Sanofi

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 20-F

(Mark One)

For the fiscal year ended December 31,2025

Or

Date of event requiring this shell company report

For the transition period from to

Commission File Number:001-31368

Sanofi

(Exact name of registrant as specified in its charter)

N/A

(Translation of registrant’s name into English)

France

(Jurisdiction of incorporation or organization)

46, avenue de la Grande Armée,75017 Paris, France

(Address of principal executive offices)

Roy Papatheodorou , Executive Vice President, General Counsel

46, avenue de la Grande Armée,75017 Paris, France. Tel: +33 1 53 77 40 00

(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:

Securities registered or to be registered pursuant to Section 12(g) of the Act: None

Securities for which there is a reporting obligation pursuant to Section 15(d) of the Act: None

The number of outstanding shares of each of the issuer’s classes of capital or common stock as of December 31,2025 was:

Ordinary shares:1,219,427,096

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☒ No ☐.

If this report is an annual or transition report, indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934. Yes ☐No ☒.

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during

the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing

requirements for the past 90 days. Yes ☒ No ☐.

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of

Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).

Yes ☒ No ☐.

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer or an emerging growth company. See

definition of “large accelerated filer”, “accelerated filer” or “emerging growth company” in Rule 12b-2 of the Exchange Act.

If an emerging growth company that prepares its financial statements in accordance with U.S. GAAP, indicate by check mark if the registrant has elected

not to use the extended transition period for complying with any new or revised financial accounting standards(1) provided pursuant to Section 13(a) of the

Exchange Act. ☐

(1) The term “new or revised financial accounting standard” refers to any update issued by the Financial Accounting Standards Board to its Accounting

Standards Codification after April 5, 2012.

Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal

control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared

or issued its audit report ☒

If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the

filing reflect the correction of an error to previously issued financial statements.☐

Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive- based compensation

received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐

Indicate by check mark which basis of accounting the registrant has used to prepare the financial statements included in this filing:

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☒.

*Not for trading but only in connection with the registration of American Depositary Shares representing such ordinary shares.

Presentation of financial

andother information

The consolidated financial statements contained in this annual report on Form 20-F have been prepared in accordance with

International Financial Reporting Standards (IFRS) as issued by the International Accounting Standards Board (IASB) and with

IFRS as endorsed by the European Union (EU), as of December 31,2025.

Unless otherwise indicated or the context requires otherwise, the terms “Sanofi,” the “Company,” the “Group,” “we,” “our,” or “us”

refer to Sanofi and its consolidated subsidiaries.

All references herein to “United States” or “US” are to the United States of America, references to “dollars” or “$” are to the

currency of the United States, references to “France” are to the Republic of France, and references to “euro” and “€” are to the

currency of the European Union member states (including France) participating in the European Monetary Union.

As of the date of this annual report on Form 20-F, all commercial trademarks mentioned here are protected, and are trademarks

of Sanofi and/or its subsidiaries, with the exception of:

•trademarks used or that may be or have been used under license by Sanofi and/or its affiliates;

•trademarks sold by Sanofi and/or its affiliates to a third party; and

•other third party trademarks.

Not all trademarks related to products under development have been authorized as of the date of this annual report by the

relevant health authorities.

The data relating to market shares and ranking information for medicines and vaccines, in particular as presented

in “Item 4. Information on the Company — B. Business Overview — B.5. Markets — B.5.1. Marketing and distribution,” are based

primarily on sales data excluding vaccines and in constant euros (unless otherwise indicated) on a September 2025 moving

annual total (MAT) basis. The data are primarily from an IQVIA local sales audit, supplemented by country-specific sources.

Product indications described in this annual report are composite summaries of the major indications approved in the product’s

principal markets. Not all indications are necessarily available in each of the markets in which the products are approved. The

summaries presented herein for the purpose of financial reporting do not substitute for careful consideration of the full labeling

approved in each market.

Cautionary statement regarding

forward-looking statements

This annual report contains certain forward-looking statements within the meaning of applicable federal securities law, including

the Private Securities Litigation Reform Act of 1995, as amended. We may also make written or oral forward-looking statements in

our periodic reports to the Securities and Exchange Commission on Form 6-K, in our annual report to shareholders, in our offering

circulars and prospectuses, in press releases and other written materials and in oral statements made by our officers, directors or

employees to third parties. Examples of such forward-looking statements include:

•projections of operating revenues, net income, business net income, earnings per share, business earnings per share, capital

expenditures, cost savings, restructuring costs, positive or negative synergies, dividends, capital structure or other financial

items or ratios;

•statements of our profit forecasts, trends, business strategies, plans, objectives or goals, including those relating to products,

clinical studies, regulatory approvals and competition; and

•statements about our future events and economic performance or that of France, the United States or any other countries in

which we operate.

Words such as “believe,” “anticipate,” “can,” “contemplate,” “could,” “plan,” “expect,” “intend,” “is designed to,” “may,” “might,”

“potential,” “objective,” "attempt," “target,” “estimate,” “project,” "strategy," "strive," "desire," “predict,” “forecast,” “ambition,”

“guideline,” "seek," “should,” “will,” "goal," or the negative of these and similar expressions are intended to identify forward-

looking statements but are not the exclusive means of identifying such statements.

Forward-looking statements involve inherent, known and unknown risks, uncertainties and assumptions associated with, for

example, the regulatory, economic, financial and competitive environment, including authorities’ decisions regarding whether

and when to approve a product candidate, political pressure in the United States to mandate lower drug prices including “most

favored nation” pricing for State Medicaid programs, and other factors that could cause actual future results to differ materially

from those expressed or implied in the forward-looking statements.

These risks, uncertainties and assumptions include risk factors, which could also affect future results and cause actual results to

differ materially from those contained in any forward-looking statements, and which include those discussed under “Item 3. Key

Information — D. Risk Factors.” Additional risks that are unknown at this time or that are currently considered immaterial by the

Group, may have the same unfavorable effect and investors may lose all or part of their investment.

As a result of these factors, we cannot assure you that the forward-looking statements in this annual report will prove to be

accurate. Furthermore, if our forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the

significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or

warranty by us or any other person that we will achieve our objectives and plans in any specified time frame or at all. Moreover,

forward-looking statements speak only as of the date they are made. Other than required by law, we do not undertake any

obligation to update them in light of new information, future developments or otherwise, except as required by law. These

forward-looking statements are based upon information, assumptions and estimates available to us as of the date of this annual

report, and while we believe such information forms a reasonable basis for such statements, such information may be limited or

incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all

potentially available relevant information. In light of these risks, uncertainties and assumptions, you should not place undue

reliance on any forward-looking statements contained herein.

You should read this annual report and the documents that we reference in this annual report and have filed as exhibits

completely and with the understanding that our actual future results may be materially different from what we expect. We qualify

all of our forward-looking statements by these statements.

Abbreviations

Principal abbreviations used in the Annual Report on Form 20-F

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PART I

ITEM 1. Identity of Directors, Senior Management and Advisers