Regeneron Pharmaceuticals, Inc.

Company Overview

Business Model: Regeneron Pharmaceuticals, Inc. is a fully integrated biotechnology company focused on inventing, developing, manufacturing, and commercializing medicines for people with serious diseases. The Company's core strategy is to leverage its proprietary technologies for scientific research and drug development, building upon this foundation with robust clinical development, manufacturing, and commercial capabilities. Its objective is to advance as an integrated, multi-product biotechnology company providing important medicines across various therapeutic areas.

Market Position: Regeneron Pharmaceuticals, Inc. operates in a highly competitive biotechnology and pharmaceutical industry. The Company's ability to compete relies on rapid development of safe and effective product candidates, efficient clinical testing and approval processes, and consistent supply of commercial quantities. Competition for approved products is based on efficacy, safety, reliability, ease of administration, dosing frequency, availability, price, and intellectual property position. The Company faces substantial competition from other pharmaceutical and biotechnology companies, many of which possess greater resources.

Recent Strategic Developments:

• EYLEA HD Approvals: In November 2025, the U.S. Food and Drug Administration ("FDA") approved EYLEA HD for the treatment of patients with retinal vein occlusion ("RVO") and for an every 4-week dosing option across approved indications. In December 2025, the FDA also approved the addition of a new manufacturer to fill vials for EYLEA HD.
• Itepekimab Phase 3 Results: In May 2025, Regeneron Pharmaceuticals, Inc. and Sanofi announced that one Phase 3 trial (AERIFY-1) for itepekimab in adults with inadequately controlled chronic obstructive pulmonary disease ("COPD") met its primary endpoint, significantly reducing moderate or severe acute exacerbations by 27% compared to placebo at week 52. A second Phase 3 trial (AERIFY-2) did not meet the same primary endpoint.
• Ordspono Regulatory Update: On July 30, 2025, the FDA issued a Complete Response Letter ("CRL") for the Biologics License Application ("BLA") for odronextamab in relapsed/refractory follicular lymphoma, citing unresolved inspection findings at a third-party manufacturing filler.
• Lynozyfic Approvals: Lynozyfic was approved by the FDA and the European Commission ("EC") for relapsed/refractory multiple myeloma.
• Strategic Collaborations:
  • Hansoh Pharmaceuticals Group Company Limited: In July 2025, Regeneron Pharmaceuticals, Inc. entered into a license agreement for development and commercial rights outside mainland China, Hong Kong, and Macau for HS-20094, a dual GLP-1/GIP receptor agonist in Phase 3 development. An $80.0 million upfront payment was made.
  • Tessera Therapeutics, Inc.: In January 2026, a collaboration agreement became effective to develop and commercialize TSRA-196 for alpha-1 antitrypsin deficiency ("AATD"). Regeneron Pharmaceuticals, Inc. made aggregate payments of $150.0 million, including an upfront payment and preferred stock purchase.
• Manufacturing Expansion: Regeneron Pharmaceuticals, Inc. is developing an approximate 100-acre parcel adjacent to its Tarrytown, New York headquarters to expand research and support facilities. In 2024, it acquired an approximate 1,000,000 square foot facility in Saratoga Springs, New York, for production support and manufacturing capacity expansion.

Geographic Footprint: Regeneron Pharmaceuticals, Inc. has a global presence with primary operational regions including the United States, European Union, and Japan. The Company manufactures bulk drug materials and products at facilities in Rensselaer, New York, and Limerick, Ireland. Its workforce is distributed with 11,961 employees in the United States, 2,149 in Ireland, and 1,300 in other countries (primarily the United Kingdom, Japan, and Germany). The Company commercializes products in the United States and co-commercializes or relies on collaborators for sales, marketing, and distribution in various international markets.

Financial Performance

Revenue Analysis

Profitability Metrics:

• Gross Margin: 81.9%
• Operating Margin: 24.9%
• Net Margin: 31.4%

Investment in Growth:

• R&D Expenditure: $5,850.2 million (40.8% of revenue)
• Capital Expenditures: $898.4 million
• Strategic Investments:
  • $80.0 million upfront payment for HS-20094 license agreement with Hansoh Pharmaceuticals Group Company Limited in 2025.
  • $155.0 million for the purchase of an FDA Rare Pediatric Disease Priority Review Voucher in 2025, which was subsequently expensed to Research and development upon decision to utilize.
  • $150.0 million aggregate payments in January 2026 for collaboration with Tessera Therapeutics, Inc. (upfront payment and preferred stock purchase).

Business Segment Analysis

Regeneron Pharmaceuticals, Inc. manages its business as one segment, encompassing all activities related to the discovery, development, and commercialization of medicines for serious diseases.

Capital Allocation Strategy

Shareholder Returns:

• Share Repurchases: $3,438.6 million (5.6 million shares) in 2025.
• Dividend Payments: $370.3 million in 2025.
• Future Capital Return Commitments: The board of directors authorized a share repurchase program for up to $3.0 billion of Common Stock in February 2025, with $1.486 billion remaining available as of December 31, 2025. The Company initiated a quarterly cash dividend program in 2025 and declared a $0.94 per share cash dividend in January 2026, payable in March 2026.

Balance Sheet Position:

• Cash and Equivalents: $3,118.1 million
• Total Debt: $2,705.9 million (comprising $1,985.9 million in long-term debt and $720.0 million in finance lease liabilities)
• Net Cash Position: $412.2 million
• Debt Maturity Profile: Senior Notes mature in September 2030 (1.750%) and September 2050 (2.800%). The Tarrytown, New York corporate headquarters lease financing matures in March 2027.

Cash Flow Generation:

• Operating Cash Flow: $4,978.9 million

Operational Excellence

Production & Service Model: Regeneron Pharmaceuticals, Inc. invents, develops, manufactures, and commercializes medicines. Its manufacturing approach involves producing bulk drug materials and products at its Rensselaer, New York, and Limerick, Ireland facilities. The Company has also constructed a fill/finish facility in Rensselaer, New York, which is undergoing process validation for commercial production. The Company relies on collaborators and third parties for certain manufacturing steps, including packaging, filling, finishing, labeling, distribution, and laboratory testing.

Supply Chain Architecture: Key Suppliers & Partners:

• Manufacturing Partners: Collaborators and unaffiliated third-party suppliers provide certain bulk drug materials, raw materials, and products. Third parties are also relied upon for packaging, filling, finishing, labeling, distribution, and laboratory testing services.
• Drug-Delivery Device Providers: Single-source, third-party providers or collaborators supply drug-delivery devices such as pre-filled syringes, patch pumps, and auto-injectors.

Facility Network:

• Manufacturing:
  • Rensselaer, New York: Approximately 1,600,000 square feet, with approximately 100,000 liters of cell culture capacity. Includes manufacturing, warehouse, laboratory, and a fill/finish facility (undergoing process validation).
  • Limerick, Ireland: Approximately 950,000 square feet, with approximately 120,000 liters of cell culture capacity. Includes manufacturing, warehouse, laboratory, and office space.
  • Saratoga Springs, New York: Acquired an approximate 1,000,000 square foot facility in 2024, currently being designed and developed for production support activities and expanded manufacturing capacity.
• Research & Development: Primarily conducted at the Tarrytown, New York corporate headquarters (approximately 1,800,000 square feet, mostly leased). An adjacent 100-acre parcel is being developed to expand research and support facilities.
• Distribution: Relies on collaborators or third parties for distribution services.

Operational Metrics:

• Gross margin on net product sales decreased to 82% in 2025 from 86% in 2024, partly due to ongoing investments in manufacturing operations and higher inventory write-offs and reserves.

Market Access & Customer Relationships

Go-to-Market Strategy: Distribution Channels:

• Direct Sales: Promotes approved medicines to healthcare professionals via a team of field employees, medical journals, exhibitions, literature, samples, and online channels. Advertises certain products directly to consumers and maintains product websites.
• Channel Partners: Sells marketed products primarily to wholesalers, specialty distributors, pharmacies, hospitals, government agencies, physicians, and other healthcare providers.
• Digital Platforms: Utilizes online channels for promotion and information dissemination.

Customer Portfolio: Customer Concentration: For the year ended December 31, 2025, sales to two distributor customers accounted for a combined 77% of total gross product revenue. These two customers also accounted for 87% of net trade accounts receivable balances as of December 31, 2025.

Geographic Revenue Distribution:

• United States: EYLEA HD and EYLEA U.S. net product sales represented 31% of total revenues in 2025.
• International: Sanofi collaboration revenue (mostly Dupixent, global profit share) represented 41% of total revenues in 2025. Bayer collaboration revenue (EYLEA HD and EYLEA outside the United States profit share) contributed to total revenues.

Competitive Intelligence

Market Structure & Dynamics

Industry Characteristics: The biotechnology and pharmaceutical industries are highly competitive, requiring significant investment in research, development, and commercialization. Competition is driven by product efficacy, safety, reliability, ease of administration, dosing frequency, availability, price, and intellectual property. The market is influenced by regulatory requirements, drug pricing regulations, and the emergence of biosimilar products.

Competitive Positioning Matrix:

Direct Competitors

Primary Competitors:

• EYLEA HD and EYLEA: Genentech/Roche (Vabysmo®, Susvimo®, Avastin®), Novartis AG (Lucentis®, Beovu®), Outlook Therapeutics, Inc. (Lytenava™), Allergan/AbbVie Inc. (Ozurdex®), Alimera Sciences, Inc. (Iluvien®). Biosimilar competitors include Amgen Inc. (Pavblu™), Sandoz (Afqlir®), Sam Chun Dang (Eiyzey), Samsung Bioepis Co., Ltd. and Harrow, Inc. (Byooviz™), Xbrane Biopharma AB and STADA Arzneimittel AG (Ximluci®), Formycon AG, Bioeq AG, Sandoz, and Teva Ltd. (Cimerli™), Formycon AG, Bioeq AG, and Zydus Lifesciences Ltd. (Nufymco®).
• Dupixent: Almirall S.A., Eli Lilly and Company (Ebglyss®), AbbVie (Rinvoq®), Galderma; Maruho Co., Ltd./Chugai Pharmaceutical Co., Ltd. (Nemluvio®/Mitchga®), LEO Pharma Inc. (Adbry™/Adtralza®), Pfizer (Cibinqo®), AstraZeneca/Amgen (Tezspire™), AstraZeneca (Fasenra®), GlaxoSmithKline ("GSK") (Nucala®, Exdensur®), Roche/Novartis (Xolair®), Celltrion (Omlyclo®), Novartis AG (Rhapsido®).
• Libtayo: Merck & Co., Inc. (Keytruda®), Bristol-Myers Squibb (Opdivo®), Roche (Tecentriq®), AstraZeneca (Imfinzi®), Pfizer/Merck KGaA (Bavencio®), GSK (Jemperli®), Checkpoint Therapeutics, Inc. (Unloxcyt™).
• Other Marketed Products: Lynozyfic faces competition from other bispecific antibodies and CAR-T cell therapies. Praluent, Evkeeza, and Kevzara compete with antibodies or other molecules targeting PCSK9, ANGPTL3, and IL-6/IL-6R, respectively.

Emerging Competitive Threats: Other pharmaceutical and biotechnology companies are actively engaged in research and development of antibody-based products (including bispecific, multispecific, and antibody-drug conjugates) and gene therapy-based products against targets also pursued by Regeneron Pharmaceuticals, Inc. These companies utilize various technologies, including RNAi, chimeric antigen receptor T ("CAR-T") cell, and gene therapy. New entrants, disruptive technologies, and alternative solutions, including small molecules, pose ongoing threats.

Competitive Response Strategy: Regeneron Pharmaceuticals, Inc. focuses on its proprietary technologies for drug discovery and development, aiming for speed and efficiency in bringing new therapeutics to market. The Company also studies its marketed products in additional indications and develops combination therapies to maintain competitive advantage.

Risk Assessment Framework

Strategic & Market Risks

• Market Dynamics: The Company is substantially dependent on the success of EYLEA HD, EYLEA, and Dupixent. Sales of EYLEA decreased in 2025 due to competitive pressures, loss in market share to compounded bevacizumab (due to patient affordability), and patient transition to EYLEA HD. Biosimilar competition for EYLEA is increasing in the U.S. and internationally, with additional biosimilars expected to launch in the U.S. in the second half of 2026. The commercial success of EYLEA HD depends on uptake efforts, differentiation, safety/efficacy in real-world use, and payor coverage.
• Technology Disruption: Competition from companies using alternative technologies like RNAi, CAR-T cell, and gene therapy, as well as small molecules, could impact the commercial success of Regeneron Pharmaceuticals, Inc.'s antibody-based product candidates.
• Customer Concentration: Sales to two distributor customers accounted for 77% of total gross product revenue in 2025, posing a concentration risk. Loss of a large customer or significant reduction in sales could adversely affect results.

Operational & Execution Risks

• Supply Chain Vulnerabilities: Regeneron Pharmaceuticals, Inc. relies on limited internal and contracted manufacturing and supply chain capacity. Dependence on collaborators and contract manufacturers for commercial quantities and fill/finish services is significant. Single-source third-party suppliers for raw materials and other services create dependency risks. Disruptions due to regulatory actions, business interruptions, labor shortages, or geopolitical developments (e.g., Russia-Ukraine, Hamas-Israel conflicts, U.S.-China trade relations) could impair manufacturing and supply.
• Geographic Concentration: Manufacturing facilities in Rensselaer, New York, and Limerick, Ireland, and reliance on China-based suppliers for certain raw materials and services, expose the Company to regional and geopolitical risks.
• Capacity Constraints: Current manufacturing capacity may be insufficient for increased demand or pipeline advancement, requiring substantial expenditures and time for expansion and regulatory approvals. The new fill/finish facility in Rensselaer, New York, is not yet approved for commercial production.

Financial & Regulatory Risks

• Market & Financial Risks: Fluctuations in foreign currency exchange rates (Japanese yen, euro, British pound sterling, Canadian dollar, Chinese yuan, Australian dollar) can impact operating results. Investments in marketable securities are subject to interest rate, liquidity, market, and issuer credit risks.
• Regulatory & Compliance Risks: Obtaining and maintaining regulatory approval is costly, time-consuming, and uncertain. Serious complications or side effects from products or product candidates could lead to regulatory action. The Company is subject to extensive "fraud and abuse" laws (e.g., federal civil False Claims Act, anti-kickback provisions), transparency laws, and the Foreign Corrupt Practices Act ("FCPA"). Non-compliance can result in civil/criminal proceedings, investigations, penalties, and reputational damage.
• Credit & Liquidity: Indebtedness of $2.706 billion as of December 31, 2025, could limit future capital access and require substantial cash flow for payments.

Geopolitical & External Risks

• Geopolitical Exposure: Operations and clinical trials in countries like Russia, Ukraine, and Israel expose the Company to political and economic risks, including armed conflict and economic embargoes, which could delay clinical programs or disrupt supply chains.
• Trade Relations: Tariffs and other trade restrictions (e.g., U.S. tariffs on imports, potential pharmaceutical tariffs, BIOSECURE Act impacting China-based suppliers) could increase operating costs and materially adversely affect results.
• Sanctions & Export Controls: Compliance with sanctions (e.g., Office of Foreign Assets Control) and export controls can limit business activities and impact patent rights in certain regions (e.g., Russia).

Innovation & Technology Leadership

Research & Development Focus: Core Technology Areas:

• Trap Technology: Fuses receptor components to antibody molecules to create drugs like EYLEA HD, EYLEA, ZALTRAP, and ARCALYST.
• VelociSuite® Platform: Used for discovering, developing, and producing fully human antibodies, bispecific antibodies, antibody-protein fusions, and antibody conjugates. Includes VelocImmune® (for human antibodies), VelociGene® (for precise DNA manipulation and humanized targets), VelociMouse® (for genetically altered mice), VelociMab® (for rapid antibody screening), Veloci-Bi® (for full-length bispecific antibodies), VelociT® (for T-cell receptors and cell-mediated immunity), and VelociHum® (for immunodeficient mouse models).
• Genetic Medicine Platforms: Complementary approaches including siRNA gene silencing, genome editing, and targeted viral-based gene delivery and expression.
• Regeneron Genetics Center® (RGC®): Leverages de-identified clinical, genomic, proteomic, and molecular data from human volunteers to identify genetic factors influencing diseases, aiming to improve drug discovery and clinical care design. RGC has sequenced over 3 million samples and identified more than 40 novel genetic targets.

Intellectual Property Portfolio:

• Patent Strategy: Files patent applications to protect technology, inventions, and improvements. Holds ownership interests in numerous issued patents and thousands of patent applications in the United States and other countries.
• Patent Holdings:
  • VelociSuite® Technologies: Patent protection extends to 2042 based on remaining issued patents.
  • EYLEA HD (aflibercept 8 mg): U.S. formulation patents expire June 14, 2027, and May 15, 2039. U.S. methods of treatment patents expire January 11, 2032, and May 10, 2039. European methods of treatment patent expires May 16, 2042. Japanese formulation patent expires March 30, 2040.
  • EYLEA (aflibercept 2 mg): U.S. formulation patents expire June 21, 2027, and June 14, 2027. U.S. methods of treatment patents expire January 11, 2032. European formulation patents expire June 14, 2027 (with SPC to May 25, 2028). Japanese formulation patent expires February 27, 2028 – October 1, 2029. Japanese methods of treatment patent expires January 11, 2032.
  • Dupixent (dupilumab): U.S. composition of matter patents expire March 28, 2031, and October 2, 2027. U.S. formulation patents expire October 17, 2032, and October 5, 2031. U.S. methods of treatment patents expire April 17, 2028, October 2, 2027, July 10, 2034, December 22, 2033, January 21, 2036, September 21, 2037, March 28, 2039, May 10, 2039, February 3, 2043, December 25, 2034, and July 5, 2042. European composition of matter patent expires October 27, 2029 (with SPC to September 28, 2032 / March 28, 2033). European methods of treatment patents expire June 20, 2034, August 20, 2033, October 27, 2029, February 20, 2035, October 29, 2038, and September 4, 2033. Japanese composition of matter patent expires October 27, 2029 – October 27, 2034. Japanese formulation patents expire October 5, 2031 – September 14, 2035. Japanese methods of treatment patents expire October 27, 2029 – February 22, 2034, August 20, 2033 – August 29, 2034, September 4, 2033, February 20, 2035, June 20, 2034 – September 2, 2035, November 13, 2035, September 21, 2037, and August 5, 2040.
  • Libtayo (cemiplimab): U.S. composition of matter patents expire September 18, 2035, and April 10, 2035. U.S. formulation patent expires March 21, 2038. U.S. methods of treatment patents expire May 12, 2037, July 18, 2038, July 2, 2038, and February 20, 2038. European composition of matter patent expires January 23, 2035. European formulation patents expire March 23, 2038. European methods of treatment patents expire May 12, 2037. Japanese composition of matter patents expire January 23, 2035 – March 15, 2039. Japanese formulation patent expires March 23, 2038. Japanese methods of treatment patents expire May 25, 2041, February 20, 2038, and August 5, 2040.
• Licensing Programs: Nonexclusive licensee of patents and patent applications, including a license agreement with Bristol-Myers Squibb, E. R. Squibb & Sons, L.L.C., and Ono Pharmaceutical Co., Ltd. for Libtayo, with royalties of 2.5% from January 1, 2024, through December 31, 2026.

Technology Partnerships:

• Sanofi: Global collaboration for development and commercialization of Dupixent, Kevzara, and itepekimab.
• Bayer: License and collaboration agreement for global development and commercialization of EYLEA 8 mg and EYLEA outside the United States.
• Alnylam Pharmaceuticals, Inc.: Collaboration to discover, develop, and commercialize RNAi therapeutics for eye, central nervous system, and liver targets. Regeneron Pharmaceuticals, Inc. is also a licensee for cemdisiran (monotherapy and in combination with pozelimab).
• Intellia Therapeutics, Inc.: License and collaboration agreement to advance CRISPR/Cas9 gene-editing technology for in vivo therapeutic development, including neurological and muscular diseases. Nex-z is subject to a co-development and co-commercialization arrangement.
• Hansoh Pharmaceuticals Group Company Limited: License agreement for HS-20094.
• Tessera Therapeutics, Inc.: Collaboration agreement for TSRA-196.

Leadership & Governance

Executive Leadership Team

Leadership Continuity: Regeneron Pharmaceuticals, Inc. invests in talent development and career opportunities, with approximately 25% of 2025 job openings filled by existing employees. The Company has expanded mentoring programs and inclusive leadership workshops. Board Composition: The board of directors oversees risk management, including cybersecurity. The Audit Committee reviews the cybersecurity risk profile with management periodically. The board will transition to annual election of all directors commencing with the 2028 annual meeting of shareholders.

Human Capital Strategy

Workforce Composition: As of December 31, 2025, Regeneron Pharmaceuticals, Inc. had 15,410 full-time employees.

• Geographic Distribution: 11,961 in the United States, 2,149 in Ireland, and 1,300 in other countries (primarily the United Kingdom, Japan, and Germany).
• Skill Mix: 2,591 in research and preclinical development, 2,274 in global clinical development and regulatory affairs, and 6,717 in industrial operations and product supply. Over 1,800 employees hold a Ph.D. and/or M.D.

Talent Management: Acquisition & Retention: The Company's employee retention rate was nearly 93% in 2025. It offers market-competitive pay, broad-based stock-based awards, comprehensive healthcare benefits, parental leave, child and elder care support, and retirement savings options. Employee Value Proposition: The Company's culture is guided by "The Regeneron Way" and a philosophy of "Doing Well by Doing Good." It emphasizes an inclusive culture, talent development, and career opportunities.

Diversity & Development: The Company fosters an inclusive culture through employee-led cross-functional resource groups and inclusive leadership workshops. It invests in STEM talent pipeline through philanthropic investments, including the Regeneron Science Talent Search and Regeneron International Science and Engineering Fair.

Environmental & Social Impact

Environmental Commitments: Regeneron Pharmaceuticals, Inc. is committed to meeting or exceeding all environmental, health, and safety ("EHS") and security regulations. It has programs, policies, and procedures to ensure workplace safety and aims for workplace injury prevention in its drive toward zero incidents. Social Impact Initiatives: The Company encourages community involvement through its matching gift program, volunteer-time-off policy, and annual company-wide service event, "Day for Doing Good." In 2025, over 7,600 employees volunteered nearly 42,000 hours, and the Company matched approximately $2.4 million in employee contributions. Regeneron Pharmaceuticals, Inc. has been named to the Civic 50 of most community-minded companies in the United States for nine consecutive years.

Business Cyclicality & Seasonality

No material information explicitly detailing business cyclicality or seasonality was provided in the filing.

Regulatory Environment & Compliance

Regulatory Framework: Regeneron Pharmaceuticals, Inc. is subject to extensive government regulation in the United States and other countries covering research, development, manufacture, and marketing of products. This includes preclinical requirements (Good Laboratory Practice requirements ("GLPs"), Animal Welfare Act), product approval processes (FDA, European Medicines Agency ("EMA"), Good Clinical Practice requirements ("GCPs"), Institutional Review Board ("IRB") oversight, New Drug Application ("NDA"), Biologics License Application ("BLA"), Marketing Authorization), and post-approval regulation (pharmacovigilance, Good Manufacturing Practice ("GMP") regulations, Risk Evaluation and Mitigation Strategy ("REMS"), Drug Supply Chain Security Act). Industry-Specific Regulations: The Company must comply with regulations for drug and biologic products, including those for combination products (drug-delivery devices). International Compliance: Compliance with regulations in the European Economic Area ("EEA") includes pharmacovigilance legislation (Pharmacovigilance System Master File ("PSMF"), Qualified Person for Pharmacovigilance ("QPPV")), and post-authorization safety/efficacy studies (PASS/PAES). Trade & Export Controls: The Company is subject to tariffs, trade protection measures, import/export licensing, trade embargoes, and sanctions (e.g., Office of Foreign Assets Control). Geopolitical developments (e.g., U.S.-China relations, BIOSECURE Act) could restrict engagement with China-based suppliers. Legal Proceedings: Regeneron Pharmaceuticals, Inc. is involved in several material legal proceedings:

• EYLEA Patent Litigation: Multiple patent infringement lawsuits against various parties (e.g., Amgen Inc., Samsung Bioepis, Celltrion, Sandoz, Formycon AG, Alvotech HF) in the U.S., Europe (e.g., UK, Germany, Netherlands), Canada, South Korea, and Australia. Several settlements have been reached, precluding biosimilar launches until specific dates in 2026.
• EYLEA Pre-filled Syringe Antitrust Lawsuit: Lawsuit against Novartis Pharma AG, Novartis Pharmaceuticals Corporation, and Novartis Technology LLC, and Vetter Pharma International GmbH alleging antitrust violations and tortious interference.
• Praluent Antitrust Lawsuit: Lawsuit against Amgen Inc. alleging an anticompetitive bundling scheme. A jury awarded Regeneron Pharmaceuticals, Inc. $135.6 million in compensatory damages and $271.2 million in punitive damages in May 2025.
• Department of Justice Matters: Civil complaints and investigations under the federal False Claims Act and Anti-Kickback Statute related to patient assistance programs and alleged inflated reimbursement rates for EYLEA.
• Shareholder Derivative Complaints: Multiple complaints alleging breaches of fiduciary duties by directors and executive officers related to the Department of Justice matters and director compensation.
• Class Action Civil Complaint: A putative class action civil complaint alleging violations of federal securities laws related to the Department of Justice matters and the launch of EYLEA HD.
• Sanofi Litigation: Lawsuit against Sanofi and affiliated entities alleging breaches of the Collaboration Agreement regarding access to material information and audit rights.

Tax Strategy & Considerations

Tax Profile: Regeneron Pharmaceuticals, Inc. is subject to U.S. federal, state, and foreign income taxes. The effective tax rate for 2025 was 13.9%, compared to 7.7% in 2024 and 5.9% in 2023. The 2025 rate was positively impacted by income earned in foreign jurisdictions with lower tax rates and federal tax credits for research activities, partially offset by the impact of the "One Big Beautiful Bill Act" ("OBBBA").

• Tax Reform Impact: The OBBBA, signed into law in July 2025, revises U.S. corporate income tax laws by restoring immediate expense recognition for U.S.-based R&D, making first-year bonus depreciation permanent, and modifying taxation on foreign earnings. This resulted in a $44.5 million charge in Q3 2025 related to the re-measurement of U.S. net deferred tax assets.
• Unrecognized Tax Benefits: Liabilities for unrecognized tax benefits totaled $1,577.9 million as of December 31, 2025.

Insurance & Risk Transfer

Risk Management Framework: Regeneron Pharmaceuticals, Inc. regularly assesses cybersecurity threats, monitors information systems for vulnerabilities, and tests systems according to its cybersecurity policies. The Technology Risk Management Committee assesses cybersecurity risks, and high-risk items are integrated into the overall risk management program overseen by the Audit Committee. The Company collaborates with third parties for cybersecurity assessments and due diligence. The Company is exposed to product liability risk from testing, manufacturing, marketing, and selling drugs, and maintains product liability insurance, though coverage may not be exhaustive.