UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
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FORM
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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 , 2022
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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Commission file number 001-36187
(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)
President and Chief Executive Officer
Telephone: +
Facsimile: +972-8-946-6724
Email: legal@evogene.com
(Name, Telephone, E-mail and/or Facsimile number and Address of Company Contact Person)
Securities registered or to be registered pursuant to Section 12(b) of the Act:
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Title of each class
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Trading symbol(s)
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Name of each exchange on which registered
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Securities registered or to be registered pursuant to Section 12(g) of the Act: None.
Securities for which there is a reporting obligation pursuant to Section 15(d) of the Act: None.
Indicate the number of outstanding shares of each of the issuer’s classes of capital or common stock as of the close of the period covered by the annual report: As of December 31, 2022, the registrant had outstanding 41,260,439 ordinary shares, par value NIS 0.02 per share.
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.
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 (§229.405 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 the definitions of “large accelerated filer,” “accelerated filer,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
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Large accelerated filer ☐
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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† provided pursuant to Section 13(a) of the Exchange Act. ☐
† 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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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 ☒
EVOGENE LTD.
FORM 20-F
ANNUAL REPORT FOR THE
FISCAL YEAR ENDED DECEMBER 31, 2021
TABLE OF CONTENTS
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PART I |
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PART II |
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| Disclosure Regarding Foreign Jurisdictions that Prevent Inspections | 118 | |
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PART III |
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F-1 | ||
3
CERTAIN
TERMS AND CONVENTIONS
In this annual report, unless otherwise specifically stated or
the context otherwise requires:
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references to “Evogene,” “we,” “us,” “our,” “our company” and “the
company” refer to Evogene Ltd. and its consolidated subsidiaries, consisting of AgPlenus Ltd., or AgPlenus, Biomica Ltd., or Biomica,
Canonic Ltd., or Canonic, Casterra Ag Ltd., or Casterra, Evogene Inc., Lavie Bio Ltd., or Lavie Bio, and their consolidated subsidiaries;
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references to “U.S. dollars,” “USD,” “$” or “dollars” are to United States dollars;
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references to “NIS” or “shekels” are to New Israeli Shekels; |
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references to the “U.S.” are to the United States; |
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references to “ordinary shares,” “our shares” and similar expressions refer to our Ordinary Shares, par value
NIS 0.02 per share; |
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references to the “articles of association” are to our Amended and Restated Articles of Association, which became effective
upon the closing of the U.S. initial public offering, as subsequently amended; |
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references to the “Companies Law” are to the Israeli Companies Law, 5759-1999, as amended; |
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references to the “Securities Act” are to the Securities Act of 1933, as amended; |
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references to the “Exchange Act” are to the Securities Exchange Act of 1934, as amended; |
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references to the “NYSE” are to the New York Stock Exchange; |
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references to the “Nasdaq” are to the Nasdaq Stock Market LLC or the Nasdaq Global Market; |
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references to the “TASE” are to the Tel Aviv Stock Exchange; and |
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references to the “SEC” are to the United States Securities and Exchange Commission. |
Unless derived from our financial statements or otherwise noted,
amounts presented in this annual report are translated at the rate of NIS 3.519 = USD 1.00, the exchange rate between the NIS and the
U.S. dollar reported by the Bank of Israel as of December 31, 2022.
This annual report includes other statistical, market and industry
data and forecasts which we obtained from publicly available information and independent industry publications and reports that we believe
to be reliable sources. Some data is also based on our good faith estimates, which are derived from management’s knowledge of the
industry and independent sources. These publicly available industry publications and reports generally state that they obtain their information
from sources that they believe to be reliable, but they do not guarantee the accuracy or completeness of the information. Although we
believe that these sources are reliable and are not aware of any misstatements regarding the industry data presented in this annual report,
we have not independently verified the information contained in such publications. Certain estimates and forecasts involve uncertainties
and risks and are subject to change based on various factors, including those discussed under the headings “—Special Note
Regarding Forward-Looking Statements” and “Item 3. Risk Factors—D. Risk Factors” in this annual report. For the
avoidance of doubt, no material on our website forms any part of this annual report. References in this annual report to documents on
our website or any other website are included as an aid to the location of such documents and such documents are not incorporated by reference
herein.
Throughout this annual report, we refer to various trademarks,
service marks and trade names that we use in our business. The “Evogene” design logo, “Evogene” and other trademarks
or service marks of Evogene Ltd. and its subsidiaries appearing in this annual report are the property of Evogene Ltd. or of its subsidiaries,
as applicable. We have several other registered trademarks, service marks and pending applications relating to our computational technologies.
Other trademarks and service marks appearing in this annual report are the property of their respective holders. Solely for convenience,
the trademarks and trade names in this annual report are referred to without the ® and ™ symbols, but such references should
not be construed as any indicator that their respective owners will not assert, to the fullest extent under applicable law, their rights
thereto. We do not intend the use or display of other companies’ trademarks and trade names to imply a relationship with, or endorsement
or sponsorship of us by, any other companies.
4
SPECIAL
NOTE REGARDING FORWARD-LOOKING STATEMENTS
In addition to historical facts, this annual report contains forward-looking
statements within the meaning of Section 27A of the Securities Act, Section 21E of the Exchange Act, and the safe harbor provisions of
the U.S. Private Securities Litigation Reform Act of 1995. We have based these forward-looking statements on our current expectations
and projections about future events. Forward-looking statements include information concerning our possible or assumed future results
of our business, financial condition, results of operations, liquidity, anticipated growth strategies, anticipated trends in our industry,
market size, our potential growth opportunities, plans and objectives. Forward-looking statements include all statements that are not
historical facts and can be identified by terms such as “anticipates,” “believes,” “could,” “seeks,”
“estimates,” “expects,” “intends,” “may,” “plans,” “potential,”
“predicts,” “projects,” “should,” “will,” “would” or similar expressions that
convey uncertainty of future events or outcomes and the negatives of those terms.
These forward-looking statements may include, but are not limited
to, statements relating to our objectives, plans and strategies, statements that contain projections of results of operations or of financial
condition and all statements (other than statements of historical facts) that address activities, events or developments that we expect,
project, believe, anticipate, intend or project will or may occur in the future. The statements that we make regarding the following matters
are forward-looking by their nature:
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our expectations regarding our revenue, expenses and other operating results; |
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whether we or our subsidiaries are able to raise capital on commercially reasonable terms to sustain the financial condition of each
respective entity; |
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our potential options with respect to Canonic; |
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the extent to which we continue to maintain our holdings in our subsidiary companies; |
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the extent to which our discoveries and product candidates will have the desired effect so as to reach the stage of commercialization;
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whether we are able to achieve commercialization of our product candidates; |
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whether we and our collaborators are able to allocate the resources needed to develop commercial products from our discoveries and
product candidates; |
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the length and degree of complexity of the process of our developing commercial products based on our discoveries and product candidates
and the probability of our success, and the success of our collaborators, in developing such products; |
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whether we are able to efficiently produce and scale up the production of our products, whether ourselves or through third party
contractors, to achieve our commercialization targets; |
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the degree of success of third parties upon whom we rely to conduct certain activities, such as field-trials and pre-clinical studies;
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whether we and our subsidiaries are able to comply with applicable law and the associated regulatory requirements that currently
apply or become applicable to each respective business; |
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the extent of the future growth of the agriculture, human health and industrial application industries in which we operate;
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whether we can maintain our current business models; |
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the actual commercial value of our key product candidates; |
5
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whether we or our collaborators receive regulatory approvals for the product candidates developed by us or our collaborators;
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whether milestones are met by us or by our collaborators with respect to our product candidates that generate revenues and whether
products containing or based on our discoveries are commercialized and generate revenues or royalties; |
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whether we are able to recruit, retain and develop knowledgeable or specialized personnel to perform our research and development
work; |
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the degree of our success at adapting to the continuous technological changes in our industries; |
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whether we can maintain our collaboration agreements with our current collaborators or enter into new collaboration agreements and
expand our research and development to new fields; |
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whether we can improve our existing, or develop and launch new, computational technologies and screening and validation systems;
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whether we can patent our discoveries and protect our trade secrets and proprietary know-how; and |
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whether the recent global coronavirus outbreak continues to harm our business and results of operations. |
The preceding list is not intended to be an exhaustive list of
all of our forward-looking statements. The forward-looking statements are based on our beliefs, assumptions and expectations of future
performance, taking into account the information currently available to us. These statements are only predictions based upon our current
expectations and projections about future events. There are important factors that could cause our actual results, levels of activity,
performance or achievements to differ materially from the results, levels of activity, performance or achievements expressed or implied
by the forward-looking statements. In particular, you should consider the risks described in “Item 3.D. Risk Factors”
and the additional information contained in “Item 4. Information on the Company” and “Item 5. Operating and Financial
Review and Prospects.”
You should not rely upon forward-looking statements as predictions
of future events. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we cannot guarantee
that future results, levels of activity, performance and events and circumstances reflected in the forward-looking statements will be
achieved or will occur. All of the forward-looking statements that we have included in this annual report are based on information available
to us on the date of this annual report. Except as required by law, we undertake no obligation to publicly update or revise any forward-looking
statement, whether as a result of new information, future events, changes in our expectations or otherwise.
SUMMARY RISK FACTORS
The risk factors described below are a summary of the principal risk
factors associated with an investment in us. These are not the only risks we face. You should carefully consider these risk
factors, together with the risk factors set forth in Item 3.D of this annual report and the other reports and documents filed
by us with the SEC.
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We have a history of operating losses and negative cash flow, and may never achieve or maintain profitability. Various factors may
delay, hinder, or prevent achievement of research and development milestones and commercialization of our product candidates. Moreover,
while entitled to royalties from our collaborators, we may experience difficulties in collecting the royalties or never receive them,
potentially resulting in costly litigation and loss of reputation. |
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We, and our subsidiaries, may need substantial additional
capital in the future which may dilute our shareholders. Additionally, subsidiary financings have diluted, and may continue to dilute,
our equity holdings in our subsidiary companies, which will likely negatively impact and/or decrease our results of operations, including
revenues, and the benefits of the value that may be created in such subsidiary companies. Additionally,
we may need to finance the cost of the development of our independent product candidates ourselves. |
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Our discoveries and product candidates may not achieve the desired effect required in order to create commercially viable products.
In addition, our product development cycle is lengthy and uncertain and various factors may delay or prevent commercialization of our
product candidates. We may never sell or earn royalties on the sale of commercial products based on our discoveries. |
6
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If we are unable to maintain our Computational Predictive Biology, or CPB, platform and its technological engines, our research and
development activities and those of our subsidiary companies may be substantially reduced. |
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If we are unable to efficiently produce and scale up the production of our products, whether ourselves or through third party contractors,
we may be unable to achieve our commercialization targets. Additionally, we or our collaborators may fail to perform obligations under
the collaboration agreements. |
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We rely on a limited number of collaborators to develop and commercialize
product candidates. In addition, a decrease in research expenditures by the major companies in our target markets may jeopardize the continuation,
or scope, of our collaborations and adversely impact our ability to continue or extend existing collaborations or enter into new collaborations.
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We are operating in multiple industries, each of which consists of multiple companies with much greater resources than us. If we
are unable to compete effectively, our financial resources will be diluted and our financial results will suffer. |
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Our efforts to develop and commercialize any of our products may be
unsuccessful. |
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If Lavie Bio and/or Canonic is unable to establish successful marketing distribution and/or retail channels for the commercialization
of its products, it will not be able to meet its commercialization plans. |
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We may fail to attract, recruit, retain and develop qualified employees, which could materially and adversely impact our business,
financial condition and results of operations. |
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Our business is subject to various government regulations and, if
we or our collaborators are unable to obtain the necessary regulatory approvals, we may not be able to continue our operations. Changes
in laws and regulations to which we are subject, or to which we may become subject in the future, may materially increase our costs of
operation, decrease our operating revenues and disrupt our business. Additionally, we could become subject to parallel reporting obligations
in Israel and the United States, which could increase compliance costs and divert management’s attention. |
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Disruption to our information technology and systems, or those of our subsidiaries could adversely affect our reputation and future
demand for our products or collaborative relationships. |
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The recent global coronavirus outbreak may continue to have an impact our business and results of operations. |
7
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We currently need, and in the future we may need, to obtain licenses of third-party technology that may not be available to us or
are available only on commercially unreasonable terms. |
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Our licenses granted to our collaborators may limit our opportunities to enter into additional licensing or other arrangements.
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We may be required to pay substantial damages as a result of product
liability, warranty liability, or personal injury claims and litigation. Additionally, our medical cannabis activity exposes us to legal
and reputational risks associated with the cannabis industry. Our operations are also subject to various health and environmental risks
associated with our use, handling and disposal of potentially toxic materials. |
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Termination of any of our leases, changes in lease terms, and long-term
leases that may not be terminated at will may jeopardize our activity and materially affect our financial condition or results of operations.
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Lavie Bio’s research and development facility in the U.S., our contracts with foreign businesses and any other current or future
operations outside of Israel expose us to additional market and operational risks. |
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Growing cycles and adverse weather conditions may decrease our results from operations. |
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Our success depends on our ability to protect our intellectual property
and our proprietary technologies. Any change to the patent laws in the U.S. or other jurisdictions may impair our ability to protect our
product candidates. |
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If we or one of our collaborators are sued for infringing the intellectual property rights of a third party, such litigation could
be costly and time consuming and could prevent us or our collaborators from developing or commercializing our product candidates.
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We may be required to pay royalties to employees who develop inventions that have been or will be commercialized by us. |
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Our employment agreements and agreements with our collaborators and third parties may not adequately prevent disclosure of trade
secrets, know-how and other proprietary information. In addition, we may not be able to fully enforce covenants not to compete with our
key employees. |
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Conditions in Israel could adversely affect our business. |
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Exchange rate fluctuations between the U.S. dollar and the NIS may
negatively affect our financial results and interest rate fluctuations may negatively affect our financial results, financial condition,
or investments. |
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The terms of our Israeli government grants may require us to satisfy specified conditions in order to manufacture products and transfer
technologies supported by such grants outside of Israel. |
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Your rights and responsibilities as our shareholder
will be governed by Israeli law, which may differ in some respects from the rights and responsibilities of shareholders of U.S. corporations.
For example, provisions of Israeli law may delay, prevent or make undesirable an acquisition of all or a significant portion of our shares
or assets. |
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The price of our ordinary shares may fluctuate significantly. Further, there is no guarantee of a continuing public market to resell
our ordinary shares. In addition, our ordinary shares are traded on more than one market and this may result in price variations.
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The requirements of being a public company in the U.S. and Israel
may strain our resources and distract our management, which could make it difficult to manage our business. |
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If a U.S. person is treated as owning at least 10% of our ordinary
shares, such holder may be subject to adverse U.S. federal income tax consequences. Additionally, we believe that we were a passive foreign
investment company, or PFIC, for U.S. federal income tax purposes in 2022, and there is significant risk that we will be a PFIC in 2023
as well. U.S. shareholders who held our ordinary shares at any time during a taxable year in which we are a PFIC may suffer adverse tax
consequences. |
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Any inability to meet the Nasdaq listing requirements may have an adverse effect on our share price and lead to our delisting from
Nasdaq. |
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If we fail to maintain effective internal control over financial reporting, the price of our ordinary shares may be adversely affected.
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9
PART I
| ITEM 1. |
IDENTITY OF DIRECTORS, SENIOR MANAGEMENT AND ADVISERS |
Not applicable.
| ITEM 2. |
OFFER STATISTICS AND EXPECTED TIMETABLE |
Not applicable.
| ITEM 3. |
KEY INFORMATION |
A. [Reserved]
B. Capitalization
and Indebtedness
Not applicable.
C. Reasons
for the Offer and Use of Proceeds
Not applicable.
D. Risk
Factors
Our business faces significant
risks. You should carefully consider all of the information set forth in this annual report and in our other filings with the SEC, including
the following risk factors which we face and which are faced by the industries in which we operate. Our business, financial condition
or results of operations could be materially adversely affected by any of these risks. This report also contains forward-looking statements
that involve risks and uncertainties. Our results could materially differ from those anticipated in those forward-looking statements,
as a result of certain factors, including the risks described below and elsewhere in this report and our other SEC filings. See “Special
Note Regarding Forward-Looking Statements” on page 5.
Risks Related to Our Business and Industry
We have a history of operating losses and negative
cash flow, and we may never achieve or maintain profitability.
We have a history of losses, and incurred operating losses of approximately
$26.9 million, $31.0 and $24.8 million for the years ended December 31, 2022, 2021, and 2020, respectively. There is no assurance
that our efforts in developing our product candidates will result in commercially successful products. We expect to continue to incur
losses in future periods, until we begin earning significant revenues or royalties on our products, the product candidates we are currently
developing or any new product candidates we develop in the future, if at all. Because we will incur significant costs and expenses for
these efforts before we obtain any incremental revenues from them, our losses in future periods could be significant. In addition, we
may find that these efforts are more expensive than we anticipate or that they do not result in profitability in the time period we anticipate,
which would further increase our losses. For example, if we are unable to adequately control the costs associated with operating our business,
including our costs of development and sales, we may deplete our cash resources and may be unable to continue to finance our business
from our existing cash resources, and, our business, financial condition, operating results and prospects will suffer. For more information
concerning our cash resources, please see “Liquidity and Capital Resources” in Item 5.B below. Additionally, due to market
conditions over the course of 2022, and as part of an overall review of our organizational structure and its associated costs and expenses,
we have implemented certain cost-cutting measures, including a structural change and a reduction in force during the year ended December
31, 2022, and may implement other cost-cutting measures in the future. As part of our overall assessment of our organizational structure,
while we are continuing to support Canonic’s growth, we are considering various longer-term options with respect to Canonic’s
business. Reductions in force may yield unintended consequences and costs, including additional attrition beyond the amount of force reduction,
distraction to our employees, reduced employee morale and adverse effects on our reputation as an employer. Such reductions in force may
also make it more difficult for us to hire new employees in the future and may limit the anticipated benefits from the reduction in force.
10
We, and our subsidiaries, may need substantial
additional capital in the future, which may cause dilution to our existing shareholders, restrict our operations or require us to relinquish
rights to our product candidates or intellectual property. If additional capital is not available, we may have to delay, reduce or cease
operations.
We and our subsidiaries may seek additional funding in the future,
which may consist of equity offerings, collaborations, licensing arrangements or any other means to develop our product candidates (including
through our subsidiaries and collaborators), fund research and data surveys, or other general corporate purposes. To the extent that we
raise additional capital through, for example, the sale of equity or convertible debt securities, our existing shareholders’ ownership
interest will be further diluted, and the terms may include liquidation or other preferences that adversely affect our shareholders’
rights. The incurrence of indebtedness or the issuance of certain equity securities could result in increased fixed payment obligations
and could also result in certain restrictive covenants, such as limitations on our ability to incur additional debt or to issue additional
equity, limitations on our ability to acquire or license intellectual property rights and other operating restrictions that could adversely
impact our ability to conduct our business. In addition, the issuance of additional equity securities by us, or the possibility of such
issuance, may cause the market price of our ordinary shares to decline. Securing additional financing may also divert our management’s
attention from our day-to-day activities, which may adversely affect our ability to develop and commercialize our product candidates.
Additional funding may not be available to us on acceptable terms,
or at all. In the event that we enter into collaborations or licensing arrangements in order to raise capital, we may be required to accept
unfavorable terms, including relinquishing or licensing to a third party on unfavorable terms our rights to product candidates or intellectual
property that we otherwise would seek to develop or commercialize ourselves or reserve for future potential arrangements when we might
be able to achieve more favorable terms.
If we, or our subsidiaries, are unable to raise additional capital
when required or on acceptable terms, we may be required to:
| • |
delay, scale back or discontinue the development, manufacturing scale-up or commercialization of our or our subsidiaries’ product
candidate; |
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accept for one or more of our or our subsidiaries’ product candidates terms that are less favorable than might otherwise be
available; or |
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relinquish or license to additional parties, on unfavorable terms, our rights to our or our subsidiaries’ product candidates
that we or our subsidiaries otherwise would seek to develop or commercialize ourselves. |
Any such consequence will have a material adverse effect on our business, operating
results and prospects and on our ability to develop our or our subsidiaries’ product candidates ourselves or through collaborators.
The dilution of our equity
holdings in our subsidiary companies will likely negatively impact and/or decrease our results of operations, including revenues, and
the benefits recognized by our shareholders from value that may be created in such subsidiary companies.
We initiated a corporate strategy and structure at the beginning of 2018, with the intent
to make product development and go-to-market more efficient and to better reflect the individual value of each of our market focused business
units. Under our corporate structure, we operate with Evogene acting as a technology hub and, below it, a growing group of divisions and
subsidiaries that benefit from the unique capabilities of Evogene’s Computational Predictive Biology, or CPB platform and its technological
engines, ChemPass AI, GeneRator AI and MicroBoost AI. Each such subsidiary is responsible for advancing its product development and pipeline,
establishing its “go-to-market” strategy via direct sales or through existing and new collaborations, and securing additional
financial resources, if and when required. Due to our limited financial resources and other investment considerations, our subsidiaries
are permitted to obtain financing from external sources and have therefore raised additional capital and may continue to raise capital
in the future. Such financings can have a dilutive impact on our ownership interest in the particular subsidiary. For example, Lavie Bio
entered into a SAFE agreement with an affiliate of ICL Group Ltd., or ICL, and Biomica entered into a Share Purchase Agreement with Shanghai
Healthcare Capital, or SHC. For more information see “Item 4.B. Information on the Company—Business Overview—Market
Segments—Agriculture—Lavie Bio Ltd.—Overview” and “Item 4.B. Information on the Company—Business Overview—Market
Segments—Human Health—Biomica Ltd.—Overview”. Such external financings have therefore resulted, and may continue
to result, in the decrease of our ownership percentage in one or more of our subsidiaries, which, in turn, will likely negatively impact
and/or reduce our operational results (including revenues), financial condition, long-term growth strategy, the value of our shares, and
the benefits we (and, indirectly, our shareholders) recognize from value established in any such subsidiary.
11
Our discoveries and product candidates may
not achieve the desired effect required in order to create commercially-viable products.
Our success depends on our ability to develop products that have
the desired effects: in our agriculture activity, on plants, in our human health activity, on humans, and in our industrial applications
activity, on the relevant industrial inputs. Research and development in these industries entails considerable uncertainty. We may spend
many years developing product candidates that will never be commercialized. The science underlying the development of our product candidates
is highly complex and, although we use innovative approaches, there is no certainty that our discoveries will result in product candidates
that satisfy market requirements. Except for our products in our medical cannabis, ag-biologicals activities, and in our castor oil activity,
none of our discoveries and product candidates has completed the development process and become commercially available so far and such
anticipated products may never reach commercialization. If our discoveries and product candidates will not have the desired effects, we
and our collaborators may not develop commercial products that are based on them, which could materially and adversely affect our results
of operations and our long-term growth strategy.
If we are unable to maintain our CPB platform
and its technological engines, ChemPass AI, GeneRator AI and MicroBoost AI, our research and development activities and those of our subsidiary
companies may be substantially reduced.
We and our subsidiary companies depend significantly on our CPB
platform and its technological engines in research and development activities. In particular, Evogene relies on CPB and its technological
engines to provide computational biology services to our subsidiaries and to support the research and development activities of our Ag-Seeds
division. If we are unable to maintain our CPB and technological engines, due to cost, technical failure or otherwise, we could experience
adverse consequences, including but not limited to loss of data, interruptions in research and development activities, loss of business
and revenues.
Our subsidiary companies rely on our CPB and its technological
engines to, among others, capture laboratory data, maintain clinical trial data and perform data analysis. Therefore, if we are unable
to maintain our CPB and technological engines, due to cost, technical failure or otherwise, our subsidiaries could experience adverse
consequences, including but not limited to loss of data (including clinical trial data) or damage to the integrity of that data, interruptions
in their research and development activities and other similar harms. Such surrounding circumstances may interrupt our subsidiaries’
clinical trials, reduce demand for our subsidiaries’ product candidates, and delay or negatively impact the development and commercialization
of our subsidiaries’ product candidates and ability to grow and operate their business.
Various factors may delay, hinder, or prevent achievement of research
and development milestones and the commercialization of our product candidates.
Our success depends in part on our ability to identify discoveries
that will improve crop performance, in our agriculture activity, obtain clinical benefits, in our human health activity, or improve industrial
inputs, in our industrial applications activity. To develop these discoveries and product candidates into commercial products, we either
license them to collaborators or develop them independently through our subsidiaries or our Ag-Seeds division.
Certain of our agreements with our collaborators in our agriculture activity entitle us to upfront fees, research and development payments
and milestone payments once certain specified milestones are met. If we or our collaborators are not successful in reaching the established
milestones in our agreements, we may not receive the referenced research and development payments and milestone payments.
In addition, pursuant to our collaboration agreements in our agriculture
activity, we are usually entitled, subject to certain conditions, to receive royalties on products that are based on, or integrate, these
discoveries. Except for Casterra’s castor seed varieties and our first products in our medical cannabis and ag-biologicals activities,
none of our product candidates has completed the development process and become commercially available. Therefore, we currently do not
earn royalties and we do not derive significant sales revenues from the sale of products based on our discoveries and product candidates.
Thus, while our long-term growth strategy is based in large part on the expectation that such royalties and revenues from product sales
will comprise a significant portion of our revenues in the future, we can provide no guarantee that any of our current or future product
candidates will ever reach commercialization that would result in royalty payments to us.
The manner in which we and our collaborators develop our product
candidates in our various fields of activity affects the period that will pass until such products are commercialized, if ever. Product
candidates based on our discoveries may never become commercialized for any of the following reasons:
| ◾ |
our discoveries and product candidates may not be successfully validated or may not have the desired effect required in order to
become, or to be incorporated into, commercial products; |
12
| ◾ |
the process of developing product candidates based on our discoveries is lengthy and expensive, and we or our collaborators may not
be able to allocate the resources needed to complete such development within the desired timeline; |
| ◾ |
we or our collaborators may decide to discontinue, pause, reduce, or alter the scope of the development efforts for our product candidates;
|
| ◾ |
we may fail to satisfy, in a timely manner or at all, relevant milestones under our agreements with our collaborators; |
| ◾ |
regulatory conditions related to our product candidates may change in different territories, thus negatively affecting the relevant
development processes and extending their length or limiting the commercialization of such product candidates; |
| ◾ |
we or our collaborators may be unable to obtain the requisite regulatory approvals for product candidates based on our discoveries;
|
| ◾ |
our competitors may launch competing or more effective products; |
| ◾ |
we or our collaborators may be unable to fully develop and commercialize product candidates containing our discoveries or may decide,
for whatever reason, not to commercialize, or to delay the commercialization of, such product candidates; |
| ◾ |
a market may not exist for products containing our discoveries or such products may not be commercially successful or relevant;
|
| ◾ |
we may be unable to protect the intellectual property underlying our discoveries in the necessary jurisdictions; and |
| ◾ |
we may encounter production and scale-up challenges with respect to our product candidates that hinder their commercialization.
|
Thus, if our collaborators are not successful in reaching the established
milestones in our agreements or if we or our collaborators are not successful in commercializing products based on our discoveries, we
will not realize revenues from such products and we may not earn a profit on our discoveries, which could materially and adversely affect
the results of operations, financial condition and our long-term growth strategy, which may ultimately cause us to cease operations.
Our product development cycle is lengthy and
uncertain, and we may never sell or earn royalties on the sale of commercial products based on our discoveries.
Research and development in our fields of activity is expensive
and prolonged and entails considerable uncertainty. We may spend many years and dedicate significant financial and other resources developing
product candidates that will never be commercialized. The process of discovering, developing and commercializing ag-chemicals, ag-biologicals,
seed traits, human microbiome-based therapeutics, medical cannabis products or castor varieties involves several phases and a long development
period. The timelines for development of product candidates by us or by our collaborators may extend beyond our expectations for many
reasons, such as:
| ◾ |
we or our collaborators may not be able to allocate the resources needed to develop product candidates based on our discoveries;
|
| ◾ |
we or our collaborators may revise the process of product development or make other decisions regarding the product development pipelines
that may extend the development period; |
| ◾ |
we or our collaborators may prioritize other development activities ahead of development activities with respect to the product candidates
on which we collaborate; |
13
| ◾ |
our discoveries may not be successfully validated or may not have the desired effect sought by us or by our collaborators; and
|
| ◾ |
we or our collaborators may be unable to obtain the requisite regulatory approvals for the product candidates based on our discoveries
within expected timelines or at all. |
Most of the product candidates we or our collaborators are developing
are in early development stages. We have little to no certainty as to which and when, if any, any of these product candidates will eventually
reach commercialization. Because of the long product development cycle and the complexities and uncertainties associated with research
in our fields of activity, there is significant uncertainty as to whether we will ever generate significant revenues or royalties, if
any, from the product candidates that we or our collaborators are developing. For more information on the product development cycle of
the product candidates we develop and a description of the phases of development, see the ‘Product Development Cycle’ paragraph
under the description of each of our activity divisions and subsidiaries in “Item 4. Information on the Company—B. Business
Overview”.
If we are unable to efficiently produce and
scale up the production of our products, whether ourselves or through third party contractors, we may be unable to achieve our commercialization
targets.
When we introduce a product to the market, and in certain cases
even in later stages of product development, we need to establish efficient production capabilities for our products. In most cases, our
products are, or are expected to be, produced by third party producers with whom we contract for such purpose. The production of our products,
and the scale up of such production, are complicated processes that require expertise. The production of all of our subsidiaries’
current commercial products (being castor beans of Casterra, medical cannabis products of Canonic and bio-inoculant of Lavie Bio) relies,
in all or in part, on third-party contractors. Failure to establish a long-term relationship with a manufacturer with sufficient capacity
and relevant cost of goods sold, will affect our subsidiaries’ ability to meet demand for their products. If we or our third party
contractors are unable to efficiently produce and scale up production as needed to meet the demand for our products, we may be unable
to achieve our commercialization targets, which may, in turn, materially and adversely affect our future results of operations.
Due to mergers and consolidations, there is
a reduced number of companies in the agriculture industry with which we might establish strategic partnerships, and we rely on a limited
number of collaborators to develop and commercialize product candidates containing our seed trait, ag-chemical and ag-biological product
candidates.
The agriculture markets are highly consolidated and dominated by
a relatively small number of large companies. In our agriculture operations, we are currently undertaking collaborations with several
of these companies to develop improved seed traits, ag-chemical and ag-biological product candidates. Due to the small number of major
companies in this industry, there are limited opportunities for us to grow our business with new collaborators. In addition, if we fail
to develop or maintain our relationships with any of our current collaborators, we could not only lose our opportunity to work with that
collaborator, but we could also suffer a reputational risk that could impact our relationships with other collaborators in what is a relatively
small industry community.
In our agriculture operations, we are currently working either
with collaborators or on independent projects to research and develop our different seed trait, ag-chemical and ag-biological product
candidates. While we seek to expand our portfolio of product candidates in the future, the research and development required to discover
and develop new product candidates is costly, time-intensive and requires significant infrastructure resources. If we are unable to enter
into new collaborations, or if we do not have the resources to develop the capabilities or resources necessary to discover and develop
such product candidates independently, we may not be able to expand our portfolio of these product candidates, which could have a material
adverse effect on our business prospects.
A decrease in research expenditures
by the major companies in our target markets may jeopardize the continuation, or scope, of our collaborations with such companies and
adversely impact our ability to continue or extend existing collaborations or enter into new collaborations on favorable financial terms.
The research and development expenditures of our existing and potential
collaborators in the agriculture, human health, and industrial applications markets we operate in may be reduced for reasons beyond our
control. For example, a global crisis or economic recession, a decrease in the prices of agricultural commodities, or the consolidation
trend in the seeds and ag-chemicals industries may result in decreased research and development expenditures in the markets relevant for
our seed trait, ag-biological and ag-chemical product candidates. Such developments may, in turn, adversely impact our ability to maintain
or extend our existing collaborations or enter into new collaborations on favorable financial terms. For example, we may not be able to
enter into new collaborations under which our collaborators cover our expenses through research and development payments.
14
We or our collaborators may fail to perform
obligations under the collaboration agreements.
We are obligated under our collaboration agreements to perform
research activities over a particular period of time. If we fail to perform our obligations under these agreements, in some cases our
collaborators may terminate our agreements with them and in other cases our collaborators’ obligations may be reduced, which may
decrease our overall revenues. More specifically, in the event that a collaborator terminates our agreement (or reduces its obligations
thereunder), the research and development costs from the particular project, which were previously covered by such collaborator, may be
borne by us. Our overall revenues will therefore be reduced by the addition of such RD costs. In addition, any of our collaborators
may fail to perform their obligations, which may hinder development and commercialization of products containing the product candidates
we develop and materially and adversely affect our future results of operations. Furthermore, the various payments we receive from our
collaborators are currently our primary source of revenues. If our collaborators do not make these payments, either due to financial hardship,
disagreement under the relevant collaboration agreement or for any other reason, our results of operations and business would be materially
and adversely affected. If disagreements with a collaborator arise, any dispute with such collaborator may negatively affect our relationship
with one or more of our other collaborators and may hinder our ability to enter into future collaboration agreements, each of which could
negatively impact our business and results of operations.
We are operating in multiple industries, each
of which consists of multiple companies with much greater resources than us. Competition in our industries is intense and requires continuous
technological development. If we are unable to compete effectively, our financial resources will be diluted and our financial results
will suffer.
We currently face significant competition in the markets in which
we operate. The agriculture, human health and industrial applications markets in which we operate are intensely competitive and rapidly
changing. Many companies engage in research and development of products in such markets, and being efficient in getting a new product
candidate to market can be a significant competitive advantage. In most segments of our operations, the number of products available to
the consumer is steadily increasing as new products are introduced by our competitors. We may be unable to compete successfully against
our current and future competitors, which may result in lower prices and margins than previously anticipated and the inability to achieve
market acceptance for our products. In addition, many of our competitors have substantially greater financial, marketing, sales, distribution
and technical resources than us. While the current market is centralized and tight, we anticipate that there may be increased competition
in the future as new companies enter these markets and new technologies become available. Our technologies may be rendered obsolete or
uneconomical by technological advances or entirely different approaches developed by one or more of our competitors or collaborators,
which will prevent or limit our ability to receive any associated research and development payments or generate revenues from the commercialization
of our product candidates.
We are working to develop and commercialize
novel ag-biological products, and our efforts may be unsuccessful.
Our majority-owned subsidiary, Lavie Bio, is developing ag-biological
product candidates, currently focused mainly on microbial-based bio-stimulants and bio-pesticides, through a novel approach, focused on
plant-microbiome relationship. In certain of its ag-biological product programs, Lavie Bio funds its early stages of research and development
efforts, while in others it funds the entire development program towards launch of a commercial product. Lavie Bio’s efforts to
develop and commercialize novel ag-biological product candidates may fail for a variety of reasons, including:
| ◾ |
failure to establish the requisite infrastructure to enable the discovery and development of microbial bio-stimulants; |
| ◾ |
failure to identify and develop microbial candidates that enhance plant performance at the desired efficacy and stability;
|
| ◾ |
failure to successfully complete development of microorganisms to achieve cost-effective and commercially viable products;
|
15
| ◾ |
failure to obtain and maintain patent and trade secret protection for its product candidates; |
| ◾ |
failure to operate without infringing or violating the valid and enforceable patents or other intellectual property rights of third
parties; |
| ◾ |
inability to obtain sufficient funding to fully execute its business plan; |
| ◾ |
failure to meet regulatory requirements; |
| ◾ |
failure to establish efficient and reliable production and scale up capabilities of Lavie Bio’s products through third party
contractors; and |
| ◾ |
failure to establish cost-effective go-to-market models for selling its products. |
If Lavie Bio’s efforts to develop and commercialize ag-biological
product candidates are unsuccessful, our results of operations could be negatively impacted.
We are working to develop and commercialize
novel ag-chemical products, and our efforts may be unsuccessful.
Our subsidiary, AgPlenus, is currently developing solutions for
crop protection through chemistry, or ag-chemistry. AgPlenus is developing these product candidates through a novel approach, focused
on biologically significant proteins called “targets”. AgPlenus’ efforts to develop novel ag-chemical product candidates
may fail for a variety of reasons, including:
| ◾ |
failure of its relatively novel target-based approach to lead to an effective product candidate or failure to identify chemical compounds
that will display required level of performance; |
| ◾ |
failure to establish cost-effective production of AgPlenus’ product candidates; |
| ◾ |
failure to obtain and maintain patent and trade secret protection for its product candidates; |
| ◾ |
failure to operate without infringing or violating the valid and enforceable patents or other intellectual property rights of third
parties; |
| ◾ |
inability to obtain sufficient funding to fully execute its ag-chemical business plan; and |
| ◾ |
failure to meet regulatory requirements. |
If AgPlenus’ efforts to develop ag-chemical product candidates
are unsuccessful, our results of operations could be negatively impacted.
We are working to develop and commercialize
seed-trait products, and our efforts may be unsuccessful.
We are developing seed-trait and insect control product candidates
in our internal Ag-Seeds division. Our efforts to develop novel product candidates may fail for a variety of reasons, including:
| ◾ |
failure to identify and develop candidate genomic elements having the desired effect on the target trait in the plant of interest;
|
| ◾ |
failure to identify and develop toxin candidates having the desired effect on the target insects when inserted into the plants of
interest; |
| ◾ |
failure to obtain and maintain patent and trade secret protection for our product candidates; |
| ◾ |
failure to operate without infringing or violating the valid and enforceable patents or other intellectual property rights of third
parties; |
16
| ◾ |
inability to obtain sufficient funding to fully execute the business plan; |
| ◾ |
failure to successfully complete development of our seed trait product candidates; and |
| ◾ |
our failure to meet regulatory requirements for seed trait and insect control product candidates. |
Furthermore, even if we are able to discover and begin to develop
effective product candidates, we may not be successful if we are unable to find collaborators for further development and commercialization
of the product candidates. If our efforts to develop seed trait product candidates are unsuccessful, our results of operations could be
negatively impacted.
We are working to develop human microbiome-based
therapeutic product candidates, and our efforts may be unsuccessful.
Our subsidiary, Biomica, is developing microbiome-based therapeutic
product candidates and is heavily dependent on the success of such product candidates, which are in pre-clinical and clinical development
stages. If Biomica is unable to advance its current or future product candidates through clinical trials, obtain marketing approval and
ultimately commercialize any product candidates it develops, or experiences significant delays in doing so, our business will be materially
harmed. Biomica’s product development efforts may be unsuccessful for a variety of reasons, including the following:
| ◾ |
failure to complete pre-clinical studies and clinical trials with positive results in which the FDA agrees with the design,
endpoints or implementation; |
| ◾ |
failure to receive regulatory approvals or authorizations for conducting our planned clinical trials or future clinical trials;
|
| ◾ |
failure to obtain sufficient financing for the development and commercialization of its product candidates; |
| ◾ |
failure to obtain and maintain patent and trade secret protection and regulatory exclusivity for its product candidates; |
| ◾ |
interruption of, or delays in receiving, supplies of our product candidates from our contract manufacturing organizations due to
staffing shortages, production slowdowns or stoppages and disruptions in delivery systems; |
| ◾ |
failure to launch commercial sales of its products, if and when approved, whether alone or in collaboration with others; |
| ◾ |
failure to enter into new collaborations throughout the development process as appropriate, from pre-clinical studies through to
commercialization; |
| ◾ |
failure to achieve acceptance of its products, if and when approved, by patients, the medical community and third-party payors;
|
| ◾ |
failure to effectively compete with companies developing and commercializing other therapies for the indications that Biomica’s
product candidates target; |
| ◾ |
failure to obtain and maintain coverage and adequate reimbursement by third-party payors, including government payors, for its products,
if approved; |
| ◾ |
failure to protect its rights in its intellectual property portfolio; |
| ◾ |
failure to operate without infringing or violating the valid and enforceable patents or other intellectual property rights of third
parties; |
| ◾ |
failure to maintain a continued acceptable safety profile of the products following approval; and |
| ◾ |
failure to maintain and develop an organization of scientists and business people who can develop and commercialize its products
and technology. |
17
If Biomica’s efforts to develop microbiome-based human
therapeutics are unsuccessful, our results of operations could be negatively impacted.
We are working to develop and commercialize
medical cannabis products, and our efforts may be unsuccessful.
Canonic, our subsidiary, is developing medical cannabis products.
Canonic’s efforts to develop and commercialize medical cannabis products may fail for a variety of reasons, including:
| ◾ |
failure to develop cannabis varieties having desired efficacy and stability; |
| ◾ |
failure to meet regulatory requirements; |
| ◾ |
failure to engage with, and successfully operate, contractors, in Israel and abroad, for performing cultivation and production services;
|
| ◾ |
failure to establish successful distribution channels, in Israel and abroad, for its medical cannabis products; |
| ◾ |
failure to satisfy the requirements for the export of seeds, seedlings of finished products; |
| ◾ |
failure to meet patients’ satisfaction; |
| ◾ |
inability to obtain sufficient funding to fully execute its business plan; |
| ◾ |
failure to secure cannabis cultivation facilities; |
| ◾ |
failure to establish efficient and reliable production capabilities for Canonic’s medical cannabis products through third party
contractors; and |
| ◾ |
the market for medical cannabis products is relatively new and suffers from high uncertainty in many aspects, including demand, supply,
pricing, regulation, customer preferences, etc. |
If Canonic’s efforts to develop and commercialize medical
cannabis products are unsuccessful, our results of operations could be negatively impacted.
We are working to develop and commercialize
castor seeds for industrial applications, and our efforts may be unsuccessful in achieving a commercial presence in this market.
Our subsidiary, Casterra, is developing improved, high-yield castor
bean seeds for use as a source of non-edible feedstock for industrial uses of castor oil. The supply chain in the market of castor oil
for industrial uses is not well established and is evolving. In order for Casterra’s castor bean seeds to be an attractive feedstock
for oil for industrial uses, it will need to demonstrate on a commercial scale that its castor beans can reliably be used as a cost-efficient
feedstock for castor oil production. Casterra’s efforts to develop castor been seeds for industrial uses may fail for a variety
of reasons, including:
| ◾ |
failure to reach desired yields of its castor seed varieties on a commercial scale to secure economic viability as bio-based oil
feedstock; |
| ◾ |
failure to establish an efficient mechanical harvest solution; |
| ◾ |
failure to establish a cost-effective production of castor bean grains, allowing grower profitability; |
| ◾ |
failure to reach large scale adoption of castor by growers, including the successful management of diseases and pests; |
| ◾ |
failure to address the health and environmental risks posed by castor bean seeds, which contain ricin, a naturally occurring poison;
|
18
| ◾ |
failure to comply with any regulatory requirement related to sales of castor beans, and in particular those related to the import
of such beans and the potential effects of ricin; |
| ◾ |
Our cultivation and agro-technical support activities in Africa and South America may be materially and adversely affected by an
economic slowdown, uncertainties with respect to the legal system and violent crime or terrorism in these regions; and |
| ◾ |
failure to establish efficient and reliable production and scale up capabilities of castor seeds, independently or through third
party contractors. |
Casterra is operating in a new industry, with limited understanding
of the dynamics involved in producing and selling castor seeds. Casterra has made initial commercial sales of castor seeds; however, we
are unable to foresee as to when significant sales will commence. If Casterra is unable to adequately address any of these challenges,
we may not find a market for our castor bean seeds and our results of operations could be materially and adversely affected.
If Lavie Bio is unable to establish successful
distribution and retail channels for the commercialization of its products, it will not be able to meet its commercialization plans.
Our majority-owned subsidiary, Lavie Bio, intends to commercialize
part of its future ag-biological product portfolio through distribution and retail channels. Lavie Bio has little experience in establishing
such channels and may be unsuccessful in doing so. In addition, Lavie Bio will be dependent on its distributers in introducing its products
to the market. If Lavie Bio or its distributors are unsuccessful in their efforts to penetrate the market, our revenues and financial
results will be adversely affected.
If Canonic is unable to establish successful
marketing and distribution channels for the commercialization of its products, it will not be able to meet its commercialization plans.
Our subsidiary, Canonic, commercializes its medical cannabis products
through licensed distributors and pharmacies. Canonic has little experience in establishing such channels and may be unsuccessful in doing
so. In addition, Canonic will be dependent on its distribution and marketing channels in introducing its products to the market. If Canonic
is unsuccessful in its efforts to penetrate the market, our revenues and financial results will be adversely affected.
Biomica’s product candidates are based
on microbiome therapeutics, which is an unproven approach to therapeutic intervention.
Biomica’s product candidates are based on microbiome therapy,
a therapeutic approach that is designed to treat disease by restoring the function of a dysbiotic microbiome. To our knowledge, no company
has received regulatory approval for a therapeutic product based on this approach. We cannot be certain that our approach will lead to
the development of approvable or marketable products. In addition, the FDA or other regulatory agencies may lack experience in evaluating
the safety and efficacy of products based on microbiome therapeutics, which could result in a longer than expected regulatory review process
or evolving FDA standards and guidance, increase Biomica’s expected development costs and delay or prevent commercialization of
its product candidates. Regulatory requirements governing microbiome therapies are still developing and may change in the future, which
may lengthen the regulatory review process, require us to perform additional preclinical studies or clinical trials, increase our development
costs, delay or prevent approval and commercialization of our current or future product candidates or lead to significant post-approval
limitations or restrictions.
Even if we are entitled to royalties from our
collaborators, we may not actually receive these royalties, or we may experience difficulties in collecting the royalties that we believe
we are entitled to, potentially resulting in costly litigation and loss of reputation.
If and when our collaborators launch commercial products containing
our licensed discoveries, we will rely on our collaborators to report to us the sales they earn from these products and to accurately
calculate the royalties we are entitled to, a process that will involve complicated calculations. Although we seek to address these concerns
in our collaboration agreements, such provisions may not be effective. Additionally, we may not be able to achieve our long-term goal
of generating revenues from royalties, and in the coming years our revenues will be entirely dependent on fees we earn for our research
and development services and milestone payments from our collaborators.
19
In addition, our ability to generate royalty payments from our
collaboration agreements depends on our ability to clearly delineate our intellectual property rights under those agreements. We often
license patented discoveries and product candidates to our collaborators, who use them to develop and commercialize products. However,
a collaborator may use our intellectual property without our permission, dispute our ownership of certain intellectual property rights
or argue that our intellectual property does not cover their marketed product. If a dispute arises, it may result in costly litigation,
and our collaborator may refuse to pay us royalty payments while the dispute is ongoing. Furthermore, regardless of any resort to legal
action, a dispute with a collaborator over intellectual property rights may damage our relationship with that collaborator, and may also
harm our reputation in the industry.
Competition for highly skilled scientific, technical and other personnel
is intense, and as a result we may fail to attract, recruit, retain and develop qualified employees, which could materially and adversely
impact our business, financial condition and results of operations.
We compete for personnel in a research and development market characterized
by rapidly changing technologies and an evolving competitive landscape. In order for us to successfully compete and grow, we must attract,
recruit, retain and develop personnel with requisite qualifications to provide expertise across a range of disciplines, including biology,
chemistry, plant genetics, agronomics, entomology, mathematics, computer science and other fields relevant to our operations.
The number of qualified and highly educated personnel in the fields
upon which our business focuses in Israel, where most of our operations are located, is limited and competition for the services of such
persons is intense. Although we have employment agreements with all of our employees, most of these agreements may be terminated on short
notice by such employees, which may create an immediate strain on our activities.
While there has been intense competition for qualified human resources
in the Israeli high-tech and bio-tech industries historically, these industries experienced record growth and activity during the COVID-19
pandemic and reached the peak in 2021. This flurry of growth and activity has caused a sharp increase in job openings in Israeli high-tech
and bio-tech companies, intensifying competition between these employers to attract qualified employees in Israel. As a result, these
industries in Israel have experienced significant levels of employee attrition and are currently facing a severe shortage of skilled human
capital, including mainly research and development professionals. Although during 2022 there was a slight shift in the attrition level
and we were able to attract more candidates to each open position, we are still facing significant and intense competition in recruiting
for our research and development positions.
Many of the companies with which we compete for qualified personnel
have significant resources, and we may not succeed in recruiting additional experienced or professional personnel, retaining personnel
or effectively replacing current personnel who may depart with qualified or effective successors. In addition, our employees may be increasingly
targeted for recruitment by competitors and other companies in the bio-tech industry, which may make it more difficult for us to retain
employees and may increase retention costs. Training of new employees with limited or no prior relevant experience could be time-consuming,
expensive and require significant resources.
In addition, as a result of the intense competition for qualified
human resources, the high-tech and bio-tech markets have also experienced and may continue to experience significant wage inflation. Accordingly,
our efforts to attract, retain and develop personnel may also result in significant additional expenses, which could adversely affect
our profitability. Furthermore, in making employment decisions, particularly in the high-tech and bio-tech industries, job candidates
often consider the value of the equity they are to receive in connection with their employment, which may force us to increase the amount
of equity awards we grant in order to recruit and retain talent.
In light of the foregoing, there can be no assurance that qualified
employees will remain in our employ or that we will be able to attract and retain qualified personnel in the future. Failure to retain
or attract qualified personnel could have a material adverse effect on our business, financial condition and results of operations.
We develop certain discoveries independent
of our collaborators, and we may need to finance the cost of the development of such product candidates ourselves.
We develop certain discoveries and product candidates independent
of our collaborators, with a goal of making such discoveries available to collaborators in later phases or developing and commercializing
end products. While we believe this will allow us to obtain more favorable license or commercialization terms with respect to such discoveries,
product candidates and products, the up-front cost to us of developing programs without a collaborator (and therefore without external
funding for the research and development expenditures we incur) in these early phases involves higher risks, since we need to fund the
research and development of such programs ourselves. If we are unsuccessful in discovering promising product candidates after having invested
significant funds, or if we are unable to find collaborators who are interested in such results and willing to fund subsequent phases
of development and commercialization, such failures could have a material and adverse effect on our business, financial condition and
results of operations. Regardless of the outcome of our research and development efforts, traditional financing sources such as bank financing
or public debt or equity financing, if available to us, could carry with them certain drawbacks, such as imposition of covenants restricting
our ability to operate, or substantial dilution to our existing shareholders.
20
Our business (including each of the businesses
of our respective subsidiaries) and that of our collaborators’ are subject to various government regulations and, if we or our collaborators
are unable to comply with the relevant respective law and regulations and/or obtain the necessary regulatory approvals, we may not be
able to continue our operations.
Our business is generally subject to two types of regulations:
regulations that apply to our operations and regulations that apply to our product candidates and products. We and/or our collaborators
may fail to comply with all currently applicable regulations, and we and/or our collaborators may become subject to new or revised regulations
or approvals in the future. Furthermore, any violation of these regulations by us and/or our collaborators may expose us to civil and
criminal penalties.
Specifically, our operations are carried out mainly in Israel and
accordingly we are regulated by the Israeli Ministry of Agriculture and Rural Development, or ISARD, and more specifically by the ISARD’s
Plants Protection and Inspection Services and the National Committee for Transgenic Plants. The regulation by ISARD addresses, among other
things, the import of agricultural materials into Israel, environmental protection requirements for our experiments and working with transgenic
plants.
Additionally, our research and development activities use chemicals
and produce waste materials, which require us to hold business licenses that may include conditions set by the Israeli Ministry of Environmental
Protection for the operations of such facilities.
Our operations in the human health sector, namely the clinical
trials by our subsidiary Biomica and the import, export, security, cultivation and marketing activities by our subsidiary Canonic, are
regulated by various laws, regulations, orders and procedures by the Israeli Ministry of Health. In particular, our clinical trials require
a permit for a research plan (protocol) by the Helsinki Committee, operating under the Public Health Regulations (Clinical Trials in Humans),
1980 and are also regulated by the Israeli Public Health Ordinance, 1940. In addition, cannabis is subject to the regulations
of the Israeli Medical Cannabis Agency, or IMCA, which require that we will obtain a license to cultivate cannabis products. Additionally,
certain security aspects of the operation of Canonic farms are also subject to a permit from the Israeli Police; for example, we are required
to provide 24/7 security and approval of a security program by the Israeli Police.
If we fail to comply with any of
the above-mentioned laws and/or regulations, we may be subject to fines and other civil, administrative or criminal sanctions (i.e., imprisonment),
including the revocation of our toxin permits, business permits, or other permits and licenses necessary to continue our business activities,
including our cannabis activities.
Once we develop a commercialized product(s), we further anticipate
that we, our subsidiaries, and/or our collaborators, will need to apply for regulatory approval of certain products and may also become
subject to additional regulatory regimes in the sale of such products. Such laws may include laws that govern which product(s) may be
sold in a particular jurisdiction along with the manner of sales and marketing permitted in that particular jurisdiction. Such laws may
be onerous to comply with and may vary from jurisdiction to jurisdiction. For example, in the United States, the regulation of biotechnology
is divided among the United States Environmental Protection Agency, or EPA, which regulates activity related to the invention of plant
pesticides and herbicides, the United States Department of Agriculture, which regulates the import, field testing and interstate movement
of specific technologies that may be used in the creation of transgenic plants, and the United States Food and Drug Administration, or
the FDA, which regulates foods derived from new plant varieties. As a result, certain of our products may have to be approved for sale
by separate agencies that may regulate a different aspect of one or more of our future products.
In addition, with respect to our product candidates in the human
health sector, the time required to obtain approval by the FDA and comparable foreign regulatory authorities is unpredictable but typically
takes many years following the commencement of clinical trials and depends upon numerous factors, including the substantial discretion
of the regulatory authorities. In addition, approval policies, laws or regulations, or the type and amount of clinical data necessary
to gain approval may change during the course of a product candidate’s clinical development and may vary among jurisdictions. It
is possible that none of our existing product candidates or any product candidates that we may seek to develop in the future will ever
obtain regulatory approval. This lengthy approval process as well as the unpredictability of future clinical trial results may result
in the failure to obtain regulatory approval to market any of our product candidates as part of our collaborator products, which would
significantly harm our underlying businesses, financial condition and results of operations. The FDA and comparable foreign regulatory
authorities have substantial discretion in the approval process, and determining when or whether regulatory approval will be obtained
for any of our product candidates. Prior to obtaining approval to commercialize a product candidate in the United States or elsewhere,
we or our collaborators must demonstrate with substantial evidence from well-controlled clinical trials, and to the satisfaction of the
FDA or comparable foreign regulatory agencies, that such product candidates are safe and effective for their intended uses. Results from
nonclinical studies and clinical trials can be interpreted in different ways. Even if we believe the data collected from clinical trials
of our product candidates is promising, such data may not be sufficient to support approval by the FDA or comparable foreign regulatory
authorities.
21
If we, our subsidiary(ies), or our collaborators are unable to
obtain the requisite regulatory approvals or there is a delay in obtaining such approvals as a result of negative market perception or
heightened regulatory standards, such product candidates will not be commercialized, which would negatively impact our business and results
of operations.
Our medical cannabis activity exposes us to
legal and reputational risks associated with the cannabis industry.
Our involvement in cannabis-related activity through our subsidiary
may expose us to legal and reputational risks. Such risks include:
| ◾ |
enhanced regulation in Israel with respect to our cannabis-related
activities. In particular, Israeli regulation requires that we obtain a specific permit for each of the following activities: research,
propagation, cultivation, production, marketing and distribution and use; |
| ◾ |
a lack of clarity with respect to the regulation of cannabis products
for medical use purposes in Israel. The current regulatory requirements in Israel may be subject to differing interpretations. This creates
a risk of differing enforcement policies by the Israeli authorities, which may change with or without notice. If the Israeli authorities
begin to enforce laws relating to cannabis in a manner that differs from the current interpretation of such laws, the Company’s
business, results of operations, financial condition and prospects and the Company generally may be materially adversely affected. Similarly,
any changes in laws, regulations, guidelines, enforcement policies, and/or interpretations by the relevant government authorities in jurisdictions
where the Company may market and/or sell its cannabis products in the future, may likewise result in significant additional compliance
costs for us or limit our ability to operate in certain jurisdictions; |
| ◾ |
certain banks will not accept deposits from or provide other bank services to businesses involved with cannabis; |
| ◾ |
third parties with whom we do business may perceive that they are exposed to reputational risk as a result of our cannabis-related
business activities and may ultimately elect not to do business with us; |
| ◾ |
certain investors or investment banks are reluctant to work with companies affiliated with activity in the cannabis industry;
|
| ◾ |
future sales of medical cannabis products may expose us to consumer complaints or legal claims with respect to product quality or
activity; and |
| ◾ |
increased premiums under our DO liability insurance policies. |
Any of the foregoing factors could adversely affect our business
and results of operations.
The cost we incur in procuring a DO liability
insurance has substantially increased during the last years. If this trend continues, it will have an adverse effect on our results of
operations.
DO liability insurance is intended to cover the liability
of the individuals serving as our directors and management, from losses incurred as a result of such service, our liability to indemnify
such individuals for such losses and to protect us from certain securities claims. Although during 2022 there was a decrease in the cost
of DO insurance, during recent years, there has been a significant increase in these costs for smaller, dual-listed public companies
such as our Company. These increases have been tied to perceived heightened levels of risk for DO insurers. Insurers have been increasing
their level of compensation (in the form of premiums), which they believe has not been commensurate with the risk being taken by them.
In parallel, there has been an increase in the amounts of the deductibles payable by public companies in situations in which an insurable
event occurs. In addition, several insurers are restricted from writing policies for companies active in the area of cannabis, which restricts
the number of insurers that can provide us with a DO liability insurance and limits our ability to negotiate the terms of such insurance.
If these trends continue, it will increase our operational expenses and have a negative effect on our financial results.
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Disruption to our information technology and
systems, or those of our subsidiaries, including a security breach or unauthorized access to our data, our customer’s data, or our
platform, could adversely affect our reputation and future demand for our products or collaborative relationships, which may have a material
adverse effect on our business and results of operations.
Our computational technologies rely on our information technology,
or IT, system to collect and analyze the biological and chemical data, which includes several petabytes of data that we produce,
review, and store. Our IT is also involved with the collection, storage, processing, transmission and other use of data, including certain
confidential, sensitive, and personal information, including those relating to our research, studies, and participants. More generally,
in the ordinary course of our business, we collect, store, transmit and otherwise process large amounts of sensitive corporate, personal
and other information, including intellectual property, proprietary business information, and other confidential information. Any security
breach, data loss, or other compromise, including those resulting from a cybersecurity attack, phishing attack, or any unauthorized access,
unauthorized usage, virus or similar breach or disruption could result in the loss or destruction of or unauthorized access to, or use,
alteration, disclosure, or acquisition of, data, damage to our reputation, loss of intellectual property protection, claims and litigation,
regulatory investigations, or other liabilities. For example, we may become the target of cyber-attacks by third parties seeking unauthorized
access to our or our customers’ data or to disrupt our ability to provide our services. These attacks may come from individual hackers,
criminal groups, and state-sponsored organizations. Ransomware attacks, including those from organized criminal threat actors, nation-states,
and nation-state supported actors, are becoming increasingly prevalent and severe, and can lead to significant interruptions in our operations,
loss of data and income, reputational loss, diversion of funds, and may result in fines, litigation and unwanted media attention. Extortion
payments may alleviate the negative impact of a ransomware attack, but we may be unwilling or unable to make such payments due to, for
example, applicable laws or regulations prohibiting payments. Additionally, companies have, in general, experienced an increase in phishing,
social engineering and other attacks from third parties in connection with the COVID-19 pandemic, and the increase in remote working further
increases these and other security threats. While we are constantly subject to common cyber-attacks including phishing, hacking, encryption,
viruses, man/monkey in the middle, etc. from time-to-time, to date, we have not reasonably identified any breach of our systems and therefore
do not believe that any such attacks have individually or in the aggregate led to costs or consequences which have materially impacted
our operations or business. If our security measures are breached as a result of third-party action, employee error or negligence, a defect
or bug in our offerings or those of our third-party service providers, malfeasance or otherwise and, as a result, someone obtains unauthorized
access to any data, including our confidential, sensitive, or personal information or the confidential, sensitive, or personal information
of our customers, or other persons, or any of these types of information is lost, destroyed, or used, altered, disclosed, or acquired
without authorization, or if any of the foregoing is perceived to have occurred, our reputation may be damaged, our business may suffer,
and we could incur significant liability, including under applicable data privacy and security laws and regulations.
Even the perception
of inadequate security may damage our reputation and market position, negatively impacting our ability to win new customers and retain
and receive timely payments from existing customers. Further, we could be required to expend significant capital and other resources to
protect against and address any data security incident or breach, which may not be covered or fully covered by our insurance and which
may involve payments for investigations, forensic analyses, regulatory compliance, breach notification, legal advice, public relations
advice, system repair or replacement, or other services. We and our collaborators, subsidiaries, and service providers also may face difficulties
or delays in identifying or responding to, and remediating and otherwise responding to, cyberattacks and other security breaches and incidents.
We have made significant efforts to protect against and address potential impacts of security breaches and incidents, and anticipate doing
so in the future. Additionally, we may be required to notify such breaches to regulators and/or individuals and operate to mitigate damages,
which may result in us incurring additional costs.
Our subsidiaries, collaborators, and other service providers store
and otherwise process our data, including personal, confidential, sensitive, and other information about individuals and ongoing research
projects. Such entities may also be the targets of cyberattacks, malicious software, phishing schemes, and fraud. Our ability to monitor
the data security of such entities is limited, and, in any event, bad actors may be able to circumvent such security measures, resulting
in the unauthorized access to, misuse, acquisition, disclosure, loss, alteration, or destruction of our data, including confidential,
sensitive, and other information about individuals and our ongoing research.
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Techniques used to sabotage or obtain unauthorized access to systems
or networks are constantly evolving and, in some instances, are not identified until after they have been launched against a target. We,
our subsidiaries, collaborators, and our service providers may be unable to anticipate these techniques, react in a timely manner, or
implement adequate preventative and mitigating measures. If we are unable to efficiently and effectively maintain and upgrade our system
safeguards, we may incur unexpected costs and certain of our systems may become more vulnerable to unauthorized access or disruption.
Any of the foregoing could have a material adverse effect on our business, financial condition, results of operations, market position,
and reputation.
We have established an internal information security committee,
that meets from time to time to provide guidelines and address security issues, but we can provide no assurance that our current IT system
is fully protected against third-party intrusions, viruses, hacker attacks, information or data theft or other similar threats. Disruption
or failure of our IT system due to technical reasons, cyberattacks, natural disasters or other unanticipated catastrophic events, including
power interruptions, storms, fires, floods, earthquakes, terrorist attacks and wars could significantly impair our internal development
efforts. We maintain an off-site date recovery site that is used for the retention of critical data to enable a potential recovery
in case of any of the described disasters.
As we continue to develop our computational technologies and expand
our datasets, we may need to update our IT system and storage capabilities. However, if our existing or future IT system does not function
properly, or if the IT system proves incompatible with our new technologies, we could experience interruptions in data transmissions and
slow response times, preventing us from completing routine research and business activities, which could adversely affect our business
and results of operations.
Development of our product candidates, particularly
during our validation and testing activities, may be adversely affected by circumstances caused by us or those beyond our control.
The industries we are engaged in are subject to various factors
that make our operations relatively unpredictable from period to period. For example, the testing of our product candidates may be adversely
affected by circumstances both caused by us and those that are beyond our control. Factors caused by us include any failure by us or our
collaborators to follow proper agronomic practice or suggested protocols for conducting our experiments, and failure to successfully complete
such experiments. Factors beyond our control include weather and climatic variations, such as droughts or heat stress, or other factors
we are unable to identify. For example, if there was prolonged or permanent disruption to the electricity, climate control or water supply
operating systems in our greenhouses or laboratories, the plants and pests on which we test our discoveries and product candidates and
the samples we store in freezers, both of which are essential to our research and development activities, would be severely damaged or
destroyed, adversely affecting our research and development activities and thereby our business and results of operations. We have experienced
these kind of failures in the past for unknown reasons, causing delays in our achievement of milestones and delivery of results, and necessitating
that we re-start the trials. Any test failure we may experience is not covered by our insurance policy, and therefore could result in
increased cost of the trials and development of our product candidates, which may negatively impact our business and results of operations.
Our business could be disrupted
by catastrophic events, such as the outbreak of COVID-19.
The COVID-19 pandemic has caused substantial global disruptions,
including in the jurisdictions where we develop our products and conduct business and may cause additional disruptions in the future.
Some of the effects that pandemic had on us were supply chain disruptions,
travel bans, governmental order or employee exposure which caused us, our customers and our suppliers delays in operations such as reduction
of routes available from certain carriers, yet none of these effects were material to our business or financials results.
While most of the COVID-19 restrictions have been lifted around
the world, there are still regions that are subject to new developing regulations. While as of yet, the pandemic has not adversely affected
our business and financial results, the extent of future impact on our business and the global economy remains uncertain. As the pandemic
continues to evolve, and we will continue to monitor the developments closely.
The occurrence of unforeseen or catastrophic events such as terrorist
attacks, extreme terrestrial or solar weather events or other natural disasters, emergence of a pandemic, or other widespread health emergencies
(or concerns over the possibility of such an emergency), could create economic and financial disruptions, and could lead to operational
difficulties that could impair our ability to manage our business.
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Consumer and government
resistance to genetically modified organisms, or GMOs, may negatively affect our public image and reduce potential sales of plants containing
our traits.
A certain part of our seed traits activity includes research and
development of genetically modified, or GM, seeds. Foods made from such seeds are not accepted by many consumers and in certain countries
production of certain GM crops is effectively prohibited, including throughout the European Union, or EU, due to concerns over such
products’ effects on food safety and the environment. Other jurisdictions and governmental authorities, including in South America
and Asia, are increasingly taking an interest in regulating agricultural products of biotechnology. Regulatory approaches vary by jurisdiction
as a result of the existing public health frameworks and phytosanitary laws, as well as other less tangible factors such as cultural and
religious norms that may have an impact on individual country risk assessments and decision-making. Each jurisdiction may have its own
regulatory framework, which may include restrictions and regulations on planting and growing genetically engineered plants, import of
grain and other plant products, and in the consumption and labeling of feed and foods derived from such novel plants, and which may apply
to future products containing our traits. The high public profile of biotechnology agriculture, especially in food production, and lack
of consumer acceptance of products to which we have devoted substantial resources could negatively affect our public image and results
of operations. For example, the prohibition on the production of certain GM crops in select countries and the current resistance from
consumer groups, particularly in Europe, to GM crops not only limits our access to such markets but also has the potential to spread to
and influence the acceptance of products developed through biotechnology in other regions of the world and may also influence regulators
in other countries to limit or ban production of GM crops, which could limit the commercial opportunities to exploit biotechnology. Moreover,
regulation of all genetically engineered plants in the EU is far more stringent than in the U.S. and Canada. U.S. and Canadian regulators
have determined that genome edited plants pose fewer risks than traditional biotechnology-derived plants subjected to modification through
the insertion of recombinant DNA. In contrast, a recent EU legal ruling indicated that the existing EU regulations for genetically engineered
plants modified by the insertion of recombinant DNA, which were already more stringent than corresponding U.S. and Canadian regulations,
should be strictly applied to genome edited plants as well. As a result, there is a sharp distinction between how EU and U.S. and Canadian
regulatory agencies oversee novel seed traits, and in particular those that are generated using the more modern techniques of genome editing.
Although we are not currently targeting EU markets for the development
or commercialization of future products containing our traits, emerging oversight regimes for genetically engineered products in other
jurisdictions may follow the EU approach and impose similarly strict requirements for the release of such products into the environment
and their incorporation into human food or other consumer products. Such jurisdictions may also elect to regulate genetically engineered
plants without distinguishing between traditional biotechnology-derived plants modified with recombinant DNA and genome edited plants.
There is no guarantee that countries for which we may have or may develop future marketing plans would not take a stricter legal and regulatory
approach to controlling genetically engineered plants similar to that of the EU, which could increase regulatory costs and delay, prevent
or limit our or our future collaborators’ ability to market our traits in such jurisdictions.
GM crops are grown principally in the United States, Brazil and
Argentina where there are fewer restrictions on the production of GM crops. If these or other countries where GM crops are grown enact
laws or regulations that ban the production of such crops or make regulations more stringent, we could experience a longer product development
cycle for our product candidates and may even have to abandon projects related to certain crops or geographies, both of which would negatively
affect our business and results of operations and could cause us to have to cease operations. Furthermore, any changes in such laws and
regulations or consumer acceptance of GM crops could negatively impact our collaborators, who in turn might terminate or reduce the scope
of their collaborations with us or seek to alter the financial terms of our agreements with them.
We currently need, and in the future we may
need to obtain licenses of third-party technology that may not be available to us or are available only on commercially unreasonable terms,
and which may cause us to operate our business in a more costly or otherwise adverse manner that was not anticipated.
We currently need, and in the future we may be required to license
technology from third parties to further develop or commercialize our investigational products. Should we be required to obtain licenses
to any third-party technology, such licenses may not be available to us on commercially reasonable terms, or at all. The inability to
obtain any third-party license required to develop or commercialize any of our products could cause us to abandon any related efforts,
which could seriously harm our business and operations.
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The licenses we grant to our collaborators
to use our discoveries are in most cases exclusive with respect to a specified discovery, product type or market area. This may limit
our opportunities to enter into additional licensing or other arrangements with respect to such discoveries, product types or market areas.
Most of the licenses we grant our collaborators to our product
candidates or to use specific discoveries we have made are exclusive in the market area of the license. That means that once these discoveries
are licensed to a collaborator, we are generally prohibited from licensing those discoveries to any third party for use in such area.
The limitations imposed by these exclusive licenses could prevent us from expanding our business and increasing our exposure to new licensees,
both of which could adversely affect our business and results of operations.
We may be required to pay substantial
damages as a result of product liability, warranty liability, or personal injury claims and litigation.
Once products integrating our discoveries and product candidates
reach commercialization, if ever, product liability, warranty liability, personal injury, or other litigation claims may become a commercial
risk to our business, particularly as some of the products that we develop may be harmful to humans or to the environment. Moreover, as
our portfolio of available products expands, we may experience increases in product liability claims asserted against us. Courts have
awarded substantial damages in the United States and elsewhere against a number of companies in the agriculture and human health industries
in past years based upon claims for injuries allegedly caused by the use of their products. Product liability claims against us and/or
our collaborators selling products that contain our product(s) or allegations of product liability relating to products containing our
discoveries may damage our reputation, harm our relationships with our collaborators, and materially and adversely affect our business,
results of operations, financial condition and prospects. Currently, we and/or our subsidiaries maintain an insurance policy according
to the specific needs of each company, which may include commercial insurance, self-insurance (including direct risk retention), or a
combination of both approaches, in amounts and on terms that we believe are reasonable and prudent in light of our business and related
risks. We currently do not carry specific product liability insurance coverage; however, we intend to obtain such insurance for Lavie
Bio in the next renewal process, to cover any sales to the U.S. market. Any such insurance we may obtain in the future on these
operations may be expensive and may not cover our potential liability in full. In addition, we may be subject to claims for which insurance
coverage that we do carry is denied, as well as claims that exceed our policy limits. As a result, we may not be able to obtain the
type and amount of insurance we desire, or any insurance on reasonable terms, in the markets in which we operate. Furthermore, while
our collaboration agreements typically require that our collaborators indemnify us for the cost of product liability claims brought against
us, such indemnification provisions may not be enforceable, and we may receive no indemnification if our own misconduct led to the claims.
Any litigation could force us to incur significant expenses,
divert management's time and attention, subject us to adverse publicity, and damage our reputation and competitive position. A successful
assertion of a claim against us may result in potentially significant monetary damages, penalties, or fines and adversely affect sales
of our products. Costs or payments made in connection with warranty and product liability claims and recalls could adversely affect our
financial condition and results of operations in a material manner.
Our facilities, in Israel and in the U.S.,
are located on leased properties. Termination of any of the leases, changes in lease terms, and long-term leases that may not be terminated
at will may jeopardize our activity and materially affect our financial condition or results of operations.
Our office spaces, labs, facilities, and farm are all situated
on properties that we lease pursuant to lease agreements, in Israel and in the U.S. Once a lease agreement ends, we may not be able to
renew it on favorable terms, or not at all, which may require us to increase our lease payments or take a new lease in another property,
adversely affecting our business and results of operations. In addition, a long-term lease may mean no or limited possibility to terminate
the lease at will before the completion of the lease period, which may lead to continued holding of an un-needed space or entry into a
sub-lease, which may adversely affect our results of operations. For more information regarding our facilities, please see “Item
4. Information on the Company—D. Property, Plants and Equipment.”
Lavie Bio’s research and development
facility in the U.S., our contracts with foreign businesses and any other current or future operations outside of Israel expose us to
additional market and operational risks, and failure to manage these risks may adversely affect our business and operating results.
Lavie Bio’s research and development facility in St. Louis,
Missouri may expose us to some of such operational risks, including:
| ◾ |
fluctuations in foreign currency exchange rates and rising global inflation; |
26
| ◾ |
potentially adverse tax consequences; |
| ◾ |
difficulties in staffing and managing foreign operations; |
| ◾ |
hiring and retention of employees and/or consultants under foreign employment laws which are not familiar to us; |
| ◾ |
laws and business practices that sometimes favor local business; |
| ◾ |
compliance with foreign legislation, being subject to laws, regulations and the court systems of multiple jurisdictions; and
|
| ◾ |
tariffs, trade barriers and other regulatory or contractual limitations on our ability to develop (and, when applicable in the future,
sell) our solutions in certain foreign markets. |
Failure to manage the market and operational risks associated with
international operations effectively could limit the future growth of our business and adversely affect our operating results.
Our operations are subject to various health
and environmental risks associated with our use, handling and disposal of potentially toxic materials.
Our operations involve various health and environmental risks.
For example, as part of our seed traits operations, we assist in the development of GM crops by inserting new genes into the genomes of
certain plants. Though we introduce these genes in order to improve plant traits, we cannot always predict the effect that these genes
may have on the plant. In some cases, the genes may render the plant poisonous or toxic, or they may cause the plant to develop other
dangerous characteristics that could harm the plant’s surrounding environment. Furthermore, while we comply with relevant environmental
laws and regulations, there is a risk that, when testing genetically modified plants, the seeds of these plants may escape the greenhouse
or field in which they are being tested and contaminate nearby fields. Poisonous or toxic plants may therefore be inadvertently introduced
into the wild, or possibly enter the food production system, harming the people and animals who come in contact with them.
Moreover, as part of Lavie Bio’s operations, it develops
novel product candidates based on microbes in order to improve plants traits. Although microbes exist naturally in the environment, we
cannot always predict the effect that microbes have on the plant and its environment. There may be cases where the microbes render the
plant poisonous or toxic, or they may cause the plant to develop other dangerous characteristics that could harm the plant’s surrounding
environment.
Similar risks are relevant to our Ag-Seeds division operations, especially with respect
to GM seeds, AgPlenus’ ag-chemicals operations, Canonic’s cannabis operations and Casterra’s castor bean operations.
Changes in laws and regulations to which we
are subject, or to which we may become subject in the future, may materially increase our costs of operation, decrease our operating revenues
and disrupt our business.
Laws and regulatory standards and procedures that impact our business
are continuously changing. Responding to these changes and meeting existing and new requirements may be costly and burdensome. Changes
in laws and regulations may occur that could:
| ◾ |
impair or eliminate our ability to research and develop our product candidates, including validating our product candidates through
lab, greenhouse, field or clinical trials; |
| ◾ |
increase our compliance and other costs of doing business through increases in the cost to patent or otherwise protect our intellectual
property or increases in the cost to our collaborators to obtain the necessary regulatory approvals to commercialize and market the product
candidates we develop with them; |
27
| ◾ |
require significant product redesign or systems redevelopment; |
| ◾ |
render our product candidates less profitable, obsolete or less attractive compared to competing products; |
| ◾ |
affect our collaborators’ willingness to do business with us; |
| ◾ |
jeopardize import or export of raw material or end products, such as with respect to medical cannabis seeds, seedlings and products;
|
| ◾ |
reduce the amount of revenues we receive from our collaborators through milestone payments or royalties; and |
| ◾ |
discourage our collaborators from offering, and consumers from purchasing, products that incorporate our discoveries. |
Any of these events could have a material adverse effect on our
business, results of operations and financial condition. For example, legislators and regulators have increased their focus on plant biotechnology
in recent years, with particular attention paid to GM crops as well as on ag-chemicals.
While none of our product candidates are currently available for
sale, other than Casterra’s castor seeds, medical cannabis products by Canonic and bio-inoculants by Lavie Bio, our future growth
relies on our ability and the ability of our collaborators to commercialize and market our product candidates, and any restrictions on
such activities could materially and adversely impact our business and results of operations. Any changes in regulations in countries
where our product candidates are used could result in our collaborators being unable or unwilling to develop, commercialize or sell products
that incorporate our discoveries. In addition, we rely on patents and other forms of intellectual property protection. Legislation
and jurisprudence on patent protection in the key target markets where we seek patent protection, such as the United States and the EU,
is evolving and changes in laws could affect our ability to obtain or maintain patent protection for our product candidates. Any changes
to these existing laws and regulations may materially increase our costs of operation, decrease our operating revenues and disrupt our
business. For more information please see ‘Government Regulation of our Operations’ and ‘Government Regulation of Product
Candidates’ paragraphs under the description of each of our activity divisions and subsidiaries under “Item 4. Information
on the Company—B. Business Overview.”
We are subject to evolving corporate governance
and public disclosure regulations and expectations, including with respect to environmental, social and governance matters that could
expose us to numerous risks.
We are subject to changing rules and regulations promulgated by
a number of governmental and self-regulatory organizations, including the SEC and Nasdaq. These rules and regulations continue to evolve
in scope and complexity and many new requirements have been created in response to laws enacted by Congress, making compliance difficult
and uncertain. In addition, increasingly regulators, customers, investors, employees and other stakeholders are focusing on environmental,
social and governance, or ESG, matters and related disclosures. These changing rules, regulations and stakeholder expectations could result
in increased general and administrative expenses and increased management time and attention spent complying with or meeting such regulations
and expectations. For example, developing and acting on ESG initiatives, and collecting, measuring, and reporting ESG information and
metrics, can be costly, difficult and time consuming and is subject to evolving reporting standards, including the SEC’s proposed
climate-related reporting requirements. We may also communicate certain initiatives and goals regarding environmental matters, diversity,
responsible sourcing, social investments and other ESG matters in our SEC filings or in other public disclosures. These initiatives and
goals could be difficult and expensive to implement, the technologies needed to implement them may not be cost effective and may not advance
at a sufficient pace, and ensuring the accuracy, adequacy, or completeness of the disclosure of our ESG initiatives can be costly, difficult
and time-consuming. We may be affected by market or regulatory responses to climate change.
Growing public concern about climate change has resulted in the
increased focus of local, state, regional, national and international regulatory bodies on greenhouse gas, or GHG, emissions and climate
change issues.
In the United States, President Joe Biden has made climate change
and the limitation of GHG emissions one of his primary objectives. We may also incur additional expenses as a result of U.S. and international
regulators requiring additional disclosures regarding GHG emissions. Compliance with such regulation and the associated potential cost
is complicated by the fact that various countries and regions are following different approaches to the regulation of climate change.
28
Growing cycles and adverse weather conditions may decrease our
results from operations.
Our operations are affected by the growing cycles of the crops,
including castor beans, that we plant, test and manufacture for our and our subsidiaries’ products. We set our planting schedules
without knowing the effect of the weather on the crops or on the entire industry’s production. Weather conditions during the course
of each crop’s growing season will affect the volume and growing time of that crop.
Risks Related to Our Intellectual Property Rights
Our success depends on our ability to protect
our intellectual property and our proprietary technologies.
Our commercial success depends in part on our ability to obtain
and maintain patent protection and trade secret protection for our proprietary computational and experimental technologies, our discoveries
and their uses, as well as our ability to operate without infringing upon the proprietary rights of others. If we do not adequately protect
our intellectual property, competitors may be able to use our technologies and erode or negate any competitive advantage we may have,
which could harm our business and ability to achieve profitability.
While we expect our patent applications to receive approval, we
cannot be certain that we will obtain such results. Despite our efforts to protect our proprietary rights, unauthorized third parties
may attempt to use, copy or otherwise obtain and market or distribute our intellectual property rights or technology or otherwise develop
products or solutions with the same functionality as our solutions. In addition, the laws of some foreign countries provide less protection
for proprietary rights than U.S. law. We face the occasional risk, moreover, that third parties may assert copyright, trademark and other
intellectual property rights against us. Such claims may result in direct or indirect liability as we have contractually agreed to indemnify
certain parties for any damages suffered as a result of infringement by us of any third-party intellectual property rights.
If we are unable to protect the confidentiality
of our trade secrets, the value of our technology could be materially adversely affected and our business would be harmed.
We treat our proprietary computational and experimental technologies,
including unpatented know-how and other proprietary information, as trade secrets. We seek to protect these trade secrets, in part, by
entering into non-disclosure and confidentiality agreements with any third parties who have access to them, such as our consultants, independent
contractors, advisors, corporate collaborators and outside scientific collaborators. We also enter into confidentiality and invention
or patent assignment agreements with employees and certain consultants. Any party with whom we have executed such an agreement may breach
that agreement and disclose our proprietary information, including our trade secrets, and we may not be able to obtain adequate remedies
for such breaches. Enforcing a claim that a party illegally disclosed or misappropriated a trade secret is difficult, expensive and time-consuming,
and the outcome is unpredictable. In addition, if any of our trade secrets were to be lawfully obtained or independently developed by
a competitor, we would have no right to prevent such third party, or those to whom it communicates that technology or information, from
using that technology or information to compete with us. If any of our trade secrets were to be disclosed to or independently developed
by a competitor, or if we otherwise lose protection for our trade secrets or proprietary know-how, the value of this information may be
greatly reduced and our business and competitive position could be harmed.
We may not be able to protect our intellectual
property rights throughout the world.
Filing, prosecuting, maintaining and defending patents on product
candidates in all countries throughout the world would be prohibitively expensive, and our intellectual property rights in some countries
outside the United States are less extensive than those in the United States. In addition, the laws of some foreign countries do not protect
intellectual property rights to the same extent as federal and state laws in the United States. Consequently, we are unable to prevent
third parties from using our inventions in all countries outside the United States, or from selling or importing products made using our
inventions in and into the jurisdictions in which we do not have patent protection. Competitors may use our technologies in jurisdictions
where we have not obtained patent protection to develop their own products, and we may be unable to prevent such competitors from importing
those infringing products into territories where we have patent protection but enforcement is not as strong as in the United States. These
products may compete with our product candidates and our patents and other intellectual property rights may not be effective or sufficient
to prevent them from competing in those jurisdictions. Moreover, farmers or others in the chain of commerce may raise legal challenges
against our intellectual property rights or may infringe upon our intellectual property rights, including through means that may be difficult
to prevent or detect. For example, the practice by some farmers of saving seeds from non-hybrid crops (such as soybeans, canola and cotton)
containing biotechnological traits may prevent us from realizing the full value of our intellectual property in countries outside of the
United States.
29
Many companies have encountered significant problems in protecting
and defending intellectual property rights in foreign jurisdictions, including China, where we have filed patent applications. The legal
systems of certain countries, including China, have not historically favored the enforcement of patents or other intellectual property
rights, which could hinder us from preventing the infringement of our patents or other intellectual property rights and result in substantial
risks to us. Proceedings to enforce our patent rights in the United States or foreign jurisdictions could result in substantial costs
and divert our efforts and attention from other aspects of our business, could put our patents at risk of being invalidated or interpreted
narrowly and our patent applications at risk of not issuing and could provoke third parties to assert patent infringement or other claims
against us. We may not prevail in any lawsuits that we initiate and the damages or other remedies awarded, if any, may not be commercially
meaningful. Accordingly, our efforts to enforce our intellectual property rights around the world may be inadequate to obtain a significant
commercial advantage from the intellectual property that we develop or license from third parties.
If we or one of our collaborators are sued for infringing the intellectual
property rights of a third party, such litigation could be costly and time consuming and could prevent us or our collaborators from developing
or commercializing our product candidates.
Our ability to generate significant revenues from our product candidates
depends on our and our collaborators’ ability to develop, market and sell our product candidates and utilize our proprietary technology
without infringing the intellectual property and other rights of any third parties. In the United States and abroad there are numerous
third party patents and patent applications that may be applied toward our proprietary technology, business processes or product candidates,
some of which may be construed as containing claims that cover the subject matter of our product candidates or intellectual property.
Because of the rapid pace of technological change, the confidentiality of patent applications in some jurisdictions, and the fact that
patent applications can take many years to issue, there may be currently pending applications that are unknown to us that may later result
in issued patents upon which our product candidates or proprietary technologies infringe. Similarly, there may be issued patents relevant
to our product candidates of which we are not aware. These patents could reduce the value of the product candidates we develop or, to
the extent they cover key technologies on which we have unknowingly relied, require that we seek to obtain licenses or cease using the
technology, no matter how valuable to our business. We may not be able to obtain such a license on commercially reasonable terms. There
is a substantial amount of litigation involving patent and other intellectual property rights in the biotechnology industry generally.
If any third party patent or patent application covers our intellectual property or proprietary rights and we are not able to obtain a
license to it, we and our collaborators may be prevented from commercializing products containing our discoveries.
As the biotechnology industry continues to develop, we may become
party to, or threatened with, litigation or other adverse proceedings regarding intellectual property or proprietary rights in our technology,
processes or product candidates. Third parties may assert claims based on existing or future intellectual property rights and the outcome
of any proceedings is subject to uncertainties that cannot be adequately quantified in advance. Any litigation proceedings could be costly
and time consuming and negative outcomes could result in liability for monetary damages, including treble damages and attorneys’
fees if we are found to have willfully infringed a patent. There is also no guarantee that we would be able to obtain a license under
such infringed intellectual property on commercially reasonable terms or at all. A finding of infringement could prevent us or our collaborators
from developing, marketing or selling a product candidate or force us to cease some or all of our business operations. Even if we are
successful in these proceedings, we may incur substantial costs and the time and attention of our management and scientific personnel
may be diverted as a result of these proceedings, which could have a material adverse effect on us. Claims that we have misappropriated
the confidential information or trade secrets of third parties could similarly have a negative impact on our business.
We may be required to pay royalties to employees
who develop inventions that have been or will be commercialized by us, even if the rights to such inventions have been assigned to us
and the employees have waived their rights to royalties or other additional compensation.
A significant portion of our intellectual property has been developed
by our employees in the course of their employment for us. Under the Israeli Patent Law, 5727-1967, or the Patent Law, inventions conceived
by an employee in the course and as a result of or arising from his or her employment with a company are regarded as “service inventions,”
which belong to the employer, absent a specific agreement between the employee and employer giving the employee proprietary rights. The
Patent Law also provides under Section 134 that if there is no agreement between an employer and an employee as to whether the employee
is entitled to consideration for service inventions, and to what extent and under which conditions, the Israeli Compensation and Royalties
Committee, or the Committee, a body constituted under the Patent Law, shall determine these issues. Section 135 of the Patent Law provides
criteria for assisting the Committee in making its decisions. According to decisions of the Committee, an employee’s right to receive
consideration for service inventions is a personal right and is entirely separate from the proprietary rights in such invention. Therefore,
this right must be explicitly waived by the employee. A decision handed down in May 2014 by the Committee clarifies that the right to
receive consideration under Section 134 can be waived and that such waiver can be made orally, in writing or by behavior like any other
contract. The Committee will examine, on a case by case basis, the general contractual framework between the parties, using interpretation
rules of the general Israeli contract laws. Further, the Committee has not yet determined one specific formula for calculating this remuneration,
nor the criteria or circumstances under which an employee’s waiver of his right to remuneration will be disregarded. Similarly,
it remains unclear whether waivers by employees in their employment agreements of the alleged right to receive consideration for service
inventions should be declared as void being a depriving provision in a standard contract. All of our employees execute invention assignment
agreements upon commencement of employment, in which they assign their rights to potential inventions and acknowledge that they will not
be entitled to additional compensation or royalties from commercialization of inventions. Although our employees have agreed to assign
to us service invention rights and have specifically waived their right to receive any special remuneration for such service inventions
beyond their regular salary and benefits, we may face claims demanding remuneration in consideration for assigned inventions.
30
Changes in U.S. patent law could diminish the
value of patents in general, thereby impairing our ability to protect our product candidates.
As is the case with other biotechnology companies, our success
is heavily dependent on intellectual property, particularly patents. Obtaining and enforcing biotechnology patents involves technological
and legal complexity, and is costly, time consuming, and inherently uncertain. In addition, the U.S. Supreme Court has ruled on several
patent cases, either narrowing the scope of patent protection available in certain circumstances or weakening the rights of patent owners
in certain situations. In addition to increasing uncertainty with regard to our ability to obtain patents in the future, this combination
of events has created uncertainty with respect to the value of patents, once obtained. Depending on decisions by the U.S. Congress, the
federal courts, and the U.S. Patent and Trademark Office, the laws and regulations governing patents could change in unpredictable ways
that may weaken or undermine our ability to obtain new patents or to enforce our existing patents and patents we might obtain in the future.
Our employment agreements with our employees
and other agreements with our collaborators and third parties may not adequately prevent disclosure of trade secrets, know-how and other
proprietary information.
A substantial portion of our technologies and intellectual property
is protected by trade secret laws. We rely on a combination of patent and other intellectual property laws as well as our employment agreements
with our employees and other agreements with our collaborators and third parties to protect and otherwise seek to control access to, and
distribution of, our proprietary information. These measures may not prevent disclosure, infringement or misappropriation of our confidential
information. Our confidentiality, nondisclosure and assignment agreements or covenants may be breached, and we may not have adequate remedies
for such a breach that would effectively prevent the further dissemination of our confidential information. We have limited control over
the protection of trade secrets used by our collaborators and could lose future trade secret protection if any unauthorized disclosure
of such information occurs. In addition, others may independently discover our trade secrets and proprietary information, and in such
cases we could not assert any trade secret rights against such parties. Laws regarding trade secret rights in certain markets where we
operate may afford little or no protection of our trade secrets. Failure to obtain or maintain trade secret protection could adversely
affect our business, sales and competitive position.
We may not be able to fully enforce covenants
not to compete with our key employees, and therefore we may be unable to prevent our competitors from benefiting from the expertise of
such employees.
Our employment agreements with key employees, which include executive
officers, contain non-compete provisions. These provisions prohibit our key employees, if they cease working for us, from competing directly
with us or working for our competitors for one year. Under applicable U.S. and Israeli laws, we may be unable to enforce these provisions.
If we cannot enforce the non-compete provisions with our key employees, we may be unable to prevent our competitors from benefiting from
the expertise of such employees. Even if these provisions are enforceable, they may not adequately protect our interests. The defection
of one or more of our employees to a competitor could materially adversely affect our business, results of operations and ability to capitalize
on our proprietary information.
31
Risks Relating to Our Incorporation and Location in Israel
Conditions in Israel could adversely affect
our business.
We are incorporated under Israeli law and our principal offices
and research and development facilities are located in Israel. Accordingly, political, economic and military conditions in Israel directly
affect our business. Since the State of Israel was established in 1948, a number of armed conflicts have occurred between Israel and its
Arab neighbors. In recent years there has been an increase in unrest and terrorist activity, and several times since 2005 (when Israel
withdrew from the Gaza Strip) conflicts arose due to Hamas’ rocket attacks against Israeli civilian targets, during which Israel
responded to rocket attacks by engaging in an armed conflict with Hamas in the Gaza Strip. Our principal place of business is located
in Rehovot, Israel, which is approximately 30 miles from the nearest point of the border with the Gaza Strip. There can be no assurance
that attacks launched from the Gaza Strip will not reach our facilities, or that hostilities will not otherwise cause a significant disruption
to our operations, such as preventing our employees from reaching our facilities and limiting our ability to monitor and otherwise conduct
the crop and other experiments we conduct at the facilities. In addition, Iran has threatened to attack Israel and is widely believed
to be developing nuclear weapons. Iran is also believed to have a strong influence among extremist groups in the region, such as Hamas
in Gaza, Hezbollah in Lebanon, and various rebel militia groups in Syria.
Several countries still restrict doing business with Israel and
Israeli companies, and additional countries may impose restrictions on doing business with Israel and Israeli companies if hostilities
in Israel or political instability in the region continues or increases. These restrictions may limit materially our ability to sell our
product candidates to companies in these countries. While some countries are eliminating these constraints, others may impose restrictions
on doing business with Israel and Israeli companies if hostilities in Israel or political instability in the region continues or increases.
Although the recent Abraham Accords have enhanced Israel’s relations with certain countries in the Middle East (i.e.,
United Arab Emirates, Bahrain, Morocco and Sudan), an ongoing state of hostility, varying in degree and intensity, has caused security
and economic problems for Israel. In addition, there have been increased efforts by activists to cause companies and consumers to boycott
Israeli goods based on Israeli government policies. Such actions, particularly if they become more widespread, may adversely impact our
ability to sell our solutions and therefore may have an adverse impact on our operating results, financial condition or the expansion
of our business.
Any hostilities involving Israel or the interruption or curtailment
of trade between Israel and its present trading partners, or significant downturn in the economic or financial condition of Israel, could
adversely affect our operations and research and development, cause our revenues to decrease and adversely affect the share price of publicly
traded companies having operations in Israel, such as ours. Further, the political and security situation in Israel may result in parties
with whom we have agreements involving performance in Israel claiming that they are not obligated to perform their commitments under those
agreements pursuant to force majeure provisions in such agreements. In addition, there have been increased efforts by activists to cause
companies and consumers to boycott Israeli goods for political reasons. Such actions, particularly if they become more widespread, may
adversely impact our ability to conduct business.
Furthermore, our business insurance does not cover losses that
may occur as a result of events associated with the security situation in the Middle East. Although the Israeli government currently covers
the reinstatement value of direct damages that are caused by terrorist attacks or acts of war, we cannot assure that this government coverage
will be maintained. Any losses or damages incurred by us could have a material adverse effect on our business and financial condition.
In addition, many Israeli citizens are obligated to perform several
days, and in some cases more, of annual military reserve duty each year until they reach the age of 40 (or older, for reservists who are
military officers or who hold certain military positions) and, in the event of a military conflict, may be called to active duty. In response
to increases in terrorist activity, there have been periods of significant call-ups of military reservists. It is possible that there
will be military reserve duty call-ups in the future. Our operations could be disrupted by such call-ups, which may include the call-up
of our key employees and members of our management. Such disruption could materially adversely affect our business, financial condition
and results of operations.
Furthermore, the Israeli government is currently pursuing extensive
changes to Israel’s judicial system. In response to the foregoing developments, individuals, organizations and institutions, both
within and outside of Israel, have voiced concerns that the proposed changes may negatively impact the business environment in Israel
including due to reluctance of foreign investors to invest or transact business in Israel as well as lead to increased currency fluctuations,
downgrades in credit rating, increased interest rates, increased volatility in securities markets, and other changes in macroeconomic
conditions. To the extent that any of these negative developments do occur, they may have an adverse effect on our business, our results
of operations and our ability to raise additional funds, if deemed necessary by our management and board of directors.
32
Exchange rate fluctuations between the U.S.
dollar and the NIS may negatively affect our financial results.
The Company’s reporting currency is U.S. dollars. In view
that a substantial part of our expenses is in NIS, any appreciation of the NIS relative to the U.S. dollar would adversely impact our
financial results. The appreciation (devaluation) of the NIS in relation to the U.S. dollar amounted to (13.2%), 3.3% and 7.0% for the
years ended December 31, 2022, 2021 and 2020, respectively. These fluctuations could cause our results of operations to differ from our
expectations or the expectations of our investors. Additionally, such foreign currency exchange rate fluctuations could make it more difficult
to detect underlying trends in our business and results of operations. As of the data of this annual report, we do not maintain a
program to hedge transactional exposures in certain foreign currencies. If we enter into hedging contracts in the future, we may be unsuccessful
in protecting against currency exchange rate fluctuations. See “Item 11. Quantitative and Qualitative Disclosure About Market Risk—Foreign
Currency Risk.”
We also cannot predict any future trends in the rate of inflation
or deflation in Israel. The Israeli annual rate of inflation (deflation) amounted to (0.7%), 2.8%, and 5.3% for the years ended December
31, 2020, 2021, and 2022, respectively.
Interest rate fluctuations may devalue our
investments and could have an adverse impact on our financial condition.
From time to time we hold corporate bonds and government
treasury notes denominated in NIS and in U.S. dollars. These investments expose us to the risk of interest rate fluctuations. A decrease
in Israeli or in U.S. interest rates could cause the fair value of these investments to decrease.
We have received Israeli government grants
for certain of our research and development activities. The terms of these grants may require us to satisfy specified conditions in order
to manufacture products and transfer technologies supported by such grants outside of Israel. In addition, in some circumstances, we may
be required to pay penalties in addition to repaying the grants.
Our research and development operations have been partly financed
through certain governmental grants. Certain of these grants are royalty-bearing grants under the terms of which we are committed
to pay royalties at a rate of 3.0% on sales proceeds from our products that were developed under Israeli National Authority for Technological
Innovation, or the IIA, programs up to the total amount of grants received, linked to the U.S. dollar and bearing interest at an annual
rate of LIBOR applicable to U.S. dollar deposits. The IIA funding bears annual interest rate based on the 12-month LIBOR. In this regard,
the United Kingdom’s Financial Conduct Authority, which regulates the London Interbank Offered Rate (LIBOR), announced that it will
no longer persuade or require banks to submit rates for LIBOR after January 1, 2022. Accordingly, there is an uncertainty regarding the
interest accrued to the IIA Funding. To date, IIA has not issued any clarification regarding an alternative interest to be used instead
of the LIBOR. In September 2021, the Bank of Israel, which determines annual interest rates, published a directive which stated that annual
interest at a variable rate linked to the LIBOR rate for loans in U.S. dollars will be replaced by the Secured Overnight Financing Rate,
or the SOFR, in June 2023. While it is not currently possible to determine precisely whether, or to what extent, the replacement of LIBOR
with SOFR would affect us, the implementation of SOFR may increase our financial liabilities to the IIA. Management continues to monitor
the status and discussions regarding SOFR. We are not yet able to reasonably estimate the expected impact.
In addition,
these Israeli governmental grants impose certain restrictions on the transfer outside of Israel of the underlying know-how and the manufacturing
or manufacturing rights of the underlying products and technologies. As of December 31, 2022, we had received from the IIA approximately
$8.9 million (including accrued interest) of royalty-bearing grants, and repaid approximately $3.5 million in royalties and an additional
approximately $4.9 million from the IIA in respect of several non-refundable projects. We may not receive the required approvals should
we wish to transfer the know-how, technology or manufacturing rights related to such government grants outside of Israel in the future
or, if we receive such required approvals, they may be subject to certain conditions and payment obligations. See “Item 5. Operating
and Financial Review and Prospects—B. Liquidity and Capital Resources—Government Grants.”
33
It may be difficult to enforce a U.S. judgment
against us, our officers and directors and the Israeli experts named in this annual report in Israel or the United States, or to assert
U.S. securities laws claims in Israel or serve process on our officers and directors and these experts.
We are incorporated in Israel. The majority of our directors and
executive officers reside outside the United States and the majority of our assets are located outside the United States. Therefore, it
may be difficult for an investor, or any other person or entity, to enforce a U.S. court judgment based upon the civil liability provisions
of the U.S. federal securities laws against us or any of these persons in a U.S. or Israeli court, or to effect service of process upon
these persons in the United States. Additionally, it may be difficult for an investor, or any other person or entity, to assert U.S. securities
law claims in original actions instituted in Israel. Israeli courts may refuse to hear a claim based on a violation of U.S. securities
laws on the grounds that Israel is not the most appropriate forum in which to bring such a claim. Even if an Israeli court agrees to hear
a claim, it may determine that Israeli law and not U.S. law is applicable to the claim. If U.S. law is found to be applicable, the content
of applicable U.S. law must be proved as a fact, which can be a time-consuming and costly process. Certain matters of procedure will also
be governed by Israeli law. There is little binding case law in Israel addressing the matters described above.
Your rights and responsibilities as our shareholder
will be governed by Israeli law, which may differ in some respects from the rights and responsibilities of shareholders of U.S. corporations.
Since we are incorporated under Israeli law, the rights and responsibilities
of our shareholders are governed by Israeli law and by our articles of association. These rights and responsibilities differ in some respects
from the rights and responsibilities of shareholders of U.S.-based corporations. In particular, a shareholder of an Israeli company has
a duty to act in good faith and in a customary manner in exercising its rights and performing its obligations towards the company and
other shareholders and to refrain from abusing its power in the company, including, among other things, in voting at the general meeting
of shareholders on certain matters, such as an amendment to the company’s articles of association, an increase of the company’s
authorized share capital, a merger of the company and approval of related party transactions that require shareholder approval. A shareholder
also has a general duty to refrain from discriminating against other shareholders. In addition, a controlling shareholder or a shareholder
who knows that it possesses the power to determine the outcome of a shareholders’ vote or to appoint or prevent the appointment
of an office holder in the company has a duty to act in fairness towards the company. However, Israeli law does not define the substance
of this duty of fairness. See “Item 6. Directors, Senior Management and Employees—C. Board Practices—Shareholder Duties.”
Since Israeli corporate law underwent extensive revisions approximately 20 years ago, the parameters and implications of the provisions
that govern shareholder behavior have not been clearly determined. These provisions may be interpreted to impose additional obligations
and liabilities on our shareholders that are not typically imposed on shareholders of U.S. corporations.
Provisions of Israeli law may delay, prevent
or make undesirable an acquisition of all or a significant portion of our shares or assets.
Certain provisions of Israeli law and our articles of association
could have the effect of delaying or preventing a change in control and may make it more difficult for a third party to acquire us or
for our shareholders to elect different individuals to our board of directors, even if doing so would be beneficial to our shareholders,
and may limit the price that investors may be willing to pay in the future for our ordinary shares. For example, Israeli corporate law
regulates mergers and requires that a tender offer be effected when certain thresholds of percentage ownership of voting power in a company
are exceeded (subject to certain conditions). Further, Israeli tax considerations may make potential transactions undesirable to us or
to some of our shareholders whose country of residence does not have a tax treaty with Israel granting tax relief to such shareholders
from Israeli tax. With respect to mergers, Israeli tax law allows for tax deferral in certain circumstances but makes the deferral contingent
on the fulfillment of numerous conditions, including a holding period of two years from the date of the transaction during which certain
sales and dispositions of shares of the participating companies are restricted. Moreover, with respect to certain share swap transactions,
the tax deferral is limited in time, and when such time expires, the tax becomes payable even if no actual disposition of the shares has
occurred. See Exhibit 2.1 to this annual report.
Furthermore, under the Encouragement of Research, Development and
Technological Innovation in the Industry Law, 5744-1984 (formerly known as the Law for the Encouragement of Research and Development in
Industry 5744-1984), and the regulations, guidelines, rules, procedures and benefit tracks thereunder, collectively, the Innovation Law,
to which we are subject due to our receipt of grants from the IIA, a recipient of IIA grants such as our company must report to the IIA
regarding any change in the holding of any means of control of our company. If following such change any non-Israeli citizen or resident
becomes an “interested party”, as defined in the Israeli Securities Law 5728-1968, such non-Israeli citizen or resident shall
execute an undertaking in favor of IIA, in a form prescribed by IIA.
34
Risks Related to Our Ordinary Shares and the Ownership and Trading
of Our Ordinary Shares
The price of our ordinary shares may fluctuate
significantly. Further, there is no guarantee of a continuing public market to resell our ordinary shares.
Our ordinary shares were first offered publicly in the United States
after our public offering in the United States in November 2013, at a price of $14.75 per share, and our ordinary shares have subsequently
traded on the NYSE (until December 2016) and on the Nasdaq (since December 2016) as high as $20.39 per share and as low as $0.6 and as
of March 15, 2023 were trading at $0.66 per share.
The market price of our ordinary shares could be highly volatile
and may fluctuate substantially as a result of many factors, including:
| ◾ |
our inability to obtain additional funding; |
| ◾ |
any delay in filing a regulatory submission for any of our product or product candidates and any adverse development or perceived
adverse development with respect to the review of that regulatory submission by the applicable regulatory body; |
| ◾ |
actual or anticipated fluctuations in our results of operations; |
| ◾ |
variance in our financial performance from the expectations of market analysts; |
| ◾ |
announcements by us or our competitors of significant business developments, changes in relationships with our collaborators, acquisitions
or expansion plans; |
| ◾ |
our involvement in litigation; |
| ◾ |
our sale, or the sale by our significant shareholders, of ordinary shares or other securities in the future; |
| ◾ |
failure to publish research or the publishing of inaccurate or unfavorable research; |
| ◾ |
market conditions in our industry and changes in estimates of the future size and growth rate of our markets; |
| ◾ |
changes in key personnel; |
| ◾ |
the trading volume of our ordinary shares; and |
| ◾ |
general economic and market conditions, including as a result of the scope and duration of the COVID-19 pandemic. |
Although our ordinary shares are listed on Nasdaq, an active trading
market on Nasdaq for our ordinary shares may not be sustained. If an active market for our ordinary shares is not sustained, it may be
difficult to sell ordinary shares in the U.S.
In addition, the stock market in general, and the Nasdaq and the
market for biotechnology companies in particular, have experienced extreme price and volume fluctuations that have often been unrelated
or disproportionate to the operating performance of companies like ours. Broad market and industry factors may materially harm the market
price of our ordinary shares, regardless of our operating performance. Further, a systemic decline in the financial markets and related
factors beyond our control may cause our share price to decline rapidly and unexpectedly. Price volatility of our ordinary shares might
be worse if the trading volume of our ordinary shares is low. In the past, following periods of volatility in the market price of a company’s
securities, securities class action litigation has often been instituted against that company. If we were involved in any similar litigation,
we could incur substantial costs and our management’s attention and resources could be diverted.
35
Any inability to meet the Nasdaq listing requirements
may have an adverse effect on our share price and lead to our delisting from Nasdaq.
We are required to meet the continued listing requirements of Nasdaq,
including those regarding minimum share price. In particular, we are required to maintain a minimum bid price for our listed ordinary
shares of $1.00 per share. On July 11, 2022, we received written notification from Nasdaq, which stated that because the closing bid price
of our ordinary shares for 31 consecutive business days was below the minimum $1.00 per share bid price requirement for continued listing
on the Nasdaq, we were not in compliance with Nasdaq Listing Rule 5550(a)(2). On August 24, 2022, Nasdaq confirmed that we regained compliance
with Nasdaq Listing Rule 5550(a)(2) concerning the minimum bid price of the Company’s ordinary shares.
On October 31, 2022, we again received written notification from
Nasdaq, which stated that because the closing bid price of our ordinary shares for 31 consecutive business days was below the minimum
$1.00 per share bid price requirement for continued listing on the Nasdaq Capital Market, we were not in compliance with Nasdaq Listing
Rule 5550(a)(2). Pursuant to Nasdaq Listing Rule 5810(c)(3)(A), the applicable grace period to regain compliance is 180 days, or until
May 1, 2023. If the Company does not demonstrate compliance prior by the end of the 180-day period ending May 1, 2023, the Nasdaq staff
will notify us that our ordinary shares will be subject to delisting. However, we may then be eligible for additional time of up to a
further 180 calendar days to regain compliance if we meet the continued listing requirement for the market value of our publicly held
shares and all other initial listing standards for Nasdaq, with the exception of the bid price requirement. To be eligible, we will also
need to provide further written notice of our intention to cure the deficiency during the second compliance period.
If Nasdaq initiates delisting proceedings or delists our ordinary
shares from trading on its exchange, we could face significant material adverse consequences including: reduced liquidity with respect
to our ordinary shares; limited amount of news and analyst coverage for our company; reputational damage; diminished investor, supplier
and employee confidence; and decreased ability to issue additional securities or obtain additional financing in the future.
Our ordinary shares are traded on more than
one market and this may result in price variations.
Our ordinary shares have been traded on the TASE since 2007, and
are currently listed on Nasdaq. Trading in our ordinary shares on these markets will take place in different currencies (U.S. dollars
on Nasdaq and NIS on the TASE), and at different times (resulting from different time zones, trading days and public holidays in the United
States and Israel). The trading prices of our ordinary shares on these two markets may differ due to these and other factors. Any decrease
in the price of our ordinary shares on the TASE could cause a decrease in the trading price of our ordinary shares on Nasdaq or vice versa.
We could become subject to parallel reporting
obligations in Israel and the United States, which could increase compliance costs and divert management attention.
In 2013, our shareholders approved our plan to transition solely
to U.S. reporting standards under the rules and regulations of the SEC. However, should this change in the future, we may become subject
to parallel reporting obligations in Israel and the United States. While similar in many respects, certain differences between Israeli
and U.S. reporting schemes may impose on us disclosure obligations that are more stringent than those generally applied to foreign private
issuers whose securities are listed only in the United States. In addition, a requirement to comply with the separate reporting obligations
under U.S. and Israeli securities laws would require additional management attention and could burden us with additional costs.
The requirements of being a public company
in the United States and Israel may strain our resources and distract our management, which could make it difficult to manage our business.
Changing laws, regulations and standards, in the United States
or Israel, relating to corporate governance and public disclosure and other matters, may be implemented in the future, which may increase
our legal and financial compliance costs, make some activities more time consuming and divert management’s time and attention from
revenue-generating activities to compliance activities. If our efforts to comply with new laws, regulations and standards differ
from the activities intended by regulatory or governing bodies due to ambiguities related to practice, regulatory authorities may initiate
legal proceedings against us and our business may be harmed. Being a publicly traded company in the United States and Israel and being
subject to U.S. and Israeli rules and regulations make it more expensive for us to obtain DO insurance, and we may be required to
accept reduced coverage or incur substantially higher costs to obtain coverage. These factors could also make it more difficult for us
to attract and retain qualified members of our board of directors, particularly to serve on our audit committee, and qualified executive
officers.
36
As a public company whose ordinary shares are listed in the United
States, we will continue to incur significant accounting, legal and other expenses, including costs associated with our reporting requirements
under the Exchange Act. We also incur additional costs associated with corporate governance requirements, including requirements under
Section 404 and other provisions of the Sarbanes-Oxley Act of 2002, or the Sarbanes-Oxley Act, rules implemented by the SEC and the Nasdaq,
and provisions of Israeli corporate and securities laws applicable to public companies. The Exchange Act requires that we file annual
and certain other reports with respect to our business and financial condition. The Sarbanes-Oxley Act requires, among other things, that
we maintain effective disclosure controls and procedures and internal control over financial reporting. These rules and regulations could
continue to increase our legal and financial compliance costs, such as the cost of hiring consultants or testing compliance processes,
and make some activities more time-consuming and costly. These activities may divert management’s attention from other business
concerns, which could have a material adverse effect on our business, financial condition, results of operations and cash flows.
As a foreign private issuer we are not subject
to the provisions of Regulation FD or U.S. proxy rules and are exempt from filing certain Exchange Act reports.
As a foreign private issuer, we are exempt from compliance with
the rules and regulations under the Exchange Act related to the furnishing and content of proxy statements, and our officers, directors,
and principal shareholders are exempt from the reporting and short-swing profit recovery provisions contained in Section 16 of the
Exchange Act. In addition, we are not required under the Exchange Act to file annual and certain other reports and financial statements
with the SEC as frequently or as promptly as U.S. domestic companies whose securities are registered under the Exchange Act, we are permitted
to disclose limited compensation information for our executive officers on an individual basis and we are generally exempt from filing
quarterly reports with the SEC under the Exchange Act. Moreover, we are not required to comply with Regulation FD, which restricts the
selective disclosure of material nonpublic information to, among others, broker-dealers and holders of a company’s securities under
circumstances in which it is reasonably foreseeable that the holder will trade in the company’s securities on the basis of the information. These
exemptions and leniencies will reduce the frequency and scope of information and protections to which you may otherwise have been eligible
in relation to a U.S. domestic issuer.
As a foreign private issuer, we have elected
to follow home country corporate governance practices instead of certain Nasdaq corporate governance requirements, which may result in
less protection than is accorded to investors under rules applicable to domestic U.S. issuers.
As a foreign private issuer whose shares are listed on the Nasdaq
Global Market, we are permitted to follow certain home country corporate governance practices instead of those otherwise required under
the corporate governance standards for U.S. domestic issuers listed on Nasdaq. We currently follow Israeli home country practices, rather
than the requirements under the Nasdaq corporate governance rules, with regard to the (i) quorum requirement for shareholder meetings,
(ii) executive sessions for independent directors and non-management directors and (iii) the requirements to obtain shareholder approval
for certain dilutive events (such as for the establishment or amendment of certain equity-based compensation plans, issuances that will
result in a change of control of the company, certain transactions other than a public offering involving issuances of a 20% or more interest
in the company and certain acquisitions of the stock or assets of another company). See “Item 16G. Corporate Governance.”
Furthermore, we may in the future elect to follow Israeli home country practices with regard to other matters such as the requirement
to have a majority independent board of directors, have a compensation committee and have a nominating committee. Accordingly, our shareholders
may not be afforded the same protection as provided under Nasdaq corporate governance rules. Following our home country governance practices
as opposed to the requirements that would otherwise apply to a United States company listed on Nasdaq may provide less protection than
is accorded to investors of domestic issuers. For further discussion, see “Item 16G. Corporate Governance.”
We may lose our status as a foreign private
issuer, which would increase our compliance costs and could thereby negatively impact our results of operations.
We would lose our foreign private issuer status if (a) a majority
of our outstanding voting securities were either directly or indirectly owned of record by residents of the United States and (b)(i) a
majority of our executive officers or directors were United States citizens or residents, (ii) more than 50 percent of our assets were
located in the United States, or (iii) our business were administered principally outside the United States. Our loss of foreign private
issuer status would make U.S. regulatory provisions mandatory. The regulatory and compliance costs to us under U.S. securities laws as
a U.S. domestic issuer may be significantly higher. If we are not a foreign private issuer, we will be required to file periodic reports
and registration statements on U.S. domestic issuer forms with the SEC, which are more detailed and extensive than the forms available
to a foreign private issuer. We would also be required to follow U.S. proxy disclosure requirements, including the requirement to disclose,
under U.S. law, more detailed information about the compensation of our senior executive officers on an individual basis. We may also
be required to modify certain of our policies to comply with accepted governance practices associated with U.S. domestic issuers. Such
conversion and modifications will involve additional costs. In addition, we would lose our ability to rely upon exemptions from certain
corporate governance requirements on U.S. stock exchanges that are available to foreign private issuers, as described in the previous
risk factor above.
37
If a United States person is treated as owning
at least 10% of our ordinary shares, such holder may be subject to adverse U.S. federal income tax consequences.
If a United States person is treated as owning (directly, indirectly
or constructively) at least 10% of the value or voting power of our ordinary shares, such person may be treated as a “United States
shareholder” with respect to each “controlled foreign corporation” in our group (if any). If our group includes one
or more U.S. subsidiaries, certain of our non-U.S. subsidiaries could be treated as controlled foreign corporations (regardless of whether
we are or are not treated as a controlled foreign corporation). A United States shareholder of a controlled foreign corporation may be
required to annually report and include in its U.S. taxable income its pro rata share of “Subpart F income”, “global
intangible low-taxed income” and investments in U.S. property by controlled foreign corporations, whether or not we make any distributions.
An individual that is a United States shareholder with respect to a controlled foreign corporation generally would not be allowed certain
tax deductions or foreign tax credits that would be allowed to a United States shareholder that is a U.S. corporation. A failure to comply
with these reporting obligations may subject you to significant monetary penalties and may prevent the statute of limitations with respect
to your U.S. federal income tax return for the year for which reporting was due from starting. We cannot provide any assurances that we
will assist investors in determining whether any of our non-U.S. subsidiaries are treated as a controlled foreign corporation or whether
such investor is treated as a United States shareholder with respect to any of such controlled foreign corporations or furnish to any
United States shareholders information that may be necessary to comply with the aforementioned reporting and tax paying obligations. A
United States investor should consult their own advisors regarding the potential application of these rules to its investment in the ordinary
shares.
We believe we were a PFIC for U.S. federal
income tax purposes in 2022, and there is significant risk we will be a PFIC in 2023 as well. U.S. shareholders who held our ordinary
shares at any time during a taxable year in which we are a PFIC may suffer adverse tax consequences.
Generally, if for any taxable year 75% or more of our gross income is passive income, or at least 50% of
the average quarterly value of our assets (which may be determined in part by the market value of our ordinary shares, which is subject
to change) are held for the production of, or produce, passive income, we would be characterized as a PFIC for United States federal income
tax purposes. According to these rules, a publicly traded non-U.S. corporation may treat the aggregate fair market value of its assets
as being equal to the sum of the aggregate value of its outstanding shares, or Market Capitalization, and the total amount of its liabilities.
We intend to take the position that the excess of our Market Capitalization plus liabilities over the book value of all of our assets
may generally be treated as attributable to non-passive assets. Based on the book value of our assets and liabilities and our Market Capitalization
in 2022, we believe that we met the PFIC asset test described above for 2022 and, as a result, we were classified as a PFIC in 2022. Furthermore,
because we currently hold, and expect to continue to hold, a substantial amount of cash and cash equivalents and other passive assets
used in our business, and because our Market Capitalization is currently below the level necessary to avoid PFIC status for 2023, there
is substantial risk we will be classified as a PFIC for the 2023 taxable year as well. However, because PFIC status is determined after
the close of each taxable year, we will not be able to determine whether we will be a PFIC for the 2023 taxable year or for any future
taxable year until after the close of such year.
U.S. shareholders who held our ordinary shares at any time in 2022
or during any other taxable year in which we are a PFIC may suffer adverse tax consequences, including having gains realized on the sale
of our ordinary shares treated as ordinary income, rather than capital gain, the loss of the preferential rate applicable to dividends
received on our ordinary shares by individuals who are U.S. Holders (as defined in “Item 10. Additional Information—E. Taxation—United
States Federal Income Taxation”), and having interest charges apply to distributions by us and the proceeds of share sales. Certain
elections may be available that would alleviate some of the adverse consequences of PFIC status and result in an alternative treatment
(such as mark-to-market treatment) of our ordinary shares; however, we do not intend to provide the information necessary for U.S. holders
to make qualified electing fund elections. See “Item 10. Additional Information—E. Taxation—United States Federal Income
Taxation—Passive Foreign Investment Company Considerations.”
38
General Risk Factors
If we fail to maintain effective internal control
over financial reporting, the price of our ordinary shares may be adversely affected.
Our internal control over financial reporting may have weaknesses
and conditions that could require correction or remediation, the disclosure of which may have an adverse impact on the price of our ordinary
shares. We are required to establish and maintain appropriate internal control over financial reporting. Failure to establish
those controls, or any failure of those controls once established, could adversely affect our public disclosures regarding our business,
prospects, financial condition or results of operations. In addition, management’s assessment of internal control over financial
reporting may identify weaknesses and conditions that need to be addressed in our internal control over financial reporting or other matters
that may raise concerns for investors. In addition, as a “non-accelerated filer,” we are exempt from the provisions
of Section 404(b) of the Sarbanes-Oxley Act requiring that independent registered public accounting firms provide an attestation report
on the effectiveness of internal control over financial reporting. Decreased disclosures in our SEC filings due to our status
as a “non-accelerated filer” may make it harder for investors to analyze our results of operations and financial prospects
and may make our ordinary shares a less attractive investment. Any actual or perceived weaknesses and conditions that need to be addressed
in our internal control over financial reporting or disclosure of management’s assessment of our internal control over financial
reporting may have an adverse impact on the price of our ordinary shares.
| ITEM 4. |
INFORMATION ON THE COMPANY |
A. History
and Development of the Company
Our History
We are a leading computational biology company aiming to revolutionize
life-science product discovery and development across several market segments, including human health, agriculture, and other industrial
applications.
Our company was founded on October 10, 1999 as Agro Leads Ltd.,
a subsidiary of Compugen Ltd. In 2002, our company was spun-off as an independent corporation under the laws of the State of Israel, and
changed its name to Evogene Ltd.
In 2018 and 2019, we reorganized certain of our divisions into
wholly owned subsidiaries of the Company, as described in this annual report.
Our shares have been listed for trading on the TASE since 2007
and were listed for trading on the NYSE commencing with our U.S. initial public offering in November 2013, until December 2016, when we
transferred the listing to Nasdaq.
We are registered with the Israeli Registrar of Companies in Jerusalem.
Our registration number is 51-283872-3. Our purpose as set forth in our articles of association is to engage in any lawful business. Our
principal executive offices are located at 13 Gad Feinstein Street, Park Rehovot, Rehovot P.O. Box 4173 Ness Ziona, 7414002, Israel, and
our telephone number is +972-8-931-1900.
Our authorized representative in the United States and agent for
service of process in the United States, Puglisi Associates, is located at 850 Library Avenue, Suite 204, Newark, Delaware 19711.
Information contained on, or that can be accessed through, our website does not constitute a part of this annual report and is not incorporated
by reference herein.
The SEC maintains an internet site, http://www.sec.gov that contains
reports, proxy and information statements, and other information regarding issuers that file electronically with the SEC. Our internet
address is www.evogene.com. The information on that website is not part of this annual report and is not incorporated by reference herein.
39
Principal Capital Expenditures
Our capital expenditures for fiscal years 2022, 2021 and 2020 amounted
to approximately $1.2 million, $0.8 million and $0.7 million, respectively. Our capital expenditures during those years consisted of investments
in property, plant and equipment. We anticipate our capital expenditures in fiscal year 2023 to include payments for maintenance and improvements
of our facilities in Israel in order to support our activities, which we anticipate we will finance with our currently available cash.
For a description of our principal capital expenditures and divestitures for the three years ended December 31, 2022 and for those currently
in progress, see “Item 5. Operating and Financial Review and Prospects—Liquidity and Capital Resources.”
B. Business
Overview
Overview
We are a leading computational biology company aiming to revolutionize
life-science product development across several market segments, including human health, agriculture, and other industries, by utilizing
cutting edge computational technologies.
The main challenge in product development in the life science industry
is finding the winning candidates out of a vast number of possible prospects that address a complex myriad of criteria to reach successful
products. We believe that by utilizing an advanced computational biology platform to identify the most promising candidates addressing
multiple development challenges towards successful life-science products, we can increase the probability of success while reducing time
and cost.
To achieve this mission, we established our unique Computational
Predictive Biology, or CPB, platform, leveraging big data and artificial intelligence and incorporating deep multidisciplinary understanding
in life sciences. The CPB platform is the basis for three technology engines, each focused on the direction and acceleration of the discovery
and development of products based on one of the following core components: Microbes – MicroBoost
AI, Small molecules – ChemPass AI, Genetic elements – GeneRator
AI. During 2022, we focused, and going forward, we intend to continue to focus our research and development efforts on MicroBoost
AI and ChemPass AI.
We use our technological engines to support the development of
products for the life science industry through dedicated subsidiaries and with strategic partners. Currently, our main subsidiaries utilize
the technological engines to develop human microbiome-based therapeutics by Biomica, medical cannabis products by Canonic, ag-chemicals
by AgPlenus and ag-biologicals by Lavie Bio.
Business Model
Since 2015, the Company’s main business model is product
development through specific market-oriented divisions. At that time, Evogene began using its technology to develop its own product pipelines,
each focusing on a specific industrial segment. When such a division and product pipeline reach a certain level of maturity, the activity
is spun into a dedicated subsidiary. Each subsidiary focuses on continued development of its pipeline and adding new products to
its commercial offering, while using Evogene’s technology as its core competitive advantage.
Currently, Evogene has four main subsidiaries, each focused on
a different type of product and target market. Each subsidiary has its own board of directors, management team, scientific advisory board,
research and development, or RD, and business development teams that focus on developing its own pipeline and go-to-market activities.
At the same time, each subsidiary benefits from using Evogene’s technology under an exclusive license from Evogene to use the CPB
platform’s discovery and development engines that are relevant to the subsidiary’s field of activity. The terms of these licenses
provide that the subsidiary owns the discoveries and product candidates that result from the utilization of the CPB platform, while Evogene
retains all rights to the CPB platform itself. According to the characteristics of the end-market, the subsidiaries can decide to commercialize
their products independently or in collaboration with partners.
Another business model, which was our main business model until
2014, is product development through collaborations. In this business model Evogene engages with partners for joint development of defined
products, requested by the partners. In this frame, Evogene typically conducts the initial RD activity, discovery and early-stage
development, while later stage development and commercialization are carried out by the partner. Under this model, Evogene’s potential
revenues include RD funding for activities that Evogene conducts in the collaboration, milestone payments for when the candidates
advance in our partners’ pipelines and revenue sharing from the end-product.
40
Until 2014, Evogene engaged in several collaborations of this type
with Bayer, Monsanto, DuPont and Syngenta, focused on improving seed traits using genetic modification, or GM, approach. Today, Evogene
has a number of smaller scale collaborations, and we aim to engage in additional collaborations in the future.
Fields of Activity
Given the broadly applicable capabilities of our technology, as
provided through our three engines, we can potentially enhance and improve product development in a variety of life science industries,
including human health and agriculture. Today, Evogene is applying its MicroBoost AI engine to direct and accelerate the discovery and
development of two types of products: human-microbiome based therapeutics in human health and ag-biological products in agriculture.
The ChemPass AI engine is used for the discovery and development of two types of products: drugs based on small molecules in human
health and ag-chemicals, such as herbicides and insecticides, in agriculture. The GeneRator AI engine is mainly applied for the discovery
and development of medical cannabis products in human health and improved seed traits in agriculture.
Evogene continuously evaluates new substantial industries with
well-recognized development roadblocks for which we can leverage our capabilities and assets for the development of next-generation products.
We will select the most suitable markets to focus on, based on a number of criteria, including: (i) market size; (ii) a well-recognized,
unmet need for next-generation products; (iii) an understanding of the scientific or technical road-blocks that challenge others from
developing next-generation products; and (iv) most importantly, the expectation that our technological engines and unique approach can
provide a significant competitive advantage in addressing these road-blocks.
Subsidiaries
As described above, since 2015 Evogene has used its three engines
to develop diverse product types through dedicated divisions and subsidiaries. In the area of human health, we established two subsidiaries:
Biomica, focusing on developing microbiome-based therapeutics, and Canonic, focusing on developing medical cannabis products. In Agriculture,
we established two subsidiaries: Lavie Bio focusing on developing ag-biologicals and AgPlenus focusing on ag-chemicals. In other industries,
we established one subsidiary, Casterra, focusing on developing ag-solutions for castor oil production.
Revenues
During 2022, except for initial sales of bio-inoculant by Lavie
Bio and medical cannabis products sales by Canonic, our revenues consisted primarily of RD payments under an RD collaboration
that AgPlenus is engaged in, in the field of ag-chemicals. A breakdown of our revenues by business activity and geographic markets for
each of the last three financial years is provided in “Item 5. Operating and Financial Review and Prospects—Key Performance
Indicators—Revenues.” In the future, we expect that we and our subsidiaries will receive milestone payments and royalty revenues
under such collaborations, as well as revenues from the sale of end-products or commercialization of product candidates.
In 2023, through our subsidiaries or directly, we expect to continue
to develop our product pipelines and initiate new collaborations with an increased focus on strategic relationships for joint product
development. We also expect to continue to evolve our organization and to continue to examine new areas in which our technology engines
can serve as a competitive advantage and additional value can be created in a relatively short period of time.
Technology
Technology highlight
Our CPB platform aims to disrupt conventional life science product
discovery and development methodology, currently challenged by inefficiencies, such as long and expensive product development process
and low probability of success. By computational selection of the most relevant core components for life-science products, such as microbes,
small molecules and genes, and then computational optimization, we are aiming to reduce time, cost and most importantly increase the probability
of success to develop life-science based products. We provide these discovery and development capabilities through three dedicated engines:
MicroBoost AI for products based on microbes, ChemPass AI for products based on small molecules and GeneRator AI for products based on
changes in genetic elements.
41
The discovery phase, based on product definition, requires the
identification and selection of a reasonable number of candidates to initiate the development process. The challenge is that out of a
vast number of possible product candidates and numerous criteria that these candidates must address, finding the winning combination for
a successful product is extremely complex. Evogene believes that this complexity should be addressed using computational predictive biology.
Evogene’s technology, the CPB platform and its three engines, was designed to predict the most promising candidates that hold true
potential for a successful product. Through computationally screening databases, according to specific product criteria, candidates can
be narrowed down to focus on those most promising.
In addition to the selection of the candidates in the discovery
phase, the CPB platform is also used in the development phase. In the development phase, the chosen candidates undergo various validation
processes on the way to becoming a commercial product with certain desired attributes. In this process, the candidates’ ability
to pass the validation criteria is improved, as required, by using our technology. Our technology is able to identify the best optimization
proposal for a product candidate, improving a specific attribute of a product with minimal impairment of any of the other attributes.
CPB Platform
As described above, the mission of the CPB platform is to revolutionize
the product discovery and development approach in life science industries by decoding the biological world using computational biology.
This platform is the outcome of over a decade long multidisciplinary effort to integrate scientific concepts with big data and advanced
computational analytics in order to develop predictions of potential product candidates that later undergo experimental validation and
optimization toward commercialization. We believe that the uniqueness of our computational prediction approach stems from our ability
to successfully address multiple product attributes at the beginning of the discovery process, and during the optimization phase.
These efforts have been enabled by two parallel revolutions taking
place over the last decades: first, the data revolution – allowing the creation of enormous amounts of high-quality biological and
chemical data in a cost-effective manner; and second, the computational processing revolution – allowing the analysis of data with
advanced algorithms such as machine learning and other artificial intelligence methods.
The CPB platform represents a revolutionary approach for the design
and prediction of novel products, based on four pillars: first, computationally modeling the specific biological challenges in the discovery
and development of each product into pre-defined criteria, based on profound scientific understanding and know-how; second, designing
genomic, chemical and microbial databases holding diverse types of curated data specifically aimed at addressing the biological challenges
identified; third, developing state of the art computational tailored analytics, including artificial intelligence algorithms, designed
to provide more accurate predictions to those challenges; and fourth, utilizing screening and validation systems, comprised of multiple
tailored bioassays, to validate the product candidates and assist in their optimization.
Proprietary Databases
Our databases leverage multiple types of tailored big data from
various sources in order to support the different research and development activities powered by our technological engines. Specifically,
we focus on four different entities: microbial organisms, microbial genes, small molecules and plant genes. Our databases on different
entities are rich and highly interconnected, enabling our analysis platforms to maximize their predictive power. Our databases draw in
part from the public domain, and in part compile increasing amounts of proprietary data, generated either in-house or received from our
collaborators.
Discovery and Development
Engines
The CPB platform is the foundation for Evogene’s three technological
engines boosting the discovery and development of novel life science products. At the core of our engines are unique computational analysis
platforms, which are comprised of algorithms designed to address a vast number of parameters required for a product. These computational
analysis platforms, which increasingly utilize artificial intelligence, machine learning driven approaches and other sophisticated algorithms,
are designed to deliver innovative solutions to key bottlenecks in the product development process, such as efficacy and stability. As
our predictions undergo validation via dedicated validation systems, we continuously improve our predictions by feeding back some of these
results into our systems.
42
MicroBoost AI employs an innovative function-based approach based
on a proprietary microbial function catalog for the identification of novel microbial candidates. This engine not only aims to identify
candidates with high potential for a specific product, but also pinpoints the biological reasoning behind its selection, improving the
chances of the initial microbial candidate to pass the subsequent optimization and development phases.
ChemPass AI combines a large, well-organized, database of over
30 billion known molecules as well as a set of AI-based algorithms and innovative chemo-informatics tools which invent, prioritize and
analyze new small molecules prior to their expensive synthesis and testing phase. This platform is used to drive and accelerate the small
molecule product development process by using a set of high-end, validated tools and algorithms for virtual screening for the identification
of small molecule hits meeting multiple end-product attributes.
GeneRator AI aims to develop life science products via targeting
and modifying genetic elements. By using a set of computational and advanced AI tools and end-to-end discovery and development pipelines,
GeneRator AI identifies genomic elements of interest that can be then applied through genome editing, genetic engineering, as biomarkers,
or through additional applications.
We are constantly working to improve and expand our engines capabilities.
For example, we are working to improve the GeneRator AI engine through participating in the CRISPR-IL consortium. This consortium, funded
by the Israeli Innovation Authority, or IIA, aims to develop an artificial intelligence-based system, “Go-Genome”, providing
users improved genome-editing workflows. The system aims to provide end-to-end solutions from user interface to an accurate measurement
tool and is expected to include the computational design of on-target DNA modification with minimal accidental, off-target modifications,
improve modification efficiency and provide an accurate measuring tool to ensure the desired modification was made.
Validation and screening
systems
Our experimental technologies include bioassays as well as screening
and validation pipelines (i.e., sets of bioassays organized in a cascade of tests). They relate to diverse scientific fields, including
molecular biology and biochemistry, microbiology plant tissue culture and plant pathology, in laboratories, greenhouses and field settings.
All processes are accompanied by precise data gathering and are coordinated by pipeline management and quality assurance.
Our validation and screening systems support three key aspects
of our research and development approach: first, generating data sets to enable development and proof of concept of tailored computational
modules and their prediction performance evaluation; second, transforming computational-based recommendation to a physical entity output;
and third, validating and screening selected product candidates by the relevant scientific teams.
Major Occurrences and Developments
The following are major occurrences and developments in the Company
over the course of 2022 and through the date of this annual report, reflecting advancement in all areas of activity:
Evogene
| ◾ |
Receipt of a $3.5 million payment related to the patent portfolio under our existing seed traits collaboration with Bayer.
|
Lavie Bio
| ◾ |
Bio-stimulant program (May 2022) – announced successful product launch of its Bio-Inoculant Thrivus™ for the 2022 spring
wheat growing season. |
| ◾ |
Bio-pesticide program (October 2022) – announced submitting the registration package for LAV.311, Lavie Bio’s novel bio-fungicide
targeting fruit rots and powdery mildews, to the EPA. |
| ◾ |
Collaboration and Investment – (August 2022) – entered into a strategic collaboration with
ICL to develop novel bio-stimulant products. As part of the collaboration, an affiliate of ICL invested $10 million in Lavie Bio.
|
|
|
|
|
43
AgPlenus
| ◾ |
Expanded AgPlenus’ product pipeline portfolio and internal capabilities into the fungicide field, and thus increasing the accessible
market by approximately $15 billion. |
Biomica
| ◾ |
Immuno-oncology program (January 2022) – announced Israeli Ministry of Health clearance for first-in-human Phase I study
of BMC-128 in combination with Bristol Myers Squibb’s Anti-PD-1 Opdivo®. |
| ◾ |
Inflammatory Bowel Disorder, or IBD, program (April 2022) – announced agreement with Sheba Medical Center for joint microbiome
clinical research. |
| ◾ |
Immuno-oncology program (July 2022) – announced it had successfully enrolled and dosed a first patient in its Phase I
study of microbiome-based immuno-oncology drug. |
| ◾ |
Finance (December 2022) – signed a definitive agreement for
a $20 million financing round. The financing was led with a $10 million investment by SHC, with the balance of the investment by Evogene.
|
Canonic
| ◾ |
Penetration into Europe (January 2022) – announced that it has shipped a first batch of its unique cannabis varieties to Portugal,
following receiving approval to export from the Israeli Ministry of Health and Ministry of Agriculture and Rural Development. |
| ◾ |
Penetration into Europe (September 2022) – entered into an agreement with GroVida Lda for the license of two of Canonic’s
cannabis varieties for cultivation and commercialization in Europe. |
| ◾ |
Commercialization (September 2022) – announced that it had launched its second-generation medical cannabis products in Israel
with high THC and unique terpene profiles. |
Casterra
| ◾ |
Market Penetration (November 2022) – announced that it has entered into a royalty agreement with Titan Castor Farms Limited
for castor oil sales in south-eastern Africa. |
| ◾ |
Market Penetration (January 2023) – announced that it has entered into an agreement with a large energy company to cultivate
its castor varieties at commercial scale. |
Market Segments
Agriculture
Lavie Bio Ltd.
Overview
In 2015, we initiated our activity for developing ag-biological
products as a division within Evogene and early in 2019 it was organized under Lavie Bio Ltd., an independent company that upon establishment
was wholly-owned by Evogene.
Lavie Bio aims to improve food quality, sustainability and agricultural
productivity through the introduction of microbiome-based ag-biologicals. Ag-biologicals are externally-applied products from biological
sources, such as microbial (micro-organisms) and naturally derived biochemistries, designed to improve crop productivity. A sub-segment
within the microbial biologicals is the “microbiome”, the microbial population living close or within the plant or other organisms,
such as pests.
Lavie Bio is focused on developing two main types of products:
(i) bio-pesticides, which are ag-biologicals for crop protection, addressing biotic stresses such as insects, diseases, and weeds and
(ii) bio-stimulants, which are ag-biologicals for crop enhancement, directly impacting crop yield or abiotic stress tolerance.
In August 2019, Corteva Agriscience invested in Lavie Bio in a
transaction that included the exchange of all shares of Corteva’s wholly-owned subsidiary, Taxon Biosciences, along with a $10 million
equity investment by Corteva in Lavie Bio in consideration of approximately 28% of Lavie Bio’s equity. The assets of Taxon Biosciences,
including, among others, a large microbial collection and a supporting computational platform, were integrated into Lavie Bio’s
microbial collection, technology platform and pipeline. In addition, Corteva received certain commercial rights with respect to Lavie
Bio’s candidate products, mainly in corn and soy. Corteva and Lavie Bio prioritized certain product programs to be executed by Lavie
Bio, and Lavie Bio committed to allocate a certain part of its research and development budget to these programs.
44
In August 2022, ICL and Lavie Bio entered a multi-year collaboration
agreement for developing novel bio-stimulant products to enrich fertilizer efficiency. As part of the collaboration, an affiliate of ICL
invested in Lavie Bio $10 million under a SAFE (simple agreement for future equity).
Market
According to the report titled Top Trends in the Agricultural Biologicals
Market by Agricultural Biologicals, Biocontrols, Bio fungicides, Bioinsecticides, Bio nematicides, Biostimulants, Biofertilizers, Inoculants,
Pheromones, Biological Seed Treatment - Global Forecast to 20261,
which is not incorporated by reference into this annual report, the market for ag-biological products was estimated at $10.6 billion in
2021, and is a growing segment in the approximately $200 billion agricultural input market, which includes the seed, crop protection and
fertilizers segments. The sales of ag-biological products significantly grew in past years, expanding from a market size of $3.2 billion
in 2015 to its current size following a shift in growers and consumer preferences to more sustainable and healthier practices, while driving
agriculture productivity. According to market estimates, this market is forecasted to reach sales of $18.5 billion in 2026, anticipated
to be driven by improvement of the product attributes of ag-biologicals, such as efficacy, stability and commercial viability.
Companies in this market can be generally divided into three groups:
(i) major seed and ag-chemical companies, such as BASF, Bayer, ChemChina and Corteva, with internal research and development units dedicated
to development of ag-biological products, (ii) small to mid-size biotech companies specializing in ag-biologicals with their own product
development programs, and (iii) academic and agricultural research institutions that pursue research activities in the field, typically
focusing on early stage activities.
Business Model
Lavie Bio has defined two main models for market access:
| (i) |
Direct sales model – in fragmented markets Lavie Bio expects to complete product development
of its products independently, while establishing a tailored market access strategy per specific product and territory, such as commercialization
through distribution channels. Under this model, the production of Lavie Bio’s products is achieved through third party toll manufacturers.
Revenues may include sales to distributors. Under the direct sales model, during the fourth quarter of 2021 Lavie Bio launched its inoculant
Thrivus™ towards the 2022 spring sowing season. |
| (ii) |
Collaboration model –
Lavie Bio offers tailored solutions to potential partners. In this model, Lavie Bio’s partner produces and commercializes the products
being developed. Lavie Bio’s revenues in such engagements may include research and development payments, payments upon achievement
of development milestones and royalties. The scope of collaboration may differ. Under a broader collaboration model Lavie Bio would typically
commence with candidate strains discovery and development, followed by co-development with the partner towards commercialization. Lavie
Bio’s collaboration with ICL is an example of the broad collaboration model. Under a narrower collaboration model, Lavie Bio would
typically utilize its platform to optimize existing product candidates of its partner in different stages of development, addressing challenges
such as efficacy, consistency and commercial viability. |
Product Development Programs
Scientific Approach
Lavie Bio’s approach is focused on 'Biology
Driven Design' for the discovery, optimization and commercialization of efficacious, consistent and commercially viable microbial-based
ag-biologicals. Lavie Bio’s approach is based on converging the plant, microbial and environmental factors to decode their complex
interactions in order to enable the amplification of the positive, elimination of the negative and retrieval of lost interactions within
the biological system.
Lavie Bio’s Biology Driven Design, or BDD, facilitates and accelerates the design
and development of microbiome-based products through the decoding of complex microbiome-host interactions and the identification of the
key genetic elements (functions) governing these interactions. This decoding is powered by big data and artificial intelligence and provides
the basis for products design. The enabling technologies for the establishment of the BDD platform are Evogene’s MicroBoost
AI tech engine and Taxon Biosciences’ Taxonia platform, which harness genomics and informatics to develop transformative
applications to agriculture, acquired as part of the Taxon Biosciences acquisition.
1 https://www.reportlinker.com/p04680744/Top-10-Trends-in-Agricultural-Biologicals-Market-Industry-Global-Forecast-to.html.
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Product Development Cycle
Lavie Bio estimates that developing an ag-biological product based
on microbial sources takes, on average, between six to eight years. The length of the process may vary depending on several factors, such
as product type, target market and applicable regulatory or registration regime, type of application, type of natural source serving as
active ingredient, as well as number of active ingredients within the final products, which impacts the development activities required
to reach a commercially viable product.
The development process for microbial-based ag-biologicals is generally
divided into four steps, or phases, which include discovery, pre-development,
development, pre-commercialization, and ending with registration
approval and commercial launch. As this is a relatively young industry, the process is not yet well-established and standardized, and
the below outline is established based on our experience and estimations.
| ◾ |
Discovery: The identification of a candidate microbial strain, or microbial
strain teams, having the potential to improve the target trait and the potential to achieve other product requirements such as consistency
and commercial viability. A collection of selected microbial candidates is typically tested on the crop(s) of choice in greenhouse screens
or limited field experiments for various efficacy, consistency and commercial viability criteria. Candidates that meet the testing criteria
are referred to as “Hits”. Typically, the duration of the discovery phase is approximately 12-18 months. |
| ◾ |
Pre-development: Promising Hits are advanced to pre-development phase,
in order to further assess and optimize performance criteria such as shelf life stability, efficacy and consistency. Successfully performing
microbial candidates are referred to as “Advanced Hits”. Typically, the duration of this phase is approximately 12-18 months.
|
| ◾ |
Development: This phase is usually divided into Development Stage 1, resulting
with a “Lead”, and Development Stage 2, resulting with a “Pre-Product”. In this phase, the fermentation and formulation
procedures are further optimized to allow for further testing and validation of efficacy and consistency in the field as well as for commercial
viability at the scale production, addressing cost of goods targets and compatibility with other agricultural inputs. Based on industry
benchmarks and its experience, Lavie Bio estimates the duration of this stage to be approximately 24 months. |
| ◾ |
Pre-commercialization: In this phase, extensive field tests are undertaken
to demonstrate the effectiveness of product candidates in enhancing the target trait, including production of data to support product
positioning. Additional activities towards launch are performed, including packaging development, upscale manufacturing protocol, registration
and regulation. Based on industry benchmarks and its experience, Lavie Bio estimates the duration of this stage in the U.S. to be approximately
24 months for bio-stimulants and 36-48 months for bio-pesticides due to longer regulation processes. |
| ◾ |
Commercial: After initial commercialization of a product, different scale-up
activities are undertaken, such as production under toll-manufacturing agreements and deployment of end-product at point of sale. Toll
manufacturing involves development of production protocols for large fermentation vessels and down-stream-process protocol with the toll
manufacturer. In addition, the product is examined for potential market expansion to new crops and against additional diseases.
|
46
Product Development Pipeline
The following table sets forth Lavie Bio’s main product development
programs:
Lavie Bio’s first product to reach
the market is LAV.211, an inoculant for yield improvement, developed under Lavie Bio’s Bio-stimulants program for spring wheat and
marketed under the brand name Thrivus™. Thrivus™ was commercially launched for 2022 spring wheat planting within target regions
in North Dakota and Minnesota. During the 2023 spring wheat planting season, Lavie Bio expects to expand its geographical footprint with
the addition of several distribution channels.
With respect to its Bio-pesticides program against fruit rots,
in October 2022, Lavie Bio announced the submission to the EPA of a registration package for LAV.311, a bio-fungicide targeting fruit
rots and powdery mildews.
Key Collaborations
Corteva (originally with DuPont-Pioneer)
In July 2017, Evogene entered a multiyear collaboration with DuPont-Pioneer
(now Corteva), for the research and development of novel microbial bio-stimulant seed treatments for the improvement of corn productivity
globally. Following the establishment of Lavie Bio, the collaboration agreement was assigned from Evogene to Lavie Bio. Under the agreement,
Lavie Bio is entitled to milestone payments for advancement of candidate strains, and royalties from product sales.
ICL Group
In August 2022, Lavie Bio entered a multiyear collaboration with
ICL for the research, development and commercialization of novel bio-stimulant products to enrich fertilizer efficiency. Under the collaboration,
Lavie Bio carries out dedicated product development programs, and ICL obtains exclusive commercialization rights for resulting candidate
microbial products. Certain commercial terms, such as Lavie Bio’s consideration for commercialization of resulting products by ICL,
will be concluded under a licensing agreement to be entered between the parties.
As part of the collaboration agreement, ICL (through an affiliate
company) invested $10 million in Lavie Bio through a SAFE agreement (simple agreement for future equity). Pursuant to the terms of such
agreement, the SAFE amount will automatically be converted into shares of Lavie Bio during enumerated events, each subject to certain
terms and conditions, to include (i) an equity financing (as such term is defined in the agreement), with such SAFE amount converting
into Safe Preferred Shares (as such term is defined in the agreement) at a 20% discount rate, or (ii) a liquidity event (as such term
is defined in the agreement), with such SAFE amount converting into shares entitling their holders to receive a portion of Proceeds due
as part of the liquidity event. The price per share for future conversion is capped at a price reflecting a valuation of $130 million
prior to the relevant event. Additionally, ICL is permitted to invest an additional amount prior to, or as part of, the next financing
of Lavie Bio, which would allow for ICL to hold up to a maximum interest of 14.29% in Lavie Bio on a fully diluted share capital basis.
If no equity financing occurs within thirty (30) months of the effective date of the agreement, ICL shall be entitled to convert the SAFE
amount at a price per share reflecting a valuation of $70 million.
Intellectual Property
Lavie Bio files for patents to cover the use of microbial strains,
or strain teams, that are the core active ingredients of the products we develop, as well as enabling technologies. Other innovative and
proprietary technologies that we develop (such as computational predictive and design technologies), are typically protected as ‘trade
secrets’.
47
Raw Materials
Lavie Bio does not significantly rely upon any sources of raw materials
for its operations.
Seasonality
Lavie Bio’s sale cycles and RD activities are dependent
on crop seasonality as they are highly dependent on crop growing and harvest periods. For example, the use of Lavie Bio’s inoculant
for yield improvement, ThrivusTM, for spring wheat in
North America requires that it be applied to wheat seeds applications in the second quarter of each calendar year, guiding the sales cycles
accordingly.
Government Regulation of our Operations and of Product Candidates
Our activities are subject to extensive regulations, which may
prevent us and/or our collaborators from developing and/or commercializing products in a timely manner and may impose expenses, delays
and other impediments to our product development and registration efforts. In general, the regulatory landscape in the evolving field
of ag-biological products is still developing. As a result, it may face additional changes in the next few years. Complexity of regulatory
processes varies between bio-stimulants and bio-pesticides and between regulatory organizations.
In the U.S., the EPA regulates our bio-pesticide products, while
our bio-stimulant and bio-inoculant products are regulated as fertilizers, auxiliary plant substances, soil amendments and/or beneficial
substances in each of the 50 states.
Generally, EPA approvals or registrations for new pesticide active
ingredients take up to 24 months. Registration processes for state and non-U.S. governments vary amongst jurisdictions and can take 2-to-24
months for state governments - with states such as California and New York taking the longest and up to 36 months or more for non-U.S.
governments. To register a crop protection product with the EPA, companies must demonstrate the product is “safe”, when used
as directed, to mammals, non-target organisms, endangered species and the environment. To demonstrate the biological pest management product’s
safety, required studies must be conducted that evaluate mammalian toxicology, toxicological effects to non-target organisms in the environment
(ecotoxicological exposures) and physical and chemical properties of the product. The registration dossier is subject to both scientific
and administrative reviews by EPA scientists and management before registration approval. The scientific review involves thorough evaluation
of submitted data and completion of risk assessments for human dietary and ecotoxicological exposures. The EPA has the authority to revoke
the registration or impose limitations on the use of any of our pest management products if we do not comply with the regulatory requirements,
if unexpected problems occur with a product, or if the EPA receives other newly discovered adverse information.
In addition to EPA approval, we are required to obtain regulatory
approval from the appropriate state regulatory authorities in individual states and non-U.S. regulatory authorities before we can market
or sell any pest management product in those jurisdictions. Non-U.S. governments typically require up to two seasons of locally generated
field efficacy data on crop-pest combinations before a product dossier can be submitted for review. California and some non-U.S. jurisdictions
also require us to submit product efficacy data.
Around the globe, the regulatory process for bio-stimulants is
significantly accelerated compared to that for bio-pesticides. In the U.S., if plant health products are not used to control pests or
do not act as plant (growth) regulators, we do not believe that we need to submit applications for EPA registrations for such products.
Products containing microbes of foreign origin may need to be “deregulated” (or determined not to be a plant pest) under the
Plant Protection Act by the USDA Animal and Plant Health Inspection Service prior to use in field trials or for large scale release.
In the EU, bio-stimulants are currently regulated as fertilizers, and bio-pesticides are regulated and registered as plant protection
products.
Our first bio-stimulant product, LAV.211, was registered and is
sold in certain U.S. individual states, as it does not require submission to the EPA. We have applied to the Canadian Food Inspection
Agency with respect to this product and are currently awaiting approval.
Our first bio-pesticide product candidate, LAV.311, has been submitted
to the EPA for registration in October 2022, and is now undergoing the review process, expected to take 18-24 months before approval.
Our RD activities also are subject to local worker safety water pollution and solid
and hazardous waste regulatory programs and periodic inspection.
48
AgPlenus Ltd.
Overview
In 2015, we initiated our activity for developing ag-chemical products
as a division within Evogene, and in 2018, we announced that it had been organized under AgPlenus Ltd., a separate company, wholly-owned
by Evogene upon establishment. AgPlenus aims to design effective and sustainable crop protection products (crop protection refers to the
science and practice of managing risks of weed, plant diseases, and insects that damage agricultural crops and forestry) by leveraging
computational predictive biology and chemistry. AgPlenus’ activities focus on discovery and development of new mode of action, or
MoA, crop protection products.
Market
According to an article published by Facts and Factors, which is
not incorporated by reference herein, the global crop protection chemicals market was estimated at approximately $63 billion in 2019 and
is expected to grow to over $90 billion by 2026.2 Lack
of available solutions for pest control and increasing resistance to existing crop protection solutions lead to a pressing need for novel
crop protection products. However, due to current technological limitations and increasing regulatory requirements, the development of
crop protection products is lengthy, complicated and expensive.
Competition
The ag-chemical RD market, as described above, can be classified
into four key groups of companies: (i) major seed and ag-chemical companies, such as BASF, Bayer, Syngenta Group and Corteva, with internal
research and development units dedicated to development of ag-chemical products, (ii) mid-size ag-chemical companies, mainly Japanese
companies focused on the Japanese market, that develop crop protection products, (iii) small to mid-size biotech companies that undertake
new approaches to research and development of novel crop protection products, and (iv) academic and agricultural research institutions,
which focus on early stage activities.
Business Model
AgPlenus’ business model is based on two commercialization
avenues:
Licensing of product candidates
– when product candidates advance towards what is referred to in the industry as a Lead,
at the end of the discovery stage, or further along the development pipeline, these product candidates gain increased value and can be
candidates for licensing to ag-chemical companies. A typical licensing agreement can include
upfront payments, payments upon achievement of pre-defined development milestones, and royalties from product sales.
RD collaborations
– early-stage collaborations, providing a tailored product offering per partner and product type, in order to build long-term research
and development relationships and to mitigate the risk associated with building an independent pipeline. A typical collaboration agreement
may include RD payments, payments upon achievement of pre-defined development milestones, and royalties from product sales, which
would typically be lower than the royalties under licensing agreements.
Currently, AgPlenus’ revenues are derived from research and
development payments under early-stage collaborations with Corteva. In the longer term we expect that: (i) as AgPlenus’ product
candidates advance through development in our partners’ pipelines, and to the extent that they are commercialized by AgPlenus’
collaboration partners, revenues are expected to include milestone payments and royalty payments; and (ii) as AgPlenus’ internal
pipeline product candidates further advance, AgPlenus will license its product candidates.
2 Facts
Factors - https://www.globenewswire.com/news-release/2021/02/02/2168067/0/en/Crop-Protection-Chemicals-Market-Size-Share-Will-Reach-to-USD-90-Billion-by-2026-Facts-Factors.html.
49
Product Development Programs
Scientific Approach
AgPlenus’ approach is based on the disruption of the traditional
methods of ag-chemical discovery and optimization by implementing a target-based approach for identifying and developing new MoA crop
protection products to address the growing resistance of pests (weeds, insects, and fungi) to existing commercial products. AgPlenus utilizes
mainly Evogene’s ChemPass AI tech engine, as well as other advanced computational technologies and know-how, to drive its ag-chemical
discovery.
AgPlenus’ approach typically begins with the computational
and research-driven identification of protein ‘targets’, which are proteins that are essential to the function of performance
of the relevant weed, insect or fungi. Following the identification and validation of such targets, AgPlenus identifies candidate Hits,
which are chemical compounds (small molecules) that potentially inhibit these targets. AgPlenus screens candidate Hits to identify those
that demonstrate an effect on the pest of focus. Hits displaying confirmed activity in the initial validation screens, enter the Hit-to-Lead
process, which includes computational optimization and additional, more advanced, validation experiments.
In addition, these capabilities can also be used independently
of each other to discover new Hits for known targets, to optimize an existing Hit-to-Lead and to optimize a commercial molecule.
Product Development Cycle
The product development cycle for ag-chemical products is generally
comprised of several stages, described as follows:
Discovery stage
| ◾ |
Identification of Targets – identification and validation of vital targets or proteins that when inhibited (for instance by
a chemical), lead to weed, insect or fungi death. |
| ◾ |
Identification of Hits – screening of chemical compounds for the identification of candidate Hits that potentially inhibit
identified vital targets and are capable of achieving the desired impact on the weeds, insects or fungi of interest. The discovery process
includes in-silico as well as biological screening and validation activities. |
| ◾ |
Hit-to-Lead process – Hits displaying confirmed activity in the initial validation screens will enter the Hit-to-Lead process,
including several optimization cycles, each constructed of compound design (in our case, focusing on computational optimization), synthesis
of compounds and validation experiments. This stage ends with a ‘Lead’ compound, which is a validated Hit that has confirmed
activity in advanced validation screens proving field translation in initial trials. |
Lead optimization
| ◾ |
In this stage, multiple field trials are conducted in diverse geographies, as well as greenhouse experiments on resistant weed biotypes
and on commercial crops, and the compound structure and formulation are finalized. Lead optimization also entails initial toxicology tests,
process engineering on the molecule and a significantly detailed cost of goods analysis. |
Pre-development stage
| ◾ |
In this stage, field trials to validate all commercial cases are conducted, including testing product mixtures, as well as additional
safety trials. This stage ends with a ‘Pre-Development’ compound. |
Development, Regulation Registration stage
| ◾ |
In the final development phases, new chemical products are registered with the proper regulatory authorities in relevant territories
and then launched for commercialization. We expect that these last stages of development will be conducted by our collaboration partners
or licensees of our product candidates. |
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Product Development Pipeline
The following table sets forth AgPlenus’ main internal product
development programs:
In 2022, AgPlenus expanded its pipeline to further include fungicides,
in addition to the existing herbicides and insecticides pipelines, thus being capable of taking part in the full $60 billion crop protection
market.
Key Collaborations
Corteva – Herbicides
In March 2020, AgPlenus entered into a multi-year collaboration
with Corteva for the discovery and development of novel herbicides. Under the terms of the collaboration agreement, AgPlenus and Corteva
work together to optimize herbicide product candidates originating from AgPlenus’ pipeline. Successful candidates from this collaboration
are expected to be further developed by Corteva.
Pursuant to the collaboration agreement, Corteva obtained a worldwide,
royalty-bearing, exclusive license to use and modify chemical compounds identified under the collaboration to develop and commercialize
weed control products containing such compounds. Moreover, AgPlenus is entitled to research and development payments, milestone payments
upon achievement of certain development milestones as well as royalty payments from sales of products developed under the collaboration.
Intellectual Property
AgPlenus is seeking patent protection for intellectual property
rights covering its leading product candidates in main target markets. Currently AgPlenus has two granted patents and one patent application
in Israel.
Government Regulation of our Operations
AgPlenus’ research development activities in Israel
(such as laboratory work, greenhouse and field experiments) and are regulated by the provisions of several Israeli governmental agencies.
Violation of these regulations may expose us to criminal or civil actions and may impose liability on us. For more information please
see “Item 3.D. Risk Factors—Our business (including each of the businesses of our respective subsidiaries) and that of our
collaborators’ are subject to various government regulations and, if we or our collaborators are unable to comply with the relevant
respective law and regulations and/or obtain the necessary regulatory approvals, we may not be able to continue our operations.”
51
Government Regulation of Product Candidates
Regulatory approvals are required prior to the commercialization
and importation of ag-chemical products in most countries. While we work toward the development of each of the particular products, the
regulatory approval is typically effectuated through our collaborators, per the terms of our collaboration agreements. AgPlenus believes
that its collaborators would likely sell products containing its compounds in the U.S., the EU, Brazil and Argentina, and would therefore
require such regulatory approvals prior to the commercialization and sale of such products in those jurisdictions.
Raw Materials
AgPlenus does not significantly rely upon any sources of raw materials
for its operations.
Seasonality
The field testing of AgPlenus’ leading product candidates,
which have reached advanced stages of product development, are highly dependent on crop seasonality.
Currently, AgPlenus does not have any commercialized products
and therefore its revenues are not subject to variations based on seasonality. However, our expectation is that, in the future, sales
cycle of the products AgPlenus develops will be dependent on crop seasonality.
Ag-Seeds Division
Overview
According to the United Nations in its reports titled “The
future of food and agriculture Trends and challenges”3
and “The United Nations World Water Development Report, 2017,”4
both of which are not incorporated by reference herein, the global population will expand approximately 9.7 billion, pushing food demand
up 70%, by 2050. Our seed traits activity is focused on the development of products improving seed traits that have a direct impact on
crop productivity through the use of GM and non-GM approaches, aiming to fulfill such growing demand. We mainly target key commercial
crops such as corn, soy, wheat, rice and cotton.
The activities of this division are divided into three categories:
(i) yield abiotic stress tolerance – increase crop performance and productivity by enhancing yield (NUE – Nutrient Use
Efficiency), tolerance to abiotic stresses such as drought, heat and salinity; (ii) disease resistance – increase crop resistance
to diseases such as fungi and nematodes; and (iii) insect control – increase crop tolerance to pests.
In general, we utilize several biotechnology approaches with the
goal of improving seed traits, including: (i) genome editing technologies, enabling deletion or modification of specific genomic regions
in the crop's genome without inserting foreign DNA to the plant, (ii) genetic modification of plants, which involves the direct manipulation
of a plant’s genome by inserting a gene into the plant’s DNA, and (iii) advanced breeding methods (e.g. genetic markers),
whereby plants with favorable characteristics are selectively crossed through genomic-guided breeding schemes.
In recent years, the CRISPR technology (gene editing) is considered
to have the potential to revolutionize the product development of new seed traits, while overcoming environmental and other challenges,
and is expected to expand the global crop industry by $110 billion between 2022 and 2025 with an expected growth of 25%, according to
the 2018 report “CRISPR Genome-Editing Market Opportunity and Key Players,” which is not incorporated by reference herein.
3 https://www.fao.org/3/i6583e/i6583e.pdf
4 https://www.unwater.org/publications/un-world-water-development-report-2017
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Market
According to the Global GMO Crops and Seeds Industry (published
in January 2023. ID: 5960955) 5, which is not incorporated
by reference herein, the global market for GMO Crops and Seeds estimated at $65.7 billion in the year 2022, is projected to reach a revised
size of $102 billion by 2030. Additionally, the GMO crops and seeds market in the U.S. is estimated at $17.9 billion in the year 2022,
while China, is forecasted to reach a projected market size of $22.7 billion by the year 2030.
Business Model
In the Ag-Seeds division activity, we collaborate with seed companies
in the development of improved seed traits. Our partners include recognized seed companies, including Bayer and Corteva, as well as regional
seed companies such as Tropical Melhoramento Genética S/A, or TMG. Typically, under these collaborations we perform the discovery
phase, during which we discover and validate candidate trait-improving genetic elements. Subsequently, our collaborators, under license
from us, test and further develop these discoveries in their product development pipelines, starting Phase I, with the goal of introducing
them into commercial crop seeds. For more information on the product development pipeline, please see “— Product Development
Pipeline” below.
In most cases, we expect to generate revenue from our collaboration
agreements at two different points: first, we expect to receive milestone payments when certain specified results are achieved, such as
when a product candidate containing our traits is submitted for regulatory approval; second, we expect to receive royalty payments once
a commercial product containing our traits is launched into the market. Under several collaboration agreements, we also receive research
and development service payments to cover the costs of our research.
In the Ag-Seeds division, we currently generate revenues from research
and development payments for our activities. All of our product development programs under our Ag-Seeds activity are currently either
in the Discovery or in Phase I stages. For more information on our product development programs in this field, see “— Product
Development Programs.”
Product Development Programs
Scientific Approach
The division uses our expertise in plant and bacterial science
and genomics to improve commercial seed traits. Evogene’s proprietary CPB platform, specifically, the GeneRator AI and MicroBoost
AI engines, validation techniques and other capabilities enable us to identify and optimize promising genetic elements that have the potential
to improve our traits of interest in target crops.
We have accumulated substantial scientific knowledge on plant,
diseases and insect mechanisms associated with yield, abiotic stress, nutrient use efficiency, disease resistance traits and insect control
traits. We maintain a large proprietary genomic data from over 200 different plant species as well as large microbial data tailored for
insect and disease control. We have also established proprietary plant, disease and insect validation systems.
Product Development Cycle
The length of the process of developing and integrating seed traits
may vary depending on the technology being applied, the complexity of the trait and the type of crop involved. The development process
for seed traits is typically divided into discrete steps, or phases, as follows:
| ◾ |
Discovery: The identification of target genetic elements for enhancing
specified plant traits. We test these elements in different validation systems to determine their ability to enhance the specified trait.
In our experience, the Discovery phase takes approximately 6-18 months. The target genetic elements may be applicable to product development
through different technological approaches (i.e. genome editing, GM or advanced breeding). In our collaborations, we typically undertake
this phase. |
5
https://www.reportlinker.com/p05960955/Global-GMO-Crops-and-Seeds-Industry.html
53
| ◾ |
Phase I, or “Proof of Concept”: Validated candidate genetic
elements are advanced to Phase I. In this phase, they are tested in target plants through greenhouse trials, field trials, or both, for
their efficacy in improving plant performance. Phase I may be conducted by us or by our collaborators, and in our experience, may last
between two and five years for a GM product or, three years for a genome editing or advanced breeding product. For products developed
through genome editing, deregulation process for classifying a product as non-GM is typically initiated during Phase I. |
| ◾ |
Phase II, or “Early Development”: In this phase, the field
tests are expanded, and our collaborators evaluate the genetic elements on multiple geographical locations and varieties, to reach commercially
viable success rates. We estimate the duration of Phase II is between two to four years. For a GM product, by the end of this phase, a
specific product candidate will be selected to advance to Phase III. For genome editing and advanced breeding products, the end of this
phase will lead straight to Phase IV (Pre-Launch). |
| ◾ |
Phase III, or “Advanced Development and Regulation”: This
phase is relevant only for the development of GM products. Extensive field trials are performed to test the effectiveness of the selected
product candidate across locations, and regulatory approvals are obtained, including potential environmental impact assessments, toxicity
and allergenicity. We estimate the duration of Phase III is between one to two years. |
| ◾ |
Phase IV, or “Pre-Launch”: This phase involves preparation
for commercial launch. The range of activities here includes preparing the seeds for commercial sales, formulation of a marketing strategy
and preparation of marketing materials. We estimate the duration of Phase IV is between one to two years. |
As indicated, the estimated timeframes of phase duration are based
on our experience and estimates according to available information. The total development time for a particular product may be longer
or shorter than the duration presented above depending on a range of factors.
Product Development Pipeline
The following table sets forth our key product development programs
in the segment of yield and abiotic stress tolerance seed traits under development with our collaborators:
|
Program |
Crop |
Technology |
Collaborator |
Development Phase |
|
1 |
Corn |
GM |
Bayer |
Phase I – at collaborator under license. |
The following table sets forth our key product development programs
in the segment of disease resistance traits, under development with our collaborators:
|
Program |
Crop |
Trait |
Technology |
Collaborator |
Development Phase |
|
1 |
Corn |
Fusarium |
GM genome editing |
Bayer |
Undisclosed. At collaborator under license. |
|
2 |
Soybean |
Nematodes |
Genome editing |
TMG |
Discovery |
Key Collaborations
Bayer (originally with Monsanto)
In August 2008, we entered into a Collaboration and License Agreement
with Monsanto (now Bayer, following the completion of the acquisition of Monsanto by Bayer in June 2018 and a later assignment of the
agreement from Monsanto to Bayer CropScience LP), as was later amended and restated. Pursuant to the agreement, Monsanto funded two research
programs in the fields of yield and abiotic stress tolerance and fusarium biotic stress.
54
We have granted Monsanto an exclusive, royalty-bearing, worldwide
license under our patents and know-how to commercially exploit and conduct research on the genes and other genetic elements we discovered
under the collaboration, in the specified crops.
Monsanto provided us with research and development payments, and
undertook to provide us with development milestone payments, if and when our product candidates reach significant milestones in its product
development pipeline, as well as royalty payments on any sales or other transfers of products it develops containing our licensed genes.
In December 2022, the parties further amended the agreement to
restructure the patent filing, prosecution, and maintenance obligations under the collaboration, in consideration of a payment to Evogene
of $3.5 million.
TMG
In December 2018, we entered into a multi-year collaboration and
license agreement with TMG, a major Brazilian developer and marketer of soybean varieties, for the development of nematode-resistant soybean
varieties using genome editing technologies. Under the agreement, we identified genomic elements for editing to attribute nematode resistance
in soybean and perform such edits on TMG’s commercial soybean germplasm. In turn, TMG validates the efficacy of the edited soybean
varieties in greenhouse assays and field trials in Brazil and for incorporation in its breeding pipeline.
Under the collaboration and license agreement, TMG obtained a worldwide,
royalty-bearing license to incorporate genome edits originating from the collaboration in its soybean varieties. Evogene, on the other
hand, obtains a non-exclusive, royalty-bearing license to commercialize such genome edits and soybean lines, subject to certain exclusivity
restrictions. According to the agreement, each party is entitled to receive royalty payments from the other party when the products of
the collaboration are commercialized. In addition, Evogene is entitled to success-based payments upon achievement of pre-defined development
milestones. We expect to have preliminary results of TMG assessment by the end of 2024, however, we cannot provide any certainty that
such results will be available as of that date.
Intellectual Property
In the AgSeeds division, we seek to obtain patent
protection for the use of the genes and genetic elements that we identify as linked to desired traits. In certain cases patent protection
determines our eligibility to receive royalties for seed traits under the licenses we grant our collaborators. To date, we have sought
and obtained patent protection for hundreds of plant genes in target territories. During 2023, we intend to focus our patent portfolio
based on geographical markets (specifically, the United States, Argentina and Brazil) and plant traits, perceived as having the most commercial
potential in the market.
Government Regulation of Product Candidates
In most of the markets where we believe that our collaborators
will sell seeds containing our traits, including the United States, the EU, Brazil and Argentina, regulatory approvals are required prior
to the commercialization and importation of biotechnologically enhanced seeds. Additional regulatory approvals are required in countries
importing grain produced from seeds containing our traits, such as China, India and certain countries in the EU. Pursuant to our collaboration
agreements in the field of seed traits, our collaborators are typically responsible for applying for all requisite regulatory approvals
prior to commercialization of the product candidates we develop with them.
The regulatory status of products developed via genome editing
technologies is currently defined in most countries with the exception of the EU. In the United States, de-regulatory approvals are required
by the USDA prior to field testing of genomic edited seeds. Several ‘non-regulated organism’ approvals have been issued by
the USDA as well as the regulatory authorities of Japan and Argentina for products that are being commercialized or under development.
55
According to Question and Answers on the regulation
of GMOs in the EU, which is not incorporated by reference herein,6
under Directive 2001/18/EC, a company intending to market a GMO must first submit an application to the competent national authority
of the respective EU member state, or Member State, where the product is to be first placed on the market. The application must include
a full environmental risk assessment. If the national authority gives a favorable opinion on the placing on the market of the GMO concerned,
this Member State informs the other Member States via the European Commission. If there are no objections by other Member States or the
European Commission, the competent authority that carried out the original evaluation grants the consent for placing the product on the
market. The product may then be placed on the market throughout the EU in conformity with any conditions required in that consent. If
objections are raised and maintained, a decision has to be taken at EU level. The European Commission first asks for the opinion of its
scientific panels composed of independent scientists, highly qualified in the fields associated with medicine, nutrition, toxicology,
biology, chemistry, or other similar disciplines. The European Food Safety Authority provides the relevant panels for this purpose. If
the scientific opinion is favorable, the European Commission then proposes a draft legislative decision to the Regulatory Committee composed
of representatives of Member States for an opinion. If the Regulatory Committee gives a favorable opinion, the European Commission adopts
the decision. If not, the draft decision is submitted to the Council of Ministers for adoption or rejection by qualified majority. If
the Council does not act within three months, the Commission shall adopt the decision. During the notification process, the public is
also informed and has access to the publicly available data. For experimental releases, notifications are examined and consent is granted
as appropriate by the authorities of the Member State in which the release is to be conducted.
Government Regulation of our Operations
The business of the AgSeeds division is subject to regulation related
to agriculture, health and the environment. To operate, we must obtain various permits and licenses from government authorities and municipalities
in jurisdictions where we are active, and we must maintain our compliance with the terms of those permits, licenses and other government
standards as necessary. These laws and regulations, particularly in relation to biotechnology, are not fully settled, but continue to
evolve in order to keep pace with technological advances.
Our operations are carried out mainly in Israel and accordingly
are regulated by the ISARD, and more specifically by the ISARD’s Plants Protection and Inspection Services. Our activities are subject
to various laws, regulations, orders and procedures, which require us, among other things, to obtain permits for conducting experiments
on genetically enhanced plants and to satisfy special conditions determined by the ISARD regarding the growing procedures of such seeds
and plants. Violation of these regulations may expose the company to criminal penalties. Pursuant to these regulations, we are also obligated
to obtain separate permits to own and operate our greenhouses and testing fields in Israel and we are routinely inspected by ISARD.
Raw Materials
Our AgSeeds division does not significantly rely upon any sources
of raw materials for our operations.
Seasonality
Our seed traits business in general, and our revenues in particular,
are not subject to variations based on crop seasonality.
Human Health
Biomica Ltd.
Overview
In 2017, we established Biomica, a subsidiary focused on the discovery
and development of innovative human microbiome-based therapeutics. The human microbiome is an array of more than 100 trillion microorganisms
that live on and in our bodies, creating a community of symbiotic, commensal and pathogenic bacteria, all of which call the human
body home. These microbes have numerous beneficial functions relevant to supporting life, such as digesting food, preventing disease-causing
pathogens from invading the body, and synthesizing essential nutrients and vitamins. Numerous studies have shown the connection between
the human microbiome and various medical disorders, and the search for microbiome therapies and treatments is a rapidly growing focus
for biotherapeutics research and development.
6 https://ec.europa.eu/commission/presscorner/detail/en/MEMO_04_102
56
Biomica focuses on the development of human-microbiome based therapies
utilizing either rationally-designed microbial consortia or small molecule approaches for (i) immuno-oncology (ii) gastrointestinal inflammatory,
or GI related disorders, and (iii) antimicrobial resistance, or AMR, an antibiotic resistant bacteria.
On December 21, 2022, Biomica announced the signing of a definitive
agreement for a $20 million financing round, led by SHC, with $10 million of which to be invested by Evogene. The financing is subject
to customary closing conditions, including clearance by Chinese regulatory authorities. SHC is a leading Chinese private equity fund,
based in Shanghai and focused on biotech and healthcare investments globally. The fund is managed by SIIC Capital, with Shanghai Pharma
as one of the founding and strategic limited partners.
The proceeds from this financing are expected to enable Biomica
to continue developing its pipeline of microbiome-based therapeutics. Biomica plans to use the proceeds to complete its current BMC128
phase 1 immuno-oncology study and advance to phase 2 clinical trial, scale up and complete GMP production of BMC333 in preparation for
a phase 1 clinical trial for the treatment of IBD; as well as advance additional programs.
Market
Biomica’s product development is currently focused in three
main markets:
Immune-Oncology
In oncology, checkpoint inhibitor antibodies, including those targeting
the programmed cell death protein/ligand 1, or PD-1/PD-L1 pathways, block the tumor’s ability to suppress the immune response. They
have significantly improved the treatment of many cancers. The cancer immunotherapy market size was estimated at $85.6 billion in 2020
and is expected to reach a market size of $309.7 billion by 2030 according to a report published in July, 2021 by Allied Market Research,
which is not incorporated by reference herein.
Even in cancers, where checkpoint inhibition is considered the
frontline standard of care, a significant percentage of the patients do not respond to PD-1 + CTLA-4 inhibitor combination and a portion
of responders relapse within a few years. In all approved cancer indications, agents with differentiated immune mechanisms of action may
be complementary to checkpoint inhibitors by both augmenting existing effects and testing alternative pathways of immunotherapy in checkpoint
inhibitor non-responsive tumor types and patients.
Given a growing body of literature, it is becoming increasingly
clear that modulation of the gut microbiota may represent a novel and important adjunct to current anti-cancer therapeutic modalities.
GI related disorders
| ◾ |
Irritable Bowel Syndrome (IBS) is a common disorder that affects the large intestine.
Signs and symptoms include cramping, abdominal pain, bloating, gas, and diarrhea or constipation, or both. It is estimated that the total
market for IBS reached $1.5 billion in 2018, with 45 million patients in the U.S. alone and is expected to reach $3.3 billion in 2026,
according to a report titled “Irritable Bowel Syndrome Treatment Market Size, Share Analysis Report By Type,” the 2019-2026
segment and an article in Bloomberg, dated July 23, 2019, both of which are not incorporated by reference herein. Existing drugs for IBS
mainly treat the symptoms of the condition, leaving patients exposed to cycles of remission and relapse that characterize this chronic
condition. |
| ◾ |
IBD is a group of GI diseases, mainly comprised of Ulcerative colitis and Crohn’s disease.
IBDs cause long term chronic as well as severe inflammation in the gastrointestinal tract without any known cause. According to the Centers
for Disease Control and Prevention, or CDC, in 2015 an estimated 3.1 million people (1.3% of the entire population) in the United States
were diagnosed either with Crohn’s disease or with Ulcerative Colitis. According to a Grand View Research, Inc. 2019 report, which
is not incorporated by reference herein, the global IBD drug market is estimated to grow from $15.9 billion in 2018 to $22.4 billion in
2026. |
57
AMR (antimicrobial resistance)
| ◾ |
Clostridium Difficile Infection (CDI) – The U.S. Centers for Disease Control and Prevention
in a report titled “Antibiotic Resistance Threats In The United States” published in December 2019, which is not incorporated
by reference herein, has identified CDI as one of the top three most urgent antibiotic-resistant bacterial threats in the United States.
CDI is most often caused by the use of broad-spectrum antibiotics which induce dysbiosis of the microbiome causing susceptibility to infection
by C. difficile, a spore forming bacterium. It is the most common cause of hospital acquired infection in the United States. |
According to “Antibiotic Resistance Threats In The United
States” a report published by U.S. Centers for Disease Control and Prevention in December 2019, which is not incorporated by reference
herein, CDI is responsible for the deaths of approximately 13,000 Americans each year. Based on this report, the incidence of CDI in the
U.S. was estimated to be 223,900 cases in hospitalized patients in 2017. CDI space across the seven major markets of the U.S., France,
Germany, Italy, Spain, the UK and Japan is set to grow from just under $630 million in 2016 to almost $1.7 billion by 2026, representing
a compound annual growth rate of 10.2%. According to an article from GlobalData on July 24, 2017, which article is not incorporated by
reference herein, the global CDI market is expected to approach $1.7 billion by 2026.
| ◾ |
Methicillin-Resistant Staphylococcus Aureus (MRSA) – One of the most common Staphylococcus
aureus infections is caused by MRSA, which is a multi-drug resistant bacterium, responsible for several difficult-to-treat infections
in humans, leading to tens of thousands of annual cases of mortality in the U.S. MRSA is the leading causative agent for hospital acquired
infections and has recently been documented as community-acquired as well as livestock-acquired. Current medical treatments include broad
spectrum antibiotics that are becoming increasingly ineffective. Bloomberg estimates according to a report published on September 24,
2019, which is not incorporated by reference herein, that the current MRSA market was valued at approximately $922 million in 2018 and
is projected to reach over $1.3 billion by 2026. |
Competition
The biotechnology and pharmaceutical industries are characterized
by rapid growth and a dynamic landscape of proprietary therapeutic candidates. The development and commercialization of new drug and biologic
products is highly competitive and is characterized by rapid and substantial technological development and product innovations. While
we believe that our computational platform and microbial drug candidates, coupled with our resources and industry expertise, give us a
competitive advantage in the field, we face competition from a variety of institutions, including larger pharmaceutical companies with
more resources. Specialty biotechnology companies, academic research institutions, governmental agencies, as well as public and private
institutions are also potential sources of competitive products and technologies.
In both inflammatory diseases and oncology, we anticipate intensifying
competition as new therapies are approved and advanced technologies become available. Many of our competitors, either alone or with strategic
partners, have considerably greater financial, technical, and human resources than we do.
Significant competition exists in the immuno-oncology and inflammatory
diseases field, where we are developing our first drug candidates in oncology and IBD. Although our rationally-designed microbial consortium
approach is unique relative to most other existing or investigational therapies in immuno-oncology, we will need to compete with all currently
or imminently available therapies within the indications where our development is focused. Although there is a wide range of potentially
competitive mechanisms, possible synergies between these and rationally-designed microbial consortia will also be evaluated.
Business Model
Biomica’s goal is to become a leading biopharmaceutical company
developing and commercializing microbiome therapeutics to address significant unmet medical needs, through strategic collaborations with
world-leading pharmaceutical companies.
Product Development Programs
Scientific Approach
Biomica aims to identify unique microbiome-based therapeutic entities
through multilayered analysis and integration of high resolution big-data originating from the human gut microbiome. Employing a holistic
approach, Biomica combines a profound understanding of the microbiome and its functions and their intricate relations with the human host.
58
Biomica’s approach relies on a multi-layered analysis of
omic and clinical / phenotypic data using an extensive nexus of modules in four key areas: (i) creation of microbial classifications –
enabling high-resolution taxonomy analysis of the microbial community down to the strain level, (ii) identification of microbial functions
– functional-level microbial community analysis profiling microbial genes, pathways and metabolites, (iii) identification of host
genomics – profiling of patients' genomic information (genetics and expression patterns), and (iv) clinical data – integrate
relevant phenotypic and physiological information manifested in patient.
Biomica’s discovery and development efforts are powered by
the predictive, high resolution, integrative selection of microbes, or PRISM, platform, which is powered by Evogene’s MicroBoost
AI engine. PRISM is a
proprietary metagenomics analysis platform for functional genomics profiling, utilizing internal comprehensive databases. These databases
have been specifically developed to allow the processing of large amounts of sequencing data, obtain high-resolution profiling of microbial
communities both at the taxonomic and the functional levels, and correlate them with specific clinically relevant host expression and
phenotypic profiles, enabling Biomica to achieve each of the below analyses:
| ◾ |
At the taxonomic level Biomica's analysis allows strain-level resolution and relies on an extensive proprietary strain database.
|
| ◾ |
At the functional level, Biomica's proprietary resources rely on a comprehensive catalog of microbial genes enabling mapping of an
average of 90% of the functions of the human gut microbiome obtained through metagenomics sequencing. |
In addition to its comprehensive computational solutions to profile
the microbiome, Biomica also utilizes Evogene's ChemPass AI engine, for virtual screening
of small molecular inhibitors to specifically target bacterial proteins of interest. This platform combines the physiochemical requirements
for binding a specific protein target and utilizes a comprehensive proprietary database of over 20 billion known molecules for the discovery
of potential therapeutics.
Product Development Pipeline
Immune-Oncology
BMC128 is an optimized consortium, which consists of four bacterial
strains derived from Biomica’s BMC121 and BMC127 (rationally-designed consortia that were identified using our computational analysis
and predictive capabilities designed to enhance an anti-tumor immune activity). BMC128 is a rationally-designed live biotherapeutic product,
comprised of unique bacterial strains, natural inhabitants of the human intestinal tract, that harbor specific functional capabilities
with the potential to enhance immunological therapeutic responses and facilitate anti-tumor immune activity though multiple biological
processes.
During 2022, Biomica continued advancing BMC128 into the clinical
phase. Biomica entered a clinical trial agreement with Rambam Health Care Campus in Israel for initiating a first in-human proof-of-concept
for BMC128 and in January 2022 Biomica received clearance to conduct such a trial from the Israeli Ministry of Health. In July 2022, Biomica
announced that the first patient was enrolled and later on dosed in its Phase I clinical trial. This clinical trial is designed primarily
to evaluate the safety and tolerability of Biomica’s microbiome-based immuno-oncology drug candidate, BMC128, in combination with
immune checkpoint inhibitor, or ICI immunotherapy, in patients with either non-small cell lung cancer, or NSCLC, melanoma or renal cell
carcinoma, or RCC. Bristol Myers Squibb’s Opdivo® is the immune checkpoint inhibitor in the trial. As of December 2022, the
third patient out of twelve has been enrolled and dosed in this study. Biomica is targeting to complete the trial in the latter part of
2023.
59
GI Disorders
In the IBD program, BMC333 is an optimized consortium, which consists
of four bacterial strains derived from Biomica’s BMC321 and BMC322 (rationally-designed consortia that were identified using Biomica’s
computational analysis and predictive capabilities designed with specific emphasis on the anti-inflammatory activity of these strains
and their potential as novel therapeutic modality for IBD). During 2022, Biomica conducted pre-clinical trials pointing to reduction of
inflammation following treatment with BMC333, demonstrating BMC333’s ability to significantly reduce intestinal tissue damage resulting
from inflammation in various animal models. During 2023, Biomica intends to initiate scale-up development in preparation for GMP clinical
batch production of BMC333.
In the IBS program, we utilize proprietary data from several clinical trials conducted
in the U.S. to develop a novel microbiome-based drug, BMC426. During 2022, Biomica conducted pre-clinical trials to evaluate the therapeutic
effects of BMC426 in IBS animal models. Positive preclinical results were obtained from a research collaboration with Prof. Margolis in
the United States at New York University for the use of BMC426 in unique animal models. Additional preclinical work is expected to take
place during 2023 in the IBS program.
AMR (antimicrobial resistance)
CDI
– Using Biomica's microbiome therapeutics platform, we are developing a small-molecule drug candidate (BMC201), designed to target
the main toxin secreted by the bacterium and hence repair dysbiosis in the colonic microbiome in the setting of primary or recurrent
CDI. BMC201 is being developed as an orally available drug.
MRSA
– Biomica is engaged in a collaboration with the Weizmann Institute of Science in Israel to develop a selective treatment against
antibiotic resistant strains of Staphylococcus aureus infection, in a microbiome focused approach. Biomica has in-licensed Prof. Ada Yonath’s,
Nobel Prize laureate, work and discoveries in high-resolution crystal structure of the large ribosomal subunit of the pathogenic Staphylococcus
aureus for the design and development of new types of selective, narrow spectrum antibiotics agents.
Both programs are currently at the discovery stage and expected
to advance to optimization phase and later potentially to first proof-of-concept preclinical studies during 2023.
Intellectual Property
Biomica aims to protect the proprietary intellectual property that
it believes is important to Biomica’s business, including seeking international patent protection for its product candidates and
promptly file patent applications for new commercially valuable inventions of Biomica’s business. Biomica also relies on trade secrets
to protect aspects of its business that it does not consider appropriate for patent protection. Biomica’s success will depend on
its ability to obtain and maintain patent and other proprietary protection for commercially important technology, inventions and know-how
related to our business, as well as defend and enforce any patents that we may obtain.
Raw Materials
Biomica does not significantly rely upon any sources of raw materials
for its operations.
Seasonality
Biomica’s business in general is not subject to variations
based on seasonality.
Government Regulation of our Operations
The FDA and other regulatory authorities at federal, state and
local levels, as well as in other countries, extensively regulate, among other things, the research, development, testing, manufacture,
quality control, import, export, safety, effectiveness, labeling, packaging, storage, distribution, record keeping, approval, advertising,
promotion, marketing, post-approval monitoring and post-approval reporting of drugs and biologics such as those Biomica is developing.
Biomica, along with its contract manufacturers, will be required to navigate the various pre-clinical, clinical and commercial approval
requirements of the governing regulatory agencies of the countries in which it wishes to conduct studies or seek approval for its product
candidates. The process of obtaining regulatory approvals and ensuring subsequent compliance with appropriate federal, state, local and
foreign statutes and regulations requires the expenditure of substantial time and financial resources.
60
In the United States, the FDA
regulates drug and biologic products under the FFDCA, its implementing regulations and other laws, including, in the case of biologics,
the Public Health Service Act. Our product candidates are subject to regulation by the FDA as biologics. Biologics require the submission
of a biologics license application, or BLA, and approval by the FDA before being marketed in the United States.
The process required by the FDA before our biologic product
candidates may be marketed in the United States generally involves the following:
• completion of preclinical laboratory tests and animal
studies performed in accordance with the FDA’s good laboratory practice, regulations;
• submission to the FDA of an investigational new drug
application, which must become effective before clinical trials in the United States may begin;
• approval by an institutional review board, or ethics
committee at each clinical site before a trial is commenced;
• performance of adequate and well-controlled human clinical
trials to establish the safety, purity and potency of the product candidate for each proposed indication, conducted in accordance with
the FDA’s good clinical practice, or GCP, regulations;
• preparation and submission to the FDA of a BLA after
completion of all pivotal trials;
• satisfactory completion of an FDA Advisory Committee
review, if applicable;
• determination by FDA within 60 days of its receipt of
a BLA to file the application for review;
• satisfactory completion of an FDA inspection of the
manufacturing facility or facilities at which the product is produced to assess compliance with GMP regulations, and to assure that the
facilities, methods and controls are adequate to preserve the biological product’s continued safety, purity and potency, and of
selected clinical investigation sites to assess compliance with GCPs; and
• FDA review and approval of the BLA prior to any commercial
marketing, sale or shipment of the product.
The testing and approval process requires substantial time,
effort and financial resources, and we cannot be certain that any approvals for Biomica’s product candidates will be granted on
a timely basis, if at all.
Government Regulation of Product Candidates
The development of therapeutic products targeting the underlying
biology of the human microbiome is an emerging field, and it is possible that the FDA and other regulatory authorities could issue regulations
or new policies in the future affecting our microbiome therapeutics that could adversely affect Biomica's product candidates. All of Biomica's
product candidates are based on microbiome therapy, a therapeutic approach that is designed to treat disease by restoring or providing
the targeted functions to a dysbiotic microbiome. Biomica has not, nor to its knowledge has any other company, received regulatory approval
for a therapeutic based on this approach.
61
Canonic Ltd.
Overview
In April 2019, we announced the establishment of Canonic, a wholly-owned subsidiary,
focusing on the development and commercialization of precise and stable medical cannabis products for better therapeutic effects using
computational biology. In October 2021, Canonic began the commercialization of its first products in Israel. While we are continuing to
support Canonic’s growth, we have made some recent structural changes to lower our overall expenses, as referenced in our Risk Factor
– "We have a history of operating losses and negative cash flow, and we may never achieve or maintain profitability", and we are
considering various options with respect to Canonic’s business.
Market
According to the Legal Cannabis Market Size, Share Trends
Analysis Report By Source (Marijuana, Hemp), By Derivative (CBD, THC), By End Use (Medical Use, Recreational Use, Industrial Use), By
Region, and Segment Forecasts, 2022 - 2030, which is not incorporated by reference herein,
the global legal cannabis market size was valued at $17.8 billion in 2021 and is expected to expand at a compound annual growth rate,
or CAGR, of 25.3% from 2022 to 2030.7 The increasing rate
of legalization of cannabis and acceptance of its use in the medical field are the key factors due to which the market is expected to
grow. Cannabis has long been used for medicinal purposes but not as the first line of treatment. Research surrounding the use of cannabis
for its medicinal properties has led to it being used for various indications. Cannabis has been found to be greatly effective in its
ability as a therapeutic for chronic pain and in treating nausea caused due to chemotherapy. It is still classified as a Schedule I drug
by the U.S. Drug Enforcement Administration, or DEA, in spite of which it has been legalized in more than two-thirds of the states in
the U.S.
In Israel alone, the Israeli Ministry of Health
has reported, in a report of the IMCA, which is not incorporated by reference herein, there were more than 100,000 medical cannabis patients
at the end of 20211 and an overall annual market of 40
tons that is estimated at an approximate market size of $260 million per year. According to Bizportal,2
which is not incorporated by reference herein, the number of patients is estimated to be 250,000 by 2025.
Canonic has identified three main challenges in the medical cannabis
market:
| ◾ |
Increased Competition – During 2022, the Israeli Ministry of Health granted licenses
to engage in medical cannabis, without taking a physical part in the local supply chain. Under these licenses, businesses were permitted
to engage in import and distribution of medical cannabis without the need for costly local operations of production and sale. These changes
led to intense competition due to the entrance of foreign leading companies and product brands, resulting in decreased product prices.
|
| ◾ |
Variety stability – Current cannabis varieties demonstrate high variability in active
compound concentration and other desired traits. The Company believes that patients continuously seek more reliably consistent products.
Recent years have demonstrated the aim of most market participants to have products with high THC content. |
| ◾ |
Cannabinoid yield – Yield in cannabis refers to the active compounds or metabolites
found in the plant. Currently, low yield leads to higher production costs and subsequently higher costs for the patients. As cannabis
becomes decriminalized in more countries, the competition in the market increases, which leads to a price reduction per gram of cannabis.
The decreasing selling price of cannabis has made this product more sensitive to the cost of production, making yield of active compounds
per growing area a significant factor. |
| ◾ |
Cannabinoid specificity – Cannabis is known to contain hundreds of active compounds,
and a critical need is to connect specific active compounds to the relevant medical indication and to develop cannabis varieties and products
that include these specific active compounds in a stable and consistent manner. The lack of clinical data demonstrating correlation between
medical indications and the genomic and cannabinoid profile of cannabis plants creates difficulties to develop indication-specific products.
|
We believe that Canonic’s combination of assets and capabilities
in the use of computational technology, together with deep understanding of plant genomics, analysis of big data and low expenses due
to a lean operational structure, can address these challenges.
7 https://www.grandviewresearch.com/industry-analysis/legal-cannabis-market
8 https://www.health.gov.il/Subjects/cannabis/Documents/licenses-status-september-2020.pdf
(the source is in Hebrew).
9 https://www.bizportal.co.il/capitalmarket/news/article/786443
(the source is in Hebrew).
62
Competition
Canonic’s competitors include plant genomics companies aiming
to improve the properties of medical cannabis varieties, as well as companies commercializing
medical cannabis products.
Business Model
In Israel, Canonic mainly markets its medical cannabis
products under its own label to pharmacies through distributors in Israel. Canonic’s medical cannabis products are sold at over
50% of all licensed cannabis pharmacies across Israel (approximately 90 out of a total of approximately 180 licensed pharmacies). After
establishing its brand in the Israeli market, Canonic intends to expand its activities to Europe, where it intends to collaborate with
local partners for the following purposes: (1) a licensing model enabling cultivation of our own varieties under a royalties mechanism;
(2) distribution of our varieties under private/white label in Europe; and (3) procurement of production to support both lower cost of
goods sold for Canonic’s current production in Israel and offseason production in geographies with opposite seasons (southern hemisphere).
Canonic has
established a value chain from genomics to product, with certain parts of the chain, such as cultivation, production and distribution,
being outsourced to contractors. Canonic aims to focus on aspects in which it has a competitive advantage, such as the development of
improved cannabis varieties having commercially desirable traits. In executing its business model, Canonic has entered into multiple production
and distribution agreements, to support production and commercialization of its products. In Israel, Canonic has executed this strategy
as demonstrated by the launch of its products during 2021 and 2022. Canonic intends to extend this approach in order to reduce costs and
improve the level of service, through competition between several contractors, which will also reduce Canonic’s operational risk
by diversifying its production and distribution resources.
In January 2022, Canonic announced that it has
shipped a first batch of its cannabis varieties to Portugal, following receiving approval to export from the Israeli Ministry of Health
and Ministry of Agriculture and Rural Development, and received the applicable certification according to European regulation.
Scientific Approach
Canonic is focused on the development of precise
and stable medical cannabis products based on proprietary cannabis varieties with unique genomic profiles. Leveraging Evogene's GeneRator
AI tech engine and high throughput screening capabilities, Canonic has established a unique cannabis database, which is based on
its diverse genetic collection. It has so far characterized more than 1,500 cannabis lines for their genetic and chemotype phenotype.
This proprietary database, coupled with genetic marker screening, has enabled the development of first cannabis varieties that exhibit
desired commercial attributes.
In addition, by leveraging Evogene's ChemPass
AI tech engine, Canonic has successfully revealed docking of certain cannabinoids with human receptors. The recently discovered
docking data while utilizing high throughput systems to identify leading varieties, may be utilized in the future for the purpose of developing
medical grade cannabis products aimed at specific clinical indications correlated with such discovered cannabinoids.
Product Development
Canonic's product development efforts include the following main
stages:
| ◾ |
Development of varieties – pre-breeding and breeding activities of tailored cannabis
varieties (i.e., selective crossing of cannabis varieties) to achieve desired properties. |
| ◾ |
Pre-production and pre-commercialization – testing of cannabis varieties, as well as
upscaling propagation and cultivation activities, and maintaining a higher security level of its own genetic varieties through tissue
culture techniques. |
| ◾ |
Production and commercialization – production of Canonic’s products through contractors
and distribution through regional distributors. |
| ◾ |
Post commercial data collection – this stage includes collecting market feedback on
Canonic’s products in order to optimize traits and clinical effects for its future products. |
63
Product Development Pipeline
Canonic has two product families under development.
MetaYield, focused on consumer
traits and enhancement of total active compounds in the plant. In this program - Canonic is developing various types of products, among
which is the G-innovation series. In October 2021, Canonic began the sale of its first MetaYield products, part of G-innovation series
in Israel, following positive feedback received from patients during Canonic’s pre-launch campaign:
| - |
G150 - marketed under the T15/C3 category (16%-24% THC10
0% - 7% CBD), as defined by the Israeli Ministry of Health; |
| - |
G200 - marketed under the T20/C4 category (16%-24% THC 0% - 7% CBD), as defined by the
Israeli Ministry of Health; |
| - |
Synergy - marketed under the T20/C4 category (16%-24% THC 0%-7% CBD), as defined by the Israeli Ministry of Health;
|
| - |
Combo - marketed under the T20/C4 category (16%-24% THC 0%-7% CBD), as defined by the Israeli Ministry of Health;
|
| - |
Mash Kush - marketed under the T20/C4 category (16%-24% THC 0%-7% CBD), as defined by the Israeli Ministry of Health;
|
| - |
Mosaic - marketed under the T20/C4 category (16%-24% THC 0%-7% CBD), as defined by the Israeli Ministry of Health;
|
| - |
Two Stars - marketed under the T20/C4 category (16%-24% THC 0%-7% CBD), as defined by the Israeli Ministry of Health;
and |
| - |
Blend Kush - marketed under the T20/C4 category (16%-24% THC 0%-7% CBD), as defined by the Israeli Ministry of Health.
|
Canonic is continuing the development of next generation product
candidates under the hybrid family of products. Canonic intends to continue research in 2023 for approaching the market’s vast needs
for high THC and high terpenes products.
| ◾ |
Precise, focused on the enhancement of specific active compounds in the plant. Due to decreased
market appetite for medical cannabis products addressing specific medical indications, Canonic has decided to focus its current product
development efforts on its MetaYield program. |
Key Agreements
Cultivation Agreement
– Telcann
In December 2020 Canonic entered an agreement with Telcann Ltd,
a licensed Israeli medical cannabis cultivator, for the provision of plant growth services in Israel.
Collaboration Agreement
– Plantis
In September 2022, Canonic entered into an agreement with Plantis
Agro Ltd., a licensed Israeli medical cannabis cultivator, pursuant to which the parties will collaborate in the production and distribution
of products derived from the medical cannabis varieties of Canonic under a joint brand.
Distribution Agreement
– Novolog
In August 2021, Canonic entered into an agreement for the distribution
in Israel of Canonic’s medical cannabis products with Novolog. According to the agreement, Novolog distributes Canonic’s medical
cannabis products in Israel through its distribution channels, on a consignment basis to licensed pharmacies, under the Canonic brand.
Consideration to be paid by Canonic will be based on a percentage of sales and for related services.
Production Agreement –
Cannassure
In November 2021, Canonic entered into an agreement
for the production of Canonic’s medical cannabis products with Cannassure. According to the agreement, Cannassure produces Canonic’s
medical cannabis products at its factory complying with GMP standards of the IMCA. The agreement is not exclusive for either party and
consideration paid will be based on the scope of production and related services provided.
10 Tetrahydrocannabinol
(THC) is the principal psychoactive constituent of cannabis and one of at least 113 total cannabinoids identified in the plant.
64
Intellectual Property
Canonic expects its intellectual property to include three layers:
| ◾ |
Evogene's existing patent portfolio – patents regarding the use of plant genes for the improvement of plant traits and the
development of genetic markers, which is licensed exclusively to Canonic for cannabis; |
| ◾ |
Breeders’ rights – plant variety protection rights to be filed for cannabis varieties developed by Canonic. Canonic has
filed breeders’ rights applications in Israel, EU and South Africa for several of its leading varieties; and |
| ◾ |
Patents – relating to the therapeutic attributes
of active compounds within the cannabis plant, resulting from pre-clinical or clinical trials conducted by Canonic. During 2021, Canonic
has filed a provisional patent application for the pre-clinical activity of the Precise products under development. Canonic has a PCT
application continuing the U.S. provisional. |
| ◾ |
Plant Breeder's Rights (PBRs) – Canonic has
PBR applications for cannabis varieties developed by the company, filed in Israel and Europe. |
Raw Materials
Canonic is producing its own reproductive materials, and therefore
it does not rely on external sources for that matter.
Seasonality
Canonic’s cultivation activities are performed under controlled
environments, which permit cultivation year-round, although in wintertime crop yield and active compound concentration may be negatively
affected. Canonic intends to extend its cultivation activity to the southern hemisphere in order to mitigate this negative effect.
Government Regulation of our Operations and Product Candidates
All cannabis related activities in Israel (including RD, cultivation,
manufacturing, distribution, import and export) are regulated by the IMCA. Every company with cannabis-related activity in Israel is subject
to the IMCA’s regulation and is required to obtain annually the relevant IMCA certifications for its activities. Relevant certifications
may include one or more of the following: (i) Good Security Practice, or GSP, (ii) Good Agriculture Practice, or GAP, (iii) GMP, (iv)
Good Distribution Practice, or GDP, (v) Good Consumption Practice, or GCP, and (vi) Good Waste Disposal Practice, or GWDP, depending on
the specific activity undertaken by the company.
Canonic operates under the IMCA’s guidelines and has received
GSP certification, approval for its RD work plan, as well as IMC-GAP certification for its propagation farm. In addition, Canonic
has obtained relevant possession licenses, seed import permits and seedlings export permits.
Under the guidelines of the IMCA, medical cannabis can be manufactured
and marketed in Israel and exported to countries that permit the import of cannabis. Main potential target markets include Europe and
North America. In Europe, each country establishes its own regulations. In North America, Canada has legalized cannabis for both medical
and recreational use. In the U.S., while federal law prohibits the use and possession of cannabis, various states, including Colorado
and Washington state, have decriminalized on a state level, making it available for sale in each of their respective states.
Industrial Applications
Casterra Ag Ltd.
Overview
Our activities related to castor beans were initiated in 2007 and
in 2012 were organized under a wholly-owned subsidiary, originally named Evofuel Ltd., and in 2019 re-named Casterra Ag Ltd., or Casterra.
Casterra focuses on the development of an integrated holistic solution for castor cultivation, including advanced non-GMO high-yielding
castor bean varieties, growth protocols, and compatible agricultural machinery. Casterra’s main target markets are the castor oil
biobased markets located in Brazil and Africa, where large scale castor agriculture and industry are well-established, and it is also
active in other selected markets.
65
Market
Castor beans are grown today for their high-quality oil, which
is used for the production of bio-polymers, biofuel and lubricants for various industries such as the cosmetics, electronics, automotive
and aerospace industries. Currently treated as a “low-tech” crop in its key production areas around the world (for example,
in India the castor bean is grown using traditional techniques such as hand picking), according to industry estimations, the castor oil
extracted from the castor bean plant may hold great promise as an input for industrial markets. According to Global Castor Oil And Derivatives
Market Insights And Forecast To 2028,11 which is
not incorporated herein by reference, due to the COVID-19 pandemic, the global castor oil and derivatives market size was estimated to
be worth $1545.9 million in 2022 and is forecast to a readjusted size of $2059.9 million by 2028 with a CAGR of 4.9% during the review
period.
Competition
Casterra’s competition includes a few relatively small companies
that supply castor seeds to growers worldwide. During 2021, Casterra improved its competitive advantage by developing a proprietary dehulling
machine for castor grain. Farmers who use Casterra’s castor seed varieties gain access to Casterra’s dehulling machine as
well as to a mechanical harvester developed and marketed by Casterra’s partner.
Business Model
Casterra’s business model is to sell a complete holistic
solution that involves the proprietary improved castor seeds, technical cultivation practices, and dehulling machine, or part of these
products and services, based on customers’ needs. The abovementioned seed varieties and growth protocols are adapted and targeted
to localized characteristics. Casterra’s offering includes high yielding varieties with plant structure suitable for mechanized
harvest, best practices for large-scale castor growing, and advanced compatible mechanical harvest and dehulling solutions.
Key agreements
Titan Castor Farms Limited
In November 2022 Casterra announced that it signed a long-term
royalty agreement with Titan Castor Farms Limited, or Titan, a Zambian cultivator, manufacturer and distributor of castor oil. Under the
framework of the agreement, Casterra will provide Titan with its advanced castor seeds for cultivation, as well as processing equipment,
know-how, and technical support as needed, at cost. This will give Titan full end-to-end capabilities from growth to manufacturing castor
oil. Titan will provide Casterra royalties on sales of its castor oil products, which are expected throughout Zambia and the surrounding
South-Eastern Africa region, starting in 2023.
World Leading Energy Company
In January 2023 Casterra announced that it has entered into an
agreement with one of the world’s leading energy companies, whereby Casterra will provide its unique castor varieties and its broad
know-how in cultivation of castor at a commercial scale for biofuel production. Under the framework of the agreement, the initial focus
is the purchase agreement of castor seed varieties from Casterra for growing castor in specific African territories and the provision
of technical support. The agreement also allows for the potential for long-term cooperation in castor cultivation between this customer
and Casterra, with the potential for expansion into additional territories on the African continent.
11https://www.marketreportsworld.com/global-castor-oil-and-derivatives-market-19862171
66
Intellectual Property
Casterra’s policy is to register relevant castor varieties
in destination territories. To date, Casterra has registered several of its varieties in several Latin America countries, including Brazil,
and plans to register them in Africa as well. In addition, Casterra filed a patent application with respect to the dehulling machine it
developed in Brazil and in Israel.
Government Regulation of our Operations
Casterra’s activities in Israel in the field of seeds are
regulated by the Israeli Ministry of Environmental Protection. Pursuant to these regulations, Casterra is required, among other things,
to obtain toxins permits, which allow it to conduct experiments using “hazardous materials,” as such term is defined in the
applicable regulations, and to follow specific rules regarding waste disposal. Violation of these regulations may expose Casterra to criminal
penalties, administrative sanctions and responsibility to compensate those injured for any environmental damages.
Government Regulation of Product Candidates
All seed production designated for export to Casterra's partners
is subject to field and warehouse inspection by the regulator in the country of destination for compliance with the local regulations,
including sampling and inspection for pests and diseases. In Kenya, which is one of the target markets, we are required to provide a phytosanitary
certificate, germination tests results, genetic homogeneity tests results, and samples for two cultivation cycles, to be tested by the
Kenyan authorities. Failure to present such results may result in inability to sell in this territory.
Raw Materials
Casterra does not significantly rely upon any sources of raw materials
for its operations.
Seasonality
Casterra’s castor seed business in general, and revenues
in particular, generated from sales of castor seeds and related agro-technical services to local castor growers, are subject to variations
based on crop seasonality. The timing of Casterra’s seed production, as well as the delivery of castor seeds to its partners and
revenue recognition with respect to such seed sales, derive substantially from the seasonality of castor growing in the locations where
it produces seeds and in its target markets.
C. Organizational
Structure
The legal name of our company is Evogene Ltd. and
we are organized under the laws of the State of Israel. As of the date of this report, we held directly and indirectly the percentage
indicated of the issued and outstanding capital stock of the following significant subsidiaries:
|
Name
of Subsidiary |
Jurisdiction
|
Ownership
Interest | ||
|
AgPlenus Ltd. |
Israel |
98.3% (1)
| ||
|
Biomica Ltd. |
Israel |
93.2% (2)
| ||
|
Canonic Ltd. |
Israel |
100% | ||
|
Casterra Ag Ltd. (formerly
known as Evofuel Ltd.). |
Israel |
100% | ||
|
Lavie Bio Ltd. |
Israel |
70.7% (3)(4)
|
| (1) |
The remaining 1.7% of AgPlenus Ltd.’s issued and outstanding
share capital is held by AgPlenus’ former Chief Executive Officer and current director as a result of exercise of options.
|
| (2) |
The remaining 6.8% of Biomica Ltd.’s issued and outstanding
share capital is held by Biomica's Chief Technology Officer. Assuming the consummation of the Initial Closing, as defined under the Share
Purchase Agreement entered into by and among Biomica Ltd., Evogene and SHC, Evogene’s ownership interest will be reduced to 75.8%,
and the remaining 24.2% of Biomica Ltd.’s issued and outstanding share capital will be held by: (i) SHC, who will hold 22.7%, and
(ii) Biomica's Chief Technology Officer, who will hold 1.5%. For more information see “Item 4.B. Information on the Company—Business
Overview—Market Segments—Human Health—Biomica Ltd.—Overview”. |
| (3) |
The remaining 29.3% of Lavie Bio Ltd.’s issued and outstanding
share capital is held by (i) Pioneer Hi-Bred International, Inc. (also known by the name Corteva), who holds 27.3%, and (ii) Lavie Bio’s
former employees, who hold 2.0% as a result of exercise of options. |
| (4) |
ICL (through an affiliate company) has an outstanding convertible amount of $10 million invested in Lavie Bio Ltd. under a SAFE agreement,
which is convertible into shares of Lavie Bio Ltd. pursuant to the terms thereof. For more information see “Item 4.B. Information
on the Company—Business Overview—Market Segments—Agriculture—Lavie Bio Ltd.—Overview”. |
67
D. Property,
Plants and Equipment
Our principal facility is located in Rehovot, Israel and consists
of 3,209 square meters (approximately 34,500 square feet) of leased office space accommodating our corporate offices and our molecular,
microbial and crop protection labs. The lease for this facility will expire December 31, 2024. A portion (500 square meters, or approximately
5,382 square feet) of the leased space was subleased to an unaffiliated company until February 2023.
We perform most of our testing in plants, or in-planta
testing, at our “Greenhouse Research Center”, located on two adjacent lots that we lease outside Rehovot, which also hosts
Canonic’s cannabis RD facility. The first lease covers approximately 13,500 square meters (approximately 145,000 square feet)
of land, and expires on July 21, 2025, and we hold an option to renew such lease for an additional 36-month period. The second lease covers
approximately 10,000 square meters (approximately 108,000 square feet) of land and expires on May 14, 2026, and we hold an option to renew
such lease for an additional 24-month period.
The Greenhouse Research Center contains greenhouses, which are
used for various in-planta experiments of the company and its subsidiaries. During 2019, we converted
part of the Evogene Farm to a designated area for cannabis greenhouse as part of the activities of Canonic, our subsidiary which is focused
on the area of medical cannabis. In addition, the Greenhouse Research Center contains warehouses, office facilities and seed banks.
Lavie Bio Inc. subleases a research and development facility located
in the City Foundry STL Project in St. Louis, Missouri, consisting of approximately 4,050 square feet, under a three-year sublease agreement,
expiring on September 30, 2024.
Unless otherwise stated, all of our facilities are fully utilized. We have no material
tangible fixed assets apart from the leased properties described above. We believe that our currently leased facilities meet our needs
for the short and mid-terms.
| ITEM 4A. |
UNRESOLVED STAFF COMMENTS |
There are no unresolved staff comments.
| ITEM 5. |
OPERATING AND FINANCIAL REVIEW AND PROSPECTS |
The information contained in this section should
be read in conjunction with our consolidated financial statements as of, and for the year ended, December 31, 2022 and related notes and
the information contained elsewhere in this annual report. Our financial statements have been prepared in accordance with IFRS as issued
by the IASB. This discussion contains forward-looking statements that are subject to known and unknown risks and uncertainties. As a result
of many factors, such as those set forth under “Item 3. Key Information—D. Risk Factors” and “Special Note Regarding
Forward-Looking Statements,” our actual results may differ materially from those anticipated in these forward-looking statements.
Summary
Evogene has four main subsidiaries, each focused on a different
type of product and target market. Each subsidiary has its own board of directors, management team, scientific advisory board, research
and development, or RD, and business development teams that focus on developing its own pipeline and go-to-market activities. At
the same time, each subsidiary benefits from using Evogene’s technology under an exclusive license from Evogene to use the CPB platform’s
discovery and development engines that are relevant to the subsidiary’s field of activity. The terms of these licenses provide that
the subsidiary owns the discoveries and product candidates that result from the utilization of the CPB platform, while Evogene retains
all rights to the CPB platform itself. According to the characteristics of the end-market, the subsidiaries can decide to commercialize
their products independently or in collaboration with partners.
68
Another business model, which was our main business model until
2014, is product development through collaborations. In this business model Evogene engages with partners for joint development of defined
products, requested by the partners. In this frame, Evogene typically conducts the initial RD activity, discovery and early-stage
development, while later stage development and commercialization are carried out by the partner. Under this model, Evogene’s potential
revenues include RD funding for activities that Evogene conducts in the collaboration, milestone payments for when the candidates
advance in our partners’ pipelines and revenue sharing from the end-product.
Until 2014, Evogene engaged in several collaborations of this type
with Bayer, Monsanto, DuPont and Syngenta, focused on improving seed traits using GM approach. Today, Evogene has a number of smaller
scale collaborations, and we aim to engage in additional collaborations in the future.
Key Performance Indicators
Revenues
Our revenues are principally derived from research and development
payments under our collaboration agreements and related arrangements with our collaborators. Some of our agreements with collaborators
also provide for success-based payments, such as milestone payments paid by our collaborators upon the occurrence of certain specified
events and royalty revenues based on the sales or transfer of products our collaborators develop that contain, or are based on, our discoveries,
which we license to them. We have not yet generated revenues from royalty payments. In October 2021, Canonic, our subsidiary in the field
of medical cannabis, began the commercialization of its first products to pharmacies and distributors in Israel.
Breakdown of Revenues by Operating Segment:
The following table presents a breakdown of net revenues by operating
segment for the periods indicated.
|
Operating Segment: |
2022 |
2021 |
2020 |
|||||||||
|
(U.S. dollars, in thousands) |
||||||||||||
|
Agriculture |
$ |
876 |
$ |
628 |
$ |
862 |
||||||
|
Industry |
72 |
40 |
33 |
|||||||||
|
Human |
513 |
183 |
75 |
|||||||||
|
Unallocated |
214 |
79 |
70 |
|||||||||
|
Total |
$ |
1,675 |
$ |
930 |
$ |
1,040 |
||||||
Geographical Breakdown of Net Revenues
The following table presents net revenues by geographic breakdown
of customers as a percentage of our total net revenues for the periods indicated. This data refers to the location of the customer and
does not take into consideration the location of the end-user (to the extent it is different).
| Year ended December 31, | ||||||||||||
| Geographical Region: |
2022 |
2021 |
2020 | |||||||||
|
United States |
51 |
% |
56 |
65 |
% | |||||||
|
Israel |
45 |
% |
38 |
22 |
% | |||||||
|
Brazil |
- |
% |
2 |
11 |
% | |||||||
|
Other |
4 |
% |
4 |
2 |
% | |||||||
|
Total |
100 |
% |
100 |
% |
100 |
% | ||||||
69
Cost of Revenues
Cost of revenues primarily consists of development costs incurred
in conjunction with our collaborations, which include: salaries and related personnel costs for our research and development employees
working on the collaborations; payments to third party suppliers that assist us in producing genomic data; and the cost of disposable
materials (such as seeds, laboratory supplies, fertilizer, water and soil), expenses related to retaining advisors, who primarily consist
of biological experts and subcontractors related to medical cannabis production.
Operating Expenses
Research and Development Expenses,
net: Research and development expenses primarily consist of costs related to our internal or independent research and development
activities, as opposed to development costs incurred in connection with our collaborations (which are included in cost of revenues). These
independent activities of ours include the further development of our product pipeline, enhancement and expansion of our CPB platform
and improvement of our computational, scientific and validation technologies, know-how and capabilities used by our subsidiaries and product
divisions. Research and development costs include: salaries and related personnel costs (including share-based compensation); payments
to third party suppliers and subcontractors, including scale-up development of GMP batch production of drug candidate, field-trials and
pre-clinical studies carried out by third parties; cost of disposable materials; expenses associated with participation in professional
conferences; operational overhead costs, which include costs related to leasing and operating our office, laboratory facilities and greenhouses;
depreciation of property, plant and equipment; and amortization of intangible assets. Expenses related to our intellectual property, such
as legal and other costs associated with patent applications, are also included as research and development expenses. We expect that our
research and developments expenses will increase during 2023 due to the expected advancement in the pipeline of our subsidiaries and expansion
in our product development activities.
Sales and Marketing Expenses:
Sales and marketing expenses consist of costs primarily related to commercialization activities of our subsidiaries for product launch
and maintaining our relationships with our collaborators and establishing new collaborations. These costs include salaries and related
personnel costs (including share-based compensation) and expenses related to legal and professional services. We expect our sales and
marketing expenses will remain at the current level during 2023.
General and Administrative Expenses:
General and administrative expenses mainly consist of salaries and related personnel costs (including share-based compensation) for our
general and administrative employees; legal, DO liability insurance, and professional services; expenses related to HR activities
and employee benefits and welfare; expenses for consulting; and other expenses associated with being a U.S. publicly listed company. We
expect that our general and administrative expenses will remain at the current level during 2023.
In view of the COVID-19 pandemic, which disrupted our operations
beginning in March 2020, we adjusted our work plans and budget, reducing and delaying certain activities. The impact of these changes
has been minimal and by the end of 2020 and during 2021 we had resumed our full activities. With respect to 2023, we expect that the impact
of the COVID-19 pandemic on our operations (assuming the pandemic to be at the level as of the date of this annual report) will be minimal.
Financing Income and Expenses
Financing income primarily consists of interest income on our cash
bank deposits and securities and foreign currency exchange income.
Financing expenses primarily consist of foreign
currency exchange expense; expenses related to a revaluation of the marketable securities we hold, which consist of money market funds,
corporate bonds and government treasury notes; interest expense for our operating lease liability; expenses related to a revaluation of
outstanding convertible amount of $10 million invested in our subsidiary Lavie Bio under a SAFE agreement with ICL; and expenses related
to bank charges and commissions. The interest due on government grants is also considered a financial expense and is recognized beginning
on the date on which we receive the grant until the date on which the grant is expected to be repaid.
Taxes on Income
We do not generate taxable income in Israel, as we have historically
incurred operating losses resulting in carryforward tax losses totaling approximately $219 million as of December 31, 2022, to be
carried forward indefinitely to future tax years. Accordingly, we do not expect to pay taxes in Israel for the foreseeable future, until
we have taxable income after the full utilization of our carryforward tax losses.
70
Our U.S. subsidiaries, Evogene Inc., Lavie Bio Inc., Lavie Bio
Tech Inc., Taxon Biosciences Inc. and AgPlenus Inc. are subject to U.S. income taxes. In 2022, the tax rates applicable to those
companies were approximately 21% and 6.5% (federal tax and state tax, respectively, where those companies operate).
Segment Data
We divide our operations into three operating segments –
agriculture, human health and industrial applications, as follows:
| ◾ |
Agriculture: our agriculture segment includes our division and subsidiaries engaged in agricultural
activities, including seed traits activity, ag-chemicals activity (now through our subsidiary AgPlenus) and ag-biologicals activity (now
through our subsidiary Lavie Bio). |
| ◾ |
Human Health: our human health segment focuses mainly on discovery and development of human
microbiome-based therapeutics (through our subsidiary Biomica) and cannabis activity (through our subsidiary Canonic). |
| ◾ |
Industrial Applications: our industrial applications segment focuses on the development and
commercialization of improved castor bean seeds for industrial uses (through our subsidiary Casterra). |
The following table presents our revenues and operating loss by
segment for the periods presented:
|
|
Agriculture
|
Industrial Applications
|
Human Health
|
Unallocated
|
Total
|
|||||||||||||||
|
(in thousands)
|
||||||||||||||||||||
|
Year ended December 31, 2022 |
||||||||||||||||||||
|
Revenues |
$ |
876 |
72 |
513 |
214 |
1,675 |
||||||||||||||
|
Operating loss |
(12,256 |
) |
(220 |
) |
(8,875 |
) |
(5,590 |
) |
(26,941 |
) | ||||||||||
|
Year ended December 31, 2021 |
||||||||||||||||||||
|
Revenues |
$ |
628 |
$ |
40 |
$ |
183 |
$ |
79 |
$ |
930 |
||||||||||
|
Operating loss |
(12,248 |
) |
(169 |
) |
(10,087 |
) |
(8,449 |
) |
(30,953 |
) | ||||||||||
|
Year ended December 31, 2020 |
||||||||||||||||||||
|
Revenues |
$ |
862 |
$ |
33 |
$ |
75 |
$ |
70 |
$ |
1,040 |
||||||||||
|
Operating loss |
(8,687 |
) |
(333 |
) |
(4,669 |
) |
(11,125 |
) |
(24,814 |
) | ||||||||||
71
A. Operating
Results
The following table sets forth our overall results of operations
(on an unsegmented basis) for the years ended December 31, 2020, 2021, and 2022. The below discussion of our results of operations omits
a comparison of our results for the years ended December 31, 2020 and 2021. In order to view that discussion, please see “Item 5.
Operating and Financial Review and Prospects—A. Operating Results—Comparison of Period-to-Period Results of Operations”
in our Annual Report on Form 20-F for the year ended December 31, 2021, which we filed with the SEC on March 31, 2022.
|
2022 |
2021 |
2020 |
||||||||||
|
Consolidated Statements of Comprehensive loss: |
||||||||||||
|
(U.S. dollars, in thousands) |
||||||||||||
|
Total Revenues |
$ |
1,675 |
$ |
930 |
$ |
1,040 |
||||||
|
Cost of revenues |
909 |
767 |
574 |
|||||||||
|
Gross profit |
766 |
163 |
466 |
|||||||||
|
Operating expenses (income): |
||||||||||||
|
Research and development, net
|
20,792 |
21,125 |
17,287 |
|||||||||
|
Sales and marketing
|
3,933 |
2,738 |
2,672 |
|||||||||
|
General and administrative
|
6,482 |
7,253 |
5,321 |
|||||||||
|
Other income |
(3,500 |
) |
-
|
-
|
||||||||
|
Total operating expenses, net |
27,707 |
31,116 |
25,280 |
|||||||||
|
Operating loss |
(26,941 |
) |
(30,953 |
) |
(24,814 |
) | ||||||
|
Financing income |
516 |
1,935 |
1,591 |
|||||||||
|
Financing expenses |
(3,329 |
) |
(1,414 |
) |
(2,951 |
) | ||||||
|
Loss before taxes on income |
(29,754 |
) |
(30,432 |
) |
(26,174 |
) | ||||||
|
Taxes on income |
90 |
13 |
32 |
|||||||||
|
Loss |
$ |
(29,844 |
) |
$ |
(30,445 |
) |
$ |
(26,206 |
) | |||
Year Ended December 31, 2022 Compared
to Year Ended December 31, 2021
Revenues
Our total revenues increased by approximately $0.8 million, or 88.9%,
to approximately $1.7 million for the year ended December 31, 2022 from $0.9 million for the year ended December 31, 2021. The
increase in revenues was primarily due to revenues recognized per the collaboration agreement of Evogene’s subsidiary AgPlenus with
Corteva, as well as revenues from sales of Canonic’s medical cannabis products in Israel.
Cost of Revenues
Cost of revenues increased by approximately $0.1 million, or 12.5%,
to approximately $0.9 million for the year ended December 31, 2022 from $0.8 million for the year ended December 31, 2021. The
increase was primarily related to an increase in the revenues recognized per the collaboration agreement of AgPlenus with Corteva and
the increased revenues of Canonic’s medical cannabis products as mentioned above.
Gross profit increased by approximately $0.6 million, or 300%,
to approximately $0.8 million for the year ended December 31, 2022 from $0.2 million for the year ended December 31, 2021, due
to the combined impact of changes in our revenues and cost of revenues, as described above.
Operating Expenses
Research and Development Expenses,
Net. Research and development expenses decreased by approximately $0.3 million, or 1.4%, to approximately $20.8 million for the
year ended December 31, 2022 from $21.1 million for the year ended December 31, 2021. This decrease was mainly attributable
to decreased costs of Biomica’s GMP microbe drug production for its first-in-human proof-of-concept study in the immuno-oncology
program.
Sales and Marketing Expenses.
Sales and marketing expenses increased by approximately $1.2 million, or 44.4%, to approximately $3.9 million for the year ended December 31,
2022 from $2.7 million for the year ended December 31, 2021. The increase was mainly due to Lavie Bio’s increased business
development personnel and commercial trials of its inoculant product, Thrivus, performed during 2022 and increased business development
personnel in Canonic.
72
General and Administrative Expenses.
General and administrative expenses decreased by approximately $0.8 million, or 11.0%, to approximately $6.5 million for the year ended
December 31, 2022 from $7.3 million for the year ended December 31, 2021. The decrease was mainly attributed to the decrease
of the costs of directors’ and officers’ insurance, and to the decrease of share-based compensation expenses.
Other Income. The amount
of $3.5 million for the year ended December 31, 2022 was received from Bayer under their joint seed traits collaboration agreement
with Evogene, as part of a restructuring and release of the patent filing, prosecution, and maintenance obligations under the collaboration,
as further described in “Item 4.B. Business Overview – Ag Seed Division”.
Financing Income and Expenses
Foreign currency and exchange
risk
A significant portion of our expenses is denominated in currencies
other than the U.S. dollar. The Company is therefore subject to non-U.S. currency risks and non-U.S. exchange exposure, especially the
NIS. A significant portion of our operating costs are in Israel, consisting principally of salaries and related personnel expenses, and
facility expenses, which are denominated in NIS. This foreign currency exposure gives rise to market risk associated with exchange rate
movements of the U.S. dollar against the NIS and other currencies. Furthermore, we anticipate that a significant portion of our expenses
will continue to be denominated in NIS. We do not hedge against currency risk through the use of forward currency contracts or other financial
instruments. See “Risk factors—Risks Relating to Our Incorporation and Location
in Israel-Exchange rate fluctuations between the U.S. dollar and the NIS may negatively affect
our financial results.” Exchange rates can be volatile and a substantial change of foreign currencies against the U.S. dollar could
increase or reduce the Company’s expenses and net loss and impact the comparability of results from period to period. The appreciation
(devaluation) of the NIS in relation to the U.S. dollar amounted to 3.3%, and (13.2%) as of December 31, 2021, and 2022, respectively.
Financing Income.
Financing income decreased by approximately $1.4 million, or 73.7%, to approximately $0.5 million for the year ended December 31,
2022 from $1.9 million for the year ended December 31, 2021. This decrease was mainly attributable to U.S. Dollar and NIS exchange
rate differences between periods.
Financing Expenses.
Financing expenses increased by approximately $1.9 million, or 135.7%, to approximately $3.3 million for the year ended December 31,
2022 from $1.4 million for the year ended December 31, 2021. This increase was primarily attributable to U.S. Dollar and NIS exchange
rate differences between periods and to a revaluation of the marketable securities we hold, which consist of money market funds, corporate
bonds and government treasury notes.
Taxes on Income
For the years ended December 31, 2022 and 2021, we recorded
insignificant amounts for taxes on income in Israel and an insignificant amount of taxes with respect to U.S. subsidiaries.
Loss
The amount of our overall loss decreased by approximately $0.6
million, or 2.0%, to approximately $29.8 million for the year ended December 31, 2022, from $30.4 million for the year ended December
31, 2021. This decrease reflected the cumulative effect of all of the above-described line items from our consolidated statements of comprehensive
loss.
B.
Liquidity and Capital Resources
Our working capital requirements generally reflect the growth in
our business and have historically been provided by cash raised from our investors, payments from our collaborators and government grants.
As of December 31, 2022, we had cash, and cash equivalents marketable securities of approximately $35.4 million, and working capital of
approximately $32.1 million, which is calculated by subtracting our current liabilities from our current assets. As of December 31, 2022,
we had approximately $4.7 million of outstanding long-term indebtedness related to government grants.
73
Capital Resources
In 2022, our primary sources of liquidity were cash on hand, proceeds
from collaboration agreements, revenues from the selling of medical cannabis products and proceeds from the issuance under the convertible
SAFE agreement between our subsidiary Lavie Bio and ICL. We used the funds under the SAFE agreement primarily to finance Lavie Bio’s
RD program related to ICL.
Public Offerings of Ordinary Shares
Cantor Controlled Equity OfferingSM Sales
Agreement
On January 14, 2021 and February 19, 2021, we entered into Controlled Equity OfferingSM
Sales Agreements, or the January Sales Agreement and February Sales Agreement, respectively, with Cantor Fitzgerald Co., or the
Agent, pursuant to which the Company could offer and sell, from time to time, its ordinary shares, through the Agent in an “at-the-market”,
or ATM offering, as defined in Rule 415(a)(4) promulgated under the Securities Act, for an aggregate offering price of up to $28.0 million
and $50.0 million, respectively. Because the public float of our ordinary shares is currently less than $75.0 million, we are limited
in the amount we can raise during any 12-month period to 1/3 of our public float on the date of sale, which was approximately $8.9 million
as of March 20, 2023. This amount may vary according to changes in our share price. In February 2021, we completed the sales of ordinary
shares under the January Sales Agreement and issued 3,803,594 ordinary shares, with a weighted average selling price of $7.36 per share,
resulting in gross proceeds of approximately $28 million. Subsequently we entered into the February Sales Agreement. As
of December 31, 2022, we sold 755,339 ordinary shares with a weighted average selling price of $3.53 per share, resulting in gross
proceeds of approximately $2.66 million. As of March 15, 2023, we sold 1,095,339 ordinary shares with a weighted average selling price
of $2.68 per share, resulting in gross proceeds of approximately $2.94 million. We are not obligated to make any sales of ordinary shares
under the February Sales Agreement and no assurance can be given that we will sell any ordinary shares under such agreement, or, if we
do, as to the price or number of such shares that we will sell or the dates on which any such sales will take place.
Registered Direct Offerings
On September 2, 2020, we issued 5,882,353 ordinary shares in a
registered direct offering. Each ordinary share was sold at $1.70 per share resulting in gross proceeds of $10 million. On November 2,
2020, we completed a second registered direct offering with certain institutional investors for the purchase of 3,920,000 ordinary shares
at a share price of $2.50 per ordinary share and 883,534 pre-funded warrants with an exercise price of $0.01 per share at price of $2.49
per warrant (which were exercised in the beginning of January 2021), resulting in gross proceeds of $12 million.
Shelf Registration Statement
On February 19, 2021, we filed a shelf registration statement on
Form F-3 with the SEC under which we may offer and sell from time to time in one or more offerings, our ordinary shares, debt securities,
rights, warrants and units having an aggregate offering price of up to $200 million. We registered up to $50 million under this Form F-3
in connection with for the February Sales Agreement. We may seek additional capital or strategic considerations, even if we believe we
have sufficient funds for our current or future operating plans.
Lavie Bio Collaboration and SAFE with ICL
In August 2022, ICL and Lavie Bio entered a multi-year collaboration
agreement for developing novel bio-stimulant products to enrich fertilizer efficiency. As part of the collaboration, ICL invested (through
an affiliate company) in Lavie Bio $10 million under a SAFE (simple agreement for future equity). Information on that transaction is set
forth in this annual report under “Item 4. Information on the Company— B. Business Overview— Market Segments—
Agriculture— Lavie Bio Ltd.— Key Collaborations— ICL Group” and is incorporated by reference herein.
Biomica Share Purchase Agreement with SHC
In December 2022, Biomica announced the signing
of a definitive agreement for a $20 million financing round, led by SHC, with $10 million of which to be invested by Evogene. Following
the initial closing of this transaction, Evogene will hold approximately 67% of the share capital of Biomica, while SHC will hold approximately
20%, in each case on a fully diluted basis. Information on that transaction is set forth in this annual report under “Item
4. Information on the Company— B. Business Overview— Market Segments— Human Health— Biomica Ltd.— Overview”
and is incorporated by reference herein.
74
Collaboration Agreements
Under our RD collaboration agreements, our revenues typically
include RD funding for activities that we conduct in the collaboration, as well as milestone payments for when the candidates advance
in our partners’ pipelines and revenue sharing from the end-product.
Outlook
We expect that our sources of liquidity for 2023 will include cash
on hand, proceeds raised from the public offering of our ordinary shares and the exercise of options, proceeds from collaboration agreements
and revenues from the selling of medical cannabis products, cash held in our bank accounts, including bank deposits and marketable securities,
proceeds from grants and other financing transactions, including by our subsidiaries.
In the future, cash may serve us in effecting MA transactions
for achieving inorganic growth in our different segments of operation. We believe that our existing cash as of December 31, 2022 will
be sufficient to meet our projected cash requirements for at least 12 months. Nevertheless, in order to accelerate our subsidiaries growth
and to strengthen their position as independent companies, we are in different levels of discussions with potential strategic and financial
investors towards potential fundraisings, including by our subsidiaries.
Although we have sufficient cash, cash equivalents, and marketable
securities that we believe will enable us to fund our operations during the next 12-month period, our ability to fund our capital needs
depends on our ongoing ability to generate cash from existing and future collaborations, our revenues, and from our ability to raise additional
funds. To the extent that existing cash, and cash equivalents, and marketable securities are insufficient to fund our future activities,
we may need to raise additional funding through debt and equity financing. Additional funds may not be available when we need them on
terms that are acceptable to us, or at all.
If adequate funds are not available to us on a timely basis, we
may be required to delay, limit, scale back or cease our research and development activities, establishment and maintenance of sales and
marketing capabilities or other activities that may be necessary to commercialize our product candidates.
Cash Flows
The following table presents the major components of net cash flows
used in or provided by (as applicable) operating, investing and financing activities for the periods presented. For a discussion of our
net cash flows for the year ended December 31, 2020, please see “Item 5. Operating and Financial Review and Prospects— B.
Liquidity and Capital Resources— Cash Flows” in our Annual Report on Form 20-F for the year ended December 31, 2021, which
we filed with the SEC on March 31, 2022:
|
2022 |
2021 |
2020 |
||||||||||
|
(U.S. dollars, in thousands) |
||||||||||||
|
Net cash used in operating activities |
$ |
(23,678 |
) |
$ |
(24,716 |
) |
$ |
(19,514 |
) | |||
|
Net cash provided by (used in) investing activities |
13,274 |
(20,566 |
) |
9,415 |
||||||||
|
Net cash provided by financing activities |
9,343 |
30,276 |
20,374 |
|||||||||
|
Exchange rate differences - cash and cash equivalents balances |
(2,284 |
) |
1,102 |
1,206 |
||||||||
|
Increase (decrease) in cash and cash equivalents |
$ |
(3,345 |
) |
$ |
(13,904 |
) |
$ |
11,481 |
||||
Cash Used in Operating Activities
Cash used in operating activities for the year
ended December 31, 2022 was approximately $23.7 million and primarily reflects our overall loss of approximately $29.8 million, as adjusted
downwards to eliminate certain non-cash items that were taken into account in calculating, and that increased, our overall loss, including
approximately $1.2 million of share-based compensation expenses, approximately $1.5 million of depreciation expenses, approximately $1.1
million amortization of intangible assets and approximately $3.0 million of non-cash net financing expenses. These downwards adjustments
to cash used were partially offset by approximately $0.8 million of changes in asset and liability items, mainly due to an increase in
inventories and a decrease in trade payables and payroll accruals balances, partially offset by a decrease in other receivables balances.
75
Cash used in operating activities
for the year ended December 31, 2021 was $24.7 million and primarily reflects our overall loss of $30.4 million, as adjusted downwards
to eliminate certain non-cash items that were taken into account in calculating, and that increased, our overall loss, including $2.6
million of share-based compensation expenses, $1.3 million of depreciation expenses and $0.9 million amortization of intangible assets
and the changes in asset and liability items of $1.7 million, mainly due to a decrease in other receivables balance and an increase in
trade and other payables balances. These downwards adjustments to cash used were partially offset by $0.9 million of non-cash net financing
income.
Cash Provided by (Used In) Investing Activities
Cash provided by investing activities was approximately $13.3 million
for the year ended December 31, 2022. That primarily reflects approximately $12.4 million of net cash proceeds from the sale of marketable
securities and $3.0 million of net cash withdrawal from bank deposits, offset by approximately $1.2 million of cash used for the purchase
of property, plant and equipment and approximately $0.9 million of net cash invested in the purchase of marketable securities.
Cash used in investing activities was $20.6 million for the year
ended December 31, 2021. That primarily reflects $23.1 million of net cash invested in the purchase of marketable securities, $1.0 million
of cash investment in bank deposits and $0.8 million of cash used for the purchase of property, plant and equipment, offset by $4.4 million
of net cash proceeds from the sale of marketable securities.
Cash Provided by Financing Activities
Cash provided by financing activities was approximately $9.3 million
for the year ended December 31, 2022. That was primarily attributable to proceeds from issuance under the convertible SAFE agreement
between Lavie Bio and ICL of $10 million, to the net proceeds of government grants of approximately $0.1 million, and partially offset
by approximately $0.8 million for the repayment of an operating lease liability.
Cash provided by financing activities was $30.3 million for the
year ended December 31, 2021. That was primarily attributable to $29.6 million of cash provided by the sale of newly-issued ordinary
shares in connection with the Controlled Equity OfferingSM
Sales Agreements, the net proceeds of government grants of $0.8 million and $0.5 million proceeds from exercise of options, partially
offset by $0.6 million for the repayment of an operating lease liability.
Government Grants
Our research and development efforts, including by our subsidiaries,
have been financed, in part, through grants from IIA, BIRD, CIIRDF and the EU. From our inception through 2022, we received grants of
approximately $13.8 million (including accrued interest), of which approximately $8.9 million (including accrued interest) are royalty-bearing
grants from the IIA, and repaid approximately $3.5 million in royalties and an additional approximately $4.9 million in respect of several
non-refundable projects. In addition, we have received grants totaling approximately $1 million (linked to the U.S. Consumer Price Index)
from BIRD and have repaid $0.5 million, whereas the amount of $0.4 million of grants from BIRD have been cancelled, as we decided to withdraw
from the relevant project. We have received grants totaling $1.1 million from the EU, which are not required to be repaid. As of December 31,
2022, we had two active research grants under which we have received funding from the IIA.
See “Item 3. Key Information—D. Risk Factors—Risks
Relating to Our Incorporation and Location in Israel—We have received Israeli government grants for certain of our research and
development activities. The terms of these grants may require us to satisfy specified conditions in order to manufacture products and
transfer technologies supported by such grants outside of Israel. We may be required to pay penalties in addition to repayment of the
grants.”
IIA Grants
Under the Innovation Law, research and development programs that
meet specified criteria and are approved by a committee of the IIA are eligible for grants. The grants awarded are typically up to 50%
of a project’s expenditures, as determined by the IIA committee and subject to the benefit track under which the grant was awarded.
A company that receives a grant from the IIA is typically required to pay 3% royalties to the IIA on income generated from products incorporating
know-how developed using that grant (including income derived from services associated with such products), until 100% of the U.S. dollar-linked
grant, plus interest at the annual London Interbank Offered Rate, or LIBOR, is repaid. Certain benefit tracks do not require payment of
royalties.
76
The obligation to pay royalties is contingent on actual income
generated from such products and services. In the absence of such income, no payment of royalties is required. It should be noted that
the restrictions under the Innovation Law, including restrictions on the sale, transfer or assignment outside of Israel of know-how developed
as part of the programs under which the grants were given will continue to apply even after the repayment of such royalties in full.
The terms of the grants under the Innovation Law also require that
the products developed as part of the programs under which the grants were given be manufactured in Israel and that the know-how developed
thereunder may not be transferred outside of Israel, unless prior written approval is received from the IIA (such approval is not required
for the transfer of a portion of the manufacturing capacity which does not exceed, in the aggregate, 10% of the manufacturing (in which
case only notification is required)), and additional payments are required to be made to the IIA, as described below. It should be noted
that this does not restrict the export of products that incorporate the funded know-how.
Ordinarily, as a condition to obtaining approval to manufacture
outside Israel, we may be required to pay royalties at an increased rate, which usually amounts to an additional 1% on top of the standard
royalties rate, and also the total amount of our liability to IIA will be increased to between 120% and 300% of the grants we received
from IIA, depending on the manufacturing volume to be performed outside of Israel.
The Innovation Law restricts the ability to transfer know-how funded
by the IIA. Transfer of IIA-funded know-how outside of Israel requires prior approval and is subject to payment of a redemption fee to
the IIA calculated according to a formula provided under the Innovation Law. A transfer for the purpose of the Innovation Law is generally
interpreted very broadly and includes, inter alia, any actual sale of the IIA-funded know-how, any license to develop the IIA-funded know-how
or the products resulting from such IIA-funded know-how or any other transaction, which, in essence, constitutes a transfer of the IIA-funded
know-how.
The IIA approval to transfer know-how created, in whole or
in part, in connection with an IIA-funded project to a third party outside Israel is subject to payment of a redemption fee to the IIA
calculated according to a formula provided under the Innovation Law that is based, in general, on the value of the transferred know-how,
multiplied by the amount of grants received from the IIA (including the accrued interest), divided by the total amounts expended by the
grant recipient on RD. To the extent any royalties were paid on account of the grants, such royalties will be deducted from the calculation.
The redemption fee is subject to a cap of six times the total amount of the IIA grants, plus interest accrued thereon, namely the total
liability to the IIA, including the accrued interest, multiplied by six. If the grant recipient undertakes that for a period of not less
than three years, at least 75% of its relevant RD positions will remain in Israel, then the cap will be reduced to three times (rather
than six times) the total liability to the IIA, calculated as set out above.
Subject to prior approval of the IIA, we may transfer the IIA-funded
know-how to another Israeli company. If the IIA-funded know-how is transferred to another Israeli entity, the transfer would still require
IIA approval but will not be subject to the payment of the redemption fee (although there will be an obligation to pay royalties to the
IIA from the income of such sale transaction as part of the royalty payment obligation). In such case, the acquiring company would have
to assume all of the selling company’s restrictions and obligations towards the IIA (including the restrictions on the transfer
of know-how and manufacturing capacity outside of Israel) as a condition to IIA approval.
We are required to pay up to 100% of the amount of grants received
by us from the IIA, plus interest at the LIBOR. In addition to paying any royalty due, we must abide by other restrictions associated
with receiving such grants under the Innovation Law. Those restrictions may impair our ability to outsource development of products containing
our traits, engage in change of control transactions or otherwise transfer our know-how outside of Israel and may require us to obtain
the approval from the IIA for certain actions and transactions and pay additional royalties and other amounts to the IIA. We cannot be
certain that any approval of the IIA will be obtained on terms that are acceptable to us, or at all. We may not receive the required approvals
should we wish to transfer IIA-funded know-how, manufacturing and/or development outside of Israel in the future. Furthermore, in the
event that we undertake a transaction involving the transfer to a non-Israeli entity of know-how developed with IIA-funding pursuant to
a merger or similar transaction, the consideration available to our shareholders may be reduced by the amounts we are required to pay
to IIA. Any approval, if given, will generally be subject to additional financial obligations. Failure to comply with the requirements
under the Innovation Law may subject us to mandatory repayment of grants received by us (together with interest and penalties), as well
as expose us to criminal proceedings. In addition, the IIA may from time to time conduct royalties audits and such audits may lead to
additional royalties being payable on additional products. Such grants may be terminated or reduced in the future, which would increase
our costs. IIA approval is not required for the marketing of products resulting from the IIA-funded research or development in the ordinary
course of business.
77
In January 2018, we announced participation in a three-year IIA-sponsored
Phenomics Consortium to develop tools and systems for precision agriculture and innovative development of agriculture products. In addition
to Evogene, the Phenomics Consortium consists of several Israeli industrial companies and academic institutions. The goal of the consortium
is to develop plant phenotyping technologies, including the generation of comprehensive agricultural ‘Big-Data’ and the development
of artificial intelligence algorithms for real time analysis of phenotypic data. The grant for the consortium was originally approved
for calendar year 2018 in an amount of approximately $5 million, of which approximately $1.4 million was granted to Evogene. By the end
of 2018, the grant was extended by an additional six months to a total period of 18 months until mid-2019, and the grant amount was updated
to approximately $7.6 million total, of which approximately $2.5 million was granted to Evogene. In June 2019, the IIA approved the continuation
of the consortium following such 18-month period, until the end of 2020, which would complete a three-year workplan, and granted an additional
amount of approximately $7.5 million, of which approximately $1.9 million was granted to Evogene.
In June 2020, we announced participation in a three-year workplan,
IIA-sponsored CRISPR-IL Consortium to develop an artificial intelligence based, end-to-end system for genome-editing to be used in multi-species
including human, plant, and certain animal DNA, applicable to market segments in pharma, agriculture and aquaculture. In addition to Evogene,
the CRISPR-IL Consortium consists of several Israeli industrial companies and academic institutions. The goal of the consortium is to
develop an artificial intelligence-based system, “Go-Genome”, providing users improved genome-editing workflows. The system
aims to provide end-to-end solutions, from user interface to an accurate measurement tool. The total budget for the consortium was approved
for the first 18 months in an amount of approximately $10.2 million, of which approximately $1.3 million was allocated to us and for the
additional 18 months was approved an amount of approximately $15.4 million, of which approximately $1.9 million was allocated to us. Participation
in the IIA-sponsored consortium programs as described above does not obligate us to pay royalties to the IIA; however, the know-how developed
in such consortium programs is subject to the provisions and restrictions under the Innovation Law.
In March 2020 and March 2021, Lavie Bio obtained an IIA
approval to receive a grant for its third and fourth year programs, respectively, for bio fungicides for mildew in fruit and vegetables.
The total approved budgets for each of the third and fourth year programs were NIS 3.9 million (approximately $1.1 million for the
third year and approximately $1.2 for the fourth year). In addition, during October 2022 Lavie Bio obtained an IIA approval to receive
a grant for the development of bio fungicide against soil diseases, seed rot, root and stem rot. The total approved budget was approximately
NIS 1.9 million (approximately $0.6 million).
In 2020, AgPlenus obtained IIA approval to receive a grant
for its first-year program for development of novel herbicides. The total approved budget was NIS 3.1 million (approximately
$1.0 million).
We entered into agreements with certain of our Israeli subsidiaries
in the framework of which they were granted permission to use our technology and related know how, which was funded by the IIA. Evogene
remains responsible to the IIA for the obligations regarding such IIA funding.
BIRD Grants
We have received two BIRD grants, covering the following programs:
(i) a joint development program with DuPont-Pioneer (now Corteva) of research and development improvements to soybean rust resistance,
which the Company has repaid in full; and (ii) a joint research and development program with Marrone Bio Innovations, or MBI, for discovery
of novel modes of biological action for insect control, which the Company has decided to withdraw from.
Under the MBI BIRD program, the grant for the joint development
will be repaid: (a) from revenues received for the licensing of products developed under the project; (b) from revenues generated from
sales of products developed under the project; (c) from proceeds received from the outright sale of the technology developed under the
project; (d) if we and our partner have concluded the development of a product within the period of development defined under each of
the programs; or (e) if within 60 months from the original grant date we and MBI did not conclude the development of a product but nevertheless
decide to continue the project. In each such case, the repayment will be in an amount of up to 150% of the total grant received, depending
on the timing of the repayment.
78
CIIRDF Grant
The CIIRDF grant that we have received was also provided to us
as part of a previous joint project of ours with Saskatchewan Wheat Pool Inc., operating under the name of Viterra, to develop canola
with improved yield and abiotic stress tolerance. This grant will be repaid from income resulting from the commercialization of a product
developed pursuant to the grant project, at a rate of 2.5% of royalties on sales of such product, in an amount up to 100% of the total
grant received. Alternatively, we may repay the grant as royalties of 2.5% of the income we receive from licensing the product developed
pursuant to the grant. Payment of such royalties is not required if commercial revenues are not generated as a result of the project.
EU Grant
In early 2016, a grant application for a consortium for research
in photosynthesis in which we participate within the EU Horizon 2020 Program for Research and Innovation was confirmed. The consortium’s
research program is focused on an innovative approach to modulate photosynthesis related pathways aiming to improve photosynthetic efficiency.
Beyond us, the consortium includes academic institutions such as the Max Planck Institute of Molecular Plant Physiology and the Institute
of Terrestrial Microbiology, the Weizmann Institute of Science, and the Imperial College of Science, Technology and Medicine. Overall,
we received a total amount of €0.9 million for our participation in the consortium during the five-year project. In March 2023,
a follow up grant of a €1.2 million was confirmed by the Horizon EIC 2022 program. The overall budget under the program is
€2.5 million and Evogene’s other partners in the project include the Max Planck Institute. The current project scope, whose
timeline is expected to be 32 months, will develop canola and rapeseed lines.
C. Research
and Development, Patents and Licenses, etc.
We continuously invest, and have for at least the last three years
historically invested, in maintaining the technological capabilities of our CPB platform, which includes tailored ‘big-data’
databases, interconnected data hubs and proprietary analysis and prediction algorithms. We also maintain laboratories, greenhouses and
fields for conducting biological validation activities for our computational predictions.
Our ongoing research and development activities are funded mainly
by internal resources, collaboration research and development payments and governmental grants. As of December 31, 2022, 92 of our employees,
representing approximately 67% of our entire work force, were engaged in research and development on a full-time basis. For more information
regarding our research and development activities, intellectual property and licenses, please see “Item 4.B. Information on the
Company—Business Overview.”
D.
Trend Information
DO insurance
Although in 2022 there was a decrease in the cost of procuring
DO liability insurance, in recent years we experienced an increase in such cost, resulting from a general increase in the cost of
DO liability insurance for smaller, dual-listed public companies such as us. This general increase has been tied to perceived heightened
levels of risk for DO insurers. Insurers have been increasing their level of compensation, in the form of premiums, which they believe
have not been commensurate with the risk being taken by them. In parallel, there has been an increase in the amounts of the deductibles
payable by public companies in situations in which an insurable event occurs. If this trend continues, it will increase our operational
expenses and have a negative effect on our financial results.
|
Market Risk |
We are exposed to market risk from changes in exchange
rates, interest rates and inflation. We therefore continue to closely monitor the macro-economic conditions that result therefrom. We
regularly assess the implications of these global conditions on our operations, liquidity, cash flow and product candidates and seek to
act to mitigate any adverse consequences, to the extent possible, in a commercially reasonable manner, if and when applicable. All of
these market risks arise in the ordinary course of business, as we do not engage in speculative trading activities. Except as otherwise
addressed herein, such market risks are further discussed in Item 11 of this annual report under the section titled “Quantitative
and Qualitative Disclosures about Market Risk”.
We are exposed to market risk from changes in exchange rates, interest
rates and inflation. All of these market risks arise in the ordinary course of business, as we do not engage in speculative trading activities.
Except as otherwise addressed herein, such market risks are further discussed in Item 11 of this annual report.
Other than as disclosed elsewhere in this annual report, we are
not aware of any trends, uncertainties, demands, commitments or events for the period from January 1, 2022 to December 31, 2022 that are
reasonably likely to have a material adverse effect on our revenues, profitability, liquidity or capital resources, or that caused the
disclosed financial information to be not necessarily indicative of future operating results or financial condition.
79
E. Critical
Accounting Estimates
We have provided a summary of our significant accounting policies,
estimates and judgments in Note 3 to our consolidated financial statements, which are included elsewhere in this annual report. The following
critical accounting discussion pertains to accounting policies management believes are most critical to the portrayal of our historical
financial condition and results of operations and that require significant, difficult, subjective or complex judgments. Other companies
in similar businesses may use different estimation policies and methodologies, which may impact the comparability of our financial condition,
results of operations and cash flows to those of other companies.
Application of Critical Accounting Policies and Estimates
Our consolidated financial statements are prepared in conformity
with IFRS. Our accounting policies affecting our financial condition and results of operations are more fully described in our consolidated
financial statements included elsewhere in this annual report. The preparation of our financial statements requires management to make
judgments, estimates and assumptions that affect the amounts reflected in the consolidated financial statements and accompanying notes,
and related disclosure of contingent assets and liabilities. We base our estimates upon various factors, including past experience, where
applicable, external sources and on other assumptions that we believe are reasonable under the circumstances, the results of which form
the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual
results may differ from these estimates under different assumptions or conditions and could have a material adverse effect on our reported
results.
In many cases, the accounting treatment of a particular transaction,
event or activity is specifically dictated by accounting principles and does not require management’s judgment in its application,
while in other cases, management’s judgment is required in the selection of the most appropriate alternative among the available
accounting principles, that allow different accounting treatment for similar transactions.
We believe that the accounting policies discussed below are
critical to our financial results and to the understanding of our past and future performance as these policies relate to the more significant
areas involving management’s estimates and assumptions. We consider an accounting estimate to be critical if: (1) it requires
us to make assumptions because information was not available at the time or it included matters that were highly uncertain at the time
we were making our estimate; and (2) changes in the estimate or different estimates that we could have selected may have had a material
impact on our financial condition or results of operations.
Revenue Recognition
We recognize revenues when the control over the goods or services
is transferred to the customer. The transaction price is the amount of the consideration that is expected to be received based on the
contract terms, excluding amounts collected on behalf of third parties (such as taxes).
We have entered into research collaboration and license agreements
under which we grant to our collaborators an exclusive license to intellectual property rights for the development and commercialization
of our proprietary product candidates. The agreements contain multiple performance obligations, including funding from periodic payments
for research and development services, payments based on achievement of specified milestones and royalties on sales of products sold by
our collaborators that include the licensed traits.
Revenues from research and development services as part of our research collaboration
and license agreements are recognized over time, during the period the customer simultaneously receives and consumes the benefits provided
by our performance. Recognition of the service is throughout the services period and is determined based on the proportion of actual costs
incurred for each reporting period to the estimated total costs, subject to the enforceable rights. We charge our customers based on payment
terms agreed upon in specific agreements. When payments are made before or after the service is performed, we recognize the resulting
contract asset or liability.
If the contract contains a single performance obligation, the entire
transaction price is allocated to the single performance obligation. Contracts that contain multiple performance obligations such as licenses,
services, royalties and milestone events require an allocation of the transaction price to each performance obligation based on a relative
standalone selling price, or SSP, basis. The Company establishes SSP based on management judgment, considering internal factors such as
margin objectives, pricing practices and historical sales.
Revenues from milestone events stipulated in the agreements are
recognized upon the occurrence of event or achievement of the milestone specified in the agreement.
80
Share-Based Compensation
We account for share-based compensation in accordance with the
fair value recognition provision of IFRS guidance on share-based compensation. Under these provisions, share-based compensation is measured
at the grant date based on the fair value of the award and is recognized as an expense, net of estimated forfeitures, over the requisite
service period, which is generally the vesting period of the respective award. Share-based compensation expense was approximately $1.2
million, $2.6 million and $4.1 million in 2022, 2021 and 2020, respectively. We selected the binomial option-pricing model as the most
appropriate method for determining the estimated fair value of our share-based compensation. The determination of the grant date fair
value of options using an option-pricing model is affected by estimates and assumptions regarding a number of complex and subjective variables.
These variables include the estimated period of time that we expect employees to hold their options, the expected volatility of our share
price over the expected term of the options (estimated using historical data from prior years, including historical forfeiture rates),
share option exercise and cancellation behaviors, risk-free interest rates, expected dividend yields (assumed to be zero as we have historically
not paid and do not intend to pay dividends on our ordinary shares) and the price of our ordinary shares. In addition, our compensation
expense is affected by our estimate of the number of awards that will ultimately vest. In the future, if the number of equity awards that
are forfeited by employees is lower than expected, the expense recognized in future periods will be higher.
Government Grants
Government grants received from the IIA are recognized as a liability
if future economic benefits are expected from the projects that will result in royalty-bearing sales.
A liability for a grant is first measured at fair value using a
discount rate that reflects a market rate of interest. The difference between the amount of the grant received and the fair value of the
liability is accounted for as a government grant and recognized as a reduction of research and development expenses. After initial recognition,
the liability is measured at amortized cost using the effective interest method. Royalty payments we make to repay the grant are treated
as a reduction of the liability. If no economic benefits are expected from the research activity, the grant receipts are recognized as
a reduction of research and development expenses, in which case, the royalty obligation is treated as a contingent liability.
There is uncertainty regarding the estimates of future cash flows
and the estimate of the capitalization rate that is used for determining the amount of the liability recognized. At the end of each reporting
period, we evaluate whether there is reasonable assurance that the liability recognized, in whole or in part, will not be repaid (since
we will not be required to pay royalties) based on the best estimate of future sales, and if so, the appropriate amount of the liability
is recognized as a reduction of research and development expenses.
Leases
We cannot readily determine the interest rate implicit in our operating
lease for our principal facility in Rehovot, Israel. We therefore use our incremental borrowing rate, IBR, to measure lease liabilities.
The IBR is the rate of interest that we would have to pay to borrow over a similar term, and with a similar security, the funds necessary
to obtain an asset of a similar value to the right-of-use asset in a similar economic environment. The IBR therefore reflects what we
‘would have to pay’, which requires estimation when no observable rates are available or when they need to be adjusted to
reflect the terms and conditions of the lease.
We estimate the IBR using observable inputs (such as market interest
rates) when available and we are required to make certain entity-specific estimates (such as the Company's stand-alone credit rating).
Fair
value of convertible SAFE
In August 2022, ICL and Lavie Bio entered a multi-year collaboration
agreement for developing novel bio-stimulant products to enrich fertilizer efficiency. As part of the collaboration, ICL (through an affiliated
company) invested in Lavie Bio $10 million under a SAFE. Per IFRS guidance on financial instruments, as conversion upon an equity financing
requires the delivery of variable number of shares, the SAFE is accounted for as a liability and measured at fair value. The fair value
of the SAFE will be remeasured at the end of each reporting period with any change to fair value recorded within financial expenses in
the statements of profit or loss. The fair value is based on the weighted average value of various scenarios assuming Lavie Bio's estimated
enterprise value at the valuation date. The enterprise value is calculated using the income approach, whereby the cash flows expected
to be generated are discounted to their present value equivalent using a rate of return that reflects the relative risk of the investment,
as well as the time value of money. The value of the SAFE assumes the probability of various possible scenarios to which an acceptable
option pricing model is applied. The inputs to the model include the enterprise value described above, the conversion price and assumptions
regarding the expected volatility and the expected life of each scenario. Financial expenses recorded in 2022 due to revaluation of the
convertible SAFE were approximately $0.1 million.
81
Intangible
assets
On August 6, 2019, Corteva invested in the Company's agriculture
biologicals subsidiary, Lavie Bio, by way of a contribution of all Corteva’s holdings in its wholly owned subsidiary Taxon Biosciences,
which included several intangible assets, and payment of an amount of $10 million in cash.
The fair value of intangible assets received through the Corteva
investment is determined upon initial recognition by either one of three traditional methods in valuating an asset. These methods include
the market approach, the income approach and the cost approach. The pipeline products and potential products were valued by applying the
income approach and the Microorganisms collection was valued using the cost approach.
The Company’s significant estimates in this analysis included,
but were not limited to, future cash flow projections, the weighted average cost of capital, the terminal growth rate, and the tax rate.
The Company believes the current assumptions and estimates utilized were both reasonable and appropriate. Future cash flow estimates
are, by their nature, subjective and actual results may differ materially from the Company’s estimates. If the Company’s
ongoing estimates of future cash flows are not met, the Company may have to record impairment charges in future periods. The Company’s
estimates of future cash flows are based on current regulatory and economic climates, recent operating results, and planned business strategy.
These estimates could be negatively affected by changes in federal, state, or local regulations or economic downturns.
The useful economic life of the intangible assets acquired by
us in this transaction was determined through years of development until final year of projected sales. When applying the income approach,
the cash flows expected to be generated by intangible assets are discounted to their present value equivalent using a rate of return that
reflects the relative risk of the investment, as well as the time value of money. For each intangible asset, a specific discount rate
was valuated using “Modified CAPM Build-Up Method”.
The Company evaluates the need to record an impairment of non-financial
assets whenever events or changes in circumstances indicate that the carrying amount is not recoverable. If the carrying amount of non-financial
assets exceeds their recoverable amount, the assets are reduced to their recoverable amount. The recoverable amount is the higher of fair
value less costs of sale and value in use. In measuring value in use, the expected future cash flows are discounted using a pre-tax discount
rate that reflects the risks specific to the asset. The recoverable amount of an asset that does not generate independent cash flows is
determined for the cash-generating unit to which the asset belongs. Impairment losses are recognized in profit or loss.
Impact of Israeli Tax Policies and Government Programs on Our Operating
Results
Tax regulations have a material impact on our business, particularly
in Israel where we have our headquarters. The following summary describes the current tax structure applicable to companies in Israel,
with special reference to its effect on us.
General Corporate Tax Structure in Israel
Israeli companies are generally subject to corporate tax on their
taxable income. In 2022, the corporate tax rate was 23%. Capital gains derived by an Israeli company are generally subject to tax at the
prevailing regular corporate tax rate.
82
Law for the Encouragement of Industry (Taxes), 5729-1969
The Law for the Encouragement of Industry (Taxes), 5729-1969, generally referred to
as the Industry Encouragement Law, provides several tax benefits for an “Industrial Company”.
The following tax benefits, among others, are available to Industrial
Companies:
The Law for the Encouragement of Industry (Taxes), 5729-1969, generally referred to
as the Industry Encouragement Law, provides several tax benefits for an “Industrial Company”.
The Industry Encouragement Law defines an “Industrial Company” as an Israeli
resident company which was incorporated in Israel, of which 90% or more of its income in any tax year, other than income from certain
government loans, is derived from an “Industrial Enterprise” owned by it and located in Israel. An “Industrial Enterprise”
is defined as an enterprise that is held by an Industrial Company whose principal activity in a given tax year is industrial production.
| ◾ |
amortization over an eight-year period of the cost of purchased know-how and patents and rights to use a patent and know-how which
were purchased in good faith and are used for the development or advancement of the Industrial Enterprise, commencing in the year in which
such rights were first exercised; |
| ◾ |
under limited conditions, an election to file consolidated tax returns together with Israeli Industrial Companies controlled by it;
and |
| ◾ |
expenses related to a public offering are deductible in equal amounts over a three-year period, commencing in the year of the offering.
|
Eligibility for benefits under the Industry Encouragement Law is
not contingent upon the approval of any governmental authority. We believe that we currently qualify as an Industrial Company within the
meaning of the Industry Encouragement Law. There can be no assurance that we will continue to qualify as an Industrial Company or that
the benefits described above will be available in the future.
Law for the Encouragement of Capital Investments,
5719-1959
The Law for the Encouragement of Capital Investments, 5719-1959,
generally referred to as the Investment Law, provides certain incentives for capital investments in production facilities (or other eligible
assets) by “Industrial Enterprises” (as defined under the Investment Law).
The Investment Law was significantly amended effective April 1,
2005 (which we refer to as the 2005 Amendment), further amended as of January 1, 2011 (which we refer to as the 2011 Amendment) and
further amended as of January 1, 2017 (which we refer to as the 2017 Amendment). Pursuant to the 2005 Amendment, tax benefits granted
in accordance with the provisions of the Investment Law prior to its revision by the 2005 Amendment remain in force but any benefits granted
subsequently are subject to the provisions of the 2005 Amendment. Similarly, the 2011 Amendment introduced new benefits to replace those
granted in accordance with the provisions of the Investment Law in effect prior to the 2011 Amendment. However, companies entitled to
benefits under the Investment Law as in effect prior to January 1, 2011 were entitled to choose to continue to enjoy such benefits,
provided that certain conditions are met, or elect instead irrevocably to forego such benefits and have the benefits of the 2011 Amendment
apply. The 2017 Amendment introduced new benefits for Technological Enterprises, alongside the existing tax benefits.
On October 24, 2010, we received a tax ruling from the Israel
Tax Authority, according to which, among other things, our activity has been qualified as an “industrial activity”, as defined
in the Investment Law and is also eligible to tax benefits as a Beneficiary Enterprise, which will apply to the turnover attributed to
such enterprise. The benefit period under this tax ruling ended in 2018, and since we did not generate any taxable income until tax year
2018, we were not entitled to any tax benefits under this tax regime.
We have reviewed and evaluated the implications and effect of the
benefits under the 2011 and 2017 Amendments, and, while potentially eligible for such benefits, we have not yet chosen to be subject to
the tax benefits introduced by the 2011 or the 2017 Amendments.
83
| ITEM 6. |
DIRECTORS, SENIOR MANAGEMENT AND EMPLOYEES |
A.
Directors and Senior Management
The following table sets forth the name, age and position of each
of our executive officers and directors as of the date of this annual report.
|
Name |
Age |
Position | ||
|
Executive officers |
||||
|
Mr. Ofer Haviv |
56 |
President and Chief Executive Officer | ||
|
Dr. Nir Arbel |
43 |
Chief Product Officer | ||
|
Mr. Yaron Eldad |
57 |
Chief Financial Officer | ||
|
Dr. Brian Ember |
46 |
Chief Executive Officer of AgPlenus Ltd. | ||
|
Dr. Elran Haber |
42 |
Chief Executive Officer of Biomica Ltd. | ||
|
Mr. Mark Kapel |
46 |
Chief Technology Officer | ||
|
Mr. Sassi Masliah |
44 |
Executive Vice President Corporate Development | ||
|
Mr. Eyal Ronen |
52 |
Executive Vice President of Business Development and Chief Executive Officer of Canonic Ltd. and of Casterra
Ag Ltd. Effective as of April 16, 2023 Mr. Ofer Haviv will serve as the interim CEO of Canonic in lieu of Mr. Eyal Ronen. |
||
|
Directors |
||||
|
Ms. Sarit Firon(3)(4)
|
56 |
Chairperson of the Board | ||
|
Mr. Dan Falk(1)(2)(4)
|
77 |
Director | ||
|
Mr. Nir Nimrodi(1)(2)(3)(4)
|
54 |
Director | ||
|
Dr. Adrian Percy(4)
|
57 |
Director | ||
|
Mr. Leon Y. Recanati(3)(4)
|
74 |
Director | ||
|
Dr. Oded Shoseyov(1)(2)(4)
|
66 |
Director |
____________________________
| (1) |
Member of our Audit Committee. |
| (2) |
Member of our Compensation and Nominating Committee. |
| (3) |
Member of our Pricing Committee. |
| (4) |
Independent director under the Nasdaq Listing Rules. |
Executive Officers
Mr. Ofer Haviv has
served as Evogene's President and Chief Executive Officer since December 2004 after having joined the company in January 2002 as Chief
Financial Officer. Mr. Haviv serves as Chairperson of the Board of Directors of our subsidiaries. From 2006 to 2007, Mr. Haviv
served as a director of the company. Mr. Haviv is a Certified Public Accountant and holds a BA in Accounting and Economics from Tel-Aviv
University, Israel.
Dr. Nir Arbel has
served as Chief Product Officer of Evogene since August 2021. Dr. Arbel has over ten years of experience in biotechnology and medical
technology companies in product development and commercialization. Prior to joining the Company, Dr. Arbel served as Chief Executive Officer
and Co-Founder of Carmentix Pte Ltd, Singapore, a company focused on high-risk pregnancy prognosis, from 2015 to 2020, and as the Operating
Partner in Esco Ventures, a medical technology fund based in Singapore, from 2016 to 2020. Dr. Arbel holds a Ph.D. in Biochemistry from
Ben-Gurion University, Israel.
84
Mr. Yaron Eldad has
served as Chief Financial Officer of Evogene since April 2022. Mr. Eldad has held various chief financial officer positions over the last
25 years in public and private technology and biotechnology companies, including Yamba Group Int. Ltd. from 2011 to 2021, Recoly NV from
2008 to 2010, and e-Sim Ltd. from 1998 to 2007. Mr. Eldad also serves on the board of directors and as chairman of the audit and compensation
committees of B.O.S. Better Online Solutions Ltd. Mr. Eldad holds a B.A. in Economics and Accounting from the Ben-Gurion University of
the Negev, Israel, an Executive MBA in Strategic Management from the Hebrew University of Jerusalem, Israel, and an M.A. in law from the
Bar-Ilan University, Israel.
Mr. Mark Kapel
was appointed as Executive Vice President Technology in February 2018, previously serving as Director of Information Technologies
Data Management from 2013. Mr. Kapel joined Evogene in 2005 and has held various positions in the company over the years. Mr. Kapel
holds a B.Sc. in Physics Computers from the Ben Gurion University of Negev, Israel, an MBA specializing in Management of Technology
from Tel-Aviv University’s Faculty of Management – Recanati Graduate School of Business Administration, Israel.
Mr. Sassi Masliah
has served as Executive Vice President Corporate Development since February 2022. Mr. Masliah has held various positions within Evogene
over the last 11 years, most recently as Evogene’s Vice President for Legal Affairs and Corporate Secretary. Mr. Masliah holds an
LL.B. and B.A. in economics from the Tel-Aviv University, Israel.
Mr. Eyal Ronen
has served as Executive Vice President of Business Development of Evogene and Chief Executive Officer of Casterra since June 2022. He
has served as Chief Executive Officer of Canonic since January 2023. Mr. Ronen has over 20 years of extensive business development experience
at various companies operating both in Israel and internationally, and focused on the biotech space. His prior experience includes Vice
President of Business Development at TransAlgae Israel Ltd. from 2020 to 2022, Vice President of Sales, Marketing, and Business Development
at Flora Fotonica Ltd. from 2018 to 2020, VP of Sales at S.T.K Stockton Group Ltd. from 2015 to 2018, CTO and Co-Founder at Seanovo
from 2014 to 2016, Growth Department Manager at Gadot Chemical Terminals (1985) Ltd. from 2012 to 2015, Director of South America at Haifa
Chemicals Ltd. from 2003 to 2012 and Agronomist at ICL Group from 1999 to 2003. Mr. Ronen holds a B.Sc in Agronomy, crop protection from
the Hebrew University of Jerusalem, an M.Sc. in Agronomy, Biomass accumulation in tobacco plants as affected by photosynthetic factors
plant nutrients from the Hebrew University of Jerusalem, and an MBA in Executive Master in Business Administration from the Haifa
University.
Dr. Brian Ember
has served as Chief Executive Officer of AgPlenus Ltd., a subsidiary of Evogene, since December 2021. Dr. Ember has previously held various
senior leadership roles, including, during 2021, Head of Global Portfolio Management and Head of Marketing and Business Development, Americas
for Biotalys, an agricultural technology company focused on reinventing food protection with protein-based biocontrol solutions; Senior
Director, Business Development for AgriMetis, an innovative crop protection company, between 2018 and 2021; and various management roles
at BASF from 2012 to 2018 and Syngenta from 2008 to 2012. Dr. Ember holds a B.Sc. in Chemistry from the University of Florida, Gainesville,
Florida; a Ph.D. in Organic Chemistry from the University of Georgia, Athens, Georgia; and an MBA from Kenan-Flagler Business School at
the University of North Carolina, Chapel Hill, North Carolina.
Dr. Elran Haber
has served as Chief Executive Officer of Biomica Ltd., a subsidiary of Evogene, since January 2018. Dr. Haber previously served as Chief
Executive Officer of Therapix Biosciences Ltd. (now known as SciSparc Ltd.) (NASDAQ: SPRC) beginning in November 2015. Prior to that,
from March 2014, Dr. Haber served as its Vice President of Business Strategy and Innovation. Dr. Haber served for more than 10 years as
Chairperson and board member of several publicly traded and privately held companies, including Issta Lines Ltd. (TASE: ISTA) from 2007
to 2012, and American Express Global Business Travel – Israel (Histour-Eltive Ltd.) from 2010 to 2012, and has been a member of
various board committees and has served in senior executive roles in various life science companies. Dr. Haber holds a Ph.D. in Pharmaceutical
Science and an MBA in Finance Financial Engineering, both from The Hebrew University of Jerusalem, Israel.
Directors
Ms. Sarit Firon has
served as a director of our Company since she was appointed by the Board in August 2016, and as chairperson since August 2021. Ms. Firon
is managing partner of Team8 Group and co-founder and managing partner of Team8 Capital, the investment arm of Team8 Group, which invests
in early-stage technology startups. Previously, she was a managing partner of Cerca Partners, an Israeli venture capital fund. She has
served at Extreme Reality Ltd., as its Chief Executive Officer from December 2012 to November 2014 and as a director since December 2014.
From November 2011 to November 2012, Ms. Firon was the Chief Financial Officer of Kenshoo Ltd. From November 2007 to October 2011, Ms.
Firon was the Chief Financial Officer of MediaMind Technologies Inc., a Nasdaq listed company which was acquired by DG, Inc. in August
2011. From May 2005 to June 2007, Ms. Firon was the Chief Financial Officer of OliveSoftware and from January 2000 to October 2004, she
was the CFO of P-Cube, a private company which was acquired in October 2004 by Cisco Systems, Inc. (Nasdaq: CSCO). From October 2004 to
January 2005, Ms. Firon was employed by Cisco to be responsible for the post-merger integration of P-Cube. From January 1995 to December
1999, Ms. Firon served in various positions at Radcom Ltd. (Nasdaq: RDCM), including as its Chief Financial Officer from September 1997
to December 1999. Since July 2015, she has served as chairperson of the board of directors of myThings Israel Ltd. Since June 2014, Ms.
Firon has served as a director of Mediwound Ltd. (Nasdaq: MDWD), and since June 2012, Ms. Firon has served as a director of Datorama Ltd.
From October 2000 to December 2006, Ms. Firon served as a director of MetaLink Ltd. (OTCMKTS: MTLK). Ms. Firon holds a B.A. in Accounting
and Economics from Tel-Aviv University, Israel.
85
Mr. Dan Falk
has served as a director of our Company since he was appointed by the Board in November 2021. Mr. Falk has extensive experience
of more than 20 years in serving as a financial expert on public and private company boards, most recently on the boards of Nice Ltd.
(NASDAQ: NICE), Ormat Technologies Inc. (NYSE: ORA) and Innoviz Technologies Ltd. (NASDAQ: INVZ). Additionally, in the past Mr. Falk held
various executive positions in Orbotech Ltd. between 1985 and 1999, and Sapiens International Corporation (NASDAQ: SPNS) between 1999-2001.
Mr. Falk holds a B.A. in Economics and Political Sciences, and an M.A. in Business Administration both from the Hebrew University of Jerusalem,
Israel.
Mr. Nir Nimrodi
has served as a director of our Company since he was appointed by the Board in September 2022. He was a consultant to the Board
of our Company from April 2020 until September 2022. Mr. Nimrodi have been the Chairman and Chief Executive Officer of Accellix Inc, a
leading cell therapy analytical company, since May 2019. Mr. Nimrodi brings more than 25 years of diverse international experience in
both start-ups and large global businesses in the life science, pharmaceutical, and biotechnology industries. Prior to joining Accellix,
Mr. Nimrodi served as the Chief Business Officer of Intrexon Corporation, a leader in synthetic biology from March 2014 to April 2019.
Prior to Intrexon, Mr. Nimrodi held several executive roles at Life Technologies Inc (now part of Thermo Fisher). While at Life Technologies,
Mr. Nimrodi served as Chief Executive Officer and Board Member of Life Technologies Israel from January 2007 to December 2008, Head of
Protein Technologies from December 2008 to December 2010, as well as Vice President and General Manager of Food Safety and Animal Health
from December 2010 to March 2014. Prior to his seven years at Life Technologies, he was the CEO of Proneuron Biotechnologies Inc. from
February 2002 to December 2006 and Mindsense Biosystems Ltd. from June 1999 to February 2002. Earlier in his career, Mr. Nimrodi was a
Director of Finance for Teva Pharmaceuticals Ltd. from April 1995 to June 1999. Mr. Nimrodi holds a B.A. in Economics and MBA from the
Tel Aviv University, Israel.
Dr. Adrian
Percy has served as a director of our Company since February 2019. Dr. Percy serves on the board of directors of BioLumic
Ltd., High Fidelity Genetics Inc. and FungiAlert Inc. (dba FA Bio). He is a member of the science and technology boards
of Terramera Inc., Oerth Bio LLC, Harpe BioHerbicide Solutions Inc., Biotalys NV and Rothamsted Research Limited. Dr. Percy is serving
as the Executive Director of the N.C. Plant Sciences Initiative at NC State University since 2021. Dr. Percy is currently a venture partner
with Finistere Ventures and frequently acts as an advisor to companies through his own consultancy company, Nomad Technology Consulting.
From 2019-2021, Dr. Percy served as Chief Technology Officer at UPL Ltd. From 2014-2018, he served as the head of research and development
for the Crop Science division of Bayer as part of its executive committee. During his 16-year tenure at Bayer, he also led regulatory
affairs activities across the entire division of Crop Science between 2013 and 2014 and crop protection development activities for Bayer
in North America between 2011 and 2013. Dr. Percy has held positions in the research and development departments of Aventis CropScience
SA between 2000 and 2002, Rhone Poulenc SA between 1996 and 2000, and Bayer in France, Germany and the United States. Dr. Percy earned
a bachelor’s degree in pharmacology at the University of Liverpool, England, as well as a master’s degree in toxicology and
a doctorate in biochemistry at the University of Birmingham, England.
Mr. Leon Y.
Recanati has served as a director of our Company since May 2005. Mr. Recanati has served as chairperson and chief executive
officer of GlenRock Israel Ltd. since 2003. Previously, Mr. Recanati was chief executive officer or chairperson positions at IDB
Holding Corporation, Clal Industries, Azorim Investment Development and Construction Co., Delek Israel Fuel Corporation, and Super-Sol.
He also founded Clal Biotechnologies Industries, a biotechnology investment company operating in Israel. Mr. Recanati holds an MBA
from The Hebrew University of Jerusalem, Israel, and Honorary Doctorates from the Technion Institute of Technology, Israel, and Tel-Aviv
University, Israel.
86
Dr. Oded Shoseyov has
served as a director of our Company since November 2018. Dr. Shoseyov is the scientific founder of 18 companies, including: Futuragene
Ltd., Collplant Ltd., Biobetter Ltd., GemmaCert Ltd., SP-Nano materials Ltd., Melodea Ltd., Valentis Nanotech. Ltd., Paulee CleanTec Ltd.,
Smart Resilin Ltd., Sensogenic Ltd., SavorEat Ltd., Rnway Ltd., Wonder Veggies Ltd., Seekwell Ltd. and Karme Yosef Winery. Dr. Shoseyov
is a faculty member of The Hebrew University of Jerusalem, Israel, where he conducts research in plant molecular biology protein engineering
and nano-biotechnology. His group’s focus is on Bio-Inspired Nanocomposite materials. He has authored or co-authored more than 350
scientific publications and is the inventor or co-inventor of 103 patents. Dr. Shoseyov is a TED speaker and a co-owner and winemaker
of Bravdo winery. Dr. Shoseyov received the Outstanding Scientist Polak Award for 2002, the 1999 and 2010 Kay Award for Innovative and
Applied Research, the 2012 Israel Prime Minister Citation for Entrepreneurship and Innovation, and the 2018 Presidential Award for his
contribution to the Economy and Society of Israel. Dr. Shoseyov holds a B.Sc., an M.Sc. and a Ph.D. from The Hebrew University of Jerusalem,
Israel.
Arrangements for Election of Directors and Members of Management;
Family Relationships
There are no arrangements or understandings with major shareholders,
customers, suppliers or others related to the election of our board of directors or the appointment of members of our senior management.
There are furthermore no family relationships among any directors or members of our senior management.
B. Compensation
Aggregate and Individual Compensation of Officers and Directors
The aggregate compensation, including non-cash share-based compensation
(consisting of expenses related to option grants), accrued by us in respect of the year ended December 31, 2022 to all persons who served
as directors and/or executive officers during that year, was approximately $3.1 million. That amount includes approximately $0.5 million
of gross compensation set aside or accrued for executive officers for purposes of pension, severance, retirement, car, phone or similar
benefits or expenses, but does not include business travel, relocation, professional and business association dues and expenses reimbursed
to executive officers, and other expenses commonly reimbursed by companies in Israel. These amounts include the partial-year compensation
paid to seven executive officers and two directors, who served in their positions over the course of 2022 and whose employment as directors
or executive officers either was terminated or has commenced during 2022.
During 2022, we granted to our executive officers and directors
an aggregate amount of 426,000 options, of which 150,000 were granted with an exercise price of NIS 4.09 ($1.16), 90,000 were granted
with an exercise price of NIS 3.62 ($1.03) per share, 150,000 were granted with an exercise price of NIS 2.85 ($0.81) per share and 36,000
were granted with an exercise price of $1.02 per share. The options detailed above expire within ten years from the date of grant. During
2022, one executive officer, who served as chief executive officer in one of our subsidiaries, was granted options to purchase equity
of such subsidiary, which are not detailed above.
The following table presents information regarding compensation
accrued in our financial statements for the year ended December 31, 2022 for our five most highly compensated executive officers, as required
under Israeli Securities Law 5728-1968 and the regulations promulgated thereunder.
|
(in thousands, US$)(1) |
||||||||||||||||
|
Name and Position |
Salary and related benefits |
Bonus(2) |
Value of Options Granted(3) |
Total |
||||||||||||
|
Ofer Haviv
President and Chief Executive Officer |
415 |
22 |
27 |
464 |
||||||||||||
|
Sassi Masliah
EVP Corporate Development |
236 |
9 |
59 |
304 |
||||||||||||
|
Mark Kapel
EVP Technology |
267 |
9 |
23 |
299 |
||||||||||||
|
Nir Arbel
Chief Product Officer |
259 |
(12 |
) |
56 |
303 |
|||||||||||
|
Brian Ember
CEO of AgPlenus |
284 |
10 |
- |
294 |
||||||||||||
| (1) |
All amounts reported in the table are in terms of cost to the Company, as recorded in our financial statements. |
| (2) |
Bonus amounts shown in this table regarding Brian Ember reflect a bonus provision recorded in the financial statements for the year
ended December 31, 2022 and paid during 2023. Bonus amounts shown in this table regarding other executive officers reflect the increase
(decrease) of bonus paid during 2022 compared to the bonus provision accrued in the financial statements for the year ended December 31,
2021 (no bonus provision was recorded for them in the financial statements for the year ended December 31, 2022). Bonus payments relating
to office holders’ service in our Company are approved by our Compensation and Nominating Committee and Board of Directors, and,
to the extent required, also by our shareholders. |
| (3) |
Consists of amounts recognized as non-cash expenses in our statement of profit or loss for the year ended December 31, 2022 in respect
of option grants. |
87
Compensation Policy
As required by the Companies Law, we have adopted a policy regarding
the terms of engagement of office holders, or a compensation policy. Under the Companies Law, the term “office holders” includes
directors and certain officers, including the general manager (i.e., chief executive officer, or CEO), chief business manager, deputy
CEO, vice CEO, any other person assuming the responsibilities of any of the foregoing positions without regard to such person’s
title, and any director or manager who reports directly to the CEO. The compensation policy serves as the basis for determining the financial
terms of employment or engagement of office holders, including exculpation, insurance, indemnification or any monetary payment or obligation
of payment in respect of employment or engagement. The compensation policy must relate to certain factors specified in the Companies Law,
including advancement of the company’s objectives, the company’s business and its long-term strategy, and creation of appropriate
incentives for executives. It must also consider, among other things, the company’s risk management, size and the nature of its
operations. The Companies Law describes what factors have to be considered by, and what principles must be included in, the compensation
policy.
Our current compensation policy was adopted in August 2021, at
an annual general meeting of our shareholders, following the recommendation of our compensation committee and our board of directors.
Approvals Required for Compensation of Directors and Officers
Under the Companies Law, the compensation of each of our directors
and our CEO requires the approval of our compensation committee, the subsequent approval of the board of directors and, unless exempted
under the regulations promulgated under the Companies Law, the approval of our shareholders at a general meeting (in the case of our CEO,
the shareholder approval must include the special majority described under “Item 6. Directors, Senior Management and Employees—C.
Board Practices—Approval of Related Party Transactions under Israeli Law— Disclosure of Personal Interests of an Office
Holder and Approval of Certain Transactions”). The compensation of any other office holder (who is neither a director nor our Chief
Executive Officer), if consistent with our compensation policy, requires the approval of our compensation committee, followed by our board
of directors. Compensation of any such office holder that deviates from our compensation policy also requires shareholders’ approval,
including by the special majority described under “Item 6. Directors, Senor Management and Employees—C. Board Practices—
Approval of Related Party Transactions under Israeli Law— Disclosure of Personal Interests of an Office Holder and Approval of Certain
Transactions.”
Compensation of Executive Officers
Our compensation for our executive officers is paid pursuant to
written employment agreements that we have entered with each of our executive officers and is based, in part, on each executive officer’s
personal contribution to our management, operations and success. Such compensation is determined consistent with our compensation policy.
For more information on our compensation policy, please see “—Compensation Policy” above.
88
Each executive officer’s entitlement to an annual bonus is
determined according to a formula that links financial and qualitative target-based goals and metrics related to the specific objectives
within the responsibility of the relevant executive officer. In the case of executive officers who are also office holders, their annual
bonus is also required to be consistent with our compensation policy. The goals and objectives of Evogene’s office holders are determined
by the compensation and nominating committee and our board of directors. For each fiscal year, our compensation and nominating committee
and board of directors determine the maximum target bonus for each of our office holders, including our CEO. Further, for our CEO, all
terms of employment, including bonus terms, require, in general, approval by a majority of our shareholders present and voting (in person
or by proxy) at a meeting of shareholders, subject to fulfillment of one of the two additional conditions described in “Item 6.
Directors, Senior Management and Employees—C. Board Practices—Approval of Related Party Transactions under Israeli Law—Disclosure
of Personal Interests of an Office Holder and Approval of Certain Transactions.”
Each of the employment agreements with our executive officers contains
provisions regarding non-competition, confidentiality of information and assignment of inventions. The non-competition provision applies
for a period that is generally 12 months following termination of employment. The enforceability of covenants not to compete in Israel
and in the United States is subject to limitations. The employment agreement of each executive officer is terminable upon 60 days written
notice by either party to the agreement, except for the employment agreement with Mr. Ofer Haviv, our President and CEO, which is terminable
at will upon 90 days written notice, by either party to the agreement, and except for the employment agreement of our EVP Business Development,
which is terminable at will upon 60 days written notice during the first year of his employment and 90 days commencing on the second year
of his employment.
Director Compensation
Our directors are entitled to cash compensation and equity compensation
as follows:
Cash Compensation of
Directors
All of our directors receive annual fees and per-meeting fees
for their service on our board and its committees, in the following amounts:
| ◾ |
Annual fees in an amount of approximately $24,600 for directors classified as experts; and |
| ◾ |
Per-meeting fees in an amount of approximately $1,300 for directors classified as experts; 60% of such amounts for participation
in meetings via telecommunication and 50% of such amounts for resolutions adopted in writing. |
Such amounts are within the range for cash compensation for
external and unaffiliated directors of a company of our size (based on level of shareholders’ equity) under the Companies Law.
Cash Compensation of
Chairperson of the Board
In accordance with shareholders’ approval from August
2021, a chairperson of the board who is determined by the Board to be an “active chairperson” in light of increased involvement
in our activities and increased time investment in the performance of the duties accompanying the chairperson’s position compared
to the other directors, shall be entitled to increased compensation relative to our other directors of approximately $6,400 per month
(equal to approximately NIS 21,500). Our Board has determined that Ms. Sarit Firon, our chairperson of the board, is an active chairperson,
and accordingly her fees as active chairperson are as aforesaid.
Equity Compensation of
Directors
In accordance with our shareholders’ approval from August
2021, and in compliance with our compensation policy, each non-employee director is granted options to purchase 18,000 ordinary shares
of the Company on the date of our annual general shareholders meeting at which such director is elected or re-elected to the board. The
chairperson of our board is granted options to purchase 36,000 ordinary shares. These options vest over a period of one year, with 25%
of the options vesting at the end of each successive three-month period following the director’s appointment or re-appointment (as
applicable) by the general meeting of shareholders, subject to continued service through each vesting date.
89
All option grants to directors following the approval of our 2021
Share Incentive Plan by our shareholders (i.e., as of August 10, 2021), are subject to the terms of our 2021 Share Incentive Plan and
are granted at an exercise price equal to the average closing sales price per ordinary share on the TASE over the thirty day calendar
period preceding the subject date (utilizing all trading days during such 30 calendar day period) (but not less than “fair market
value” with respect to grantees subject to U.S. tax). All option grants to directors prior to August 10, 2021, are subject to the
terms of our 2013 Share Option Plan and were granted at an exercise price equal to the higher of (i) the average closing price of our
ordinary shares on the TASE during the 30 trading days prior to the date of option allocation, plus 5% and (ii) the closing price of our
ordinary shares on the TASE on the date of option allocation. All such options expire 10 years following the date of grant thereof.
Information regarding the options to purchase our ordinary shares
(including number of options, exercise price and expiration date of all such options) held by each of our directors and executive officers
who beneficially owns our ordinary shares, after including ordinary shares underlying options held by them, which, as of March 20, 2023,
were exercisable or exercisable within 60 days, appears in the beneficial ownership table in Item 7.A below and in the footnotes thereto.
Share Option and Incentive Plans
Company Option and Incentive
Plans
We maintain four share option and incentive plans: Evogene Ltd.
2002 Share Option Plan, Evogene Ltd. 2003 Key Employee Share Incentive Plan, Evogene Ltd. 2013 Share Option Plan, and Evogene Ltd. 2021
Share Incentive Plan, or the 2021 Plan. No new grants will be made under the first three plans, although outstanding awards under those
plans remain subject to the terms of those plans. All such option and incentive plans provide for the grant of options to purchase our
ordinary shares, and the 2021 Plan also provides for the issuance of restricted shares, the grant of restricted shares units, or RSUs,
and the issuance or grant of other equity-based awards.
As of March 20, 2023, options to purchase 4,198,312
ordinary shares, having a weighted average exercise price of $3.65 per share, and 505,066 RSUs, having no exercise price, were outstanding
under our option and incentive plans, of which, options to purchase 2,694,238 ordinary shares were exercisable and 76,129 RSUs were vested.
An additional 1,134,485 ordinary shares remained available for future grant under our 2021 Plan as of that date.
Among other types of equity-based awards, our share option and
incentive plans provide for granting awards in compliance with Section 102 of the Israeli Income Tax Ordinance [New Version], 5721-1961,
or the Tax Ordinance, which provides to employees, directors and officers, who are not controlling shareholders (i.e.,
who hold less than 10% of our share capital) and are Israeli residents, favorable tax treatment for compensation in the form of shares,
options, RSUs or other types of equity awards issued or granted, as applicable, to a trustee under the “capital gains track”
for the benefit of the relevant employee, director or officer and are held by the trustee for at least two years after the date of grant
or issuance. Under the “capital gains track”, we are not allowed to deduct an expense with respect to the grant or issuance
of the relevant equity-based awards.
The 2021 Plan also permits us to grant equity-based awards to
U.S. residents, in accordance with the applicable provisions of the U.S. Internal Revenue Code of 1986, as amended, or the Code.
Awards granted under our plans may be subject to vesting schedules.
Options to purchase our ordinary shares granted under our plans expire 10 years from the grant date. The plans address the treatment of
vested and unvested awards upon the termination of employment of the award holder as well as upon consummation of a merger or consolidation
of our company, or sale of all or substantially all of our shares or assets.
90
Subsidiary Equity Incentive
Plans
In addition to the share option and incentive plans at our parent
company level, each of our subsidiaries has adopted its own equity incentive plan. The following table presents information regarding
our subsidiaries’ equity incentive plans, including the percentage of the equity of those companies that may be issued or granted
as equity incentives to employees, directors or service providers of those companies and the percentage of that equity that has been issued
or granted as of March 20, 2023 (in both cases, after including shares underlying options).
|
Subsidiary |
Percentage of Subsidiary's Equity Issuable as Equity Incentives
|
Percentage of Equity Granted to Date as Equity
Incentives |
||||||
|
AgPlenus |
9.6 |
% |
3.5 |
% | ||||
|
Biomica |
18.9 |
% |
17.7 |
% | ||||
|
Casterra |
8.0 |
% |
0.5 |
% | ||||
|
Canonic |
10.8 |
% |
8.1 |
% | ||||
|
Lavie Bio |
10.5 |
% |
9.3 |
% | ||||
Grants under our subsidiaries’ equity incentive plans may
qualify for favorable treatment under the tax law provisions of the United States or Israel.
The share-based payments under our subsidiary equity incentive
plans are presented as non-controlling interests in the financial statements and were valued at approximately $0.6 million in 2022, as
detailed in Note 18.f. to the financial statements included in this annual report under Item 18.
C. Board
Practices
Board of Directors
Under the Companies Law and our articles of association, the supervision
of the management of our business is vested in our board of directors. Our board of directors may exercise all powers and may take all
actions that are not specifically granted to our shareholders or to executive management. Our Chief Executive Officer (referred to as
a “general manager” under the Companies Law) is responsible for our day-to-day management. Our Chief Executive Officer is
appointed by, and serves at the discretion of, our board of directors, subject to the employment agreement that we have entered into with
him. All other executive officers are appointed by the Chief Executive Officer and are subject to the terms of any applicable employment
agreements that we may enter into with them.
Under our articles of association and the Companies Law, our board
of directors must consist of not less than three and no more than seven directors. Currently our board of directors consists of six directors.
Our directors are elected annually, by a simple majority vote of
holders of our voting shares participating and voting at the annual meeting of our shareholders, for a one-year term, from the annual
general meeting of our shareholders at which they are elected until the next annual general meeting and until their respective successors
are elected and qualified or until their earlier removal by our shareholders at a general meeting, or upon the occurrence of certain events,
in accordance with the Companies Law and our articles of association. The duration of service of each of our current directors can be
found in their respective biographies in Item 6.A. above.
In addition, under our articles of association, our board of directors
may appoint directors to fill vacancies or as new directors for a term of office that lasts until the next annual meeting of our shareholders.
In the event of a vacancy resulting in the board consisting of less than the minimum number of directors required by our articles of association,
our board of directors may only act in order to convene a general meeting of our shareholders for the purpose of electing such additional
number of directors.
Pursuant to the terms of a put option agreement we entered into
with Monsanto (now Bayer) in October 2013, Monsanto has the right to nominate a non-voting observer to our board of directors so long
as Monsanto holds at least 5% of our voting rights. In addition, pursuant to a share purchase agreement we entered into with Bayer in
December 2010 and as amended in June 2013, Bayer also has the right to appoint one observer to our board of directors so long as Bayer
holds at least 3% of our issued and outstanding shares. In each case, the observer is entitled to be advised reasonably in advance of
board meetings and is to receive copies of all material distributed in connection with such meetings. The observer would not have any
voting rights. To date, neither Monsanto nor Bayer has appointed an observer.
91
Chairperson of the Board
Our articles of association provide that the chairperson of the
board is appointed by the members of the board of directors and serves as chairperson of the board throughout his term as a director,
unless resolved otherwise by the board of directors. Under the Companies Law, the general manager (i.e., the Chief Executive Officer)
or a relative of the general manager may not serve as the chairperson of the board of directors, and the chairperson or a relative of
the chairperson may not be vested with authorities of the general manager, in each case without shareholder approval consisting of a majority
vote of the shares present and voting at a shareholders meeting, provided that either:
| ◾ |
such majority includes at least 2/3 of the shares held by all shareholders who are not controlling shareholders and do not have a
personal interest in such appointment, present and voting at such meeting; or |
| ◾ |
the total number of shares of non-controlling shareholders who do not have a personal interest in such appointment voting against
such appointment does not exceed two percent of the aggregate voting rights in the company. |
In addition, a person subordinated, directly or indirectly, to
the general manager may not serve as the chairperson of the board of directors; the chairperson of the board may not be vested with authorities
that are granted to those subordinated to the general manager; and the chairperson of the board may not serve in any other position in
the company or a controlled company, except that he may serve as a director or chairperson of a subsidiary.
External Directors
In general, under the Companies Law, the board of directors of
an Israeli public company (such as ours) is required to include at least two external directors. According to regulations promulgated
under the Companies Law, a person may be appointed as an external director if such person has either professional qualifications or accounting
and financial expertise. In addition, at least one of the external directors must be determined by our board of directors to have accounting
and financial expertise.
However, pursuant to regulations enacted under the Companies Law
in 2016, the board of directors of a company whose shares are listed on certain non-Israeli stock exchanges (including the Nasdaq Global
Market), which company does not have a controlling shareholder (as such term is defined in the Companies Law), may elect not to comply
with the requirements of the Companies Law relating to the election of external directors and to the composition of the audit committee
and compensation committee. Such an election may be made by the board of directors, and is contingent upon the company’s satisfaction,
in an ongoing manner, of the applicable foreign country stock exchange rules that apply to companies organized in that country relating
to the appointment of independent directors and the composition of the audit and compensation committees.
Because our company did not have, in May 2016, and still does not
have, a controlling shareholder, and as we comply with the Nasdaq Listing Rules applicable to domestic U.S. companies with respect to
a majority of our directors being independent and with respect to the composition of our audit committee and compensation committee, our
board of directors determined, in May 2016, to opt-out of the requirement to elect external directors. If in the future we were to have
a controlling shareholder, we would likely again be required to comply with the Companies Law requirements relating to external directors
and composition of the audit committee and compensation committee.
The term controlling shareholder, as used in the Companies Law
for purposes of all matters related to external directors and for certain other purposes, means a shareholder that has the ability to
direct the activities of the company, other than by virtue of being an office holder. For purposes of all matters related to external
directors, a shareholder is presumed to be a controlling shareholder if the shareholder holds 50% or more of the voting rights in the
company or has the right to appoint the majority of the directors of the company or its general manager (chief executive officer).
Directors’ Service Contracts
There are no arrangements or understandings between us, on the
one hand, and any of our directors, on the other hand, providing for benefits upon termination of their service as directors of our company.
Financial Statements Review and Audit Committee
Our financial statements review and audit committee, or audit committee,
consists of Mr. Dan Falk, Mr. Nir Nimrodi and Dr. Oded Shoseyov. Mr. Falk serves as the Chairperson of the audit committee.
92
Requirements as to Composition
Companies Law Requirements
Under the Companies Law, the board of directors of a public company must appoint an
audit committee. The audit committee must be comprised of at least three directors.
Following the promulgation of the regulations described above,
we may comply with the requirements of the Companies Law by appointing an audit committee whose composition complies with the Nasdaq Listing
Rules. Under the Nasdaq Listing Rules, we are required to maintain an audit committee consisting of at least three independent directors,
each of whom is financially literate and at least one of whom has accounting or related financial management expertise.
All members of our audit committee meet the requirements for independence
and financial literacy under the Nasdaq Listing Rules. Our board of directors has determined that each of Mr. Dan Falk and Mr. Nir Nimrodi
is furthermore an audit committee financial expert, as defined by the SEC rules, and has the requisite financial experience required under
the Nasdaq Listing Rules.
Each of the members of the audit committee is also “independent”
as required by, and as such term is defined in, Rule 10A-3(b)(1) under the Exchange Act, which is different from the general test for
independence of board and committee members under the Nasdaq Listing Rules.
Audit Committee Role
Our board of directors (following the approval by our audit committee)
has adopted an audit committee charter setting forth the required composition, meeting procedures and other matters related to the terms
of operation of the committee. The charter also describes the responsibilities of the audit committee consistent with the rules of the
SEC and the Nasdaq Listing Rules, which include, among others:
| ◾ |
retaining and terminating the services of our independent auditors, subject to the approval of the board of directors and shareholders;
|
| ◾ |
pre-approval of audit and non-audit services to be provided by the independent auditors; |
| ◾ |
reviewing with management and our independent directors our financial reports prior to their submission to the SEC; and |
| ◾ |
approval of certain transactions with office holders and other related-party transactions. |
The charter of the audit committee is available on our website.
The contents of that website do not constitute a part of this annual report.
Our audit committee provides assistance to our board of directors
in fulfilling its legal and fiduciary obligations in matters involving our accounting, auditing, financial reporting, internal control
and legal compliance functions by pre-approving the services performed by our independent accountants and reviewing their reports regarding
our accounting practices and systems of internal control over financial reporting. Our audit committee also oversees the audit efforts
of our independent accountants and takes those actions that it deems necessary to satisfy itself that the accountants are independent
of management.
Additionally, under the Companies Law, an audit committee is required,
among other things, to (i) identify deficiencies in the administration of the company (including by consulting with the internal auditor),
and recommend remedial actions with respect to such deficiencies, (ii) review and approve certain related party transactions, including
determining whether or not such transactions are extraordinary transactions or insignificant transactions, and (iii) adopt procedures
with respect to processing employee complaints in connection with deficiencies in the administration of the company, and the appropriate
means of protection afforded to such employees. In addition, the audit committee is responsible for overseeing the internal control procedures
of the company. Under the Companies Law, the approval of the audit committee is required for specified actions and transactions with office
holders and controlling shareholders. See “—Approval of Related Party Transactions under Israeli Law.”
93
Compensation and Nominating Committee
Our compensation and nominating committee, or compensation committee,
consists of Mr. Dan Falk, Mr. Nir Nimrodi and Dr. Oded Shoseyov. Mr. Falk serves as the Chairperson of the committee.
Requirements as to Composition
Following the promulgation of the regulations described above,
we may comply with the requirements of the Companies Law by appointing a compensation committee whose composition complies with the Nasdaq
Listing Rules. Under the Nasdaq Listing Rules, we are required to maintain a compensation committee consisting of at least two members,
each of whom qualifies as an independent director (as defined under the Nasdaq Listing Rules). Each compensation committee member must
furthermore be deemed by our board of directors to meet the enhanced independence requirements for members of the compensation committee
under the Nasdaq Listing Rules, which require that our board of directors consider (among other things) the source of each such committee
member’s compensation in determining whether he or she is independent.
Our board of directors has determined that each of the members
of our compensation committee is considered “independent” under the Nasdaq Listing Rules and meets the enhanced independence
requirements for members of the compensation committee under the Nasdaq Listing Rules and Rule 10C-1 under the Exchange Act.
Compensation and Nominating
Committee Role
Our board of directors (following approval by our compensation
committee) has adopted a compensation and nominating committee charter setting forth the required composition, meeting procedures and
other matters related to the terms of operation of the committee. The charter also describes the responsibilities of the compensation
committee consistent with the Nasdaq Listing Rules and the Companies Law, which include, among others:
| ◾ |
reviewing and recommending an overall compensation policy with respect to our Chief Executive Officer and other executive officers,
as described above under “Item 6. Directors, Senior Management and Employees—B. Compensation—Compensation Policy”;
|
| ◾ |
reviewing and approving corporate goals and objectives relevant to the compensation of our Chief Executive Officer and other executive
officers, including evaluating their performance in light of such goals and objectives; |
| ◾ |
reviewing and recommending to our board of directors to approve the granting of options and other incentive awards; |
| ◾ |
reviewing, evaluating and making recommendations regarding the compensation and benefits for our non-employee directors; and
|
| ◾ |
advising our board of directors in selecting individuals who are best able to fulfill the responsibilities of a director or executive
officer of our company. |
The charter of the compensation and nominating committee is available
on our website. The contents of that website do not constitute a part of this annual report.
Compensation Policy under the Companies Law
In general, under the Companies Law, a public company must have
a compensation policy approved by the board of directors after receiving and considering the recommendations of the compensation committee.
In addition, our compensation policy must be approved at least once every three years, first, by our board of directors, upon recommendation
of our compensation committee, and second, by a simple majority of the ordinary shares present, in person or by proxy, and voting (excluding
abstentions) at a general meeting of shareholders, provided that either:
| • |
such majority includes at least a majority of the shares held by shareholders who are not controlling shareholders and shareholders
who do not have a personal interest in such compensation policy; or |
94
| • |
the total number of shares of non-controlling shareholders and shareholders who do not have a personal interest in the compensation
policy and who vote against the policy, does not exceed two percent (2%) of the aggregate voting rights in the Company. |
Under special circumstances, the board of directors may approve
the compensation policy despite the objection of the shareholders on the condition that the compensation committee and then the board
of directors decide, on the basis of detailed grounds and after discussing again the compensation policy, that, despite the objection
of shareholders, approval of the compensation policy is for the benefit of the company.
The compensation policy must be based on certain considerations, include provisions
and matters specifically set forth in the Companies Law.
The compensation policy must serve as the basis for decisions concerning
the financial terms of employment or engagement of office holders, including exculpation, insurance, indemnification or any monetary payment
or obligation of payment in respect of employment or engagement. The compensation policy must be determined and later reevaluated according
to certain factors, including: the advancement of the company’s objectives, business plan and long-term strategy; the creation of
appropriate incentives for office holders, while considering, among other things, the company’s risk management policy; the size
and the nature of the company’s operations; and with respect to variable compensation, the contribution of the office holder towards
the achievement of the company’s long-term goals and the maximization of its profits, all with a long-term objective and according
to the position of the office holder. The compensation policy must furthermore consider the following additional factors:
| • |
the education, skills, experience, expertise and accomplishments of the relevant office holder; |
| • |
the office holder’s position and responsibilities; |
| • |
prior compensation agreements with the office holder; |
| • |
the ratio between the cost of the terms of employment of an office holder and the cost of the employment of other employees of the
company, including employees employed through contractors who provide services to the company, in particular the ratio between such cost
to the average and median salary of such employees of the company, as well as the impact of disparities between them on the work;
|
| • |
relationships in the company; |
| • |
if the terms of employment include variable components — the possibility of reducing variable components at the discretion
of the board of directors and the possibility of setting a limit on the value of non-cash variable equity-based components; and
|
| • |
if the terms of employment include severance compensation — the term of employment or office of the office holder, the terms
of the office holder’s compensation during such period, the company’s performance during such period, the office holder’s
individual contribution to the achievement of the company’s goals and the maximization of its profits and the circumstances under
which he or she is leaving the company. |
The compensation policy must also include, among other things:
| • |
with regard to variable components: |
| o |
with the exception of office holders who report to the chief executive officer, a means of determining the variable components on
the basis of long-term performance and measurable criteria; provided that the company may determine that an immaterial part of the variable
components of the compensation package of an office holder shall be awarded based on non-measurable criteria, or if such amount is not
higher than three months’ salary per annum, taking into account such office holder’s contribution to the company; and
|
| o |
the ratio between variable and fixed components, as well as the limit of the values of variable components at the time of their payment,
or in the case of equity-based compensation, at the time of grant; |
| • |
a condition under which the office holder will return to the company, according to conditions to be set forth in the compensation
policy, any amounts paid as part of the office holder’s terms of employment, if such amounts were paid based on information later
to be discovered to be wrong, and such information was restated in the company’s financial statements; |
| • |
the minimum holding or vesting period of variable equity-based components, while taking into consideration long-term incentives;
and |
| • |
a limit to retirement grants. |
95
Internal Auditor
Under the Companies Law, the board of directors of an Israeli public
company must appoint an internal auditor recommended by the audit committee. Under the Companies Law, the internal auditor may be an employee
of the company but not an office holder, an affiliate, or a relative of an office holder or affiliate, and may not be the company’s
independent accountant or its representative.
The role of the internal auditor is to examine, among other things,
our compliance with applicable law and orderly business procedures. The audit committee is required to oversee the activities and to assess
the performance of the internal auditor as well as to review the internal auditor’s work plan. Mr. Yisrael Gewirtz, CPA, has been
appointed as our internal auditor. Mr. Gewirtz is a certified internal auditor and a partner of Fahn Kanne Control Management Ltd., an
affiliate of Grant Thornton LLP.
Our internal auditor also provides management and the audit committee
ongoing assessments of our risk management processes and our internal controls.
Approval of Related Party Transactions under Israeli Law
Fiduciary Duties of Directors and Executive
Officers
The Companies Law codifies the fiduciary duties that office holders
owe to a company. Many of the executive officers listed in the table under “Item 6. Directors, Senior Management and Employees—
A. Directors and Senior Management” are also office holders under the Companies Law. An office holder’s fiduciary duties consist
of a duty of care and a duty of loyalty. The duty of care requires an office holder to act with the level of care with which a reasonable
office holder in the same position would have acted under the same circumstances. The duty of loyalty requires that an office holder act
in good faith and in the best interests of the company. The duty of care includes a duty to use reasonable means to obtain (i) information
on the appropriateness of a given action submitted for his or her approval or performed by virtue of his or her position; and (ii) all
other important information pertaining to these actions. The duty of loyalty includes a duty to (i) refrain from any conflict of interest
between the performance of his or her duties in the company and his or her personal affairs; (ii) refrain from any activity that is competitive
with the business of the company; (iii) refrain from exploiting any business opportunity of the company in order to receive a personal
gain for himself or herself or others; and (iv) disclose to the company any information or documents relating to the company’s affairs
which the office holder received as a result of his or her position as an office holder.
Disclosure of Personal Interests of an Office
Holder and Approval of Certain Transactions
The Companies Law requires that an office holder promptly disclose
to the board of directors any conflict of interest (referred to under the Companies Law as a “personal interest”) that he
or she may have and all related material information known to him or her concerning any existing or proposed transaction with the company.
If it is determined that an office holder has a personal interest in a transaction, approval by the board of directors is required for
the transaction, unless the company’s articles of association provide for a different method of approval. Our articles of association
provide that for non-extraordinary interested party transactions, the board of directors may delegate its approval, or may provide a general
approval to certain types of non-extraordinary interested party transactions. Every interested party transaction requires that our board
of directors determine affirmatively that the transaction is favorable to the company. Approval first by the company’s audit committee
and subsequently by the board of directors is required for an extraordinary transaction, meaning any transaction that is not in the ordinary
course of business, not on market terms or that is likely to have a material impact on the company’s profitability, assets or liabilities.
A director and any other office holder who has a personal interest in a transaction which is considered at a meeting of the board of directors
or the audit committee may generally (unless it is with respect to a transaction which is not an extraordinary transaction) not be present
at such a meeting or vote on that matter unless a majority of the directors or members of the audit committee, as applicable, have a personal
interest in the matter. If a majority of the members of the audit committee or the board of directors has a personal interest in the approval
of such a transaction then all of the directors may participate in deliberations of the audit committee or board of directors, as applicable,
with respect to such transaction and vote on the approval thereof and, in such case, shareholder approval is also required.
96
Pursuant to the Companies Law, extraordinary transactions with
our office holders who are not directors require audit committee approval and subsequent approval by our board of directors. Compensation,
insurance, indemnification or exculpation arrangements for office holders who are not directors require approval by our compensation committee,
followed by our board of directors and, if deviating from our compensation policy, our shareholders as well, via a special majority. Compensation
arrangements with directors, including in their capacities as executive officers, or with our Chief Executive Officer, as well as insurance
(unless exempted under the applicable regulations), indemnification or exculpation of directors or our Chief Executive Officer, require
the approval of the compensation committee, the board of directors and our shareholders, in that order. In the case of our Chief Executive
Officer, the shareholder approval must fulfill, in addition to an ordinary majority, one of the following two special majority requirements:
| ◾ |
at least a majority of the voting rights in the company held by non-controlling shareholders who have no conflict of interest (referred
to under the Companies Law as a “personal interest”) in the transaction or arrangement and who are present and voting (in
person or by proxy) at the general meeting, must be voted in favor of approving the transaction or arrangement (for this purpose, abstentions
are disregarded); or |
| ◾ |
the voting rights held by non-controlling, non-conflicted shareholders (as described in the previous bullet point) who are present
and voting (in person or by proxy) at the general meeting, and who vote against the transaction, do not exceed two percent of the voting
rights in the company. |
As described above (concerning votes related to external directors),
a shareholder is presumed to be a controlling shareholder if the shareholder holds 50% or more of the voting rights in the company or
has the right to appoint the majority of the directors of the company or its general manager (chief executive officer). In addition, as
it relates to the approval of related party transactions, a controlling shareholder is furthermore deemed to include any shareholder possessing
25% or more of the voting rights if no other shareholder possesses more than 50% of the voting rights.
If the transaction or compensation arrangement of the office holder
brought for approval amends an existing arrangement, then only the approval of the audit committee or compensation committee (as appropriate)
is required if that committee determines that the amendment is not material in relation to the existing arrangement.
Disclosure of Personal Interests of Controlling
Shareholders and Approval of Certain Transactions
Pursuant to the Companies Law, the disclosure requirements regarding
personal interests that apply to directors and executive officers also apply to a controlling shareholder of a public company. In the
case of an extraordinary transaction between a public company and a controlling shareholder, or in which a controlling shareholder has
a personal interest, the shareholder approval requirement—by a special majority—that applies to a compensation arrangement
for the chief executive officer (as described above) also applies to the extraordinary transaction (except that a controlling shareholder’s
vote is not excluded from the special majority determination, unless the controlling shareholder possesses a conflict of interest/ personal
interest). We currently do not have a controlling shareholder.
Shareholder Duties
Pursuant to the Companies Law, a shareholder has a duty to act
in good faith and in a customary manner toward the company and other shareholders and to refrain from abusing his, her or its power with
respect to the company, including, among other things, in voting at a general meeting and at shareholder class meetings with respect to
the following matters: (i) an amendment to the company’s articles of association; (ii) an increase of the company’s authorized
share capital; (iii) a merger; or (iv) an interested party transaction that requires shareholder approval.
In addition, a shareholder has a general duty to refrain from discriminating
against other shareholders. Certain shareholders also have a duty of fairness toward the company. These shareholders include any controlling
shareholder, any shareholder who knows that it has the power to determine the outcome of a shareholder vote and any shareholder who has
the power to appoint or to prevent the appointment of an office holder of the company or exercise any other rights available to it under
the company’s articles of association with respect to the company. The Companies Law does not define the substance of this duty
of fairness, except to state that the remedies generally available upon a breach of contract will also apply in the event of a breach
of the duty of fairness. Israeli courts have not yet interpreted the scope or nature of any of these duties.
Approval of Private Placements
Under the Companies Law, a significant private placement of securities
requires approval by the board of directors and the shareholders by a simple majority. A private placement is considered a significant
private placement if it results in a person becoming a controlling shareholder, or if all of the following conditions are met: (i) the
securities issued amount to 20% or more of the company’s outstanding voting rights before the issuance; (ii) some or all of the
consideration is other than cash or listed securities or the transaction is not on market terms; and (iii) the transaction will increase
the relative holdings of a shareholder who holds 5% or more of the company’s outstanding share capital or voting rights, or will
cause any person to become, as a result of the issuance, a holder of more than 5% of the company’s outstanding share capital or
voting rights.
97
Exculpation, Insurance and Indemnification
of Office Holders
Under the Companies Law, a company may not exculpate an office
holder from liability for a breach of the duty of loyalty. An Israeli company may exculpate an office holder in advance from liability
to the company, in whole or in part, for damages caused to the company as a result of a breach of duty of care but only if a provision
authorizing such exculpation is included in its articles of association. Our articles of association include such a provision. An Israeli
company may not exculpate a director from liability arising out of a prohibited dividend or distribution to shareholders.
An Israeli company may indemnify an office holder in respect of
the following liabilities and expenses incurred for acts performed as an office holder, either in advance of an event or following an
event, provided a provision authorizing such indemnification is contained in its articles of association:
| ◾ |
financial liability imposed on him or her in favor of another person pursuant to a judgment, settlement or arbitrator’s award
approved by a court. However, if an undertaking to indemnify an office holder with respect to such liability is provided in advance, then
such an undertaking must be limited to events which, in the opinion of the board of directors, can be foreseen based on the company’s
activities when the undertaking to indemnify is given, and to an amount or according to criteria determined by the board of directors
as reasonable under the circumstances, and such undertaking shall detail the abovementioned events and amount or criteria; |
| ◾ |
reasonable litigation expenses, including attorneys’ fees, incurred by the office holder as a result of an investigation or
proceeding instituted against him or her by an authority authorized to conduct such investigation or proceeding, provided that (i) no
indictment was filed against such office holder as a result of such investigation or proceeding; and (ii) no financial liability,
such as a criminal penalty, was imposed upon him or her as a substitute for the criminal proceeding as a result of such investigation
or proceeding or, if such financial liability was imposed, it was imposed with respect to an offense that does not require proof of criminal
intent; and |
| ◾ |
reasonable litigation expenses, including attorneys’ fees, incurred by the office holder or imposed by a court in proceedings
instituted against him or her by the company, on its behalf or by a third party or in connection with criminal proceedings in which the
office holder was acquitted or as a result of a conviction for an offense that does not require proof of criminal intent. |
An Israeli company may insure an office holder against the following
liabilities incurred for acts performed as an office holder if and to the extent provided in the company’s articles of association:
(i) a breach of the duty of loyalty to the company, to the extent that the office holder acted in good faith and had a reasonable basis
to believe that the act would not prejudice the company; (ii) a breach of the duty of care to the company or to a third party, including
a breach arising out of the negligent conduct of the office holder; (iii) a financial liability imposed on the office holder in favor
of a third party; (iv) a financial liability imposed on the office holder in favor of a third party harmed by a breach in an administrative
proceeding; and (v) reasonable litigation expenses, including attorneys’ fees, incurred by the office holder as a result of an administrative
proceeding instituted against him or her.
An Israeli company may not indemnify or insure an office holder
against any of the following: (i) a breach of the duty of loyalty, except to the extent that the office holder acted in good faith and
had a reasonable basis to believe that the act would not prejudice the company; (ii) a breach of the duty of care committed intentionally
or recklessly, excluding a breach arising out of the negligent conduct of the office holder; (iii) an act or omission committed with intent
to derive illegal personal benefit; or (iv) a fine or forfeit levied against the office holder.
Under the Companies Law, exculpation, indemnification and insurance
of office holders must be approved by the compensation and nominating committee and the board of directors and, with respect to directors
and our Chief Executive Officer, also by our shareholders (in the case of our Chief Executive Officer, by a special majority, as described
above under “—Approval of Related Party Transactions under Israeli Law—Disclosure of Personal Interests of an Officer
Holder and Approval of Certain Transactions”, unless an applicable exemption applies).
98
Our articles of association allow us to indemnify and insure our
office holders for any liability imposed on them as a consequence of an act which was performed by virtue of being an office holder. Our
shareholders have approved an amendment to our articles of association that extends such indemnification and insurance to cover omissions
by our office holders (in their role as such) as well. Our office holders are currently covered by a directors’ and officers’
insurance policy.
We have entered into agreements with each of our directors and
executive officers. Each such agreement exculpates our director or officer, to the fullest extent permitted by law, from liability to
us for damages caused to us as a result of a breach of duty of care and undertaking to indemnify them to the fullest extent permitted
by law. This indemnification is limited to events determined as foreseeable by the board of directors based on our activities, and to
an amount or according to criteria determined by the board of directors as reasonable under the circumstances.
The maximum indemnification amount set forth in such agreements
is limited to an amount equal to 25% of our shareholders’ equity as reflected in our most recent consolidated financial statements
prior to the date on which the indemnity payment is made. If the amount equal to 25% of our shareholders’ equity is insufficient
to cover all indemnity amounts payable with respect to all indemnifiable directors and executive officers, such amount will be allocated
among our directors and executive officers pro rata, in accordance with their relative culpabilities, as finally determined by a court
with respect to a particular claim. The maximum amount set forth in such agreements is in addition to any amount paid (if paid) under
insurance and/or by a third party pursuant to an indemnification arrangement. In the opinion of the SEC, indemnification of directors
and office holders for liabilities arising under the Securities Act is against public policy and therefore unenforceable.
D.
Employees
The total number of employees in Evogene and its
subsidiaries as of December 31, 2020, 2021 and 2022 was 130 ,141 and 137, respectively. As of December 31, 2022, our research and development
activities involved 92 employees amounting to approximately 67% of our total full-time workforce, of which 43 were employed by Evogene
and 49 were employed by our subsidiaries. Evogene used six (6) temporary employees during 2022. In 2022 our employees included members
with degrees in biology, chemistry, plant genetics, agronomics, mathematics, computer and data science and other related fields and 39
of our employees hold a Ph.D. As of March 20, 2023, the total number of employees in Evogene and its subsidiaries was 133.
The rate of male v. female in our company and our subsidiaries
as of December 31, 2022, was as follows:
|
Company |
Female |
Male |
Total |
|
Evogene |
53% |
47% |
75 |
|
AgPlenus |
66% |
34% |
12 |
|
Lavie Bio |
48% |
52% |
27 |
|
Canonic |
22% |
78% |
9 |
|
Biomica |
69% |
31% |
13 |
|
Casterra |
0% |
100% |
1 |
|
Total |
53% |
47% |
137 |
The rate of male v. female in a managing position (i.e., any such
person that oversees and supervises other employees) in our company and our subsidiaries as of December 31, 2022, was as follows:
|
Company |
Female |
Male |
|
|
Evogene |
53% |
47% |
|
|
AgPlenus |
80% |
20% |
|
|
Lavie Bio |
30% |
70% |
|
|
Canonic |
25% |
75% |
|
|
Biomica |
50% |
50% |
|
|
Casterra* |
N/A |
N/A |
* Casterra employs one employee who is managed by an Evogene manager.
99
As of the date hereof, all of our employees are based in Israel,
except for seven U.S.-based employees. Of our seven U.S.-based employees, six are employed by Lavie Bio Inc., a U.S. subsidiary of Lavie
Bio Ltd., the majority of whom are based at Lavie Bio’s U.S. research and development site in St. Louis, Missouri. In addition,
AgPlenus Ltd.’s CEO is located in North Carolina. In addition, during 2022, we had, on average, approximately 25 hourly employees
who are based in Israel. The following table shows the breakdown of our employees by division/category of activity and by location as
of December 31, 2020 ,2021 and 2022, excluding hourly employees:
|
As of December 31, 2020 |
As of December 31, 2021 |
As of December 31, 2022 |
||||||||||||||||||||||||||||||||||
|
Israel |
U.S. |
Total |
Israel |
U.S. |
Total |
Israel |
U.S. |
Total |
||||||||||||||||||||||||||||
|
Executive management |
4 |
- |
4 |
5 |
- |
5 |
6 |
- |
6 |
|||||||||||||||||||||||||||
|
Lavie Bio Ltd. |
28 |
- |
28 |
33 |
- |
33 |
25 |
- |
25 |
|||||||||||||||||||||||||||
|
AgPlenus Ltd. |
48 |
- |
48 |
41 |
- |
41 |
44 |
- |
44 |
|||||||||||||||||||||||||||
|
Ag-Seeds division |
2 |
- |
2 |
2 |
- |
2 |
- |
- |
- |
|||||||||||||||||||||||||||
|
Casterra Ag Ltd. |
17 |
5 |
22 |
17 |
7 |
24 |
21 |
6 |
27 |
|||||||||||||||||||||||||||
|
Biomica Ltd. |
11 |
1 |
12 |
11 |
1 |
12 |
11 |
1 |
12 |
|||||||||||||||||||||||||||
|
Canonic Ltd. |
1 |
- |
1 |
1 |
- |
1 |
1 |
- |
1 |
|||||||||||||||||||||||||||
|
Technology platform |
7 |
- |
7 |
13 |
- |
13 |
13 |
- |
13 |
|||||||||||||||||||||||||||
|
General and administrative |
6 |
- |
6 |
10 |
- |
10 |
9 |
- |
9 |
|||||||||||||||||||||||||||
|
Total |
124 |
6 |
130 |
133 |
8 |
141 |
130 |
7 |
137 |
|||||||||||||||||||||||||||
Israeli labor laws govern the length of the workday, minimum wages
for employees, procedures for hiring and dismissing employees, determination of severance pay, annual leave, sick days, advance notice
of termination of employment, equal opportunity and anti-discrimination laws and other conditions of employment. Subject to certain exceptions,
Israeli law generally requires severance pay upon the retirement, death or dismissal of an employee, and requires us and our employees
to make payments to the National Insurance Institute, which is similar to the U.S. Social Security Administration. Our employees have
pension plans that comply with the applicable Israeli legal requirements.
While none of our employees is party to any collective bargaining
agreements, certain provisions of the collective bargaining agreements between the “Histadrut”
(the General Union of Workers in Israel) and the Coordination Bureau of Economic Organizations (including the Industrialists’ Associations)
are applicable to our employees in Israel by order of the Israeli Ministry of the Economy and Industry. These provisions primarily concern
pension fund benefits for all employees, insurance for work-related accidents, recuperation pay and travel expenses.
None of our employees is represented by a labor union or covered
under a collective bargaining agreement. We have never experienced any employment-related work stoppages and believe our relationships
with our employees are good.
The employees of our U.S. subsidiaries are subject to the U.S.
labor laws and have insurance coverage, health benefits and are covered by certain plans, such as (i) medical and dental care; (ii) long
term disability protection plans; (iii) life insurance; and (iv) a 401(k) savings plan.
E.
Share Ownership
For information regarding the share ownership of our directors
and executive officers, please refer to the table in “Item 7. Major Shareholders and Related Party Transactions—A. Major
Shareholders.” For information regarding our equity incentive plans, see “Item 6.B. Director, Senior Management and Employees—Compensation—Equity
Incentive Plans.”
F. Disclosure
of a Registrant’s Action to Recover Erroneously Awarded Compensation
Not applicable.
| ITEM 7. |
MAJOR SHAREHOLDERS AND RELATED PARTY TRANSACTIONS |
A.
Major Shareholders
The following table sets forth information with
respect to the beneficial ownership of our shares as of March 20, 2023 (unless otherwise indicated) by: (i) each person or entity known
by us to own beneficially more than 5% of our outstanding shares; (ii) each of our directors and executive officers, and certain former
officers and directors, individually; and (iii) all of our executive officers and directors, and certain former officers and directors,
as a group.
100
The beneficial ownership of ordinary shares is determined in accordance
with the rules of the SEC, and generally includes any ordinary shares over which a person exercises sole or shared voting or investment
power, or the right to receive the economic benefit of ownership. For purposes of the table below, we deem shares subject to options that
are currently exercisable or exercisable within 60 days of March 20, 2023, to be outstanding and to be beneficially owned by the
person holding the options for the purposes of computing the percentage ownership of that person, but we do not treat them as outstanding
for the purpose of computing the percentage ownership of any other person.
The percentage of shares beneficially owned by any shareholder
has been calculated based on 41,616,303 ordinary shares outstanding as of March 20, 2023. Unless otherwise indicated below, to our
knowledge, all persons named in the table have sole voting and investment power with respect to their shares, except to the extent that
authority is shared by spouses under community property laws.
Unless otherwise noted below, each shareholder’s address
is c/o Evogene Ltd., 13 Gad Feinstein Street, Park Rehovot, Rehovot P.O. Box 4173, Ness Ziona, 7414002, Israel. The shareholders listed
below (including our directors and executive officers) do not have any different voting rights than any of our other shareholders. We
know of no arrangements that would, at a subsequent date, result in a change of control of our company. A description of any material
relationship that our principal shareholders have had with us or any of our predecessors or affiliates within the past year is included
under “Item 7. Major Shareholders and Related Party Transactions—B. Related Party Transactions.”
|
Shares Beneficially Held
|
||||||||
|
Name of Beneficial Owner |
Number
|
Percentage of Class
|
||||||
|
Principal Shareholders |
||||||||
|
Executive Officers and Directors |
||||||||
|
Mr. Ofer Haviv |
985,000 |
(1) |
2.3 |
% | ||||
|
Dr. Nir Arbel |
46,874 |
(2) |
* |
|||||
|
Mr. Lazer Bezdin |
0 |
(**) |
* |
|||||
|
Mr. Yaron Eldad |
37,500 |
(3) |
* |
|||||
|
Dr. Brian N. Ember |
0 |
* |
||||||
|
Dr. Elran Haber |
21,872 |
(4) |
* |
|||||
|
Dr. Arnon Heyman |
103,000 |
(5) |
* |
|||||
|
Mr. Mark Kapel |
190,255 |
(6) |
* |
|||||
|
Ms. Dorit Kreiner |
117,739 |
(7)(**) |
* |
|||||
|
Mr. Sassi Masliah |
145,000 |
(8) |
* |
|||||
|
Mr. Gur Oron |
0 |
(**) |
||||||
|
Mr. Eyal Ronen |
0 |
* |
||||||
|
Ms. Sarit Firon |
70,875 |
(9) |
* |
|||||
|
Mr. Dan Falk |
0 |
* |
||||||
|
Mr. Ziv Kop |
(**) |
* |
||||||
|
Mr. Nir Nimrodi |
25,000 |
(10) |
* |
|||||
|
Dr. Adrian Percy |
37,625 |
(11) |
* |
|||||
|
Mr. Leon Y. Recanati |
882,734 |
(12) |
2.1 |
% | ||||
|
Prof. Oded Shoseyov |
39,500 |
(13) |
* |
|||||
|
All directors and executive officers as a group (19 persons**) |
2,702,974 |
6.1 |
% | |||||
_______________________________
| * |
Less than 1%. |
| ** |
The engagement of each of Ms. Kreiner, Mr. Oron and Mr. Bezdin as executive officers and of Mr. Kop as a director ended during 2022.
Beneficial ownership information for such persons is based on our own internal records as of the date on which their engagement ended.
|
| (1) |
Consists of 985,000 ordinary shares issuable upon exercise of options that are currently exercisable or exercisable within 60 days
of March 20, 2023, of which options to purchase the following number of shares expire on the following dates, respectively: 215,000 on
July 17, 2023, 170,000 on March 22, 2025, 225,000 on August 8, 2027 and 375,000 on April 21, 2030. The weighted average exercise price
of these options is NIS 23.05 per ordinary share. |
| (2) |
Consists of 46,874 ordinary shares issuable upon exercise of options that are currently exercisable or exercisable within 60 days
of March 20, 2023, which expire on September 1, 2031. The per share exercise price of these options is NIS 9.17 per ordinary share.
|
| (3) |
Consists of 37,500 ordinary shares issuable upon exercise of options that are currently exercisable or exercisable within 60 days
of March 20, 2023, which expire on March 30, 2032. The exercise price of these options is NIS 4.09 per ordinary share. |
101
| (4) |
Consists of 21,872 ordinary shares of Evogene issuable upon exercise of options that are currently exercisable or exercisable within
60 days of March 20, 2023, which expire on September 1, 2031. The exercise price of these options is NIS 9.17 per ordinary share. Elran
Haber serves as the CEO of our subsidiary company Biomica, and as such, also holds options to purchase shares of Biomica. For a description
of our subsidiaries’ equity incentive plans, please see “Item 6. Directors, Senior Management and Employees—B. Compensation—Share
Option and Incentive Plans—Subsidiary Equity Incentive Plans”. |
| (5) |
Consists of 103,000 ordinary shares of Evogene issuable upon exercise of options that are currently exercisable or exercisable within
60 days of March 20, 2023, of which options to purchase the following number of shares expire on the following dates, respectively: 10,000
on November 9, 2024, 18,000 on May 18, 2026, 50,000 on August 8, 2027, and 25,000 on February 26, 2028. The weighted average exercise
price of these options is NIS 21.27 per ordinary share. Arnon Heyman served as the CEO, and currently serves as director, of our subsidiary
company Canonic, and as such, also holds options to purchase shares of Canonic. For a description of our subsidiaries’ equity incentive
plans, please see “Item 6. Directors, Senior Management and Employees—B. Compensation—Share Option and Incentive Plans—Subsidiary
Equity Incentive Plans”. |
| (6) |
Consists of 190,255 ordinary shares issuable upon exercise of options that are currently exercisable or exercisable within 60 days
of March 20, 2023, of which options to purchase the following number of shares expire on the following dates, respectively: 13,500 on
July 15, 2023, 12,000 on March 22, 2025, 23,200 on August 8, 2027, 60,000 on February 26, 2028, 30,000 on February 4, 2029, 32,805 on
July 30, 2029 and 18,750 on November 16, 2031. The weighted average exercise price of these options is NIS 15.35 per ordinary share.
|
| (7) |
Includes 116,239 ordinary shares issuable upon exercise of options
that are currently exercisable or exercisable within 60 days of March 20, 2023, which expire on March 31, 2023. The weighted average exercise
price of these options is NIS 6.45 per ordinary share. Also includes 1,500 ordinary shares held by a trustee in favor of Ms. Kreiner.
|
| (8) |
Includes 145,000 ordinary shares issuable upon exercise of options that are currently exercisable or exercisable within 60 days of
March 20, 2023, of which options to purchase the following number of shares expire on the following dates, respectively: 5,000 on July
15, 2023, 17,000 on March 22, 2025, 18,000 on August 8, 2027, 3,750 on May 28, 2028, 10,000 on February 4, 2029, 22,500 on July 30, 2029,
31,250 on September 22, 2030 and 37,500 on November 16, 2031. The weighted average exercise price of these options is NIS 13.44 per ordinary
share. |
| (9) |
Consists of 70,875 ordinary shares issuable upon exercise of options that are currently exercisable or exercisable within 60 days
of March 20, 2023, of which options to purchase the following number of shares expire on the following dates, respectively: 10,000 on
August 10, 2026, 2,500 on August 8, 2027,2,500 on August 6, 2028, 1,875 on September 23, 2029, 36,000 on September 1, 2031 and 18,000
on September 15, 2032. The weighted average exercise price of these options is NIS 10.57 per ordinary share. |
| (10) |
Consists of 25,000 ordinary shares issuable upon exercise of options that are currently exercisable or exercisable within 60 days
of March 20, 2023, which expire on April 20, 2030. The exercise price of these options is $1.10 per ordinary share. |
| (11) |
Consists of 37,625 ordinary shares issuable upon exercise of options that are currently exercisable or exercisable within 60 days
of March 20, 2023, of which options to purchase the following number of shares expire on the following dates, respectively: 10,000 on
December 23, 2028, 625 on February 1, 2030, 18,000 on August 10, 2031 and 9,000 on September 15, 2032. The weighted average exercise price
of these options is $2.38 per ordinary share. |
| (12) |
Includes 838,859 ordinary shares held by Mr. Recanati. Also includes 43,875 ordinary shares issuable upon exercise of options
that are currently exercisable or exercisable within 60 days of March 20, 2023, of which options to purchase the following number of shares
expire on the following dates, respectively: 2,500 on September 15, 2023, 2,500 on August 17, 2024, 2,500 on July 2, 2025, 2,500 on May
18, 2026, 2,500 on May 16, 2027, 2,500 on June 25, 2028, 1,875 on July 30, 2029, 18,000 on September 1, 2031 and 9,000 on
September 15, 2032. The weighted average exercise price of these options is NIS 16.29 per ordinary share. |
| (13) |
Consists of 39,500 ordinary shares issuable upon exercise of options that are currently exercisable or exercisable within 60 days
of March 20, 2023, of which options to purchase the following number of shares expire on the following dates, respectively: 10,000 on
November 13, 2028, 2,500 on December 19, 2029, 18,000 on September 1, 2031 and 9,000 on September 15, 2032. The exercise price of
these options is NIS 8.08 per ordinary share. |
Changes in Percentage Ownership by Major Shareholders
Over the course of 2022, there was a decrease in the percentage
ownership of a significant shareholder (which we define as a holder of at least 5% of our issued and outstanding share capital), ARK Investment
Management LLC, or ARK, (from 6.01% to 0%), based on Form 13F-HR as filed by ARK on January
24, 2023.
Over the course of 2021, there was a decrease in the percentage
ownership of a ARK (from 11.4% to 6.01%). In addition, over the course of 2021, based on publicly available information, we believe that
entities affiliated with Waddell Reed Financial, Inc. were acquired by Macquarie Group Ltd. or its affiliates. Macquarie Group
Ltd. filed with the SEC a Schedule 13G/A dated February 11, 2022 to report that it had decreased its ownership of our ordinary shares
and has ceased to be the beneficial owner of more than 5% of our ordinary shares. Waddell Reed Financial, Inc. and its affiliates
had previously reported on a Schedule 13G/A ownership of 6.8% of our issued and outstanding share capital.
102
Over the course of 2020, there were increases in the percentage
ownership of ARK (from below 5% to 11.4%). On the other hand, there were decreases in the percentage ownership of some of our former significant
shareholders, each of which fell below 5% beneficial ownership of our issued and outstanding share capital from the following ownership
percentage levels, including: (i) entities affiliated with Phoenix Holdings Ltd. (formerly 7.6%), (ii) entities affiliated with Senvest
Management, LLC, (formerly 8.5%), (iii) Monsanto Company (formerly 6.4%), (iii) entities affiliated with UBS Group AG (formerly 5.3%),
and (iv) Alpha Capital Anstalt (formerly 8.8%).
The information above regarding changes in percentage
ownership by major shareholders during the years ended December 31, 2020 through 2022 is based solely on information contained in Schedule
13Gs and Form 13F (as may be amended) as filed by such persons with the SEC.
Record Holders
As of March 20, 2023, all of our issued and outstanding ordinary
shares were held of record in the United States, in the name of a single record shareholder — Cede Co., as nominee for the
Depository Trust Company. The number of record holders is not representative of the number of beneficial holders of our ordinary shares,
nor is it representative of where such beneficial holders reside, since the shares held in the name of Cede Co. are listed for trading
on Nasdaq and the TASE and are beneficially owned by a wide range of underlying beneficial shareholders who hold their shares in “street
name,” including Israeli and other non-U.S. shareholders.
B.
Related Party Transactions
Except as described below or elsewhere in this annual report, since
January 1, 2022, we have had no transaction, nor do we have any presently proposed transaction, and neither we nor our subsidiaries have
had any loan, nor do we or our subsidiaries have any presently proposed loan, involving any related party described in Item 7.B. of this
annual report.
Agreements with Directors and Officers
Employment Agreements
We have entered into written employment agreements with all of
our executive officers. Each of these agreements contains provisions regarding non-competition, confidentiality of information and assignment
of inventions. The non-competition provision applies for a period that is generally 12 months following termination of employment. The
enforceability of covenants not to compete in Israel and in the United States is subject to limitations.
Equity Awards
See “Item 6. Directors, Senior Management and Employee—B. Compensation—Share
Option and Incentive Plans.”
Indemnification Agreements
Our articles of association allow us to indemnify and insure our
office holders for any liability imposed on them as a consequence of an act which was performed by virtue of being an office holder. They
also allow us to exculpate an office holder in advance from liability to the company, in whole or in part, for damages caused to the company
as a result of a breach of duty of care. In furtherance of such allowance, we have entered into agreements with each of our directors
and executive officers exculpating them, to the fullest extent permitted by law, from liability to us for damages caused to us as a result
of a breach of duty of care, and undertaking to indemnify them to the fullest extent permitted by law. See “Item 6. Directors, Senior
Management and Employees—C. Board Practices—Exculpation, Insurance and Indemnification of Office Holders.”
Agreement with a Close Family Member of Key Management Personnel
During 2022, we entered into an employment agreement with Mr. Almog
Haviv, son of our Chief Executive Officer. The engagement of Mr. Almog was made on an hourly basis, at a scope of approximately 30 hours
per week, for an hourly rate of approximately $15, which is customary for the position held by Mr. Almog Haviv.
103
C. Interests
of Experts and Counsel
Not applicable.
| ITEM 8. |
FINANCIAL INFORMATION |
A.
Consolidated Statements and Other Financial Information
Consolidated financial statements
We have appended our consolidated financial statements at the end
of this annual report, together with the report of our independent auditor on those financial statements, beginning on page F-2, as part
of this annual report.
Legal Proceedings
From time to time, we may be subject to legal proceedings and claims
in the ordinary course of business. We are currently not involved in any pending or contemplated legal proceedings that could reasonably
be expected to have a significant effect on our financial position, profitability or cash flows. We may become involved in material legal
proceedings in the future. Regardless of the outcome, litigation can have an adverse impact on us because of defense and settlement costs,
diversion of management resources and other factors.
Dividend Policy
Since our inception, we have not declared or paid any cash or other
form of dividends on our ordinary shares. We currently intend to retain any earnings for use in our business and do not currently intend
to pay cash dividends on our ordinary shares. Dividends, if any, on our outstanding ordinary shares will be declared by and subject to
the discretion of our board of directors. Even if our board of directors decides to distribute dividends, the form, frequency and amount
of such dividends will depend upon our future operations and earnings, capital requirements and surplus, general financial condition,
contractual restrictions and other factors our board of directors may deem relevant.
In addition, the distribution of dividends may be limited by Israeli
law, which permits the distribution of dividends only out of distributable profits. See “Dividend and Liquidation Rights”
in Exhibit 2.1 to this annual report.
B.
Significant Changes
No significant changes have occurred since December 31, 2022, except
as otherwise disclosed in this annual report.
| ITEM 9. |
THE OFFER AND LISTING |
A.
Offer and Listing Details
Our ordinary shares have been listed for trading on the TASE since
2007 and were listed for trading on the NYSE commencing with our U.S. initial public offering in November 2013 until December 2016, at
which point we transferred the listing to Nasdaq, where they have been listed from December 2016 to the present time. “EVGN”
has served as the trading symbol for each such listing.
B.
Plan of Distribution
Not applicable.
C. Markets
See “—A. Offer and Listing Details” above.
D.
Selling Shareholders
Not applicable.
104
E. Dilution
Not applicable.
F.
Expenses of the Issue
Not applicable.
| ITEM 10. |
ADDITIONAL INFORMATION |
A.
Share Capital
Not applicable.
B.
Memorandum and Articles of Association
For a discussion of the provisions of the company’s articles
of association with respect to the powers of directors, see “Item 6. Directors, Senior Management and Employees—C. Board Practices.”
A copy of our articles of association is attached as Exhibit 1.1 to this annual report. The information called for by this Item 10.B is
set forth in Exhibit 2.1 to this annual report and is incorporated by reference into this annual report.
C.
Material Contracts
The following is a summary of each material contract, other than
material contracts entered into in the ordinary course of business, to which we are or have been a party, for the two years immediately
preceding the date of this annual report:
Controlled Equity Offering Sales Agreements
On January 14, 2021 and February 19, 2021, we entered into Controlled
Equity OfferingSM Sales Agreements, or the January
Sales Agreement and February Sales Agreement, respectively, with Cantor Fitzgerald Co., or the Agent, pursuant to which the Company
could offer and sell, from time to time, its ordinary shares, through the Agent in an at-the-market offering, as defined in Rule 415(a)(4)
promulgated under the Securities Act, for aggregate offering price of up to $28.0 million and $50.0 million, respectively. In February
2021, we completed the sales of ordinary shares under the January Sales Agreement and subsequently entered into the February Sales Agreement.
We are not obligated to make any sales of ordinary shares under the February Sales Agreement and no assurance can be given that we will
sell any ordinary shares under such agreement, or, if we do, as to the price or number of such shares that we will sell, or the dates
on which any such sales will take place.
AgPlenus Collaboration Agreement with Corteva
In March 2020, AgPlenus entered into a collaboration agreement
with Corteva for the discovery and development of novel herbicides. Information on the collaboration is provided in this annual report
under “Item 4. Information on the Company— B. Business Overview— Market Segments— Ag-Business Market— AgPlenus
Ltd.— Key Collaborations— Corteva-Herbicides” and is incorporated by reference herein.
Lavie Bio Collaboration and SAFE with ICL
In August 2022, ICL and Lavie Bio entered a multi-year collaboration
agreement for developing novel bio-stimulant products to enrich fertilizer efficiency. As part of the collaboration, ICL invested (through
an affiliate company) in Lavie Bio $10 million under a SAFE (simple agreement for future equity). Information on that transaction is set
forth in this annual report under “Item 4. Information on the Company—B. Business Overview— Market Segments— Agriculture—
Lavie Bio Ltd.— Key Collaborations— ICL Group” and is incorporated by reference herein.
105
Biomica Share Purchase Agreement with SHC
In December, 2022, Biomica announced the signing of a definitive
agreement for a $20 million financing round, led by SHC, with $10 million of which to be invested by Evogene. Following the initial closing
of this transaction, Evogene will hold approximately 67% of the share capital of Biomica, while SHC will hold approximately 20%, in each
case on a fully diluted basis. Information on that transaction is set forth in this annual report under “Item 4. Information on
the Company— B. Business Overview— Market Segments— Human Health—Biomica Ltd.—Overview” and is incorporated
by reference herein.
Indemnification Agreements
We have entered into indemnification agreements with our office
holders. Information on the indemnification agreements may be found in this annual report under “Item 7. Major Shareholders and
Related Party Transactions—B. Related Party Transactions—Agreements with Directors and Officers—Indemnification Agreements,”
and is incorporated herein by reference.
Other Compensation Agreements
| ◾ |
Evogene Ltd. Officers Compensation Policy. See “Item 6. Directors, Senior Management and Employees” for more information
about this document. |
| ◾ |
Evogene Share Option Plan (2002). See “Item 6. Directors, Senior Management and Employees” for more information about
this document. |
| ◾ |
Evogene Ltd. Key Employee Share Incentive Plan, 2003. See “Item 6. Directors, Senior Management and Employees” for more
information about this document. |
| ◾ |
Evogene Ltd. 2013 Share Option Plan. See “Item 6. Directors, Senior Management and Employees” for more information about
this document. |
| ◾ |
Evogene 2021 Share Incentive Plan. See “Item 6. Directors, Senior Management and Employees” for more information about
this document. |
D.
Exchange Controls
Other than general anti-money laundering regulations, there are
currently no Israeli currency control regulations in effect that restrict our import or export of capital to or from the State of Israel,
or the availability of cash and cash equivalents for use by our affiliated companies. Under the Bank of Israel Law, 5770-2010, the Governor
of the Bank of Israel, with the approval of the monetary policy committee of the Bank of Israel, is authorized to issue an administrative
order restricting the transfer of funds to or from Israel. However, such an order is only likely to be issued under emergency circumstances
and only for a temporary period, if necessary for the achievement of the goals of the Bank of Israel or the carrying out of its responsibilities
under Israeli law. Furthermore, Israel has agreed, pursuant to international agreements to which it is a party (including incident to
Israel’s having joined the International Monetary Fund) to allow for the free flow of capital to and from within its borders. Certain
transactions nevertheless require the filing of reports with the Bank of Israel.
Similarly, there are no currently effective Israeli governmental
laws, decrees, regulations or other legislation that restrict the payment of dividends or other distributions with respect to our ordinary
shares or the proceeds from the sale of the shares, except for the obligation of Israeli residents to file reports with the Bank of Israel
regarding some transactions. However, legislation remains in effect under which currency controls can be imposed by administrative action
at any time.
E.
Taxation
Israel Income Tax Consequences
This section discusses the material Israeli income tax consequences
concerning the ownership and disposition of our ordinary shares by our non-Israeli shareholders. This summary does not discuss all the
aspects of Israeli tax law that may be relevant to a particular investor in light of his or her personal investment circumstances or to
some types of investors subject to special treatment under Israeli law. Examples of such investors include traders in securities who are
subject to special tax regimes not covered in this discussion. Because parts of this discussion are based on new tax legislation that
has not yet been subject to judicial or administrative interpretation, we cannot assure you that the appropriate tax authorities or the
courts will accept the views expressed in this discussion. The discussion below is subject to change, including due to amendments under
Israeli law or changes to the applicable judicial or administrative interpretations of Israeli law, which change could affect the tax
consequences described below.
106
Taxation of Our Non-Israeli Shareholders
Capital Gains Taxes Applicable
to Non-Israeli Resident Shareholders. A non-Israeli resident (whether individual or corporation) who derives capital gains from
the sale of shares in an Israeli resident company that were purchased after the company was listed for trading on a stock exchange outside
of Israel should generally be exempt from Israeli tax so long as the shares were not held through a permanent establishment that the non-resident
maintains in Israel and that such shareholder is not subject to the Israeli Income Tax Law (Inflationary Adjustments) 5745-1985. However,
non-Israeli corporations will not be entitled to the foregoing exemption if Israeli residents: (i) have a controlling interest of
more than 25% in such non-Israeli corporation or (ii) are the beneficiaries of, or are entitled to, 25% or more of the revenues or
profits of such non-Israeli corporation, whether directly or indirectly. Additionally, such exemption is not applicable to a person whose
gains from selling or otherwise disposing of the shares are deemed to be business income.
If not exempt, a non-Israeli resident shareholder would generally
be subject to tax on capital gain at the ordinary corporate tax rate (23% in 2022), if generated by a company, or at the rate of 25%,
if generated by an individual, or 30%, if generated by an individual who is a “substantial shareholder” (as defined under
the Israeli Tax Ordinance), at the time of sale or at any time during the preceding 12-month period (or if the shareholder claims a deduction
for interest and linkage differences expenses in connection with the purchase and holding of such shares). A “substantial shareholder”
is generally a person who alone or together with such person’s relative or another person who collaborates with such person on a
permanent basis, holds, directly or indirectly, at least 10% of any of the “means of control” of the corporation. “Means
of control” generally include, among others, the right to vote, receive profits, nominate a director or an executive officer, receive
assets upon liquidation, or order someone who holds any of the aforesaid rights how to act, regardless of the source of such right. Individual
and corporate shareholders dealing in securities in Israel are taxed at the tax rates applicable to business income (a corporate tax rate
for a corporation (23% in 2022) and a marginal tax rate of up to 47% for an individual in 2022 (excluding excess tax as discussed below))
unless contrary provisions in a relevant tax treaty apply.
Additionally, a sale of shares by a non-Israeli resident may be
exempt from Israeli capital gains tax under the provisions of an applicable tax treaty (subject to the receipt in advance of a valid certificate
from the Israel Tax Authority allowing for an exemption). For example, under the United States-Israel Tax Treaty, the disposition of shares
by a shareholder who is a United States resident (for purposes of the United States-Israel Tax Treaty) holding the shares as a capital
asset and is entitled to claim the benefits afforded to such person by the treaty, is generally exempt from Israeli capital gains
tax unless, among other things, (i) the capital gain arising from the disposition can be attributed to a permanent establishment of the
shareholder which is maintained in Israel; (ii) the shareholder holds, directly or indirectly, shares representing 10% or more of
the voting capital during any part of the 12-month period preceding such sale, exchange or disposition, subject to certain conditions;
or (iii) such U.S. resident is an individual and was present in Israel for a period or periods aggregating to 183 days or more during
the relevant taxable year. In each case, the sale, exchange or disposition of such shares would be subject to Israeli tax, to the extent
applicable; however, under the United States-Israel Tax Treaty, the United States resident would be permitted to claim a credit for the
Israeli tax against the United States federal income tax imposed with respect to the sale, exchange or disposition, subject to the limitations
in United States laws applicable to foreign tax credits. The United States-Israel Tax Treaty does not relate to U.S. state or local taxes.
In some instances, where our shareholders may be liable for Israeli
tax on the sale of their ordinary shares, the payment of the consideration may be subject to the withholding of Israeli tax at source.
Shareholders may be required to demonstrate that they are exempt from tax on their capital gains in order to avoid withholding at source
at the time of sale. Specifically, in transactions involving a sale of all of the shares of an Israeli resident company, in the form of
a merger or otherwise, the Israel Tax Authority may require from shareholders who are not liable for Israeli tax to sign declarations
in forms specified by this authority or obtain a specific exemption from the Israel Tax Authority to confirm their status as non-Israeli
resident, and, in the absence of such declarations or exemptions, may require the purchaser of the shares to withhold taxes at source.
Taxation of Non-Israeli Shareholders
on Receipt of Dividends. Non-Israeli residents (whether individuals or corporations) are generally subject to Israeli income tax
on the receipt of dividends paid on our ordinary shares at the rate of 25%. With respect to a person who is a “substantial shareholder”
(as defined above) at the time of receiving the dividend or on any time during the preceding twelve months, the applicable tax rate is
30%. “Means of control” generally include the right to vote, receive profits, nominate a director or an executive officer,
receive assets upon liquidation, or order someone who holds any of the aforesaid rights how to act, regardless of the source of such right.
Dividends paid on publicly traded shares, which are registered with and held by a nominee company, to non-Israeli residents are generally
subject to Israeli withholding tax at a rate of 25% (whether the recipient is a “substantial shareholder” or not), unless
a lower rate is provided under an applicable tax treaty between Israel and the shareholder’s country of residence and provided that
a certificate from the Israel Tax Authority allowing for a reduced withholding tax rate is obtained in advance.
107
In this regard, under the United States-Israel Tax Treaty and subject
to the eligibility to the benefits under this treaty, the maximum rate of tax withheld at source in Israel on dividends paid to a holder
of our ordinary shares who is a United States resident (for purposes of the United States-Israel Tax Treaty) is 25%. However, generally,
the maximum rate of withholding tax on dividends, not generated by an Approved Enterprise or a Beneficiary Enterprise (as such terms are
defined in the Encouragement Law), that are paid to a United States corporation holding at least 10% or more of our outstanding voting
capital throughout the tax year in which the dividend is distributed as well as during the previous tax year, is 12.5%, provided that
no more than 25% of our gross income for such preceding year consists of certain types of dividends and interest. Notwithstanding the
foregoing, dividends distributed from income attributed to an Approved Enterprise, or a Beneficiary Enterprise are not entitled to such
reduction under such tax treaty but are subject to withholding tax at the rate of 15% for such a United States corporate shareholder,
provided that the conditions related to the holding of 10% of our voting capital and to our gross income for the previous year (as set
forth in the previous sentence) are met. The aforementioned rates under the United States-Israel Tax Treaty would not apply if the
dividend income is derived through a permanent establishment of the U.S. resident which is maintained in Israel. We cannot assure you
that we will designate the profits that we may distribute in a way that will reduce shareholders’ tax liability. United States residents
who are subject to Israeli withholding tax on a dividend may be entitled to a credit or deduction for Untied States federal income tax
purposes in the amount of the taxes withheld, subject to detailed rules contained in United States tax legislation.
A non-Israeli resident who receives dividends from which tax was
withheld is generally exempt from the obligation to file tax returns in Israel with respect to such income, provided that (i) such
income was not derived from a business conducted in Israel by the taxpayer, (ii) the taxpayer has no other taxable sources of income
in Israel with respect to which a tax return is required to be filed, and (iii) in the case of individuals, the taxpayer is not obliged
to pay excess tax (as further explained below).
Excess Tax
Subject to the provisions of an applicable tax treaty, individuals
who are subject to tax in Israel (whether any such individual is an Israeli resident or non-Israeli resident) are also subject to an additional
tax at a rate of 3% on annual taxable income (including, but not limited to, dividends, interest and capital gain) exceeding a certain
threshold (NIS 663,240 for 2022), which amount is linked to the annual change in the Israeli consumer price index, including, but
not limited to, dividends, interest and capital gain.
United States Federal Income Taxation
The following is a description of the material United States
federal income tax consequences to U.S. Holders (as defined below) of the acquisition, ownership and disposition of our ordinary shares.
This description addresses only the United States federal income tax consequences to holders of our ordinary shares that hold such ordinary
shares as capital assets. This description does not address tax considerations applicable to holders that may be subject to special tax
rules, including, without limitation:
| ◾ |
banks, financial institutions or insurance companies; |
| ◾ |
real estate investment trusts, regulated investment companies or grantor trusts; |
| ◾ |
dealers or traders in securities, commodities or currencies; |
| ◾ |
tax-exempt entities; |
| ◾ |
certain former citizens or long-term residents of the United States; |
108
| ◾ |
persons that received our shares as compensation for the performance of services; |
| ◾ |
persons that will hold our shares as part of a “hedging,” “integrated” or “conversion” transaction
or as a position in a “straddle” for United States federal income tax purposes; |
| ◾ |
partnerships (including entities classified as partnerships for United States federal income tax purposes) or other pass-through
entities, or holders that will hold our shares through such an entity; |
| ◾ |
persons subject to special tax accounting rules as a result of any item of gross income with respect to the ordinary shares being
taken into account in an “applicable financial statement” pursuant to Section 451(b) of the Code; |
| ◾ |
U.S. Holders (as defined below) whose “functional currency” is not the U.S. dollar; or |
| ◾ |
holders that own directly, indirectly or through attribution 10.0% or more of the voting power or value of our shares. |
Moreover, this description does not address the United States federal
estate, gift or alternative minimum tax consequences, or any state, local or foreign tax consequences, of the acquisition, ownership and
disposition of our ordinary shares.
This description is based on the Code, existing, proposed and temporary
United States Treasury Regulations and judicial and administrative interpretations thereof, in each case as in effect and available on
the date hereof. Each of the foregoing is subject to change, which change could apply retroactively and could affect the tax consequences
described below. There can be no assurances that the U.S. Internal Revenue Service will not take a different position concerning the tax
consequences of the acquisition, ownership and disposition of our ordinary shares or that such a position would not be sustained.
For purposes of this description, a “U.S. Holder” is
a beneficial owner of our ordinary shares that, for United States federal income tax purposes, is:
| ◾ |
a citizen or resident of the United States; |
| ◾ |
a corporation (or other entity treated as a corporation for United States federal income tax purposes) created or organized in or
under the laws of the United States or any state thereof, including the District of Columbia; |
| ◾ |
an estate the income of which is subject to United States federal income taxation regardless of its source; or |
| ◾ |
a trust if such trust has validly elected to be treated as a United States person for United States federal income tax purposes or
if (1) a court within the United States is able to exercise primary supervision over its administration and (2) one or more
United States persons have the authority to control all of the substantial decisions of such trust. |
A “Non-U.S. Holder” is a beneficial owner of our ordinary
shares that is neither a U.S. Holder nor a partnership (or other entity treated as a partnership for United States federal income tax
purposes).
If a partnership (or any other entity treated as a partnership
for United States federal income tax purposes) holds our ordinary shares, the tax treatment of a partner in such partnership will generally
depend on the status of the partner and the activities of the partnership. Such a partner or partnership is encouraged to consult its
tax advisor as to its tax consequences.
You are encouraged to consult your advisor with
respect to the United States federal, state, local and foreign tax consequences of acquiring, owning and disposing of our ordinary shares.
Distributions
Subject to the discussion below under “Passive Foreign Investment Company Considerations,”
if you are a U.S. Holder, the gross amount of any distribution that we pay you with respect to our ordinary shares before reduction for
any Israeli taxes withheld therefrom generally will be includible in your income as dividend income to the extent such distribution is
paid out of our current or accumulated earnings and profits as determined under United States federal income tax principles. To the extent
that the amount of any cash distribution exceeds our current and accumulated earnings and profits as determined under United States federal
income tax principles, it will be treated first as a tax-free return of your adjusted tax basis in our ordinary shares and thereafter
as capital gain. We do not expect to maintain calculations of our earnings and profits under United States federal income tax principles.
Therefore, if you are a U.S. Holder you should expect that the entire amount of any cash distribution generally will be reported as dividend
income to you; provided, however, that distributions of ordinary shares to U.S. Holders that are part of a pro rata distribution to all
of our shareholders generally will not be subject to United States federal income tax. Subject to the PFIC rules discussed below, non-corporate
U.S. Holders may qualify for the lower rates of taxation with respect to dividends on ordinary shares applicable to long-term capital
gains (i.e., gains from the sale of capital assets held for more than one year), provided that
certain conditions are met, including certain holding period requirements and the absence of certain risk reduction transactions. Moreover,
such reduced rate shall not apply if we are a PFIC for the taxable year in which we pay a dividend, or were a PFIC for the preceding taxable
year. As discussed below, we believe we were classified as a PFIC for the year ended December 31, 2022. Dividends will not be eligible
for the dividends received deduction generally allowed to corporate U.S. Holders.
109
If you are a U.S. Holder, dividends that we pay you with respect
to our ordinary shares will be treated as foreign source income, which may be relevant in calculating your foreign tax credit limitation.
Subject to certain conditions and limitations, Israeli tax withheld on dividends may be deducted from your taxable income or credited
against your United States federal income tax liability. The limitation on foreign taxes eligible for credit is calculated separately
with respect to specific classes of income. For this purpose, dividends that we distribute generally should constitute “passive
category income.” A foreign tax credit for foreign taxes imposed on distributions may be denied if you do not satisfy certain minimum
holding period requirements. The rules relating to the determination of the foreign tax credit are complex, and you are encouraged to
consult your tax advisor to determine whether and to what extent you will be entitled to this credit.
Sale, Exchange or Other Disposition of Ordinary
Shares
Subject to the discussion below under “Passive Foreign Investment Company Considerations,”
if you are a U.S. Holder, you generally will recognize an amount of gain or loss on the sale, exchange or other disposition of our ordinary
shares equal to the difference between the amount realized on such sale, exchange or other disposition and your tax basis in our ordinary
shares, and such gain or loss will be capital gain or loss. The tax basis in an ordinary share generally will equal the cost of such ordinary
share. If you are a non-corporate U.S. Holder, capital gain from the sale, exchange or other disposition of ordinary shares generally
will be eligible for a preferential rate of taxation applicable to capital gains, if your holding period for such ordinary shares exceeds
one year. The deductibility of capital losses for United States federal income tax purposes is subject to limitations under the Code.
However, as discussed below, we believe we were classified as a PFIC for the year ended December 31, 2022, in which case special rules
may apply as explained below. Any such gain or loss that a U.S. Holder recognizes generally will be treated as U.S. source income or loss
for foreign tax credit limitation purposes.
Passive Foreign Investment Company Considerations
Based on certain estimates of our gross income and gross assets
and the nature of our business, we believe that we were classified as a PFIC for the taxable year ending December 31, 2022. As a
result, a U.S. Holder who held our ordinary shares at any time during 2022 would be subject to special rules generally intended to reduce
or eliminate any benefits from the deferral of U.S. federal income tax that a U.S. Holder could derive from investing in a non-U.S. company
that does not distribute all of its earnings on a current basis.
A non-U.S. corporation will be classified as a PFIC for federal
income tax purposes in any taxable year in which, after applying certain look-through rules, either:
| ◾ |
at least 75% of its gross income is “passive income”; or |
| ◾ |
at least 50% of the average quarterly value of its gross assets (which may be determined in part by the market value of our ordinary
shares, which is subject to change) is attributable to assets that produce “passive income” or are held for the production
of passive income. |
Passive income for this purpose generally includes dividends, interest,
royalties, rents, gains from commodities and securities transactions, the excess of gains over losses from the disposition of assets which
produce passive income, and includes amounts derived by reason of the temporary investment of funds raised in offerings of our ordinary
shares. If a non-U.S. corporation owns at least 25% by value of the stock of another corporation, the non-U.S. corporation is treated
for purposes of the PFIC tests as owning its proportionate share of the assets of the other corporation and as receiving directly its
proportionate share of the other corporation’s income. For publicly traded corporations, the PFIC asset test described above is
applied using the fair market value of the non-U.S. corporation’s assets. For purposes of a the PFIC asset test, a publicly traded
non-U.S. corporation may treat the aggregate fair market value of its assets as being equal to the sum of its Market Capitalization and
the total amount of its liabilities. We intend to take the position that the excess of our Market Capitalization plus liabilities over
the book value of all of our assets may generally be treated as attributable to non-passive asset. If we are classified as a PFIC in any
year with respect to which a U.S. Holder owns our ordinary shares, we will continue to be treated as a PFIC with respect to such U.S.
Holder in all succeeding years during which the U.S. Holder owns our ordinary shares, regardless of whether we continue to meet the tests
described above.
110
Based on the book value of our assets and liabilities and our Market
Capitalization in 2022, we believe that we met the PFIC asset test described above for 2022 and, as a result, we were classified as a
PFIC in 2022. Furthermore, because we currently hold, and expect to continue to hold, a substantial amount of cash and cash equivalents
and other passive assets used in our business, and because our Market Capitalization is currently below the level necessary to avoid PFIC
status for 2022, there is substantial risk we will be classified as a PFIC for the 2022 taxable year as well. However, because PFIC status
is based on our income, assets and activities for the entire taxable year, and our Market Capitalization, it is not possible to determine
whether we will be characterized as a PFIC for the 2022 taxable year until after the close of the year. Moreover, we must determine our
PFIC status annually after the close of each taxable year based on tests which are factual in nature, and our status in future years will
depend on our income, assets, activities and Market Capitalization in those years. Thus, there can be no assurance that we will not be
considered a PFIC for the current taxable year or any future taxable year.
If we are a PFIC for any taxable year during which a U.S. Holder
owns ordinary shares, we will generally continue to be treated as a PFIC with respect to such U.S. Holder for all succeeding years during
which such U.S. Holder owns such ordinary shares, unless we cease to be a PFIC and the U.S. Holder makes a “deemed sale” election
with respect to such ordinary shares. If such election is made, the U.S. Holder will be deemed to have sold the ordinary shares it holds
at their fair market value and any gain from the deemed sale would be subject to the rules described in the following paragraph. After
the deemed sale election, so long as we do not become a PFIC in a subsequent taxable year, the ordinary shares with respect to which such
election was made will not be treated as shares in a PFIC and will not be subject to the rules described below with respect to any “excess
distribution” the U.S. Holder receives from us or any gain from an actual sale or other disposition of such ordinary shares. U.S.
Holders are strongly urged to consult their tax advisors as to the possibility and consequences of making a deemed sale election if we
were to become and then cease to be a PFIC, and such election becomes available.
If you are a U.S. Holder that owns our ordinary shares during 2020
or any other taxable year for which we are a PFIC, then unless you make one of the elections described below, a special tax regime will
apply to both (a) any “excess distribution” by us to you (generally, your ratable portion of distributions in any year
which are greater than 125% of the average annual distribution received by you in the shorter of the three preceding years or your holding
period for our ordinary shares) and (b) any gain realized on the sale or other disposition of the ordinary shares. Under this regime,
any excess distribution and realized gain will be treated as ordinary income (even if you hold the ordinary shares as capital assets)
and will be subject to tax as if (a) the excess distribution or gain had been realized ratably over your holding period, (b) the
amount deemed realized in each year had been subject to tax in each year of that holding period at the highest marginal rate for such
year (other than income allocated to the current period or any taxable period before we became a PFIC, which would be subject to tax at
the U.S. Holder’s regular ordinary income rate for the current year and would not be subject to the interest change discussed below),
and (c) the interest charge generally applicable to underpayments of tax had been imposed on the taxes deemed to have been payable
in those years. The tax liability for amounts allocated to years prior to the year of disposition or excess distribution cannot be offset
by any net operating losses for such years.
If we are a PFIC for any taxable year during which a U.S. Holder
holds our ordinary shares, then in lieu of being subject to the tax and interest charge rules discussed above, a U.S. Holder may make
an election to include gain on the stock of a PFIC as ordinary income under a mark-to-market method, provided that such ordinary shares
are “regularly traded” on a “qualified exchange.” In general, our ordinary shares will be treated as “regularly
traded” for a given calendar year if more than a de minimis quantity of our ordinary shares
are traded on a qualified exchange on at least 15 days during each calendar quarter of such calendar year. Our ordinary shares are listed,
and we expect them to continue to be listed for the foreseeable future, on the New York Stock Exchange, which is a qualifying exchange
for this purpose. However, no assurance can be given that our ordinary shares will continue to be regularly traded on a “qualified
exchange” for purposes of the mark-to-market election. In addition, because a mark-to-market election cannot be made for any lower-tier
PFICs that we may own, a U.S. Holder may continue to be subject to the PFIC rules discussed above with respect to such holder’s
indirect interest in any investments we hold that are treated as an equity interest in a PFIC for United States federal income tax purposes.
111
If a U.S. Holder makes an effective mark-to-market election, in
each year that we are a PFIC, such U.S. Holder will include in each year that we are a PFIC as ordinary income the excess of the fair
market value of such U.S. Holder’s ordinary shares at the end of the year over such U.S. Holder’s adjusted tax basis in the
shares. Such U.S. Holder will be entitled to deduct as an ordinary loss in each such year the excess of such U.S. Holder’s adjusted
tax basis in the ordinary shares over their fair market value at the end of the year, but only to the extent of the net amount previously
included in income as a result of the mark-to-market election. If a U.S. Holder makes an effective mark-to-market election, in each year
that we are a PFIC, any gain such U.S. Holder recognizes upon the sale or other disposition of such U.S. Holder’s ordinary shares
will be treated as ordinary income and any loss will be treated as ordinary loss, but only to the extent of the net amount of previously
included income as a result of the mark-to-market election.
A U.S. Holder’s adjusted tax basis in the ordinary shares
will be increased by the amount of any income inclusion and decreased by the amount of any deductions under the mark-to-market rules discussed
above. If a U.S. Holder makes an effective mark-to-market election, it will be effective for the taxable year for which the election is
made and all subsequent taxable years unless the ordinary shares are no longer regularly traded on a qualified exchange or the IRS consents
to the revocation of the election. U.S. Holders are encouraged to consult their tax advisers about the availability of the mark-to-market
election, and whether making the election would be advisable in their particular circumstances.
In certain circumstances, a U.S. equity holder in a PFIC may avoid
the adverse tax and interest-charge regime described above by making a “qualified electing fund” election to include in income
its share of the corporation’s income on a current basis. However, a U.S. Holder may make a qualified electing fund election with
respect to the ordinary shares only if we agree to furnish you annually with a PFIC annual information statement as specified in the applicable
Treasury regulations.
We do not intend to provide the information necessary for U.S.
Holders to make qualified electing fund elections if we are classified as a PFIC. U.S. Holders are encouraged to consult their tax advisors
to determine whether any of these elections would be available and if so, what the consequences of the alternative treatments would be
in their particular circumstances.
If we are determined to be a PFIC for any year in which a U.S.
Holder holds our ordinary shares, the general tax treatment for the U.S. Holder described in this paragraph would apply to indirect distributions
and gains deemed to be realized by the U.S. Holders in respect of any of our subsidiaries that also may be determined to be PFICs.
If a U.S. Holder owns ordinary shares during any year in which
we are a PFIC and the U.S. Holder recognizes gain on a disposition of our ordinary shares or receives distributions with respect to our
ordinary shares, the U.S. Holder generally will be required to file an IRS Form 8621 with respect to the company, generally with the U.S.
Holder’s federal income tax return for that year. If our company were a PFIC for a given taxable year, then you are encouraged to
consult your tax advisor concerning your annual filing requirements.
U.S. Holders are strongly encouraged to consult
their tax advisors regarding the consequences of our classification as a PFIC for our 2022 taxable year, our potential classification
as a PFIC in 2023 and future taxable years, and the application of the PFIC rules on their investment.
Backup Withholding Tax and Information Reporting
Requirements
United States backup withholding tax and information reporting
requirements may apply to certain payments to certain holders of stock. Information reporting generally will apply to payments of dividends
on, and to proceeds from the sale or redemption of, our ordinary shares made within the United States, or by a United States payor or
United States middleman, to a holder of our ordinary shares, other than an exempt recipient (including a payee that is not a United States
person that provides an appropriate certification and certain other persons). A payor will be required to withhold backup withholding
tax from any payments of dividends on, or the proceeds from the sale or redemption of, ordinary shares within the United States, or by
a United States payor or United States middleman, to a holder, other than an exempt recipient, if such holder fails to furnish its correct
taxpayer identification number or otherwise fails to comply with, or establish an exemption from, such backup withholding tax requirements.
Any amounts withheld under the backup withholding rules will be allowed as a credit against the beneficial owner’s United States
federal income tax liability, if any, and any excess amounts withheld under the backup withholding rules may be refunded, provided that
the required information is timely furnished to the Internal Revenue Service.
112
Foreign Asset Reporting
Certain U.S. Holders who are individuals are required to report
information relating to an interest in our ordinary shares, subject to certain exceptions (including an exception for shares held in accounts
maintained by financial institutions). U.S. Holders are encouraged to consult their tax advisors regarding their information reporting
obligations, if any, with respect to their ownership and disposition of our ordinary shares.
Medicare Tax
Certain U.S. Holders that are individuals, estates or trusts are
subject to a 3.8% tax on all or a portion of their “net investment income,” which may include all or a portion of their dividend
income and net gains from the disposition of ordinary shares. Each U.S. Holder that is an individual, estate or trust is encouraged to
consult its tax advisors regarding the applicability of the Medicare tax to its income and gains in respect of its investment in the ordinary
shares.
The above description is not intended to constitute
a complete analysis of all tax consequences relating to acquisition, ownership and disposition of our ordinary shares. You are encouraged
to consult your tax advisor concerning the tax consequences of your particular situation.
F.
Dividends and Paying Agents
Not applicable.
G.
Statement by Experts
Not applicable.
H. Documents
on Display
We are currently subject to the informational requirements of the
Exchange Act applicable to foreign private issuers and fulfill the obligations of these requirements by filing reports with the SEC. As
a foreign private issuer, we are exempt from the rules under the Exchange Act relating to the furnishing and content of proxy statements,
and our officers, directors and principal shareholders are exempt from the reporting and short-swing profit recovery provisions contained
in Section 16 of the Exchange Act. In addition, we are not required under the Exchange Act to file periodic reports and financial statements
with the SEC as frequently or as promptly as U.S. companies whose securities are registered under the Exchange Act. However, we intend
to file with the SEC, within 120 days after the end of each subsequent fiscal year, an annual report on Form 20-F containing financial
statements which will be examined and reported on, with an opinion expressed, by an independent public accounting firm. We also intend
to furnish to the SEC reports of foreign private issuer on Form 6-K containing unaudited quarterly financial information.
The SEC maintains an Internet website at http://www.sec.gov that
contains reports, including this annual report and the documents referred to herein, proxy statements, information statements and other
material that are filed through the SEC’s Electronic Data Gathering, Analysis and Retrieval, or “EDGAR” system.
We also file annual and special reports and other information with
the Israeli Securities Authority through its fair disclosure electronic system called MAGNA. You may review these filings on the website
of the MAGNA system operated by the Israeli Securities Authority at www.magna.isa.gov.il or on the website of the TASE at www.tase.co.il.
Our ordinary shares are quoted on the TASE and, since December
2016, on Nasdaq (after being listed on the NYSE from November 2013 until December 2016). Information about us is also available on our
website at http://www.evogene.com. Our website and the information contained therein or connected thereto will not be deemed to be incorporated
into this annual report and you should not rely on any such information in making your decision whether to purchase our ordinary shares.
113
I.
Subsidiary Information
Not applicable.
J. Annual
Report to Security Holders
Not applicable.
| ITEM 11. |
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK |
We are exposed to market risk from changes in exchange
rates, interest rates and inflation. We therefore continue to closely monitor the macro-economic conditions that result therefrom. We
regularly assess the implications of these global conditions on our operations, liquidity, cash flow and product candidates and seek to
act to mitigate any adverse consequences, to the extent possible, in a commercially reasonable manner, if and when applicable. For a sensitivity
analysis of our exposure to foreign currency exchange fluctuations and changes in market prices of listed securities, see Note 14d to
our consolidated financial statements as of, and for the year ended, December 31, 2022 included elsewhere in this annual report.
Foreign Currency Risk
A significant portion of our expenses is denominated
in currencies other than the U.S. dollar. We are therefore subject to non-U.S. currency risks and non-U.S. exchange exposure, especially
the NIS. A significant portion of our operating costs are in Israel, consisting principally of salaries and related personnel expenses,
and facility expenses, which are denominated in NIS. This foreign currency exposure gives rise to market risk associated with exchange
rate movements of the U.S. dollar against the NIS and other currencies. Furthermore, we anticipate that a significant portion of our expenses
will continue to be denominated in NIS. We do not hedge against currency risk through the use of forward currency contracts or other financial
instruments. See “Risk factors— Risks Relating to Our Incorporation and Location in Israel-Exchange
rate fluctuations between the U.S. dollar and the NIS may negatively affect our financial results.” Exchange rates can be volatile
and a substantial change of foreign currencies against the U.S. dollar could increase or reduce the Company’s expenses and net loss
and impact the comparability of results from period to period.
Most of our revenues are denominated in U.S. dollars. By contrast,
we incur expenses primarily denominated in NIS. As a result, any appreciation of the NIS relative to the U.S. dollar adversely impacts
our profitability due to the portion of our expenses that are incurred in NIS. As of December 31, 2022, we did not have any open forward
currency contracts. In the future we may enter into hedging transactions in order to decrease our foreign currency risk; however, these
transactions may not fully protect us from such risk.
The following table presents information about the changes in the
exchange rate of the NIS against the U.S. dollar:
|
Period |
Depreciation (Appreciation) of the U.S. dollar against the NIS (%) Based on
Average of Daily Exchange Rates Throughout Year Compared to Previous Year |
|
|
2022 |
4.0 | |
|
2021 |
(6.0) | |
|
2020 |
(7.0) | |
|
2019 |
(7.7) | |
|
2018 |
(0.1) |
Our exposure related to exchange rate changes on our net asset
position denominated in currencies other than U.S. dollars varies with changes in our net asset position. Net asset position refers to
financial assets, such as trade receivables and cash and cash deposits, less financial liabilities, such as trade payable and other payables.
The impact of any such transaction gains or losses is reflected in financing expenses or income. Our most significant exposure relates
to a potential change in the U.S. dollar-NIS exchange rates. Assuming a 10% increase in the U.S. dollar relative to the NIS, and assuming
no other change, our financing expenses would have increased by approximately $0.1 million in 2022, increased by $1.3 million in
2021 and increased by $1.0 million in 2020 due to our positive current net asset position denominated in NIS as of December 31, 2022,
2021 and 2020. As of December 31, 2022, we did not have any hedge arrangements in place to protect our exposure to foreign currency risk.
Commodity Price Risk
Changes in commodity prices in the agriculture markets may affect
our reported operating results and cash flows in view of our activity in the agriculture segment. For example, a decrease in the prices
of corn and soy grains may adversely impact the budget for, and size of, research and development expenditures of our existing and potential
collaborators and, in turn, our ability to continue or extend existing collaborations or enter into new ones. Further, the royalties we
may receive from our collaborators on the sales and transfers of seeds containing the traits
we develop could be affected by fluctuations in seed commodity prices. As of December 31, 2022, we did not have any hedge arrangements
in place to protect our exposure to commodity price fluctuations.
114
Interest rate risk
From time to time, we hold corporate bonds and
government treasury notes denominated in NIS and in U.S. dollars. These investments expose us to the risk of interest rate fluctuations.
A decrease in Israeli or in U.S. interest rates could cause the fair value of these investments to decrease.
Impact of inflation
While it is difficult to accurately measure the impact of inflation
due to the imprecise nature of the estimates required, we do not believe inflation has had a material effect on our historical results
of operations and financial condition. However, if our costs were to become subject to significant inflationary pressures, we will not
be able to fully offset higher costs through price increases or other corrective measures due to our lack of a commercialized product
in the market, and it could adversely affect our business, financial condition and results of operations.
| ITEM 12. |
DESCRIPTION OF SECURITIES OTHER THAN EQUITY SECURITIES |
Not applicable.
PART II
| ITEM 13. |
DEFAULTS, DIVIDEND ARREARAGES AND DELINQUENCIES |
None.
| ITEM 14. |
MATERIAL MODIFICATIONS TO THE RIGHTS OF SECURITY HOLDERS AND USE OF PROCEEDS |
None.
| ITEM 15. |
CONTROLS AND PROCEDURES |
| (a) |
Disclosure Controls and Procedures |
Our management, including our Chief Executive Officer and Chief
Financial Officer, has evaluated the effectiveness of our disclosure controls and procedures (as such term is defined in Rules 13a-15(e)
and 15d-15(e) under the Exchange Act) as of December 31, 2022. Our management recognizes that any controls and procedures, no matter how
well designed and operated, can provide only reasonable assurance of achieving their objectives and our management necessarily applies
its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on this evaluation, our Chief Executive
Officer and Chief Financial Officer concluded that our disclosure controls and procedures were effective as of December 31, 2022, to provide
reasonable assurance that the information required to be disclosed in filings and submissions under the Exchange Act, is recorded, processed,
summarized and reported within the time periods specified by the SEC’s rules and forms, and that such information related to us
and our consolidated subsidiaries is accumulated and communicated to management, including the Chief Executive Officer and Chief Financial
Officer, as appropriate to allow timely decisions about required disclosure.
115
| (b) |
Management’s Annual Report on Internal Control Over Financial Reporting |
Our management is responsible for establishing and maintaining
adequate internal control over financial reporting, as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act. Our 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.
Our management recognizes that there are inherent limitations in
the effectiveness of any system of internal control over financial reporting, including the possibility of human error and the circumvention
or override of internal control. Accordingly, even effective internal control over financial reporting can provide only reasonable assurance
with respect to financial statement preparation and may not prevent or detect all misstatements. Further, because of changes in conditions,
the effectiveness of internal control over financial reporting may vary over time.
Our management assessed the effectiveness of our internal control
over financial reporting as of December 31, 2022. In conducting its assessment of internal control over financial reporting, management
used the framework and criteria established in Internal Control – Integrated Framework (2013) issued by the Committee of Sponsoring
Organizations of the Treadway Commission (COSO) as of the end of the period covered by this report. Based on that evaluation, our management
has concluded that our internal control over financial reporting was effective as of December 31, 2022.
| (c) |
Attestation Report of Registered Public Accounting Firm |
We are neither an
accelerated filer nor a large accelerated filer as defined in Rule 12b-2 under the Securities Exchange Act of 1934, as amended. Therefore,
we are not required under Section 202 of the Sarbanes-Oxley
Act (and the SEC rules and regulations thereunder) to provide an attestation report on management’s assessment of our internal control
over financial reporting from a registered public accounting firm in this annual report.
| (d) |
Changes in internal control over financial reporting |
During the period covered by this annual report, no changes in
our internal control over financial reporting (as such term is defined in Rules 13a-15(f) and 15d-15(f) promulgated under the Exchange
Act), have occurred that have materially affected, or are reasonably likely to materially affect, our internal control over financial
reporting.
| ITEM 16. |
[RESERVED] |
| ITEM 16A. |
AUDIT COMMITTEE FINANCIAL EXPERT |
Our board of directors has determined that each of Mr. Dan Falk
and Mr. Ziv Kop qualifies as an audit committee financial expert, as defined by the rules of the SEC, and has the requisite financial
experience required by the Nasdaq Listing Rules. In addition, each of Mr. Falk and Mr. Kop is independent, as such term is defined in
Rule 10A-3(b)(1) under the Exchange Act and under the Nasdaq Listing Rules.
| ITEM 16B. |
CODE OF ETHICS |
We have adopted a Code of Ethics and Proper Business Conduct applicable
to our executive officers, directors and all other employees, which is a “code of ethics” as defined in this Item 16B of Form
20-F promulgated by the SEC. We have also implemented a training program for new and existing employees concerning our Code of Ethics
and Proper Business Conduct. A copy of the code is delivered to every employee of Evogene Ltd. and all of its subsidiaries, and is available
to investors and others, without charge, on our website at http://www.evogene.com/investor-relations/corporate-governance/ or by contacting
our investor relations department. Information contained on, or that can be accessed through, our website does not constitute a part of
this Form 20-F and is not incorporated by reference herein. Under Item 16B of Form 20-F, if a waiver or amendment of the Code
of Business Conduct and Ethics applies to our principal executive officer, principal financial officer, principal accounting officer,
controller or other persons performing similar functions and relates to standards promoting any of the values described in Item 16B(b)
of Form 20-F, we will disclose such waiver or amendment on our website within four business days following the date of amendment
or waiver in accordance with the requirements of the Nasdaq listing rules and Instruction 4 to such Item 16B. We granted no
waivers under our Code of Ethics and Proper Business Conduct in 2022. We also intend to disclose any amendments to, or waivers of, the
Code of Ethics and Proper Business Conduct applicable to our directors or executive officers on our website.
116
| ITEM 16C. |
PRINCIPAL ACCOUNTANT FEES AND SERVICES |
Principal Accountant Fees and Services.
We paid or accrued the following fees for professional
services rendered by Kost, Forer, Gabbay Kasierer, a member of Ernst Young Global and an independent registered public accounting
firm, for the fiscal years ended December 31, 2021 and 2022:
|
2021 |
2022 |
|||||||
|
Audit Fees |
$ |
260,000 |
$ |
190,000 |
||||
|
Audit-Related Fees |
- |
- |
||||||
|
Tax Fees |
25,000 |
20,000 |
||||||
|
All Other Fees |
-
|
-
|
||||||
|
Total |
$ |
285,000 |
$ |
210,000 |
||||
“Audit Fees” are the aggregate fees billed for the
audit of our annual financial statements. This category also includes services that generally the independent accountant provides, such
as consents and assistance with and review of documents filed with the SEC.
“Tax fees” include fees for professional services rendered
by our auditors for tax compliance and tax consulting in connection with international transfer pricing.
Our audit committee has adopted a pre-approval policy for the engagement of our independent
accountant to perform certain audit and non-audit services. Pursuant to this policy, which is designed to assure that such engagements
do not impair the independence of our auditors, the audit committee pre-approves annually any specific audit and non-audit services, audit-related
services and tax services that may be performed by our independent accountants. Pursuant to that policy, our audit committee pre-approved
all fees paid to our auditors for the year ended December 31, 2022.
| ITEM 16D. |
EXEMPTIONS FROM THE LISTING STANDARDS FOR AUDIT COMMITTEES |
Not applicable.
| ITEM 16E. |
PURCHASES OF EQUITY SECURITIES BY THE ISSUER AND AFFILIATED PURCHASERS |
Not applicable.
| ITEM 16F. |
CHANGE IN REGISTRANT’S CERTIFYING ACCOUNTANT |
Not applicable.
| ITEM 16G. |
CORPORATE GOVERNANCE |
Except as otherwise indicated, we are in compliance with corporate
governance standards as currently applicable to us under Israeli, U.S., SEC and Nasdaq laws, rules and/or regulations, as applicable.
Under the Nasdaq Listing Rules, as a foreign private issuer (as such term is defined in Rule 3b-4 under the Securities Exchange Act of
1934, as amended), we may elect to follow certain corporate governance practices permitted under the Companies Law in lieu of compliance
with corresponding corporate governance requirements otherwise imposed by the Nasdaq Listing Rules for U.S. domestic issuers. We currently
follow the provisions of the Companies Law, rather than the Nasdaq Listing Rules, solely with respect to the following requirements:
| ◾ |
Quorum. As permitted under the Companies Law, pursuant to our articles of association, the
quorum required for an ordinary meeting of shareholders consists of at least two shareholders present in person, by proxy or by other
voting instrument in accordance with the Companies Law, who hold at least 25% of the voting power of our shares (and in an adjourned meeting,
with some exceptions, at least two shareholders), instead of 33 1/3% of the issued share capital, as required under the Nasdaq Listing
Rules. |
| ◾ |
Executive sessions of independent directors. Israeli law does not require executive sessions
of independent directors. Although all of our current directors are “independent directors” under the applicable Nasdaq criteria,
we do not intend to comply with this requirement if we have directors who are not independent. |
117
| ◾ |
Shareholder approval. We seek shareholder approval for all corporate actions requiring such
approval under the Companies Law, which include (i) transactions with directors concerning the terms of their service or indemnification,
exemption and insurance for their service (or for any other position that they may hold at our company), (ii) transactions concerning
the compensation, indemnification, exculpation and insurance of the chief executive officer; (iii) the compensation policy recommended
by the compensation committee of our board of directors and approved by our board of directors (and any amendments thereto); (iv) extraordinary
transactions with, and the terms of employment or other engagement of, a controlling shareholder (if and when this becomes relevant to
our company), (v) amendments to our articles of association, and (vi) certain non-public issuances of securities. In addition,
under the Companies Law, a merger requires approval of the shareholders of each of the merging companies. We are not required, however,
to seek shareholder approval for any of the following events described in the Nasdaq Listing Rules: |
| ◾ |
certain issuances of shares in excess of 20% of the outstanding shares of the Company; |
| ◾ |
an issuance that will result in a change of control of our company; and |
| ◾ |
adoption of, or material changes to, our equity compensation plans. |
| ITEM 16H. |
MINE SAFETY DISCLOSURE |
Not applicable.
| ITEM 16I. |
DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS |
Not applicable
PART III
| ITEM 17. |
FINANCIAL STATEMENTS |
We have provided financial statements pursuant to Item 18.
| ITEM 18. |
FINANCIAL STATEMENTS |
The audited consolidated financial statements as required under
Item 18 are attached hereto starting on page F-2 of this annual report. The audit report of Kost Forer Gabbay Kasierer, a member
of Ernst Young Global, an independent registered public accounting firm, is included herein preceding the audited consolidated financial
statements.
118
| ITEM 19. |
EXHIBITS |
|
ANNUAL REPORT ON FORM 20-F
INDEX OF EXHIBITS
| |
|
Exhibit No.
|
Description
|
|
101 |
The following financial information
from Evogene Ltd.’s Annual Report on Form 20-F for the year ended December 31, 2022 formatted in inline XBRL (eXtensible Business
Reporting Language): (i) Consolidated Statements of Financial Position at December 31, 2022 and 2021; (ii) Consolidated Statements of
Profit or Loss for the years ended December 31, 2022, 2021 and 2020; (iii) Consolidated Statements of Changes in Equity for the years
ended December 31, 2022, 2021 and 2020; (iv) Consolidated Statements of Cash Flows for the years ended December 31, 2022, 2021 and 2020;
and (v) Notes to Consolidated Financial Statements, tagged as blocks of text.† |
|
104 |
Cover Page Interactive Data File 101 |
| † |
Filed herewith. |
| ^ |
Furnished herewith. |
| * |
In accordance with the rules of the SEC certain confidential information contained in this exhibit, has been omitted because it (i)
is not material and (ii) is the type that the Company treats as private or confidential. |
119
SIGNATURES
The registrant hereby certifies that it meets all of the requirements
for filing on Form 20-F and that it has duly caused and authorized the undersigned to sign this Annual Report on its behalf.
|
Evogene Ltd.
| |
|
Date: March 30, 2023 |
By: /s/ Ofer Haviv Name: Ofer Haviv Title: President and Chief Executive Officer |
120
EVOGENE LTD. AND ITS SUBSIDIARIES
CONSOLIDATED FINANCIAL STATEMENTS
AS OF DECEMBER 31, 2022
U.S. DOLLARS IN THOUSANDS
INDEX
|
Page
|
|
|
Report of Independent Registered Public Accounting Firm (PCAOB ID:
|
F - 2 - F - 3
|
|
F - 4
|
|
|
F - 5
|
|
|
F - 6 - F - 7
|
|
|
F - 8 - F - 9
|
|
|
F - 10 - F - 53
|
 |
Kost Forer Gabbay & Kasierer
144 Menachem Begin Road, Building A
Tel-Aviv 6492102, Israel
|
Tel: +972-3-6232525
Fax: +972-3-5622555
ey.com
|
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Shareholders and Board of Directors of
EVOGENE LTD.
Opinion on the Financial Statements
We have audited the accompanying consolidated statements of financial position of Evogene Ltd. and its subsidiaries (the “Company”) as of December 31, 2022 and 2021, the related consolidated statements of profit or loss, changes in equity and cash flows for each of the three years in the period ended December 31, 2022, and the related notes (collectively referred to as the “consolidated financial statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company at December 31, 2022 and 2021, and the results of its operations and its cash flows for each of the three years in the period ended December 31, 2022, in conformity with International Financial Reporting Standards as issued by the International Accounting Standards Board.
Basis for Opinion
These financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on the Company’s financial statements based on our audits. We are a public accounting firm registered with the 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 financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company's internal control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.
Critical Audit Matter
The critical audit matter communicated below is a matter arising from the current period audit of the financial statements that was communicated or required to be communicated to the audit committee and that: (1) relates to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective or complex judgments. The communication of the critical audit matter 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 matter below, providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates.
F - 2
|
|
Kost Forer Gabbay & Kasierer
144 Menachem Begin Road, Building A
Tel-Aviv 6492102, Israel
|
Tel: +972-3-6232525
Fax: +972-3-5622555
ey.com
|
Intangible Assets
Description of the matter
As of December 31, 2022, the Company’s intangible assets with finite lives were $14,140 thousand. As described in Notes 2 and 11 to the consolidated financial statements, intangible assets with finite lives are assessed for recoverability whenever events or changes in circumstances indicate that the carrying amount of the assets may not be fully recoverable. The Company evaluates assets for potential impairment by comparing the recoverable amount to the carrying amount of the asset. If the carrying amount of the assets exceeds the recoverable amount, impairment is measured based on the difference between the carrying amount of the assets and the recoverable amount.
Auditing the Company’s impairment tests for intangible assets with finite lives was complex and highly judgmental due to the significant estimation in management’s assumptions to calculate the recoverable amount. The Company's methodologies for estimating the recoverable value of these assets involve significant assumptions and inputs, including projected financial information, amortization period and discount rates, all of which are sensitive to and affected by economic, industry, and company-specific qualitative factors. These assumptions can significantly affect the cash flows used to determine the recoverable amount of the intangible assets.
How we addressed the matter in our audit
We obtained an understanding of the significant inputs and assumptions used by management in the calculations of cash flows to determine the recoverable amount.
To test the Company’s impairment assessment for intangible assets with finite lives, we performed audit procedures that included, among others, assessing the methodologies used by management in deriving the recoverable value, testing the significant assumptions and the underlying data used by the Company in its analyses. We compared the significant assumptions used by management to current industry and economic trends, historical financial results and other relevant factors. We also performed sensitivity analyses of the significant assumptions to evaluate the potential change in the recoverable values of these assets resulting from hypothetical changes in underlying assumptions. We also used an internal valuation specialist to assist in our evaluation of the methodologies used and significant assumptions and inputs used to determine the recoverable value of the intangible assets.
/s/ KOST FORER GABBAY & KASIERER
KOST FORER GABBAY & KASIERER
A Member of Ernst & Young Global
We have served as the Company's auditor since 2002.
March 30, 2023
F - 3
EVOGENE LTD. AND ITS SUBSIDIARIES
CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
U.S. dollars in thousands
|
December 31,
|
||||||||||||
|
Note
|
2022
|
2021
|
||||||||||
|
CURRENT ASSETS:
|
||||||||||||
|
Cash and cash equivalents
|
6
|
$
|
|
$
|
|
|||||||
|
Short-term bank deposits
|
|
|
||||||||||
|
Marketable securities
|
7
|
|
|
|||||||||
|
Trade receivables
|
|
|
||||||||||
|
Other receivables and prepaid expenses
|
8
|
|
|
|||||||||
|
Inventories
|
|
|
||||||||||
|
|
|
|||||||||||
|
LONG-TERM ASSETS:
|
||||||||||||
|
Long-term deposits and other receivables
|
|
|
||||||||||
|
Deferred taxes
|
17d |
|
|
|||||||||
|
Right-of-use-assets
|
9
|
|
|
|||||||||
|
Property, plant and equipment, net
|
10
|
|
|
|||||||||
|
Intangible assets, net
|
11
|
|
|
|||||||||
|
|
|
|||||||||||
|
$
|
|
$
|
|
|||||||||
|
CURRENT LIABILITIES:
|
||||||||||||
|
Trade payables
|
$
|
|
$
|
|
||||||||
|
Employees and payroll accruals
|
|
|
||||||||||
|
Lease liability
|
9
|
|
|
|||||||||
|
Liabilities in respect of government grants
|
12
|
|
|
|||||||||
|
Deferred revenues and other advances
|
|
|
||||||||||
|
Other payables
|
|
|
||||||||||
|
|
|
|||||||||||
|
LONG-TERM LIABILITIES:
|
||||||||||||
|
Lease liability
|
9
|
|
|
|||||||||
|
Liabilities in respect of government grants
|
12
|
|
|
|||||||||
|
Convertible SAFE
|
5d ,13
|
|
|
|||||||||
|
|
|
|||||||||||
|
SHAREHOLDERS’ EQUITY:
|
18
|
|||||||||||
|
Ordinary shares of NIS
Authorized –
|
|
|
||||||||||
|
Share premium and other capital reserves
|
|
|
||||||||||
|
Accumulated deficit
|
(
|
)
|
(
|
)
|
||||||||
|
Equity attributable to equity holders of the Company
|
|
|
||||||||||
|
Non-controlling interests
|
|
|
||||||||||
|
Total equity
|
|
|
||||||||||
|
$
|
|
$
|
|
|||||||||
The accompanying notes are an integral part of the consolidated financial statements.
| March 30, 2023 | ||||||
|
Date of approval of the
|
Sarit Firon
|
Ofer Haviv
|
Yaron Eldad
|
|||
|
financial statements
|
Chairperson of the board
|
Chief Executive Officer
|
Chief Financial Officer
|
F - 4
EVOGENE LTD. AND ITS SUBSIDIARIES
CONSOLIDATED STATEMENTS OF PROFIT OR LOSS
U.S. dollars in thousands (except share and per share amounts)
|
Year ended December 31,
|
||||||||||||||||
|
Note
|
2022
|
2021
|
2020
|
|||||||||||||
|
Revenues
|
$
|
|
$
|
|
$
|
|
||||||||||
|
Cost of revenues
|
20a
|
|
|
|
||||||||||||
|
Gross profit
|
|
|
|
|||||||||||||
|
Operating expenses (income):
|
||||||||||||||||
|
Research and development, net
|
20b
|
|
|
|
||||||||||||
|
Sales and marketing
|
20c
|
|
|
|
||||||||||||
|
General and administrative
|
20d
|
|
|
|
||||||||||||
|
Other income
|
20e
|
(
|
)
|
|
|
|||||||||||
|
Total operating expenses, net
|
|
|
|
|||||||||||||
|
Operating loss
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||||||
|
Financing income
|
20f
|
|
|
|
||||||||||||
|
Financing expenses
|
20f
|
(
|
)
|
(
|
)
|
(
|
)
|
|||||||||
|
Financing income (expenses), net
|
(
|
)
|
|
(
|
)
|
|||||||||||
|
Loss before taxes on income
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||||||
|
Taxes on income
|
17 |
|
|
|
||||||||||||
|
Loss
|
$
|
(
|
)
|
$
|
(
|
)
|
$
|
(
|
)
|
|||||||
|
Attributable to:
|
||||||||||||||||
|
Equity holders of the Company
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||||||
|
Non-controlling interests
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||||||
|
$
|
(
|
)
|
$
|
(
|
)
|
$
|
(
|
)
|
||||||||
|
Basic and diluted loss per share, attributable to equity holders of the Company
|
21
|
$
|
(
|
)
|
$
|
(
|
)
|
$
|
(
|
)
|
||||||
|
Weighted average number of shares used in computing basic and diluted loss per share
|
|
|
|
|||||||||||||
The accompanying notes are an integral part of the consolidated financial statements.
F - 5
EVOGENE LTD. AND ITS SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY
U.S. dollars in thousands
|
Attributable to equity holders of the Company
|
||||||||||||||||||||||||
|
Share
capital
|
Share premium and other capital reserves
|
Accumulated
deficit
|
Total
|
Non-
controlling
interests
|
Total equity
|
|||||||||||||||||||
|
Balance as of January 01, 2020
|
$
|
|
$
|
|
$
|
(
|
)
|
$
|
|
$
|
|
$
|
|
|||||||||||
|
Loss
|
|
|
(
|
)
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||||||||||
|
Issuance of ordinary shares on September 2, 2020
|
|
|
|
|
|
|
||||||||||||||||||
|
Issuance of ordinary shares on November 2, 2020
|
|
|
|
|
|
|
||||||||||||||||||
|
Exercise of subsidiary options
|
|
(
|
)
|
|
(
|
)
|
|
|
||||||||||||||||
|
Forfeiture of non-controlling interests regarding share-based compensation
|
|
|
|
|
(
|
)
|
|
|||||||||||||||||
|
Benefit to non-controlling interests regarding share-based compensation
|
|
(
|
)
|
|
(
|
)
|
|
|
||||||||||||||||
|
Exercise of options
|
|
)
|
|
|
|
|
|
|||||||||||||||||
|
Share-based compensation
|
|
|
|
|
|
|
||||||||||||||||||
|
Balance as of December 31, 2020
|
$
|
|
$
|
|
$
|
(
|
)
|
$
|
|
$
|
|
$
|
|
|||||||||||
|
Loss
|
|
|
(
|
)
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||||||||||
|
Issuance of ordinary shares, net
|
|
|
|
|
|
|
||||||||||||||||||
|
Forfeiture of non-controlling interests regarding share-based compensation
|
|
|
|
|
(
|
)
|
|
|||||||||||||||||
|
Benefit to non-controlling interests regarding share-based compensation
|
|
(
|
)
|
|
(
|
)
|
|
|
||||||||||||||||
|
Exercise of subsidiary options
|
|
(
|
)
|
|
(
|
)
|
|
|
||||||||||||||||
|
Exercise of pre-funded warrants
|
|
|
|
|
|
|
||||||||||||||||||
|
Exercise of options
|
|
|
|
|
|
|
||||||||||||||||||
|
RSUs vested
|
|
)
|
|
)
|
|
|
|
|
||||||||||||||||
|
Share-based compensation and RSUs
|
|
|
|
|
|
|
||||||||||||||||||
|
Balance as of December 31, 2021
|
$
|
|
$
|
|
$
|
(
|
)
|
$
|
|
$
|
|
$
|
|
|||||||||||
*) Represents an amount lower than $1
The accompanying notes are an integral part of the consolidated financial statements.
F - 6
EVOGENE LTD. AND ITS SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY
U.S. dollars in thousands
|
Attributable to equity holders of the Company
|
||||||||||||||||||||||||
|
Share
capital
|
Share
premium and
other capital
reserves
|
Accumulated
deficit
|
Total
|
Non-
controlling
interests
|
Total equity
|
|||||||||||||||||||
|
Balance as of December 31, 2021
|
$
|
|
$
|
|
$
|
(
|
)
|
$
|
|
$
|
|
$
|
|
|||||||||||
|
Loss
|
|
|
(
|
)
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||||||||||
|
Issuance of ordinary shares, net
|
|
|
|
|
|
|
||||||||||||||||||
|
Forfeiture of non-controlling interests regarding share-based compensation
|
|
|
|
|
(
|
)
|
|
|||||||||||||||||
|
Benefit to non-controlling interests regarding share-based compensation
|
|
(
|
)
|
|
(
|
)
|
|
|
||||||||||||||||
|
Exercise of subsidiary options
|
|
|
)
|
|
|
)
|
|
|
)
|
|||||||||||||||
|
Exercise of options
|
|
)
|
|
|
|
|
|
|||||||||||||||||
| RSUs vested |
|
)
|
|
)
|
|
|
)
|
|
|
)
|
||||||||||||||
|
Share-based compensation and RSUs
|
|
|
|
|
|
|
||||||||||||||||||
|
Balance as of December 31, 2022
|
$
|
|
$
|
|
$
|
(
|
)
|
$
|
|
$
|
|
$
|
|
|||||||||||
*) Represents an amount lower than $1
The accompanying notes are an integral part of the consolidated financial statements.
F - 7
EVOGENE LTD. AND ITS SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
U.S. dollars in thousands
|
Year ended
December 31,
|
||||||||||||
|
2022
|
2021
|
2020
|
||||||||||
|
Cash flows from operating activities:
|
||||||||||||
|
Loss
|
$
|
(
|
)
|
$
|
(
|
)
|
$
|
(
|
)
|
|||
|
Adjustments to reconcile loss to net cash used in operating activities:
|
||||||||||||
|
Adjustments to the profit or loss items:
|
||||||||||||
|
Depreciation
|
|
|
|
|||||||||
|
Amortization of intangible assets
|
|
|
|
|||||||||
|
Share-based compensation
|
|
|
|
|||||||||
|
Revaluation of convertible SAFE
|
|
|
|
|||||||||
|
Pre-funded warrants issuance expenses
|
|
|
|
|||||||||
|
Net financing expenses (income)
|
|
(
|
)
|
|
||||||||
|
Decrease in accrued bank interest
|
|
|
|
|||||||||
|
Loss from derecognition of property, plant and equipment
|
|
|
|
|||||||||
|
Taxes on income
|
|
|
|
|||||||||
|
|
|
|
||||||||||
|
Changes in asset and liability items:
|
||||||||||||
|
Increase in trade receivables
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||
|
Decrease (increase) in other receivables
|
|
|
(
|
)
|
||||||||
|
Increase in inventories
|
(
|
)
|
(
|
)
|
|
|||||||
|
Increase in deferred taxes
|
(
|
)
|
|
|
||||||||
|
Increase (decrease) in trade payables
|
(
|
)
|
|
(
|
)
|
|||||||
|
Increase (decrease) in employees and payroll accruals
|
(
|
)
|
|
|
||||||||
|
Increase (decrease) in other payables
|
|
|
(
|
)
|
||||||||
|
Increase (decrease) in deferred revenues and other advances
|
(
|
)
|
|
(
|
)
|
|||||||
|
(
|
)
|
|
(
|
)
|
||||||||
|
Cash received (paid) during the year for:
|
||||||||||||
|
Interest received
|
|
|
|
|||||||||
|
Interest paid
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||
|
Taxes paid
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||
|
Net cash used in operating activities
|
$
|
(
|
)
|
$
|
(
|
)
|
$
|
(
|
)
|
|||
The accompanying notes are an integral part of the consolidated financial statements.
F - 8
EVOGENE LTD. AND ITS SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
U.S. dollars in thousands
|
Year ended
December 31,
|
||||||||||||
|
2022
|
2021
|
2020
|
||||||||||
|
Cash flows from investing activities:
|
||||||||||||
|
Purchase of property, plant and equipment
|
$
|
(
|
)
|
$
|
(
|
)
|
$
|
(
|
)
|
|||
|
Proceeds from sale of marketable securities
|
|
|
|
|||||||||
|
Purchase of marketable securities
|
(
|
)
|
(
|
)
|
|
|||||||
|
Withdrawal from (investment in) bank deposits, net
|
|
(
|
)
|
|
||||||||
|
Net cash provided by (used in) investing activities
|
|
(
|
)
|
|
||||||||
|
Cash flows from financing activities:
|
||||||||||||
|
Proceeds from issuance of ordinary shares, net of issuance expenses
|
|
|
|
|||||||||
|
Proceeds from issuance of convertible SAFE
|
|
|
|
|||||||||
|
Proceeds from issuance of pre-funded warrants
|
|
|
|
|||||||||
|
Proceeds from advances for pre-funded warrants
|
|
|
|
|||||||||
|
Proceeds from exercise of options
|
|
|
|
|||||||||
|
Repayment of lease liability
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||
|
Proceeds from government grants
|
|
|
|
|||||||||
|
Repayment of government grants
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||
|
Net cash provided by financing activities
|
|
|
|
|||||||||
|
Exchange rate differences - cash and cash equivalent balances
|
(
|
)
|
|
|
||||||||
|
Increase (decrease) in cash and cash equivalents
|
(
|
)
|
(
|
)
|
|
|||||||
|
Cash and cash equivalents beginning of the year
|
|
|
|
|||||||||
|
Cash and cash equivalents end of the year
|
$
|
|
$
|
|
$
|
|
||||||
|
Significant non-cash activities
|
||||||||||||
|
Acquisition of property, plant and equipment
|
$
|
|
$
|
|
$
|
|
||||||
|
Increase (decrease) of right-of-use asset recognized with corresponding lease liability
|
$
|
|
$
|
|
$
|
(
|
)
|
|||||
|
Exercise of options
|
$
|
|
$
|
|
$
|
|
||||||
|
Exercise of pre-funded warrants
|
$
|
|
$
|
|
$
|
|
||||||
The accompanying notes are an integral part of the consolidated financial statements.
F - 9
EVOGENE LTD. AND ITS SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands (except share and per share data)
NOTE 1: - GENERAL
Evogene Ltd. together with its subsidiaries (the "Company" or "Evogene") is a leading computational biology company aiming to revolutionize life-science product development across several market segments, including human health, agriculture, and other industries, by utilizing cutting edge computational technologies. To achieve this mission, Evogene established its unique Computational Predictive Biology (“CPB”) platform, leveraging big data and artificial intelligence, and incorporating deep multidisciplinary understanding in life sciences. The CPB platform is the basis for three technology engines, each focused on the direction and acceleration of the discovery and development of products based on one of the following core components: Microbes - MicroBoost AI, Small molecules - ChemPass AI, Genetic elements - GeneRator AI. Evogene uses its technological engines to support the development of products for the life science industry through dedicated subsidiaries and with strategic partners. Currently, Evogene’s main subsidiaries utilize the technological engines to develop human microbiome-based therapeutics by Biomica Ltd., medical cannabis products by Canonic Ltd., ag-chemicals by AgPlenus Ltd. and ag-biologicals by Lavie Bio Ltd. The Company has a history of losses and incurred operating losses of $26,941 and $30,953 during the years ended December 31, 2022, and 2021, respectively.
Furthermore, the Company intends to continue to finance its operating activities by raising capital, by seeking collaborations with multinational companies in the industry (see Note 18b) as well as from revenues derived from the sale of end-products or commercialization of product candidates.
The Company's management and board of directors are of the opinion that the Company’s current financial resources will be sufficient to continue the development of the Company's products in the foreseeable future.
Evogene Ltd. was founded on October 10, 1999, as Agro Leads Ltd., a division of Compugen Ltd. In 2002, the Company was spun-off as an independent corporation under the laws of the State of Israel, and changed its name to Evogene Ltd.
The Company’s shares have been listed for trading on the Tel Aviv Stock Exchange (“TASE”) since 2007, on the New York Stock Exchange (“NYSE”) from November 2013 until December 2016, and on the Nasdaq Stock Market (“NASDAQ”) since December 2016.
| a. |
The Company principally derives its revenues from collaboration arrangements and since October 2021, from Canonic Ltd.’s commercialization of its first medical cannabis products in Israel, see Note 5c. As to major customers, see Note 22c.
|
| b. |
The Company has the following direct and indirect subsidiaries: Casterra Ag Ltd. (formerly Evofuel Ltd.), Evogene Inc., Biomica Ltd., AgPlenus Ltd., AgPlenus Inc., Lavie Bio Ltd., Lavie Bio Inc., Lavie Tech Inc., Taxon Biosciences, Inc. and Canonic Ltd.
|
Casterra Ag Ltd. was incorporated on December 29, 2011 and is currently focusing on the development of improved castor bean seeds for industrial uses.
Evogene Inc. was incorporated in Delaware, United States on September 22, 2006. From 2015 to 2019, Evogene Inc. was engaged in research and development in the field of insect control and located in the Bio-Research and Development Growth (BRDG) Park, in St. Louis, Missouri, United States.
F - 10
EVOGENE LTD. AND ITS SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands (except share and per share data)
NOTE 1: - GENERAL (Cont.)
Biomica Ltd. was incorporated on March 2, 2017, with the mission of discovering and developing human microbiome-based therapeutics.
AgPlenus Ltd. was incorporated on June 10, 2018, with the mission to design effective and sustainable crop protection ag-chemicals products by leveraging predictive biology.
On August 27, 2020, AgPlenus Ltd. incorporated a wholly owned U.S. subsidiary, AgPlenus Inc.
Lavie Bio Ltd. was incorporated on January 21, 2019, with the mission to improve food quality and sustainability through the introduction of microbiome-based ag-biological products. In 2019, Lavie Bio Ltd. incorporated two wholly owned subsidiaries, Lavie Bio Inc., located in the City Foundry STL Project, in St. Louis, Missouri, United States, and Lavie Tech Inc. Lavie Tech Inc. wholly owns as a subsidiary Taxon Biosciences, Inc. (see item c below).
Canonic Ltd. was incorporated on March 25, 2019, with the mission to develop next-generation medical cannabis products.
| c. |
On August 6, 2019, Corteva Inc. (“Corteva”), through its subsidiary Pioneer Hi-Bred International, Inc., made an investment in the Company’s agriculture biologicals subsidiary, Lavie Bio Ltd., which included a cash investment of $
|
| d. |
On September 2, 2020, the Company issued
|
| e. |
In January 2021, the Company entered into a Controlled Equity Offering Sales Agreement, pursuant to which the Company issued
|
| f. |
On February 19, 2021, the Company entered into a new Controlled Equity Offering Sales Agreement, having an aggregate offering price of up to $
|
F - 11
EVOGENE LTD. AND ITS SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands (except share and per share data)
NOTE 1: - GENERAL (Cont.)
| g. |
The Company’s subsidiaries and divisions are split into three operating segments: (1) Agriculture – Evogene seed traits division, Lavie Bio Ltd. and AgPlenus Ltd.; (2)
|
Human health – Biomica Ltd. and Canonic Ltd.; and (3) Industrial – Casterra Ag Ltd. (see also Note 22).
| h. |
Definitions
In these Financial Statements - |
| Subsidiary - |
A company that is controlled by the Company (as defined in International Financial Reporting Standards (“IFRS”) 10- Consolidated Financial Statements) and whose accounts are consolidated with those of the Company.
|
| Related parties - |
As defined in International Accounting Standard (“IAS”) 24- Related Party Disclosures.
|
|
NOTE 2: - |
SIGNIFICANT ACCOUNTING POLICIES |
The following accounting policies have been applied consistently in the financial statements for all periods presented, unless otherwise stated.
| a. |
Basis of presentation of the financial statements:
|
These financial statements have been prepared in accordance with IFRS as issued by the International Accounting Standards Board (“IASB”).
The Company’s financial statements have been prepared on a cost basis, except for financial assets and liabilities (including derivatives) which are presented at fair value through profit or loss.
The Company has elected to present profit or loss items using the function of expense method.
| b. |
Consolidated financial statements:
|
The consolidated financial statements comprise the financial statements of companies that are controlled by the Company (subsidiaries). Control is achieved when the Company is exposed, or has rights, to variable returns from its involvement with the investee and has the ability to affect those returns through its power over the investee. Potential voting rights are considered when assessing whether an entity has control.
The consolidation of the financial statements commences on the date on which control is obtained and ends when such control ceases. The financial statements of the Company and of the subsidiaries are prepared as of the same dates and periods. The consolidated financial statements are prepared using uniform accounting policies by all companies controlled by the Company. Significant intracompany balances and transactions and gains or losses resulting from intracompany transactions are eliminated in full in the consolidated financial statements. Non-controlling interests in subsidiaries represent the equity in subsidiaries not attributable, directly or indirectly, to a parent. Non-controlling interests are presented in equity separately from the equity attributable to the equity holders of the Company. Profit or loss and components of other comprehensive income are attributed to the Company and to non-controlling interests. Losses are attributed to non-controlling interests even if they result in a negative balance of non-controlling interests in the consolidated statement of financial position.
F - 12
EVOGENE LTD. AND ITS SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands (except share and per share data)
| NOTE 2: - |
SIGNIFICANT ACCOUNTING POLICIES (Cont.)
|
| c. |
Other comprehensive loss:
|
The Company has no components of comprehensive loss other than net loss. Thus, comprehensive loss is the same as net loss for the period presented.
| d. |
Functional currency, presentation currency and foreign currency:
|
| 1. |
Functional currency and presentation currency:
|
The presentation currency of the financial statements is the U.S. dollar.
The Company and its subsidiaries determine the functional currency of each entity, and this currency is used to separately measure each entity's financial position and operating results. The Company's functional currency is the U.S. dollar.
| 2. |
Transactions, assets and liabilities in foreign currency:
|
Transactions denominated in foreign currency are recorded upon initial recognition at the exchange rate at the date of the transaction. After initial recognition, monetary assets and liabilities denominated in foreign currency are translated at each reporting date into the functional currency at the exchange rate at that date. Exchange rate differences, other than those capitalized to qualifying assets or accounted for as hedging transactions in equity, are recognized in profit or loss. Non-monetary assets and liabilities denominated in foreign currency and measured at cost are translated at the exchange rate at the date of the transaction. Non-monetary assets and liabilities denominated in foreign currency and measured at fair value are translated into the functional currency using the exchange rate prevailing at the date when the fair value was determined.
| e. |
Cash equivalents:
|
Cash equivalents are considered as highly liquid investments, including unrestricted short-term bank deposits with an original maturity of three months or less from the date of investment or with a maturity of more than three months, but which are redeemable on demand without penalty, and which form part of the Company's cash management.
F - 13
EVOGENE LTD. AND ITS SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands (except share and per share data)
| NOTE 2: - |
SIGNIFICANT ACCOUNTING POLICIES (Cont.)
|
| f. |
Short-term deposits:
|
Short-term bank deposits are deposits with an original maturity of more than three months from the date of investment and which do not meet the definition of cash equivalents. The deposits are presented according to their terms of deposit.
| g. |
Inventories:
|
Inventories are measured at the lower of cost and net realizable value. The cost of inventories comprises costs of purchase and 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. The Company reviews inventory for obsolete, redundant and slow-moving goods and any such inventory is written-down to net realizable value.
Inventories of purchased finished goods and packing materials are initially valued at cost and subsequently at the lower of cost and net realizable value.
| h. |
Government grants:
|
Government grants received from the Israel Innovation Authority (“IIA”) and the Israel-U.S. Binational Industrial Research and Development Foundation (“BIRD”) are recognized upon receipt as a liability if future economic benefits are expected from the research project that will result in royalty-bearing sales.
A liability for the loan is first measured at fair value using a discount rate that reflects a market rate of interest. The difference between the amount of the grant received and the fair value of the liability is accounted for as a government grant and recognized as a reduction of research and development expenses. After initial recognition, the liability is measured at amortized cost using the effective interest method. Royalty payments are treated as a reduction of the liability. If no economic benefits are expected from the research activity, the grant receipts are recognized as a reduction of the related research and development expenses. In that event, the royalty obligation is treated as a contingent liability in accordance with IAS 37- Provisions, Contingent Liabilities and Contingent Assets (“IAS 37”).
In each reporting date, the Company evaluates whether there is reasonable assurance that the liability recognized, in whole or in part, will not be repaid (since the Company will not be required to pay royalties) based on the best estimate of future sales and using the original effective interest method, and if so, the appropriate amount of the liability is derecognized against a corresponding reduction in research and development expenses.
Amounts paid as royalties are recognized as settlement of the liability.
Non-refundable grants from the IIA and the European Union Horizon 2020 for funding research and development projects are recognized at the time the Company is entitled to such grants on the basis of the related costs incurred and recorded as a deduction from research and development expenses.
F - 14
EVOGENE LTD. AND ITS SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands (except share and per share data)
| NOTE 2: - |
SIGNIFICANT ACCOUNTING POLICIES (Cont.)
|
| i. |
Leases:
|
The Company applies a single recognition and measurement approach for all leases, except for short-term leases and leases of low-value assets. The Company recognizes lease liabilities to make lease payments and right-of-use assets representing the right to use the underlying asset.
|
1.
|
Right-of-use assets
|
The Company recognizes right-of-use assets at the commencement date of the lease (i.e., the date the underlying asset is available for use). Right-of-use assets are measured at cost, less any accumulated depreciation and impairment losses, and adjusted for any remeasurement of lease liabilities. The cost of right-of-use assets includes the amount of lease liabilities recognized, initial direct costs incurred, and lease payments made at or before the commencement date less any lease incentives received.
Following are the amortization periods of the right-of-use assets by class of underlying asset:
|
Years
|
Mainly
|
|||
|
Office space
|
|
|
||
|
Laboratory space
|
|
|
||
|
Motor vehicles
|
|
|
If ownership of the leased asset transfers to the Company at the end of the lease term or the cost reflects the exercise of a purchase option, depreciation is calculated using the estimated useful life of the asset.
| 2. |
Lease liabilities
|
At the commencement date of the lease, the Company recognizes lease liabilities measured at the present value of lease payments to be made over the lease term. The lease payments include fixed payments (including in substance fixed payments) less any lease incentives receivable, variable lease payments that depend on an index or a rate, and amounts expected to be paid under residual value guarantees. The lease payments also include the exercise price of a purchase option reasonably certain to be exercised by the Company and payments of penalties for terminating the lease, if the lease term reflects the Company exercising the option to terminate.
In calculating the present value of lease payments, the Company uses its incremental borrowing rate (“IBR”) at the lease commencement date because the interest rate implicit in the lease is not readily determinable. After the commencement date, the amount of lease liabilities is increased to reflect the accretion of interest and reduced for the lease payments made. In addition, the carrying amount of lease liabilities is remeasured if there is a modification, a change in the lease term, a change in the lease payments (e.g., changes to future payments resulting from a change in the consumer price index (“CPI”) or rate used to determine such lease payments) or a change in the assessment of an option to purchase the underlying asset.
F - 15
EVOGENE LTD. AND ITS SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands (except share and per share data)
| NOTE 2: - |
SIGNIFICANT ACCOUNTING POLICIES (Cont.)
|
| 3. |
Short-term leases and leases of low-value assets
|
The Company applies the short-term lease recognition exemption to its short-term leases of motor vehicles (i.e., those leases that have a lease term of 12 months or less from the commencement date and do not contain a purchase option). It also applies the lease of low-value assets recognition exemption to leases of office equipment that are considered to be low value. Lease payments on short-term leases and leases of low value assets are recognized as expense on a straight-line basis over the lease term.
| j. |
Property, plant and equipment:
|
Property, plant and equipment are measured at cost, including directly attributable costs, less accumulated depreciation, accumulated impairment losses and any related investment grants and excluding day-to-day servicing expenses.
Depreciation is calculated on a straight-line basis over the useful life of the assets at annual rates as follows:
|
%
|
Mainly %
|
|||
|
Laboratory equipment
|
|
|
||
|
Computers and peripheral equipment
|
|
|
||
|
Office equipment and furniture
|
|
|
||
|
Leasehold improvements
|
see below
|
The useful life, depreciation method and residual value of an asset are reviewed at least each year-end and any changes are accounted for prospectively as a change in accounting estimate. Depreciation of an asset ceases at the earlier of the date that the asset is classified as held for sale and the date that the asset is derecognized.
| k. |
Intangible assets:
|
Intangible assets acquired separately are measured on initial recognition at cost. Following initial recognition, intangible assets are carried at cost less any accumulated amortization and accumulated impairment losses.
Intangible assets with finite lives are amortized over the useful economic life and assessed for impairment whenever there is an indication that the intangible asset may be impaired. The amortization period and the amortization method for intangible assets with a finite useful life are reviewed at least at the end of each reporting period. Changes in the expected useful life or the expected pattern of consumption of future economic benefits embodied in the asset are considered to modify the amortization period or method, as appropriate, and are treated as changes in accounting estimates.
F - 16
EVOGENE LTD. AND ITS SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands (except share and per share data)
| NOTE 2: - |
SIGNIFICANT ACCOUNTING POLICIES (Cont.)
|
The amortization expense on intangible assets with finite lives is recognized in the statement of profit or loss in the expense category that is consistent with the function of the intangible assets.
An intangible asset is derecognized upon disposal (i.e., at the date the recipient obtains control) or when no future economic benefits are expected from its use or disposal. Any gain or loss arising upon derecognition of the asset (calculated as the difference between the net disposal proceeds and the carrying amount of the asset) is included in the statement of profit or loss (see Note 11).
A summary of the useful economic lives of the intangible assets purchased by the Company is as follows:
|
Years
|
||
|
Pipeline Products
|
|
|
|
Potential Products
|
|
|
|
Microorganisms Collection
|
|
| l. |
Impairment of non-financial assets:
|
The Company evaluates the need to record an impairment of non-financial assets whenever events or changes in circumstances indicate that the carrying amount is not recoverable. If the carrying amount of non-financial assets exceeds their recoverable amount, the assets are reduced to their recoverable amount. The recoverable amount is the higher of fair value less costs of sale and value in use. In measuring value in use, the expected future cash flows are discounted using a pre-tax discount rate that reflects the risks specific to the asset. The recoverable amount of an asset that does not generate independent cash flows is determined for the cash-generating unit to which the asset belongs. Impairment losses are recognized in profit or loss.
| m. |
Revenue recognition:
|
The revenue recognition is in accordance with IFRS 15, “Revenue from Contracts with Customers” (“IFRS 15”).
IFRS 15 introduces a five-step model that applies to revenue earned from contracts with customers:
Step 1: Identify the contract with a customer, including reference to contract combination and accounting for contract modifications.
Step 2: Identify the distinct performance obligations in the contract.
F - 17
EVOGENE LTD. AND ITS SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands (except share and per share data)
| NOTE 2: - |
SIGNIFICANT ACCOUNTING POLICIES (Cont.)
|
Step 3: Determine the transaction price, including reference to variable consideration, significant financing components, non-cash consideration and any consideration payable to the customer.
Step 4: Allocate the transaction price to the distinct performance obligations on a relative stand-alone selling price basis using observable prices, if available, or using estimates and assessments.
Step 5: Recognize revenue when a performance obligation is satisfied, either at a point in time or over time.
Revenue from contracts with customers is recognized when the control over the goods or services is transferred to the customer. The transaction price is the amount of the consideration that is expected to be received based on the contract terms, excluding amounts collected on behalf of third parties (such as taxes).
If the contract contains a single performance obligation, the entire transaction price is allocated to the single performance obligation. Contracts that contain multiple performance obligations such as licenses, services, royalties and milestone events require an allocation of the transaction price to each performance obligation based on a relative standalone selling price (“SSP”) basis. The Company establishes SSP based on management judgment, considering internal factors such as margin objectives, pricing practices and historical sales.
Revenue from each performance obligation is recognized when the performance obligation related to that revenue is satisfied and only to the extent of the consideration that is not contingent upon completion or satisfaction of future performance obligations in the contract.
Revenues from research and development services as part of the Company's collaboration agreements are recognized over time, during the period the customer simultaneously receives and consumes the benefits provided by the Company's performance. Recognition of the service is throughout the services period and is determined based on the proportion of actual costs incurred for each reporting period to the estimated total costs, subject to the enforceable rights. The Company charges its customers based on payment terms agreed upon in specific agreements. When payments are made before or after the service is performed, the Company recognizes the resulting contract asset or liability.
Revenues from milestone events stipulated in the agreements are recognized upon the occurrence of the event or achievement of the milestone specified in the agreement.
Costs to fulfill a contract:
Costs incurred in fulfilling contracts or anticipated contracts with customers are recognized as an asset when the costs are expected to be recovered. Costs to fulfill a contract comprise direct identifiable costs and indirect costs that can be directly attributed to a contract based on a reasonable allocation method. Costs to fulfill a contract are expensed consistently with the recognition of revenues under the specific contract.
F - 18
EVOGENE LTD. AND ITS SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands (except share and per share data)
| NOTE 2: - |
SIGNIFICANT ACCOUNTING POLICIES (Cont.)
|
| n. |
Taxes on income:
|
Current or deferred taxes are recognized in profit or loss, except to the extent that they relate to items which are recognized in other comprehensive income (loss) or equity.
| 1. |
Current taxes:
|
The current tax liability is measured using the tax rates and tax laws that have been enacted or substantively enacted by the reporting date as well as adjustments required in connection with the tax liability in respect of previous years.
| 2. |
Deferred taxes:
|
Deferred taxes are computed in respect of temporary differences between the carrying amounts in the financial statements and the amounts attributed for tax purposes.
Deferred taxes are measured at the tax rate that is expected to apply when the asset is realized, or the liability is settled, based on tax laws that have been enacted or substantively enacted by the reporting date.
Deferred tax assets are reviewed at each reporting date and reduced to the extent that it is not probable that they will be utilized. Temporary differences for which deferred tax assets had not been recognized are reviewed at each reporting date and a respective deferred tax asset is recognized to the extent that their utilization is probable.
| o. |
Financial instruments:
|
The accounting for financial instruments is in accordance with IFRS 9, “Financial Instruments” (“IFRS 9”).
| 1. |
Financial assets:
|
Financial assets are measured upon initial recognition at fair value plus transaction costs that are directly attributable to the acquisition of the financial assets, except for financial assets measured at fair value through profit or loss in respect of which transaction costs are recorded in profit or loss.
The Company classifies and measures debt instruments in the financial statements based on the following criteria:
- The Company's business model for managing financial assets; and
- The contractual cash flow terms of the financial asset.
Debt instruments are measured at amortized cost when:
The Company's business model is to hold the financial assets in order to collect their contractual cash flows, and the contractual terms of the financial assets give rise on specified dates to cash flows that are solely payments of principal and interest on the principal amount outstanding. After initial recognition, the instruments in this category are measured according to their terms at amortized cost using the effective interest rate method, less any provision for impairment.
F - 19
EVOGENE LTD. AND ITS SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands (except share and per share data)
| NOTE 2: - |
SIGNIFICANT ACCOUNTING POLICIES (Cont.)
|
On the date of initial recognition, the Company may irrevocably designate a debt instrument as measured at fair value through profit or loss if doing so eliminates or significantly reduces a measurement or recognition inconsistency, such as when a related financial liability is also measured at fair value through profit or loss.
| 2. |
Impairment of financial assets:
|
The Company evaluates at the end of each reporting period the loss allowance for financial debt instruments which are not measured at fair value through profit or loss.
The Company has short-term financial assets such as trade receivables in respect of which the Company applies a simplified approach and measures the loss allowance in an amount equal to the lifetime expected credit losses. An impairment loss on debt instruments measured at amortized cost is recognized in profit or loss with a corresponding loss allowance that is offset from the carrying amount of the financial asset.
| 3. |
Financial liabilities:
|
| a) |
Financial liabilities measured at amortized cost:
|
Financial liabilities are initially recognized at fair value less transaction costs that are directly attributable to the issue of the financial liability.
After initial recognition, the accounting treatment of financial liabilities is based on their classification as follows:
After initial recognition, the Company measures all financial liabilities at amortized cost using the effective interest rate method, except for financial liabilities at fair value through profit or loss such as derivatives.
| b) |
Financial liabilities measured at fair value through profit or loss:
|
At initial recognition, the Company measures financial liabilities that are not measured at amortized cost at fair value. Transaction costs are recognized in profit or loss.
After initial recognition, changes in fair value are recognized in profit or loss.
F - 20
EVOGENE LTD. AND ITS SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands (except share and per share data)
| NOTE 2: - |
SIGNIFICANT ACCOUNTING POLICIES (Cont.)
|
| 4. |
Offsetting financial instruments:
|
Financial assets and financial liabilities are offset, and the net amount is reported in the consolidated statement of financial position if there is a currently enforceable legal right to offset the recognized amounts and there is an intention to settle on a net basis, to realize the assets and settle the liabilities simultaneously.
| 5. |
De-recognition of financial instruments:
|
| a. |
Financial assets:
|
A financial asset is derecognized when the contractual rights to the cash flows from the financial asset expire or the Company has transferred its contractual rights to receive cash flows from the financial asset or assumes an obligation to pay the cash flows in full without material delay to a third party and has transferred substantially all the risks and rewards of the asset or has neither transferred nor retained substantially all the risks and rewards of the asset, but has transferred control of the asset.
| b. |
Financial liabilities:
|
A financial liability is derecognized when it is extinguished, that is when the obligation is discharged or cancelled or expires. A financial liability is extinguished when the debtor (the Company) discharges the liability by paying in cash, other financial assets, goods or services; or is legally released from the liability.
|
p.
|
Fair value measurement:
|
Fair value is the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date.
Fair value measurement is based on the assumption that the transaction will take place in the asset's or the liability's principal market, or in the absence of a principal market, in the most advantageous market.
The fair value of an asset or a liability is measured using the assumptions that market participants would use when pricing the asset or liability, assuming that market participants act in their economic best interest.
Fair value measurement of a non-financial asset takes into account a market participant's ability to generate economic benefits by using the asset in its highest and best use or by selling it to another market participant that would use the asset in its highest and best use.
F - 21
EVOGENE LTD. AND ITS SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands (except share and per share data)
| NOTE 2: - |
SIGNIFICANT ACCOUNTING POLICIES (Cont.)
|
The Company uses valuation techniques that are appropriate in the circumstances and for which sufficient data are available to measure fair value, maximizing the use of relevant observable inputs and minimizing the use of unobservable inputs.
All assets and liabilities measured at fair value or for which fair value is disclosed are categorized into levels within the fair value hierarchy based on the lowest level input that is significant to the fair value measurement:
|
Level 1
|
-
|
Quoted prices (unadjusted) in active markets for identical assets or liabilities.
|
|
Level 2
|
-
|
Inputs other than quoted prices included within Level 1 that are observable directly or indirectly.
|
|
Level 3
|
-
|
Inputs that are not based on observable market data (valuation techniques which use inputs that are not based on observable market data).
|
|
q.
|
Provisions:
|
A provision in accordance with IAS 37 is recognized when the Company has a present obligation (legal or constructive) as a result of a past event, it is probable that an outflow of resources embodying economic benefits will be required to settle the obligation and a reliable estimate can be made of the amount of the obligation.
| r. |
Employee benefit liabilities:
|
The Company has several employee benefits plans:
| 1. |
Short-term employee benefits:
|
Short-term employee benefits are benefits that are expected to be settled wholly before twelve months after the end of the annual reporting period in which the employees render the related services. These benefits include salaries, paid annual leave, paid sick leave, recreation and social security contributions and are recognized as expenses as the services are rendered. A liability in respect of a cash bonus or a profit-sharing plan is recognized when the Company has a legal or constructive obligation to make such payment as a result of past service rendered by an employee and a reliable estimate of the amount can be made.
| 2. |
Post-employment benefits:
|
The plans are normally financed by contributions to insurance companies and classified as defined contribution plans or as defined benefit plans.
The Company has defined contribution plans pursuant to section 14 of the Israeli Severance Pay Law (the “Severance Law”) under which the Company pays fixed contributions and will have no legal or constructive obligation to pay further contributions if the fund does not hold sufficient amounts to pay all employee benefits relating to employee service in the current and prior periods.
F - 22
EVOGENE LTD. AND ITS SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands (except share and per share data)
| NOTE 2: - |
SIGNIFICANT ACCOUNTING POLICIES (Cont.)
|
Contributions to the defined contribution plan in respect of severance or retirement pay are recognized as an expense when contributed concurrently with the performance of the employee's services.
In respect of its severance pay obligation to certain of its employees, the Company makes current deposits in pension funds and insurance companies (“the plan assets”). Plan assets comprise assets held by a long-term employee benefit fund or qualifying insurance policies. Plan assets are not available to the Company's own creditors and cannot be returned directly to the Company.
|
s.
|
Share-based payment transactions:
|
The Company's employees and consultants are entitled to remuneration in the form of equity-settled share-based payment transactions.
Equity-settled transactions:
The cost of equity-settled transactions with employees is measured at the fair value of the equity instruments granted at the grant date. The fair value is determined using an acceptable option pricing model.
As for consultants, the cost of the transactions is measured at the fair value of the services received as consideration for equity instruments granted.
The cost of equity-settled transactions is recognized in profit or loss together with a corresponding increase in equity during the period which the performance and/or service conditions are to be satisfied ending on the date on which the relevant employees become entitled to the award (“the vesting period”). The cumulative expense recognized for equity-settled transactions at the end of each reporting period until the vesting date reflects the extent to which the vesting period has expired and the Company's best estimate of the number of equity instruments that will ultimately vest. No expense is recognized for awards that do not ultimately vest.
If the Company modifies the conditions on which equity-instruments were granted, an additional expense is recognized for any modification that increases the total fair value of the share-based payment arrangement or is otherwise beneficial to the employee or other service provider at the modification date.
| t. |
Loss per share:
|
Loss per share is calculated by dividing the loss attributable to equity holders of the Company by the weighted number of ordinary shares outstanding during the period.
Potential ordinary shares are included in the computation of diluted earnings per share when their conversion decreases earnings per share from continuing operations.
| u. |
Reclassification:
|
Certain amounts previously reported in the consolidated financial statements have been reclassified to conform to the current year’s presentation. Such reclassifications did not affect statements of financial position, statements of loss, statements of changes in equity or statements of cash flows.
F - 23
EVOGENE LTD. AND ITS SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands (except share and per share data)
| NOTE 3: - |
SIGNIFICANT ACCOUNTING JUDGMENTS, ESTIMATES AND ASSUPMTIONS USED IN THE PREPARATION OF THE FINANCIAL STATEMENTS
|
In the process of applying the significant accounting policies, the Company has made the following judgments which have the most significant effect on the amounts recognized in the financial statements:
| a. |
Judgments:
|
| - |
Determining the timing of satisfaction of performance obligations:
|
In order to determine the timing of recognizing revenues from contracts with customers at a point in time or over time, the Company evaluates the date of transfer of control over the assets or services promised in the contracts. Among others, the Company evaluates whether the customer obtains control of the asset at a specific point in time or consumes the economic benefits associated with the contract simultaneously with the Company's performance. In determining the timing of revenue recognition, the Company also considers the provisions of applicable laws and regulations.
| - |
Discount rate for a lease liability:
|
When the Company is unable to readily determine the discount rate implicit in the lease for calculating the lease liability, it uses an IBR that represents the rate of interest that a lessee would have to pay to borrow over a similar term and with similar security, the funds necessary to obtain an asset of similar value to the right-of-use asset in a similar economic environment. When the Company cannot rely on borrowing transactions, it determines the IBR based on its financing risk, the lease period and other economic variables dictated by the lease contract's existing conditions and restrictions. The Company occasionally hires an external valuation expert for determining the IBR.
| b. |
Estimates and assumptions:
|
The preparation of the financial statements requires management to make estimates and assumptions that have an effect on the application of the accounting policies and on the reported amounts of assets, liabilities, revenues and expenses. Changes in accounting estimates are reported in the period of the change in estimate.
The key assumptions made in the financial statements concerning uncertainties at the reporting date and the critical estimates computed by the Company that may result in a material adjustment to the carrying amounts of assets and liabilities within the next financial year are discussed below.
| - |
Government grants:
|
Government grants received from the IIA are recognized as liabilities if future economic benefits are expected from the research and development activity that will result in royalty-bearing sales. There is uncertainty regarding the estimated future cash flows used to measure the amount of the liability.
F - 24
EVOGENE LTD. AND ITS SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands (except share and per share data)
| NOTE 3: - |
SIGNIFICANT ACCOUNTING JUDGMENTS, ESTIMATES AND ASSUPMTIONS USED IN THE PREPARATION OF THE FINANCIAL STATEMENTS (Cont.)
|
| - |
Legal claims:
|
In estimating the likelihood of outcome of legal claims filed against the Company and its investees, the Company relies on the opinion of its legal counsel. These estimates are based on the legal counsel's best professional judgment, taking into account the stage of proceedings and legal precedents in respect of the different issues. Since the outcome of the claims will be determined in courts, the results could differ from these estimates.
| - |
Determining the fair value of share-based payment transactions:
|
The fair value of share-based payment transactions is determined upon initial recognition by an acceptable option pricing model. The inputs to the model include share price (as the Company’s subsidiaries’ shares are not publicly traded, the fair value of the subsidiaries’ shares was estimated by valuation reports prepared by third-party valuation specialists) and exercise price and assumptions regarding expected volatility, expected life of share option and expected dividend yield.
| - |
Determining the fair value of convertible SAFE:
|
The fair value of the SAFE issued to ICL (see Note 5d and Note 13) is based on the weighted average value of various scenarios assuming Lavie Bio's estimated enterprise value at the valuation date. The enterprise value is calculated using the income approach, whereby the cash flows expected to be generated are discounted to their present value equivalent using a rate of return that reflects the relative risk of the investment, as well as the time value of money. The value of the SAFE assumes the probability of various possible scenarios to which an acceptable option pricing model is applied. The inputs to the model include the enterprise value described above, the conversion price and assumptions regarding the expected volatility and the expected life of each scenario.
| - |
Leases - Estimating the IBR:
|
The Company cannot readily determine the interest rate implicit in the lease; therefore, it uses its IBR to measure lease liabilities. The IBR is the rate of interest that the Company would have to pay to borrow over a similar term, and with a similar security, the funds necessary to obtain an asset of a similar value to the right-of-use asset in a similar economic environment. The IBR therefore reflects what the Company ‘would have to pay’, which requires estimation when no observable rates are available or when they need to be adjusted to reflect the terms and conditions of the lease.
F - 25
EVOGENE LTD. AND ITS SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands (except share and per share data)
| NOTE 3: - |
SIGNIFICANT ACCOUNTING JUDGMENTS, ESTIMATES AND ASSUPMTIONS USED IN THE PREPARATION OF THE FINANCIAL STATEMENTS (Cont.)
|
The Company estimates the IBR using observable inputs (such as market interest rates) when available and is required to make certain entity-specific estimates (such as the Company's stand-alone credit rating).
| - |
Lease extension and/or termination options:
|
In evaluating whether it is reasonably certain that the Company will exercise an option to extend a lease or not exercise an option to terminate a lease, the Company considers all relevant facts and circumstances that create an economic incentive for the Company to exercise the option to extend or not exercise the option to terminate such as, but not limited to: significant amounts invested in leasehold improvements, the significance of the underlying asset to the Company's operation and whether it is a specialized asset and the Company's past experience with similar leases.
After the commencement date, the Company reassesses the term of the lease upon the occurrence of a significant event or a significant change in circumstances that affects whether the Company is reasonably certain to exercise an option to extend or not exercise an option to terminate previously included in the determination of the lease term, such as significant leasehold improvements that had not been anticipated on the lease commencement date, sublease of the underlying asset for a period that exceeds the end of the previously determined lease period, etc.
| - |
Intangible assets - Estimating the fair value:
|
The fair value of intangible assets purchased is determined upon initial recognition and when the recoverability of those assets is assessed for impairment, by either one of three traditional methods in evaluating an asset. These methods include the market approach, the income approach and the cost approach. The pipeline products and potential products were valued by applying the income approach and the microorganisms collection was valued using the cost approach. The useful economic life was determined through years of development until the final year of projected sales. When applying the income approach, the cash flows expected to be generated by intangible assets are discounted to their present value equivalent using a rate of return that reflects the relative risk of the investment, as well as the time value of money. For each intangible asset, a specific discount rate was calculated using the “Modified CAPM Build-Up Method”.
F - 26
EVOGENE LTD. AND ITS SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands (except share and per share data)
| NOTE 4: - |
DISCLOSURE OF NEW STANDARDS IN THE PERIOD PRIOR TO THEIR ADOPTION
|
| a. |
Amendment to IAS 1, “Presentation of Financial Statements”:
|
In February 2021, the IASB issued an amendment to IAS 1, “Presentation of Financial Statements” (the IAS 1 Amendment). According to the IAS 1 Amendment, companies must provide disclosure of their material accounting policies rather than their significant accounting policies.
The IAS 1 Amendment is applicable for annual periods beginning on or after January 1, 2023. Earlier application is permitted. The Company is currently evaluating the effects of the IAS 1 Amendment on its financial statements with no intension for early adoption.
| b. |
Amendment to IAS 8, “Accounting Policies, Changes to Accounting Estimates and Errors”:
|
In February 2021, the IASB issued an amendment to IAS 8, “Accounting Policies, Changes to Accounting Estimates and Errors” (“the IAS 8 Amendment”), in which it introduces a new definition of “accounting estimates”.
Accounting estimates are defined as “monetary amounts in financial statements that are subject to measurement uncertainty”. The IAS 8 Amendment clarifies the distinction between changes in accounting estimates and changes in accounting policies and the correction of errors.
The IAS 8 Amendment is to be applied prospectively for annual reporting periods beginning on or after January 1, 2023 and is applicable to changes in accounting policies and changes in accounting estimates that occur on or after the start of that period. Early application is permitted.
The Company is currently evaluating the effects of the IAS 8 Amendment on its financial statements with no intension for early adoption.
| NOTE 5: - |
COLLABORATION, RESEARCH AND DISTRIBUTION AGREEMENTS-
|
Each of the following agreements amounted to 10% or more of the Company’s total revenues in 2022, 2021 and 2020:
| a. |
In March 2020, AgPlenus Ltd. entered into a multi-year collaboration with Corteva for the discovery and development of novel herbicides. Under the terms of the collaboration agreement, AgPlenus Ltd. and Corteva work together to optimize herbicide product candidates originating from the Company’s pipeline. Successful candidates from this collaboration are expected to be further developed by Corteva.
|
| b. |
In April 2020, Lavie Bio Ltd. entered into a proof-of-concept agreement with customer B (see Note 22c) for the purpose of optimization of a bioinsecticide.
|
F - 27
EVOGENE LTD. AND ITS SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands (except share and per share data)
| NOTE 5: - |
COLLABORATION, RESEARCH AND DISTRIBUTION AGREEMENTS- (Cont.)
|
| c. |
In August 2021, Canonic Ltd. entered into an agreement with customer C (see Note 22c) for the distribution in Israel of Canonic Ltd.’s medical cannabis products, through its distribution channels, on a consignment basis to licensed pharmacies, under the Canonic brand. The initial term of the agreement is 36 months.
|
Additional agreements signed during 2022:
| d. |
In August 2022, an affiliate company of ICL and Lavie Bio Ltd. entered a multi-year collaboration agreement for developing novel bio-stimulant products to enrich fertilizer efficiency. Under the Agreement, Lavie Bio Ltd. carries out dedicated product development programs, and Lavie Bio Ltd. and ICL will enter a licensing agreement that will define, among other aspects, Lavie Bio Ltd.’s consideration for commercialization of resulting products by ICL. As part of the collaboration, ICL invested through an affiliate company in Lavie Bio Ltd. $
|
| e. |
In September 2022, Canonic Ltd. entered into an agreement with a licensed Israeli medical cannabis cultivator, pursuant to which the parties will collaborate in the production and distribution of products derived from the medical cannabis varieties of Canonic Ltd. under a joint brand.
|
| f. |
In November 2022, Casterra Ag Ltd. entered into an agreement with a customer, under which Casterra Ag Ltd. would sell to the customer castor seeds, equipment, machinery and materials. The original period of the agreement is 12 months commencing on November 1, 2022.
|
NOTE 6: - CASH AND CASH EQUIVALENTS
|
December 31,
|
||||||||
|
2022
|
2021
|
|||||||
|
Cash for immediate withdrawal in USD
|
$
|
|
$
|
|
||||
|
Cash for immediate withdrawal in New Israeli Shekels (“NIS”)
|
|
|
||||||
|
Cash for immediate withdrawal in Euro and other currencies
|
|
|
||||||
|
$
|
|
$
|
|
|||||
NOTE 7: - MARKETABLE SECURITIES
Financial assets measured at fair value through profit and loss (see Note 14):
|
December 31,
|
||||||||
|
2022
|
2021
|
|||||||
|
Corporate bonds and government treasury notes
|
$
|
|
$
|
|
||||
F - 28
EVOGENE LTD. AND ITS SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands (except share and per share data)
NOTE 8: - OTHER RECEIVABLES AND PREPAID EXPENSES
|
December 31,
|
||||||||
|
2022
|
2021
|
|||||||
|
Government authorities
|
$
|
|
$
|
|
||||
|
Grant receivables
|
|
|
||||||
|
Patent cost reimbursement
|
|
|
||||||
|
Accrued bank interests
|
|
|
||||||
|
Prepaid expenses
|
|
|
||||||
|
Restricted cash
|
|
|
||||||
|
Other
|
|
|
||||||
|
$
|
|
$
|
|
|||||
NOTE 9: - LEASES
The Company has entered into various lease agreements for certain of its offices and car leases with original lease periods expiring between 2023 and 2028 . Most of the lease agreements include one or more options to renew. The Company does not assume renewals in determination of the lease term unless the renewals are deemed to be reasonably certain at lease commencement.
Lease payments included in the measurement of the lease liability comprise the following: the fixed non-cancelable lease payments and payments for optional renewal periods where it is reasonably certain the renewal period will be exercised. The Company's lease agreements do not contain any material residual value guarantees or material restrictive covenants.
| a. |
Information on leases in which the Company is a lessee:
|
|
Year ended December 31
|
||||||||
|
2022
|
2021
|
|||||||
|
Interest expense on lease liabilities
|
$
|
|
$
|
|
||||
|
Exchange rate differences
|
(
|
)
|
(
|
)
|
||||
|
CPI recognized on lease liabilities and right-of-use assets
|
|
|
||||||
|
Depreciation expenses on right-of-use assets
|
|
|
||||||
|
Income (expense) due to removal of lease liabilities and right-of-use assets
|
(
|
)
|
*
|
)
|
||||
*) Represents an income amount lower than $1.
F - 29
EVOGENE LTD. AND ITS SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands (except share and per share data)
NOTE 9: - LEASES (Cont.)
| b. |
Lease extension and cancelation options:
|
The Company has leases that include both extension and cancelation options. These are used to maximize operational flexibility in terms of managing the assets used in the Company's operations. The Company exercises significant judgements in deciding whether it is reasonably certain that the extension and cancelation options will be exercised.
In leaseholds for periods of 5 -7 years, the Company recognizes any extension options exercised as per lease agreements in the lease period. In these leases, the Company usually exercises the lease extension option to avoid critical impairment to its operating activities in the event that an alternative asset is not available immediately upon termination of the noncancelable lease period.
In leases of motor vehicles, the Company does not include in the lease term the exercise of extension options since the Company does not ordinarily exercise options that extend the lease period beyond 3 years .
Moreover, the lease period subject to the termination option is accounted for as part of the lease period when it is reasonably certain that the termination option will not be exercised.
| c. |
Disclosures of right-of-use assets:
|
|
Leasehold
|
Motor vehicles
|
Total
|
||||||||||
|
Cost:
|
||||||||||||
|
Balance as of January 1, 2022
|
$ |
|
$ |
|
$ |
|
||||||
|
Additions during the year:
|
||||||||||||
|
Additions to right-of-use assets for new leases in the period
|
|
|
|
|||||||||
|
Revaluation recognized in CPI
|
|
|
|
|||||||||
|
Disposals during the year:
|
||||||||||||
|
Disposals of right-of-use assets for leases terminated in the period
|
|
(
|
)
|
(
|
)
|
|||||||
|
Balance as of December 31, 2022
|
|
|
|
|||||||||
|
Accumulated depreciation:
|
||||||||||||
|
Balance as of January 1, 2022
|
|
|
|
|||||||||
|
Additions during the year:
|
||||||||||||
|
Depreciation
|
|
|
|
|||||||||
|
Disposals during the year:
|
||||||||||||
|
Disposals of right-of-use assets
|
|
(
|
)
|
(
|
)
|
|||||||
|
Balance as of December 31, 2022
|
|
|
|
|||||||||
|
Depreciated cost on December 31, 2022
|
$ |
|
$ |
|
$ |
|
||||||
F - 30
EVOGENE LTD. AND ITS SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands (except share and per share data)
NOTE 9: - LEASES (Cont.)
|
Leasehold
|
Motor vehicles
|
Total
|
||||||||||
|
Cost:
|
||||||||||||
|
Balance as of January 1, 2021
|
$ |
|
$ |
|
$ |
|
||||||
|
Additions during the year:
|
||||||||||||
|
Additions to right-of-use assets for new leases in the period
|
|
|
|
|||||||||
|
Revaluation recognized in CPI
|
|
|
|
|||||||||
|
Disposals during the year:
|
||||||||||||
|
Disposals of right-of-use assets for leases terminated in the period
|
|
(
|
)
|
(
|
)
|
|||||||
|
Balance as of December 31, 2021
|
|
|
|
|||||||||
|
Accumulated depreciation:
|
||||||||||||
|
Balance as of January 1, 2021
|
|
|
|
|||||||||
|
Additions during the year:
|
||||||||||||
|
Depreciation
|
|
|
|
|||||||||
|
Disposals during the year:
|
||||||||||||
|
Disposals of right-of-use assets
|
|
(
|
)
|
(
|
)
|
|||||||
|
Balance as of December 31, 2021
|
|
|
|
|||||||||
|
Depreciated cost on December 31, 2021
|
$ |
|
$ |
|
$ |
|
||||||
F - 31
EVOGENE LTD. AND ITS SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands (except share and per share data)
NOTE 9: - LEASES (Cont.)
| d. |
Disclosures of lease liability:
|
|
Leasehold
|
Motor vehicles
|
Total
|
||||||||||
|
Balance as of January 1, 2022
|
$ |
|
$ |
|
$ |
|
||||||
|
Lease payments
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||
|
Lease deposits
|
|
(
|
)
|
(
|
)
|
|||||||
|
Interest expense
|
|
|
|
|||||||||
|
Exchange rate differences
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||
|
Additions to lease liability for new leases in the period
|
|
|
|
|||||||||
|
Reduction of lease liability for leases terminated in the period
|
|
(
|
)
|
(
|
)
|
|||||||
|
Revaluation recognized in CPI
|
|
|
|
|||||||||
|
Balance as of December 31, 2022
|
$ |
|
$ |
|
$ |
|
||||||
|
Leasehold
|
Motor vehicles
|
Total
|
||||||||||
|
Balance as of January 1, 2021
|
$ |
|
$ |
|
$ |
|
||||||
|
Lease payments
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||
|
Lease deposits
|
|
(
|
)
|
(
|
)
|
|||||||
|
Interest expense
|
|
|
|
|||||||||
|
Exchange rate differences
|
(
|
)
|
|
(
|
)
|
|||||||
|
Additions to lease liability for new leases in the period
|
|
|
|
|||||||||
|
Reduction of lease liability for leases terminated in the period
|
|
(
|
)
|
(
|
)
|
|||||||
|
Revaluation recognized in CPI
|
|
|
|
|||||||||
|
Balance as of December 31, 2021
|
$ |
|
$ |
|
$ |
|
||||||
The Company leases facilities for its offices and research and development activities, as well as motor vehicles under leases. As of December 31, 2022, the future minimum lease payments under non-cancelable leases for the years ending December 31, are as follows:
|
Leasehold
|
Motor vehicles
|
Total
|
||||||||||
|
2023
|
$
|
|
$
|
|
$
|
|
||||||
|
2024
|
|
|
|
|||||||||
|
2025
|
|
|
|
|||||||||
|
2026
|
|
|
|
|||||||||
|
2027 and thereafter
|
|
|
|
|||||||||
|
Total lease payments
|
$
|
|
$
|
|
$
|
|
||||||
|
Less: imputed interest
|
|
|
|
|||||||||
|
Present value of lease liabilities
|
$
|
|
$
|
|
$
|
|
||||||
F - 32
EVOGENE LTD. AND ITS SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands (except share and per share data)
| NOTE 10: - |
PROPERTY, PLANT AND EQUIPMENT, NET
|
|
Laboratory equipment
|
Computers and peripheral equipment
|
Office equipment and furniture
|
Leasehold improvements
|
Total
|
||||||||||||||||
|
Cost:
|
||||||||||||||||||||
|
Balance on January 1, 2022
|
$
|
|
$
|
|
$
|
|
$
|
|
$
|
|
||||||||||
|
Additions
|
|
|
|
|
|
|||||||||||||||
|
Deductions
|
|
|
|
|
|
|||||||||||||||
|
Balance on December 31, 2022
|
|
|
|
|
|
|||||||||||||||
|
Accumulated Depreciation:
|
||||||||||||||||||||
|
Balance on January 1, 2022
|
|
|
|
|
|
|||||||||||||||
|
Additions
|
|
|
|
|
|
|||||||||||||||
|
Deductions
|
|
|
|
|
|
|||||||||||||||
|
Balance on December 31, 2022
|
|
|
|
|
|
|||||||||||||||
|
Depreciated cost on December 31, 2022
|
$
|
|
$
|
|
$
|
|
$
|
|
$
|
|
||||||||||
|
Laboratory equipment
|
Computers and peripheral equipment
|
Office equipment and furniture
|
Leasehold improvements
|
Total
|
||||||||||||||||
|
Cost:
|
||||||||||||||||||||
|
Balance on January 1, 2021
|
$
|
|
$
|
|
$
|
|
$
|
|
$
|
|
||||||||||
|
Additions
|
|
|
|
|
|
|||||||||||||||
|
Deductions
|
(
|
)
|
(
|
)
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||||||
|
Balance on December 31, 2021
|
|
|
|
|
|
|||||||||||||||
|
Accumulated Depreciation:
|
||||||||||||||||||||
|
Balance on January 1, 2021
|
|
|
|
|
|
|||||||||||||||
|
Additions
|
|
|
|
|
|
|||||||||||||||
|
Deductions
|
(
|
)
|
(
|
)
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||||||
|
Balance on December 31, 2021
|
|
|
|
|
|
|||||||||||||||
|
Depreciated cost on December 31, 2021
|
$
|
|
$
|
|
$
|
|
$
|
|
$
|
|
||||||||||
NOTE 11: - INTANGIBLE ASSETS, NET
On August 6, 2019, Corteva, through its subsidiary Pioneer Hi-Bred International, Inc., made an investment in the Company's agriculture biologicals subsidiary, Lavie Bio Ltd., which included the contribution of all Corteva’s holdings in its wholly owned subsidiary Taxon Biosciences, Inc. along with an amount of $10,000 in consideration for Lavie Bio Ltd.'s shares. This transaction included the following intangible assets (see also Note 18f):
F - 33
EVOGENE LTD. AND ITS SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands (except share and per share data)
NOTE 11: - INTANGIBLE ASSETS, NET (Cont.)
|
Pipeline Products
|
Potential Products
|
Microorganisms Collection
|
Total
|
|||||||||||||
|
Cost:
|
||||||||||||||||
|
Balance on January 1, 2022
|
$
|
|
$
|
|
$
|
|
$
|
|
||||||||
|
Additions
|
|
|
|
|
||||||||||||
|
Balance on December 31, 2022
|
$
|
|
$
|
|
$
|
|
$
|
|
||||||||
|
Accumulated Depreciation:
|
||||||||||||||||
|
Balance on January 1, 2022
|
$
|
|
$
|
|
$
|
|
$
|
|
||||||||
|
Additions
|
|
|
|
|
||||||||||||
|
Balance on December 31, 2022
|
|
|
|
|
||||||||||||
|
Amortized cost on December 31, 2022
|
$
|
|
$
|
|
$
|
|
$
|
|
||||||||
|
Pipeline Products
|
Potential Products
|
Microorganisms Collection
|
Total
|
|||||||||||||
|
Cost:
|
||||||||||||||||
|
Balance on January 1, 2021
|
$
|
|
$
|
|
$
|
|
$
|
|
||||||||
|
Additions
|
|
|
|
|
||||||||||||
|
Balance on December 31, 2021
|
|
|
|
|
||||||||||||
|
Accumulated Depreciation:
|
||||||||||||||||
|
Balance on January 1, 2021
|
$
|
|
$
|
|
$
|
|
$
|
|
||||||||
|
Additions
|
|
|
|
|
||||||||||||
|
Balance on December 31, 2021
|
|
|
|
|
||||||||||||
|
Amortized cost on December 31, 2021
|
$
|
|
$
|
|
$
|
|
$
|
|
||||||||
Amortization expenses of intangible assets are classified in profit or loss in research and development, net.
| NOTE 12: - |
LIABILITIES IN RESPECT OF GOVERNMENT GRANTS
|
|
2022
|
2021
|
|||||||
|
Balance on January 1,
|
$
|
|
$
|
|
||||
|
Grants received
|
|
|
||||||
|
Royalties paid
|
(
|
)
|
(
|
)
|
||||
|
Amounts recorded in profit or loss
|
|
(
|
)
|
|||||
|
Balance on December 31,
|
$
|
|
$
|
|
||||
F - 34
EVOGENE LTD. AND ITS SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands (except share and per share data)
NOTE 12: - LIABILITIES IN RESPECT OF GOVERNMENT GRANTS (Cont.)
The Company received research and development grants from the IIA and undertook to pay royalties of
In July 2022, Canonic Ltd received the Israeli Ministry of Economy approval to be included in “Smart money” grants program for marketing operations in Germany. The maximum grants amount from this program is approximately $85 . Canonic Ltd. undertook to pay royalties of 3% of yearly revenues above approximately $284 derived from the operation in Germany, up to 100 % of the grants received. As of December 31, 2022, Canonic Ltd. expects to receive $19 for marketing expenses in Germany incurred until December 31, 2022.
NOTE 13: - CONVERTIBLE SAFE
In August 2022, ICL and Lavie Bio Ltd. (“Lavie”) entered a multi-year collaboration agreement for developing novel bio-stimulant products to enrich fertilizer efficiency. As part of the collaboration, ICL (through its affiliate company) invested $10,000 in Lavie using a SAFE agreement (simple agreement for future equity). Pursuant to the terms of that agreement, the SAFE amount will automatically be converted during enumerated events, each subject to certain terms and conditions, to include (i) an equity financing (as such term is defined in the agreement), with such SAFE amount converting into equity at a 20 % discount rate, or (ii) a liquidity event (as such term is defined in the agreement), with such SAFE amount converting into shares to receive a portion of proceeds due as part of the liquidity event. The price per share for future conversion is capped at a price reflecting a valuation of $130,000 prior to the relevant event. Additionally, ICL is permitted to invest an additional amount prior to, or as part of, the next financing of Lavie, which may result in ICL holding up to a maximum interest of 14.29 % in Lavie on a fully diluted share capital basis. If no equity financing occurs within thirty (30) months of the effective date of the agreement, ICL shall be entitled to convert the SAFE amount at a price per share reflecting a valuation of $70,000 . According to IAS 32, "Financial Instruments: Presentation", as conversion upon an equity financing requires the delivery of variable number of shares, the SAFE is accounted for as a liability and measured at fair value according to IFRS 9. The fair value of the SAFE will be remeasured at the end of each reporting period with any change to fair value recorded within financial expenses in the statements of profit or loss. The fair value of the SAFE at initial recognition equals the transaction price of $10,000 . As of December 31, 2022 the fair value of the SAFE, based on a valuation prepared by third-party valuation specialists, is $10,114 .
| NOTE 14: - |
FINANCIAL INSTRUMENTS
|
| a. |
Classification of financial instruments by fair value hierarchy:
|
|
December 31,
|
||||||||
|
2022
|
2021
|
|||||||
|
Financial assets:
|
||||||||
|
Marketable securities – Level 1 |
$
|
|
$
|
|
||||
During 2022 and 2021, there were no transfers due to the fair value measurement of any financial instrument to or from Levels 1, 2 and 3.
F - 35
EVOGENE LTD. AND ITS SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands (except share and per share data)
| NOTE 14: - |
FINANCIAL INSTRUMENTS (Cont.)
|
| b. |
Financial risk factors:
|
The Company's operations are exposed to various financial risks, such as market risk (foreign currency risk, price risk), credit risk and liquidity risk. The Company's comprehensive risk management plan focuses on measures to minimize possible negative effects on the financial performance of the Company.
The Company's Board of Directors has provided guidelines for risk management, and specific policies for various risk exposures, such as foreign currency risk, interest-rate risk, credit risk, and the use of derivative financial instruments, non-derivative financial instruments, and excess-liquidity investments.
1. Market Risk:
| a. |
Foreign currency risk:
The Company operates primarily in Israel and has an exchange rate risk as it incurs fixed expenses in NIS, which differs from its functional currency.
|
| b. |
Price risk:
The Company has investments in bonds, classified as financial instruments, which are measured at fair value through profit and loss. Accordingly, the Company is exposed to a risk from changes in the fair value of these investments.
|
| 2. |
Credit Risk:
|
The Company holds cash and cash equivalents, short-term investments and other financial instruments with various financial institutions. Its policy is to spread its investments among various institutions. In accordance with this policy, the Company invests its funds with stable financial institutions.
The Company has no trade receivables balances past due, and accordingly has not recognized any provision for doubtful accounts.
| 3. |
Liquidity Risk:
|
The following table presents the repayment dates of the Company's financial liabilities, by contractual terms, in nominal amounts (including interest payments):
F - 36
EVOGENE LTD. AND ITS SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands (except share and per share data)
| NOTE 14: - |
FINANCIAL INSTRUMENTS (Cont.)
|
Balance on December 31, 2022:
|
Up to 1 year
|
1 year to 2 years
|
2 years
to 3 years
|
3 years to 4 years
|
4 years to 5 years
|
Over 5 years
|
Total
|
||||||||||||||||||||||
|
Trade payables
|
$ |
|
$ |
|
$ |
|
$ |
|
$ |
|
$ |
|
$ |
|
||||||||||||||
|
Employees and payroll accruals
|
|
|
|
|
|
|
|
|||||||||||||||||||||
|
Other payables
|
|
|
|
|
|
|
|
|||||||||||||||||||||
|
Leases liability
|
|
|
|
|
|
|
|
|||||||||||||||||||||
|
Liabilities in respect of government grants
|
|
|
|
|
|
|
|
|||||||||||||||||||||
| $ |
|
$ |
|
$ |
|
$ |
|
$ |
|
$ |
|
$ |
|
|||||||||||||||
Balance on December 31, 2021:
|
Up to 1 year
|
1 year to 2 years
|
2 years
to 3 years
|
3 years to 4 years
|
4 years to 5 years
|
Over 5 years
|
Total
|
||||||||||||||||||||||
|
Trade payables
|
$
|
|
$
|
|
$
|
|
$
|
|
$
|
|
$
|
|
$
|
|
||||||||||||||
|
Employees and payroll accruals
|
|
|
|
|
|
|
|
|||||||||||||||||||||
|
Other payables
|
|
|
|
|
|
|
|
|||||||||||||||||||||
|
Leases liability
|
|
|
|
|
|
|
|
|||||||||||||||||||||
|
Liabilities in respect of government grants
|
|
|
|
|
|
|
|
|||||||||||||||||||||
|
$
|
|
$
|
|
$
|
|
$
|
|
$
|
|
$
|
|
$
|
|
|||||||||||||||
| c. |
Fair Value:
|
The carrying amounts of cash and cash equivalents, short-term investments, other receivables, trade payables and other payables approximate their fair values due to the short-term maturities of such instruments.
The fair value of the liabilities in respect of government grants is measured using a discount rate that reflects the applicable market rate of interest at the date the grants are received, which approximates the fair value at the respective balance sheet date.
The fair value of lease liability is measured using a discount rate that reflects the IBR of interest at the date of the contract.
The fair value of the SAFE is based on the weighted average value of various scenarios assuming Lavie Bio's estimated enterprise value at the valuation date. The enterprise value is calculated using the income approach, whereby the cash flows expected to be generated are discounted to their present value equivalent using a rate of return that reflects the relative risk of the investment, as well as the time value of money.
F - 37
EVOGENE LTD. AND ITS SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands (except share and per share data)
| NOTE 14: - |
FINANCIAL INSTRUMENTS (Cont.)
|
| d. |
Sensitivity tests relating to changes in market factors:
|
|
December 31,
|
||||||||
|
2022
|
2021
|
|||||||
|
Sensitivity test to changes in the USD/NIS exchange rate:
|
||||||||
|
Gain (loss) from the change:
|
||||||||
|
Increase of 5% in exchange rate
|
$
|
(
|
) |
$
|
(
|
)
|
||
|
Decrease of 5% in exchange rate
|
$
|
|
|
$ |
|
|||
|
Sensitivity test to changes in the market price of listed securities:
|
||||||||
|
Gain (loss) from the change:
|
||||||||
|
Increase of 5% in market price
|
$ |
|
$ |
|
||||
|
Decrease of 5% in market price
|
$ |
(
|
)
|
$
|
(
|
)
|
||
Sensitivity tests and principal work assumptions:
The selected changes in the relevant risk variables were determined based on management's estimate as to reasonable possible changes in these risk variables.
NOTE 15: - COMMITMENTS AND CONTINGENT LIABILITIES
| a. |
Claims:
As of December 31, 2022, the Company is not involved in any material claims.
|
| b. |
Government grants:
The Company received research and development grants from the IIA. See Note 12. If no economic benefits are expected from the research activity, the royalty obligation is not recorded as a liability and instead is treated as a contingent liability in accordance with IAS 37. The grants from the IIA impose certain restrictions on the transfer outside of Israel of the underlying know-how and the manufacturing or manufacturing rights of the underlying products and technologies.
|
F - 38
EVOGENE LTD. AND ITS SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands (except share and per share data)
| NOTE 16: - |
SEVERANCE PAY LIABILITY
|
Labor laws and the Severance Law require the Company to pay compensation to employees upon dismissal or retirement, or to make routine contributions in defined contribution plans pursuant to Section 14 of the Severance Law, as described below. The Company's liability is accounted for as a post-employment benefit. The Company's employee benefit liability is based on a valid labor agreement, the employee's salary, and the applicable terms of employment, which together generate a right to severance compensation.
Post-employment employee benefits are financed by deposits with defined deposit plans, as detailed below.
Contributions in accordance with Section 14 to the Severance Law release the Company from any additional liability to employees for whom said contributions were made. These contributions represent defined contribution plans.
|
Year ended December 31,
|
||||||||||||
|
2022
|
2021
|
2020
|
||||||||||
|
Expenses - defined contribution plan
|
$
|
|
$
|
|
$
|
|
||||||
| NOTE 17: - |
TAXES ON INCOME
|
a. Tax rates applicable to the Company and its subsidiaries:
| 1. |
The Israeli corporate income tax rate was
|
| 2. |
The Company’s U.S. subsidiaries, Evogene Inc., Lavie Bio Inc., Lavie Tech Inc., Taxon Biosciences, Inc., and AgPlenus Inc., are subject to U.S. income taxes. During the years 2018 through 2022, the tax rates applicable to those companies were approximately
|
b. Tax assessments:
Evogene Ltd. and its subsidiary Casterra Ag Ltd. received assessments that are considered final, up to and including the 2016 tax year.
The Company’s Israeli subsidiaries, Biomica Ltd., AgPlenus Ltd., Lavie Bio Ltd. and Canonic Ltd. have not received final tax assessments since their incorporation.
| c. |
Carryforward losses for tax purposes and other temporary differences:
As of December 31, 2022, Evogene Ltd. and its Israeli subsidiaries have carryforward operating tax losses amounting to approximately $
|
| d. |
Deferred taxes:
The Company did not record deferred tax assets with respect to net operating losses incurred by the Company and the Israeli subsidiaries since it is not probable that they will generate a taxable income in future years.
The Company recorded current tax liability in one of its US subsidiaries in the amount of $
|
F - 39
EVOGENE LTD. AND ITS SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands (except share and per share data)
| NOTE 17: - |
TAXES ON INCOME (Cont.)
|
| e. |
Theoretical tax:
|
As the Company has incurred operating losses during the years ended December 31, 2022, 2021 and 2020 for which deferred taxes were not recorded, as mentioned in note 17d. The reconciliation between the tax expense, assuming that all the income and expenses, gains and losses in the statement of income were taxed at the statutory tax rate, and the taxes on income recorded in profit or loss, does not provide significant information and is therefore not presented.
| NOTE 18: - |
SHAREHOLDERS' EQUITY
|
| a. |
Share capital:
|
|
December 31,
|
||||||||||||||||
|
2022
|
2021
|
|||||||||||||||
|
Authorized
|
Issued and Outstanding
|
Authorized
|
Issued and Outstanding
|
|||||||||||||
|
Number of shares
|
||||||||||||||||
|
Ordinary shares of NIS 0.02 par value each
|
||||||||||||||||
| b. |
Changes in share capital:
|
Share capital issued and outstanding:
|
Number of shares
|
NIS par value
|
|||||||
|
Outstanding on January 1, 2021
|
||||||||
|
Exercise of options and vesting of restricted share units ("RSUs")
|
||||||||
| Exercise of pre-funded warrants | ||||||||
|
Issuance of ordinary shares
|
||||||||
|
Outstanding on December 31, 2021
|
||||||||
|
Exercise of options and vesting of RSUs |
|
|
||||||
|
Issuance of ordinary shares
|
||||||||
|
Outstanding on December 31, 2022
|
||||||||
F - 40
EVOGENE LTD. AND ITS SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands (except share and per share data)
| NOTE 18: - |
SHAREHOLDERS' EQUITY (Cont.)
|
Issuance of shares and pre-funded warrants:
| 1. |
On September 2, 2020, the Company issued
|
| 2. |
On November 2, 2020, the Company completed a second registered direct offering with certain institutional investors for the purchase of
|
| 3. |
On January 4, 2021, the
|
| 4. |
On January 14, 2021, the Company entered a Controlled Equity Offering Sales Agreement, pursuant to which it issued
|
| 5. |
On February 19, 2021, the Company entered a new Controlled Equity Offering Sales Agreement. In accordance with the terms of the sales agreement, from time to time the Company may offer and sell its ordinary shares in an ATM offering having an aggregate offering price of up to $
|
|
| 6. | During December 2022, |
| c. |
Rights attached to shares:
|
The Company’s ordinary shares have voting rights at the general meeting, rights to dividends, rights upon liquidation of the Company and the right to nominate directors in the Company.
F - 41
EVOGENE LTD. AND ITS SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands (except share and per share data)
| NOTE 18: - |
SHAREHOLDERS' EQUITY (Cont.)
|
| d. |
Rights attached to pre-funded warrants:
|
Until the pre-funded warrants are exercised into ordinary shares, there are no rights with respect to the ordinary shares underlying such pre-funded warrants. Upon exercise of the pre-funded warrants into ordinary shares, the holder is entitled to exercise the rights attached to shares only as to matters for which the record date occurs after the exercise date.
| e. |
Capital management in the Company:
|
The Company's objectives in managing capital are as follows:
To maintain its ability to ensure the continuity of the business, and thus to generate a return to equity holders, investors and other parties. The Company manages its capital structure and makes adjustments following changes in economic conditions and the risk-nature of its operations. In order to maintain or to adjust the necessary capital structure, the Company takes various steps, such as raising funds by capital issues.
| f. |
Composition of non-controlling interests in the statement of financial position:
|
|
December 31,
|
||||||||
|
2022
|
2021
|
|||||||
|
Balance on January 1,
|
$
|
|
$
|
|
||||
|
Forfeiture of non-controlling interests regarding share-based compensation
|
(
|
)
|
(
|
)
|
||||
|
Share-based compensation
|
|
|
||||||
|
Exercise of subsidiary options
|
|
|
||||||
|
Benefit to non-controlling interests regarding Share-based compensation
|
|
|
||||||
|
Loss attributed to non-controlling interests
|
(
|
)
|
(
|
)
|
||||
|
Balance on December 31,
|
$
|
|
$
|
|
||||
Issuance of shares by subsidiary:
| 1. |
On August 6, 2019, Corteva, through its subsidiary Pioneer Hi-Bred International, Inc., made an investment in the Company's agriculture biologicals subsidiary, Lavie Bio Ltd., which included the contribution of all Corteva’s holdings in its wholly owned subsidiary Taxon Biosciences, Inc. along with an amount of $
|
F - 42
EVOGENE LTD. AND ITS SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands (except share and per share data)
| NOTE 18: - |
SHAREHOLDERS' EQUITY (Cont.)
|
| 2. |
On July 24, 2020,
|
| 3. |
On November 16, 2021,
|
| NOTE 19: - |
SHARE- BASED COMPENSATION
|
| a. |
Expenses recognized in the financial statements:
|
The expense recognized in the Company's financial statements for services provided by employees and service-providers is as follows:
|
Year ended December 31,
|
||||||||||||
|
2022
|
2021
|
2020
|
||||||||||
|
Share-based compensation - Attributable to equity holders of the Company
|
$
|
$
|
$
|
|||||||||
|
Share-based compensation - Attributable to non-controlling interests (see Note 18f)
|
||||||||||||
|
$
|
$
|
$
|
||||||||||
|
b.
|
The Company maintains four share option and incentive plans: the
|
| c. |
Evogene Ltd. Share-based payment plan for employees, directors and consultants:
|
During 2022, 2021 and 2020, the board of directors of the Company approved to grant its employees, directors and consultants 605,500 , 987,750 and 1,046,500 options, respectively. The fair value of the options granted in 2022, 2021 and 2020 determined at their grant date using the binomial model, was approximately $323 , $957 and $629 , respectively.
F - 43
EVOGENE LTD. AND ITS SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands (except share and per share data)
| NOTE 19: - |
SHARE- BASED COMPENSATION (Cont.)
|
| d. |
Evogene Ltd. Share options activity:
|
The following table summarizes the number of share options, the weighted average exercise price, and the changes that were made in the option plans to employees, consultants and directors of the Company:
|
2022
|
2021
|
2020
|
||||||||||||||||||||||
|
Number of |
Weighted |
Number of |
Weighted |
Number of |
Weighted |
|||||||||||||||||||
|
Outstanding on January 1,
|
|
|
|
|
|
|
||||||||||||||||||
|
Granted
|
|
|
|
|
|
|
||||||||||||||||||
|
Exercised
|
(
|
)
|
|
(
|
)
|
|
(
|
)
|
|
|||||||||||||||
|
Forfeited
|
(
|
)
|
|
(
|
)
|
|
(
|
)
|
|
|||||||||||||||
|
Outstanding at December 31,
|
|
|
|
|
|
|
||||||||||||||||||
|
Exercisable at December 31,
|
|
|
|
|
|
|
||||||||||||||||||
The following table summarizes information about share options outstanding at December 31, 2022:
|
Options outstanding
|
||||||||||||
|
Range of exercise prices ($)
|
Number |
Average |
Weighted |
|||||||||
|
0.48 - 1.76 |
||||||||||||
|
1.85 - 3.42 |
||||||||||||
|
3.61 - 5.88 |
||||||||||||
|
7.09 -11.26 |
||||||||||||
|
12.07 - 18.34 |
||||||||||||
|
Total
|
||||||||||||
The weighted average outstanding remaining life contractual term of the options as of December 31, 2022 is 5.82 years (as of December 31, 2021, it was 5.94 years).
The weighted average fair value of options granted during 2022 was $0.53 (for options granted during 2021, the weighted average fair value was $0.97 ).
F - 44
EVOGENE LTD. AND ITS SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands (except share and per share data)
| NOTE 19: - |
SHARE- BASED COMPENSATION (Cont.)
|
The fair value of Company share options granted to employees, directors and consultants for the years ended December 31, 2022, 2021 and 2020 was estimated using the binomial model with the following assumptions:
|
2022
|
2021
|
2020
|
||||||||||
|
Dividend yield (%)
|
|
|
|
|||||||||
|
Expected volatility of the share prices (%)
|
|
|
|
|||||||||
|
Risk-free interest rate (%)
|
|
|
|
|||||||||
|
Suboptimal factor
|
|
|
|
|||||||||
|
Post-vesting forfeiture rate (%)
|
|
|
|
|||||||||
The expected volatility of the share prices reflects the assumption that the historical volatility of the share prices is reasonably indicative of expected future trends.
|
e.
|
Evogene Ltd. RSUs activity:
|
The 2021 Plan also provides for the grant of restricted shares and RSUs. During 2022 and 2021, the board of directors of the Company approved to grant its employees, directors and consultants
The following table summarizes the number of RSUs, and the changes that were made under the 2021 Plan to employees, consultants and directors of the Company during 2022 and 2021:
|
|
2022 |
2021 |
||||||||||||||
|
|
Number of RSUs |
Weighted average grant date fair value |
Number of RSUs |
Weighted average grant date fair value |
||||||||||||
|
|
||||||||||||||||
|
Outstanding on January 1 |
|
|
|
|
||||||||||||
|
Granted |
|
|
|
|
||||||||||||
|
Vested |
( |
) |
|
( |
) |
|
||||||||||
|
Forfeited |
( |
) |
|
( |
) |
|
||||||||||
|
|
||||||||||||||||
|
Outstanding at December 31 |
|
|
|
|
||||||||||||
| f. |
The Company's subsidiaries maintain share option and incentive plans with similar terms and conditions. |
The following table summarizes the number of share options, the weighted average exercise price, and the changes that were made in the option plans to employees, consultants and directors of the Company's subsidiaries:
F - 45
EVOGENE LTD. AND ITS SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands (except share and per share data)
| NOTE 19: - |
SHARE- BASED COMPENSATION (Cont.)
|
|
2022
|
2021
|
|||||||||||||||
|
Number of |
Weighted |
Number of |
Weighted |
|||||||||||||
|
Outstanding on January 1,
|
|
|
|
|
||||||||||||
|
Granted
|
|
|
|
|
||||||||||||
|
Exercised
|
(
|
)
|
|
(
|
)
|
|
||||||||||
|
Forfeited
|
(
|
)
|
|
(
|
)
|
|
||||||||||
|
Outstanding on December 31,
|
|
|
|
|
||||||||||||
|
Exercisable on December 31,
|
|
|
|
|
||||||||||||
| g. |
The fair value of Company's subsidiaries’ share options granted to employees, directors and consultants for the years ended December 31, 2022 and 2021 was estimated using the binomial model with the following assumptions: |
|
2022
|
2021
|
|||||||
|
Dividend yield (%)
|
|
|
||||||
|
Expected volatility of the share prices (%)
|
|
|
||||||
|
Risk-free interest rate (%)
|
|
|
||||||
|
Suboptimal factor
|
|
|
||||||
|
Post-vesting forfeiture rate (%)
|
|
|
||||||
| NOTE 20: - |
STATEMENTS OF PROFIT OR LOSS – ADDITIONAL INFORMATION |
| a. |
Cost of revenues:
|
|
Year ended December 31,
|
||||||||||||
|
2022
|
2021
|
2020
|
||||||||||
|
Salaries and benefits
|
$
|
$
|
$
|
|||||||||
|
Materials and sub-contractors
|
||||||||||||
|
$
|
$
|
$
|
||||||||||
F - 46
EVOGENE LTD. AND ITS SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands (except share and per share data)
| NOTE 20: - |
STATEMENTS OF COMPREHENSIVE LOSS – ADDITIONAL INFORMATION (Cont.) |
| b. |
Research and development, net:
|
|
Year ended December 31,
|
||||||||||||
|
2022
|
2021
|
2020
|
||||||||||
|
Salaries and benefits
|
$
|
$
|
$
|
|||||||||
|
Share-based compensation
|
||||||||||||
|
Materials and sub-contractors
|
||||||||||||
|
Plant growth and greenhouse maintenance
|
||||||||||||
|
Rentals and office maintenance
|
||||||||||||
|
Depreciation and amortization
|
||||||||||||
|
Loss from derecognition of property, plant and equipment
|
|
|
|
|||||||||
|
Other
|
||||||||||||
|
Participation in respect of government grants
|
( |
)
|
( |
)
|
( |
)
|
||||||
|
$
|
$
|
$
|
||||||||||
| c. |
Sales and marketing:
|
|
Year ended December 31,
|
||||||||||||
|
2022
|
2021
|
2020
|
||||||||||
|
Salaries and benefits
|
$
|
$
|
$
|
|||||||||
|
Share-based compensation
|
||||||||||||
|
Subcontractors and professional fees |
||||||||||||
|
Travel
|
||||||||||||
|
Legal
|
||||||||||||
|
Other
|
||||||||||||
|
$
|
$
|
$
|
||||||||||
| d. |
General and administrative:
|
|
Year ended December 31,
|
||||||||||||
|
2022
|
2021
|
2020
|
||||||||||
|
Salaries and benefits
|
$
|
$
|
$
|
|||||||||
|
Share-based compensation
|
||||||||||||
|
Professional fees
|
||||||||||||
|
Other
|
||||||||||||
|
$
|
$
|
$
|
||||||||||
| e. |
Other income:
During the year ended December 31, 2022, the Company received an amount of $ |
F - 47
EVOGENE LTD. AND ITS SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands (except share and per share data)
| NOTE 20: - |
STATEMENTS OF COMPREHENSIVE LOSS – ADDITIONAL INFORMATION (Cont.) |
| f. |
Financing income and expenses
|
Financing income:
|
Year ended December 31,
|
||||||||||||
|
2022
|
2021
|
2020
|
||||||||||
|
Exchange differences
|
$
|
|
$
|
|
$
|
|
||||||
|
Interest income
|
|
|
|
|||||||||
|
Financial expenses in respect of government grants |
||||||||||||
|
Change in the fair value of marketable securities
|
|
|
|
|||||||||
|
$
|
|
$
|
|
$
|
|
|||||||
Financing expenses:
|
Year ended December 31,
|
||||||||||||
|
2022
|
2021
|
2020
|
||||||||||
|
Bank expenses and commissions
|
$
|
$
|
$
|
|||||||||
|
Exchange differences
|
||||||||||||
|
Change in the fair value of marketable securities
|
||||||||||||
|
Pre-funded warrants issuance expenses
|
||||||||||||
|
Revaluation of pre-funded warrants
|
||||||||||||
|
Lease liability interest
|
||||||||||||
|
Revaluation of Convertible SAFE |
||||||||||||
|
Financial expenses in respect of government grants |
||||||||||||
|
$
|
$
|
$
|
||||||||||
|
NOTE 21: - |
LOSS PER SHARE |
Details of the number of shares and loss used in the computation of loss per share:
|
Year ended December 31,
|
||||||||||||||||||||||||
|
2022
|
2021
|
2020
|
||||||||||||||||||||||
|
Weighted |
Loss |
Weighted |
Loss |
Weighted |
Loss |
|||||||||||||||||||
|
Number of shares and loss
|
|
(
|
)
|
|
(
|
)
|
|
(
|
)
|
|||||||||||||||
| *) |
To compute diluted loss per share, potential ordinary shares have not been taken into account due to their anti-dilutive effect. See Notes 19(d) and Note 19(e) for number of outstanding options and RSUs.
|
F - 48
EVOGENE LTD. AND ITS SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands (except share and per share data)
|
NOTE 22: - |
OPERATING SEGMENTS |
| a. |
General:
|
The Company operates across several market segments, including human health, agriculture, and other industrial applications. The agriculture segment consists of the certain parent Company’s activities and two of the Company's subsidiaries, Lavie Bio Ltd. and AgPlenus Ltd. The human health segment consists of the Company's subsidiaries, Biomica Ltd. and Canonic Ltd. The industrial applications segment consists of the Company's subsidiary Casterra Ag Ltd. The segments were determined on the basis of information considered by the Chief Operating Decision-Maker (“CODM”) for purposes of decision-making on the allocation of resources and evaluation of performance. The following Company's segments are engaged in business activities for which they earn revenues and incur expenses, their results are reviewed by the CODM and discrete financial information is available:
|
Agriculture segment
|
-
|
Develops seed traits, ag-chemical products, and ag-biological products to improve plant performance.
|
|
Industrial
applications
segment
|
-
|
Develops improved castor bean seeds to serve as a feedstock source for other industrial uses.
|
|
Human health segment
|
-
|
Discovers and develops human microbiome-based therapeutics and cannabis activity.
|
|
Unallocated
|
-
|
Other corporate expenses and general development of enabling technologies discovery and optimization.
|
Each segment’s performance is determined based on operating loss reported in the financial statements. The results of a segment reported to the CODM include items attributed directly to a segment, as well as other items, which are indirectly attributed using reasonable assumptions and exclude share-based compensation charges as they are not considered in the internal operating plans and measurement of the segment’s financial performance.
|
b. |
The following table presents our revenues and operating loss by segments: |
|
Agriculture
|
Industrial
application
|
Human
health
|
Unallocated
|
Total
|
||||||||||||||||
|
For the Year Ended December 31, 2022
|
||||||||||||||||||||
|
Revenues
|
$
|
|
$
|
|
$
|
|
$
|
|
$
|
|
||||||||||
|
Operating loss
|
$
|
(
|
)
|
$
|
(
|
)
|
$
|
(
|
)
|
$
|
(
|
)
|
$
|
(
|
)
|
|||||
|
Net financing expenses
|
$
|
(
|
)
|
|||||||||||||||||
|
Loss before taxes on income
|
$
|
(
|
)
|
|||||||||||||||||
F - 49
EVOGENE LTD. AND ITS SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands (except share and per share data)
| NOTE 22: - |
OPERATING SEGMENTS (Cont.)
|
|
Agriculture
|
Industrial
application |
Human
health |
Unallocated
|
Total
|
||||||||||||||||
|
For the Year Ended December 31, 2021
|
||||||||||||||||||||
|
Revenues
|
$
|
|
$
|
|
$
|
|
$
|
|
$
|
|
||||||||||
|
Operating loss
|
$
|
(
|
)
|
$
|
(
|
)
|
$
|
(
|
)
|
$
|
(
|
)
|
$
|
(
|
)
|
|||||
|
Net financing income
|
$
|
|
||||||||||||||||||
|
Loss before taxes on income
|
$
|
(
|
)
|
|||||||||||||||||
|
Agriculture
|
Industrial
application
|
Human
health
|
Unallocated
|
Total
|
||||||||||||||||
|
For the Year Ended December 31, 2020
|
||||||||||||||||||||
|
Revenues
|
$
|
|
$
|
|
$
|
|
$
|
|
$
|
|
||||||||||
|
Operating loss
|
$
|
(
|
)
|
$
|
(
|
)
|
$
|
(
|
)
|
$
|
(
|
)
|
$
|
(
|
)
|
|||||
|
Net financing expenses
|
$
|
(
|
)
|
|||||||||||||||||
|
Loss before taxes on income
|
$
|
(
|
)
|
|||||||||||||||||
| c. |
Major customers:
|
Revenues from major customers each of whom amounts to 10% or more of total revenues. The revenues from major customers detailed below were recorded in the Agriculture segment:
|
Year ended December 31,
|
||||||||||||
|
2022
|
2021
|
2020
|
||||||||||
|
Customer A (subsidiary shareholder)
|
|
%
|
|
%
|
|
%
|
||||||
|
Customer B
|
|
|
%
|
|
%
|
|||||||
|
Customer C
|
|
%
|
|
%
|
|
|||||||
F - 50
EVOGENE LTD. AND ITS SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands (except share and per share data)
| NOTE 22: - |
OPERATING SEGMENTS (Cont.)
|
| d. |
Geographical information:
|
Revenues based on the location of the customers, are as follows:
|
Year ended December 31,
|
||||||||||||
|
2022
|
2021
|
2020
|
||||||||||
|
United States
|
|
%
|
|
%
|
|
%
|
||||||
|
Israel
|
|
%
|
|
%
|
|
%
|
||||||
|
Brazil
|
|
|
%
|
|
%
|
|||||||
|
Other
|
|
%
|
|
%
|
|
%
|
||||||
|
|
%
|
|
%
|
|
%
|
|||||||
The carrying amounts of non-current assets (right-of-use-assets, property, plant and equipment property and intangible assets) in the Company's country of domicile (Israel) and in the United States based on the location of the assets, are as follows:
|
December 31,
|
||||||||||||
|
2022
|
2021
|
2020
|
||||||||||
|
United States
|
|
%
|
|
%
|
|
%
|
||||||
|
Israel
|
|
%
|
|
%
|
|
%
|
||||||
|
|
%
|
|
%
|
|
%
|
|||||||
| NOTE 23: - |
BALANCES AND TRANSACTIONS WITH EXECUTIVE OFFICERS AND CERTAIN SHAREHOLDERS
|
| a. |
As reported by the shareholders, and based on publicly available information, the Company believes that as of December 31, 2022, Corteva (through its subsidiary Pioneer Hi-Bred International, Inc.) holds
|
| b. |
Balances:
|
Balance at December 31, 2022:
|
Executive
officers |
Certain
shareholders |
|||||||
|
Receivables
|
$
|
|
$
|
|
||||
|
Other payables
|
$
|
|
$
|
|
||||
Balance at December 31, 2021:
|
Executive
officers |
Certain
shareholders |
|||||||
|
Receivables
|
$
|
|
$
|
|
||||
|
Other payables
|
$
|
|
$
|
|
||||
F - 51
EVOGENE LTD. AND ITS SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands (except share and per share data)
| NOTE 23: - |
BALANCES AND TRANSACTIONS WITH EXECUTIVE OFFICERS AND CERTAIN SHAREHOLDERS (Cont.)
|
| c. |
Benefits to directors:
|
|
Year ended December 31,
|
||||||||||||
|
2022
|
2021
|
2020
|
||||||||||
|
Compensation to directors not employed by the Company or on its behalf
|
$
|
|
$
|
|
$
|
|
||||||
|
Share-based compensation to directors not employed by the Company or on its behalf
|
|
|
|
|||||||||
|
$
|
|
$
|
|
$
|
|
|||||||
|
Number of directors that received the above compensation by the Company
|
|
|
|
|||||||||
| d. |
Salary and Benefits to Executive officers:
|
|
Year ended December 31,
|
||||||||||||
|
2022
|
2021
|
2020
|
||||||||||
|
Salary and related benefits
|
$
|
|
$
|
|
$
|
|
||||||
|
Share-based compensation
|
|
|
|
|||||||||
|
$
|
|
$
|
|
$
|
|
|||||||
|
Number of people that received salary and benefits
|
|
|
|
|||||||||
| e. |
Transactions:
|
|
For the year ended December 31, 2022:
|
|
Executive
officers |
Certain
shareholders |
|||||||
|
Revenues (see Note 5)
|
$
|
|
$
|
|
||||
|
Other income
|
|
|
||||||
|
Participation in research and development expenses
|
|
|
||||||
|
Research and development expenses
|
|
|
||||||
|
Sales and marketing expenses
|
|
|
||||||
|
General and administrative expenses
|
$
|
|
$
|
|
||||
F - 52
EVOGENE LTD. AND ITS SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands (except share and per share data)
| NOTE 23: - |
BALANCES AND TRANSACTIONS WITH EXECUTIVE OFFICERS AND CERTAIN SHAREHOLDERS (Cont.)
|
For the year ended December 31, 2021:
|
Executive
officers |
Certain
shareholders |
|||||||
|
Revenues
|
$
|
|
$
|
|
||||
|
Participation in research and development expenses
|
|
|
||||||
|
Research and development expenses
|
|
|
||||||
|
Sales and marketing expenses
|
|
|
||||||
|
General and administrative expenses
|
|
|
||||||
|
Financing expenses
|
$
|
|
$
|
|
||||
For the year ended December 31, 2020:
|
Executive
officers |
Certain
shareholder |
|||||||
|
Revenues
|
$
|
|
$
|
|
||||
|
Cost of revenues
|
|
|
||||||
|
Participation in research and development expenses
|
|
|
||||||
|
Research and development expenses
|
|
|
||||||
|
Sales and marketing expenses
|
|
|
||||||
|
General and administrative expenses
|
|
|
||||||
|
Financing expenses
|
$
|
|
$
|
|
||||
| NOTE 24: - |
SUBSEQUENT EVENTS
|
| a. |
During January 1, 2023 through March 15, 2023
|
| b. |
In March 2023, the Company received confirmation for a grant of a €
|
| c. |
On December 21, 2022, one of the Company's subsidiaries, Biomica, signed a definitive agreement for a $
|
F - 53
TABLE OF CONTENTS
Part IItem 1. Identity Of Directors, Senior Management and AdvisersItem 2. Offer Statistics and Expected TimetableItem 3. Key InformationItem 4. Information on The CompanyItem 4A. Unresolved Staff CommentsItem 5. Operating and Financial Review and ProspectsItem 6. Directors, Senior Management and EmployeesItem 7. Major Shareholders and Related Party TransactionsItem 8. Financial InformationItem 9. The Offer and ListingItem 10. Additional InformationItem 11. Quantitative and Qualitative Disclosures About Market RiskItem 12. Description Of Securities Other Than Equity SecuritiesPart IIItem 13. Defaults, Dividend Arrearages and DelinquenciesItem 14. Material Modifications To The Rights Of Security Holders and Use Of ProceedsItem 15. Controls and ProceduresItem 16. [reserved]Item 16A. Audit Committee Financial ExpertItem 16B. Code Of EthicsItem 16C. Principal Accountant Fees and ServicesItem 16D. Exemptions From The Listing Standards For Audit CommitteesItem 16E. Purchases Of Equity Securities By The Issuer and Affiliated PurchasersItem 16F. Change in Registrant S Certifying AccountantItem 16G. Corporate GovernanceItem 16H. Mine Safety DisclosureItem 16I. Disclosure Regarding Foreign Jurisdictions That Prevent InspectionsPart IIIItem 17. Financial StatementsItem 18. Financial StatementsItem 19. ExhibitsNote 1: - GeneralNote 1: - General (cont.)Note 2: - Significant Accounting PoliciesNote 2: - Significant Accounting Policies (cont.)Note 3: - Significant Accounting Judgments, Estimates and Assupmtions Used in The Preparation Of The Financial StatementsNote 3: - Significant Accounting Judgments, Estimates and Assupmtions Used in The Preparation Of The Financial Statements (cont.)Note 4: - Disclosure Of New Standards in The Period Prior To Their AdoptionNote 5: - Collaboration, Research and Distribution Agreements-Note 5: - Collaboration, Research and Distribution Agreements- (cont.)Note 6: - Cash and Cash EquivalentsNote 7: - Marketable SecuritiesNote 8: - Other Receivables and Prepaid ExpensesNote 9: - LeasesNote 9: - Leases (cont.)Note 10: - Property, Plant and Equipment, NetNote 10: -Note 11: - Intangible Assets, NetNote 11: - Intangible Assets, Net (cont.)Note 12: - Liabilities in Respect Of Government GrantsNote 12: -Note 12: - Liabilities in Respect Of Government Grants (cont.)Note 13: - Convertible SafeNote 14: - Financial InstrumentsNote 14: -Note 14: - Financial Instruments (cont.)Note 15: - Commitments and Contingent LiabilitiesNote 15: -Note 16: - Severance Pay LiabilityNote 16: -Note 17: - Taxes on IncomeNote 17: -Note 17: - Taxes on Income (cont.)Note 18: - Shareholders' EquityNote 18: -Note 18: - Shareholders' Equity (cont.)Note 19: - Share- Based CompensationNote 19: -Note 19: - Share- Based Compensation (cont.)Note 20: - Statements Of Profit Or Loss Additional InformationNote 20: -Note 20: - Statements Of Comprehensive Loss Additional Information (cont.)Note 21: - Loss Per ShareNote 21: -Note 22: - Operating SegmentsNote 22: -Note 22: - Operating Segments (cont.)Note 23: - Balances and Transactions with Executive Officers and Certain ShareholdersNote 23: -Note 23: - Balances and Transactions with Executive Officers and Certain Shareholders (cont.)Note 24: - Subsequent EventsNote 24: -