Regeneron Pharmaceuticals, Inc. (REGN)

Sector: Healthcare|Industry: Biotechnology|Market Cap: $76.89B|Employees: 13.4K


Regeneron Pharmaceuticals is a biotechnology company focused on discovering, developing, and commercializing medicines for serious diseases. Their core business model centers around research and development, manufacturing, and commercialization of innovative therapies, primarily in the areas of eye diseases, allergic and inflammatory conditions, cancer, and cardiovascular and metabolic disorders. Regeneron maintains a strong market position with a focus on scientific research and discovery, with a geographic presence in the United States, Europe, and Japan.

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Business Summary

Regeneron Pharmaceuticals, Inc. is a fully integrated biotechnology company focused on inventing, developing, manufacturing, and commercializing medicines for serious diseases. The company's core business strategy is to maintain a strong foundation in basic scientific research and discovery-enabling technologies, and to build on that foundation with clinical development, manufacturing, and commercial capabilities. Their products and product candidates are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, hematologic conditions, infectious diseases, and rare diseases. Regeneron aims to advance as an integrated, multi-product biotechnology company that provides patients and medical professionals with important medicines for preventing and treating human diseases.

Key Statistics

  • Employees: 13,450 (as of December 31, 2023)
  • Geographic Footprint: Operations in the United States, Ireland, United Kingdom, Japan, and Germany
  • Headquarters: Tarrytown, New York
  • Founded: 1988
  • Number of locations/facilities: Manufacturing facilities in Rensselaer, New York and Limerick, Ireland, and leased research, manufacturing, office, laboratory, and warehouse space in Tarrytown, New York
  • Revenue: $13.117 billion (FY2023)
  • Trading Symbol: REGN (NASDAQ Global Select Market)

Leadership

  • CEO: Leonard S. Schleifer, M.D., Ph.D.
  • CFO: Robert E. Landry
  • President and Chief Scientific Officer: George D. Yancopoulos, M.D., Ph.D.

Key Financial Metrics

  • Annual Revenue: $13.117 billion (FY2023)
  • Net Income: $3.954 billion (FY2023)
  • Total Assets: $33.080 billion (as of December 31, 2023)
  • Employees: 13,450 (as of December 31, 2023)
  • Key Financial Highlights: Net product sales of EYLEA in the United States decreased in 2023, compared to 2022, primarily due to changing market dynamics, resulting in a lower net selling price and lower volumes. EYLEA volumes in 2023 were impacted by the August 2023 launch of EYLEA HD and subsequent transition of EYLEA patients to EYLEA HD.

Products and Services

Regeneron's marketed products include:

  • EYLEA HD (aflibercept) Injection 8 mg: For wet age-related macular degeneration, diabetic macular edema, and diabetic retinopathy.
  • EYLEA (aflibercept) Injection: For wet age-related macular degeneration, diabetic macular edema, diabetic retinopathy, macular edema following retinal vein occlusion, myopic choroidal neovascularization, neovascular glaucoma, and retinopathy of prematurity.
  • Dupixent (dupilumab) Injection: For atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis, and prurigo nodularis.
  • Libtayo (cemiplimab) Injection: For metastatic or locally advanced non-small cell lung cancer, metastatic or locally advanced basal cell carcinoma, metastatic or locally advanced cutaneous squamous cell carcinoma, and metastatic or recurrent second-line cervical cancer.
  • Praluent (alirocumab) Injection: For LDL-lowering in heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease, and homozygous familial hypercholesterolemia.
  • REGEN-COV: For COVID-19.
  • Kevzara (sarilumab) Injection: For rheumatoid arthritis and polymyalgia rheumatica.
  • Evkeeza (evinacumab) Injection: For homozygous familial hypercholesterolemia.
  • Inmazeb (atoltivimab, maftivimab, and odesivimab) Injection: For infection caused by Zaire ebolavirus.
  • Veopoz (pozelimab) Injection: For CD55-deficient protein-losing enteropathy.
  • ARCALYST (rilonacept) Injection: For cryopyrin-associated periodic syndromes, deficiency of interleukin-1 receptor antagonist, and recurrent pericarditis.
  • ZALTRAP (ziv-aflibercept) Injection for Intravenous Infusion: For metastatic colorectal cancer.

Key Business Segments

The company manages its business as one segment which includes all activities related to the discovery, development, and commercialization of medicines for serious diseases. Financial information related to this segment is included in the Consolidated Financial Statements and related notes.

Business Strategy

Regeneron's core business strategy is to maintain a strong foundation in basic scientific research and discovery-enabling technologies, and to build on that foundation with clinical development, manufacturing, and commercial capabilities. The company aims to advance as an integrated, multi-product biotechnology company that provides patients and medical professionals with important medicines for preventing and treating human diseases. Key strategic initiatives include advancing clinical programs, expanding commercial capabilities, and investing in research and development. The company is focused on leveraging its technologies to develop new therapeutics and expand into new markets. They are also focused on building additional commercial capabilities outside the United States as a result of obtaining the rights to commercialize Libtayo outside the United States in 2022.

Industry Context

Regeneron operates in the biotechnology and pharmaceuticals industries, facing substantial competition from other pharmaceutical, biotechnology, and chemical companies. Competition is based on factors such as the speed of product development, clinical testing, regulatory approvals, and the ability to supply commercial quantities of products. The company competes with companies that are using various technologies, including their own antibody generation technologies, RNAi, chimeric antigen receptor T cell (CAR-T cell), and gene therapy technologies.

  • Market Position: The company is a leader in the biotechnology and pharmaceuticals industries, with a portfolio of marketed products and product candidates in various therapeutic areas.
  • Key Competitors: The company faces competition from numerous companies, including those that market or are developing products for the same indications as Regeneron's products. Key competitors include companies such as Novartis, Genentech/Roche, Sanofi, and others.
  • Industry Trends: Key market trends affecting Regeneron include the increasing demand for innovative therapeutics, the growing importance of biologics, and the increasing focus on precision medicine and personalized treatments.

Risk Factors

  • Commercialization Risks: Dependence on the success of EYLEA, EYLEA HD, and Dupixent; reliance on third-party payors for coverage and reimbursement; and competition from other products and product candidates.
  • Regulatory and Development Risks: Uncertainties in drug development and regulatory approval, including safety issues, manufacturing challenges, and potential delays.
  • Intellectual Property and Market Exclusivity Risks: Inability to protect proprietary rights, potential infringement of third-party rights, and loss of market exclusivity due to patent expirations and biosimilar competition.
  • Manufacturing and Supply Risks: Reliance on limited internal and contracted manufacturing capacity, potential supply chain disruptions, and dependence on third-party suppliers.
  • Other Regulatory and Litigation Risks: Potential product liability claims, challenges under healthcare laws, and risks from improper conduct of employees or collaborators.

Last Updated

2024-02-05

(Generated from latest 10-K filing)