REGENERON PHARMACEUTICALS, INC. 10-K

Item 9A. Controls and Procedures Evaluation of Disclosure Controls and Procedures Our management, with the participation of our principal executive officer and principal financial officer, conducted an evaluation of the effectiveness of our disclosure controls and procedures (as such term is defined in Rules 13a-15(e) or 15d-15(e) under the Securities Exchange Act of 1934, as amended (the "Exchange Act")), as of the end of the period covered by this Annual Report on Form 10-K. Based on this evaluation, our principal executive officer and principal financial officer each concluded that, as of the end of such period, our disclosure controls and procedures were effective in ensuring that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized, and reported on a timely basis, and is accumulated and communicated to our management, including our principal executive officer and principal financial officer, as appropriate to allow timely decisions regarding required disclosures. Management's Report on Internal Control over Financial Reporting Our management is responsible for establishing and maintaining adequate internal control over financial reporting, as such term is defined in Rules 13a-15(f) or 15d-15(f) under the Exchange Act. Our management conducted an evaluation of the effectiveness of our internal control over financial reporting as of December 31, 2024 using the framework in Internal Control - Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission. Based on that evaluation, our management has concluded that our internal control over financial reporting was effective as of December 31, 2024. The effectiveness of the Company's internal control over financial reporting as of December 31, 2024 has been audited by PricewaterhouseCoopers LLP, an independent registered public accounting firm, as stated in their report which appears under Part IV, Item 15. Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate. Changes in Internal Control over Financial Reporting There has been no change in our internal control over financial reporting (as such term is defined in Rules 13a-15(f) or 15d-15(f) under the Exchange Act) during the quarter ended December 31, 2024 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting. Inherent Limitations on Effectiveness of Controls 85 Table of Contents Our management, including our principal executive officer and principal financial officer, does not expect that our disclosure controls and procedures or internal controls over financial reporting will prevent all errors and all fraud. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the system are met and cannot detect all deviations. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud or deviations, if any, within the company have been detected. Projections of any evaluation of effectiveness to future periods are subject to the risks that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate. Item 9B. Other Information As disclosed in the table below, during the three months ended December 31, 2024, certain of our directors and/or executive officers adopted plans for trading arrangements intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) of the Exchange Act. Name Position Date of Plan Adoption Scheduled End Date of Trading Arrangement (a) Total Number of Securities to Be Sold Under the Plan Kathryn Guarini, Ph.D. Director 11/1/2024 11/14/2025 1,000 (a) The trading arrangement may expire on an earlier date if and when all transactions under the arrangement are completed. Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections Not applicable. PART III Item 10. Directors, Executive Officers and Corporate Governance The information required by this item (other than the information set forth in the next paragraph in this Item 10) will be included in our definitive proxy statement with respect to our 2025 Annual Meeting of Shareholders to be filed with the SEC, and is incorporated herein by reference. We have adopted a code of business conduct and ethics that applies to our officers, directors, and employees. The full text of our code of business conduct and ethics can be found on our website (http://www.regeneron.com) under the "Governance" heading on the "Investors & Media" page. We may satisfy the disclosure requirements under Item 5.05 of Form 8-K regarding an amendment to, or a waiver from, a provision of our code of business conduct and ethics that applies to our principal executive officer, principal financial officer, principal accounting officer, or controller, or persons performing similar functions, by posting such information on our website where it is accessible through the same link noted above. Item 11. Executive Compensation The information called for by this item will be included in our definitive proxy statement with respect to our 2025 Annual Meeting of Shareholders to be filed with the SEC, and is incorporated herein by reference. Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters The information called for by this item will be included in our definitive proxy statement with respect to our 2025 Annual Meeting of Shareholders to be filed with the SEC, and is incorporated herein by reference. Item 13. Certain Relationships and Related Transactions, and Director Independence The information called for by this item will be included in our definitive proxy statement with respect to our 2025 Annual Meeting of Shareholders to be filed with the SEC, and is incorporated herein by reference. Item 14. Principal Accountant Fees and Services The information called for by this item will be included in our definitive proxy statement with respect to our 2025 Annual Meeting of Shareholders to be filed with the SEC, and is incorporated herein by reference. 86 Table of Contents PART IV Item 15. Exhibits and Financial Statement Schedules (a) 1. Financial Statements The consolidated financial statements filed as part of this report are listed on the Index to Financial Statements on page F-1. 2. Financial Statement Schedules All schedules for which provision is made in the applicable accounting regulations of the SEC are not required under the related instructions or are inapplicable and, therefore, have been omitted. 3. Exhibits Exhibit Number Description 3.1 Restated Certificate of Incorporation, as amended. (Incorporated by reference from the Form 10-Q for Regeneron Pharmaceuticals, Inc. (the "Registrant"), for the quarter ended June 30, 2015, filed August 4, 2015.) 3.2 Amended and Restated By-Laws. (Incorporated by reference from the Form 8-K for the Registrant filed December 21, 2016.) 3.2.1 Amendment to the Amended and Restated By-Laws effective June 9, 2023. (Incorporated by reference from the Form 8-K for the Registrant filed June 14, 2023.) 4.1 Description of Securities Registered Pursuant to Section 12 of the Securities Exchange Act of 1934. 4.2 Indenture, dated August 12, 2020, between the Registrant and U.S. Bank National Association. (Incorporated by reference from the Form 8-K for the Registrant, filed August 12, 2020.) 4.3 First Supplemental Indenture, dated August 12, 2020, between the Registrant and U.S. Bank National Association. (Incorporated by reference from the Form 8-K for the Registrant, filed August 12, 2020.) 4.4 Form of 1.750% Senior Note due 2030 (included in Exhibit 4.3). 4.5 Form of 2.800% Senior Note due 2050 (included in Exhibit 4.3). 10.1 + R ege neron Pharm aceuticals, Inc. 20 1 4 Long-Term I ncentiv e Plan. (Incorporated by reference from the Registration Statement on Form S-8 for the Registrant, filed June 16, 2014.) 10.1.1 + Form of stock option agreement and related notice of grant for use in connection with the grant of non-qualified stock options to the Registrant's executive officers under the Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive Plan. (Incorporated by reference from the Form 8-K for the Registrant, filed June 18, 2014.) 10.1.2 + Form of restricted stock award agreement and related notice of grant for use in connection with the grant of restricted stock awards to the Registrant's executive officers under the Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive Plan. (Incorporated by reference from the Form 8-K for the Registrant, filed June 18, 2014.) 10.1.3 + Form of stock option agreement and related notice of grant for use in connection with the grant of non-qualified stock options to the Registrant's non-employee directors under the Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive Plan. (Incorporated by reference from the Form 8-K for the Registrant, filed June 18, 2014.) 10.1.4 + Form of stock option agreement and related notice of grant for use in connection with the grant of non-qualified stock options to the Registrant's executive officers under the Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive Plan (revised). (Incorporated by reference from the Form 8-K for the Registrant, filed November 19, 2015.) 10.1.5 + Form of restricted stock award agreement and related notice of grant for use in connection with the grant of restricted stock awards to the Registrant's executive officers under the Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive Plan (revised). (Incorporated by reference from the Form 8-K for the Registrant, filed November 19, 2015.) 10.1.6 + Form of stock option agreement and related notice of grant for use in connection with the grant of non-qualified stock options to the Registrant's non-employee directors under the Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive Plan (revised). (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2015, filed February 11, 2016.) 10.2 + Amended and Restated Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive Plan. (Incorporated by reference from the Registration Statement on Form S-8 for the Registrant, filed June 12, 2017.) 10.2.1 + Form of stock option agreement and related notice of grant for use in connection with the grant of non-qualified stock options to the Registrant's executive officers under the Amended and Restated Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive Plan. (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2017, filed February 8, 2018.) 87 Table of Contents 10.2.2 + Form of restricted stock award agreement and related notice of grant for use in connection with the grant of restricted stock awards to the Registrant's executive officers under the Amended and Restated Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive Plan. (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2017, filed February 8, 2018.) 10.2.3 + Form of stock option agreement and related notice of grant for use in connection with the grant of non-qualified stock options to the Registrant's non-employee directors under the Amended and Restated Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive Plan. (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2017, filed February 8, 2018.) 10.2.4 + Form of stock option agreement and related notice of grant for use in connection with the grant of non-qualified stock options to the Registrant's executive officers under the Amended and Restated Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive Plan (revised 2018). (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2018, filed February 7, 2019.) 10.2.5 + Form of restricted stock award agreement and related notice of grant for use in connection with the grant of restricted stock awards to the Registrant's executive officers under the Amended and Restated Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive Plan (revised 2018). (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2018, filed February 7, 2019.) 10.2.6 + Form of stock option agreement and related notice of grant for use in connection with the grant of non-qualified stock options to the Registrant's non-employee directors under the Amended and Restated Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive Plan (revised 2018). (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2018, filed February 7, 2019.) 10.2.7 + Form of restricted stock unit award agreement and related notice of grant for use in connection with the grant of restricted stock units to the Registrant's non-employee directors under the Amended and Restated Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive Plan. (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2018, filed February 7, 2019.) 10.2.8 + Form of stock option agreement and related notice of grant for use in connection with the grant of non-qualified stock options to the Registrant's executive officers under the Amended and Restated Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive Plan (revised 2019). (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2019, filed February 7, 2020.) 10.2.9 + Form of restricted stock award agreement and related notice of grant for use in connection with the grant of restricted stock awards to the Registrant's executive officers under the Amended and Restated Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive Plan (revised 2019). (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2019, filed February 7, 2020.) 10.2.10 + Form of stock option agreement and related notice of grant for use in connection with the grant of non-qualified stock options to the Registrant's non-employee directors under the Amended and Restated Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive Plan (revised 2019). (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2019, filed February 7, 2020.) 10.2.11 + Form of restricted stock unit award agreement and related notice of grant for use in connection with the grant of restricted stock units to the Registrant's non-employee directors under the Amended and Restated Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive Plan (revised 2019). (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2019, filed February 7, 2020.) 10.3 + Second Amended and Restated Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive Plan. (Incorporated by reference from the Registration Statement on Form S-8 for the Registrant, filed June 16, 2020.) 10.3.1 + Form of stock option agreement and related notice of grant for use in connection with the grant of non-qualified stock options to the Registrant's executive officers under the Second Amended and Restated Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive Plan. (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2020, filed February 8, 2021.) 10.3.2 + Form of restricted stock award agreement and related notice of grant for use in connection with the grant of restricted stock awards to the Registrant's executive officers under the Second Amended and Restated Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive Plan. (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2020, filed February 8, 2021.) 10.3.3 + Form of stock option agreement and related notice of grant for use in connection with the grant of non-qualified stock options to the Registrant's non-employee directors under the Second Amended and Restated Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive Plan. (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2020, filed February 8, 2021.) 10.3.4 + Form of restricted stock unit award agreement and related notice of grant for use in connection with the grant of restricted stock units to the Registrant's non-employee directors under the Second Amended and Restated Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive Plan. (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2020, filed February 8, 2021.) 10.3.5 + Form of performance restricted stock unit award agreement and related notice of grant for use in connection with the grant of performance restricted stock units to Leonard S. Schleifer, M.D., Ph.D. and George D. Yancopoulos, M.D., Ph.D. under the Second Amended and Restated Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive Plan. (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2020, filed February 8, 2021.) 88 Table of Contents 10.3.6 + Form of stock option agreement and related notice of grant for use in connection with the grant of non-qualified stock options to the Registrant's executive officers under the Second Amended and Restated Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive Plan (revised 2023). (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2023, filed February 5, 2024.) 10.3.7 + Form of restricted stock award agreement and related notice of grant for use in connection with the grant of restricted stock awards to the Registrant's executive officers under the Second Amended and Restated Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive Plan (revised 2023). (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2023, filed February 5, 2024.) 10.4 + Amended and Restated Employment Agreement, dated as of November 14, 2008, between the Registrant and Leonard S. Schleifer, M.D., Ph.D. (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2008, filed February 26, 2009.) 10.4.1 + Waiver and Consent, dated as of April 14, 2023, pursuant to the Amended and Restated Employment Agreement, dated as of November 14, 2008, between the Registrant and Leonard S. Schleifer, M.D., Ph.D. (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended June 30, 2023, filed August 3, 2023.) 10.5 + Regeneron Pharmaceuticals, Inc. Change in Control Severance Plan, amended and restated effective as of November 14, 2008. (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2008, filed February 26, 2009.) 10.6 + Regeneron Pharmaceuticals, Inc. Cash Incentive Bonus Plan. (Incorporated by reference from the Form 8-K for the Registrant, filed June 17, 2015.) 10.6.1 + First Amendment to Cash Incentive Bonus Plan. (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended March 31, 2023, filed May 4, 2023.) 10.7* IL-1 Antibody Termination Agreement by and between Novartis Pharma AG, Novartis Pharmaceuticals Corporation and the Registrant, dated as of June 8, 2009. (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended June 30, 2009, filed August 4, 2009.) 10.8* License and Collaboration Agreement, dated as of October 18, 2006, by and between Bayer HealthCare LLC and the Registrant. (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended September 30, 2006, filed November 6, 2006.) 10.8.1** Restated Amendment Agreement, dated December 30, 2014 and entered into effective as of May 7, 2012, by and between Bayer HealthCare LLC and the Registrant. 10.8.2** Second Amendment Agreement, dated December 19, 2019, by and between Bayer HealthCare LLC and the Registrant. (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2019, filed February 7, 2020.) 10.9* Amended and Restated License and Collaboration Agreement, dated as of November 10, 2009, by and among Aventis Pharmaceuticals Inc., sanofi-aventis Amerique du Nord, and the Registrant. (Incorporated by reference from the Form 10-K/A for the Registrant, for the year ended December 31, 2009, filed June 2, 2010.) 10.9.1** First Amendment to Amended and Restated License and Collaboration Agreement by and between the Registrant and Aventis Pharmaceuticals Inc., dated May 1, 2013. (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended June 30, 2023, filed August 3, 2023.) 10.9.2* Amendment No. 2 to Amended and Restated License and Collaboration Agreement, dated July 27, 2015 and entered into effective as of July 1, 2015, by and between the Registrant and Sanofi Biotechnology SAS, as successor-in-interest to Aventis Pharmaceuticals, Inc. (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended September 30, 2015, filed November 4, 2015.) 10.9.3** Third Amendment to Amended and Restated License and Collaboration Agreement, dated as of April 5, 2020, and effective as of April 1, 2020, by and between the Registrant, Sanofi Biotechnology SAS, and Sanofi. (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended June 30, 2020, filed August 5, 2020.) 10.9.4** Fourth Amendment to Amended and Restated License and Collaboration Agreement, dated as of October 6, 2021, by and between the Registrant, Sanofi Biotechnology SAS, and Sanofi. (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2021, filed February 7, 2022.) 10.9.5** Fifth Amendment to Amended and Restated License and Collaboration Agreement, dated as of June 1, 2022, by and between the Registrant, Sanofi Biotechnology SAS, and Sanofi. (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended June 30, 2022, filed August 3, 2022.) 10.10** Praluent Cross License & Commercialization Agreement, dated as of April 5, 2020, and effective as of April 1, 2020, by and between the Registrant and Sanofi Biotechnology SAS. (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended June 30, 2020, filed August 5, 2020.) 10.11 Amended and Restated Investor Agreement, dated as of January 11, 2014, by and among Sanofi, sanofi-aventis US LLC, Aventis Pharmaceuticals Inc., sanofi-aventis Amerique du Nord, and the Registrant. (Incorporated by reference from the Form 8-K for the Registrant, filed January 13, 2014.) 10.11.1 Amendment to the Amended and Restated Investor Agreement, dated as of May 25, 2020, by and among the Registrant, Sanofi, Sanofi-Aventis US LLC, and Aventisub LLC. (Incorporated by reference from the Form 8-K for the Registrant, filed May 29, 2020.) 89 Table of Contents 10.12*** Credit Agreement, dated as of December 19, 2022, by and among the Registrant, as a borrower and guarantor, certain direct subsidiaries of the Registrant, as the initial subsidiary borrowers, the lenders and issuing banks party thereto, and JPMorgan Chase Bank, N.A., as administrative agent, swingline lender, and an issuing bank. (Incorporated by reference from the Form 8-K for the Registrant, filed December 20, 2022.) 10.13** Amended and Restated Immuno-oncology License and Collaboration Agreement, dated as of June 1, 2022, by and between the Registrant and Sanofi Biotechnology SAS. (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended June 30, 2022, filed August 3, 2022.) 10.14* Purchase Agreement, dated as of December 30, 2016, by and among BMR-Landmark at Eastview LLC and BMR-Landmark at Eastview IV LLC and the Registrant. (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2016, filed February 9, 2017.) 10.15*** Third Amended and Restated Participation Agreement, dated as of March 27, 2023, by and among Old Saw Mill Holdings LLC, as lessee, Bank of America, N.A., as administrative agent, BA Leasing BSC, LLC, as lessor, and the rent assignees party thereto from time to time. (Incorporated by reference from the Form 8-K for the Registrant, filed March 29, 2023.) 10.16*** Third Amended and Restated Lease and Remedies Agreement, dated as of March 27, 2023, between Old Saw Mill Holdings LLC, as lessee, and BA Leasing BSC, LLC, as lessor. (Incorporated by reference from the Form 8-K for the Registrant, filed March 29, 2023.) 10.17*** Third Amended and Restated Guaranty, dated as of March 27, 2023, made by the Registrant, Regeneron Healthcare Solutions, Inc., and Regeneron Genetics Center LLC, as guarantors. (Incorporated by reference from the Form 8-K for the Registrant, filed March 29, 2023.) 10.18** Master Agreement, dated as of April 8, 2019, by and between the Registrant and Alnylam Pharmaceuticals, Inc. (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended June 30, 2019, filed August 6, 2019.) 10.18.1** Form of Co-Co Collaboration Agreement (Exhibit B to Master Agreement contained in Exhibit 10.1 8 ). 10.18.2** Form of License Agreement (Exhibit C to Master Agreement contained in Exhibit 10.1 8 ). 10.18.3** Amendment No. 1 to Master Agreement, dated as of April 10, 2023, by and between the Registrant and Alnylam Pharmaceuticals, Inc. (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended June 30, 2023, filed August 3, 2023.) 10.18.4** Amendment No. 2 to Master Agreement, dated as of March 7, 2024, by and between the Registrant and Alnylam Pharmaceuticals, Inc. (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended March 3 1 , 202 4 , filed May 2 , 202 4 .) 10.18.5** Amendment No. 3 to Master Agreement, dated as of August 1, 2024, by and between the R egistrant and Alnylam Pharmaceuticals, Inc. (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended September 30, 202 4 , filed Octob er 3 1 , 202 4 .) 19.1 I nsider Trading Policy. 21.1 Subsidiaries of the Registrant. 23.1 Consent of PricewaterhouseCoopers LLP, Independent Registered Public Accounting Firm. 24.1 Power of Attorney (included on the signature page of this Annual Report on Form 10-K). 31.1 Certification of Principal Executive Officer pursuant to Rule 13a-14(a) under the Securities Exchange Act of 1934. 31.2 Certification of Principal Financial Officer pursuant to Rule 13a-14(a) under the Securities Exchange Act of 1934. 32 Certification of Principal Executive Officer and Principal Financial Officer pursuant to 18 U.S.C. Section 1350. 97.1 Clawback Policy. (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2023, filed February 5, 2024.) 101 Interactive Data Files pursuant to Rule 405 of Regulation S-T formatted in Inline Extensible Business Reporting Language ("Inline XBRL"): (i) the Registrant's Consolidated Balance Sheets as of December 31, 2024 and 2023; (ii) the Registrant's Consolidated Statements of Operations and Comprehensive Income for the years ended December 31, 2024, 2023, and 2022; (iii) the Registrant's Consolidated Statements of Stockholders’ Equity for the years ended December 31, 2024, 2023, and 2022; (iv) the Registrant's Consolidated Statements of Cash Flows for the years ended December 31, 2024, 2023, and 2022; and (v) the notes to the Registrant's Consolidated Financial Statements. 104 Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101). _______ 90 Table of Contents * Portions of this document have been omitted and filed separately with the SEC pursuant to requests for confidential treatment pursuant to Rule 24b-2. ** Certain confidential portions of this Exhibit were omitted in accordance with Item 601(b)(10) of Regulation S-K. The Registrant agrees to furnish supplementally a copy of all confidential portions of this Exhibit that were omitted to the SEC upon its request. *** Certain of the exhibits and/or schedules to this Exhibit have been omitted in accordance with Item 601(a)(5) of Regulation S-K. The Registrant agrees to furnish supplementally a copy of all omitted exhibits and schedules of this Exhibit to the SEC upon its request. + Indicates a management contract or compensatory plan or arrangement. Item 16. Form 10-K Summary None. 91 Table of Contents SIGNATURES Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized. REGENERON PHARMACEUTICALS, INC. Date: February 5, 2025 By: /s/ LEONARD S. SCHLEIFER Leonard S. Schleifer, M.D., Ph.D. President and Chief Executive Officer 92 Table of Contents POWER OF ATTORNEY KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints Leonard S. Schleifer and Christopher Fenimore, and each of them, his or her true and lawful attorney-in-fact and agent, with the full power of substitution and resubstitution, for him or her and in his or her name, place, and stead, in any and all capacities therewith, to sign any and all amendments to this Annual Report on Form 10-K, and to file the same, with all exhibits thereto, and other documents in connection therewith, with the Securities and Exchange Commission, granting unto each said attorney-in-fact and agent full power and authority to do and perform each and every act and thing requisite and necessary to be done, as fully to all intents and purposes as such person might or could do in person, hereby ratifying and confirming all that each said attorney-in-fact and agent, or either of them, or their or his substitute or substitutes, may lawfully do or cause to be done by virtue hereof. Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated: Signature Title Date /s/ LEONARD S. SCHLEIFER Board co-Chair, President and Chief Executive Officer (Principal Executive Officer) February 5, 2025 Leonard S. Schleifer, M.D., Ph.D. /s/ CHRISTOPHER FENIMORE Executive Vice President, Finance and Chief Financial Officer (Principal Financial Officer) February 5, 2025 Christopher Fenimore /s/ JASON PITOFSKY Vice President, Controller (Principal Accounting Officer) February 5, 2025 Jason Pitofsky /s/ GEORGE D. YANCOPOULOS Board co-Chair, President and Chief Scientific Officer February 5, 2025 George D. Yancopoulos, M.D., Ph.D. /s/ BONNIE L. BASSLER Director February 5, 2025 Bonnie L. Bassler, Ph.D. /s/ MICHAEL S. BROWN Director February 5, 2025 Michael S. Brown, M.D. /s/ N. ANTHONY COLES Director February 5, 2025 N. Anthony Coles, M.D. /s/ JOSEPH L. GOLDSTEIN Director February 5, 2025 Joseph L. Goldstein, M.D. /s/ KATHRYN GUARINI Director February 5, 2025 Kathryn Guarini, Ph.D. /s/ CHRISTINE A. POON Director February 5, 2025 Christine A. Poon /s/ ARTHUR F. RYAN Director February 5, 2025 Arthur F. Ryan /s/ DAVID P. SCHENKEIN Director February 5, 2025 David P. Schenkein, M.D. /s/ GEORGE L. SING Director February 5, 2025 George L. Sing /s/ CRAIG B. THOMPSON Director February 5, 2025 Craig B. Thompson, M.D. /s/ HUDA Y. ZOGHBI Director February 5, 2025 Huda Y. Zoghbi, M.D. 93 Table of Contents REGENERON PHARMACEUTICALS, INC. INDEX TO FINANCIAL STATEMENTS Page Numbers Report of Independent Registered Public Accounting Firm (PCAOB ID 238 ) F- 2 Consolidated Balance Sheets as of December 31, 202 4 and 202 3 F- 4 Consolidated Statements of Operations and Comprehensive Income for the Years Ended December 31, 202 4 , 202 3 , and 202 2 F- 5 Consolidated Statements of Stockholders' Equity for the Years Ended December 31, 202 4 , 202 3 , and 202 2 F- 6 Consolidated Statements of Cash Flows for the Years Ended December 31, 202 4 , 202 3 , and 202 2 F- 8 Notes to Consolidated Financial Statements F- 9 to F- 41 F-1 Table of Contents Report of Independent Registered Public Accounting Firm To the Board of Directors and Stockholders of Regeneron Pharmaceuticals, Inc. Opinions on the Financial Statements and Internal Control over Financial Reporting We have audited the accompanying consolidated balance sheets of Regeneron Pharmaceuticals, Inc. and its subsidiaries (the "Company") as of December 31, 2024 and 2023, and the related consolidated statements of operations and comprehensive income, of stockholders' equity and of cash flows for each of the three years in the period ended December 31, 2024, including the related notes (collectively referred to as the "consolidated financial statements"). We also have audited the Company's internal control over financial reporting as of December 31, 2024, based on criteria established in Internal Control - Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO). In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the financial position of the Company as of December 31, 2024 and 2023, and the results of its operations and its cash flows for each of the three years in the period ended December 31, 2024 in conformity with accounting principles generally accepted in the United States of America. Also in our opinion, the Company maintained, in all material respects, effective internal control over financial reporting as of December 31, 2024, based on criteria established in Internal Control - Integrated Framework (2013) issued by the COSO. Basis for Opinions The Company's management is responsible for these consolidated financial statements, for maintaining effective internal control over financial reporting, and for its assessment of the effectiveness of internal control over financial reporting, included in Management's Report on Internal Control over Financial Reporting appearing under Item 9A. Our responsibility is to express opinions on the Company's consolidated financial statements and on the Company's internal control over financial reporting 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 audits to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud, and whether effective internal control over financial reporting was maintained in all material respects. Our audits of the consolidated financial statements included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements. Our audit of internal control over financial reporting included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, and testing and evaluating the design and operating effectiveness of internal control based on the assessed risk. Our audits also included performing such other procedures as we considered necessary in the circumstances. We believe that our audits provide a reasonable basis for our opinions. Definition and Limitations of Internal Control over Financial Reporting A company's internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. A company's internal control over financial reporting includes those policies and procedures that (i) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (ii) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and (iii) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company's assets that could have a material effect on the financial statements. F-2 Table of Contents Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate. Critical Audit Matters The critical audit matter communicated below is a matter arising from the current period audit of the consolidated financial statements that was communicated or required to be communicated to the audit committee and that (i) relates to accounts or disclosures that are material to the consolidated financial statements and (ii) involved our especially challenging, subjective, or complex judgments. The communication of critical audit matters does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates. Certain Reserves for Uncertain Tax Positions As described in Notes 1 and 15 to the consolidated financial statements, the Company's reserves for uncertain tax positions were $ 1,313.7 million as of December 31, 2024. Certain reserves for uncertain tax positions represent a significant portion of the consolidated balance. The Company recognizes the financial statement effects of a tax position when management's assessment is that there is more than a 50% probability that the position will be sustained upon examination by a taxing authority based upon its technical merits. Uncertain tax positions are recorded based upon certain recognition and measurement criteria. Management re-evaluates uncertain tax positions and considers various factors, including, but not limited to, changes in tax law, the measurement of tax positions taken or expected to be taken in tax returns, and changes in facts or circumstances related to a tax position. The Company adjusts the amount of the liability to reflect any subsequent changes in the relevant facts and circumstances surrounding the uncertain tax positions. The principal considerations for our determination that performing procedures relating to certain reserves for uncertain tax positions is a critical audit matter are (i) the significant judgment by management when determining certain reserves for uncertain tax positions; (ii) a high degree of auditor judgment, subjectivity, and effort in performing procedures and evaluating management's determination of certain reserves for uncertain tax positions; (iii) the assessment and evaluation of audit evidence available to support certain reserves for uncertain tax positions is complex; and (iv) the audit effort involved the use of professionals with specialized skill and knowledge. Addressing the matter involved performing procedures and evaluating audit evidence in connection with forming our overall opinion on the consolidated financial statements. These procedures included testing the effectiveness of controls relating to the recognition of reserves for uncertain tax positions. These procedures also included, among others (i) testing the information used in the calculation of certain reserves for uncertain tax positions, such as international and federal filing positions, and the related final tax returns; (ii) testing the calculation of certain reserves for uncertain tax positions; and (iii) evaluating management's assessment of the technical merits of the tax positions and estimates of the amount of tax benefits expected to be sustained, as well as the likelihood of the possible outcomes, for certain reserves for uncertain tax positions. Professionals with specialized skill and knowledge were used to assist in evaluating the technical merits and the tax benefits expected to be sustained and the application of relevant tax laws. /s/ PricewaterhouseCoopers LLP Florham Park, New Jersey February 5, 2025 We have served as the Company’s auditor since 1989. F-3 Table of Contents REGENERON PHARMACEUTICALS, INC. CONSOLIDATED BALANCE SHEETS (In millions, except per share data) December 31, 2024 2023 ASSETS Current assets: Cash and cash equivalents $ 2,488.2 $ 2,730.0 Marketable securities 6,524.3 8,114.8 Accounts receivable, net 6,211.9 5,667.3 Inventories 3,087.3 2,580.5 Prepaid expenses and other current assets 349.2 386.6 Total current assets 18,660.9 19,479.2 Marketable securities 8,900.1 5,396.5 Property, plant, and equipment, net 4,599.7 4,146.4 Intangible assets, net 1,148.6 1,038.6 Deferred tax assets 3,314.1 2,575.4 Other noncurrent assets 1,136.0 444.1 Total assets $ 37,759.4 $ 33,080.2 LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable $ 789.5 $ 606.6 Accrued expenses and other current liabilities 2,527.1 2,357.9 Deferred revenue 627.7 458.9 Total current liabilities 3,944.3 3,423.4 Long-term debt 1,984.4 1,982.9 Finance lease liabilities 720.0 720.0 Deferred revenue 185.7 126.7 Other noncurrent liabilities 1,571.4 854.1 Total liabilities 8,405.8 7,107.1 Commitments and contingencies Stockholders' equity: Preferred Stock, par value $ .01 per share; 30.0 shares authorized; shares issued and outstanding - none — — Class A Stock, convertible, par value $ .001 per share; 40.0 shares authorized; shares issued and outstanding - 1.8 in 2024 and 2023 — — Common Stock, par value $ .001 per share; 320.0 shares authorized; shares issued - 136.0 in 2024 and 133.1 in 2023 0.1 0.1 Additional paid-in capital 12,855.9 11,354.0 Retained earnings 31,672.9 27,260.3 Accumulated other comprehensive loss ( 7.9 ) ( 80.9 ) Treasury Stock, at cost; 28.2 shares in 2024 and 25.5 shares in 2023 ( 15,167.4 ) ( 12,560.4 ) Total stockholders' equity 29,353.6 25,973.1 Total liabilities and stockholders' equity $ 37,759.4 $ 33,080.2 The accompanying notes are an integral part of the financial statements. F-4 Table of Contents REGENERON PHARMACEUTICALS, INC. CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (In millions, except per share data) Year Ended December 31, 2024 2023 2022 Statements of Operations Revenues: Net product sales $ 7,629.2 $ 7,078.0 $ 6,893.7 Collaboration revenue 6,057.8 5,503.1 4,914.1 Other revenue 515.0 536.1 365.1 14,202.0 13,117.2 12,172.9 Expenses: Research and development 5,132.0 4,439.0 3,592.5 Acquired in-process research and development 101.0 186.1 255.1 Selling, general, and administrative 2,954.4 2,631.3 2,115.9 Cost of goods sold 1,087.3 932.1 800.0 Cost of collaboration and contract manufacturing 883.2 883.7 760.4 Other operating expense (income), net 53.4 ( 2.1 ) ( 89.9 ) 10,211.3 9,070.1 7,434.0 Income from operations 3,990.7 4,047.1 4,738.9 Other income (expense): Other income (expense), net 844.4 225.2 179.3 Interest expense ( 55.2 ) ( 73.0 ) ( 59.4 ) 789.2 152.2 119.9 Income before income taxes 4,779.9 4,199.3 4,858.8 Income tax expense 367.3 245.7 520.4 Net income $ 4,412.6 $ 3,953.6 $ 4,338.4 Net income per share - basic $ 40.90 $ 37.05 $ 40.51 Net income per share - diluted $ 38.34 $ 34.77 $ 38.22 Weighted average shares outstanding - basic 107.9 106.7 107.1 Weighted average shares outstanding - diluted 115.1 113.7 113.5 Statements of Comprehensive Income Net income $ 4,412.6 $ 3,953.6 $ 4,338.4 Other comprehensive income (loss), net of tax: Unrealized gain (loss) on debt securities 73.6 158.2 ( 213.6 ) Loss on foreign currency translation ( 0.6 ) ( 0.3 ) — Unrealized gain on cash flow hedges — — 1.0 Comprehensive income $ 4,485.6 $ 4,111.5 $ 4,125.8 The accompanying notes are an integral part of the financial statements. F-5 Table of Contents REGENERON PHARMACEUTICALS, INC. CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (In millions) Class A Stock Common Stock Additional Paid-in Capital Retained Earnings Accumulated Other Comprehensive Income (Loss) Treasury Stock Total Stockholders' Equity Shares Amount Shares Amount Shares Amount Balance, December 31, 2021 1.8 $ — 126.2 $ 0.1 $ 8,087.5 $ 18,968.3 $ ( 26.2 ) ( 19.4 ) $ ( 8,260.9 ) $ 18,768.8 Issuance of Common Stock for equity awards granted under long-term incentive plans — — 4.8 — 1,517.4 — — — — 1,517.4 Common Stock tendered upon exercise of stock options and vesting of restricted stock for employee tax obligations — — ( 0.6 ) — ( 445.7 ) — — — — ( 445.7 ) Issuance/distribution of Common Stock for 401(k) Savings Plan — — — — 52.3 — — 0.1 7.4 59.7 Repurchases of Common Stock — — — — — — — ( 3.3 ) ( 2,099.8 ) ( 2,099.8 ) Stock-based compensation charges — — — — 737.8 — — — — 737.8 Net income — — — — — 4,338.4 — — — 4,338.4 Other comprehensive loss, net of tax — — — — — — ( 212.6 ) — — ( 212.6 ) Balance, December 31, 2022 1.8 — 130.4 0.1 9,949.3 23,306.7 ( 238.8 ) ( 22.6 ) ( 10,353.3 ) 22,664.0 Issuance of Common Stock for equity awards granted under long-term incentive plans — — 3.5 — 1,152.2 — — — — 1,152.2 Common Stock tendered upon exercise of stock options and vesting of restricted stock for employee tax obligations — — ( 0.8 ) — ( 708.4 ) — — — — ( 708.4 ) Issuance/distribution of Common Stock for 401(k) Savings Plan — — — — 66.6 — — 0.1 7.5 74.1 Repurchases of Common Stock — — — — — — — ( 3.0 ) ( 2,214.6 ) ( 2,214.6 ) Stock-based compensation charges — — — — 894.3 — — — — 894.3 Net income — — — — — 3,953.6 — — — 3,953.6 Other comprehensive income, net of tax — — — — — — 157.9 — — 157.9 Balance, December 31, 2023 1.8 — 133.1 0.1 11,354.0 27,260.3 ( 80.9 ) ( 25.5 ) ( 12,560.4 ) 25,973.1 F-6 Table of Contents CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (continued) Class A Stock Common Stock Additional Paid-in Capital Retained Earnings Accumulated Other Comprehensive Income (Loss) Treasury Stock Total Stockholders' Equity Shares Amount Shares Amount Shares Amount Issuance of Common Stock for equity awards granted under long-term incentive plans — — 4.1 — 1,454.6 — — — — 1,454.6 Common Stock tendered upon exercise of stock options and vesting of restricted stock for employee tax obligations — — ( 1.2 ) — ( 1,021.3 ) — — — — ( 1,021.3 ) Issuance/distribution of Common Stock for 401(k) Savings Plan — — — — 71.7 — — 0.1 6.9 78.6 Repurchases of Common Stock — — — — — — — ( 2.8 ) ( 2,613.9 ) ( 2,613.9 ) Stock-based compensation charges — — — — 996.9 — — — — 996.9 Net income — — — — — 4,412.6 — — — 4,412.6 Other comprehensive income, net of tax — — — — — — 73.0 — — 73.0 Balance, December 31, 2024 1.8 $ — 136.0 $ 0.1 $ 12,855.9 $ 31,672.9 $ ( 7.9 ) ( 28.2 ) $ ( 15,167.4 ) $ 29,353.6 The accompanying notes are an integral part of the financial statements. F-7 Table of Contents REGENERON PHARMACEUTICALS, INC. CONSOLIDATED STATEMENTS OF CASH FLOWS (In millions) Year Ended December 31, 2024 2023 2022 Cash flows from operating activities: Net income $ 4,412.6 $ 3,953.6 $ 4,338.4 Adjustments to reconcile net income to net cash provided by operating activities: Depreciation and amortization 482.9 421.0 341.4 Stock-based compensation expense 982.8 885.0 725.0 (Gains) losses on marketable and other securities, net ( 118.3 ) 266.4 36.8 Other non-cash items, net 23.5 ( 0.1 ) 368.0 Deferred income taxes ( 757.3 ) ( 837.8 ) ( 746.4 ) Acquired in-process research and development in connection with asset acquisition 12.6 — 195.0 Changes in assets and liabilities: (Increase) decrease in accounts receivable ( 554.0 ) ( 338.8 ) 707.8 Increase in inventories ( 619.7 ) ( 271.7 ) ( 696.5 ) Increase in prepaid expenses and other assets ( 407.5 ) ( 120.1 ) ( 148.6 ) Increase in deferred revenue 227.8 37.9 32.4 Increase (decrease) in accounts payable, accrued expenses, and other liabilities 735.1 598.6 ( 138.4 ) Total adjustments 7.9 640.4 676.5 Net cash provided by operating activities 4,420.5 4,594.0 5,014.9 Cash flows from investing activities: Purchases of marketable and other securities ( 16,617.4 ) ( 11,646.0 ) ( 7,487.9 ) Sales or maturities of marketable and other securities 15,027.3 9,442.2 5,550.5 Capital expenditures ( 755.9 ) ( 718.6 ) ( 590.1 ) Proceeds from sale of property, plant, and equipment 20.1 — — Payments for Libtayo intangible asset ( 125.7 ) ( 207.8 ) ( 1,026.8 ) Acquisitions, net of cash acquired ( 16.5 ) ( 54.9 ) ( 230.3 ) Net cash used in investing activities ( 2,468.1 ) ( 3,185.1 ) ( 3,784.6 ) Cash flows from financing activities: Proceeds from issuance of Common Stock 1,465.3 1,145.5 1,519.5 Payments in connection with Common Stock tendered for employee tax obligations ( 1,029.1 ) ( 700.6 ) ( 445.7 ) Repurchases of Common Stock ( 2,603.3 ) ( 2,235.0 ) ( 2,082.8 ) Other ( 33.4 ) — — Net cash used in financing activities ( 2,200.5 ) ( 1,790.1 ) ( 1,009.0 ) Effect of exchange rate changes on cash, cash equivalents, and restricted cash ( 0.7 ) ( 0.4 ) — Net (decrease) increase in cash, cash equivalents, and restricted cash ( 248.8 ) ( 381.6 ) 221.3 Cash, cash equivalents, and restricted cash at beginning of period 2,737.8 3,119.4 2,898.1 Cash, cash equivalents, and restricted cash at end of period $ 2,489.0 $ 2,737.8 $ 3,119.4 Supplemental disclosure of cash flow information Cash paid for interest (net of amounts capitalized) $ 52.6 $ 73.1 $ 53.7 Cash paid for income taxes $ 743.0 $ 870.3 $ 1,502.4 The accompanying notes are an integral part of the financial statements. F-8 Table of Contents REGENERON PHARMACEUTICALS, INC. NOTES TO CONSOLIDATED FINANCIAL STATEMENTS 1. Business Overview and Summary of Significant Accounting Policies Organization and Business Regeneron Pharmaceuticals, Inc. and its subsidiaries ("Regeneron," "Company," "we," "us," and "our") is a fully integrated biotechnology company that invents, develops, manufactures, and commercializes medicines for people with serious diseases. The Company's products and product candidates in development are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases, and rare diseases. The Company's research and development efforts have led to numerous products that have received marketing approval. The Company is a party to collaboration and license agreements to develop and commercialize, as applicable, certain products and product candidates (see Note 3). The Company's business is subject to certain risks including, but not limited to, uncertainties relating to conducting research activities, product development, obtaining regulatory approvals, competition, and obtaining and enforcing patents. Segment Reporting The Company operates in one business segment, which includes all activities related to the discovery, development, and commercialization of medicines for serious diseases. The determination of a single business segment is consistent with the consolidated financial information regularly provided to the Company’s chief operating decision maker (“CODM”). The Company’s CODM is its Chief Executive Officer, who reviews and evaluates consolidated net income for purposes of assessing performance, making operating decisions, allocating resources, and planning and forecasting for future periods. In addition to the significant expense categories included within consolidated net income presented on the Company's Consolidated Statements of Operations, see below for disaggregated amounts that comprise research and development expenses: Year Ended December 31, (In millions) 2024 2023 2022 Direct research and development expenses (a) $ 1,588.8 $ 1,295.6 $ 1,042.9 Indirect research and development expenses: Payroll and benefits 1,681.7 1,537.0 1,195.5 Lab supplies and other research and development costs 241.5 210.6 181.0 Occupancy and other operating costs 614.9 518.2 508.5 Total indirect research and development expenses 2,538.1 2,265.8 1,885.0 Clinical manufacturing costs 1,195.9 1,053.9 938.3 Reimbursement of research and development expenses by collaborators ( 190.8 ) ( 176.3 ) ( 273.7 ) Total research and development expenses $ 5,132.0 $ 4,439.0 $ 3,592.5 (a) Direct research and development expenses are comprised primarily of costs paid to third parties for clinical and product development activities, and the portion of research and development expenses incurred by our collaborators that we are obligated to reimburse. Basis of Presentation The consolidated financial statements include the accounts of Regeneron and its wholly-owned subsidiaries. Intercompany balances and transactions are eliminated in consolidation. Certain reclassifications have been made to prior period amounts to conform with the current period's presentation. Use of Estimates The preparation of financial statements in conformity with generally accepted accounting principles requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Actual results F-9 Table of Contents could differ from those estimates. Concentration of Credit Risk Financial instruments which potentially expose the Company to concentrations of credit risk consist of cash, cash equivalents, certain investments, and accounts receivable. In accordance with the Company's policies, the Company mandates asset diversification and monitors exposure with its counterparties. Concentrations of credit risk with respect to receivables from collaborators (see Note 3) are significant. In addition, concentrations of credit risk with respect to customer accounts receivable are also significant. As of December 31, 2024 and 2023, two individual customers accounted for 79 % and 83 % of the Company's net trade accounts receivable balances, respectively. The Company has contractual payment terms with each of its collaborators and customers, and the Company monitors their financial performance and credit worthiness so that it can properly assess and respond to any changes in their credit profile. As of and for the years ended December 31, 2024 and 2023, there were no write-offs and allowances of accounts receivable related to credit risk for the Company's collaborators or customers. Significant Accounting Policies Cash and Cash Equivalents The Company considers all highly liquid debt instruments with a maturity of three months or less when purchased to be cash equivalents. The carrying amount reported in the Consolidated Balance Sheet for cash and cash equivalents approximates its fair value. Debt and Equity Securities The Company has an investment policy that includes guidelines on acceptable investment securities, minimum credit quality, maturity parameters, and diversification. The Company invests its cash primarily in debt securities. The Company considers its investments in debt securities to be "available-for-sale," as defined by authoritative guidance issued by the Financial Accounting Standards Board ("FASB"). These assets are carried at fair value and the unrealized gains and losses are included in accumulated other comprehensive income (loss). Realized gains and losses on available-for-sale debt securities are included in other income (expense), net. The Company reviews its portfolio of available-for-sale debt securities, using both quantitative and qualitative factors, to determine if declines in fair value below cost have resulted from a credit-related loss or other factors. If the decline in fair value is due to credit-related factors, a loss is recognized in net income, whereas if the decline in fair value is not due to credit-related factors, the loss is recorded in other comprehensive income (loss). The Company also has investments in equity securities that are carried at fair value with changes in fair value recognized within other income (expense), net. The Company has elected to measure certain equity investments it holds that do not have readily determinable fair values at cost less impairment, if any, and adjusts for observable price changes in orderly transactions for identical or similar investments of the same issuer within other income (expense), net. Accounts Receivable The Company's trade accounts receivable arise from product sales and represent amounts due from its customers. In addition, the Company records accounts receivable arising from its collaboration and licensing agreements. The Company monitors the financial performance and credit worthiness of its counterparties so that it can properly assess and respond to changes in their credit profile. The Company provides allowances against receivables for estimated losses, if any, that may result from a counterparty's inability to pay. Amounts determined to be uncollectible are written-off against the allowance. Inventories Inventories are stated at the lower of cost or net realizable value. The Company determines the cost of inventory using the first-in, first-out, or FIFO, method. The Company capitalizes inventory costs associated with the Company's products prior to regulatory approval when, based on management's judgment, future commercialization is considered probable and future economic benefit is expected to be realized; otherwise, such costs are expensed. The determination to capitalize inventory costs is based on various factors, including status and expectations of the regulatory approval process, any known safety or efficacy concerns, potential labeling restrictions, and any other impediments to obtaining regulatory approval. F-10 Table of Contents The Company periodically analyzes its inventory levels to identify inventory that may expire prior to expected sale or has a cost basis in excess of its estimated realizable value. In addition, the Company's products are subject to strict quality control and monitoring which the Company performs throughout the manufacturing process. If certain batches or units of product no longer meet quality specifications or become obsolete due to expiration, the Company records a charge to write down such inventory to its estimated realizable value. Property, Plant, and Equipment Property, plant, and equipment are stated at cost, net of accumulated depreciation. Depreciation is calculated on a straight-line basis over the estimated useful lives of the assets. Leasehold improvements are amortized over the shorter of the estimated useful lives of the assets or the remaining lease term. Costs of construction of certain long-lived assets include capitalized interest, which is amortized over the estimated useful life of the related asset. Expenditures for maintenance and repairs which do not materially extend the useful lives of the assets are charged to expense as incurred. The cost and accumulated depreciation or amortization of assets retired or sold are removed from the respective accounts, and any gain or loss is recognized within income from operations. The estimated useful lives of property, plant, and equipment are as follows: Building and improvements 10 – 50 years Laboratory and other equipment 3 – 10 years Furniture and fixtures 5 years The Company periodically assesses the recoverability of long-lived assets, such as property, plant, and equipment, and evaluates such assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Leases The Company determines if an arrangement is a lease considering whether there is an identified asset and the contract conveys the right to control its use. Leases with an initial term of 12 months or less are not recorded on the balance sheet. The Company may include options to extend or terminate a lease within the lease term when it is reasonably certain that it will exercise that option. The Company accounts for lease components (e.g., rental payments) separately from non-lease components (e.g., common area maintenance costs). Lease liabilities are recognized at the lease commencement date based on the present value of the remaining lease payments, discounted using the rate implicit in the lease. For leases where an implicit rate is not readily determinable, the Company uses its incremental borrowing rate based on information available at the lease commencement date to determine the present value of future lease payments. Lease expense for operating leases is recognized on a straight-line basis over the expected lease term. Acquisitions The Company makes a determination whether a transaction should be accounted for as a business combination or as an asset acquisition. In a business combination, the acquisition method of accounting generally requires that the assets acquired and liabilities assumed be recorded as of the date of the acquisition at their respective fair values. Amounts allocated to acquired in-process research and development are capitalized as indefinite-lived intangible assets. Any excess of the purchase price (consideration transferred) over the fair values of net assets acquired is recorded as goodwill. Contingent consideration obligations are recorded at fair value as of the acquisition date and remeasured each subsequent reporting period until the contingencies have been resolved, with any changes in fair value recorded in Other operating (income) expense, net. If it is determined that the assets acquired do not meet the definition of a business, or if substantially all of the fair value of the assets acquired are concentrated in a single identifiable asset, then the transaction is accounted for as an asset acquisition rather than a business combination. In an asset acquisition, assets acquired are recorded at cost, goodwill is not recognized, and acquired in-process research and development with no alternative future use is charged to expense. F-11 Table of Contents Intangible Assets Intangible assets acquired in a business combination are recorded at fair value, while intangible assets acquired in connection with an asset acquisition are recorded at cost. Payments to acquire intangible assets in an asset acquisition may include up-front payments and contingent consideration. With regard to contingent consideration in an asset acquisition, the Company recognizes regulatory milestones upon achievement, royalties in the period in which the underlying sales occur, and sales-based milestones when the milestone is deemed probable by the Company of being achieved. If contingent consideration is recognized subsequent to the acquisition date in an asset acquisition, the amount of such consideration is recorded as an addition to the cost basis of the intangible asset with a cumulative catch-up adjustment for amortization expense as if the additional amount of consideration had been accrued from the outset of the acquisition. Indefinite-lived intangible assets are subject to impairment testing until completion or abandonment of the associated research and development efforts. Definite-lived intangible assets are amortized to Cost of goods sold over the estimated useful lives of the assets based on the pattern in which the economic benefits of the intangible assets are consumed; if that pattern cannot be reliably determined, a straight-line basis is used. Intangible assets are reviewed for recoverability whenever events or changes in circumstances indicate that the carrying amount of the asset may not be recoverable. If an indicator of impairment exists, the Company compares the projected undiscounted cash flows to be generated by the asset to the intangible asset's carrying amount. If the projected undiscounted cash flows of the intangible asset are less than the carrying amount, an impairment loss is recognized within operating expenses and the intangible asset is written down to its fair value in the period in which the impairment occurs. Product Revenue Revenue from product sales is recognized at a point in time when the Company's customer is deemed to have obtained control of the product, which generally occurs upon receipt or acceptance by its customer. The amount of revenue the Company recognizes from product sales may vary due to rebates, chargebacks, and discounts provided under governmental and other programs, distribution-related fees, and other sales-related deductions. In order to determine the transaction price, the Company estimates, utilizing the expected value method, the amount of variable consideration to which the Company will be entitled. This estimate is based upon contracts with customers, healthcare providers, payors, and government agencies, statutorily-defined discounts applicable to government-funded programs, historical experience, estimated payor mix, and other relevant factors. The Company reviews its estimates of rebates, chargebacks, and other applicable provisions each period and records any necessary adjustments in the current period's net product sales. • Rebates: The Company's rebates include amounts paid to managed care organizations, group purchasing organizations, state Medicaid programs, and other rebate programs. The Company estimates reductions to product sales for each type of rebate and records an allowance for rebates in the same period in which the related product sales are recognized. The Company's liability for rebates consists of estimates for claims related to the current and prior periods that have not been paid and estimates for claims that will be made related to product that exists in the distribution channel at the end of the period. • Chargebacks and Discounts: The Company's reserves related to discounted pricing to eligible physicians, Veterans' Administration ("VA"), Public Health Services, and others (collectively, "qualified healthcare providers") represent the Company's estimated obligations resulting from contractual commitments to sell products to qualified healthcare providers at prices lower than the list prices the Company charges to its customers (i.e., distributors and specialty pharmacies). The Company's customers charge the Company for the difference between what they pay for the products and the discounted selling price to the qualified healthcare providers. The Company estimates reductions to product sales for each type of chargeback and records an allowance for chargebacks in the same period that the related product sales are recognized. The Company's reserve for chargebacks consists of amounts for which it expects to issue credit based on expected sales by its customers to qualified healthcare providers and chargebacks that customers have claimed but for which the Company has not yet issued credit. • Distribution-Related Fees: The Company has written contracts with its customers that include terms for distribution-related fees. The Company estimates and records distribution and related fees due to its customers generally based on gross sales. • Other Sales-Related Deductions : The Company's other sales-related deductions include co-pay assistance programs and product returns. The Company estimates and records other sales-related deductions generally based on gross sales, written contracts, and other relevant factors. Consistent with industry practice, the Company generally offers its customers a limited right to return product purchased directly from the Company, which is principally based upon the F-12 Table of Contents product's expiration date. Product returned is generally not resalable given the nature of the Company's products and method of administration. The Company develops estimates for product returns based upon historical experience, shelf life of the product, and other relevant factors. The Company monitors product supply levels in the distribution channel, as well as sales by its customers, using product-specific data provided by its customers. If necessary, the Company's estimates of product returns may be adjusted in the future based on actual returns experience, known or expected changes in the marketplace, or other factors. Collaborative Arrangements The Company has entered into various collaborative arrangements to research, develop, manufacture, and commercialize products and/or product candidates. Although each of these arrangements is unique in nature, such arrangements involve a joint operating activity where both parties are active participants in the activities of the collaboration and exposed to significant risks and rewards dependent on the commercial success of the activities. In arrangements where the Company does not deem its collaborator to be its customer, payments to and from its collaborator are presented in the Company's statement of operations based on the nature of our business operations, the nature of the arrangement, including the contractual terms, and the nature of the payments. In general, the presentation of such amounts is summarized below. Nature/Type of Payment Statement of Operations Presentation Regeneron's share of profits or losses in connection with commercialization of products Collaboration revenue Reimbursement for manufacturing of commercial supplies Collaboration revenue Royalties and/or sales-based milestones earned Collaboration revenue Reimbursement of Regeneron's research and development expenses Reduction to Research and development expense Regeneron's obligation for its share of collaborator's research and development expenses Research and development expense Up-front, opt-in, and development milestone payments; and premiums paid on equity securities Acquired in-process research and development expense Reimbursement of Regeneron's commercialization-related expenses Reduction to Selling, general, and administrative expense Regeneron's obligation for its share of collaborator's commercialization-related expenses Selling, general, and administrative expense Regeneron's obligation to pay collaborator for its share of gross profits when Regeneron is deemed to be the principal Cost of goods sold Up-front and development milestones earned (when there is a combined unit of account which includes a license and providing research and development services) Other operating income In agreements involving multiple goods or services promised to be transferred to the Company's collaborator, the Company assesses, at the inception of the contract, whether each promise represents a separate obligation (i.e., is "distinct"), or whether such promises should be combined as a single unit of account. When the Company has a combined unit of account which includes a license and providing research and development services to its collaborator, recognition of up-front payments and development milestones earned from its collaborator is deferred (as a liability) and recognized over the development period (i.e., over time) typically using an input method on the basis of the Company's research and development costs incurred relative to the total expected cost which determines the extent of the Company's progress toward completion. The Company reviews its estimates each period and makes revisions to such estimates as necessary. When the Company is entitled to reimbursement of all or a portion of the expenses (e.g., research and development expenses) that it incurs under a collaboration, it records those reimbursable amounts in the period in which such costs are incurred. When the Company enters into an arrangement with another party to fund its research and development costs, the Company considers whether the costs that it may be obligated to repay represent a liability within the scope of Accounting Standards Codification ("ASC") 730-20, Research and Development . If the Company concludes that such funding does not represent a substantive and genuine transfer of risk, a liability is recorded. If the Company's collaborator performs research and development work or commercialization-related activities and the parties share the related costs, the Company also recognizes, as expense (e.g., research and development expense or selling, general, and administrative expense, as applicable) in the period when its collaborator incurs such expenses, the portion of the collaborator's F-13 Table of Contents expenses that the Company is obligated to reimburse. The Company's collaborators provide the Company with estimated expenses for the most recent fiscal quarter. The estimates are revised, if necessary, in subsequent periods if actual expenses differ from those estimates. Under certain of the Company's collaboration agreements, product sales and cost of sales may be recorded by the Company's collaborators as they are deemed to be the principal in the transaction. In arrangements where the Company: • supplies commercial product to its collaborator, the Company may be reimbursed for its manufacturing costs as commercial product is shipped to the collaborator (however, recognition of such cost reimbursements may be deferred until the product is sold by the Company's collaborator to third-party customers); • shares in any profits or losses arising from the commercialization of such products, the Company records its share of the variable consideration, representing net product sales less cost of goods sold and shared commercialization and other expenses, in the period in which such underlying sales occur and costs are incurred by the collaborator; • receives royalties and/or sales-based milestone payments from its collaborator, the Company recognizes such amounts in the period earned. The Company's collaborators provide it with estimates of product sales and the Company's share of profits or losses, as applicable, for each quarter. The estimates are revised, if necessary, in subsequent periods if the Company's actual share of profits or losses differ from those estimates. Research and Development Expenses Research and development expenses include costs attributable to the conduct of research and development programs, including the cost of salaries, payroll taxes, employee benefits, materials, supplies, depreciation on and maintenance of research equipment, costs related to research collaboration and licensing agreements, clinical trial expenses, the cost of services provided by outside contractors, including services related to the Company's clinical trials, the cost of manufacturing drug for use in research and development, amounts that the Company is obligated to reimburse to collaborators for research and development expenses that they incur, and the allocable portions of facility costs. Costs associated with research and development are expensed. For each clinical trial that the Company conducts, certain clinical trial costs are expensed immediately, while others are expensed over time based on the expected total number of patients in the trial, the rate at which patients enter and remain in the trial, and/or the period over which clinical investigators, contract research organizations ("CROs"), or other third-party service providers are expected to provide services. In the event of early termination of a clinical trial, the Company accrues and recognizes expenses in an amount based on its estimate of the remaining noncancelable obligations associated with the winding-down of the clinical trial, including any applicable penalties. Stock-based Compensation The Company recognizes stock-based compensation expense for equity grants under the Company's long-term incentive plans (including stock options, restricted stock awards, and restricted stock units (both time-based and performance-based)) to employees and non-employee members of the Company's board of directors (as applicable) based on the grant-date fair value of those awards. The grant-date fair value of an award is generally recognized as compensation expense over the award's requisite service period. Stock-based compensation expense also includes an estimate, which is made at the time of grant, of the number of awards that are expected to be forfeited. The forfeiture rate estimate is calculated by considering both historical forfeiture experience and an estimate of expected future forfeitures for currently outstanding unvested awards. This estimate is reviewed at least annually and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. The Company uses the Black-Scholes model to compute the estimated fair value of stock option awards. Additionally, the Company uses a Monte Carlo simulation to compute the estimated fair value of performance-based restricted stock units that are subject to vesting based on the Company’s attainment of pre-established criteria that include a market condition. For performance-based restricted stock units that contain a performance condition, the Company recognizes stock-based compensation expense if and when the Company determines that it is probable the performance condition will be achieved (based on the number of shares expected to be vested and issued). The Company reassesses the probability of achievement at each reporting period and adjusts compensation cost, as necessary. If there are any changes in the Company's probability assessment, the Company recognizes a cumulative catch-up adjustment in the period of the change in estimate, with the remaining unrecognized expense recognized prospectively over the remaining requisite service period. If the Company subsequently determines that the performance criteria are not met or are not expected to be met, any amounts previously recognized as compensation expense are reversed in the period when such determination is made. F-14 Table of Contents Income Taxes The provision for income taxes includes U.S. federal, state, local, and foreign taxes. Income taxes are accounted for under the liability method. Deferred tax assets and liabilities are recognized for the expected future tax consequences of events that have been included in the financial statements or tax returns, including deferred tax assets and liabilities for expected amounts of global intangible low-taxed income ("GILTI") inclusions. Deferred tax assets and liabilities are determined as the difference between the tax basis of assets and liabilities and their respective financial reporting amounts ("temporary differences") at enacted tax rates in effect for the years in which the differences are expected to reverse. A valuation allowance is established for deferred tax assets for which it is more likely than not that some portion or all of the deferred tax assets will not be realized. The Company recognizes the financial statement effects of a tax position when management's assessment is that there is more than a 50% probability that the position will be sustained upon examination by a taxing authority based upon its technical merits. Uncertain tax positions are recorded based upon certain recognition and measurement criteria. The Company re-evaluates uncertain tax positions and considers various factors, including, but not limited to, changes in tax law, the measurement of tax positions taken or expected to be taken in tax returns, the effective settlement of matters subject to audit, information obtained during in-process audit activities, and changes in facts or circumstances related to a tax position. The Company adjusts the amount of the liability to reflect any subsequent changes in the relevant facts and circumstances surrounding the uncertain tax positions. The Company recognizes interest and penalties related to income tax matters in income tax expense. Per Share Data Basic net income per share is computed by dividing net income by the weighted average number of shares of Common Stock and Class A Stock outstanding. Net income per share is presented on a combined basis, inclusive of Common Stock and Class A Stock outstanding, as each class of stock has equivalent economic rights. Basic net income per share excludes restricted stock until vested. Diluted net income per share includes the potential dilutive effect of common stock equivalents as if such securities were converted or exercised during the period, when the effect is dilutive. Common stock equivalents include outstanding stock options and unvested restricted stock under the Company's long-term incentive plans, which are included under the treasury stock method when dilutive. Recently Issued Accounting Standards Standard/Description Effective Date Impact of Adoption on the Company's Financial Statements ASU 2023-09: In December 2023, the FASB issued amended guidance related to improvements to income tax disclosures . The amendments require annually (i) enhanced disclosures in connection with an entity's effective tax rate reconciliation and (ii) income taxes paid disaggregated by jurisdiction. January 1, 2025 No significant impact expected ASU 2024-03: In November 2024, the FASB issued new guidance which requires disclosure of disaggregated income statement expense information about specific categories (including purchases of inventory, employee compensation, depreciation, and intangible asset amortization) in the notes to financial statements. January 1, 2027 for annual reporting periods and January 1, 2028 for interim reporting periods Currently evaluating impact F-15 Table of Contents 2. Product Sales Net product sales consist of the following: Year Ended December 31, (In millions) 2024 2023 2022 EYLEA HD ® U.S. $ 1,201.1 $ 165.8 $ — EYLEA ® U.S. 4,767.1 5,719.6 6,264.6 Total EYLEA HD and EYLEA U.S. 5,968.2 5,885.4 6,264.6 Libtayo ® U.S. 787.3 538.8 374.5 Libtayo (a) Rest of world 429.5 324.3 73.0 Total Libtayo Global 1,216.8 863.1 447.5 Praluent ® U.S. 241.7 182.4 130.0 Evkeeza ® U.S. 125.7 77.3 48.6 Inmazeb ® U.S. 76.8 69.8 3.0 $ 7,629.2 $ 7,078.0 $ 6,893.7 (a) Effective July 1, 2022, the Company obtained the exclusive right to develop, commercialize, and manufacture Libtayo worldwide and, as a result, began recording net product sales of Libtayo outside the United States. See Note 3 for further details. As of December 31, 2024 and 2023, the Company had $ 4.278 billion and $ 3.888 billion, respectively, of trade accounts receivable that were recorded within Accounts receivable, net. The Company had product sales to certain customers that each accounted for more than 10% of total gross product revenue for the years ended December 31, 2024, 2023, and 2022. Sales to each of these customers as a percentage of the Company's total gross product revenue are as follows: Year Ended December 31, 2024 2023 2022 Besse Medical, a subsidiary of Cencora, Inc. 50 % 51 % 55 % McKesson Corporation 24 % 25 % 28 % Revenue from product sales is recorded net of applicable provisions for rebates, chargebacks, and discounts, distribution-related fees, and other sales-related deductions. Accruals for chargebacks and discounts are recorded as a direct reduction to accounts receivable. Accruals for rebates, distribution-related fees, and other sales-related deductions are recorded within accrued liabilities. The following table summarizes the provisions, and credits/payments, for sales-related deductions: (In millions) Rebates, Chargebacks, and Discounts Distribution- Related Fees Other Sales- Related Deductions Total Balance as of December 31, 2021 $ 214.6 $ 80.0 $ 67.6 $ 362.2 Provisions 1,537.3 431.1 141.1 2,109.5 Credits/payments ( 1,398.0 ) ( 399.7 ) ( 127.2 ) ( 1,924.9 ) Balance as of December 31, 2022 353.9 111.4 81.5 546.8 Provisions 2,074.5 439.2 155.3 2,669.0 Credits/payments ( 1,972.7 ) ( 388.3 ) ( 157.5 ) ( 2,518.5 ) Balance as of December 31, 2023 455.7 162.3 79.3 697.3 Provisions 2,447.3 462.7 143.0 3,053.0 Credits/payments ( 2,363.9 ) ( 497.2 ) ( 128.8 ) ( 2,989.9 ) Balance as of December 31, 2024 $ 539.1 $ 127.8 $ 93.5 $ 760.4 F-16 Table of Contents 3. Collaboration, License, and Other Agreements a. Sanofi Amounts recognized in the Company's Statements of Operations in connection with its collaborations with Sanofi are as follows: Statement of Operations Classification Year Ended December 31, (In millions) 2024 2023 2022 Antibody: Regeneron's share of profits Collaboration revenue $ 3,923.5 $ 3,136.5 $ 2,082.0 * Sales-based milestones earned Collaboration revenue $ — $ 50.0 $ 100.0 Reimbursement for manufacturing of commercial supplies Collaboration revenue $ 607.9 $ 613.0 $ 633.7 Other Collaboration revenue $ — $ — $ 28.7 Regeneron's obligation for its share of Sanofi R&D expenses, net of reimbursement of R&D expenses (R&D expense)/Reduction of R&D expense $ ( 46.8 ) $ ( 83.7 ) $ 43.0 Reimbursement of commercialization-related expenses Reduction of SG&A expense $ 655.4 $ 534.4 $ 437.4 Immuno-oncology (a) : Regeneron's share of profits in connection with commercialization of Libtayo outside the United States Collaboration revenue $ — $ — $ 6.7 Reimbursement for manufacturing of ex-U.S. commercial supplies Collaboration revenue $ — $ — $ 4.6 Reimbursement of R&D expenses Reduction of R&D expense $ — $ — $ 42.7 Reimbursement of commercialization-related expenses, net of Regeneron's obligation for its share of Sanofi commercialization-related expenses Reduction of SG&A expense $ — $ — $ 21.5 Regeneron's obligation for Sanofi's share of Libtayo U.S. gross profits Cost of goods sold $ — $ — $ ( 70.1 ) Amounts recognized in connection with up-front payments received Other operating income $ — $ — $ 35.1 * Net of one-time payment of $ 56.9 million to Sanofi in connection with the amendment to the Antibody License and Collaboration Agreement (a) As described within the " Immuno-Oncology " section below, effective July 1, 2022, the Company obtained the exclusive right to develop, commercialize, and manufacture Libtayo worldwide. Antibody The Company is party to a global, strategic collaboration with Sanofi to research, develop, and commercialize fully human monoclonal antibodies (the "Antibody Collaboration"), which currently consists of Dupixent ® (dupilumab), Kevzara ® (sarilumab), and itepekimab . Under the terms of the Antibody License and Collaboration Agreement (the "LCA"), Sanofi is generally responsible for funding 80 % to 100 % of agreed-upon development costs. The Company is obligated to reimburse Sanofi for 30 % to 50 % of worldwide development expenses that were funded by Sanofi based on the Company's share of collaboration profits from commercialization of collaboration products. Under the terms of the LCA, the Company was required to apply 10 % of its share of the profits from the Antibody Collaboration in any calendar quarter to reimburse Sanofi for these development costs. On July 1, 2022, an amendment to the LCA became effective, which had been entered into in connection with our acquisition of exclusive worldwide rights to Libtayo (cemiplimab). Pursuant to this amendment, the percentage of the Company's share of profits used to reimburse Sanofi for such development costs has increased from 10 % to 20 %. The estimated net present value differential between the 10 % repayment rate and the 20 % repayment rate was deemed to be contingent consideration attributable to the Company's acquisition of the Libtayo rights described within the " Immuno-Oncology " section below; this portion is recorded as an increase to the Libtayo intangible asset over time as the Company repays such development costs to Sanofi. The Company's contingent reimbursement obligation (i.e., "development balance") to Sanofi under the Antibody Collaboration was approximately $ 1.635 billion as of December 31, 2024. F-17 Table of Contents Sanofi leads commercialization activities for products under the Antibody Collaboration, subject to the Company's right to co-commercialize such products. The Company co-commercializes Dupixent in the United States and in certain countries outside the United States. The parties equally share profits from sales within the United States. The parties share profits outside the United States on a sliding scale based on sales starting at 65 % (Sanofi)/ 35 % (Regeneron) and ending at 55 % (Sanofi)/ 45 % (Regeneron). In addition to profit sharing, the Company was entitled to receive sales milestone payments from Sanofi. In 2023, the Company earned the final $ 50.0 million sales-based milestone from Sanofi upon aggregate annual sales of antibodies outside the United States exceeding $ 3.0 billion on a rolling twelve-month basis. In 2022, the Company earned two $ 50.0 million sales-based milestones from Sanofi, upon aggregate annual sales of antibodies outside the United States exceeding $ 2.0 billion and $ 2.5 billion, respectively, on a rolling twelve-month basis. The Company's significant promised goods and services in connection with the Antibody Collaboration consist of providing research and development services, including the manufacturing of clinical supplies, and providing commercial-related services, including the manufacturing of commercial supplies. The Company recognizes amounts in connection with the Antibody Collaboration based on the amount it has the right to invoice and such amount corresponds directly with the Company's performance to date. The following table summarizes contract balances in connection with the Company's Antibody Collaboration with Sanofi: As of December 31, (In millions) 2024 2023 Accounts receivable, net $ 1,216.2 $ 1,029.1 Deferred revenue $ 571.7 $ 427.7 Immuno-Oncology The Company was previously a party to a collaboration with Sanofi for antibody-based cancer treatments in the field of immuno-oncology, including for the co-development and co-commercialization of Libtayo. The parties shared equally, on an ongoing basis, development and commercialization expenses for Libtayo. The Company had principal control over the development of Libtayo and led commercialization activities in the United States, while Sanofi led commercialization activities outside the United States. The parties shared equally in profits and losses in connection with the commercialization of Libtayo. Effective July 1, 2022, the Company obtained the exclusive right to develop, commercialize, and manufacture Libtayo worldwide. In connection with this agreement, in 2022, the Company made a $ 900.0 million up-front payment to Sanofi, as well as a $ 100.0 million regulatory milestone payment. In addition, Sanofi was eligible to earn an aggregate of $ 100.0 million in Libtayo sales-based milestones, of which it earned $ 65.0 million in 2022 and $ 35.0 million in 2023. The Company also pays Sanofi an 11 % royalty on net product sales of Libtayo through March 31, 2034. The transaction was accounted for as an asset acquisition and amounts paid to Sanofi in connection with obtaining the worldwide rights to Libtayo, including the up-front payment and any contingent consideration, are recorded as an intangible asset. See Note 8 for additional information related to the intangible asset. b. Bayer The Company is party to a license and collaboration agreement with Bayer for the global development and commercialization of EYLEA 8 mg (aflibercept 8 mg) and EYLEA (aflibercept) outside the United States. Agreed-upon development expenses incurred by the Company and Bayer are generally shared equally. The Company is also obligated to use commercially reasonable efforts to supply clinical and commercial bulk product. F-18 Table of Contents Bayer is responsible for commercialization activities outside the United States, and the companies share equally in profits from such sales. Within the United States, the Company is responsible for commercialization and retains profits from such sales. The Company is obligated to reimburse Bayer out of the Company's share of the collaboration profits for 50 % of the agreed-upon development expenses that Bayer has incurred in accordance with a formula based on the amount of development expenses that Bayer has incurred and the Company's share of the collaboration profits, or at a faster rate at the Company's option. The Company's contingent reimbursement obligation to Bayer was approximately $ 315 million as of December 31, 2024. Amounts recognized in the Company's Statements of Operations in connection with its Bayer collaboration are as follows: Statement of Operations Classification Year Ended December 31, (In millions) 2024 2023 2022 Regeneron's share of profits Collaboration revenue $ 1,403.3 $ 1,376.4 $ 1,317.4 Reimbursement for manufacturing of ex-U.S. commercial supplies Collaboration revenue $ 95.7 $ 111.1 $ 91.4 One-time payment in connection with change in Japan arrangement Collaboration revenue $ — $ — $ 21.9 Regeneron's obligation for its share of Bayer R&D expenses, net of reimbursement of R&D expenses (R&D expense)/Reduction of R&D expense $ ( 48.5 ) $ ( 44.0 ) $ 16.7 The following table summarizes contract balances in connection with the Company's Bayer collaboration: As of December 31, (In millions) 2024 2023 Accounts receivable, net $ 349.9 $ 381.7 Deferred revenue $ 216.3 $ 138.2 c. Roche The Company is a party to a collaboration agreement with Roche to develop, manufacture, and distribute the casirivimab and imdevimab antibody cocktail (known as REGEN-COV ® in the United States and Ronapreve ™ in other countries). Under the terms of the collaboration agreement, the Company has the right to distribute the product in the United States while Roche has the right to distribute the product outside the United States. The parties share gross profits from worldwide sales based on a pre-specified formula. Amounts recognized in the Company's Statements of Operations in connection with its Roche collaboration are as follows: Statement of Operations Classification Year Ended December 31, (In millions) 2024 2023 2022 Regeneron's share of profits Collaboration revenue $ 1.4 $ 224.3 $ 627.3 Other Collaboration revenue $ — $ ( 13.3 ) $ — Reimbursement of research and development expenses from Roche was not material for the years ended December 31, 2024, 2023, and 2022. Contract balances in the Company's Balance Sheets in connection with the Roche collaboration were not material as of December 31, 2024 and 2023. d. Other In addition to the collaboration and license agreements discussed above, the Company has various other collaboration and license agreements that are not individually significant to its operating results or financial condition at this time. Pursuant to the terms of those agreements, the Company may be required to pay, or it may receive, additional amounts contingent upon the occurrence of various future events (e.g., upon the achievement of various development and commercial milestones), which in the aggregate could be significant. The Company may also incur, or get reimbursed for, research and development costs. F-19 Table of Contents Acquired In-process Research and Development ("IPR&D") Expenses During the year ended December 31, 2024, the Company recorded as Acquired IPR&D expense a $ 45.0 million development milestone in connection with the Company's collaboration agreement with Sonoma Biotherapeutics, Inc. During the year ended December 31, 2023, the Company recorded as Acquired IPR&D expense a $ 100.0 million development milestone in connection with its collaboration agreement with Alnylam Pharmaceuticals, Inc., a $ 45.0 million up-front payment in connection with its collaboration agreement with Sonoma, and a $ 30.0 million extension payment under its collaboration agreement with Intellia Therapeutics, Inc. During the year ended December 31, 2022, the Company recorded as Acquired IPR&D expense a $ 195.0 million charge related to its acquisition of Checkmate Pharmaceuticals, Inc. Royalties The Company has also in-licensed patent and/or technology pursuant to agreements which contain provisions that require the Company to pay royalties, as defined, at rates that range from 0.5 % to 12.0 %, in the event the Company sells or licenses any proprietary products developed under the respective agreements. As described above, as a result of obtaining worldwide rights to Libtayo, the Company pays Sanofi a royalty on net product sales of Libtayo. In addition, in 2018, the Company and Sanofi entered into a license agreement with Bristol-Myers Squibb Company, E. R. Squibb & Sons, L.L.C., and Ono Pharmaceutical Co., Ltd. to obtain a license under certain patents owned and/or exclusively licensed by one or more of those parties that includes the right to develop and sell Libtayo. Under the agreement, the Company paid royalties of 8.0 % on worldwide sales of Libtayo through December 31, 2023, and is obligated to pay royalties of 2.5 % from January 1, 2024 through December 31, 2026. For the years ended December 31, 2024, 2023, and 2022, the Company recorded royalty expense (net of reimbursements from collaborators, as applicable) of $ 82.9 million, $ 117.6 million, and $ 84.5 million, respectively, based on product sales under various licensing agreements. F-20 Table of Contents 4. Marketable Securities Marketable securities as of December 31, 2024 and 2023 consist of both available-for-sale debt securities of investment grade issuers (see below and Note 5) as well as equity securities of publicly traded companies (see Note 5). The following tables summarize the Company's investments in available-for-sale debt securities: (In millions) Amortized Unrealized Fair As of December 31, 2024 Cost Basis Gains Losses Value Corporate bonds $ 8,226.9 $ 25.1 $ ( 31.4 ) $ 8,220.6 U.S. government and government agency obligations 4,820.5 3.4 ( 6.9 ) 4,817.0 Commercial paper 548.3 0.4 — 548.7 Certificates of deposit 380.6 0.5 — 381.1 Asset-backed securities 279.0 0.6 ( 0.3 ) 279.3 Sovereign bonds 82.7 0.1 ( 0.4 ) 82.4 $ 14,338.0 $ 30.1 $ ( 39.0 ) $ 14,329.1 As of December 31, 2023 Corporate bonds $ 6,492.5 $ 10.4 $ ( 104.9 ) $ 6,398.0 U.S. government and government agency obligations 4,839.6 2.4 ( 8.6 ) 4,833.4 Commercial paper 636.8 0.2 ( 0.2 ) 636.8 Certificates of deposit 520.8 0.6 — 521.4 Asset-backed securities 88.2 0.1 ( 1.2 ) 87.1 Sovereign bonds 58.1 — ( 0.9 ) 57.2 $ 12,636.0 $ 13.7 $ ( 115.8 ) $ 12,533.9 The Company classifies its investments in available-for-sale debt securities based on their contractual maturity dates. The available-for-sale debt securities as of December 31, 2024 mature at various dates through December 2029. The fair values of available-for-sale debt securities by contractual maturity consist of the following: As of December 31, (In millions) 2024 2023 Maturities within one year $ 6,524.3 $ 8,114.8 Maturities after one year through five years 7,804.8 4,414.5 Maturities after five years — 4.6 $ 14,329.1 $ 12,533.9 F-21 Table of Contents The following table shows the fair value and gross unrealized losses by category and disaggregated by the length of time that the Company's available-for-sale debt securities have been in a continuous unrealized loss position. Less than 12 Months 12 Months or Greater Total (In millions) As of December 31, 2024 Fair Value Unrealized Losses Fair Value Unrealized Losses Fair Value Unrealized Losses Corporate bonds $ 7,175.8 $ ( 14.2 ) $ 1,044.8 $ ( 17.2 ) $ 8,220.6 $ ( 31.4 ) U.S. government and government agency obligations 4,675.3 ( 6.2 ) 141.7 ( 0.7 ) 4,817.0 ( 6.9 ) Sovereign bonds 63.3 ( 0.3 ) 19.1 ( 0.1 ) 82.4 ( 0.4 ) Asset-backed securities 265.4 ( 0.3 ) 13.9 — 279.3 ( 0.3 ) $ 12,179.8 $ ( 21.0 ) $ 1,219.5 $ ( 18.0 ) $ 13,399.3 $ ( 39.0 ) As of December 31, 2023 Corporate bonds $ 2,363.3 $ ( 2.4 ) $ 4,034.7 $ ( 102.5 ) $ 6,398.0 $ ( 104.9 ) U.S. government and government agency obligations 4,780.6 ( 6.0 ) 52.7 ( 2.6 ) 4,833.3 ( 8.6 ) Sovereign bonds 12.4 ( 0.1 ) 44.8 ( 0.8 ) 57.2 ( 0.9 ) Commercial paper 636.8 ( 0.2 ) — — 636.8 ( 0.2 ) Asset-backed securities 61.8 ( 0.3 ) 25.3 ( 0.9 ) 87.1 ( 1.2 ) $ 7,854.9 $ ( 9.0 ) $ 4,157.5 $ ( 106.8 ) $ 12,012.4 $ ( 115.8 ) The unrealized losses on corporate bonds were primarily driven by changes in interest rates. The Company has reviewed its portfolio of available-for-sale debt securities and determined that the decline in fair value below cost did not result from credit-related factors. In addition, the Company does not intend to sell, and it is not more likely than not that the Company will be required to sell, such securities before recovery of their amortized cost bases. With respect to marketable securities, for the years ended December 31, 2024, 2023, and 2022, amounts reclassified from Accumulated other comprehensive loss into Other income (expense), net were related to realized gains/losses on sales of available-for-sale debt securities. For the years ended December 31, 2024, 2023, and 2022, realized gains/losses on sales of marketable securities were not material. The Company recognized interest income of $ 711.4 million, $ 495.9 million, and $ 160.1 million for the years ended December 31, 2024, 2023, and 2022, respectively, in Other income (expense), net. F-22 Table of Contents 5. Fair Value Measurements The table below summarizes the Company's assets and liabilities which are measured at fair value on a recurring basis. The following fair value hierarchy is used to classify assets and liabilities, based on inputs to valuation techniques utilized to measure fair value: • Level 1 - Quoted prices in active markets for identical assets or liabilities • Level 2 - Significant other observable inputs, such as quoted market prices for similar instruments in active markets, quoted prices for identical or similar instruments in markets that are not active, or model-based valuations in which significant inputs used are observable • Level 3 - Significant other unobservable inputs (In millions) Fair Value Measurements at Reporting Date As of December 31, 2024 Fair Value Level 1 Level 2 Level 3 Assets: Cash equivalents $ 1,452.2 $ 1,264.2 $ 188.0 $ — Available-for-sale debt securities: Corporate bonds 8,220.6 — 8,220.6 — U.S. government and government agency obligations 4,817.0 — 4,817.0 — Commercial paper 548.7 — 548.7 — Certificates of deposit 381.1 — 381.1 — Asset-backed securities 279.3 — 279.3 — Sovereign bonds 82.4 — 82.4 — Equity securities (unrestricted) 1,052.1 1,052.1 — — Equity securities (restricted) (a) 43.2 43.2 — — Total assets $ 16,876.6 $ 2,359.5 $ 14,517.1 $ — Liabilities: Contingent consideration $ 52.3 $ — $ — $ 52.3 As of December 31, 2023 Assets: Cash equivalents $ 928.1 $ 6.4 $ 921.7 $ — Available-for-sale debt securities: Corporate bonds 6,398.0 — 6,398.0 — U.S. government and government agency obligations 4,833.4 — 4,833.4 — Commercial paper 636.8 — 636.8 — Certificates of deposit 521.4 — 521.4 — Asset-backed securities 87.1 — 87.1 — Sovereign bonds 57.2 — 57.2 — Equity securities (unrestricted) 864.5 864.5 — — Equity securities (restricted) 112.9 112.9 — — Total assets $ 14,439.4 $ 983.8 $ 13,455.6 $ — Liabilities: Contingent consideration $ 43.7 $ — $ — $ 43.7 (a) Includes equity securities which are subject to transfer restrictions that expire in April 2026 In addition to the investments summarized in the table above, as of December 31, 2024 and 2023, the Company had $ 159.8 million and $ 74.3 million, respectively, in equity investments that do not have a readily determinable fair value. These F-23 Table of Contents investments are recorded within Other noncurrent assets. Also recorded within Other noncurrent assets as of December 31, 2024 were equity investments of $ 52.0 million which are measured at fair value based on Level 3 inputs; no such investments were held by the Company as of December 31, 2023. During the year ended December 31, 2024, the Company recorded $ 117.7 million of net unrealized gains on equity securities in Other income (expense), net. During the years ended December 31, 2023 and 2022, the Company recorded $ 237.8 million and $ 39.8 million, respectively, of net unrealized losses on equity securities in Other income (expense), net. In addition, during the year ended December 31, 2023, the Company recorded a write-down of $ 29.0 million in Other income (expense), net related to the Company's investments in private companies. The fair value of the Company's long-term debt (see Note 10), which was determined based on Level 2 inputs, was estimated to be $ 1.484 billion and $ 1.528 billion as of December 31, 2024 and 2023, respectively. 6. Inventories Inventories consist of the following: As of December 31, (In millions) 2024 2023 Raw materials $ 879.5 $ 789.3 Work-in-process 1,342.3 1,121.8 Finished goods 139.8 147.3 Deferred costs 725.7 522.1 $ 3,087.3 $ 2,580.5 Deferred costs represent the costs of product manufactured and shipped to the Company's collaborators for which recognition of revenue has been deferred. For the years ended December 31, 2024, 2023, and 2022, Cost of goods sold included inventory write-offs and reserves of $ 126.3 million, $ 102.3 million, and $ 258.7 million, respectively. Inventory write-offs and reserves for the year ended December 31, 2022 primarily related to REGEN-COV. 7. Property, Plant, and Equipment Property, plant, and equipment, net consists of the following: As of December 31, (In millions) 2024 2023 Building and improvements $ 2,573.2 $ 2,423.1 Leasehold improvements 154.5 133.9 Laboratory equipment 1,494.5 1,384.5 Computer equipment and software 450.8 389.7 Furniture, office equipment, and other 203.8 165.9 Land 288.2 283.1 Construction in progress 1,721.6 1,345.0 6,886.6 6,125.2 Accumulated depreciation and amortization ( 2,286.9 ) ( 1,978.8 ) $ 4,599.7 $ 4,146.4 Property, plant, and equipment in the table above includes leased property under the Company's finance lease at its Tarrytown, New York corporate headquarters. See Note 11. Depreciation and amortization expense on property, plant, and equipment was $ 354.1 million, $ 328.8 million, and $ 303.9 million for the years ended December 31, 2024, 2023, and 2022, respectively. F-24 Table of Contents As of December 31, 2024 and 2023, $ 3.884 billion and $ 3.375 billion, respectively, of the Company's net property, plant, and equipment was located in the United States and $ 715.9 million and $ 771.4 million, respectively, was located outside the United States (primarily in Ireland). 8. Intangible Assets Intangible assets, net consist of the following: As of December 31, 2024 2023 (In millions) Estimated Useful Life Gross Carrying Amount Accumulated Amortization Net Carrying Amount Gross carrying Amount Accumulated Amortization Net Carrying Amount Acquired product rights - Libtayo 13 years $ 1,347.7 $ ( 254.3 ) $ 1,093.4 $ 1,119.1 $ ( 126.7 ) $ 992.4 Other intangibles 8 years 10.0 ( 7.6 ) 2.4 10.0 ( 6.3 ) 3.7 Acquired in-process research and development Indefinite 52.8 — 52.8 42.5 — 42.5 $ 1,410.5 $ ( 261.9 ) $ 1,148.6 $ 1,171.6 $ ( 133.0 ) $ 1,038.6 During the years ended December 31, 2024 and 2023, the Company recorded additions to the Libtayo intangible asset related to contingent consideration due to Sanofi (see Note 3). In addition, during the years ended December 31, 2024 and 2023, the Company recorded indefinite-lived intangible assets in connection with the acquisition of in-process and research and development programs. Amortization expense on intangible assets was $ 128.9 million, $ 92.2 million, and $ 37.6 million for the years ended December 31, 2024, 2023, and 2022, respectively. As of December 31, 2024, assuming no changes in the gross carrying amount of intangible assets, amortization expense is estimated to be approximately $ 102 million for each of the years ending December 31, 2025 through December 31, 2029. 9. Accrued Expenses and Other Current Liabilities Accrued expenses and other current liabilities consist of the following: As of December 31, (In millions) 2024 2023 Accrued payroll and related costs $ 640.9 $ 618.2 Accrued clinical expenses 315.7 292.2 Accrued sales-related costs 786.2 780.8 Income tax-related costs 213.2 11.7 Other accrued expenses and liabilities 571.1 655.0 $ 2,527.1 $ 2,357.9 10. Debt a. Senior Notes Long-term debt, net of underwriting discounts and offering expenses (which are being amortized as additional interest expense over the period of issuance through maturity), consists of the following: As of December 31, (In millions) 2024 2023 1.750 % Senior Notes due September 2030 $ 1,243.3 $ 1,242.2 2.800 % Senior Notes due September 2050 741.1 740.7 $ 1,984.4 $ 1,982.9 F-25 Table of Contents Interest on each series of senior notes is payable semi-annually until the applicable maturity dates. Interest expense related to the debt was $ 44.4 million in each of the years ended December 31, 2024, 2023, and 2022. b. Credit Facility The Company is party to an agreement with a syndicate of lenders (the "Credit Agreement") which provides for a $ 750.0 million senior unsecured five-year revolving credit facility (the "Credit Facility"). The Credit Agreement includes an option for the Company to elect to increase the commitments under the Credit Facility and/or to enter into one or more tranches of term loans in the aggregate principal amount of up to $ 500.0 million, subject to the consent of the lenders providing the additional commitments or term loans, as applicable, and certain other conditions. The Credit Agreement also provides a $ 50.0 million sublimit for letters of credit. Proceeds of the loans under the Credit Facility may be used to finance working capital needs, and for general corporate or other lawful purposes, of Regeneron and its subsidiaries. Regeneron Pharmaceuticals, Inc. has guaranteed all obligations under the Credit Facility. The Credit Agreement includes an option for the Company to elect to extend the maturity date of the Credit Facility beyond December 2027, subject to the consent of the extending lenders and certain other conditions. The Company had no borrowings outstanding under the Credit Facility as of December 31, 2024. The Credit Agreement contains operating covenants and a maximum total leverage ratio financial covenant. The Company was in compliance with all covenants of the Credit Agreement as of December 31, 2024. 11. Leases The Company conducts certain of its research, development, and administrative activities at leased facilities. The Company also leases vehicles and other assets. Tarrytown, New York Corporate Headquarters The Company leases laboratory and office facilities for its corporate headquarters in Tarrytown, New York (the "Facility") under the Third Amended and Restated Lease and Remedies Agreement (the "Lease") with BA Leasing BSC, LLC, an affiliate of Banc of America Leasing & Capital, LLC ("BAL"), as lessor, and the Third Amended and Restated Participation Agreement (the "Participation Agreement") with Bank of America, N.A., as administrative agent, and a syndicate of lenders (collectively with BAL, the "Participants"), as rent assignees. The Lease, Participation Agreement, and certain related agreements provide for $ 720.0 million of lease financing (previously advanced by the Participants in March 2017 in connection with the acquisition by BAL of the Facility and the Company's lease of the Facility from BAL), which matures when the term of the Lease expires in March 2027, at which time all amounts outstanding thereunder will become payable in full. The Company has the option to further extend the maturity date of the Participation Agreement and the term of the Lease for an additional five-year period, subject to the consent of the Participants and certain other conditions. The Company also has the option to (a) purchase the Facility by paying an amount equal to the outstanding principal amount of the Participants' advances under the Participation Agreement, all accrued and unpaid yield thereon, and all other outstanding amounts under the Participation Agreement, Lease, and certain related documents or (b) sell the Facility to a third party on behalf of BAL. Pursuant to the Lease, the Company pays all maintenance, insurance, taxes, and other costs arising out of the use of the Facility. The Company is also required to make monthly payments of basic rent to satisfy the yield payable to the Participants on their outstanding advances under the Participation Agreement. Such advances accrue yield at a variable rate per annum based on the one-month forward-looking Secured Overnight Financing Rate ("SOFR") term rate, plus a spread adjustment, plus an applicable margin that varies with the Company's debt rating and total leverage ratio. The Lease is classified as a finance lease as the Company has the option to purchase the Facility under terms that make it reasonably certain to be exercised. The agreements governing the Lease financing contain financial and operating covenants. Such financial covenants and certain of the operating covenants are substantially similar to the covenants set forth in the Credit Agreement. The Company was in compliance with all such covenants as of December 31, 2024. F-26 Table of Contents Aggregate Lease Information Amounts recognized in the Consolidated Balance Sheet related to the Company's leases are included in the table below. As of December 31, (In millions) Classification 2024 2023 Assets: Finance lease right-of-use assets Property, plant, and equipment, net (a) $ 591.2 $ 605.7 Operating lease right-of-use assets Other noncurrent assets (b) 217.4 78.0 $ 808.6 $ 683.7 Liabilities: Finance lease liabilities - noncurrent Finance lease liabilities $ 720.0 $ 720.0 Operating lease liabilities - current Accrued expenses and other current liabilities 30.3 19.0 Operating lease liabilities - noncurrent Other noncurrent liabilities 204.1 68.7 $ 954.4 $ 807.7 (a) Finance lease right-of-use assets were recorded net of accumulated amortization of $ 148.4 million and $ 133.9 million as of December 31, 2024 and 2023, respectively. (b) Operating lease right-of-use assets were recorded net of accumulated amortization of $ 78.4 million and $ 44.6 million as of December 31, 2024 and 2023, respectively. Lease costs consist of the following: Year Ended December 31, (In millions) 2024 2023 2022 Operating lease costs $ 36.5 $ 19.2 $ 12.4 Finance lease costs: Amortization of finance lease right-of-use assets 14.5 14.5 14.5 Interest on finance lease liabilities 46.1 45.0 21.6 Total finance lease costs 60.6 59.5 36.1 Total lease costs $ 97.1 $ 78.7 $ 48.5 Other information related to the Company's leases includes the following: As of December 31, 2024 2023 Weighted-average remaining lease term (in years): Finance leases 2.2 3.2 Operating leases 7.2 7.4 Weighted-average discount rate: Finance leases 5.03 % 5.08 % Operating leases 5.52 % 5.38 % F-27 Table of Contents Supplemental cash flow information related to the Company's leases includes the following: Year Ended December 31, (In millions) 2024 2023 2022 Cash paid for amounts included in the measurement of operating lease liabilities (included within cash flows from operating activities) $ 41.4 $ 22.5 $ 7.7 Right-of-use assets obtained in exchange for operating lease liabilities $ 188.1 $ 31.9 $ 35.1 The following is a maturity analysis of the Company's lease liabilities as of December 31, 2024: (In millions) Finance Leases Operating Leases Total 2025 $ 38.6 $ 43.1 $ 81.7 2026 36.8 44.8 81.6 2027 729.1 42.6 771.7 2028 — 33.2 33.2 2029 — 30.3 30.3 Thereafter — 96.9 96.9 Total undiscounted lease payments 804.5 290.9 1,095.4 Imputed interest ( 84.5 ) ( 56.5 ) ( 141.0 ) Total lease liabilities $ 720.0 $ 234.4 $ 954.4 12. Stockholders' Equity The Company's Restated Certificate of Incorporation, as amended, provides for the issuance of up to 40 million shares of Class A Stock, par value $ 0.001 per share, and 320 million shares of Common Stock, par value $ 0.001 per share. Shares of Class A Stock are convertible, at any time, at the option of the holder into shares of Common Stock on a share-for-share basis. Holders of Class A Stock have rights and privileges identical to Common Stockholders except that each share of Class A is entitled to ten votes per share, while each share of Common Stock is entitled to one vote per share. Class A Stock may only be transferred to specified Permitted Transferees, as defined. Under the Company's Restated Certificate of Incorporation, the Company's board of directors is authorized to issue up to 30 million shares of Preferred Stock, in series, with rights, privileges, and qualifications of each series determined by the board of directors. a. Share Repurchase Programs In November 2021, the Company's board of directors authorized a share repurchase program to repurchase up to $ 3.0 billion of the Company's Common Stock. As of June 30, 2023, the Company had repurchased the entire $ 3.0 billion of its Common Stock it was authorized to repurchase under the program. In January 2023, the Company's board of directors authorized a share repurchase program to repurchase up to an additional $ 3.0 billion of the Company's Common Stock. As of September 30, 2024, the Company had repurchased the entire $ 3.0 billion of its Common Stock that it was authorized to repurchase under the program. In April 2024, the Company's board of directors authorized a share repurchase program to repurchase up to an additional $ 3.0 billion of the Company's Common Stock. The share repurchase program permits the Company to make repurchases through a variety of methods, including open-market transactions (including pursuant to a trading plan adopted in accordance with Rule 10b5-1 of the Securities Exchange Act of 1934, as amended (the "Exchange Act")), privately negotiated transactions, accelerated share repurchases, block trades, and other transactions in compliance with Rule 10b-18 of the Exchange Act. F-28 Table of Contents The table below summarizes the shares of the Company's Common Stock that the Company repurchased and the cost of such shares, which were recorded as Treasury Stock. Year Ended December 31, (In millions) 2024 2023 2022 Number of shares 2.8 2.9 3.3 Total cost of shares $ 2,613.9 $ 2,214.6 $ 2,099.8 As of December 31, 2024, $ 1.917 billion remained available for share repurchases under the April 2024 program. In February 2025, the Company's board of directors authorized a share repurchase program to repurchase up to an additional $ 3.0 billion of the Company's Common Stock. The share repurchase program was approved under terms substantially similar to the repurchase programs described above. b. Dividend In February 2025, the Company's board of directors declared the Company's first quarterly cash dividend, in the amount of $ 0.88 per share on its Common Stock and Class A Stock. The cash dividend will be payable on March 20, 2025 to shareholders of record as of February 20, 2025. 13. Long-Term Incentive Plans The Company has used long-term incentive plans for the purpose of granting equity awards to employees of the Company, including officers, and non-employee members of the Company's board of directors (collectively, "Participants"). The Participants may receive awards as determined by a committee of independent members of the Company's board of directors or, to the extent authorized by such committee with respect to certain Participants, a duly authorized employee (collectively, the "Committee"). The incentive plan currently used by the Company is the Second Amended and Restated Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive Plan (the "Second Amended and Restated 2014 Incentive Plan"). It was most recently adopted and approved by the Company's shareholders in 2020. As of the most recent shareholder approval date, the Second Amended and Restated 2014 Incentive Plan provided for the issuance of up to 22.3 million shares of Common Stock in respect of awards. In addition, upon expiration, forfeiture, surrender, exchange, cancellation, or termination of any award previously granted under the Amended and Restated Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive Plan (the "Amended and Restated 2014 Incentive Plan"), the Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive Plan (the "Original 2014 Incentive Plan"), or the Second Amended and Restated 2000 Long-Term Incentive Plan (the "2000 Incentive Plan"), any shares subject to such award are added to the pool of shares available for grant under the Second Amended and Restated 2014 Incentive Plan. The awards that may be made under the Second Amended and Restated 2014 Incentive Plan include: (a) non-qualified stock options and incentive stock options, (b) restricted stock awards, (c) shares of phantom stock (also referred to as restricted stock units, which may be time- or performance-based), and (d) other awards. Any award granted may (but is not required to) be subject to vesting based on the attainment by the Company of performance goals pre-established by the Committee. Stock option awards grant Participants the right to purchase shares of Common Stock at prices determined by the Committee, with exercise prices that are equal to or greater than the average of the high and low market prices of the Company's Common Stock on the date of grant (the "Market Price"). Options vest over a period of time determined by the Committee, generally on a pro rata basis over a four-year period. The Committee also determines the expiration date of each option. The maximum term of options that have been awarded under the 2000 Incentive Plan, the Original 2014 Incentive Plan, the Amended and Restated 2014 Incentive Plan, and the Second Amended and Restated 2014 Incentive Plan (collectively, the "Incentive Plans") is ten years . Restricted stock awards grant Participants shares of restricted Common Stock. Such shares are nontransferable for a period determined by the Committee ("vesting period"). Should employment terminate, as specified in the Incentive Plans, except as determined by the Committee in its discretion and subject to the applicable Incentive Plan documents, the ownership of any unvested restricted stock awards will be transferred to the Company. Phantom stock awards provide the Participant the right to receive Common Stock or an amount of cash based on the value of the Common Stock at a future date. The award is subject to such restrictions, if any, as the Committee may impose at the date of grant or thereafter, including a specified period of employment or the achievement of performance goals. Time-based restricted stock units and performance-based restricted stock units are each a type of phantom stock award permitted under the Second Amended and Restated 2014 Incentive Plan. F-29 Table of Contents The Incentive Plans contain provisions that allow for the Committee to provide for the immediate vesting of awards upon a change in control of the Company, as defined in the Incentive Plans. As of December 31, 2024, there were 13.1 million shares available for future grants under the Second Amended and Restated 2014 Incentive Plan. a. Stock Options The table below summarizes the activity related to stock option awards under the Company's Incentive Plans during 2024. Number of Shares (In millions) Weighted-Average Exercise Price Weighted-Average Remaining Contractual Term Intrinsic Value (In millions) Outstanding as of December 31, 2023 14.2 $ 534.13 2024: Granted 1.9 $ 786.79 Forfeited ( 0.2 ) $ 698.92 Exercised ( 3.2 ) $ 454.70 Outstanding as of December 31, 2024 12.7 $ 588.47 6.1 years $ 1,891.0 Vested and expected to vest as of December 31, 2024 12.3 $ 582.36 6.0 years $ 1,888.5 Exercisable as of December 31, 2024 8.3 $ 495.19 4.7 years $ 1,834.8 The Company satisfies stock option exercises with newly issued shares of the Company's Common Stock. The total intrinsic value of stock options exercised during 2024, 2023, and 2022 was $ 1.682 billion, $ 1.096 billion, and $ 1.214 billion, respectively. The intrinsic value represents the amount by which the market price of the underlying stock exceeds the exercise price of an option. The table below summarizes the weighted-average exercise prices and weighted-average grant-date fair values of options issued during the years ended December 31, 2024, 2023, and 2022. Number of Options Granted (In millions) Weighted-Average Exercise Price Weighted-Average Fair Value 2024: Exercise price equal to Market Price 1.9 $ 786.79 $ 235.32 2023: Exercise price equal to Market Price 1.6 $ 835.91 $ 264.37 2022: Exercise price equal to Market Price 2.0 $ 705.02 $ 220.88 For the years ended December 31, 2024, 2023, and 2022, the Company recognized $ 376.0 million, $ 357.1 million, and $ 341.9 million, respectively, of stock-based compensation expense related to stock option awards (net of amounts capitalized as inventory, which were not material for each of the three years). As of December 31, 2024, there was $ 626.7 million of stock-based compensation cost related to unvested stock options, net of estimated forfeitures, which had not yet been recognized. The Company expects to recognize this compensation cost over a weighted-average period of 1.9 years. F-30 Table of Contents Fair Value Assumptions: The following table summarizes the weighted average values of the assumptions used in computing the fair value of option grants during 2024, 2023, and 2022. 2024 2023 2022 Expected volatility 25 % 26 % 28 % Expected lives from grant date 5.0 years 5.1 years 5.2 years Expected dividend yield 0 % 0 % 0 % Risk-free interest rate 4.11 % 4.29 % 3.50 % Expected volatility has been estimated based on actual movements in the Company's stock price over the most recent historical periods equivalent to the options' expected lives. Expected lives are principally based on the Company's historical exercise experience with previously issued employee and board of directors' option grants. During 2024, 2023, and 2022, the expected dividend yield was zero as the Company had not paid dividends nor did it expect to at the time of option grants. The risk-free interest rates are based on quoted U.S. Treasury rates for securities with maturities approximating the options' expected lives. b. Restricted Stock Awards and Time-Based Restricted Stock Units A summary of the Company's activity related to restricted stock awards and time-based restricted stock units (excluding performance-based restricted stock units, which are detailed further below) (collectively, "restricted stock") during 2024 is summarized below. Number of Shares/Units (In millions) Weighted-Average Grant Date Fair Value Unvested as of December 31, 2023 2.3 $ 705.37 2024: Granted 1.0 $ 787.15 Vested ( 0.7 ) $ 617.50 Forfeited ( 0.1 ) $ 704.57 Unvested as of December 31, 2024 2.5 $ 760.35 For the years ended December 31, 2024, 2023, and 2022, the Company recognized $ 554.7 million, $ 475.9 million, and $ 331.1 million, respectively, of stock-based compensation expense related to restricted stock (net of amounts capitalized as inventory, which were not material for each of the three years). As of December 31, 2024, there was $ 1.219 billion of stock-based compensation cost related to unvested restricted stock which had not yet been recognized. The Company expects to recognize this compensation cost over a weighted-average period of 2.3 years. F-31 Table of Contents c. Performance-based Restricted Stock Units Performance-based restricted stock units ("PSUs") have been granted to certain members of senior management of the Company. PSUs may be earned based upon the attainment of pre-established performance criteria, which may include a market and/or performance condition. Depending on the terms of the PSUs and the outcome of the pre-established performance criteria, a recipient may ultimately earn the target number of PSUs granted or a specified multiple thereof at the end of a 4 – 6 year vesting period, as applicable. As of December 31, 2024 and 2023, 1.4 million PSUs were unvested with a weighted-average grant date fair value of $ 247.91 per unit. The number of unvested PSUs represents the maximum number of units that are eligible to be earned. During the year ended December 31, 2024, the Company did not grant new PSUs and no PSUs were vested, forfeited, or cancelled. For each of the years ended December 31, 2024, 2023, and 2022 the Company recognized $ 52.1 million of stock-based compensation expense related to PSUs. As of December 31, 2024, there was $ 52.0 million of stock-based compensation cost related to unvested PSUs which had not yet been recognized. The Company expects to recognize this compensation cost on a straight-line basis over a weighted average period of 1.0 year. Fair Value Assumptions: The following table summarizes the weighted average values of the assumptions used in computing the fair value of PSUs that were granted during 2022. The Company did not grant PSUs during 2024 and 2023. 2022 Expected volatility 32 % Expected dividend yield 0 % Risk-free interest rate 3.3 % 14. Employee Savings Plans The Company maintains the Regeneron Pharmaceuticals, Inc. 401(k) Savings Plan, as amended and restated (the "Savings Plan"). The terms of the Savings Plan allow U.S. employees (as defined by the Savings Plan) to contribute to the Savings Plan a percentage of their compensation. In addition, the Company may make discretionary contributions, as defined, to the accounts of participants under the Savings Plan. The Company also maintains additional employee savings plans outside the United States, which cover eligible employees. Expenses recognized by the Company related to contributions to such plans were $ 90.2 million, $ 84.7 million, and $ 67.6 million for the years ended December 31, 2024, 2023, and 2022, respectively. F-32 Table of Contents 15. Income Taxes The Company is subject to U.S. federal, state, and foreign income taxes. Components of income before income taxes consist of the following: Year Ended December 31, (In millions) 2024 2023 2022 United States $ ( 411.3 ) $ ( 362.3 ) $ 839.9 Foreign 5,191.2 4,561.6 4,018.9 $ 4,779.9 $ 4,199.3 $ 4,858.8 Components of income tax expense consist of the following: Year Ended December 31, (In millions) 2024 2023 2022 Current: Federal $ 1,092.6 $ 667.9 $ 968.5 State ( 11.1 ) 7.7 7.4 Foreign 43.1 407.9 290.9 Total current tax expense 1,124.6 1,083.5 1,266.8 Deferred: Federal ( 935.5 ) ( 834.5 ) ( 797.7 ) State ( 4.9 ) ( 6.5 ) ( 2.7 ) Foreign 183.1 3.2 54.0 Total deferred tax benefit ( 757.3 ) ( 837.8 ) ( 746.4 ) $ 367.3 $ 245.7 $ 520.4 A reconciliation of the U.S. statutory income tax rate to the Company's effective income tax rate is as follows: Year Ended December 31, 2024 2023 2022 U.S. federal statutory tax rate 21.0 % 21.0 % 21.0 % Stock-based compensation ( 4.9 ) ( 4.6 ) ( 2.9 ) Taxation of non-U.S. operations ( 4.0 ) ( 6.6 ) ( 5.5 ) Income tax credits ( 3.5 ) ( 3.2 ) ( 2.0 ) Foreign-derived intangible income deduction ( 0.8 ) ( 0.3 ) ( 1.0 ) Other permanent differences ( 0.1 ) ( 0.4 ) 1.1 Effective income tax rate 7.7 % 5.9 % 10.7 % F-33 Table of Contents Deferred income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. Significant components of the Company's deferred tax assets and liabilities are as follows: As of December 31, (In millions) 2024 2023 Deferred tax assets: Capitalized research and development expenses $ 2,530.2 $ 1,728.2 Deferred compensation 419.7 413.6 Accrued expenses 185.0 214.1 Fixed assets and intangible assets 145.1 154.8 Tax attribute carryforwards 84.1 88.7 Other 43.0 26.4 Total deferred tax assets 3,407.1 2,625.8 Deferred tax liabilities: Unrealized gains on investments ( 93.0 ) ( 50.4 ) Net deferred tax assets $ 3,314.1 $ 2,575.4 The Company's federal income tax returns for 2017 through 2023 remain open to examination by the IRS. The Company's 2017 and 2018 federal income tax returns are currently under audit by the IRS. In general, the Company's state income tax returns from 2020 to 2023 remain open to examination. The Company's income tax returns outside the United States remain open to examination from 2019 to 2023. The United States and many states generally have statutes of limitation ranging from 3 to 5 years; however, those statutes could be extended due to the Company's tax credit carryforward position. In general, tax authorities have the ability to review income tax returns in which the statute of limitation has previously expired to adjust the tax credits generated in those years. The following table reconciles the beginning and ending amounts of unrecognized tax benefits: (In millions) 2024 2023 2022 Balance as of January 1 $ 696.4 $ 542.8 $ 410.9 Gross increases related to current year tax positions 353.5 153.4 136.9 Gross increases (decreases) related to prior year tax positions 264.8 3.2 ( 5.0 ) Gross decreases due to settlements and lapse of statutes of limitations ( 1.0 ) ( 3.0 ) — Balance as of December 31 $ 1,313.7 $ 696.4 $ 542.8 In 2024, 2023, and 2022, the increases in unrecognized tax benefits primarily related to the Company's calculation of certain tax credits and other items related to the Company's international operations. Interest expense related to unrecognized tax benefits was $ 165.4 million, $ 77.2 million, and $ 38.0 million in 2024, 2023, and 2022, respectively. The Company expects the IRS to conclude its examination of the Company's 2017 and 2018 federal income tax returns within the next twelve months, and, as a result, the Company may be required to make a payment of approximately $ 120 million. The Company's unrecognized tax benefits for the years under examination exceed the expected payment amount, which would result in the Company recognizing a net tax benefit within the next twelve months. The amount of net unrecognized tax benefits that, if settled, would impact the effective tax rate is $ 635.4 million, $ 442.5 million, and $ 373.7 million as of December 31, 2024, 2023, and 2022, respectively. F-34 Table of Contents 16. Legal Matters From time to time, the Company is a party to legal proceedings in the course of the Company's business. The outcome of any such proceedings, regardless of the merits, is inherently uncertain. If the Company is unable to prevail in one or more of such proceedings, its consolidated financial position, results of operations, and future cash flows may be materially adversely impacted. Costs associated with the Company's involvement in legal proceedings are expensed as incurred . The Company recognizes accruals for loss contingencies associated with such proceedings when it is probable that a liability will be incurred and the amount of loss can be reasonably estimated. As of December 31, 2024 and 2023, the Company's accruals for loss contingencies were not material. There are certain loss contingencies that the Company deems reasonably possible for which the possible loss or range of possible loss is not estimable at this time. Proceedings Relating to EYLEA (aflibercept) Injection Certain of the Company's patents pertaining to EYLEA are subject to post-grant proceedings before the United States Patent and Trademark Office ("USPTO"), the European Patent Office (the "EPO"), or other comparable foreign authorities, including those described in greater detail below. In addition, the Company has filed patent infringement lawsuits in several jurisdictions alleging infringement of certain Company patents pertaining to EYLEA, including those described in greater detail below. United States U.S. Patent Litigation On August 2, 2022, the Company filed a patent infringement lawsuit against Mylan, a wholly-owned subsidiary of Viatris Inc., in the United States District Court for the Northern District of West Virginia alleging that Mylan's filing for U.S. Food and Drug Administration ("FDA") approval of an aflibercept 2 mg biosimilar infringes certain Company patents. On June 5, 2023, Biocon, as successor-in-interest to the aflibercept 2 mg biosimilar, was joined as a defendant to the lawsuit. A trial was held from June 12, 2023 through June 23, 2023 concerning certain claims of the '601 Patent, the '572 Patent, and the Company's U.S. Patent No. 11,084,865 (the "'865 Patent"). On December 27, 2023, the court issued a decision finding that (i) the asserted claims of the '865 Patent were valid and infringed by Mylan and Biocon and (ii) the asserted claims of the '601 and '572 Patents were infringed by Mylan and Biocon but were invalid as obvious. On June 11, 2024, the court granted the Company's motion for a permanent injunction, enjoining Mylan and Biocon from selling in the United States their aflibercept 2 mg biosimilar until the expiration of the '865 Patent. On June 21, 2024, Mylan and Biocon filed a notice of appeal of the court's December 27, 2023 and June 11, 2024 decisions to the Federal Circuit. An oral hearing concerning Mylan and Biocon's appeal has been scheduled for February 7, 2025. On November 8, November 22, and November 29, 2023, respectively, the Company filed patent infringement lawsuits against Celltrion, Samsung Bioepis, and Formycon AG in the United States District Court for the Northern District of West Virginia following service on Regeneron of each company's notice of commercial marketing. The lawsuits allege that each company has infringed certain Company patents, including based on each company's filing for FDA approval of an aflibercept 2 mg biosimilar. On December 27, 2023, the Company filed a second patent infringement lawsuit against Samsung Bioepis in the United States District Court for the Northern District of West Virginia alleging that Samsung's filing for FDA approval of an aflibercept 2 mg biosimilar infringes certain Company patents. On June 14, June 21, and June 28, 2024, respectively, the court granted the Company's motions for preliminary injunctions against Samsung Bioepis, Formycon, and Celltrion. On June 14, June 25, and July 8, 2024, respectively, Samsung Bioepis, Formycon, and Celltrion filed notices of appeal of the court's preliminary injunction decisions to the Federal Circuit. An oral hearing concerning the respective appeals of Samsung Bioepis and Formycon was held on December 5, 2024. On January 29, 2025, the Federal Circuit affirmed the lower court's preliminary injunction decisions against Samsung Bioepis and Formycon. An oral hearing concerning Celltrion's appeal has been scheduled for February 7, 2025. On January 10, 2024, the Company filed a patent infringement lawsuit against Amgen in the United States District Court for the Central District of California alleging that Amgen's filing for FDA approval of an aflibercept 2 mg biosimilar infringes certain Company patents. On April 11, 2024, the United States Judicial Panel on Multidistrict Litigation granted the Company's motion to transfer this lawsuit to the United States District Court for the Northern District of West Virginia for coordinated and consolidated pretrial proceedings with the lawsuits described in the preceding paragraph. On June 7, 2024, the Company filed a motion for a preliminary injunction against Amgen. On September 23, 2024, the court denied the Company's motion for a preliminary injunction, and the Company filed (i) a notice of appeal of such decision to the Federal Circuit, (ii) a motion for an immediate administrative stay, and (iii) a motion for a temporary injunction preventing Amgen from launching its aflibercept 2 mg biosimilar during the pendency of such appeal. On September 25, 2024, the Federal Circuit issued an administrative stay pending its review of the Company's temporary injunction motion. On October 22, 2024, the Federal Circuit denied the Company's temporary injunction motion and lifted the administrative stay. An expedited oral hearing concerning the Company's appeal of the court's preliminary injunction decision was held on January 14, 2025. F-35 Table of Contents On August 26, 2024, the Company filed a patent infringement lawsuit against Sandoz Inc. in the United States District Court for the District of New Jersey alleging that Sandoz's filing for FDA approval of an aflibercept 2 mg biosimilar infringes certain Company patents. On September 12, 2024, the United States Judicial Panel on Multidistrict Litigation granted the Company's motion to transfer this lawsuit to the United States District Court for the Northern District of West Virginia for coordinated and consolidated pretrial proceedings with the lawsuits described in the preceding paragraphs. Post-Grant Proceedings Before the USPTO On November 20, 2024, November 29, 2024, and January 15, 2025, Samsung Bioepis Co., Ltd., Formycon AG, and Celltrion Inc., respectively, filed inter partes review ("IPR") petitions in the USPTO against the Company's U.S. Patent No. 11,084,865 (the "'865 Patent"), each seeking a declaration that the '865 Patent is invalid. Europe EPO Post-Grant Proceedings Various parties, including Amgen and other anonymous parties, are seeking revocation of the Company's European Patent Nos. 2,944,306 (the "'306 Patent"), 3,716,992 (the "'992 Patent"), and 3,384,049 (the "'049 Patent") before the Opposition Division of the EPO. On November 26, 2024, following an oral hearing, the Opposition Division ("OD") of the EPO announced its decision to revoke the '306 Patent. The Company plans to appeal the OD's decision. Oral proceedings concerning the '992 Patent are scheduled for October 2025. Country-Specific Proceedings Various parties, including Amgen, Samsung Bioepis, and Formycon and/or their affiliated entities, are seeking revocation of the '306 Patent, the '992 Patent, and the Company's European Patent No. 2,364,691 (the "'691 Patent") and/or a declaration that its aflibercept 2 mg biosimilar would not infringe these patents in several European national courts (including those in France, Germany, Italy, the Netherlands, and the United Kingdom). In the United Kingdom, the Company has filed a preemptive counterclaim against Formycon AG and Klinge Biopharma GmbH, Samsung Bioepis UK Limited, and Amgen Inc. for infringement of the '306 Patent and the '691 Patent. In Germany, a trial concerning the '691 Patent has been scheduled to begin in June 2025. In the United Kingdom, trials concerning the '691 and '306 Patents have been scheduled to begin in June 2025, and the '992 Patent proceedings are stayed pending resolution of the EPO proceedings concerning this patent. In the Netherlands, a trial concerning the '691 and '306 Patents has been scheduled to begin in July 2025. The Company has commenced proceedings in Belgium against various parties, including Amgen Inc., Celltrion Inc., Sterigenics (Petit-Rechain) NV, and Sandoz GmbH, for infringement of the Company's European Patent No. 1,183,353 (as extended by Supplementary Protection Certificate 2013C/029). Canada Proceedings against Amgen Canada On May 9, 2023, Amgen Canada Inc. ("Amgen Canada") filed invalidation proceedings against the Company in the Federal Court of Canada seeking revocation of the Company's Canadian Patent Nos. 2,654,510 (the "'510 Patent") and 3,007,276 (the "'276 Patent"). On September 14, 2023, the Company, Bayer Inc., and Bayer Healthcare LLC filed patent infringement lawsuits against Amgen Canada in the Federal Court of Canada seeking a declaration that the making, constructing, using, or selling of an aflibercept 2 mg biosimilar would directly or indirectly infringe one or more claims of Bayer Healthcare LLC's Canadian Patent No. 2,970,315 (the "'315 Patent"). On September 14, 2023, the Company and Bayer Inc. filed three separate patent infringement lawsuits against Amgen Canada in the Federal Court of Canada seeking a declaration that the making, constructing, using, or selling of an aflibercept 2 mg biosimilar would directly or indirectly infringe one or more claims of the Company's Canadian Patent Nos. 3,129,193 (the "'193 Patent"), 2,965,495 (the "'495 Patent"), and 2,906,768 (the "'768 Patent"), respectively. On October 11, 2023, the Company, Bayer Inc., and Bayer Healthcare LLC filed two separate patent infringement lawsuits against Amgen Canada in the Federal Court of Canada seeking a declaration that the making, constructing, using, or selling of an aflibercept 2 mg biosimilar would directly or indirectly infringe one or more claims of the Company's '510 Patent and '276 Patent, respectively. On May 7, 2024 and June 28, 2024, respectively, Amgen filed a summary trial motion with respect to the '510 Patent and a motion to delist the '276 Patent from the Canada Patent Register. On November 20, 2024, the court granted Amgen's motion to delist the '276 Patent from the Canada Patent Register, which decision has been appealed by the Company and Bayer. A trial for the lawsuits concerning the '510 Patent and the '276 Patent has been scheduled for May–June 2025; and a trial for the lawsuits concerning the '315 Patent and the '193 Patent has been scheduled for August–September 2025. F-36 Table of Contents Proceedings against Sandoz On January 24, 2025, the Company, Bayer Inc., and Bayer Healthcare LLC filed patent infringement lawsuits against Sandoz Canada Inc. in the Federal Court of Canada seeking a declaration that the making, constructing, using, or selling of an aflibercept 2 mg biosimilar would directly or indirectly infringe one or more claims of the '510 Patent, the '276 Patent, the '495 Patent, the '768 Patent, the '193 Patent, the '315 Patent, and Canadian Patent No. 3,137,326 (the "'326 Patent"). South Korea On October 31, 2022 and December 13, 2022, Samsung Bioepis Co., Ltd. initiated invalidation proceedings before the Intellectual Property Trial and Appeal Board of the Korean Intellectual Property Office ("KIPO") against the Company's Korean Patent Nos. 1131429 (the "'429 Patent") and 1406811 (the "'811 Patent"), respectively, seeking revocation of each such patent in its entirety. On October 23, 2024, the KIPO maintained the '811 Patent as valid, and Samsung appealed this decision on November 6, 2024. On November 20, 2024, the KIPO maintained the '429 Patent as valid in an amended form that no longer contains claims to aflibercept. The Company and, as applicable, Bayer Consumer Care AG, have also filed patent infringement lawsuits in the Seoul Central District Court against various parties including Samsung Bioepis Co., Ltd. and its parent company Samsung Biologics Co., Ltd., Sam Chun Dang Pharm. Co., Ltd. and OPTUS Pharmaceutical Co., Ltd, and Celltrion Inc. These lawsuits seek damages and/or injunctive relief and allege that the making, constructing, using, or selling of an aflibercept 2 mg biosimilar by the relevant defendant(s) would infringe one or more claims of the '811 Patent and/or the Company's Korean Patent Nos. 659477 (the "'477 Patent") and 2519234 (the "'234 Patent"). Proceedings Relating to EYLEA (aflibercept) Injection Pre-filled Syringe On June 19, 2020, Novartis Pharma AG, Novartis Pharmaceuticals Corporation, and Novartis Technology LLC (collectively, "Novartis") filed a patent infringement lawsuit (as amended on August 2, 2021) in the U.S. District Court for the Northern District of New York asserting claims of Novartis's U.S. Patent No. 9,220,631 (the "'631 Patent"). On November 13, 2024, this lawsuit was dismissed in light of the final resolution of the IPR proceeding discussed below. On July 16, 2020, the Company initiated two IPR petitions in the USPTO seeking a declaration that the '631 Patent is invalid on two separate grounds. On October 25, 2022, the Patent Trial and Appeal Board ("PTAB") of the USPTO issued a final written decision invalidating all claims of the '631 Patent; and on September 23, 2024, the Federal Circuit affirmed the PTAB's decision invalidating all claims of the '631 Patent. On July 17, 2020, the Company filed an antitrust lawsuit against Novartis and Vetter Pharma International Gmbh ("Vetter") in the United States District Court for the Southern District of New York seeking a declaration that the '631 Patent is unenforceable and a judgment that the defendants' conduct violates Sections 1 and 2 of the Sherman Antitrust Act of 1890, as amended (the "Sherman Antitrust Act"). The Company is also seeking injunctive relief and treble damages. On September 21, 2021, this lawsuit was transferred to the Northern District of New York. On June 10, 2022, the Company filed an appeal of the District Court's decision to dismiss the amended complaint with the U.S. Court of Appeals for the Second Circuit (the "Second Circuit"). On March 18, 2024, the Second Circuit reversed the District Court's decision to dismiss the amended complaint and remanded the lawsuit to the District Court for further proceedings consistent with the Second Circuit's opinion. On November 19, 2024, the Company moved to transfer the lawsuit back to the Southern District of New York, which motion was granted on December 5, 2024. Proceedings Relating to Praluent (alirocumab) Injection United States On May 27, 2022, the Company filed a lawsuit against Amgen Inc. in the United States District Court for the District of Delaware, alleging that, beginning in 2020, Amgen engaged in an anticompetitive bundling scheme which was designed to exclude Praluent from the market in violation of federal and state laws. The lawsuit seeks damages for harm caused by the alleged scheme, as well as injunctive relief restraining Amgen from continuing its alleged anticompetitive conduct. On August 1 and 11, 2022, Amgen filed a motion to dismiss the complaint and a motion to stay these proceedings, respectively. On February 10, 2023, the court denied Amgen's motion to stay; and on March 21, 2023, the court denied Amgen's motion to dismiss. On August 28, 2023, the Company filed an amended complaint in this matter; and, as part of its response, on September 20, 2023, Amgen filed a counterclaim alleging that the Company engaged in unfair business practices in violation of state law. On May 22, 2024, Amgen filed a motion for summary judgment. An oral hearing on Amgen's motion for summary judgment was held on November 20, 2024. A trial has been scheduled to begin in May 2025. F-37 Table of Contents Europe On June 1, 2023, Sanofi filed an action in the Munich Central Division of the Unified Patent Court (the "UPC") seeking revocation of Amgen's European Patent No. 3,666,797 (the "'797 Patent"). The '797 Patent is a divisional patent of European Patent No. 2,215,124 (the "'124 Patent") (i.e., a patent that shares the same priority date, disclosure, and patent term of the parent '124 Patent), which was previously invalidated by the Technical Board of Appeal of the EPO. On July 16, 2024, following a trial, the Munich Central Division of the UPC issued a decision revoking the '797 Patent in its entirety. On September 16, 2024, Amgen appealed the decision of the Munich Central Division of the UPC to the Court of Appeal of the UPC. An oral hearing before the Court of Appeal of the UPC has been scheduled for May 2025. Also on June 1, 2023, Amgen filed a lawsuit against the Company and certain of Sanofi's affiliated entities in the Munich Local Division of the UPC alleging infringement of the '797 Patent. The lawsuit seeks, among other things, a permanent injunction in several countries in Europe and monetary damages. On July 29, 2024, the Munich Local Division of the UPC ordered a stay of the infringement lawsuit in light of the decision of the Munich Central Division of the UPC to revoke the '797 Patent in its entirety (discussed above). Proceedings Relating to REGEN-COV (casirivimab and imdevimab) On October 5, 2020, Allele Biotechnology and Pharmaceuticals, Inc. ("Allele") filed a lawsuit (as amended on April 8, 2021 and December 12, 2022) against the Company in the United States District Court for the Southern District of New York, asserting infringement of U.S. Patent No. 10,221,221. Effective December 5, 2024, the parties entered into a settlement agreement, pursuant to which this lawsuit has been dismissed. Department of Justice Matters In January 2017, the Company received a subpoena from the U.S. Attorney's Office for the District of Massachusetts requesting documents relating to its support of 501(c)(3) organizations that provide financial assistance to patients; documents concerning its provision of financial assistance to patients with respect to products sold or developed by Regeneron (including EYLEA, Praluent, ARCALYST ® , and ZALTRAP ® ); and certain other related documents and communications. On June 24, 2020, the U.S. Attorney's Office for the District of Massachusetts filed a civil complaint in the U.S. District Court for the District of Massachusetts alleging violations of the federal Anti-Kickback Statute, and asserting causes of action under the federal False Claims Act and state law (the "June 2020 Civil Complaint"). On August 24, 2020, the Company filed a motion to dismiss the June 2020 Civil Complaint in its entirety. On December 4, 2020, the court denied the motion to dismiss. On December 28, 2022, the U.S. Attorney's Office for the District of Massachusetts filed a motion for partial summary judgment. On January 31, 2023, the Company filed a motion for summary judgment. An oral hearing on the parties' respective motions for summary judgment was held on July 21, 2023. On September 27, 2023, the court (i) denied in part and granted in part the Company's motion for summary judgment and (ii) denied in its entirety the motion for partial summary judgment filed by the U.S. Attorney's Office for the District of Massachusetts. On October 25, 2023, the court certified for interlocutory appeal a portion of the court's September 27, 2023 order that addressed the causation standard applicable to the alleged violations of the federal Anti-Kickback Statute and federal False Claims Act; and on December 11, 2023, the U.S. Court of Appeals for the First Circuit certified for appeal (i.e., accepted for review) the court's September 27, 2023 order. An oral hearing concerning the appeal to the U.S. Court of Appeals for the First Circuit was held on July 22, 2024. In September 2019, the Company and Regeneron Healthcare Solutions, Inc., a wholly-owned subsidiary of the Company, each received a civil investigative demand ("CID") from the U.S. Department of Justice pursuant to the federal False Claims Act relating to remuneration paid to physicians in the form of consulting fees, advisory boards, speaker fees, and payment or reimbursement for travel and entertainment allegedly in violation of the federal Anti-Kickback Statute. The CIDs relate to EYLEA, Praluent, Dupixent, ZALTRAP, ARCALYST, and Kevzara and cover the period from January 2015 to the present. On June 3, 2021, the United States District Court for the Central District of California unsealed a qui tam complaint filed against the Company, Regeneron Healthcare Solutions, Inc., and Sanofi-Aventis U.S. LLC by two qui tam plaintiffs (known as relators) purportedly on behalf of the United States and various states (the "State Plaintiffs"), asserting causes of action under the federal False Claims Act and state law. Also on June 3, 2021, the United States and the State Plaintiffs notified the court of their decision to decline to intervene in the case. On October 29, 2021, the qui tam plaintiffs filed an amended complaint in this matter. On January 14, 2022, the Company filed a motion to dismiss the amended complaint in its entirety. On July 25, 2023, the court granted in part and denied in part the Company's motion to dismiss. On September 1, 2023, the Company filed a second motion to dismiss the amended complaint or, in the alternative, a motion for judgment on the pleadings. On July 31, 2024 and August 15, 2024, respectively, the District Court granted the Company's second motion to dismiss the amended complaint with respect to the remaining causes of action under federal law and declined to exercise supplemental jurisdiction over the remaining causes of action under state law. On August 26, 2024, the qui tam plaintiffs filed a notice of appeal. F-38 Table of Contents In June 2021, the Company received a CID from the U.S. Department of Justice pursuant to the federal False Claims Act. The CID states that the investigation concerns allegations that the Company (i) violated the False Claims Act by paying kickbacks to distributors and ophthalmology practices to induce purchase of EYLEA, including through discounts, rebates, credit card fees, free units of EYLEA, and inventory management systems; and (ii) inflated reimbursement rates for EYLEA by excluding applicable discounts, rebates, and benefits from the average sales price reported to the Centers for Medicare & Medicaid Services. The CID covers the period from January 2011 through June 2021. On November 29, 2023, the U.S. Department of Justice informed the Company that it had filed a notice of partial intervention in this matter. On March 28, 2024, the Department of Justice and the U.S. Attorney's Office for the District of Massachusetts filed a civil complaint intervention (the "March 2024 Civil Complaint") in the U.S. District Court for the District of Massachusetts asserting causes of action under the federal False Claims Act and a claim for unjust enrichment. Also on March 28, 2024, the U.S. District Court of the District of Massachusetts unsealed a qui tam complaint against the Company, AmerisourceBergen, and Besse Medical by two qui tam plaintiffs (known as relators) purportedly on behalf of the United States and various states and municipalities, asserting causes of action under the federal False Claims Act and state and local laws, and alleging violations of the federal Anti-Kickback statute. On June 25, 2024, the States of Colorado, Georgia, Michigan, North Carolina, Texas, and Washington filed a civil complaint in partial intervention (the "June 2024 Civil Complaint") in the U.S. District Court for the District of Massachusetts asserting causes of action under various state laws. On July 18, 2024, the Company filed a motion to dismiss the March 2024 Civil Complaint and the June 2024 Civil Complaint. An oral hearing on the Company's motion to dismiss was held on December 16, 2024. Proceedings Initiated by Other Payors The Company is party to several lawsuits relating to the conduct alleged in the June 2020 Civil Complaint discussed under "Department of Justice Matters" above. These lawsuits were filed by UnitedHealthcare Insurance Company and United Healthcare Services, Inc. (collectively, "UHC") and Humana Inc. ("Humana") in the United States District Court for the Southern District of New York on December 17, 2020 and July 22, 2021, respectively; and by Blue Cross and Blue Shield of Massachusetts, Inc. and Blue Cross and Blue Shield of Massachusetts HMO Blue, Inc. (collectively, "BCBS"), Medical Mutual of Ohio ("MMO"), Horizon Healthcare Services, Inc. d/b/a Horizon Blue Cross Blue Shield of New Jersey ("Horizon"), and Local 464A United Food and Commercial Workers Union Welfare Service Benefit Fund ("Local 464A") in the U.S. District Court for the District of Massachusetts on December 20, 2021, February 23, 2022, April 4, 2022, and June 17, 2022, respectively. These lawsuits allege causes of action under state law and the federal Racketeer Influenced and Corrupt Organizations Act ("RICO") and seek monetary damages and equitable relief. The MMO and Local 464A lawsuits are putative class action lawsuits. On December 29, 2021, the lawsuits filed by UHC and Humana were stayed by the United States District Court for the Southern District of New York pending resolution of the proceedings before the U.S. District Court for the District of Massachusetts concerning the allegations in the June 2020 Civil Complaint. On September 27, 2022, the lawsuits filed by BCBS, MMO, and Horizon were stayed by the U.S. District Court for the District of Massachusetts pending resolution of the proceedings before the same court concerning the allegations in the June 2020 Civil Complaint; and, in light of these stays, the parties to the Local 464A action have also agreed to stay that matter. On June 24, 2024, a group of plaintiffs purporting to be assignees of claims by various Medicare Advantage plans and related entities filed a putative class action complaint in the U.S. District Court for the District of Columbia on behalf of Medicare Advantage plans and other payors. The lawsuit relates to the conduct alleged in the June 2020 Civil Complaint, March 2024 Civil Complaint, and June 2024 Civil Complaint discussed under "Department of Justice Matters" above. The lawsuit alleges causes of action under state law and RICO and seeks monetary damages and equitable relief. On October 22, 2024, the Company filed a motion to transfer the proceedings to the U.S. District Court for the District of Massachusetts or, in the alternative, to stay the proceedings or dismiss the proceedings. On January 28, 2025, pursuant to a stipulation among the parties, the proceedings were transferred to the U.S. District Court for the District of Massachusetts. F-39 Table of Contents 2021 Shareholder Derivative Complaint On June 29, 2021, an alleged shareholder filed a shareholder derivative complaint in the New York Supreme Court, naming the then-current and certain former members of the Company's board of directors and certain then-current and former executive officers of the Company as defendants and Regeneron as a nominal defendant. The complaint asserts that the individual defendants breached their fiduciary duties in relation to the allegations in the June 2020 Civil Complaint discussed under "Department of Justice Matters" above. The complaint seeks an award of damages allegedly sustained by the Company; an order requiring Regeneron to take all necessary actions to reform and improve its corporate governance and internal procedures; disgorgement from the individual defendants of all profits and benefits obtained by them resulting from their sales of Regeneron stock; and costs and disbursements of the action, including attorneys' fees. On July 28, 2021, the defendants filed a notice of removal, removing the case from the New York Supreme Court to the U.S. District Court for the Southern District of New York. On September 23, 2021, the plaintiff moved to remand the case to the New York Supreme Court. Also on September 23, 2021, the individual defendants moved to dismiss the complaint in its entirety. On December 19, 2022, the U.S. District Court for the Southern District of New York denied the plaintiff's motion to remand the case and granted a motion to stay the case pending resolution of the proceedings before the U.S. District Court for the District of Massachusetts concerning the allegations in the June 2020 Civil Complaint. As a result of the stay, the court also terminated the Company's motion to dismiss the complaint without prejudice. The Company can therefore renew the motion to dismiss upon conclusion of the stay. Class Action Civil Complaint On January 7, 2025, a purported shareholder filed a putative class action civil complaint, on behalf of himself and all others similarly situated, in the U.S. District Court for the Southern District of New York against the Company and certain current and former executive officers of the Company. The complaint asserts violations of federal securities laws in connection with statements or disclosures purportedly related to the conduct alleged in the March 2024 Civil Complaint discussed under "Department of Justice Matters" above. 2025 Shareholder Derivative Complaints On January 16 and January 22, 2025, purported shareholders filed two separate shareholder derivative complaints in the U.S. District Court for the Southern District of New York against members of the Company's board of directors and certain current and former executive officers of the Company as defendants and Regeneron as a nominal defendant. The complaints each allege that the individual defendants, among other things, breached their fiduciary duties to the Company by failing to properly manage and oversee the Company in connection with the conduct alleged in the March 2024 Civil Complaint discussed under "Department of Justice Matters" above. The complaints also each allege that the individual defendants breached the federal securities laws, wasted corporate assets, and unjustly enriched themselves at the expense of the Company. The complaints each seek, among other things, an award of damages allegedly sustained by the Company as a result of the alleged misconduct of the individual defendants; an order requiring the individual defendants to take all necessary actions to reform and improve the Company’s corporate governance and internal procedures; and costs and disbursements of the applicable action, including attorneys' fees. Sanofi Litigation On November 18, 2024, the Company filed a lawsuit (as amended on December 20, 2024) in the United States District Court for the Southern District of New York against Sanofi and certain of its affiliated entities. The lawsuit alleges that the defendants breached certain provisions of the parties' Amended and Restated License and Collaboration Agreement, dated as of November 10, 2009 (as amended, the "Collaboration Agreement"), concerning Sanofi's obligation to provide Regeneron with full access to material information relating to the commercialization of Dupixent or other products commercialized pursuant to the Collaboration Agreement and Regeneron's audit rights under the Collaboration Agreement. The lawsuit seeks a declaratory judgment, injunctive relief, damages, and other relief. F-40 Table of Contents 17. Net Income Per Share The calculations of basic and diluted net income per share are as follows: Year Ended December 31, (In millions, except per share data) 2024 2023 2022 Net income - basic and diluted $ 4,412.6 $ 3,953.6 $ 4,338.4 Weighted average shares - basic 107.9 106.7 107.1 Effect of dilutive securities: Stock options 4.8 4.9 4.9 Restricted stock awards and restricted stock units 2.4 2.1 1.5 Weighted average shares - diluted 115.1 113.7 113.5 Net income per share - basic $ 40.90 $ 37.05 $ 40.51 Net income per share - diluted $ 38.34 $ 34.77 $ 38.22 Shares which have been excluded from diluted per share amounts because their effect would have been antidilutive include the following: Year Ended December 31, (Shares in millions) 2024 2023 2022 Stock options 1.6 1.8 2.3 18. Statement of Cash Flows The following provides a reconciliation of cash, cash equivalents, and restricted cash reported within the Consolidated Balance Sheets to the total of the same such amounts shown in the Consolidated Statements of Cash Flows: December 31, (In millions) 2024 2023 2022 Cash and cash equivalents $ 2,488.2 $ 2,730.0 $ 3,105.9 Restricted cash included in Other current assets 0.8 — — Restricted cash included in Other noncurrent assets — 7.8 13.5 Total cash, cash equivalents, and restricted cash shown in the Consolidated Statements of Cash Flows $ 2,489.0 $ 2,737.8 $ 3,119.4 Restricted cash consists of amounts held by financial institutions pursuant to contractual arrangements. Supplemental disclosure of non-cash investing and financing activities As of December 31, (In millions) 2024 2023 2022 Accrued capital expenditures $ 151.6 $ 75.4 $ 70.8 Accrued contingent consideration in connection with acquisitions $ 62.7 $ 71.6 $ 135.5 F-41