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REGENERON PHARMACEUTICALS, INC.

REGN
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Business Summary

Regeneron Pharmaceuticals, Inc. is a fully integrated biotechnology company that invents, develops, manufactures, and commercializes medicines for people with serious diseases. The company operates in the biotechnology and pharmaceuticals industries, which are characterized by substantial competition from pharmaceutical and biotechnology companies, many of which have substantially greater research, preclinical and clinical product development, and manufacturing capabilities, as well as financial, marketing, and human resources. Regeneron's core business strategy is to maintain a strong foundation in scientific research and drug development using its proprietary technologies, including the VelociSuite platform and the Regeneron Genetics Center, and to build on that foundation with its clinical development, manufacturing, and commercial capabilities.

Regeneron faces substantial competition from pharmaceutical and biotechnology companies. Named competitors include Genentech/Roche, Novartis AG, Amgen Inc., Sandoz, Merck & Co., Inc., Bristol-Myers Squibb, AstraZeneca, and many others. The company's competitive advantages are rooted in its proprietary VelociSuite technologies, including the VelocImmune mouse platform used to generate fully human antibodies, and the Regeneron Genetics Center, which has identified more than 40 novel genetic targets. Regeneron's ability to compete depends on how fast it can develop safe and effective product candidates, complete clinical testing and approval processes, and supply commercial quantities of the product to the market. Competition among approved products is based on efficacy, safety, reliability, ease of administration, dosing frequency, availability, price, patent and other intellectual property position, and other factors.

Regeneron generates revenue through net product sales of its marketed products, collaboration revenue from its partnerships (primarily with Sanofi and Bayer), and other revenue including royalties and manufacturing services. The company's revenue mix includes product sales recorded directly by Regeneron (such as EYLEA HD, EYLEA, Libtayo, and Praluent in the U.S.) and collaboration revenue from its share of profits on products commercialized by collaborators (such as Dupixent and Kevzara with Sanofi, and EYLEA HD and EYLEA outside the U.S. with Bayer). The company also earns other revenue from royalties on sales of Novartis' Ilaris and its share of profits from sales of ARCALYST by Kiniksa. Regeneron manages its business as one segment which includes all activities related to the discovery, development, and commercialization of medicines for serious diseases.

Regeneron's key products include EYLEA HD (aflibercept) Injection 8 mg, approved in the U.S. for wet age-related macular degeneration, diabetic macular edema, diabetic retinopathy, and macular edema following retinal vein occlusion, and in the EU and Japan for wAMD, DME, and RVO. EYLEA (aflibercept) Injection is approved in the U.S., EU, and Japan for wAMD, DME, RVO, and other indications. Dupixent (dupilumab) Injection, developed in collaboration with Sanofi, is approved in the U.S., EU, and Japan for atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, COPD, eosinophilic esophagitis, prurigo nodularis, chronic spontaneous urticaria, and bullous pemphigoid. Libtayo (cemiplimab) Injection is approved for various cancers including NSCLC, BCC, CSCC, and cervical cancer. Other marketed products include Praluent (alirocumab), Kevzara (sarilumab), Evkeeza (evinacumab), Ordspono (odronextamab), Lynozyfic (linvoseltamab), Inmazeb, Veopoz (pozelimab), ARCALYST (rilonacept), and ZALTRAP (ziv-aflibercept). For the year ended December 31, 2025, total EYLEA HD and EYLEA net product sales were $7.891 billion , Dupixent global net product sales were $17.8067 billion , and Libtayo global net product sales were $1.4522 billion .

In July 2025, Regeneron's license agreement with Hansoh Pharmaceuticals Group Company Limited to acquire development and commercial rights outside of mainland China, Hong Kong, and Macau for HS-20094 (a dual GLP-1/GIP receptor agonist) became effective, with an $80.0 million up-front payment made in July 2025. In January 2026, the collaboration agreement with Tessera Therapeutics, Inc. to develop and commercialize TSRA-196 for alpha-1 antitrypsin deficiency became effective, with aggregate payments of $150.0 million made in January 2026. In February 2025, the board of directors authorized a share repurchase program for up to $3.0 billion of Common Stock, of which $1.486 billion remained available as of December 31, 2025. In 2025, the board of directors also initiated a quarterly cash dividend program, declaring quarterly cash dividends of $0.88 per share on Common Stock and Class A Stock. In January 2026, the board declared a cash dividend of $0.94 per share.

For the year ended December 31, 2025, total revenues were $14.3429 billion , compared to $14.2020 billion in 2024 and $13.1172 billion in 2023. Net income was $4.5049 billion in 2025, compared to $4.4126 billion in 2024 and $3.9536 billion in 2023. Diluted net income per share was $41.48 in 2025, compared to $38.34 in 2024 and $34.77 in 2023. The increase in total revenues was driven by higher collaboration revenue from Sanofi, which increased to $5.8840 billion in 2025 from $4.5314 billion in 2024, partially offset by a decline in net product sales to $6.3091 billion in 2025 from $7.6292 billion in 2024, primarily due to a $2.0193 billion decrease in EYLEA U.S. net product sales.

Business Outlook

Regeneron expects to incur capital expenditures of $1.100 billion to $1.300 billion in 2026, including in connection with the continued expansion of its facilities in Tarrytown, New York and developing its property in Saratoga Springs, New York for production support activities and additional manufacturing capacity. The company expects continued significant capital expenditures over the next several years related to these expansion projects.

A key growth vector is the continued development and commercialization of EYLEA HD. The FDA approved EYLEA HD for the treatment of patients with RVO and for an every 4-week dosing option across approved indications in November 2025. The company submitted a regulatory application seeking approval of the EYLEA HD pre-filled syringe using a new manufacturer in December 2025, with an FDA decision expected in the second quarter of 2026. Another major growth vector is the expansion of Dupixent into new indications. In 2025, Dupixent was approved by the FDA for bullous pemphigoid and by the FDA and EC for CSU in adults and adolescents. The company reported that a Phase 3 trial in AFRS met its primary and key secondary endpoints, with an FDA decision on the sBLA expected in February 2026. Additionally, the company is advancing its pipeline of product candidates in late-stage clinical development, including itepekimab for COPD, fianlimab for first-line metastatic melanoma, garetosmab for FOP, and cemdisiran for myasthenia gravis.

The company's gross margin on net product sales decreased to 82% in 2025 from 86% in 2024, partly due to ongoing investments to support manufacturing operations and higher inventory write-offs and reserves, as well as higher amortization expense associated with the Libtayo intangible asset. Research and development expenses increased to $5.8502 billion in 2025 from $5.1320 billion in 2024, driven by higher clinical manufacturing costs and a $155.0 million charge related to a Priority Review Voucher. Selling, general, and administrative expenses decreased to $2.7000 billion in 2025 from $2.9544 billion in 2024, primarily due to lower charitable contributions to Good Days. The company expects to continue to incur substantial expenses related to research and development activities and commercialization of marketed products.

Regeneron currently manufactures bulk drug materials and products at its manufacturing facilities in Rensselaer, New York and Limerick, Ireland. The Rensselaer facility has approximately 100,000 liters of cell culture capacity, and the Limerick facility has approximately 120,000 liters of cell culture capacity. The company has constructed a fill/finish facility in Rensselaer, New York that is undergoing process validation and has yet to be approved for commercial production. The company relies on collaborators and third parties for certain manufacturing, filling, finishing, packaging, labeling, distribution, and laboratory testing services. As of December 31, 2025, the company had 15,410 full-time employees. The company expects to continue to expand its manufacturing capacity and may lease, operate, purchase, or construct additional facilities.

Research and development expenses for 2025 were $5.8502 billion , including stock-based compensation expense of $545.4 million . The company expects to continue to incur significant costs in connection with its research and development activities. Capital expenditures in 2025 primarily included costs incurred in connection with the expansion of research, preclinical manufacturing, and support facilities at the Tarrytown, New York corporate headquarters, as well as costs associated with the expansion of manufacturing facilities. As of December 31, 2025, $1.486 billion remained available for share repurchases under the company's share repurchase programs. In 2025, the board of directors declared quarterly cash dividends of $0.88 per share on Common Stock and Class A Stock, and in January 2026, declared a cash dividend of $0.94 per share.

The company faces significant headwinds from biosimilar competition for EYLEA. Following the expiration of the U.S. regulatory exclusivity period for EYLEA in May 2024, several biosimilar versions have been approved by the FDA, and one such product has launched in the United States. EYLEA U.S. net product sales declined by 42% in 2025 compared to 2024 as a result of competitive pressures. The company expects that biosimilar competition for EYLEA will continue to increase as additional biosimilar versions are launched in the United States in the second half of 2026. Additionally, the company faces risks from drug price control measures, including the Inflation Reduction Act, which established a Medicare Drug Price Negotiation Program, and executive orders directing the HHS to take steps to reduce drug prices, including potential most-favored-nation pricing.

Risk Factors

Regeneron is substantially dependent on the success of EYLEA HD, EYLEA, and Dupixent. For the years ended December 31, 2025 and 2024, aggregate EYLEA HD and EYLEA net product sales in the United States represented 31% and 42% of total revenues, respectively. Sanofi collaboration revenue (most of which is attributable to Dupixent) represented 41% and 32% of total revenues in 2025 and 2024, respectively. EYLEA U.S. net product sales declined by 42% in 2025 compared to 2024 due to competitive pressures, including biosimilar competition following the expiration of U.S. regulatory exclusivity in May 2024. The company faces significant competition from biosimilar versions of EYLEA, with one product launched in the U.S. and additional launches expected in the second half of 2026. The company also faces risks related to drug price control measures, including the Inflation Reduction Act's Medicare Drug Price Negotiation Program and executive orders directing the HHS to reduce drug prices, which could materially adversely affect sales of marketed products. Additionally, the company relies on collaborations with Sanofi and Bayer for commercializing some of its marketed products; if these collaborations are terminated or if the collaborators materially breach their obligations, the company's ability to develop, manufacture, and commercialize certain products would be materially harmed.

Management Priorities

Management's message emphasizes Regeneron's position as a fully integrated biotechnology company with a strong foundation in scientific research and drug development using proprietary technologies. The company's objective is to continue to advance as an integrated, multi-product biotechnology company that provides patients and medical professionals with important medicines. Key strategic priorities include maintaining a strong foundation in scientific research and drug development using proprietary technologies, building on that foundation with clinical development, manufacturing, and commercial capabilities, and continuing to advance as an integrated, multi-product biotechnology company. Management highlights the company's pipeline productivity and ability to innovate, discover, and develop new products, and bring those products to market either alone or based on contractual arrangements with other parties. The company expects to continue to incur substantial expenses related to research and development activities, and research and development activities and related costs which are not reimbursed by collaborators are expected to expand and require additional resources. The company also expects to incur substantial costs related to the commercialization of its marketed products.

View Source Annual Report on SEC.gov ↗

References

  1. [1] Item 1, Business — Products
  2. [2] Item 1, Business — Products
  3. [3] Item 1, Business — Products
  4. [4] Item 1, Business — Collaboration, License, and Other Agreements
  5. [5] Item 1, Business — Collaboration, License, and Other Agreements
  6. [6] Item 7, MD&A — Liquidity and Capital Resources — Share Repurchase Programs
  7. [7] Item 7, MD&A — Liquidity and Capital Resources — Share Repurchase Programs
  8. [8] Item 7, MD&A — Liquidity and Capital Resources — Dividends
  9. [9] Item 7, MD&A — Liquidity and Capital Resources — Dividends
  10. [10] Item 7, MD&A — Results of Operations — Net Income
  11. [11] Item 7, MD&A — Results of Operations — Net Income
  12. [12] Item 7, MD&A — Results of Operations — Net Income
  13. [13] Item 7, MD&A — Results of Operations — Net Income
  14. [14] Item 7, MD&A — Results of Operations — Net Income
  15. [15] Item 7, MD&A — Results of Operations — Net Income
  16. [16] Item 7, MD&A — Results of Operations — Net Income
  17. [17] Item 7, MD&A — Results of Operations — Net Income
  18. [18] Item 7, MD&A — Results of Operations — Net Income
  19. [19] Item 7, MD&A — Results of Operations — Revenues — Sanofi Collaboration Revenue
  20. [20] Item 7, MD&A — Results of Operations — Revenues — Sanofi Collaboration Revenue
  21. [21] Item 7, MD&A — Results of Operations — Revenues — Net Product Sales
  22. [22] Item 7, MD&A — Results of Operations — Revenues — Net Product Sales
  23. [23] Item 7, MD&A — Results of Operations — Revenues — Net Product Sales
  24. [24] Item 7, MD&A — Liquidity and Capital Resources — Cash Flows from Investing Activities
  25. [25] Item 7, MD&A — Results of Operations — Cost of Goods Sold
  26. [26] Item 7, MD&A — Results of Operations — Cost of Goods Sold
  27. [27] Item 7, MD&A — Results of Operations — Research and Development Expenses
  28. [28] Item 7, MD&A — Results of Operations — Research and Development Expenses
  29. [29] Item 7, MD&A — Results of Operations — Research and Development Expenses
  30. [30] Item 7, MD&A — Results of Operations — Selling, General, and Administrative Expenses
  31. [31] Item 7, MD&A — Results of Operations — Selling, General, and Administrative Expenses
  32. [32] Item 1, Business — Manufacturing
  33. [33] Item 1, Business — Manufacturing
  34. [34] Item 1, Business — Human Capital Resources — Workforce Profile
  35. [35] Item 7, MD&A — Results of Operations — Research and Development Expenses
  36. [36] Item 7, MD&A — Results of Operations — Research and Development Expenses
  37. [37] Item 7, MD&A — Liquidity and Capital Resources — Share Repurchase Programs
  38. [38] Item 7, MD&A — Liquidity and Capital Resources — Dividends
  39. [39] Item 7, MD&A — Liquidity and Capital Resources — Dividends
  40. [40] Item 7, MD&A — Results of Operations — Revenues — Net Product Sales
  41. [41] Item 1A, Risk Factors — Risks Related to Commercialization
  42. [42] Item 1A, Risk Factors — Risks Related to Commercialization
  43. [43] Item 1A, Risk Factors — Risks Related to Commercialization
  44. [44] Item 1A, Risk Factors — Risks Related to Commercialization
  45. [45] Item 7, MD&A — Results of Operations — Revenues — Net Product Sales
  46. [46] Item 7, MD&A — Results of Operations — Net Income
  47. [47] Item 7, MD&A — Results of Operations — Net Income
  48. [48] Item 7, MD&A — Results of Operations — Net Income
  49. [49] Item 7, MD&A — Results of Operations — Net Income
  50. [50] Item 7, MD&A — Results of Operations — Net Income
  51. [51] Item 7, MD&A — Results of Operations — Net Income
  52. [52] Item 7, MD&A — Results of Operations — Net Income
  53. [53] Item 7, MD&A — Results of Operations — Net Income
  54. [54] Item 7, MD&A — Results of Operations — Income Taxes
  55. [55] Item 7, MD&A — Results of Operations — Income Taxes
  56. [56] Item 7, MD&A — Results of Operations — Other Income (Expense)
  57. [57] Item 7, MD&A — Results of Operations — Other Income (Expense)
  58. [58] Item 7, MD&A — Liquidity and Capital Resources
  59. [59] Item 7, MD&A — Liquidity and Capital Resources
  60. [60] Item 7, MD&A — Liquidity and Capital Resources
  61. [61] Item 7, MD&A — Liquidity and Capital Resources
  62. [62] Item 7, MD&A — Liquidity and Capital Resources
  63. [63] Item 7, MD&A — Liquidity and Capital Resources
  64. [64] Item 7, MD&A — Liquidity and Capital Resources
  65. [65] Item 7, MD&A — Liquidity and Capital Resources — Credit Facility
  66. [66] Item 7, MD&A — Liquidity and Capital Resources — Sources and Uses of Cash
  67. [67] Item 7, MD&A — Liquidity and Capital Resources — Sources and Uses of Cash
  68. [68] Item 7, MD&A — Results of Operations — Revenues — Sanofi Collaboration Revenue
  69. [69] Item 7, MD&A — Results of Operations — Revenues — Sanofi Collaboration Revenue
  70. [70] Item 7, MD&A — Results of Operations — Revenues — Net Product Sales
  71. [71] Item 7, MD&A — Results of Operations — Revenues — Net Product Sales
  72. [72] Item 7, MD&A — Results of Operations — Revenues — Net Product Sales
  73. [73] Item 7, MD&A — Results of Operations — Revenues — Net Product Sales
  74. [74] Item 7, MD&A — Results of Operations — Revenues — Net Product Sales

Analysis on 6/8/2026