimates and assumptions, the actual outflows
resulting from the realization of those risks could differ from our estimates.
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2024
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ITEM 5. Operating and Financial Review and Prospects
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A.2. Results of operations
Year ended
December 31, 2024
compared with year ended
December 31, 2023
Consolidated income statements
|
(€ million)
|
2024
|
as % of net
sales
|
2023(a)
|
as % of net
sales
|
|
Net sales
|
41,081
|
100.0%
|
37,817
|
100.0%
|
|
Other revenues
|
3,205
|
7.8%
|
3,801
|
10.1%
|
|
Cost of sales
|
(13,205)
|
-32.1%
|
(12,628)
|
-33.4%
|
|
Gross profit
|
31,081
|
75.7%
|
28,990
|
76.7%
|
|
Research and development expenses
|
(7,394)
|
-18.0%
|
(6,507)
|
-17.2%
|
|
Selling and general expenses
|
(9,183)
|
-22.4%
|
(8,933)
|
-23.6%
|
|
Other operating income
|
1,089
|
979
|
||
|
Other operating expenses
|
(4,382)
|
(3,443)
|
||
|
Amortization of intangible assets
|
(1,749)
|
(1,911)
|
||
|
Impairment of intangible assets
|
(248)
|
(896)
|
||
|
Fair value remeasurement of contingent consideration
|
(96)
|
(93)
|
||
|
Restructuring costs and similar items
|
(1,396)
|
(1,030)
|
||
|
Other gains and losses, and litigation
|
(470)
|
(196)
|
||
|
Operating income
|
7,252
|
17.7%
|
6,960
|
18.4%
|
|
Financial expenses
|
(1,073)
|
(1,293)
|
||
|
Financial income
|
519
|
584
|
||
|
Income before tax and investments accounted for using the equity
method
|
6,698
|
16.3%
|
6,251
|
16.5%
|
|
Income tax expense
|
(1,204)
|
(1,017)
|
||
|
Share of profit/(loss) from investments accounted for using the equity
method
|
60
|
(136)
|
||
|
Net income from continuing operations
|
5,554
|
5,098
|
||
|
Net income from discontinued operations
|
64
|
338
|
||
|
Net income
|
5,618
|
13.7%
|
5,436
|
14.4%
|
|
Net income attributable to non-controlling interests
|
58
|
36
|
||
|
Net income attributable to equity holders of Sanofi
|
5,560
|
13.5%
|
5,400
|
14.3%
|
|
Average number of shares outstanding (million)
|
1,251.4
|
1,251.7
|
||
|
Average number of shares after dilution (million)
|
1,256.1
|
1,256.4
|
||
|
•
Basic earnings per share from continuing operations (€)
|
4.40
|
4.06
|
||
|
•
Basic earnings per share from discontinued operations (€)
|
0.04
|
0.25
|
||
|
Basic earnings per share (€)
|
4.44
|
4.31
|
||
|
•
Diluted earnings per share from continuing operations (€)
|
4.39
|
4.30
|
||
|
•
Diluted earnings per share from discontinued operations (€)
|
0.04
|
4.05
|
||
|
Diluted earnings per share (€)
|
4.43
|
4.30
|
(a)
Figures for the comparative period (2023) have been re-presented on a consistent basis to reflect the classification of Opella as a discontinued
operation.
|
72
|
SANOFI
FORM 20-F
2024
|
|
PART I
|
|
ITEM 5. Operating and Financial Review and Prospects
|
A.2.1. Net sales
Consolidated net sales for the year ended
December 31, 2024
amounted to €
41,081
million,
8.6
% higher than in
2023
on a
reported basis. Exchange rate fluctuations had a negative effect of
2.7
percentage points overall, due mainly to adverse trends in
the Argentine peso, Japanese yen and Turkish lira against the euro. At constant exchange rates (CER), net sales rose by
11.3
%,
driven mainly by strong performances for Dupixent, Beyfortus and ALTUVIIIO.
Reconciliation of Net sales (IFRS) to Net sales at CER (non-IFRS)
|
(€ million)
|
2024
|
2023(a)
|
Change
|
|
Net sales (IFRS)
|
41,081
|
37,817
|
+8.6
%
|
|
Effect of exchange rates
|
992
|
||
|
Net sales at constant exchange rates (non-IFRS)
|
42,073
|
37,817
|
+11.3
%
|
(a)
Figures for the comparative period (2023) have been re-presented on a consistent basis to reflect the classification of Opella as a discontinued
operation.
To facilitate analysis and comparisons with prior periods, some figures are given at CER.
We calculate net sales at CER by recalculating net sales for the relevant period using the exchange rates that were used for the
previous period.
1/ Net sales by operating segment
Our net sales comprise the net sales generated by our Biopharma segment.
|
(€ million)
|
2024
|
2023(a)
|
Change on a
reported basis
(IFRS)
|
Change at constant
exchange rates
(non-IFRS)
|
|
Biopharma segment
|
41,081
|
37,817
|
+8.6
%
|
+11.3
%
|
|
Total net sales
|
41,081
|
37,817
|
+8.6
%
|
+11.3
%
|
(a)
Figures for the comparative period (2023) have been re-presented on a consistent basis to reflect the classification of Opella as a discontinued
operation.
|
SANOFI
FORM 20-F
2024
|
73
|
|
PART I
|
|
ITEM 5. Operating and Financial Review and Prospects
|
2/ Net sales by medicine, vaccine and geography
– 2024 compared with 2023
|
(€ million)
|
Total sales
|
Change
(reported)
|
Change
(CER)
|
United
States
|
Change
(CER)
|
Europe
|
Change
(CER)
|
Rest of
the world
|
Change
(CER)
|
|
Immunology
|
|||||||||
|
Dupixent
|
13,072
|
+22.0%
|
+23.1%
|
9,544
|
+17.2%
|
1,618
|
+31.9%
|
1,910
|
+50.8%
|
|
Kevzara
|
424
|
+18.8%
|
+21.0%
|
246
|
+26.2%
|
121
|
+5.2%
|
57
|
+38.3%
|
|
Rare diseases
|
|||||||||
|
Fabrazyme
|
1,047
|
+5.8%
|
+9.1%
|
531
|
+5.6%
|
254
|
+5.4%
|
262
|
+19.9%
|
|
Cerezyme
|
742
|
+8.2%
|
+20.3%
|
191
|
+1.1%
|
244
|
+6.6%
|
307
|
+45.5%
|
|
ALTUVIIIO (*)
|
682
|
+328.9%
|
+330.2%
|
617
|
+298.1%
|
—
|
—%
|
65
|
+1575.0%
|
|
Myozyme
|
671
|
-14.2%
|
-12.3%
|
234
|
-7.5%
|
260
|
-23.8%
|
177
|
+2.1%
|
|
Nexviazyme / Nexviadyme (*)
|
667
|
+56.9%
|
+61.2%
|
361
|
+32.7%
|
201
|
+101.0%
|
105
|
+132.1%
|
|
Alprolix
|
588
|
+8.9%
|
+9.6%
|
464
|
+5.5%
|
—
|
—%
|
124
|
+28.0%
|
|
Eloctate
|
368
|
-21.9%
|
-20.8%
|
236
|
-30.8%
|
—
|
—%
|
132
|
+5.4%
|
|
Cerdelga
|
333
|
+11.7%
|
+12.8%
|
186
|
+13.4%
|
128
|
+8.5%
|
19
|
+37.5%
|
|
Aldurazyme
|
297
|
+6.5%
|
+12.2%
|
72
|
+7.5%
|
84
|
+2.4%
|
141
|
+20.8%
|
|
Cablivi (*)
|
249
|
+9.7%
|
+9.7%
|
136
|
+21.4%
|
93
|
-6.1%
|
20
|
+23.5%
|
|
Xenpozyme (*)
|
151
|
+65.9%
|
+68.1%
|
81
|
+55.8%
|
46
|
+48.4%
|
24
|
+225.0%
|
|
Enjaymo (*)
|
105
|
+45.8%
|
+48.6%
|
58
|
+40.5%
|
17
|
+183.3%
|
30
|
+29.2%
|
|
Neurology
|
|||||||||
|
Aubagio
|
379
|
-60.3%
|
-59.4%
|
187
|
-59.1%
|
152
|
-65.2%
|
40
|
-17.2%
|
|
Oncology
|
|||||||||
|
Sarclisa (*)
|
471
|
+23.6%
|
+29.7%
|
200
|
+21.2%
|
134
|
+20.7%
|
137
|
+52.4%
|
|
Jevtana
|
290
|
-9.4%
|
-7.8%
|
214
|
-7.0%
|
7
|
-41.7%
|
69
|
-5.1%
|
|
Fasturtec
|
183
|
+7.6%
|
+8.2%
|
119
|
+8.2%
|
48
|
+9.3%
|
16
|
+5.9%
|
|
Other medicines
|
|||||||||
|
Lantus
|
1,628
|
+14.6%
|
+20.8%
|
638
|
+127.0%
|
340
|
-4.8%
|
650
|
-5.8%
|
|
Toujeo
|
1,227
|
+9.3%
|
+13.4%
|
217
|
+1.9%
|
479
|
+8.6%
|
531
|
+23.0%
|
|
Lovenox
|
982
|
-12.5%
|
-7.0%
|
9
|
+28.6%
|
567
|
-9.0%
|
406
|
-4.9%
|
|
Plavix
|
914
|
-3.6%
|
-0.4%
|
6
|
-25.0%
|
91
|
-5.2%
|
817
|
+0.4%
|
|
Thymoglobulin
|
492
|
+2.9%
|
+7.3%
|
312
|
+6.5%
|
39
|
+2.7%
|
141
|
+10.1%
|
|
Praluent
|
483
|
+14.5%
|
+15.2%
|
—
|
-100.0%
|
340
|
+14.9%
|
143
|
+15.0%
|
|
Rezurock (*)
|
470
|
+51.6%
|
+51.6%
|
425
|
+40.6%
|
28
|
+460.0%
|
17
|
+700.0%
|
|
Aprovel
|
416
|
-0.2%
|
+1.0%
|
4
|
-55.6%
|
73
|
-6.4%
|
339
|
+4.2%
|
|
Multaq
|
311
|
-9.6%
|
-9.6%
|
278
|
-10.3%
|
11
|
-8.3%
|
22
|
—%
|
|
Soliqua/iGlarLixi
|
227
|
+4.6%
|
+7.8%
|
75
|
-20.0%
|
48
|
+40.0%
|
104
|
+25.3%
|
|
Mozobil
|
74
|
-66.4%
|
-65.9%
|
12
|
-89.9%
|
39
|
-44.3%
|
23
|
-22.6%
|
|
Tzield (*)
|
54
|
+116.0%
|
+116.0%
|
52
|
+108.0%
|
1
|
—%
|
1
|
—%
|
|
Other
|
4,262
|
-11.7%
|
-7.7%
|
364
|
-16.9%
|
1,263
|
-6.8%
|
2,635
|
-6.8%
|
|
Industrial Sales
|
523
|
-5.1%
|
-5.1%
|
1
|
-75.0%
|
520
|
-1.5%
|
2
|
-89.5%
|
|
Vaccines
|
|||||||||
|
Polio / Pertussis / Hib Vaccines
& Boosters
|
2,741
|
-0.9%
|
+1.2%
|
679
|
-5.5%
|
497
|
+4.0%
|
1,565
|
+3.5%
|
|
Influenza Vaccines
|
2,555
|
-4.3%
|
-1.3%
|
1,433
|
+4.3%
|
640
|
-7.8%
|
482
|
-7.4%
|
|
RSV (Beyfortus) (*)
|
1,686
|
+208.2%
|
+214.4%
|
1,068
|
+167.3%
|
440
|
+214.3%
|
178
|
—%
|
|
Meningitis, Travel and Endemics
Vaccines
|
1,316
|
+3.9%
|
+5.4%
|
736
|
+1.5%
|
204
|
+28.7%
|
376
|
+3.2%
|
|
Biopharma
|
41,081
|
+8.6%
|
+11.3%
|
19,986
|
+16.2%
|
9,027
|
+2.3%
|
12,068
|
+10.7%
|
|
Of which new launches (*)
|
4,535
|
+102.7%
|
+106.3%
|
2,998
|
+97.0%
|
960
|
+95.3%
|
577
|
+199.1%
|
|
74
|
SANOFI
FORM 20-F
2024
|
|
PART I
|
|
ITEM 5. Operating and Financial Review and Prospects
|
3/ Net sales – Biopharma segment
In
2024
, net sales for the Biopharma segment (see " — A.1.5. Segment Information and Business net income” for detailed
disclosures about our operating segments and Note D.35. to our consolidated financial statements included at Item 18. of this
annual report) amounted to €
41,081
million, up
8.6%
on a reported basis and
11.3%
at CER. The
year-on-year
reported-basis
increase of €
3,264
million reflects adverse exchange rate effects amounting to €
992
million, and the following principal effects
at CER:
•
a solid performance from Dupixent (+€
2,480
million, a
23.1%
increase), ALTUVIIIO (+€
525
million), and Lantus (+
€295
million);
which more than offset a drop in sales of Aubagio (-€
567
million); and
•
triple-digit growth for Beyfortus (to €
1,173
million, a
214.4%
increase).
Comments on the performances of our major Biopharma segment products are provided below.
New launches
ALTUVIIIO
(
hemophilia A) posted sales of €
682
million in
2024
, with
90%
generated in the United States. Growth continued to be
driven by patient switches from older
factor medicines and increasingly, from non-factor treatments
. Sales also benefited from
supplies to Sanofi’s partner in Europe, where the medicine obtained regulatory approval. Total hemophilia A franchise sales
(ALTUVIIIO + Eloctate) amounted to €
1,050
million (+
67.8%
CER), representing an increase in Sanofi’s market share of factor-
based treatments as well as of the overall hemophilia A market.
Nexviazyme/Nexviadyme
(Pompe disease) sales were €
667
million (including €
361
million in the United States), up
61.2%
year-on-
year
, driven by switches from Myozyme/Lumizyme in the eligible late-onset Pompe disease popula
tion and by an increase in new
patients. Total sales for the Pompe franchise (Nexviazyme/Nexviadyme + Myozyme/Lumizyme) were €
1,338
million.
Nexviazyme/
Nexviadyme
now account for
50%
of total Pompe franchise sales.
Sarclisa
(multiple myeloma) reported sales of €
471
million, up
29.7%
CER, driven by strong growth in all three regions. Sales
reached €
200
million in the United States (
+21.2%
CER), €
134
million in Europe (
+20.7%
CER), and €
137
million in the Rest of the
World region (
+52.4%
CER).
Sales of
Rezurock
(chronic graft-versus-host disease) were €
470
million in
2024
, an increase of
51.6%
CER, driven by continued
strong uptake in the US (€
425
million, +
40.6%
CER)
, where the product is becoming the standard of care in the indicated setting
,
and by rapid uptake in launch countries (especially China and the United Kingdom). Globally, more than 9,400 patients have
been prescribed Rezurock (including 830 patients in early access or
managed access
programs) since launch, key drivers being
the product's real-world efficacy, tolerability and oral route of administration.
Cablivi
(acquired thrombotic thrombocytopenic purpura) reported 2024 sales of €
249
million (
+9.7%
CER), including €
136
million
(
+21.4%
CER) in the United States driven by patient growth.
Xenpozyme
(acid sphingomyelinase deficiency) achieved sales of €
151
million in
2024
(+
68.1%
CER), with most of the growth
coming in the United States.
Enjaymo
(cold agglutinin disease) posted sales of €
105
million, up
48.6%
CER
, driven by all regions. On November 29, 2024,
Sanofi entered into a definitive agreement with Recordati for the sale of its worldwide rights to Enjaymo.
Sales of
Tzield
(delayed onset of type 1 diabetes) amounted to €
54
million. As expected, sales are on a gradual uptrend, driven by
continued growth in
infusions
supported by increased awareness and screening.
Immunology & Inflammation
Dupixent
(collaboration with Regeneron) generated net sales of €
13,072
million in
2024
, up
22.0
% on a reported basis and
23.1%
at constant exchange rates. In the United States, sales of Dupixent reached €
9,544
million (+
17.2
%
CER),
driven by continuing
strong demand in the product’s approved indications: atopic dermatitis (AD), asthma, chronic rhinosinusitis with nasal polyposis
(CRSwNP), eosinophilic esophagitis, and prurigo nodularis. In Europe, the product’s net sales for
2024
totaled €
1,618
million, up
31.9
% CER, reflecting continued growth in all approved indications and emerging sales in chronic obstructive pulmonary disease
(COPD). In the Rest of the World region, Dupixent posted net sales of €
1,910
million (
+50.8
% CER), driven mainly by Japan and
China. More than one million patients are currently being treated with Dupixent globally.
Other medicines
Lantus
sales increased to €
1,628
million (+
20.8%
CER)
. In the United States, sales were up
127.0%
CER,
reflecting the withdrawal
of a competing medicine from the market and a lower comparative base in terms of net-price adjustments. In the Rest of the
World region and Europe, sales were down by
5.8%
and
4.8%
CER, respectively, mainly due to the strategy of switching to Toujeo
in China
.
Toujeo
sales increased by
13.4%
CER to €
1,227
million, driven by China, where the product’s market share now exceeds that of
Lantus. Sales slowly increased in the United States, mainly due to the withdrawal of a competing medicine.
Sales of
Fabrazyme
reached €
1,047
million
in
2024
(
+
9.1%
CER
), propelled by the Rest of World region due to growth in the
number of patients.
Lovenox
sales decreased by
7.0%
CER
to €
982
million, reflecting impacts from volume-based procurement (VBP) in China and
from biosimilar competition in Europe.
Plavix
sales decreased by
0.4%
CER to €
914
million due to a deceleration of market share in the Rest of the World region, partially
offset by volume growth in China from VBP inclusion.
|
SANOFI
FORM 20-F
2024
|
75
|
|
PART I
|
|
ITEM 5. Operating and Financial Review and Prospects
|
Cerezyme
sales rose by
20.3%
CER to €
742
million, reflecting growth in high-inflation countries (Argentina and Turkey) included
in the Rest of the World region.
Sales of
Myozyme/Lumizyme
decreased by
12.3%
CER in
2024
to €
671
million, reflecting switches to Nexviazyme/Nexviadyme as
mentioned above.
In
2024
, sales of
Alprolix
amounted to €
588
million, up
9.6%
CER
, driven by the Rest of the World region and the United States.
Thymoglobulin
sales rose by
7.3%
CER to
€492
million, driven by the United States and the Rest of the World region.
Net sales of
Praluent
for 2024 reached €
483
million, up
15.2%
CER
, underpinned by Europe and
the Rest of the World region
.
Sales of
Aubagio
were down
59.4%
CER at €
379
million, reflecting the loss of exclusivity in the United States in March 2023
followed by Europe in September 2023.
Eloctate
posted sales of €
368
million in
2024
, down
20.8%
CER
, reflecting switches to ALTUVIIIO.
Cerdelga
sales were €
333
million, up
12.8%
, underpinned by continued growth in the United States and Europe.
Vaccines
In
2024
, Vaccines sales were up
11.0%
on a reported basis and
13.5%
CER, at €
8,299
million. Sales reflected a strong Beyfortus
ramp-up, which more than offset the absence of COVID-19 vaccine sales in the period (versus €
226
million in 2023).
Sales of
Polio/Pertussis/Hib
Vaccines and Boosters
, reached €
2,741
million, up
1.2%
CER. Growth was driven by increased demand
for Booster vaccines across all regions, and continued expansion of our pediatric combination vaccines in the Rest of World
region. In the United States, Vaxelis became market leader in the three-dose primary series market for infants at the end of 2023.
Vaxelis sales in the United States are not consolidated by Sanofi, but profits are shared equally between Sanofi and Merck & Co.
Sales of
Influenza Vaccines
reached €
2,555
million, down
1.3%
CER, due to
soft
vaccination coverage.
Beyfortus
sales reached €
1,686
million, driven by a successful rollout in the first full year of launch. In collaboration with
AstraZeneca, who manufacture Beyfortus, increased supply was enabled by additional capacity.
Meningitis, Travel and Endemics Vaccines
sales increased by
5.4%
CER to €
1,316
million, reflecting the expansion of MenQuadfi in
Europe and the Rest of the World region.
4/ Net sales by geographical region
The table below sets forth our net sales for
2024
and
2023
by geographical region:
|
(€ million)
|
2024
|
2023
|
Change on
a reported basis
|
Change at constant
exchange rates
|
|
United States
|
19,986
|
17,262
|
+15.8
%
|
+16.2
%
|
|
Europe
|
9,027
|
8,816
|
+2.4
%
|
+2.3
%
|
|
Rest of the World
|
12,068
|
11,739
|
+2.8
%
|
+10.7
%
|
|
of which China
|
2,666
|
2,728
|
-2.3
%
|
-0.5
%
|
|
Total net sales
|
41,081
|
37,817
|
+8.6
%
|
+11.3
%
|
In
2024
, net sales in the
United States
reached €
19,986
million, up
15.8%
on a reported basis and
16.2%
CER. The strong
performance was driven by new launches including Beyfortus and ALTUVIIIO
(
€1,068
million and €
617
million respectively), and
by Dupixent (+
17.2%
CER at €
9,544
million) and Lantus. Sales growth was slightly dampened by lower sales of legacy medicines.
In
Europe
, net sales advanced by
2.4%
on a reported basis and
2.3%
at CER in
2024
to €
9,027
million. The effects of Aubagio
generics and a high comparative base for vaccines due to COVID-19 vaccine sales recorded in 2023 were more than offset by the
strong performance of Dupixent and Beyfortus.
In the
Rest of the World region
, net sales for
2024
increased by
2.8%
on a reported basis and by
10.7%
CER to €
12,068
million,
due to exceptional performances from Dupixent (
+50.8%
CER at €
1,910
million) and the launch of Beyfortus in two countries in
the southern hemisphere.
A.2.2. Other income statement items
1/ Other revenues
Other revenues
decreased by
15.7
% to €
3,205
million in
2024
(versus €
3,801
million in
2023
), due largely to the absence in 2024
of COVID-19 sales, which represented €509 million in 2023.
The
Other revenues
line item also includes VaxServe sales of non-Sanofi products, amounting to €
1,959
million (versus
€
2,167
million in 2023). In addition,
Other revenues
included sales of Opella products in markets retained by Sanofi (€
339
million);
sales to entities within the Opella scope that are classified as held for sale (€
163
million); royalties (€
121
million); and other services/
manufacturing services (€
623
million).
|
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2024
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|
|
ITEM 5. Operating and Financial Review and Prospects
|
2/ Gross profit
Gross profit
for
2024
amounted to €
31,081
million compared with €
28,990
million in
2023
,
an increase
of
7.2
%. Gross margin (the
ratio of gross profit to net sales) decreased, reaching
75.7
% in
2024
, versus
76.7
% in
2023
. The lower gross margin was primarily
due to the lack of COVID-19 revenues in 2024.
3/ Research and development expenses
Research and development (R&D) expenses amounted to €
7,394
million in
2024
, versus €
6,507
million in
2023
, an increase
of
13.6
%, reflecting an acceleration in immunology, neurology, vaccines and digital R&D, while spend on oncology was reduced.
R&D expenses represented
18.0
% of net sales in
2024
, versus
17.2
%
in
2023
.
4/ Selling and general expenses
Selling and general expenses amounted to €
9,183
million in
2024
(
22.4
% of net sales), versus €
8,933
million in
2023
(
23.6
% of net
sales), a
2.8%
year-on-year increase.
5/ Other operating income and expenses
Other operating income amounted to €
1,089
million in
2024
(versus €
979
million in
2023
), and other operating expenses
to €
4,382
million (versus €
3,443
million in
2023
).
Overall, this represented a net expense of €
3,293
million in
2024
, compared with a net expense of €
2,464
million in
2023
.
|
(€ million)
|
2024
|
2023
|
Change
|
|
Other operating income
|
1,089
|
979
|
110
|
|
Other operating expenses
|
(4,382)
|
(3,443)
|
(939)
|
|
Other operating income/(expenses), net
|
(3,293)
|
(2,464)
|
(829)
|
The increase of €
829
million mainly reflects an increase in the share of profits generated by the monoclonal antibody alliance
with Regeneron under the collaboration agreement (see Note C.1. to our consolidated financial statements), the principal factor
being increased sales of Dupixent.
The net contribution of items related to Regeneron to this line item is as follows:
|
(€ million)
|
2024
|
2023
|
|
Income & expense related to (profit)/loss sharing under the Monoclonal Antibody Alliance
|
(4,143)
|
(3,321)
|
|
Additional share of profit paid by Regeneron towards development costs
(a)
|
833
|
668
|
|
Reimbursement to Regeneron of selling expenses incurred
|
(637)
|
(543)
|
|
Total: Monoclonal Antibody Alliance
|
(3,947)
|
(3,196)
|
|
Other (mainly Zaltrap and Libtayo)
|
158
|
217
|
|
Other operating income/(expenses), net related to Regeneron Alliance
|
(3,789)
|
(2,979)
|
|
of which amount presented in “Other operating income”
|
166
|
227
|
(a)
As of December 31, 2024, the commitment received by Sanofi in respect of the additional profit share payable by Regeneron towards development
costs amounted to €
1.6 billion
, compared with €
2.1 billion
as of
December 31, 2023
(see Note D.21.to our consolidated financial statements).
6/ Amortization of intangible assets
Amortization charged against intangible assets amounted to €
1,749
million in
2024
, compared with €
1,911
million in
2023
.
This reduction was mainly driven by the impact of some intangible assets reaching the end of their amortization periods.
7/ Impairment of intangible assets, net of reversals
The monitoring of impairment indicators for other intangible assets led to the recognition of net impairment losses of
€
248
million in
2024
, comprising (i) an impairment loss of
€640 million
in connection with various research and development
projects - including a €239 million loss resulting from the discontinuation in February 2025 of a phase 3 clinical study
investigating of a vaccine candidate to prevent invasive E.coli disease - and (ii) an impairment reversal totalling €
392
million
recognized in connection with the divestment of the ProXTen technology platform and of Enjaymo, a commercialized product,
certain assets within which had been subject to impairment losses in previous years.
For
2023
, this line shows a net loss of €
896
million, mainly comprising an impairment loss of €833 million reflecting the impact of
the strategic decision to de-prioritize certain R&D programs, in particular those related to the NK Cell and ProXTen technology
platforms.
8/ Fair value remeasurement of contingent consideration
Fair value remeasurements of contingent consideration assets and liabilities (recognized on acquisitions or disposals of
activities) represented a net expense of €
96
million in
2024
, versus a net expense of €
93
million in
2023
. For 2024, this line item
mainly comprises a fair value adjustment to the amount of contingent consideration vis-à-vis Shire as a result of a transaction
carried out by Translate Bio, Inc. prior to the acquisition of that entity by Sanofi (expense of €94 million in 2024, versus
€74 million in 2023).
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2024
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|
|
ITEM 5. Operating and Financial Review and Prospects
|
9/ Restructuring costs and similar items
Restructuring costs and similar items
represented a total charge of €
1,396
million in
2024
, versus a charge of €
1,030
million in
2023
, an increase of €
366
million
. For
2024
, they mainly comprise costs relating to severance plans announced by Sanofi during
the year. For
2023
they included the impact of pension reform in France on future annuities under the rules of each severance
plan. Restructuring costs and similar items also include the effects of Sanofi's ongoing transformation projects.
10/ Other gains and losses, and litigation
Other gains and losses, and litigation
for
2024
represent a charge of €
470
millio
n, mainly comprising a provision recognized in
respect of the litigation related to Plavix (clopidogrel) in the US state of Hawaii (see Note D.22.)
For
2023
, this line item represented a charge of
€196
million
related to major litigation.
11/ Operating income
Operating income amounted to €
7,252
million in
2024
, versus €
6,960
million in
2023
.
12/ Financial income and expenses
Net financial expenses were €
554
million in
2024
, versus €
709
million in
2023
, a decrease of €
155
million.
The 2024 amount includes a financial expense of €
291
million (€
541
million in 2023) in respect of the liability recognized in the
balance sheet for estimated future royalties on US sales of Beyfortus, which were remeasured to reflect the successful US launch
of the product (see Notes C.2. and D.29. to our consolidated financial statements).
The cost of our net debt (see the definition in “— B. Liquidity and Capital Resources” below and Note D.29. to our consolidated
financial statements) was €
186
million in
2024
, compared with €
25
million in
2023
; the rise of €161 was mainly explained by a
lower level of income from short-term investments and deposits (
€413
million in 2024 versus €527 million in 2023, a decrease of
€114 million).
13/ Income before tax and investments accounted for using the equity method
Income before tax and investments accounted for using the equity method
reached €
6,698
million in
2024
, versus
€
6,251
million in
2023
.
14/ Income tax expense
Income tax expense represented €
1,204
million in
2024
, versus €
1,017
million in
2023
, giving an effective tax rate based on
consolidated net income of
18.0
% in
2024
, compared with
16.3
% in
2023
. The increase in the effective tax rate is mainly explained
by an increase in the weighted average tax rate applicable across all the tax jurisdictions in which Sanofi operates (see Note D.30
to our consolidated financial statements), including additional tax recognized pursuant to the application of Pillar Two rules
(€58 million in 2024).
The effective tax rate based on business net income is a non-IFRS financial measure (see definition under “— Segment
information — Business Net Income” above). It is calculated on the basis of business operating income, minus net financial
expenses and before (i) the share of profit/loss from investments accounted for using the equity method and (ii) net income
attributable to non-controlling interests. We believe the presentation of this measure, used by our management, is also useful for
investors as it provides a means to analyze the effective cost of taxes on our profits excluding (i) the reconciling items described
in section A.1.5. above and (ii) non-recurring or unusual tax effects. However, it should not be seen as a substitute for the effective
tax rate based on our consolidated net income.
When calculated on business net income, our effective tax rate was
19.8
% in
2024
, compared with
17.7%
in
2023
.
The main
factors in this year-on-year change were (i) the impact of the OECD Pillar Two model rules, which aim to ensure that large
multinationals pay a minimum level of tax on the income arising in each jurisdiction where they operate; and (ii) updates to
estimates of prior period tax liabilities following progress of reviews and closure of open issues with tax authorities in various
jurisdictions.
The table below reconciles our effective tax rate based on consolidated net income to our effective tax rate based on business
net income:
|
(as a percentage)
|
2024
|
2023
|
|
Effective tax rate based on consolidated net income (IFRS)
|
18.0%
|
16.3%
|
|
Tax effects:
|
||
|
Amortization and impairment of intangible assets
|
(0.4)
|
(0.3)
|
|
Restructuring costs and similar items
|
0.5
|
1.6
|
|
Other tax effects
|
1.7
|
0.1
|
|
Effective tax rate based on business net income (non-IFRS)
|
19.8%
|
17.7%
|
15/ Share of profit/(loss) from investments accounted for using the equity method
The line item
Share of profit/(loss) from investments accounted for using the equity method
showed net income of
€
60
million in 2024 (after charging an impairment loss of
€77 million
on the equity-accounted investment in EUROAPI – see Note
D.6.), compared with a net loss of €
136
million for 2023
.
|
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2024
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|
|
ITEM 5. Operating and Financial Review and Prospects
|
16/ Net income from continuing operations
Net income from continuing operations
amounted to €
5,554
million in
2024
, compared with €
5,098
million in
2023
.
17/ Net income from discontinued operations
Due to (i) the classification of Opella's assets and liabilities as held for sale since the announcement on October 21, 2024 of the
opening of exclusive negotiations with CD&R for the transfer of those assets and liabilities and (ii) the assessment that Opella
qualifies as a principal line of business within the meaning of IFRS 5, the net income or loss of Opella is presented in a separate line
item,
Net income from discontinued operations
(see Notes D.1. and D.36. to our consolidated financial statements included at
Item 18. of this annual report). This business reported net income of
€64
million in 2024, compared with net income of €338
million in 2023.
Net income from the Opella discontinued operation was €274 million lower in 2024 than in 2023. This year-on-year change
reflects in particular the acceleration in 2024 of the transformational project to create the standalone Opella entity; transaction
costs incurred in 2024 in respect of the proposed Opella transfer; and changes in gains from asset divestments within the Opella
scope between the two periods.
In addition, net income from the Opella discontinued operation for the year ended December 31, 2024 includes a net tax expense
of €122 million relating to the tax cost of the legal restructuring of the Opella scope. For the year ended December 31, 2023, net
income from the Opella discontinued operation includes a €365 million deferred tax liability recognized in respect of investments
in consolidated entities in light of the proposed separation of the Opella business.
18/ Net income attributable to non-controlling interests
Net income attributable to non-controlling interests
was €
58
million in
2024
, versus €
36
million in
2023
.
19/ Net income attributable to equity holders of Sanofi
Net income attributable to equity holders of Sanofi
amounted to €
5,560
million in
2024
, compared with €
5,400
million in
2023
.
Basic earnings per share for
2024
was €
4.44
versus €
4.31
for
2023
, based on an average number of shares outstanding
of
1,251.4
million in
2024
and
1,251.7
million in
2023
. Diluted earnings per share for
2024
was €
4.43
versus €
4.30
for
2023
, based
on an average number of shares after dilution of
1,256.1
million in
2024
and
1,256.4
million in
2023
.
A.2.3. Segment results
Our business operating income, as defined in Note D.35. (“Segment information”) to our consolidated financial statements
included at Item 18. of this annual report, was €
11,343
million in
2024
, compared with €
11,178
million in
2023
(a increase of
1.5
%). It
represented
27.6
% of our net sales in 2024, compared with
29.6
% in
2023
.
Our business operating income (non-IFRS) is reconciled with our operating income (IFRS) in N
ote "D.35. Segment information —
D.35.1.2. Business operating income" of the financial statements included at Item 18. of this annual report.
The table below sets forth our business operating income for the years ended
December 31, 2024
and
2023
:
|
(€ million)
|
December 31, 2024
|
December 31, 2023
|
Change
|
Change at CER
|
|
Biopharma operating segment
|
11,285
|
11,155
|
+1.2%
|
+7.3%
|
|
As percentage of sales
|
27.5%
|
29.5%
|
||
|
Other
|
58
|
23
|
+152.2%
|
+160.9 %
|
|
Business operating income (non-IFRS)
|
11,343
|
11,178
|
+1.5%
|
+7.6%
|
|
As percentage of sales
|
27.6%
|
29.6%
|
|
SANOFI
FORM 20-F
2024
|
79
|
|
PART I
|
|
ITEM 5. Operating and Financial Review and Prospects
|
A.3.
Results of operations
Year ended
December 31, 2023
compared with year ended
December 31, 2022
Consolidated income statements
|
(€ million)
(a)
|
2023
|
as % of net
sales
|
2022
|
as % of net
sales
|
|
Net sales
|
37,817
|
100.0%
|
37,651
|
100.0%
|
|
Other revenues
|
3,801
|
10.1%
|
2,910
|
7.7%
|
|
Cost of sales
|
(12,628)
|
-33.4%
|
(11,882)
|
-31.6%
|
|
Gross profit
|
28,990
|
76.7%
|
28,679
|
76.2%
|
|
Research and development expenses
|
(6,507)
|
-17.2%
|
(6,501)
|
-17.3%
|
|
Selling and general expenses
|
(8,933)
|
-23.6%
|
(8,739)
|
-23.2%
|
|
Other operating income
|
979
|
1,814
|
||
|
Other operating expenses
|
(3,443)
|
(2,523)
|
||
|
Amortization of intangible assets
|
(1,911)
|
(1,804)
|
||
|
Impairment of intangible assets
|
(896)
|
429
|
||
|
Fair value remeasurement of contingent consideration
|
(93)
|
27
|
||
|
Restructuring costs and similar items
|
(1,030)
|
(1,077)
|
||
|
Other gains and losses, and litigation
|
(196)
|
(143)
|
||
|
Operating income
|
6,960
|
18.4%
|
10,162
|
27.0%
|
|
Financial expenses
|
(1,293)
|
(430)
|
||
|
Financial income
|
584
|
205
|
||
|
Income before tax and investments accounted for using the equity
method
|
6,251
|
16.5%
|
9,937
|
26.4%
|
|
Income tax expense
|
(1,017)
|
(1,909)
|
||
|
Share of profit/(loss) from investments accounted for using the equity
method
|
(136)
|
55
|
||
|
Net income from continuing operations
|
5,098
|
8,083
|
||
|
Net income from discontinued operations
|
338
|
401
|
||
|
Net income
|
5,436
|
14.4%
|
8,484
|
22.5%
|
|
Net income attributable to non-controlling interests
|
36
|
113
|
||
|
Net income attributable to equity holders of Sanofi
|
5,400
|
14.3%
|
8,371
|
22.2%
|
|
Average number of shares outstanding (million)
|
1,251.7
|
1,251.9
|
||
|
Average number of shares after dilution (million)
|
1,256.4
|
1,256.9
|
||
|
•
Basic earnings per share from continuing operations (€)
|
4.06
|
6.38
|
||
|
•
Basic earnings per share from discontinued operations (€)
|
0.25
|
0.31
|
||
|
Basic earnings per share (€)
|
4.31
|
6.69
|
||
|
•
Diluted earnings per share from continuing operations (€)
|
4.05
|
6.35
|
||
|
•
Diluted earnings per share from discontinued operations (€)
|
0.25
|
0.31
|
||
|
Diluted earnings per share (€)
|
4.30
|
6.66
|
(a)
Figures for 2023 and 2022 have been re-presented on a consistent basis to reflect the classification of Opella as a discontinued operation.
(1)
Non-IFRS financial measure: see definition in “A.2.1 — Presentation of Net Sales.”
|
80
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SANOFI
FORM 20-F
2024
|
|
PART I
|
|
ITEM 5. Operating and Financial Review and Prospects
|
A.3.1. Net sales
Consolidated net sales for the year en
ded
December 31, 2023
a
mounted to €
37,817
million,
0.4%
higher than in
2022
on a
reported basis. Exchange rate fluctuations had a negative effect of
5.0
percentage points overall, due mainly to adverse trends in
the US dollar and Argentine peso against the euro. At CER
(1)
, net sales rose by
5.4%
, driven mainly by strong performances for
Dupixent and increased sales for our Vaccines business, more than offsetting lower sales for
other medicines
.
Reconciliation of Net sales (IFRS) to net sales at CER (non-IFRS)
|
(€ million)
(a)
|
2023
|
2022
|
Change
|
|
Net sales (IFRS)
|
37,817
|
37,651
|
+0.4
%
|
|
Effect of exchange rates
|
1,859
|
||
|
Net sales at constant exchange rates (non-IFRS)
|
39,676
|
37,651
|
+5.4
%
|
(a)
Figures for 2023 and 2022 have been re-presented on a consistent basis to reflect the classification of Opella as a discontinued operation.
1/ Net sales by operating segment
Our net sales comprise the net sales generated by our Biopharma segment.
|
(€ million)
(a)
|
2023
|
2022
|
Change on a
reported basis
|
Change at constant
exchange rates
|
|
Biopharma segment
|
37,817
|
37,651
|
+0.4%
|
+5.4%
|
|
Total net sales
|
37,817
|
37,651
|
+0.4%
|
+5.4%
|
(a)
Figures for comparative periods (2023 and 2022) have been re-presented on a consistent basis to reflect the classification of Opella as a discontinued
operation.
|
SANOFI
FORM 20-F
2024
|
81
|
|
PART I
|
|
ITEM 5. Operating and Financial Review and Prospects
|
2/ Net sales by medicine, vaccine and geography – 2023 compared with 2022
|
(€ million)
|
Total sales
|
Change
(CER)
|
Change
(reported)
|
United
States
|
Change
(CER)
|
Europe
|
Change
(CER)
|
Rest of
the world
|
Change
(CER)
|
|
Immunology
|
|||||||||
|
Dupixent
|
10,715
|
+34.0%
|
+29.2%
|
8,145
|
+32.6%
|
1,224
|
+30.9%
|
1,346
|
+46.2%
|
|
Kevzara
|
357
|
+9.7%
|
+5.3%
|
195
|
+8.6%
|
115
|
+8.5%
|
47
|
+17.0%
|
|
Rare diseases
|
|||||||||
|
Fabrazyme
|
990
|
+11.9%
|
+6.3%
|
503
|
+9.8%
|
241
|
+6.1%
|
246
|
+22.0%
|
|
ALTUVIIIO (*)
|
159
|
—%
|
—%
|
155
|
—%
|
—
|
—%
|
4
|
—%
|
|
Myozyme
|
782
|
-14.8%
|
-17.9%
|
254
|
-17.9%
|
341
|
-16.4%
|
187
|
-7.5%
|
|
Cerezyme
|
686
|
+10.1%
|
-2.0%
|
189
|
+0.5%
|
229
|
-3.3%
|
268
|
+29.2%
|
|
Nexviazyme / Nexviadyme (*)
|
425
|
+126.0%
|
+116.8%
|
272
|
+77.8%
|
100
|
+494.1%
|
53
|
+190.5%
|
|
Alprolix
|
540
|
+11.3%
|
+7.1%
|
440
|
+11.6%
|
—
|
—%
|
100
|
+10.2%
|
|
Eloctate
|
471
|
-15.5%
|
-18.8%
|
341
|
-22.0%
|
—
|
—%
|
130
|
+6.9%
|
|
Cerdelga
|
298
|
+6.9%
|
+3.5%
|
164
|
+5.6%
|
118
|
+6.3%
|
16
|
+23.5%
|
|
Aldurazyme
|
279
|
+16.3%
|
+8.6%
|
67
|
+13.1%
|
82
|
-4.7%
|
130
|
+34.5%
|
|
Cablivi (*)
|
227
|
+10.0%
|
+7.6%
|
112
|
+4.5%
|
98
|
+4.3%
|
17
|
+171.4%
|
|
Xenpozyme (*)
|
91
|
+347.6%
|
+333.3%
|
52
|
+980.0%
|
31
|
+106.7%
|
8
|
+800.0%
|
|
Enjaymo (*)
|
72
|
+240.9%
|
+227.3%
|
42
|
+152.9%
|
6
|
—%
|
24
|
+420.0%
|
|
Neurology
|
|||||||||
|
Aubagio
|
955
|
-52.6%
|
-52.9%
|
460
|
-67.8%
|
437
|
-14.3%
|
58
|
-31.6%
|
|
Oncology
|
|||||||||
|
Sarclisa (*)
|
381
|
+37.1%
|
+29.6%
|
165
|
+33.9%
|
111
|
+27.3%
|
105
|
+53.2%
|
|
Jevtana
|
320
|
-14.2%
|
-17.5%
|
230
|
-14.2%
|
12
|
-63.6%
|
78
|
+6.3%
|
|
Fasturtec
|
170
|
-1.1%
|
-4.0%
|
110
|
—%
|
43
|
-8.3%
|
17
|
+12.5%
|
|
Other medicines
|
|||||||||
|
Lantus
|
1,420
|
-32.0%
|
-36.9%
|
281
|
-62.6%
|
357
|
-15.7%
|
782
|
-16.9%
|
|
Toujeo
|
1,123
|
+6.8%
|
+1.2%
|
213
|
-23.0%
|
441
|
+5.5%
|
469
|
+29.1%
|
|
Lovenox
|
1,122
|
-7.8%
|
-13.3%
|
7
|
-58.8%
|
622
|
-5.5%
|
493
|
-8.9%
|
|
Plavix
|
948
|
+4.5%
|
-3.5%
|
8
|
-11.1%
|
96
|
-5.0%
|
844
|
+5.7%
|
|
Rezurock (*)
|
310
|
+54.6%
|
+49.8%
|
303
|
+51.9%
|
5
|
+400.0%
|
2
|
—%
|
|
Praluent
|
422
|
+15.2%
|
+12.2%
|
(1)
|
-101.8%
|
296
|
+30.6%
|
127
|
+46.7%
|
|
Thymoglobulin
|
478
|
+15.2%
|
+8.1%
|
292
|
+11.9%
|
37
|
+8.8%
|
149
|
+23.0%
|
|
Aprovel
|
417
|
-8.8%
|
-12.8%
|
9
|
+28.6%
|
78
|
-4.9%
|
330
|
-10.3%
|
|
Multaq
|
344
|
-7.6%
|
-10.2%
|
310
|
-8.1%
|
12
|
-25.0%
|
22
|
+15.0%
|
|
Soliqua/iGlarLixi
|
217
|
+5.6%
|
+0.9%
|
95
|
-18.5%
|
35
|
+24.1%
|
87
|
+40.3%
|
|
Mozobil
|
220
|
-14.6%
|
-15.7%
|
119
|
-22.1%
|
70
|
+6.0%
|
31
|
-20.0%
|
|
Tzield (*)
|
25
|
—%
|
—%
|
25
|
—%
|
—
|
—%
|
—
|
—%
|
|
Others
|
4,825
|
-8.5%
|
-14.6%
|
437
|
-29.5%
|
1,354
|
-14.2%
|
3,034
|
-1.9%
|
|
Industrial Sales
|
551
|
-8.7%
|
-9.4%
|
4
|
-76.5%
|
528
|
-8.3%
|
19
|
+72.7%
|
|
Vaccines
|
|||||||||
|
Influenza Vaccines
|
2,669
|
-5.5%
|
-10.3%
|
1,406
|
-12.8%
|
694
|
+1.9%
|
569
|
+8.2%
|
|
Polio / Pertussis / Hib vaccines & Boosters
|
2,766
|
+1.4%
|
-3.3%
|
721
|
-5.7%
|
477
|
-0.2%
|
1,568
|
+5.5%
|
|
RSV vaccines (Beyfortus) (*)
|
547
|
—%
|
—%
|
407
|
—%
|
140
|
—%
|
—
|
—%
|
|
Meningitis, travel and endemics vaccines
|
1,266
|
+0.5%
|
-3.3%
|
730
|
-0.8%
|
157
|
+40.2%
|
379
|
-7.4%
|
|
Biopharma
|
37,817
|
+5.4%
|
+0.4%
|
17,262
|
+5.2%
|
8,816
|
+4.2%
|
11,739
|
+6.4%
|
|
Of which new launches (*)
|
2,237
|
+145.3%
|
+135.2%
|
1,533
|
+156.7%
|
491
|
+129.3%
|
213
|
+113.3%
|
|
82
|
SANOFI
FORM 20-F
2024
|
|
PART I
|
|
ITEM 5. Operating and Financial Review and Prospects
|
3/ Net sales – Biopharma segment
In
2023
, net sales for the Biopharma segment amounted to €
37,817
million, up
0.4%
on a reported basis and
5.4%
at CER.
Comments on the performances of our major Biopharma segment products are provided below.
New launches
ALTUVIIIO
, a first-in-class, once-weekly factor VIII replacement therapy that confers significant protection against bleeds for
hemophilia A patients, was launched in the United States at the end of March 2023 and generated sales of €
159
million in
2023
.
Sales of
Nexviazyme/Nexviadyme
reached €
425
million, including €
272
million in the United States, reflecting switches of eligible
Pompe patients (advanced stage) from Myozyme/Lumizyme and increased uptake by new patients.
Net sales of
Rezurock
reached €
310
million, a significant increase of
54.6%
CER. Since its launch, approximately 4,000 patients
have been treated, with strong persistency rates. Sanofi recently reacquired rights to be the sole marketing authorization holder
for Rezurock in China, where in August 2023 the China National Medical Products Administration (NMPA) approved belumosudil
(Rezurock) for the treatment of patients aged 12 years and older with chronic Graft Versus Host Disease (cGVHD) who have an
inadequate response to corticosteroids or other systemic treatments.
Net sales of
Sarclisa
(multiple myeloma) in
2023
were €
381
million, up
37.1%
CER
, with good performances in all three regions: the
United States (€
165
million, +
33.9%
CER); Europe (€
111
million, +
27.3%
CER); and the Rest of the Word, especially Japan where
sales reached €77 million (+
28.8% CER).
Cablivi
posted net sales of €
227
million in
2023
, up
10.0%
CER, reflecting increased awareness of acquired thrombotic thrombo-
cytopenic purpura (aTTP), and treatment in line with guidelines from the International Society on Thrombosis and Haemostasis
(ISTH) recommending first-line use of Cablivi for all aTTP patients. Sales reached €
112
million in the United States (+
4.5%
CER),
and in Europe net sales were up
4.3%
CER at €
98
million, mainly due to greater market penetration as a result of increased
product awareness.
Xenpozyme
reported net sales of €
91
million, mainly in the United States (€
52
million) and Europe (€
31
million)
.
Net sales of
Enjaymo
reached €
72
million, with sales being generated primarily in the United States and Japan.
In the second quarter of 2023, Sanofi acquired Provention, adding
Tzield
, an innovative first-in-class treatment for people with
type 1 diabetes, to the core medicines portfolio. In
2023
, Tzield sales were €25 million, in line with the expected gradual ramp-up
as a result of early patient identification programs.
Immunology & Inflammation
Dupixent
(developed in collaboration with Regeneron) generated net sales of €
10,715
million in
2023
, up
29.2%
on a reported
basis and
34.0%
at CER. In the United States, sales of Dupixent reached €
8,145
million in
2023
, up
32.6%
CER, boosted by
continuing strong demand in the product's approved indications: atopic dermatitis, asthma, nasal polyps, eosinophilic
esophagitis, and prurigo nodularis. In Europe, the product posted
2023
net sales of €
1,224
million, up
30.9%
CER, driven by
continuing growth in atopic dermatitis, asthma and nasal polyps. In the Rest of the World
region, Dupixent posted net sales of
€
1,346
million (
+46.2%
CER), driven mainly by Japan and China.
Other medicines
Lantus
sales fell to €
1,420
million (
-32.0%
CER) in 2023
. In the United States, sales were down
62.6%
CER,
reflecting lower net
selling prices due to a change in reimbursement channel mix and an inventory adjustment in anticipation of the previously-
announced 2024 US list price reduction. In the Rest of the World region, sales were down by
16.9%
CER, mainly due to the Value
Based Procurement rollout in China.
Toujeo
net sales were €
1,123
million in 2023, up
6.8%
CER. Growth was driven mainly by the Rest of the World region (
+29.1%
CER), due to the Value Based Procurement program in China and the associated acceleration in sales volumes. The impact was
partly offset by lower sales in the United States (
-23.0%
CER) due to price erosion.
Net sales of the Fabry
disease
treatment
Fabrazyme
in
2023
were €
990
million (+
11.9%
CER), driven by the Rest of the World
region (+
22.0%
CER at €
246
million) followed by the United States (+
9.8%
CER at
€
503
million). The year-on-year increase
reflects more patients adopting the product across all three regions.
Net sales of
Lovenox
were €
1,122
million in
2023
, down
7.8%
CER, reflecting strong biosimilar competition across all geographies.
Plavix
net sales reached €
948
million in
2023
, up
4.5%
CER
, in line with consistent volume growth in China.
Sales of
Myozyme/Lumizyme
(Pompe disease) were down year-on-year (
-14.8%
CER at €
782
million) as patients switched to
Nexviazyme. In
2023
, sales of Nexviazyme/Nexviadyme
represented
35.2%
of total sales for the Pompe disease franchise.
Cerezyme
sales were up
10.1%
CER at €
686
million on a solid performance in the Rest of the World region (+
29.2%
CER
at €
268
million), driven by new patients on therapy and favorable pricing.
In
2023
, net sales of
Alprolix
were €
540
million, up
11.3%
CER, driven by the United States where sales of the product reached
€
440
million, up
11.6%
CER.
Praluent
posted net sales of
€
422
milli
on, up
15.2%
CER. Growth was reported in Europe (+
30.6%
CER) and the Rest of the World
region (+46.7% CER, due mainly due to China), though the effect was partly offset by lower sales in the United States following
the release of a glyceryl trinitrate.
Thymoglobulin
sales rose by
15.2%
CER
in
2023
to €
478
million, driven by the United States.
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2024
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ITEM 5. Operating and Financial Review and Prospects
|
Eloctate
generated net sales of €
471
million in
2023
, down
15.5%
CER, due to the adoption of ALTUVIIIO and competitive
pressures
.
Net sales of
Aubagio
fell by
52.6%
CER in
2023
to €
955
million, mainly due to the arrival of generics. In the United States, where
generics came on the market on March 12, 2023, Aubagio fell by
67.8%
CER at €
460
million. In Europe, generic competition for
Aubagio began at the end of September 2023.
Cerdelga
sales rose by
6.9%
CER to €
298
million, with growth reported in the United States (+
5.6%
CER at €
164
million), Europe
(+
6.3%
CER at €
118
million), and the Rest of the World region (+
23.5%
CER at €
16
million)
as new patients adopted the product or
switched treatment.
Vaccines
In
2023
, the vaccines posted total net sales of €
7,477
million, up
3.6%
on a reported basis and
8.6%
CER. T
he main driver was the
launch of Beyfortus, which more than offset slow sales of influenza vaccines
.
Sales of
Influenza Vaccines
decreased by
5.5%
CER in
2023
to €
2,669
million, due to a slight reduction in vaccine uptake and
increased competition in the United States.
Polio/Pertussis/Hib Vaccines and boosters
, posted net sales of €
2,766
million in
2023
(
+1.4%
CER), reflecting the ongoing
expansion of Vaxelis in the United States at the expense of pentavalent vaccines in the first series of infant vaccinations.
In the
US,
Vaxelis
became market leader at the end of 2023 in the three-dose primary series market. As a reminder, sales of
Vaxelis
in
the United States are not consolidated, and the profits are shared equally between Sanofi and Merck & Co.
The
Beyfortus
launch began in late September 2023, in the United States and Europe. Sales of the product reached €
547
million
in
2023
, reflecting strong demand through All Infant Protection Programs rolled out in United States, Spain and France
.
Net sales of
Meningitis, Travel and Endemics Vaccines
for
2023
reached €
1,266
million, up
0.5%
CER, with
40.2%
growth in
Europe more than offsetting lower sales in the Rest of the World region (
-7.4%
CER) and the United States (
-0.8%
CER at
€
730
million), reflecting a favorable pattern in the US, while the divestment of the Japanese Encephalitis vaccine in 2022
impacted the Rest of the World region.
4/ Net sales by geographical region
The table below sets forth our net sales for
2023
and
2022
by geographical region:
|
(€ million)
|
2023
|
2022
|
Change on
a reported basis
|
Change at constant
exchange rates
|
|
United States
|
17,262
|
16,986
|
+1.6%
|
+5.2%
|
|
Europe
|
8,816
|
8,490
|
+3.8%
|
+4.2%
|
|
Rest of the World
|
11,739
|
12,175
|
-3.6%
|
+6.4%
|
|
of which China
|
2,728
|
2,950
|
-7.5%
|
-0.3%
|
|
Total net sales
|
37,817
|
37,651
|
+0.4%
|
+5.4%
|
In
2023
, net sales in the
United States
reached €
17,262
million, up
5.2%
at CER, reflecting a strong performance from Dupixent
(+
32.6%
CER at €
8,145
million) and the
launches of Beyfortus (€
407
million) and ALTUVIIIO, (€
155
million) partly offsetting by the
impact of generics of Aubagio and lower sales of Lantus and influenza vaccines .
In
Europe
, net sales advanced by
4.2%
at CER in
2023
to €
8,816
million. The performance of Dupixent
(+
30.9
% CER at
€
1,224
million) and
the launch of Beyfortus (€
140
million) were partially offset by the impact of Aubagio generics and the decline
in sales of non-strategic products.
In the
Rest of the World region
, net sales for
2023
increased by
6.4%
at CER to €
11,739
million, due to exceptional performances
from Dupixent (
+46.2%
CER at €
1,346
million).
A.3.2. Other income statement items
1/ Other revenues
Other revenues increased by
30.6%
to €
3,801
million in
2023
(versus €
2,910
million in
2022
). This line item mainly comprises
VaxServe sales of non-Sanofi vaccines (€2,167 million in
2023
versus €1,567 million in
2022
). The year-on-year increase also reflects
higher revenues from manufacturing services contracts and revenues from the COVID-19 vaccine (in particular, €411 million received
from the US government in connection with the supply contract for the recombinant COVID-19 vaccine candidate).
2/ Gross profit
Gross profit for
2023
amounted to €
28,990
million compared with €
28,679
million in
2022
, an increase of
1.1%
. Gross margin (the
ratio of gross profit to net sales) also rose, reaching
76.7%
in
2023
, versus
76.2%
in
2022
. The year-on-year increase in gross
margin reflects largely a favorable product mix and revenues related to the COVID-19 vaccine, which more than offset the effects
of generic competition for Aubagio and unfavorable pricing effects for
Lantus
in the United States.
3/ Research and development expenses
Research and development (R&D) expenses amounted to €
6,507
million in
2023
, versus €
6,501
million in
2022
, an increase
of
0.1%
, as investment stabilized. R&D expenses represented
17.3%
of net sales in
2023
, the same as in
2022
.
|
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ITEM 5. Operating and Financial Review and Prospects
|
4/ Selling and general expenses
Selling and general expenses amounted to €
8,933
million in
2023
(
23.6%
of net sales), versus €
8,739
million in
2022
(
23.2%
of net
sales), a
2.2%
increase.
5/ Other operating income and expenses
Other operating income amounted to €
979
million in
2023
(versus €
1,814
million in
2022
), and other operating expenses
to €
3,443
million (versus €
2,523
million in
2022
).
Overall, this represented a net expense of €
2,464
million in
2023
, compared with a net expense of €
709
million in
2022
.
|
(€ million)
|
2023
|
2022
|
Change
|
|
Other operating income
|
979
|
1,814
|
(835)
|
|
Other operating expenses
|
(3,443)
|
(2,523)
|
(920)
|
|
Other operating income/(expenses), net
|
(2,464)
|
(709)
|
(1,755)
|
The increase of €
1,755
million mainly reflects an increase in the share of profits generated by the monoclonal antibody alliance
with Regeneron under the collaboration agreement, the principal factors being (i) increased sales of Dupixent and (ii) the impact
in 2022 of the recognition of the proceeds arising from the restructuring of the immuno-oncology (IO) collaboration agreement
between Sanofi and Regeneron (see Note C.1. to our consolidated financial statements).
The net contribution of items related to Regeneron to this line item is as follows:
|
(€ million)
|
2023
|
2022
|
|
Income & expense related to (profit)/loss sharing under the Monoclonal Antibody Alliance
|
(3,321)
|
(2,325)
|
|
Additional share of profit paid by Regeneron towards development costs
(a)
|
668
|
434
|
|
Reimbursement to Regeneron of selling expenses incurred
|
(543)
|
(476)
|
|
Total: Monoclonal Antibody Alliance
|
(3,196)
|
(2,367)
|
|
Immuno-Oncology Alliance
|
—
|
16
|
|
Other (mainly Zaltrap and Libtayo)
|
217
|
1,120
|
|
Other operating income/(expenses), net related to Regeneron Alliance
|
(2,979)
|
(1,231)
|
|
of which amount presented in “Other operating income”
|
227
|
1,147
|
(a)
As of December 31, 2023, the commitment received by Sanofi in respect of the additional profit share payable by Regeneron towards development
costs amounted
to €
2.1 billion
, compared with €
2.7 billion
as of
December 31, 2022
.
6/ Amortization of intangible assets
Amortization charged against intangible assets amounted to €
1,911
million in
2023
, compared with €
1,804
million in
2022
.
This €
107
million increase was mainly due to (i) increased amortization expense in 2023 against Eloctate franchise assets further
to FDA approval for ALTUVIIIO (€206 million) and (ii) the acquisition of Provention Bio, Inc., which led to €144 million of
amortization being charged from the acquisition date against the intangible asset related to Tzield product; those effects were
partly offset by the non-recurrence of the €226 million accelerated amortization charge taken in 2022 against Libtayo rights
following the restructuring of the IO LCA with Regeneron (see Note C.1. to our consolidated financial statements).
7/ Impairment of intangible assets, net of reversals
For
2023
, this line shows a net loss of €
896
million, mainly comprising an impairment loss of €833 million reflecting the impact of
the strategic decision to de-prioritize certain R&D programs, in particular those related to the NK Cell and ProXTen technology
platforms.
For
2022
, this line item shows a net gain of €
429
million, mainly comprising:
•
a reversal of €2,154 million relating to Eloctate
franchise assets, following FDA approval of ALTUVIIIO (the commercial name of
efanesoctocog alpha, corresponding to the BIVV001 project); and
•
an impairment loss of €1,586 million relating to the development project for SAR444245 (non-alpha interleukin-2), based on
revised cash flow projections reflecting unfavorable developments in the launch schedule.
8/ Fair value remeasurement of contingent consideration
Fair value remeasurements of contingent consideration assets and liabilities recognized in business combinations represented a
net expense of €
93
million in
2023
, versus a net gain of €
27
million in
2022
. For 2023, this line item mainly comprises a change in
the amount of contingent consideration payable to Shire as a result of a transaction carried out by Translate Bio, Inc. prior to the
acquisition of that entity by Sanofi (expense of €74 million in 2023, versus €2 million in 2022).
9/ Restructuring costs and similar items
Restructuring costs and similar items represented a total charge of €
1,030
million in
2023
, versus a charge of €
1,077
million in
2022
.
|
SANOFI
FORM 20-F
2024
|
85
|
|
PART I
|
|
ITEM 5. Operating and Financial Review and Prospects
|
Restructuring costs and similar items decreased by €
47
million year-on-year. For
2023
they include the impact of French pension
reforms on future annuities under the rules of each severance plan, while for
2022
they mainly comprised severance costs
recognized further to the announcements made during that period. Also included in restructuring costs are the impacts of
ongoing transformational projects.
10/ Other gains and losses, and litigation
For
2023
, this line item represented a charge of
€196
million
related to major litigations.
For
2022
, this line item represented a charge of
€143
million
, comprising the pre-tax loss arising on the deconsolidation of
EUROAPI (see Note D.1.3.) and costs related to major litigation.
11/ Operating income
Operating income amounted to €
6,960
million in
2023
, versus €
10,162
million in
2022
.
The year-on-year decrease was largely due to the movements in impairment allowances against intangible assets.
12/ Financial income and expenses
Net financial expenses were €
709
million in
2023
, versus €
225
million in
2022
, a increase of €
484
million.
The cost of our net debt (see the definition in “— Liquidity and Capital Resources” below and Note D.29. to our consolidated
financial statements, included at Item 18. of this annual report) was €
25
million in
2023
, compared with €
123
million in
2022
; the
reduction of €
98
million was largely due to an increased return on cash, cash equivalents and associated derivatives (€527 million
in 2023 versus €239 million in 2022, an increase of €288 million).
In addition, a financial expense of
€541
million was recognized in
2023
in respect of the liability recognized in the balance sheet
for estimated future royalties on US sales of Beyfortus, which was remeasured as of December 31, 2023 to reflect the very
successful US launch of the product (see Notes C.2. and D.29. to our consolidated financial statements).
13/ Income before tax and investments accounted for using the equity method
Income before tax and investments accounted for using the equity method reached €
6,251
million in
2023
, versus €
9,937
million
in
2022
.
14/ Income tax expense
Income tax expense represented
€1,017 million
in
2023
, versus
€1,909 million
in
2022
, giving an effective tax rate based on
consolidated net income of
16.3%
in
2023
, compared with
19.2%
in
2022
. The reduction in income tax expense was mainly due to
a year-on-year increase in net amortization and impairment losses charged against intangible assets (impact of €563 million in
2023 and €268 million in 2022). In addition, a deferred tax asset of €133 million was recognized on the remeasurement of the
financial liability recognized in the balance sheet to reflect estimated future royalties on US sales of Beyfortus
In 2022, income tax expense included the effect of the reversal of impairment losses relating to ALTUVIIIO (€503 million impact)
following FDA approval.
The effective tax rate based on business net income is a non-IFRS financial measure (see definition under “— Segment
information — Business Net Income” above). It is calculated on the basis of business operating income, minus net financial
expenses and before (i) the share of profit/loss from investments accounted for using the equity method and (ii) net income
attributable to non-controlling interests. We believe the presentation of this measure, used by our management, is also useful for
investors as it provides a means to analyze the effective tax cost of our current business activities. It should not be seen as a
substitute for the effective tax rate based on consolidated net income.
The table below reconciles our effective tax rate based on consolidated net income to our effective tax rate based on business
net income:
|
(as a percentage)
|
2023
|
2022
|
|
Effective tax rate based on consolidated net income (IFRS)
|
16.3
%
|
19.2
%
|
|
Tax effects:
|
||
|
Amortization and impairment of intangible assets
|
(0.3)
|
(0.4)
|
|
Restructuring costs and similar items
|
1.6
|
(0.3)
|
|
Other tax effects
|
0.1
|
1.2
|
|
Effective tax rate based on business net income (non-IFRS)
|
17.7
%
|
19.7
%
|
15/ Share of profit/(loss) from investments accounted for using the equity method
The line item
Share of profit/(loss) from investments accounted for using the equity method
was a net loss of €
136
million in
2023 (including an impairment loss of
€231 million
on the equity-accounted investment in EUROAPI – see Note D.6.), compared
with net income of €
55
million for 2022
16/ Net income from continuing operations
Net income from continuing operations
amounted to
€5,098 million
in
2023
, compared with
€8,083 million
in
2022
.
|
86
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FORM 20-F
2024
|
|
PART I
|
|
ITEM 5. Operating and Financial Review and Prospects
|
17/ Net income from discontinued operations
In accordance with IFRS 5, the net income or loss of the Opella business is presented in a separate line item, “
Net income from
discontinued operations
” (see Notes D.1. and D.36. to our consolidated financial statements). This business reported a net
income of €
338
million in 2023, compared with net income of €
401
million in 2022. In 2023, this line item includes income tax
expense of €365 million arising from taxable temporary differences relating to holdings in subsidiaries, because it became
probable that those differences would reverse.
18/ Net income attributable to non-controlling interests
Net income attributable to non-controlling interests was
€36 million
in
2023
, versus €
113
million in
2022
.
19/ Net income attributable to equity holders of Sanofi
Net income attributable to equity holders of Sanofi amounted to
€5,400 million
in
2023
, compared with
€8,371 million
in
2022
.
Basic earnings per share for
2023
was €
4.31
versus €
6.69
for
2022
, based on an average number of shares outstanding
of
1,251.7
million in
2023
and
1,251.9
million in
2022
. Diluted earnings per share for
2023
was €
4.30
versus €
6.66
for
2022
, based
on an average number of shares after dilution of
1,256.4
million in
2023
and
1,256.9
million in
2022
.
A.3.3. Segment results
Our business operating income, as defined in Note D.35. (“Segment information”) to our consolidated financial statements
included at Item 18. of this annual report, was €
11,178
million in
2023
compared with €
12,793
million in 2022 (a decrease of
12.6%
).
It represented
29.6
% in
2023
compared with
34.0 %
in 2022.
Our business operating income (non-IFRS) is reconciled with our operating income (IFRS) in Note "D.35. Segment information —
D.35.1.2. Business operating income" of the financial statements included at Item 18. of this annual report.
The table below sets forth our business operating income for the years ended December 31,
2023
and 2022:
|
(€ million)
|
December 31,
2023
|
December 31,
2022
|
Change
|
|
Biopharma operating segment
|
11,155
|
12,764
|
-12.6%
|
|
As percentage of sales
|
29.5%
|
33.9%
|
|
|
Other
|
23
|
29
|
-20.7%
|
|
Business operating income (non-IFRS)
|
11,178
|
12,793
|
-12.6%
|
|
As percentage of sales
|
29.6%
|
34.0%
|
B. Liquidity and capital resources
Our operations generate significant positive cash flows. We fund our day-to-day investments (with the exception of significant
acquisitions) primarily with operating cash flow, and pay regular dividends on our shares.
“Net debt” is a non-IFRS financial indicator which is reviewed by our management, and which we believe provides useful
information to measure our overall liquidity and capital resources. We define “net debt” as (i) the sum total of long-term debt,
short-term debt and current portion of long-term debt, and interest rate and currency derivatives used to manage debt, minus
(ii) the sum total of cash and cash equivalents and interest rate and currency derivatives used to manage cash and cash
equivalents. Lease liabilities are not included in net debt.
As of
December 31, 2024
our net debt was €
8,772
million, compared with €
7,793
million as of
December 31, 2023
and
€
6,437
million as of
December 31, 2022
. For an explanation of the increase in our net debt, refer to section “— B.2. Consolidated
Balance Sheet and Debt” below.
In order to assess our financing risk, we also use the “gearing ratio," a non-IFRS financial measure (see table in section
“— B.2. Consolidated Balance Sheet and Debt” below). We define the gearing ratio as the ratio of net debt to total equity. As
of
December 31, 2024
, our gearing ratio was
11.3
%, compared with
10.5
% as of
December 31, 2023
and
8.6%
as of
December 31,
2022
.
Because our net debt and gearing ratio are not standardized measures, they may not be directly comparable with the non-IFRS
financial measures of other companies using the same or similar non-IFRS financial measures. Despite the use of non-IFRS
measures by management in setting goals and measuring performance, these are non-IFRS measures that have no standardized
meaning prescribed by IFRS.
|
SANOFI
FORM 20-F
2024
|
87
|
|
PART I
|
|
ITEM 5. Operating and Financial Review and Prospects
|
B.1. Consolidated statement of cash flows
Generally, factors that affect our earnings – for example, pricing, volume, costs and exchange rates – flow through to cash from
operations. The most significant source of cash from operations is sales of our branded medicines and vaccines. Receipts of
royalty payments also contribute to cash from operations.
Summarized consolidated statements of cash flows
|
(€ million)
(a)
|
2024
|
2023
|
2022
|
|
Net cash provided by/(used in) continuing operating activities
|
8,607
|
9,271
|
9,638
|
|
Net cash provided by/(used in) operating activities of the discontinued Opella business
|
|
|
|
|
Net cash provided by/(used in) operating activities
|
9,081
|
10,258
|
10,526
|
|
Net cash provided by/(used in) continuing investing activities
|
(4,298)
|
(4,950)
|
(2,117)
|
|
Net cash provided by/(used in) investing activities of the discontinued Opella business
|
(
|
(
|
|
|
Net cash provided by/(used in) investing activities
|
(4,407)
|
(6,200)
|
(2,075)
|
|
Net cash provided by/(used in) continuing financing activities
|
(5,751)
|
(8,048)
|
(5,807)
|
|
Net cash provided by/(used in) financing activities of the discontinued Opella business
|
(
|
(
|
(
|
|
Net cash provided by/(used in)financing activities
|
(5,763)
|
(8,052)
|
(5,821)
|
|
Impact of exchange rates on cash and cash equivalents
|
(13)
|
(32)
|
8
|
|
Impact on cash and cash equivalents of the reclassification of the Opella business to
"Assets held for sale"
|
(
|
|
|
|
Net change in cash and cash equivalents
|
(
|
(
|
|
|
Cash and cash equivalent, beginning of period
|
8,710
|
12,736
|
10,098
|
|
Cash and cash equivalent, end of period
|
7,441
|
8,710
|
12,736
|
(a)
Cash flows of the Opella business are presented separately in accordance with IFRS 5 (Non-current Assets Held for sale and Discontinued Operations).
Year Ended December 31, 2024 Compared with Year Ended December 31, 2023
Net cash provided by/used in continuing operating activities
represented a net cash inflow of
€
8,607
million in
2024
,
compared with €
9,271
million in
2023
. The year-on-year decrease was due mainly to a higher level of operating cash flow before
changes in working capital (€
9,222
million in
2024
, versus €
8,858
million in
2023
), more than offset by a net decrease of
€
615
million in the working capital requirement in
2024
(versus a net increase of €
413
million in
2023
),
including a decrease in US
rebate provisions (€1,330 million) following the decision to reduce the Lantus list price effective January 1, 2024.
Net cash provided by/used in continuing investing activities
represented a net cash outflow of €
4,298
million in
2024
,
compared with a net outflow of €
4,950
million in
2023
. The net outflow in
2024
was mainly a result of the acquisition of
Inhibrx.inc (
$2,035 million
). The net outflow in
2023
was mainly a result of the acquisition of Provention Bio, Inc. (
$2,722 million
).
Acquisitions of property, plant and equipment and intangible assets amounted to €
3,195
million, versus €
2,906
million in
2023
.
There were €
1,733
million of acquisitions of property, plant and equipment (versus €
1,619
million in
2023
), most of which related
to industrial facilities. Acquisitions of intangible assets (€
1,462
million, versus €
1,287
million in
2023
) mainly comprised contractual
payments for intangible rights under license and collaboration agreements.
After-tax proceeds from disposals (€
1,461
million in
2024
, €
807
million in
2023
) exclude proceeds from divestments of
investments in consolidated undertakings and investments accounted for using the equity method, and mainly comprised the
sale of the Enjaymo global rights to Recordati for pre-tax proceeds of €768 million.
Net cash provided by/used in continuing financing activities
represented a net cash outflow of €
5,751
million in
2024
,
compared with a net cash outflow of €
8,048
million in
2023
. The
2024
figure includes the redemption of a €600 million bond
issue. Other movements included (i) the dividend payout to our shareholders of €
4,704
million (versus €
4,454
million in
2023
);
and (ii) the effect of changes in our share capital (repurchases of our own shares, net of capital increases), representing a net cash
outflow of €
115
million in
2024
versus a net cash outflow of €
398
million in
2023
.
The
net change in cash and cash equivalents of continuing operations
in
2024
was a decrease of €
1,442
million, versus a
decrease of €
3,727
million in
2023
.
Net cash flows of the discontinued Opella business
represented a net cash inflow of €
353
million in 2024, versus a net cash
outflow of €
267
million in 2023.
The
net change in cash and cash equivalents
during 2024 (after the €
167
million impact on cash and cash equivalents of the
reclassification of the Opella business to
Assets held for sale
), was a decrease of €
1,269
million; this compares with a decrease of
€
4,026
million in 2023.
“Free cash flow” (a non-IFRS measure)
for the year ended December 31,
2024
was €
5,955
million, a decrease from the
2023
figure of €
7,409
million.
For details of the arrangements in place to manage our liquidity needs for current operations as of December 31,
2024
, refer to
Note 17.1.(b) to our consolidated financial statements, included at Item 18. of this annual report.
(1)
Above a cap of €500 million per transaction.
(2)
Non-IFRS financial measure, as defined in “— Segment Information — Business Net income” above.
(3)
Not exceeding a cap of €500 million per transaction.
|
88
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SANOFI
FORM 20-F
2024
|
|
PART I
|
|
ITEM 5. Operating and Financial Review and Prospects
|
Year Ended December 31, 2023 Compared with Year Ended December 31, 2022
Net cash provided by/used in continuing operating activities
represented a net cash inflow of
€
9,271
million in
2023
,
compared with €
9,638
million in
2022
. The year-on-year decrease was due mainly to a lower level of operating cash flow before
changes in working capital (€
8,858
million in
2023
versus €
10,432
million in
2022
) and a net increase of €
413
million in the
working capital requirement in
2024
(versus a net decrease of €
794
million in
2022
).
Net cash provided by/used in continuing investing activities
represented a net cash outflow of €
4,950
million in
2023
versus a
net outflow of €
2,117
million in
2022
. For
2022
,
the net cash outflow was mainly due to the acquisition of Amunix Pharmaceuticals,
Inc (€
852
million), partly offset by the proceeds of €150 million from the sale of a 12% equity interest in EUROAPI to EPIC
Bpifrance.
Acquisitions of property, plant and equipment and intangible assets amounted to €
2,906
million in
2023
versus €
2,103
million in
2022
. There were €
1,619
million of acquisitions of property, plant and equipment (versus €
1,529
million in
2022
), most of which
related to industrial facilities. Acquisitions of intangible assets (€
1,287
million in
2023
versus €
574
million in
2022
) mainly
comprised contractual payments for intangible rights under license and collaboration agreements.
After-tax proceeds from disposals (€
807
million in
2023
versus €
1,340
million in
2022
) exclude proceeds from divestments of
investments in consolidated undertakings and investments accounted for using the equity method, and mainly comprised
divestments of assets and activities related to the streamlining of the portfolio, and disposals of equity and debt instruments.
Net cash provided by/used in continuing financing activities
represented a net cash outflow €
8,048
million in
2023
versus a
net cash outflow of €
5,807
million in
2022
. The
2023
figure includes the redemption of bond issues totalling €
3,664
million.
Other movements included (i) the dividend payout to our shareholders of €
4,454
million (versus €
4,168
million in
2022
); and
(ii) the effect of changes in our share capital (repurchases of our own shares, net of capital increases), representing a net cash
outflow of €
398
million in
2023
versus a net cash outflow of €
309
million in
2022
.
The
net change in cash and cash equivalents of continuing operations
in
2023
was a decrease of €
3,727
million, versus an
increase of €
1,714
million in
2022
.
Net cash flows for the discontinued Opella business
represented net cash outflows of €
267
million in
2023
versus a net cash
inflows €
916
million in
2022
.
The
net change in cash and cash equivalents
during
2023
was a reduction of €
4,026
million; this compares with an increase of
€
2,638
million in
2022
.
“Free cash flow,” a non-IFRS measure,
for the year ended December 31,
2023
was €
7,409
million, this compares with the
2022
figure of €
7,579
million.
For details of the arrangements in place to manage our liquidity needs for current operations as of December 31, 2023, refer to
Note 17.1.(b) to our consolidated financial statements, included at Item 18. of this annual report.
“Free cash flow” is a non-IFRS financial indicator which is reviewed by our management, and which we believe provides useful
information to measure the net cash generated from our operations that is available for strategic investments
(1)
(net of
divestments
(1)
), for debt repayment, and for payments to shareholders. “
Free cash flow” comprises cash flows generated from our
continuing operations; it is calculated from our “Business net
income”
(2)
after adding back (in the case of expenses and losses) or
deducting (in the case of income and gains) the following items: depreciation, amortization and impairment, share of undistributed
earnings from investments accounted for using the equity method, gains & losses on disposals, net change in provisions including
pensions and other post-employment benefits, deferred taxes, share-based payment expense and other non-cash items. It also
includes net changes in working capital, capital expenditures and other asset acquisitions
(3)
net of disposal proceeds
(3)
, and
payments related to restructuring and similar items. “Free cash flow” is not defined by IFRS, and is not a substitute for
Net cash
provided by operating activities
as reported under IFRS. Management recognizes that the term “Free cash flow” may be
interpreted differently by other companies and under different circumstances.
|
SANOFI
FORM 20-F
2024
|
89
|
|
PART I
|
|
ITEM 5. Operating and Financial Review and Prospects
|
The table below sets forth a reconciliation between
Net cash provided by continuing operating activities
and “Free cash flow”:
|
(€ million)
|
2024
|
2023
(d)
|
2022
(d)
|
|
Net cash provided by/(used in) operating activities (IFRS)
|
9,081
|
10,258
|
10,526
|
|
Net cash provided by/(used in) operating activities (IFRS) of the discontinued Opella
business
|
(474)
|
(987)
|
(888)
|
|
Acquisitions of property, plant and equipment and software
|
(1,808)
|
(1,677)
|
(1,599)
|
|
Acquisitions of intangible assets, equity interests and other non-current financial assets
(a)
|
(1,434)
|
(1,091)
|
(796)
|
|
Proceeds from disposals of property, plant and equipment, intangible assets and other
non-current assets, net of tax
(a)
|
805
|
789
|
1,382
|
|
Repayments of lease liabilities
(b)
|
(282)
|
(253)
|
(280)
|
|
Other items
(c)
|
67
|
370
|
(766)
|
|
Free cash flow (non-IFRS)
|
5,955
|
7,409
|
7,579
|
(a)
Free cash flow includes investments and divestments not exceeding a cap of €500 million per transaction.
(b)
Cash outflows relating to repayments of the principal portion of lease liabilities (IFRS 16) are included in free cash flow.
(c)
In 2022, includes an upfront payment of $900 million, a regulatory milestone payment of $100 million in connection with the one-time income from the
Libtayo transaction further to the restructuring of the Immuno-Oncology collaboration agreement with Regeneron (see Note C.1. to our consolidated
financial statements, included at Item 18. of this annual report).
(d)
Figures for comparative periods (2023 and 2022) have been re-presented on a consistent basis to reflect the classification of Opella as a discontinued
operation.
B.2. Consolidated balance sheet and debt
Total assets were €
132,798
million as of
December 31, 2024
, compared with €
126,464
million as of
December 31, 2023
, a increase
of €
6,334
million.
Total
equity
was €
77,857
million as of
December 31, 2024
, versus €
74,353
million as of
December 31, 2023
. The year-on-year net
change reflects the following principal factors:
•
increases: our net income for
2024
(€
5,618
million) and positive currency translation differences (€
2,459
million); and
•
decreases: the dividend paid to our shareholders in respect of the
2023
financial year (€
4,704
million) and repurchases of our
own shares (€
302
million).
Net debt
was €
8,772
million as of
December 31, 2024
, compared with €
7,793
million as of
December 31, 2023
. The increase in
2024
mainly reflects cash outflows of €2,035 million on the acquisition of Inhibrx, Inc. and of €
4,704
million for the dividend
payout to our shareholders, less the €
5,955
million of free cash flow generated in the year (see reconciliation with
Net cash
provided by/(used in)operating activities
from continuing operations in section B.1. above).
“Net debt” is a non-IFRS financial measure which is reviewed by our management, and which we believe provides useful
information to measure our overall liquidity and capital resources. We define “net debt” as (i) the sum total of long-term debt,
short-term debt and current portion of long-term debt and interest rate and currency derivatives used to manage debt, minus
(ii) the sum total of cash and cash equivalents and interest rate and currency derivatives used to manage cash and cash
equivalents.
|
(€ million)
|
2024
|
2023
|
2022
|
|
Long-term debt
|
11,791
|
14,347
|
14,857
|
|
Short-term debt and current portion of long-term debt
|
4,209
|
2,045
|
4,174
|
|
Interest rate and currency derivatives used to manage debt
|
137
|
139
|
187
|
|
Total debt (IFRS)
|
16,137
|
16,531
|
19,218
|
|
Cash and cash equivalents
|
(7,441)
|
(8,710)
|
(12,736)
|
|
Interest rate and currency derivatives used to manage cash and cash equivalents
|
76
|
(28)
|
(45)
|
|
Net debt
(a)
(non- IFRS)
|
8,772
|
7,793
|
6,437
|
|
Total equity
|
77,857
|
74,353
|
75,152
|
|
Gearing ratio (non-IFRS)
|
11.3
%
|
10.5
%
|
8.6
%
|
(a)
Net debt does not include lease liabilities, which amounted to €
1,906
million as of December 31,
2024
, €
2,030
million as of December 31,
2023
and
€
2,181
million as of
December 31, 2022
“Net debt” is a non-IFRS financial measure used by management and investors to measure Sanofi’s overall net indebtedness.
To assess our financing risk, we use the “gearing ratio”, a non-IFRS financial measure. This ratio (which we define as the ratio of
net debt to total equity) increased from
10.5
% as of December 31,
2023
to
11.3
% as of December 31,
2024
. Analyses of debt as
of
December 31, 2024
,
December 31, 2023
and December 31, 2022
by type, maturity, interest rate and currency, are provided in
Note D.17.1. to our consolidated financial statements, included at Item 18. of this annual report.
|
90
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2024
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|
PART I
|
|
ITEM 5. Operating and Financial Review and Prospects
|
We expect that the future cash flows generated by our operating activities will be sufficient to repay our debt. The financing
arrangements in place as of December 31,
2024
at the Sanofi parent company level are not subject to covenants regarding
financial ratios and do not contain any clauses linking fees to Sanofi’s credit rating.
As of
December 31, 2024
, we held
9.5
million of our own shares, recorded as a deduction from equity and representing
0.75
% of
our share capital. As of
December 31, 2023
, we were holding
13.5
million of our own shares, recorded as a deduction from equity
and representing
1.06%
of our share capital.
Goodwill
and
Other intangible assets
(€
66,013
million in total) decreased by €
7,710
million
, mainly following the reclassification
of Opella assets on the line Assets held for sale, including goodwill for an amount of
7,255
million euros.
Investments accounted for using the equity method
(€
316
million) decreased by €
108
million, mainly reflecting an impairment
loss taken against the equity-accounted investment in EUROAPI to reflect
the significant and lasting
drop in the quoted market
price of EUROAPI shares.
Other non-current assets
amounted to €
3,753
million, a year-on-year increase of €
535
million.
Net deferred tax assets
amounted to €
5,801
million as of
December 31, 2024
, versus €
4,570
million as of
December 31, 2023
a
year-on-year increase of €
1,231
million. The year-on-year increase mainly reflects (i) reversals of deferred tax liabilities relating to
remeasurements of other acquired intangible assets further to the amortization charged in the period; (ii) an increase in deferred
tax assets on consolidation adjustments (eliminiation of intragroup margin in inventory); and (iii) an increase in deferred tax assets
arising on the spread tax deduction of R&D expenses in the United States.
Non-current provisions and other non-current liabilities
(€
8,096
million) showed an increase of €
494
million, mainly due
a
provision recognized in respect of the litigation related to Plavix (clopidogrel) in the US state of Hawaii (see Note D.22.) and an
increase in restructuring provisions.
Liabilities related to business combinations and to non-controlling interests
were €
68
million lower year-on-year, at
€
641
million.
Assets held for sale (€
13,489
million) and liabilities related to assets held for sale (€
2,131
million) mainly comprise the assets and
liabilities of the held for sale Opella business (see Note D.8. to our consolidated financial statements included at Item 18. of this
annual report).
B.3. Liquidity
We expect that our existing cash resources and cash from operations will be sufficient to finance our foreseeable working capital
requirements, in both the short term (i.e. the 12 months following the year ended December 31,
2024
) and the long term
(i.e. beyond such additional 12-month period). As of December 31,
2024
, we held cash and cash equivalents amounting to
€
7,441
million, substantially all of which were held in euros (see Note D.13. to our consolidated financial statements, included at
Item 18. of this annual report). As of
December 31, 2024
,
€446 million
of our cash and cash equivalents were held by captive
insurance and reinsurance companies in accordance with insurance regulations.
We run the risk of delayed payments or even non-payment by our customers, who consist principally of wholesalers, distributors,
pharmacies, hospitals, clinics and government agencies (see “Item 3. Key information — D. Risk Factors — 2. Risks Relating to Our
Business — We are subject to the risk of non-payment by our customers”). Deteriorating credit and economic conditions and other
factors in some countries have resulted in, and may continue to result in, an increase in the average length of time taken to collect our
accounts receivable in these countries. Should these factors continue, it may require us to re-evaluate the collectability of these
receivables in future periods. We carefully monitor sovereign debt issues and economic conditions and evaluate accounts receivable in
these countries for potential collection risks. We have been conducting an active recovery policy, adapted to each country and including
intense communication with customers, negotiations of payment plans, charging of interest for late payments, and legal action. Over our
business as a whole, the amount of trade receivables overdue by more than 12 months (which primarily consists of amounts due from
public sector bodies) decreased from €
81
million as of December 31,
2023
to €
44
million as of
December 31, 2024
(see Note D.10. to our
consolidated financial statements included at Item 18. of this annual report).
As of December 31,
2024
, we had no commitments for capital expenditures that we consider to be material to our consolidated
financial position. Undrawn confirmed credit facilities amounted to a total of €
8,000
million at
December 31, 2024
. For a
discussion of our treasury policies, see “Item 11. Quantitative and Qualitative Disclosures about Market Risk.”
We expect that cash from our operations will be sufficient to repay our debt. For a discussion of our liquidity risks,
see “Item 11. Quantitative and Qualitative Disclosures about Market Risk.”
B.4. Off balance sheet arrangements/Contractual obligations and other commercial commitments
We have various contractual obligations and other commercial commitments arising from our operations. Our contractual
obligations and our other commercial commitments as of
December 31, 2024
are shown in Notes
D.3., D.17
., D.18., and D.21. to our
consolidated financial statements, included at Item 18. of this annual report. Note D.21. to our consolidated financial statements
included at Item 18. of this annual report discloses details of commitments under our principal research and development
collaboration agreements. For a description of the principal contingencies arising from certain business divestitures, refer to
Note D.22.d.) to our
2024
consolidated financial statements included at Item 18. of this annual report.
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2024
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91
|
|
PART I
|
|
ITEM 5. Operating and Financial Review and Prospects
|
Off balance sheet commitments relating to Sanofi’s operating activities, not including as of December 31, 2024 the commitments
of the held-for-sale Opella operation, comprise the following (for Opella off balance sheet commitments please refer to
Note D.36.):
|
December 31, 2024
|
Payments due by period
|
||||
|
(€ million)
|
Total
|
Less than
1 year
|
1 to
3 years
|
3 to
5 years
|
More than
5 years
|
|
Future contractual cash flows relating to debt and debt hedging
instruments
(a)
|
17,238
|
4,399
|
4,582
|
3,190
|
5,067
|
|
Principal payments related to lease liabilities
(b)
|
2,080
|
377
|
498
|
386
|
819
|
|
Other lease obligations (with a term of less than 12 months, low value asset
leases and lease contracts committed but not yet commenced)
(c)
|
554
|
28
|
34
|
41
|
451
|
|
Irrevocable purchase commitments
(d)
|
|||||
|
•
Given
|
3,683
|
1,152
|
1,195
|
442
|
894
|
|
•
Received
|
(391)
|
(288)
|
(96)
|
(7)
|
—
|
|
Research & development license agreements
|
|||||
|
•
Commitments related to R&D and other commitments
|
84
|
42
|
29
|
6
|
7
|
|
•
Potential milestone payments
(e)
|
4,230
|
941
|
635
|
470
|
2,184
|
|
Obligations relating to business combinations
(f)
|
72
|
72
|
—
|
—
|
—
|
|
Estimated benefit payments on unfunded pensions and post employment
benefits
(g)
|
1,035
|
67
|
122
|
131
|
715
|
|
Total contractual obligations and other commitments
|
28,585
|
6,790
|
6,999
|
4,659
|
10,137
|
|
Undrawn general-purpose credit facilities
|
8,000
|
—
|
4,000
|
—
|
4,000
|
(a)
See Note D.17.1. to our consolidated financial statements, included at Item 18. of this annual report.
(b)
See Note D.17.2. to our consolidated financial statements, included at Item 18. of this annual report.
(c)
See Note D.21.1. to our consolidated financial statements, included at Item 18. of this annual report.
(d)
These comprise irrevocable commitments to suppliers of (i) property, plant and equipment, net of down payments (see Note D.3. to our consolidated
financial statements, included at Item 18. of this annual report) and (ii) goods and services.
(e)
This line includes all milestone payments on projects regarded as reasonably possible, i.e. on projects in the development phase.
(f)
See Note D.18. to our consolidated financial statements, included at Item 18. of this annual report.
(g)
See Note D.19.1. to our consolidated financial statements, included at Item 18. of this annual report. The table above does not include ongoing annual
employer’s contributions to plan assets, estimated at €
77
million for 2024.
We may have payments due to our current or former research and development partners under collaboration agreements.
These agreements typically cover multiple products, and give us the option to participate in development on a product-by-
product basis. When we exercise our option with respect to a product, we pay our collaboration partner a fee and receive
intellectual property rights to the product in exchange. We are also generally required to fund some or all of the development
costs for the products that we select, and to make payments to our partners when those products reach development
milestones.
We have entered into collaboration agreements under which we have rights to acquire products or technology from third parties
through the acquisition of shares, loans, license agreements, joint development, co-marketing and other contractual
arrangements. In addition to upfront payments on signature of the agreement, our contracts frequently require us to make
payments contingent upon the completion of development milestones by our alliance partner or upon the granting of approvals
or licenses.
Because of the uncertain nature of development work, it is impossible to predict (i) whether Sanofi will exercise further options for
products, or (ii) whether the expected milestones will be achieved, or (iii) the number of compounds that will reach the relevant
milestones. It is therefore impossible to estimate the maximum aggregate amount that Sanofi will actually pay in the future under
existing collaboration agreements.
Given the nature of its business, it is highly unlikely that Sanofi will exercise all options for all products or that all milestones will be
achieved.
The main collaboration agreements relating to development projects are described in Note D.21.1. to our consolidated financial
statements, included at Item 18. of this annual report. Milestone payments relating to development projects under these
agreements included in the table above exclude projects still in the research phase (€
14.4
billion in
2024
, €
16.8
billion in
2023
)
and payments contingent upon the attainment of sales targets once a product is on the market (€
15.2
billion in
2024
, €
17.9
billion
in
2023
).
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2024
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|
PART I
|
|
ITEM 5. Operating and Financial Review and Prospects
|
C. Research and development, patents and licenses, etc.
Our research and development teams utilize our deep expertise to contribute to the growth of our business. As of December 31,
2024
, we had
8,940
employees engaged in research and development activities. In the years ended December 31,
2022
,
2023
and
2024
we spent €
6,501
million, €
6,507
million and €
7,394
million, respectively, on research and development. For a discussion
of our research and development activities, see “Item 4. Information on the Company — B. Business Overview” and section
“— A. Operating Results” above.
D. Trend information
For a discussion of trends, see “Item 4. Information on the Company — Business Overview” and sections “— A. Operating Results”
and “— Liquidity and Capital Resources” above
.
E. Critical accounting estimates
For a discussion of our critical accounting estimates, see
Note A.3 o
f our consolidated financial statements included in Item 18. of
this annual report.
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FORM 20-F
2024
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93
|
|
PART I
|
|
ITEM 6. Directors, Senior Management and Employees
|
Item 6. Directors, Senior Management and Employees
A. Directors and Senior Management
Since January 1, 2007, Sanofi has separated the offices of Chairman and Chief Executive Officer. Annual evaluations conducted
since that date have indicated that this governance structure is appropriate to Sanofi’s current configuration. When the term of
office of Serge Weinberg as Chairman ended and Frédéric Oudéa was appointed in May 2023, our Board of Directors decided to
continue separating the offices of Chairman and Chief Executive Officer. The Board believes this governance structure is still
appropriate to the current context in which Sanofi operates and its share ownership structure, as well as protecting the rights of
all of its stakeholders.
The
Chairman
organizes and directs the work of the Board, and is responsible for ensuring the proper functioning of the
corporate decision-making bodies in compliance with good governance principles. The Chairman coordinates the work of the
Board of Directors with that of its Committees. He ensures that the Company’s management bodies function properly, and in
particular that the directors are able to fulfill their duties. The Chairman is accountable to the Shareholders’ General Meeting,
which he chairs.
In addition to these roles conferred by law, the Chairman:
•
in coordination with the Chief Executive Officer, liaises between the Board of Directors and the shareholders of the Company;
•
is kept regularly informed by the Chief Executive Officer of significant events and situations affecting the affairs of the
Company, and may request from the Chief Executive Officer any information useful to the Board of Directors;
•
may, in close collaboration with the Chief Executive Officer, represent the Company in high-level dealings with governmental
bodies and with key partners of the Company and/or of its subsidiaries, both nationally and internationally;
•
seeks to prevent any conflict of interest and manages any situation that might give rise to a conflict of interest. He also gives
rulings, in the name of the Board, on requests to take up external directorships of which he may become aware or that may be
submitted to him by a director;
•
may interview the statutory auditors in preparation for the work of the Board of Directors and the Audit Committee; and
•
strives to promote in all circumstances the values and image of the Company.
The Chairman is also required to develop and maintain a proper relationship of trust between the Board and the Chief Executive
Officer, so as to ensure that the latter consistently and continuously implements the orientations determined by the Board.
In fulfilling his remit, the Chairman may meet with any individual, including senior executives of the Company, while avoiding any
involvement in directing the Company or managing its operations, which are exclusively the responsibility of the Chief Executive
Officer.
Finally, the Chairman reports to the Board on the fulfillment of his remit.
The Chairman carries out his duties during the entire period of his term of office, subject to the caveat that a director who is a
natural person may not be appointed or reappointed once that director has reached the age of 70.
The
Chief Executive Officer
manages the Company, and represents it in dealings with third parties within the limit of the
corporate purpose. The Chief Executive Officer has the broadest powers to act in all circumstances in the name of the Company,
subject to the powers that are attributed by law to the Board of Directors and to the Shareholders’ General Meeting and within
the limits set by the Board of Directors.
The Chief Executive Officer must be less than 65 years old.
Limitations on the powers of the Chief Executive Officer set by the Board
The limitations on the powers of the Chief Executive Officer are specified in the Board Charter. Without prejudice to legal
provisions regarding authorizations that must be granted by the Board (regulated agreements, guarantees, divestments of equity
holdings or real estate, etc.), prior approval from the Board of Directors is required for transactions or decisions resulting in an
investment or divestment, or an expenditure or guarantee commitment, made by the Company and its subsidiaries, in excess of:
•
a cap of €500 million (per transaction) for transactions, decisions or commitments pertaining to a previously approved
strategy; and
•
a cap of €150 million (per transaction) for transactions, decisions or commitments not pertaining to a previously approved
strategy.
When such transactions, decisions or commitments give rise to installment payments to the contracting third party (or parties)
that are contingent upon future results or objectives, such as the registration of one or more products, attainment of the caps is
calculated by aggregating the various payments due from the signing of the contract until (and including) the filing of the first
application for marketing authorization in the United States or in Europe.
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2024
|
|
PART I
|
|
ITEM 6. Directors, Senior Management and Employees
|
Attainment of the above caps is also assessed after taking into account all commitments to make payments upon exercising a
firm or conditional option with immediate or deferred effect, and all guarantees or collateral to be provided to third parties over
the duration of such commitments.
The prior approval procedure does not apply to transactions and decisions that result in the signature of agreements that solely
involve subsidiaries and the Company itself.
Remit of the Board of Directors
The Board of Directors establishes the orientation of the Company’s activities and ensures that they are implemented, paying
due consideration to social and environmental issues. Subject to those powers expressly attributed to Shareholders’ General
Meetings and within the limits set by the corporate purpose, the Board addresses any issue of relevance to the proper conduct of
the Company’s affairs and, through its deliberations, settles matters concerning the Company.
French law, Articles of Association and Board Charter
The rules and operating procedures of our Board of Directors are defined by French law, by our Articles of Association, and by our
Board Charter
(English language versions of which are reproduced in full as Exhibit 1.1 and Exhibit 1.2 to this annual report).
Our Board Charter describes the rights and obligations of Board members; the composition, role and operating procedures of the
Board of Directors and Board Committees; and the roles and powers of the Chairman and the Chief Executive Officer. It is
prepared in accordance with the French Commercial Code and our Articles of Association.
Composition of the Board of Directors
As of December 31, 2024, the Sanofi Board of Directors had 17 members, including 12 independent directors and two directors
representing employees; 47
% of our Board members were women (excluding directors representing employees, in accordance
with Order no. 2024-934 of October 15, 2024 transposing into French law Directive (EU) 2022/2381 of the European Parliament
and of the Council of November 23, 2022 on improving the
gender balance
among directors of listed companies and related
measures); and 41% were non-French nationals (including directors representing employees).
On January 1, 2025, Jean-Paul Kress joined the Sanofi Board of Directors, following the Board's decision to co-opt him as an
independent director, replacing Gilles Schnepp, who resigned from office, effective December 31, 2024. In accordance with
French law, Mr. Kress’s appointment must be ratified by the shareholders at the Annual General Meeting of April 30, 2025, in
which case Mr. Kress will serve for the remainder of Gilles Schnepp’s term of office, i.e. until the close of the Annual General
Meeting held in 2026 to approve the financial statements for the accounts for the year ended December 31, 2025. Following this
co-option, the proportion of women and of non-French nationals (including directors representing employees) remains
unchanged. The table below gives further detail about
the composition of our Board of Directors as of February 12, 2025.
Fabienne Lecorvaisier's term of office will end at the close of the Annual General Meeting of April 30, 2025 and will not be
renewed. Once her term of office ends, the Board will be composed of 16 members.
|
SANOFI
FORM 20-F
2024
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95
|
|
PART I
|
|
ITEM 6. Directors, Senior Management and Employees
|
|
As of February 12, 2025
|
Age
|
Nationality
|
Number of
Sanofi shares
held
|
Number of
directorships in
listed
companies
(a)
|
Date first
appointed
|
End of current
term of office
(AGM)
|
Years of service
on Board
|
Audit
Committee
|
Appointments,
Governance &
CSR Committee
|
Compensation
Committee
|
Strategy
Committee
|
Scientific
Committee
|
||
|
CHAIRMAN
|
Frédéric Oudéa
|
|
61
|
|
1,000
|
3
|
2023
(b)
|
2027
|
2
|
ò
|
Í
|
ò
|
||
|
CHIEF
EXECUTIVE
OFFICER
|
Paul Hudson
|
|
57
|
|
136,628
(c)
|
1
|
2019
|
2026
|
5
|
ò
|
||||
|
NON-INDEPENDENT
DIRECTORS
|
Christophe Babule
|
|
59
|
|
1,000
|
1
|
2019
|
2026
|
5
|
ò
|
||||
|
Barbara Lavernos
|
|
56
|
|
1,000
|
1
|
2021
|
2025
|
3
|
ò
|
ò
|
||||
|
INDEPENDENT DIRECTORS
|
Clotilde Delbos
|
|
57
|
|
500
|
4
|
2024
|
2027
|
1
|
ò
|
ò
|
|||
|
Rachel Duan
|
|
54
|
|
1,000
|
4
|
2020
|
2028
|
4
|
ò
|
|||||
|
Carole Ferrand
|
|
54
|
|
1,000
|
1
|
2022
|
2025
|
2
|
Í
|
|||||
|
Lise Kingo
|
|
63
|
|
1,000
|
3
|
2020
|
2028
|
4
|
ò
|
|||||
|
Jean-Paul Kress
|
|
59
|
|
1,000
|
1
|
2025
(d)
|
2026
|
0
|
ò
|
ò
|
||||
|
Patrick Kron
|
|
71
|
|
1,000
|
3
|
2014
|
2026
|
10
|
Í
(e)
|
Í
|
ò
|
|||
|
Fabienne Lecorvaisier
|
|
62
|
|
1,000
|
3
|
2013
|
2025
|
11
|
ò
|
|||||
|
Anne-Françoise Nesmes
|
|
53
|
|
533
|
2
|
2024
|
2027
|
1
|
ò
|
|||||
|
John Sundy
|
|
63
|
|
500
|
1
|
2024
|
2027
|
1
|
ò
|
|||||
|
Emile Vœst
|
|
65
|
|
1,000
|
1
|
2022
|
2025
|
2
|
ò
|
|||||
|
Antoine Yver
|
|
67
|
|
1,000
|
1
|
2022
|
2025
|
2
|
ò
|
Í
|
||||
|
DIRECTORS
REPRESENTING
EMPLOYEES
|
Wolfgang Laux
|
|
57
|
|
See
biography
|
1
|
2021
|
2025
|
3
|
ò
|
||||
|
Yann Tran
|
|
59
|
|
See
biography
|
1
|
2021
|
2025
|
3
|
||||||
Í
Chair
ò
Member
(a)
Includes all directorships held in listed companies. The office held within Sanofi is included.
(b)
Frédéric Oudéa was initially appointed as a non-voting director by the Board on September 2, 2022, and then appointed as a director by the Annual
General Meeting on May 25, 2023.
(c)
Includes shares that vested in May 2023 and May 2024 under the equity-based compensation plans of April 28, 2020 and April 30, 2021.
(d)
Jean-Paul Kress was co-opted as a director by the Board of Directors meeting of December 19, 2024 with effect from January 1, 2025, to replace Gilles
Schnepp who resigned from office effective December 31, 2024.
(e)
Patrick Kron was appointed as Chair of the Appointments, Governance & CSR Committee with effect from January 1, 2025 on an interim basis until the
close of the 2025 AGM following Gilles Schnepp's registration as a director.
|
96
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SANOFI
FORM 20-F
2024
|
|
PART I
|
|
ITEM 6. Directors, Senior Management and Employees
|
Director who held office during the year ended December 31, 2024
|
Age
|
Nationality
|
Number of Sanofi
shares held
|
Number of
directorships in
listed companies
(a)
|
Date first appointed
|
End of term of
office
|
Years of service on
Board
|
Audit Committee
|
Appointments,
Governance & CSR
Committee
|
Compensation
Committee
|
Strategy
Committee
|
Scientific
Committee
|
|||
|
Gilles Schnepp
(a)
|
|
66
|
|
1,000
|
3
|
2020
|
2024
|
4
|
Í
|
ò
|
||||
(a)
Gilles Schnepp resigned from his office as a director, effective December 31, 2024.
In line with current legislation and given that less than 3% of our share capital is owned by our employees, Sanofi does not have a
director representing its employee shareholders.
Term of Office
The term of office of directors is four years. Directors are required to seek reappointment by rotation, such that members of the
Board are required to seek reappointment on a regular basis in the most equal proportions possible. Exceptionally, the
Shareholders’ Ordinary General Meeting may appoint a director to serve for a term of one, two or three years, in order to ensure
an adequate rotation of Board members. Each director standing down is eligible for reappointment. Should one or more
directorships fall vacant as a result of death or resignation, the Board of Directors may make provisional appointments in the
period between two Shareholders’ General Meetings, in accordance with applicable laws.
Directors may be removed from office at any time by a Shareholders’ General Meeting.
A natural person cannot be appointed or reappointed as a director once he or she reaches the age of 70. As soon as the number
of directors over the age of 70 represents more than one-third of the directors in office, the oldest director shall be deemed to
have resigned; his or her term of office shall end at the date of the next Shareholders’ Ordinary General Meeting.
Changes in the composition of the Board of Directors during 2023, 2024 and early 2025
The table below shows changes in the composition of the Board of Directors during 2023 and 2024, and in early 2025:
|
Annual General Meeting
of May 25, 2023
|
Annual General Meeting
of April 30, 2024
|
Subsequent to Annual General
Meeting of April 30, 2024
|
|
|
End of term of office
|
Serge Weinberg
|
Diane Souza
Thomas Südhof
|
None
|
|
Renewal of term of office
|
None
|
Rachel Duan
Lise Kingo
|
None
|
|
Proposed new appointments
|
Frédéric Oudéa
|
Clotilde Delbos
Anne-Françoise Nesmes
John Sundy
|
None
|
|
Co-opted
|
None
|
None
|
Jean-Paul Kress
(a)
|
|
Other
|
None
|
None
|
Gilles Schnepp
(b)
|
(a)
Jean-Paul Kress was co-opted as a director by the Board of Directors meeting of December 19, 2024 with effect from January 1, 2025, to replace Gilles
Schnepp, who resigned from office effective December 31, 2024.
(b)
Gilles Schnepp resigned from office as a director effective December 31, 2024.
Changes in Board membership to be submitted for shareholder approval at the Annual General
Meeting on April 30, 2025
|
Expiry of term of office
|
Fabienne Lecorvaisier
|
|
Proposed reappointments
|
See below
|
|
Proposed new appointments
|
See below
|
|
Ratification of co-option
|
Jean-Paul Kress
|
|
Other
|
None
|
|
SANOFI
FORM 20-F
2024
|
97
|
|
PART I
|
|
ITEM 6. Directors, Senior Management and Employees
|
The terms of office of Carole Ferrand, Barbara Lavernos, Fabienne Lecorvaisier, Emile Voest and Antoine Yver will expire at the
close of the Annual General Meeting to be held on April 30, 2025. The Appointments, Governance and CSR Committee held on
February 4, 2025 recommended the renewal of the mandates of Carole Ferrand, Barbara Lavernos, Emile Voest and Antoine
Yver. Proposed resolutions to be submitted for shareholder approval at the Annual General Meeting on April 30, 2025 will be
approved by the Board of Directors on March 2025 and will be communicated in the notice of meeting of said Annual General
Meeting. To date, however, it is specified that:
•
Fabienne Lecorvaisier's term of office cannot be renewed because she will have served as a director of Sanofi for 12 years and
will therefore no longer be considered independent according to the AFEP-MEDEF Code; and
•
the ratification of the co-option of Jean-Paul Kress will be proposed.
In addition, t
he terms of office of Wolfgang Laux and Yann Tran as directors representing employees will expire at the close of the
Annual General Meeting of April 30, 2025. Designation of directors representing employees will be made in accordance with
Article 11 of our Articles of Association.
Rules relating to the composition of the Board and its Committees
Each year, the Board of Directors conducts a review to ensure that there is an appropriate balance in its composition and in the
composition of its Committees. In particular, the Board seeks gender balance and a broad diversity of competencies,
experiences, nationalities and ages, reflecting our status as a diversified global business. The Board investigates and evaluates not
only potential candidates, but also whether existing directors should seek reappointment. Above all, the Board seeks directors
who show independence of mind and are competent, dedicated and committed, with compatible and complementary
personalities.
Acting on proposals from the Chief Executive Officer and in liaison with the Appointments, Governance and CSR Committee, the
Board sets objectives for gender
representation
in Sanofi’s executive bodies, and more generally to apply that an inclusion (non-
discrimination) and diversity policy within the Company. That policy of diversity, fairness and inclusion is included in our Play to
Win strategy. As of
December 31, 2024
, 31% of our 13 Executive Committee members were women, and 61% were non-French
nationals.
The Board of Directors is also kept informed, in particular on the occasion of its annual discussion on its equal opportunity and
equal pay policy, on how Sanofi’s inclusion and diversity policy is cascaded down to “Senior Leaders” and “Executives” (the
positions in Sanofi with the highest level of responsibility).
Competencies of Board members
The Board of Directors, in liaison with the Appointments, Governance and CSR Committee, must ensure that the composition of
the Board is balanced, diverse and fit for purpose.
In assessing its composition, the Board takes account of the new challenges facing Sanofi and our corporate strategy, and
determines whether the qualities and skills of serving directors are sufficient for the Board to deliver on its remit.
In recent years, the Board has adapted its composition by
bringing additional scientific expertise onto the Board and maintaining
the level of other key competencies, especially in finance and accounting.
|
98
|
SANOFI
FORM 20-F
2024
|
|
PART I
|
|
ITEM 6. Directors, Senior Management and Employees
|
The Board has completed an overview of the Board’s current competencies. The matrix below
(a)
shows a complete and balanced
spread of the types of competencies required, both in general terms and by reference to our strategic ambitions (the matrix
shows the number of directors possessing each of those competencies). The detailed information about individual Board
members presented in “—Detailed information about Board members” below aligns with the competencies summarized in the
matrix, including specific competencies in Sustainable Development and Digitalization/AI implementation, which were added to
the matrix further to a recommendation made by the Appointments, Governance & CSR Committee on February 4, 2025.
|
Scientific
training
|
Healthcare/
pharmaceutical
industry
experience
|
Senior
executive role
in international
group
|
Directorship in
international
group
|
International
experience
|
Mergers
&
Acquisitions
|
Finance/
Accounting
|
Sustainable
development
|
Digitalization/
IA
implementation
|
|
|
|
|
|
|
|
|
|
|
|
|
Frédéric Oudéa
|
l
|
l
|
l
|
l
|
l
|
l
|
l
|
||
|
Paul Hudson
|
l
|
l
|
l
|
l
|
l
|
l
|
|||
|
Christophe
Babule
|
l
|
l
|
l
|
l
|
l
|
l
|
|||
|
Clotilde Delbos
|
l
|
l
|
l
|
l
|
l
|
l
|
|||
|
Rachel Duan
|
l
|
l
|
l
|
l
|
l
|
l
|
|||
|
Carole Ferrand
|
l
|
l
|
l
|
l
|
l
|
l
|
|||
|
Lise Kingo
|
l
|
l
|
l
|
l
|
l
|
l
|
|||
|
Jean-Paul Kress
|
l
|
l
|
l
|
l
|
l
|
l
|
|||
|
Patrick Kron
|
l
|
l
|
l
|
l
|
|||||
|
Wolfgang Laux
|
l
|
l
|
l
|
l
|
|||||
|
Barbara
Lavernos
|
l
|
l
|
l
|
l
|
|||||
|
Fabienne
Lecorvaisier
|
l
|
l
|
l
|
l
|
l
|
l
|
|||
|
Anne-Françoise
Nesmes
|
l
|
l
|
l
|
l
|
l
|
l
|
l
|
||
|
John Sundy
|
l
|
l
|
l
|
l
|
l
|
l
|
|||
|
Yann Tran
|
l
|
l
|
|||||||
|
Emile Vœst
|
l
|
l
|
l
|
l
|
|||||
|
Antoine Yver
|
l
|
l
|
l
|
l
|
|||||
|
% COMPETENCY
SCORE
|
35%
|
59%
|
76%
|
59%
|
88%
|
65%
|
47%
|
53%
|
47%
|
(a)
Matrix based on Board composition (including directors representing employees) as of February 12, 2025.
Director Training
In 2024, Board members received three training modules on artificial intelligence (AI), cybersecurity and CSR. Delivered by in-
house and/or external specialists (depending on the topic), those modules enabled participants to address more specifically the
following key issues:
•
AI: the concept of AI, Sanofi's strategy of embedding AI in its operations, and training plans for executives and other staff;
•
Cybersecurity: cybersecurity issues and Sanofi's largest recent cyberattacks, Sanofi's cybersecurity organization and
capabilities, and the role and responsibilities of the Sanofi Board of Directors with respect to cybersecurity matters; and
•
CSR: the interaction of scientific issues and business issues, attitudes among stakeholders (regulators, civil society, investors)
with respect to sustainability issues, the role of corporations in sustainable transformation and long-term value creation,
opportunities for the
pharmaceutical
industry, and the European Corporate Sustainability Reporting Directive (CSRD).
The formal evaluation of the Board identified the training needs of Board members (see “—Evaluation of the Board and its
Committees” below). On that basis, a training plan for 2025 was agreed upon by the Board of Directors on February 12, 2025.
That training plan will include a training on key principles in Immunology, EU regulatory framework, equitable access to care, and
AI.
Independence of Board Members
Under the terms of the AFEP-MEDEF Code, a director is independent when he or she has no relationship of any kind whatsoever
with the Company, its group or its senior management that may color his or her judgment. More specifically, a director can only
be regarded as independent if he or she:
|
SANOFI
FORM 20-F
2024
|
99
|
|
PART I
|
|
ITEM 6. Directors, Senior Management and Employees
|
•
is not (and has not been during the past five years):
–
an employee or executive officer of the Company,
–
an employee, executive officer or director of an entity consolidated by the Company, or
–
an employee, executive officer or director of the Company’s parent, or of an entity consolidated by that parent (criterion 1);
•
is not an executive officer of an entity in which (i) the Company directly or indirectly holds a directorship or (ii) an employee of
the Company is designated as a director or (iii) an executive officer of the Company (currently, or who has held office within
the past five years) holds a directorship (criterion 2);
•
is not a customer, supplier, investment banker or corporate banker that is material to the Company or its group, or for whom
the Company or its group represents a significant proportion of its business (criterion 3);
•
has no close family ties with a corporate officer of the Company (criterion 4);
•
has not acted as an auditor for the Company over the course of the past five years (criterion 5);
•
has not been a director of the Company for more than 12 years (criterion 6);
•
does not receive variable compensation in cash or in the form of shares or any compensation linked to the performance of the
Company or its group (criterion 7); or
•
does not represent a shareholder that has a significant or controlling interest in the Company (criterion 8).
The influence of other factors such as the ability to understand challenges and risks, and the courage to express ideas and form a
judgment, is also evaluated before it is decided whether a director can be regarded as independent.
In accordance with our Board Charter and pursuant to the AFEP-MEDEF Code, the Board of Directors’ meeting of
February 12, 2025 discussed the independence of the current directors. Of the 17 directors in office on that date, 12 were deemed
to be independent directors by reference to the independence criteria used by the Board of Directors pursuant to the AFEP-
MEDEF Code: Frédéric Oudéa, Clotilde Delbos, Rachel Duan, Carole Ferrand, Lise Kingo, Jean-Paul Kress, Patrick Kron, Fabienne
Lecorvaisier, Anne-Françoise Nesmes, John Sundy, Emile Voest and Antoine Yver.
In accordance with the rules described above, Paul Hudson (who is an executive director of Sanofi), and Barbara Lavernos and
Christophe Babule
(who were appointed on the recommendation of L’Oréal, a major shareholder of Sanofi), are not deemed
independent.
Consequently, the proportion of independent directors is 80%. This complies with the AFEP-MEDEF recommendation of at
least 50% in companies with dispersed ownership and no controlling shareholder (which is the case for Sanofi). In accordance
with the recommendations of the AFEP-MEDEF Code, directors representing employees are excluded when calculating the
proportion of independent directors.
|
Frédéric Oudéa
|
Paul Hudson
|
Christophe Babule
(a)
|
Clotilde Delbos
|
Rachel Duan
|
Carole Ferrand
|
Lise Kingo
|
Jean-Paul Kress
|
Patrick Kron
|
Barbara Lavernos
|
Fabienne Lecorvaisier
|
Anne-Françoise Nesmes
|
John Sundy
|
Emile Voest
|
Antoine Yver
|
|
|
Criterion 1:
employee/executive
officer in past 5 years
|
l
|
X
|
l
|
l
|
l
|
l
|
l
|
l
|
l
|
l
|
l
|
l
|
l
|
l
|
l
|
|
Criterion 2:
cross-directorships
|
l
|
l
|
l
|
l
|
l
|
l
|
l
|
l
|
l
|
l
|
l
|
l
|
l
|
l
|
l
|
|
Criterion 3:
significant business
relationship
|
l
|
l
|
l
|
l
|
l
|
l
|
l
|
l
|
l
|
l
|
l
|
l
|
l
|
l
|
l
|
|
Criterion 4:
close family ties
|
l
|
l
|
l
|
l
|
l
|
l
|
l
|
l
|
l
|
l
|
l
|
l
|
l
|
l
|
l
|
|
Criterion 5:
auditor
|
l
|
l
|
l
|
l
|
l
|
l
|
l
|
l
|
l
|
l
|
l
|
l
|
l
|
l
|
l
|
|
Criterion 6:
held office for > 12 years
|
l
|
l
|
l
|
l
|
l
|
l
|
l
|
l
|
l
|
l
|
l
|
l
|
l
|
l
|
l
|
|
Criterion 7:
non-executive director in
receipt of variable or
performance-linked
compensation
|
l
|
l
|
l
|
l
|
l
|
l
|
l
|
l
|
l
|
l
|
l
|
l
|
l
|
l
|
l
|
|
Criterion 8:
significant shareholder
|
l
|
l
|
X
|
l
|
l
|
l
|
l
|
l
|
l
|
X
|
l
|
l
|
l
|
l
|
l
|
|
Deemed independent
|
YES
|
NO
|
NO
|
YES
|
YES
|
YES
|
YES
|
YES
|
YES
|
NO
|
YES
|
YES
|
YES
|
YES
|
YES
|
l
Independence criterion met
X
Independence criterion not met
(a)
This table only refers to independence as defined under the AFEP-MEDEF Code. However, Christophe Babule is independent for the purposes of the
NASDAQ Listing Rules and Rule 10A-3 under the Exchange Act.
|
100
|
SANOFI
FORM 20-F
2024
|
|
PART I
|
|
ITEM 6. Directors, Senior Management and Employees
|
Failure to fulfil one of the criteria does not automatically disqualify a director from being independent.
In assessing the criterion related to significant business relationships (criterion 3), the Board of Directors took into account the
various relationships between directors and Sanofi and concluded that there was no relationship of a kind that might undermine
their independence. The Board of Directors noted that the Company and its subsidiaries had, in the normal course of business,
over the past three years, sold products and provided services to, and/or purchased products and received services from,
companies in which certain of the Company's directors, who are classified as independent (or their close family members) were
senior executives or employees during 2024. In each case, the amounts paid to or received from such companies over the past
three years were determined on an arm's length basis and not at amounts that the Board regarded as undermining the
independence of the directors in question.
Selection process for Board members
The Appointments, Governance and CSR Committee has a remit to organize a procedure for selecting future independent
directors. Once the desired profile and skillset for a new director has been defined, a search for potential candidates is conducted
by external consultants.
Once a shortlist has been established, the Committee interviews two or three candidates. The candidates also meet with the
Chairs of the other Board committees, and in some cases the other Committee members as well. In all cases, they meet with the
Chairman of the Board of Directors and the Chief Executive Officer. After completing the interviews, the Committee makes a
recommendation to the Board on the candidate with the best fit for the profile, supporting that recommendation with an
explanation of how the interviews were conducted and giving reasons why a candidate was selected. Before recommending a
candidate to the Board, the Committee obtains assurance as to their availability, in particular as regards any other executive
posts or offices the candidate may hold.
Overview of selection process for Board members
|
Definition of profile
and skillset
|
Pre-selection
|
Selection
|
Appointment
|
|||||||||
|
Independent
directors
|
Appointments,
Governance & CSR
Committee defines the
profile and skillset
|
Appointments,
Governance & CSR
Committee pre-selects
three potential
candidates from a long-
list suggested by an
external consultant
|
Some or all Committee
members interviews two
or three short-listed
candidates
|
Appointments, Governance &
CSR Committee recommends a
candidate, and explains the
reasons for its
recommendation
|
||||||||
|
Directors
representing
employees
|
•
One Director representing
employees is designated by
the trade union body which is
the most representative, in
the Company and those of its
direct or indirect subsidiaries
that have their registered
office in French territory,
•
One Director representing
employees is designated by
the European Works Council
|
|||||||||||
Succession planning
General principles
The remit of the Appointments, Governance and CSR Committee includes preparing for the future of the Company’s executive
bodies, in particular through the establishment of a succession plan for executive officers.
The succession plan, which is reviewed at meetings of the Appointments, Governance and CSR Committee, addresses various
scenarios:
•
unplanned vacancy due to prohibition, resignation or death;
•
forced vacancy due to poor performance, mismanagement or misconduct; and
•
planned vacancy due to retirement or expiration of term of office.
Through its work and discussions, the Committee seeks to devise a succession plan that is adaptable to situations arising in the
short, medium or long term, but which also builds in diversity – in all its facets – as a key factor.
To fulfill its remit, the Appointments, Governance and CSR Committee:
•
provides the Board with progress reports, in particular at executive sessions;
•
co-ordinates with the Compensation Committee. In that regard, having a director that sits on both Committees is a great advantage;
|
SANOFI
FORM 20-F
2024
|
101
|
|
PART I
|
|
ITEM 6. Directors, Senior Management and Employees
|
•
works closely with the Chief Executive Officer to (i) ensure the succession plan is consistent with the Company’s own practices
and market practices, (ii) ensure high-potential internal prospects receive appropriate support and training, and (iii) check
there is adequate monitoring of key posts likely to fall vacant;
•
meets key executives on an ad hoc basis; and
•
involves the Chairman and the Chief Executive Officer insofar as each has a key role in planning for his own successor, though
without them directing the process.
In fulfilling their remit, Committee members are acutely conscious of confidentiality issues.
Although aware that separating the offices of Chairman and Chief Executive Officer provides continuity of power, the Committee
nonetheless assesses the situation of the Chairman as well as that of the executive team.
Succession planning for the Chief Executive Officer is also reviewed regularly by the Appointments, Governance and CSR
Committee.
Evaluation of the Board and its Committees
Under the terms of the Board Charter, and in accordance with the AFEP-MEDEF Code, a discussion of the operating procedures
of the Board and its committees must be included on the agenda of one Board meeting every year. The Charter also requires a
formal evaluation to be performed at least every three years under the direction of the Appointments, Governance and CSR
Committee, with assistance from an independent consultant.
Since 2023 the evaluation procedure has included one-on-one interviews with each director (including the Chief Executive
Officer), intended to measure the contribution of each director to the work of the Board and its committees and to record any
suggestions they may have.
In practice, even in years when the three-yearly formal evaluation procedure (assisted by an independent consultant) is not
conducted, an annual internal evaluation is conducted using a detailed questionnaire sent to directors by the Secretary to the
Board, and covering the composition and the operation of the Board and its committees. The responses (which are confidential)
are analyzed by the Secretary to the Board. The results are then presented and discussed at a meeting of the Appointments,
Governance and CSR Committee; a detailed report prepared for that meeting is then submitted to a Board meeting at the start
of the following year.
In
2024
, a formal evaluation was conducted under the direction of the Appointments, Governance and CSR Committee with the
assistance of an independent consultant.
Evaluation of the Board and its Committees in 2023 - Internal evaluation
In 2023, the evaluation was conducted internally via a detailed questionnaire (as described above). Actions taken to address
areas of progress and vigilance identified during that evaluation are shown below:
|
Areas of progress and vigilance identified in 2023 evaluation
|
Actions implemented in 2024
|
|
Even closer monitoring of R&D governance and drug pipeline
development following installation of new management team in the fall
of
2023.
|
In 2024, Sanofi held its first “R&D Pipeline Review Week” which all members of
the Scientific Committee were able to attend, giving them an opportunity for
in-depth scrutiny of the strategy for key therapeutic areas. The Executive Vice
President, Head of R&D gave members of the Scientific Commitee a
presentation about progress on delivery of the strategy during one of the
strategy seminars.
|
|
More in-depth analysis of acquisitions strategy, in line with the R&D
strategy and the broader Play to Win strategy.
|
The 2024 M&A and business development roadmap, including leadtimes and
costs associated with projects under review, was presented to Board members,
giving them a broader overview of the acquisitions strategy and how it dovetails
with the R&D strategy.
|
|
Sharper focus on digital strategy and artificial intelligence.
|
In parallel with dedicated artificial intelligence training, Board members were
given a presentation on the AI strategy and the use of IT systems. This gave
them insights into how IT projects align with the digital strategy, especially in
R&D and the Manufacturing & Supply organization.
|
|
Closer monitoring of all transformation projects such as those relating to
manufacturing operations, changes in the Opella business, and cost
control plans.
|
Board members were able to scrutinize ongoing transformation and
governance programs (organizational change in R&D and Manufacturing &
Supply, commercial support for pre-launch and launch phases) and cost
efficiency programs.
|
|
More time to be allocated to human resources, especially talent
management and succession planning.
|
Board members had the opportunity to address issues around the corporate
culture (employee satisfaction survey, promotion of Sanofi values) and talent
management. These included a presentation on succession planning for critical
roles, with a particular focus on R&D.
|
|
102
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SANOFI
FORM 20-F
2024
|
|
PART I
|
|
ITEM 6. Directors, Senior Management and Employees
|
Evaluation of the Board and its Committees in 2024 - Internal evaluation with assistance
from an independent consultant
In 2024 there was a formal evaluation under the direction of the Appointments, Governance and CSR Committee, with assistance
from an independent consultancy firm.
The evaluation, which took several weeks, was conducted as follows:
•
issuance of a questionnaire to all directors, the main topics addressed being: alignment of the composition of the Board with
Sanofi's requirements; quality of documentation and presentations; working practices; usefulness of resources provided to the
Board and its committees; compliance of corporate governance with best practice; quality of debates and freedom of
expression; composition and remit of committees; relations between the Board and the Executive Committee, shareholders
and stakeholders; directors' expectations; personal contributions, including by the Chairman competencies and effective
participation in debate;
•
review of responses received from the directors; and
•
individual interviews conducted by the selected consultant.
In addition, all along 2024, the Chairman of the Board conducted discussions with each director intended to measure their
contribution to the work of the Board and its committees and to record any suggestions they may have.
The results of the 2024 evaluation were presented and discussed at a meeting of the Appointments, Governance and CSR
Committee on February 4, 2025, and the detail report finalized at that meeting was presented to the Sanofi Board of Directors on
February 12, 2025.
Overall, the board members considered that the functioning of the board improved in 2024 and that the board has been able to
conduct a robust decision-making process on key strategic projects, while having more open and collegial interactions. The
board demonstrated an increased capacity to work together and sustain a very dense agenda over the last months. The structure
of the agendas and the time allocation to each topic are considered as adequate. The development of the board as a team has
been enhanced by the visit to China.
The composition and the size of the board are considered as appropriate with the right level of diversity of all kinds, especially
with regards to nationalities, gender and expertise. The recent changes contributed to increase the expertise in the pharma
sector, in particular in the areas of therapeutic focus of the company. In terms of evolution of the board’s composition,
strengthening skills in that domain and in the digital transformation could be considered in the coming years.
The chairman onboarding process was considered satisfactory in the first year in the role with a rapid ramp-up on the core topics
of the company.
The articulation between the committees and the board and between the committees themselves is key in particular regarding
the cross-fertilization between the scientific and strategic committees. Progress has been made regarding the process of
validating acquisition opportunities.
The areas of progress identified for 2025 are as follows:
•
Continued reinforcement of the supervision of the transformation of R&D, including AI usage;
•
Supervision of the capital allocation and the Business Development / M&A progresses;
•
Review of the US activities;
•
Strategy in China;
•
In depth review of succession plans and talent management;
•
Enhancement of the training program for board members with at least three sessions planned to address the US market and
its evolution, the key principles in Immunology and the equitable access to care.
Detailed information about Board members
The following pages provide key information about each director individually:
•
directorships and appointments held during 2024 (directorships in listed companies are indicated by an asterisk, and each
director’s principal position is indicated in bold);
•
other directorships held during the last five years; and
•
training and professional experience.
|
SANOFI
FORM 20-F
2024
|
103
|
|
PART I
|
|
ITEM 6. Directors, Senior Management and Employees
|
|
Frédéric Oudéa
|
|
|
|
Date of birth: July 3, 1963 (aged 61)
|
|
Nationality: French
|
|
|
First appointed: May 2023
|
|
|
Term expires: 2027
|
|
|
Business address: Sanofi –
46, avenue de la Grande Armée
–
75017
Paris
– France
|
|
|
Number of shares held: 1,000
|
|
|
Current directorships and appointments
|
||
|
WITHIN THE SANOFI GROUP
|
OUTSIDE THE SANOFI GROUP
|
|
|
Chairman of the Board of Directors
|
In French companies
|
|
|
•
Chairman of the Strategy Committee
•
Member of the Appointments, Governance and CSR Committee
•
Member of the Scientific Committee
|
•
Lead independent Director of Capgemini*
•
Director of Sienna Investment managers SA since December 11, 2023
•
Member of the Supervisory Board of Sonic Topco, simplified joint stock
company
(société par actions simplifiée)
- since February 1, 2024
|
|
|
Chairman of Foundation S
|
In foreign companies
|
|
|
•
Member of the Supervisory Board of Umicore* (Belgium)
|
||
|
Past directorships expiring within the last five years
|
||
|
WITHIN THE SANOFI GROUP
|
OUTSIDE THE SANOFI GROUP
|
|
|
•
None
|
In French companies
|
|
|
•
Board member of ALD Automotive*
|
||
|
In foreign companies
|
||
|
•
None
|
||
|
Education and professional experience
|
||
|
•
Graduate of ENA (
École Nationale d'Administration
)
•
Degree from
École Polytechnique
|
||
|
Since November 2023
|
Senior Executive Advisor of Bruxelles Lambert Group*
|
|
|
Since May 2023
|
Chairman of the Board of Directors of Sanofi*
|
|
|
2015-2023
|
Chief Executive Officer of Société Générale*
|
|
|
2009-2015
|
Chief Executive Officer and Chairman of the Board of Société Générale*
|
|
|
2008-2009
|
Chief Executive Officer of Société Générale*
|
|
|
2003-2008
|
Group Chief Financial Officer of Société Générale*
|
|
|
2002-2003
|
Deputy Group Chief Financial Officer of Société Générale*
|
|
|
1998-2002
|
Head of global supervision and development of the Equity Department of Société Générale*
|
|
|
1995-1998
|
Assistant Manager, then Manager of the Corporate Banking department in London at Société Générale*
|
|
|
1987-1995
|
Various positions within the French Civil Service (General Inspectorate of Finance Service, Ministry of the Economy and
Finance, Ministry of the Budget and Office of the Minister of Budget and Communication)
|
|
* Listed company.
|
104
|
SANOFI
FORM 20-F
2024
|
|
PART I
|
|
ITEM 6. Directors, Senior Management and Employees
|
|
Paul Hudson
|
|
|
|
Date of birth: October 14, 1967 (aged 57)
|
|
Nationality: British
|
|
|
First appointed: September 2019
|
|
|
Last reappointment: May 2022
|
|
|
Term expires: 2026
|
|
|
Business address: Sanofi –
46, avenue de la Grande Armée
–
75017
Paris
– France
|
|
|
Number of shares held: 136,628
|
|
|
Current directorships and appointments
|
||
|
WITHIN THE SANOFI GROUP
|
OUTSIDE THE SANOFI GROUP
|
|
|
Chief Executive Officer
|
In French companies
|
|
|
•
Director
•
Member of the Strategy Committee
|
•
None
|
|
|
In foreign companies
|
||
|
•
None
|
||
|
Past directorships expiring within the last five years
|
||
|
WITHIN THE SANOFI GROUP
|
OUTSIDE THE SANOFI GROUP
|
|
|
•
None
|
In French companies
|
|
|
•
None
|
||
|
In foreign companies
|
||
|
•
None
|
||
|
Education and professional experience
|
||
|
•
Degree in economics from Manchester Metropolitan University, UK
|
||
|
•
Diploma in marketing from the Chartered Institute of Marketing, UK
|
||
|
•
Honorary Doctorate in Business Administration, Manchester Metropolitan University, UK
|
||
|
Since September 1,
2019
|
Chief Executive Officer of Sanofi*
|
|
|
2016-2019
|
CEO of Novartis Pharmaceuticals*, member of Executive Committee
|
|
|
2006-2016
|
Various operational and managerial positions at AstraZeneca* (including President, AstraZeneca US; Executive Vice President,
North America; Representative Director & President, AstraZeneca KK, Japan; President of AstraZeneca Spain; and Vice-
President and head of Primary Care United Kingdom)
|
|
|
Before 2006
|
Various operational and managerial positions at Schering-Plough, including Head of Global Marketing for biologicals.
Various sales and marketing positions at GlaxoSmithKline* UK and Sanofi-Synthélabo UK
|
|
* Listed company.
|
SANOFI
FORM 20-F
2024
|
105
|
|
PART I
|
|
ITEM 6. Directors, Senior Management and Employees
|
|
Christophe Babule
|
|
|
|
Date of birth: September 20, 1965 (aged 59)
|
|
Nationality: French
|
|
|
First appointed: February 2019
|
|
|
Last reappointment: May 2022
|
|
|
Term expires: 2026
|
|
|
Business address: Sanofi – 46, avenue de la Grande Armée – 75017 Paris – France
|
|
|
Number of shares held: 1,000
|
|
|
Current directorships and appointments
|
||
|
WITHIN THE SANOFI GROUP
|
OUTSIDE THE SANOFI GROUP
|
|
|
Director
|
In French companies
|
|
|
•
Member of the Audit Committee
|
•
Director of the “L'Oréal Fund for Women” charitable endowment fund
|
|
|
In foreign companies
|
||
|
•
None
|
||
|
Past directorships expiring within the last five years
|
||
|
WITHIN THE SANOFI GROUP
|
OUTSIDE THE SANOFI GROUP
|
|
|
•
None
|
In French companies
|
|
|
•
None
|
||
|
In foreign companies
|
||
|
L'Oréal* Group:
|
||
|
•
Director of L'Oréal US Inc. (United States)
|
||
|
Education and professional experience
|
||
|
•
MBA, HEC School of Management
|
||
|
Since February 2019
|
Chief Financial Officer at L'Oréal*
|
|
|
Since 1988
|
Various positions within the L’Oréal* Group, including as Director of Administration & Finance for China, then Mexico; Director
of Internal Audit; and Director of Administration & Finance for the Asia Pacific Zone
|
|
* Listed company.
|
106
|
SANOFI
FORM 20-F
2024
|
|
PART I
|
|
ITEM 6. Directors, Senior Management and Employees
|
|
Clotilde Delbos
|
|
|
|
Date of birth: September 30, 1967 (aged 57)
|
|
Nationality: French
|
|
|
First appointed: April 2024
|
|
|
Term expires: 2027
|
|
|
Business adress: Sanofi -
46, avenue de la Grande Armée
-
75017
Paris
-
France
.
|
|
|
Number of shares held: 500
|
|
|
Current directorships and appointments
|
||
|
WITHIN THE SANOFI GROUP
|
OUTSIDE THE SANOFI GROUP
|
|
|
Independent director
|
In French companies
|
|
|
•
Member of the Audit Committee
•
Member of the Compensation Committee
|
•
Director of AXA *
•
Director of Alstom * (Chairwoman of the Audit and Risks Committee)
•
Directeur of Schneider Electric *
•
Co-gérant
of Hactif Patrimoine
•
President of Hactif Advisory
|
|
|
In foreign companies
|
||
|
•
None
|
||
|
Past directorships expiring within the last five years
|
||
|
WITHIN THE SANOFI GROUP
|
OUTSIDE THE SANOFI GROUP
|
|
|
•
None
|
In French companies
|
|
|
•
President of Mobilize Invest
•
President of RCI Banque SA
•
President of Renault Venture Capital
•
President of Renault Mobility as an Industry
|
||
|
In foreign companies
|
||
|
•
Director of Renault Espana
•
Member of the Management Board of Alliance Rostec Auto BV
•
Member of the Management Board of Renault Nissan BV
•
Member of the Supervisory Board of Alliance Ventures BV
•
President of Renault Nissan BV
|
||
|
Education and professional experience
|
||
|
•
MBA EM Lyon in Finance and Accounting
|
||
|
2012 - 2022
|
Various positions at Renault Group * including Group Chief Financial Officer, Chairwoman of the Board of Directors of RCI
Banque, Interim Chief Executive Officer of Renault SA, Deputy Chief Executive Officer of the Renault group and Chief
Executive Officer of Mobilize.
|
|
|
Before 2012
|
Various positions in Internal Audit, Mergers & Acquisitions and Treasury, including at PricewaterhouseCoopers and Pechiney.
|
|
* Listed company.
|
SANOFI
FORM 20-F
2024
|
107
|
|
PART I
|
|
ITEM 6. Directors, Senior Management and Employees
|
|
Rachel Duan
|
|
|
|
Date of birth: July 25, 1970 (aged 54)
|
|
Nationality: Chinese
|
|
|
First appointed: April 2020
|
|
|
Last reappointment: April 2024
|
|
|
Term expires: 2028
|
|
|
Business address: Sanofi –
46, avenue de la Grande Armée
–
75017
Paris
– France
|
|
|
Number of shares held: 1,000
|
|
|
Current directorships and appointments
|
||
|
WITHIN THE SANOFI GROUP
|
OUTSIDE THE SANOFI GROUP
|
|
|
Independent director
|
In French companies
|
|
|
•
Member of the Compensation Committee
|
•
Director of Kering *
|
|
|
In foreign companies
|
||
|
•
Director of HSBC*
|
||
|
•
Director of Adecco Group*
|
||
|
Past directorships expiring within the last five years
|
||
|
WITHIN THE SANOFI GROUP
|
OUTSIDE THE SANOFI GROUP
|
|
|
•
None
|
In French companies
|
|
|
•
Director of AXA*
|
||
|
In foreign companies
|
||
|
•
None
|
||
|
Education and professional experience
|
||
|
•
MBA, University of Wisconsin-Madison (United States)
|
||
|
•
Bachelor’s degree in Economics and International Trade, Shanghai International Studies University (China)
|
||
|
Since March 2024
|
Independent Director, Kering*
|
|
|
Since September 2021
|
Independent Director, HSBC*
|
|
|
Since April 2020
|
Independent Director, Adecco Group*
|
|
|
2018-2024
|
Independent Director, AXA*
|
|
|
1996-2020
|
Senior Vice President of General Electric* (United States) and President & CEO of GE Global Markets (China)
|
|
* Listed company.
|
108
|
SANOFI
FORM 20-F
2024
|
|
PART I
|
|
ITEM 6. Directors, Senior Management and Employees
|
|
Carole Ferrand
|
|
|
|
Date of birth: April 2, 1970 (aged 54)
|
|
Nationality: French
|
|
|
First appointed: May 2022
|
|
|
Term expires: 2025
|
|
|
Business address: Sanofi –
46, avenue de la Grande Armée
–
75017
Paris
– France
|
|
|
Number of shares held: 1,000
|
|
|
Current directorships and appointments
|
||
|
WITHIN THE SANOFI GROUP
|
OUTSIDE THE SANOFI GROUP
|
|
|
Independent director
|
In French companies
|
|
|
•
Chairwoman of the Audit Committee
|
•
Honorary President and Director of Terra Nova (non-profit association)
•
Director and member of the Commitments Committee of France
Télévisions
|
|
|
In foreign companies
|
||
|
•
None
|
||
|
Past directorships expiring within the last five years
|
||
|
WITHIN THE SANOFI GROUP
|
OUTSIDE THE SANOFI GROUP
|
|
|
•
None
|
In French companies
|
|
|
•
Director and Chair of the Audit Committee of Fnac Darty*
•
Member of the Executive Committee of June 21 SAS
•
President of Capgemini Ventures SAS
|
||
|
In foreign companies
|
||
|
•
Director of June 21 SAS
•
Substitute of Alain de Marcellus, Capgemini Brasil SA (Brazil)
•
Director of Capgemini Solutions Canada Inc.
•
Director of Capgemini UK plc
•
Director of CGS Holdings Ltd (United Kingdom)
•
Director of Capgemini Espana SL (Spain)
•
Director of Altran Innovacion SLU (Spain)
|
||
|
Education and professional experience
|
||
|
•
HEC School of Management, Master's degree
|
||
|
2024
|
Head of Strategy and Development of Motier Holding
|
|
|
2018 - 2023
|
Chief Financial Officer of Capgemini*
|
|
|
2013-2018
|
Financing Operations Director of Groupe Artémis
|
|
|
2011-2012
|
Chief Financial Officer of EuropaCorp
|
|
|
2000-2011
|
Chief Financial Officer and General Counsel of Sony France
|
|
|
1992-2000
|
Audit and Transaction Services at PricewaterhouseCoopers (PwC)
|
|
* Listed company.
|
SANOFI
FORM 20-F
2024
|
109
|
|
PART I
|
|
ITEM 6. Directors, Senior Management and Employees
|
|
Lise Kingo
|
|
|
|
Date of birth: August 3, 1961 (aged 63)
|
|
Nationality: Danish
|
|
|
First appointed: April 2020
|
|
|
Last reappointment: April 2024
|
|
|
Term expires: 2028
|
|
|
Business address: Sanofi –
46, avenue de la Grande Armée
–
75017
Paris
– France
|
|
|
Number of shares held: 1,000
|
|
|
Current directorships and appointments
|
||
|
WITHIN THE SANOFI GROUP
|
OUTSIDE THE SANOFI GROUP
|
|
|
Independent director
|
In French companies
|
|
|
•
Member of the Appointments, Governance & CSR Committee
|
•
Director of Danone*
|
|
|
In foreign companies
|
||
|
•
Member of the Supervisory Board of Covestro AG* (Germany)
•
Director of Allianz Trade
|
||
|
Past directorships expiring within the last five years
|
||
|
WITHIN THE SANOFI GROUP
|
OUTSIDE THE SANOFI GROUP
|
|
|
•
None
|
In French companies
|
|
|
•
None
|
||
|
In foreign companies
|
||
|
•
Independent Director, Aker Horizons ASA* (Norway)
•
Member of the Advisory Panel for Humanitarian and Development Aid
Coordination, Novo Nordisk Foundation (Denmark)
|
||
|
Education and professional experience
|
|||
|
•
Master’s degree in Responsibility & Business, University of Bath (United Kingdom)
|
|||
|
•
Bachelor’s degree in Marketing and Economics, Copenhagen Business School (Denmark)
|
|||
|
•
Bachelor’s degree in Religions and Ancient Greek Art, University of Aarhus (Denmark)
|
|||
|
•
Director Certification, INSEAD (France)
|
|||
|
Since 2022
|
Independent director of Danone*
|
||
|
Since 2021
|
Independent director of Covestro AG* (Germany)
|
||
|
2021-2023
|
Independent Director, Aker Horizons ASA* (Norway)
|
||
|
2015-2020
|
CEO & Executive Director of United Nations Global Compact (US)
|
||
|
2002-2014
|
Executive Vice President Corporate Relations & Chief of Staff at Novo Nordisk A/S (Denmark)
|
||
|
1999-2002
|
Senior Vice President, Stakeholder Relations at Novo Holding (Denmark)
|
||
|
1988-1999
|
Director, Environmental Affairs of Novozymes (Denmark)
|
||
* Listed company.
|
110
|
SANOFI
FORM 20-F
2024
|
|
PART I
|
|
ITEM 6. Directors, Senior Management and Employees
|
|
Jean-Paul Kress
|
|
|
|
Date of birth: August 1, 1965 (aged 59)
|
|
Nationality: French
|
|
|
First appointed (co-option): January 1, 2025
|
|
|
Term expires: 2026
|
|
|
Business address: Sanofi –
46, avenue de la Grande Armée
–
75017
Paris
– France
|
|
|
Number of shares held: 2,000
American Depositary Receipts, equivalent to
1,000 shares
and
51.5635
FCPE shares
|
|
|
Current directorships and appointments
|
||
|
WITHIN THE SANOFI GROUP
|
OUTSIDE THE SANOFI GROUP
|
|
|
Independent director
|
In French companies
|
|
|
•
Member of the Strategy Committee
•
Member of the Scientific Committee
|
•
Chairman of the Board of Directors of EnnoDC
|
|
|
In foreign companies
|
||
|
•
None
|
||
|
Past directorships expiring within the last five years
|
||
|
WITHIN THE SANOFI GROUP
|
OUTSIDE THE SANOFI GROUP
|
|
|
•
None
|
In French companies
|
|
|
•
Chairman of the Board of Directors of ERYTECH Pharma*
|
||
|
In foreign companies
|
||
|
•
None
|
||
|
Education and professional experience
|
||
|
•
M.D. from Faculté Necker-Enfants Malades in Paris and Master of Sciences in molecular and cellular pharmacology from Ecole normale supérieure (Ulm)
in Paris
|
||
|
2019-2024
|
CEO of MorphoSys* (acquired by Novartis)
|
|
|
2019-2023
|
Chairman of the Board of Directors of ERYTECH Pharma*
|
|
|
2018
|
Chairman and CEO of Syntimmune (acquired by Alexion)
|
|
|
2017-2018
|
Executive Vice President, International President and Head of Global Therapeutic Operations of Biogen
|
|
|
2015-2017
|
Member of the Board of Directors of Sarepta Therapeutics
|
|
|
2015-2017
|
Senior Vice President, Head of North America at Sanofi Genzyme
|
|
|
2011-2015
|
Chairman and CEO at Sanofi Pasteur MSD
|
|
|
2006-2011
|
Several positions at Gilead Sciences:
•
Vice-President and General Manager France
•
Vice-President, US Sales and marketing, Antiviral Business Unit
|
|
|
1997-2006
|
General Manager, Denmark / Various US and EU Roles in Marketing, Commercial Operations & Business Development at Abbott
|
|
|
1993-1996
|
Product Manager at Eli Lilly
|
|
* Listed company.
|
SANOFI
FORM 20-F
2024
|
111
|
|
PART I
|
|
ITEM 6. Directors, Senior Management and Employees
|
|
Patrick Kron
|
|
|
|
Date of birth: September 26, 1953 (aged 71)
|
|
Nationality: French
|
|
|
First appointed: May 2014
|
|
|
Last reappointment: May 2022
|
|
|
Term expires: 2026
|
|
|
Business address: Sanofi –
46, avenue de la Grande Armée
–
75017
Paris
– France
|
|
|
Number of shares held: 1,000
|
|
|
Current directorships and appointments
|
||
|
WITHIN THE SANOFI GROUP
|
OUTSIDE THE SANOFI GROUP
|
|
|
Independent director
|
In French companies
|
|
|
•
Chairman of the Compensation Committee
•
Chairman of the Appointments, Governance and CSR Committee
•
Member of the Strategy Committee
|
•
Chairman of Imerys*
•
Chairman of PKC&I SAS:
–
Permanent representative of PKC&I on the Supervisory Board of
Segula Technologies
|
|
|
In foreign companies
|
||
|
•
Director of Viohalco* (Belgium)
|
||
|
Past directorships expiring within the last five years
|
||
|
WITHIN THE SANOFI GROUP
|
OUTSIDE THE SANOFI GROUP
|
|
|
•
None
|
In French companies
|
|
|
•
Interim Chief Executive Officer of Imerys*
•
Chairman of Truffle Capital SAS
|
||
|
In foreign companies
|
||
|
•
ElvalHalcor* (Greece)
|
||
|
•
Director of Holcim* (Switzerland)
|
||
|
Education and professional experience
|
||
|
•
Degree from
École Polytechnique
and
École Nationale Supérieure des Mines de Paris
|
||
|
Since 2019
|
Chairman of Imerys* (and Interim Chief Executive Officer from October 2019 to February 2020)
|
|
|
Since 2016
|
Chairman of PKC&I SAS
|
|
|
2016-2024
|
Chairman of Truffle Capital SAS
|
|
|
2003-2016
|
Chief Executive Officer, then Chairman and Chief Executive Officer of Alstom*
|
|
|
1998-2002
|
Chairman of the Managing Board of Imerys
|
|
|
1995-1997
|
Manager of the Food and Health Care Packaging Sector at Pechiney, and Chief Operating Officer of American National Can
Company in Chicago (United States)
|
|
|
1993-1997
|
Chairman and Chief Executive Officer of Carbone Lorraine
|
|
|
1993
|
Member of the Executive Committee of the Pechiney Group
|
|
|
1988-1993
|
Various senior operational and financial positions within the Pechiney Group
|
|
|
1984-1988
|
Operational responsibilities in one of the Pechiney Group’s biggest factories in Greece, then manager of the Greek subsidiary of
Pechiney
|
|
|
1979-1984
|
Various positions at the French Ministry of Industry, including as project officer at the
Direction régionale de l’Industrie,
de la Recherche et de l’Environnement
(DRIRE) and in the Ministry’s general directorate
|
|
* Listed company.
|
112
|
SANOFI
FORM 20-F
2024
|
|
PART I
|
|
ITEM 6. Directors, Senior Management and Employees
|
|
Wolfgang Laux
|
|
|
|
Date of birth: January 24, 1968 (aged 57)
|
|
Nationality: German
|
|
|
First appointed: April 2021
|
|
|
Term expires: 2025
|
|
|
Business address: Sanofi –
46, avenue de la Grande Armée
–
75017
Paris
– France
|
|
|
Number of shares held:
2,647 FCPE units and 1,558 performance
shares
|
|
|
Current directorships and appointments
|
||
|
WITHIN THE SANOFI GROUP
|
OUTSIDE THE SANOFI GROUP
|
|
|
Director representing employees
|
In French companies
|
|
|
•
Member of the Compensation Committee
|
•
None
|
|
|
In foreign companies
|
||
|
•
None
|
||
|
Past directorships expiring within the last five years
|
||
|
WITHIN THE SANOFI GROUP
|
OUTSIDE THE SANOFI GROUP
|
|
|
•
None
|
In French companies
|
|
|
•
None
|
||
|
In foreign companies
|
||
|
•
None
|
||
|
Education and professional experience
|
||
|
•
Post-doctoral research fellow at the State University of New York at Stony Brook (1998-2000) and at the University of Montpellier (1996-1997)
•
Ph.D. in organic chemistry from the University of Frankfurt am Main
•
Corporate Director’s Certificate from SciencesPo/IFA
(Certificat Administrateur de Sociétés)
•
European Board Diploma by ecoDa
|
||
|
Since 2006
|
Industrialization Coordinator at Sanofi Chimie and Sanofi Winthrop Industries, Croix-de-Berny and Gentilly (France)
|
|
|
Since 2014
|
Staff representative on the CFE-CGC ticket
|
|
|
2016-2021
|
Union delegate
|
|
|
2014-2021
|
Member of the Works Council, Sanofi Chimie headquarters
|
|
|
2016-2019
|
Member of the Committee on health, safety and working conditions (CHSCT)
|
|
|
2000-2006
|
Senior scientist in Process Development at the Frankfurt site of Höchst AG
|
|
* Listed company.
|
SANOFI
FORM 20-F
2024
|
113
|
|
PART I
|
|
ITEM 6. Directors, Senior Management and Employees
|
|
Barbara Lavernos
|
|
|
|
Date of birth: April 22, 1968 (aged 56)
|
|
Nationality: French
|
|
|
First appointed: April 2021
|
|
|
Term expires: 2025
|
|
|
Business address: Sanofi –
46, avenue de la Grande Armée
–
75017
Paris
– France
|
|
|
Number of shares held: 1,000
|
|
|
Current directorships and appointments
|
||
|
WITHIN THE SANOFI GROUP
|
OUTSIDE THE SANOFI GROUP
|
|
|
Director
|
In French companies
|
|
|
•
Member of the Appointments, Governance and CSR Committee
|
•
Vice-Chair of the L'Oréal Climate Emergency Fund
|
|
|
•
Member of the Strategy Committee
|
In foreign companies
|
|
|
•
None
|
||
|
Past directorships expiring within the last five years
|
||
|
WITHIN THE SANOFI GROUP
|
OUTSIDE THE SANOFI GROUP
|
|
|
•
None
|
In French companies
|
|
|
•
Director of Bpifrance Investment and Bpifrance Participations
|
||
|
In foreign companies
|
||
|
L'Oréal Group*:
|
||
|
•
Board member of Lactobio A/S (Denmark)
|
||
|
•
Board member of Bak Skincare ApS (Denmark)
|
||
|
Education and professional experience
|
||
|
•
Graduate of the HEI chemical engineering school at Lille, France
|
||
|
Since May 2021
|
Deputy CEO of L'Oréal* in charge of Research, Innovation and Technology
|
|
|
February 2021-
May 2021
|
President Research, Innovation and Technologies at L’Oréal*– Member of the Executive Committee at L’Oréal*
|
|
|
2018-2021
|
Chief Technology and Operations Officer at L’Oréal* – Member of the Executive Committee
|
|
|
2014-2018
|
Executive Vice-President Operations at L’Oréal* – Member of the Executive Committee
|
|
|
2011-2014
|
Managing Director of Travel Retail at L'Oréal*
|
|
|
2004-2011
|
Global Chief Procurement Officer at L'Oréal*
|
|
* Listed company.
|
114
|
SANOFI
FORM 20-F
2024
|
|
PART I
|
|
ITEM 6. Directors, Senior Management and Employees
|
|
Fabienne Lecorvaisier
|
|
|
|
Date of birth: August 27, 1962 (aged 62)
|
|
Nationality: French
|
|
|
First appointed: May 2013
|
|
|
Last reappointment: April 2021
|
|
|
Term expires: 2025
|
|
|
Business address: Sanofi –
46, avenue de la Grande Armée
–
75017
Paris
– France
|
|
|
Number of shares held: 1,000
|
|
|
Current directorships and appointments
|
||
|
WITHIN THE SANOFI GROUP
|
OUTSIDE THE SANOFI GROUP
|
|
|
Independent director
|
In French companies
|
|
|
•
Member of the Audit Committee
|
•
Director of Safran *
(Member of the Audit and Risk Committee)
|
|
|
•
Member of the Supervisory Board of Wendel *
(Member of the Audit, Risk and Compliance Committee and member of
the Governance and Sustainability Committee)
|
||
|
In foreign companies
|
||
|
•
None
|
||
|
Past directorships expiring within the last five years
|
||
|
WITHIN THE SANOFI GROUP
|
OUTSIDE THE SANOFI GROUP
|
|
|
•
None
|
In French companies
|
|
|
Air Liquide Group*:
|
||
|
•
Director of Air Liquide International
|
||
|
•
Director of The Hydrogen Company
|
||
|
•
Director of Air Liquide Finance
|
||
|
•
Director of ANSA (
Association Nationale des Sociétés par Actions
)
|
||
|
•
Director of Rexecode (economic research institute)
|
||
|
In foreign companies
|
||
|
Air Liquide Group*:
•
Chairwoman of Air Liquide US LLC
•
Executive Vice President of Air Liquide International Corporation
|
||
|
•
Director of American Air Liquide Holdings, Inc.
|
||
|
Education and professional experience
|
||
|
•
Civil engineer, graduate of
École Nationale des Ponts et Chaussées
|
||
|
2021- May 2023
|
Executive Vice President in charge of Sustainable Development, Public and International Affairs, Social Programs and General
Secretariat of Air Liquide*
|
|
|
July 2017-July 2021
|
Executive Vice President of Air Liquide*
|
|
|
2008-2023
|
Executive Committee member of Air Liquide*
|
|
|
2008-2021
|
Chief Financial Officer of Air Liquide*
|
|
|
1993-2008
|
Various positions within Essilor* including Group Chief Financial Officer (2001-2007) and Chief Strategy and Acquisitions
Officer (2007-2008)
|
|
|
1990-1993
|
Assistant General Manager of Banque du Louvre, Taittinger Group
|
|
|
1989-1990
|
Senior Banking Executive in charge of the LBO Department (Paris)/Corporate Finance Department (Paris and London)
at Barclays
|
|
|
1985-1989
|
Member of the Corporate Finance Department, then Mergers and Acquisitions Department of Société Générale*
|
|
* Listed company.
|
SANOFI
FORM 20-F
2024
|
115
|
|
PART I
|
|
ITEM 6. Directors, Senior Management and Employees
|
|
Anne-Françoise Nesmes
|
|
|
|
Date of birth: May 16, 1971 (aged 53)
|
|
Nationality: British and French
|
|
|
First appointed: April 2024
|
|
|
Term expires: 2027
|
|
|
Business address : Sanofi - 46, avenue de la Grande Armée - 75017 Paris - France
|
|
|
Number of shares held: 533
|
|
|
Current directorships and appointments
|
||
|
WITHIN THE SANOFI GROUP
|
OUTSIDE THE SANOFI GROUP
|
|
|
Independent Director
|
In French companies
|
|
|
•
Member of the Audit Committee
|
•
None
|
|
|
In foreign companies
|
||
|
Director of Compass Group PLC (UK) * (Chairwoman of the Audit
Committee and member of the Corporate Responsibility Committee,
Nomination Committee and Remuneration Committee)
|
||
|
Past directorships expiring within the last five years
|
||
|
WITHIN THE SANOFI GROUP
|
OUTSIDE THE SANOFI GROUP
|
|
|
•
None
|
In French companies
|
|
|
•
None
|
||
|
In foreign companies
|
||
|
•
Chief Financial Officer of Smith + Nephew PLC *
|
||
|
Education and professional experience
|
||
|
•
Master's degree from Grenoble Business School and a Master's degree in Business Administration from Henley Business School
•
Chartered Management Accountant
|
||
|
2020-2024
|
Chief Financial Officer of Smith + Nephew PLC
|
|
|
2016-2020
|
Chief Financial Officer of Merlin Entertainments PLC
|
|
|
2013-2016
|
Chief Financial Officer of Dechra Pharmaceuticals PLC
|
|
|
1997-2013
|
Various finance positions at GlaxoSmithKline PLC * including Senior Vice President of Finance for global vaccines
|
|
* Listed company.
|
116
|
SANOFI
FORM 20-F
2024
|
|
PART I
|
|
ITEM 6. Directors, Senior Management and Employees
|
|
John Sundy
|
|
|
|
Date of birth: October 7, 1961 (aged 63)
|
|
Nationality: American
|
|
|
First appointed: April 2024
|
|
|
Term expires: 2027
|
|
|
Business address: Sanofi - 46, avenue de la Grande Armée - 75017 Paris - France
|
|
|
Number of shares held: 1,000
American Depositary Receipts, equivalent to
500
shares
|
|
|
Current directorships and appointments
|
||
|
WITHIN THE SANOFI GROUP
|
OUTSIDE THE SANOFI GROUP
|
|
|
Independent director
|
In French companies
|
|
|
•
Member of the Scientific Committee
|
•
None
|
|
|
In foreign companies
|
||
|
•
Director of Neutrolis Inc
•
Director of the Childhood Arthritis and Rheumatology Research
Alliance (CARRA)
|
||
|
Past directorships expiring within the last five years
|
||
|
WITHIN THE SANOFI GROUP
|
OUTSIDE THE SANOFI GROUP
|
|
|
•
None
|
In French companies
|
|
|
•
None
|
||
|
In foreign companies
|
||
|
•
None
|
||
|
Education and professional experience
|
||
|
•
B. S. in biology from Bucknell University
•
M.D. from Hahnemann University
•
Ph. D in immunology from Hahnemann University
•
Clinical training in rheumatology and allergy/immunology at Duke
|
||
|
Since 2022
|
Chief Medical Officer and Head of Research and Development at Seismic Therapeutic
|
|
|
2020-2021
|
Chief Medical Officer at Pandion Therapeutics
|
|
|
2014-2020
|
Several management positions including Senior Vice President at Gilead Sciences
|
|
|
2006-2014
|
Adjunct Professor of Medicine in the Division of Rheumatology and Immunology at Duke University School of Medicine
|
|
* Listed company.
|
SANOFI
FORM 20-F
2024
|
117
|
|
PART I
|
|
ITEM 6. Directors, Senior Management and Employees
|
|
Yann Tran
|
|
|
|
Date of birth: December 5, 1965 (aged 59)
|
|
Nationality: French
|
|
|
First appointed: May 2021
|
|
|
Term expires: 2025
|
|
|
Business address: Sanofi –
46, avenue de la Grande Armée
–
75017
Paris
– France
|
|
|
Number of shares held: 1,546 FCPE units
|
|
|
Current directorships and appointments
|
||
|
WITHIN THE SANOFI GROUP
|
OUTSIDE THE SANOFI GROUP
|
|
|
Director representing employees
|
In French companies
|
|
|
•
None
|
||
|
In foreign companies
|
||
|
•
None
|
||
|
Past directorships expiring within the last five years
|
||
|
WITHIN THE SANOFI GROUP
|
OUTSIDE THE SANOFI GROUP
|
|
|
•
Coordinator for Industrial Europe on the Sanofi European Works Council
|
In French companies
|
|
|
•
None
|
||
|
In foreign companies
|
||
|
•
None
|
||
|
Education and professional experience
|
||
|
•
IFA Company Director Certificate from Sciences Po (2022)
|
||
|
•
DEA in Biochemistry: Integrative Protein Biology from the University of Paris VII (France)
|
||
|
•
Master's degree in Biochemical and Biological Engineering Sciences and Techniques from the University of Paris XII (France)
|
||
|
Since 2010
|
Head of Labor Relations, France at Sanofi
|
|
|
2021
|
Coordinator for IndustriALL Europe on the Sanofi European Works Council
|
|
|
2014-2021
|
Federation delegate for the Pharmaceuticals industry, in charge of negotiating and monitoring of industry agreements and
national collective agreements
|
|
|
2014-2021
|
FCE-CFDT federation delegate for social welfare
|
|
|
2010-2021
|
Trade union leader in labor relations in the Sanofi Group
|
|
|
2010-2014
|
Member of the Supervisory Board of Sanofi employee savings plans (PEG and PERCO) and member of the Sanofi Group
Committee
|
|
|
2006-2010
|
Bioinformatics researcher at Sanofi R&D
|
|
|
1995-2006
|
Researcher in molecular biology at Sanofi and Aventis
|
|
* Listed company.
|
118
|
SANOFI
FORM 20-F
2024
|
|
PART I
|
|
ITEM 6. Directors, Senior Management and Employees
|
|
Emile Voest
|
|
|
|
Date of birth: August 20, 1959 (aged 65)
|
|
Nationality: Dutch
|
|
|
First appointed: May 2022
|
|
|
Term expires: 2025
|
|
|
Business address: Sanofi –
46, avenue de la Grande Armée
–
75017
Paris
– France
|
|
|
Number of shares held: 1,000
|
|
|
Current directorships and appointments
|
||
|
WITHIN THE SANOFI GROUP
|
OUTSIDE THE SANOFI GROUP
|
|
|
Independent director
|
In French companies
|
|
|
•
Member of the Scientific Committee
|
•
None
|
|
|
In foreign companies
|
||
|
•
Board Member of the Center for Personalized Cancer Treatment
•
Member of the Supervisory Board of the Hartwig Medical Foundation
|
||
|
Past directorships expiring within the last five years
|
||
|
WITHIN THE SANOFI GROUP
|
OUTSIDE THE SANOFI GROUP
|
|
|
•
None
|
In French companies
|
|
|
•
None
|
||
|
In foreign companies
|
||
|
•
Chairman of the Board of Cancer Core Europe
|
||
|
Education and professional experience
|
||
|
•
Ph.D. in Medicine, cum laude, University of Utrecht
|
||
|
Since 2021
|
Founder of Mosaic Therapeutics and Strategic Advisor
|
|
|
Since 2019
|
Senior Group Leader of the Oncode Institute
|
|
|
Since 2015
|
Founder and Member of Supervisory Board of the Hartwig Medical Foundation
|
|
|
2016-2023
|
Director of Cancer Core Europe
|
|
|
2015-2020
|
ESMO (European Society for Medical Oncology)
•
Chair of the Publications Committee (2016-2020)
•
Member of the Executive Board (2015-2020)
|
|
|
Since 2014
|
The Netherlands Cancer Institute
•
Medical Oncologist (since 2014)
•
Exe
cutive Medical Director (2014-2020) and senior group leader
|
|
|
2013-2016
|
Co-founder and Non-Executive Medical Director of Hubrecht Organoid Technology
|
|
|
Since 2010
|
Co-founder and Member of the Executive Board of the Center for Personalized Cancer Treatment (CPCT)
|
|
|
Since 1999
|
Professor of Medical Oncology at UMC Utrecht
|
|
* Listed company.
|
SANOFI
FORM 20-F
2024
|
119
|
|
PART I
|
|
ITEM 6. Directors, Senior Management and Employees
|
|
Antoine Yver
|
|
|
|
Date of birth: January 31, 1958 (aged 67)
|
|
Nationality: American, French, Swiss
|
|
|
First appointed: May 2022
|
|
|
Term expires: 2025
|
|
|
Business address: Sanofi –
46, avenue de la Grande Armée
–
75017
Paris
– France
|
|
|
Number of shares held:
2,000
American Depositary Receipts, equivalent to
1,000
shares
|
|
|
Current directorships and appointments
|
||
|
WITHIN THE SANOFI GROUP
|
OUTSIDE THE SANOFI GROUP
|
|
|
Independent director
|
In French companies
|
|
|
•
Chairman of the Scientific Committee
•
Member of the Strategy Committee
|
•
Director of Allspim, Paris
|
|
|
In foreign companies
|
||
|
•
Director of D3Biologics, Shanghai (PRC)
•
Director of Stipple Therapeutics (USA)
•
Chair of One Carbon Therapeutics, Stockholm (Sweden)
|
||
|
Past directorships expiring within the last five years
|
||
|
WITHIN THE SANOFI GROUP
|
OUTSIDE THE SANOFI GROUP
|
|
|
•
None
|
In French companies
|
|
|
•
None
|
||
|
In foreign companies
|
||
|
•
Director of Spotlight Therapeutics *
|
||
|
Education and professional experience
|
||
|
•
Doctor of Medicine and Pediatrics, University of Paris-Sud 11
|
||
|
Since 2024
|
Pediatrician
|
|
|
Current
|
Advisor of Centessa, TOAD, Soley Therapeutics, Lilly Asia Ventures, Duality biologics, AptarGroup
|
|
|
2021-2024
|
Chairman of Development of Centessa Pharmaceuticals
|
|
|
2016-2021
|
EVP Global Head Oncology R&D at Daiichi Sankyo, Inc.
|
|
|
2009-2016
|
AstraZeneca*
•
SVP Head Oncology Global Medicines Development & Lead China GMD (2013-2016)
•
VP Head Oncology Global Medicines Development & Lead China GMD (2012-2013)
•
VP Clinical Oncology & New Opportunities (2011-2012)
•
VP Clinical Oncology & Infection (2009-2011)
|
|
|
2006-2009
|
Executive Director in Oncology at the Schering-Plough Research Institute
|
|
|
2005-2006
|
Senior Director Oncology at Johnson & Johnson*
|
|
|
1990-2005
|
Senior Director Clinical Research at Aventis
|
|
|
1981-1990
|
Medical doctor at the
Assistance Publique des Hôpitaux de Paris
|
|
* Listed company.
|
120
|
SANOFI
FORM 20-F
2024
|
|
PART I
|
|
ITEM 6. Directors, Senior Management and Employees
|
Attendance Rates of Board members
|
Director
|
Attendance rate
at Board meetings
|
Attendance rate
at Committee meetings
|
|
Frédéric Oudéa
|
100%
|
94%
|
|
Paul Hudson
|
100%
|
100%
|
|
Christophe Babule
|
100%
|
93%
|
|
Clotilde Delbos
(a)(b)
|
100%
|
100%
|
|
Rachel Duan
|
92%
|
100%
|
|
Carole Ferrand
|
100%
|
100%
|
|
Lise Kingo
|
100%
|
100%
|
|
Patrick Kron
|
100%
|
100%
|
|
Wolfgang Laux
|
100%
|
100%
|
|
Barbara Lavernos
|
100%
|
84%
|
|
Fabienne Lecorvaisier
|
100%
|
100%
|
|
Anne-Françoise Nesmes
(a)(c)
|
100%
|
100%
|
|
Gilles Schnepp
(d)
|
75%
|
93%
|
|
Diane Souza
(e)
|
100%
|
100%
|
|
Thomas Südhof
(e)
|
100%
|
100%
|
|
John Sundy
(a)(f)
|
100%
|
88%
|
|
Yann Tran
|
100%
|
100%
|
|
Emile Voest
|
100%
|
100%
|
|
Antoine Yver
(g)
|
100%
|
100%
|
|
Average attendance rate
at Board meetings
|
Average attendance rate
at Committee meetings
|
||
|
98%
|
97%
|
(a)
Clotilde Delbos, Anne-Françoise Nesmes and John Sundy joined the Board during 2024.
(b)
Clotilde Delbos joined the Audit Committee and Compensation Committee in April 2024, and attended the four and two meetings, respectively, held
subsequent to her appointment.
(c)
Anne-Françoise Nesmes joined the Audit Committee in April 2024, and attended the four meetings held subsequent to her appointment.
(d)
Gilles Schnepp left the Board on December 31, 2024. He did not take part to the Board meetings dedicated to the Opella separation.
(e)
Diane Souza and Thomas Südhof left the Board during 2024.
(f)
John Sundy joined the Scientific Committee in April 2024, and attended three meetings out of four held subsequent to his appointment.
(g)
Antoine Yver joined the Strategy Committee in April 2024, and attended the three meetings held subsequent to his appointment.
Directors who were absent from some meetings provided clear and substantiated explanations for their absence, which related
mainly to personal matters or to unscheduled meetings called at short notice (especially where sudden developments on an
ongoing project necessitated a Board meeting).
Declarations by Board members (including convictions and conflicts of interest)
As of December 31, 2024, no corporate officer has been the subject of any conviction or court order, or been associated with any
bankruptcy or winding-up order. As of this day, there is no potential conflict of interest between any corporate officer and Sanofi.
As of December 31, 2024, the members of our Board of Directors collectively held (directly, or via the employee share ownership
fund associated with the Group savings scheme) 155,251 of our shares, representing 0.012% of our share capital.
Service agreements entered into with Board members
Except as otherwise described below, there are no existing service agreements or arrangements between the Company or any of
its subsidiaries, and any Board member or corporate officer providing for benefits upon termination of employment.
Executive Committee
The Executive Committee is chaired by the Chief Executive Officer.
Three new members joine
d the Executive Committee in 2024: François Roger (Executive Vice President, Chief Financial Officer),
Audrey Duval (Executive Vice President, Corporate Affairs), and Brian Foard (Executive Vice President, Specialty Care).
As of February 13, 2025, the
Executive Committee had 13 members, four of whom are women. In accordance with our Board
Charter, the Board of Directors – in liaison with the Compensation Committee and the Appointments, Governance and CSR
Committee, and on a proposal from the Chief Executive Officer – has established a policy on gender
representation
within
Sanofi's executive bodies. A key objective of this policy is to support the creation of a talent pool of both women and men who
can potentially join the Executive Committee in future.
|
SANOFI
FORM 20-F
2024
|
121
|
|
PART I
|
|
ITEM 6. Directors, Senior Management and Employees
|
Paul Hudson
Chief Executive Officer
Date of birth: October 14, 1967.
Paul Hudson joined Sanofi as Chief Executive Officer on September 1, 2019.
Previously CEO of Novartis Pharmaceuticals (2016-2019), where he was a member of the Executive Committee, Paul has had an
extensive international career in healthcare that spans the US, Japan and Europe.
Prior to Novartis, he worked for AstraZeneca, where he held several increasingly senior positions and most recently carried out
the roles of President, AstraZeneca United States and Executive Vice President, North America.
He began his career in sales and marketing roles at GlaxoSmithKline UK and Sanofi-Synthélabo UK.
Paul holds a degree in economics from Manchester Metropolitan University in the UK and in 2018, his alma mater awarded him an
honorary Doctor of Business Administration for his achievements in industry. He also holds a diploma in marketing from the
Chartered Institute of Marketing, also in the UK.
Paul Hudson is a citizen of the United Kingdom.
Houman Ashrafian
Executive Vice President, Head of Research and Development
Date of birth: February 4, 1975.
Houman Ashrafian joined Sanofi on September 11, 2023.
Houman joined Sanofi from SV Health Investors where he was Managing Partner of the global private equity and venture capital
investment platform which has a special focus on biotechnology, healthcare growth equity, and medtech. He has a robust track
record in building high value, successful companies in the healthcare space, that brought transformational medicines from
discovery to market: he co-founded and chaired the biotechs Alchemab Therapeutics, Dualitas, Enara Bio, Mestag Therapeutics,
Sitryx and Trex Bio. Previously, he was Vice President and head of the Clinical Science Group at UCB with a main focus on
precision medicine strategies and early clinical activities across the R&D portfolio. He also co-founded Cardiac Report, a cardiac
services company, Heart Metabolics, Catamaran Bio, as well as Weatherden, a boutique clinical consultancy.
Houman is an Honorary Consultant Cardiologist at the John Radcliffe Hospital in Oxford, and a Visiting Professor at the University
of Oxford in the UK. He has received numerous prestigious awards and recognitions over the course of his career, including the
Michael Davies Early Career Award from the British Cardiovascular Society and the Schuldham Prize.
Houman has a bachelor’s and master’s degree from the University of Cambridge (UK) and a BM BCh and DPhil from the University
of Oxford (UK).
Houman Ashrafian is a citizen of the United Kingdom.
Natalie Bickford
Executive Vice President, Chief People Officer
Date of birth: July 16, 1970.
Natalie Bickford joined Sanofi on August 1, 2020. She has worked in HR and HR leadership for more than 20 years and brings a
wealth of experience in consumer-facing industries to Sanofi.
Prior to joining Sanofi, Natalie was Group HR Director at Merlin Entertainments, the world’s second largest location-based
entertainment business, where she was responsible for 30,000 employees across Europe, North America, and Asia Pacific. She
also held senior HR positions at Sodexo, AstraZeneca and Kingfisher Plc.
Natalie has a strong track record of transforming organizations, with a strong focus on inclusion and diversity. She was awarded
“HR Diversity Champion of the Year” at the European Diversity Awards in November 2019. Natalie is also Board member of the
Kronos Workforce Institute, a reflection of her deep interest in understanding and shaping the future of work. Natalie is a Board
Advisor to the Coalition for Epidemic Preparedness Innovation (CEPI).
Natalie holds a degree in French and International Politics from the University of Warwick in the UK.
Natalie Bickford is a citizen of the United Kingdom.
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ITEM 6. Directors, Senior Management and Employees
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Olivier Charmeil
Executive Vice President, General Medicines
Date of birth: February 19, 1963.
From 1989 to 1994, Olivier Charmeil worked in the Mergers & Acquisitions department of Banque de l’Union Européenne. He
joined Sanofi Pharma in 1994 as head of Business Development. Subsequently, he held various positions within Sanofi, including
Chief Financial Officer (Asia) of Sanofi-Synthélabo in 1999 and Attaché to the Chairman, Jean-François Dehecq, in 2000, before
being appointed as Vice President, Development within the Sanofi-Synthélabo International Operations Directorate, where he
was responsible for China and support functions. In 2003, Olivier Charmeil was appointed Chairman and Chief Executive Officer
of Sanofi-Synthélabo France, before taking the position of Senior Vice President, Business Management and Support within the
Pharmaceutical Operations Directorate. In this role, he piloted the operational integration of Sanofi-Synthélabo and Aventis. He
was appointed Senior Vice President Asia/Pacific, Pharmaceutical Operations in February 2006; Operations Japan reported to
him from January 1, 2008, as did Asia/Pacific and Japan Vaccines from February 2009. On January 1, 2011, Olivier Charmeil was
appointed Executive Vice President Vaccines, and joined our Executive Committee.
In May 2015, Olivier Charmeil and André Syrota were appointed as Co-Leaders of “Medicine of the Future”, an initiative
developed by the French Minister for Economy, Industry and Digital Affairs, the French Minister for Social Affairs, Health and
Women’s Rights and the French Minister for National and Higher Education and Research. They have been tasked with
assembling a group of industrialists and academics, with the objective of imagining how French industry can accelerate the
launch and export of innovative industrial products, with an emphasis on new biotechnologies.
From June 2016 to December 2018, Olivier Charmeil served as Executive Vice President of our General Medicines and Emerging
Markets Global Business Unit.
He took up the position of Executive Vice President China & Emerging Markets in January 2019. In February 2020 he was
appointed to lead the General Medicines GBU, created out of the former Primary Care and China & Emerging Markets GBUs. He
also serves as sponsor for China. Also in 2020, Olivier became a Board Member of the European Federation of Pharmaceutical
Industries and Associations (EFPIA).
Olivier is a graduate of HEC (
École des Hautes Études Commerciales
) and of the
Institut d’Études Politiques
in Paris.
Olivier Charmeil is a citizen of France.
Audrey Duval
Executive Vice President, Corporate Affairs
Date of birth: December 6, 1977.
Audrey Duval joined Sanofi in September 2022, as President, Sanofi France.
Audrey began her career in public hospitals in Paris and went on to work as a Researcher at the Pasteur Research Center of Hong
Kong University and then as a Scientific Expert at Salusmed, based in Hong Kong. She later returned to France to join Pfizer,
working in medical affairs in the areas of Endocrinology, Transplant and Rheumatology. and continues to retain that role,
supporting and coordinating Sanofi’s representation to its various external stakeholders in France. Prior to joining Sanofi, Audrey
worked for Novartis, where she served as Business Franchise Head for Ophthalmology and then Country President for the
company’s operations in Ireland.
Audrey holds a Medical Doctorate from the Paris Faculty of Medicine Cochin, and a Bachelor of Science in Medical Biology.
Audrey Duval is a citizen of France.
Brian Foard
Executive Vice President, Specialty Care
Date of birth: December 20, 1973.
As head of our Specialty Care GBU, Brian oversees an extensive portfolio of medicines in immunology, neuro-inflammation, rare
diseases, and oncology. Brian and his colleagues are responsible for launching treatments in those fields, and for implementing
the strategy to bring Sanofi’s scientific breakthroughs to patients.
Brian joined Sanofi in March 2017 as the Global Head of Dermatology and Respiratory, and held roles of increasing responsibility,
including as Head of Global Immunology for Sanofi and then as US Country Lead and Head of Specialty Care for North America.
He has over 20 years’ experience in the specialist biopharma industry, and began his career with Galderma where he spent more
than 10 years in the US before relocating to Paris to lead global marketing and launch readiness. During his time at Galderma,
Brian also served in roles including General Manager for Australia & New Zealand and Vice President & General Manager of the
global prescription business unit.
Brian received a degree in business from East Carolina University and has completed an executive education course at Wharton.
Brian Foard is a citizen of the United States.
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ITEM 6. Directors, Senior Management and Employees
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Emmanuel Frenehard
Executive Vice President, Chief Digital Officer
Date of birth: October 18, 1972.
Emmanuel joined Sanofi in 2020 as Global Head of Digital, and was appointed to the Executive Committee on August 31, 2023.
Prior to being appointed Chief Digital Officer, he held the positions of Global Head, Digital GBU teams and Digital Products. He
also led the Sanofi Digital Accelerator and a number of digital commerce initiatives.
Before joining Sanofi, Emmanuel spent 20 years leading large global organizations as well as three years in startups. He has built
and launched multiple global digital products in support of existing and new business models. In particular, he managed iflix’s
rollout across Southeast Asia and led the launch of DisneyLife, Disney’s direct-to-consumer digital subscription service, in the UK.
Emmanuel is a graduate of the European Business School (EBS) and holds a Master II in Business, Finance and Audit from the
Institut Supérieur de Gestion
(ISG).
Emmanuel Frenehard is a citizen of France.
Brendan O’Callaghan
Executive Vice President, Global Manufacturing & Supply
Date of birth:
July 16, 1961.
Brendan O’Callaghan joined Sanofi on January 1, 2015. He joined the Executive Committee on October 1, 2021.
Brendan joined Sanofi in 2015 and was previously Global Head of Biologics and Industrial Affairs Head of the Specialty Care
portfolio. He has played a key role in supporting our transformation to a fully integrated BioPharmaceutical company and
advancing the digital transformation of our manufacturing network.
Prior to Sanofi, Brendan worked at Schering-Plough before moving to Merck/MSD as Head of Biologics and later Vice President
of its Europe, Middle East and Africa Operations.
Brendan graduated in chemical engineering from the University College of Dublin, where he currently serves as an honorary
adjunct Professor of Chemical and Biochemical Engineering.
Brendan O’Callaghan is a citizen of Ireland.
Julie Van Ongevalle
Executive Vice President, Consumer Healthcare
Date of birth: November 22, 1974.
Julie Van Ongevalle joined Sanofi on September 1, 2020.
With over 20 years of international experience, Julie Van Ongevalle has a deep knowledge of consumers and digital, as well as a
proven track record in brand building, from identifying growth opportunities to building and implementing delivery strategies.
Prior to joining Sanofi, Julie worked at the Estée Lauder Companies, where she held roles of increasing responsibility across the
company, starting in 2004. As Global Brand President of the Origins brand from 2016, she led a global organization
of 4,000 people, growing the company’s market share across geographies. Prior to Origins, she spent eight years in the
M.A.C. Cosmetics division, first as General Manager Benelux, then of the EMEA Region and finally North America.
Julie started her career as a marketing manager at GSK Consumer Healthcare and Clinique.
Julie graduated from the
Institut Catholique des Hautes Études Commerciales
(Belgium) with a Master of Science in Commercial
and Financial Sciences.
Julie Van Ongevalle is a citizen of Belgium.
Roy Papatheodorou
Executive Vic
e President, General Counsel
Date of birth: May 15, 1978.
Roy Papatheodorou joined Sanofi on February 1, 2022.
Roy Papatheodorou leads the Legal, Ethics and Business Integrity and Global Security (LEBI & GS) team. The LEBI & GS team is
composed of lawyers, patent attorneys, compliance officers and security professionals covering Sanofi’s operations around the
world. Its team members play an essential role in protecting the interests of the company and of its patients, customers,
shareholders, and employees while delivering on Sanofi’s Play to Win roadmap and contributing to its long-term ambition to
transform the practice of medicine.
Before joining Sanofi, Roy served as General Counsel of Novartis Pharmaceuticals from 2017. Prior to that, he headed up Legal
Transactions at Novartis covering mergers & acquisitions, business development & licensing, antitrust, corporate & finance law,
and venture funds.
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From 2011 to 2013, he was Group General Counsel and Secretary to the Board of Directors at Actavis, a leading global generic
pharmaceuticals company. Prior to this, Roy spent several years at Linklaters in London, Moscow and Sao Paulo, advising mainly
on corporate law, international mergers & acquisitions, private equity, and restructurings.
Roy completed a Legal Practice Course from BPP School of Law in London and holds an LLB in Law from King’s College London.
He is a qualified solicitor in England & Wales.
Roy Papatheodorou is a citizen of Cyprus and Italy.
Madeleine Roach
Executive Vice President, Business Operations
Date of birth: May 23, 1984.
Madeleine Roach joined Sanofi in 2022 as Head of Internal Audit and Risk Management, before being appointed to the Executive
Committee on October 1, 2023.
Prior to joining Sanofi, Madeleine served at AstraZeneca as Head of Group Finance Services, Asia-Pacific and Head of Global
Business Services Site Lead in Malaysia, delivering a wide range of business services to stakeholders and further expanding the
site with the addition of value-added services and digitalization capabilities, whilst attracting top talent through strong employer
branding.
Madeleine also held positions of growing responsibility in Finance and Global Business Services at AstraZeneca, after starting her
career at PricewaterhouseCoopers and KPMG in Assurance and Advisory services, in Germany and the UK.
Madeleine holds a BA (Hons) in Economics and Politics from the School of Oriental and African Studies, University of London.
Madeleine Roach is a citizen of Germany.
François Roger
Executive Vice President, Chief Financial Officer
Date of birth: May 14, 1962.
François Roger has served as Chief Financial Officer of Sanofi since April 2024, leading a team that manages financial risk and
capital allocation to create value and growth for Sanofi.
François joined Sanofi from Nestlé where he was CFO for nearly nine years. Before Nestlé, he served from 2013 to 2015 as CFO of
Takeda Pharmaceuticals, based in Japan. He spent the first 14 years of his career working in the pharmaceutical industry, first at
Roussel, Hoechst and later Aventis, serving in various countries. He worked at Danone from 2000 to 2008 in various finance roles
and was CFO of Millicom, a NASDAQ listed, global mobile phone operator from 2008 to 2013. He has lived and worked in Europe,
the United States, Asia, Africa and Latin America.
François holds an MBA from Ohio State University in the US and a Major in Accounting from Audencia Business School in France.
François Roger is a citizen of France.
Thomas Triomphe
Executive Vice President, Vaccines
Date of birth: August 6, 1974.
Thomas Triomphe joined Vaccines in 2004 and has since advanced within the company in several roles of increasing
responsibility in sales and marketing at country, regional and global levels. From 2015 to 2018, he was Head of the Asia-Pacific
Region, based in Singapore. Before that, he served as Head of Vaccines Japan from 2012 to 2015. In 2010, he became Associate
Vice President, Head of the Influenza-Pneumo Franchise after three years as Director for the same franchise, based in the United
States. Earlier in his career, Thomas worked in banking and strategic consulting.
Thomas served as Vice President and Head of Franchise & Product Strategy for Vaccines from January 2018, in which position he
implemented the strategy for our vaccine franchises, in close collaboration with Manufacturing & Supply and R&D.
He was appointed to his current position on June 15, 2020.
Thomas earned his MSc in industrial engineering from
École des Ponts ParisTech
and the IFP School, and he also holds an MBA
from INSEAD.
Thomas Triomphe is a citizen of France.
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ITEM 6. Directors, Senior Management and Employees
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B. Compensation
Compensation and other arrangements for corporate officers
Process for determining the compensation policy for corporate officers
The compensation policy for corporate officers is established by the Board of Directors, acting on the recommendation of the
Compensation Committee. The Board of Directors applies the AFEP-MEDEF Code when determining the compensation and
benefits awarded to our executive and non-executive corporate officers.
All members of the Compensation Committee are independent, and were chosen for their technical competencies and their
good understanding of current standards, emerging trends and Sanofi’s practices.
To fulfill their remit, the Committee regularly invites Sanofi’s Chief People Officer and Head of Reward and Performance to attend
their meetings, although the latter absent themselves when the Committee deliberates. Committee members also work with the
Chairman and the Secretary of the Board, who have contacts with our principal institutional shareholders ahead of the Annual
General Meeting.
In addition, the Chair of the Committee:
•
discusses the financial, accounting and tax impacts of the proposed compensation policy with the Chair of the Audit
Committee;
•
plays an active role at meetings of the Appointments, Governance and CSR Committee and the Strategy Committee (to both
of which he/she belongs), thereby gaining assurance that the proposed performance criteria are consistent and appropriate in
light of Sanofi’s strategic ambitions.
The compensation policy is not subject to annual review, although some arrangements for implementing the policy – such as the
performance criteria applicable to the Chief Executive Officer’s annual variable compensation, for example – are defined by the
Board of Directors on an annual basis.
After consulting the Compensation Committee and as the case may be the other Board Committees, the Board of Directors may,
under the second paragraph of item III of Article L. 22-10-8 of the French Commercial Code, temporarily derogate from the
approved compensation policy for the Chief Executive Officer in exceptional circumstances and to the extent that the changes
are aligned with the corporate interest and necessary to safeguard the continuity or viability of Sanofi. Derogations from the
approved policy are possible in respect of the performance conditions applied to the Chief Executive Officer’s compensation,
and may result in either an increase or a decrease in compensation. Such derogations are possible in the event of a change in the
structure of the Sanofi group or major events affecting the markets. Such derogations may only be temporary and must be
properly substantiated.
Compensation policy for corporate officers
This section describes the compensation policy for corporate officers of Sanofi, as established pursuant to Article L. 22-10-8 of
the French Commercial Code. That policy describes all the components of compensation awarded to corporate officers of Sanofi
as consideration for holding office, and explains the process by which it is determined, allocated, reviewed and implemented.
Our compensation policy for corporate officers has three distinct elements: (i) the compensation policy for directors; (ii) the
compensation policy for the Chairman of the Board; and (iii) the compensation policy for the Chief Executive Officer.
Each of those policies is submitted for approval by our shareholders at the Annual General Meeting, in accordance with
Article L. 22-10-8 II of the French Commercial Code. The compensation policy approved in any given year applies to any person holding
corporate office in that year. When a corporate officer is appointed between two Annual General Meetings, their compensation is
defined by applying the terms of the compensation policy approved by the most recent Annual General Meeting of shareholders.
General principles and objectives
Our compensation policy is based on the following general principles:
•
the policy must be simple;
•
the policy must prioritize long-term performance;
•
the level of compensation must be competitive, so that we can attract and retain talent; and
•
there must be a fair balance between the corporate interest, the challenges of delivering on our strategy, and the
expectations of our stakeholders.
The Compensation Committee must ensure that trends in the compensation of corporate officers over the medium term are not
uncorrelated with trends in the compensation of all our employees. In terms of annual variable compensation and equity-based
compensation, the Compensation Committee aims to achieve convergence between the performance criteria applied to our
Senior Leaders and those applied to the Chief Executive Officer.
Our equity-based compensation policy, which aims to align employee and shareholder interests and reinforce loyalty to Sanofi, is
a critical tool for our worldwide attractiveness as an employer.
Grantees of equity-based compensation plans (including our Chief Executive Officer) can only be awarded performance shares.
Awarding performance shares reduces the dilutive effect of equity-based compensation plans while maintaining the same level
of motivation for grantees.
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Acting on the recommendation of the Compensation Committee, the Board of Directors determines the performance conditions
attached to equity-based compensation for all grantees at Sanofi and its subsidiaries worldwide, thereby furthering the
attainment of our objectives.
The Board of Directors makes any grant of performance shares contingent on multiple, exacting multi-year performance criteria
in order to ensure that our equity-based compensation plans incentivize overall performance. Failure to achieve those criteria
over the entire performance measurement period results in a reduction or loss of the initial grant.
In order to align equity-based compensation with our long-term performance, performance is measured over three financial
years (the “vesting period”). Awards of performance shares are also contingent on continued employment in the Sanofi group
during the vesting period, followed by stringent lock-up obligations in the case of the Chief Executive Officer (see below).
The terms of prior awards cannot be reset subsequently, for instance with less exacting performance conditions.
Compensation policy for directors
Directors hold office for a four-year term, as specified in our Articles of Association. They may be removed from office by a
shareholders’ meeting, at any time and without restriction.
The maximum annual amount of overall compensation allocated to the directors was set at €2,500,000 by the Annual General
Meeting of May 25, 2023. The arrangements for allocating the overall annual amount set by the Annual General Meeting between
the directors are determined by the Board of Directors, acting on a recommendation from the Compensation Committee.
Directors’ compensation comprises an annual fixed amount of €30,000, apportioned on a time basis for directors who assumed
or left office during the year; and a variable amount, allocated by the Board according to actual attendance at Board and
Committee meetings. As required by the AFEP-MEDEF Code, directors’ compensation is allocated predominantly on a variable
basis.
The table below shows how the variable amount payable to directors for attendance at Board and committee meetings is
determined
.
|
Compensation per meeting
|
||||
|
Directors
resident in France
|
Directors resident
outside France but
within Europe
|
Directors resident
outside Europe
|
Chairman/Chairwoman
|
|
|
Board of Directors
|
€5,500
|
€8,250
|
€11,000
|
N/A
|
|
Audit Committee
|
€8,250
|
€11,000
|
€13,750
|
€13,750
|
|
Compensation Committee
|
€5,500
|
€8,250
|
€11,000
|
€11,000
|
|
Appointments, Governance and CSR Committee
|
€5,500
|
€8,250
|
€11,000
|
€11,000
|
|
Strategy Committee
|
€5,500
|
€8,250
|
€11,000
|
N/A
|
|
Scientific Committee
|
€5,500
|
€8,250
|
€11,000
|
€11,000
|
The introduction of a separate compensation scale depending on whether or not the director is a European resident is intended
to take into account the significantly longer travel time required to attend Board meetings in person.
Directors who take part via videoconference receive compensation equivalent to that paid to a director resident in France
attending in person. Committee Chairs continue to receive the usual compensation in respect of the Committee they chair.
As an exception, in certain cases two meetings held on the same day give entitlement only to a single payment:
•
if on the day of a Shareholders’ General Meeting, the Board of Directors meets both before and after the Meeting, only one
payment is made for the two Board meetings; and
•
if on the same day a director participates in a meeting of the Compensation Committee and a meeting of the Appointments,
Governance and CSR Committee, only the higher of the two payments is made to cover both meetings.
Directors do not receive any exceptional compensation or equity-based compensation and have no entitlement to a top-up
pension plan.
Neither the Chairman of the Board nor the Chief Executive Officer receives any compensation for serving as a director.
Compensation policy for the Chairman of the Board of Directors
The term of office of the Chairman of the Board is the same as that of the other directors (four years), and the Chairman’s term is
aligned with his term of office as a director. He may be removed from office at any time by the Board of Directors.
The compensation policy for the Chairman of the Board of Directors is discussed by the Compensation Committee, which then
makes a recommendation to the Board of Directors. The Chairman of the Board is not a member of the Committee, and does not
attend meetings where his compensation is discussed.
The compensation of the Chairman of the Board of Directors (where the office of Chairman is separate from that of Chief
Executive Officer, as is currently the case) consists solely of fixed compensation and benefits in kind and excludes any variable or
exceptional compensation, any awards of stock options or performance shares, and any compensation for serving as a director.
The annual fixed compensation awarded to the Chairman of the Board of Directors is €880,000 gross; that amount was set at
the Board meeting of February 22, 2023, and became applicable with effect from May 25, 2023, date on which the current
Chairman took office.
(1)
Amgen, AstraZeneca plc, Bayer AG, Bristol-Myers-Squibb Inc., Eli Lilly and Company Inc., GlaxoSmithKline plc, Johnson & Johnson Inc., Merck Inc.,
Novartis AG, Novo Nordisk, Pfizer Inc. and Roche Holding Ltd.
(2)
Air Liquide, Airbus, AXA, Danone, Dassault Systèmes, EssilorLuxottica, Kering, L'Oréal, LVMH, Saint-Gobain, Schneider Electric, Stellantis, TotalEnergies, and Vinci.
(3)
Studies carried out on the basis of figures communicated by the companies Pay Governance and Boracay
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This amount takes account of the specific remit of the Chairman of the Board of Directors as described in the Sanofi Board
Charter, and of his membership of three Board Committees (the Strategy Committee, which he chairs; the Appointments,
Governance and CSR Committee; and the Scientific Committee).
The compensation of the Chairman of the Board of Directors is not subject to annual review.
Where the office of Chairman is separate from that of Chief Executive Officer, the Chairman of the Board is not entitled to the
Sanofi top-up defined-contribution pension plan.
Nor is he entitled to a termination benefit or a non-compete indemnity.
Compensation policy for the Chief Executive Officer
General principles
Our Chief Executive Officer is not appointed for a fixed term of office. He may be removed from office on legitimate grounds at
any time by the Board of Directors.
The compensation policy for the Chief Executive Officer is established by the Board of Directors, acting on the recommendation
of the Compensation Committee. The compensation structure is not subject to annual review and is applicable for as long as it
remains unchanged. The arrangements for implementing the policy may vary from year to year; a table showing the changes
made to those arrangements in 2025 and 2024 is provided at the end of the present section.
The overall compensation of the Chief Executive Officer is determined with reference to practices adopted by (i) a panel of
companies in the CAC 40 and (ii) a panel of pharmaceutical companies with which Sanofi is in competition. Because Sanofi
operates in a particularly competitive international environment and has broad geographical reach (with over three-quarters of
its net sales generated in the United States and non-European countries), a panel is used comprising the Chief Executive Officer
compensation of 12 leading global pharmaceutical companies with comparable levels of net sales to Sanofi, but with no limitation
as to geography
(1)
. That panel has remained unchanged since 2020.
This consistency with market practice is fundamental in order to attract and retain the talents necessary to our success, but does
not imply that Sanofi should adopt in every respect practices that are in some cases widely divergent, especially as regards the
level of long term compensation.
Panel of CAC 40 companies
Local practices are reviewed by reference to a panel of 14 CAC 40 companies
(2)
with a comparable profile to Sanofi in terms of
market capitalization, net sales, market presence, return on capital employed, etc; the panel was selected with assistance from an
independent consultant
(3)
. This study showed that Sanofi is in the fourth quartile of the panel in terms of market capitalization,
and close to the panel median in terms of net sales.
Based on the panel, the fixed compensation of our Chief Executive Officer is above the median, while his target short-term
compensation (fixed plus variable) is in the third quartile. His equity-based compensation is in the fourth quartile of the panel,
largely because our Compensation Committee takes into account practices adopted by our pharmaceutical industry competitors
(see below). His target overall compensation (fixed, variable and equity-based) is in the lower range of the fourth quartile.
Panel of pharmaceutical companies
In 2024, on the basis of information published as of the date of this annual report, the median fixed compe
nsation of the Chief
Executive Officers of the companies belonging to the pharmaceutical panel was approximately €1,768,000; the median of the
annual variable compensation awarded was in the region of €3,074,000; and the median of the long-term compensation
awarded (whether equity-based or in cash) represented approximately 922% of fixed compensat
ion. In 2024, Paul Hudson’s
overall compensation (fixed, variable and equity-based) was within in the first quartile of the panel, whereas in 2023 it was in the
lower range of the second quartile
.
Review of the Chief Executive Officer's compensation at the Board meeting of February 12, 2025
The quantum and structure of the Chief Executive Officer's compensation, which had been unchanged since 2022, were subject
to an in-depth review by the Board of Directors at their meeting of February 12, 2025. Issues considered by the Board included:
•
Sanofi's performance during the 2022-2024 period, including (i) the continuation of the Play to Win strategy led by Paul
Hudson, involving a major transformation in our profile to a global immunology leader combined with the separation of our
Consumer Healthcare business; (ii) further successful launches; and (iii) favorable readouts from a number of Phase 3 studies;
•
Paul Hudson's international profile, reflecting his thorough understanding and recognized international experience of the
pharmaceutical industry and his ability, since his appointment, to develop an ambitious strategy in a competitive, concentrated
sector, combined with the need to ensure
continuity (with support from the Executive Committee) in delivering this strategy in
the years ahead – including performance improvement and change management, especially in our R&D teams; and
•
trends in compensation practices for the Chief Executive Officers of the panel companies mentioned above, the relative ranking
of Sanofi, and the widening gap with the panel of pharmaceutical companies, given that Paul Hudson's compensation has been
reviewed only once since he took office in 2019, with a 7.7% increase in his annual fixed compensation and 10% in his equity-
based compensation in 2022.
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Following this latest review, our Board of Directors, acting on a recommendati
on from the Compensation Committee, decided to
(i) raise the Chief Executive Officer's annual fixed compensation to €1,600,000,
a 14.3% rise
(equivalent to 4.77% on an annual
basis over the last three years),
and (ii) increase th
e quantum of his allocation of equity-based compensation for 2025, subject to
the ceiling set by the compensation policy (see above). The other components of his compensation would remain unchanged.
That overall increase is in line with the average increase for Sanofi employee salaries between 2022 and 2024 in the countries
where Sanofi employs the highest number of people (a 13.9% increase across a group of countries representing approximately
two-thirds of our workforce).
Following that increase, Paul Hudson's short-term compensation (fixed + variable) would remain below the median compensation
of the panel of pharmaceutical companies (based on compensation paid in respect of 2023). His equity-based compensation
would be slightly above the first quartile. His target overall compensation (fixed + variable + equity-based) would be in the second
quartile of the panel
.
The Board of Directors takes the view that the proposed increase would keep Paul Hudson's compensation competitive relative
to practices in the pharmaceutical industry while remaining consistent with practices adopted by the CAC 40 panel. During the
decision-making process, our Board of Directors was careful to take into account not only our positioning relative to our peers
(size, market capitalization, etc.), but also the specific characteristics of certain markets. Unlike the practices adopted by some
pharmaceutical companies, (i) the long-term component, representing 60%-65% of our Chief Executive Officer's overall
compensation, is awarded solely in the form of performance shares and (ii) the final number of shares vesting may not exceed
100% of the initial award. Moreover, the overall compensation of our Chief Executive Officer will remain predominantly variable
(85%) and subject to the attainment of stringent performance conditions (as illustrated by the historical rates of attainment of
annual variable compensation and equity-based compensation since his appointment).
To achieve further alignment between the respective interests of Sanofi, the Chief Executive Officer and our shareholders, and to
reinforce the stringent nature of the performance conditions, the weighting of the Total Shareholder Return (TSR) criterion for
the Chief Executive Officer's performance share plan would be increased from 20% to 30% with effect from 2025.
In addition, the Chief Executive Officer is obliged to ret
ain, until he ceases to hold office, a number of Sanofi shares equivalent to
50% of the capital gain as calculated on the vesting date, net of associated taxes and contributions. At present, the number of
shares that the Chief Executive Officer is obliged to retain under past compensation plans which have now vested is 22,166. As of
February 12, 2025, those shares were valued at €2,309,697, representing around 144% of Paul Hudson's new annual fixed
compensation.
On taking up office
When the Chief Executive Officer is an outside appointment, the Board of Directors may decide, acting on a recommendation
from the Compensation Committee, to compensate the appointee for some or all of the benefits he may have forfeited on
leaving his previous employer. In such a case, the terms on which the Chief Executive Officer is hired aim to replicate the diversity
of what was forfeited, with a comparable level of risk (variable portion, medium-term equity-based or cash compensation).
During the term of office
Compensation structure
Our policy aims at achieving and maintaining a balance in the compensation structure between fixed compensation, benefits in
kind, short-term variable cash compensation, and medium-term variable equity-based compensation.
The compensation policy for the Chief Executive Officer is designed to motivate and reward performance by ensuring that a
significant portion of compensation is contingent on the attainment of financial, operational and extra-financial criteria that
reflect Sanofi’s objectives, and are aligned with the corporate interest and with the creation of shareholder value. Variable cash
compensation and equity-based compensation are the two principal levers for action, and are intended to align the interests of
the Chief Executive Officer with those of our shareholders and stakeholders.
During the meeting that follows the Board meeting held to close off the financial statements for the previous year, the
Compensation Committee examines the levels of attainment of variable compensation for that year. In advance of that meeting,
the Chief Executive Officer presents the Committee with a report containing narrative and quantitative information necessary to
measure attainment of the objectives. The members of the Compensation Committee then discuss the information provided and
report to the Board on those discussions, giving an evaluation of the Chief Executive Officer’s performance against each of the
criteria (determining the level of attainment for quantitative objectives, and evaluating the level of attainment for qualitative
objectives compared to the objectives set at the beginning of the year).
Annual fixed compensation
The annual fixed compensation of the Chief Executive Officer was set at €1,400,000 gross from 2022 through 2024; it had
previously remained unchanged since 2019.
The amount of fixed compensation is not subject to annual review. It may however be changed, provided that such changes are
not material:
•
on the appointment of a new Chief Executive Officer, to reflect the new appointee’s competencies and/or then current
market practice; and
•
in exceptional circumstances, to take account of changes in (i) the role or responsibilities of the Chief Executive Officer, for
e
xample in terms of market conditions or the size of the Sanofi group or (ii) the performance level of Sanofi over a given period.
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The Board meeting of February 12, 2025 decided to increase the annual fixed compensation of the Chief Executive Officer to
€1,600,000 gross with effect from January 1
st
, 2025; for an explanation, refer to “
—
Review of the Chief Executive Officer's
compensation at the Board meeting of February 12, 2025” above.
Annual variable compensation
Annual variable compensation is in a range between 0% and 250% of fixed compensation, with a target of 150%. It is subject to
a range of varied and exacting performance criteria, both quantitative and qualitative. The criteria are reviewed annually in light
of the strategic objectives determined by Sanofi. The Board of Directors sets the criteria for each year at the start of that year
on the recommendation of the Compensation Committee.
For 2025, the criteria are:
•
60% based on financial indicators published by Sanofi: sales growth, free cash flow (FCF) and business earnings per share
(business EPS), each accounting for 20%; and
•
40% based on specific individual objectives: transformation (15%), R&D pipeline (15%), and CSR (10%). The individual objectives
set for variable remuneration for 2024 are described in “— Compensation and benefits of all kinds awardable to corporate
officers in respect of 2024” below.
Although for each of those financial criteria the Board of Directors (acting on a proposal from the Compensation Committee) has
set specific objectives, those objectives cannot be disclosed for confidentiality reasons. Nevertheless, to align on shareholder
expectations Sanofi will henceforth provide ex-post disclosures for each financial criterion, showing key thresholds within the
range of outcomes
that enable attainment levels for the past financial year to be calculated (see “—
Compensation and benefits
of all kinds paid during 2024 or awarded in respect of 2024 to Paul Hudson, Chief Executive Officer” below).
The percentage of variable compensation linked to the attainment of quantitative criteria may be scaled down regardless of
actual performance, in order to give greater weight to the attainment of qualitative criteria. This flexibility can only operate to
reduce the amount of variable compensation, and cannot compensate for underperformance on quantitative criteria.
Payment of annual variable compensation in a given year in respect of the previous year is contingent on a favorable shareholder
vote at the Annual General Meeting.
Equity-based compensation
The Chief Executive Officer’s equity-based compensation, which can only be in the form of performance shares, may not
exceed 250% of his target short-term compensation (fixed plus variable).
The Chief Executive Officer’s equity-based compensation is contingent upon attainment of exacting performance conditions, all
of them quantitative, measured over a three-year-period. Such awards ar
e contingent upon both:
•
internal criteria based upon:
–
business earnings per share (business EPS), free cash flow (FCF), and development of the R&D pipeline,
–
Affordable Access and Planet Care – extra-financial criteria; and
•
an external criterion based on Sanofi's total shareholder return (TSR) relative to a benchmark panel of the 12 leading global
pharmaceutical companies: Amgen, AstraZeneca plc, Bayer AG, Bristol-Myers Squibb Inc., Eli Lilly and Company Inc.,
GlaxoSmithKline plc, Johnson & Johnson Inc., Merck Inc., Novartis AG, Novo Nordisk, Pfizer Inc., and Roche Holding Ltd.
As indicated in our currently applicable performance share plans, our Board of Directors reserves the right to adjust, both
upwards and downwards and within the limits of policy, the performance conditions in exceptional circumstances justifying such
an adjustment (if the Compensation Committee so advises), and specifically in the event of (i) a change in the structure of the
Sanofi group, (ii) a change in accounting policy, or (iii) any other circumstances that would justify such an adjustment, in the
opinion of our Board of Directors. The purpose of such an adjustment would be to ensure that the results of applying
performance conditions reflect the above-mentioned changes. Any such adjustments would be justified and disclosed ex-post in
our annual report on Form 20-F.
Acting on a proposal from the Compensation Committee, the Board of Directors has sought to maintain common criteria for
annual variable compensation and equity-based compensation, in order to ensure that short-term performance does not come
at the expense of long-term performance.
The valuation of performance shares is calculated at the date of grant, weighted between (i) fair value determined using the
Monte Carlo model and (ii) the market price of Sanofi shares at the date of grant, adjusted for dividends expected during the
vesting period.
Each award to our Chief Executive Officer takes into account previous awards and his overall compensation. In any event, the
maximum number of shares to be delivered may not be more than the number of performance shares initially awarded.
For details of the proposed award to the Chief Executive Officer in respect of 2025, refer to “— Compensation and benefits of all
kinds awardable to corporate officers in respect of 2025” below.
Share ownership and lock-up obligation of the Chief Executive Officer
The Chief Executive Officer is bound by the same obligations regarding share ownership specified in our Articles of Association
and Board Charter as our other corporate officers.
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In addition, the Chief Executive Officer is bound by an obligation to retain, until he ceases to hold office, a quantity of Sanofi
shares corresponding to 50% of the capital gain (net of taxes and social contributions) arising on the vesting of his shares,
calculated as of the date on which they vest. Those shares must be held in registered form until he ceases to hold office.
In compliance with the AFEP-MEDEF Code and our Board Charter, the Chief Executive Officer must undertake to refrain from
entering into speculative or hedging transactions.
Multi-year variable compensation
The Chief Executive Officer does not receive multi-year variable compensation.
Compensation for serving as a director
Executive officers of Sanofi do not receive any compensation for serving as directors. Consequently, the Chief Executive Officer
does not receive compensation in his capacity as a director or as a member of the Strategy Committee.
Exceptional compensation
No exceptional compensation can be awarded to the Chief Executive Officer.
On leaving office
The Chief Executive Officer is entitled to a top-up defined-contribution pension plan, a termination
benefit, and a non-compete
indemnity.
Such arrangements are part of the overall compensation package generally awarded to executive officers; in line with the
recommendations of the AFEP-MEDEF code, there are very strict rules about how they are implemented. The termination benefit
and non-compete indemnity are intended to compensate for the fact that the Chief Executive Officer may be dismissed at any
time.
Each of those benefits is taken into account by the Board of Directors when fixing the overall compensation of the Chief
Executive Officer.
Pension arrangements
The Chief Executive Officer is entitled to benefits under the top-up defined-contribution pension plan introduced within Sanofi
on January 1, 2020. This is a collective plan falling within the scope of Article 82 of the French General Tax Code. It is also offered
to members of our Executive Committee and to all senior executives whose position is classified within the Sanofi grade scale
as “Executive Level 1 or 2”. The Chief Executive Officer’s entitlement under this plan may be withdrawn by a decision of the Board
of Directors, but not retroactively.
Under the terms of the plan, the Chief Executive Officer receives an annual contribution the amount of which (subject to
attainment of a performance condition) may be up to 25% of his reference compensation (annual fixed and variable cash-based
compensation only; all other compensation is excluded). The rights accruing under the plan are those that are generated by the
capitalization contract taken out with the insurer, and vest even if the Chief Executive Officer does not remain with Sanofi until
retirement. The Chief Executive Officer may elect for the rights to be transferable as a survivor’s pension.
The performance condition is as follows:
•
if the level of attainment for variable compensation is equal to or greater than the target (i.e. 150% of fixed compensation),
100% of the contribution is paid;
•
if the level of attainment for variable compensation is less than 100% of fixed compensation, no contribution is paid; and
•
between those two limits, the contribution is calculated on a pro rata basis.
Because this performance condition is linked to the attainment of the performance criteria for annual variable compensation
(which itself is determined with reference to the strategic objectives of Sanofi), it ensures that no pension contributions could be
made in the event that the Chief Executive Officer fails to deliver.
The plan is wholly funded by Sanofi, which pays the full amount of the gross contributions. Because it is treated as equivalent to
compensation, the contribution is subject to payroll taxes and employer’s social security charges, and to income tax in the hands
of the Chief Executive Officer; all of the above are charged on the basis of the bands, rates and other conditions applicable to
compensation, and paid and declared on his pay slips for the contribution period.
Subject to (i) formal confirmation by the Board of Directors that the performance condition for the previous year has been met
and (ii) approval of the Chief Executive Officer’s compensation package for that year by the Annual General Meeting of our
shareholders, the annual gross contribution is paid as follows:
•
50% as a gross insurance premium to the fund manager; and
•
50% to the Chief Executive Officer, to indemnify him for the social security and tax charges for which he will become
immediately liable.
In accordance with Article 39.5 bis of the French General Tax Code, deferred compensation as defined in section 4 of
Article L. 22-10-9.4 of the French Commercial Code can be offset against corporate profits as a taxable expense up to a limit set
at three times the annual social security ceiling per beneficiary.
The pension entitlement is not cumulative with (i) any termination benefit paid in the event of forced departure or (ii) any non-
compete indemnity.
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ITEM 6. Directors, Senior Management and Employees
|
Termination arrangements
The termination benefit only becomes payable if the departure of the Chief Executive Officer is forced, i.e. in the event of
removal from office or resignation linked to a change in strategy or control of Sanofi. Compensation for non-renewal of the term
of office is irrelevant in the case of the Chief Executive Officer, because this office is held for an indefinite term.
In addition, no termination benefit is payable and the arrangement is deemed to have been rescinded in the following
circumstances:
•
removal from office for gross or serious misconduct
(faute grave ou lourde)
;
•
if the Chief Executive Officer elects to leave Sanofi to take up another position;
•
if the Chief Executive Officer is assigned to another position within Sanofi; or
•
if the Chief Executive Officer takes his pension.
Payment of the termination benefit is contingent upon fulfillment of a performance condition, which is deemed to have been met
if the attainment rate for the individual variable compensation objectives exceeded 90% of the target; that condition is assessed
over the three financial years preceding the Chief Executive Officer leaving office.
The amount of the termination benefit is capped at 24 months of the Chief Executive Officer’s most recent total compensation
on the basis of (i) the fixed compensation effective on the date of leaving office and (ii) the last variable compensation received
prior to that date subject to fulfillment of the performance condition.
The amount of the termination benefit is reduced by any amount received as consideration for the non-compete undertaking,
such that the aggregate amount of those two benefits may never exceed two years of total fixed and variable compensation.
Non-compete undertaking
In the event of his departure from Sanofi, the Chief Executive Officer undertakes, during the 12-month period following his
departure, not to join a competitor of Sanofi as an employee or corporate officer, or to provide services to or cooperate with such
a competitor.
In return for this undertaking, he receives an indemnity corresponding to one year’s total compensation, based on his fixed
compensation effective on the day he leaves office and on the last individual variable compensation he received prior to that
date. This indemnity is payable in 12 monthly installments.
However, the Board of Directors reserves the right to release the Chief Executive Officer from that undertaking for some or all of
that 12-month period. In such cases, the non-compete indemnity would not be due for the period of time waived by the
Company.
Consequences of the Chief Executive Officer’s departure for equity-based compensation
If the Chief Executive Officer leaves Sanofi for reasons other than resignation or removal from office for gross or serious
misconduct (in which case any award of equity-based compensation is forfeited in full), the overall allocation percentage is
prorated to reflect the amount of time the Chief Executive Officer remained with Sanofi during the vesting period.
If at any time prior to the expiration of the vesting period of his performance shares the Chief Executive Officer joins a competitor
of Sanofi as an employee or corporate officer, or provides services to or cooperates with such a competitor, he irrevocably loses
those performance shares regardless of any full or partial discharge by the Board of Directors of the non-compete undertaking
relating to his office as Chief Executive Officer.
Since 2021, if the Chief Executive Officer retires at the statutory retirement age prior to the expiration of the vesting period of his
performance shares, the overall allocation rate will be apportioned on a
pro rata
basis to reflect the amount of time for which the
Chief Executive Officer remained in the employment of Sanofi during the vesting period.
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ITEM 6. Directors, Senior Management and Employees
|
Summary of benefits awarded to the Chief Executive Officer on leaving office
The table below presents a summary of the benefits (as described above) that could be claimed by the Chief Executive Officer on
leaving office, depending on the terms of his departure. The information provided in this summary is without prejudice to any
decisions that may be made by the Board of Directors.
|
Voluntary departure/Removal from
office for gross or serious misconduct
|
Forced departure
|
Retirement
|
|
|
Termination benefit
(a)
|
/
|
24 months of fixed compensation as of the
date of leaving office
+
24 months of most recent individual variable
compensation received
(d)
–
Amounts received as non-compete indemnity
|
/
|
|
Non-compete
indemnity
(b)
|
12 months of fixed compensation as of the
date of leaving office
+
12 months of most recent individual variable
compensation received prior to leaving
office
|
12 months of fixed compensation as of date of
leaving office
+
12 months of most recent individual variable
compensation received prior to leaving
office
(e)
|
/
|
|
Top-up pension
(c)
|
/
|
/
|
Annual contribution of up to 25%
of reference compensation
|
|
Performance share plans
not yet vested
|
Forfeited in full
|
Rights retained
pro rata
to period of
employment within Sanofi
(f)
|
Rights retained
pro rata
to period
of employment within Sanofi
(f)
|
(a)
The amount of the termination benefit is reduced by any indemnity received as consideration for the non-compete undertaking, such that the
aggregate amount of those two benefits may never exceed two years of total fixed and variable compensation.
(b)
The Board of Directors may decide to release the Chief Executive Officer from the non-compete undertaking for some or all of the 12-month period. In
that case, the non-compete indemnity would not be due, or would be scaled down proportionately.
(c)
Defined-contribution pension plan, within the scope of Article 82 of the French General Tax Code. Subject to fulfillment of the performance condition,
assessed annually.
(d)
Subject to fulfillment of the performance condition assessed over the three financial years preceding departure from office, as described above.
(e)
Subject to the Board of Directors enforcing the non-compete undertaking, the amount of the termination benefit is reduced by any indemnity received as
consideration for the non-compete undertaking, such that the aggregate amount of those two benefits may never exceed two years of total fixed and
variable compensation.
(f)
In this case, the Chief Executive Officer remains subject to the terms of the plans, including the performance conditions and the non-compete clause.
Policy to recover erroneously-awarded compensation (“clawback”)
In 2023, the NASDAQ listing rules were amended to include Rule 5608, in application of
Section 10D-1 of the Securities Exchange
Act of 1934 which requires listed companies to implement a c
lawback policy.
On October 26, 2023, our Board of Directors adopted a clawback policy under which Sanofi must, within a reasonable time-
frame, recover the portion of the Chief Executive Officer’s variable compensation (cash-based or equity-based) that is wholly or
partly contingent on the attainment of financial performance criteria and was paid to him (according to the definition contained
in the NASDAQ listing rules)
based on financial information that has been determined to be erroneous and has required
accounting restatement to correct an error in previously-published financial statements. The policy applies to compensation paid
on or after October 2, 2023.
The clawback policy also applies to members of our Executive Committee and to our Head of Consolidation (equivalent to the
Chief Accounting Officer within the meaning of the NASDAQ listing rules).
Summary of changes made to the compensation policy for the Chief Executive Officer
The table below summarizes adjustments made to the compensation policy for the Chief Executive Officer and to the content o
f
the information published in the compensation report, some of which have been discussed in depth with our shareholders.
|
2025
|
2024
|
|
•
Annual fixed compensation:
–
Annual fixed compensation is increased from €1,4
00,000 gross to
€1,600,000 from 2025.
•
Equity-based compensation:
–
Given the increase in the number of performance shares it is
proposed to award to the Chief Executive Officer in respect of 2025,
it is proposed to increase the weighting of the TSR criterion from
20% to 30%. To enable the TSR weighting to increase to 30%, the
Business EPS weighting would reduce from 35% to 30%, and the FCF
weighting from 25% to 20%; the R&D and CSR criteria would remain
unchanged.
Furthermore, in order to align with market practices, the
Board of Directors has decided to review the mechanism and
remunerate Sanofi's relative positioning vis-à-vis the peer panel.
•
Transparency on performance criteria applicable to annual variable
compensation:
–
Transparency on the financial performance criteria applicable to
annual variable compensation has been enhanced:
information about
the thresholds (floor, target and maximum attainment level) used by
the Board of Directors to determine the overall attainment level and
payout is now published for each criterion.
|
•
Annual variable compensation:
–
To reflect shareholder expectations, the weighting of financial
objectives was increased from 50% to 60% (removal of criteria
related to business net income, business operating income margin
and new asset growth, addition of a criterion based on business EPS.
•
Equity-based compensation:
–
The criterion related to business net income has been replaced by
business EPS.
–
To demonstrate Sanofi's commitment to delivering on the strategic
roadmap, a criterion linked to the R&D pipeline has been included in
the Chief Executive Officer's equity-based compensation plan.
•
Clawback Policy:
–
Pursuant to the NASDAQ listing rules as amended in 2023, on
October 26, 2023, our Board of Directors adopted a clause allowing
the clawback, in full or in part, of compensation paid to the Chief
Executive Officer wholly or partly contingent on the attainment of
financial criteria based on erroneous financial information.
|
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2024
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133
|
|
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|
|
ITEM 6. Directors, Senior Management and Employees
|
Arrangements in favor of executive officers in office as of December 31, 2024 (table No. 11 of the AFEP-MEDEF Code)
|
Executive officer
|
Contract of
employment
|
Top-up
pension plan
|
Indemnities or benefits
payable or
potentially payable
on cessation of office
|
Indemnities
payable under
non-compete clause
|
|
Chairman of the Board
|
No
|
No
|
No
|
No
|
|
Chief Executive Officer
|
No
|
Yes
|
Yes
|
Yes
|
Compensation and benefits of all kinds awardable to corporate officers in respect of 2025
The section below describes the components of the compensation and benefits of all kinds awardable to corporate officers in
respect of the 2025 financial year, pursuant to the compensation policies described in “— Compensation policy for corporate
officers” above.
Compensation and benefits of all kinds awardable to directors in respect of 2025
The amounts to be awarded to directors in respect of 2025 will be determined in accordance with the principles described above
in “— Compensation policy for corporate officers — Compensation policy for directors.”
Compensation and benefits of all kinds awardable in respect of 2025 to the Chairman of the Board
of Directors
The components of compensation awardable to the Chairman of the Board of Directors are described above in
“— Compensation policy for corporate officers — Compensation policy for the Chairman of the Board of Directors.”
Acting on a recommendation from the Compensation Committee, the Board of Directors meeting of February 12, 2025 decided
to maintain the amount of compensation payable to the Chairman of the Board of Directors at €880,000 gross.
The Chairman of the Board of Directors does not receive any variable compensation, stock options or performance shares, in
accordance with AMF recommendations. Nor does he receive any compensation (i) for serving as a director or (ii) from any
company included in Sanofi’s scope of consolidation within the meaning of Article L. 233-16 of the French Commercial Code.
Benefits in kind for 2025 comprise a company car with a driver.
Compensation and benefits of all kinds awardable in respect of 2025 to Paul Hudson,
Chief Executive Officer
Fixed and variable annual compensation
Acting on a recommendation from the Compensation Committee, the Board of Directors meeting of February 12, 2025
determined the components of Paul Hudson’s compensation for the 2025 financial year.
Paul Hudson’s annual compensation comprises (i) annual fixed gross co
mpensation of €1,600,000 (see
the explanations provided
under “— Compensation policy for corporate officers — Compensation policy for the Chief Executive Officer” above) and
(ii) annual
variable compensation in a range from 0% to 250% of his annual fixed compensation, with a target of 150%, and subject
to both quantitative and qualitative criteria.
The objectives are based 60% on financial indicators – sales growth, FCF and business EPS – each accounting for 20%.
Floors have been set for each financial criterion, below which no variable compensation is payable for that criterion.
|
Objectives based on financial indicators – unchanged for 2025
|
|||
|
2025
|
2024
|
||
|
Sales growth
|
20%
|
Sales growth
|
20%
|
|
FCF
|
20%
|
FCF
|
20%
|
|
Business EPS
|
20%
|
Business EPS
|
20%
|
|
TOTAL
|
60%
|
60%
|
|
The structure of individual objectives was streamlined in 2024.
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|
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|
|
ITEM 6. Directors, Senior Management and Employees
|
Individual objectives for 2025 and 2024 are shown below:
|
2025 individual objectives
|
2024 individual objectives *
|
||
|
Business transformation
(R&D Platform Optimization, Review of Manufacturing & Supply
Operating Model, Smart Spending, Asset Portfolio, Ongoing Digital
Transformation)
|
15.0%
|
Business transformation
(Reallocation of Pipeline Resources, Centralization, Hub Strategy,
Smart Spending, Asset Portfolio, Digital Transformation)
|
15.0%
|
|
Development pipeline
M1 (Lead selection), M2 (Candidate selection), First in Human,
Pivotal Studies, Submissions, Approvals
|
15.0%
|
Development pipeline
M1 (Lead selection), M2 (Candidate selection), First in Human,
Pivotal Studies, Submissions, Approvals
|
15.0%
|
|
CSR
People & Culture, Environment, Governance (efficient Executive
Committee operations and effective Board interactions)
|
10.0%
|
CSR
People & Culture, Environment, Governance (reinforcement of the
strategic dialogue with the Board of Directors and functioning of
the new Executive Committee)
|
10.0%
|
(*)
For details of individual objectives for 2024 refer to "— Compensation and benefits of all kinds paid during 2024 or awarded in respect of 2024 to Paul
Hudson, Chief Executive Officer" below.
Equity-based compensation
Acting on a recommendation from the Compensation Committee and within the limits set out in the Chief Executive Officer's
compensation policy, the Board of Directors meeting of February 12, 2025 proposes awarding 90,000 performance shares to
Paul Hudson in respect of 2025. In accordance with the AFEP-MEDEF Code, the entire award will be subject to criteria that are
both internal and external. Given the proposed increase in the number of performance shares awarded in respect of 2025 (see
"— Compensation Policy for the Chief Executive Officer" above), the Board of Directors decided, on a recommendation from the
Compensation Committee, to raise the proportion based on the external criterion ( TSR) from 20% to 30% for the Chief Executive
Officer (see below). T
o enable this, the Business EPS weighting would reduce from 35% to 30%, and the FCF weighting from 25%
to 20%; the R&D and CSR criteria would remain unchanged.
The criteria applied to the Chief Executive Officer's 2025 performance share plan are as follows:
•
internal criteria, based on Business EPS 30%, FCF 20%, R&D pipeline 10%, and CSR criteria 10%; and
•
an external criterion (accounting for 30%) based on the level of TSR as compared with that of a panel of 12 leading global
pharmaceutical companies: Amgen, AstraZeneca plc, Bayer AG, Bristol-Myers Squibb Inc., Eli Lilly and Company Inc.,
GlaxoSmithKline plc, Johnson & Johnson Inc., Merck Inc., Novartis AG, Novo Nordisk, Pfizer Inc., and Roche Holding Ltd.
Any
TSR-linked payment is contingent on Sanofi achieving an Endpoint Rank greater than or equal to the median of the TSR panel.
To achieve even further alignment between the respective interests of Sanofi, the Chief Executive Officer and our
shareholders, an
d to reinforce the stringent nature of the performance conditions, the weighting of the Total Shareholder
Return (TSR) criterion for the Chief Executive Officer's performance share plan will be increased from 20% to 30% with effect
from 2025. Furthermore, in order to align with market practices, the Board of Directors has decided to review the mechanism
and reward Sanofi's relative positioning vis-à-vis the peer panel.
The CSR criteria, both of which are quantitative and which count for 10% of the award, are:
1.
Affordable Access: providing essential medicines to non-communicable disease patients through Sanofi Global Health; and
2.
Planet Care: Carbon Footprint Reduction, scopes 1 & 2 (reduction in CO
2
emissions vs 2019).
Details of the performance objectives applicable to the Chief Executive Officer's equity-based compensation plan for 2025,
including the mechanisms used to determine the attainment level for each criterion, will be published on our corporate website, in
the "Compensation" section of the "Governance" pages, in advance of the Annual General Meeting.
|
Summary of performance objectives applicable to equity-based compensation plans
|
|||||
|
2025
|
2024
|
||||
|
Business EPS
|
Internal financial criterion
|
30%
|
Business EPS
|
35%
|
|
|
FCF
|
Internal financial criterion
|
20%
|
FCF
|
25%
|
|
|
TSR
|
External financial criterion
|
30%
|
TSR
|
20%
|
|
|
R&D pipeline
|
Internal criterion
|
10%
|
R&D pipeline
|
10%
|
|
|
CSR criteria
|
Internal extra-financial criteria
|
10%
|
CSR criteria
|
10%
|
|
|
TOTAL
|
100%
|
100%
|
|||
In accordance with the AFEP-MEDEF Code, Paul Hudson is bound by rules on insider trading that impose blackout periods, as
contained in our Board Charter.
In accordance with the AFEP-MEDEF Code and our Board Charter, Paul Hudson has undertaken not to engage in speculative or
hedging transactions, and as far as the company is aware, no hedging instruments have been contracted.
|
SANOFI
FORM 20-F
2024
|
135
|
|
PART I
|
|
ITEM 6. Directors, Senior Management and Employees
|
Compensation and benefits of all kinds paid during 2024 or awarded in respect of 2024 to corporate officers
The section below constitutes the report on compensation of corporate officers required by Articles L. 225-37 and L. 22-10-8 of
the French Commercial Code. The arrangements described therein will be submitted for approval by our shareholders at the
Annual General Meeting called to approve the financial statements for the year ended December 31, 2024 pursuant to
Article L. 22-10-34 of the French Commercial Code.
Compensation elements and benefits of all kinds paid during 2024 or awarded in respect of 2024 to directors
The compensation policy for directors (as described above in the section entitled “— Compensation policy for directors”) defines
the fixed amount of compensation, and the principles for allocating the variable portion between directors, up to the limit of the
overall amount approved by the Annual General Meeting.
Directors’ compensation includes an annual fixed payment, apportioned on a time basis for directors who assumed or left office
during the year; and a variable amount, allocated by the Board according to actual attendance at Board and Committee
meetings. As required by the AFEP-MEDEF Code, directors’ compensation is allocated predominantly on a variable basis.
For 2024, directors’ compensation was determined in accordance with the compensation policy for directors as described above
in the section entitled “— Compensation policy for directors.”
Compensation allocated to directors for serving as directors (table No. 3 of the AFEP-MEDEF Code)
The table below shows amounts paid in respect of 2024 and 2023 to each member of our Board of Directors, including those
whose term of office ended during those years.
Directors’ compensation for 2023, the amount of which was approved at the Board meeting of February 22, 2024, was partially
paid in July 2023, with an additional payment made in 2024.
Directors’ compensation for 2024, the amount of which was approved at the Board meeting of February 12, 2025, was partially
paid in July 2024, with an additional payment to be made in 2025.
|
(€)
|
Compensation in respect of 2024
|
Compensation in respect of 2023
|
||||
|
Name
|
Fixed
portion
|
Variable
portion
|
Total amount
(variable
+ fixed portion)
|
Fixed
portion
|
Variable
portion
|
Total gross
compensation
|
|
Christophe Babule
|
30,000
|
132,000
|
162,000
|
30,000
|
104,500
|
134,500
|
|
Clotilde Delbos
(a)
|
20,000
|
104,500
|
124,500
|
—
|
—
|
—
|
|
Rachel Duan
(b)
|
30,000
|
115,500
|
145,500
|
30,000
|
115,500
|
145,500
|
|
Carole Ferrand
|
30,000
|
167,750
|
197,750
|
30,000
|
110,000
|
140,000
|
|
Lise Kingo
(c)
|
30,000
|
137,500
|
167,500
|
30,000
|
118,250
|
148,250
|
|
Patrick Kron
|
30,000
|
165,000
|
195,000
|
30,000
|
145,750
|
175,750
|
|
Wolfgang Laux
(d)
|
30,000
|
99,000
|
129,000
|
30,000
|
77,000
|
107,000
|
|
Barbara Lavernos
|
30,000
|
126,500
|
156,500
|
30,000
|
104,500
|
134,500
|
|
Fabienne Lecorvaisier
|
30,000
|
140,250
|
170,250
|
30,000
|
126,500
|
156,500
|
|
Anne-Françoise Nesmes
(a)(b)
|
20,000
|
104,500
|
124,500
|
—
|
—
|
—
|
|
Gilles Schnepp
|
30,000
|
165,000
|
195,000
|
30,000
|
145,750
|
175,750
|
|
Diane Souza
(b)
|
10,000
|
68,750
|
78,750
|
30,000
|
187,000
|
217,000
|
|
John Sundy
(a)(b)
|
20,000
|
93,500
|
113,500
|
—
|
—
|
—
|
|
Thomas Südhof
(b)
|
10,000
|
55,000
|
65,000
|
30,000
|
192,500
|
222,500
|
|
Yann Tran
(d)(e)
|
30,000
|
82,500
|
112,500
|
30,000
|
60,500
|
90,500
|
|
Emile Voest
(c)
|
30,000
|
129,250
|
159,250
|
30,000
|
148,500
|
178,500
|
|
Antoine Yver
|
30,000
|
154,000
|
184,000
|
30,000
|
187,000
|
217,000
|
|
Frédéric Oudéa
(f)
|
—
|
—
|
—
|
12,016
|
33,000
|
45,016
|
|
Total
|
440,000
|
2,040,500
|
2,480,500
|
432,016
|
1,856,250
|
2,288,266
|
The amounts reported are gross amounts before taxes.
(a)
Director appointed by the General Meeting of April 30, 2024.
(b)
Director resident outside Europe.
(c)
Director resident outside France but within Europe.
(d)
Director representing employees.
(e)
Compensation due to Yann Tran is paid directly to Fédération Chimie Énergie CFDT.
(f)
Frédéric Oudéa was appointed as a non-voting Board member appointed by the Board of Directors on September 2, 2022 until his appointment as
Chairman of the Board on May 25, 2023. In accordance with our Articles of Association, the compensation of non-voting Board members is deducted
from the annual amount allocated by the General Meeting.
Each of the two directors representing employees has a contract of employment with a Sanofi subsidiary, under which they
receive compensation unrelated to their office as director. Consequently, that remuneration is not disclosed.
Variable compensation allocated to directors in respect of 2024 represented 82.26% of their total compensation.
|
136
|
SANOFI
FORM 20-F
2024
|
|
PART I
|
|
ITEM 6. Directors, Senior Management and Employees
|
Compensation and benefits of all kinds paid during 2024 or awarded in respect of 2024
to Frédéric Oudéa, Chairman of the Board of Directors
Frédéric Oudéa was appointed Chairman of the Board of Directors on May 25, 2023. He does not have a contract of employment
with Sanofi.
As Chairman of the Board, Frédéric Oudéa is a member of the Appointments, Governance and CSR Committee and the Scientific
Committee, and Chair of the Strategy Committee.
The remit of the Chairman of the Board is specified in the Board Charter, which is reproduced in its entirety in Exhibit 1.2. to this
annual report.
During 2024, the activities of Frédéric Oudéa as Chairman of the Board of Directors included:
•
chairing meetings of the Board of Directors (twelve meetings), attending meetings of Committees of which he is a member (six
meetings of the Appointments, Governance and CSR Committee, five meetings of the Strategy Committee, and six meetings
of the Scientific Committee), attending Committee meetings to which he was invited (Audit Committee and Compensation
Committee), and attending the R&D pipeline review week;
•
organizing and chairing the strategy seminars held in April and October 2024, and organizing meetings and visits in China in
December 2024;
•
monitoring of the proper implementation of the decisions taken by the Board;
•
meetings with directors, including (i) in connection with the evaluation of the Board’s operating procedures, (ii) on matters
relating to the projects presented to the Board, and (iii) on corporate governance matters;
•
regular meetings with the members of the Executive Committee;
•
meetings with Sanofi employees and visits to subsidiaries of Sanofi;
•
meetings with biotech and medtech companies; and
•
representing Sanofi at events or official meetings (in France and abroad) with representatives of the public authorities and
other stakeholders, in line with his remit as defined by the Board Charter, and in particular with the French State in respect of
the proposed separation of Sanofi's Consumer Healthcare business.
The Chairman also has a role in explaining positions taken by the Board within its sphere of competence, especially in terms of
strategy, governance and executive compensation. In furtherance of this role, the Chairman drew on his experience of corporate
communications in:
•
answering letters from investors and shareholders; and
•
holding meetings with certain shareholders.
Those tasks were carried out in coordination with the Chief Executive Officer.
Compensation paid in respect of the
2024
financial year
Acting on a recommendation from the Compensation Committee, the Board meeting of February 12, 2025 determined the
components of Frédéric Oudéa's compensation for the 2024 financial year. For that year, Frédéric Oudéa's fixed compensation
was unchanged from the 2023 financial year at €880,000 gross
.
In line with our compensation policy for the Chairman of the Board, Frédéric Oudéa did not receive any variable compensation,
and was not awarded any stock options or performance shares. He received no compensation for serving as a director, and no
compensation from any company included in Sanofi’s scope of consolidation within the meaning of Article L. 233-16 of the
French Commercial Code.
Benefits in k
ind amounted to €4,836
, and relate to a company car with a driver.
Frédéric Oudéa is not covered by the Sanofi defined-contribution pension plan.
Compensation, options and shares awarded to Frédéric Oudéa
(table No. 1 of the AFEP-MEDEF Code)
|
(€)
|
2024
|
2023
|
|
Compensation awarded for the year (details provided in the following table)
|
884,836
|
528,505
|
|
Valuation of stock options awarded during the year
|
N/A
|
N/A
|
|
Valuation of performance shares awarded during the year
|
N/A
|
N/A
|
|
Valuation of other long-term compensation plans
|
N/A
|
N/A
|
|
Total
|
884,836
|
528,505
|
|
SANOFI
FORM 20-F
2024
|
137
|
|
PART I
|
|
ITEM 6. Directors, Senior Management and Employees
|
Compensation awarded to Frédéric Oudéa
(table No. 2 of the AFEP-MEDEF Code)
|
2024
|
2023
|
|||
|
(€)
|
Amounts
due
|
Amounts
paid
|
Amounts
due
|
Amounts
paid
|
|
Fixed compensation
(a)
|
880,000
|
880,000
|
526,087
|
526,087
|
|
Annual variable compensation
|
N/A
|
N/A
|
N/A
|
N/A
|
|
Exceptional compensation
|
N/A
|
N/A
|
N/A
|
N/A
|
|
Compensation for serving as a director
(b)
|
N/A
|
N/A
|
N/A
|
N/A
|
|
Benefits in kind
|
4,836
|
4,836
|
2,418
|
2,418
|
|
Total
|
884,836
|
884,836
|
528,505
|
528,505
|
The amounts reported are gross amounts before taxes.
(a)
Fixed compensation due in respect of a given year is paid during that year.
(b) Compensation awarded to Frédéric Oudéa for service as a non-voting Board member, an office he held from September 2, 2022 to May 25, 2023 (the
date on which he was appointed Chairman of the Board of Directors), is disclosed in the section entitled "Compensation elements and benefits of all
kinds paid during 2024 or awarded in respect of 2024 to directors" above.
Compensation and benefits of all kinds paid during 2024 or awarded in respect of 2024 to Paul Hudson,
Chief Executive Officer
Paul Hudson has served as Chief Executive Officer of Sanofi since September 1, 2019, and holds office for an indeterminate
period.
Paul Hudson does not have a contract of employment with Sanofi, and receives no compensation from any company included in
Sanofi’s scope of consolidation within the meaning of Article L. 233-16 of the French Commercial Code.
Compensation awarded to Paul Hudson
(table No. 1 of the AFEP-MEDEF Code)
|
(€)
|
2024
|
2023
|
|
Compensation awarded for the year (details provided in the following table)
|
3,979,697
|
3,792,797
|
|
Valuation of performance shares awarded during the year
(a)
|
5,971,350
|
6,779,025
|
|
Total
|
9,951,047
|
10,571,822
|
(a)
Weighting between (i) fair value determined using the Monte Carlo model and (ii) market price of Sanofi shares at the date of grant, adjusted for
dividends expected during the vesting period.
The parameters used to calculate the valuations are market parameters available in the financial press.
Fixed and variable compensation awarded to Paul Hudson
(table No. 2 of the AFEP-MEDEF Code)
|
2024
|
2023
|
|||
|
(€)
|
Amounts
due
|
Amounts
paid
|
Amounts
due
|
Amounts
paid
|
|
Fixed compensation
(a)
|
1,400,000
|
1,400,000
|
1,400,000
|
1,400,000
|
|
Annual variable compensation
(b)
|
2,566,200
|
2,379,300
|
2,379,300
|
2,337,300
|
|
Cash bonus (sign-on bonus)
|
N/A
|
N/A
|
N/A
|
N/A
|
|
Exceptional compensation
|
N/A
|
N/A
|
N/A
|
N/A
|
|
Compensation for serving as a director
|
N/A
|
N/A
|
N/A
|
N/A
|
|
Benefits in kind
|
13,497
|
13,497
|
13,497
|
13,497
|
|
Total
|
3,979,697
|
3,792,797
|
3,792,797
|
3,750,797
|
The amounts reported are gross amounts before taxes.
(a)
Fixed compensation due in respect of a given year is paid during that year.
(b)
Variable compensation in respect of a given year is determined at the start of the following year and paid after the Annual General Meeting in that year,
subject to shareholder approval.
|
138
|
SANOFI
FORM 20-F
2024
|
|
PART I
|
|
ITEM 6. Directors, Senior Management and Employees
|
Fixed and variable compensation
Acting on a recommendation from the Compensation Committee, the Board meeting of February 12, 2025 determined the
components of Paul Hudson’s compensation for the 2024 financial year.
In accordance with the compensation policy for the Chief Executive Officer as approved by the Annual General Meeting of
Sanofi's shareholders on April 30, 2024, his annual compensation for 2024 comp
rises (i) annual fixed gross compensation of
€1,400,000; and (ii) annual variable compensation in a range from 0% to 250% of his annual fixed compensation, with a target of
150%, and subject to both quantitative and qualitative criteria.
The objectives applicable to annual variable compensation in respect of 2024 were:
•
60% based on financial indicators: sales growth, FCF and business earnings per share Business EPS, each accounting for 20%;
and
•
40% based on specific individual objectives. For 2024, the individual objectives set by the Board were:
–
business transformation (15%) – quantitative and qualitative objective,
–
development pipeline (15%) – quantitative objective,
–
CSR (10%) – quantitative and qualitative objective.
In the interests of transparency, Sanofi is now disclosing, for each financial criterion, information about the thresholds (floor,
target and maximum attainment level) used by the Board of Directors to determine the overall attainment level and payout.
|
Objective
|
Measured against
|
Payout
|
||
|
Threshold (floor)
Payout = 0%
|
Target (X, in %)
Payout = 100%
|
Maximum
payout = 166.67%
|
||
|
Attainment level
|
||||
|
Sales growth
|
Growth compared to the 2024 budget
|
X -4% percentage points
|
100%
|
X +4% percentage points
|
|
Business earnings per share
(Business EPS)
|
Attainment level vs 2024 budget
|
X -5% percentage points
|
100%
|
X +5% percentage points
|
|
Free cash flow
|
Growth compared to the 2024 budget
|
X -15% percentage points
|
100%
|
X +50% percentage points
|
Likewise, at
the start of each year, the Board of Directors establishes a precise matrix for determining each of the individual
objectives. Sanofi discloses the content of the qualitative criteria, accompanied by narrative for each sub-criterion explaining the
level of attainment reached. Those criteria are always assessed by reference to the performances of the leading global
pharmaceutical companies.
|
SANOFI
FORM 20-F
2024
|
139
|
|
PART I
|
|
ITEM 6. Directors, Senior Management and Employees
|
Acting on a recom
mendation from the Compensation Committee, the Board meeting of February 12, 2025 reviewed the
attainment level of each criterion and sub-criterion. The Board’s conclusions are summarized in the table below.
|
Criterion
|
Type
|
Weight
|
Target/
Maximum
(as % of fixed
compensation)
|
2024
Attainment
level
|
2023
reference
|
Comments
|
Payout
(as % of fixed
compensation)
|
|
|
Financial objectives
|
||||||||
|
Sales growth
|
Quantitative
|
20%
|
30%/5
0%
|
158.56%
|
112.90%
|
Confidential target,
Performance above budget
|
47.57%
|
|
|
Business earnings
per share
(Business EPS)
|
Quantitative
|
20%
|
30%/50%
|
112.54%
|
112.43%
|
Confidential target,
Performance above budget
|
33.76%
|
|
|
Free cash flow
|
Quantitative
|
20%
|
30%/50%
|
116.92%
|
105.61%
|
Confidential target,
Performance above budget
|
35.08%
|
|
|
Individual objectives
|
||||||||
|
Business
Transformation
|
Quantitative
/
Qualitative
|
15%
|
22.5% / 37.5%
|
102.17%
|
101.83%
|
Overall Business
•
Double-digit growth sustained through successful
launches of innovative medicines.
•
Significant progress made in modernizing the
Group with progress on initiatives to achieve
external commitments : deployment of a new
standard commercial blueprint model across all
business units, significant progress on the hub
strategy to foster synergies & innovation, dynamic
reallocation of resources across the Group to fund
the pipeline and growth through optimized supplier
relationships, realignment of the R&D footprint to
focus research platforms towards an ambition of
becoming an Immunology powerhouse.
|
22.99%
|
|
|
Manufacturing and Supply
•
Significant progress on the implementation of the
Manufacturing and Supply Operating Model with
key performance outcomes improved across
Safety, Quality, Supply and Cost, and improved
industrial performance delivered vs. 2023.
|
||||||||
|
Asset Portfolio
•
Opella: Achieved milestones on separation planning
and strategy for Consumer Healthcare business.
|
||||||||
|
Digital
•
Advance made on Sanofi’s data-driven mindset
development programs, extending digital
executive programs to senior leaders. (target
exceeded with more than 700 executives trained).
•
Successful deployment of new generative AI cases
across the organization:
–
In R&D: 60% of medical writers trained for
Clinical Study reports writing with GenAI tool.
–
In M&S: implementation of GenAI tool for
Product quality report (PQR) writing in 68% of
manufacturing sites.
|
||||||||
|
Developement
Pipeline
|
Quantitative
|
15%
|
22.5% / 37.5%
|
118.50%
|
120.82%
|
R&D achieved above execution focused KPI with:
•
21 submissions and 14 regulatory approvals in
different indications across major countries,
•
4 priority reviews and 11 regulatory designations
received;
•
Increased productivity in clinical development:
7 phase 3 studies and 11 phase 2 initiated, 6 new
molecular (NMEs) or vaccines (NVEs) entities
entered the clinical phase (FIH);
•
Scientific research has achieved above execution
focused KPI with delivery of: 16 entries into M1, 9
development candidates into M2.
•
Reinforcement of the pipeline through business
development and acquisitions: 35 new BD
partnerships (25 pharma; 5 vaccines; and 5
outlicensing) signed. Acquisition and integration of
Inhibrx (Pharma).
|
26.66%
|
|
|
140
|
SANOFI
FORM 20-F
2024
|
|
PART I
|
|
ITEM 6. Directors, Senior Management and Employees
|
|
Criterion
|
Type
|
Weight
|
Target/
Maximum
(as % of fixed
compensation)
|
2024
Attainment
level
|
2023
reference
|
Comments
|
Payout
(as % of fixed
compensation)
|
|
|
CSR / ESG
|
Quantitative
/
Qualitative
|
10%
|
15%/25%
|
114.58%
|
105%
|
People & Culture:
•
Significant progress on Sanofi culture shift with
global engagement score increased vs 2023.
•
Balanced representation of men and women
among identified succession candidates for
executive roles.
|
17.19%
|
|
|
Environmental
•
CO
2
(Scope 1&2) reduction between Q3 2023 and
Q3 2024 = 14%.
•
CO
2
(Scope 3) reduction between Q3 2023 and Q3
2024 = 6.5%.
|
||||||||
|
Governance
•
Cohesive and high-performing Executive
Committee successfully assembled
•
Effective communication channels and
collaborative relationships established between
the new team and the Board of Directors.
|
||||||||
|
Total
|
100%
|
150%/250%
|
122.20%
|
113.30%
|
183.25%
|
|||
(a)
For a definition, see “Item 5. Operating and Financial Review and Prospects –
A. Operating results — 1.5. Business net income”
in this annual report.
(b)
Business net income criterion has been replaced by Business EPS criterion starting from 2024.
Acting on a recommendation from the Compensation Committee, the Board meeting of February 12, 2025 set Paul Hudson’s
variable compensation for 202
4 at €2,566,200 gross, equivalent to 183.25% of his fixed
compensation.
Payment of Paul Hudson’s variable compensation in respect of the 2024 financial year is contingent on approval of his
compensation package by the shareholders in an Ordinary General Meeting, on the terms stipulated in Article L. 22-10-34 II of the
French Commercial Code.
Equity-based compensation
Using the authorization granted by our shareholders via the twentieth resolution of the Annual General Meeting of April 30, 2024,
the Board meeting held on that day decided, acting on the recommendation of the Compensation Committee, to award Paul
Hudson 82,500 performance shares in respect of 2024. The valuation of that award as of April 30, 2024, determined in
accordance with IFRS and incorporating a market-related condition, was €5,971,350, equivalent to 4.27 times his fixed
compensation.
The entire amount of the award is contingent upon the attainment of performance objectives based on (i) internal criteria based
on business earnings per share (Business EPS), free cash flow (FCF), corporate social responsibility (CSR) and the R&D pipeline,
and (ii) an external criterion based on improvement in total shareholder return (TSR) relative to that of a benchmark panel of
12 leading global pharmaceutical companies (plus Sanofi): Amgen, AstraZeneca plc, Bayer AG, Bristol-Myers Squibb Inc., Eli Lilly
and Company Inc., GlaxoSmithKline plc, Johnson & Johnson Inc., Merck Inc., Novartis AG, Novo Nordisk, Pfizer Inc., and Roche
Holding Ltd.
To align equity-based compensation on our medium-term performance, a three-year period (2024-2026) is used to measure
performance.
The above criteria were selected because they align medium-term equity-based compensation on the strategy adopted by
Sanofi.
The arrangements relating to these awards are as follows:
•
The Business EPS criterion accounts for 35% of the award (Business EPS represents Sanofi's “business net income” divided by
the number of Sanofi shares), and is determined as the average actual-to-budget ratio of Business EPS attained over the
entire vesting period at constant exchange rates.
The objective cannot be less than the lower end of the range of the annual guidance announced publicly by Sanofi at the start
of each year. If the attainment level is less than 95%, no payment will be made for this criterion.
|
Business EPS actual-to-budget attainment level (B)
|
Business EPS allocation rate
|
|
If B < 95%
|
0%
|
|
If B = 95%
|
50%
|
|
If B is > 95% but < 98%
|
(50 + [(B - 95) x 16])%
|
|
If B is ≥ 98% but ≤ 105%
|
B%
|
|
If B is > 105% but < 110%
|
(105 + [(B - 105) x 3])%
|
|
If B is ≥ 110%
|
120%
|
•
The FCF criterion accounts for 25% of the award. This criterion was selected because it is aligned with Sanofi’s current
strategic objectives, and is transparent both within and outside the company.
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|
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|
|
ITEM 6. Directors, Senior Management and Employees
|
The FCF criterion represents the average actual-to-budget FCF ratio attained over the entire period. The award is based on a
target FCF, below which some or all of the performance shares are forfeited; i
f the attainment level is less than 70%, no
payment will be made for this criterion.
|
FCF actual-to-budget attainment level (F)
|
FCF allocation rate
|
|
If F is ≤ 70%
|
0%
|
|
If F is > 70% but < 80%
|
[(F - 70) x 5]%
|
|
If F = 80%
|
50%
|
|
If F is > 80% but < 100%
|
(50 + [(F – 80) x 2.5])%
|
|
If F = 100%
|
100%
|
|
If F is > 100% but < 120%
|
F%
|
|
If F is ≥ 120%
|
120%
|
•
The TSR Rank Improvement criterion accounts for 20% of the award. It corresponds to the change in rank of Sanofi’s TSR as
compared to the TSR of peer companies included in a panel (see above). The TSR corresponds to the quoted market price of
Sanofi shares uplifted by dividends per share during the measurement periods, without reinvestment. The Sanofi TSR Rank
Improvement is determined by comparing the Endpoint Sanofi TSR rank (determined over a three-year period) to the Baseline
Sanofi TSR rank (determined over a one-year period).
•
The Baseline Sanofi TSR equal to the following formula: (average share price for 2023 – average share price for 2022
+ dividends per share for 2023)/average share price for 2022.
•
The Endpoint Sanofi TSR is equal to the following formula: (average share price for 2026 – average share price for 2023
+ dividends per share for 2024 and 2025)/average share price for 2022.
Our TSR is compared with the benchmark panel of 12 companies listed above, so as to determine the ranking of Sanofi within the
panel. The number of performance shares vesting depends upon the improvement in our TSR ranking, as follows:
|
Sanofi's improvement in the rankings
|
TSR allocation rate
|
|
+3 or more
|
150%
|
|
+2
|
100%
|
|
+1
|
50%
|
|
No improvement
|
0%
|
Even if there is an improvement in Sanofi’s TSR ranking based on the principles set out above, no TSR allocation can be made if
Sanofi’s ranking is below median TSR, defined as the performance of the company ranked seventh in the panel.
•
The CSR criterion accounts for 10% of the award. This performance condition equates to the attainment over a three-year
period of annual objectives plus a "stretch" objective, linked to the following pillars of Sanofi’s CSR strategy:
1.
Affordable Access: providing essential medicines to non-communicable disease patients through Sanofi Global Health;
2.
Planet Care: Carbon Footprint Reduction, scopes 1 & 2 (% reduction in CO
2
emissions vs 2019).
Attainment of each annual CSR objective will earn one performance point; a maximum of three points, plus one extra point linked
to the "stretch" objective, can be earned for each CSR pillar. For each criterion, attainment of the objectives for 2026 will earn
three points even if the annual objectives were not attained.
At the end of the period, the Board of Directors will determine the CSR Allocation Rate, corresponding to the number of points
earned, as shown, below:
|
CSR points earned
|
CSR Allocation Rate
|
|
Less than 3 points
|
0%
|
|
3 points
|
50%
|
|
4 points
|
67%
|
|
5 points
|
83%
|
|
6 points
|
100%
|
|
7 points
|
110%
|
|
8 points
|
120%
|
•
The R&D pipeline criterion, accounting for 10% of the award, was introduced in 2024 to reflect the importance of Sanofi's
commitment to developing a robust R&D pipeline. The performance criterion is based on the attainment levels of two equally-
weighted performance indicators measured over a three-year period.
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2024
|
|
PART I
|
|
ITEM 6. Directors, Senior Management and Employees
|
1.
Clinical Trial Readouts (CTRs) - the number of clinical trial results based on forecast pipeline deliveries
At the end of the period, the CTR attainment level will be calculated on the basis of the number of CTRs achieved in the period as
follows:
|
Number of Clinical Trial Readouts (CTRs)
|
CTR Attainment Level
|
|
CTR < 15
|
0%
|
|
CTR = 15
|
50%
|
|
CTR > 15, but < 25
|
(50+ [CTR – 15] x 5)%
|
|
CTR = 25
|
100%
|
|
CTR >25 but <30
|
(100+ [CTR– 25] x 4)%
|
|
CTR ≥ 30
|
120%
|
2.
Regulatory Approvals – the number of regulatory approvals obtained for new molecular entities (NMEs), new vaccine entities
(NVEs) or line extensions in key markets, relative to forecast pipeline deliveries
At the end of the period, the “Regulatory Approval” (RA)
attainment level will be calculated on the basis of the number of RAs
obtained in the period as follows
:
|
Number of regulatory approvals (RA) of NMEs, NVEs
and line extensions in key markets
|
RA attainment level
|
|
RA < 15
|
0%
|
|
RA = 15
|
50%
|
|
RA > 15 but < 25
|
(50+ [RA – 15] X 5)%
|
|
RDA = 25
|
100%
|
|
RA >25 but < 30
|
(100+ [RA – 25] x 4)%
|
|
RA ≥ 30
|
120%
|
The R&D Allocation Rate will be determined as the weighted average of the CTR attainment level and the RA attainment level.
Other terms and conditions
Paul Hudson is under an obligation to retain, until he ceases to hold office, a quantity of Sanofi shares equivalent to 50% of any
gain (net of taxes and social contributions) arising on the vesting of his performance shares, calculated as of the date on which
those shares vest.
In compliance with the AFEP-MEDEF Code and our Board Charter, Paul Hudson has undertaken to refrain from entering into
speculative or hedging transactions, and so far as Sanofi is aware no hedging instruments have been contracted.
Historical allocation rates
In the interests of transparency, we disclose below attainment levels and allocation rates for the most recent performance-linked
equity-based compensation plans awarded to our
Chief Executive Officer.
|
Attainment level
|
Allocation rate
|
|||
|
BNI
|
FCF
|
TSR
|
||
|
April 28, 2020 plans
|
2020-2022: 103.27%
|
2020-2022: 117.67%
|
2020-2022: 0%
|
2020-2022: 86.94%
i.e. 65,205 performance
shares
|
|
April 30, 2021 plans
|
2021-20
23: 103.58%
|
2021-2023: 110.31%
|
2021-20
23: 51.77%
|
2021-2
023: 95.23%
i.e. 71,423
performance
shares
|
|
May 3, 2022 plans
|
2022-2024: 102.56%
|
2022-2024: 110.25%
|
2022-20
24: 0%
|
2022-2
024:
84.36
%
i.e.
69,597 performance
shares
|
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2024
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143
|
|
PART I
|
|
ITEM 6. Directors, Senior Management and Employees
|
Performance shares awarded to Paul Hudson in 2024
(table No. 6 of the AFEP-MEDEF Code)
|
Source
|
Plan date
|
Valuation of
performance shares
(€)
|
Number of performance
shares awarded
during the period
|
Vesting
date
|
Availability
date
(a)
|
Performance
conditions
|
|
Sanofi
|
04/30/2024
|
5,971,350
|
82,500
|
04/30/2027
|
04/30/2027
|
Yes
|
(a)
Under the terms of our Board Charter, Paul Hudson is required to retain a quantity of shares corresponding to 50% of the capital gain arising on the
vesting of the shares, net of the associated taxes and social contributions.
Each performance share awarded on April 30
, 2024, was valued at €72.38, valuing the total benefit at €5,971,350.
The General Meeting of April 30, 2024 restricted the number of performance shares that can be awarded to executive officers
to 5% of the overall limit (itself set at 1.5% of the share capital). The number of shares awarded to Paul Hudson in 2024
r
epresent
s 0.43% of the total limit approved by that Meeting and 0.006%
of our share capital at the date of grant.
Performance shares awarded to Paul Hudson which became available in 2024
(table No. 7 of the AFEP-MEDEF Code)
Paul Hudson was awarded 75,000 performance shares on April 20, 2021. The Board of Directors meeting of February 22, 2024
noted the level of achievement of the performance conditions applicable to this plan (95%), and 71,423 shares vested in Paul
Hudson on May 2, 2024.
|
Source
|
Plan date
|
Number of performance
shares vesting
during the period
|
|
Sanofi
|
April 30, 2021
|
71,423
|
In accordance with the compensation policy for the Chief Executive Officer, until he ceases to hold office Paul Hudson must
retain a quantity of Sanofi shares equivalent to 50% of the capital gain calculated as of the vesting date of performance shares,
net of taxes and social security/health insurance contributions that would apply in the event of a sale on that date (i.e. on
May 2, 2024, the delivery date), at the highest applicable marginal rate. Pursuant to that rule, Paul Hudson must retain 11,577
shares under the plan dated April 30, 2021.
Because awards of stock options to our Chief Executive Officer are not permitted under our compensation policy, tables No. 4
and No. 5 of the AFEP-MEDEF Code are not applicable.
Pension rights
Paul Hudson is entitled to benefits under the top-up defined-contribution pension plan introduced within Sanofi on
January 1, 2020. Under the terms of the plan, the Chief Executive Officer receives (subject to attainment of a performance
condition) an annual contribution of up to 25% of his reference compensation (annual fixed and variable compensation).
The performance condition for the vesting of pension rights is linked to the attainment of the performance criteria for 2024
variable compensation. The Board of Directors, at its meeting of February 12, 2025, ascertained whether that performance
condition had been met, noting that
the global attainment level for the variable portion of Paul Hudson’s compensation for the
2024 financial year was 122.20%
.
The annual gross contribution is paid as follows:
•
50% as a gross insurance premium to the fund manager – the amount due to the fund manager with respect to 2024 is
€
495,775
; and
•
50% to Paul Hudson, to indemnify him for the social security and tax charges for which he will become immediately liable. The
amount due to Paul Hudson in respect of 2024 was set by the Board of Directors at its meeting of February 22, 2024
at €
495,775
.
Payment of those amounts is contingent on approval of the Chief Executive Officer’s compensation package by the shareholders
in an Ordinary General Meeting, on the terms stipulated in Article L. 22-10-34 II of the French Commercial Code.
Social welfare and
health insurance
Paul Hudson is subject to, benefits from and contributes to the same health cover, and death and disability plans, as are
applicable to other employees of Sanofi based in France. He also benefits from an unemployment insurance scheme.
Benefits in kind
The benefits in kind received by Paul Hu
dson in 2024 were valued at €13,497, and correspond to a company car with a driver.
|
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|
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|
|
ITEM 6. Directors, Senior Management and Employees
|
Compensation and benefits for other Executive Committee members
Compensation
The compensation of Executive Committee members other than the Chief Executive Officer is reviewed by the Compensation
Committee, taking into consideration the practices of leading global pharmaceutical companies.
In addition to fixed compensation, they receive variable compensation. Their target variable compensation depends on their
position, and can represent up to 100% of their fixed compensation. The target amount of individual variable compensation is
determined in line with market practice. It rewards the joint contribution of all Executive Committee members to Sanofi’s
performance.
Fo
r 2024, the variable component consisted of three elements:
•
attainment of quantitative objectives (accounting for 60%) measured at consolidated level: sales growth 20%, business
earnings per share (Business EPS) 20%, research and development outcomes 10%, and free cash flow (FCF) 10%;
•
attainment of corporate social responsibility (CSR) objectives measured at consolidated level (accounting for 10%); and
•
attainment of individual quantitative and qualitative objectives (accounting for 30%).
The indicators used are intended to
measure Sanofi’s annual performance objectives; individual objectives; the attainment of
human capital objectives (such as gender
representation
in senior executive roles and transformation of the corporate culture to
align with the Play to Win strategy; and an objective relating to the reduction in Sanofi's carbon footprint.
In addition, Executive Committee members may be awarded performance shares.
For 2024, the total gross compensation paid and accrued in respect of members of the Executive Committee (excluding the
Chief Executive Officer) was €21 million, of which €9 million was fixed compensation.
A total of
298,471
performance shares were awarded in 2024 to members of the Executive Committee (excluding the award to
the Chief Executive Officer). No stock options were awarded to members of the Executive Committee or the Chief Executive
Officer in 2024.
In compliance with the AFEP-MEDEF Code, all awards are contingent upon four internal criteria: business earnings per share
(Business EPS), free cash flow (FCF), a CSR criterion, and a new criterion linked to the R&D pipeline. An external criterion based on
total shareholder return (TSR) is also applied. Those criteria were selected because they align equity-based compensation with
the strategy adopted by Sanofi. The Board believes that the performance conditions applied are good indicators of shareholder
value creation in terms of the quality of investment decisions and the commitment to deliver exacting financial results in a
difficult economic environment.
The arrangements relating to these awards are as follows:
•
The performance criterion based on business earnings per share (Business EPS) accounts for 35% of the award. Business EPS
represents Sanofi's “business net income” divided by the number of Sanofi shares; this criterion corresponds to the average
actual-to-budget ratio of Business EPS attained over the entire period. Budgeted business net income is derived from the
budget as approved by the Board of Directors at the beginning of each financial year. The Business EPS objective may not be
lower than the bottom end of the full-year guidance range publicly announced by Sanofi at the beginning of each year. If the
ratio is less than 95% of the objective, the corresponding performance shares are forfeited.
|
Business EPS actual-to-budget attainment level (B)
|
Business EPS allocation rate
|
|
If B is < 95%
|
0%
|
|
If B = 95%
|
50%
|
|
If B is > 95% but < 98%
|
(50 + [(B –95) x 16])%
|
|
If B is ≥ 98% but ≤ 105%
|
B%
|
|
If B is > 105% but < 110%
|
(105 + [(B –105) x 3])%
|
|
If B is ≥ 110%
|
120%
|
•
The FCF criterion accounts for 25% of the award. It represents the average actual-to-budget ratio of FCF attained over the
entire period. The award is based on a target FCF, below which some or all performance shares are forfeited.
|
FCF actual-to-budget attainment level (F)
|
FCF allocation rate
|
|
If F is ≤ 70%
|
0%
|
|
If F is > 70% but < 80%
|
[(F – 70) x 5]%
|
|
If F = 80%
|
50%
|
|
If F is > 80% but < 100%
|
(50 + [(F – 80) x 2.5])%
|
|
If F = 100%
|
100%
|
|
If F is > 100% but < 120%
|
F%
|
|
If F is > 120%
|
120%
|
•
The criterion based on Total Shareholder Return (“TSR”) Rank Improvement accounts for 20% of the award.
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|
|
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|
|
ITEM 6. Directors, Senior Management and Employees
|
The TSR Rank Improvement corresponds to the change in Sanofi’s TSR rank relative to the TSR of a panel of Sanofi
plus 12 peer companies (Amgen, AstraZeneca plc, Bayer AG, Bristol-Myers Squibb Inc., Eli Lilly and Company Inc.,
GlaxoSmithKline plc, Johnson & Johnson Inc., Merck Inc., Novartis AG, Novo Nordisk, Pfizer Inc., and Roche Holding Ltd).
TSR corresponds to the market performance of Sanofi shares uplifted by dividends per share during the measurement periods,
without reinvestment.
For the plan applicable to Executive Committee members, the TSR Rank Improvement is determined by comparing the
Endpoint Sanofi TSR rank (measured over a three-year period) with the Baseline Sanofi TSR rank (measured over a one-year
period). The TSR payment would amount to 50% for an improvement of one place in the rankings, 100% for two places in the
rankings, and 150% for three places in the rankings;
•
The criterion based on CSR accounts for 10% of the award, and is linked to attainment of (i) annual objectives over a three-
year period and (ii) a "stretch" objective, linked to the following pillars:
1.
Affordable Access: providing essential medicines to non-communicable disease patients through Sanofi Global Health;
2.
Planet Care - Carbon Footprint Reduction, scopes 1 & 2 (% CO
2
emissions reduction vs 2019).
Attainment of each annual CSR objective will generate one performance point; a maximum of three points (plus one bonus
point for the "stretch" objective) may be obtained for each pillar. For each criterion, attainment of the 2025 objectives will
generate three points, even if the annual objectives are not attained.
•
The R&D pipeline criterion, accounting for 10% of the award, corresponds to the attainment levels of two equally-weighted
performance indicators measured over a three-year period:
1.
Clinical Trial Readouts (CTRs) - the number of clinical trial results based on forecast pipeline deliveries;
2.
Regulatory Approvals – the number of regulatory approvals obtained for new molecular entities (NMEs), new vaccine
entities (NVEs) or line extensions in key markets, relative to forecast pipeline deliveries.
•
The number of performance shares vesting depends on the overall allocation rate, which for each period is the weighted
average of the Business EPS allocation rate (35%), the FCF allocation rate (25%), the TSR allocation rate for the period (20%),
the CSR allocation rate (10%), and the R&D allocation rate (10%).
•
A multiplier is applied that will uplift the number of performance shares vesting by 10% if (i) the maximum TSR allocation rate is
attained and (ii) Sanofi ranks higher than or equal to the median for the TSR benchmark panel at the endpoint.
•
In order to align equity-based compensation with medium-term performance, performance is measured over three financial years.
•
Vesting is subject to a non-compete clause.
•
The entire award is forfeited in the event of resignation, or dismissal for gross or serious misconduct;
•
In the event of (i) individual dismissal other than for gross or serious misconduct, (ii) retirement before the age of 60, (iii) the
beneficiary’s employer ceasing to be part of the Sanofi group or (iv) termination of employment contract under the terms of a
collective separation plan initiated by the employer in accordance with locally applicable legislation or measures approved by
local authorities, the overall allocation percentage is apportioned on a pro rata time basis to reflect the amount of time the
person remained with the Sanofi group during the vesting period.
•
If any of the following events occur, full rights to the award are retained: (i) retirement on or after reaching the statutory
retirement age, or after the age of 60 under any circumstances;; (ii) disability classified in the second or third categories as
stipulated in Article L. 314-4 of the French Social Security Code; or (iii) death of the beneficiary.
Pension arrangements
The total amount accrued as of December 31, 2024 in respect of corporate pension plans for persons who have held an executive
position during 2024 was €
9
million. That amount includes an expense of €1 million recognized in profit or loss during 2024.
Pay ratio between compensation of executive officers and average/median compensation of Sanofi
employees – changes in compensation of executive officers and employees relative to the performance
of Sanofi
This information is disclosed in accordance with Article L. 22-10-9 6° of the French Commercial Code, further to the enactment
of the “Pacte” law.
Sanofi has referred to the guidance on compensation multiples issued by AFEP (version issued February 2021) in establishing the
calculation methods used for the ratios presented.
Explanations of calculation methods and of year-on-year changes in the executive pay ratio:
•
the scope includes Sanofi SA (the parent company) and all of its direct and indirect subsidiaries located in France, and hence
covers more than 80% of total payroll of permanent employees in France. No separate ratios are published for Sanofi SA (the
parent company), as the low headcount at Sanofi SA means that such ratios would not be representative of our total
headcount in France;
•
the employee compensation used in the calculation is the full time equivalent (FTE) compensation of permanent employees
with at least two financial years of uninterrupted employment;
•
direct compensation includes fixed compensation awarded during the reference year, and variable compensation related to
the previous year and paid during the reference year. All compensation amounts are gross amounts;
|
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2024
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|
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|
|
ITEM 6. Directors, Senior Management and Employees
|
•
in order to maintain consistency, we have excluded from the numerator (i) compensation items not included in the denominator
and (ii) non-recurring compensation items. This applies in particular to accommodation expenses related to the relocation to
France of the Chief Executive Officer (Paul Hudson) in 2020, and to expenses related to unemployment insurance;
•
long term variable compensation: performance shares and stock options awarded during each reference year are valued at
the date of grant in accordance with International Financial Reporting Standards. The valuation of performance shares that
include the Total Shareholder Return (TSR) performance condition incorporates market conditions where applicable. Awards
are subject to a continuing employment condition (three years minimum) and to performance conditions. Consequently, the
valuation at the date of grant is not necessarily indicative of the value of stock options and performance shares at the end of
the vesting period, especially if the performance conditions are not met;
•
since Olivier Brandicourt (our previous Chief Executive Officer) received the same number of stock options and performance
shares each year from 2016 to 2019, fluctuations in the Sanofi share price had a significant impact on the pay ratio during this
period;
•
2018 and 2019 figures have been restated for comparative purposes, to (i) exclude Sanofi’s equity-accounted share of
Regeneron’s net profits (see Note D.1. to our consolidated financial statements, included at Item 18. of this annual report) and
(ii) include the effects of IFRS 16;
•
regular benchmarking reviews are conducted to ensure that the level of compensation awarded to our employees and CEO is
competitive and consistent with pharmaceutical industry levels.
Comparison of compensation of Sanofi executive officers with employee compensation* (parent company and all direct
and indirect subsidiaries located in France), and year-on-year change in compensation of corporate officers and employees
with reference to the company’s performance
|
Chief Executive Officer
(a)
|
2020
vs 2019
|
2021
vs 2020
|
2022
vs 2021
|
2023
vs 2022
|
2024
vs 2023
|
|
Change in compensation (%)
|
9.2
%
|
-1.0
%
|
20.5
%
|
-1.5
%
|
1.7
%
|
|
Ratio versus average employee compensation
|
110.64
|
111.44
|
124.55
|
124.49
|
124.42
|
|
Year-on-year change in ratio (%)
|
3.8
%
|
0.7
%
|
11.8
%
|
-0.1
%
|
-0.1
%
|
|
Ratio to median employee compensation
|
142.78
|
142.11
|
159.17
|
159.97
|
158.01
|
|
Year-on-year change in ratio (%)
|
5.5
%
|
-0.5
%
|
12.0
%
|
0.5
%
|
-1.2
%
|
|
Chairman of the Board
(b)
|
2020
vs 2019
|
2021
vs 2020
|
2022
vs 2021
|
2023
vs 2022
|
2024
vs 2023
|
|
Change in compensation (%)
|
14.1
%
|
—
%
|
—
%
|
5.7
%
|
3.7
%
|
|
Ratio versus average employee compensation
|
9.98
|
10.15
|
9.41
|
10.09
|
10.28
|
|
Year-on-year change in ratio (%)
|
8.4
%
|
1.7
%
|
-7.3
%
|
7.2
%
|
1.9
%
|
|
Ratio versus median employee compensation
|
12.87
|
12.94
|
12.03
|
12.97
|
13.06
|
|
Year-on-year change in ratio (%)
|
10.1
%
|
0.5
%
|
-7.1
%
|
7.8
%
|
0.7
%
|
|
Employees
|
2020
vs 2019
|
2021
vs 2020
|
2022
vs 2021
|
2023
vs 2022
|
2024
vs 2023
|
|
Change in compensation (%)
|
5.2
%
|
-1.7
%
|
7.8
%
|
-1.4
%
|
1.8
%
|
|
Company Performance
|
|||||
|
Financial criterion
|
BNI
|
BNI
|
BNI
|
BNI
|
BNI
|
|
Year-on-year change (%)
|
4.2
%
|
11.8
%
|
25.9
%
|
-1.8
%
|
0.2
%
|
*
Table based on the model table recommended in the AFEP guidance on compensation multiples (February 2021).
(a)
2019: Olivier Brandicourt left office on August 31. Paul Hudson was appointed as CEO on September 1, 2019.
2020: The 2020 CEO compensation includes Paul Hudson’s 2020 fixed compensation (€1.3 million), his 2019 variable compensation as paid in 2020 and
annualized (€1.95 million), and 75,000 performance shares awarded in 2020.
(b)
Frédéric Oudéa (since May 25, 2023). Serge Weinberg’s term of office expired on May 25, 2023.
Based on full-time equivalent permanent employees of all Sanofi legal entities worldwide with at least two years of uninterrupted
employment, the ratios for 2024 were as follows:
•
CEO:
–
ratio versus average compensation: 117.9; and
–
ratio versus median compensation: 166.3.
•
Chairman of the Board of Directors:
–
ratio versus average compensation: 9.6; and
–
ratio versus median compensation: 13.5.
These ratios were calculated on the basis of annualized basic compensation, variable compensation in respect of the previous
year, and performance shares awarded during 2024, applying 2024 average exchange rates.
|
SANOFI
FORM 20-F
2024
|
147
|
|
PART I
|
|
ITEM 6. Directors, Senior Management and Employees
|
C. Board Practices
Application of the AFEP-MEDEF Code
The corporate governance code applied by Sanofi is the December 2022 version of the AFEP-MEDEF Code which is available at
https://hcge.fr/le-code-afep-medef/.
Our Board Charter requires at least one-half of our directors to be independent; contains a section on the ethical rules applicable
to our directors; sets out the remit and operating procedures of the Board; defines the roles and powers of our Chairman and our
Chief Executive Officer; and describes the composition, remit and operating procedures of the Board committees, in accordance
with the recommendations of the AFEP-MEDEF Code. Collectively, our Articles of Association and our Board Charter establish
the framework within which Sanofi implements its principles of corporate governance
Our Board practices comply with the AFEP-MEDEF Code recommendations, with certain exceptions, and with the report of the
Autorité de marchés financiers
on Audit Committees, issued on July 22, 2010.
Activities of the Board of Directors in 2024
During 2024, the Board of Directors met 14 times (including strategy seminars), with an overall attendance rate among Board
members of 98%.
The following persons attended meetings of the Board of Directors:
•
the directors;
•
the Secretary to the Board;
•
frequently: members of the Executive Committee; and
•
occasionally: the statutory auditors, managers of our global support functions, and other company employees.
The agenda for each meeting of the Board is prepared by the Secretary after consultation with the Chairman, taking account of
the agendas for the meetings of the specialist Committees and the suggestions of the directors.
Approximately one week prior to each meeting of the Board of Directors, the directors each receive a file containing the agenda,
the minutes of the previous meeting, and documentation relating to the agenda.
The minutes of each meeting are expressly approved at the next meeting of the Board of Directors.
In compliance with our Board Charter, certain issues are examined in advance by the various Committees according to their areas
of competence, to enable them to make a recommendation; those issues are then submitted for a decision by the Board of
Directors.
Since 2016, acting on a recommendation from the Appointments, Governance and CSR Committee, each year the Board has held
at least two executive sessions, i.e. meetings held without the Chief Executive Officer present. If the Chairman of the Board so
decides, such sessions may also be held without the directors representing employees (or any other Sanofi employee) being
present. The primary purpose of such sessions is to evaluate the way the Board and its Committees operate, discuss the
performance of the Chief Executive Officer, and debate succession planning. Three executive sessions were held in 2024: two
one-hour sessions in January and February, and a 20-minute session in April.
|
148
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SANOFI
FORM 20-F
2024
|
|
PART I
|
|
ITEM 6. Directors, Senior Management and Employees
|
In 2024, the main activities of the Board of Directors related to the following issues:
|
FINANCIAL STATEMENTS AND FINANCIAL MANAGEMENT
|
|
|
l
|
Review of the individual company and consolidated financial statements for the 2023 financial year and for the first half of 2024, review of the
consolidated financial statements for the first three quarters of 2024, and review of draft press releases and presentations to analysts relating to
the publication of those financial statements.
|
|
l
|
Projected 2024 accounting close, presentation of 2025 budget and 2025-2027 financial forecasts.
|
|
l
|
Review of forward-looking management documents.
|
|
l
|
Proposed dividend for the 2023 financial year.
|
|
l
|
Renewal of share repurchase program.
|
|
l
|
Formally recording the share capital, and amending the Articles of Association accordingly.
|
|
l
|
Delegation to the Chief Executive Officer of the power to issue bonds.
|
|
l
|
Authorizations in respect of guarantees, endorsements and sureties, and report on the use made of the authorizations granted in 2023.
|
|
OPERATIONS, STRATEGY AND RISK MANAGEMENT
|
|
|
l
|
Review of the minutes of the Strategy Committee and Scientific Committee meetings.
|
|
l
|
Update on risks, and review of risk management activity report and 2024 risk profile analysis.
|
|
l
|
Review of acquisition projects.
|
|
l
|
Update on business development projects.
|
|
«
|
Update on the Opella separation.
|
|
«
|
Update on vaccines.
|
|
«
|
Update on France, and the Manufacturing & Supply strategy.
|
|
«
|
Update on litigation (including Zantac).
|
|
«
|
Artificial intelligence and the use of data and IT systems.
|
|
APPOINTMENTS AND GOVERNANCE
|
|
|
l
|
Composition of the Board and its committees
.
|
|
l
|
Review of director independence.
|
|
l
|
Review of management report, corporate governance report, and statutory auditors' reports.
|
|
l
|
Adoption of draft resolutions, the Board report on the resolutions, and special reports on awards of stock options and performance shares.
|
|
l
|
Annual evaluation of the work of the Board and its Committees.
|
|
l
|
Review of previously-approved related-party agreements.
|
|
l
|
Update on the Action 2024 employee share ownership plan.
|
|
«
|
Refresher on conflicts of interest policy.
|
|
COMPENSATION
|
|
|
l
|
Determination of the compensation of corporate officers:
•
review of the components of compensation paid in 2023;
•
determination of compensation policies.
|
|
l
|
Allocation of directors' compensation for 2023, and principles for the 2024 allocation.
|
|
l
|
Review of fixed and variable Executive Committee compensation for 2023 and 2024.
|
|
l
|
Adoption of performance share plans for 2024, sign-off on attainment of performance conditions for prior equity-based compensation plans.
|
|
CORPORATE SOCIAL RESPONSIBILITY
|
|
|
l
|
Monitoring of progress on the CSR strategy.
|
|
l
|
Monitoring of objectives for gender representation in executive bodies, and more generally of Sanofi's diversity policy in accordance with
legislation.
|
|
l
|
Monitoring of Sanofi's equal pay and equal opportunity policy.
|
|
«
|
Ethics and corporate culture update – feedback on the "Your Voice" survey.
|
|
«
|
Implementation of the European Corporate Sustainability Reporting Directive (CSRD).
|
|
l
Annual items
|
«
Non-recurring items
|
|
SANOFI
FORM 20-F
2024
|
149
|
|
PART I
|
|
ITEM 6. Directors, Senior Management and Employees
|
In addit
ion, two strategy seminars were held, in April and October 2024, in which all members of the Executive Committee took
part. The seminar gave directors an opportunity to address issues including:
•
monitoring delivery of phase 2 of the the Play to Win strategy;
•
feedback from “Strat Days” (a two-day Executive Committee meeting designed to address long-term strategic decisions);
•
modernization of Manufacturing & Supply;
•
R&D transformation plan;
•
mergers & acquisitions in the pharmaceutical market over the past few years;
•
update on mergers & acquisitions strategy;
•
in-depth review of mRNA; and
•
emerging markets strategy, especially in China.
Remit and Operation of Board Committees
Our Board of Directors is assisted in its deliberations and decisions by five specialist Committees (for a description of the remit of
each Committee, refer to our Board Charter, provided
as Exhibit 1.2 to this annual report
). Chairs and members of these
Committees are chosen by the Board from among its members, based on their experience.
The Committees are responsible for the preparation of certain items on the agenda of the Board of Directors. Decisions of the
Committees are adopted by a simple majority with the Chair of the Committee having a casting vote. Minutes are prepared, and
approved by the Committee members.
The Chair of each Committee reports to the Board on the work of that Committee, so that the Board is fully informed whenever it
takes a decision.
Audit Committee
Composition
of the Committee in 2024
|
Audit Committee
|
||
|
Composition as of January 1, 2024
|
Composition as of December 31, 2024
|
|
|
Chair
|
Fabienne Lecorvaisier (independent director)
|
Carole Ferrand (independent director)
(b)
|
|
Members
|
Christophe Babule
(a)
Carole Ferrand (independent director)
Diane Souza (independent director)
|
Christophe Babule
(a)
Clotilde Delbos (independent director)
(c)
Fabienne Lecorvaisier (independent director)
Anne-Françoise Nesmes (independent director)
(c)
|
|
Proportion of independent directors: 75% (3/4)
|
Proportion of independent directors: 80% (4/5)
|
|
(a)
This table only refers to independence as defined under the AFEP-MEDEF Code. However, Christophe Babule is independent for the purposes of the
NASDAQ Listing Rules and Rule 10A-3 under the Exchange Act.
(b)
Carole Ferrand was appointed as Chair of the Audit Committee by a Board decision of April 30, 2024 to facilitate the handover with Fabienne
Lecorvaisier, whose term of office as member of the board and Chair of the Audit Committee will expire at the close of the Annual General Meeting
called to approve the financial statements for the year ended December 31, 2024.
(c)
Clotilde Delbos and Anne-Françoise Nesmes were appointed members of the Audit Committee by a Board decision of April 30, 2024.
All members of the Audit Committee have financial or accounting expertise as a consequence of their training and professional
experience, and all are deemed to be financial experts as defined by the Sarbanes-Oxley Act and by Article L. 823-19 of the
French Commercial Code. See “Item 16A. Audit Committee Financial Expert”.
Remit of the Committee
The remit of the Committee is described in our Board Charter, provided as
Exhibit 1.2 to this annual report
.
Since December 2023, our Audit Committee has been tasked with reviewing the process for the preparation and certification of
sustainability disclosures. In fulfilling that role, the Audit Committee works in conjunction with the Appointments, Governance and
CSR Committee. Collectively, the two committees determined the material sustainability issues facing Sanofi.
Operation of the Committee
In addition to the statutory auditors, the principal financial officers, the Senior Vice President Group Internal Audit and other
members of the senior management team attend meetings of the Audit Committee.
The statutory auditors attend all meetings of the Audit Committee; they presented their opinions on the annual and half-year
financial statements at the Committee meetings of January 30 and July 23, 2024, respectively. The Committee meets regularly
with the statutory auditors without management present.
The Chair of the Committee also meets regularly with certain members of management, in particular the heads of Internal Audit,
Risk Management and Ethics/Compliance.
For information about Audit Committee oversight of internal control and risks relating to the processing of accounting and
financial information, refer to “Item 15. Controls and Procedures.”
|
150
|
SANOFI
FORM 20-F
2024
|
|
PART I
|
|
ITEM 6. Directors, Senior Management and Employees
|
Work of the Committee in 2024
The work of the Committee i
n 2024 is summarized below
:
|
FINANCIAL POSITION
|
|
|
l
|
Preliminary review of the individual company and consolidated financial statements for the 2023 financial year, review of the individual company
and consolidated financial statements for the first half of 2024, review of the consolidated financial statements for the first three quarters of 2024,
and review of draft press releases.
|
|
l
|
Financial position of Sanofi, indebtedness and liquidity, off balance sheet commitments.
|
|
INTERNAL AUDIT, INTERNAL CONTROL AND RISK MANAGEMENT
|
|
|
l
|
Review of the work of the Internal Control function and evaluation of that work for 2023 as certified by the statutory auditors pursuant to
Section 404 of the Sarbanes-Oxley Act, and examination of the 2023 annual report on Form 20-F.
|
|
l
|
Principal risks (risk management and risk profiles) including CSR risks; Risk Committee report for 2024; tracking of whistleblowing and material
compliance investigations; review of emerging risks, including geopolitical and macroeconomic risks; review of tax risks and deferred tax assets;
review of material litigation.
|
|
l
|
Conclusions of Sanofi senior management on internal control procedures and review of the 2023 Management Report, in particular the description
of risk factors in the Universal Registration Document and annual report on Form 20-F.
|
|
l
|
Internal audit report for 2024 and audit program for 2025.
|
|
l
|
Reporting on guarantees, endorsements and sureties.
|
|
l
|
Cybersecurity.
|
|
«
|
Update on end-to-end global supply chain.
|
|
«
|
Update on crisis management and business continuity.
|
|
«
|
Update on the combatting falsified medicines.
|
|
«
|
Ethics and data protection.
|
|
STRATEGY AND COMPENSATION
|
|
|
l
|
Presentation of 2025 budget.
|
|
l
|
Review of attainment of performance conditions for 2021 equity-based compensation plans.
|
|
«
|
Update on financial strategy.
|
|
«
|
Proposed separation of Opella business – financial and tax implications.
|
|
COMPLIANCE, BUSINESS ETHICS AND CSR
|
|
|
l
|
Review of European Green Taxonomy indicators included in the Universal Registration Document.
|
|
l
|
Audit plan for sustainability disclosures under the CSRD.
|
|
l
|
Progress report on CSRD implementation.
|
|
l
|
Joint meeting with Appointments, Governance and CSR Committee on CSRD implementation.
|
|
«
|
Update on business ethics and compliance.
|
|
«
|
Update on governance and management of third parties.
|
|
RELATIONS WITH STATUTORY AUDITORS
|
|
|
l
|
Audit engagements and fees.
|
|
l
|
Review and budget for non-audit services (audit-related services, tax, and other).
|
|
l
Annual items
|
«
Non-recurring items
|
On October 31, 2024, the Audit Committee and the Appointments, Governance and CSR Committee held a joint meeting on the
implementation of the European Corporate Sustainability Reporting Directive (CSRD), dealing with the following issues:
•
overview of the CSRD;
•
presentation of internal governance structures supporting CSRD implementation;
•
update on double materiality and Impacts/Risks/Opportunities (IRO);
•
interactions with the external auditors; and
•
next steps.
Attendance rates in 2024
The Audit Committee met seven times in 2024, including meetings immediately prior to the Board meetings that approved the
financial statements. Committee members had an attendance rate of 97%.
|
SANOFI
FORM 20-F
2024
|
151
|
|
PART I
|
|
ITEM 6. Directors, Senior Management and Employees
|
Appointments, Governance and CSR Committee
Composition of the Committee in 2024
|
Appointments, Governance and CSR Committee
|
||
|
Composition as of January 1, 2024
|
Composition as of December 31, 2024
(a)
|
|
|
Chair
|
Gilles Schnepp (independent director)
|
Gilles Schnepp (independent director)
|
|
Members
|
Lise Kingo (independent director)
Patrick Kron (independent director)
Barbara Lavernos
Frédéric Oudéa (independent director)
|
Lise Kingo (independent director)
Patrick Kron (independent director)
Barbara Lavernos
Frédéric Oudéa (independent director)
|
|
Proportion of independent directors: 80% (4/5)
|
Proportion of independent directors: 80% (4/5)
|
|
(a) Patrick Kron was appointed temporarily as Chair of the Appointments, Governance & CSR Committee by a Board decision of December 19, 2024 with
effect from January 1, 2025, to replace Gilles Schnepp who left office on December 31, 2024.
The Chief Executive Officer is involved in the work of the Committee.
Remit of the Committee
The remit of the Committee is described in our Board Charter,
provided as Exhibit 1.2 to this annual report
.
The remit to review the process for the preparation and certification of sustainability disclosures has been given to our Audit
Committee (see above). The Appointments, Governance and CSR Committee plays a role in this work through joint meetings.
Work of the Committee in 2024
The work of the Appointments, Governance and CSR Committee during 2024 covered the following issues:
|
APPOINTMENTS
|
|
|
l
|
Succession planning for the Chairman, Chief Executive Officer and Executive Committee.
|
|
l
|
Changes to the composition of the Board and its committees.
|
|
l
|
Review of expiring terms of office, and appointment of new Board members.
|
|
GOVERNANCE
|
|
|
l
|
Update on annual evaluation of the Board and its committees.
|
|
l
|
Review of director independence.
|
|
l
|
Review of management report and corporate governance report in the 2023 Universal Registration Document and annual report on Form 20-F.
|
|
l
|
Governance roadshows with key Sanofi investors, and analysis of the policies of proxy advisors.
|
|
«
|
Review of Board competencies matrix.
|
|
CSR
|
|
|
l
|
Annual overview
|
|
l
|
Review of the CSR chapter in the 2023 Universal Registration Document.
|
|
«
|
New sustainable development strategy.
|
|
«
|
Sustainable procurement and human rights.
|
|
«
|
Update on environmental issues.
|
|
«
|
Joint meeting with Audit Committee on implementation of the Corporate Sustainability Reporting Directive (CSRD).
|
|
«
|
Update on Foundation S.
|
|
l
Annual items
|
«
Non-recurring items
|
Attendance rates in 2024
The Committee met seven times in 2024, including a joint meeting with the Audit Committee, with an overall attendance rate of
94%.
|
152
|
SANOFI
FORM 20-F
2024
|
|
PART I
|
|
ITEM 6. Directors, Senior Management and Employees
|
Compensation Committee
Composition of the Committee in 2024
|
Compensation Committee
|
||
|
Composition as of January 1, 2024
|
Composition as of December 31, 2024
|
|
|
Chair
|
Patrick Kron (independent director)
|
Patrick Kron (independent director)
|
|
Members
|
Rachel Duan (independent director)
Wolfgang Laux
Diane Souza (independent director)
|
Clotilde Delbos (independent director)
(a)
Rachel Duan (independent director)
Wolfgang Laux
|
|
Proportion of independent directors: 75% (3/4)
|
Proportion of independent directors: 75% (3/4)
|
|
(a)
Clotilde Delbos was appointed as a member of the Audit Committee by a Board decision of April 30, 2024.
Work of the Committee in 2024
The work of the Compensation Committee during 2024 covered the following issues:
|
COMPENSATION OF CORPORATE OFFICERS
|
|
|
l
|
Components of the compensation of corporate officers (Chief Executive Officer and Chairman of the Board of Directors).
|
|
l
|
Review of performance conditions applicable to the compensation of the Chief Executive Officer, in particular CSR criteria.
|
|
l
|
Allocation of directors’ compensation for 2023, and review of general principles of the compensation policy applicable to directors.
|
|
l
|
Review of the disclosures about compensation contained in the corporate governance section of the 2023 Universal Registration Document and
the annual report on Form 20-F, and of equal pay ratios.
|
|
l
|
Review of the draft "say on pay" resolutions to be submitted to the Annual General Meeting of April 30, 2024.
|
|
l
|
Governance roadshows with key Sanofi investors, and analysis of the policies of proxy advisors.
|
|
«
|
Review of the structure of the Chief Executive Officer's compensation, and objectives for 2025.
|
|
EQUITY-BASED COMPENSATION
|
|
|
l
|
Implementation of equity-based compensation plans awarded in prior years (sign-off on attainment of performance conditions for 2021 plans).
|
|
«
|
Introduction of a new R&D criterion into the 2024 long-term incentive plan for the Chief Executive Officer.
|
|
EMPLOYEE SHARE OWNERSHIP
|
|
|
l
|
Status report and analysis of 2024 employee share ownership plan.
|
|
l
|
Consideration of next employee share ownership plan, and implementation of Action 2025 plan.
|
|
EXECUTIVE COMMITTEE COMPENSATION
|
|
|
l
|
Monitoring of fixed and variable compensation of Executive Committee members in 2023 and 2024.
|
|
«
|
Terms for incoming and outgoing Executive Committee members.
|
|
l
Annual items
|
«
Non-recurring items
|
When the Committee discusses the compensation policy for members of senior management who are not corporate officers,
i.e. the members of the Executive Committee, the Committee invites the Chief Executive Officer to attend.
Attendance rates in 2024
The Committee met three times in 2024, with an overall attendance rate of 100%.
Strategy Committee
Composition of the Committee in 2024
|
Strategy Committee
|
||
|
Composition as of January 1, 2024
|
Composition as of December 31, 2024
(a)
|
|
|
Chair
|
Frédéric Oudéa (independent director)
|
Frédéric Oudéa (independent director)
|
|
Members
|
Paul Hudson
Patrick Kron (independent director)
Barbara Lavernos
Gilles Schnepp (independent director)
|
Paul Hudson
Patrick Kron (independent director)
Barbara Lavernos
Gilles Schnepp (independent director)
Antoine Yver
(b)
|
|
Proportion of independent directors: 60% (3/5)
|
Proportion of independent directors: 66% (4/6)
|
|
(a)
Jean-Paul Kress was appointed as member of the Strategy Committee by a Board decision of December 19, 2024, with effect from January 1, 2025, to
replace Gilles Schnepp who left office on December 31, 2024.
(b)
Antoine Yver was appointed as a member of the Strategy Committee by a Board decision of April 30, 2024.
|
SANOFI
FORM 20-F
2024
|
153
|
|
PART I
|
|
ITEM 6. Directors, Senior Management and Employees
|
Work of the Committee in
2024
During 2024, the Committee's work included the following key issues:
|
l
|
Divestment and acquisition projects, and business development priorities.
|
|
l
|
Update on phase 2 of the Play to Win strategy.
|
|
«
|
Update on the Opella separation, including options review.
|
|
«
|
Review of the Opella business plan.
|
|
«
|
Update on investments in Manufacturing & Supply projects.
|
|
«
|
Update on the transformation plan for France.
|
|
l
Annual items
|
«
Non-recurring items
|
Attendance rates in 2024
The Committee met five times in 2024, with an overall attendance rate of 93%.
Scientific Committee
Composition of the Committee in 2024
|
Scientific Committee
|
||
|
Composition as of January 1, 2024
|
Composition as of December 31, 2024
(a)
|
|
|
Chair
|
Thomas Südhof (independent director)
|
Antoine Yver (independent director)
|
|
Members
|
Frédéric Oudéa (independent director)
Emile Voest (independent director)
Antoine Yver (independent director)
|
Frédéric Oudéa (independent director)
John Sundy (independent director)
Emile Voest (independent director)
|
|
Proportion of independent directors: 100% (4/4)
|
Proportion of independent directors: 100% (4/4)
|
|
(a)
Jean-Paul Kress was appointed as a member of the Scientific Committee by a Board decision of December 19, 2024, with effect from January 1, 2025.
For the current composition of the Committee, refer to the Governance section of our corporate website: https://www.sanofi.com/en..
(b)
Antoine Yver was appointed as Chair of the Scientific Committee by a Board decision of April 30, 2024.
Work of the Committee in 2024
During 2024, the Committee’s work included the following key issues:
|
l
|
Review of product portfolio.
|
|
l
|
Review of acquisition and alliance projects.
|
|
l
|
Update on Vaccines.
|
|
l
|
Update on R&D transformation and roadmap.
|
|
«
|
Update on R&D in France.
|
|
«
|
Update on Centers of Excellence.
|
|
«
|
Update on fundamental research and early-stage development in immunology and inflammation including risk review, M&A/business development
strategy, and white space analysis.
|
|
l
Annual items
|
«
Non-recurring items
|
Attendance rates in 2024
The Committee met six times in 2024, with an overall attendance rate of 90%.
|
154
|
SANOFI
FORM 20-F
2024
|
|
PART I
|
|
ITEM 6. Directors, Senior Management and Employees
|
D. Employees
Number of Employees
(a)
In
2024
, Sanofi e
mployed
82,878
people
worldwide, 3,210 fewer than in
2023
. The tables below give a breakdown of employees
by geographical area and function as of December 31,
2024
,
2023
and
2022
.
Employees by Geographical Area
(a)
|
As of December 31,
|
||||||
|
2024
|
%
|
2023
|
%
|
2022
|
%
|
|
|
Europe
|
41,193
|
50%
|
42,115
|
49%
|
42,151
|
47%
|
|
United States
|
12,898
|
16%
|
13,418
|
16
%
|
13,761
|
15%
|
|
Rest of the World
|
28,787
|
35%
|
30,555
|
35
%
|
33,912
|
38
%
|
|
Total
|
82,878
|
100.0%
|
86,088
|
100.0%
|
89,824
|
100.0%
|
Employees by Function
(a)
|
As of December 31,
|
||||
|
2024
|
2023
|
2022
|
||
|
Biopharma
|
General Medicines
|
10,039
|
11,784
|
15,290
|
|
Go To Market Capabilities
|
1,330
|
N/A
|
N/A
|
|
|
Specialty Care
|
7,459
|
9,694
|
9,411
|
|
|
Vaccines
|
5,103
|
5,444
|
15,541
|
|
|
Research and Development
|
8,940
|
9,257
|
9,449
|
|
|
Manufacturing and Supply
|
28,450
|
29,184
|
21,441
|
|
|
Corporate Functions
|
11,186
|
10,078
|
9,803
|
|
|
Sub-total Biopharma
|
72,507
|
75,441
|
80,935
|
|
|
Opella
|
Consumer Healthcare -Opella
|
10,371
|
10,647
|
8,889
|
|
Total
|
82,878
|
86,088
|
89,824
|
|
(a)
Employees on garden leave and Executive Committee management level are excluded from the data.
Industrial Relations
In all countries where we operate, we seek to strike a balance between our economic interests and those of our employees, which
we regard as inseparable.
Our belief in a balanced workplace for our employees is based on the basic principles of our Social Charter, which outlines the
rights and duties of all Sanofi employees. The Social Charter addresses our key ambitions vis-à-vis our workforce: equal
opportunity for all people without discrimination, the right to health and safety, respect for privacy, the right to information and
professional training, social protection for employees and their families, freedom of association and the right to collective
bargaining, and respect for the principles contained in the Global Compact on labor relations and ILO conventions governing the
physical and emotional well-being and safety of children.
Our labor relations are based on respect and dialogue. In this spirit, management and employee representatives meet regularly to
exchange views, negotiate, sign agreements and ensure that agreements are being implemented.
Employee dialogue takes place in different ways from country to country, as dictated by specific local circumstances. Depending
on the circumstances, employee dialogue relating to information, consultation and negotiation processes may take place at
national, regional or company level. It may be organized on an interprofessional or sectorial basis, or both. Employee dialogue
may be informal or implemented through a specific formal body, or a combination of both methods. Whatever the situation,
Sanofi encourages employees to voice their opinions, help create a stimulating work environment and take part in decisions
aiming to improve the way we work. These efforts reflect one of the principles of the Social Charter, whereby improving working
conditions and the necessary adaptation to our business environment go hand-in-hand.
|
SANOFI
FORM 20-F
2024
|
155
|
|
PART I
|
|
ITEM 6. Directors, Senior Management and Employees
|
Profit-sharing Schemes, Employee Savings Schemes and Employee Share Ownership
Profit-sharing schemes
All employees of our French companies belong to voluntary and statutory profit-sharing schemes.
Voluntary schemes
Voluntary schemes
(intéressement des salariés)
are collective schemes that are optional for the employer and contingent upon
pe
rformance. The aim is to give employees an interest in the growth of the business and improvements in its performance.
In June 2023, we entered into a new fixed-term statutory profit-sharing agreement for the 2023, 2024 and 2025 financial years,
which applies to all employees of our French companies. Under the agreement, Sanofi pays collective variable compensation
determined on the basis of the more favorable of (i) growth in consolidated net sales (at constant exchange rates and on a
constant structure basis) or (ii) the ratio of business operating income to net sales on a reported basis (BOI margin). For each of
those criteria, a matrix determines what percentage of total payroll is to be allocated to the scheme. An additional sum capped at
0.5% of total payroll may also be distributed, determined on the basis of two CSR-related performance conditions, each
weighted at 0.25%:
•
a criterion reflecting progress in environmental matters (reduction in Sanofi greenhouse gas emissions
worldwide); and
•
a social responsibility criterion: the number of employees in France registered on Sanofi-referenced volunteering programs.
This overall allocation is reduced by the amount required by law to be transferred to a special profit-sharing reserve. The balance
is then distributed between the employees unless the transfer to the reserve equals or exceeds the maximum amount determined
under the specified criteria, in which case no profit share is paid to the employees.
No distribution was made under the voluntary scheme in 2024 in respect of 2023.
Statutory scheme
The statutory scheme
(participation des salariés aux résultats de l’entreprise)
is a French legal obligation for companies with
more than 50 employees that made a profit in the previous financial year.
The amo
unt distributed by our French companies in 2024 in respect of the statutory scheme for the year ended December 31,
2023 represented 10.62% of total payroll.
Distribution formula
In order to favor lower-paid employees, the voluntary and statutory profit-sharing agreements entered into since 2005 split the
benefit between those entitled as follows:
•
60% prorated on the basis of time spent in the Company’s employment in the year; and
•
40% prorated on the basis of gross annual salary received during the year, subject to a lower limit equal to the social security
ceiling and an upper limit of three times the social security ceiling.
Employee savings schemes and collective retirement savings plan
The employee savings arrangements operated by Sanofi are based on a collective savings scheme
(Plan d’Épargne Groupe)
and a
collective retirement savings scheme
(Plan d’Épargne pour la Retraite Collectif)
. Those schemes reinvest the sums derived from
the statutory and voluntary profit-sharing schemes, plus voluntary contributions from employees.
In 2024
, 92% o
f the employees who benefited from the profit-sharing schemes opted to invest in the collective savings scheme,
and nea
rly 80%
opted to invest in the collective retirement savings scheme.
Sanofi supplements the amount invested by employees in these schemes by making a top-up contribution.
In 202
4, €141.3 mill
ion
and €58.1 m
illion were invested in the collective savings scheme and the collective retirement savings
scheme respectively through the voluntary and statutory schemes, and through top-up contributions.
Employee share ownership
As of December 31, 2024, shares held under the collective savings scheme or in registered form by employees of Sanofi,
employees of related companies and former employees amoun
te
d to 2.9% of our share capital.
For more information about our most recent employee share ownership plan, refer to “Item 10. Additional Information — Changes
in Share Capital — Increases in Share Capital”.
|
156
|
SANOFI
FORM 20-F
2024
|
|
PART I
|
|
ITEM 6. Directors, Senior Management and Employees
|
E. Share Ownership
Senior Management
Members of the Executive Committee hold shares of our Company amounting in the aggregate to less than 1% of our share
capital.
Existing Option Plans as of December 31, 2024
In 2019, the Board of Directors reviewed Sanofi’s compensation policy and decided that stock options would no longer be
awarded from 2020 onwards. That decision was taken to standardize the terms of equity-based compensation awards within
Sanofi, and in response to feedback from some shareholders and proxy advisors who had concerns about stock options given
their dilutive effect and potential unintended consequences.
Share Purchase Option Plans
As of December 31, 2024 there were no stock purchase option plans outstanding.
Share Subscription Option Plans
|
Source
|
Date of
shareholder
authorization
|
Date of
grant
|
Total
number
of
options
granted
|
to
corporate
officers
(a)
|
to the 10
employees
awarded
the most
options
(b)
|
Start
date of
exercise
period
|
Expiry
date
|
Exercise
price
(€)
|
Number of
shares
subscribed
as of
12/31/
2024
|
Number of
options
canceled
as of
12/31/
2024
(c)
|
Number of
options
outstanding
|
|
Sanofi
|
May 3, 2013
|
Mar 5, 2014
|
769,250
|
—
|
364,500
|
Mar 6, 2018
|
Mar 5, 2024
|
73.48
|
666,625
|
102,625
|
|
|
Sanofi
|
May 3, 2013
|
Mar 5, 2014
|
240,000
|
240,000
|
—
|
Mar 6, 2018
|
Mar 5, 2024
|
73.48
|
193,440
|
46,560
|
|
|
Sanofi
|
May 3, 2013
|
Jun 24, 2015
|
12,500
|
—
|
12,500
|
Jun 25, 2019
|
Jun 24, 2025
|
89.38
|
2,250
|
8,500
|
1,750
|
|
Sanofi
|
May 3, 2013
|
Jun 24, 2015
|
202,500
|
—
|
202,500
|
Jun 25, 2019
|
Jun 24, 2025
|
89.38
|
45,000
|
157,500
|
|
|
Sanofi
|
May 3, 2013
|
Jun 24, 2015
|
220,000
|
220,000
|
—
|
Jun 25, 2019
|
Jun 24, 2025
|
89.38
|
178,464
|
41,536
|
|
|
Sanofi
|
May 4, 2016
|
May 4, 2016
|
17,750
|
—
|
17,750
|
May 5, 2020
|
May 4, 2026
|
75.90
|
4,500
|
9,750
|
3,500
|
|
Sanofi
|
May 4, 2016
|
May 4, 2016
|
165,000
|
—
|
165,000
|
May 5, 2020
|
May 4, 2026
|
75.90
|
82,500
|
82,500
|
|
|
Sanofi
|
May 4, 2016
|
May 4, 2016
|
220,000
|
220,000
|
—
|
May 5, 2020
|
May 4, 2026
|
75.90
|
128,750
|
41,250
|
50,000
|
|
Sanofi
|
May 10, 2017
|
May 10, 2017
|
158,040
|
—
|
157,140
|
May 11, 2021
|
May 10, 2027
|
88.97
|
34,184
|
44,276
|
79,580
|
|
Sanofi
|
May 10, 2017
|
May 10, 2017
|
220,000
|
220,000
|
—
|
May 11, 2021
|
May 10, 2027
|
88.97
|
42,570
|
177,430
|
|
|
Sanofi
|
May 2, 2018
|
May 2, 2018
|
220,000
|
220,000
|
—
|
May 3, 2022
|
May 3, 2028
|
65.84
|
51,216
|
168,784
|
|
|
Sanofi
|
Apr 30, 2019
|
Apr 30, 2019
|
220,000
|
220,000
|
—
|
May 1, 2023
|
Apr 30, 2029
|
76.71
|
6,600
|
213,400
|
(a)
Comprises the Chief Executive Officer, and any Deputy Chief Executive Officers or members of the Management Board in office at the date of grant.
(b)
In office at the date of grant.
(c)
Includes 293,812 options cancelled due to partial non-fulfillment of performance conditions.
In 2024, 23,187 stock options were exercised by individuals who were Executive Committee members as of December 31, 2024.
The plan involved post-dates the creation of the Executive Committee (Sanofi plan of March 5, 2014, exercise price €73.48).
As of December 31, 2024, a total of
934,444
stock subscription options remained outstanding. As of the same date,
934,444
options were immediately exercisable.
Existing Performance Share Plans as of December 31, 2024
The Board of Directors awards shares to certain employees in order to give them a direct stake in our future and performances
via trends in the share price, as a partial substitute for the granting of stock options.
Shares are awarded to employees by the Board of Directors on the basis of a list submitted to the Compensation Committee. The
Board of Directors sets terms of the awards, including continuing employment conditions and performance conditions (measured
over three financial years).
The employee plans have a three-year vesting period, with no lock-up period.
•
At its meeting of April 30, 2024, the Board of Directors awarded a share performance plan, cascaded down into three sub-plans:
–
a plan under which 470 beneficiaries classified as “Senior Executives” were awarded a total of 1,394,478 shares;
–
a plan under which 8,234 beneficiaries not classified as “Senior Executives” were awarded a total of 2,888,502 shares;
–
a plan under which 82,500 performance shares were awarded to the Chief Executive Officer.
Of the 8,705 beneficiaries, 50% were women.
•
At its meeting of December 4, 2024, the Board of Directors awarded a share performance plan, cascaded down into two sub-
plans:
–
a plan under which 15 beneficiaries classified as “Senior Executives” were awarded a total of 82,222 performance shares;
–
a plan under which five beneficiaries not classified as “Senior Executives” were awarded a total of 6,649 performance shares.
|
SANOFI
FORM 20-F
2024
|
157
|
|
PART I
|
|
ITEM 6. Directors, Senior Management and Employees
|
Of those 20 beneficiaries, 40% were women.
The entirety of those awards is contingent upon criteria based on business net income (BNI), free cash flow (FCF) and Corporate
Social Responsibility (CSR); in the case of employees classified as “Senior Executives”, two additional criteria based on (i) total
shareholder return (TSR) and (ii) the R&D allocation rate were added, accounting for respectively 20% and 10% of the total.
Vesting is subject to a non-compete clause.
The number of shares awarded to the Chief Executive Officer in 2024 represents 0.4% of the total limit approved by our
shareholders at the Annual General Meeting of April 30, 2024 (1.5% of our share capital) and 1.85% of the total amount awarded to
all beneficiaries in 2024.
The 2024 awards represent a dilution of approximately 0.21% of our undiluted share capital as of December 31, 2024.
Not all of our employees were awarded performance shares, but a new voluntary profit-sharing agreement was signed in June
2023, which gives all of our employees an interest in Sanofi’s performance (for more details refer to “— Profit-Sharing Schemes,
Employee Savings Schemes and Employee Share Ownership” above).
Performance Share Plans
|
Source
|
Date of
shareholder
authorization
|
Date of
award
|
Total
number
of shares
awarded
|
to
corporate
officers
(a)
|
to the 10
employees
awarded
the most
shares
(b)
|
Start date
of vesting
period
(c)
|
Vesting
date
|
End of lock-
up period
|
Number of
shares
vested as of
12/31/
2024
|
Number of
rights
canceled
as of
12/31/
2024
(d)
|
Number of
shares not
yet vested
|
|
Sanofi
|
April 30, 2021
|
April 30,
2021
|
1,614,023
|
—
|
19,407
|
April 30,
2021
|
May 01,
2024
|
May 01,
2024
|
1,280,302
|
333,721
|
—
|
|
Sanofi
|
April 30, 2021
|
April 30,
2021
|
701,824
|
—
|
163,877
|
April 30,
2021
|
May 01,
2024
|
May 01,
2024
|
468,036
|
233,788
|
—
|
|
Sanofi
|
April 30, 2021
|
April 30,
2021
|
595,878
|
—
|
10,918
|
April 30,
2021
|
May 01,
2024
|
May 01,
2024
|
556,745
|
39,133
|
—
|
|
Sanofi
|
April 30, 2021
|
April 30,
2021
|
497,695
|
—
|
150,339
|
April 30,
2021
|
May 01,
2024
|
May 01,
2024
|
429,739
|
67,956
|
—
|
|
Sanofi
|
April 30, 2021
|
April 30,
2021
|
75,000
|
75,000
|
—
|
April 30,
2021
|
May 01,
2024
|
May 01,
2024
|
71,423
|
3,577
|
—
|
|
Sanofi
|
April 30, 2021
|
October 27,
2021
|
13,521
|
—
|
13,521
|
October 27,
2021
|
October 28,
2024
|
October 28,
2024
|
10,917
|
2,604
|
—
|
|
Sanofi
|
April 30, 2021
|
May 03,
2022
|
2,000,627
|
—
|
25,882
|
May 03,
2022
|
May 03,
2025
|
May 04,
2025
|
1,295
|
265,897
|
1,733,435
|
|
Sanofi
|
April 30, 2021
|
May 03,
2022
|
1,146,431
|
—
|
192,542
|
May 03,
2022
|
May 03,
2025
|
May 04,
2025
|
227,001
|
919,430
|
|
|
Sanofi
|
April 30, 2021
|
May 03,
2022
|
82,500
|
82,500
|
—
|
May 03,
2022
|
May 03,
2025
|
May 04,
2025
|
82,500
|
||
|
Sanofi
|
April 30, 2021
|
December
14, 2022
|
90,580
|
—
|
77,111
|
December
14, 2022
|
December
14, 2025
|
December
15, 2025
|
1,206
|
89,374
|
|
|
Sanofi
|
April 30, 2021
|
December
14, 2022
|
10,335
|
—
|
10,335
|
December
14, 2022
|
December
14, 2025
|
December
15, 2025
|
267
|
10,068
|
|
|
Sanofi
|
April 30, 2021
|
May 25,
2023
|
2,425,047
|
—
|
25,417
|
May 25,
2023
|
May 25,
2026
|
May 25,
2026
|
820
|
236,854
|
2,187,373
|
|
Sanofi
|
April 30, 2021
|
May 25,
2023
|
1,209,790
|
—
|
192,417
|
May 25,
2023
|
May 25,
2026
|
May 25,
2026
|
164,801
|
1,044,989
|
|
|
Sanofi
|
April 30, 2021
|
May 25,
2023
|
82,500
|
82,500
|
—
|
May 25,
2023
|
May 25,
2026
|
May 25,
2026
|
82,500
|
||
|
Sanofi
|
April 30, 2021
|
December
13, 2023
|
58,347
|
—
|
58,347
|
December
13, 2023
|
December
14, 2026
|
December
14, 2026
|
58,347
|
||
|
Sanofi
|
April 30, 2021
|
December
13, 2023
|
944
|
—
|
944
|
December
13, 2023
|
December
14, 2026
|
December
14, 2026
|
944
|
||
|
Sanofi
|
April 30, 2024
|
April 30,
2024
|
2,888,502
|
—
|
25,656
|
April 30,
2024
|
May 01,
2027
|
May 02,
2027
|
104,300
|
2,784,202
|
|
|
Sanofi
|
April 30, 2024
|
April 30,
2024
|
1,394,478
|
—
|
244,434
|
April 30,
2024
|
May 01,
2027
|
May 02,
2027
|
43,646
|
1,350,832
|
|
|
Sanofi
|
April 30, 2024
|
April 30,
2024
|
82,500
|
82,500
|
—
|
April 30,
2024
|
May 01,
2027
|
May 02,
2027
|
82,500
|
||
|
Sanofi
|
April 30, 2024
|
December
04, 2024
|
6,649
|
—
|
6,649
|
December
04, 2024
|
December
05, 2027
|
December
06, 2027
|
6,649
|
||
|
Sanofi
|
April 30, 2024
|
December
04, 2024
|
82,222
|
—
|
76,702
|
December
04, 2024
|
December
05, 2027
|
December
06, 2027
|
82,222
|
(a)
Comprises the Chief Executive Officer, and any Deputy Chief Executive Officers or members of the Management Board in office at the date of grant.
(b)
In office at the date of grant.
(c)
Subject to the conditions set.
(d)
48,885 rights were cancelled due to partial non-fulfillment of performance condition.
As of December 31, 2024, 10,515,365 shares had not yet vested pending fulfillment of performance conditions.
|
158
|
SANOFI
FORM 20-F
2024
|
|
PART I
|
|
ITEM 6. Directors, Senior Management and Employees
|
Shares Owned by Members of the Board of Directors
As of December 31, 2024,
members of our Board of Directors held in the aggregate 155,251 shares, or under 1% of the share
capital and of the voting rights, excluding
the beneficial ownership of 118,227,307 shares held by L’Oréal
as of such date which
may be attributed to Barbara Lavernos or Christophe Babule (who disclaim beneficial ownership of such shares)
.
Transactions in Shares by Members of the Board of Directors and Equivalent Persons in 2024 and
early 2025
As far as Sanofi is aware, transactions in our securities carried out during 2024 and early 2025 by (i) Board members,
(ii) executives with the power to make management decisions affecting our future development and corporate strategy and
(iii) persons with close personal ties to such individuals (as per Article L. 621-18-2 of the French Monetary and Financial Code),
were as follows:
•
April 26, 2024: Antoine Yver, director, acquired 1,000 shares at a price of €91.38 per share, and concomitantly sold
2,000 ADSs (
American Depositary Shares
);
•
May 2, 2024: Paul Hudson, Chief Executive Officer, acquired 71,423 restricted shares;
•
June 21, 2024: John Sundy, director, acquired 887 ADSs at a price of $46.94 per ADS;
•
September 16, 2024: Anne-Françoise Nesmes, director, acquired 533 shares at a price of £87.02 per share;
•
October 31, 2024: Clotilde Delbos, director, acquired 500 shares at a price of €97.53 per share;
•
February 4, 2025: Jean-Paul Kress, director, acquired 2,000 ADSs at a price of $53.12 per ADS.
F. Disclosure of action to recover erroneously awarded compensation
N/A
|
SANOFI
FORM 20-F
2024
|
159
|
|
PART I
|
|
ITEM 7. Major Shareholders and Related Party Transactions
|
Item 7. Major Shareholders and Related Party Transactions
A. Major Shareholders
The table below shows the ownership of our shares as of January 31, 2025, indicating the beneficial owners of our shares. To the
best of our knowledge and on the basis of the notifications received as disclosed below, except for L’Oréal and BlackRock, Inc.,
no other shareholder currently holds more than 5% of our share capital or voting rights.
|
Total number of
issued shares
|
Actual number of
voting rights
(excluding treasury shares)
(e)
|
Theoretical number
of voting rights
(including treasury shares)
(f)
|
||||
|
Number
|
%
|
Number
|
%
|
Number
|
%
|
|
|
L’Oréal
(a)
|
118,227,307
|
9.36
|
236,454,614
|
16.69
|
236,454,614
|
16.58
|
|
BlackRock
(b)
|
87,967,799
|
6.96
|
87,967,799
|
6.21
|
87,967,799
|
6.17
|
|
Employees
(c)
|
32,197,639
|
2.55
|
67,419,659
|
4.76
|
67,419,659
|
4.73
|
|
Public
|
1,015,198,895
|
80.37
|
1,024,583,360
|
72.34
|
1,024,583,360
|
71.85
|
|
Treasury shares
(a)(d)
|
9,531,081
|
0.75
|
—
|
—
|
9,531,081
|
0.67
|
|
Total
|
1,263,122,721
|
100
|
1,416,425,432
|
100
|
1,425,956,513
|
100
|
(a)
On February 2, 2025, Sanofi and L'Oréal entered into a share buyback agreement pursuant to which Sanofi repurchased 29,556,650 shares from
L’Oréal, a significant shareholder, at €101.50 per share, for a total amount of approximately €3 billion. After the transaction and cancellation of the
shares, L’Oréal will hold 7.2% of Sanofi’s share capital and 13.1% of its voting rights (excluding treasury shares). The transaction closed on February 5,
2025. Sanofi will cancel the shares acquired from L'Oréal at the latest on April 29, 2025. For more information, see "Item 8. Financial Information - B.
Significant Changes".
(b)
Based on BlackRock’s declaration dated January 23, 2025.
(c)
Shares held by the employees according to article L.225-102 of the French Commercial Code.
(d)
Number of shares repurchased as of January 31, 2025 under the share repurchase program in force.
(e)
Based on the total number of voting rights as of January 31, 2025.
(f)
Based on the total number of voting rights as of January 31, 2025 as published in accordance with Article 223-11 and seq. of the General Regulations of
the Autorité des marchés financiers (i.e. including treasury shares, the voting rights of which are suspended).
Our Articles of Association provide for double voting rights for shares held in registered form for at least two years. All of our
shareholders may benefit from double voting rights if these conditions are met, and no shareholder benefits from specific voting
rights. For more information relating to our shares, see “Item 10. Additional Information — B. Memorandum and Articles of
Association.”
Neither L’Oréal nor BlackRock holds different voting rights from those of our other shareholders.
To the best of our knowledge, no other shareholder currently holds, directly or indirectly and acting alone or in concert, more
than 5% of our share capital or voting rights. Furthermore, we believe that we are not directly or indirectly owned or controlled by
another corporation or government, or by any other natural or legal persons. To our knowledge, there are no arrangements that
may result in a change of control.
During the year ended December 31, 2024 we did not receive any share ownership declarations informing us that a legal
threshold had been passed, as required under Article L. 233-7 of the French Commercial Code.
In addition to the statutory requirement to inform the Company and the
Autorité des marchés financiers
(AMF, the French
Financial Markets Regulator)
that they hold a number of shares (or of securities equivalent to shares or of voting rights
pursuant to Article L. 233-9 of the French Commercial Code) representing more than one-twentieth (5%), one-tenth (10%),
three-twentieths (15%), one-fifth (20%), one-quarter (25%), three-tenths (30%), one-third (1/3), one-half (50%), two-thirds (2/3),
nine-tenths (90%) or nineteen-twentieths (95%) of the share capital or theoretical voting rights within four trading days after
crossing any such ownership threshold (Article L. 233-7 of the French Commercial Code), any natural or legal person who directly
or indirectly comes to hold a percentage of the share capital, voting rights or securities giving future access to the Company’s
capital that is equal to or greater than 1% or any multiple of that percentage, is obliged to inform the Company thereof by
registered mail, return receipt requested, indicating the number of securities held, within five trading days following the date on
which each of the thresholds was crossed.
If such declaration is not made, the shares in excess of the fraction that should have been declared will be stripped of voting
rights at shareholders’ meetings, if on the occasion of such meeting, the failure to declare has been formally noted and one or
more shareholders collectively holding at least 5% of the Company’s share capital or voting rights so request at that meeting.
Any natural or legal person is also required to inform the Company, in the forms and within the time limits stipulated above for
passing above a specified threshold, if their direct or indirect holding passes below any of the aforementioned thresholds.
Since January 1, 2025 Sanofi has
received declarations of the passing of share ownership as required under the Articles of
Association; and one
share ownership declaration was received informing us that a legal threshold had been pass
ed (in which
L'Oréal declared that on February 5, 2025, it had passed below the 15% threshold in terms of voting rights, and holds 7.02% of our
share capital and 12.73% of our voting rights).
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As of December 31, 2024, Sanofi had approximately
27,247
shareholders listed in its share register, representing approximately
13.20% of issued shares. Based on the Sanofi share register and excluding treasury shares, approximately 98.40% of the shares
registered by name were held in France, and approximately 0.011% were held in the United States. In France, our country of
incorporation, there were 11,552 identified shareholders of record. In the United States, our host country, there were 53 identified
shareholders of record and
17,526
i
dentified ADS holders of record.
Shareholders’ Agreement
We are unaware of any shareholders’
agreement
currently in force.
B. Related Party Transactions
See Note D.33. to our consolidated financial statements included at Item 18. of this annual report.
On February 2, 2025, Sanofi and L'Oréal entered into a share buyback agreement pursuant to which Sanofi repurchased
29,556,650 shares from L’Oréal, a significant shareholder, at €101.50 per share, for a total amount of approximately €3 billion.
After the transaction and cancellation of the shares, L’Oréal will hold 7.2% of Sanofi’s share capital and 13.1% of its actual voting
rights (excluding treasury shares). The transaction closed on February 5, 2025. Sanofi will cancel the shares acquired from L'Oréal
at the latest on April 29, 2025.
For more information, see "Item 8. Financial Information - B. Significant Changes".
C. Interests of Experts and Counsel
N/A
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ITEM 8. Financial Information
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Item 8. Financial Information
A. Consolidated Financial Statements and Other Financial Information
Our consolidated financial statements as of and for the years ended
December 31, 2024
,
2023
and
2022
are included in this
annual report at “Item 18. Financial Statements.”
Dividends on ordinary shares
We paid annual dividends for the years ended December 31,
2020
,
2021
,
2022
and
2023
and our shareholders will be asked to
approve the payment of an annual dividend of €
3.92
per share for the
2024
fiscal year at our next annual shareholders’ meeting.
If approved, this dividend will be paid on May 15, 2025.
We expect that we will continue to pay regular dividends based on our financial condition and results of operations. The
proposed
2024
dividend equates to a distribution of
55.0
% of our business net income. For information on the non-IFRS financial
measure “business earnings per share” see “Item 5. Operating and Financial Review and Prospects —
Business Net Income
.”
The following table sets forth information with respect to the dividends paid by our Company in respect of the
2020
,
2021
,
2022
and
2023
fiscal years and the dividend that will be proposed for approval by our shareholders in respect of the
2024
fiscal year at
our April 30, 2025 shareholders’ meeting.
|
2024
|
(a)
|
2023
|
2022
|
2021
|
(b)
|
2020
|
|
|
Dividend per Share (€)
|
3.92
|
3.76
|
3.56
|
3.33
|
3.20
|
(a)
Proposal, subject to shareholder approval.
(b)
Plus a dividend in kind of EUROAPI shares, at a ratio of one EUROAPI share per 23 Sanofi shares.
The declaration, amount and payment of any future dividends will be determined by majority vote of the holders of our shares at
an ordinary general meeting, following the recommendation of our Board of Directors. Any declaration will depend on our results
of operations, financial condition, cash requirements, future prospects and other factors deemed relevant by our shareholders.
Accordingly, we cannot assure you that we will pay dividends in the future on a continuous and regular basis. Under French law,
we are required to pay dividends approved by an ordinary general meeting of shareholders within nine months following the
meeting at which they are approved.
Disclosure pursuant to Section 13(r) of the United States Exchange Act of 1934
Sanofi engages in limited business activities with Iran related to human health products – namely, sales of bulk and branded
pharmaceuticals and vaccines. These activities, which are disclosed pursuant to Section 13(r) of the United States Exchange Act
of 1934, as amended, are not financially material to Sanofi and contributed well under 1% of Sanofi’s consolidated net sales
in
2024
.
Sanofi’s US affiliates and non-US affiliates owned or controlled by Sanofi’s US affiliates either do not engage in Iran-related
activities or act under licenses issued by the US Department of the Treasury’s Office of Foreign Assets Control (OFAC).
Sanofi and certain non-US Sanofi affiliates engage in limited business activities that neither are expressly authorized by OFAC nor
require such authorization.
In 2016, Sanofi and the Iran Food and Drug Administration (IFDA), an entity affiliated with the Iranian Ministry of Health and
Medical Education, signed a Memorandum of Cooperation (MOC) regarding: (i) potential future projects to reinforce current
partnerships with reputable Iranian manufacturers (in particular, to enhance industrial quality standards); (ii) collaborating with
the Ministry of Health and Medical Education on programs for the prevention and control of certain chronic and non-
communicable diseases (in particular, diabetes); and (iii) potential future collaboration on epidemiological studies. In
2024
,
activities conducted under the MOC did not generate any revenue or net profits.
Certain non-US Sanofi affiliates engage in limited business with Iranian counterparties associated with the Iranian Ministry of
Health, such as public hospitals or distributors.
In
2024
, those business activities generated approximately €29.3 million in gross
revenue and contributed no more than €2.0 million in net loss.
Finally, a representative office in Tehran currently under liquidation incurs incidental expenses from state-owned utilities.
Sanofi believes that it and its affiliates’ activities are compliant with applicable law, and in light of the nature of the activities
concerned, Sanofi and its affiliates intend to continue their ongoing activities in Iran.
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ITEM 8. Financial Information
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Information on Legal or Arbitration Proceedings
This Item 8. incorporates by reference the disclosures found in Note D.22. to the consolidated financial statements at
Item 18. of this annual report; material updates thereto as of the date of this annual report are found below under the
heading “— B. Significant Changes — Updates to Note D.22.”.
Sanofi and its subsidiaries are involved in litigation, arbitration and other legal proceedings. These proceedings typically are
related to product liability claims, intellectual property rights (particularly claims against generic companies seeking to limit the
patent protection of Sanofi products), competition law and trade practices, commercial claims, employment and wrongful
discharge claims, tax assessment claims, waste disposal and pollution claims, and claims under warranties or indemnification
arrangements relating to business divestitures. As a result, we may become subject to substantial liabilities that may not be
covered by insurance and could affect our business and reputation. While we do not currently believe that any of these legal
proceedings will have a material adverse effect on our financial position, litigation is inherently unpredictable. As a
consequence, we may in the future incur judgments or enter into settlements of claims that could have a material adverse
effect on results of operations, cash flows and/or our reputation.
Government Investigations and Related Litigation
From time to time, subsidiaries of Sanofi are subject to governmental investigations and information requests from regulatory
authorities inquiring as to the practices of Sanofi with respect to the sales, marketing, and promotion of its products.
From 2017 through 2024, several federal and state government agencies issued Civil Investigative Demands (CIDs) or other
discovery requests calling for the production of documents and information relating to Sanofi’s trade and pricing practices for
its insulin products and/or Lantus-related litigation. Several of those investigations have concluded: Sanofi US reached a
resolution with the New York Attorney General in April 2023; the Ohio Attorney General closed its investigation in November
2023; and although the Federal Trade Commission (FTC) has not formally closed its investigation, it filed a lawsuit against
Pharmacy Benefit Managers (PBMs) only in September 2024, and Sanofi does not expect the FTC to commence litigation
against the manufacturers at this time. Although several other investigations (including by the State Attorney General’s offices
in California, Colorado, Texas, Vermont and Washington), have not been closed, those investigations have been dormant for
several years and Sanofi US does not anticipate undertaking further action on them at this time.
In September 2019, Sanofi US received a CID from the US Department of Justice concerning Dupixent, Kevzara, Praluent and
Zaltrap. In June 2021, the government declined to intervene in the underlying complaint which was filed in November 2018.
The government investigation into this matter is now closed. Relators, however, filed their First Amended Complaint
in October 2021, which the Court dismissed with prejudice in August 2023. Relators have since filed an appeal to the Ninth
Circuit Court of Appeals in this non intervened False Claims Act matter against Sanofi and co-promotion partner Regeneron.
In February 2020, Genzyme Corporation received a CID from the US Department of Justice. The CID requests documents and
information relating to Genzyme Corporation’s payments made to vendors or developers of electronic health record
technology. Genzyme Corporation has cooperated with this investigation, which has been dormant over the past year.
Genzyme Corporation does not expect further activity in this matter.
In November 2023, Sanofi US received a CID from the US Department of Justice regarding an investigation into Sanofi’s
pricing submissions for Admelog. On February 26, 2024, the US District Court unsealed the underlying whistleblower complaint
and granted Sanofi's motion to dismiss in August 2024. Plaintiff filed a second amended complaint, which the Court dismissed
with prejudice on December 10, 2024. Plaintiff did not appeal and this matter is now closed.
Insulin-Related Litigation
In December 2016 and January 2017, two putative class actions were filed against Sanofi US and Sanofi GmbH in the US
Federal Court in Massachusetts on behalf of direct purchasers of Lantus alleging certain antitrust violations. Sanofi GmbH was
later dismissed from the actions. In January 2018, the Court dismissed Plaintiffs’ consolidated amended complaint against
Sanofi US. Plaintiffs appealed that order to the Court of Appeals for the First Circuit, which issued its decision on February 13,
2020, reversing and remanding to the district court. In January 2021, Sanofi-Aventis Puerto Rico, Inc. (Sanofi PR) was added as
a defendant. In October 2022, plaintiffs informed Sanofi US and Sanofi PR that they would proceed via joinder rather than
move for class certification. Consistent with the Court's joinder deadline, new plaintiffs moved to intervene on January 3,
2023. Fact discovery has completed, and expert discovery is underway.
There are a number of insulin-related litigation matters pending in the US federal and state courts. These include cases
brought on behalf of putative classes of consumers, wholesale purchasers of insulin, and state and local governments. The
cases, which have been filed against Sanofi US along with other insulin manufacturers and, in some cases, pharmacy benefit
managers, challenge those entities’ insulin pricing practices (including Sanofi’s pricing practices for Lantus, Apidra, Toujeo
and/or Soliqua). The suits allege some combination of: violations of the Racketeer Influenced and Corrupt Organizations Act
(“RICO Act”); violations of the Robinson-Patman Act; violations of various state unfair/deceptive trade practices statutes;
unjust enrichment; common-law fraud; and civil conspiracy. In August 2023, the vast majority of the insulin-related litigation
was consolidated in a multidistrict litigation (MDL) in federal court in New Jersey. The MDL proceedings currently include
cases brought by 14 state attorneys general (Arizona, Arkansas, California, Illinois, Indiana, Kansas, Kentucky, Louisiana,
Massachusetts, Mississippi, Montana, Oklahoma, Texas, and Utah) and Puerto Rico, as well as over 400 cases brought by
other plaintiffs. On January 24, 2024, the District Court for the District of New Jersey (which is presiding over the MDL)
issued a decision denying plaintiffs’ motion for class certification in a putative class action on behalf of consumers.
Following denial of plaintiffs’ appeal of that decision, plaintiffs filed an amended complaint, which defendants have moved
to strike or dismiss. On December 31, 2024, the District Court dismissed some of plaintiffs’ claims but allowed others to
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proceed. Sanofi has also settled (on non-monetary terms) a case brought by Minnesota’s Attorney General and has secured
the voluntary dismissal of another case brought by a group of entities known as Medicare Secondary Payer (MSP)
Recoveries.
Mylan vs Sanofi antitrust complaint
In May 2023, Mylan Pharmaceuticals Inc., Mylan Specialty LP and Mylan Inc. (Mylan) filed suit against Sanofi-Aventis US LLC,
Sanofi SA, Aventis Pharma SA and Sanofi-Aventis Puerto Rico (Sanofi) in the Western District of Pennsylvania for alleged antitrust
violations related to Mylan’s insulin product Semglee. Sanofi has moved to dismiss the complaint.
B. Significant Changes
Updates to Note D.22.
N/A
Other Changes
On January 21, 2025, Opella announced that the US Food and Drug Administration (FDA) has lifted a clinical hold on its
planned actual use trial(AUT) to support the switch of Cialis (tadalafil) from a prescription to an over-the-counter medicine.
This decision allows for the initiation of the AUT and makes Cialis the first PDE-5 inhibitor to achieve this milestone.
During the meeting of the Board of Directors on January 29, 2025, the Board authorized Sanofi to repurchase the Company's
shares, for an amount not exceeding €5 billion, under the terms and conditions set by the General Meeting of April 30, 2024 in
its 19th resolution.
As part of this authorization, Sanofi entered into a share buyback agreement with its historical shareholder L'Oréal on
February 2, 2025 for the acquisition of 2.34% of its share capital, or the equivalent of 29,556,650 shares, for a total amount
of approximately €3 billion, representing a price of €101.50 per share. The conclusion of this agreement was approved by the
Board of Directors on the same day prior to the signing of said agreement and in accordance with the procedure of Articles
L. 225-38 et seq. of the French Commercial Code. In addition, on February 6, 2025, Sanofi entered into a mandate with an
investment services provider to repurchase its own shares for a maximum amount of €2 billion, between February 7, 2025
and December 31, 2025 at the latest.
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ITEM 9. The Offer and Listing
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Item 9. The Offer and Listing
A. Offer and Listing Details
We have one class of shares. Each American Depositary Share, or ADS, represents one-half of one share. The ADSs are evidenced
by American Depositary Receipts, or ADRs, which are issued by JPMorgan Chase Bank, NA.
Our shares trade on Compartment A of the regulated market of Euronext Paris under the symbol "SAN," and our ADSs trade on
the Nasdaq Global Select Market, or Nasdaq, under the symbol "SNY."
B. Plan of Distribution
N/A
C. Markets
Shares and ADSs
Our shares are listed on Euronext Paris under the symbol “SAN” and our ADSs are listed on the Nasdaq under the symbol “SNY.”
As of the date of this annual report, our shares are included in a large number of indexes, including the “CAC 40 Index,” the
principal French index published by Euronext Paris. This index contains 40 stocks selected among the top 100 companies based
on free-float capitalization and the most active stocks listed on the Euronext Paris market. The CAC 40 Index indicates trends in
the French stock market as a whole and is one of the most widely followed stock price indices in France.
Our shares are included in European indexes, such as the EURO STOXX 50, STOXX Europe 600 index, FTSE Eurofirst 300,
MSCI Europe, MSCI Pan Euro, Euronext 100, and STOXX Europe 600 Health Care. They are also included in American and
international indexes, such as the NASDAQ Composite, NASDAQ Health Care, S&P Global 100, MSCI World, and MSCI World
Pharmaceuticals, Biotechnology and Life Sciences.
Our shares are also part of the main extra-financial rating indices, taking into account environmental, social, and governance
criteria (FTSE4Good, STOXX Global ESG Leaders, and EURO STOXX 50 Low Carbon).
Trading by Sanofi in our own Shares
Under French law, a company may not issue shares to itself, but it may purchase its own shares in the limited cases described
at “Item 10. Additional Information — B. Memorandum and Articles of Association — Trading in Our Own Shares.”
D. Selling Shareholders
N/A
E. Dilution
N/A
F. Expenses of the Issue
N/A
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ITEM 10. Additional Information
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Item 10. Additional Information
A. Share Capital
N/A
B. Memorandum and Articles of Association
General
Our Company is a
société anonyme
, a form of limited liability company, organized under the laws of France. The LEI number of
the Company is 549300E9PC51EN656011.
In this section, we summarize material information concerning our share capital, together with material provisions of applicable
French law and our Articles of Association
(statuts)
, an English translation of which has been filed as an exhibit to this annual
report. For a description of certain provisions of our Articles of Association relating to our Board of Directors and statutory
auditors, see “Item 6. Directors, Senior Management and Employees." You may obtain copies of our Articles of Association in
French from the
greffe
(Clerk) of the
Registre du Commerce et des Sociétés de Paris
(Registry of Commerce and Companies of
Paris, France, registration number: 395 030 844). Please refer to that full document for additional details.
Our Articles of Association specify that our corporate affairs are governed by:
•
applicable laws and regulations (in particular, Title II of the French Commercial Code); and
•
the Articles of Association themselves.
Article 3 of our Articles of Association specifies that the Company’s corporate purpose, in France and abroad, is:
•
acquiring interests and holdings, in any form whatsoever, in any company or enterprise, in existence or to be created,
connected directly or indirectly with the health and fine chemistry sectors, human and animal therapeutics, nutrition and bio-
industry:
–
in the following areas:
•
purchase and sale of all raw materials and products necessary for these activities,
•
research, study and development of new products, techniques and processes,
•
manufacture and sale of all chemical, biological, dietary and hygienic products,
•
obtaining or acquiring all intellectual property rights related to results obtained and, in particular, filing all patents,
trademarks and models, processes or inventions,
•
operating directly or indirectly, purchasing, and transferring – for free or for consideration – pledging or securing all
intellectual property rights, particularly all patents, trademarks and models, processes or inventions,
•
obtaining, operating, holding and granting all licenses,
•
within the framework of a group-wide policy and subject to compliance with the relevant legislation, participating in
treasury management transactions, whether as lead company or otherwise, in the form of centralized currency risk
management or intra-group netting, or any other form permitted under the relevant laws and regulations,
–
and, more generally:
•
all commercial, industrial, real or personal property, financial or other transactions, connected directly or indirectly,
totally or partially, with the activities described above and with all similar or related activities and even with any other
purposes likely to encourage or develop the Company’s activities.
Directors
Transactions in which directors are materially interested
Under French law, any agreement entered into (directly or through an intermediary) between our Company and any one of the
members of the Board of Directors that is not entered into (i) in the ordinary course of our business and (ii) under normal
conditions, is subject to the prior authorization of the disinterested members of the Board of Directors. The same provision
applies to agreements between our Company and another company if one of the members of the Board of Directors is the
owner, general partner, manager, director, general manager or member of the executive or supervisory board of the other
company, as well as to agreements in which one of the members of the Board of Directors has an indirect interest.
The Board of Directors must also approve any undertaking taken by our Company for the benefit of our Chairman, Chief
Executive Officer
(directeur général)
or his delegates
(directeurs généraux délégués)
pursuant to which such persons will or may
be granted compensation, benefits or any other advantages as a result of the termination of or a change in their offices or
following such termination or change, in accordance with Article L. 22-10-8 III of the French Commercial Code. Each such
undertaking must be included in our compensation policy for corporate officers, which is submitted for approval by our
shareholders at the Annual General Meeting in accordance with Article L. 22-10-8 II of the French Commercial Code. No such
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compensation or undertaking may be determined, awarded or paid unless in accordance with such compensation policy.
See “Item 6. Directors, Senior Management and Employees — B. Compensation” for a description of the process for establishing
and authorizing such compensation policy.
Directors’ compensation
The aggregate amount of compensation of the Board of Directors is determined at the Shareholders’ Ordinary General Meeting.
The Board of Directors then divides this aggregate amount among its members by a simple majority vote. In addition, the Board
of Directors may grant exceptional compensation
(rémunérations exceptionnelles)
to individual directors on a case-by-case basis
for special assignments following the procedures described above at “— Transactions in which directors are materially
interested”. The Board of Directors may also authorize the reimbursement of travel and accommodation expenses, as well as
other expenses incurred by Directors in the corporate interest. See also “Item 6. Directors, Senior Management and Employees.”
Furthermore, under our Articles of Association, the Board of Directors may compensate any observers
(censeurs)
to the Board of
Directors, which would reduce by the same amount the total annual compensation available for allocation to the Board of
Directors.
Board of Directors’ authority to take out loans or borrow money on behalf of the Company
All loans or borrowings on behalf of the Company may be decided by the Board of Directors within the limits, if any, imposed by
the Shareholders’ Extraordinary General Meeting. There are currently no limits imposed on the amounts of loans or borrowings
that the Board of Directors may approve.
Directors’ age limits
For a description of the provisions of our Articles of Association relating to age limits applicable to our Directors, see
“Item 6. Directors, Senior Management and Employees – A. Directors and Senior Management."
Directors’ share ownership requirements
Pursuant to our Articles of Association, each director appointed by a Shareholders’ Ordinary General Meeting must own at
least 500 shares throughout their term of office. In addition, pursuant to the Board Charter, our Directors must within no more
than two years from their appointment hold at least 1,000 Sanofi shares in their own name, which must be retained until they
cease to hold office.
Shareholders’ meetings
General
In accordance with the provisions of the French Commercial Code, there are three types of shareholders’ meetings: ordinary,
extraordinary and special.
Ordinary general meetings of shareholders are required for matters such as:
•
electing, replacing and removing Directors;
•
appointing independent auditors;
•
approving the annual financial statements;
•
declaring dividends or authorizing dividends to be paid in shares, provided the Articles of Association contain a provision to
that effect; and
•
approving share repurchase programs.
Extraordinary general meetings of shareholders are required for approval of matters such as amendments to our Articles of
Association, including any amendment required in connection with extraordinary corporate actions. Extraordinary corporate
actions include:
•
changing our Company’s name or corporate purpose;
•
increasing or decreasing our share capital;
•
creating a new class of equity securities;
•
authorizing the issuance of:
–
shares giving access to our share capital or giving the right to receive debt instruments, or
–
other securities giving access to our share capital;
•
establishing any other rights to equity securities;
•
selling or transferring substantially all of our assets; and
•
the voluntary liquidation of our Company.
Special meetings of shareholders of a certain category of shares or shares with certain specific rights (such as shares with double
voting rights) are required for any modification of the rights derived from that category of shares. The resolutions of the
shareholders’ general meeting affecting these rights are effective only after approval by the relevant special meeting.
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Annual ordinary meetings
The French Commercial Code requires the Board of Directors to convene an annual ordinary general shareholders’ meeting to
approve the annual financial statements. This meeting must be held within six months of the end of each fiscal year.
The Board of Directors may also convene an ordinary or extraordinary general shareholders’ meeting upon proper notice at any
time during the year. If the Board of Directors fails to convene a shareholders’ meeting, our independent auditors may call the
meeting. In case of bankruptcy, the liquidator or court-appointed agent may also call a shareholders’ meeting in some instances.
In addition, any of the following may request the court to appoint an agent for the purpose of calling a shareholders’ meeting:
•
one or several shareholders holding at least 5% of our share capital;
•
duly qualified associations of shareholders who have held their shares in registered form for at least two years and who
together hold at least 1% of our voting rights;
•
the works council in cases of urgency; or
•
any interested party in cases of urgency.
Under our Articles of Association, the Board of Directors may take decisions by written consultation under the conditions
permitted by law and as specified in the Board Charter (an English language version of which is reproduced in full as Exhibit 1.2 to
this annual report), including the possibility to convene an ordinary or extraordinary general meeting.
Notice of shareholders’ meetings
All prior notice periods provided for below are minimum periods required by French law and cannot be shortened, except in case
of a public tender offer for our shares.
We must announce general meetings at least thirty-five days in advance by means of a preliminary notice
(avis de réunion)
, which
is published in the
Bulletin des Annonces Légales Obligatoires
, or BALO. The preliminary notice must first be sent to the French
Financial markets authority (
Autorité des marchés financiers
, the “AMF”), with an indication of the date on which it will be
published in the BALO. It must be published on our website at least twenty-one days prior to the general meeting. The
preliminary notice must contain, among other things, the agenda, a draft of the resolutions to be submitted to the shareholders
for consideration at the general meeting and a detailed description of the voting procedures (proxy voting, electronic voting or
voting by mail), the procedures permitting shareholders to submit additional resolutions or items to the agenda and to ask written
questions to the Board of Directors. The AMF also recommends that, prior to or simultaneously with the publication of the
preliminary notice, we publish a summary of the notice indicating the date, time and place of the meeting in a newspaper of
national circulation in France and on our website.
At least fifteen days prior to the date set for a first convening, and at least ten days prior to any second convening, we must send
a final notice
(avis de convocation)
containing the final agenda, the date, time and place of the meeting and other information
related to the meeting. Such final notice must be sent by mail to all registered shareholders who have held shares in registered
form for more than one month prior to the date of the final notice and by registered mail, if shareholders have asked for it and
paid the corresponding charges. The final notice must also be published in a newspaper authorized to publish legal
announcements in the local administrative department
(département)
in which our Company is registered as well as in the BALO,
with prior notice having been given to the AMF for informational purposes. Even if there are no proposals for new resolutions or
items to be submitted to the shareholders at the meeting, we must publish a final notice in a newspaper authorized to publish
legal announcements in the local administrative department
(département)
in which our Company is registered as well as in
the BALO.
Other issues
In general, shareholders can only take action at shareholders’ meetings on matters listed on the agenda. As an exception to this
rule, shareholders may take action with respect to the appointment and dismissal of directors even if this action has not been
included on the agenda.
Additional resolutions to be submitted for approval by the shareholders at the shareholders’ meeting may be proposed to the
Board of Directors, for recommendation to the shareholders at any time from the publication of the preliminary notice in
the BALO until twenty-five days prior to the general meeting and in any case no later than twenty days following the publication
of the preliminary notice in the BALO by:
•
one or several shareholders together holding a specified percentage of shares;
•
a duly qualified association of shareholders who have held their shares in registered form for at least two years and who
together hold at least 1% of our voting rights; or
•
the works council.
Within the same period, the shareholders may also propose additional items (points) to be submitted and discussed during the
shareholders’ meeting, without a shareholders’ vote. The shareholders must substantiate the reasons for their proposals of
additional items.
The resolutions and the list of items added to the agenda of the shareholders’ meeting must be promptly published on
our website.
The Board of Directors must submit the resolutions to a vote of the shareholders after having made a recommendation thereon.
The Board of Directors may also comment on the items that are submitted to the shareholders’ meeting.
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Following the date on which documents must be made available to the shareholders (including documents to be submitted to the
shareholders’ meeting and resolutions proposed by the Board of Directors, which must be published on our website at least
twenty-one days prior to the general meeting), shareholders may submit written questions to the Board of Directors relating to
the agenda for the meeting until the fourth business day prior to the general meeting. The Board of Directors must respond to
these questions during the meeting or may refer to a Q&A section located on our website in which the question submitted by a
shareholder has already been answered.
Attendance at shareholders’ meetings; proxies and votes by mail
In general, all shareholders may participate in general meetings either in person or by proxy. Shareholders may vote in person, by
proxy or by mail.
The right of shareholders to participate in general meetings is subject to the recording (inscription en compte) of their shares on
the second business day, 12:00 a.m. (Paris time), preceding the general meeting:
•
for holders of registered shares: in the registered shareholder account held by the Company or on its behalf by an agent
appointed by it; and
•
for holders of bearer shares: in the bearer shareholder account held by the accredited financial intermediary with whom such
holders have deposited their shares; such financial intermediaries shall deliver to holders of bearer shares a shareholding
certificate
(attestation de participation)
enabling them to participate in the general meeting.
Attendance in person
Any shareholder may attend ordinary general meetings and extraordinary general meetings and exercise its voting rights subject
to the conditions specified in the French Commercial Code, the French Civil Code and our Articles of Association.
An attendance sheet and written minutes are established for each shareholders’ meeting; failure to do so could lead to
cancellation of the decisions at the shareholders’ meeting.
Proxies and votes by mail
Proxies are sent to any shareholder upon a request received between the publication of the final notice of meeting and six days
before the general meeting and must be made available on our website at least twenty-one days before the general meeting. In
order to be counted, such proxies must be received at our registered office, or at any other address indicated on the notice of the
meeting or by any electronic mail indicated on the notice of the meeting, prior to the date of the meeting (in practice, we request
that shareholders return proxies at least three business days prior to the meeting; electronic proxies must be returned
before 3 p.m. Paris time, on the day prior to the general meeting). A shareholder may grant proxies to any natural person or legal
entity. The agent may be required to disclose certain information to the shareholder or to the public.
A proxy is only valid for one meeting (or by way of exception for two meetings, one being ordinary and the other extraordinary,
held on the same day or within a single 15-day period); it remains valid in the event such meeting is convened multiple times for
the same agenda, and may be revoked by written statement of the shareholder granting the proxy.
Alternatively, the shareholder may send us a blank proxy without nominating any representative. In this case, the chairman of the
meeting will vote the blank proxies in favor of all resolutions proposed or approved by the Board of Directors and against
all others.
With respect to votes by mail, we must send shareholders a voting form upon request or must make available a voting form on our
website at least twenty-one days before the general meeting. The completed form must be returned to us at least three days
prior to the date of the shareholders’ meeting. For holders of registered shares, in addition to traditional voting by mail,
instructions may also be given via the Internet.
Quorum
The French Commercial Code requires that shareholders holding in the aggregate at least 20% of the shares entitled to vote
must be present in person, or vote by mail or by proxy, in order to fulfill the quorum requirement for:
•
an ordinary general meeting; and
•
an extraordinary general meeting where the only resolutions pertain to either (a) a proposed increase in our share capital
through incorporation of reserves, profits or share premium, or (b) the potential issuance of free share warrants in the event of
a public tender offer for our shares (Article L. 233-32 of the French Commercial Code).
For any other extraordinary general meeting the quorum requirement is at least 25% of the shares entitled to vote, held by
shareholders present in person, voting by mail or by proxy.
For a special meeting of holders of a certain category of shares, the quorum requirement is one third of the shares entitled to
vote in that category, held by shareholders present in person, voting by mail or by proxy.
If a quorum is not present at a meeting, the meeting is adjourned. However, only questions that were on the agenda of the
adjourned meeting may be discussed and voted upon once the meeting resumes.
When an adjourned meeting is resumed, there is no quorum requirement for meetings cited in the first paragraph of this
“Quorum” section. In the case of any other reconvened extraordinary general meeting or special meeting, the quorum
requirement is 20% of the shares entitled to vote (or voting shares belonging to the relevant category for special meetings of
holders of shares of such specific category), held by shareholders present in person or voting by mail or by proxy. If a quorum is
not met, the reconvened meeting may be adjourned for a maximum of two months with the same quorum requirement. No
deliberation or action by the shareholders may take place without a quorum.
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C. Material Contracts
In the ordinary course of our business, we enter into agreements for licensing or collaboration in the development and
commercialization of products, as well as agreements for the purchase or sale of other businesses. Certain of the agreements
which have led to successful commercialization to date are summarized in “Item 5. Operating and financial review and prospects
— A.1.7 Financial presentation of alliances.”. Agreements in connection with the potential sale and purchase of a 50% controlling
stake in Opella are described in "Item 4. Information on the Company — B.3 Opella".
Share Repurchase Agreement with L'Oréal
On February 2, 2025, Sanofi and L'Oréal entered into a share buyback agreement pursuant to which Sanofi repurchased
29,556,650 shares from L’Oréal, a significant shareholder, at €101.50 per share, for a total amount of approximately €3 billion.
After the transaction and cancellation of the shares, L’Oréal will hold 7.2% of Sanofi’s share capital and 13.1% of its voting rights
(excluding treasury shares). The transaction closed on February 5, 2025. Sanofi will cancel the shares acquired from L'Oréal at the
latest on April 29, 2025. For more information, see "Item 8. Financial Information - B. Significant Changes".
D. Exchange Controls
French exchange control regulations currently do not limit the amount of payments that we may remit to non-residents of
France. Laws and regulations concerning foreign exchange controls do require, however, that all payments or transfers of funds
made by a French resident to a non-resident be handled by an accredited intermediary.
E. Taxation
General
The following generally summarizes the material French and US federal income tax consequences to US holders (as defined
below) of purchasing, owning and disposing of our ADSs and ordinary shares (collectively the “Securities”). This discussion is
intended only as a descriptive summary and does not purport to be a complete analysis or listing of all potential tax effects of the
purchase, ownership or disposition of our Securities. All of the following is subject to change. Such changes could apply
retroactively and could affect the consequences described below.
In particular, the French Finance Bill for 2025 (
Loi de Finances pour 2025
) was adopted by the French Parliament on February 6,
2025, but has not yet been enacted into law. The French Finance Bill for 2025 contains certain measures that would affect the
French taxation of US holders purchasing the Securities (as mentioned
below). As of February 12, 2025, certain articles of the
Finance Bill for 2025 are under review by the French Constitutional Council (
Conseil Constitutionnel
).
This summary does not constitute a legal opinion or tax advice. Holders are urged to consult their own tax advisers regarding
the tax consequences of the purchase, ownership and disposition of Securities in light of their particular circumstances,
including the effect of any US federal, state, local or other national tax laws.
A set of tax rules is applicable to French assets that are held by or in foreign trusts. These rules provide inter alia for the inclusion
of trust assets in the settlor’s net assets for purpose of applying the French real estate wealth tax, for the application of French
gift and death duties to French assets held in trust, for a specific tax on capital on the French assets of foreign trusts not already
subject to the French real estate wealth tax and for a number of French tax reporting and disclosure obligations. The following
discussion does not address the French tax consequences applicable to Securities held in trusts.
If Securities are held in trust, the
grantor, trustee and beneficiary are urged to consult their own tax adviser regarding the specific tax consequences of acquiring,
owning and disposing of Securities.
The description of the French and US federal income tax consequences set forth below is based on the laws (including, for
US federal income tax purposes, the Internal Revenue Code of 1986, as amended (the “Code”), final, temporary and proposed
US Treasury Regulations promulgated thereunder and administrative and judicial interpretations thereof) in force as of the date
of this annual report, the Convention Between the Government of the United States of America and the Government of the
French Republic for the Avoidance of Double Taxation and the Prevention of Fiscal Evasion with Respect to Taxes on Income and
Capital of August 31, 1994 (the “Treaty”), which entered into force on December 30, 1995 (as amended by any subsequent
protocols, including the protocol of January 13, 2009), and the tax regulations issued by the French tax authorities within the
Bulletin Officiel des Finances Publiques-Impôts
(the “Regulations”) in force as of the date of this report.
US holders are advised to
consult their own tax advisers regarding their eligibility for Treaty benefits, especially with regard to the “Limitations on
Benefits” provision, in light of their own particular circumstances.
No advance ruling has been obtained with respect to the tax consequences of the acquisition, ownership or disposition of the
Securities from either the French or US tax authorities. Thus, there can no assurances that either or both of such authorities will
not take a position concerning said tax consequences different from that set out herein or that such a position would not be
sustained by a court.
For the purposes of this discussion, a US holder is a beneficial owner of Securities that is (i) an individual who is a US citizen or
resident for US federal income tax purposes, (ii) a US domestic corporation created or organized in or under the laws of the
United States or any state thereof, including the District of Columbia, or (iii) certain estates or trusts that are subject to US tax
jurisdiction.
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If a partnership holds Securities, the tax treatment of a partner generally will depend upon the status of the partner and the
activities of the partnership.
If a US holder is an estate or trust or
partner in a partnership that holds Securities, the holder is
urged to consult its own tax adviser regarding the specific tax consequences of acquiring, owning and disposing of Securities.
This discussion is intended only as a general summary and does not purport to be a complete analysis or listing of all potential tax
effects of the acquisition, ownership or disposition of the Securities to any particular investor, and does not discuss tax
considerations that arise from rules of general application or that are generally assumed to be known by investors. The discussion
applies only to investors that hold our Securities as capital assets that have the US dollar as their functional currency, that are
entitled to Treaty benefits under the “Limitation on Benefits” provision contained in the Treaty, and whose ownership of the
Securities is not effectively connected to a permanent establishment or a fixed base in France. Certain holders (including, but not
limited to, US expatriates, partnerships or other entities classified as partnerships for US federal income tax purposes, banks,
insurance companies, regulated investment companies, tax-exempt organizations, financial institutions, persons subject to the
alternative minimum tax, persons who acquired the Securities pursuant to the exercise of employee stock options or otherwise as
compensation, persons that own (directly, indirectly or by attribution) 5% or more of our voting stock or 5% or more of our
outstanding share capital, dealers in securities or currencies, persons that elect to mark their securities to market for US federal
income tax purposes, persons that acquire ADSs in “pre-release” transactions (i.e. prior to deposit of the relevant ordinary shares,
although our depositary has indicated that such transactions have been halted) and persons holding Securities as a position in a
synthetic security, straddle or conversion transaction) may be subject to special rules not discussed below.
Holders of Securities
are advised to consult their own tax advisers with regard to the application of French tax law and US federal tax law to their
particular situations, as well as any tax consequences arising under the laws of any state, local or other foreign jurisdiction.
French taxes
Estate and gift taxes and transfer taxes
In general, a transfer of Securities by gift or by reason of death of a US holder that would otherwise be subject to French gift or
inheritance tax, respectively, will not be subject to such French tax by reason of the Convention between the Government of the
United States of America and the Government of the French Republic for the Avoidance of Double Taxation and the Prevention
of Fiscal Evasion with Respect to Taxes on Estates, Inheritances and Gifts, dated November 24, 1978, unless the donor or the
transferor is domiciled in France at the time of making the gift or at the time of his or her death, or the Securities were used in, or
held for use in, the conduct of a business through a permanent establishment or a fixed base in France.
Pursuant to Article 235 ter ZD of the French General Tax Code, purchases of Securities are currently subject to a 0.3% French tax
on financial transactions (the “FTFF”). According to Article 26
quater
of the Finance Bill for 2025, the rate of the FTFF will be
increased to 0.4% for purchases of Securities as from the first day of the second month following the enactment of the Finance
Bill for 2025. Purchases of Securities are subject to the FTFF provided that Sanofi’s market capitalization exceeds €1 billion as of
December 1 of the year preceding the taxation year. A list of companies whose market capitalization exceeds €1 billion as of
December 1 of the year preceding the taxation year used to be published annually by the French Ministry of Economy. It is now
published by the French tax authorities, and could be amended at any time. Pursuant to Regulations BOI-
ANNX-000467-23/12/2024 issued on Decemb
er 23, 2024, purch
ases of Sanofi’s Securities in 2025 should be subject to the FTFF
as the market capitalization of Sanofi exceeded €1 billion as of December 1, 2024. In accordance with Article 726-II-d of the
French General Tax Code, purchases which are subject to the FTFF should however not be subject to transfer taxes
(droits
d’enregistrement)
in France.
Wealth tax
The French wealth tax
(impôt de solidarité sur la fortune)
has been replaced with a French real estate wealth tax
(impôt sur la
fortune immobilière)
with effect from January 1, 2018. French real estate wealth tax applies only to individuals and does not
generally apply to the Securities if the holder is a US resident, as defined pursuant to the provisions of the Treaty, provided that
the individual does not own directly or indirectly a shareholding exceeding 10% of the financial rights and voting rights.
US taxes
Ownership of the securities
Deposits and withdrawals by a US holder of ordinary shares in exchange for ADSs, will not be taxable events for US federal
income tax purposes. For US tax purposes, holders of ADSs will be treated as owners of the ordinary shares represented by such
ADSs. Accordingly, the discussion that follows regarding the US federal income tax consequences of acquiring, owning and
disposing of ordinary shares is equally applicable to ADSs.
Information reporting and backup withholding tax
Distributions made to holders and proceeds paid from the sale, exchange, redemption or disposal of Securities may be subject to
information reporting to the Internal Revenue Service. Such payments may be subject to backup withholding taxes unless the holder
(i) is a corporation or other exempt recipient or (ii) provides a taxpayer identification number and certifies that no loss of exemption
from backup withholding has occurred. Holders that are not US persons generally are not subject to information reporting or backup
withholding. However, such a holder may be required to provide a certification of its non-US status in connection with payments
received within the United States or through a US-related financial intermediary to establish that it is an exempt recipient. Backup
withholding is not an additional tax. Amounts withheld as backup withholding may be credited against a holder’s US federal income
tax liability. A holder may obtain a refund of any excess amounts withheld under the backup withholding rules by filing the
appropriate claim for refund with the Internal Revenue Service and furnishing any required information.
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Foreign asset reporting
In addition, a US holder that is an individual or certain entities may be subject to reporting obligations with respect to ordinary
shares and ADSs if the aggregate value of these and certain other “specified foreign financial assets” exceeds $50,000 on
the last day of the tax year or more than $75,000 at any time during the tax year. If required, this disclosure is made by
filing Form 8938 with the US Internal Revenue Service. Significant penalties can apply if holders are required to make this
disclosure and fail to do so. In addition, a US holder should consider the possible obligation to file online a FinCEN Form 114 –
Foreign Bank and Financial Accounts Report as a result of holding ordinary shares or ADSs. Holders are encouraged to consult
their US tax advisors with respect to these and other reporting requirements that may apply to their acquisition of ordinary shares
and ADSs.
State and local taxes
In addition to US federal income tax, US holders of Securities may be subject to US state and local taxes with respect to such
Securities.
Holders of Securities are advised to consult their own tax advisers with regard to the application of US state and local
income tax law to their particular situation.
ADSs-Ordinary Shares
French taxes
Taxation of dividends
Under French law, dividends paid by a French corporation, such as Sanofi, to non-residents of France are generally subject to
French withholding tax at a rate of (i) 25% for payments benefiting legal persons who are beneficial owners and are not French
tax residents (and 15% for distributions made to not-for-profit organizations with a head office in a Member State of the European
Economic Area which would be subject to the tax regime set forth under Article 206 paragraph 2 of the French General Tax Code
if its head office were located in France and which meet the criteria set forth in the Regulations BOI-RPPM-
RCM-30-30-10-70-24/12/2019, No. 130), and (ii) 12.8% for payments benefiting individuals who are beneficial owners and are not
French tax residents. Dividends paid by a French corporation, such as Sanofi, towards non-cooperative States or territories, as
defined in Article 238-0 A of the French General Tax Code (other than those mentioned in 2° of 2 bis of the same Article 238-0 A
of the French Tax Code), will generally be subject to French withholding tax at a rate of 75%, irrespective of the tax residence of
the beneficiary of the dividends if the dividends are received in such States or territories; however, eligible US holders entitled to
Treaty benefits under the “Limitation on Benefits” provision contained in the Treaty who are US residents, as defined pursuant to
the provisions of the Treaty and who receive dividends in non-cooperative States or territories, will not be subject to this 75%
withholding tax rate.
Under the Treaty, the rate of French withholding tax on dividends paid to an eligible US holder who is a US resident as defined
pursuant to the provisions of the Treaty and whose ownership of the ordinary shares or ADSs is not effectively connected with a
permanent establishment or fixed base that such US holder has in France, is reduced to 15%, or to 5% if such US holder is a
corporation and owns directly or indirectly at least 10% of the share capital of the issuing company; such US holder may claim a
refund from the French tax authorities of the amount withheld in excess of the Treaty rates of 15% or 5%, if any. For US holders
that are not individuals but are US residents, as defined pursuant to the provisions of the Treaty, the requirements for eligibility
for Treaty benefits, including the reduced 5% or 15% withholding tax rates contained in the “Limitation on Benefits” provision
of the Treaty, are complicated, and certain technical changes were made to these requirements by the protocol of
January 13, 2009. US holders are advised to consult their own tax advisers regarding their eligibility for Treaty benefits in light of
their own particular circumstances.
Dividends paid to an eligible US holder may immediately be subject to the reduced rates of 5% or 15% provided that such holder
establishes before the date of payment that it is a US resident under the Treaty by completing and providing the depositary with
a treaty form (Form 5000). Dividends paid to a US holder that has not filed the Form 5000 before the dividend payment date will
be subject to French withholding tax at the rate of 25% and then reduced at a later date to 5% or 15%, provided that such holder
duly completes and provides the French tax authorities with the treaty forms Form 5000 and Form 5001 (due to recent case law
regarding the status of limitations for filing a withholding tax claim, U.S. holders are advised to consult their own tax advisors in
this respect). Pension funds and certain other tax-exempt entities are subject to the same general filing requirements as other
US holders except that they may have to supply additional documentation evidencing their entitlement to these benefits.
The depositary agrees to use reasonable efforts to follow the procedures established, or that may be established, by the French
tax authorities (i) to enable eligible US holders to qualify for the reduced withholding tax rate provided by the Treaty, if available
at the time the dividends are paid, or (ii) to recover any excess French withholding taxes initially withheld or deducted with
respect to dividends and other distributions to which such US holders may be eligible from the French tax authorities and (iii) to
recover any other available tax credits. In particular, associated forms (including Form 5000 and Form 5001, together with their
instructions), will be made available by the depositary to all US holders registered with the depositary, and are also generally
available from the US Internal Revenue Service.
The withholding tax refund, if any, ordinarily is paid within 12 months of filing the applicable French Treasury Form, but not before
January 15 of the year following the calendar year in which the related dividend is paid.
In addition, please note that, pursuant to Article 235 quater of the French Tax Code and under certain conditions (in particular, in
addition to certain reporting obligations, the interest held in the distributing company must not enable the beneficiary to
participate effectively in the management or control of that company and the beneficiary company must be located in a country
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that has signed an administrative assistance agreement with France to combat tax evasion and avoidance, as well as an
administrative assistance agreement on tax collection, and that is not a non-cooperative country), a corporate U.S. holder in a tax
loss position or whose tax result is nil due to offset of tax losses for the fiscal year during which the dividend is received may be
entitled to a deferral regime, and obtain a withholding tax refund. The tax deferral ends in respect of the first financial year during
which this U.S. holder is in a profit making position, as well as in the cases set out in Article 235 quater of the French Tax Code.
The refund must be claimed within the same period applicable to claims related to taxes other than local taxes. Also, pursuant to
Article 235 quinquies of the French Tax Code and under certain conditions, a corporate U.S. holder may be entitled to a refund of
a fraction of the withholding tax, up to the difference between the withholding tax paid (on a gross basis) and the withholding tax
based on the dividend net of the expenses incurred for the acquisition and conservation directly related to the income, provided
(i) that these expenses would have been tax deductible had the U.S. holder been established in France, and (ii) that the tax rules in
the United States do not allow the U.S. holder to offset the withholding tax.
Given the special features of the ADSs, U.S. holders are urged to consult their own tax advisor about the possible application to
ADSs of such provisions in light of their own circumstances.
Tax on sale or other disposition
In general, under the Treaty, a US holder who is a US resident for purposes of the Treaty will not be subject to French tax on any
capital gain from the redemption (other than redemption proceeds characterized as dividends under French domestic law), sale
or exchange of ordinary shares or ADSs unless the ordinary shares or the ADSs form part of the business property of a permanent
establishment or fixed base that the US holder has in France. Special rules apply to holders who are residents of more than
one country.
US Taxes
Taxation of dividends
For US federal income tax purposes, the gross amount of any distribution paid to US holders (that is, the net distribution received
plus any tax withheld therefrom) will be treated as ordinary dividend income to the extent paid or deemed paid out of the current
or accumulated earnings and profits of Sanofi (as determined under US federal income tax principles). Dividends paid by Sanofi
will not be eligible for the dividends-received deduction generally allowed to corporate US holders.
Subject to certain exceptions for short-term and hedged positions, the US dollar amount of dividends received by an individual
US holder with respect to the ADSs or our ordinary shares is currently subject to taxation at a maximum rate of 20% if the
dividends are “qualified dividends”. Dividends paid on the ordinary shares or ADSs will be treated as qualified dividends if (i) the
issuer is eligible for the benefits of a comprehensive income tax treaty with the United States that the Internal Revenue Service
has approved for the purposes of the qualified dividend rules and (ii) the issuer was not, in the year prior to the year in which the
dividend was paid, and is not, in the year in which the dividend is paid, a passive foreign investment company (PFIC). The Treaty
has been approved for the purposes of the qualified dividend rules. Based on our financial statements and relevant market and
shareholder data, we believe Sanofi was not a PFIC for US federal income tax purposes with respect to its 2024 taxable year. In
addition, based on its current expectations regarding the value and nature of its assets, the sources and nature of its income, and
relevant market and shareholder data, we do not anticipate that Sanofi will become a PFIC for its 2025 taxable year.
Holders of
ordinary shares and ADSs should consult their own tax advisers regarding the availability of the reduced dividend tax rate in
light of their own particular circumstances.
If you are a US holder, dividend income received by you with respect to ADSs or ordinary shares generally will be treated as
foreign source income for foreign tax credit purposes. The limitation on foreign taxes eligible for credit is calculated separately
with respect to specific classes of income. Distributions out of earnings and profits with respect to the ADSs or ordinary shares
generally will be treated as “passive category” income (or, in the case of certain US holders, “general category” income). Subject
to certain limitations and the Foreign Tax Credit Regulations (as defined below), French income tax withheld in connection with
any distribution with respect to the ADSs or ordinary shares may be claimed as a credit against the US federal income tax liability
of a US holder if such US holder elects for that year to credit all foreign income taxes. Alternatively, such French withholding tax
may be taken as a deduction against taxable income. Foreign tax credits will not be allowed for withholding taxes imposed in
respect of certain short-term or hedged positions in Securities and may not be allowed in respect of certain arrangements in
which a US holder’s expected economic profit is insubstantial. Further, certain Treasury regulations addressing foreign tax credits
(the "Foreign Tax Credit Regulations") impose additional requirements for foreign taxes to be eligible for a foreign tax credit if the
relevant taxpayer does not elect to apply the benefits of an applicable income tax treaty, and there can be no assurance that
those requirements will be satisfied. Recent notices from the Internal Revenue Service provide temporary relief by allowing
taxpayers that comply with applicable requirements to apply many aspects of the foreign tax credit regulations as they previously
existed (before the release of the current Foreign Tax Credit Regulations) for taxable years ending before the date that a notice
or other guidance withdrawing or modifying the temporary relief is issued (or any later date specified in such notice or other
guidance).
The US federal income tax rules governing the availability and
computation of foreign tax credits are complex.
US holders should consult their own tax advisers concerning the implications of these rules, including the Foreign Tax Credit
Regulations and the related temporary relief in the Internal Revenue Service notices, in light of their particular circumstances.
To the extent that an amount received by a US holder exceeds the allocable share of our current and accumulated earnings and
profits, such excess will be applied first to reduce such US holder’s tax basis in its ordinary shares or ADSs and then, to the extent
it exceeds the US holder’s tax basis, it will constitute capital gain from a deemed sale or exchange of such ordinary shares or ADSs
(see “— Tax on Sale or Other Disposition”, below).
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The amount of any distribution paid in euros will be equal to the US dollar value of the euro amount distributed, calculated by
reference to the exchange rate in effect on the date the dividend is received by a US holder of ordinary shares (or by the
depositary, in the case of ADSs) regardless of whether the payment is in fact converted into US dollars on such date.
US holders
should consult their own tax advisers regarding the treatment of foreign currency gain or loss, if any, on any euros received by a
US holder that are converted into US dollars on a date subsequent to receipt.
Distributions to holders of additional ordinary shares (or ADSs) with respect to their ordinary shares (or ADSs) that are made as
part of a pro rata distribution to all ordinary shareholders generally will not be subject to US federal income tax. However, if a
US holder has the option to receive a distribution in shares (or ADSs) or to receive cash in lieu of such shares (or ADSs), the
distribution of shares (or ADSs) will be taxable as if the holder had received an amount equal to the fair market value of the
distributed shares (or ADSs), and such holder’s tax basis in the distributed shares (or ADSs) will be equal to such amount.
Tax on sale or other disposition
In general, for US federal income tax purposes, a US holder that sells, exchanges or otherwise disposes of its ordinary shares
or ADSs will recognize capital gain or loss in an amount equal to the US dollar value of the difference between the amount realized
for the ordinary shares or ADSs and the US holder’s adjusted tax basis (determined in US dollars and under US federal income tax
rules) in the ordinary shares or ADSs. Such gain or loss generally will be US-source gain or loss, and will be treated as long-term
capital gain or loss if the US holder’s holding period in the ordinary shares or ADSs exceeds one year at the time of disposition. If
the US holder is an individual, any capital gain generally will be subject to US federal income tax at preferential rates (currently a
maximum of 20%) if specified minimum holding periods are met. The deductibility of capital losses is subject to significant
limitations.
Medicare tax
Certain US holders who are individuals, estates or trusts are required to pay a Medicare tax of 3.8% (in addition to taxes they
would otherwise be subject to) on their “net investment income” which would include, among other things, dividends and capital
gains from the ordinary shares and ADSs.
F. Dividends and Paying Agents
N/A
G. Statement by Experts
N/A
H. Documents on Display
We are subject to the information requirements of the US Securities Exchange Act of 1934, as amended, or Exchange Act, and,
in accordance therewith, we are required to file reports, including this annual report, and other information with the US Securities
and Exchange Commission, or Commission, by electronic means.
You may review a copy of our filings with the Commission, as well as other information furnished to the Commission, including
exhibits and schedules filed with it, at the Commission’s public reference room at 100 F Street, N.E., Washington, D.C. 20549.
Please call the SEC at 1-800-SEC-0330 for further information. In addition, the Commission maintains an Internet site at
http://www.sec.gov that contains reports and other information regarding issuers that file electronically with the Commission
(these documents are not incorporated by reference in this annual report).
I. Subsidiary Information
N/A.
J. Annual Report to Security Holders
To the extent we furnish an annual report to security holders, we will promptly submit an English version of this annual report to
US security holders under the cover of Form 6-K.
(1)
The disclosures in this section supplement those provided in Note B.8.7. to the consolidated financial statements as regards the disclosure requirements
of IFRS 7, and are covered by the independent registered public accounting firms' opinion on the consolidated financial statements.
|
174
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SANOFI
FORM 20-F
2024
|
|
PART I
|
|
ITEM 11. Quantitative and Qualitative Disclosures about Market Risk
|
Item 11. Quantitative and Qualitative Disclosures about Market Risk
(1)
General policy
Liquidity risk, foreign exchange risk and interest rate risk, as well as related counterparty risks, are managed centrally by our
dedicated treasury team within the Group Finance Department. Where it is not possible to manage those risks centrally – in
particular due to regulatory restrictions (such as foreign exchange controls) or local tax restrictions – credit facilities and/or
currency lines, guaranteed whenever necessary by the parent company, are contracted by our subsidiaries locally with banks,
under the supervision of the central treasury team.
Our financing and investment strategies, and our interest rate and currency hedging strategies, are reviewed monthly by the
Group Finance Department.
Our policy prohibits the use of derivatives for speculative purposes.
Counterparty risk
Our financing and investing transactions, and our currency and interest rate hedges, are contracted with leading counterparties.
We set limits for investment and derivative transactions with individual financial institutions, depending on the rating of each
institution. Compliance with these limits, which are based on the notional amounts of the investments and the fair value of the
hedging instruments, is monitored on a daily basis.
The table below shows our total exposure as of
December 31, 2024
by rating and in terms of our percentage exposure to the
dominant counterparty.
|
(€ million)
|
Cash and cash
equivalents
(excluding mutual
funds)
|
(a)
|
Notional
amounts of
currency
hedges
|
(b)
|
Fair value of
currency
hedges
|
Notional
amounts of
interest rate
hedges
|
(b)
|
Fair value of
interest rate
hedges
|
General
corporate
purpose
credit facilities
|
|
AA
|
390
|
967
|
23
|
—
|
—
|
500
|
|||
|
AA-
|
652
|
10,157
|
188
|
1,083
|
(49)
|
1,000
|
|||
|
A+
|
649
|
10,512
|
217
|
690
|
(37)
|
4,000
|
|||
|
A
|
427
|
6,393
|
110
|
347
|
(21)
|
2,000
|
|||
|
A-
|
3
|
504
|
11
|
347
|
(20)
|
500
|
|||
|
BBB+
|
—
|
—
|
—
|
—
|
—
|
—
|
|||
|
Unallocated
|
128
|
—
|
—
|
—
|
—
|
—
|
|||
|
Total
|
2,249
|
28,534
|
550
|
2,466
|
(128)
|
8,000
|
|||
|
%/rating of dominant counterparty
|
24,8% / AA-
|
12,1% /A+
|
20,1 % /A+
|
6 % /A+
|
(a)
Cash equivalents include mutual fund investments of €
4,157
million.
(b)
The notional amounts are translated into euros at the relevant closing exchange rate as of
December 31, 2024
.
As of
December 31, 2024
, we held investments in euro and US dollar denominated money-market mutual funds. Those
instruments have low volatility, low sensitivity to interest rate risk, and a very low probability of loss of principal. The depositary
banks of the mutual funds, and of Sanofi itself, have a long-term rating of at least A. Realization of counterparty risk could impact
our liquidity in certain circumstances.
Foreign exchange risk
A. Operating foreign exchange risk
A substantial portion of our net sales is generated in countries where the euro, which is our reporting currency, is not the
functional currency. In
2024
, for example,
48.7%
of our net sales were generated in the United States;
22.0%
in Europe; and
29.4%
in the Rest of the World region (see the definition in “Item 5. Operating and Financial Review and Prospects
— A. Operating results), including countries that are, or may in the future become, subject to exchange controls, of which
6.5%
was generated in China and
3.4%
in Japan. Although we also incur expenses in those countries, the impact of those expenses is
not enough wholly to offset the impact of exchange rates on our net sales. Consequently, our operating income may be
materially affected by fluctuations in exchange rates between the euro and other currencies. Sanofi operates a foreign exchange
risk hedging policy to reduce the exposure of operating income to exchange rate movements. That policy involves regular
assessments of Sanofi’s worldwide foreign currency exposure, based on foreign currency transactions carried out by the parent
company and its subsidiaries. Those transactions mainly comprise sales, purchases, research costs, co-marketing and co-
promotion expenses, and royalties. To reduce the exposure of those transactions to exchange rate movements, Sanofi contracts
hedges using liquid derivative instruments, mainly forward currency purchases and sales, and also foreign exchange swaps. See
also “Item 5. Operating and Financial Review and Prospects — A. Operating results — A.1.8 Impact of Exchange Rates.”
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SANOFI
FORM 20-F
2024
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175
|
|
PART I
|
|
ITEM 11. Quantitative and Qualitative Disclosures about Market Risk
|
The table below shows operating currency hedging instruments in place as of
December 31, 2024
, with the notional amount
translated into euros at the relevant closing exchange rate (see Note D.20. to the consolidated financial statements for the
accounting classification of those instruments as of
December 31, 2024
).
Operating foreign exchange derivatives as of
December 31, 2024
|
(€ million)
|
Notional amount
|
Fair value
|
|
Forward currency sales
|
7,521
|
(67)
|
|
of which US dollar
|
3,974
|
(59)
|
|
of which Chinese yuan renminbi
|
703
|
(5)
|
|
of which Pound sterling
|
368
|
(1)
|
|
of which Japanese yen
|
241
|
2
|
|
of which Turkish lira
|
216
|
(23)
|
|
Forward currency purchases
|
4,796
|
37
|
|
of which US dollar
|
2,660
|
24
|
|
of which Singapore dollar
|
484
|
3
|
|
of which Chinese yuan renminbi
|
451
|
2
|
|
of which Turkish lira
|
203
|
19
|
|
of which Canadian dollar
|
126
|
—
|
|
Total
|
12,317
|
(30)
|
The above positions mainly hedge future material foreign-currency cash flows arising after the end of the reporting period in
relation to transactions carried out during the year ended
December 31, 2024
and recognized in the balance sheet at that date.
Gains and losses on hedging instruments (forward contracts) are calculated and recognized in parallel with the recognition of
gains and losses on the hedged items. Due to this hedging relationship, the commercial foreign exchange profit or loss on these
items (hedging instruments and hedged transactions) was immaterial in
2024
.
B. Financial foreign exchange risk
The cash pooling arrangements for foreign subsidiaries outside the euro zone, and some of Sanofi’s financing activities, expose
certain Sanofi entities to financial foreign exchange risk (i.e. the risk of changes in the value of borrowings and loans denominated
in a currency other than the functional currency of the borrower or lender). That foreign exchange exposure is hedged using
derivative instruments (foreign exchange swaps, forward contracts or currency swaps) that alter the currency split of Sanofi’s net
debt once those instruments are taken into account.
The table below shows financial currency hedging instruments in place as of
December 31, 2024
, with the notional amounts
translated into euros at the relevant closing exchange rate (see also Note D.20. to the consolidated financial statements for the
accounting classification of these instruments as of
December 31, 2024
).
Financial foreign exchange derivatives as of
December 31, 2024
|
(€ million)
|
Notional amount
|
Fair value
|
Expiry
|
|
|
Forward currency sales
|
10,377
|
(195)
|
||
|
of which US dollar
|
8,923
|
(a)
|
(176)
|
2025
|
|
of which Japanese yen
|
371
|
4
|
2025
|
|
|
of which Chinese yuan renminbi
|
235
|
(1)
|
2025
|
|
|
Forward currency purchases
|
6,884
|
112
|
||
|
of which US dollar
|
4,397
|
(b)
|
123
|
2025
|
|
of which Singapore dollar
|
819
|
2
|
2025
|
|
|
of which Hungarian forint
|
641
|
(9)
|
2025
|
|
|
Total
|
17,261
|
(83)
|
(a)
Includes forward sales with a notional amount of
$3,615 million
expiring in
2025
, designated as a hedge of Sanofi’s net investment in Bioverativ. As of
December 31, 2024
, the fair value of these forward contracts represented a liability of
€88 million
; the opposite entry was recognized in “Other
comprehensive income," with the impact on financial income and expense being immaterial.
(b)
Includes forward purchases with a notional amount of $
1,000 million
expiring in
2025
, designated as a fair value hedge of the exposure of $
1,000 million
of bond issues to fluctuations in the EUR/USD spot rate. As of
December 31, 2024
, the fair value of the contracts represented an asset of €
75 million
, the
opposite entry for €0.2 million of which was debited from "Other comprehensive income" under the cost of hedging accounting treatment.
(c)
Includes forward purchases with a notional amount of $
1,250 million
expiring in
2025
, designated as a fair value hedge of the exposure of $
1,250 million
of commercial paper. As of
December 31, 2024
, the fair value of these forward contracts swaps represented an asset of €
23 million
, the opposite entry
for €0.1 million of which was credited to "Other comprehensive income" under the cost of hedging accounting treatment.
These hedging instruments generate a net financial gain or loss arising from the interest rate differential between the hedged
currency and the euro, given that the foreign exchange gain or loss on the foreign-currency borrowing and loans is offset by the
change in the intrinsic value of the hedging instruments. The interest rate differential is recognized within cost of net debt
(see Note D.29. to our consolidated financial statements). We may also hedge some future foreign-currency investment or
divestment cash flows.
|
176
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SANOFI
FORM 20-F
2024
|
|
PART I
|
|
ITEM 11. Quantitative and Qualitative Disclosures about Market Risk
|
C. Other foreign exchange risks
A significant proportion of our net assets is denominated in US dollars (see Note D.35. to the consolidated financial statements).
As a result, any fluctuation in the exchange rate of the US dollar against the euro automatically impacts the amount of our equity
as expressed in euros.
In addition, we use the euro as our reporting currency. Consequently, if one or more European Union Member States were to
abandon the euro as a currency, the resulting economic upheavals – in particular, fluctuations in exchange rates – could have a
significant impact on the terms under which we can obtain financing and on our financial results, the extent and consequences of
which are not currently foreseeable.
Liquidity risk
We operate a centralized treasury platform whereby all surplus cash and financing needs of our subsidiaries are invested with or
funded by the parent company (where permitted by local legislation). The central treasury department manages our current and
projected financing, and ensures that Sanofi is able to meet its financial commitments by maintaining sufficient cash and
confirmed credit facilities for the size of our operations and the maturity of our debt (see Notes D.17.1.c. and D.17.1.g. to the
consolidated financial statements).
We diversify our short-term investments with leading counterparties using money-market products with instant access or with a
maturity of less than three months.
As of
December 31, 2024
, cash and cash equivalents amounted to €
7,441 million
, and short-term investments predominantly
comprised:
•
collective investments in euro and US dollar denominated money-market mutual funds. All such funds can be traded on a daily
basis and the amount invested in each fund may not exceed 10% of the aggregate amount invested in such funds; and
•
amounts invested directly with banks and non-financial institutions in the form of instant access deposits, term deposits, and
Negotiable European Commercial Paper with a maturity of no more than three months.
As of
December 31, 2024
we also had €8 billion of undrawn general corporate purpose confirmed credit facilities, half of which
expires in December 2027 and half in March 2030. Those credit facilities are not subject to financial covenant ratios.
Our policy is to diversify our sources of funding through public or private issuances of debt securities, in the United States (shelf
registration statement) and Europe (Euro Medium Term Note program). In addition, our A-1+/P-1 short-term rating gives us access
to commercial paper programs in the United States, and to Negotiable European Commercial Paper programs in France. The
average maturity of our total debt was 3.56 years as of
December 31, 2024
, compared with 4.45 years as of
December 31, 2023
.
Average drawdowns under the Negotiable European Commercial Paper program during
2024
were €0.1 billion (with a maximum
of €0.4 billion); the average maturity of those drawdowns was two months.
As of December 31, 2024, this program was not being
utilized;
Average drawdowns under the US Commercial Paper program during
2024
were €5.8 billion (with a maximum of €8.9 billion);
the average maturity of those drawdowns was three months. As of
December 31, 2024
, drawdowns under the program amounted
to €1.3 billion.
In the event of a liquidity crisis, we could be exposed to difficulties in calling up our available cash, a scarcity of sources of funding
including the above-mentioned programs, and/or a deterioration in their terms. This situation could damage our capacity to
refinance our debt or to issue new debt on reasonable terms.
Interest rate risk
Sanofi issues debt in
two
currencies, the euro and the US dollar, and also invests its cash and cash equivalents in those currencies.
Sanofi also operates cash pooling arrangements to manage the surplus cash and short-term liquidity needs of foreign subsidiaries
located outside the euro zone.
To optimize the cost of debt or reduce the volatility of debt and manage its exposure to financial foreign exchange risk, Sanofi
uses derivative instruments (interest rate swaps, currency swaps, foreign exchange swaps and forward contracts) that alter the
fixed/floating rate split and the currency split of its net debt.
The projected full-year sensitivity to interest rate fluctuations of our debt, net of cash and cash equivalents for
2025
is as follows:
|
Change in short-term interest rates
|
Impact on pre-tax net income
(€ million)
|
Impact on pre-tax income/(expense)
recognized directly in equity
(€ million)
|
|
+100 bp
|
34
|
—
|
|
+25 bp
|
8
|
—
|
|
-25 bp
|
(8)
|
—
|
|
-100 bp
|
(34)
|
—
|
Stock market risk
It is our policy not to trade on the stock market for speculative purposes.
|
SANOFI
FORM 20-F
2024
|
177
|
|
PART I
|
|
ITEM 12. Description of Securities other than Equity Securities
|
Item 12. Description of Securities other than Equity Securities
12.A. Debt securities
Not applicable.
12.B. Warrants and rights
Not applicable.
12.C. Other securities
Not applicable.
12.D. American depositary shares
General
JPMorgan Chase Bank, NA (“JPMorgan”), as depositary, issues Sanofi ADSs in certificated form (evidenced by an ADR) or book-
entry form. Each ADR is a certificate evidencing a specific number of Sanofi ADSs. Each Sanofi ADS represents one-half of one
Sanofi ordinary share (or the right to receive one-half of one Sanofi ordinary share) deposited with the Paris, France office of BNP
Paribas, as custodian. Each Sanofi ADS also represents an interest in any other securities, cash or other property that may
be held by the depositary under the Second Amended and Restated Deposit Agreement between Sanofi and JPMorgan
dated February 13, 2015, as amended by Amendment No. 1 dated July 23, 2020 (“Amendment No. 1”), Amendment No. 2
dated December 18, 2023 ("Amendment No. 2"), and as may be further amended from time to time (together, the “deposit
agreement”). The depositary’s principal executive office is located at 383 Madison Avenue, 11th Floor, New York, New York 10179.
For additional information on our ADSs, please refer to Exhibit 2.2 “Description of securities registered under section 12 of the
Exchange Act.” of this Annual Report.
Fees and expenses
Fees payable by ADS holders
Pursuant to the deposit agreement, holders of our ADSs may have to pay to JPMorgan, either directly or indirectly, fees, charges
and expenses up to the amounts set forth in the table below.
|
Associated Fee
|
Depositary Action
|
|
$5.00 or less per 100 ADSs (or portion thereof)
|
The deposit of shares and/or the execution and delivery of ADRs (pursuant
to distribution in shares or distribution of rights to subscribe for additional
shares, or distribution of any rights of any other nature), and/or the
reduction of ADSs and surrender of ADRs for the purposes of withdrawal,
including the termination of the deposit agreement.
|
|
$0.05 or less per ADS (or portion thereof)
|
Any distribution made pursuant to the deposit agreement, including, among
other things:
•
any cash distribution made, or for any elective cash/stock dividend
offered; and
•
the direct or indirect distribution of securities (other than ADSs or rights
to purchase additional ADSs) or the net cash proceeds from the public or
private sale of any such securities.
|
|
$0.05 or less per ADS per calendar year (or portion thereof)
|
Services performed in administering the ADRs (which fee may be charged on
a periodic basis during each calendar year).
|
|
An amount for the reimbursement of such fees, charges and expenses as are
incurred by JPMorgan and/or any of its agents (including, without limitation
BNP Paribas, as custodian and expenses incurred on behalf of owners in
connection with compliance with foreign exchange control regulations or
any law or regulation relating to foreign investment)
|
Compliance with foreign exchange control regulations or any law or
regulation relating to foreign investment, servicing of shares or other
deposited securities, sale of securities, delivery of deposited securities or
otherwise.
|
|
Expenses incurred by JPMorgan
|
Foreign currency conversion into dollars.
|
The Depositary may sell (by public or private sale) sufficient securities and property received in respect of Share distributions,
rights and other distributions prior to a deposit to pay any charge owing.
In addition to the fees outlined above, each holder will be responsible for any taxes or other governmental charges payable on his
or her Sanofi ADSs or on the deposited securities underlying his or her Sanofi ADSs. The depositary may refuse to transfer a
holder’s Sanofi ADSs or allow a holder to withdraw the deposited securities underlying his or her Sanofi ADSs until such taxes or
other charges are paid. It may apply payments owed to a holder or sell deposited securities underlying a holder’s Sanofi ADSs to
pay any taxes owed, and the holder will remain liable for any deficiency. If it sells deposited securities, it will, if appropriate, reduce
the number of Sanofi ADSs to reflect the sale and pay to the holder any proceeds, or send to the holder any property, remaining
after it has paid the taxes. For additional information regarding taxation, see “Item 10. Additional Information — E. Taxation”.
|
178
|
SANOFI
FORM 20-F
2024
|
|
PART I
|
|
ITEM 12. Description of Securities other than Equity Securities
|
Fees paid to Sanofi by the depositary
JPMorgan, as depositary, has agreed to reimburse Sanofi for certain expenses that Sanofi incurs relating to the establishment and
maintenance of the ADR program, as agreed from time to time. Pursuant to a letter agreement dated October 4, 2022 (the “letter
agreement”), JPMorgan as our ADS depositary has agreed to make (i) an initial contribution to Sanofi, within 30 days of the
commencement date of the letter agreement and (ii) with respect to each 12-month period beginning on the anniversary of the
effective date of the agreement (each such 12-month period, a “Contract Year”), a contribution, paid at the end of such Contract
Year quarter, equal to the aggregate of the program share (equal to 100% of routine program revenues and 50% of non-routine
program revenues) of any program revenues, less the aggregate of any program costs for the applicable Contract Year and any
invoiced supplementary costs not paid within 60 days of the date of the applicable invoice.
To the extent in any given Contract Year the depositary does not collect/recoup the entirety of the program costs and unpaid
supplementary costs, no contribution shall be payable to Sanofi and such excess will, at the discretion of the depositary, either be
deducted from future contributions or be payable to the depositary by Sanofi promptly upon invoicing as supplementary costs
under the letter agreement.
JPMorgan has further agreed to waive the $0.05 per ADS issuance fees that would normally be owed by Sanofi in connection
with our deposits of shares as part of our employee stock purchase plans. Sanofi is responsible for reimbursing JPMorgan for all
taxes and governmental charges in connection with payments to JPMorgan under the letter agreement.
From January 1, 2024 to December 31, 2024, we received a total amount of $23,374,305.08 from JPMorgan pursuant to the letter
agreement.
|
SANOFI
FORM 20-F
2024
|
179
|
|
PART II
|
|
ITEM 13. Defaults, Dividend Arrearages and Delinquencies
|
Part II
Item 13. Defaults, Dividend Arrearages and Delinquencies
N/A
Item 14. Material Modifications to the Rights of Security Holders
N/A
Item 15. Controls and Procedures
a.
Our Chief Executive Officer and principal financial officer, after evaluating the effectiveness of our disclosure controls and
procedures (as defined in Exchange Act Rule 13a-15(e)) as of the end of the period covered by this Form 20-F, have concluded
that, as of such date, our disclosure controls and procedures were effective to ensure that material information relating to
Sanofi was timely made known to them by others within Sanofi.
b.
Report of Management on Internal Control Over Financial Reporting.
Management of the Company is responsible for establishing and maintaining adequate internal control over financial
reporting, as such term is defined in Exchange Act Rule 13a-15(f). Management assessed the effectiveness of internal
control over financial reporting as of
December 31, 2024
based on the framework in “Internal Control — Integrated
Framework” (2013 framework) issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO).
Based on that assessment, management has concluded that the Company’s internal control over financial reporting was
effective as of
December 31, 2024
to provide reasonable assurance regarding the reliability of its financial reporting and the
preparation of its financial statements for external purposes, in accordance with generally accepted accounting principles.
Due to its inherent limitations, internal control over financial reporting may not prevent or detect misstatements, and can only
provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements. Also,
projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate
because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
The effectiveness of the Company’s internal control over financial reporting has been audited by PricewaterhouseCoopers
Audit (PCAOB ID
1347
) and
Forvis Mazars SA
(PCAOB ID
1334
) independent registered public accounting firms, as stated in
their report on the Company’s internal control over financial reporting as of
December 31, 2024
, which is included herein. See
paragraph (c) of the present Item 15., below.
c.
See report of PricewaterhouseCoopers Audit and
Forvis Mazars SA
, independent registered public accounting firms, included
d.
There were no changes to our internal control over financial reporting that occurred during the period covered by this
Form 20-F that have materially affected, or are reasonably likely to materially affect, our internal control over financial
reporting.
|
180
|
SANOFI
FORM 20-F
2024
|
|
PART II
|
|
ITEM 16A. Audit Committee Financial Expert
|
Item 16A. Audit Committee Financial Expert
The Audit Committee is composed of Carole Ferrand, Clotilde Delbos, Christophe Babule, Fabienne Lecorvaisier and Anne-
Françoise Nesmes.
Our Board of Directors has determined that all directors are independent financial experts within the meaning of Section 407 of
the Sarbanes-Oxley Act of 2002.
The Board of Directors deemed Carole Ferrand to be a financial expert based on her education and experience in audit at
PricewaterhouseCoopers and as Chief Financial Officer of Sony France, EuropaCorp, Groupe Artémis and Capgemini. She is now
Head of Strategy and Development of Motier Holding.
The Board of Directors deemed Clotilde Delbos to be a financial expert based on her education and experience in Audit, Mergers
& Acquisitions and Treasury, including at Price Waterhouse and Pechiney. She has also been Chief Financial Officer of Renault
Group for six years.
The Board of Directors deemed Christophe Babule to be a financial expert based on his education and experience in audit and
corporate finance in major corporations and as Executive Vice President and Chief Financial Officer of L’Oréal. He has also served
as a director of L’Oréal US Inc.
The Board of Directors deemed Fabienne Lecorvaisier to be a financial expert based on her education and experience in
corporate finance in various international banks and as Chief Financial Officer of Essilor and Air Liquide. Until May 2023, she was
Executive Vice President, in charge of Sustainable Development, Public and International Affairs as well as the supervision of the
Social Programs and the General Secretariat of Air Liquide Group. Ms. Lecorvaisier’s term of office as a member of the Board of
Directors will expire at the close of the Annual General Meeting of April 30, 2025 and will not be renewed.
The Board of Directors deemed Anne-Françoise Nesmes to be a financial expert based on her education and experience as a
Chief Financial Officer of several listed companies: Dechra Pharmaceuticals PLC, Merlin Entertainments PLC, and
Smith + Nephew PLC. She was Chief Financial Officer of Smith + Nephew PLC until the end of 2024.
The Board of Directors has determined that all five directors meet the independence criteria of US Securities and Exchange
Commission Rule 10A-3, although only Carole Ferrand, Clotilde Delbos, Fabienne Lecorvaisier and Anne-Françoise Nesmes meet
the French AFEP-MEDEF Code criteria of independence applied by the Board of Directors for general corporate governance
purposes (see Item 16G., below).
Item 16B. Code of Ethics
We have adopted a code of ethics
(hereafter the "Code of Conduct"), as defined in Item 16B. of Form 20-F under the Exchange
Act, containing specific rules relating to financial ethics. Our Code of Conduct applies to our Chief Executive Officer, Chief
Financial Officer, Chief Accounting Officer and other officers performing similar functions, as designated from time to time. Our
Code of Conduct was amended on December 16, 2024 and this amended version is available on our website at www.sanofi.com
(information on our website is not incorporated by reference in this annual report). A copy of our Code of Conduct may also be
obtained free of charge by addressing a written request to the attention of Individual Shareholder Relations at our headquarters
in Paris. We will disclose any future amendments to the provisions of such financial Code of Conduct on our website.
Item 16C. Principal Accountants’ Fees and Services
The Audit Committee has adopted an Audit and Non-Audit Services Pre-Approval Policy that sets forth the procedures and the
conditions pursuant to which services proposed to be performed by the statutory auditors may be pre-approved and that are not
prohibited by regulatory or other professional requirements. This policy provides for pre-approval of certain types of services
through the use of an annual budget approved by the Audit Committee for these types of services. The Audit Committee reviews
on an annual basis the services provided by the statutory auditors.
See
Note E. to our consolidate
d financial statements included at Item 18. of this annual report.
Item 16D. Exemptions from the Listing Standards for Audit
Committees
N/A
|
SANOFI
FORM 20-F
2024
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181
|
|
PART II
|
|
ITEM 16E. Purchases of Equity Securities by the Issuer and Affiliated Purchasers
|
Item 16E. Purchases of Equity Securities by the Issuer and Affiliated
Purchasers
In
2024
, Sanofi made the following purchases of its ordinary shares.
|
Period
(a)
|
(A) Total Number of
Shares Purchased
|
(B) Average Price Paid
per Share
|
(C) Total Number
of Shares Purchased
as Part of Publicly
Announced Plans
or Programs
(b)
|
(D) Approximate
Value of Shares
that May Yet Be
Purchased Under the
Plans or Programs
(c)
|
|
January 2024
|
3,215,460
|
93.57
|
3,215,460
|
18,382
|
|
Total
|
3,215,460
|
(a)
On February 2, 2025, Sanofi and L'Oréal entered into a share purchase agreement pursuant to which Sanofi repurchased 29,556,650 shares from
L’Oréal, a significant shareholder, at €101.50 per share, for a total amount of approximately €3 billion. After the transaction, L’Oréal holds 7.2% of
Sanofi’s share capital and 13.1% of its actual voting rights (excluding treasury shares). The transaction closed on February 5, 2025. Sanofi will cancel the
shares acquired from L'Oréal at the latest on April 29, 2025. In addition, on February 6, 2025 Sanofi mandated an investment services provider to carry
out further share repurchases up to a maximum of €2 billion, between February 7, 2025 and December 31, 2025
at the latest.
. For more information, see
"Item 8. Financial Information - B. Significant Changes".
(b)
Sanofi was authorized to repurchase up to €18,912,535,950 of its own shares for a period of eighteen months (i.e. through November 25, 2024) by the
Annual Shareholders’ Meeting held on May 25, 2023. Sanofi was subsequently authorized to repurchase up to €18,971,999,400 of its own shares for a
period of eighteen months (i.e. through October 30, 2025) by the Annual Shareholders’ Meeting held on April 30, 2024.
(c)
Millions of euros.
For more information see “Exhibit 2.2. "Description of securities registered under section 12 of the Exchange Act." of this annual
report”.
Item 16F. Change in Registrant’s Certifying Accountant
Forvis Mazars SA
was appointed as joint statutory auditor for a six-year term by the annual shareholders’ meeting held on April 30,
2024. The term of office of Forvis Mazars SA will expire at the end of the annual shareholders’ meeting to be held in 2030, which
will approve the financial statements for 2029. This appointment follows the Audit Committee’s recommendation and the
decision of the Board of Directors taken on October 27, 2022.
The term of office of Ernst & Young et Autres expired at the 2024 Annual Shareholders’ Meeting and could not be renewed
because it had reached the maximum legal duration. The report of Ernst & Young et Autres on the consolidated financial
statements for each of the years ended December
31, 2023 and 2022 did
not contain an adverse opinion or a disclaimer of
opinion and was not qualified or modified as to uncertainty, audit scope or accounting principles and there were no
“disagreements” (as that term is described in Item 16F.(a)(1)(iv) of the Instructions to Form 20-F and the Instructions to Item 16F.)
or “reportable events” (as that term is defined in Item 16F.(a)(1)(v) of the Instructions to Form 20-F) during those periods.
A copy of Ernst & Young et Autres’ letter, dated February 23, 2024, was filed as Exhibit 15.3 to the annual report on Form 20-F
filed on February 23, 2024.
Item 16G. Corporate Governance
Sanofi is incorporated under the laws of France, with securities listed on regulated public markets in the United States (Nasdaq
Global Select Market – NASDAQ) and France (Euronext Paris). Consequently, as described further in this annual report, our
corporate governance framework reflects the mandatory provisions of French corporate law, the securities laws and regulations
of France and the United States and the rules of the aforementioned public markets.
As a “foreign private issuer,” as defined in the rules promulgated under the US Securities Exchange Act of 1934, as amended, (the
“Exchange Act”), Sanofi is permitted, pursuant to NASDAQ Listing Rule 5615(a)(3), to follow its home country practice in lieu of
certain NASDAQ corporate governance requirements applicable to US corporations listed on the NASDAQ. Sanofi has informed
NASDAQ that it intends to follow corporate governance standards under French law to the extent permitted by the NASDAQ
listing rules and US securities laws, as further discussed below.
We generally follow the “AFEP-MEDEF” corporate governance recommendations for French listed issuers (hereafter referred to
as the “AFEP-MEDEF Code”). As a result, our corporate governance framework is similar in many respects to, and provides
investor protections that are comparable to – or in some cases, more stringent than – the corresponding rules of the NASDAQ.
Nevertheless, there are certain important differences.
In line with NASDAQ listing rules applicable to domestic issuers, a majority of Sanofi’s Board of Directors is comprised of
independent directors. Sanofi evaluates the independence of members of our Board of Directors using the standards of the
French AFEP-MEDEF Code as the principal reference. We believe that AFEP-MEDEF’s overarching criteria for independence –
that Board members have no relationship of any kind whatsoever with the Company, its group or the management of either such
|
182
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2024
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PART II
|
|
ITEM 16G. Corporate Governance
|
a
s to color a Board member’s judgment – is on the whole consistent with the goals of the NASDAQ's listing rules; however, the
specific tests proposed under the two standards may vary on some points. Our Audit Committee complies with
the independence and other requirements of Rule 10A-3 under the Exchange Act, adopted pursuant to the Sarbanes-Oxley
Act of 2002. Our Audit Committee includes one member, Christophe Babule, who is considered non-independent under the
AFEP-MEDEF Code, and which is permitted under the AFEP-MEDEF Code. Three out of the four members of our Compensation
Committee meet the independence standards of the AFEP-MEDEF Code (the Director representing employees is not
considered as independent) and the independence requirements of NASDAQ’s listing rules.
Sanofi follows the recommendation of the AFEP-MEDEF Code that at least one meeting of the Board of Directors not attended
by the company’s executive officers be organized each year. Accordingly, Sanofi’s Board Charter provides that the Board of
Directors shall organize at least two meetings a year without its executive officers, thereby providing the Chairman with the
option of whether to include directors representing employees or any other Group employee, as the case may require,
depending on the agenda of the meeting. Sanofi’s practice in that respect departs from NASDAQ Listing Rule 5605(b)(2), which
provides that independent directors must have regularly scheduled meetings at which only independent directors are present.
Under French law, the committees of our Board of Directors are advisory only, and where the NASDAQ Listing Rule 5600 series
would vest certain decision-making powers with specific committees by delegation (e.g. the appointment of Sanofi’s auditors by
the Audit Committee), under French law, our Board of Directors remains the only competent body to take such decisions, albeit
taking into account the recommendation of the relevant committees. Additionally, under French corporate law, it is the
shareholders of Sanofi voting at the Shareholders’ General Meeting that have the authority to appoint our auditors upon
consideration of the proposal of our Board of Directors, although our Board Charter provides that the Board of Directors will
make its proposal on the basis of the recommendation of our Audit Committee. We believe that this requirement of French law,
together with the additional legal requirement that two sets of statutory auditors be appointed, is in line with the NASDAQ's
underlying goal of ensuring that the audit of our accounts be conducted by auditors independent from company management.
NASDAQ Listing Rule 5635 requires a NASDAQ listed company to obtain shareholder approval prior to certain issuances of
securities, including: (a) issuances in connection with the acquisition of the stock or assets of another company if upon issuance
the issued shares will equal 20% or more of the number of shares or voting power outstanding prior to the issuance, or if certain
specified persons have a 5% or greater interest in the assets or company to be acquired (NASDAQ Listing Rule 5635(a));
(b) issuances or potential issuances that will result in a change of control of us (NASDAQ Listing Rule 5635(b)); (c) issuances in
connection with equity compensation arrangements (NASDAQ Listing Rule 5635(c)); and (d) 20% or greater issuances in
transactions other than public offerings, as defined in the NASDAQ listing rules (NASDAQ Listing Rule 5635(d)). Under French
law, our shareholders may approve issuances of equity, as a general matter, through the adoption of delegation of authority
resolutions at the Company’s shareholders’ meeting pursuant to which shareholders may delegate their authority to the Board
of Directors to increase the Company’s share capital within specified parameters set by the shareholders, which may include a
time limitation to carry out the share capital increase, the cancellation of their preferential subscription rights to the benefit of
named persons or a category of persons, specified price limitations and/or specific or aggregate limitations on the size of the
share capital increase. Due to differences between French law and corporate governance practices and NASDAQ Listing
Rule 5635, the Company follows French home country practice, rather than complying with this NASDAQ Listing Rule.
In addition to the oversight role of our Compensation Committee for questions of management compensation including by way
of equity, under French law any option or restricted share plans or other share capital increases, whether for the benefit of senior
management or employees, may only be adopted by the Board of Directors pursuant to and within the limits of a shareholder
resolution approving the related capital increase and delegating to the Board the authority to implement such operations. While
NASDAQ rules require shareholder approval when a plan or other equity compensation arrangement is established or materially
amended, under French law our shareholders must decide any issuance of equity, as a general matter. We intend to follow our
French home country practice and ask our shareholders to delegate their authority to issue incentive equity and define the final
terms of any equity compensation plan or arrangements to our Board of Directors. We may, from time to time, ask for our
shareholders’ subsequent approval on an equity compensation arrangement in order to obtain advantageous tax treatment or
otherwise. In addition, under French law, our Board of Directors must obtain the prior approval of our shareholders before
establishing or amending a plan or arrangement that would exceed the limits of the granted delegation.
As described above, a number of issues, which could be resolved directly by a board or its committees in the United States,
require the additional protection of direct shareholder consultation in France.
Because we are a “foreign private issuer” as described above, our Chief Executive Officer and our Chief Financial Officer issue
the certifications required by Section 302 and Section 906 of the Sarbanes-Oxley Act of 2002 on an annual basis (with the filing
of our annual report) rather than on a quarterly basis as would be the case of a US corporation filing quarterly reports on
Form 10- Q.
French corporate law provides that the Board of Directors must vote to approve a broadly defined range of transactions that
could potentially create conflicts of interest between Sanofi on the one hand and its directors and Chief Executive Officer on
the other hand, which are then presented to shareholders for approval at the next annual meeting. This legal safeguard
operates in place of certain provisions of the NASDAQ listing rules.
Sanofi is governed by the French Commercial Code, which provides that an ordinary general meeting of the shareholders may
validly deliberate when first convened if the shareholders present or represented hold at least one-fifth of the voting shares.
If it is reconvened, no quorum is required. The French Commercial Code further provides that the shareholders at an
extraordinary general meeting may validly deliberate when first convened only if the shareholders present or represented hold
at least one-quarter of the voting shares and, if reconvened, one-fifth of the voting shares. Therefore, Sanofi will not follow
NASDAQ Listing Rule 5620(c), which provides that the minimum quorum requirement for a meeting of shareholders is 33
1
⁄
3
% of
|
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FORM 20-F
2024
|
183
|
|
PART II
|
|
ITEM 16H. Mine Safety Disclosure
|
the outstanding common voting shares of the company. In accordance with the provisions of the French Commercial Code, the
required majority for the adoption of a decision is a simple majority (for an ordinary general meeting of the shareholders) or a
two-thirds majority (for an extraordinary general meeting) of the votes cast by the shareholders present or represented.
The Company has, pursuant to Rule 10D-1 under the Exchange Act, adopted a recovery policy for compensation erroneously
paid to “executive officers” (as defined in Rule 10D-1(d) under the Exchange Act) based in whole or in part on any financial
reporting measures pursuant to the applicable NASDAQ listing rules, Rule 10D-1 under the Exchange Act and applicable
interpretive guidance. For more information concerning our recovery policy for compensation erroneously paid to “executive
officers”, see also “Item 6. Directors, Senior Management and Employees – B. Compensation”. Our recovery policy for
compensation erroneously paid to “executive officers” is filed as Exhibit 97 to this annual report.
Item 16H. Mine Safety Disclosure
N/A
Item 16I. Disclosure regarding foreign jurisdictions that prevent
inspections
N/A
Item 16J. Insider Trading Policies
Sanofi has
adopted
a Global Operating Procedure on the Prevention of Insider Trading governing the purchase, sale, and other
dispositions of securities by directors, senior management, and employees that is reasonably designed to promote compliance
with applicable insider trading laws, rules and regulations, and any applicable listing standards. A copy of the policy is included as
Exhibit 11.1.
Item 16K.
Cybersecurity
Sanofi has implemented a cybersecurity strategy i
nvolving various dedicated personnel and resources aimed at preventing,
detecting and responding to cyberattacks, as well as being able to recover promptly in the event of material impact following a
cyberattack. Additionally, Sanofi has set up various cybersecurity proces
ses applicable to subsidiaries within the Sanofi group.
Sanofi regularly updates its
cybersecurity
processes to address cybersecurity trends and threats. Cybersecurity processes have
been established to address material cybersecurity risks, including in connection with the following areas:
•
information technology and solution usage;
•
access control;
•
patch management;
•
security on specific environments (i.e. cloud, virtualization, SAP, automated systems, IoT, etc.);
•
log management;
•
network security;
•
systems security standards;
•
remote access;
•
secure development of applications;
•
cryptography;
•
mobile devices;
•
third-party management (including cybersecurity requirements in contracts); and
•
incident management.
Sanofi utilizes security standards and frameworks (i.e. the NIST framework) and has established cross-functional risk control
capabilities to facilitate operational implementation aligned with its cybersecurity processes.
|
184
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FORM 20-F
2024
|
|
PART II
|
|
Item 16K. Cybersecurity
|
S
anofi regularly analyzes its Internet-based services and performs regular penetration tests and attack simulations to assess the
protections and the detections capabilities. The cybersecurity compliance status of computing assets connected to Sanofi’s
network is routinely consolidated for Sanofi's business units, including within manufacturing, and research and development sites.
Monthly dashboards are published and shared within Sanofi’s different business units and global functions. Sanofi implements
corrective measures and improvement actions in response to these processes. Data classification and protection tools are in place,
such as the implementation of a specific process and technology aimed at detecting and responding to abnormal data flows.
well as coordinating Sanofi-wide incident responses. Incident response trainings and simulations are run within Sanofi to seek to
be better prepared in case of a cybersecurity incident. In addition, Sanofi’s employees, who are the main users of Sanofi’s digital
assets, are regularly trained to face cybersecurity threats and attacks. In the event of a cyberattack, Sanofi has established a plan
that includes criteria triggering the notification process for material cybersecurity incidents including from the cybersecurity
operation center and the Chief Information Security Officer who can use the internal escalation channels to inform the
management and the Board of Directors and, as appropriate, the relevant regulatory bodies.
When dealing with
third
parties
, our main commercial contracts include cybersecurity clauses aimed at ensuring such third
parties comply with Sanofi’s cybersecurity rules and requirements, especially when providing services to and processing data
from Sanofi. Additionally, Sanofi set up a vendor’s risk assessment program to evaluate the digital maturity of a vendor, which
covers their business continuity as well as their related internal regulations, such as data privacy. As part of their contractual
commitments major vendors and partners must report to Sanofi any cybersecurity incident that may have a significant impact for
Sanofi. A dedicated process has been implemented for third parties’ networks interconnected with Sanofi’s network, aimed at
limiting any propagation of a cyberattack to Sanofi’s digital assets.
Sanofi’s cybersecurity
risk
management processes are integrated into its overall risk management system through its enterprise
risk management process, which seeks to identify and address material risks to the organization. Each year, specific risk
committees identify the risks that affect Sanofi’s local businesses in each country it operates and Sanofi’s global functions, such
as Research and Development or Manufacturing and Supply.
Although Sanofi has put in place the cybersecurity processes described above, Sanofi remains exposed to cybersecurity attacks
and incidents and misuse or manipulation of any of its IT systems, which could have a material adverse effect on its business
strategy, results of operations or financial condition (see “Item 3. Key Information — D. Risk Factors —
Risks relating to our
business — Breaches of data security, disruptions of information technology systems and cyber threats could result in financial,
legal, competitive, operational, business or reputational harm
”).
Sanofi has appointed a
Chief Information Security Officer
who oversees Sanofi's information, cybersecurity, and technology
security. Our current Chief Information Security Officer has been working for Sanofi in this capacity since 2014 and has seventeen
years of experience in the cybersecurity industry, including eight years as the global head of cybersecurity at one of France’s
largest telecommunications companies.
The Chief Information Security Officer is informed about and monitors the prevention,
detection, mitigation, and remediation of cybersecurity incidents through the cybersecurity operation center. He develops
appropriate plans to mitigate such risks. Such plans are validated by the Chief Digital Officer and shared with the Executive
Committee.
the Executive Committee. In addition, the Chief Information Security Officer is a permanent member of the group Risk
Committee and reports on the cybersecurity risk to such group Risk Committee, to the Audit Committee and to the Executive
Committee regularly. The reporting covers various matters, such as the outcomes of audits on Sanofi’s information systems, the
main incidents encountered over the preceding period, Sanofi’s digital transformation or the cybersecurity strategy and
framework for the coming years.
specific committees and targets the high priority risks Sanofi is facing. The group Risk Committee then allocates each risk to the
relevant Executive Committee member (i.e. the cybersecurity risk is allocated to the Chief Digital Officer as the relevant member
of the Executive Committee, who manages the mitigation of such risk with the Chief Information Security Officer) and reports
regularly to the Audit Committee. Following this identification and allocation process, the group Risk Committee reports on a
quarterly basis to the Executive Committee on the progress of the mitigation plans.
Directors. The Board of Directors is also informed of such risks, as well as other cybersecurity matters, through periodic reports
from the Chief Digital Officer, the Head of the group Risk Committee, or the Chief Information Security Officer.
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185
|
|
PART III
|
|
ITEM 17. Financial Statements
|
Part III
Item 17. Financial Statements
See Item 18.
Item 18. Financial Statements
Item 19. Exhibits
|
1.1.
|
|
|
1.2.
|
Board Charter (Règlement Intérieur) of Sanofi (English translation) (Incorporated by reference to Exhibit 1.2 of the Company’s Annual Report on
Form 20-F for the year ended December 31, 2023)
|
|
2.1.
|
The total amount of long-term debt securities authorized under any instrument does not exceed 10% of the total assets of the Company and its
subsidiaries on a consolidated basis. We hereby agree to furnish to the SEC, upon its request, a copy of any instrument defining the rights of
holders of long-term debt of the Company or of its subsidiaries for which consolidated or unconsolidated financial statements are required to be
filed.
|
|
2.2.
|
|
|
4.1
|
|
|
8.1.
|
|
|
11.1
|
Global Operating Procedure on the Prevention of
Insider Trading
|
|
12.1.
|
|
|
12.2.
|
|
|
13.1.
|
|
|
13.2.
|
|
|
15.1.
|
|
|
15.2.
|
|
|
15.3
|
|
|
97.
|
Clawback policy (Incorporated by reference to Exhibit 97 of the Company’s Annual Report on Form 20-F for the year ended December 31, 2023)
|
|
101.INS
|
XBRL Instance Document.
|
|
101.SCH
|
XBRL Taxonomy Extension Schema.
|
|
101.CAL
|
XBRL Taxonomy Extension Calculation Linkbase.
|
|
101.DEF
|
XBRL Taxonomy Extension Definition Linkbase.
|
|
101.LAB
|
XBRL Taxonomy Extension Label Linkbase.
|
|
101.PRE
|
XBRL Taxonomy Extension Presentation Linkbase.
|
|
104.1
|
Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101).
|
|
186
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2024
|
|
Signatures
|
Signature
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 its behalf.
|
Sanofi
|
|
|
By:
|
/s/ PAUL HUDSON
|
|
Name:
|
Paul Hudson
|
|
Title:
|
Chief Executive Officer
|
Date:
February 13, 2025
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187
|
|
2024
CONSOLIDATED FINANCIAL STATEMENTS
|
|
Report of Independent Registered Public Accounting Firms
|
Report of Independent Registered Public Accounting Firms
To the Shareholders and the Board of Directors of Sanofi,
Opinion on the Consolidated Financial Statements
We have audited the accompanying consolidated balance sheet of Sanofi and its subsidiaries (the “Company”) as of
December 31, 2024, and the related consolidated income statement, and consolidated statements of comprehensive income, of
changes in equity and of cash flows for the year then ended December 31, 2024, including 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 as of December 31, 2024, and the results of its operations and its cash flows for
the year then ended, in conformity with International Financial Reporting Standards (“IFRS”) as issued by the International
Accounting Standards Board and in conformity with IFRS as endorsed by the European Union.
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
February 13, 2025
expressed an unqualified opinion thereon.
Basis for Opinion
The Company's management is responsible for these consolidated financial statements. Our responsibility is to express an
opinion on the Company’s consolidated financial statements based on our audit. We are public accounting firms 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 the consolidated financial statements are free of material misstatement,
whether due to error or fraud.
Our audit of the consolidated financial statements included performing procedures to assess the risks of material misstatement
of the consolidated 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 consolidated
financial statements. Our audit also included evaluating the accounting principles used and significant estimates made by
management, as well as evaluating the overall presentation of the consolidated financial statements. We believe that our audit
provides 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 consolidated 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 consolidated 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.
|
188
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2024
CONSOLIDATED FINANCIAL STATEMENTS
|
|
Report of Independent Registered Public Accounting Firms
|
Recoverable amount of other intangible assets - Acquired R&D, products, trademarks
and other rights
|
Description
of the Matter
|
Other intangible assets composed of acquired R&D, products, trademarks and other rights amounted to €22,210 million at
December 31, 2024. Management recognized a net loss of €248 million relating to impairment charges and reversals for the year
ended December 31, 2024. As described in Notes B.6.1., D.4. and D.5. to the consolidated financial statements, other intangible
assets not yet available for use are tested for impairment annually and whenever events or circumstances indicate that impairment
might exist. Other intangible assets that generate separate cash flows and assets included in cash-generating units (CGUs) are
assessed for impairment when events or changes in circumstances indicate that the asset or CGU may be impaired. Management
estimates the recoverable amount of the asset and recognizes an impairment loss if the carrying amount of the asset exceeds its
recoverable amount. The recoverable amount of the asset is the higher of its fair value less costs to sell or its value in use. Value in
use is determined by management using estimated future cash flows generated by the asset or CGU which are discounted and
prepared using the same methods as those used in the initial measurement of the assets and on the basis of medium-term
strategic plans. Management cash flow projections include significant assumptions related to mid and long-term sales forecasts;
perpetual growth or attrition rate, where applicable; discount rate; and probability of success of current research and
development projects.
The principal considerations for our determination that auditing the recoverable amount of other intangible assets is especially
challenging, subjective, and required complex auditor judgment related to the significant judgments made by management when
developing the significant assumptions utilized in the future cash flow projections as described above.
|
|
How We Addressed
the Matter in Our
Audit
|
Addressing the matter involved performing procedures and evaluating audit evidence in connection with forming our overall
opinion on the consolidated financial statements. These audit procedures included obtaining an understanding of the process and
assessing the design and testing the operating effectiveness of controls relating to management’s other intangible assets
impairment assessment, including controls over the significant assumptions used in the impairment testing of the other intangible
assets. These audit procedures also included, among others, evaluating the appropriateness of the discounted cash flow model;
testing the completeness, accuracy, and relevance of underlying data used in the model; and evaluating the significant
assumptions used by management as described above. Evaluating management’s assumptions involved evaluating whether the
assumptions used by management were reasonable by considering the current and past performance of other intangible assets in
comparison to management’s previous forecasts and current trends, the consistency of certain assumptions with external market
and industry data, and whether these assumptions were consistent with evidence obtained in other areas of the audit such as
internal company communications and presentations and external communications. We involved our professionals with specialized
skills and knowledge to assist us notably in the assessment of the discount rate used by management.
|
Valuation of the provisions for rebates relating to Sanofi’s business in the United States –
Medicaid, Medicare and Managed Care
|
Description
of the Matter
|
As described in Notes B.13.1. and D.23. to the consolidated financial statements, products sold in the United States are covered by
various Government and State programs (of which Medicaid and Medicare are the most significant) and are subject to commercial
agreements with healthcare authorities and certain customers and distributors. Estimates of discounts and rebates incentives
(hereinafter the “Rebates”) to be provided to customers under those arrangements are recognized as a reduction of gross sales in
the period in which the underlying sales are recognized. Provisions for the Medicaid, Medicare and Managed Care Rebates
amounted to €1,193 million, €722 million and €1,097million, respectively, at December 31, 2024. The Rebates estimated by
management are based on the nature and patient profile of the underlying product; the applicable regulations or the specific
terms and conditions of contracts with governmental authorities, wholesalers and other customers; historical data relating to
similar contracts; past experience and sales growth trends for the same or similar products; actual inventory levels in distribution
channels, monitored by Sanofi using internal sales data and externally provided data; market trends including competition, pricing
and demand.
The principal considerations for our determination that auditing the provisions for Rebates relating to the Company’s business in
the United States is especially challenging and required complex auditor judgment related to the significant judgment by
management due to significant measurement uncertainty involved in developing these provisions. These provisions are estimated
based on multiple factors as described above.
|
|
How We Addressed
the Matter in Our
Audit
|
Addressing the matter involved performing procedures and evaluating audit evidence in connection with forming our overall
opinion on the consolidated financial statements. These audit procedures included obtaining an understanding of the process and
assessing the design and testing the operating effectiveness of controls relating to management’s estimates of the provisions for
Rebates relating to the Company’s business in the United States, including controls over the assumptions used to estimate these
Rebates. These procedures also included, among others, developing an independent estimate of the provisions for Rebates by
utilizing third party data on inventory levels in distribution channels, volume, changes to price, the terms of the specific rebate
programs, and the historical trend of actual rebate claims paid. The independent estimate was compared to the provisions
recorded by the Company. Additionally, these procedures included testing actual rebate claims paid and evaluating the
contractual terms of the Company’s rebate agreements.
|
|
SANOFI
FORM 20-F
2024
|
189
|
|
2024
CONSOLIDATED FINANCIAL STATEMENTS
|
|
Report of Independent Registered Public Accounting Firms
|
Provisions for product liability risks, litigation and other and contingent liabilities
|
Description
of the Matter
|
Provisions for product liability risks, litigation and other were recorded in an amount of €1,676 million at December 31, 2024. As
described in Notes B.12., D.19.3. and D.22. to the consolidated financial statements, the Company records such provisions when an
outflow of resources is probable and the amount of the outflow can be reliably estimated. The Company also discloses the
contingent liabilities in circumstances where 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 not probable.
The pharmaceutical industry is highly regulated, which increases the inherent risk of litigation and arbitration. The Company is
involved in litigation, arbitration and other legal proceedings. These proceedings are typically related to litigation concerning
product liability claims, intellectual property rights, competition law and trade practices, as well as claims under warranties or
indemnification arrangements relating to business divestments. The issues raised by these claims are highly complex and subject
to substantial uncertainties; therefore, the probability of loss and an estimation of damages are difficult to ascertain.
The principal considerations for our determination that auditing the provision for product liability risks, litigation and other, and
auditing the contingent liabilities is especially challenging, subjective and required complex auditor judgment resulted from the
determination that the measurement of the provisions can involve a series of complex judgments about future events and can rely
heavily on estimates and assumptions by management. There is inherent uncertainty related to these cases and in estimating the
likelihood and outcome of the cases.
|
|
How We Addressed
the Matter in
Our Audit
|
Addressing the matter involved performing procedures and evaluating audit evidence in connection with forming our overall
opinion on the consolidated financial statements. These audit procedures included obtaining an understanding of the process and
assessing the design and testing the operating effectiveness of controls relating to management’s evaluation of the provisions for
product liability risks, litigation and other, including controls over determining whether a loss is probable and whether the amount
of loss can be reasonably estimated, as well as the need for and the level of financial statement disclosures. These procedures also
included, among others, obtaining and evaluating the letters of audit inquiry with internal and external legal counsels, evaluating
management’s assessment regarding whether an unfavorable outcome is reasonably possible or probable and reasonably
estimable through the evaluation of the legal letters and summaries of the proceedings and lawsuit correspondence. We also
evaluated the Company’s disclosures for contingent liabilities.
|
Uncertain tax positions
|
Description
of the Matter
|
As described in Notes B.22. and D.19.4. to the consolidated financial statements, the Company has recorded liabilities pertaining to
uncertain tax positions of €1,512 million at December 31, 2024. The Company operates in multiple tax jurisdictions, carrying out
potentially complex transactions that require management to make judgments and estimates as to the tax impact of those
transactions. The positions adopted by the Company in tax matters are based on its interpretation of tax laws and regulations.
Some of those positions may be subject to uncertainty. In such cases, the Company assesses the amount of the tax liability on the
basis of the following assumptions: that its position will be examined by one or more tax authorities on the basis of all relevant
information; that a technical assessment is carried out with reference to legislation, case law, regulations, and established practice;
and that each position is assessed individually (or collectively where appropriate), with no offset or aggregation between positions.
Those assumptions are assessed on the basis of facts and circumstances existing at the end of the reporting period. When an
uncertain tax liability is regarded as probable, it is measured on the basis of the Company’s best estimate.
The principal considerations for our determination that auditing uncertain tax positions is especially challenging, subjective and
required complex auditor judgment related to the significant judgment by management when determining the liability for
uncertain tax positions, including a high degree of estimation uncertainty of certain assumptions and interpretations of the tax
laws and regulations underlying the positions.
|
|
How We Addressed
the Matter
in Our Audit
|
Addressing the matter involved performing procedures and evaluating audit evidence in connection with forming our overall
opinion on the consolidated financial statements. These audit procedures included obtaining an understanding of the process and
assessing the design and testing the operating effectiveness of controls relating to the identification and recognition of the liability
for uncertain tax positions, management’s assessment and interpretation of tax laws and its evaluation of which tax positions may
not be sustained upon audit and controls over measurement of the liability. These procedures also included, among others, testing
the completeness and accuracy of the underlying data used in the calculation of the liability for uncertain tax positions and
evaluating the assumptions used by management when determining its tax positions, the status of tax audits and investigations,
and the potential impact of past claims. Our tax professionals assisted in evaluating management’s assessments by comparing the
positions taken by management with tax regulations and past decisions from tax authorities and where applicable, evaluating
opinions from the Company’s external tax advisors. We also evaluated the disclosures provided in the notes to the consolidated
financial statements concerning uncertain tax positions.
|
|
/s/ PricewaterhouseCoopers Audit
|
/s/ Forvis Mazars SA
|
|
|
190
|
SANOFI
FORM 20-F
2024
|
|
2024
CONSOLIDATED FINANCIAL STATEMENTS
|
|
Report of Independent Registered Public Accounting Firms
|
Report of Independent Registered Public Accounting Firms
To the Shareholders and the Board of Directors of Sanofi,
Opinion on the Consolidated Financial Statements
We have audited the accompanying consolidated balance sheets of Sanofi and its subsidiaries ("the Company") as of December
31, 2023 and 2022, the related consolidated income statements, statements of comprehensive income, changes in equity, and
cash flows for each of the years in the two-year period ended December 31, 2023, and the related notes (collectively, "the
consolidated financial statements"), before the effects of the adjustments to retrospectively reflect the classification as
discontinued operations of Opella described in Note D.1.1.2 and before the recast of the segment information described in Note
D.35.
In our opinion, the consolidated financial statements, before the effects of the adjustments to retrospectively reflect the
classification as discontinued operations of Opella described in Note D.1.1.2 and before the recast of the segment information
described in Note D.35, present fairly, in all material respects, the financial position of the Company as of December 31, 2023 and
2022, and the results of its operations and its cash flows for each of the years in the two-year period ended December 31, 2023,
in conformity with International Financial Reporting Standards as issued by the International Accounting Standards Board and in
conformity with International Financial Reporting Standards as endorsed by the European Union (the 2023 and 2022 financial
statements before the effects of the adjustments described in Note D.1.1.2 and before the recast of the segment information
described in Note D.35 are not presented herein).
ERNST & YOUNG et Autres was not engaged to audit, review, or apply any procedures to the adjustments to retrospectively
reflect the classification as discontinued operations of Opella described in Note D.1.1.2 and to the recast of the segment
information described in Note D.35, and, accordingly ERNST & YOUNG et Autres does not express an opinion or any other form of
assurance about whether such adjustments are appropriate and have been properly applied. Those adjustments were audited by
PricewaterhouseCoopers Audit in 2024. In the opinion of PricewaterhouseCoopers Audit, such adjustments are appropriate and
have been properly applied.
Basis for Opinion
These consolidated financial statements are the responsibility of the Company's management. Our responsibility is to express an
opinion on these consolidated financial statements based on our audits. We are public accounting firms registered with the
Public Company Accounting Oversight Board (United States) ("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 consolidated 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 consolidated 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 consolidated 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 consolidated financial statements. We believe that our audits provide a reasonable basis for our opinion.
|
/s/ PricewaterhouseCoopers Audit
|
/s/ ERNST & YOUNG et Autres
|
|
PricewaterhouseCoopers Audit and ERNST & YOUNG et Autres have served as the Company’s auditors since 1999 and 1986 to
2024, respectively.
|
Neuilly-sur-Seine, France, February 23, 2024, except for
the effect of the classification as discontinued
operations of Opella described in Note D.1.1.2 and for the
recast of the segment information described in Note
D.35, as to which the date is February 13, 2025
|
Paris La Défense, France, February 23, 2024
|
|
SANOFI
FORM 20-F
2024
|
191
|
|
2024
CONSOLIDATED FINANCIAL STATEMENTS
|
|
Report of Independent Registered Public Accounting Firms
|
Report of Independent Registered Public Accounting Firms
To the Shareholders and the Board of Directors of Sanofi,
Opinion on Internal Control over Financial Reporting
We have audited Sanofi and its subsidiaries’ (together the “Company”) 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, 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 balance sheet of the Company as of December 31, 2024, and the related consolidated income
statement, and consolidated statements of comprehensive income, of changes in equity and of cash flows for the year ended
December 31, 2024, including the related notes (collectively referred to as the “consolidated financial statements”) and our report
dated
February 13, 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 Report of Management on Internal
Control Over Financial Reporting appearing under Item 15. Our responsibility is to express an opinion on the Company's internal
control over financial reporting based on our audit. We are public accounting firms 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 of internal control over financial reporting included obtaining an understanding of internal control over financial
reporting, assessing the risk that a material weakness exists, and testing and evaluating the design and operating effectiveness of
internal control based on the assessed risk. Our audits also included 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 controls may become inadequate
because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
|
/s/ PricewaterhouseCoopers Audit
|
/s/ Forvis Mazars SA
|
|
Neuilly-sur-Seine and Courbevoie
, France,
February 13, 2025
|
192
|
SANOFI
FORM 20-F
2024
|
|
2024
CONSOLIDATED FINANCIAL STATEMENTS
|
|
[THIS PAGE HAS BEEN INTENTIONALLY LEFT BLANK]
|
|
SANOFI
FORM 20-F
2024
|
F-1
|
|
2024
CONSOLIDATED FINANCIAL STATEMENTS
|
2024
Consolidated financial statements
The financial statements are presented in accordance with International Financial Reporting Standards (IFRS).
|
F-2
|
SANOFI
FORM 20-F
2024
|
|
2024
CONSOLIDATED FINANCIAL STATEMENTS
|
|
Consolidated balance sheets - assets
|
Consolidated balance sheets -
assets
|
(€ million)
|
Note
|
December 31, 2024
|
December 31, 2023
|
December 31, 2022
|
|
Property, plant and equipment
|
D.3.1.
|
|
|
|
|
Right-of-use assets
|
D.3.2.
|
|
|
|
|
Goodwill
|
D.4.
|
|
|
|
|
Other intangible assets
|
D.4.
|
|
|
|
|
Investments accounted for using the equity method
|
D.6.
|
|
|
|
|
Other non-current assets
|
D.7.
|
|
|
|
|
Non-current income tax assets
|
|
|
|
|
|
Deferred tax assets
|
D.14.
|
|
|
|
|
Non-current assets
|
|
|
|
|
|
Inventories
|
D.9.
|
|
|
|
|
Accounts receivable
|
D.10.
|
|
|
|
|
Other current assets
|
D.11.
|
|
|
|
|
Current income tax assets
|
|
|
|
|
|
Cash and cash equivalents
|
D.13. - D.17.1.
|
|
|
|
|
Assets held for sale
|
D.8. - D.36.
|
|
|
|
|
Current assets
|
|
|
|
|
|
Total assets
|
|
|
|
|
SANOFI
FORM 20-F
2024
|
F-3
|
|
2024
CONSOLIDATED FINANCIAL STATEMENTS
|
|
Consolidated balance sheets - equity and liabilities
|
Consolidated
balance sheets – equity and liabilities
|
(€ million)
|
Note
|
December 31, 2024
|
December 31, 2023
|
December 31, 2022
|
|
Equity attributable to equity holders of Sanofi
|
D.15.
|
|
|
|
|
Equity attributable to non-controlling interests
|
D.16.
|
|
|
|
|
Total equity
|
|
|
|
|
|
Long-term debt
|
D.17.1.
|
|
|
|
|
Non-current lease liabilities
|
D.17.2.
|
|
|
|
|
Non-current liabilities related to business combinations
and to non-controlling interests
|
D.18.
|
|
|
|
|
Non-current provisions and other non-current liabilities
|
D.19.
|
|
|
|
|
Non-current income tax liabilities
|
D.19.4.
|
|
|
|
|
Deferred tax liabilities
|
D.14.
|
|
|
|
|
Non-current liabilities
|
|
|
|
|
|
Accounts payable
|
|
|
|
|
|
Current liabilities related to business combinations
and to non-controlling interests
|
D.18.
|
|
|
|
|
Current provisions and other current liabilities
|
D.19.5.
|
|
|
|
|
Current income tax liabilities
|
|
|
|
|
|
Current lease liabilities
|
D.17.2.
|
|
|
|
|
Short-term debt and current portion of long-term debt
|
D.17.1.
|
|
|
|
|
Liabilities related to assets held for sale
|
D.8. - D.36.
|
|
|
|
|
Current liabilities
|
|
|
|
|
|
Total equity and liabilities
|
|
|
|
|
F-4
|
SANOFI
FORM 20-F
2024
|
|
2024
CONSOLIDATED FINANCIAL STATEMENTS
|
|
Consolidated income statements
|
Consolidated income
statements
|
(€ million)
|
Note
|
2024
|
2023
(a)
|
2022
(a)
|
|
Net sales
|
D.34.
|
|
|
|
|
Other revenues
|
D.34.
|
|
|
|
|
Cost of sales
|
(
|
(
|
(
|
|
|
Gross profit
|
|
|
|
|
|
Research and development expenses
|
(
|
(
|
(
|
|
|
Selling and general expenses
|
(
|
(
|
(
|
|
|
Other operating income
|
D.25.
|
|
|
|
|
Other operating expenses
|
D.26.
|
(
|
(
|
(
|
|
Amortization of intangible assets
|
D.4.
|
(
|
(
|
(
|
|
Impairment of intangible assets
|
D.5.
|
(
|
(
|
|
|
Fair value remeasurement of contingent consideration
|
D.12. - D.18.
|
(
|
(
|
|
|
Restructuring costs and similar items
|
D.27.
|
(
|
(
|
(
|
|
Other gains and losses, and litigation
|
D.28.
|
(
|
(
|
(
|
|
Operating income
|
|
|
|
|
|
Financial expenses
|
D.29.
|
(
|
(
|
(
|
|
Financial income
|
D.29.
|
|
|
|
|
Income before tax and investments accounted for using
the equity method
|
D.35.1.
|
|
|
|
|
Income tax expense
|
D.30.
|
(
|
(
|
(
|
|
Share of profit/(loss) from investments accounted for using
the equity method
|
D.31.
|
|
(
|
|
|
Net income from continuing operations
|
|
|
|
|
|
Net income from discontinued operations
|
D.36.
|
|
|
|
|
Net income
|
|
|
|
|
|
Net income attributable to non-controlling interests
|
D.32.
|
|
|
|
|
Net income attributable to equity holders of Sanofi
|
|
|
|
|
|
Average number of shares outstanding
(million)
|
D.15.9.
|
|
|
|
|
Average number of shares after dilution
(million)
|
D.15.9.
|
|
|
|
|
•
Basic earnings per share from continuing operations (€)
|
|
|
|
|
|
•
Basic earnings per share from discontinued operations (€)
|
|
|
|
|
|
Basic earnings per share (€)
|
|
|
|
|
|
•
Diluted earnings per share from continuing operations (€)
|
|
|
|
|
|
•
Diluted earnings per share from discontinued operations (€)
|
|
|
|
|
|
Diluted earnings per share (€)
|
|
|
|
(a)
Figures for comparative periods (2023 and 2022) have been re-presented on a consistent basis to reflect the classification of Opella as a discontinued
|
SANOFI
FORM 20-F
2024
|
F-5
|
|
2024
CONSOLIDATED FINANCIAL STATEMENTS
|
|
Consolidated statements of comprehensive income
|
Consolidated statements of comprehensive income
|
(€ million)
|
Note
|
2024
|
2023
|
2022
|
|
Net income
|
|
|
|
|
|
Attributable to equity holders of Sanofi
|
|
|
|
|
|
Attributable to non-controlling interests
|
|
|
|
|
|
Other comprehensive income:
|
||||
|
•
Actuarial gains/(losses)
|
D.15.7.
|
|
(
|
|
|
•
Change in fair value of equity instruments included in financial assets and
financial liabilities
|
D.15.7.
|
(
|
|
|
|
•
Tax effects
|
D.15.7.
|
(
|
(
|
(
|
|
Sub-total: items not subsequently reclassifiable to profit or loss
from continuing operations (A)
|
(
|
(
|
|
|
|
•
Change in fair value of debt instruments included in financial assets
|
D.15.7.
|
|
|
(
|
|
•
Change in fair value of cash flow hedges
|
D.15.7.
|
(
|
(
|
|
|
•
Change in currency translation differences
|
D.15.7.
|
|
(
|
|
|
•
Tax effects
|
D.15.7.
|
|
(
|
|
|
Sub-total: items subsequently reclassifiable to profit or loss
from continuing operations (B)
|
|
(
|
|
|
|
Other comprehensive income / (loss) from continuing operations
for the period, net of taxes (A+B)
|
|
(
|
|
|
|
Other comprehensive income / (loss) for the period from discontinued
operations, net of taxes (C)
|
(
|
(
|
(
|
|
|
Comprehensive income
|
|
|
|
|
|
Attributable to equity holders of Sanofi
|
|
|
|
|
|
•
Continuing operations
|
|
|
|
|
|
•
Discontinued operations
|
|
|
|
|
|
Attributable to non-controlling interests
|
|
|
|
|
F-6
|
SANOFI
FORM 20-F
2024
|
|
2024
CONSOLIDATED FINANCIAL STATEMENTS
|
|
Consolidated statements of changes in equity
|
Consolidated statements of changes in equity
|
(€ million)
|
Share
capital
|
Additional
paid-in
capital
|
Treasury
shares
|
Reserves
and
retained
earnings
|
Stock
options and
other share-
based
payments
|
Other
comprehensive
income
|
Attributable
to equity
holders of
Sanofi
|
Attributable
to non-
controlling
interests
|
Total
equity
|
|
Balance at
January 1, 2022
|
|
|
(
|
|
|
(
|
|
|
|
|
Other comprehensive income
for the period
|
—
|
—
|
—
|
|
—
|
|
|
|
|
|
Net income for the period
|
—
|
—
|
—
|
|
—
|
—
|
|
|
|
|
Comprehensive income
for the period
|
—
|
—
|
—
|
|
—
|
|
|
|
|
|
Dividend paid out of 2021 earnings
(
€
|
—
|
—
|
—
|
(
|
—
|
—
|
(
|
—
|
(
|
|
Effect of the distribution of an
exceptional supplementary dividend of
equity holders of Sanofi
(e)
|
—
|
—
|
—
|
(
|
—
|
—
|
(
|
—
|
(
|
|
Payment of dividends to
non-controlling interests
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(
|
(
|
|
Share repurchase program
(a)
|
—
|
—
|
(
|
—
|
—
|
—
|
(
|
—
|
(
|
|
Reduction in share capital
(a)
|
(
|
(
|
|
|
—
|
—
|
—
|
—
|
|
|
Share-based payment plans:
|
|||||||||
|
•
Exercise of stock options
(a)
|
|
|
—
|
—
|
—
|
—
|
|
—
|
|
|
•
Issuance of restricted shares and
vesting of existing restricted
shares
(a)(c)
|
|
(
|
|
(
|
—
|
—
|
|
—
|
|
|
•
Employee share ownership plan
(a)
|
|
|
—
|
—
|
—
|
—
|
|
—
|
|
|
•
Value of services obtained from
employees
|
—
|
—
|
—
|
—
|
|
—
|
|
—
|
|
|
•
Tax effects on share-based
payments
|
—
|
—
|
—
|
—
|
|
—
|
|
—
|
|
|
Other movements
|
—
|
—
|
—
|
(
|
—
|
—
|
(
|
—
|
(
|
|
Balance at
December 31, 2022
|
|
|
(
|
|
|
|
|
|
|
|
(€ million)
|
Share
capital
|
Additional
paid-in
capital
|
Treasury
shares
|
Reserves
and
retained
earnings
|
Stock
options and
other share-
based
payments
|
Other
comprehensive
income
|
Attributable
to equity
holders of
Sanofi
|
Attributable
to non-
controlling
interests
|
Total
equity
|
|
Balance at
January 1, 2023
|
|
|
(
|
|
|
|
|
|
|
|
Other comprehensive income
for the period
|
—
|
—
|
—
|
(
|
—
|
(
|
(
|
(
|
(
|
|
Net income for the period
|
—
|
—
|
—
|
|
—
|
—
|
|
|
|
|
Comprehensive income for the period
|
—
|
—
|
—
|
|
—
|
(
|
|
|
|
|
Dividend paid out of 2022 earnings
(
€
|
—
|
—
|
—
|
(
|
—
|
—
|
(
|
—
|
(
|
|
Payment of dividends to non-
controlling interests
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(
|
(
|
|
Share repurchase program
(a)
|
—
|
—
|
(
|
—
|
—
|
—
|
(
|
—
|
(
|
|
Share-based payment plans:
|
|||||||||
|
•
Exercise of stock options
(a)
|
|
|
—
|
—
|
—
|
—
|
|
—
|
|
|
•
Issuance of restricted shares and
vesting of existing restricted
shares
(a)/(c)
|
|
(
|
|
(
|
—
|
—
|
|
—
|
|
|
•
Employee share ownership plan
(a)
|
|
|
—
|
—
|
—
|
—
|
|
—
|
|
|
•
Value of services obtained
from employees
|
—
|
—
|
—
|
—
|
|
—
|
|
—
|
|
|
•
Tax effects on share-based
payments
|
—
|
—
|
—
|
—
|
|
—
|
|
—
|
|
|
Other changes arising from issuance of
restricted shares
(b)
|
—
|
—
|
—
|
|
—
|
—
|
|
—
|
|
|
Other changes in non-controlling
interests
(d)
|
—
|
—
|
—
|
|
—
|
—
|
|
(
|
(
|
|
Balance at
December 31, 2023
|
|
|
(
|
|
|
(
|
|
|
|
|
SANOFI
FORM 20-F
2024
|
F-7
|
|
2024
CONSOLIDATED FINANCIAL STATEMENTS
|
|
Consolidated statements of changes in equity
|
|
(€ million)
|
Share
capital
|
Additional
paid-in
capital
|
Treasury
shares
|
Reserves
and
retained
earnings
|
Stock
options and
other share-
based
payments
|
Other
comprehensive
income
|
Attributable
to equity
holders of
Sanofi
|
Attributable
to non-
controlling
interests
|
Total
equity
|
|
Balance at
January 1, 2024
|
|
|
(
|
|
|
(
|
|
|
|
|
Other comprehensive income
for the period
|
—
|
—
|
—
|
(
|
—
|
|
|
|
|
|
Net income for the period
|
—
|
—
|
—
|
|
—
|
—
|
|
|
|
|
Comprehensive income for the period
|
—
|
—
|
—
|
|
—
|
|
|
|
|
|
Dividend paid out
of 2023 earnings
(
€
|
—
|
—
|
—
|
(
|
—
|
—
|
(
|
—
|
(
|
|
Payment of dividends to non-
controlling interests
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(
|
(
|
|
Share repurchase program
(a)
|
—
|
—
|
(
|
—
|
—
|
—
|
(
|
—
|
(
|
|
Reduction in share capital
(a)
|
(
|
(
|
|
(
|
—
|
—
|
|
—
|
|
|
Share-based payment plans:
|
|||||||||
|
•
Exercise of stock options
(a)
|
|
|
—
|
—
|
—
|
—
|
|
—
|
|
|
•
Issuance of restricted shares and
vesting of existing restricted
shares
(a)/(c)
|
|
(
|
|
(
|
—
|
—
|
|
—
|
|
|
•
Employee share ownership plan
(a)
|
|
|
—
|
—
|
—
|
—
|
|
—
|
|
|
•
Value of services obtained
from employees
|
—
|
—
|
—
|
—
|
|
—
|
|
—
|
|
|
•
Tax effects on share-based
payments
|
—
|
—
|
—
|
—
|
|
—
|
|
—
|
|
|
Other changes arising from issuance of
restricted shares
(b)
|
—
|
—
|
—
|
|
—
|
—
|
|
—
|
|
|
Change in non-controlling interests
without loss of control
|
—
|
—
|
—
|
(
|
—
|
—
|
(
|
|
|
|
Balance at
December 31, 2024
|
|
|
(
|
|
|
|
|
|
|
(a)
See Notes D.15.1., D.15.3., D.15.4. and D.15.5.
(b)
This line comprises the impact of the i
ssuance of restricted shares to former employees of EUROAPI subsequent to the date on which Sanofi lost control
of EUROAPI
.
(c)
This line includes the use of existing shares to fulfill vested rights under restricted share plans.
(d)
This line mainly comprises changes in non-controlling interests arising from divestments and acquisitions.
(e)
This a
mount includes the valuation of the shares distributed as a dividend in kind, at a price of
€
14.58
per share, as of May 10, 2022 (see Note D.1.3).
|
F-8
|
SANOFI
FORM 20-F
2024
|
|
2024
CONSOLIDATED FINANCIAL STATEMENTS
|
|
Consolidated statements of cash flows
|
Consolidated statements of
cash flows
|
(€ million)
|
Note
|
2024
|
2023
(a)
|
2022
(a)
|
|
Net income attributable to equity holders of Sanofi
|
|
|
|
|
|
Net (income)/loss from the discontinued Opella business
(a)
|
(
|
(
|
(
|
|
|
Non-controlling interests
|
D.32.
|
|
|
|
|
Share of undistributed earnings from investments accounted for using the equity method
|
|
|
(
|
|
|
Depreciation, amortization and impairment of property, plant and equipment, right-of-use assets and
intangible assets
|
|
|
|
|
|
Gains and losses on disposals of non-current assets, net of tax
(b)
|
(
|
(
|
(
|
|
|
Net change in deferred taxes
|
(
|
(
|
(
|
|
|
Net change in non-current provisions and other non-current liabilities
(c)
|
|
|
|
|
|
Cost of employee benefits (share-based payments)
|
D.15.2. -
D.15.3. -
D.15.8.
|
|
|
|
|
Impact of the workdown of acquired inventories remeasured at fair value
|
D.35.1.
|
|
|
|
|
Other profit or loss items with no cash effect on cash flows generated by operating activities
(d)
|
|
|
|
|
|
Operating cash flow before changes in working capital of continuing operations
|
|
|
|
|
|
(Increase)/decrease in inventories
|
(
|
(
|
(
|
|
|
(Increase)/decrease in accounts receivable
|
(
|
(
|
(
|
|
|
Increase/(decrease) in accounts payable
|
|
|
|
|
|
Net change in other current assets and other current liabilities
|
(
|
|
|
|
|
Net cash provided by/(used in) continuing operating activities
|
|
|
|
|
|
Net cash provided by/(used in) operating activities of the discontinued Opella business
|
|
|
|
|
|
Net cash provided by/(used in) operating activities
(e)
|
|
|
|
|
|
Acquisition of property, plant and equipment and intangible assets
|
D.3. - D.4.
|
(
|
(
|
(
|
|
Acquisitions of consolidated undertakings and investments accounted for using the equity method
(f)
|
D.1. - D.18.
|
(
|
(
|
(
|
|
Acquisitions of other equity investments
|
D.7.
|
(
|
(
|
(
|
|
Proceeds from disposals of property, plant and equipment, intangible assets and other non-current
assets, net of tax
(g)
|
|
|
|
|
|
Disposal of consolidated undertakings and investments accounted for using the equity method, net of tax
(h)
|
|
|
|
|
|
Net change in other non-current assets
|
(
|
(
|
(
|
|
|
Net cash provided by/(used in) continuing investing activities
|
(
|
(
|
(
|
|
|
Net cash provided by/(used in) investing activities of the discontinued Opella business
(i)
|
(
|
(
|
|
|
|
Net cash provided by/(used in) investing activities
|
(
|
(
|
(
|
|
|
Issuance of Sanofi shares
|
D.15.1.
|
|
|
|
|
Dividends paid:
|
||||
|
•
to shareholders of Sanofi
|
(
|
(
|
(
|
|
|
•
to non-controlling interests
|
(
|
(
|
(
|
|
|
Payments received/(made) on changes of ownership interest in a subsidiary without loss of control
|
|
(
|
|
|
|
Additional long-term debt contracted
|
D.17.1.
|
|
|
|
|
Repayments of long-term debt
|
D.17.1.
|
(
|
(
|
(
|
|
Repayments of lease liabilities
|
(
|
(
|
(
|
|
|
Net change in short-term debt and other financial instruments
(j)
|
|
|
|
|
|
Acquisitions of treasury shares
|
D.15.4.
|
(
|
(
|
(
|
|
Net cash provided by/(used in) continuing financing activities
|
(
|
(
|
(
|
|
|
Net cash provided by/(used in) financing activities of the discontinued Opella business
|
(
|
(
|
(
|
|
|
Net cash provided by/(used in) financing activities
|
(
|
(
|
(
|
|
|
Impact of exchange rates on cash and cash equivalents
|
(
|
(
|
|
|
|
Impact on cash and cash equivalents of the reclassification of the Opella business to "Assets held for sale"
|
(
|
|
|
|
|
Net change in cash and cash equivalents
|
(
|
(
|
|
|
|
Cash and cash equivalents, beginning of period
|
|
|
|
|
|
Cash and cash equivalents, end of period
|
D.13.
|
|
|
|
|
Cash and cash equivalents, beginning of period of discontinued operations reported as held for sale
|
|
|
|
|
|
Cash and cash equivalents, end of period of discontinued operations reported as held for sale
|
|
|
|
(a)
Cash flows of the Opella business are presented separately in accordance with IFRS 5 (Non-Current Assets Held for Sale and Discontinued Operations).
(b)
Includes
non-current financial assets.
(c)
This line item includes contributions paid to pension funds (see Note D.19.1.).
(d)
This line item mainly comprises unrealized foreign exchange gains and losses arising on the remeasurement of monetary items in non-functional
currencies and on instruments used to hedge such items.
|
SANOFI
FORM 20-F
2024
|
F-9
|
|
2024
CONSOLIDATED FINANCIAL STATEMENTS
|
|
Consolidated statements of cash flows
|
(e)
Including:
|
2024
|
2023
|
2022
|
|
|
•
Income tax paid
|
(
|
(
|
(
|
|
•
Interest paid
|
(
|
(
|
(
|
|
•
Interest received
|
|
|
|
|
•
Dividends received from non-consolidated entities
|
|
|
|
(f)
This line item includes payments made in respect of contingent consideration identified and recognized as a liability in business combinations. For 2024,
it includes the net cash outflow relating to the acquisition of Inhibrx, Inc. (see Note D.1..1). For 2023, it includes the net cash outflow on the acquisitions of
Provention Bio (see Note D.1.). For 2022, it includes the net cash outflow on the acquisition of Amunix (see Note D.1.)
(g
)
For
2024
, this line item includes the sale of the Enjaymo global rights to Recordati for pre-tax proceeds of
€
768
million
. For
2023
and
2022
, this line item
mainly comprises disposals of assets and activities related to portfolio streamlining, and disposals
of
equity and debt instruments.
(h)
For 2022, this line item includes the net cash inflows (before taxes) of
€
101
million
on the divestment of EUROAPI (see Note D.1.).
(i)
For 2023, this line item includes the net cash outflow on the acquisition of QRIB (see Note D.1.)
(j)
For 2024, this line item mainly includes a US commercial paper program for
€
262
million
. For
2024
,
2023
and
2022
, it also includes
realized foreign
exchange differences on (i) cash and cash equivalents in non-functional currencies (primarily the US dollar) and (ii) derivative instruments used to
manage such cash and cash equivalents.
|
F-10
|
SANOFI
FORM 20-F
2024
|
|
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
|
Notes to the Consolidated Financial
Statements
Sanofi, together with its subsidiaries (collectively “Sanofi”, “the Group” or “the Company”), is a global healthcare leader engaged
in the research, development and marketing of therapeutic solutions focused on patient needs.
Sanofi is listed in Paris (Euronext: SAN) and New York (Nasdaq: SNY).
The consolidated financial statements for the year ended
December 31, 2024
, and the notes thereto, were signed off by the
Sanofi Board of Directors on
February 12, 2025.
A/
Basis of preparation
A.1.
International financial reporting standards (IFRS)
The consolidated financial statements cover the twelve-month periods ended
December 31, 2024
,
2023
and
2022
.
In accordance with Regulation No. 1606/2002 of the European Parliament and Council of July 19, 2002 on the application
of international accounting standards, Sanofi has presented its consolidated financial statements in accordance with IFRS
since January 1, 2005. The term “IFRS” refers collectively to international accounting and financial reporting standards
(IASs and IFRSs) and to interpretations of the interpretations committees (SIC and IFRIC) with mandatory application as of
December 31, 2024
.
The consolidated financial statements of Sanofi as of
December 31, 2024
have been prepared in compliance with IFRS
as issued by the International Accounting Standards Board (IASB) and with IFRS as endorsed by the European Union as of
December 31, 2024
.
IFRS as endorsed by the European Union as of
December 31, 2024
are available under the heading “IFRS Financial Statements”
via the following web link:
https://www.efrag.org/Endorsement
The consolidated financial statements have been prepared in accordance with the IFRS general principles of fair presentation,
going concern, accrual basis of accounting, consistency of presentation, materiality, and aggregation.
A.2.
New standards, amendments and interpretations
A.2.1. New standards applicable from
January 1, 2024
On September 22, 2022, the IASB issued an amendment to IFRS 16 (Leases) relating to lease liabilities in a sale-and-leaseback
arrangement, which is applicable from January 1, 2024 and had no impact on Sanofi's financial statements.
On January 23, 2020, the IASB issued “Classification of Liabilities as Current or Non-current”, an amendment to IAS 1, and then
on October 31, 2022 issued “Non-current Liabilities with Covenants”, a further amendment to IAS 1. The amendments, which are
applicable from January 1, 2024, had no impact on Sanofi's financial statements.
On May 25, 2023, the IASB issued "
Su
pplier Finance Arrangements
", amendments to
IAS 7 and IFRS 7
, applicable from January 1,
2024. The
amendments relate to disclosures of information about such arrangements
, and have led to the following clarification:
within
Accounts payable
, amounts representing payables that are managed via a paying agent contract under which a bank
manages the settlement of Sanofi's trade accounts payable on behalf of Sanofi and that have already been paid to suppliers by
the bank represented around 2% as of December 31, 2024. As those amounts are not material, Sanofi does not provide additional
information in respect of those amendments.
A.2.2.
New pronouncements issued by the IASB and applicable from 2025 or later
This note describes standards, amendments and interpretations issued by the IASB that will have mandatory application in
2025
or subsequent years, and Sanofi’s position regarding future application.
On August 15, 2023, the IASB iss
ued "Lack of Exchangeability", an am
endment to IAS 21 (The Effects of Changes in Foreign
Exchange Rates), relating to how to determine the exchange rate when a currency is not exchangeable. The amendment is
applicable at the earliest from January 1, 2025 ; it will not have a material impact on the Sanofi financial statements, and Sanofi
will not early adopt it.
On April 9, 2024, the IASB issued IFRS 18 (Presentation and Disclosure in Financial Statements), applicable from January 1, 2027
(subject to endorsement by the European Union). An impact assessment is currently under way. Sanofi will not early adopt this
new standard.
|
SANOFI
FORM 20-F
2024
|
F-11
|
|
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
|
On May 30, 2024, the IASB issued amendments to IFRS 9 and IFRS 7 relating to the classification and measurement of financial
instruments, applicable no earlier than January 1, 2026 (subject to endorsement by the European Union). Sanofi does not expect
any material impact, and will not early adopt these amendments.
On July 18, 2024, the IASB issued Volume 11 of its annual improvements to various standards, which are essentially in the nature of
clarifications, applicable from January 1, 2026 at the earliest (subject to endorsement by the European Union). Sanofi does not
expect any material impact, and will not early adopt these amendments.
On December 18, 2024, the IASB issued "Contracts referencing nature-dependent electricity", amendments to IFRS 9 and IFRS 7,
applicable (subject to endorsement by the European Union) from January 1, 2026. The amendments clarify the application of the
‘own use’ exemption to Power Purchase Agreements (PPAs) with physical delivery of renewable electricity, and modify the hedge
accounting requirements for contracts without physical delivery (VPPAs). Sanofi does not expect any material impact and does
not intend to early adopt these amendments. Renewable energy purchase contracts entered into by Sanofi as of December 31,
2024 are described in note D.21.
A.3.
Use of estimates and judgments
The preparation of financial statements requires management to make reasonable estimates and assumptions based on
information available at the date of the finalization of the financial statements. Those estimates and assumptions may affect the
reported amounts of assets, liabilities, revenues and expenses in the financial statements, and disclosures of contingent assets
and contingent liabilities as of the date of the review of the financial statements. Examples of estimates and assumptions include:
•
amounts deducted from sales for projected sales returns, chargeback incentives, rebates and price reductions (see Notes B.13.
and D.23.);
•
impairment of property, plant and equipment and intangible assets (see Notes B.6. and D.5.);
•
the valuation of goodwill and the valuation and estimated useful life of acquired intangible assets (see Notes B.3.2., B.4., D.4.
and D.5.);
•
the measurement of contingent consideration receivable in connection with asset divestments (see Notes B.8.5. and D.12.)
and of contingent consideration payable (see Notes B.3. and D.18.);
•
the measurement of financial assets and liabilities at amortized cost (see Note B.8.5.);
•
the amount of post-employment benefit obligations (see Notes B.23. and D.19.1.);
•
the amount of liabilities or provisions for restructuring, litigation, tax risks relating to corporate income taxes, and
environmental risks (see Notes B.12., B.19., B.20., D.19. and D.22.); and
•
the amount of deferred tax assets resulting from tax losses available for carry-forward and deductible temporary differences
(see Notes B.22. and D.14.).
Actual results could differ from these estimates.
Management is also required to exercise judgment in assessing whether the criteria required under IFRS 5 (Non-Current Assets
Held For Sale and Discontinued Operations) are met for (i) classifying a non-current asset or a group of assets as held for sale and
(ii) presenting a discontinued operation on a separate line item in the consolidated balance sheet, income statement, statement
of comprehensive income and cash flow statement. Such assessments are reviewed at the end of each reporting period each
closing date to take account of changes in events and circumstances.
In preparing the consolidated financial statements, Sanofi has also taken account of risks related to the effects of climate change
and energy transition.
As part of its Planet Care program, Sanofi has committed to move towards carbon neutrality by 2030 and net
zero
emissions
by 2045 for its Scope 1, 2 and 3 emissions. That involves:
•
aiming for a
55
%
reduction in greenhouse gas (GHG) emissions from Sanofi’s own activities (Scopes 1 & 2) and a
30
%
reduction
in Scope 3 GHG emissions by 2030 (versus a 2019 baseline), and a
90
%
reduction in GHG emissions (all scopes) by 2045.
These objectives have been validated by the Science Based Target initiative (STBi);
•
supplying all our sites with
100
%
renewably-sourced electricity by 2030;
•
promoting an eco-friendly vehicle fleet by 2030; and
•
engaging the Sanofi supply chain in reducing Scope 3 emissions.
The analysis of climate-related physical and transition risks facing Sanofi was updated in 2023 on the basis of
three
global
warming scenarios out to 2030 and 2050. A number of assumptions – on issues such as carbon costs, natural disasters, water
stress, raw material scarcity and logistics disruption – were built into this analysis, which also takes account of certain capital
expenditures on mitigations derived from the Planet Care roadmap.
In preparing the consolidated financial statements, that analysis was taken into account as follows:
•
the value of intangible assets and property, plant and equipment was subject to impairment testing conducted at CGU level,
as described in Note D.5. Certain climate-related assumptions, such as the evolution of energy costs, transitioning to
sustainable agriculture, and waste management, are already built into the forecast used for impairment testing purposes. For
those assumptions not yet built into budgets, sensitivity analyses can be performed as needed;
•
the periodic reviews conducted on the useful lives of property, plant and equipment take account of environmental regulatory
constraints, including not only GHG emissions but also physical risks;
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2024
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|
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
|
•
environmental risks are covered by provisions on the basis described in Note D.19.3.; and
•
the credit facilities available to Sanofi as of December 31,
2024
incorporate performance objectives, including objectives
related to cutting Sanofi’s carbon footprint, which could reduce the cost of debt if they are attained (see Note D.17.).
It is important to bear in mind that estimating climate change related risks involves an element of unpredictability. Uncertainties
may arise from factors such as changes in government policy, rapid technological change, and varied responses from
stakeholders. That high level of uncertainty adds complexity to assessment of the potential impacts on our operations, and to
how those impacts are reflected in our budgets. Actual impacts on Sanofi’s profits and financial position could therefore differ
from initial estimates.
Finally, in line with its environmental protection objectives, Sanofi has initiated projects to build eco-design into its products so as
to limit their environmental impacts over their entire life cycle. Those projects will require Sanofi to redefine all of its production
methods, and as such have also been built into definitions of the useful lives of Sanofi production facilities.
A.4.
Hyperinflation
In
2024
, Sanofi continued to account for subsidiaries based in Venezuela using the full consolidation method, on the basis that
the criteria for control as specified in IFRS 10 (Consolidated Financial Statements) are still met. The contribution of the
Venezuelan subsidiaries to the consolidated financial statements is immaterial.
In Argentina, the cumulative rate of inflation over the last three years is in excess of
100
%
, based on a combination of indices used
to measure inflation in that country. Consequently, Sanofi has since July 1, 2018 treated Argentina as a hyperinflationary economy
and has applied IAS 29. The impact of the resulting restatements is immaterial at Sanofi group level.
In Turkey, the cumulative rate of inflation over the last three years is in excess of
100
%
based on a combination of indices used to
measure inflation in that country. Consequently, Sanofi has since January 1, 2022 treated Turkey as a hyperinflationary economy
and has applied IAS 29. The impact of the resulting restatements is immaterial at Sanofi
group level.
by Sanofi in collaboration with GSK
On February 18, 2020, Sanofi and the US Department of Health and Human Services extended their research and development
partnership to leverage Sanofi’s previous development work on a SARS vaccine to attempt to unlock a fast path forward for
developing a COVID-19 vaccine. Under the terms of the collaboration, the Biomedical Advanced Research and Development
Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response within the US Department of
Health and Human Services, is helping to fund the research and development undertaken by Sanofi.
On April 14, 2020, Sanofi and GlaxoSmithKline (GSK) entered into a collaboration agreement to develop a recombinant COVID-19
vaccine candidate, with Sanofi contributing its S‑protein COVID-19 antigen (based on recombinant DNA technology) and GSK
contributing its pandemic adjuvant technology. Sanofi is leading clinical development and the registration process for the vaccine.
On July 31, 2020, the recombinant COVID-19 vaccine candidate developed by Sanofi in collaboration with GSK was selected by
the US government’s Operation Warp Speed (OWS) program. Under the OWS, the US government is providing funds to support
further development of the vaccine, including clinical studies and scaling-up of manufacturing capacity. Initially, the agreement
also provided for the supply of
100
million
doses of the vaccine. In light of the evolving context of the pandemic (including
variants of the virus) and the availability of vaccines on the market, the parties decided to review the initial supply contract. At the
end of 2023, the agreement was amended in respect of the supply clause, confirming that Sanofi had fulfilled its contractual
obligations and setting the amount of compensation paid to Sanofi. On the basis of that signed amendment, Sanofi recognized
an amount of
€
411
million
within the line item
Other revenues
; that amount was paid to Sanofi in December 2023.
Sanofi has recognized the funding received from the US government as a deduction from the development expenses incurred, in
accordance with IAS 20 (Accounting for Government Grants and Disclosure of Government Assistance).
The amount of government aid received from the US federal government and BARDA and recognized
as a deduction from
development expenses
and other operating expenses was
€
58
million
in 2024, compared with
€
59
million
in 2023 and
€
265
million
in 2022.
In September 2020, Sanofi and GSK signed pre-order contracts with the Canadian and UK governments and with the European
Union for doses of the vaccine candidate. During 2021, Sanofi and GSK contractualized with the Canadian and UK governments
and with the European Union on the number of doses ordered.
On December 15, 2021, Sanofi and GSK announced positive preliminary data on their COVID-19 booster vaccine candidate and
indicated that their Phase 3 study was to continue, based on recommendations from an independent monitoring board.
On November 10, 2022, in line with the positive opinion issued by the Committee for Medicinal Products for Human Use (CHMP)
of the European Medicines Agency, the European Commission approved VidPrevtyn Beta vaccine as booster for the prevention
of COVID-19 in adults aged 18 years and older. Designed to provide broad protection against multiple variants, this protein-based
COVID-19 booster vaccine is based on the Beta variant antigen and includes GSK’s pandemic adjuvant. VidPrevtyn
Beta is
indicated as a booster for active immunization against SARS-CoV-2 in adults who have previously received an mRNA or
adenoviral COVID-19 vaccine.
On December 21, 2022, following the European Commission approval, the Medicines and Healthcare Products Regulatory Agency
(MHRA) approved VidPrevtyn Beta vaccine for the prevention of COVID-19 in adults aged 18 and over within the UK.
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SANOFI
FORM 20-F
2024
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F-13
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NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
|
In accordance with IFRS 15 (see Note B.13.1.), Sanofi recognizes revenue when control over the product is transferred to the
customer (for vaccines, transfer of control is determined by reference to the terms of release and acceptance of batches of
vaccine). Payments received subsequent to signature of vaccine pre-order contracts relating to doses not yet delivered are
customer contract liabilities (i.e. an obligation for the entity to supply goods to a customer, for which consideration has been
received from the customer). They are presented within “Customer contract liabilities” in the balance sheet (see Note D.19.5.),
and within “Net change in other current assets and other current liabilities” in the statement of cash flows.
The pre-order contracts for Canada, the United Kingdom and the European Union expired in 2023. The customer contract
liabilities, which amounted to
€
269
million
as of December 31, 2022 and
€
319
million
as of December 31, 2021 (see Note D.19.5.,
“
Current provisions and other current liabilities”
) were released to profit or loss in 2023, including an amount of
€
94
million
classified in
Other revenue
in respect of doses
which
there was no longer an obligation to deliver as of December 31, 2023.
B/
Summary of significant accounting policies
B.1.
Basis of consolidation
In accordance with IFRS 10 (Consolidated Financial Statements), the consolidated financial statements of Sanofi include the
financial statements of entities that Sanofi controls directly or indirectly, regardless of the level of the equity interest in those
entities. An entity is controlled when Sanofi has power over the entity, exposure or rights to variable returns from its involvement
with the entity, and the ability to affect those returns through its power over the entity. In determining whether control exists,
potential voting rights must be taken into account if those rights are substantive, in other words they can be exercised on a
timely basis when decisions about the relevant activities of the entity are to be taken.
Entities consolidated by Sanofi are referred to as “subsidiaries”. Entities that Sanofi controls by means other than voting rights are
referred to as “consolidated structured entities”.
In accordance with IFRS 11 (Joint Arrangements), Sanofi classifies its joint arrangements (i.e. arrangements in which Sanofi
exercises joint control with one or more other parties) either as a joint operation (in which case, Sanofi recognizes the assets and
liabilities of the operation in proportion to its rights and obligations relating to those assets and liabilities) or as a joint venture.
Sanofi exercises joint control over a joint arrangement when decisions relating to the relevant activities of the arrangement
require the unanimous consent of Sanofi and the other parties with whom control is shared.
Sanofi exercises significant influence over an entity when it has the power to participate in the financial and operating policy
decisions of that entity, but does not have the power to exercise control or joint control over those policies.
In accordance with IAS 28 (Investments in Associates and Joint Ventures), the equity method is used to account for joint ventures
(i.e. entities over which Sanofi exercises joint control) and for associates (i.e. entities over which Sanofi exercises significant
influence).
Under the equity method, the investment is initially recognized at cost, and subsequently adjusted to reflect changes in the net
assets of the associate or joint venture. IAS 28 does not specify the treatment to be adopted on first-time application of the
equity method to an investee following a step acquisition. Consequently, by reference to paragraph 10 of IAS 28, Sanofi has
opted to apply the cost method, whereby the carrying amount of the investment represents the sum of the historical cost
amounts for each step in the acquisition. As of the date on which the equity method is first applied, goodwill (which is included in
the carrying amount of the investment) is determined for each acquisition step. The same applies to subsequent increases in the
percentage interest in the equity-accounted investment.
When the criteria of IFRS 5 are met, Sanofi recognizes the equity interest within the balance sheet line item
Assets held for sale
.
The equity method is not applied to equity interests that are classified as held for sale assets.
Transactions between consolidated companies are eliminated, as are intragroup profits.
A list of the principal companies included in the consolidation in
2024
is presented in Note F.
B.2.
Foreign currency translation
B.2.1. Accounting for foreign currency transactions in the financial statements of consolidated
entities
Non-current assets and inventories acquired in foreign currencies are translated into the functional currency using the exchange
rate prevailing at the acquisition date.
Monetary assets and liabilities denominated in foreign currencies are translated using the exchange rate prevailing at the end of
the reporting period. The gains and losses resulting from foreign currency translation are recorded in the income statement.
However, foreign exchange gains and losses arising from the translation of advances between consolidated subsidiaries for which
settlement is neither planned nor likely to occur in the foreseeable future are recognized in equity, in the line item
Change in
currency translation differences.
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NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
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B.2.2. Foreign currency translation of the financial statements of foreign entities
Sanofi presents its consolidated financial statements in euros (€). In accordance with IAS 21 (The Effects of Changes in Foreign
Exchange Rates), each subsidiary accounts for its transactions in the currency that is most representative of its economic
environment (the functional currency).
All assets and liabilities are translated into euros using the exchange rate of the subsidiary’s functional currency prevailing at the
end of the reporting period. Income statements are translated using a weighted average exchange rate for the period, except in
the case of foreign subsidiaries in a hyperinflationary economy. The resulting currency translation difference is recognized as a
separate component of equity in the consolidated statement of comprehensive income, and is recognized in the income
statement only when the subsidiary is sold or is wholly or partially liquidated.
B.3.
Business combinations and transactions with non-controlling interests
B.3.1. Accounting for business combinations, transactions with non-controlling interests and loss
of control
Business combinations are accounted for in accordance with IFRS 3 (Business Combinations) and IFRS 10 (Consolidated Financial
Statements).
Business combinations are accounted for using the acquisition method. Under this method, the acquiree’s identifiable assets and
liabilities that satisfy the recognition criteria of IFRS 3 (Business Combinations) are measured initially at their fair values at the
date of acquisition, except for (i) non-current assets classified as held for sale (which are measured at fair value less costs to sell)
and (ii) assets and liabilities that fall within the scope of IAS 12 (Income Taxes) and IAS 19 (Employee Benefits). Restructuring
liabilities are recognized as a liability of the acquiree only if the acquiree has an obligation as of the acquisition date to carry out
the restructuring.
The principal accounting rules applicable to business combinations and transactions with non-controlling interests include:
•
acquisition-related costs are recognized as an expense, as a component of
Operating income
;
•
contingent consideration is recognized in equity if the contingent payment is settled by delivery of a fixed number
of the acquirer’s equity instruments; otherwise, it is recognized i
n liabilities related to business combinations.
Contingent consideration is recognized at fair value at the acquisition date irrespective of the probability of payment. If the
contingent consideration was originally recognized as a financial liability, subsequent adjustments to the liability are
recognized in profit or loss in the line item
Fair value remeasurement of contingent consideration
, unless the adjustment is
made within the 12 months following the acquisition date and relates to facts and circumstances existing as of that date; and
•
goodwill may be calculated on the basis of either (i) the entire fair value of the acquiree, or (ii) a share of the fair value of the
acquiree proportionate to the interest acquired. This option is elected for each acquisition individually.
Purchase price allocations are performed under the responsibility of management, with assistance from an independent valuer in
the case of major acquisitions. IFRS 3 does not specify an accounting treatment for contingent consideration arising from a
business combination made by an entity prior to the acquisition of control in that entity and carried as a liability in the acquired
entity’s balance sheet. The accounting treatment applied by Sanofi to such a liability is to measure it at fair value as of the
acquisition date and to report it in the line item
Liabilities related to business combinations and to non-controlling
interests,
with subsequent remeasurements recognized in profit or loss. This treatment is consistent with the accounting applied to
contingent consideration in the books of the acquirer.
Finally, management may where it deems fit elect to apply the optional test to identify concentration of fair value permitted
under IFRS 3 in order to determine whether a transaction is a business combination within the meaning of IFRS 3, or merely the
acquisition of an asset or of a group of similar assets.
B.3.2. Goodwill
The excess of the cost of an acquisition over Sanofi’s interest in the fair value of the identifiable assets and liabilities of the
acquiree is recognized as goodwill at the date of the business combination.
Goodwill
arising on the acquisition of subsidiaries is
shown in a separate balance sheet line item, whereas goodwill arising on the acquisition of investments accounted for using the
equity method is recorded in
Investments accounted for using the equity method.
Goodwill arising on foreign operations is expressed in the functional currency of the country concerned and translated into euros
using the exchange rate prevailing at the end of the reporting period.
In accordance with IAS 36 (Impairment of Assets), goodwill is carried at cost less accumulated impairment (see Note B.6.).
Goodwill is tested for impairment annually and whenever events or circumstances indicate that impairment might exist. Such
events or circumstances include significant changes more likely than not to have an other-than-temporary impact on the
substance of the original investment.
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SANOFI
FORM 20-F
2024
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F-15
|
|
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
|
B.4.
Other intangible assets
Other intangible assets are initially measured at acquisition cost or production cost, including any directly attributable costs of
preparing the asset for its intended use, or (in the case of assets acquired in a business combination) at fair value as of the date of
the business combination. Intangible assets are amortized on a straight line basis over their useful lives.
The useful lives of other intangible assets are reviewed at the end of each reporting period. The effect of any adjustment to
useful lives is recognized prospectively as a change in accounting estimate.
Amortization of other intangible assets is recognized in the income statement within
Amortization of intangible assets
except
for amortization charged against (i) acquired or internally-developed software and (ii) other rights of an industrial or operational
nature, which is recognized in the relevant classification of expense by function.
Sanofi does not own any intangible assets with an indefinite useful life, other than goodwill.
Intangible assets (other than goodwill) are carried at cost less accumulated amortization and accumulated impairment, if any, in
accordance with IAS 36 (see Note B.6.).
B.4.1. Research and development not acquired in a business combination
Internally generated research and development
Under IAS 38, research expenses are recognized in profit or loss when incurred.
Internally generated development expenses are recognized as an intangible asset if, and only if, all the following six criteria can be
demonstrated: (a) the technical feasibility of completing the development project; (b) Sanofi’s intention to complete the project;
(c) Sanofi’s ability to use the project; (d) the probability that the project will generate future economic benefits; (e) the availability
of adequate technical, financial and other resources to complete the project; and (f) the ability to measure the development
expenditure reliably.
Due to the risks and uncertainties relating to regulatory approval and to the research and development process, the six criteria
for capitalization are usually considered not to have been met until the product has obtained marketing approval from the
regulatory authorities. Consequently, internally generated development expenses arising before marketing approval has been
obtained, mainly the cost of clinical studies, are generally expensed as incurred within
Research and development expenses
.
Some industrial development expenses (such as those incurred in developing a second-generation synthesis process) are
incurred after marketing approval has been obtained, in order to improve the industrial process for an active ingredient. To the
extent that the six IAS 38 criteria are considered as having been met, such expenses are recognized as an asset in the balance
sheet within
Other intangible assets
as incurred. Similarly, some clinical studies, for example those undertaken to obtain a
geographical extension for a molecule that has already obtained marketing approval in a major market, may in certain
circumstances meet the six capitalization criteria under IAS 38, in which case the related expenses are recognized as an asset in
the balance sheet within
Other intangible assets
.
Separately acquired research and development
Payments for separately acquired research and development are capitalized within
Other intangible assets
provided that they
meet the definition of an intangible asset: a resource that is (i) controlled by Sanofi, (ii) expected to provide future economic benefits
for Sanofi, and (iii) identifiable (i.e. it is either separable or arises from contractual or legal rights). Under paragraph 25 of IAS 38, the
first condition for capitalization (the probability that the expected future economic benefits from the asset will flow to the entity) is
considered to be satisfied for separately acquired research and development. Consequently, upfront and milestone payments to
third parties related to pharmaceutical products for which marketing approval has not yet been obtained are recognized as
intangible assets, and amortized on a straight line basis over their useful lives beginning when marketing approval is obtained.
Payments under research and development arrangements relating to access to technology or to databases, and payments made
to purchase generics dossiers, are also capitalized, and amortized over the useful life of the intangible asset.
Subcontracting arrangements, payments for research and development services, and continuous payments under research and
development collaborations which are unrelated to the outcome of that collaboration, are expensed over the service term.
B.4.2. Other intangible assets not acquired in a business combination
Licenses other than those related to pharmaceutical products and research projects, in particular software licenses, are
capitalized at acquisition cost, including any directly attributable cost of preparing the software for its intended use. Software
licenses are amortized on a straight line basis over their useful lives for Sanofi (
three
to
five years
).
Internally generated costs incurred to develop or upgrade software are capitalized if the IAS 38 recognition criteria are satisfied,
and amortized on a straight line basis over the useful life of the software from the date on which the software is ready for use.
B.4.3. Other intangible assets acquired in a business combination
Other intangible assets acquired in a business combination (in-process research and development, technology platforms, and
currently marketed products) that are reliably measurable are identified separately from goodwill, measured at fair value, and
capitalized within
Other intangible assets
in accordance with IFRS 3 (Business Combinations) and IAS 38 (Intangible Assets). The
related deferred tax liability is also recognized if a deductible or taxable temporary difference exists.
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2024
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NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
|
In-process research and development acquired in a business combination is amortized on a straight line basis over its useful life
from the date of receipt of marketing approval.
Rights to technology platforms and to products currently marketed by Sanofi are amortized on a straight line basis over their
useful lives, determined (in particular for marketed products) on the basis of cash flow forecasts which take into account the
patent protection period of the marketed product.
B.5.
Property, plant and equipment owned and leased
B.5.1. Property, plant and equipment owned
Property, plant and equipment is initially measured and recognized at acquisition cost, including any directly attributable cost of
preparing the asset for its intended use, or (in the case of assets acquired in a business combination) at fair value as of the date of
the business combination. The component-based approach to accounting for property, plant and equipment is applied. Under
this approach, each component of an item of property, plant and equipment with a cost which is significant in relation to the total
cost of the item and which has a different useful life from the other components must be depreciated separately.
After initial measurement, property, plant and equipment is carried at cost less accumulated depreciation and impairment, except
for land which is carried at cost less impairment.
Subsequent costs are not recognized as assets unless (i) it is probable that future economic benefits associated with those costs
will flow to Sanofi and (ii) the costs can be measured reliably.
Borrowing costs attributable to the financing of items of property, plant and equipment, and incurred during the construction
period, are capitalized as part of the acquisition cost of the item.
Government grants relating to property, plant and equipment are deducted from the acquisition cost of the asset to which
they relate.
The depreciable amount of items of property, plant and equipment, net of any residual value, is depreciated on a straight line
basis over the useful life of the asset. The useful life of an asset is usually equivalent to its economic life.
|
Buildings
|
|
|
Fixtures
|
|
|
Machinery and equipment
|
|
|
Other
|
|
Useful lives and residual values of property, plant and equipment are reviewed annually. The effect of any adjustment to useful
lives or residual values is recognized prospectively as a change in accounting estimate.
Depreciation of property, plant and equipment is recognized as an expense in the income statement, in the relevant classification
of expense by function.
B.5.2. Property, plant and equipment leased
Leases contracted by Sanofi have been accounted for in accordance with IFRS 16 (Leases). Sanofi recognizes a right-of-use asset
and a lease liability for all of its lease contracts, except for (i) leases relating to low-value assets and (ii) short-term leases
(12 months or less). Payments made in respect of leases not recognized on the balance sheet are recognized as an operating
expense on a straight line basis over the lease term.
On commencement of a lease, the liability for future lease payments is discounted at the incremental borrowing rate, which is a
risk-free rate adjusted to reflect the specific risk profile of each Sanofi entity. Because lease payments are spread over the lease
term, Sanofi applies a discount rate based on the duration of those payments.
The payments used to determine the liability for future lease payments exclude non-lease components, but include fixed
payments that Sanofi expects to make to the lessor over the estimated lease term.
After commencement of the lease, the liability for future lease payments is reduced by the amount of the lease payments made,
and increased to reflect interest on the liability. In the event of a reassessment or modification of future lease payments, the lease
liability is remeasured. The right-of-use asset – which is initially measured at cost including direct costs of the lessee,
prepayments made at or prior to the commencement date, less lease incentives received and restoration costs – is depreciated
on a straight line basis over the lease term, and tested for impairment as required.
Sanofi recognizes deferred taxes in respect of right-of-use assets and lease liabilities.
Leasehold improvements are depreciated over their economic life, which is capped at the lease term as determined
under IFRS 16.
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SANOFI
FORM 20-F
2024
|
F-17
|
|
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
|
B.6.
Impairment of property, plant and equipment, intangible assets, and investments
accounted for using the equity method
B.6.1. Impairment of property, plant and equipment and intangible assets
In accordance with IAS 36 (Impairment of Assets), assets that generate separate cash flows and assets included in cash-
generating units (CGUs) are assessed for impairment when events or changes in circumstances indicate that the asset or CGU
may be impaired. A CGU is the smallest identifiable group of assets that generates cash inflows that are largely independent of
the cash inflows from other assets or groups of assets.
Under IAS 36, each CGU or group of CGUs to which goodwill is allocated must (i) represent the lowest level within the entity at
which the goodwill is monitored for internal management purposes, and (ii) not be larger than an operating segment determined
in accordance with IFRS 8 (Operating Segments), before application of the IFRS 8 aggregation criteria (see Note B.26.).
Quantitative and qualitative indications of impairment (primarily relating to the status of the research and development portfolio,
pharmacovigilance, patent litigation, and the launch of competing products) are reviewed at the end of each reporting period. If
there is any internal or external indication of impairment, Sanofi estimates the recoverable amount of the asset or CGU.
Other intangible assets not yet available for use (such as capitalized in-process research and development), and CGUs or groups
of CGUs that include goodwill, are tested for impairment annually whether or not there is any indication of impairment, and more
frequently if any event or circumstance indicates that they might be impaired. Such assets are not amortized.
When there is an internal or external indication of impairment, Sanofi estimates the recoverable amount of the asset and
recognizes an impairment loss if the carrying amount of the asset exceeds its recoverable amount. The recoverable amount of
the asset is the higher of its fair value less costs to sell or its value in use. To determine value in use, Sanofi uses estimates of future
cash flows generated by the asset or CGU, prepared using the same methods as those used in the initial measurement of the
asset or CGU on the basis of medium-term strategic plans.
In the case of goodwill, estimates of future cash flows are based on a
six-year
strategic plan and a terminal value. In the case of
other
intangible
assets, the period used is based on the economic life of the asset.
Estimated cash flows are discounted at long-term market interest rates that reflect the best estimate by Sanofi of the time value
of money, the risks specific to the asset or CGU, and economic conditions in the geographical regions in which the business
activity associated with the asset or CGU is located.
Certain assets and liabilities that are not directly attributable to a specific CGU are allocated between CGUs on a basis that is
reasonable, and consistent with the allocation of the corresponding goodwill.
Impairment losses arising on property, plant and equipment, software and certain rights, are recognized within the appropriate
income statement line item according to the origin of the impairment.
Impairment losses arising on other intangible assets (products, trademarks, technology platforms, acquired R&D) are recognized
within
Impairment of intangible assets
in the income statement.
B.6.2. Impairment of investments accounted for using the equity method
In accordance with IAS 28 (Investments in Associates and Joint Ventures), Sanofi determines whether investments accounted for
using the equity method may be impaired based on indicators such as default in contractual payments, significant financial
difficulties, probability of bankruptcy, or a prolonged or significant decline in quoted market price. If an investment is impaired,
the amount of the impairment loss is determined by applying IAS 36 (see Note B.6.1.) and recognized in
Share of profit/(loss)
from investments accounted for using the equity method.
B.6.3. Reversals of impairment losses charged against property, plant and equipment,
intangible assets, and investments accounted for using the equity method
At the end of each reporting period, Sanofi assesses whether events or changes in circumstances indicate that an impairment
loss recognized in a prior period in respect of an asset (other than goodwill) or an investment accounted for using the equity
method can be reversed. If this is the case, and the recoverable amount as determined based on the revised estimates exceeds
the carrying amount of the asset, Sanofi reverses the impairment loss only to the extent of the carrying amount that would have
been determined had no impairment loss been recognized for the asset.
Reversals of impairment losses in respect of other intangible assets are recognized within the income statement line item
Impairment of intangible assets
, while reversals of impairment losses in respect of investments accounted for using the equity
method are recognized within the income statement line item
Share of profit/(loss) from investments accounted for using the
equity method
. Impairment losses taken against goodwill are never reversed, unless the goodwill is part of the carrying amount
of an investment accounted for using the equity method.
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FORM 20-F
2024
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|
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
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B.7.
Assets held for sale and liabilities related to assets held for sale and discontinued
operations
In accordance with IFRS 5 (Non-Current Assets Held for sale and Discontinued Operations), non-current assets and groups of
assets are classified as held for sale in the balance sheet if their carrying amount will be recovered principally through a sale
transaction rather than through continuing use. Within the meaning of IFRS 5, the term “sale” also includes exchanges for other
assets.
Non-current assets or asset groups held for sale must be available for immediate sale in their present condition, subject only to
terms that are usual and customary for sales of such assets, and a sale must be highly probable. Criteria used to determine
whether a sale is highly probable include:
•
the appropriate level of management must be committed to a plan to sell;
•
an active program to locate a buyer and complete the plan must have been initiated;
•
the asset must be actively marketed for sale at a price that is reasonable in relation to its current fair value;
•
completion of the sale should be foreseeable within the 12 months following the date of reclassification to
Assets held for
sale
; and
•
actions required to complete the plan should indicate that it is unlikely that significant changes to the plan will be made or that
the plan will be withdrawn.
Before initial reclassification of the non-current asset (or asset group) to
Assets held for sale
, the carrying amounts of the asset
(or of all the assets and liabilities in the asset group) must be measured in accordance with the applicable standards.
Subsequent to reclassification to
Assets held for sale
, the non-current asset (or asset group) is measured at the lower of carrying
amount or fair value less costs to sell, with any write-down recognized by means of an impairment loss. Once a non-current asset
has been reclassified as held for sale or exchange, it is no longer depreciated or amortized.
From the date of reclassification:
•
property, plant and equipment, right-of-use assets and intangible assets are no longer subject to individual depreciation,
amortization or impairment; and
•
the share of profits and losses from investments accounted for using the equity method is no longer recognized.
In a disposal of an equity interest leading to loss of control, all the assets and liabilities of the entity involved are classified as held
for sale assets or liabilities within the balance sheet line items
Assets held for sale
or
Liabilities related to assets held for sale
,
provided that the disposal satisfies the IFRS 5 classification criteria.
The profit or loss generated by a held for sale asset group is reported in a separate line item in the income statement for the
current period and for the comparative periods presented, provided that the asset group:
•
represents a separate major line of business or geographical area of operations; or
•
is part of a single coordinated plan to dispose of a separate major line of business or geographical area of operations; or
•
is a subsidiary acquired exclusively with a view to resale.
In accordance with IFRS 10, intragroup balances and transactions relating to held for sale entities are eliminated.
In the absence of any specific accounting treatment under IFRS 5, Sanofi has opted to eliminate transactions between
discontinued operations and continuing operations so as to reflect the impact of such transactions consistently with the way
they are presented in the income statement after effective loss of control.
Events or circumstances beyond Sanofi’s control may extend the period to complete the sale or exchange beyond one year
without precluding classification of the asset (or disposal group) in
Assets held for sale
provided that there is sufficient evidence
that Sanofi remains committed to the planned sale or exchange. Finally, in the event of changes to a plan of sale that requires an
asset no longer to be classified as held for sale, IFRS 5 specifies the following treatment:
•
the assets and liabilities previously classified as held for sale are reclassified to the appropriate balance sheet line items, with
no restatement of comparative periods;
•
each asset is measured at the lower of (a) its carrying amount before the asset was reclassified as held for sale, adjusted for
any depreciation, amortization or revaluation that would have been recognized if the asset had not been reclassified as held
for sale, or (b) its recoverable amount at the date of reclassification;
•
the backlog of depreciation, amortization and impairment not recognized while non-current assets were classified as held for
sale must be reported in the same income statement line item that was used to report impairment losses arising on initial
reclassification of assets as held for sale and gains or losses arising on the sale of such assets. In the consolidated income
statement, those impacts are reported within the line item
Other gains and losses, and litigation
;
•
the net income of a business previously classified as discontinued or as held for sale or exchange and reported on a separate
line in the income statement must be reclassified and included in net income from continuing operations, for all periods
presented; and
•
in addition, segment information relating to the income statement and the statement of cash flows (acquisitions of non-
current assets) must be disclosed in the notes to the financial statements in accordance with IFRS 8 (Operating Segments),
and must also be restated for all prior periods presented.
|
SANOFI
FORM 20-F
2024
|
F-19
|
|
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
|
B.8.
Financial instruments
B.8.1. Non-derivative financial assets
In accordance with IFRS 9 (Financial Instruments) and IAS 32 (Financial Instruments: Presentation), Sanofi has adopted the
classification of non-derivative financial assets described below. The classification used depends on (i) the characteristics of the
contractual cash flows (i.e. whether they represent interest or principal) and (ii) the business model for managing the asset
applied at the time of initial recognition.
Financial assets at fair value through other comprehensive
income
These mainly comprise:
•
quoted and unquoted equity investments that Sanofi does not hold for trading purposes and that management has
designated at “fair value through other comprehensive income” on initial recognition. Gains and losses arising from changes in
fair value are recognized in equity within the statement of comprehensive income in the period in which they occur. When
such instruments are derecognized, the previously-recognized changes in fair value remain within
Other comprehensive
income
, as does the gain or loss on divestment. Dividends received are recognized in profit or loss for the period, within the
line item
Financial income
; and
•
debt instruments whose contractual cash flows represent payments of interest or repayments of principal, and which are
managed with a view to collecting cash flows and selling the asset. Gains and losses arising from changes in fair value are
recognized in equity within the statement of comprehensive income in the period in which they occur. When such assets are
derecognized, the cumulative gains and losses previously recognized in equity are reclassified to profit or loss for the period
within the line items
Financial income
or
Financial expenses
.
Financial assets at fair value
through
profit or loss
These mainly comprise:
•
contingent consideration already carried in the books of an acquired entity or granted in connection with a business
combination;
•
instruments whose contractual cash flows represent payments of interest and repayments of principal, which are managed
with a
view to selling the
asset in the short term
;
•
instruments that management has designated at “fair value through profit or loss” on initial recognition; and
•
quoted and unquoted equity investments: equity instruments that are not held for trading and which management did not
designate at “fair value through other comprehensive income” on initial recognition, and instruments that do not meet the
IFRS definition of “equity instruments”.
Gains and losses arising from changes in fair value are recognized in profit or loss within the line items
Financial income
or
Financial expenses
. Dividends received are recognized in profit or loss for the period, within the line item
Financial income
.
Fair value of equity investments in unquoted entities
On initial recognition of an equity investment in an entity not quoted in an active market, the fair value of the investment is the
transaction price except in specific circumstances. This acquisition cost ceases to be a representative measure of the fair value of
an unquoted equity investment when Sanofi identifies significant changes in the investee, or in the environment in which it
operates. In such cases, an internal valuation is carried out, based mainly on growth forecasts or by reference to similar
transactions contracted with third parties.
Financial assets measured at amortized cost
Financial assets at amortized cost comprise instruments whose contractual cash flows represent payments of interest and
repayments of principal and which are managed with a view to collecting cash flows. The main assets in this category are loans
and receivables. They are presented within the line items
Other non-current assets
,
Other current assets
,
Accounts receivable
and
Cash and cash equivalents
. Loans with a maturity of more than 12 months are presented in “Long-term loans and
advances” within
Other non-current assets
. These financial assets are measured at amortized cost using the effective interest
method.
Impairment of financial assets measured at amortized cost
The main assets involved are accounts receivable. Accounts receivable are initially recognized at the amount invoiced to the
customer. Impairment losses on trade accounts receivable are estimated using the
expected credit loss
method, in order to take
account of the risk of payment default throughout the lifetime of the receivables. The
expected
credit loss is estimated
collectively for all accounts receivable at each reporting date using an average expected loss rate, determined primarily on the
basis of historical credit loss rates. However, that average expected loss rate may be adjusted if there are indications of a likely
significant increase in credit risk. If a receivable is subject to a known credit risk, a specific impairment loss is recognized for that
receivable. The amount of expected losses is recognized in the balance sheet as a reduction in the gross amount of accounts
receivable. Impairment losses on accounts receivable are recognized within
Selling and general expenses
in the income
statement.
|
F-20
|
SANOFI
FORM 20-F
2024
|
|
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
|
B.8.2. Derivative instruments
Derivative instruments that do not qualify for hedge accounting are initially and subsequently measured at fair value, with
changes in fair value recognized in the income statement in
Other operating income
or in
Financial income
or
Financial
expenses
, depending on the nature of the underlying economic item which is hedged.
Derivative instruments that qualify for hedge accounting are measured using the policies described in Note B.8.3. below.
IFRS 13 (Fair Value Measurement) requires counterparty credit risk to be taken into account when measuring the fair value of
financial instruments. That risk is estimated on the basis of observable, publicly-available statistical data.
Policy on offsetting
In order for a financial asset and a financial liability to be presented as a net amount in the balance sheet under IAS 32, there must
be:
(a) a legally enforceable right to offset; and
(b) the intention either to settle on a net basis, or to realize the asset and settle the liability simultaneously.
B.8.3. Hedging
As part of its overall market risk management policy, Sanofi enters into various hedging transactions involving derivative or non-
derivative instruments; these may include forward contracts, currency swaps or options, interest rate swaps or options, cross-
currency swaps, and debt placings or issues.
Such financial instruments are designated as hedging instruments and recognized using the hedge accounting principles
of IFRS 9 when (a) there is formal designation and documentation of the hedging relationship, of how the effectiveness of the
hedging relationship will be assessed, and of the underlying market risk management objective and strategy; (b) the hedged item
and the hedging instrument are eligible for hedge accounting; and (c) there is an economic relationship between the hedged
item and the hedging instrument, defined on the basis of a hedge ratio that is consistent with the underlying market risk
management strategy, and the residual credit risk does not dominate the value changes that result from that economic
relationship.
Fair value hedge
A fair value hedge is a hedge of the exposure to changes in fair value of an asset, liability or firm commitment that is attributable
to one or more risk components and could affect profit or loss.
Changes in fair value of the hedging instrument and changes in fair value of the hedged item attributable to the hedged risk
components are generally recognized in the income statement, within
Other operating income
for hedges related to operating
activities, or within
Financial income
or
Financial expenses
for hedges related to investing or financing activities.
Cash flow hedge
A cash flow hedge is a hedge of the exposure to variability in cash flows from an asset, liability or highly probable forecast
transaction that is attributable to one or more risk components and could affect profit or loss.
Changes in fair value of the hedging instrument attributable to the effective portion of the hedge are recognized directly in
equity in the consolidated statement of comprehensive income. Changes in fair value attributable to the ineffective portion of
the hedge are recognized in the income statement within
Other operating income
for hedges related to operating activities, and
within
Financial income
or
Financial expenses
for hedges related to investing or financing activities.
Cumulative changes in fair value of the hedging instrument previously recognized in equity are reclassified to the income
statement when the hedged transaction affects profit or loss. Those reclassified gains and losses are recognized within
Other
operating income
for hedges related to operating activities, and within
Financial income
or
Financial expenses
for hedges
related to investing or financing activities.
When a forecast transaction results in the recognition of a non-financial asset or liability, cumulative changes in the fair value of
the hedging instrument previously recognized in equity are incorporated in the initial carrying amount of that asset or liability.
When the hedging instrument expires or is sold, terminated or exercised, the cumulative gain or loss previously recognized in
equity remains separately recognized in equity and is not reclassified to the income statement, or recognized as an adjustment to
the initial cost of the related non-financial asset or liability, until the forecast transaction occurs. However, if Sanofi no longer
expects the forecast transaction to occur, the cumulative gain or loss previously recognized in equity is recognized immediately
in profit or loss.
Hedge of a net investment in a foreign operation
In a hedge of a net investment in a foreign operation, changes in the fair value of the hedging instrument attributable to the
effective portion of the hedge are recognized directly in equity in the consolidated statement of comprehensive income.
Changes in fair value attributable to the ineffective portion of the hedge are recognized in the income statement within
Financial income
or
Financial expenses
. When the investment in the foreign operation is sold, the changes in the fair value of
the hedging instrument previously recognized in equity are reclassified to the income statement within
Financial income
or
Financial expenses
.
|
SANOFI
FORM 20-F
2024
|
F-21
|
|
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
|
Cost of hedging
As part of its market risk management policy, Sanofi may designate currency options or interest rate options as hedging
instruments, the effectiveness of which is measured on the basis of changes in intrinsic value. In such cases, the time value of the
option is treated as a hedging cost and accounted for as follows:
•
if the option includes a component that is not aligned on the critical features of the hedged item, the corresponding change in
the time value is taken to profit or loss;
•
otherwise, the change in the time value is taken to equity within the statement of comprehensive income, and then:
–
if the hedged item is linked to a transaction that results in the recognition of a financial asset or liability, the change in the
time value is reclassified to profit or loss symmetrically with the hedged item, or
–
if the hedged item is linked to a transaction that results in the recognition of a non-financial asset or liability, the change in
the time value is incorporated in the initial carrying amount of that asset or liability, or
–
if the hedged item is linked to a period of time, the change in time value is reclassified to profit or loss on a straight line basis
over the life of the hedging relationship.
In the case of forward contracts and foreign exchange swaps, and of cross-currency swaps that qualify for hedge accounting on
the basis of changes in spot rates, Sanofi may elect for each transaction to use the option whereby the premium/discount or
foreign currency basis spread are treated in the same way as the time value of an option.
Discontinuation of hedge accounting
Hedge accounting is discontinued when the eligibility criteria are no longer met (in particular, when the hedging instrument
expires or is sold, terminated or exercised), or if there is a change in the market risk management objective of the hedging
relationship.
B.8.4. Non-derivative financial liabilities
Borrowings and debt
Bank borrowings and debt instruments are initially measured at fair value of the consideration received, net of directly
attributable transaction costs.
Subsequently, they are measured at amortized cost using the effective interest method. All costs related to the issuance of
borrowings or debt instruments, and all differences between
the
issue
proceeds
net of transaction costs
and the value on
redemption, are recognized within
Financial expenses
in the income statement over the term of the debt using the effective
interest method.
Liabilities related to business combinations and to non-controlling interests
These line items record the fair value of (i) contingent consideration payable in connection with business combinations and
(ii) commitments to buy out equity holders of subsidiaries, including put options granted to non-controlling interests.
Adjustments to the fair value of commitments to buy out equity holders of subsidiaries, including put options granted to non-
controlling interests, are recognized in equity.
Other non-derivative financial liabilities
Other non-derivative financial liabilities include trade accounts payable, which are measured at fair value (which in most cases
equates to face value) on initial recognition, and subsequently at amortized cost.
B.8.5. Fair value of financial instruments
Under IFRS 13 (Fair Value Measurement) and IFRS 7 (Financial Instruments: Disclosures), fair value measurements must be
classified using a hierarchy based on the inputs used to measure the fair value of the instrument. This hierarchy has three levels:
a.
level 1: quoted prices in active markets for identical assets or liabilities (without modification or repackaging);
b.
level 2: quoted prices in active markets for similar assets and liabilities, or valuation techniques in which all important inputs are
derived from observable market data; and
c.
level 3: valuation techniques in which not all important inputs are derived from observable market data.
|
F-22
|
SANOFI
FORM 20-F
2024
|
|
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
|
instruments.
|
Note
|
Type of financial instrument
|
Measurement
principle
|
Level in
fair value
hierarchy
|
Valuation
technique
|
Method used to determine fair value
|
||
|
Valuation
model
|
Market data
|
||||||
|
Exchange
rate
|
Interest
rate
|
||||||
|
D.7.
|
Financial assets measured at fair value
(quoted equity instruments)
|
Fair value
|
1
|
Market value
|
Quoted
market price
|
N/A
|
|
|
D.7.
|
Financial assets measured at fair value
(quoted debt instruments)
|
Fair value
|
1
|
Market value
|
Quoted market
price
|
N/A
|
|
|
D.7.
|
Financial assets measured at fair value
(unquoted equity instruments)
|
Fair value
|
3
|
Cost/
Approach
based on
comparables
|
If cost ceases to be a representative measure of fair value, an
internal valuation is carried out, based mainly on comparables.
|
||
|
D.7.
|
Financial assets measured at fair value
(contingent consideration receivable)
|
Fair value
|
3
|
Revenue-
based
approach
|
The fair value of contingent consideration receivable is
determined by adjusting the contingent consideration at
the end of the reporting period using the method described
in Note D.7.3.
|
||
|
D.7.
|
Financial assets measured at fair value
held to meet obligations under
post-employment benefit plans
|
Fair value
|
1
|
Market value
|
Quoted market
price
|
N/A
|
|
|
D.7.
|
Financial assets designated at fair value
held to meet obligations under deferred
compensation plans
|
Fair value
|
1
|
Market value
|
Quoted market
price
|
N/A
|
|
|
D.7.
|
Long-term loans and advances and other
non-current receivables
|
Amortized cost
|
N/A
|
N/A
|
The amortized cost of long-term loans and advances and other
non-current receivables at the end of the reporting period is
not materially different from their fair value.
|
||
|
D.13.
|
Investments in mutual funds
|
Fair value
|
1
|
Market value
|
Net asset value
|
N/A
|
|
|
D.13.
|
Negotiable debt instruments, commercial
paper, instant access deposits and term
deposits
|
Amortized cost
|
N/A
|
N/A
|
Because these instruments have a maturity of less than
three months, amortized cost is regarded as an acceptable
approximation of fair value as disclosed in the notes to
the consolidated financial statements.
|
||
|
D.17.1.,
D.19.
|
Debt
|
Amortized
cost
(a)
|
N/A
|
N/A
|
In the case of debt with a maturity of less than three months,
amortized cost is regarded as an acceptable approximation of
fair value as reported in the notes to the consolidated financial
statements.
For debt with a maturity of more than three months, fair value
as reported in the notes to the consolidated financial
statements is determined either by reference to quoted market
prices at the end of the reporting period (quoted instruments)
or by discounting the future cash flows based on observable
market data at the end of the reporting period (unquoted
instruments).
For financial liabilities based on variable payments such as
royalties, fair value is determined on the basis of discounted
cash flow projections.
|
||
|
D.17.2.
|
Lease liabilities
|
Amortized cost
|
N/A
|
N/A
|
The liability for future lease payments is discounted using
the incremental borrowing rate.
|
||
|
D.20.
|
Forward currency contracts
|
Fair value
|
2
|
Present value of
future cash flows
|
Mid
Market
|
< 1 year:
Mid Money Market
> 1 year:
Mid Zero Coupon
|
|
|
D.20.
|
Interest rate swaps
|
Fair value
|
2
|
Revenue-
based
approach
|
Present value of
future cash flows
|
Mid
Market
Spot
|
< 1 year:
Mid Money Market and
LIFFE interest rate futures
> 1 year:
Mid Zero Coupon
|
|
D.20.
|
Cross-currency swaps
|
Fair value
|
2
|
Present value of
future cash flows
|
Mid
Market
Spot
|
< 1 year:
Mid Money Market and
LIFFE interest rate futures
> 1 year:
Mid Zero Coupon
|
|
|
D.18.
|
Liabilities related to business combinations
and to non-controlling interests (CVRs)
|
Fair value
|
1
|
Market value
|
Quoted market
price
|
||
|
D.18.
|
Liabilities related to business combinations
and to non-controlling interests (other than
CVRs)
|
Fair value
|
3
|
Revenue-
based
approach
|
Under IAS 32, contingent consideration payable in a business
combination is a financial liability. The fair value of such
liabilities is determined by adjusting the contingent
consideration at the end of the reporting period using the
method described in Note B.8.4.
|
||
(a)
In the case of debt designated as a hedged item in a fair value hedging relationship, the carrying amount in the consolidated balance sheet includes
changes in fair value attributable to the hedged risk(s).
|
SANOFI
FORM 20-F
2024
|
F-23
|
|
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
|
B.8.6. Derecognition of financial instruments
Financial assets are derecognized when the contractual rights to cash flows from the asset have ended or have been transferred
and when Sanofi has transferred substantially all the risks and rewards of ownership of the asset. If Sanofi has neither transferred
nor retained substantially all the risks and rewards of ownership of a financial asset, it is derecognized if Sanofi does not retain
control of the asset.
A financial liability is derecognized when Sanofi’s contractual obligations in respect of the liability are discharged, cancelled or
extinguished.
B.8.7. Risks relating to financial instruments
Market risks in respect of non-current financial assets, cash equivalents, derivative instruments and debt are described in the
discussions of risk factors presented in “
Item 3. Key Information — D. Risk factors” and “Item 11. Quantitative and Qualitative
Disclosures about Market Risk”
of Sanofi’s annual report on Form 20-F for
2024
.
Credit risk is the risk that customers may fail to pay their debts.
For a description of credit risk, refer to “We are subject to the risk
of non-payment by our customers” within “Item 3. Key Information — D. Risk factors” and “Item 11. Quantitative and Qualitative
Disclosures about Market Risk” of Sanofi’s annual report on Form 20-F for
2024
.
B.9.
Inventories
Inventories are measured at the lower of cost or net realizable value. Cost is calculated using the weighted average cost method
or the first-in, first-out method, depending on the nature of the inventory.
The cost of finished goods inventories includes costs of purchase, costs of conversion and other costs incurred in bringing the
inventories to their present location and condition.
Net realizable value is the estimated selling price in the ordinary course of business less the estimated costs of completion and
the estimated costs necessary to make the sale.
During the launch phase of a new product, any inventories of that product are written down to zero pending regulatory approval,
other than in specific circumstances which make it possible to estimate that there is a high probability at the end of the reporting
period that the carrying amount of the inventories will be recoverable. The write-down is reversed once it becomes highly
probable that marketing approval will be obtained.
B.10.
Cash and cash equivalents
Cash and cash equivalents as shown in the consolidated balance sheet and statement of cash flows comprise cash, plus liquid
short-term investments that are readily convertible into cash and are subject to an insignificant risk of changes in value in the
event of movements in interest rates.
B.11.
Treasury shares
In accordance with IAS 32, Sanofi treasury shares are deducted from equity, irrespective of the purpose for which they are held.
B.12.
Provisions
for risks
In accordance with IAS 37 (Provisions, Contingent Liabilities and Contingent Assets), Sanofi records a provision when it has a
present obligation, whether 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
outflow of resources.
If the obligation is expected to be settled more than 12 months after the end of the reporting period, or has no definite settlement
date, the provision is recorded within
Non-current provisions and other non-current liabilities
.
Provisions relating to the insurance programs in which Sanofi’s captive insurance company participates are based on risk
exposure estimates calculated by management, with assistance from independent actuaries, using IBNR (Incurred But Not
Reported) techniques. Those techniques use past claims experience, within Sanofi and in the market, to estimate future trends in
the cost of claims.
Contingent liabilities are not recognized, but are disclosed in the notes to the financial statements unless the possibility of an
outflow of economic resources is remote.
Sanofi estimates provisions on the basis of events and circumstances related to present obligations at the end of the reporting
period and of past experience, and to the best of management’s knowledge at the date of preparation of the financial
statements.
Reimbursements offsetting the probable outflow of resources are recognized as assets only if it is virtually certain that they will
be received. Contingent assets are not recognized.
Restructuring provisions are recognized if Sanofi has a detailed, formal restructuring plan at the end of the reporting period and
has announced its intention to implement this plan to those affected by it.
|
F-24
|
SANOFI
FORM 20-F
2024
|
|
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
|
Sanofi records non-current provisions for certain obligations, such as legal or constructive obligations, where an outflow of
resources is probable and the amount of the outflow can be reliably estimated.
In the case of environmental risks, including at sites where operations are ongoing, Sanofi recognizes a provision where there is a
violation of integrity in respect of human health or the environment resulting from past contamination at a site that requires
remediation. The amount of the provision is a best estimate of the future expenditures to be incurred on the remediation plan.
Where the effect of the time value of money is material, those provisions are measured at the present value of the expenditures
expected to be required to settle the obligation, calculated using a discount rate that reflects an estimate of the time value of
money and the risks specific to the obligation.
Increases in provisions to reflect the effects of the passage of time are recognized within
Financial expenses
.
B.13.
Revenue recognition
B.13.1. Net sales
Revenue arising from the sale of goods is presented in the income statement within
Net sales
. Net sales comprise revenue from
sales of medicines, vaccines and active ingredients, net of sales returns, of customer incentives and discounts, and of certain
sales-based payments paid or payable to the healthcare authorities. Analyses of net sales are provided in Note D.34.1. “ Analysis
of net sales”.
In accordance with IFRS 15 (Revenue from Contracts with Customers), such revenue is recognized when Sanofi transfers control
over the product to the customer; control of an asset refers to the ability to direct the use of, and obtain substantially all of the
remaining benefits from that asset. For the vast majority of contracts, revenue is recognized when the product is physically
transferred, in accordance with the delivery and acceptance terms agreed with the customer.
For contracts entered into by Vaccines franchise, transfer of control is usually determined by reference to the terms of release
(immediate or deferred) and acceptance of batches of vaccine.
In the case of contracts with distributors, Sanofi does not recognize revenue when the product is physically transferred to the
distributor if the products are sold on consignment, or if the distributor acts as agent. In such cases, revenue is recognized when
control is transferred to the end customer, and the distributor’s commission is presented within the line item
Selling and general
expenses
in the income statement.
The amount of revenue recognized reflects the various types of price reductions or rights of return offered by Sanofi to its
customers on certain products. Such price reductions and rights of return qualify as variable consideration under IFRS 15.
In particular, products sold in the United States are covered by various Government and State programs (such as Medicare and
Medicaid) under which products are sold at a discount. Rebates are granted to healthcare authorities, and under contractual
arrangements with certain customers. Some wholesalers are entitled to chargeback incentives based on the selling price to the
end customer, under specific contractual arrangements. Cash discounts may also be granted for prompt payment. Returns,
discounts, incentives and rebates, as described above, are recognized in the period in which the underlying sales are recognized
as a reduction of
gross sales
.
These amounts are calculated as follows:
•
the amount of chargeback incentives is estimated on the basis of the relevant subsidiary’s standard sales terms and
conditions, and in certain cases on the basis of specific contractual arrangements with the customer;
•
the amount of rebates based on attainment of sales targets is estimated and accrued as each of the underlying sales
transactions is recognized;
•
the amount of price reductions under Government and State programs, largely in the United States, is estimated on the basis
of the specific terms of the relevant regulations or agreements, and accrued as each of the underlying sales transactions is
recognized; and
•
the amount of sales returns is calculated on the basis of management’s best estimate of the amount of product that will
ultimately be returned by customers. In countries where product returns are permitted, Sanofi operates a returns policy that
allows the customer to return products within a certain period either side of the expiry date (usually 12 months after the expiry
date). The amount recognized for returns is estimated on the basis of past experience of sales returns. Sanofi also takes into
account factors such as levels of inventory in its various distribution channels, product expiry dates, information about
potential discontinuation of products, the entry of competing generics into the market, and the launch of over-the-counter
medicines. Most product return clauses relate solely to date-expired products, which cannot be resold and are destroyed.
Sanofi does not recognize a right of return asset in the balance sheet for contracts that allow for the return of time-expired
products, since those products have no value.
|
SANOFI
FORM 20-F
2024
|
F-25
|
|
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
|
The estimated amounts described above are recognized in the income statement within
Net sales
as a reduction of gross sales,
and within
Other current liabilities
in the balance sheet. They are subject to regular review and adjustment as appropriate based
on the most recent data available to management. Sanofi believes that it has the ability to measure each of the above amounts
reliably, using the following factors in developing its estimates:
•
the nature and patient profile of the underlying product;
•
the applicable regulations or the specific terms and conditions of contracts with governmental authorities, wholesalers and
other customers;
•
historical data relating to similar contracts, in the case of qualitative and quantitative rebates and chargeback incentives;
•
past experience and sales growth trends for the same or similar products;
•
actual inventory levels in distribution channels, monitored by Sanofi using internal sales data and externally provided data;
•
the shelf life of Sanofi products; and
•
market trends including competition, pricing and demand.
An analysis of provisions for discounts, rebates and sales returns is provided in Note D.23.
B.13.2. Other revenues
The line item
Other revenues
is used to recognize all revenue that falls within the scope of IFRS 15 but does not relate to sales of
Sanofi products.
It mainly comprises (i) royalties received from licensing intellectual property rights to third parties; (ii) VaxServe sales of products
sourced from third-party manufacturers; and (iii) revenue received under agreements for Sanofi to provide manufacturing
services to third parties.
Royalties received under licensing arrangements are recognized over the period during which the underlying sales are
recognized.
VaxServe is a vaccines related entity whose operations include the distribution within the United States of vaccines and
other products manufactured by third parties. VaxServe sales of products sourced from third-party manufacturers are presented
within
Other revenues
.
Other revenues
is also used to recognize revenues arising from the manufacturing of
Consumer Healthcare
products by legal
entities within the scope of continuing operations on behalf of legal entities within the scope of discontinued operations (see
Note B.7.).
Other revenues
includes revenues associated with Consumer Healthcare operations not transferred on the effective date of loss
of control of Opella. These comprise primarily, but not exclusively, Consumer Healthcare activities that will not be transferred on
the effective date of loss of control of Opella, primarily (i) hospital sales of Opella products in China, the transfer of which will be
finalized no earlier than 2028 after a transitional period required to complete the transfer plan agreed with Sanofi in the context
of public tendering arrangements ; (ii) sales made by the dedicated entity Opella Russie, the equity interests in which will be
retained by Sanofi. Sanofi will continue to distribute Opella products in Russian territory under the distribution agreement signed
in connection with the separation, the parties reserving the right to discuss the transfer of this retained interest during the
distribution agreement term ; and
(iii) sales of the Gold Bond product range, which are continuing in the United States through
the retained subsidiary Gold Bond LLC (holder of the associated worldwide property rights)
.
B.14.
Cost of sales
Cost of sales
consists primarily of the industrial cost of goods sold, royalties paid for in-licensing of intellectual property, and
distribution costs. The industrial cost of goods sold includes the cost of materials, depreciation of
property, plant and equipment
,
amortization of software, personnel costs, and other expenses attributable to prod
uction
.
This line also includes the purchase
price of manufactured pharmaceutical products sourced from Opella.
B.15.
Research and development
Note B.4.1. “Research and development not acquired in a business combination” and Note B.4.3. “Other intangible assets
acquired in a business combination” describe the principles applied to the recognition of research and development costs.
Contributions or reimbursements received from alliance partners are recorded as a reduction of
Research and development
expenses
.
B.16.
Other operating income and expenses
B.16.1. Other operating income
Other operating income
includes the share of profits that Sanofi is entitled to receive from alliance partners in respect of
product marketing agreements. It also includes revenues generated under certain agreements, which may include partnership,
co-promotion arrangements and licenses not included in
Other revenues
.
This line item also includes realized and unrealized foreign exchange gains and losses on operating activities (see Note B.8.3.), and
operating gains on disposals not regarded as major disposals (see Note B.20.).
|
F-26
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FORM 20-F
2024
|
|
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
|
B.16.2. Other operating expenses
Other operating expenses
mainly comprise the share of profits that alliance partners are entitled to receive from Sanofi under
product marketing agreements.
B.17.
Amortization and impairment of intangible assets
B.17.1. Amortization of intangible assets
The expenses recorded in this line item comprise amortization charged against intangible assets (products, trademarks and
technology platforms, see Note D.4.) whose contribution to Sanofi’s commercial, industrial and development functions cannot be
separately identified.
Amortization of software, and of other rights of an industrial or operational nature, is recognized as an expense in the income
statement, in the relevant line items of expense by function.
B.17.2. Impairment of intangible assets
This line item records impairment losses taken against intangible assets (products, trademarks, technology platforms and
acquired research), and any reversals of such impairment losses.
B.18.
Fair value remeasurement of contingent consideration
Changes in the fair value of contingent consideration that was (i) already carried in the books of an acquired entity, or (ii) granted
in connection with a business combination and initially recognized as a liability in accordance with IFRS 3, are reported in profit or
loss. Such adjustments are reported separately in the income statement, in the line item
Fair value remeasurement of
contingent consideration
.
This line item also includes changes in the fair value of contingent consideration receivable in connection with a divestment and
classified as a financial asset at fair value through profit or loss.
Finally, it includes the effect of the unwinding of discount, and of exchange rate movements where the asset or liability is
expressed in a currency other than the functional currency of the reporting entity.
B.19.
Restructuring costs and similar items
Restructuring costs are expenses incurred in connection with the transformation or reorganization of Sanofi’s operations or support
functions.
Such
costs include collective redundancy plans, compensation to third parties for early termination of contracts, and
commitments made in connection with transformation or reorganization decisions. They also include accelerated depreciation
charges arising from site closures (including closures of leased sites), and losses on asset disposals resulting from such decisions.
In addition, this line item includes expenses incurred in connection with programs implemented as part of the transformation
strategy announced in December 2019 and recently renewed in October 2023, and intended primarily to deliver a global
information systems solution, further supported by the implementation from 2021 of Sanofi’s n
ew digital strategy
.
B.20.
Other gains and losses, and litigation
The line item
Other gains and losses, and litigation
includes the impact of material transactions of an unusual nature or amount
which Sanofi believes it necessary to report separately in the income statement in order to improve the relevance of the financial
statements, such as:
•
gains and losses on major disposals of property, plant and equipment, of intangible assets, of assets (or groups of assets and
liabilities) held for sale, or of a business within the meaning of IFRS 3, other than those considered to be restructuring costs;
•
impairment losses and reversals of impairment losses on assets (or groups of assets and liabilities) held for sale, other than
those considered to be restructuring costs;
•
gains on bargain purchases;
•
costs relating to major litigation; and
•
pre-tax separation costs associated with the process of disinvesting from operations in the event of a major divestment.
B.21.
Financial expenses and income
B.21.1. Financial expenses
Financial expenses
mainly comprise interest charges on Sanofi's debt financing; negative changes in the fair value of certain
financial instruments (where changes in fair value are recognized in profit or loss); realized and unrealized foreign exchange losses
on financing and investing activities; impairment losses on financial instruments; and any reversals of impairment losses on
financial instruments.
Financial expenses
also include expenses arising from the unwinding of discount on long-term provisions, and the net interest
cost related to employee benefits. This line item does not include commercial cash discounts, which are deducted from net sales.
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SANOFI
FORM 20-F
2024
|
F-27
|
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NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
|
B.21.2. Financial income
Financial income
includes interest and dividend income; positive changes in the fair value of certain financial instruments (where
changes in fair value are recognized in profit or loss); realized and unrealized foreign exchange gains on financing and investing
activities; and gains on disposals of financial assets at fair value through profit or loss.
B.22.
Income tax expense
Income tax expense
includes all current and deferred taxes of consolidated companies.
Sanofi accounts for deferred taxes in accordance with IAS 12 (Income Taxes), using the methods described below:
•
deferred tax assets and liabilities are recognized on taxable and deductible temporary differences, and on tax loss carry-
forwards. Temporary differences are differences between the carrying amount of an asset or liability in the balance sheet and
its tax base;
•
French business taxes include a value added based component: “CVAE”
(Cotisation sur la Valeur Ajoutée des Entreprises)
.
Given that CVAE is (i) calculated as the amount by which certain revenues exceed certain expenses and (ii) borne primarily by
companies that own intellectual property rights on income derived from those rights (royalties, and margin on sales to third
parties and to Sanofi entities), it is regarded as meeting the definition of income taxes specified in IAS 12, paragraph 2 (“taxes
which are based on taxable profits”);
•
deferred tax assets and liabilities are calculated using the tax rate expected to apply in the period when the corresponding
temporary differences are expected to reverse, based on tax rates enacted or substantively enacted at the end of the
reporting period;
•
deferred tax assets are recognized in respect of deductible temporary differences, tax losses available for carry-forward and
unused tax credits to the extent that future recovery is regarded as probable. The recoverability of deferred tax assets is
assessed on a case-by-case basis, taking into account the profit forecasts contained in Sanofi’s medium-term business plan;
•
a deferred tax liability is recognized for temporary differences relating to interests in subsidiaries, associates and joint
ventures, except in cases where Sanofi is able to control the timing of the reversal of the temporary differences. This applies in
particular when Sanofi is able to control dividend policy and it is probable that the temporary differences will not reverse in the
foreseeable future;
•
no deferred tax is recognized on eliminations of intragroup transfers of interests in subsidiaries, associates or joint ventures;
•
each tax entity calculates its own net deferred tax position. All net deferred tax asset and liability positions are then
aggregated and shown in separate line items on the relevant side of the consolidated balance sheet. Deferred tax assets and
liabilities are offset only if (i) Sanofi has a legally enforceable right to offset current tax assets and current tax liabilities, and
(ii) the deferred tax assets and deferred tax liabilities relate to income taxes levied by the same taxation authority;
•
deferred taxes are not discounted, except implicitly in the case of deferred taxes on assets and liabilities which are already
impacted by discounting. In addition, Sanofi has elected not to discount current taxes payable or receivable where the
amounts in question are payable or receivable in the long term; and
•
withholding taxes on intragroup royalties and dividends, and on royalties and dividends collected from third parties, are
accounted for as current income taxes.
In accounting for business combinations, Sanofi complies with IFRS 3 as regards the recognition of deferred tax assets after the
initial accounting period. Consequently, any deferred tax assets recognized by the acquiree after the end of that period in
respect of temporary differences or tax loss carry-forwards existing at the acquisition date are recognized in profit or loss.
The positions adopted by Sanofi in tax matters are based on its interpretation of tax laws and regulations. Some of those positions
may be subject to uncertainty. In such cases, Sanofi assesses the amount of the tax liability on the basis of the following
assumptions: that its position will be examined by one or more tax authorities on the basis of all relevant information; that a technical
assessment is carried out with reference to legislation, case law, regulations, and established practice; and that each position is
assessed individually (or collectively where appropriate), with no offset or aggregation between positions. Those assumptions are
assessed on the basis of facts and circumstances existing at the end of the reporting period. When an uncertain tax liability is
regarded as probable, it is measured on the basis of Sanofi’s best estimate and recognized as a liability; uncertain tax assets are not
recognized. The amount of the liability includes any penalties and late payment interest. The line item
Income tax expense
includes
the effects of tax reassessments and tax disputes, and any penalties and late payment interest arising from such disputes that have
the characteristics of income taxes within the meaning of paragraph 2 of IAS 12 (“taxes which are based on taxable profits”). Tax
exposures relating to corporate income taxes are presented separately within
Non-current income tax liabilities
(see Note D.19.4.).
taxed income (GILTI) provisions. The related tax expense is recognized in the year in which it is declared in the tax return to the
extent that it arises from the existence of non-US profits that exceed the theoretical return on investment specified in the
GILTI provisions and are taxed at a rate lower than the applicable US tax rate.
As a reminder, Sanofi has applied in its consolidated financial statements “International Tax Reform – Pillar Two Model Rules”, an
amendment to IAS 12 issued by the IASB on May 23, 2023, and has not recognized deferred tax on temporary differences related
to Pillar Two rules.
In accordance with IAS 1 (Presentation of Financial Statements), current income tax assets and liabilities are presented as
separate line items in the consolidated balance sheet.
|
F-28
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SANOFI
FORM 20-F
2024
|
|
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
|
B.23.
Employee benefit obligations
Sanofi offers retirement benefits to employees and retirees. Such benefits are accounted for in accordance with IAS 19 (Employee
Benefits).
Benefits are provided in the form of either defined contribution plans or defined benefit plans. In the case of defined contribution
plans, the cost is recognized immediately in the period in which it is incurred, and equates to the amount of the contributions paid
by Sanofi. For defined benefit plans, Sanofi recognizes its obligations to pay pensions and similar benefits to employees as a liability,
based on an actuarial estimate of the rights vested or currently vesting in employees and retirees, using the projected unit credit
method. Estimates are performed at least once a year, and rely on financial assumptions (such as discount rates, the inflation rate
and the rate of salary increases) and demographic assumptions (such as life expectancy, retirement age and employee turnover).
Obligations relating to other post-employment benefits (healthcare and
life insurance
) offered by Sanofi companies to
employees are also recognized as a liability based on an actuarial estimate of the rights vested or currently vesting in employees
and retirees at the end of the reporting period.
Such liabilities are recognized net of the fair value of plan assets.
In the case of multi-employer defined benefit plans where plan assets cannot be allocated to each participating employer with
sufficient reliability, the plan is accounted for as a defined contribution plan, in accordance with paragraph 34 of IAS 19.
The benefit cost for the period consists primarily of current service cost, past service cost, net interest cost, gains or losses arising
from plan settlements not specified in the terms of the plan, and the impact of plan curtailments. Net interest cost for the period
is determined by applying the opening
discount rate
specified in IAS 19 to the net liability (i.e. the amount of the obligation, net of
plan assets) recognized in respect of defined benefit plans. Past service cost is recognized immediately in profit or loss in the
period in which it is incurred, regardless of whether or not the rights have vested at the time of adoption (in the case of a new
plan) or of amendment (in the case of an existing plan).
Actuarial gains and losses on defined benefit plans (pensions and other post-employment benefits), also referred to
as “Remeasurements of the net defined benefit liability (asset)”
,
arise as a result of changes in financial and demographic
assumptions, experience adjustments, and the difference between the actual return and the return on plan assets included in the
calculation of the net interest cost. The impacts of those remeasurements are recognized in
Other comprehensive income
, net
of deferred taxes; they are not subsequently reclassifiable to profit or loss.
B.24.
Share-based payment
Share-based payment expense is recognized as a component of operating income, in the relevant classification of expense by
function. In measuring the expense, the level of attainment of any performance conditions is taken into account.
B.24.1. Stock option plans
Sanofi has granted a number of equity-settled share-based payment plans (stock option plans) to some of its employees. The
terms of those plans may make the award contingent on the attainment of performance criteria for some of the grantees.
In accordance with IFRS 2 (Share-Based Payment), services received from employees as consideration for stock options are
recognized as an expense in the income statement, with the opposite entry recognized in equity. The expense corresponds to the
fair value of the stock option plans, and is charged to income on a straight-line basis over the
four
-year
vesting period of the plan.
The fair value of stock option plans is measured at the date of grant using the Black-Scholes valuation model, taking into account
the expected life of the options. The resulting expense also takes into account the expected cancellation rate of the options.
The
expense is adjusted over the vesting period to reflect (i) actual cancellation rates resulting from option-holders ceasing to be
employed by Sanofi and (ii) attainment of non-market performance conditions.
B.24.2. Employee share ownership plans
Sanofi may offer its employees the opportunity to subscribe to reserved share issues at a discount to the reference market price. Shares
awarded to employees under such plans fall within the scope of IFRS 2.
Consequently, an expense is recognized at the subscription
date, based on the value of the discount offered to employees, with
the opposite entry
recognized in equity.
B.24.3. Restricted share plans
Sanofi may award restricted share plans to certain of its employees. The terms of those plans may make the award contingent on
the attainment of performance criteria for some of the grantees.
In accordance with IFRS 2, an expense equivalent to the fair value of such plans is recognized in profit or loss on a straight line
basis over the vesting period of the plan, with the opposite entry recognized in equity. The vesting period is
three years
.
The fair value of restricted share plans is based on the quoted market price of Sanofi shares at the date of grant, adjusted for
expected dividends during the vesting period; it also takes account of any vesting conditions contingent on stock market
performance, measured using the Monte-Carlo valuation model. Other vesting conditions are taken into account in the estimate
of the number of shares awarded during the vesting period; that number is then definitively adjusted based on the actual number
of shares awarded on the vesting date.
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SANOFI
FORM 20-F
2024
|
F-29
|
|
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
|
B.25.
Earnings per share
Basic earnings per share is calculated using the weighted average number of shares outstanding during the reporting period,
adjusted on a time-weighted basis from the acquisition date to reflect the number of own shares held by Sanofi. Diluted earnings
per share is calculated on the basis of the weighted average number of ordinary shares, computed using the treasury stock method.
This method assumes that (i) all outstanding dilutive options and warrants are exercised, and (ii) Sanofi acquires its own shares at
the quoted market price for an amount equivalent to the cash received as consideration for the exercise of the options or
warrants, plus the expense arising on unamortized stock options.
In accordance with IFRS 8 (Operating Segments), the segment information reported by Sanofi is prepared on the basis of internal
management data provided to our Chief Executive Officer, who is the chief operating decision maker of Sanofi. The performance
of the segment is monitored individually using internal reports and indicators.
Information about operating segments in accordance with IFRS 8 is presented in Note D.35., “Segment information”.
C.1. Alliance arrangements with Regeneron Pharmaceuticals, Inc. (Regeneron)
Collaboration agreements on human therapeutic antibodies
In November 2007, Sanofi and Regeneron signed
two
agreements (amended in November 2009) relating to human therapeutic
antibodies: (i) the Discovery and Preclinical Development Agreement, and (ii) the License and Collaboration Agreement, relating
to clinical development and commercialization. Under the License and Collaboration Agreement, Sanofi had an option to develop
and commercialize antibodies discovered by Regeneron under the Discovery and Preclinical Development Agreement.
Discovery and development
Because Sanofi decided not to exercise its option to extend the Discovery and Preclinical Development Agreement, that
agreement expired on December 31, 2017.
As a result of Sanofi’s exercise of an option with respect to an antibody under the Discovery and Preclinical Development
Agreement, such antibody became a “Licensed Product” under the License and Collaboration Agreement, pursuant to which
Sanofi and Regeneron co-develop the antibody with Sanofi initially being wholly responsible for funding the development
program. On receipt of the first positive Phase 3 study results for any antibody being developed under the License and
Collaboration Agreement, the subsequent development costs for that antibody are split
80
%
Sanofi,
20
%
Regeneron. Amounts
received from Regeneron under the License and Collaboration Agreement are recognized by Sanofi as a reduction in the line
item
Research and development expenses
. Co-development with Regeneron of the antibodies Dupixent, Kevzara and
REGN3500 (SAR440340 - itepekimab) is ongoing under the License and Collaboration Agreement as of December 31, 2024.
Once a product begins to be commercialized, and provided that the share of quarterly results under the agreement represents a
profit, Sanofi is entitled to an additional portion of Regeneron’s profit-share (capped at
20
%
of Regeneron’s share of quarterly
profits since April 1, 2022, and at
10
%
until March 31, 2022) until Regeneron has paid
50
%
of the cumulative development costs
incurred by the parties in the collaboration (see Note D.21.1.).
On the later of (i)
24
months
before the scheduled launch date or (ii) the first positive Phase 3 study results, Sanofi and Regeneron
share the commercial expenses of the antibodies co-developed under the License and Collaboration Agreement.
Commercialization
Sanofi is the lead party with respect to the commercialization of all co-developed antibodies, and Regeneron has certain option
rights to co-promote the antibodies. Regeneron has exercised its co-promotion rights in the United States and in certain other
countries. Sanofi recognizes all sales of the antibodies. Profits and losses arising from commercial operations in the United States
are split
50
/50. Outside the United States, Sanofi is entitled to between
55
%
and
65
%
of profits depending on sales of the
antibodies, and bears
55
%
of any losses. The share of profits and losses due to or from Regeneron under the agreement is
recognized within the line items
Other operating income
or
Other operating expenses
, which are components of
Operating
income
.
In addition, Regeneron is entitled to receive payments contingent on the attainment of specified levels of aggregate sales on all
antibodies outside the United States, on a rolling twelve-month basis. The opposite entry for that liability is capitalized within
Other intangible assets
on the balance sheet.
Two
payments of
$
50
million
each were made in 2022, following attainment first
of
$
2.0
billion
and then of
$
2.5
billion
in sales of all antibodies outside the United States on a rolling twelve-month basis. The final
milestone payment of
$
50
million
, payable to Regeneron in the event that
$
3.0
billion
in sales on a rolling twelve-month basis is
attained, was made in 2023
.
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F-30
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SANOFI
FORM 20-F
2024
|
|
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
|
Amendments to the collaboration agreements
In January 2018, Sanofi and Regeneron signed a set of amendments to their collaboration agreements, including an amendment
that allowed for the funding of additional programs on Dupixent and REGN3500 (SAR440340 – itepekimab) with an intended
focus on extending the current range of indications, finding new indications, and improving co-morbidity between multiple
pathologies.
Effective April 1, 2020, Sanofi and Regeneron signed a Cross License and Commercialization Agreement for Praluent, whereby
Sanofi obtained sole ex-US rights to Praluent, and Regeneron obtained sole US rights to Praluent along with a right to
5
%
royalties on Sanofi’s sales of Praluent outside the United States. Each party is solely responsible for funding the development,
manufacturing and commercialization of Praluent in their respective territories. Although each party has sole responsibility for
supplying Praluent in its respective territory, Sanofi and Regeneron entered into agreements to support manufacturing needs for
each other.
Effective September 30, 2021, Sanofi and Regeneron signed an amendment to their collaboration agreement in order to specify
allocations of responsibilities and associated resources between the two parties in connection with the co-promotion of Dupixent
in certain countries. The terms of the collaboration relating to REGN3500 (SAR440340 – itepekimab) are unchanged.
Effective July 1, 2022, Sanofi and Regeneron signed an amendment to their collaboration agreement in order to increase the
additional portion of Regeneron’s quarterly profit-share attributable to Sanofi from
10
%
to
20
%
with retroactive impact as of
April 1, 2022.
Immuno-oncology (IO) collaboration agreements
On July 1, 2015, Sanofi and Regeneron signed
two
agreements – the IO Discovery and Development Agreement and the IO
License and Collaboration Agreement (IO LCA) – relating to new antibody cancer treatments in the field of immuno-oncology.
The Amended IO Discovery Agreement, effective from December 31, 2018, was terminated through a Letter Amendment dated
March 16, 2021 in which Sanofi formalized its opt-out from the BCMAxCD3 and MUC16xCD3 programs.
LIBTAYO
(cemiplimab)
Under the 2015 IO LCA as amended in January 2018, Sanofi and Regeneron committed funding of no more than
$
1,640
million
,
split on a
50
/50 basis (
$
820
million
per company), for the development of REGN2810 (cemiplimab, trademark Libtayo), a PD-1
inhibitor antibody. The funding was raised to
$
1,840
million
by way of amendment effective on September 30, 2021. Regeneron
was responsible for the commercialization of Libtayo in the United States, and Sanofi in all other territories. Sanofi has exercised
its option to co-promote Libtayo in the United States. In 2021, Regeneron exercised its option to co-promote Libtayo in certain
other countries.
The IO LCA also provided for a one-time milestone payment of
$
375
million
by Sanofi to Regeneron in the event that sales of a
PD-1 product were to exceed, in the aggregate,
$
2
billion
in any consecutive 12-month period.
Under the IO LCA Sanofi and Regeneron shared equally in profits and losses generated by the commercialization of collaboration
products, except that Sanofi was entitled to an additional portion of Regeneron’s profit-share (capped at
10
%
of Regeneron’s
share of quarterly profits) until Regeneron had paid
50
%
of the cumulative development costs incurred by the parties under the
IO Discovery Agreement, as amended.
In June 2022, Sanofi and Regeneron restructured their IO LCA. Under the terms of the Amended and Restated IO LCA,
Regeneron holds exclusive worldwide licensing rights to Libtayo with effect from July 1, 2022.
In July 2022, Sanofi received as consideration an upfront payment of
$
900
million
(
€
856
million
), which was recognized within
Other operating income
on the date of receipt. The same line item also includes a regulatory milestone payment of
$
100
million
(
€
96
million
) following the US FDA approval in November 2022 of Libtayo in combination with chemotherapy as a first line
treatment for NSCLC (non-small cell lung cancer). In addition, Sanofi is entitled to royalties of
11
%
and to milestone payments
(
€
116
million
in 2023,
€
111
million
in 2022) linked to global net sales of Libtayo; those royalties are recognized within
Other
operating income
in line with the pattern of sales
. All of the cash inflows relating to the above items (
€
117
million
in 2024,
€
196
million
in 2023,
€
952
million
in 2022) are presented within
Net cash provided by/(used in) operating activities
in the
consolidated statement of cash flows.
The amendment to the terms of the IO LCA resulted in Sanofi recognizing an accelerated amortization charge of
€
226
million
in 2022
; this was allocated to the Libtayo product rights included within the residual carrying amount of the intangible asset
recognized in July 2015 to reflect rights to an antibody targeting the immune checkpoint receptor PD-1 (programmed cell death
protein-1) under the Sanofi/Regeneron alliance.
The transaction also includes time-limited transitional services agreements with Regeneron which include manufacturing,
distribution (for which Sanofi acts as agent), and promotion.
Investor agreement
In 2014 and 2020, Sanofi and Regeneron amended the investor agreement entered into by the two companies in 2007. Under
the terms of the amendments, Sanofi accepted various restrictions, including “standstill” provisions that contractually prohibit
Sanofi from seeking to directly or indirectly exert control of Regeneron or acquiring more than
30
%
of Regeneron’s capital stock
(consisting of the outstanding shares of common stock and the shares of Class A stock). This prohibition remains in place until the
earlier of (i) the later of the fifth anniversaries of the expiration or earlier termination of the Zaltrap collaboration agreement with
|
SANOFI
FORM 20-F
2024
|
F-31
|
|
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
|
Regeneron (related to the development and commercialization of Zaltrap) or the collaboration agreement with Regeneron on
monoclonal antibodies (see “Collaboration agreements on human therapeutic antibodies” above), each as amended or (ii) other
specified events.
Starting in 2018 Sanofi began to sell shares of Regeneron stock and announced on May 29, 2020 the closing of its sale of
Pursuant to subsequent sales in 2022, Sanofi no longer holds any shares of Regeneron stock, as of December 31, 2024.
C.2. Agreements on the commercialization of Beyfortus
(nirsevimab, previously MEDI8897) in the US
On March 1, 2017, Sanofi and AstraZeneca entered into an agreement to develop and commercialize a monoclonal antibody
(MEDI8897, nirsevimab) for the prevention of Respiratory Syncytial Virus (RSV) associated illness in newborns and infants.
Under the terms of the agreement, Sanofi made an upfront payment of
€
120
million
in March 2017, a development milestone
payment of
€
30
million
in the third quarter of 2019, a regulatory milestone payment of
€
25
million
associated with the approval of
Beyfortus (nirsevimab) by the EMA in Europe in November 2022, and a regulatory milestone payment of
€
65
million
associated
with the approval of Beyfortus (nirsevimab) by the US FDA in July 2023.
In addition, Sanofi could pay AstraZeneca up to
€
375
million
if sales objectives are met
. Those amounts are recognized as a
component of the value of the intangible asset when payment becomes probable. In 2024, payments of
€
25
million
and of
€
50
million
were made, and an amount of €
100
million
was recognized as an accrued expense further to a contractual threshold
being met.
The agreement also specifies that AstraZeneca is responsible for development and manufacturing, and Sanofi for
commercialization. Sanofi recognizes the sales and cost of sales (purchases of finished products from AstraZeneca) and shares
the Alliance’s commercial profits (i)
50
/
50
in major territories and (ii) based on
25
%
of net sales in other territories. The share of
commercial profits and losses due to or from AstraZeneca is recognized as a component of operating income, within the line
items
Other operating income
or
Other operating expenses
. In addition, Sanofi and AstraZeneca share development costs
50
/50, with Sanofi’s portion recognized within the income statement line item
Research and development expenses
.
On April 9, 2023, Sanofi and AstraZeneca simplified their contractual agreements for the development and commercialization of
Beyfortus (nirsevimab) in the US. Sanofi thereby obtained control of all commercial rights to Beyfortus (nirsevimab) in the US, and
ended the sharing of commercial profits between the two partners in that territory. In line with the terms of the revised
agreements and in accordance with IAS 38, Sanofi recognized an intangible asset of
€
1.6
billion
for the fair value of the additional
US rights. On the same date, AstraZeneca and Sobi ended their participation agreement, signed in 2018, which transferred the
economic rights for the US territory to Sobi.
Sanofi simultaneously entered into an agreement with Sobi relating to direct royalties on US net sales of Beyfortus (nirsevimab). In
line with the terms of that agreement, on April 9, 2023 Sanofi recognized a financial liability amounting to
€
1.6
billion
. That liability
is classified as a financial liability at amortized cost under IFRS 9. Other than royalty payments, subsequent movements in the
liability comprise (i) the unwinding of discount and (ii) changes in estimates of future cash outflows for royalty payments. Those
movements will be recognized in the income statement within
Net financial income/(expenses)
in accordance with paragraph
B.5.4.6 of IFRS 9.
As of December 31, 2024 the liability was remeasured by an amount of
€
291
million
.
As of December 31, 2023 the liability was
remeasured by an amount of
€
541
million
, reflecting the strong success of the US launch of Beyfortus, which led to sales
forecasts being revised upward from the initial estimate. The resulting adjustment was recognized within
Financial expenses
.
For territories other than the US (except for China, which is now considered a “major market,” with profits/losses shared
50
/50
with AstraZeneca), the existing agreement between AstraZeneca and Sanofi continues to govern the principal terms of the
collaboration: Sanofi recognizes the sales and cost of sales and shares the Alliance’s commercial profits with AstraZeneca.
In May 2023, data from the HARMONIE Phase 3b study confirmed that nirsevimab prevents infant hospitalizations due to RSV
with consistent and high efficacy.
Beyfortus was approved in Europe in November 2022, in the United States in July 2023, and in a number of other countries
(including China and Japan) in 2024.
|
F-32
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SANOFI
FORM 20-F
2024
|
|
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
|
D/
Presentation of the financial statements
D.1.1.
Significant transactions of
2024
D.1.1.1. Acquisition of Inhibrx, Inc
On
May 30, 2024
, Sanofi completed the acquisition of Inhibrx, Inc (“
Inhibrx”), adding
SAR447537 (formerly INBRX-101) to Sanofi’s
rare disease pipeline. SAR447537 is a human recombinant protein that holds the promise of allowing alpha-1 antitrypsin
deficiency (AATD) patients to achieve normalization of serum AAT levels with less frequent (monthly vs. weekly) dosing. AATD is
an inherited rare disease characterized by low levels of AAT protein, predominantly affecting the lungs with progressive tissue
deterioration. SAR447537 may help to reduce inflammation and prevent further deterioration of lung function in affected
individuals.
The transaction did not meet the criteria for a business combination under IFRS 3, and consequently was accounted for as an
acquisition of a group of assets.
The acquisition price was
$
2,035
million
. Of that amount (plus acquisition-related costs),
$
1,885
million
was allocated to in-
process development in respect of SAR447537 and recognized within
Other intangible assets
in accordance with IAS 38. The
difference between that amount and the acquisition price corresponds to the other assets acquired and liabilities assumed in the
transaction.
In addition, Sanofi awarded the former shareholders of Inhibrx an unquoted, non-negotiable Contingent Value Right (CVR)
certificate that entitles them to a deferred cash payment of
$
5.00
per Inhibrx share, subject to attainment of a specified
regulatory milestone before June 30, 2027. The nominal value of that off balance sheet commitment is
$
300
million
.
The impact of this acquisition, as reflected within the line item
Acquisitions of consolidated undertakings and investments
accounted for using the equity method
in the consolidated statement of cash flows, is a net cash outflow of
$
2,035
million
.
D.1.1.2.
Project
to divest a
controlling interest in Opella
On October 21, 2024, Sanofi and Clayton, Dubilier & Rice (CD&R) entered into exclusive negotiations for the transfer of a
controlling interest in Opella (in which Sanofi will remain a significant shareholder), leading to the signature of a f
ully-funded
unilateral put option agreement
.
On closing of the transaction, Sanofi would retain an equity interest of approximately
50
%
in the
new entity which will indirectly own the Opella scope of companies, comprising Opella Healthcare and its subsidiaries.
The put option agreement is based on a valuation of Opella, determined by the parties, of approximately
€
16
billion
.
On February
3, 2025, Sanofi exercised the put option agreement, confirming its intention to sign the share purchase agreement appended to
the put option agreement.
At the current stage of the ongoing discussions with CD&R, further heads of agreement have been agreed and appended to the
put option agreement, including but not limited to: (i) a future shareholder agreement setting forth governance arrangements for
the new entity; (ii) an investment agreement governing the structure of the target entity (in which Sanofi and CD&R will hold
equity interests in the proportions specified in the contract) and conferring control of the relevant activities of Opella on CD&R, in
accordance with the requirements of IFRS 10 (see below); and (iii) an amended version of the Separation Agreement of July 24,
2024, specifying the arrangements for the separation of the Opella activities from Sanofi.
Under the terms of that agreement, certain Opella activities will not be transferred on the effective date of loss of control upon
closing of the transaction
.
These are primarily (i) hospital sales of Opella products in China, the transfer of which will be finalized
no earlier than 2028 after a transitional period required to complete the transfer plan agreed with Sanofi in the context of public
tendering arrangements and (ii) sales made by the dedicated entity Opella Russie, the equity interests in which will be retained by
Sanofi. Sanofi will continue to distribute Opella products in Russian territory under the distribution agreement signed in
connection with the separation, the parties reserving the right to discuss the transfer of this retained interest during the
distribution agreement term .
As regards the product liability claims described in Note D.22. "Legal and arbitral proceedings", and in particular the ongoing
litigation relating to Zantac in the United States, the Separation Agreement specifies that Sanofi will indemnify Opella, without
limitation as to amount, for all liabilities resulting from the marketing of any Zantac brand product containing ranitidine as an
active pharmaceutical ingredient, including product liability claims.
In addition, under the same Separation Agreement, Sanofi retains the worldwide rights to the Gold Bond product. The assets
associated with those rights, and the liabilities recognized in respect of the ongoing Gold Bond litigation in the United States, are
retained by Sanofi. Gold Bond will continue to be marketed in the United States through the retained subsidiary Gold Bond LLC.
All social processes have been conducted, and are now completed.
The proposed transaction remains subject to
obtaining customary regulatory
approvals from the competent authorities.
Closing of the transaction is expected in the second quarter of 2025 at the earliest.
|
SANOFI
FORM 20-F
2024
|
F-33
|
|
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
|
Following the closing of the transaction, Sanofi will lose control of Opella. The analysis of where power resides is based primarily
on the agreement reached on the key terms of the future shareholder agreement between CD&R and Sanofi, as appended to the
put option agreement signed on October 21, 2024, under which CD&R will hold a majority of voting rights in shareholder meetings
of the newly-constituted entity that will indirectly own Opella, with the exception of certain decisions that must be made jointly,
those being primarily decisions of a protective nature relating to fundamental changes to the nature of the activities carried on
by the new entity. In addition, CD&R will have a majority on the governance body of the new entity, giving CD&R power over that
entity and consequently over decisions related to the activities of Opella, thereby leading to the loss of control by Sanofi over
Opella based on the criteria for assessment of control specified in IFRS 10 and the Basis of Conclusions thereto.
BpiFrance is expected to participate as a minority shareholder with a c.2% stake in Opella, which does not change the analysis of
control set forth above.
With effect from the date of closing of the transaction, Sanofi will exercise significant influence over Opella. The share of profits
or losses from the retained interest in Opella will then be reported within the line item
Share of profit/(loss) from investments
accounted for using the equity method
in the Sanofi income statement.
Completion of the transaction is considered highly probable. In accordance with the classification and presentation requirements
of IFRS 5 (see Note B.7.), all assets of Opella and all liabilities directly related to those assets are classified from October 21, 2024
in the line items
Assets held for sale
and
Liabilities related to assets held for sale
, respectively, in the consolidated balance
sheet (see Notes D.8. and D.36.).
Opella (formerly known as Consumer Healthcare) constituted an operating segment of Sanofi until October 21, 2024 (see Note
D.35., "Segment Information"). Consequently, Opella meets the definition of a discontinued operation under IFRS 5 (see Note
B.7.), as a result of which the net income from this business is presented separately within the line item
Net income from
discontinued operations
in the consolidated income statement. This presentation in a separate income statement line item
applies to operations for the year ended December 31, 2024, and on a consistent basis for the comparative periods presented.
The cash flows arising from operating, investing and financing activities of the Opella business are also presented in separate line
items in the consolidated statements of cash flows for the year ended December 31, 2024 and for the comparative periods
presented.
For detailed information about the contribution of the Opella business to the consolidated financial statements refer to Note
D.36., “Information related to Opella
”.
D.1.1.3. Enjaymo divestment
On November 29, 2024, Sanofi entered into a definitive agreement with Recordati for the sale of Sanofi's global rights to Enjaymo
and the transfer of specific employees. Under this agreement, Sanofi received an upfront payment of
$
825
million
and will be
eligible for milestone payments of up to
$
250
million
based on sales.
This agreement led to the de-recognition of assets relating to the Enjaymo activity, including goodwill of
€
276
million
. The gain
arising on the divestment is immaterial.
The impact of the disposal in the consolidated cash flow statement, as reflected in the line item
Proceeds from disposals of
tangible, intangible and other non-current assets net of tax
, is a pre-tax cash inflow of
€
768
million
.
D.1.2. Significant transactions of
2023
Acquisition of Provention Bio, Inc.
On March 13, 2023, Sanofi entered into a merger agreement with Provention Bio, Inc. (Provention), a US-based publicly traded
biopharmaceutical company developing therapies to prevent and intercept immune-mediated diseases including type 1 diabetes.
Under the terms of the agreement, Sanofi acquired the outstanding shares of Provention common stock for
$
25.00
per share in
an all-cash transaction valued at approximately
$
2.8
billion
.
The acquisition of Provention was completed on April 27, 2023, with Sanofi holding all of the shares of Provention on expiration of
the tender offer.
Sanofi applied the optional test to identify concentration of fair value under paragraph B7A of IFRS 3. The transaction was
accounted for as an acquisition of a group of assets, given that the principal asset (teplizumab-mzwv, commercialized in the
United States under the name Tzield) concentrates substantially all of the fair value of the acquired set of activities and assets.
Under the terms of a share purchase agreement entered into by Sanofi and Provention in February 2023, Sanofi already held an
equity interest in Provention, representing approximately
3
%
of Provention’s share capital. On the date Sanofi obtained control of
Provention, that equity interest was remeasured at a price of $
25.00
per share, representing a total amount of $
68
million
. The
impact of the remeasurement was recognized in
Other comprehensive income
.
The acquisition price for the shares not already held was $
2,806
million
. Out of the total price (including the fair value of the
shares already held),
$
2,810
million
was allocated to Tzield and recognized within
Other intangible assets
. The difference
between that amount and the acquisition price corresponds to the other assets acquired and liabilities assumed as part of the
transaction, after taking account of the previously-held shares and acquisition-related costs.
The impact of this acquisition as reflected within the line item
Acquisitions of consolidated undertakings and investments
accounted for using the equity method
in the consolidated statement of cash flows is a net cash outflow of $
2,722
million
.
|
F-34
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SANOFI
FORM 20-F
2024
|
|
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
|
Acquisition of QRIB Intermediate Holdings, LLC
On July 28, 2023, Sanofi announced that it had acquired QRIB Intermediate Holdings, LLC (QRIB), the owner of Qunol, a market-
leading US-based health & wellness brand. The acquisition strengthened Opella's operations in the Vitamin, Mineral and
Supplements (VMS) category.
The acquisition of QRIB by Sanofi was completed on September 29, 2023, at a purchase price of
$
1,419
million
.
The final purchase price allocation led to the recognition of goodwill of
€
484
million
, determined as follows:
|
(€ million)
|
Fair value at acquisition date
|
|
Other intangible assets
|
|
|
Other current and non-current assets and liabilities
|
|
|
Cash and cash equivalents
|
|
|
Deferred taxes, net
|
(
|
|
Net assets of QRIB Intermediate Holdings, LLC
|
|
|
Goodwill
|
|
|
Purchase price
|
|
The other acquired intangible assets identified consist of the
Qunol brand.
Goodwill
mainly represents the expected future profits attributable to the development of the VMS platform in the United States
as a result of the integration of QRIB into the Sanofi group.
The entire amount of goodwill is deductible for tax purposes over a period of
15
years
.
The imp
act of this acquisition is reflected in
Net cash provided by/(used in) investing activities of the discontinued Opella
business
in the consolidated statement of cash flows, and represents a net cash outflow of
$
1,410
million
.
Net assets related to this acquisition, including associated goodwill, are part of Opella's net assets and are therefore reclassified
to
Assets held for sale
and
Liabilities related to assets held for sale
(see Note D.36.).
D.1.3. Significant transactions of
2022
Acquisition of Amunix Pharmaceuticals, Inc.
On February 8, 2022, Sanofi acquired the entire share capital of the immuno-oncology company Amunix Pharmaceuticals, Inc.
(Amunix), thereby gaining access to Amunix’s innovative ProXTen technology and a promising pipeline of immunotherapies.
The acquisition price of Amunix comprises a fixed cash payment of
€
970
million
, plus contingent consideration in the form of
milestone payments based on attainment of certain future development objectives of up to
$
225
million
, the fair value of which
as of the acquisition date was
€
156
million
. In accordance with IFRS 3, this contingent purchase consideration was recognized in
Liabilities related to business combinations and non-controlling interests
(see Note D.18.).
The final purchase price allocation led to the recognition of
€
609
million
of goodwill, determined as follows:
|
(€ million)
|
Fair value at acquisition date
|
|
Other intangible assets
|
|
|
Other current and non-current assets and liabilities
|
(
|
|
Cash and cash equivalents
|
|
|
Deferred taxes, net
|
(
|
|
Net assets of Amunix
|
|
|
Goodwill
|
|
|
Purchase price
|
|
Other intangible assets
comprise ProXTen, an innovative universal protease-releasable masking technology platform for the
discovery and development of transformative cytokine therapies and T-cell engager (TCE) immunotherapies for patients with
cancer. In 2023, an impairment loss was taken against the ProXTen platform, in line with a strategic decision to de-prioritize
certain R&D programs (see Note D.5., "Impairment of intangible assets and property, plant and equipment").
The license agreement entered into with Vir Biotechnology, Inc. in September 2024 led to the derecognition of the ProXTen
intangible asset for its full value, after recognizing a partial reversal of the impairment recognized in 2023.
Goodwill mainly represents the value of Amunix’s upstream research and development pipeline of immuno-oncology therapies
based on next-generation conditionally activated biologics, especially when combined with Sanofi’s existing oncology portfolio.
The goodwill generated on this acquisition does not give rise to any deduction for income tax purposes.
Amunixhas no commercial operations.
T
he impact of this acquisition as reflected within the line item
Acquisitions of consolidated undertakings and investments
accounted for using the equity method
in the consolidated statement of cash flows is a cash outflow of
€
852
million
.
|
SANOFI
FORM 20-F
2024
|
F-35
|
|
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
|
EUROAPI - Loss of control and accounting implications
On March 17, 2022, the Sanofi Board of Directors approved a decision to put to a shareholder vote the proposed distribution
in kind of approximately
58
%
of the share capital of EUROAPI, thereby confirming Sanofi’s commitment (announced in
February 2020) to discontinue its active pharmaceutical ingredient operations. As part of the same corporate action and on the
same date, Sanofi entered into an investment agreement with EPIC Bpifrance, which undertook to acquire from Sanofi – via the
French Tech Souveraineté fund – a
12
%
equity interest in EUROAPI at a price not exceeding
€
150
million and to be determined on
the basis of the volume weighted average price (VWAP) of EUROAPI shares on the Euronext Paris regulated market over
the
thirty-day
period starting from the date of initial listing, i.e. May 6, 2022. On completion of those transactions, Sanofi holds an
equity interest of
30.1
%
in EUROAPI, which it has undertaken to retain for at least
two years
from the date of the distribution,
subject to the customary exceptions. With effect from that date, Sanofi exercises significant influence over EUROAPI as a result
of (i) its equity interest, and (ii) having one representative on the EUROAPI Board of Directors.
On May 3, 2022, the General Meeting of Sanofi shareholders approved the decision of the Board of Directors to distribute
approximately
58
%
of the share capital of EUROAPI in the form of an exceptional dividend in kind.
On May 10, 2022, the payment date of the dividend in kind in the days following the admission to listing of EUROAPI shares, those
Sanofi shareholders who had retained their Sanofi shares received
1
EUROAPI share per
23
Sanofi shares, representing in
total
57.88
%
of the share capital of EUROAPI. As of that date, Sanofi lost control over the EUROAPI entities, based on an
assessment of the criteria specified in IFRS 10 (Consolidated financial statements). The assets and liabilities of EUROAPI, which
since March 17, 2022 had been presented as assets and liabilities held for sale within the Sanofi balance sheet in accordance with
IFRS 5 (Non-Current Assets Held for sale), were deconsolidated. In addition, because EUROAPI operations do not constitute a
discontinued operation under IFRS 5, the contribution from EUROAPI has not been presented within separate line items in the
income statement and statement of cash flows or in information for prior comparative periods. The contribution of EUROAPI
operations to the consolidated net sales of Sanofi in the year ended December 31, 2021 was
€
486
million.
The principal consequences of the deconsolidation of EUROAPI are described below:
•
the derecognition of the carrying amount of all the assets and liabilities of EUROAPI, representing a net amount of
€
1,227
million
as of May 10, 2022. This includes goodwill of
€
164
million, determined in accordance with IAS 36 (“Impairment of Assets”), which
was historically allocated to the Pharmaceuticals cash generating unit (CGU), and which for the purposes of the deconsolidation
was allocated using an alternative method based on the relative values of goodwill as of the date of consolidation (the “notional
goodwill method”). That method was considered more appropriate to the capital-intensive nature of EUROAPI operations than
the method based on the relative values of EUROAPI operations and the retained portion of the CGU;
•
a reduction in
Equity attributable to equity holders
of Sanofi
reflecting the distribution in kind, measured at
€
793
million based
on the weighted average price of
€
14.58
per share as of the date of delivery of the EUROAPI shares to Sanofi shareholders and
corresponding to the fair value of the distribution in accordance with IFRIC 17 (Distribution of Non-Cash Assets to Owners);
•
a cash inflow of
€
150
million from the divestment of
12
%
of the share capital of EUROAPI to EPIC Bpifrance as of the
settlement date of the shares, i.e. June 17, 2022;
•
the recognition in the balance sheet within the line item
Investments accounted for using the equity method
, of the
retained
30.1
%
equity interest in EUROAPI at an amount of
€
413
million, determined on the basis of the weighted average
price of
€
14.58
per share and representing the fair value of the equity interest in accordance with IFRS 10;
•
the reclassification within the net gain/loss on deconsolidation of unrealized foreign exchange losses amounting to
€
35
million
arising on EUROAPI subsidiaries, in accordance with IAS 21 (The Effects of Changes in Foreign Exchange Rates);
•
the recognition of transaction-related costs and of the effects of undertakings made under agreements entered into
with EUROAPI setting out the principles and terms of the legal reorganization carried out ahead of the date of
deconsolidation. The principal undertakings made to EUROAPI relate to compensation for:
–
environmental remediation obligations on non-operational chemical sites in France transferred to EUROAPI, amounting
to
€
14
million, and
–
regulatory compliance costs relating to certain state-of-the-art active pharmaceutical ingredients of EUROAPI, capped
at
€
15
million.
These elements collectively resulted in a pre-tax loss on deconsolidation of
€
3
million, presented within the line item
Other gains
and losses, and litigation
in the income statement. The tax effect of the deconsolidation was a net gain of
€
111
million, presented
within the line item
Income tax expense
in the income statement.
The cash impact of the deconsolidation of EUROAPI, presented within the line item
Disposals of consolidated undertakings
and investments accounted for using the equity method
in the statement of cash flows, was a net cash inflow of
€
101
million.
Sanofi has entered into an agreement with EUROAPI for the manufacture and supply of active pharmaceutical ingredients,
intermediates and other substances, which took effect on October 1, 2021 and expires five years after the loss of control. Under
the terms of the agreement, Sanofi committed to target annual net sales of approximately
€
300
million for a list of specified
active ingredients until the agreement expires in 2026. As of December 31, 2022, that commitment amounted to
€
1.1
billion.
As of the date of deconsolidation, the
30.1
%
equity interest in EUROAPI is accounted for using the equity method in accordance
with IAS 28 (Investments in Associates and Joint Ventures), and the share of EUROAPI profits or losses arising from application of
the equity method is excluded from “Business operating income”, the non-IFRS financial indicator used internally by Sanofi to
measure the performance of its operating segments.
|
F-36
|
SANOFI
FORM 20-F
2024
|
|
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
|
D.2.1. Capital management information
In order to maintain or adjust the capital structure, Sanofi can adjust the amount of dividends paid to shareholders, repurchase its
own shares, issue new shares, or issue securities giving access to its capital.
The following objectives are defined under the terms of Sanofi’s share repurchase programs:
•
the implementation of any stock option plan giving entitlement to purchase shares in the Sanofi parent company (see Note
D.15.);
•
the allotment or sale of shares to employees under statutory profit sharing schemes and employee savings plans;
•
the consideration-free allotment of shares (i.e. restricted share plans) (see Note D.15.);
•
the cancellation of some or all of the repurchased shares (see Note D.15.);
•
market-making in the secondary market by an investment services provider under a liquidity contract in compliance with the
ethical code recognized by the
Autorité des marchés financiers
(AMF);
•
the delivery of shares on the exercise of rights attached to securities giving access to the capital by redemption, conversion,
exchange, presentation of a warrant or any other means;
•
the delivery of shares (in exchange, as payment, or otherwise) in connection with mergers and acquisitions;
•
the execution by an investment services provider of purchases, sales or transfers by any means, in particular via off-market
trading; or
•
any other purpose that is or may in the future be authorized under the applicable laws and regulations.
Sanofi is not subject to any constraints on equity capital imposed by third parties.
Sanofi defines “Net debt” as (i) the sum of short-term debt, long-term debt and interest rate derivatives and currency derivatives
used to hedge debt, minus (ii) the sum of cash and cash equivalents and interest rate derivatives and currency derivatives used to
hedge cash and cash equivalents (see Note D.17.).
D.2.2. Financial risk management
Credit risk
Credit risk is the risk that customers (wholesalers, distributors, pharmacies, hospitals, clinics or government agencies) may fail to
pay their debts; for Sanofi, that risk is mainly concentrated on amounts receivable from wholesalers in the United States. Sanofi
manages credit risk by vetting customers in order to set credit limits and risk levels, and asking for guarantees or insurance where
necessary; performing controls; and monitoring qualitative and quantitative indicators of accounts receivable balances, such as
the period of credit taken and overdue payments.
Sales generated by Sanofi with its biggest customers are disclosed in Note D.35.
Market risks
Please refer to "Item 11. Quantitative and Qualitative Disclosures about Market Risk" of this Annual Report on Form 20-F, and to
Notes D.17 and D.20. below.
|
SANOFI
FORM 20-F
2024
|
F-37
|
|
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
|
D.3.
Property, plant and equipment
D.3.1. Property, plant and equipment owned
|
(€ million)
|
Land
|
Buildings
|
Machinery and
equipment
|
Fixtures, fittings
and other
|
Property, plant and
equipment in process
|
Total
|
|
Gross value at January 1, 2022
|
|
|
|
|
|
|
|
Changes in scope of consolidation
|
(
|
(
|
(
|
(
|
(
|
(
|
|
Acquisitions and other increases
|
|
|
|
|
|
|
|
Disposals and other decreases
|
(
|
(
|
(
|
(
|
(
|
(
|
|
Currency translation differences
|
|
|
|
|
|
|
|
Transfers
(a)
|
(
|
|
|
|
(
|
(
|
|
Gross value at December 31, 2022
|
|
|
|
|
|
|
|
Changes in scope of consolidation
|
|
(
|
(
|
(
|
(
|
(
|
|
Acquisitions and other increases
|
|
|
|
|
|
|
|
Disposals and other decreases
|
(
|
(
|
(
|
(
|
(
|
(
|
|
Currency translation differences
|
(
|
(
|
(
|
(
|
(
|
(
|
|
Transfers
(a)
|
(
|
|
|
|
(
|
(
|
|
Gross value at December 31, 2023
|
|
|
|
|
|
|
|
Changes in scope of consolidation
|
|
|
|
|
|
|
|
Acquisitions and other increases
|
|
|
|
|
|
|
|
Disposals and other decreases
|
(
|
(
|
(
|
(
|
(
|
(
|
|
Currency translation differences
|
|
|
|
|
|
|
|
Transfers
(a)
|
(
|
|
|
|
(
|
|
|
Opella reclassification
(b)
|
(
|
(
|
(
|
(
|
(
|
(
|
|
Gross value at December 31, 2024
|
|
|
|
|
|
|
|
Accumulated depreciation & impairment
at January 1, 2022
|
(
|
(
|
(
|
(
|
(
|
(
|
|
Changes in scope of consolidation
|
|
|
|
|
|
|
|
Depreciation expense
|
|
(
|
(
|
(
|
|
(
|
|
Impairment losses, net of reversals
|
(
|
(
|
(
|
(
|
(
|
(
|
|
Disposals and other decreases
|
|
|
|
|
|
|
|
Currency translation differences
|
|
(
|
(
|
(
|
|
(
|
|
Transfers
(a)
|
|
|
|
|
(
|
|
|
Accumulated depreciation & impairment
at December 31, 2022
|
(
|
(
|
(
|
(
|
(
|
(
|
|
Changes in scope of consolidation
|
|
|
|
|
|
|
|
Depreciation expense
|
|
(
|
(
|
(
|
|
(
|
|
Impairment losses, net of reversals
|
|
(
|
(
|
(
|
(
|
(
|
|
Disposals and other decreases
|
|
|
|
|
|
|
|
Currency translation differences
|
|
|
|
|
|
|
|
Transfers
(a)
|
|
(
|
|
(
|
|
|
|
Accumulated depreciation & impairment
at December 31, 2023
|
(
|
(
|
(
|
(
|
(
|
(
|
|
Changes in scope of consolidation
|
|
|
|
|
|
|
|
Depreciation expense
|
|
(
|
(
|
(
|
|
(
|
|
Impairment losses, net of reversals
|
|
(
|
(
|
(
|
(
|
(
|
|
Disposals and other decreases
|
|
|
|
|
|
|
|
Currency translation differences
|
|
(
|
(
|
(
|
|
(
|
|
Transfers
(a)
|
|
|
|
|
(
|
|
|
Opella reclassification
(b)
|
|
|
|
|
|
|
|
Accumulated depreciation & impairment
at December 31, 2024
|
|
(
|
(
|
(
|
(
|
(
|
|
Carrying amount at December 31, 2022
|
|
|
|
|
|
|
|
Carrying amount at December 31, 2023
|
|
|
|
|
|
|
|
Carrying amount at December 31, 2024
|
|
|
|
|
|
|
Opella assets) to
Assets held for sale
.
|
F-38
|
SANOFI
FORM 20-F
2024
|
|
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
|
|
(€ million)
|
2024
|
2023
|
2022
|
|
Acquisitions
|
|
|
|
|
Biopharma (operating segment)
|
|
|
|
|
of which Manufacturing & Supply
|
|
|
|
|
Opella (discontinued operation, see Note D.1.)
|
|
|
|
|
of which Manufacturing & Supply
|
|
|
|
|
Of which capitalized interest
|
|
|
|
below:
|
(€ million)
|
2024
|
2023
|
2022
|
|
Firm orders of property, plant and equipment
|
|
|
|
|
Property, plant and equipment pledged as security for liabilities
|
|
|
|
|
(€ million)
|
2024
|
2023
|
2022
|
|
Net impairment losses on property, plant and equipment
(a)
|
|
|
|
shutdowns or changes in use of industrial sites.
|
SANOFI
FORM 20-F
2024
|
F-39
|
|
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
|
D.3.2. Property, plant and equipment leased – right-of-use assets
|
(€ million)
|
Right-of-use assets
|
|
Gross value at January 1, 2022
|
|
|
Changes in scope of consolidation
|
(
|
|
Acquisitions and other increases
|
|
|
Disposals and other decreases
|
(
|
|
Currency translation differences
|
|
|
Transfers
(a)
|
(
|
|
Gross value at December 31, 2022
|
|
|
Acquisitions and other increases
|
|
|
Disposals and other decreases
|
(
|
|
Currency translation differences
|
(
|
|
Transfers
(a)
|
(
|
|
Gross value at December 31, 2023
|
|
|
Acquisitions and other increases
|
|
|
Disposals and other decreases
|
(
|
|
Currency translation differences
|
|
|
Transfers(a)
|
(
|
|
Opella reclassification
(b)
|
(
|
|
Gross value at December 31, 2024
|
|
|
Accumulated depreciation & impairment at January 1, 2022
|
(
|
|
Changes in scope of consolidation
|
|
|
Depreciation and impairment charged in the period
|
(
|
|
Disposals and other decreases
|
|
|
Currency translation differences
|
(
|
|
Transfers
(a)
|
|
|
Accumulated depreciation & impairment at December 31, 2022
|
(
|
|
Depreciation and impairment charged in the period
|
(
|
|
Disposals and other decreases
|
|
|
Currency translation differences
|
|
|
Transfers
(a)
|
|
|
Accumulated depreciation & impairment at December 31, 2023
|
(
|
|
Depreciation and impairment charged in the period
|
(
|
|
Disposals and other decreases
|
|
|
Currency translation differences
|
(
|
|
Transfers
(a)
|
|
|
Opella reclassification
(b)
|
|
|
Accumulated depreciation & impairment at December 31, 2024
|
(
|
|
Carrying amount at December 31, 2022
|
|
|
Carrying amount at December 31, 2023
|
|
|
Carrying amount at December 31, 2024
|
|
Leased assets comprised offices and industrial premises (
90
%
) and the vehicle fleet (
10
%
) as of
December 31, 2024
.
Annual lease costs on short term leases and low value asset leases amounted to
€
16
million
in the year ended
December 31, 2024
,
€
19
million
in the year ended
December 31, 2023
, and
€
26
million
in the year ended
December 31, 2022
. Variable lease payments,
sub-leasing activities, and sale-and-leaseback transactions were immaterial.
Total cash outflows on leases (excluding annual lease costs on short term leases and low value asset leases) were
€
348
million
in the year ended
December 31, 2024
,
€
315
million
in the year ended
December 31, 2023
, and
€
389
million
in the year
ended
December 31, 2022
.
|
F-40
|
SANOFI
FORM 20-F
2024
|
|
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
|
A maturity analysis of the lease liability is disclosed in Note D.17.2.
Commitments related to short-term leases and low value asset leases, including future payments for lease contracts committed
but not yet commenced, are disclosed in Note D.21.
D.4.
Goodwill and other intangible assets
|
(€ million)
|
Goodwill
|
|
Balance at January 1, 2022
|
|
|
Acquisitions during the period
|
|
|
Other movements during the period
(a)
|
(
|
|
Currency translation differences
|
|
|
Balance at December 31, 2022
|
|
|
Acquisitions during the period
(c)
|
|
|
Other movements during the period
(a)
|
(
|
|
Currency translation differences
|
(
|
|
Balance at December 31, 2023
|
|
|
Acquisitions during the period
|
|
|
Other movements during the period
(a)
|
(
|
|
Currency translation differences
|
|
|
Opella reclassification
(b)
|
(
|
|
Balance at December 31, 2024
|
|
allocated goodwill relating to the divestment of the Enjaymo activity to Recordati (see Note D.1.). For 2022, this line includes the loss of control of
EUROAPI (see Note D.1.).
€
774
million as of the acquisition date (September 29, 2023) and of goodwill measured at
€
484
million as of the acquisition date (see Note D.1.).
In accordance with IAS 36, goodwill is allocated to groups of Cash Generating Units (CGUs) at a level corresponding to the
Biopharma operating segment (see Note D.35.).
For the purpose of annual impairment testing of goodwill, the recoverable amount was determined on the basis of value in use, as
derived from discounted estimates of the future cash flows in accordance with the policies described in Note B.6.1.
Acquisition of Amunix Pharmaceuticals, Inc. (2022)
The final purchase price allocation for Amunix Pharmaceuticals, Inc. resulted in the recognition of intangible assets (other than
goodwill) o
f
€
493
million as of the acquisition date (February 8, 2022), and of goodwill measured at
€
609
million as of the
acquisition date (see Note D.1.).
|
SANOFI
FORM 20-F
2024
|
F-41
|
|
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
|
|
(€ million)
|
Acquired R&D
|
Products,
trademarks and
other rights
|
Software
|
Total other
intangible assets
|
|
Gross value at
January 1, 2022
(a)
|
|
|
|
|
|
Changes in scope of consolidation
(c)
|
|
|
(
|
|
|
Acquisitions and other increases
|
|
|
|
|
|
Disposals and other decreases
|
(
|
(
|
(
|
(
|
|
Currency translation differences
|
|
|
|
|
|
Transfers
(b)
|
(
|
|
(
|
(
|
|
Gross value at
December 31, 2022
|
|
|
|
|
|
Changes in scope of consolidation
(c)
|
|
|
|
|
|
Acquisitions and other increases
(f)
|
|
|
|
|
|
Disposals and other decreases
|
(
|
(
|
(
|
(
|
|
Currency translation differences
|
(
|
(
|
(
|
(
|
|
Transfers
(b)
|
(
|
|
(
|
(
|
|
Gross value at
December 31, 2023
|
|
|
|
|
|
Changes in scope of consolidation
(c)
|
|
|
|
|
|
Acquisitions and other increases
(f)
|
|
|
|
|
|
Disposals and other decreases
|
(
|
(
|
(
|
(
|
|
Currency translation differences
|
|
|
|
|
|
Transfers
(b)
|
(
|
|
(
|
|
|
Opella reclassification
(a)
|
(
|
(
|
(
|
(
|
|
Gross value at December 31, 2024
|
|
|
|
|
|
Accumulated amortization & impairment at
January 1, 2022
(a)
|
(
|
(
|
(
|
(
|
|
Changes in scope of consolidation
|
|
|
|
|
|
Amortization expense
(e)
|
|
(
|
(
|
(
|
|
Impairment losses, net of reversals
(d)
|
(
|
|
|
|
|
Disposals and other decreases
|
|
|
|
|
|
Currency translation differences
|
(
|
(
|
(
|
(
|
|
Transfers
(b)
|
|
(
|
|
|
|
Accumulated amortization & impairment at
December 31, 2022
|
(
|
(
|
(
|
(
|
|
Changes in scope of consolidation
(c)
|
|
|
|
|
|
Amortization expense
|
|
(
|
(
|
(
|
|
Impairment losses, net of reversals
(d)
|
(
|
(
|
|
(
|
|
Disposals and other decreases
|
|
|
|
|
|
Currency translation differences
|
|
|
|
|
|
Transfers
(b)
|
|
|
|
|
|
Accumulated amortization & impairment at
December 31, 2023
|
(
|
(
|
(
|
(
|
|
Amortization expense
|
|
(
|
(
|
(
|
|
Impairment losses, net of reversals
(d)
|
(
|
|
|
(
|
|
Disposals and other decreases
|
|
|
|
|
|
Currency translation differences
|
(
|
(
|
(
|
(
|
|
Transfers
(b)
|
(
|
(
|
|
(
|
|
Opella reclassification
(a)
|
|
|
|
|
|
Accumulated amortization & impairment at December 31, 2024
|
(
|
(
|
(
|
(
|
|
Carrying amount at December 31, 2022
|
|
|
|
|
|
Carrying amount at December 31, 2023
|
|
|
|
|
|
Carrying amount at December 31, 2024
|
|
|
|
|
Opella assets) as
Assets held for sale
.
|
F-42
|
SANOFI
FORM 20-F
2024
|
|
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
|
In 2023:
–
the rights acquired as a result of the simplification agreed between Sanofi and AstraZeneca in April 2023 in respect of the agreements on Beyfortus
(nirsevimab) (see Note C.2.);
–
an upfront payment of
$
500
million
relating to the rights acquired under the agreement with Teva Pharmaceuticals on the co-development and co-
commercialization of TEV’574;and
–
an upfront payment of
$
175
million
for the rights acquired under the agreement with Janssen Pharmaceuticals, Inc. relating to a vaccine against
extra-intestinal pathogenic strains of E-Coli.
In 2024:
–
an upfront payment of
$
500
million
for the rights acquired under the agreement with Novavax relating to the co-exclusive license agreement for the
co-commercialization of a COVID-19 vaccine and the development of a combined flu-COVID-19 vaccine; and
–
an upfront payment of
$
300
million
for the rights acquired under an agreement with Corxel Pharmaceuticals for the development and
commercialization rights to aficamten in China.
“Products, trademarks and other rights” mainly comprise:
•
“marketed products”, with a carrying amount of
€
12.7
billion
as of
December 31, 2024
(versus
€
16.6
billion
as of
December 31,
2023
and
€
12.7
billion
as of
December 31, 2022
) and a weighted average amortization period of approximately
10
years; and
•
“technology platforms”, with a carrying amount of
€
1.1
billion
as of
December 31, 2024
(versus €
1.2
billion as of
December 31,
2023
and €
2.2
billion as of
December 31, 2022
) and a weighted average amortization period of approximately
18
years.
acquisitions made by Sanofi and represented
95
%
of the carrying amount of that item as of
December 31, 2024
:
|
(€ million)
|
Gross
value
|
Accumulated
amortization &
impairment
|
December 31,
2024
|
Amortization
period
(years)
(a)
|
Residual
amortization
period
(years)
(b)
|
Carrying
amount at
December 31,
2023
|
Carrying
amount at
December 31,
2022
|
|
Genzyme
(c)
|
|
(
|
|
|
|
|
|
|
Boehringer Ingelheim
(c)
|
|
(
|
|
|
|
|
|
|
Aventis
(c)
|
|
(
|
|
|
|
|
|
|
Chattem
(c)
|
|
(
|
|
|
|
|
|
|
Protein Sciences
(c)
|
|
(
|
|
|
|
|
|
|
Ablynx
(c)
|
|
(
|
|
|
|
|
|
|
Bioverativ
(c)
|
|
(
|
|
|
|
|
|
|
Rezurock
|
|
(
|
|
|
|
|
|
|
Tzield
|
|
(
|
|
|
|
|
|
|
Beyfortus
|
|
(
|
|
|
|
|
|
|
Qunol
|
|
(
|
|
|
|
|
|
|
Total: principal marketed products
incl. Opella products presented in
"Assets held for sale"
|
|
(
|
|
|
|
||
|
Total: principal marketed products
excl. Opella products presented in
"Assets held for sale"
|
|
(
|
|
|
|
(see Note D.1.).
During
2023
, some of the acquired research and development came into commercial use, and started being amortized from the
date of marketing approval; the main item involved was ALTUVIIIO (efanesoctocog alfa) which extends protection from bleeds
and treats acute hemorrhages in people with hemophilia A.
The main asset brought into service during
2022
was Enjaymo (sutimlimab-jome), a treatment for cold agglutinin disease.
|
SANOFI
FORM 20-F
2024
|
F-43
|
|
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
|
Amortization of other intangible assets is recognized in the income statement within the line item
Amortization of intangible
assets
, except for amortization of software and other rights of an industrial or operational nature which is recognized in the
relevant classification of expense by function.
An analysis of amortization of software is shown in the table below:
|
(€ million)
|
2024
|
2023
(a)
|
2022
(a)
|
|
Cost of sales
|
|
|
|
|
Research and development expenses
|
|
|
|
|
Selling and general expenses
|
|
|
|
|
Other operating expenses
|
|
|
|
|
Net income from discontinued operations
|
|
|
|
|
Total
|
|
|
|
D.5.
Impairment of intangible assets and property, plant and equipment
Goodwill
When testing goodwill annually for impairment, the recoverable amount is determined for the Biopharma segment on the basis of
value in use, as derived from discounted estimates of the future cash flows in accordance with the policies described in
Note B.6.1.
The value in use of the Biopharma segment was determined by applying an after-tax discount rate to estimated future after-tax
cash flows; the rate used for impairment testing of the Biopharma segment in
2024
was
7.25
%
.
The pre-tax discount rate applied to estimated pre-tax cash flows is calculated by iteration from the previously-determined value
in use; the rate used for the Biopharma segment was
9.8
%
.
The assumptions used in testing goodwill for impairment are reviewed annually. Apart from the discount rate, the principal
assumptions used in
2024
were as follows:
•
the perpetual growth rate applied to future cash flows for the Biopharma segment was
zero
; and
•
Sanofi also applies assumptions on the probability of success of current research and development projects, and more
generally on its ability to renew the product portfolio in the longer term.
Value in use (determined as described above) is compared with the carrying amount, and this comparison is then subject to
sensitivity analyses by reference to key parameters including:
•
changes in the discount rate;
•
changes in the perpetual growth rate; and
•
fluctuations in operating margin.
No impairment of the goodwill would need to be recognized in the event of a reasonably possible change in the assumptions
used in
2024
.
Other intangible assets
When there is evidence that an asset may have become impaired, the asset’s value in use is calculated by applying an after-tax
discount rate to the estimated future after-tax cash flows from that asset. For the purposes of impairment testing, the tax cash
flows relating to the asset are determined using a notional tax rate incorporating the notional tax benefit that would result from
amortizing the asset if its value in use were regarded as its depreciable amount for tax purposes. Applying after-tax discount
rates to after-tax cash flows gives the same values in use as would be obtained by applying pre-tax discount rates to pre-tax
cash flows.
The after-tax discount rates used in
2024
for impairment testing of other intangible assets were obtained by adjusting Sanofi’s
weighted average cost of capital to reflect specific country and business risks, giving after-tax discount rates in a range from
In most instances, there are no market data that would enable fair value less costs to sell to be determined other than by means
of developing a similar estimate based on future cash flows. Consequently, recoverable amount is in substance equal to value in
use. The estimates used to determine value in use are sensitive to assumptions specific to the nature of the asset and to Sanofi's
activities. Apart from the discount rate, the principal assumptions used in
2024
were as follows:
•
mid-term and long-term forecasts;
•
perpetual growth or attrition rates, when applicable; and
•
probability of success of current research and development projects.
|
F-44
|
SANOFI
FORM 20-F
2024
|
|
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
|
The assumptions used in testing intangible assets for impairment are reviewed at least annually.
impairment losses as shown below (the table presents all net impairments of the Group including Opella, over all periods):
|
(€ million)
|
2024
|
2023
|
2022
|
|
Impairment of other intangible assets, net of reversals (excluding software)
|
|
|
(
|
|
Marketed products
|
(
|
|
(
|
|
Biopharma
(a)
|
(
|
|
(
|
|
Opella
|
|
|
(
|
|
Research and development projects and technology platforms
(b)(c)(d)
|
|
|
|
|
Others
|
|
|
|
For 2022, this amount mainly comprises a reversal of
€
2,154
million
of impairment losses taken against Eloctate and BIVV001 (assets belonging to the
Eloctate franchise), consisting of
€
1,554
million
for marketed products and
€
600
million
for research and development projects respectively. In 2019,
the launch of competing products for Eloctate led Sanofi to update its sales forecasts for products belonging to the franchise, as a result of which
impairment losses of
€
2.8
billion
were recognized against the assets in question. The reversal reflects the approval by the FDA on February 22, 2023 of
ALTUVIIIO (the commercial name of efanesoctocog alpha, corresponding to the BIVV001 project), which was submitted in 2022.
(i) impairment losses of
€
640
million
against various research and development projects - including a
€
239
million
loss resulting from the decision taken
in February 2025 to discontinue a phase 3 clinical study investigating of a vaccine candidate to prevent invasive E.coli disease - and (ii) an impairment
reversal of
€
225
million
recognized in connection with the disposal of the ProXTen technology platform.
programs, in particular those related to the NK Cell and ProXTen technology platforms.
–
an impairment loss of
€
1,586
million
taken against the development project for SAR444245 (non-alpha interleukin-2), recognized following revised
cash flow projections reflecting unfavorable developments in the launch schedule;
–
the
€
600
million
reversal relating to the BIVV001 project (see above).
As required by
IFRS 5, the other intangible assets of Opella were measured in accordance with IAS 36 immediately before their
reclassification as assets held for sale; this assessment did not result in any impairment of their carrying amount being recognized.
Property, plant and equipment
Impairment losses taken against property, plant and equipment are disclosed in Note D.3.
Risks and opportunities related to climate change
Sanofi has identified specific plausible scenarios to assess climate risks and opportunities liable to impact its activities in the
medium and longer term.
These include:
•
an Aggressive Mitigation scenario, based on global collaboration to start reducing emissions immediately to meet Paris
Agreement goals (limit temperature increase to 1.5°C above pre-industrial levels), generating risks related to transitioning to a
lower carbon economy and entailing extensive policy, legal, technology, and market changes to address mitigation and
adaptation requirements;
•
a No Climate Action scenario (leading to global warming of 4°C above pre-industrial levels by 2100), with event-driven physical
risks resulting from climate change or longer term shifts in climate patterns leading to potential financial implications such as
direct damage to assets and indirect impacts from supply chain disruption; changes in water availability, and in the sourcing or
quality of resources; food security; and extreme temperature changes affecting premises, operations, supply chain, transport
needs, and employee safety; and
•
a Most Likely scenario, encompassing fragmented regional efforts to start reducing emissions but not at a sufficient level to
meet Paris Agreement g
oals (emissions continue to increase but at a slowed rate, leading to a 2.8°C temperature increase).
The importance and likelihood of such risks have been assessed and have not led Sanofi to identify any material impact that could
generate a risk of impairment of the assets of Sanofi’s CGUs.
|
SANOFI
FORM 20-F
2024
|
F-45
|
|
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
|
D.6.
Investments accounted for using the equity method
Investments accounted for using the equity method comprise associates and joint ventures (see Note B.1.), and are set forth
below.
|
(€ million)
|
% interest
|
2024
|
2023
|
2022
|
|
EUROAPI
(a)
|
|
|
|
|
|
Infraserv GmbH & Co. Höchst KG
(b)
|
|
|
|
|
|
MSP Vaccine Company
(c)
|
|
|
|
|
|
Other investments
|
|
|
|
|
|
Total
|
|
|
|
for using the equity method, showing the split between associates and joint ventures in accordance with IFRS 12 (the amounts for
each individual associate or joint venture are not material):
|
2024
|
2023
|
2022
|
||||
|
(€ million)
|
Joint ventures
|
Associates
|
Joint ventures
|
Associates
|
Joint ventures
|
Associates
|
|
Share of profit/(loss) from investments
accounted for using the equity method
(a)
|
|
(
|
|
(
|
|
(
|
|
Share of other comprehensive income from
investments accounted for using the equity
method
|
|
(
|
(
|
|
(
|
(
|
|
Total
|
|
(
|
|
(
|
|
(
|
as of December 31, 2023).
The financial statements include arm’s length transactions between Sanofi and some equity-accounted investments that are
classified as related parties.
The principal transactions and balances with related parties are summarized below:
|
(€ million)
|
2024
|
2023
|
2022(a)
|
|
Sales
(d)
|
|
|
|
|
Royalties and other income
(d)
|
|
|
|
|
Accounts receivable and other receivables
(b)
|
|
|
|
|
Other assets
(c)
|
|
|
|
|
Purchases and other expenses (including research expenses)
(d)
|
|
|
|
|
Accounts payable and other liabilities
|
|
|
|
investment as of
December 31, 2024
is €
189
million.
operation.
There were
no
funding commitments to associates and joint ventures as of
December 31, 2024
,
December 31, 2023
or
December 31, 2022
.
For off balance sheet commitments of an operational nature involving joint ventures, see Note D.21.1.
|
F-46
|
SANOFI
FORM 20-F
2024
|
|
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
|
D.7.
Other non-current assets
|
(€ million)
|
2024
|
2023
|
2022
|
|
Equity instruments at fair value through other comprehensive income (D.7.1.)
|
|
|
|
|
Debt instruments at fair value through other comprehensive income (D.7.2.)
|
|
|
|
|
Other financial assets at fair value through profit or loss (D.7.3.)
|
|
|
|
|
Pre-funded pension obligations (Note D.19.1.)
|
|
|
|
|
Long-term prepaid expenses
|
|
|
|
|
Long-term loans and advances and other non-current receivables
(a)
|
|
|
|
|
Derivative financial instruments (Note D.20.)
|
|
|
|
|
Total
|
|
|
|
–
Loan of €
149
million to the BioAtrium joint venture which matures on December 1, 2031, of which
€
156
million
was recognized in "Other current
assets" as of December 31, 2022;
–
a receivable under a sub-lease amounting to
€
116
million
(
€
181
million
before discounting), versus €
132
million (or €
195
million before discounting) as
D.7.1. Equity instruments at fair value through other comprehensive income
Quoted equity instruments
The line “Equity instruments at fair value through other comprehensive income” includes equity investments quoted in an active
market with a carrying amount of
€
467
million
as of
December 31, 2024
,
€
470
million
as of
December 31, 2023
and
€
387
million
as of
December 31, 2022
.
The movement i
n quoted equity investments included in the “Equity instruments at fair value through other comprehensive
income” category in the year ended December 31, 2024 was mainly due to Sanofi taking a non-controlling equity interest in
Novavax in May 2024.
The main changes during previous years in quoted equity investments included in the “Equity instruments at fair value through
other comprehensive income” category are described below:
•
In
2023
: t
here were no material movements in quoted equity investments during the year ended December 31, 2023.
•
In
2022
:
–
the sale in June 2022 of the residual equity interest in Regeneron (see Note C.1.) for $
174
million
, the entire loss on which
was recorded within
Other comprehensive income
, and
–
the acquisition of an equity interest in Innovent Biologics, in connection with a strategic collaboration agreement to
intensify development in oncology medicines signed in August 2022, which had a fair value of
€
250
million
as of that date
and
€
228
million
as of December 31, 2022.
A
10%
decline in stock prices of the quoted equity investments included within “Equity instruments at fair value
through other comprehensive income” would have had a pre-tax impact of
€
47
million
on
Other comprehensive income
as
of
December 31, 2024
.
Unquoted equity instruments
The line item “Equity instruments at fair value through other comprehensive income” also includes equity investments not quoted
in an active market with a carrying amount of
€
1,092
million
as of
December 31, 2024
,
€
618
million
as of
December 31, 2023
and
€
549
million
as of
December 31, 2022
.
The change in unquoted equity investments included in the “Equity instruments at fair value through other comprehensive
income” category during the year ended
December 31, 2024
was mainly due to an investment in EUROAPI in the form of a
perpetual subordinated hybrid bond of which the value at inception date was
€
200
million
and the value as of December 31,
2024 is
€
189
million
, and various equity stakes acquired through the Sanofi Ventures fund.
In addition, commitments relating to equity investments classified in this asset category amounted to
€
360
million
as of
December 31, 2024 (versus
€
65
million
as of December 31, 2023). The figure as of December 31, 2024 includes
€
300
million
relating to an equity interest of approximately
16
%
in Orano Med, a new entity
valued at
€
1.9
billion
focused on the discovery,
design, and clinical development of next-generation radioligand therapies (RLTs) based on lead-212 (212Pb) alpha-emitting
isotopes.
|
SANOFI
FORM 20-F
2024
|
F-47
|
|
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
|
D.7.2. Debt instruments at fair value through other comprehensive income
The “Debt instruments at fair value through other comprehensive income” category includes quoted euro-denominated senior
bonds amounting to
€
357
million
as of
December 31, 2024
, including
€
110
million
of securities obtained in exchange for financial
assets held to meet obligations to employees under post-employment benefit plans.
Sanofi held
€
346
million
of quoted senior bonds as of
December 31, 2023
and
€
329
million
as of
December 31, 2022
.
As regards debt instruments held to meet obligations to employees under post-employment benefit plans, an increase of
10
basis
points in market interest rates as of
December 31, 2024
would have had a pre-tax impact of
€
1
million
on
Other comprehensive
income
.
As regards other quoted debt instruments, an increase of
10
basis points in market interest rates as of
December 31, 2024
would
have had a pre-tax impact of
€
1
million
on
Other comprehensive income
.
Other comprehensive income recognized in respect of “Equity instruments at fair value through other comprehensive income”
and “Debt instruments at fair value through other comprehensive income” represented unrealized after-tax gains of
€
342
million
for the year ended
December 31, 2024
, versus unrealized after-tax gains of
€
349
million
for the year ended
December 31, 2023
and of €
256
million
for the year ended
December 31, 2022
.
An analysis of the change in gains and losses recognized in
Other comprehensive income
, and of items reclassified to profit or
loss, is presented in Note D.15.7.
D.7.3. Other financial assets at fair value through profit or loss
The “Other financial assets at fair value through profit or loss”
category mainly includes:
•
a portfolio of financial investments (amounting to
€
688
million
as of
December 31, 2024
) held to fund a deferred
compensation plan provided to certain employees (versus
€
572
million
as of
December 31, 2023
and
€
512
million
as
of
December 31, 2022
);
•
unquoted securities not meeting the definition of equity instruments amounting to
€
165
million
as of
December 31, 2024
(versus
€
132
million
as of
December 31, 2023
and
€
115
million
as of
December 31, 2022
).
In addition, commitments relating to
unquoted securities classified in this asset category amount to
€
168
million
as of December 31, 2024 (compared to
€
159
million
as of December 31, 2023).
•
contingent consideration receivable by Sanofi following the sale of Enjaymo (see note D.1) based on the probability of
achieving certain levels of future sales, and discounted. If the discount rate were to increase by one percentage point, the fair
value of the contingent consideration would decrease by approximately
7
%
. Changes in the fair value of this contingent
consideration are recognized within the income statement line item
Fair value remeasurement of contingent consideration
(see note B.18.). As of December 31, 2024, the contingent consideration amounted to
€
104
million
, recorded entirely as a non-
current asset; and
•
up to December 31, 2023, contingent consideration receivable by Sanofi following the dissolution of the Sanofi Pasteur MSD
(SPMSD) joint venture, based on a percentage of MSD’s future sales during the 2017-2024 period of specified products
previously distributed by SPMSD (see Note D.12.).
Changes in the fair value of this contingent consideration are recognized in the income statement within the line item
Fair
value remeasurement of contingent consideration
(see Note B.18.). As of
December 31, 2024
, the contingent consideration
asset amounted to
€
113
million
(entirely recognized as a current asset), versus
€
214
million
(non-current portion:
€
104
million
)
D.8.
Assets held for
sale
and liabilities related to assets held for sale
|
(€ million)
|
December 31, 2024
|
December 31, 2023
|
December 31, 2022
|
|
Opella (D.36.)
|
|
|
|
|
Other
|
|
|
|
|
Assets held for sale
|
|
|
|
|
Opella (D.36.)
|
|
|
|
|
Other
|
|
|
|
|
Liabilities related to assets held for sale
|
|
|
|
|
F-48
|
SANOFI
FORM 20-F
2024
|
|
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
|
D.9.
Inventories
|
2024
|
2023
|
2022
|
|||||||
|
(€ million)
|
Gross
value
|
Allowances
|
Carrying
amount
|
Gross
value
|
Allowances
|
Carrying
amount
|
Gross
value
|
Allowances
|
Carrying
amount
|
|
Raw materials
|
|
(
|
|
|
(
|
|
|
(
|
|
|
Work in process
|
|
(
|
|
|
(
|
|
|
(
|
|
|
Finished goods
|
|
(
|
|
|
(
|
|
|
(
|
|
|
Total
|
|
(
|
|
|
(
|
|
|
(
|
|
Allowances include write-downs of products on hand pending marketing approval, except in specific circumstances where it is
possible to estimate that recovery of the value of inventories as of the end of the reporting period is highly probable.
No
inventories were pledged as security for liabilities as of
December 31, 2024
(versus
zero
as of
December 31, 2023
and
€
3
million
as of
December 31, 2022
).
D.10.
Accounts receivable
|
(€ million)
|
December 31, 2024
|
December 31, 2023
|
December 31, 2022
|
|
Gross value
|
|
|
|
|
Allowances
|
(
|
(
|
(
|
|
Carrying amount
|
|
|
|
The impact of allowances against accounts receivable in
2024
was a net expense of
€
19
million
(versus a net expense
of
€
8
million
in
2023
and a net amount of less than
€
1
million
in
2022
).
The gross value of overdue receivables was €
650
million
as of
December 31, 2024
, versus €
689
million
as of
December 31, 2023
and €
452
million
as of
December 31, 2022
.
|
(€ million)
|
Overdue accounts
gross value
|
Overdue by
<1 month
|
Overdue by
1 to 3 months
|
Overdue by
3 to 6 months
|
Overdue by
6 to 12 months
|
Overdue by
> 12 months
|
|
December 31, 2024
|
|
|
|
|
|
|
|
December 31, 2023
|
|
|
|
|
|
|
|
December 31, 2022
|
|
|
|
|
|
|
Amounts overdue by more than one month relate mainly to public-sector customers.
Some Sanofi subsidiaries have assigned receivables to factoring companies or banks without recourse
. The amount of
receivables derecognized was
€
14
million
as of
December 31, 2024
(
€
761
million
as of
December 31, 2023
and
€
131
million
as
of
December 31, 2022
). The residual guarantees relating to such transfers were immaterial as of
December 31, 2024
.
D.11.
Other current assets
|
(€ million)
|
2024
|
2023
|
2022
|
|
Tax receivables, other than corporate income taxes
|
|
|
|
|
Prepaid expenses
|
|
|
|
|
Other receivables
(a)
|
|
|
|
|
Currency derivatives measured at fair value (see Note D.20.)
|
|
|
|
|
Other financial assets at fair value through profit or loss
|
|
|
|
|
Other current financial assets
(b)
|
|
|
|
|
Total
|
|
|
|
agreement.
|
SANOFI
FORM 20-F
2024
|
F-49
|
|
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
|
D.12.
Financial assets and liabilities measured at fair value
Under IFRS 7 (Financial Instruments: Disclosures), fair value measurements must be classified using a fair value hierarchy with the
following levels:
•
level 1: quoted prices in active markets for identical assets or liabilities (without modification or repackaging);
•
level 2: quoted prices in active markets for similar assets and liabilities, or valuation techniques in which all important inputs are
derived from observable market data; and
•
level 3: valuation techniques in which not all important inputs are derived from observable market data.
The valuation techniques used are described in Note B.8.5.
|
2024
|
2023
|
2022
|
||||||||
|
Level in the fair value
hierarchy
|
Level in the fair value
hierarchy
|
Level in the fair value
hierarchy
|
||||||||
|
(€ million)
|
Note
|
Level 1
|
Level 2
|
Level 3
|
Level 1
|
Level 2
|
Level 3
|
Level 1
|
Level 2
|
Level 3
|
|
Financial assets measured at fair value
|
||||||||||
|
Quoted equity investments
|
D.7.1.
|
|
|
|
|
|
|
|
|
|
|
Unquoted equity investments
|
D.7.1.
|
|
|
|
|
|
|
|
|
|
|
Quoted debt securities
|
D.7.2.
|
|
|
|
|
|
|
|
|
|
|
Unquoted debt securities not meeting the
definition of equity instruments
|
D.7.3.
|
|
|
|
|
|
|
|
|
|
|
Contingent consideration relating to divestments
|
D.7.3. &
D.11.
|
|
|
|
|
|
|
|
|
|
|
Financial assets held to meet obligations under
deferred compensation plans
|
D.7.3. &
D.11.
|
|
|
|
|
|
|
|
|
|
|
Non-current derivatives
|
D.7.
|
|
|
|
|
|
|
|
|
|
|
Current derivatives
|
D.11.
|
|
|
|
|
|
|
|
|
|
|
Mutual fund investments
|
D.13.
|
|
|
|
|
|
|
|
|
|
|
Total financial assets measured at fair value
|
|
|
|
|
|
|
|
|
|
|
|
Financial liabilities measured at fair value
|
||||||||||
|
Bayer contingent purchase consideration arising
from the acquisition of Genzyme
|
D.18.
|
|
|
|
|
|
|
|
|
|
|
MSD contingent consideration (European
vaccines business)
|
D.18.
|
|
|
|
|
|
|
|
|
|
|
Shire contingent consideration arising from the
acquisition of Translate Bio
|
D.18.
|
|
|
|
|
|
|
|
|
|
|
Contingent consideration arising from acquisition
of Amunix
|
D.18.
|
|
|
|
|
|
|
|
|
|
|
Other contingent consideration arising from
business combinations and acquisitions
|
D.18.
|
|
|
|
|
|
|
|
|
|
|
Non-current derivatives
|
D.20.
|
|
|
|
|
|
|
|
|
|
|
Current derivatives
|
D.19.5
|
|
|
|
|
|
|
|
|
|
|
Total financial liabilities measured at fair value
|
|
|
|
|
|
|
|
|
|
|
No transfers between the different levels of the fair value hierarchy occurred during
2024
.
D.13.
Cash and cash equivalents
|
(€ million)
|
2024
|
2023
|
2022
|
|
Cash
|
|
|
|
|
Cash equivalents
(a)
|
|
|
|
|
Cash and cash equivalents
|
|
|
|
mutual funds (
December 31, 2023
:
€
5,349
million
;
December 31, 2022
:
€
9,537
million
); (ii)
€
1,293
million
of term deposits (
December 31,
2023
:
€
1,191
million
;
December 31, 2022
:
€
1,167
million
) and (iii)
zero
commercial paper (
December 31, 2023
:
zero
;
December 31, 2022
:
zero
). Cash
equivalents also include
€
446
million
held by captive insurance and reinsurance companies in accordance with insurance regulations (
December 31,
2023
:
€
476
million
;
December 31, 2022
:
€
439
million
).
|
F-50
|
SANOFI
FORM 20-F
2024
|
|
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
|
D.14.
Net deferred tax position
|
(€ million)
|
2024
|
2023
|
2022
|
|
|
Deferred taxes on:
|
||||
|
Consolidation adjustments (intragroup margin in inventory)
|
|
|
|
|
|
Provision for pensions and other employee benefits
|
|
|
|
|
|
Remeasurement of other acquired intangible assets
|
(
|
(a)
|
(
|
(
|
|
Recognition of acquired property, plant and equipment at fair value
|
(
|
(
|
(
|
|
|
Equity interests in subsidiaries and investments in other entities
(b)
|
(
|
(
|
(
|
|
|
Tax losses available for carry-forward
|
|
|
|
|
|
Stock options and other share-based payments
|
|
|
|
|
|
Accrued expenses and provisions deductible at the time of payment
(c)
|
|
|
|
|
|
Other
(d)
|
|
|
|
|
|
Net deferred tax asset/(liability)
|
|
|
|
(€
178
million
) and Genzyme (
€
15
million
).
deferred tax liability on the reserves of French and foreign subsidiaries (approximately €
64.9
billion
) which it regards as likely to be distributed in the
foreseeable future. In determining the amount of the deferred tax liability as of
December 31, 2024
, Sanofi took into account changes in the ownership
structure of certain subsidiaries, and the effects of changes in the taxation of dividends in France, following the ruling of the Court of Justice of
the European Union in the Steria case and the resulting amendments to the 2015 Finance Act. As of December 31, 2023, this line includes a deferred tax
liability arising from temporary differences on investments in subsidiaries which Sanofi expects will reverse in connection with the proposed separation
of the Opella business, as announced in October 2023 (see Note D.30.).
2023
, and
€
256
million
as of
December 31, 2022
.
December 31, 2023
, and
€
742
million
as of
December 31, 2022
.
The reserves of Sanofi subsidiaries that would be taxable if distributed but for which no distribution is planned, and for which no
deferred tax liability has therefore been recognized, totaled
€
10.5
billion
as of
December 31, 2024
, compared with
€
10.0
billion
as
of
December 31, 2023
and
€
10.6
billion
as of
December 31, 2022
.
Most of Sanofi’s tax loss carry-forwards are available indefinitely. For a description of policies on the recognition of deferred tax
assets, refer to Note B.22. For each tax consolidation, the recognition of deferred tax assets is determined on the basis of profit
forecasts that are consistent with Sanofi’s medium-term strategic plan, and taking into consideration the tax consequences of
the strategic opportunities available to Sanofi within the period of availability of tax loss carry-forwards and the specific
circumstances of each tax consolidation. Deferred tax assets relating to tax loss carry-forwards as of
December 31, 2024
amounted to
€
3,010
million
, of which
€
2,039
million
were not recognized (primarily composed of prior period tax liabilities
following progress of reviews with tax authorities and capital losses
). This compares with
€
2,729
million
as of
December 31, 2023
(of which
€
1,203
million
were not recognized) and
€
2,650
million
as of
December 31, 2022
(of which
€
1,144
million
were not
recognized).
|
(€ million)
|
Tax losses available for carry-forward
(a)
|
|
2025
|
|
|
2026
|
|
|
2027
|
|
|
2028
|
|
|
2029
|
|
|
2030 and later
|
|
|
Total as of December 31, 2024
|
|
|
Total as of December 31, 2023
|
|
|
Total as of December 31, 2022
|
|
Use of tax loss carry-forwards is limited to the entity in which they arose. In jurisdictions where tax consolidations are in place, tax
losses can be netted against taxable income generated by entities in the same tax consolidation.
Deferred tax assets not recognized because their future recovery was not regarded as probable given the expected results of the
entities in question and unagreed tax positions amounted to
€
2,117
million
in
2024
,
€
1,261
million
in
2023
and
€
1,197
million
in
2022
.
|
SANOFI
FORM 20-F
2024
|
F-51
|
|
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
|
D.15.
Consolidated shareholders’ equity
D.15.1. Share capital
As of
December 31, 2024
, the share capital w
as
€
2,526,245,442
, consisting of
1,263,122,721
shar
es with a par value of
€
2
.
Treasury
shares held by Sanofi are as follows:
|
Number of shares
(million)
|
% of share capital
for the period
|
|
|
December 31, 2024
|
|
|
|
December 31, 2023
|
|
|
|
December 31, 2022
|
|
|
|
January 1, 2022
|
|
|
Treasury shares are deducted from shareholders’ equity. Gains and losses on disposals of treasury shares are recorded directly in
equity and are not recognized in net income for the period.
|
Date
|
Transaction
|
Number of shares
|
|
December 31, 2021
|
|
|
|
During 2022
|
Capital increase by exercise of stock subscription options
(a)
|
|
|
During 2022
|
Capital increase by issuance of restricted shares
(b)
|
|
|
Board meeting of July 27, 2022
|
Capital increase reserved for employees
|
|
|
Board meeting of December 14, 2022
|
Reduction in share capital by cancellation of treasury shares
|
(
|
|
December 31, 2022
|
|
|
|
During 2023
|
Capital increase by exercise of stock subscription options
(a)
|
|
|
During 2023
|
Capital increase by issuance of restricted shares
(b)
|
|
|
Board meeting of July 27, 2023
|
Capital increase reserved for employees
|
|
|
December 31, 2023
|
|
|
|
During 2024
|
Capital increase by exercise of stock subscription options
(a)
|
|
|
During 2024
|
Capital increase by issuance of restricted shares
(b)
|
|
|
Board meeting of July 24, 2024
|
Capital increase reserved for employees
|
|
|
Board meeting of December 4, 2024
|
Reduction in share capital by cancellation of treasury shares
|
(
|
|
December 31, 2024
|
|
For the disclosures about the management of capital required under IFRS 7, refer to Note D.2.
|
F-52
|
SANOFI
FORM 20-F
2024
|
|
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
|
D.15.2. Restricted share plans
those plans are as follows:
|
2024
|
2023
|
2022
|
||||
|
Type of plan
|
Performance
share plans
|
Performance
share plans
|
Performance
share plans
|
Performance
share plans
|
Performance
share plans
|
Performance
share plans
|
|
Date of Board meeting approving the plan
|
April 30, 2024
|
December 4,
2024
|
May 25, 2023
|
December 13,
2023
|
May 3, 2022
|
December 14,
2022
|
|
Service period
|
|
|
|
|
|
|
|
Total number of shares awarded
(a)
|
|
|
|
|
|
|
|
Of which with no market condition
|
|
|
|
|
|
|
|
Fair value per share awarded
(b)
|
€
|
€
|
€
|
€
|
€
|
€
|
|
Of which with market condition
|
|
|
|
|
|
|
|
Fair value per share awarded other than to the Chief
Executive Officer
(c)
|
€
|
€
|
€
|
€
|
€
|
€
|
|
Fair value per share awarded other than to the Chief
Executive Officer - additional shares
(d)
|
€
|
€
|
€
|
€
|
€
|
€
|
|
Fair value per share awarded to the Chief Executive
Officer
(c)
|
€
|
|
€
|
|
€
|
|
|
Fair value of plan at the date of grant
(€ million)
|
|
|
|
|
|
|
dividends expected during the vesting period.
December
2024
(versus
121,097
awarded in May
2023
,
5,838
awarded in December
2023
,
114,874
awarded in May
2022
and
9,066
awarded in
December
2022
).
the table below:
|
2024(a)
|
2023(a)
|
2022(a)
|
|
|
Total expense for restricted share plans (€ million)
|
|
|
|
|
Number of shares not yet fully vested as of December 31
|
|
|
|
|
Under 2024 plans
|
|
|
|
|
Under 2023 plans
|
|
|
|
|
Under 2022 plans
|
|
|
|
|
Under 2021 plans
|
|
|
|
|
Under 2020 plans
|
|
|
|
D.15.3. Capital increases
in
2024
,
2023
and
2022
are summarized in the table below:
|
2024
|
2023
|
2022
|
|
|
Date of Board meeting approving the plan
|
January 31, 2024
|
February 2, 2023
|
February 3, 2022
|
|
Subscription price (€)
(a)
|
|
|
|
|
Subscription period
|
June 4-24, 2024
|
June 5-23, 2023
|
June 9-29, 2022
|
|
Number of shares subscribed
|
|
|
|
|
Number of shares issued immediately as employer’s contribution
|
|
|
|
|
SANOFI
FORM 20-F
2024
|
F-53
|
|
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
|
|
(€ million)
|
2024
|
2023
|
2022
|
|
Expense recognized
|
|
|
|
|
of which employer’s contribution
|
|
|
|
D.15.4. Repurchase of Sanofi shares
The Annual General Meetings of Sanofi shareholders held on April 30, 2024, May 25, 2023 and May 3, 2022 each authorized a
share repurchase program for a period of
18
months
.
The following repurchases have been made under those programs:
|
(in number of shares
and € million)
Year of authorization
|
2024
|
2023
|
2022
|
|||
|
Number
of shares
|
Value
|
Number
of shares
|
Value
|
Number
of shares
|
Value
|
|
|
2024 program
|
|
|
—
|
—
|
—
|
—
|
|
2023 program
|
|
|
|
|
—
|
—
|
|
2022 program
|
—
|
—
|
|
|
|
|
|
2021 program
|
—
|
—
|
—
|
—
|
|
|
D.15.5. Reductions in share capital
Reductions in share capital for the accounting periods presented are described in the table included at Note D.15.1. above.
Those reductions have
no impact on shareholders’ equity.
D.15.6. Currency translation differences
|
(€ million)
|
2024
|
2023
|
2022
|
|
Attributable to equity holders of Sanofi
|
|
(
|
|
|
Attributable to non-controlling interests
|
(
|
(
|
(
|
|
Total
|
|
(
|
|
The balance as of
December 31, 2024
includes an after-tax amount of
€(
679
) million
relating to hedges of net investments
in foreign operations (refer to Note B.8.3. for a description of the relevant accounting policy), compared with €
(
574
) million
as
of
December 31, 2023
and €
(
580
) million
as of
December 31, 2022
.
This balance also includes an amount of
€(
300
) million
relating to translation differences of Opella, the assets and liabilities
of
which are presented in
Assets held for sale
and
Liabilities related to assets held for sale
as of December 31, 2024.
The movement in
Currency translation differences
is mainly attributable to the US dollar.
|
F-54
|
SANOFI
FORM 20-F
2024
|
|
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
|
D.15.7. Other comprehensive income
|
(€ million)
|
2024
|
2023
|
2022
|
|
Actuarial gains/(losses):
|
|||
|
•
Actuarial gains/(losses) excluding investments accounted for using the equity
method (see Note D.19.1.)
|
|
(
|
|
|
•
Actuarial gains/(losses) of investments accounted for using the equity method,
net of taxes
|
(
|
|
|
|
•
Tax effects
|
(
|
|
(
|
|
Equity instruments included in financial assets and financial liabilities:
|
|||
|
•
Change in fair value (excluding investments accounted for using the
equity method)
|
(
|
|
(
|
|
•
Change in fair value (investments accounted for using the equity method,
net of taxes)
|
|
|
|
|
•
Equity risk hedging instruments designated as fair value hedges
|
|
|
|
|
•
Tax effects
|
|
(
|
(
|
|
Items not subsequently reclassifiable to profit or loss
(a)
|
(
|
(
|
|
|
Debt instruments included in financial assets:
|
|||
|
•
Change in fair value (excluding investments accounted for using the equity
method)
(b)
|
|
|
(
|
|
•
Tax effects
|
|
(
|
|
|
Cash flow and fair value hedges:
|
|||
|
•
Change in fair value (excluding investments accounted for using the equity
method)
(c)
|
(
|
|
|
|
•
Change in fair value (investments accounted for using the equity method,
net of taxes)
|
(
|
(
|
|
|
▪
Tax effects
|
|
|
(
|
|
Change in currency translation differences:
|
|||
|
•
Currency translation differences on foreign subsidiaries (excluding investments
accounted for using the equity method)
(d)
|
|
(
|
|
|
•
Currency translation differences (investments accounted for using the equity
method)
(d)
|
|
|
(
|
|
•
Hedges of net investments in foreign operations
(d)
|
(
|
|
(
|
|
•
Tax effects
|
|
(
|
|
|
Items subsequently reclassifiable to profit or loss
(e)
|
|
(
|
|
deconsolidation of EUROAPI). Currency translation differences arise from the translation into euros of the financial statements of foreign subsidiaries,
and are mainly due to the appreciation of the dollar against the euro.
|
SANOFI
FORM 20-F
2024
|
F-55
|
|
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
|
D.15.8. Stock options
Stock option plans awarded and measurement of stock option plans
No stock options were awarded during
2024
,
2023
or
2022
.
Stock subscription option plans
Details of the terms of exercise of stock subscription options granted under the various plans are presented below in Sanofi share
equivalents. These plans were awarded to certain corporate officers and employees of Sanofi companies.
ended
December 31, 2024
:
|
Source
|
Date of grant
|
Number of
options
granted
|
Start date of
exercise
period
|
Expiry date
|
Exercise
price
(€)
|
Number of
options
outstanding as of
12/31/2024
|
|
Sanofi
|
03/05/2014
|
|
03/06/2018
|
03/05/2024
|
|
|
|
Sanofi
|
06/24/2015
|
|
06/25/2019
|
06/24/2025
|
|
|
|
Sanofi
|
05/04/2016
|
|
05/05/2020
|
05/04/2026
|
|
|
|
Sanofi
|
05/10/2017
|
|
05/11/2021
|
05/10/2027
|
|
|
|
Sanofi
|
05/02/2018
|
|
05/03/2022
|
05/02/2028
|
|
|
|
Sanofi
|
04/30/2019
|
|
05/01/2023
|
04/30/2029
|
|
|
|
Total
|
|
The exercise of all outstanding stock subscription options would increase shareholders’ equity by approximately
€
75
million
.
The exercise of each option results in the issuance of
one
share.
Summary of stock option plans
below:
|
Number of
options
|
Weighted average
exercise price
per share
(€)
|
Total
(€ million)
|
|
|
Options outstanding at January 1, 2022
|
|
|
|
|
Options exercisable
|
|
|
|
|
Options exercised
|
(
|
|
(
|
|
Options cancelled
(a)
|
(
|
|
(
|
|
Options outstanding at December 31, 2022
|
|
|
|
|
Options exercisable
|
|
|
|
|
Options exercised
|
(
|
|
(
|
|
Options outstanding at December 31, 2023
|
|
|
|
|
Options exercisable
|
|
|
|
|
Options exercised
|
(
|
|
(
|
|
Options outstanding at December 31, 2024
|
|
|
|
|
Options exercisable
|
|
|
|
|
Outstanding
|
Exercisable
|
||||
|
Range of exercise prices per share
|
Number of
options
|
Weighted average
residual life
(years)
|
Weighted average
exercise price
per share
(€)
|
Number of
options
|
Weighted average
exercise price
per share
(€)
|
|
From
€
|
|
|
|
|
|
|
From
€
|
|
|
|
|
|
|
From
€
|
|
|
|
|
|
|
Total
|
|
|
|||
|
F-56
|
SANOFI
FORM 20-F
2024
|
|
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
|
D.15.9. Number of shares used to compute diluted earnings per share
Diluted earnings per share is computed using the number of shares outstanding plus stock options with dilutive effect and
restricted shares.
|
(million)
|
2024
|
2023
|
2022
|
|
Average number of shares outstanding
|
|
|
|
|
Adjustment for stock options with dilutive effect
|
|
|
|
|
Adjustment for restricted shares
|
|
|
|
|
Average number of shares used to compute diluted earnings per share
|
|
|
|
In
2024
,
2023
and
2022
, all stock options were taken into account in computing diluted earnings per share because they all had a
D.16.
N
on-controlling interests
Non-controlling interests did not represent a material component of Sanofi’s consolidated financial statements in the years
D.17.
Debt, cash and cash equivalents and lease liabilities
D.17.1. Debt, cash and cash equivalents
|
(€ million)
|
2024
|
2023
|
2022
|
|
Long-term debt
|
|
|
|
|
Short-term debt and current portion of long-term debt
|
|
|
|
|
Interest rate and currency derivatives used to manage debt
|
|
|
|
|
Total debt
|
|
|
|
|
Cash and cash equivalents
|
(
|
(
|
(
|
|
Interest rate and currency derivatives used to manage cash and cash equivalents
|
|
(
|
(
|
|
Net debt
(a)
|
|
|
|
“Net debt” is a non-IFRS financial measure used by management and investors to measure Sanofi’s overall net indebtedness.
|
Value on redemption
|
||||||
|
(€ million)
|
Carrying
amount at
December 31,
2024
|
Amortized
cost
|
Adjustment
to debt
measured at
fair value
|
December 31,
2024
|
December 31,
2023
|
December 31,
2022
|
|
Long-term debt
|
|
|
|
|
|
|
|
Short-term debt and current portion
of long-term debt
|
|
|
|
|
|
|
|
Interest rate and currency derivatives
used to manage debt
|
|
|
(
|
|
(
|
(
|
|
Total debt
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
(
|
|
|
(
|
(
|
(
|
|
Interest rate and currency derivatives
used to manage cash and cash
equivalents
|
|
|
|
|
(
|
(
|
|
Net debt
|
|
|
|
|
|
|
|
SANOFI
FORM 20-F
2024
|
F-57
|
|
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
|
a) Principal financing transactions during the year
|
Cash flows from
financing activities
|
Non-cash items
|
|||||||
|
(€ million)
|
December 31,
2023
|
Repayments
|
New
borrowings
|
Other
cash
flows
(a)
|
Currency
translation
differences
(b)
|
Reclassification
from non-current
to current
|
Other
items
(c)
|
December 31,
2024
|
|
Long-term debt
|
|
(
|
|
|
|
(
|
|
|
|
Short-term debt and
current portion of
long-term debt
|
|
(
|
|
|
|
|
(
|
|
|
Interest rate and
currency derivatives
used to manage debt
|
|
|
|
(
|
|
|
(
|
|
|
Total debt
|
|
(
|
|
|
|
|
(
|
|
Sanofi did not carry out any bond issues in 2024.
Sanofi exercised an extension option on one of its two syndicated credit facilities linked to social and environmental indicators,
thereby extending the maturity of that
€
4
billion
facility (put in place in March 2023) to March 6, 2030.
Consequently, as of December 31, 2024, Sanofi had
two
syndicated credit facilities to provide liquidity for the purposes of current
operations, each of them linked to environmental and social indicators:
•
a
€
4
billion
facility maturing December 6, 2027, with no further extension option available; and
•
a
€
4
billion
facility maturing March 6, 2030,
with no further extension option available
.
In line with Sanofi’s commitment to embed sustainable development in the “Play to Win” strategy, those
two
revolving credit
facilities build in an adjustment mechanism that links the credit spread to the attainment of
two
sustainable development
performance indicators:
•
for the facility maturing in December 2027: (i) Sanofi’s contribution to polio eradication, and (ii) the reduction in Sanofi’s
carbon footprint; and
•
for the facility maturing in March 2030: (i) Sanofi’s contribution to improving access to essential medicines in low-income and
intermediate-income countries via its Sanofi Global Health non-profit unit, and (ii) the reduction in Sanofi’s carbon footprint.
|
Cash flows from
financing activities
|
Non-cash items
|
|||||||
|
(€ million)
|
December 31,
2022
|
Repayments
|
New
borrowings
|
Other
cash
flows
(a)
|
Currency
translation
differences
(b)
|
Reclassification
from non-current
to current
|
Other
items
(c)
|
December 31,
2023
|
|
Long-term debt
|
|
(
|
|
|
(
|
(
|
|
|
|
Short-term debt and
current portion of
long-term debt
|
|
(
|
|
|
(
|
|
|
|
|
Interest rate and
currency derivatives
used to manage debt
|
|
|
|
(
|
|
|
(
|
|
|
Total debt
|
|
(
|
|
|
(
|
|
|
|
|
F-58
|
SANOFI
FORM 20-F
2024
|
|
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
|
|
Cash flows from
financing activities
|
Non-cash items
|
|||||||
|
(€ million)
|
December 31,
2021
|
Repayments
|
New
borrowings
|
Other
cash
flows
|
Currency
translation
differences
(a)
|
Reclassification
from non-current
to current
|
Other
items
(b)
|
December 31,
2022
|
|
Long-term debt
|
|
(
|
|
|
|
(
|
(
|
|
|
Short-term debt and
current portion of
long-term debt
|
|
(
|
|
|
|
|
|
|
|
Interest rate and
currency derivatives
used to manage debt
|
(
|
|
|
(
|
|
|
|
|
|
Total debt
|
|
(
|
|
(
|
|
|
|
|
b) Net
debt
by type, at value on redemption
|
2024
|
2023
|
2022
|
|||||||
|
(€ million)
|
Non-
current
|
Current
|
Total
|
Non-
current
|
Current
|
Total
|
Non-
current
|
Current
|
Total
|
|
Bond issues
|
|
|
|
|
|
|
|
|
|
|
Other bank borrowings
|
|
|
|
|
|
|
|
|
|
|
Other borrowings
|
|
|
|
|
|
|
|
|
|
|
Bank credit balances
|
|
|
|
|
|
|
|
|
|
|
Interest rate and currency
derivatives used to manage debt
|
|
|
|
|
(
|
(
|
|
(
|
(
|
|
Total debt
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
(
|
(
|
|
(
|
(
|
|
(
|
(
|
|
Interest rate and currency
derivatives used to manage cash
and cash equivalents
|
|
|
|
|
(
|
(
|
|
(
|
(
|
|
Net debt
(a)
|
|
(
|
|
|
(
|
|
|
(
|
|
|
Issuer
|
ISIN code
|
Issue date
|
Maturity
|
Annual
interest rate
|
Amount
(€ million)
|
Type
|
|
Sanofi
|
FR0013505104
|
March 2020
|
April 2025
|
|
|
EMTN program
|
|
Sanofi
|
FR0014009KS6
|
April 2022
|
April 2025
|
|
|
Standalone Prospectus
|
|
Sanofi
|
FR0012969038
|
September 2015
|
September 2025
|
|
|
EMTN program
|
|
Sanofi
|
FR0013324340
|
March 2018
|
March 2026
|
|
|
EMTN program
|
|
Sanofi
|
FR0012146801
|
September 2014
|
September 2026
|
|
|
EMTN program
|
|
Sanofi
|
FR0013201639
|
September 2016
|
January 2027
|
|
|
EMTN program
|
|
Sanofi
|
FR0013144003
|
April 2016
|
April 2028
|
|
|
EMTN program
|
|
Sanofi
|
FR0013409844
|
March 2019
|
March 2029
|
|
|
EMTN program
|
|
Sanofi
|
FR0014009KQ0
|
April 2022
|
April 2029
|
|
|
Standalone Prospectus
|
|
Sanofi
|
FR0013324357
|
March 2018
|
March 2030
|
|
|
EMTN program
|
|
Sanofi
|
FR0013505112
|
March 2020
|
April 2030
|
|
|
EMTN program
|
|
Sanofi
|
FR0013409851
|
March 2019
|
March 2034
|
|
|
EMTN program
|
|
Sanofi
|
FR0013324373
|
March 2018
|
March 2038
|
|
|
EMTN program
|
Bond issues denominated in US dollars carried out by Sanofi under the public bond issue program (shelf registration statement)
registered with the US Securities and Exchange Commission (SEC) comprise:
|
Issuer
|
ISIN code
|
Issue date
|
Maturity
|
Annual
interest rate
|
Amount
($ million)
|
Type
|
|
Sanofi
|
US801060AD60
|
June 2018
|
June 2028
|
|
|
SEC registered
|
The “Other borrowings” line mainly comprises participating shares issued between 1983 and 1987, of which
57,844
remain
outstanding, with a nominal amount of
€
9
million
.
|
SANOFI
FORM 20-F
2024
|
F-59
|
|
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
|
In order to manage its liquidity needs for current operations, as of December 31, 2024 Sanofi had:
•
a syndicated credit facility of
€
4
billion
, drawable in euros and in US dollars, maturing December 6, 2027; and
•
a syndicated credit facility of
€
4
billion
, drawable in euros and in US dollars, maturing March 6, 2030.
Sanofi also has
two
commercial paper programs:
•
a
€
6
billion
Negotiable European Commercial Paper program in France, with an average drawdown of
€
0.1
billion
and a
maximum drawdown of
€
0.4
billion
during 2024. As of December 31, 2024, this program was not being utilized; and
•
a
$
10
billion
Commercial Paper program in the United States, with an average drawdown of
$
5.8
billion
and a maximum
drawdown of
$
8.9
billion
during 2024, and an amount of
$
1.3
billion
drawn down as of December 31, 2024.
The financing in place as of
December 31, 2024
at the level of the holding company (which manages most of Sanofi’s financing
needs centrally) is not subject to any financial covenants, and contains no clauses linking spreads or fees to the credit rating.
c) Debt by maturity, at value on redemption
|
December 31, 2024
|
Current
|
Non-current
|
|||||
|
(€ million)
|
Total
|
2025
|
2026
|
2027
|
2028
|
2029
|
2030 and
later
|
|
Bond issues
|
|
|
|
|
|
|
|
|
Other bank borrowings
|
|
|
|
|
|
|
|
|
Other borrowings
|
|
|
|
|
|
|
|
|
Bank credit balances
|
|
|
|
|
|
|
|
|
Interest rate and currency derivatives used
to manage debt
|
|
|
|
|
|
|
|
|
Total debt
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
(
|
(
|
|
|
|
|
|
|
Interest rate and currency derivatives used
to manage cash and cash equivalents
|
|
|
|
|
|
|
|
|
Net debt
(a)
|
|
(
|
|
|
|
|
|
and €
2,181
million as of December 31, 2022
(see the maturity analysis at Note D.17.2.).
As of
December 31, 2024
, the main undrawn confirmed general-purpose credit facilities at holding company level amounted
to
€
8
billion
, half of which expired in 2027 and the other half of which expires in 2030.
As of
December 31, 2024
,
no
single counterparty represented more than
6%
of Sanofi’s undrawn confirmed credit facilities.
|
December 31, 2023
|
Current
|
Non-current
|
|||||
|
(€ million)
|
Total
|
2024
|
2025
|
2026
|
2027
|
2028
|
2029 and
later
|
|
Bond issues
|
|
|
|
|
|
|
|
|
Other bank borrowings
|
|
|
|
|
|
|
|
|
Other borrowings
|
|
|
|
|
|
|
|
|
Bank credit balances
|
|
|
|
|
|
|
|
|
Interest rate and currency derivatives used to manage
debt
|
(
|
(
|
|
|
|
|
|
|
Total debt
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
(
|
(
|
|
|
|
|
|
|
Interest rate and currency derivatives used to manage
cash and cash equivalents
|
(
|
(
|
|
|
|
|
|
|
Net debt
|
|
(
|
|
|
|
|
|
|
F-60
|
SANOFI
FORM 20-F
2024
|
|
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
|
|
December 31, 2022
|
Current
|
Non-current
|
|||||
|
(€ million)
|
Total
|
2023
|
2024
|
2025
|
2026
|
2027
|
2028 and
later
|
|
Bond issues
|
|
|
|
|
|
|
|
|
Other bank borrowings
|
|
|
|
|
|
|
|
|
Other borrowings
|
|
|
|
|
|
|
|
|
Bank credit balances
|
|
|
|
|
|
|
|
|
Interest rate and currency derivatives used to manage
debt
|
(
|
(
|
|
|
|
|
|
|
Total debt
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
(
|
(
|
|
|
|
|
|
|
Interest rate and currency derivatives used to manage
cash and cash equivalents
|
(
|
(
|
|
|
|
|
|
|
Net debt
|
|
(
|
|
|
|
|
|
d) Debt by interest rate, at value on redemption
values on redemption, before the effects of derivative instruments:
|
(€ million)
|
Total
|
2025
|
2026
|
2027
|
2028
|
2029
|
2030 and
later
|
|
Fixed-rate debt
|
|
|
|
|
|
|
|
|
of which euro
|
|
||||||
|
of which US dollar
|
|
||||||
|
% fixed-rate
|
|
||||||
|
Floating-rate debt
|
|
|
|
|
|
|
|
|
of which euro
|
|
||||||
|
of which US dollar
|
|
||||||
|
% floating-rate
|
|
||||||
|
Debt
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
(
|
(
|
|
|
|
|
|
|
of which euro
|
(
|
||||||
|
of which US dollar
|
(
|
||||||
|
% floating-rate
|
|
||||||
|
Net debt
|
|
(
|
|
|
|
|
|
Sanofi issues debt in
two
currencies, the euro and the US dollar, and also invests its cash and cash equivalents in those currencies.
Sanofi also operates cash pooling arrangements to manage the surplus cash and short-term liquidity needs of foreign subsidiaries
located outside the euro zone.
|
SANOFI
FORM 20-F
2024
|
F-61
|
|
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
|
uses derivative instruments (interest rate swaps, currency swaps, foreign exchange swaps and forward contracts) that alter the
fixed/floating rate split and the currency split of its net debt:
|
(€ million)
|
Total
|
2025
|
2026
|
2027
|
2028
|
2029
|
2030 and
later
|
|
Fixed-rate debt
|
|
(
|
|
|
|
|
|
|
of which euro
|
|
||||||
|
of which US dollar
|
|
||||||
|
% fixed-rate
|
|
||||||
|
Floating-rate debt
|
|
|
|
|
|
|
|
|
of which euro
|
|
||||||
|
of which US dollar
|
|
||||||
|
% floating-rate
|
|
||||||
|
Debt
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
(
|
(
|
|
|
|
|
|
|
of which euro
|
(
|
||||||
|
of which US dollar
|
(
|
||||||
|
of which Singapore dollar
|
(
|
||||||
|
% floating-rate
|
|
||||||
|
Net debt
|
|
(
|
|
|
|
|
|
instruments as of
December 31, 2023
and December 31,
2022
:
|
(€ million)
|
2023
|
%
|
2022
|
%
|
|
Fixed-rate debt
|
|
|
|
|
|
Floating-rate debt
|
|
|
|
|
|
Debt
|
|
|
|
|
|
Cash and cash equivalents
|
(
|
(
|
||
|
Net debt
|
|
|
The weighted average interest rate on debt as of
December 31, 2024
was
1.7
%
before derivative instruments and
2.1
%
after
derivative instruments. Cash and cash equivalents were invested as of
December 31, 2024
at an average rate of
4.2
%
before
derivative instruments and
4.1
%
after derivative instruments.
|
Change in short-term interest rates
|
Impact on pre-tax net
income
(€ million)
|
Impact on pre-tax
income/(expense) recognized
directly in equity
(€ million)
|
|
+100 bp
|
|
|
|
+25 bp
|
|
|
|
-25 bp
|
(
|
|
|
-100 bp
|
(
|
|
e) Debt by currency, at value on redemption
convert the foreign-currency net debt of exposed entities into their functional currency:
|
(€ million)
|
Before derivative instruments
|
After derivative instruments
|
|
Euro
|
|
|
|
US dollar
|
(
|
|
|
Singapore dollar
|
(
|
(
|
|
Hungarian forint
|
|
(
|
|
Chinese yuan renminbi
|
(
|
|
|
Other currencies
|
|
|
|
Net debt
|
|
|
|
F-62
|
SANOFI
FORM 20-F
2024
|
|
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
|
the foreign currency net debt of exposed entities into their functional currency:
|
(€ million)
|
2023
|
2022
|
|
Euro
|
|
|
|
US dollar
|
|
(
|
|
Other currencies
|
(
|
(
|
|
Net debt
|
|
|
f) Market value of net
debt
|
(€ million)
|
2024
|
2023
|
2022
|
|
Market value
|
|
|
|
|
Value on redemption
|
|
|
|
The fair value of net debt is determined by reference to quoted market prices at the balance sheet date in the case of quoted
instruments (level 1 in the IFRS 7 hierarchy, see Note D.12.), and by reference to the fair value of interest rate and currency
derivatives used to manage net debt (level 2 in the IFRS 7 hierarchy, see Note D.12.).
g) Future contractual cash flows relating to debt and related derivatives
derivative instruments designated as hedges of debt:
|
December 31, 2024
|
Payments due by period
|
||||||
|
(€ million)
|
Total
|
2025
|
2026
|
2027
|
2028
|
2029
|
2030 and
later
|
|
Debt
|
|
|
|
|
|
|
|
|
Principal
|
|
|
|
|
|
|
|
|
Interest
(a)
|
|
|
|
|
|
|
|
|
Net cash flows related to derivative instruments
|
|
|
|
|
|
|
|
|
Total
|
|
|
|
|
|
|
|
Future contractual cash flows are shown on the basis of the carrying amount in the balance sheet at the reporting date, without
reference to any subsequent management decision that might materially alter the structure of Sanofi’s debt or its hedging policy.
derivative instruments designated as hedges of debt as of
December 31, 2023
and
2022
:
|
December 31, 2023
|
Payments due by period
|
||||||
|
(€ million)
|
Total
|
2024
|
2025
|
2026
|
2026
|
2028
|
2029 and
later
|
|
Debt
|
|
|
|
|
|
|
|
|
Principal
|
|
|
|
|
|
|
|
|
Interest
(a)
|
|
|
|
|
|
|
|
|
Net cash flows related to derivative instruments
|
|
|
|
|
|
|
|
|
Total
|
|
|
|
|
|
|
|
|
December 31, 2022
|
Payments due by period
|
||||||
|
(€ million)
|
Total
|
2023
|
2024
|
2025
|
2026
|
2026
|
2028 and
later
|
|
Debt
|
|
|
|
|
|
|
|
|
Principal
|
|
|
|
|
|
|
|
|
Interest
(a)
|
|
|
|
|
|
|
|
|
Net cash flows related to derivative instruments
|
|
|
|
|
|
|
|
|
Total
|
|
|
|
|
|
|
|
|
SANOFI
FORM 20-F
2024
|
F-63
|
|
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
|
D.17.2. Lease liabilities
|
Undiscounted future minimum lease payments
|
||||||
|
(€ million)
|
Total
|
Less than
1 year
|
From 1 to
3 years
|
From 3 to
5 years
|
More than
5 years
|
Discounting
effect
|
|
Total lease liabilities as of
December 31, 2024
(a)
|
|
|
|
|
|
(
|
|
Total lease liabilities as of
December 31, 2023
|
|
|
|
|
|
(
|
|
Total lease liabilities as of
December 31, 2022
|
|
|
|
|
|
(
|
(a)
2024 amounts exclude Opella discontinued operations, while 2023 and 2022 include them.
Lease liabilities include leases relating to real estate assets located at Cambridge, MA (United States), which have a lease term of
D.18.
Liabilities related to business combinations and to non-controlling interests
For a description of the nature of the liabilities reported in the line item
Liabilities related to business combinations and to
non-controlling interests
, refer to Note B.8.5. The principal acquisitions are described in Notes D.1. and D.2.
The liabilities related to business combinations and to non-controlling interests shown in the table below are level 3 instruments
under the IFRS 7 fair value hierarchy (see Note D.12.).
|
(€ million)
|
Bayer
contingent
consideration
arising from the
acquisition of
Genzyme
|
MSD
contingent
consideration
(European
Vaccines
business)
|
Shire
contingent
consideration
arising from the
acquisition of
Translate Bio
|
Contingent
consideration
arising from
acquisition of
Amunix
|
Other
|
Total
(a)
|
|
Balance at January 1, 2022
|
|
|
|
|
|
|
|
New transactions
|
|
|
|
|
|
|
|
Payments made
|
(
|
(
|
|
|
(
|
(
|
|
Fair value remeasurements through profit or loss:
(gain)/loss (including unwinding of discount)
(b)
|
(
|
|
|
(
|
|
|
|
Other movements
|
|
|
|
|
|
|
|
Currency translation differences
|
|
|
|
|
|
|
|
Balance at December 31, 2022
|
|
|
|
|
|
|
|
New transactions
|
|
|
|
|
|
|
|
Payments made
|
(
|
(
|
|
(
|
|
(
|
|
Fair value remeasurements through profit or loss:
(gain)/loss (including unwinding of discount)
(b)
|
(
|
|
|
|
|
|
|
Other movements
|
|
|
|
|
|
|
|
Currency translation differences
|
|
|
(
|
(
|
|
(
|
|
Balance at December 31, 2023
|
|
|
|
|
|
|
|
New transactions
|
|
|
|
|
|
|
|
Payments made
|
|
(
|
|
|
(
|
(
|
|
Fair value remeasurements through profit or loss:
(gain)/loss (including unwinding of discount)
(b)
|
|
|
|
|
|
|
|
Other movements
|
|
|
|
(
|
(
|
(
|
|
Currency translation differences
|
|
(
|
|
|
|
|
|
Balance at December 31, 2024
|
|
|
|
|
|
|
2022
); portion due within less than one year:
€
72
million
as of
December 31, 2024
(
€
208
million
as of
December 31, 2023
and
€
105
million
as
of
December 31, 2022
).
As of
December 31, 2024
,
Liabilities related to business combinations and to non-controlling interests
mainly comprised:
•
the MSD contingent consideration liability arising from the 2016 acquisition of the Sanofi Pasteur activities carried on within
the former Sanofi Pasteur MSD joint venture, which amounted to
€
72
million
as of
December 31, 2024
,
€
127
million
as
of
December 31, 2023
and
€
204
million
as of
December 31, 2022
(see Note D.12.). The fair value of this contingent
consideration is determined by applying the royalty percentage stipulated in the contract to discounted sales proje
ctions;
|
F-64
|
SANOFI
FORM 20-F
2024
|
|
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
|
•
a contingent consideration liability towards Shire Human Genetic Therapies Inc. (Shire) arising from Sanofi’s acquisition of
Translate Bio in September 2021. In a business combination carried out in December 2016 and predating the acquisition of
control by Sanofi, Translate Bio (then called Rana Therapeutics, Inc.) acquired from Shire the intellectual property rights
relating to the latter’s Messenger RNA Therapeutics (MRT) program.
As of
December 31, 2024
, Shire was entitled to receive the
following potential payments:
–
milestone payments contingent on the launch of products based on MRT technology, and on the attainment of a specified
level of sales of those products, and
–
a percentage of sales of those products
.
The fair value of the Shire liability was measured at
€
568
million
as of
December 31, 2024
, compared with
€
441
million
as
of
December 31, 2023
and
€
380
million
as of
December 31, 2022
; it was determined by applying the contractual terms to
development and sales projections which were weighted to reflect the probability of success, and discounted. If the discount
rate were to fall by one percentage point, the fair value of the Shire liability would increase by approximately
13
%
;
•
Following the exclusive licensing agreement on the ProXTen technology platform entered into with Vir Biotechnology in
September 2024 , Inc., Sanofi no longer has any contingent consideration liability arising from the acquisition of Amunix in
2022 . The fair value of that contingent consideration liability was €
137
million
as of December 31, 2023 and
€
165
million
as of
December 31, 2022.
•
The Bayer contingent consideration liability arising from Sanofi’s acquisition of Genzyme in 2011 was extinguished during 2023
in accordance with the contractual terms.
|
December 31, 2024
|
Payments due by period
|
||||
|
(€ million)
|
Total
|
Less than
1 year
|
From 1 to
3 years
|
From 3 to
5 years
|
More than
5 years
|
|
Commitments relating to contingent consideration in
connection with business combinations
|
|
|
|
|
|
The nominal amount of contingent consideration was
€
133
million
as of
December 31, 2023
and
€
604
million
as of
December 31,
D.19.
Provisions, income tax liabilities and other liabilities
|
(€ million)
|
2024
|
2023
|
2022
|
|
Provisions
|
|
|
|
|
Other non-current liabilities
(a)
|
|
|
|
|
Total
|
|
|
|
2022
.
The figure as of
December 31, 2024
includes €
2,007
million for the liability in respect of royalties payable to Sobi on net sales of Beyfortus (nirsevimab) in
the United States (see Note C.2.). Given the method used to calculate royalties payable, an increase or decrease in sales forecasts would lead to a
proportionate change in the amount of the liability. The nominal value of payments estimated to be due within more than one year but less than five
years is €
1,140
million; the nominal value of payments estimated to be due after more than five years is €
2,792
million.
Non-current income tax liabilities are described in Note D.19.4., and other current liabilities in Note D.19.5.
|
SANOFI
FORM 20-F
2024
|
F-65
|
|
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
|
|
(€ million)
|
Provisions for
pensions and
other post-
employment
benefits
(D.19.1.)
|
Provisions
for other
long-term
benefits
|
Restructuring
provisions
(D.19.2.)
|
Other
provisions
(D.19.3.)
|
Total
|
||
|
Balance at January 1, 2022
|
|
|
|
|
|
||
|
Changes in scope of consolidation
|
(
|
(
|
|
(
|
(
|
||
|
Increases in provisions
|
|
(a)
|
|
|
|
|
|
|
Provisions utilized
|
(
|
(a)
|
(
|
(
|
(
|
(
|
|
|
Reversals of unutilized provisions
|
(
|
(a)
|
(
|
(
|
(
|
(
|
|
|
Transfers
|
|
|
(
|
(
|
(
|
||
|
Net interest related to employee benefits,
and unwinding of discount
|
|
|
|
|
|
||
|
Currency translation differences
|
|
|
(
|
|
|
||
|
Actuarial gains and losses on defined-benefit plans
|
(
|
|
|
|
(
|
||
|
Balance at December 31, 2022
|
|
|
|
|
|
||
|
Increases in provisions
|
|
(a)
|
|
|
|
|
|
|
Provisions utilized
|
(
|
(a)
|
(
|
(
|
(
|
(
|
|
|
Reversals of unutilized provisions
|
(
|
(a)
|
(
|
(
|
(
|
(
|
|
|
Transfers
|
(
|
|
(
|
(
|
(
|
||
|
Net interest related to employee benefits,
and unwinding of discount
|
|
|
|
|
|
||
|
Currency translation differences
|
(
|
(
|
|
(
|
(
|
||
|
Actuarial gains and losses on defined-benefit plans
|
|
|
|
|
|
||
|
Balance at December 31, 2023
|
|
|
|
|
|
||
|
Changes in scope of consolidation
|
|
|
|
|
|
||
|
Increases in provisions
|
|
(a)
|
|
|
|
|
|
|
Provisions utilized
|
(
|
(a)
|
(
|
(
|
(
|
(
|
|
|
Reversals of unutilized provisions
|
(
|
(a)
|
|
(
|
(
|
(
|
|
|
Transfers
|
(
|
|
(
|
(
|
(
|
||
|
Net interest related to employee benefits,
and unwinding of discount
|
|
|
|
|
|
||
|
Currency translation differences
|
|
|
(
|
|
|
||
|
Actuarial gains and losses on defined-benefit plans
|
(
|
|
|
|
(
|
||
|
Opella reclassification
(b)
|
(
|
(
|
(
|
(
|
(
|
||
|
Balance at December 31, 2024
|
|
|
|
|
|
employees during the period, and past service cost; the “Provisions utilized” line corresponds to contributions paid into pension funds and to
beneficiaries; and the “Reversals of unutilized provisions” line corresponds to plan curtailments, settlements and amendments.
D.19.1. Provisions for pensions and other post-employment benefits
Sanofi offers its employees pension plans and other post-employment benefit plans. The specific features of the plans (benefit
formulas, fund investment policy and fund assets held) vary depending on the applicable laws and regulations in each country
where the employees work. These employee benefits are accounted for in accordance with IAS 19 (see Note B.23.).
Sanofi’s pension obligations in
four
major countries represented approximately
88
%
of the total value of the defined-benefit
obligation and approximately
87
%
of the total value of plan assets as of
December 31, 2024
. The features of the principal defined-
benefit plans in each of those four countries are described below.
France
Lump-sum retirement benefit plans
All employees working for Sanofi in France are entitled on retirement to a lump-sum payment, the amount of which depends both
on their length of service and on the rights guaranteed by collective and internal agreements. The employee’s final salary is used
in calculating the amount of these lump-sum retirement benefits. These plans represent approximately
38
%
of Sanofi’s total
obligation in France.
|
F-66
|
SANOFI
FORM 20-F
2024
|
|
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
|
Defined-benefit pension plans
These plans provide benefits from the date of retirement. Employees must fulfil a number of criteria to be eligible for these
benefits. All of these plans are now closed. These plans represent approximately
62
%
of Sanofi’s total obligation in France.
Germany
Top-up defined-benefit pension plan
The benefits offered under this pension plan are wholly funded by the employer (there are no employee contributions) via a
Contractual Trust Agreement (CTA), under which benefits are estimated on the basis of a career average salary. Employees are
entitled to receive an annuity under this plan if their salary exceeds the social security ceiling. The amount of the pension is
calculated by reference to a range of vesting rates corresponding to salary bands. The plan also includes disability and death
benefits. This plan represents approximately
61
%
of Sanofi’s total obligation in Germany.
Sanofi-Aventis plus (SAV plus)
A top-up pension plan (SAV plus) replaced a previous top-up defined-benefit plan. New entrants joining the plan after
April 1, 2015 contribute to a defined-contribution plan that is partially funded via the company’s CTA.
All employees whose salary exceeds the social security ceiling are automatically covered by the plan. The employer’s contribution
is
14
%
of the amount by which the employee’s salary exceeds the social security ceiling.
Multi-employer plan
(Pensionskasse)
This is a defined-benefit plan treated as a defined-contribution plan, in accordance with the accounting policies described
in Note B.23. Currently, contributions cover the level of annuities. Only the portion relating to the future revaluation
of the annuities is included in the defined-benefit pension obligation. The obligation relating to this revaluation amounted
to
€
682
million
as of
December 31, 2024
, versus
€
744
million
as of
December 31, 2023
and
€
652
million
as of
December 31, 2022
.
This plan represents approximately
26
%
of Sanofi’s total defined-benefit obligation in Germany.
United States
Defined-benefit pension plans
In the United States, there are
two
types of defined-benefit plan:
•
“qualified” plans within the meaning of the Employee Retirement Income Security Act of 1974 (ERISA), which provide
guaranteed benefits to eligible employees during retirement, and in the event of death or disability. Employees can elect to
receive a reduced annuity, in exchange for an annuity to be paid in the event of their death to a person designated by them.
An annuity is also granted under the plan if the employee dies before retirement age. Eligible employees do not pay any
contributions. These plans are closed to new entrants, and the vesting of rights for future service periods is partially frozen.
These plans represent approximately
57
%
of Sanofi’s total obligation in the United States;
•
“non-qualified” plans within the meaning of ERISA provide top-up retirement benefits to some eligible employees depending
on the employee’s level of responsibility and subject to a salary cap. These plans represent approximately
16
%
of Sanofi’s total
obligation in the United States.
Healthcare cover and life insurance
Sanofi companies provide some eligible employees with healthcare cover and life insurance during the retirement period (the
company’s contributions are capped at a specified level). These plans represent approximately
27
%
(or
€
381
million
) of Sanofi’s
total obligation and
3
%
(or
€
20
million
) of total plan assets in the United States.
United Kingdom
Defined-benefit pension plans
Sanofi operates a number of pension plans in the United Kingdom that reflect past acquisitions. The most significant
arrangements are defined-benefit plans that have been closed since October 1, 2015. With effect from that date, employees can
no longer pay into these plans.
Under these defined-benefit plans, an annuity is paid from the retirement date. This annuity is calculated on the basis of the
employee’s length of service as of September 30, 2015, and of the employee’s final salary (or salary on the date he or she leaves
Sanofi).
The rates used for the vesting of rights vary from member to member. For most members, rights vest at the rate of
1.25
% or
1.50
%
of final salary for each qualifying year of service giving entitlement. The notional retirement age varies according to the category
to which the member belongs, but in most cases retirement is at age
65
. Members may choose to retire before or after the
notional retirement age (
60
years), in which case the amount of the annual pension is adjusted to reflect the revised estimate of
the length of the retirement phase. Pensions are usually indexed to the Retail Price Index (RPI). Members paid a fixed-percentage
contribution into their pension plan (the percentage varied according to the employee category), and the employer topped up
the contribution to the required amount. These plans represent approximately
100
%
of Sanofi’s total obligation in the United
Kingdom.
|
SANOFI
FORM 20-F
2024
|
F-67
|
|
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
|
In November 2024, a bulk annuity purchase transaction, commonly known as a “buy-in”, was executed for the main defined
benefit pension scheme in the United Kingdom covering the majority of uninsured pension liabilities. Through this transaction,
and in conjunction with the previous pensioner buy-in executed in 2021, the main defined benefit pension plan in the United
Kingdom is largely insured against investment, longevity, interest rate and inflation risks. Pension obligations will be funded by the
insurer’s annuity payments and the buy-in policies are held as an asset of the pension scheme. The pension scheme retains full
legal responsibility to pay the benefits to plan participants using insurance payments. The insurance contract is deemed to be the
present value of the matched obligations. The variation of
€(
204
) million
of the fair value of assets held by the pension scheme
generated by the purchase of the qualifying insurance policy is booked in the other comprehensive income. After the end of the
reporting period, Sanofi completed a further buy-in covering the remaining uninsured liabilities meaning all members of the
scheme are now fully insured by the transaction, except those arising from guaranteed minimum pensions equalization.
For service periods subsequent to October 1, 2015, employees belong to a new defined-contribution plan.
Actuarial assumptions used to measure Sanofi’s obligations
Actuarial valuations of Sanofi’s benefit obligations were computed by management with assistance from external actuaries as
of
December 31, 2024
,
2023
and
2022
.
|
2024
|
2023
|
2022
|
||||||||||
|
France
|
Germany
|
US
|
UK
|
France
|
Germany
|
US
|
UK
|
France
|
Germany
|
US
|
UK
|
|
|
Discount
rate
(a)(b)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General
inflation
rate
(c)
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
Pension
benefit
indexation
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
Healthcare
cost
inflation
rate
(d)
|
—
|
—
|
to
|
—
|
—
|
—
|
to
|
—
|
—
|
—
|
|
—
|
|
Retirement
age
|
to
|
|
to
|
to
|
to
|
|
to
|
to
|
to
|
|
to
|
to
|
|
Mortality
table
|
TGH/
TGF
05
|
Heubeck
RT
2018 G
|
RP2012
Proj.
MP2021
White
Collar
|
SAPS
S3
|
TGH/
TGF
05
|
Heubeck
RT
2018 G
|
RP2012
Proj.
MP2021
White
Collar
|
SAPS
S3
|
TGH/
TGF
05
|
Heubeck
RT
2018 G
|
RP2012
Proj.
MP2021
White
Collar
|
SAPS
S3
|
under the plans. The benchmarks used to determine discount rates were the same for all periods presented.
Weighted average duration of obligation for pensions and other long-term benefits in principal
countries
|
2024
|
2023
|
2022
|
||||||||||
|
(years)
|
France
|
Germany
|
US
|
UK
|
France
|
Germany
|
US
|
UK
|
France
|
Germany
|
US
|
UK
|
|
Weighted average duration
|
|
|
|
|
|
|
|
|
|
|
|
|
Sensitivity analysis
actuarial assumptions:
|
(€ million)
|
Pensions and other post-employment benefits, by principal country
|
||||
|
Measurement of defined-benefit obligation
|
Change in
assumption
|
France
|
Germany
|
US
|
UK
|
|
Discount rate
|
-
|
+
|
+
|
+
|
+
|
|
General inflation rate
|
+
|
+
|
+
|
|
+
|
|
Pension benefit indexation
|
+
|
+
|
+
|
|
+
|
|
Healthcare cost inflation rate
|
+
|
|
|
+
|
+
|
|
Mortality table
|
+1 year
|
+
|
+
|
+
|
+
|
|
F-68
|
SANOFI
FORM 20-F
2024
|
|
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
|
amounts recognized in the consolidated financial statements:
|
Pensions and other post-employment benefits
|
|||
|
(€ million)
|
2024
|
2023
|
2022
|
|
Measurement of the obligation:
|
|||
|
Beginning of period
|
|
|
|
|
Current service cost
|
|
|
|
|
Interest cost
|
|
|
|
|
Actuarial losses/(gains) due to changes in demographic assumptions
|
(
|
(
|
(
|
|
Actuarial losses/(gains) due to changes in financial assumptions
|
(
|
|
(
|
|
Actuarial losses/(gains) due to experience adjustments
|
(
|
|
|
|
Plan amendments, curtailments or settlements not specified in the terms of the plan
(b)
|
(
|
(
|
(
|
|
Plan settlements specified in the terms of the plan
|
(
|
(
|
(
|
|
Benefits paid
|
(
|
(
|
(
|
|
Changes in scope of consolidation and transfers
|
|
(
|
(
|
|
Currency translation differences
|
|
(
|
|
|
Opella reclassification
|
(
|
|
|
|
Obligation at end of period
|
|
|
|
|
Fair value of plan assets:
|
|||
|
Beginning of period
|
|
|
|
|
Interest income on plan assets
|
|
|
|
|
Difference between actual return and interest income on plan assets
(c)
|
(
|
|
(
|
|
Administration costs
|
(
|
(
|
(
|
|
Plan settlements specified in the terms of the plan
|
(
|
(
|
(
|
|
Plan settlements not specified in the terms of the plan
|
(
|
(
|
(
|
|
Contributions from plan members
|
|
|
|
|
Employer’s contributions
|
|
|
|
|
Benefits paid
|
(
|
(
|
(
|
|
Changes in scope of consolidation and transfers
|
(
|
(
|
(
|
|
Currency translation differences
|
|
|
(
|
|
Opella reclassification
|
(
|
|
|
|
Fair value of plan assets at end of period
|
|
|
|
|
Net amount shown in the balance sheet:
|
|||
|
Net obligation
|
|
|
|
|
Effect of asset ceiling
|
|
|
|
|
Net amount shown in the balance sheet at end of period
|
|
|
|
|
Amounts recognized in the balance sheet:
|
|||
|
Pre-funded obligations (see Note D.7.)
(a)
|
(
|
(
|
(
|
|
Obligations provided for
|
|
|
|
|
Net amount recognized at end of period
|
|
|
|
|
Benefit cost for the period:
(d)
|
|||
|
Current service cost
|
|
|
|
|
(Gains)/losses related to plan amendments, curtailments or settlements not specified
in the terms of the plan
|
(
|
(
|
(
|
|
Net interest (income)/cost
|
|
|
|
|
Contributions from plan members
|
(
|
(
|
(
|
|
Administration costs and taxes paid during the period
|
|
|
|
|
Expense recognized directly in profit or loss
|
|
|
|
|
Remeasurement of net defined-benefit (asset)/liability (actuarial gains and losses)
(b)
|
(
|
|
(
|
|
Expense/(gain) for the period
|
|
|
(
|
in accordance with IFRIC 14.
|
SANOFI
FORM 20-F
2024
|
F-69
|
|
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
|
region:
|
(€ million)
|
Pensions and other post-employment benefits by geographical region
|
|||||
|
December 31, 2024
|
France
|
Germany
|
US
|
UK
|
Other
|
Total
|
|
Measurement of obligation
|
|
|
|
|
|
|
|
Fair value of plan assets
|
|
|
|
|
|
|
|
Effect of asset ceiling
|
|
|
|
|
(
|
(
|
|
Net amount shown in the balance sheet at end
of period
|
|
|
|
|
|
|
|
(€ million)
|
Pensions and other post-employment benefits by geographical region
|
|||||
|
December 31, 2023
|
France
|
Germany
|
US
|
UK
|
Other
|
Total
|
|
Measurement of obligation
|
|
|
|
|
|
|
|
Fair value of plan assets
|
|
|
|
|
|
|
|
Effect of asset ceiling
|
|
|
|
|
(
|
(
|
|
Net amount shown in the balance sheet at end
of period
|
|
|
|
(
|
|
|
|
(€ million)
|
Pensions and other post-employment benefits by geographical region
|
|||||
|
December 31, 2022
|
France
|
Germany
|
US
|
UK
|
Other
|
Total
|
|
Measurement of obligation
|
|
|
|
|
|
|
|
Fair value of plan assets
|
|
|
|
|
|
|
|
Effect of asset ceiling
|
|
|
|
|
(
|
(
|
|
Net amount shown in the balance sheet at end
of period
|
|
|
|
(
|
|
|
The adoption in April 2023 of pension reforms in France (including the raising of the retirement age from
62
to
64
years) qualifies
as a plan amendment within the meaning of IAS 19, and resulted in the recognition of an immaterial amount in the income
statement and the balance sheet for the year ended December 31, 2023.
category:
|
2024
|
2023
|
2022
|
|
|
Securities quoted in an active market
|
|
|
|
|
Cash and cash equivalents
|
|
|
|
|
Equity instruments
|
|
|
|
|
Bonds and similar instruments
|
|
|
|
|
Real estate
|
|
|
|
|
Derivatives
|
(
|
|
|
|
Commodities
|
|
|
|
|
Other
|
|
|
|
|
Other securities
|
|
|
|
|
Hedge funds
|
|
|
|
|
Insurance policies
|
|
|
|
|
Total
|
|
|
|
Sanofi has a long-term objective of maintaining or increasing the extent to which its pension obligations are covered by assets.
To this end, Sanofi uses an asset-liability management strategy, matching plan assets to its pension obligations. This policy aims
to ensure the best fit between the assets held on the one hand, and the associated liabilities and expected future payments to
plan members on the other. To meet this aim, Sanofi operates a risk monitoring and management strategy (mainly focused on
interest rate risk and inflation risk), while investing a growing proportion of assets in high-quality bonds with comparable
maturities to those of the underlying obligations and in contracts entered into with leading insurance companies to fund certain
post-employment benefit obligations.
|
F-70
|
SANOFI
FORM 20-F
2024
|
|
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
|
|
(€ million)
|
Pensions and other post-employment benefits by geographical region
|
|||||
|
Service cost for 2024
|
France
|
Germany
|
US
|
UK
|
Other
|
Total
|
|
Current service cost
|
|
|
|
|
|
|
|
(Gains)/losses related to plan amendments, curtailments
or settlements not specified in the terms of the plan
|
(
|
|
(
|
|
(
|
(
|
|
Net interest cost/(income) including administration costs
and taxes paid during the period
|
|
|
|
(
|
|
|
|
Contributions from plan members
|
|
|
|
|
(
|
(
|
|
Expense/(gain) recognized directly in profit or loss
|
(
|
|
|
(
|
|
|
|
Remeasurement of net defined-benefit (asset)/ liability
(actuarial gains and losses)
|
(
|
(
|
(
|
|
(
|
(
|
|
Expense/(gain) for the period
|
(
|
(
|
(
|
|
|
|
|
(€ million)
|
Pensions and other post-employment benefits by geographical region
|
|||||
|
Service cost for 2023
|
France
|
Germany
|
US
|
UK
|
Other
|
Total
|
|
Current service cost
|
|
|
|
|
|
|
|
(Gains)/losses related to plan amendments, curtailments
or settlements not specified in the terms of the plan
|
(
|
|
|
|
(
|
(
|
|
Net interest cost/(income) including administration costs
and taxes paid during the period
|
|
|
|
(
|
|
|
|
Contributions from plan members
|
|
|
|
|
(
|
(
|
|
Expense/(gain) recognized directly in profit or loss
|
|
|
|
(
|
|
|
|
Remeasurement of net defined-benefit (asset)/ liability
(actuarial gains and losses)
|
|
|
|
|
|
|
|
Expense/(gain) for the period
|
|
|
|
|
|
|
|
(€ million)
|
Pensions and other post-employment benefits by geographical region
|
|||||
|
Service cost for 2022
|
France
|
Germany
|
US
|
UK
|
Other
|
Total
|
|
Current service cost
|
|
|
|
|
|
|
|
(Gains)/losses related to plan amendments, curtailments
or settlements not specified in the terms of the plan
|
(
|
|
|
(
|
(
|
(
|
|
Net interest cost/(income) including administration costs
and taxes paid during the period
|
|
|
|
(
|
|
|
|
Contributions from plan members
|
|
|
|
|
(
|
(
|
|
Expense/(gain) recognized directly in profit or loss
|
|
|
|
(
|
|
|
|
Remeasurement of net defined-benefit (asset)/liability
(actuarial gains and losses)
|
(
|
(
|
(
|
|
(
|
(
|
|
Expense/(gain) for the period
|
(
|
(
|
(
|
|
(
|
(
|
is set forth below:
|
(€ million)
|
2024
|
2023
|
2022
|
|||||||||
|
France
|
Germany
|
US
|
UK
|
France
|
Germany
|
US
|
UK
|
France
|
Germany
|
US
|
UK
|
|
|
Actuarial gains/(losses) arising
during the period
|
|
|
|
(
|
(
|
(
|
(
|
(
|
|
|
|
(
|
|
Comprising:
|
||||||||||||
|
Gains/(losses)
on experience adjustments
(a)
|
|
|
(
|
(
|
|
(
|
(
|
(
|
(
|
(
|
(
|
(
|
|
Gains/(losses)
on demographic assumptions
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gains/(losses)
on financial assumptions
|
|
|
|
|
(
|
(
|
(
|
(
|
|
|
|
|
presented below:
|
(€ million)
|
2024
|
2023
|
2022
|
|
Net pre-tax actuarial loss
|
(
|
(
|
(
|
|
SANOFI
FORM 20-F
2024
|
F-71
|
|
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
|
reporting period is shown below:
|
(€ million)
|
2024
|
2023
|
2022
|
|
Present value of wholly or partially funded obligations in respect of pension and other
post-employment benefit plans
|
|
|
|
|
Present value of unfunded obligations
|
|
|
|
|
Total
|
|
|
|
statement line items as follows:
|
(€ million)
|
2024
|
2023
|
2022
|
|
Cost of sales
|
|
|
|
|
Research and development expenses
|
|
|
|
|
Selling and general expenses
|
|
|
|
|
Other operating (income)/expenses, net
|
|
|
(
|
|
Restructuring costs
|
(
|
(
|
(
|
|
Financial expenses
|
|
|
|
|
Net income from discontinued operations
|
|
|
|
|
Total
|
|
|
|
|
(€ million)
|
France
|
Germany
|
US
|
UK
|
Other
|
Total
|
|
Employer’s contributions in 2024 (estimate):
|
||||||
|
2025
|
|
|
|
|
|
|
future years:
|
(€ million)
|
France
|
Germany
|
US
|
UK
|
Other
|
Total
|
|
Estimated future benefit payments
|
||||||
|
2025
|
|
|
|
|
|
|
|
2026
|
|
|
|
|
|
|
|
2027
|
|
|
|
|
|
|
|
2028
|
|
|
|
|
|
|
|
2029
|
|
|
|
|
|
|
|
2030
to 2034
|
|
|
|
|
|
|
other post-employment benefit plans:
|
Payments due by period
|
|||||
|
(€ million)
|
Total
|
Less than 1 year
|
1 to
3 years
|
3 to
5 years
|
More than
5 years
|
|
Estimated payments
|
|
|
|
|
|
|
F-72
|
SANOFI
FORM 20-F
2024
|
|
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
|
D.19.2. Restructuring provisions
|
(€ million)
|
2024
|
2023
|
2022
|
|
Balance, beginning of period
|
|
|
|
|
Of which:
|
|||
|
•
Classified in non-current liabilities
|
|
|
|
|
•
Classified in current liabilities
|
|
|
|
|
Change in provisions recognized in profit or loss for the period
|
|
|
|
|
Provisions utilized
(a)
|
(
|
(
|
(
|
|
Transfers
|
(
|
|
|
|
Unwinding of discount
|
|
|
|
|
Currency translation differences
|
|
(
|
(
|
|
Opella reclassification
(b)
|
(
|
|
|
|
Balance, end of period
|
|
|
|
|
Of which:
|
|||
|
•
Classified in non-current liabilities
|
|
|
|
|
•
Classified in current liabilities
|
|
|
|
(see Note D.1.).
Provisions for employee termination benefits as of
December 31, 2024
amounted to
€
1,318
million
(compared with €
968
million as
of
December 31, 2023
and
€
1,039
million
as of
December 31, 2022
).
The provisions apply mainly to France, and relate to various voluntary redundancy programs:
•
a
greement under the Job Management and Career Paths (GEPP) scheme affecting several French legal entities, signed
on February 28,
2022
and announced in April
2022
as part of the “Play to Win” strategy. The agreement provides internal
transfer and outplacement opportunities for employees whose jobs are undergoing transformation, and also includes an end-
of-career paid leave program and an external retraining program. The plan began to be implemented in
2022
. The provisions
charged in
2023
reflect adjustments to the job profiles deemed to be "sensitive"; the reversals recognized during
2023
are due
mainly to the Borne Law, which raises the retirement age to 64 and hence disqualifies some participants eligible under
previous legislation (in light of the maximum period for portage workers). In
2024
, the agreement was renewed to cover the
years
2024
to
2026
, and the new provisions charged in
2024
relate mainly to scope extensions in the job profiles affected by
transformations;
•
a voluntary redundancy program announced in
2024
in connection with the reorganization of R&D operations to make Sanofi
a leader in immunology, including an end-of-career paid leave plan and an end-of-career transition plan; and
•
collectively-agreed separation programs involving a number of legal entities announced at the end of June
2020
as part of
the rollout of the “Play to Win” strategy; these include an end-of-career paid leave plan and an external retraining program,
and were still ongoing during
2024
. The same applies to Sanofi-Aventis Recherche & Développement, which announced a
voluntary redundancy program associated with R&D reorganization in
2020
, and implemented that program in
2021
.
The provision includes the present values of:
•
gross annuities for self-funded plans;
•
employer’s social security charges on early retirement annuities for all plans (outsourced and self-funded); and
•
the levy charged on those annuities under the “Fillon” law (only for plans with termination of employment contracts).
The average residual portage periods under these plans were
2.18
years,
2.22
years and
2.60
years as of
December 31, 2024
,
2023
and
2022
, respectively.
The main other countries covered by restructuring provisions are Germany, Japan and the United States.
|
SANOFI
FORM 20-F
2024
|
F-73
|
|
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
|
|
December 31, 2024
|
Benefit payments by period
|
||||
|
(€ million)
|
Total
|
Less than
1 year
|
1 to
3 years
|
3 to
5 years
|
More than
5 years
|
|
Employee termination benefits
|
|||||
|
•
France
|
|
|
|
|
|
|
•
Other countries
|
|
|
|
|
|
|
Total
|
|
|
|
|
|
|
December 31, 2023
|
Benefit payments by period
|
||||
|
(€ million)
|
Total
|
Less than
1 year
|
1 to
3 years
|
3 to
5 years
|
More than
5 years
|
|
Employee termination benefits
|
|||||
|
•
France
|
|
|
|
|
|
|
•
Other countries
|
|
|
|
|
|
|
Total
|
|
|
|
|
|
|
December 31, 2022
|
Benefit payments by period
|
||||
|
(€ million)
|
Total
|
Less than
1 year
|
1 to
3 years
|
3 to
5 years
|
More than
5 years
|
|
Employee termination benefits
|
|||||
|
•
France
|
|
|
|
|
|
|
•
Other countries
|
|
|
|
|
|
|
Total
|
|
|
|
|
|
D.19.3. Other provisions
|
(€ million)
|
2024
|
2023
|
2022
|
|
Environmental risks
|
|
|
|
|
Product liability risks, litigation and other
|
|
|
|
|
Total
|
|
|
|
Provisions for environmental risks relate primarily to contingencies arising from business divestitures, and include remediation
costs relating to such environmental risks.
Identified environmental risks are covered by provisions estimated on the basis of the costs Sanofi believes it will be obliged to
meet over a period not exceeding (other than in exceptional cases)
30
years. Sanofi expects that
€
67
million
of those provisions
will be utilized in
2025
, and
€
203
million
over the period from
2026
through
2029
.
As regards greenhouse gas emission quotas, which relate to Sanofi production facilities in France and Ireland, in the absence of
specific IFRS pronouncements Sanofi has adopted the "net liability approach". That involves recognizing a liability at the balance
sheet date if actual emissions exceed the quotas held, in accordance with IAS 37 and French GAAP (
Plan Comptable Général,
Article 615-1s). Quotas are managed as a production cost, and as such are recognized in inventory at a zero value (if received free
of charge) and at acquisition cost (if bought on the market). As of
December 31, 2024
, a provision of
€
1
million
has been
recognized.
“Product liability risks, litigation and other” mainly comprises provisions for risks relating to product liability (including IBNR
provisions as described in Note B.12.), government investigations, regulatory or antitrust law claims, contingencies arising from
business divestitures (other than environmental risks), and remediation costs related to leases.
The main pending legal and arbitral proceedings and government investigations are described in Note D.22.
A full risk and litigation assessment is performed with the assistance of Sanofi’s legal advisers, and provisions are recorded as
required by circumstances in accordance with the principles described in Note B.12.
|
F-74
|
SANOFI
FORM 20-F
2024
|
|
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
|
D.19.4. Non-current income tax liabilities
Non-current income tax liabilities
amounted to €
1,512
million
as of
December 31, 2024
(versus €
1,842
million
as of
December 31,
2023
and €
1,979
million
as of
December 31, 2022
)
. These amounts include uncertainties over income tax treatment totalling
€
1,512
million
as of
December 31, 2024
, versus
€
1,595
million
as of
December 31, 2023
and
€
1,520
million
as of
December 31,
2022
.
Until
December 31, 2023
, this line item includes the residual liability due after more than one year arising from
the estimated tax
charge on deemed repatriation attributable to the accumulated earnings of non-US operations (
€
247
million as of
December 31,
2023
and €
459
million
as of
December 31, 2022
)
. The expense was initially recognized in 2018 at an amount of
$
1,092
million
, and
payment is being made over
eight years
through
2025
. As of
December 31, 2024
, the residual liability is included in the line item
Current income tax liabilities
.
A US legal restructuring resulted in a capital loss of €
3
billion
recognized in the
2020
final tax filing.
One-third
of the capital loss
has been used against
2020
capital gains and the remaining balance will be eligible to carry back for
three years
. Due to
management’s judgement about potential alternative interpretations of the prevailing tax law, no tax benefit has been
recognized on this transaction in accordance with IFRIC 23.
D.19.5. Current provisions and other current liabilities
|
(€ million)
|
2024
|
2023
|
2022
|
|
Taxes payable, other than corporate income taxes
|
|
|
|
|
Employee-related liabilities
|
|
|
|
|
Restructuring provisions (see Note D.19.2.)
|
|
|
|
|
Interest rate derivatives (see Note D.20.)
|
|
|
|
|
Currency derivatives (see Note D.20.)
|
|
|
|
|
Equity derivatives (see Note D.20.)
|
|
|
|
|
Amounts payable for acquisitions of non-current assets
|
|
|
|
|
Customer contract liabilities
(a)
|
|
|
|
|
Other current liabilities
(b)(c)
|
|
|
|
|
Total
|
|
|
|
change in this item between
2023
and
2022
includes revenue
of
€
269
million
recognized in
profit or loss during
2023
(previously included in
“
Customer
contract liabilities
”
as of
December 31, 2022
).
healthcare authorities and governmental programs (see Note D.23.); and the liability payable at each reporting date under the Monoclonal Antibody
Alliance with Regeneron.
D.20.
Derivative financial instruments and market risks
|
(€ million)
|
Non-
current
assets
|
Current
assets
|
Total
assets
|
Non-current
liabilities
|
Current
liabilities
|
Total
liabilities
|
Market value at
December 31,
2024 (net)
|
Market value at
December 31,
2023 (net)
|
Market value at
December 31,
2022 (net)
|
|
Currency
derivatives
|
|
|
|
|
(
|
(
|
(
|
|
|
|
operating
|
|
|
|
|
(
|
(
|
(
|
|
|
|
financial
|
|
|
|
|
(
|
(
|
(
|
|
|
|
Interest rate
derivatives
|
|
|
|
(
|
(
|
(
|
(
|
(
|
(
|
|
Equity derivatives
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
|
(
|
(
|
(
|
(
|
(
|
(
|
|
SANOFI
FORM 20-F
2024
|
F-75
|
|
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
|
Objectives of the use of derivative financial instruments
Sanofi uses derivative instruments to manage operating exposure to movements in exchange rates, and financial exposure to
movements in interest rates and exchange rates (where the debt or receivable is not contracted in the functional currency of the
borrower or lender entity). On occasion, Sanofi uses equity derivatives in connection with the management of its portfolio of
equity investments.
Sanofi performs periodic reviews of its transactions and contractual agreements in order to identify any embedded derivatives,
which are accounted for separately from the host contract in accordance with IFRS 9. Sanofi had no material embedded
derivatives as of
December 31, 2024
,
2023
or
2022
.
Counterparty risk
For a description of counterparty risk, refer to “Item 11. — Quantitative and Qualitative Disclosures about Market Risk”.
a) Currency derivatives used to manage operating risk exposures
For a description of Sanofi’s objectives, policies and procedures for the management of operating foreign exchange risk, refer to
“Item 11. — Quantitative and Qualitative Disclosures about Market Risk”.
translated into euros at the relevant closing exchange rate:
|
December 31, 2024
|
Of which derivatives designated as
cash flow hedges
|
Of which derivatives not
eligible for hedge accounting
|
|||||
|
(€ million)
|
Notional
amount
|
Fair
value
|
Notional
amount
|
Fair
value
|
Of which
recognized in equity
|
Notional
amount
|
Fair value
|
|
Forward currency sales
|
|
(
|
|
|
|
|
(
|
|
of which US dollar
|
|
(
|
|
|
|
|
(
|
|
of which Chinese yuan renminbi
|
|
(
|
|
|
|
|
(
|
|
of which Pound sterling
|
|
(
|
|
|
|
|
(
|
|
of which Japanese yen
|
|
|
|
|
|
|
|
|
of which Turkish lira
|
|
(
|
|
|
|
|
(
|
|
Forward currency purchases
|
|
|
|
|
|
|
|
|
of which US dollar
|
|
|
|
|
|
|
|
|
of which Singapore dollar
|
|
|
|
|
|
|
|
|
of which Chinese yuan renminbi
|
|
|
|
|
|
|
|
|
of which Turkish lira
|
|
|
|
|
|
|
|
|
of which Canadian dollar
|
|
|
|
|
|
|
|
|
Total
|
|
(
|
|
|
|
|
(
|
translated into euros at the relevant closing exchange rate:
|
December 31, 2023
|
Of which derivatives
designated as cash flow hedges
|
Of which derivatives not
eligible for hedge accounting
|
|||||
|
(€ million)
|
Notional
amount
|
Fair
value
|
Notional
amount
|
Fair
value
|
Of which
recognized in equity
|
Notional
amount
|
Fair value
|
|
Forward currency sales
|
|
|
|
|
|
|
|
|
of which US dollar
|
|
|
|
|
|
|
|
|
of which Chinese yuan renminbi
|
|
|
|
|
|
|
|
|
of which Singapore dollar
|
|
(
|
|
|
|
|
(
|
|
of which Japanese yen
|
|
(
|
|
|
|
|
(
|
|
of which Korean won
|
|
(
|
|
|
|
|
(
|
|
Forward currency purchases
|
|
(
|
|
|
|
|
(
|
|
of which US dollar
|
|
(
|
|
|
|
|
(
|
|
of which Singapore dollar
|
|
|
|
|
|
|
|
|
of which Chinese yuan renminbi
|
|
(
|
|
|
|
|
(
|
|
of which Korean won
|
|
|
|
|
|
|
|
|
of which Japanese yen
|
|
|
|
|
|
|
|
|
Total
|
|
|
|
|
|
|
|
|
F-76
|
SANOFI
FORM 20-F
2024
|
|
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
|
The table below shows operating currency hedging instruments in place as of
December 31, 2022
, with the notional amount
translated into euros at the relevant closing exchange rate:
|
December 31, 2022
|
Of which derivatives
designated as cash flow hedges
|
Of which derivatives not
eligible for hedge accounting
|
|||||
|
(€ million)
|
Notional
amount
|
Fair
value
|
Notional
amount
|
Fair
value
|
Of which
recognized
in equity
|
Notional
amount
|
Fair value
|
|
Forward currency sales
|
|
|
|
|
|
|
|
|
of which US dollar
|
|
|
|
|
|
|
|
|
of which Chinese yuan
renminbi
|
|
|
|
|
|
|
|
|
of which Japanese yen
|
|
(
|
|
|
|
|
(
|
|
of which Singapore dollar
|
|
|
|
|
|
|
|
|
of which Korean won
|
|
(
|
|
|
|
|
(
|
|
Forward currency purchases
|
|
(
|
|
|
|
|
(
|
|
of which US dollar
|
|
(
|
|
|
|
|
(
|
|
of which Singapore dollar
|
|
(
|
|
|
|
|
(
|
|
of which Chinese yuan
renminbi
|
|
|
|
|
|
|
|
|
of which Korean won
|
|
|
|
|
|
|
|
|
of which Taiwan dollar
|
|
|
|
|
|
|
|
|
Total
|
|
|
|
|
|
|
|
b) Currency and interest rate derivatives used to manage financial exposure
For a description of Sanofi’s objectives, policies and procedures for the management of financial foreign exchange risk and
interest rate risk, refer to “Item 11. — Quantitative and Qualitative Disclosures about Market Risk”.
relevant closing exchange rate:
|
2024
|
2023
|
2022
|
||||||||
|
(€ million)
|
Notional
amount
|
Fair
value
|
Expiry
|
Notional
amount
|
Fair
value
|
Expiry
|
Notional
amount
|
Fair
value
|
Expiry
|
|
|
Forward currency sales
|
|
(
|
|
|
|
|
||||
|
of which US dollar
|
|
(a)
|
(
|
2025
|
|
|
2024
|
|
|
2023
|
|
of which Japanese yen
|
|
|
2025
|
|
(
|
2024
|
|
|
2023
|
|
|
of which Chinese yuan renminbi
|
|
(
|
2025
|
|
|
2024
|
|
|
2023
|
|
|
Forward currency purchases
|
|
|
|
(
|
|
|
||||
|
of which US dollar
|
|
(b)
|
|
2025
|
|
(
|
2024
|
|
(
|
2023
|
|
of which Singapore dollar
|
|
|
2025
|
|
(
|
2024
|
|
|
2023
|
|
|
of which Hungarian forint
|
|
(
|
2025
|
|
|
2024
|
|
|
2023
|
|
|
Total
|
|
(
|
|
|
|
|
||||
December 31, 2024
, the fair value of these forward contracts represented a liability of
€
88
million
; the opposite entry was recognized in "Other
comprehensive income", with the impact on financial income and expense being immaterial.
of bond issues to fluctuations in the EUR/USD spot rate. As of
December 31, 2024
, the fair value of the contracts was an asset of €
75
million
, the
opposite entry for
€
0.2
million
of which was debited to “Other comprehensive income” under the cost of hedging accounting treatment.
|
SANOFI
FORM 20-F
2024
|
F-77
|
|
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
|
|
Notional amounts by expiry date as of December 31,
2024
|
Of which
designated as
fair value hedges
|
Of which designated as
cash flow hedges
|
|||||||||||
|
(€ million)
|
2025
|
2026
|
2027
|
2028
|
2029
|
2030
and
later
|
Total
|
Fair
value
|
Notional
amount
|
Fair
value
|
Notional
amount
|
Fair
value
|
Of which
recognized
in equity
|
|
Interest rate swaps
|
|||||||||||||
|
pay capitalized SOFR USD/
receive
|
|
|
|
|
|
|
|
(
|
|
(
|
|
|
|
|
pay capitalized SOFR USD/
receive
|
|
|
|
|
|
|
|
(
|
|
(
|
|
|
|
|
pay capitalized Ester/receive
|
|
|
|
|
|
|
|
(
|
|
(
|
|
|
|
|
pay capitalized Ester/receive
|
|
|
|
|
|
|
|
(
|
|
(
|
|
|
|
|
Total
|
|
|
|
|
|
|
|
(
|
|
(
|
|
|
|
The table below shows interest rate hedging instruments in place as of
December 31, 2023
:
|
Notional amounts by expiry date as of December 31,
2023
|
Of which
designated as
fair value hedges
|
Of which designated as
cash flow hedges
|
|||||||||||
|
(€ million)
|
2024
|
2025
|
2026
|
2027
|
2028
|
2029
and
later
|
Total
|
Fair
value
|
Notional
amount
|
Fair
value
|
Notional
amount
|
Fair
value
|
Of which
recognized
in equity
|
|
Interest rate swaps
|
|||||||||||||
|
pay capitalized SOFR USD/
receive
|
|
|
|
|
|
|
|
(
|
|
(
|
|
|
|
|
pay capitalized SOFR USD/
receive
|
|
|
|
|
|
|
|
(
|
|
(
|
|
|
|
|
pay capitalized Ester/receive
|
|
|
|
|
|
|
|
(
|
|
(
|
|
|
|
|
pay capitalized Ester/receive
|
|
|
|
|
|
|
|
(
|
|
(
|
|
|
|
|
pay capitalized Ester/receive
3.43%
|
|
|
|
|
|
|
|
(
|
|
(
|
|
|
|
|
Total
|
|
|
|
|
|
|
|
(
|
|
(
|
|
|
|
The table below shows interest rate hedging instruments in place as of
December 31, 2022
:
|
Notional amounts by expiry date as of December 31,
2022
|
Of which
designated as
fair value hedges
|
Of which designated as
cash flow hedges
|
|||||||||||
|
(€ million)
|
2023
|
2024
|
2025
|
2026
|
2027
|
2028
and
later
|
Total
|
Fair
value
|
Notional
amount
|
Fair
value
|
Notional
amount
|
Fair
value
|
Of which
recognized
in equity
|
|
Interest rate swaps
|
|||||||||||||
|
pay capitalized SOFR USD/
receive
|
|
|
|
|
|
|
|
(
|
|
(
|
|
|
|
|
pay capitalized SOFR USD/
receive
|
|
|
|
|
|
|
|
(
|
|
(
|
|
|
|
|
pay capitalized Ester/
receive
|
|
|
|
|
|
|
|
(
|
|
(
|
|
|
|
|
pay capitalized Ester/
receive
|
|
|
|
|
|
|
|
(
|
|
(
|
|
|
|
|
Total
|
|
|
|
|
|
|
|
(
|
|
(
|
|
|
|
|
F-78
|
SANOFI
FORM 20-F
2024
|
|
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
|
c) Actual or potential effects of netting arrangements
|
(€ million)
|
2024
|
2023
|
2022
|
|||
|
Derivative
financial
assets
|
Derivative
financial
liabilities
|
Derivative
financial
assets
|
Derivative
financial
liabilities
|
Derivative
financial
assets
|
Derivative
financial
liabilities
|
|
|
Gross carrying amounts before offset (a)
|
|
(
|
|
(
|
|
(
|
|
Gross amounts offset (in accordance with
IAS 32) (b)
|
|
|
|
|
|
|
|
Net amounts as reported in the balance sheet
(a) - (b) = (c)
|
|
(
|
|
(
|
|
(
|
|
Effects of other netting arrangements (not
fulfilling the IAS 32 criteria for offsetting) (d)
|
|
|
||||
|
Financial instruments
|
(
|
|
(
|
|
(
|
|
|
Fair value of financial collateral
|
N/A
|
N/A
|
N/A
|
N/A
|
N/A
|
N/A
|
|
Net exposure (c) + (d)
|
|
(
|
|
(
|
|
(
|
D.21.
Off balance sheet commitments
The off balance sheet commitments presented below are shown at their nominal value.
D.21.1. Off balance sheet commitments relating to operating activities
of the Opella held-for-sale operation, comprise the following:
|
December 31, 2024
|
Payments due by period
|
||||
|
(€ million)
|
Total
|
Less than
1 year
|
1 to
3 years
|
3 to
5 years
|
More than
5 years
|
|
Leases with a term of less than 12 months, low value asset leases and lease
contracts committed but not yet commenced
(a)
|
|
|
|
|
|
|
Irrevocable purchase commitments
(b)
|
|||||
|
•
given
(c)
|
|
|
|
|
|
|
•
received
|
(
|
(
|
(
|
(
|
|
|
Research and development license agreements - commitments given
|
|||||
|
•
commitments related to R&D and other commitments
(d)
|
|
|
|
|
|
|
•
contingent milestone payments in connection with development
programs in progress
(e)
|
|
|
|
|
|
|
Total - net commitments given
|
|
|
|
|
|
commitments as of December 31, 2023 was €
221
million.
During
2023
, Sanofi signed a
15-year
lease which will take effect in 2025 and to which Sanofi is committed for a minimum period of
12
years
,
corresponding to a commitment of $
0.2
billion. The lease includes
two
extension options of
five years
each.
During
2024
, Sanofi signed a
12-year
lease in France which will take effect in 2027, representing a commitment of €
0.2
billion.
(b)
These comprise irrevocable commitments to suppliers of (i) property, plant and equipment, net of down-payments (see Note D.3.) and (ii) goods and
services. As of
December 31, 2023
, irrevocable commitments amounted to
€
6,141
million
given (including
€
754
million
related to Opella) and €
550
million
received (zero related to Opella).
commitment to EUROAPI as described in Note D.1. and amounting to €
535
million
as of December 31, 2024, and (ii) commitments related to long-term
renewable energy purchase contracts lasting between 15 and 20 years giving rise to the physical supply of electricity mainly in France for an estimated
total annual volume of 329 GWh.
In pursuance of its strategy, Sanofi may acquire technologies and rights to products. Such acquisitions may be made in various
contractual forms: acquisitions of shares, loans, license agreements, joint development, and co-marketing. These arrangements
generally involve upfront payments on signature of the agreement, development milestone payments, and royalties. Some of
these complex agreements include undertakings to fund research programs in future years and payments contingent upon
achieving specified development milestones, the granting of approvals or licenses, or the attainment of sales targets once a
product is commercialized.
|
SANOFI
FORM 20-F
2024
|
F-79
|
|
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
|
The “Research and development license agreements” line comprises future service commitments to fund research and
development or technology, and contingent milestone payments regarded as reasonably achievable (i.e. all potential milestone
payments relating to projects in the development phase, for which the future financial consequences are known or probable and
for which there is a sufficiently reliable estimate). This line excludes:
•
commitments given relating to (i) projects in the research phase, amounting to
€
14.4
billion
as of December 31,
2024
and
€
16.8
billion
as of December 31,
2023
and (ii) payments contingent upon the attainment of sales targets once a product is
commercialized, amounting to
€
15.2
billion
as of December 31,
2024
and
€
17.9
billion
as of December 31,
2023
);
•
commitments received amounting to
€
13.0
billion
as of December 31,
2024
(
€
10.0
billion
as of December 31,
2023
),
mainly comprising research, development and commercialization agreements with partners further to the acquisitions
of (i) Ablynx (
€
0.7
billion
as of
December 31, 2024
, versus
€
0.9
billion
as of December 31,
2023
); (ii) Kymab (€
0.3
billion
as
of
December 31, 2024
, versus €
0.2
billion
as of December 31,
2023
) and (iii) Provention Bio (€
0.4
billion as of
December 31,
2024
, versus
€
0.3
billion
as of December 31,
2023
), plus contingent consideration receivable based on attainment of
regulatory and sales milestones for commercialized products under the terms of licenses or rights assignment agreements
amounting to €
11.2
billion
as of
December 31, 2024
(€
8.5
billion
as of December 31, 2023).
The major agreements entered into by Sanofi in
2024
are described below:
•
On May 10,
2024
, Sanofi entered into a co-exclusive licensing agreement with Novavax. The terms of the agreement include
(i) a co-exclusive license to co-commercialize Novavax’s current stand-alone adjuvanted COVID-19 vaccine worldwide (except
in countries with existing Advance Purchase Agreements and in India, Japan, and South Korea, where Novavax has existing
partnership agreements); (ii) a sole license to Novavax’s adjuvanted COVID-19 vaccine for use in combination with Sanofi’s flu
vaccines; and (iii) a non-exclusive license to use the Matrix-M adjuvant in vaccine products. Novavax received an upfront
payment of $
500
million and could receive up to $
700
million contingent on attainment of development, regulatory and
commercialization milestones, representing up to
$
1.2
billion
in total. Starting in 2025, Sanofi will recognize sales of Novavax’s
adjuvanted COVID-19 vaccine and will bear certain R&D, regulatory and commercialization expenses. Novavax will receive
double-digit tiered royalties on Sanofi sales of COVID-19 vaccines and combined influenza/COVID-19 vaccines. Novavax is also
entitled to additional launch and sales milestone payments of up to $
200
million, plus single-digit royalties for each additional
Sanofi vaccine product developed under a non-exclusive license using Novavax’s Matrix-M adjuvant technology. In addition,
Sanofi took a minority equity interest of less than
5
%
in Novavax. Outside of the collaboration, each party may develop and
commercialize their own flu and COVID-19 vaccines and their own adjuvanted products at their own cost.
•
On September 12,
2024
, Sanofi entered into an exclusive licensing agreement with RadioMedix, Inc. and Orano Med for
AlphaMedix (SAR447873), a late-stage project currently being evaluated for the treatment of adult patients with unresectable
or metastatic progressive somatostatin-receptor expressing neuroendocrine tumors (NETs), a rare cancer. Under the licensing
agreement, Sanofi will be responsible for the global commercialization of AlphaMedix, while Orano Med will be responsible for
the manufacturing of AlphaMedix through its global industrial platform currently under development. Under the terms of the
agreement, RadioMedix and Orano Med received an upfront payment of €
100
million and could receive up to €
220
million
based on sales milestones, as well as being eligible for tiered sales-based royalties.
•
On December 20,
2024
, Sanofi entered into an exclusive licensing agreement with Corxel Pharmaceuticals (CORXEL) to
develop and commercialize aficamten in China, Hong Kong, Macao and Taiwan for the treatment of patients with obstructive
and non-obstructive hypertrophic cardiomyopathy (HCM). Aficamten is an investigational, next-in-class selective small
molecule cardiac myosin inhibitor discovered and developed globally by Cytokinetics. Sanofi will now acquire CORXEL’s rights
relating to aficamten in China, Hong Kong, Macao and Taiwan for an undisclosed amount. Cytokinetics remains eligible to
receive up to $
150
million in development and commercial milestone payments from Sanofi as well as royalties in the low-to-
high teens on future sales of aficamten in China, Hong Kong, Macao and Taiwan. Cytokinetics is now also eligible to receive
additional undisclosed payments in connection with the execution of the agreement between Sanofi and CORXEL.
The amount reported for commitments as of December 31,
2024
also includes commitments under agreements entered into by
Sanofi in prior years. The main such agreements are described below; for a full description of each agreement, refer to the Annual
Report on Form 20-F for the year in which the agreement was entered into.
The major agreements entered into by Sanofi in
2023
are described below:
•
expan
ded collaboration with Scribe Therapeutics signed in September 2022, and an exclusive license agreement on CasX-
Editor(XE) genome editing technology associated with guide RNAs for multiple targets including sickle cell disease and other
genomic diseases;
•
agreement with Janssen Pharmaceuticals, Inc. (Janssen) to develop and commercialize a vaccine candidate against extra
intestinal pathogenic strains of E. coli developed by Janssen. In February 2025, a scheduled review of the E.mbrace phase 3
study conducted by independent data monitoring committee (IDMC) determined that the vaccine candidate was not
sufficiently effective at preventing invasive E. coli disease (IED) compared to placebo. As a result of the IDMC's determination,
the E.mbrace study is being discontinued (see Note D.5.);
•
collaboration agreement with Teva Pharmaceuticals to co-develop and co-commercialize TEV’574 (duvakitug), for which positive
Phase 2b clinical study results in patients with ulcerative colitis and Crohn’s disease were announced on December 17, 2024.
|
F-80
|
SANOFI
FORM 20-F
2024
|
|
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
|
In addition, by acquiring all of the outstanding shares of Provention Bio, Inc. on April 27, 2023 (see Note D.1.), Sanofi assumed
commitments amounting to
€
946
million made by that company to various partners under collaboration agreements previously
entered into.
The principal agreements entered into by Sanofi in earlier years are listed below:
•
Exscientia
(2022):
an innovative license agreement and research collaboration to develop up to
15
novel small molecule
candidates across oncology and immunology, leveraging Exscientia’s end-to-end AI-driven platform utilizing actual patient
samples;
•
ABL Bio
(2022)
: a licensing and collaboration agreement for the development of ABL301, a bispecific antibody intended as a
treatment for alpha-synucleinopathies;
•
Adagene Inc., a company specializing in the discovery and development of antibody-based therapies
(2022)
: collaboration
and exclusive license agreement;
•
Blackstone
(2022)
: a strategic risk-sharing collaboration under which funds managed by Blackstone Life Sciences (BXLS) will
contribute up to €
300
million
to accelerate the global pivotal studies and clinical development program for the subcutaneous
formulation and delivery of the anti-CD38 antibody Sarclisa, to treat patients with multiple myeloma. That amount will be paid
to Sanofi on the basis of development expenses incurred. In addition, Sanofi may pay royalties on future sales of this solution;
•
IGM Biosciences Inc.
(2022)
: an exclusive collaboration agreement to create, develop, manufacture and commercialize IgM
antibody agonists against
three
oncology targets and
three
immunology/inflammation targets;
•
Atomwise
(2022)
: a collaboration agreement that will leverage Atomwise's ATOMNET platform to identify and synthesize up to
•
Scribe Therapeutics
(2022)
: a research collaboration to leverage Scribe's CRISPR by Design platform and to obtain a non-
exclusive license to CasX-Editor(XE) genome editing technology for multiple oncology targets;
•
Insilico Medicine
(2022)
: a strategic research collaboration to leverage Insilico Medicine’s AI platform, Pharma.AI, to advance
drug development candidates for up to
six
new therapeutic targets;
•
Innate Pharma SA
(2022)
: an expanded collaboration, with Sanofi licensing a natural killer (NK) cell engager program targeting
B7-H3 from Innate’s ANKET (Antibody-based NK Cell Engager Therapeutics) platform;
•
Kymera (2020): agreement to develop and commercialize protein degrader therapies targeting IRAK4 in patients with
immune-inflammatory diseases;
•
Nurix Therapeutics (2020): collaboration to develop novel targeted protein degradation therapies; and
•
Denali Therapeutics Inc. (2018): collaboration agreement on the development of multiple molecules with the potential to treat
a range of systemic inflammatory diseases such as ulcerative colitis.
Sanofi did not discontinue any collaboration agreement that would have resulted in a significant reduction in commitments as of
December 31, 2024
.
In addition, under the collaboration agreement with Regeneron on monoclonal antibodies (see Note C.1.), Sanofi is entitled to
receive an additional share of quarterly profits (capped at
10
%
of Regeneron’s share of quarterly profits until March 31, 2022, and
thereafter at
20
%
), until Regeneron has paid
50
%
of the cumulative development costs incurred by the parties to the alliance.
As of
December 31, 2024
this represented total commitments received of €
1.6
billion
(versus €
2.1
billion
as of December 31,
2023
),
against cumulative development costs of €
9.7
billion
.
Sanofi entered into an agreement with Royalty Pharma in December 2014 relating to development programs, under which
Royalty Pharma bore a portion of the remaining development costs of the project on a quarterly basis in return for royalties on
future sales. The products in development under that
agreement have been launched in territories including the United States
and Europe, marking the end of the joint development programs.
On February 27, 2017, Sanofi and Lonza announced a strategic partnership in the form of a joint venture (BioAtrium AG) to build
and operate a large-scale mammalian cell culture facility for monoclonal antibody production in Visp, Switzerland. An initial
investment of approximately
€
0.3
billion
to finance construction of the facility, split
50
/
50
between the two partners, has now
been made in full. In addition, Sanofi could pay BioAtrium AG in the region of
€
0.6
billion
over the 2025-2031 period as its share
of operating expenses and the cost of producing future batches.
In February 2014, pursuant to the “Pandemic Influenza Preparedness Framework for the sharing of influenza viruses and access to
vaccines and other benefits” (still effective as of
December 31, 2024
), Sanofi Pasteur and the World Health Organization (WHO)
signed a bilateral “Standard Material Transfer Agreement” (SMTA 2). This agreement stipulates that Sanofi Pasteur will, during
declared pandemic periods, (i) donate
7.5
%
of its real-time production of pandemic vaccines against any strain with potential to
cause a pandemic, and (ii) reserve a further
7.5
%
of such production on affordable terms. The agreement cancels and replaces all
preceding commitments to donate pandemic vaccines to the WHO.
Sanofi has also entered into power purchase agreements in furtherance of its sustainability strategy.
|
SANOFI
FORM 20-F
2024
|
F-81
|
|
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
|
The characteristics of the principal power purchase agreements in place as of December 31, 2024 are summarized below:
|
Country
|
Type of Energy
|
Annual Volume
|
Start Date
|
Term
|
Type of Contract
|
Accounting
Treatment
|
|
France
|
Solar
|
8 GWh
|
2025
|
20 years
|
PPA
(a)
|
Own use
procurement
contract
(b)
|
|
Wind
|
46 GWh
|
2025
|
20 years
|
|||
|
Wind
|
29 GWh
|
2025
|
20 years
|
|||
|
Wind
|
21 GWh
|
2025
|
20 years
|
|||
|
Wind
|
32 GWh
|
2025
|
20 years
|
|||
|
Wind
|
22 GWh
|
2025
|
20 years
|
|||
|
Solar
|
6 GWh
|
2025
|
20 years
|
|||
|
Solar
|
6 GWh
|
2025
|
20 years
|
|||
|
Solar
|
7 GWh
|
2025
|
20 years
|
|||
|
Wind
|
21 GWh
|
2025
|
15 years
|
|||
|
Wind
|
40 GWh
|
2025
|
15 years
|
|||
|
Germany
|
Wind
|
70 GWh
|
2025
|
18 years
|
||
|
Belgium
|
Wind
|
20 GWh
|
2026
|
15 years
|
(a)
PPA (Power Purchase Agreement): long-term renewable energy contract resulting in physical supply of electricity at a predetermined fixed price for the
entire duration of the contract.
(b)
At the current stage of analysis with reference to IFRS 10 (Consolidated Financial Statements), IFRS 16 (Leases) and IFRS 9 (Financial Instruments),
Sanofi has concluded that it can apply the own use exception as permitted by paragraph 2.4 of IFRS 9.
These contracts help secure the objective of 100% electricity from renewable sources supply across all Sanofi operations by
2030.
D.21.2. Off balance sheet commitments relating to financing activities
Credit facilities
|
December 31, 2024
|
Expiry
|
||||
|
(€ million)
|
Total
|
Less than
1 year
|
1 to
3 years
|
3 to
5 years
|
More than
5 years
|
|
General-purpose credit facilities
|
|
|
|
|
|
As of
December 31, 2024
, total credit facilities amounted to
€
8,000
million
(versus
€
8,000
million
as of
December 31, 2023
and
€
8,000
million
as of
December 31, 2022
).
Guarantees
|
(€ million)
|
2024
|
2023
|
2022
|
|
Guarantees given:
|
|
|
|
|
•
Guarantees provided to banks in connection with credit facilities
|
|
|
|
|
•
Other guarantees given
|
|
|
|
|
Guarantees received
|
(
|
(
|
(
|
D.21.3. Off balance sheet commitments relating to asset acquisitions and divestments, and to
changes in the scope of consolidation
As of
December 31, 2024
, Sanof
i had received commitments amounting in aggregate to €
0.5
billion in respect of (i) divestments
of assets relating to transactions not yet finalized as of that date and (ii) contingent consideration arising under past agreements.
Off balance sheet commitments of a financing nature with associates and joint ventures are disclosed in N
ote D.6.
Off-balance sheet commitments relating to securities classified in the categories Equity instruments at fair value through other
comprehensive income and Unquoted debt securities not meeting the definition of equity instruments are respectively disclosed
in Notes D .7.1. and D.7.3..
The maximum amount of contingent consideration relating to business combinations is disclosed in Note D.18.
|
F-82
|
SANOFI
FORM 20-F
2024
|
|
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
|
D.22.
Legal and arbitral proceedings
Sanofi and its affiliates are involved in litigation, arbitration and other legal proceedings. These proceedings typically are related
to product liability claims, intellectual property rights (particularly claims against generic companies seeking to limit the patent
protection of Sanofi products), competition law and trade practices, commercial claims, employment and wrongful discharge
claims, tax assessment claims, waste disposal and pollution claims, and claims under warranties or indemnification arrangements
relating to business divestitures. Provisions related to legal and arbitral proceedings are recorded in accordance with the
principles described in Note B.12.
Most of the issues raised by these claims are highly complex and subject to substantial uncertainties; therefore, the probability of
loss and an estimation of damages are difficult to ascertain. Contingent liabilities are cases for which either we are 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 not probable. In either case, a brief description of the nature of the contingent liability is disclosed and, where
practicable, an estimate of its financial effect, an indication of the uncertainties relating to the amount and timing of any outflow,
and the possibility of any reimbursement are provided in application of paragraph 86 of IAS 37.
In the cases that have been settled or adjudicated, or where quantifiable fines and penalties have been assessed, we have
indicated our losses or the amount of provision accrued that is the estimate of the probable loss.
In a limited number of ongoing cases, while we are able to make a reasonable estimate of the expected loss or range of the
possible loss and have accrued a provision for such loss, we believe that publication of this information on a case-by-case basis or
by class would seriously prejudice the Company’s position in the ongoing legal proceedings or in any related settlement
discussions. Accordingly, in those cases, we have disclosed information with respect to the nature of the contingency but have
not disclosed our estimate of the range of potential loss, in accordance with paragraph 92 of IAS 37.
These assessments can involve a series of complex judgments about future events and can rely heavily on estimates and
assumptions. Our assessments are based on estimates and assumptions that have been deemed reasonable by management. We
believe that the aggregate provisions recorded for the above matters are adequate based upon currently available information.
However, given the inherent uncertainties related to these cases and involved in estimating contingent liabilities, we could in the
future incur judgments that could have a material adverse effect on our net income in any particular period.
Long term provisions are disclosed in Note D.19. They include:
•
provisions for product liability risks, litigation and other amount to
€
1,676
million
in
2024
. These provisions are mainly related
to product liabilities, government investigations, competition law, regulatory claims, warranties in connection with certain
contingent liabilities arising from business divestitures other than environmental matters and other claims;
•
provisions for environmental risks and remediation amount to
€
474
million
in
2024
, the majority of which are related to
contingencies that have arisen from business divestitures.
a) Products
Sanofi Pasteur Hepatitis B Vaccine Product Litigation
Since 1996, more than
180
lawsuits have been filed in various French civil courts against Sanofi Pasteur (a French subsidiary of
Sanofi) and/or Sanofi Pasteur MSD SNC (a joint venture company with Merck & Co., Inc. now terminated), for which past ongoing
litigation is now managed by the originating party. In such lawsuits, the plaintiffs allege that they suffer from a variety of
neurological disorders and autoimmune diseases, including multiple sclerosis and Guillain-Barré syndrome, as a result of receiving
the hepatitis B vaccine.
In January 2018, the Appeal Court of Bordeaux found a causal link between hepatitis B vaccine and multiple sclerosis. In July
2019, the French Supreme Court
(Cour de cassation)
cancelled the judgment of the Appeal Court of Bordeaux and referred
the case back to the Appeal Court of Toulouse. On March 30, 2022, the Appeal Court of Toulouse dismissed all the plaintiffs'
claims.
As of December 31,
2024
, there were
four
ongoing lawsuits related to Sanofi Pasteur hepatitis B vaccine.
Taxotere Product Litigation in the US
A number of lawsuits have been filed against affiliates of Sanofi under US state law for personal injuries allegedly sustained in
connection with the use of Taxotere. The actions are held in several jurisdictions around the country. In 2021, there were
Sanofi's favor. Throughout 2024, Sanofi entered into a number of settlement agreements or agreements in principle with many
plaintiffs’ firms encompassing nearly all the remaining cases. These agreements, still a work in progress, require the consent of the
individual plaintiffs and will take some time to conclude, in order to ensure that certain threshold participation requirements are
met. At the end of the settlement process, Sanofi expects approximately 100 plaintiffs to opt out of the settlement and litigation
will continue.
It is not possible, at this stage, to assess with certainty the outcome of these lawsuits.
|
SANOFI
FORM 20-F
2024
|
F-83
|
|
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
|
Zantac Litigation in the US
In September 2019, the US Food and Drug Administration (FDA) announced it was investigating the claims of an online
pharmacy’s Citizen Petition that the medication Zantac (the brand name for ranitidine) used for stomach heartburn contains or
can generate the chemical N-Nitrosodimethylamine (NDMA), an alleged human carcinogen. As a precautionary measure, Sanofi
initiated a voluntary recall of branded over-the-counter Zantac in October 2019. Concurrent with the FDA investigation, multiple
personal injury lawsuits and class actions alleging that Zantac causes various cancers and seeking damages for either alleged
personal injuries or alleged economic injuries were filed. Federal court cases were coordinated into a Multi-Districts Litigation
(MDL) in the Southern District of Florida in February 2020.
On December 6, 2022, the MDL Court granted Sanofi and other defendants’
Daubert
and summary judgment motions. As a
result, the Court entered final judgment in all cases involving plaintiffs’
five
designated cancers and dismissed the class action
cases. Based on the preliminary estimates, more than
12,000
plaintiffs have filed notices to appeal the
Daubert
ruling in the
Eleventh Circuit. The MDL Court subsequently dismissed all pending cases alleging a non-designated cancer for failure to serve
expert reports.
Other cases are pending in various state courts. The majority of the state court plaintiffs have cases pending in Delaware, where a
hearing on defendants’
Daubert
motions to exclude plaintiffs’ experts took place in January 2024. In May 2024, the State of
Delaware court decided not to exclude plaintiffs’ experts from the cases. Sanofi has appealed this decision to the Delaware
Supreme Court which has granted review, and a decision is expected in June 2025. To date, there have been five trials against
other defendants, but none against Sanofi as yet.
In March 2024, Sanofi reached agreement in principle with a number of plaintiffs’ lawyers to resolve Zantac personal injury cases
pending against it in all US state courts outside of Delaware. This agreement would resolve approximately 75% of nearly 4,400
cases. The agreement requires the consent of individual plaintiffs and will take some time to conclude.
Overall, as of December 31, 2024, there were around
1,623
product liability “complaints” filed. These complaints
encompass
24,922
individual product liability “plaintiffs” who have all filed against Sanofi. The vast majority of these plaintiffs
participated in the MDL Court’s census registry program, allege cancers that the plaintiffs’ leadership decided not to designate
and pursue in the MDL, and have since filed their complaints in state courts. Additional cases may be filed.
In addition, in November 2019, Sanofi received a Civil Investigative Demand (CID) related to this issue from the Arizona Attorney
General. Sanofi provided responses in December 2019 and July 2020 and has not received any follow-up requests.
In June 2020, the New Mexico Attorney General filed a complaint against Sanofi, the previous marketing authorization holders for
branded Zantac, a dozen generic manufacturers, and several retailers. The complaint brings claims for alleged violations of the
New Mexico Unfair Practices Act, violations of the New Mexico False Advertising Act, violations of the New Mexico Public
Nuisance Statute, common law public nuisance, and negligence. Trial in the case is scheduled for September 2025.
In June 2020, Sanofi received a notice from the US Department of Justice Civil Division and US Attorney’s Office for the Eastern
District of Pennsylvania of an investigation into allegations that pharmaceutical manufacturers violated the False Claims
Act, 31 U.S.C. § 3729, in relation to the drug Zantac and ranitidine hydrochloride through alleged failure to disclose to the federal
government information about the potential presence of NDMA. In response to the notice, Sanofi provided information and
documents including applications and communications with FDA, in August 2020. Sanofi has not received any subsequent
requests from the federal government.
In November 2020, the Mayor and City Council of Baltimore filed a complaint against Sanofi, the previous marketing
authorization holders for branded Zantac, generic manufacturers, and several retailers. The complaint alleges violations of the
Maryland Consumer Protection statute, public nuisance, and negligence. Trial in the case is scheduled for September 2026.
In January 2021, Sanofi had been served with the Center for Environmental Health’s Second Amended Complaint alleging
Proposition 65 violations. The case which was pending in California Superior Court in Alameda County was settled in 2024 and is
now concluded.
It is not possible, at this stage, to assess with certainty the outcome of these lawsuits.
Zantac Litigation in Canada
Between 2019 and 2022,
seven
proposed class actions naming some or all of Sanofi Consumer Health Inc., Sanofi-Aventis Canada
Inc., Chattem (Canada) Inc., Sanofi and Sanofi Pasteur Limited as Defendants, relating to ranitidine were filed in courts in various
Canadian provinces. The cases allege that proposed class members suffered personal injury from the ingestion of ranitidine, and
seek damages in unspecified amounts, disgorgement of profits, restitution in the amount of the purchase price of Zantac and
subrogated damages on behalf of provincial health insurers for health care costs related to ranitidine use.
Between 2021-2024, a total of 122 individual claims naming Sanofi Consumer Health Inc., Sanofi-Aventis Canada Inc., Sanofi
Pasteur Limited and Chattem (Canada) Inc. were filed in Ontario and British Columbia.
In May 2023, in the proceedings pending before the Supreme Court of British Columbia, the court dismissed the action, ruling
that there is no scientific support for the plaintiffs' claims. The Superior Court of Quebec has stayed the corresponding proposed
Zantac class proceedings in Quebec until the result of the US Multi-District Litigation (MDL) appeal is announced or October 15,
2025 (whichever comes first).
It is not possible, at this stage, to assess with certainty the outcome of the remaining lawsuits.
|
F-84
|
SANOFI
FORM 20-F
2024
|
|
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
|
Talc Product Litigation in the US
Over the last few years, Sanofi affiliates have been named in product liability actions in the United States regarding the alleged
presence of asbestos in talc products originating from past acquisitions. A certain number of these claims were also dismissed
during that time. As of December 31, 2024, there were approximately
700
ongoing product liability actions. To date,
no
cases
have proceeded to trial.
It is not possible, at this stage, to assess with certainty the outcome of these lawsuits.
Depakine Product Litigation in France
Civil proceedings
As of
December 31, 2024
,
79
families had brought a civil claim involving
133
people
exposed in utero to sodium valproate against a
French
affiliate
of Sanofi seeking indemnification under French law for personal injuries allegedly suffered by children in
connection with the use of sodium valproate (Depakine) by their mothers during pregnancy to treat their epilepsy. These actions
are being held in several jurisdictions in France.
which in November 2019 issued a ruling sending the case before the Paris Appeal Court to rule on Sanofi’s argument on the
compliance of the product with mandatory regulations, as well as on the question of defectiveness of the product and the
assessment of damages. In January 2023, the Paris Appeal Court ordered a stay in the proceedings until the submission of the
second expert opinion report as part of the criminal investigation (see below).
Court declared the judicial expert report null and void and the Court dismissed one claim in another case.
Concerning
three
other cases relating to births that occurred between 2005 and 2009, the Court held, on the basis of a non-
fault liability, that Sanofi was liable in light of the wording of the patient information leaflet. Provisional compensation amounts
were set in the range of
€
0.1
million
to
€
0.5
million
.
To date,
four first instance cases have ruled in favour of plaintiffs and two first
instance rulings excluded Sanofi’s liability.
All the judgments have been appealed and are still pending.
In the class action lawsuit filed in May 2017 by the APESAC
(Association des Parents d’Enfants souffrant du Syndrome de l’Anti-
Convulsivant)
against the French affiliate, the Judicial Tribunal of Paris ruled on January 5, 2022 that a class is admissible,
retaining Sanofi’s liability between 1984 and January 2006 for malformations and between 2001 and January 2006 for neuro-
developmental disorders (NDD). This decision is based on the conclusions of a criminal expert report within the frame of ongoing
criminal proceedings, for which the
Chambre de l’Instruction
of the Appeal Court of Paris had ordered a counter-expertise
(see below). The APESAC, Sanofi and its insurers appealed the Judicial Tribunal of Paris’ ruling related to the class action.
On July 21, 2021, the Judicial Tribunal of Créteil (France) dismissed a claim for damages brought against Sanofi regarding a child
born in 1995. The Judicial Tribunal considered that the risk of occurrence of NDD in children born to a mother exposed to sodium
valproate during pregnancy was not demonstrated by the state of scientific knowledge at the time of her pregnancy. This
decision was appealed and the proceeding is now pending before the Appeal Court of Paris, which had ordered a stay in the
proceeding until the end of the criminal investigation.
Several questions on the Product Liability Directive have been referred to the
Court of Justice of the European Union (CJEU
),
which will have an impact on the pending Depakine cases. A ruling from the
CJEU
is expected between September and
December 2025.
Since July 2020, a collective redress has been filed against the French affiliate representing as of December 2024 approximately
2024, the court denied
Sanofi’s request related to the stay of proceeding pending the
CJEU
ruling and rejected Sanofi's statute
of limitation arguments.
In September 2024, Sanofi filed an appeal.
Criminal investigation
A criminal investigation was initiated in May 2015 before the Paris Civil Court. In January 2020, the French affiliate of Sanofi was
indicted for aggravated deception and involuntary injuries and in July 2020 for involuntary manslaughter. In July 2020, a judicial
supervision of the affiliate was ordered, together with the implementation of financial guarantees. In November 2020, the Health
Authority (
ANSM) was similarly indicted for involuntary injuries and involuntary manslaughters.
On March 9, 2022, the
Chambre de l’Instruction
of the Appeal Court of Paris
(Cour d’appel)
ruled that certain complaints for
involuntary manslaughter and several others for aggravated deception and involuntary injuries were time-barred. The Public
Prosecutor, as well as the civil parties, have brought the matter before the
Chambre Criminelle
of the Supreme Court
(Cour de
cassation)
.
In September 2022, the investigating judges appointed
two
experts for a counter-expertise following the
Chambre de
l’Instruction’s
ruling handed down end of 2021.
Since 2022, several individual medical assessments have been ordered by the
investigating judge.
In June 2023, the
Chambre Criminelle
of the French Supreme Court
(
Cour de cassation
)
confirmed the Paris Court of Appeal’s
decision
(
Chambre de l’Instruction
)
dated March 2022 which had ruled that certain complaints for involuntary manslaughter and
several others for aggravated deception and involuntary injuries were time-barred. In August 2023, Sanofi received the counter
expertise report and sent its comments in November 2023.
|
SANOFI
FORM 20-F
2024
|
F-85
|
|
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
|
Public compensation scheme
In 2017, the French government set up a public compensation scheme to indemnify patients for damages suffered in connection
with the prescription of sodium valproate and its derivatives. The scheme was further amended through the 2020 Finance Law,
with notably the introduction of presumptions of failure to inform the mother since 1982 for malformations and since 1984 for
NDD. The scheme was amended again through the 2021 Finance Law in order to increase the maximum premium applicable in
the event of refusal to make an offer (or making an insufficient offer) where this would be deemed unjustified by a court ruling.
The committee of the compensation scheme has issued several final opinions holding the French affiliate liable for damages
either in full or in part along with the French State, and, in some cases, healthcare practitioners. The French affiliate disagreed
with the committee’s conclusions and has accordingly not offered indemnification to the claimants who have received
compensation from the ONIAM
(Office National d’Indemnisation des Accidents Médicaux)
. The ONIAM is now seeking
reimbursement from Sanofi, which has filed legal actions to oppose ONIAM’s payment orders.
Administrative Actions
In July 2020, March and June 2021, the Montreuil Administrative Court held the French State liable in
five
administrative
proceedings initiated by families against the State. In March 2021, the Administrative Court did not find any failure to inform the
mother regarding the risk of neurodevelopmental disorders for births in 1999 and in 2002, based on the state of scientific
knowledge at the time. However, regarding the risk of malformations, liabilities were retained against the State, the healthcare
professionals and Sanofi, notably for discrepancy between the SmPC (Summary of the Product Characteristics) and the patient
leaflet. In other cases involving births in 2005-2008, the State was held liable both for malformations and neurodevelopmental
disorders but partially exonerated, taking into account the roles of healthcare practitioners and Sanofi. Given that the French
affiliate was not a party to these administrative proceedings, its arguments (including several requests from the French affiliate to
the Health Authorities to reinforce warnings to healthcare professionals and patients in relation to Depakine) were not
considered. All rulings were appealed by the claimants. Sanofi has filed requests for voluntary intervention in these proceedings
to present its arguments before the Administrative Court of Appeal, which has been granted for some of them. In one
proceeding, the claimants decided to withdraw their claims. In January 2025, the Paris Administrative Court of Appeal handed
down five rulings. In cases concerning births in 2006 onwards, the Court retained the State’s liability and no fault from Sanofi due
to the reiterated variation requests of the medicine’s information documents. In a case concerning births in 1999 and 2002, the
Court retained the State’s liability with a 50% liability retained for Sanofi.
It i
s not possible, at this stage, to make a reliable assessment of the outcome of these cases.
Depakine Product Litigation in other EU countries, in the UK and Switzerland
In Switzerland,
eleven
families have filed a civil claim for damages concerning
seventeen
people exposed in utero. Some of them
also involve the claimants’ physicians. In November 2022,
one
action was declared time-barred by the judge. The claimant
appealed this court decision on the merit. In November 2024, the court confirmed the first instance judgment. The claimant
appealed against this court decision to the Federal Tribunal (last Instance).
In Spain, there are
seven
ongoing actions relating to
fifteen
children. In March 2022, in one trial, the Court ordered Sanofi to
indemnify
four
patients. Sanofi appealed this decision. In January 2023, in another trial filed by one patient, the Appeal Court
confirmed the first instance's decision and dismissed the claim. As of December 2024, two actions are pending in front of the
Supreme Court and five are at the first instance stage.
In Belgium, there are
two
civil proceedings (currently on hold) and a criminal complaint against X and against Sanofi. In the
criminal complaint, the court ruled in September 2024 that the action was time-barred. Claimants have appealed.
In Ireland, there are
two
cases in Pre-Action stage and
two
civil claims ongoing.
In the United Kingdom, there is
one
case in the Pre-Action stage in Great Britain and
one
civil claim ongoing in Northern Ireland.
It is not possible, at this stage, to assess reliably the outcome of these cases.
Dengvaxia (Philippines)
From early 2018 up to present date, several claims have been filed in the Philippines by parents of deceased children whose
deaths were allegedly due to vaccination with Dengvaxia. In early March 2019 and in 2020 and 2022, the Philippine Department
of Justice (DOJ) prosecution panel announced it had found probable cause to indict several Sanofi employees/former employees
and former Government officials for “reckless imprudence” resulting in homicides. Since then, several criminal actions have been
filed in court as a result of this finding and are pending at various stages of the legal procedure. Petitions for Review to the DOJ
Secretary have been filed and the said petitions remain pending. Meanwhile, the majority of the respondents have challenged the
jurisdiction of the lower court where the first
eight
cases had been assigned and this issue was filed with the Supreme Court.
There are several claims that have not yet been filed in any court despite resolutions by the DOJ that there is probable cause.
In July 2024, the Court dismissed the first eight criminal cases, ruling the prosecution failed to establish the elements of “reckless
imprudence” resulting in homicide. Remaining cases are still pending at various stages.
|
F-86
|
SANOFI
FORM 20-F
2024
|
|
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
|
b) Patents
Ramipril Canada Patent Litigation
Sanofi was involved in a number of legal proceedings involving companies which market generic Altace (ramipril) in
Canada. In 2004, Sanofi unsuccessfully brought Notice of Compliance proceedings (NOC proceedings) at the end of which
Canada. Sanofi filed unsuccessful patent infringement actions against all those companies and ultimately Sanofi was liable for
damages under Section 8. Sanofi made payment in complete satisfaction of those awards.
In June 2011, Apotex commenced an action in the Ontario Superior Court of Justice asserting damages under the Ontario Statute
of Monopolies, the UK Statute of Monopolies, and the Trade-marks Act (the “Ontario Action”).
At the request of the parties, in June 2021 the Court ordered that the action be stayed in view of the lower court’s decision in
March in the Apotex vs. Lilly case. In the Lilly case, the Court dismissed Apotex’s Statute of Monopolies claim by way of summary
judgment.
In April 2023, the Canadian Supreme Court denied Apotex’s application for leave to appeal in the Lilly case and based
on the Supreme Court decision, Apotex’s claim no longer has any basis. O
n February 6, 2025, Apotex formally discontinued the
case against Sanofi. Sanofi continues to pursue recovery of appropriate costs.
Praluent (alirocumab)-related Amgen Patent Litigation in the US
In 2014, Amgen filed
four
separate complaints against Sanofi and Regeneron in the US District Court for the District of Delaware
(“District Court”) asserting patent infringement relating to Sanofi and Regeneron’s Praluent product. Together these complaints
alleged that Praluent infringed
seven
patents for antibodies targeting PCSK9 and sought injunctive relief and unspecified
damages.
In February 2021, the Federal Circuit affirmed the District Court’s ruling invalidating the Amgen asserted patent claims.
In November 2021, Amgen filed a petition with the US Supreme Court, asking it to overturn the Federal Circuit decision.
On November 4, 2022, the US Supreme Court granted Amgen’s petition for review.
In May 2023, the Supreme Court issued a
unanimous decision in favor of Sanofi and Regeneron regarding the
patent infringement actions filed in 2014 by Amgen relating
to Sanofi and Regeneron’s Praluent product. Sanofi is in the process of seeking certain legal costs from Amgen, which is pending
before the District of Delaware Court.
Praluent (alirocumab)-related Amgen Patent Litigation in Europe
In June 2023, Amgen filed an action for infringement of EP 3 666 797 against Sanofi and Regeneron concerning Praluent in the
Munich Local Division of the Unified Patent Court. Amgen seeks a permanent injunction and unspecified damages and
compensation from March 1, 2023. In June 2023, Sanofi filed a revocation action attacking the validity of EP 3 666 797 in the
Munich Central Division of the Unified Patent Court. In this action, a decision on the Amgen patent’s validity was issued in July
2024, revoking Amgen’s patent, hence supporting Sanofi’s position. Amgen has appealed this decision, and the appeal is
underway. Amgen’s action for infringement in the Munich Local Division of the Unified Patent Court is suspended pending this
appeal.
Sanofi and Regeneron have also attacked the validity of the same EP 3 666 797 patent at the European Patent Office. These
proceedings are ongoing and a first instance oral hearing at the Opposition Division of the European Patent Office is scheduled in
March-April 2025.
Plavix Litigation (Commonwealth) in Australia
In August 2007, GenRX (a subsidiary of Apotex) obtained registration of a generic clopidogrel bisulfate product on the Australian
Register of Therapeutic Goods. At the same time, GenRX filed a patent invalidation action with the Federal Court of Australia,
seeking revocation of Sanofi’s Australian enantiomer patent claiming clopidogrel salts (a “nullity action”). In September 2007,
Sanofi obtained a preliminary injunction from the Federal Court preventing commercial launch of this generic clopidogrel
bisulfate product until judgment on the substantive issues of patent validity and infringement.
In August 2008, the Australian Federal Court confirmed that the claim in Sanofi’s Australian enantiomer patent directed to
clopidogrel bisulfate (the salt form in Plavix) was valid and the patent infringed. On appeal, the Full Federal Court of Australia held
in September 2009 that all claims in the patent are invalid. Sanofi’s appeal to the Australia High Court was denied in March 2010.
On conclusion of the proceedings in 2010, the Sanofi patent was invalidated.
In April 2013, the Australian Department of Health and Ageing (“Commonwealth”) filed an application before the Federal
Court of Australia seeking payment of damages from Sanofi related to the Apotex preliminary injunction.
Sanofi and BMS settled the patent litigation with Apotex in November 2014. In April 2020, the Commonwealth’s claim was
dismissed. In May 2020, the Commonwealth filed a Notice of Appeal to the Full Court of the Federal Court. On appeal, the
Commonwealth reduced its claim to a range of
AUD
223.3
million
(
€
137.8
million
) to
AUD
280.2
million
(
€
172.9
million
) which,
inclusive of interest to December 31, 2023, ranges from
AUD
360.5
million
(
€
218.0
million
) to
AUD
487.5
million
(
€
294.3
million
).
In June 2023, the Full Court of the Federal Court of Australia unanimously dismissed the Commonwealth’s appeal following
its
application seeking payment of damages from Sanofi/BMS related to the preliminary injunction. O
n July 24, 2023,
the Commonwealth filed an application for special leave to appeal to the High Court of Australia, which was granted
on December 18, 2023.
On December 11, 2024, the High Court of Australia dismissed the appeal from the June 2023 decision of
the Full Court of the Federal Court of Australia. The only outstanding issue in this matter is the enforcement of the costs order.
|
SANOFI
FORM 20-F
2024
|
F-87
|
|
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
|
c) Other litigation
Plavix (clopidogrel) – Attorney General Action in Hawaii
In March 2014, the Hawaii Attorney General (AG) filed a complaint that sets forth allegations related to the sale and marketing of
and variability of response to Plavix. The Hawaii AG specifically alleged that Plavix had a diminished effect in patients of certain
genetic backgrounds and that Sanofi and BMS had failed to make an earlier disclosure of this information.
In February 2021, the Court issued its decision, imposing penalties in the total amount of
$
834
million against both Sanofi and
Bristol Myers Squibb (BMS), with
$
417
million being apportioned to each company. In June 2021, Sanofi and BMS appealed
this judgment. The appeal was transferred directly to the Hawaii Supreme Court. In March 2023, the Hawaii Supreme Court
vacated the judgment and ordered a new trial. A second trial was concluded in October 2023
and in 2024 a judgment was
rendered against the defendants for
$
916
million
(
$
458
million
against Sanofi)
. Sanofi and BMS have appealed this decision to the
Hawaii Supreme Court.
Plavix (clopidogrel)-related litigation in France
In France, in the claim concerning allegations that Sanofi’s communication and promotional practices inhibited the entry on
the market of generics of clopidogrel (the active ingredient of Plavix), the French Antitrust Authority issued its decision
on May 14, 2013, imposing on Sanofi a fine of
€
40.6
million
. This decision was confirmed by the Supreme Court
(Cour de
cassation)
in 2016. As a consequence of the May 2013 ruling, claims were filed by Sandoz and by Teva in 2014 before the
Commercial Court of Paris for compensation of their alleged damages: loss of margin and other ancillary damages. In June and
November 2016 respectively, settlement agreements were entered into with Sandoz and Teva. Consequently, they subsequently
withdrew their civil claims, jointly and severally. In September 2017, Sanofi and its French affiliate received a summons before
the Paris Commercial Court from the French
Caisse Nationale d’Assurance Maladie –
CNAM
(French Social Security)
claiming
€
115.8
million
for their alleged damages. On October 1, 2019, the Paris Commercial Court dismissed the CNAM’s action as
time barred. On February 9, 2022, the Paris Court of Appeals overturned the Paris Commercial Court's ruling, finding the CNAM’s
action as not time-barred and designated an expert to determine the amount of damages.
The expert report was issued in
March 2024.
A judgment is expected in 2025.
340B Drug Pricing Program in the United States
Sanofi is currently involved in several matters relating to the 340B program in the US (a federal program that requires drug
manufacturers to supply certain products to certain “covered entities” at reduced prices). In 2021, Sanofi filed a lawsuit against
the Department of Health and Human Services (HHS), the Health Resources and Services Administration (HRSA), and certain
of their administrators in the US District Court for the District of New Jersey challenging (i) HHS’s December 2020 Advisory
Opinion (AO) stating that drug manufacturers are legally obligated to deliver discounts under the 340B program to an
unlimited number of contract pharmacies; (ii) HHS’s December 2020 Administrative Dispute Resolution (ADR) Rule; and
(iii) HRSA’s May 2021 letter to Sanofi concluding that Sanofi’s 340B integrity initiative (under which Sanofi collects limited, de-
identified, claims data on 340B-priced drugs dispensed by contract pharmacies) violates section 340B and that Sanofi has
therefore “overcharged” certain covered entities. The court issued its opinion in November 2021, upholding HRSA’s conclusion
in the May 2021 letter, but did not impose any fines, penalties or refund obligations against Sanofi for any “overcharges”. The
court also rejected Sanofi’s challenge to the ADR Rule and dismissed its challenge to the AO as moot. Sanofi appealed the
court’s decision to the Third Circuit Court of Appeals (Third Circuit) and the government filed a cross-appeal.
In January 2023, the Third Circuit held that Sanofi’s restrictions on delivery to contract pharmacies do not violate
Section 340B. It also enjoined HHS from enforcing against Sanofi its reading of Section 340B in the AO and the May 2021
violation letter. As to Sanofi’s challenge to the 340B ADR rule, the Third Circuit held that HHS did not violate the Administrative
Procedure Act in promulgating the ADR Rule (HHS revised and finalized a new ADR rule in April 2024). The Third Circuit
remanded the case back to the US District Court for the District of New Jersey (District Court) and on May 24, 2023, the
District Court issued an injunction and declaratory judgment consistent with the Third Circuit’s opinion. This ruling concluded
the case as to Sanofi. On May 21, 2024, the District Court Circuit, in cases brought by Novartis and United Therapeutics, issued
an opinion holding that Section 340B does not categorically prohibit manufacturers from imposing conditions on the
distribution of covered drugs to covered entities. The Court further held that the conditions at issue in the case did not violate
section 340B on their face and that the lower court had correctly set aside enforcement letters to Novartis and United
Therapeutics. On September 17, 2024, based on the District Court Circuit’s decision, the United States District Court for the
District of Columbia entered stipulated final judgments upholding contract pharmacy restrictions that Amgen, Boehringer
Ingelheim, Merck and UCB each placed in 2021. The rulings vacated letters that HRSA sent each drugmaker in 2021 or 2022
that declared their contract pharmacy restrictions illegal. A similar case, brought by Eli Lilly, remains pending in the Seventh
Circuit.
On May 31, 2024, Sanofi filed a lawsuit in the United States District Court for the District of Columbia against HHS and HRSA
under the Freedom of Information Act (FOIA) seeking an order declaring that Sanofi is entitled to covered entities’ pharmacy
contracts, requiring HRSA to produce the contracts and enjoining HRSA from withholding pharmacy contracts from Sanofi
pursuant to its FOIA request. The government has produced certain documents since the filing of the lawsuit. The government
responded to Sanofi’s complaint on August 2, 2024 and the parties completed summary judgment briefing on December 9, 2024.
In an effort to further mitigate 340B program fraud and abuse, in November 2024, Sanofi announced its intention to implement a
340B Credit Model, where Sanofi will provide credits to covered entities for the difference between the 340B price and the price
initially paid by the covered entity to reflect the 340B discount. On December 16, 2024, Sanofi filed a lawsuit against HHS, HRSA
and their respective administrators, seeking a court order: (i) declaring that HHS’s letter informing Sanofi that its Credit Model
violates 340B is unlawful and setting it aside; (ii) declaring that Sanofi’s Credit Model complies with Section 340B; and
|
F-88
|
SANOFI
FORM 20-F
2024
|
|
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
|
(iii) enjoining defendants from taking enforcement action against Sanofi relating to its Credit Model. In January 2025, the court
entered a scheduling order. Several manufacturers (including Johnson & Johnson, Eli Lilly, Bristol Myers Squibb, and Novartis) as
well as information technology company Kalderos have filed similar lawsuits in the District Court for the District of Columbia.
ADR Proceedings
In January 2021, the National Association of Community Health Centers (NACHC) filed an ADR proceeding before HRSA on
behalf of a number of covered entities, seeking to require Sanofi and AstraZeneca to supply contract pharmacies with 340B
discounts without conditions. On August 10, 2022, the ADR panel granted the motions to dismiss filed both by Sanofi and
AstraZeneca, holding that the Delaware district court’s decision granting AstraZeneca’s motion for summary judgment precluded
NACHC’s ADR claims against both AstraZeneca and Sanofi.
In September 2023, the University of Washington Medical Center and Harborview Medical Center filed a petition for monetary
and equitable relief against Sanofi before the ADR Panel. The petition alleges that Sanofi has violated Section 340B, by imposing
data reporting requirements on “Covered Entities” that are authorized under that statute to receive discounts on certain
prescription drugs and that in June 2023, Sanofi further restricted access to 340B discounted drugs. On August 14, 2024, HRSA
informed petitioner that the petition was complete. Sanofi’s response was submitted on December 11, 2024.
Enforcement Proceedings and Investigations
In September 2021, HRSA referred Sanofi (as well as other manufacturers) to the HHS Office of the Inspector General (OIG) in
accordance with the 340B Program Ceiling Price and Civil Monetary Penalties Final Rule. The Third Circuit’s decision and the
District Court’s injunction and declaratory judgment (described above) would preclude action against Sanofi based on the
particular program at issue in the Third Circuit case.
In February 2021, the Vermont Attorney General issued a Civil Investigative Subpoena seeking certain information about Sanofi’s
participation in the 340B program. Sanofi cooperated with this investigation, including producing documents to the Vermont
Attorney General’s office.
State Litigation
PhRMA and certain manufacturers have filed lawsuits challenging laws passed in certain states purporting to force manufacturers
to provide 340B-pricing to contract pharmacies in their respective states. Those cases are in various stages of litigation. The
most advanced of those cases, was brought by PhRMA challenging an Arkansas 340B law. In that case, the Eighth Circuit held on
March 12, 2024, that the Arkansas statute was not preempted by the federal 340B statute. On December 9, 2024, the Supreme
Court denied PhRMA’s petition for certiorari.
On July 23, 2024, Sanofi filed its own lawsuit challenging the Arkansas law. Sanofi seeks a declaratory judgment that the Arkansas
law is preempted to the extent it requires Sanofi to deliver 340B-priced drugs to contract pharmacies that obtain title to those
drugs in violation of federal law and to enjoin enforcement against Sanofi for its updated integrity initiative. This case is stayed
pending resolution of a case filed by AstraZeneca challenging the Arkansas law. In the interim, Arkansas has agreed not to pursue
enforcement action against Sanofi in connection with its updated integrity initiative.
In lawsuits filed by PhRMA and certain other manufacturers challenging a law passed by the State of West Virginia, the court
granted plaintiffs a preliminary injunction enjoining the State from enforcing its contract pharmacy law and denying defendants’
motion to dismiss the PhRMA action. The State of West Virginia has appealed that decision to the Fourth Circuit.
Mosaic Health
In July 2021, Mosaic Health Inc. and Central Virginia Health Services (covered entities) filed a nationwide antitrust class action
complaint against Sanofi and
three
other manufacturers in the United States District Court for the Western District of New York.
Plaintiffs allege that Sanofi and the other defendants conspired to eliminate favorable 340B pricing, particularly with respect to
diabetes therapies. On September 2, 2022, the court granted Defendants’ motion to dismiss the complaint. On October 3, 2022,
plaintiffs filed a motion for leave to file a second amended complaint, which the court denied on February 1, 2024. Plaintiffs filed
an
appeal.
Adventist Health System/West
In June 2023, Adventist Health System/West sued several drug manufacturing companies, including Sanofi-Aventis US LLC,
Sanofi US Services Inc. and Genzyme Corporation, alleging that the companies violated state and federal False Claims Acts
through overcharging for 340B Program drugs in violation of federal “penny pricing” policy. The manufacturers jointly moved to
dismiss, which was granted by the court in March 2024. Plaintiffs filed an appeal.
Preliminary investigation by the Parquet National Financier (PNF) in France
In November 2023, Sanofi learnt through the press of an ongoing preliminary investigation by the French financial prosecutor
(
Parquet National Financier –
PNF) started in March 2023 relating to allegations regarding Sanofi’s financial communication on
the launch of Dupixent at the end of 2017. Sanofi considers these allegations as groundless and cooperated with the PNF to
respond to the potential questions relating to the investigation. In 2024, the PNF decided to close the case with no further action.
|
SANOFI
FORM 20-F
2024
|
F-89
|
|
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
|
d) Contingencies arising from certain mergers & acquisitions transactions
As a result of divestitures, Sanofi is subject to a number of ongoing contractual and legal obligations regarding the state of the
sold businesses, their assets, and their liabilities, some of which may be subject to dispute.
Aventis CropScience Retained Liabilities
The sale by Aventis Agriculture SA and Hoechst GmbH (both legacy companies of Sanofi) of their aggregate
76
%
participation in
Aventis CropScience Holding (ACS) to Bayer and Bayer CropScience AG (BCS), the wholly owned subsidiary of Bayer which holds
the ACS shares, was effective on June 3, 2002. The Stock Purchase Agreement (SPA) dated October 2, 2001, contained
customary representations and warranties with respect to the sold business, as well as a number of indemnifications subject to
limitation periods and caps, in particular with respect to environmental liabilities for which some outstanding claims from Bayer
remain unresolved.
Infraserv Hoechst Retained Liabilities
By the Asset Contribution Agreement dated December 19/20, 1996, as amended in 1997, Hoechst contributed all land, buildings,
and related assets of the Hoechst site at Frankfurt Hoechst to Infraserv GmbH & Co. Hoechst KG. Infraserv Hoechst undertook to
indemnify Hoechst against environmental liabilities at the Hoechst site and with respect to certain landfills. As consideration for
the indemnification undertaking, Hoechst transferred to Infraserv Hoechst approximately
€
57
million
to fund reserves. In 1997,
Hoechst also agreed it would reimburse current and future Infraserv Hoechst environmental expenses up to
€
143
million
. As a
former operator of the land and as a former user of the landfills, Hoechst may ultimately be liable for costs of remedial action in
excess of this amount.
D
.23.
Provisions for discounts, rebates and sales returns
Adjustments between gross sales and net sales, as described in Note B.13., are recognized either as provisions or as reductions in
accounts receivable, depending on their nature.
|
(€ million)
|
Government
and State
programs
(a)
|
Managed care
and GPO
programs
(b)
|
Chargeback
incentives
|
Rebates
and
discounts
|
Sales
returns
|
Other
deductions
|
Total
|
|
|
Balance at January 1, 2022
|
|
|
|
|
|
|
|
|
|
Provision related to current period sales
|
|
|
|
|
|
|
|
|
|
Net change in provision related to prior
period sales
|
(
|
(
|
(
|
(
|
(
|
|
(
|
|
|
Payments made
|
(
|
(
|
(
|
(
|
(
|
(
|
(
|
|
|
Currency translation differences
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2022
|
(c)
|
|
|
|
|
|
|
|
|
Changes in scope of consolidation
|
|
|
(
|
(
|
(
|
|
(
|
|
|
Provision related to current period sales
|
|
|
|
|
|
|
|
|
|
Net change in provision related to prior
period sales
|
(
|
(
|
(
|
(
|
(
|
|
(
|
|
|
Payments made
|
(
|
(
|
(
|
(
|
(
|
(
|
(
|
|
|
Currency translation differences
|
(
|
(
|
(
|
(
|
(
|
(
|
(
|
|
|
Balance at December 31, 2023
|
(c)
|
|
|
|
|
|
|
|
|
Provision related to current period sales
|
|
|
|
|
|
|
|
|
|
Net change in provision related to prior
period sales
|
(
|
(
|
(
|
(
|
(
|
|
(
|
|
|
Payments made
|
(
|
(
|
(
|
(
|
(
|
(
|
(
|
|
|
Currency translation differences
|
|
|
|
|
|
(
|
|
|
|
Opella reclassification
(d)
|
(d)
|
(
|
|
(
|
(
|
(
|
(
|
(
|
|
Balance at December 31, 2024
|
(c)
|
|
|
|
|
|
|
|
€
1,099
million
in
2023
and
€
775
million
in
2022
).
€
1,028
million
in
2023
and €
934
million
in
2022
).
of
December 31, 2022
.
|
F-90
|
SANOFI
FORM 20-F
2024
|
|
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
|
D.24.
Personnel costs
|
(€ million)
|
2024
|
2023
|
2022
|
|
Salaries
|
|
|
|
|
Social security charges (including defined-contribution pension plans)
|
|
|
|
|
Other employee benefits
(
a)
|
|
|
|
|
Total
(b)
|
|
|
|
T
he total number of registered employees was
84,587
as of
December 31, 2024
, compared with
87,994
as of
December 31, 2023
and
91,573
as of
December 31, 2022
.
D.25.
Other operating income
Other operating income
totaled
€
1,089
million
in
2024
, versus
€
979
million
in
2023
and
€
1,814
million
in
2022
.
Other operating income includes (i) gains from asset divestments, amounting to €
539
million in
2024
(versus €
484
million
in
2023
and €
481
million
in
2022
); and (ii) income from Sanofi’s pharmaceutical partners, amounting to €
221
million
in
2024
(including €
166
million
from Regeneron, see Note D.26. below and Note C.1.), compared with €
285
million
in
2023
(including €
227
million
from Regeneron), and €
1,179
million
in
2022
.
Figures for comparative periods (2023 and 2022) have been re-presented on a consistent basis to reflect the classification of
Opella as a discontinued operation.
D.26.
Other operating expenses
Other operating expenses
totaled
€
4,382
million
in
2024
, compared with
€
3,443
million
in
2023
and
€
2,523
million
in
2022
.
Figures for comparative periods (2023 and 2022) have been re-presented on a consistent basis to reflect the classification of
Opella as a discontinued operation.
and
€
2,378
million
for
2022
(as shown in the table below):
|
(€ million)
|
2024
|
2023
|
2022
|
|
Income & expense related to sharing of (profits)/losses under the Monoclonal
Antibody Alliance
|
(
|
(
|
(
|
|
Additional share of profit paid by Regeneron towards development costs
(a)
|
|
|
|
|
Reimbursement to Regeneron of selling expenses incurred
|
(
|
(
|
(
|
|
Total - Monoclonal Antibody Alliance
|
(
|
(
|
(
|
|
Immuno-Oncology Alliance
|
|
|
|
|
Other (mainly Zaltrap and Libtayo)
|
|
|
|
|
Other operating income/(expenses), net related to Regeneron
|
(
|
(
|
(
|
|
of which amount presented in
Other operating income
(Note D.25.)
|
|
|
|
costs amounted to €
1.6
billion
, compared with €
2.1
billion
as of
December 31, 2023
(see Note D.21.).
Charges to provisions for litigation and environmental risks are also recorded within this line item.
D.27.
Restructuring costs and similar items
were comprised of the following items:
|
(€ million)
|
2024
|
2023
|
(a)
|
2022
|
(a)
|
|
Employee-related expenses
|
|
|
|
||
|
Charges, gains or losses on assets
(b)
|
|
|
|
||
|
Costs related to transformation programs
|
|
|
|
||
|
Other
|
|
|
|
||
|
Total
|
|
|
|
operation.
|
SANOFI
FORM 20-F
2024
|
F-91
|
|
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
|
Restructuring costs and similar items
were €
366
million higher in
2024
than
2023
. For
2024
, they mainly comprise costs
relating to severance plans announced by Sanofi. For
2023
,
they included the impact of pension reform in France on future
annuities under the rules of each severance plan.
Restructuring costs and similar items
also include the effects of Sanofi's
ongoing transformation projects.
D.28.
Other gains and losses, and litigation
Other gains and losses, and litigation
for
2024
represent a charge of €
470
millio
n, mainly comprising a provision recognized in
respect of the litigation related to Plavix (clopidogrel) in the US state of Hawaii (see Note D.22.)
For
2023
, this line item represented a charge of
€
196
million
related to major litigation.
For
2022
, this line item represented a charge of
€
143
million
, comprising the pre-tax loss arising on the deconsolidation of
EUROAPI (see Note D.1.3.) and costs related to major litigation.
Figures for comparative periods (2023 and 2022) have been re-presented on a consistent basis to reflect the classification of
Opella as a discontinued operation.
D.29.
Financial expenses and income
|
(€ million)
|
2024
|
2023
|
(a)
|
2022
|
(a)
|
|
Cost of debt
(b)
|
(
|
(
|
(
|
||
|
Interest income
(c)
|
|
|
|
||
|
Cost of net debt
|
(
|
(
|
(
|
||
|
Non-operating foreign exchange gains/(losses)
|
|
(
|
(
|
||
|
Unwinding of discounting of provisions
(d)
|
(
|
(
|
(
|
||
|
Net interest cost related to employee benefits
|
(
|
(
|
(
|
||
|
Gains/(losses) on disposals of financial assets
|
|
(
|
|
||
|
Net interest expense on lease liabilities
|
(
|
(
|
(
|
||
|
Other
(e)
|
(
|
(
|
|
||
|
Net financial income/(expenses)
|
(
|
(
|
(
|
||
|
comprising: Financial expenses
|
(
|
(
|
(
|
||
|
Financial income
|
|
|
|
operation.
2022
.
€
68
million
in
2022
.
Beyfortus sales in the US. In
2023
, that expense amounted to €
541
million, reflecting the successful launch of Beyfortus (see Note C.2.).
Sanofi has elected for tax consolidations in a number of countries, principally France, Germany, the United Kingdom and the
United States.
|
(€ million)
|
2024
|
2023
|
(a)
|
2022
|
(a)
|
|
Current taxes
|
(
|
(
|
(
|
||
|
Deferred taxes
|
|
|
|
||
|
Total
|
(
|
(
|
(
|
||
|
Income before tax and investments accounted for using the equity method
|
|
|
|
operation.
|
F-92
|
SANOFI
FORM 20-F
2024
|
|
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
|
follows:
|
(%)
|
2024
|
2023
|
(a)
|
2022
|
(a)
|
|
Standard tax rate applicable in France
|
|
|
|
||
|
Difference between the standard French tax rate and the rates applicable to Sanofi
(b)
|
(
|
(
|
(
|
||
|
Revisions to tax exposures and settlements of tax disputes
|
|
|
(
|
||
|
Fair value remeasurement of contingent consideration
|
|
|
(
|
||
|
Other items
(c)
|
|
|
|
||
|
Effective tax rate
|
|
|
|
operation.
countries, most of which have lower tax rates than France. For the year ended December 31, 2024, this line includes a tax expense of
€
58
million
,
representing the estimated impact of Pillar Two based on Sanofi’s current understanding of Pillar Two rules.
(c)
In determining the amount of the deferred tax liability for
2024
,
2023
and
2022
, Sanofi took into account changes in the ownership structure of certain
For the periods presented, the amount of deferred tax assets recognized in profit or loss that were initially subject to impairment
losses at the time of a business combination is immaterial.
The line item
Share of profit/(loss) from investments accounted for using the equity method
showed net income of
€
60
million in 2024 (after charging an impairment loss of
€
77
million
on the equity-accounted investment in EUROAPI – see Note
D.6.), compared with a net loss of €
136
million for 2023
and a net gain of €
55
million for 2022.
Figures for comparative periods (2023 and 2022) have been re-presented on a consistent basis to reflect the classification of
Opella as a discontinued operation.
|
(€ million)
|
2024
|
2023
|
2022
|
|
Share of net income attributable to non-controlling interests
|
|
|
|
|
Total
|
|
|
|
The principal related parties are companies over which Sanofi has control or significant influence, joint ventures, key
management personnel, and principal shareholders.
Sanofi has not entered into any material transactions with any key management personnel. Financial relations with Sanofi’s
principal shareholders fall within the ordinary course of business and were immaterial in the years ended
December 31, 2024
,
2023
and
2022
.
Note F.1. lists the principal companies controlled by Sanofi; those companies are fully consolidated, as described in Note B.1.
Transactions between those companies, and between the parent company and its subsidiaries, are eliminated when preparing
the consolidated financial statements.
Transactions with companies over which Sanofi has significant influence, and with joint ventures, are presented in Note D.6.
Key management personnel include corporate officers and the members of the Executive Committee (an average of
13
m
embers
in
2024
,
10
in
2023
and
11
in
2022
).
|
(€ million)
|
2024
|
2023
|
2022
|
|
Short-term benefits
(a)
|
|
|
|
|
Post-employment benefits
|
|
|
|
|
Share-based payment
|
|
|
|
|
Total recognized in profit or loss
|
|
|
|
obligations).
|
SANOFI
FORM 20-F
2024
|
F-93
|
|
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
|
held executive positions within Sanofi during that period.
|
(€ million)
|
2024
|
2023
|
2022
|
|
Aggregate top-up pension obligation in favor of certain corporate officers and of
Executive Committee members
|
|
|
|
|
Aggregate termination benefits and lump-sum retirement benefits in favor of key
management personnel
|
|
|
|
D.34.1. Analysis of net sales
|
(€ million)
|
Europe
|
United
States
|
Other
countries
|
2024
|
Europe
|
United
States
|
Other
countries
|
2023
(a)
|
Europe
|
United
States
|
Other
countries
|
2022
(a)
|
|
|
Total Group
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Immunology
|
|||||||||||||
|
of which
|
Dupixent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Rare diseases
|
|||||||||||||
|
of which
|
ALTUVIIIO
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nexviazyme
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cablivi
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Xenpozyme
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Enjaymo
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Neurology
|
|||||||||||||
|
of which
|
Aubagio
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Oncology
|
|||||||||||||
|
of which
|
Sarclisa
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other medicines
|
|||||||||||||
|
of which
|
Rezurock
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Tzield
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Industrial sales
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vaccines
|
|||||||||||||
|
of which
|
Influenza
Vaccines
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Polio/Pertussis/
Hib Vaccines
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
RSV vaccines
(Beyfortus)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Meningitis, travel
and endemics
vaccines
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Of which total launches
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
F-94
|
SANOFI
FORM 20-F
2024
|
|
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
|
D.34.2. Other revenues
|
(€ million)
|
2024
|
2023
(a)
|
2022
(a)
|
|
VaxServe sales of non-Sanofi products
|
|
|
|
|
COVID-19 vaccine related revenues
|
|
|
|
|
Intragroup sales from continuing to discontinued operations
(b)
|
|
|
|
|
Royalties
|
|
|
|
|
Other
(c)
|
|
|
|
|
Total Biopharma Other revenues
|
|
|
|
|
Sales / Revenues from Opella products
(d)
|
|
|
|
|
Total Other revenues
|
|
|
|
operation.
within the scope of discontinued operations.
Opella products in China, the transfer of which will be finalized no earlier than 2028 after a transitional period required to complete the transfer plan
agreed with Sanofi in the context of public tendering arrangements ; (ii) sales made by the dedicated entity Opella Russie, the equity interests in which
will be retained by Sanofi. Sanofi will continue to distribute Opella products in Russian territory under the distribution agreement signed in connection
with the separation, the parties reserving the right to discuss the transfer of this retained interest during the distribution agreement term ; and (iii) sales
of the Gold Bond product range, which are continuing in the United States through the retained subsidiary Gold Bond LLC (holder of the associated
worldwide property rights).
Sanofi reports segment information for the Biopharma operating segment, further to the opening of exclusive negotiations
between Sanofi and Clayton, Dubilier & Rice (CD&R) on October 21, 2024 with a view to selling an equity interest in Opella, which
would lead to loss of control over Opella on the effective closing date, scheduled for the second quarter of 2025 at the earliest.
Prior to the opening of those exclusive negotiations, Opella (formerly Consumer Healthcare) was an operating segment of Sanofi.
As a result of the announcement of the Proposed Opella Transaction (
as defined in Note D.1.1.2. Project to divest a controlling
interest in Opella)
, as of the fourth quarter of 2024 Opella meets the criteria for a discontinued operation under IFRS 5 (
see Note
B.7
.), and the net income from this business is now presented separately within the line item
Net income from discontinued
operations
in the consolidated income statement. This presentation in a separate line item in the income statement applies to
results of operations for the current period, and for the comparative periods presented. With effect from that date, Sanofi
became a dedicated Biopharma company of which the performance, based on internal management reporting, is subject to
regular review by the Chief Executive Officer, Sanofi's chief operating decision-maker.
The Biopharma operating segment comprises commercial operations and research, development and production activities
relating to the Specialty Care, General Medicines and Vaccines franchises plus support and corporate functions, for all
geographical territories. It also includes revenues generated by legal entities within the Biopharma segment (and included in the
scope of continuing operations) from the manufacture of Consumer Healthcare products on behalf of legal entities within Opella;
those revenues are presented within
Other Revenues
in the income statement. The Biopharma operating segment also includes
the the purchase price of Biopharma products manufactured by legal entities within the Opella scope.
The “Other” category comprises primarily, but not exclusively, Consumer Healthcare activities that will not be transferred on the
effective date of loss of control of Opella. These are primarily (i) hospital sales of Opella products in China, the transfer of which
will be finalized no earlier than 2028 after a transitional period required to complete the transfer plan agreed with Sanofi in the
context of public tendering arrangements ; (ii) sales made by the dedicated entity Opella Russie, the equity interests in which will
be retained by Sanofi. Sanofi will continue to distribute Opella products in Russian territory under the distribution agreement
signed in connection with the separation, the parties reserving the right to discuss the transfer of this retained interest during the
distribution agreement term
; and (iii) sales of the Gold Bond product range, which are continuing in the United States through
the retained subsidiary Gold Bond LLC (holder of the associated worldwide property rights).
Figures for comparative periods (2023 and 2022) have been re-presented on a consistent basis to reflect the classification of
Opella as a discontinued operation.
|
SANOFI
FORM 20-F
2024
|
F-95
|
|
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
|
D.35.1. Segment results
Sanofi reports segment results on the basis of “Business operating income”. This indicator is used internally by Sanofi’s chief operating
decision maker to measure the performance of the operating segment and to allocate resources.
“Business operating income” is derived from
Operating income
, adjusted as follows:
•
amortization and impairment losses charged against intangible assets (other than software and other rights of an industrial or
operational nature), are eliminated;
•
fair value remeasurements of contingent consideration relating to business combinations (IFRS 3) or business divestments,
and presented within the line item
Fair value remeasurement of contingent consideration
, are eliminated;
•
expenses arising from the remeasurement of inventories following business combinations (IFRS 3) or acquisitions of groups of
assets that do not constitute a business within the meaning of paragraph 2b of IFRS 3, are eliminated;
•
amounts reported within the line items
Restructuring costs and similar items
are eliminated;
•
other gains and losses including gains and losses on major divestments, presented within the line item
Other gains and losses,
and litigation
, are eliminated;
•
other costs and provisions related to litigation, presented within the line item
Other gains and losses, and litigation
, are
eliminated;
•
the share of profits/losses from investments accounted for using the equity method is added, to the extent that this relates
to joint ventures and associates with which Sanofi has a strategic alliance; and
•
the portion of business operating income net of tax attributable to non-controlling interests is deducted; and
•
net income attributable to non-controlling interests related to continuing operations and excluding the effects of the above
reconciliation items, is deducted.
2022
:
|
2024
|
|||||||||
|
(€ million)
|
Biopharma
|
Other
|
Total
|
||||||
|
2024
|
Change
vs. 2023
on a
reported
basis
(IFRS)
|
Change
vs. 2023
at
constant
exchange
rates
(non-
IFRS)
|
2024
|
Change
vs. 2023
on a
reported
basis
(IFRS)
|
Change
vs. 2023
at
constant
exchange
rates
(non-
IFRS)
|
2024
|
Change
vs. 2023
on a
reported
basis
(IFRS)
|
Change
vs. 2023
at
constant
exchange
rates
(non-
IFRS)
|
|
|
Net sales
|
|
8.6%
|
11.3%
|
|
|
8.6%
|
11.3%
|
||
|
Other revenues
|
|
(18.2%)
|
(16.3%)
|
|
14.5%
|
23.3%
|
|
(15.7%)
|
(13.3%)
|
|
Cost of sales
|
(
|
4.5%
|
5.7%
|
(
|
8.8%
|
20.1%
|
(
|
4.6%
|
6.0%
|
|
Research and development expenses
|
(
|
13.7%
|
14.6%
|
(
|
(50.0%)
|
(50.0%)
|
(
|
13.6%
|
14.6%
|
|
Selling and general expenses
|
(
|
2.9%
|
4.6%
|
(
|
(11.4%)
|
(3.8%)
|
(
|
2.8%
|
4.5%
|
|
Other operating income and expenses
|
(
|
|
(
|
||||||
|
Share of profit/(loss) from investments
accounted for using the equity method
|
|
|
|
||||||
|
Net income attributable to non-controlling
interests
|
(
|
|
(
|
||||||
|
Business operating income
|
|
1.2%
|
7.3%
|
|
152.2%
|
160.9%
|
|
1.5%
|
7.6%
|
|
As % of net sales
|
27.5%
|
27.6%
|
|||||||
|
2023
(a)
|
|||
|
(€ million)
|
Biopharma
|
Other
|
Total
|
|
Net sales
|
|
|
|
|
Other revenues
|
|
|
|
|
Cost of sales
|
(
|
(
|
(
|
|
Research and development expenses
|
(
|
(
|
(
|
|
Selling and general expenses
|
(
|
(
|
(
|
|
Other operating income and expenses
|
(
|
|
(
|
|
Share of profit/(loss) from investments accounted for using the equity method
|
|
|
|
|
Net income attributable to non-controlling interests
|
(
|
|
(
|
|
Business operating income
|
|
|
|
(a)
Figures for the comparative period (2023) have been re-presented on a consistent basis to reflect the classification of Opella as a discontinued
operation.
|
F-96
|
SANOFI
FORM 20-F
2024
|
|
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
|
|
2022
(a)(b)
|
|||
|
(€ million)
|
Biopharma
|
Other
|
Total
|
|
Net sales
|
|
|
|
|
Other revenues
|
|
|
|
|
Cost of sales
|
(
|
(
|
(
|
|
Research and development expenses
|
(
|
(
|
(
|
|
Selling and general expenses
|
(
|
(
|
(
|
|
Other operating income and expenses
|
(
|
|
(
|
|
Share of profit/(loss) from investments accounted for using the equity method
|
|
|
|
|
Net income attributable to non-controlling interests
|
(
|
|
(
|
|
Business operating income
|
|
|
|
operation.
transaction (€
706
million
net of tax).
for the segment and
Income before tax and investments accounted for using the equity method
:
|
(€ million)
|
2024
|
2023
(a)
|
2022
(a)(h)
|
|
Business operating income
|
|
|
|
|
Share of profit/(loss) from investments accounted for using the equity method
(b)
|
(
|
(
|
(
|
|
Net income attributable to non-controlling interests
(c)
|
|
|
|
|
Amortization and impairment of intangible assets
(d)
|
(
|
(
|
(
|
|
Fair value remeasurement of contingent consideration
|
(
|
(
|
|
|
Expenses arising from the impact of acquisitions on inventories
(e)
|
(
|
(
|
(
|
|
Restructuring costs and similar items
(f)
|
(
|
(
|
(
|
|
Other gains and losses, and litigation
(g)
|
(
|
(
|
(
|
|
Operating income
|
|
|
|
|
Financial expenses
|
(
|
(
|
(
|
|
Financial income
|
|
|
|
|
Income before tax and investments accounted for using the equity method
|
|
|
|
operation.
research and development projects – including a
€
239
million
loss resulting from the decision taken in February 2025 to discontinue a phase 3 clinical
study investigating of a vaccine candidate to prevent invasive E.coli disease - partially offset by impairment losses reversals
, recognized in connection
with the disposals of the ProXTen platform and Enjaymo, for €
225
million and €
167
million respectively. For 2023, this amount mainly comprises an
impairment loss of
€
833
million
, reflecting the impact of the strategic decision to de-prioritize certain R&D programs, in particular those related to the
NK Cell and ProXTen technology platforms. For 2022, this line includes a reversal of
€
2,154
million
on Eloctate franchise products following FDA
approval of ALTUVIIIO
on February 22, 2023, partially offset by an impairment loss of
€
1,586
million
on intangible assets relating to SAR444245 (non-
alpha interleukin-2).
(h)
2022 business operating income has been recast from the amount previously reported to include the one-time income of
€
952
million from the Libtayo
D.35.2. Other segment information
Figures for comparative periods (2023 and 2022) have been re-presented on a consistent basis to reflect the classification of
Opella as a discontinued operation.
The tables below show the split by operating segment of (i) the carrying amount of investments accounted for using the equity
method with which Sanofi has entered into a strategic alliance, (ii) acquisitions of property, plant and equipment, and
(iii) acquisitions of intangible assets.
The principal investments accounted for using the equity method in the Biopharma segment are the interests in MSP Vaccine
Company, and Infraserv GmbH & Co. Höchst KG (see Note D.6.).
|
SANOFI
FORM 20-F
2024
|
F-97
|
|
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
|
|
Biopharma
|
|||
|
(€ million)
|
2024
|
2023
|
2022
|
|
Investments accounted for using the equity method
(a)
|
|
|
|
|
Acquisitions of property, plant and equipment
|
|
|
|
|
Acquisitions of other intangible assets
|
|
|
|
D.35.3. Information by geographical region
with IFRS 8, the non-current assets reported below exclude right-of-use assets relating to leases as determined under IFRS 16,
investments accounted for using the equity method, other non-current assets, non-current income tax assets, and deferred tax
assets.
|
2024
|
|||||
|
(€ million)
|
Total
|
Europe
|
of which
France
|
United States
|
Other
countries
|
|
Net sales
|
|
|
|
|
|
|
Non-current assets:
|
|||||
|
•
property, plant and equipment owned
|
|
|
|
|
|
|
•
goodwill
|
|
|
|
|
|
|
▪
other intangible assets
|
|
|
|
|
|
|
(€ million)
|
2023
|
||||
|
Total
|
Europe
|
of which
France
|
United States
|
Other
countries
|
|
|
Net sales
(a)
|
|
|
|
|
|
|
Non-current assets:
|
|||||
|
•
property, plant and equipment owned
|
|
|
|
|
|
|
•
goodwill
|
|
|
|
|
|
|
•
other intangible assets
|
|
|
|
|
|
|
(€ million)
|
2022
|
||||
|
Total
|
Europe
|
of which
France
|
United States
|
Other
countries
|
|
|
Net sales
(a)
|
|
|
|
|
|
|
Non-current assets:
|
|||||
|
•
property, plant and equipment owned
|
|
|
|
|
|
|
•
goodwill
|
|
|
|
|
|
|
•
other intangible assets
|
|
|
|
|
|
As stated in Note D.5., goodwill is not allocated by geographical region.
D.35.4. Disclosures about major customers
Sales generated by Sanofi with its biggest customers, in particular certain wholesalers in the United States, represented
34
%
of
net sales in
2024
. The three largest customers respectively accounted for approximately
15
%
,
11
%
and
8
%
of Sanofi's net sales
in
2024
(
13
%
,
10
%
and
8
%
in
2023
;
13
%
,
9
%
and
8
%
in
2022
).
|
F-98
|
SANOFI
FORM 20-F
2024
|
|
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
|
In accordance with IFRS 5 (see Notes B.7. and D.1.), all assets of Opella and all liabilities directly related to those assets are
classified as of December 31, 2024 within the line items
Assets held for sale
and
Liabilities related to assets held for sale
,
respectively, in the consolidated balance sheet as of that date (see Note D.8.).
An analysis of those line items is provided below:
|
(€ million)
|
2024
|
|
Assets
|
|
|
Property, plant and equipment owned
|
|
|
Right-of-use assets
|
|
|
Goodwill
|
|
|
Other intangible assets
|
|
|
Inventories
|
|
|
Accounts receivable
|
|
|
Other assets
|
|
|
Total assets held for sale
|
|
|
Liabilities
|
|
|
Llease liabilities
|
|
|
Non-current provisions and other non-current liabilities
|
|
|
Accounts payable
|
|
|
Current provisions and other current liabilities
|
|
|
Other liabilities
|
|
|
Total liabilities related to assets held for sale
|
|
In accordance with IFRS 5, the Opella held for sale asset group, and the related liabilities, have been measured at the lower of
carrying amount and fair value less costs to sell. This valuation did not result in the recognition of any impairment.
The table below details the main items presented within
Net income from discontinued operations
:
|
(€ million)
|
2024
|
2023
|
2022
|
|
Net sales
|
|
|
|
|
Operating income
|
|
|
|
|
Income before tax and investments accounted for using the equity method
|
|
|
|
|
Income tax expense
|
(
|
(
|
(
|
|
Net income from discontinued operations (Opella)
|
|
|
|
Net income from the Opella discontinued operation was
€
274
million
lower in 2024 than in 2023. This year-on-year change
reflects in particular the acceleration in 2024 of the transformational project to create the standalone Opella entity - transaction
costs incurred in 2024 in respect of the proposed Opella transfer - and changes in gains from asset divestments within the Opella
scope between the two periods.
In addition, net income from the Opella discontinued operation for the year ended December 31, 2024 includes a net tax expense
of
€
122
million
relating to the tax cost of the legal restructuring of the Opella scope. For the year ended December 31, 2023, net
income from the Opella discontinued operation includes a
€
365
million
deferred tax liability recognized in respect of investments
in consolidated entities in light of the proposed separation of the Opella business.
(Earnings per Share):
|
(€ million)
|
2024
|
2023
|
2022
|
|
Net income from discontinued operations (Opella)
|
|
|
|
|
Average number of shares outstanding (million)
|
|
|
|
|
Average number of shares after dilution (million)
|
|
|
|
|
Basic earnings per share (in euros)
|
|
|
|
|
Diluted earnings per share (in euros)
|
|
|
|
|
SANOFI
FORM 20-F
2024
|
F-99
|
|
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
|
Off balance sheet commitments relating to Opella operating activities break down as follows:
|
December 31, 2024
|
Payments due by period
|
||||
|
(€ million)
|
Total
|
Less than
1 year
|
1 to 3 years
|
3 to 5 years
|
More than
5 years
|
|
Irrevocable purchase commitments
|
|
|
|
|
|
|
•
given
|
|
|
|
|
|
|
•
received
|
(
|
(
|
|
|
|
|
Research and development license agreements -
commitments given
|
|
|
|
|
|
|
Total
|
|
|
|
|
|
PricewaterhouseCoopers Audit and Forvis Mazars SA served as independent auditors of Sanofi for the year ended
December 31,
2024
, and PricewaterhouseCoopers Audit and Ernst & Young in 2023.
The table below shows fees charged by those firms and
member firms of their networks to Sanofi and consolidated subsidiaries in the years ended
December 31, 2024
and
2023
.
|
Forvis Mazars
|
PricewaterhouseCoopers
|
Ernst & Young
|
||||||
|
2024
|
2024
|
2023
|
2023
|
|||||
|
(€ million)
|
Amount
|
%
|
Amount
|
%
|
Amount
|
%
|
Amount
|
%
|
|
Statutory audit of separate and
consolidated financial statements
(a)
|
|
|
|
|
|
|
|
|
|
Limited review of sustainability
statement
(b)
|
|
|
|
|
|
|
|
|
|
Services other than statutory audit
(c)
|
|
|
|
|
|
|
|
|
|
Audit-related services
(d)(e)
|
|
|
|
|
||||
|
Tax
|
|
|
|
|
||||
|
Other
|
|
|
|
|
||||
|
Total
|
|
|
|
|
|
|
|
|
PricewaterhouseCoopers Audit
€
12.5
million
in
2024
,
€
8.3
million
in
2023
and Ernst & Young
€
7.9
million
in
2023
.
- assurance engagements, agreed-upon procedures, tax compliance work and technical consultancy.
Services other than statutory audit provided by PricewaterhouseCoopers during
2024
comprised:
- contractual audits, including on the combined financial statements of the Opella business;
- additional procedures to enable reports previously signed by the firm to be incorporated by reference; and
- assurance engagements, agreed-upon procedures, tax compliance work and technical consultancy.
PricewaterhouseCoopers Audit
€
3.5
million
in
2024
,
€
3.6
million
in
2023
and Ernst & Young
€
5.2
million
in
2023
.
(which qualify as audit fees under SEC rules).
|
F-100
|
SANOFI
FORM 20-F
2024
|
|
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
|
of consolidation during
2024
F.1. Principal fully consolidated companies
|
Europe
|
Financial interest (%) as of
December 31, 2024
|
|
|
Hoechst GmbH *
|
Germany
|
|
|
Sanofi-Aventis Deutschland GmbH
|
Germany
|
|
|
A. Nattermann & Cie GmbH
|
Germany
|
|
|
Sanofi-Aventis GmbH
|
Austria
|
|
|
Sanofi Belgium
|
Belgium
|
|
|
Ablynx NV
|
Belgium
|
|
|
Genzyme Flanders BV
|
Belgium
|
|
|
Sanofi A/S
|
Denmark
|
|
|
Sanofi-Aventis SA
|
Spain
|
|
|
Opella Healthcare Spain, SL
|
Spain
|
|
|
Sanofi Oy
|
Finland
|
|
|
Sanofi
|
France
|
|
|
Sanofi Winthrop Industrie *
|
France
|
|
|
Sanofi-Aventis Recherche & Développement
|
France
|
|
|
Sanofi-Aventis Groupe
|
France
|
|
|
Sanofi-Aventis Participations *
|
France
|
|
|
Sanofi Pasteur
|
France
|
|
|
Aventis Pharma SA
|
France
|
|
|
Aventis Agriculture
|
France
|
|
|
Sanofi Biotechnology *
|
France
|
|
|
Sanofi Pasteur NVL
|
France
|
|
|
Sanofi Pasteur Europe
|
France
|
|
|
Opella Healthcare
|
France
|
|
|
Sanofi Pasteur Merieux SAS
|
France
|
|
|
Opella Healthcare International SAS
|
France
|
|
|
Opella Healthcare France SAS
|
France
|
|
|
Opella Healthcare Group SAS
|
France
|
|
|
Genzyme Polyclonals SAS
|
France
|
|
|
Sanofi-Aventis AEBE
|
Greece
|
|
|
Sanofi-Aventis Private Co Ltd
|
Hungary
|
|
|
Chinoin Private Co Ltd
|
Hungary
|
|
|
Opella Healthcare Hungary Commercial KFT
|
Hungary
|
|
|
Opella Healthcare Hungary KFT
|
Hungary
|
|
|
Carraig Insurance DAC
|
Ireland
|
|
|
Genzyme Ireland Limited
|
Ireland
|
|
|
Sanofi-Aventis Ireland Ltd
|
Ireland
|
|
|
Sanofi-aventis Holdings (Ireland) Ltd
|
Ireland
|
|
|
Sanofi SRL
|
Italy
|
|
|
Opella Healthcare Italy SRL
|
Italy
|
|
|
Genzyme Global Sarl
|
Luxembourg
|
|
|
Genzyme Luxembourg Sarl
|
Luxembourg
|
|
|
Le Rock Re
|
Luxembourg
|
|
|
Sanofi-aventis Norge AS
|
Norway
|
|
|
Sanofi BV *
|
Netherlands
|
|
|
Sanofi Foreign Participations BV *
|
Netherlands
|
|
|
SANOFI
FORM 20-F
2024
|
F-101
|
|
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
|
|
Europe
|
Financial interest (%) as of
December 31, 2024
|
|
|
Opella Healthcare Participation BV
|
Netherlands
|
|
|
Sanofi-Aventis Sp zoo
|
Poland
|
|
|
Opella Healthcare Poland sp.ZOO
|
Poland
|
|
|
Sanofi Produtos Farmaceuticos Lda
|
Portugal
|
|
|
Sanofi sro
|
Czech Republic
|
|
|
Sanofi Romania SRL
|
Romania
|
|
|
Opella Healthcare Romania SRL
|
Romania
|
|
|
Sanofi-Aventis UK Holdings Limited
|
United Kingdom
|
|
|
Aventis Pharma Limited
|
United Kingdom
|
|
|
Sanofi-Synthelabo UK Ltd
|
United Kingdom
|
|
|
Aventis Pharma Holdings Ltd
|
United Kingdom
|
|
|
Opella Healthcare UK Limited
|
United Kingdom
|
|
|
AO Sanofi Russia
|
Russia
|
|
|
Opella Healthcare LLC
|
Russia
|
|
|
Sanofi AB
|
Sweden
|
|
|
Sanofi-Aventis (Suisse) SA
|
Switzerland
|
|
|
Genzyme Global Sarl Baar Intellectual Property Branch
|
Switzerland
|
|
|
Sanofi Ilac Sanayi ve Ticaret AS
|
Turkey
|
|
|
Sanofi Pasteur Asi Ticaret AS
|
Turkey
|
|
|
Opella Healthcare Tüketici Sağlığı Anonim Şirketi
|
Turkey
|
|
|
Sanofi Saglik Urunleri Limited Sirketi
|
Turkey
|
|
|
United States
|
Financial interest (%) as of
December 31, 2024
|
|
|
Genzyme Therapeutic Products Limited Partnership
|
United States
|
|
|
Aventis Inc *
|
United States
|
|
|
Sanofi US Services Inc
|
United States
|
|
|
Sanofi-Aventis U.S. LLC
|
United States
|
|
|
Chattem, Inc
|
United States
|
|
|
Aventisub LLC
|
United States
|
|
|
Genzyme Corporation *
|
United States
|
|
|
Sanofi Pasteur Inc *
|
United States
|
|
|
VaxServe, Inc
|
United States
|
|
|
Bioverativ Inc
|
United States
|
|
|
Bioverativ U.S.LLC
|
United States
|
|
|
Bioverativ USA Inc
|
United States
|
|
|
Bioverativ Therapeutics Inc
|
United States
|
|
|
Principia Biopharma Inc
|
United States
|
|
|
Sanofi Ventures LLC
|
United States
|
|
|
Sanofi Bioverativ Holdings LLC
|
United States
|
|
|
RPR US Ltd
|
United States
|
|
|
Kadmon Pharmaceuticals LLC
|
United States
|
|
|
Kadmon Corporation, LLC
|
United States
|
|
|
Synthorx, Inc
|
United States
|
|
|
Provention Bio
|
United States
|
|
|
QRIB Intermediate Holding
|
United States
|
|
|
QRI
|
United States
|
|
|
Gold Bond Co LLC
|
United States
|
|
|
Chattem (GB) Holding
|
United States
|
|
|
Sanofi AATD, Inc
|
United States
|
|
|
Translate Bio, Inc
|
United States
|
|
|
F-102
|
SANOFI
FORM 20-F
2024
|
|
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
|
|
Other Countries
|
Financial interest (%) as of
December 31, 2024
|
|
|
Sanofi-Aventis South Africa (Pty) Ltd
|
South Africa
|
|
|
Sanofi-Aventis Algérie
|
Algeria
|
|
|
Sanofi Arabia Trading Company Limited
|
Saudi Arabia
|
|
|
Sanofi-Aventis Argentina SA
|
Argentina
|
|
|
Opella Healthcare Argentina SAU
|
Argentina
|
|
|
Genzyme de Argentina SA
|
Argentina
|
|
|
Sanofi-Aventis Healthcare Pty Ltd
|
Australia
|
|
|
Sanofi-Aventis Australia Pty Ltd
|
Australia
|
|
|
Sanofi Medley Farmaceutica Ltda
|
Brazil
|
|
|
Opella Healthcare Brazil Ltda
|
Brazil
|
|
|
Sanofi-Aventis Canada Inc
|
Canada
|
|
|
Sanofi Pasteur Limited
|
Canada
|
|
|
Merieux Canada Holdings ULC (Canada)
|
Canada
|
|
|
Sanofi Vaccines Chile SA
|
Chile
|
|
|
Sanofi (Hangzhou) Pharmaceuticals Co Ltd
|
China
|
|
|
Opella Healthcare Shanghai LTD
|
China
|
|
|
Sanofi (China) Investment Co Ltd
|
China
|
|
|
Sanofi (Beijing) Pharmaceuticals Co Ltd
|
China
|
|
|
Sanofi (Jiangsu) Biologics Co Ltd
|
China
|
|
|
Shenzhen Sanofi pasteur Biological Products Co Ltd
|
China
|
|
|
Shanghai Rongheng Pharmaceutical Co Ltd
|
China
|
|
|
Opella Healthcare Colombia SAS
|
Colombia
|
|
|
Sanofi-Aventis de Colombia SA
|
Colombia
|
|
|
Sanofi-Aventis Korea Co Ltd
|
South Korea
|
|
|
Sanofi-Aventis Gulf FZE
|
United Arab Emirates
|
|
|
Sanofi Egypt
|
Egypt
|
|
|
Sanofi Hong-Kong Limited
|
Hong Kong
|
|
|
Sanofi India Limited
|
India
|
|
|
Sanofi Healthcare India Private Limited
|
India
|
|
|
Sanofi-Aventis Israël Ltd
|
Israel
|
|
|
Sanofi KK
|
Japan
|
|
|
SSP Co Ltd
|
Japan
|
|
|
Sanofi-Aventis (Malaysia) SDN BHD
|
Malaysia
|
|
|
Sanofi-Aventis Maroc
|
Morocco
|
|
|
Sanofi-Aventis de Mexico SA de CV
|
Mexico
|
|
|
Sanofi Pasteur SA de CV
|
Mexico
|
|
|
Azteca Vacunas SA de CV
|
Mexico
|
|
|
Sanofi-Aventis de Panama SA
|
Panama
|
|
|
Opella Healthcare Panama SA
|
Panama
|
|
|
sanofi-aventis Puerto Rico Inc
|
Puerto Rico
|
|
|
Sanofi-Aventis Philippines Inc
|
Philippines
|
|
|
Opella Healthcare Philippines Inc
|
Philippines
|
|
|
Sanofi-Aventis Singapore Pte Ltd *
|
Singapore
|
|
|
Aventis Pharma (Manufacturing) Pte Ltd
|
Singapore
|
|
|
Sanofi Manufacturing Pte Ltd
|
Singapore
|
|
|
Sanofi Taiwan Co Ltd
|
Taiwan
|
|
|
Sanofi-Aventis (Thailand) Ltd
|
Thailand
|
|
|
Sanofi-Aventis de Venezuela SA
|
Venezuela
|
|
|
Sanofi-aventis Vietnam Company Limited
|
Vietnam
|
|
|
Sanofi Vietnam Shareholding Company Limited
|
Vietnam
|
|
|
SANOFI
FORM 20-F
2024
|
F-103
|
|
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
|
F.2. Principal investments accounted for using the equity method
|
Financial interest (%) as of
December 31, 2024
|
||
|
Haleon US, LP
|
United States
|
|
|
Infraserv GmbH & Co. Höchst KG
|
Germany
|
|
|
Maphar
|
Morocco
|
|
|
MCM Vaccine BV
|
Netherlands
|
|
|
MSP Vaccine Company (formerly MCM company)
|
United States
|
|
|
EUROAPI
|
France
|
|
During the meeting of the Board of Directors on January 29, 2025, the Board authorized Sanofi to repurchase the Company's
shares, for an amount not exceeding
€
5
billion
, under the terms and conditions set by the General Meeting of April 30, 2024 in its
19th resolution.
As part of this authorization, Sanofi entered into a share buyback agreement with its historical shareholder L'Oréal on February 2,
2025 for the acquisition of 2.34% of its share capital, or the equivalent of
29,556,650
shares
, for a total amount of approximately
€
3
billion
, representing a price of
€
101.50
per share. The conclusion of this agreement was approved by the Board of Directors on
the same day prior to the signing of said agreement and in accordance with the procedure of Articles L. 225-38 et seq. of the
French Commercial Code. In addition, on February 6, 2025, Sanofi entered into a mandate with an investment services provider
|
F-104
|
SANOFI
FORM 20-F
2024
|
|
Notes
|
|
.................................................................................................................................................................................................................................................................
|
|
.................................................................................................................................................................................................................................................................
|
|
.................................................................................................................................................................................................................................................................
|
|
.................................................................................................................................................................................................................................................................
|
|
.................................................................................................................................................................................................................................................................
|
|
.................................................................................................................................................................................................................................................................
|
|
.................................................................................................................................................................................................................................................................
|
|
.................................................................................................................................................................................................................................................................
|
|
.................................................................................................................................................................................................................................................................
|
|
.................................................................................................................................................................................................................................................................
|
|
.................................................................................................................................................................................................................................................................
|
|
.................................................................................................................................................................................................................................................................
|
|
.................................................................................................................................................................................................................................................................
|
|
.................................................................................................................................................................................................................................................................
|
|
.................................................................................................................................................................................................................................................................
|
|
.................................................................................................................................................................................................................................................................
|
|
.................................................................................................................................................................................................................................................................
|
|
.................................................................................................................................................................................................................................................................
|
|
.................................................................................................................................................................................................................................................................
|
|
.................................................................................................................................................................................................................................................................
|
|
.................................................................................................................................................................................................................................................................
|
|
.................................................................................................................................................................................................................................................................
|
|
.................................................................................................................................................................................................................................................................
|
|
.................................................................................................................................................................................................................................................................
|
|
.................................................................................................................................................................................................................................................................
|
|
.................................................................................................................................................................................................................................................................
|
|
.................................................................................................................................................................................................................................................................
|
|
.................................................................................................................................................................................................................................................................
|
|
.................................................................................................................................................................................................................................................................
|
|
.................................................................................................................................................................................................................................................................
|
|
SANOFI
FORM 20-F
2024
|
F-105
|
|
Notes
|
|
.................................................................................................................................................................................................................................................................
|
|
.................................................................................................................................................................................................................................................................
|
|
.................................................................................................................................................................................................................................................................
|
|
.................................................................................................................................................................................................................................................................
|
|
.................................................................................................................................................................................................................................................................
|
|
.................................................................................................................................................................................................................................................................
|
|
.................................................................................................................................................................................................................................................................
|
|
.................................................................................................................................................................................................................................................................
|
|
.................................................................................................................................................................................................................................................................
|
|
.................................................................................................................................................................................................................................................................
|
|
.................................................................................................................................................................................................................................................................
|
|
.................................................................................................................................................................................................................................................................
|
|
.................................................................................................................................................................................................................................................................
|
|
.................................................................................................................................................................................................................................................................
|
|
.................................................................................................................................................................................................................................................................
|
|
.................................................................................................................................................................................................................................................................
|
|
.................................................................................................................................................................................................................................................................
|
|
.................................................................................................................................................................................................................................................................
|
|
.................................................................................................................................................................................................................................................................
|
|
.................................................................................................................................................................................................................................................................
|
|
.................................................................................................................................................................................................................................................................
|
|
.................................................................................................................................................................................................................................................................
|
|
.................................................................................................................................................................................................................................................................
|
|
.................................................................................................................................................................................................................................................................
|
|
.................................................................................................................................................................................................................................................................
|
|
.................................................................................................................................................................................................................................................................
|
|
.................................................................................................................................................................................................................................................................
|
|
.................................................................................................................................................................................................................................................................
|
|
.................................................................................................................................................................................................................................................................
|
|
.................................................................................................................................................................................................................................................................
|
|
F-106
|
SANOFI
FORM 20-F
2024
|
|
Notes
|
|
.................................................................................................................................................................................................................................................................
|
|
.................................................................................................................................................................................................................................................................
|
|
.................................................................................................................................................................................................................................................................
|
|
.................................................................................................................................................................................................................................................................
|
|
.................................................................................................................................................................................................................................................................
|
|
.................................................................................................................................................................................................................................................................
|
|
.................................................................................................................................................................................................................................................................
|
|
.................................................................................................................................................................................................................................................................
|
|
.................................................................................................................................................................................................................................................................
|
|
.................................................................................................................................................................................................................................................................
|
|
.................................................................................................................................................................................................................................................................
|
|
.................................................................................................................................................................................................................................................................
|
|
.................................................................................................................................................................................................................................................................
|
|
.................................................................................................................................................................................................................................................................
|
|
.................................................................................................................................................................................................................................................................
|
|
.................................................................................................................................................................................................................................................................
|
|
.................................................................................................................................................................................................................................................................
|
|
.................................................................................................................................................................................................................................................................
|
|
.................................................................................................................................................................................................................................................................
|
|
.................................................................................................................................................................................................................................................................
|
|
.................................................................................................................................................................................................................................................................
|
|
.................................................................................................................................................................................................................................................................
|
|
.................................................................................................................................................................................................................................................................
|
|
.................................................................................................................................................................................................................................................................
|
|
.................................................................................................................................................................................................................................................................
|
|
.................................................................................................................................................................................................................................................................
|
|
.................................................................................................................................................................................................................................................................
|
|
.................................................................................................................................................................................................................................................................
|
|
.................................................................................................................................................................................................................................................................
|
|
.................................................................................................................................................................................................................................................................
|
|
||
|
English translation and language consultancy: Stephen Reynolds & Jane Lambert.
Photo credits: Front cover: Karine Roblot, Vaccine Formulation Technician, France © Simon Buxton - p.96: © Legrand - p.
103
: © Yann Audic
- p.
104
: © Jean Chiscano - p.
105
: © Alain Buu - p.
106
: @ Label image , 24 rue Gambetta, 78800 Houilles - p.
107
: © GE China - p.
108
: ©
Christel Sasso/Capa Pictures - p.
109
: © Lisbeth Holten, Denmark – p.
110
: @ Yann Audic - p.
111
: Christel Sasso/Capa Pictures - p.
112
: ©
|
||
|
TABLE OF CONTENTS
Part IItem 12. Description Of Securities Other Than Equity SecuritiesPart Iiitem 13. Defaults, Dividend Arrearages and DelinquenciesPart IIItem 13. Defaults, Dividend Arrearages and DelinquenciesItem 14. Material Modifications To The Rights Of Security HoldersItem 15. Controls and ProceduresPart Iiitem 16A. Audit Committee Financial ExpertItem 16A. Audit Committee Financial ExpertItem 16B. Code Of EthicsItem 16C. Principal Accountants Fees and ServicesItem 16D. Exemptions From The Listing Standards For AuditPart Iiitem 16E. Purchases Of Equity Securities By The Issuer and Affiliated PurchasersItem 16E. Purchases Of Equity Securities By The Issuer and Affiliated PurchasersItem 16E. Purchases Of Equity Securities By The Issuer and AffiliatedItem 16F. Change in Registrant S Certifying AccountantItem 16G. Corporate GovernancePart Iiitem 16G. Corporate GovernancePart Iiitem 16H. Mine Safety DisclosureItem 16H. Mine Safety DisclosureItem 16I. Disclosure Regarding Foreign Jurisdictions That PreventItem 16J. Insider Trading PoliciesItem 16K. CybersecurityPart Iiitem 16K. CybersecurityPart Iiiitem 17. Financial StatementsPart IIIItem 17. Financial StatementsItem 18. Financial StatementsItem 19. ExhibitsItem and The Hedging Instrument, Defined on The Basis Of A Hedge Ratio That Is Consistent with The Underlying Market RiskItem 3. Key Information D. Risk Factors and Item 11. Quantitative and QualitativeItem Research and Development Expenses. Co-development with Regeneron Of The Antibodies Dupixent, Kevzara and