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What changed in Regeneron Pharmaceuticals's 10-K — 2024 vs 2025

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Paragraph-level year-over-year comparison of Regeneron Pharmaceuticals's 2024 and 2025 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2025 report.

+613 added−574 removedSource: 10-K (2026-02-04) vs 10-K (2025-02-05)

Top changes in Regeneron Pharmaceuticals's 2025 10-K

613 paragraphs added · 574 removed · 472 edited across 7 sections

Item 1. Business

Business — how the company describes what it does

147 edited+39 added−46 removed169 unchanged
Biggest changeFood and Drug Administration ("FDA") decision on supplemental Biologics License Application ("sBLA") with two-year data for wAMD and DME (target action date of April 20, 2025) –FDA decision for pre-filled syringe (mid-2025) –Submit sBLA for RVO (first quarter 2025) –Submit sBLA for every 4-week dosing regimen (first quarter 2025) Pozelimab (f) (REGN3918) Antibody to C5 –Geographic atrophy, cemdisiran combination (l) Immunology & Inflammation Dupixent (dupilumab) (b) Antibody to IL-4R alpha subunit –Ulcerative colitis –Asthma in pediatrics (2–5 years of age) –Bullous pemphigoid (c) –CSU –Chronic pruritus of unknown origin ("CPUO") –Lichen simplex chronicus –COPD with type 2 inflammatory phenotype (Japan) –CSU in adults and adolescents (U.S. and EU) –Bullous pemphigoid (U.S.) –Approved by FDA for CRSwNP in adolescents –Approved by FDA and EC for EoE in pediatrics (1–11 years of age) –EMA's Committee for Medicinal Products for Human Use ("CHMP") adopted positive opinion for EoE in pediatrics (1–11 years of age) –Results from Phase 3 trial in pediatrics (1–11 years of age) with EoE published in New England Journal of Medicine (" NEJM ") –MHLW decision on regulatory submission for COPD (first half 2025) –FDA decision on sBLA (target action date of April 18, 2025) and EC decision on regulatory submission (first half 2025) for CSU in adults and adolescents –FDA decision on sBLA for bullous pemphigoid (second half 2025) –Submit regulatory application in the EU for bullous pemphigoid (first half 2025) 7 Table of Contents Clinical Program (continued) Phase 2 Phase 3 Regulatory Review (h) 2024 and 2025 Events to Date Select Upcoming Milestones Dupixent (dupilumab) (b) (continued) –Approved by MHLW for CSU in adults and adolescents –Reported that second Phase 3 trial in CSU in biologic-naïve patients met its primary and key secondary endpoints –Approved by FDA, EC, and National Medical Products Administration ("NMPA") in China for uncontrolled COPD and an eosinophilic phenotype –Reported that Phase 3 NOTUS trial in COPD with evidence of type 2 inflammation met its primary and key secondary endpoints; results presented at 2024 American Thoracic Society International Conference and published in NEJM –Reported that Phase 3 trial in bullous pemphigoid met its primary and all key secondary endpoints –Reported that first Phase 3 trial in CPUO did not achieve statistical significance in its primary itch responder endpoint Kevzara (sarilumab) (b) Antibody to IL-6R –Systemic juvenile idiopathic arthritis ("sJIA") (pivotal study) –Approved by FDA and EC for pJIA –Approved by EC for PMR 8 Table of Contents Clinical Program (continued) Phase 2 Phase 3 Regulatory Review (h) 2024 and 2025 Events to Date Select Upcoming Milestones Itepekimab (b) (REGN3500) Antibody to IL-33 –Non-cystic fibrosis bronchiectasis ("NCFB") –Chronic rhinosinusitis without nasal polyposis ("CRSsNP") –COPD (e) –Report results from Phase 3 study in COPD (second half 2025) –Initiate additional Phase 3 studies (first half 2025) REGN5713-5715 Multi-antibody therapy to Bet v 1 –Birch allergy REGN1908-1909 (f) Multi-antibody therapy to Fel d 1 –Cat allergy Solid Organ Oncology Libtayo (cemiplimab) (g) Antibody to PD-1 –Neoadjuvant CSCC –First-line NSCLC, BNT116 (i) combination –Neoadjuvant NSCLC –Neoadjuvant hepatocellular carcinoma ("HCC") –Adjuvant CSCC –Early-stage CSCC (intralesional) –First-line NSCLC, monotherapy and chemotherapy combination (Japan) –Presented positive five-year survival data from Phase 3 NSCLC monotherapy trial at IASLC 2024 World Conference on Lung Cancer –Reported positive interim data from Phase 3 study in adjuvant CSCC –MHLW decision on regulatory submission for NSCLC, monotherapy and chemotherapy combination (second half 2025) –Submit sBLA for adjuvant CSCC (first half 2025) Fianlimab (f) (REGN3767) Antibody to LAG-3 –First-line advanced NSCLC (Phase 2/3) –Perioperative NSCLC –Perioperative melanoma –First-line metastatic melanoma (e) –Adjuvant melanoma –Presented positive two-year data from Phase 1 trial (in combination with Libtayo) in advanced melanoma at European Society for Medical Oncology ("ESMO") Annual Meeting –Initiate Phase 2 study (in combination with Libtayo) in first-line metastatic head and neck squamous cell carcinoma (2025) –Report results from Phase 3 study versus pembrolizumab in first-line metastatic melanoma (second half 2025) –Report initial data from Phase 2/3 study in first-line advanced NSCLC (first half 2025) Vidutolimod Immune activator targeting TLR9 –Company discontinued Phase 2 study due to drug supply Ubamatamab (f) (REGN4018) Bispecific antibody targeting MUC16 and CD3 –Platinum-resistant ovarian cancer –Report additional data from study in platinum-resistant ovarian cancer (2025) 9 Table of Contents Clinical Program (continued) Phase 2 Phase 3 Regulatory Review (h) 2024 and 2025 Events to Date Select Upcoming Milestones Nezastomig (REGN5678) Bispecific antibody targeting PSMA and CD28 –Prostate cancer –Report additional data from study in prostate cancer (2025) REGN7075 Bispecific antibody targeting EGFR and CD28 –Solid tumors –Presented positive results from dose escalation portion of Phase 1/2 trial (in combination with Libtayo) in advanced solid tumors at American Society of Clinical Oncology ("ASCO") 2024 Annual Meeting –Report additional data from study in solid tumors (2025) Davutamig (REGN5093) Bispecific antibody targeting two distinct MET epitopes –MET-altered advanced NSCLC Hematology Pozelimab (f) (REGN3918) Antibody to C5 –Myasthenia gravis, cemdisiran combination (c)(l) –Paroxysmal nocturnal hemoglobinuria ("PNH"), cemdisiran combination (c)(l) –Presented positive updated data from Phase 3 trial (in combination with cemdisiran) in PNH at American Society of Hematology ("ASH") Annual Meeting –Report results from Phase 3 cemdisiran combination study in myasthenia gravis (second half 2025) Ordspono (odronextamab) Bispecific antibody targeting CD20 and CD3 –B-cell non-Hodgkin lymphoma ("B-NHL") (pivotal study) –FL (e) –DLBCL (e) –FL (U.S.) –FDA issued Complete Response Letters ("CRLs") for BLA for relapsed/refractory FL and DLBCL due to enrollment status of confirmatory Phase 3 trials; subsequently resubmitted BLA for FL –Approved by EC for relapsed/refractory FL and DLBCL –Presented new and updated data for several B-NHL subtypes across earlier lines of treatment at ASH Annual Meeting –FDA decision on BLA for relapsed/refractory FL (second half 2025) 10 Table of Contents Clinical Program (continued) Phase 2 Phase 3 Regulatory Review (h) 2024 and 2025 Events to Date Select Upcoming Milestones Linvoseltamab (f) (REGN5458) Bispecific antibody targeting BCMA and CD3 –Multiple myeloma (pivotal study) (c)(e) –Earlier (pre-malignant) multiple myeloma –Monoclonal gammopathy of undetermined significance ("MGUS") –Light chain amyloidosis ("ALA") –Multiple myeloma (c)(e) –Relapsed/refractory multiple myeloma (U.S. and EU) –Resubmitted BLA for relapsed/refractory multiple myeloma following resolution of third-party manufacturing issues –Presented 14-month median follow-up data from pivotal Phase 1/2 trial in multiple myeloma at European Hematology Association ("EHA") Congress 2024 and published these data in Journal of Clinical Oncology –FDA decision on BLA (mid-2025) and EC decision on regulatory application (first half 2025) for relapsed/refractory multiple myeloma Nexiguran ziclumeran (Nex-z, NTLA-2001) (j) TTR gene knockout using CRISPR/Cas9 –Transthyretin amyloidosis with cardiomyopathy ("ATTR-CM") (c) –Hereditary transthyretin amyloidosis with polyneuropathy ("ATTRv-PN") (c)(m) REGN9933 Antibody to Factor XI –Thrombosis –Reported positive results from Phase 2 trial in thrombosis –Initiate Phase 3 program (2025) REGN7508 Antibody to Factor XI –Thrombosis –Reported positive results from Phase 2 trial in thrombosis –Initiate Phase 3 program (2025) REGN7257 Antibody to IL2Rg –Aplastic anemia REGN7999 Antibody to TMPRSS6 –Iron overload in beta-thalassemia Internal Medicine/Genetic Medicines Garetosmab (f) (REGN2477) Antibody to Activin A –Fibrodysplasia ossificans progressiva ("FOP") (c)(d)(e) –Report results from Phase 3 study in FOP (second half 2025) Trevogrumab (f) (REGN1033) Antibody to myostatin (GDF8) –Obesity (n) –Completed enrollment in Phase 2 study in obesity –Report results from Phase 2 study in obesity (second half 2025) 11 Table of Contents Clinical Program (continued) Phase 2 Phase 3 Regulatory Review (h) 2024 and 2025 Events to Date Select Upcoming Milestones Mibavademab (f)(o) (REGN4461) Agonist antibody to leptin receptor ("LEPR") –Generalized lipodystrophy (d)(e) REGN5381 Agonist antibody to NPR1 –Heart failure REGN7544 Antagonist antibody to NPR1 –Postural orthostatic tachycardia syndrome ("POTS") Rapirosiran (ALN-HSD) (k) RNAi therapeutic targeting HSD17B13 –Metabolic dysfunction-associated steatohepatitis ("MASH") DB-OTO AAV-based gene therapy –Hearing deficit due to variants of the otoferlin gene (c)(m) (Phase 1/2) –Presented updated data from Phase 1/2 trial at American Society of Gene and Cell Therapy ("ASGCT") annual conference –Report additional data from Phase 1/2 study (mid-2025) Note: For purposes of the table above, a program is classified in Phase 2 or 3 clinical development after recruitment for the corresponding study or studies has commenced.
Biggest changeFood and Drug Administration ("FDA") decision for pre-filled syringe (second quarter 2026) 7 Table of Contents Clinical Program (continued) Phase 2 Phase 3 Regulatory Review (h) 2025 and 2026 Events to Date Select Upcoming Milestones Pozelimab (f) (antibody to C5) + cemdisiran (l) (siRNA therapeutic targeting C5) –Geographic atrophy (q) –Report initial results from lead-in cohort of Phase 3 study in geographic atrophy (combination and cemdisiran monotherapy) (second half 2026) Immunology & Inflammation Dupixent (dupilumab) (b) Antibody to IL-4R alpha subunit –Asthma in pediatrics (2–5 years of age) –Chronic pruritus of unknown origin ("CPUO") –Lichen simplex chronicus –CSU in pediatrics (2–11 years of age) (U.S., EU, and Japan) –Bullous pemphigoid (EU and Japan) –Allergic fungal rhinosinusitis ("AFRS") (U.S.) –Approved by Japan's Ministry of Health, Labour and Welfare ("MHLW") for asthma in pediatrics (6–11 years of age) –Approved by MHLW for COPD –Approved by FDA and EC for CSU in adults and adolescents –Presented positive data from Phase 2/3 bullous pemphigoid trial at 2025 American Academy of Dermatology ("AAD") Annual Meeting –Approved by FDA for bullous pemphigoid –Reported that Phase 3 trial in AFRS met its primary and key secondary endpoints –EC decision on regulatory submission for bullous pemphigoid (first half 2026) –FDA decision on sBLA for AFRS (February 2026) Kevzara (sarilumab) (b) Antibody to IL-6R –Systemic juvenile idiopathic arthritis ("sJIA") (pivotal study) –Approved by EC for pJIA Itepekimab (b) (REGN3500) Antibody to IL-33 –Chronic rhinosinusitis without nasal polyposis ("CRSsNP") –COPD (e) –CRSwNP –Reported that Phase 3 trial (AERIFY-1) in COPD met its primary endpoint; second Phase 3 trial (AERIFY-2) did not meet same primary endpoint 8 Table of Contents Clinical Program (continued) Phase 2 Phase 3 Regulatory Review (h) 2025 and 2026 Events to Date Select Upcoming Milestones Itepekimab (b) (REGN3500) (continued) –Discontinued Phase 2 study in non-cystic fibrosis bronchiectasis ("NCFB") REGN5713-5715 Multi-antibody therapy to Bet v 1 –Birch allergy –Reported that Phase 3 trial in birch allergy met its primary and key secondary endpoints –Initiated second Phase 3 trial in birch allergy REGN1908-1909 (f) Multi-antibody therapy to Fel d 1 –Cat allergy –Reported that Phase 3 trial in cat allergy met its primary and key secondary endpoints –Initiate second Phase 3 study in cat allergy (first half 2026) Solid Organ Oncology Libtayo (cemiplimab) (g) Antibody to PD-1 –Neoadjuvant CSCC –First-line NSCLC, BNT116 (i) combination –Neoadjuvant NSCLC –Neoadjuvant hepatocellular carcinoma ("HCC") –Early-stage CSCC (intralesional) –Adjuvant CSCC (Japan) –Approved by FDA and EC for adjuvant CSCC –Reported positive data from Phase 3 trial in adjuvant CSCC; results presented at 2025 American Society of Clinical Oncology ("ASCO") Annual Meeting and published in New England Journal of Medicine ("NEJM") –Approved by MHLW for NSCLC, monotherapy and chemotherapy combination –Reported positive five-year follow-up data from Phase 3 trial in combination with chemotherapy for NSCLC; results presented at IASLC 2025 World Conference on Lung Cancer ("WCLC") Fianlimab (f) (REGN3767) Antibody to LAG-3 –First-line advanced NSCLC (Phase 2/3) –Perioperative NSCLC –First-line metastatic melanoma (e) –Adjuvant melanoma –Report results from Phase 3 study versus pembrolizumab in first-line metastatic melanoma (first half 2026) 9 Table of Contents Clinical Program (continued) Phase 2 Phase 3 Regulatory Review (h) 2025 and 2026 Events to Date Select Upcoming Milestones Fianlimab (f) (REGN3767) (continued) –Perioperative melanoma –Based on pre-planned interim analysis of two Phase 2/3 studies in first-line advanced NSCLC, Phase 2 portion of the studies will continue unchanged –Report Phase 2 data in first-line advanced NSCLC (first half 2026) Vidutolimod Immune activator targeting TLR9 Ubamatamab (f) (REGN4018) Bispecific antibody targeting MUC16 and CD3 –Ovarian cancer –Presented additional data from Phase 2 study in platinum-resistant ovarian cancer at European Society for Medical Oncology ("ESMO") 2025 Meeting REGN5668 (p) Bispecific antibody targeting MUC16 and CD28 –Ovarian cancer Nezastomig (REGN5678) Bispecific antibody targeting PSMA and CD28 –Prostate cancer –Reported additional data from study in prostate cancer at American Association for Cancer Research ("AACR") Annual Meeting Marlotamig (REGN7075) Bispecific antibody targeting EGFR and CD28 –Solid tumors Davutamig (REGN5093) Bispecific antibody targeting two distinct MET epitopes –MET-altered advanced NSCLC Hematology Pozelimab (f) (antibody to C5) + cemdisiran (l) (siRNA therapeutic targeting C5) –Paroxysmal nocturnal hemoglobinuria ("PNH") (c) –Report results from Phase 3 study in PNH (fourth quarter 2026/first quarter 2027) Ordspono (odronextamab) Bispecific antibody targeting CD20 and CD3 –B-cell non-Hodgkin lymphoma ("B-NHL") (pivotal study) –Lymphoma (c)(e) (multiple lines and settings) –FDA issued CRL for BLA for relapsed/refractory FL Lynozyfic (linvoseltamab) (f) Bispecific antibody targeting BCMA and CD3 –Multiple myeloma precursor and related conditions –Multiple myeloma (c)(e) (multiple lines and settings) –Approved by FDA and EC for relapsed/refractory multiple myeloma –Initiate additional Phase 3 studies in multiple myeloma and precursor conditions (2026) 10 Table of Contents Clinical Program (continued) Phase 2 Phase 3 Regulatory Review (h) 2025 and 2026 Events to Date Select Upcoming Milestones Lynozyfic (linvoseltamab) (f) (continued) –Completed enrollment in Phase 3 confirmatory trial (LINKER-MM3) in relapsed/refractory multiple myeloma Nexiguran ziclumeran (Nex-z, NTLA-2001) (j) TTR gene knockout using CRISPR/Cas9 –Transthyretin amyloidosis with cardiomyopathy ("ATTR-CM") (c)(m) –Hereditary transthyretin amyloidosis with polyneuropathy ("ATTRv-PN") (c)(m) –Phase 3 ATTR-CM trial enrollment on FDA clinical hold REGN7508 Antibody to Factor XI (catalytic domain) –Thrombosis –Venous thromboembolism after total knee replacement surgery –Initiate additional Phase 3 studies in anticoagulation (first half 2026) REGN9933 Antibody to Factor XI (A2 domain) –Thrombosis –Initiate Phase 3 studies in anticoagulation (first half 2026) REGN7257 Antibody to IL2Rg –Discontinued study in aplastic anemia REGN7999 Antibody to TMPRSS6 –Iron overload in beta-thalassemia Internal Medicine/Neurology/Rare Diseases Garetosmab (f) (REGN2477) Antibody to Activin A –Fibrodysplasia ossificans progressiva ("FOP") (c)(d)(e) –FOP (U.S. and EU) –Reported that Phase 3 trial in FOP met its primary endpoint –FDA decision on BLA and EC decision on Marketing Authorization Application ("MAA") for FOP (second half 2026) Cemdisiran (l) siRNA therapeutic targeting C5 –Myasthenia gravis (c) –Reported that Phase 3 trial in myasthenia gravis met its primary and key secondary endpoints –Submit New Drug Application ("NDA") for myasthenia gravis (first quarter 2026) Mibavademab (f)(o) (REGN4461) Agonist antibody to leptin receptor ("LEPR") –Functional hypothalamic amenorrhea –Generalized lipodystrophy (c)(d)(e) Trevogrumab (f) (REGN1033) Antibody to myostatin (GDF8) –Obesity (n) –Reported 26-week results from Phase 2 study in obesity –Report additional data from Phase 2 study in obesity (2026) 11 Table of Contents Clinical Program (continued) Phase 2 Phase 3 Regulatory Review (h) 2025 and 2026 Events to Date Select Upcoming Milestones REGN7544 Antagonist antibody to NPR1 –Postural orthostatic tachycardia syndrome ("POTS") –Sepsis-induced hypotension Rapirosiran (ALN-HSD) (k) RNAi therapeutic targeting HSD17B13 –Metabolic dysfunction-associated steatohepatitis ("MASH") ALN-ANG3 (k)(r) RNAi therapeutic targeting ANGPTL3 –Diabetic kidney disease DB-OTO AAV-based gene therapy –Hearing deficit due to variants of otoferlin gene (c)(e)(m) (Phase 1/2) (pivotal study) –Hearing deficit due to variants of otoferlin gene (U.S.) –Presented updated data from Phase 1/2 trial and published in NEJM –FDA granted Commissioner's National Priority Voucher –FDA decision on BLA for hearing deficit due to variants of otoferlin gene (first half 2026) 12 Table of Contents Note 1: For purposes of the table above, a program is classified in Phase 2 or 3 clinical development after recruitment for the corresponding study or studies has commenced Note 2: We have discontinued further clinical development of REGN5381, an agonist antibody to NPR1, which was previously being studied in heart failure and uncontrolled hypertension (a) In collaboration with Bayer outside the United States (b) In collaboration with Sanofi (c) FDA granted Orphan Drug designation for one or more indications (d) FDA granted Breakthrough Therapy designation for one or more indications (e) FDA granted Fast Track designation for one or more indications (f) Sanofi is entitled to receive royalties on sales of the product (g) Studied as monotherapy and in combination with other antibodies and treatments (h) Information in this column captures submissions to U.S., EU, and/or Japan regulatory authorities (i) BioNTech's BNT116 is an mRNA cancer vaccine (j) In collaboration with Intellia (k) Alnylam is entitled to receive royalties on sales of the product (l) Under the terms of our license agreement for cemdisiran, Alnylam is entitled to receive royalties on sales, as well as milestone payments (m) FDA granted Regenerative Medicine Advanced Therapy ("RMAT") designation for one or more indications (n) Studied in combination with semaglutide with and without garetosmab (o) A Phase 2 study, sponsored by Eli Lilly, is also ongoing and testing the combination of tirzepatide and mibavademab compared with tirzepatide alone in patients with obesity (p) Studied in combination with ubamatamab or fianlimab (q) Geographic atrophy also studied with cemdisiran monotherapy (r) Studied as monotherapy and in combination with Evkeeza (evinacumab) 13 Table of Contents Additional Information - Clinical Development Programs EYLEA HD In August 2025, the FDA extended the target action dates for the Company's FDA applications for EYLEA HD (pre-filled syringe, every-four-week dosing, and for the treatment of RVO).
These companies are using various technologies in competition with our VelocImmune technology and our other antibody generation technologies, including their own antibody generation technologies and other approaches such as RNAi, chimeric antigen receptor T cell (CAR-T cell), and gene therapy technologies.
These companies are using various technologies in competition with our VelocImmune technology and our other antibody generation technologies, including their own antibody generation technologies and other approaches such as RNAi, chimeric antigen receptor T ("CAR-T") cell, and gene therapy technologies.
"Risk Factors - Risks Related to Intellectual Property and Market Exclusivity - We may be restricted in our development, manufacturing, and/or commercialization activities by patents or other proprietary rights of others, and could be subject to awards of damages if we are found to have infringed such patents or rights "; and Note 16 to our Consolidated Financial Statements).
"Risk Factors - Risks Related to Intellectual Property and Market Exclusivity - We may be restricted in our development, manufacturing, and/or commercialization activities by patents or other proprietary rights of others, and could be subject to awards of damages if we are found to have infringed such patents or rights "; and Note 16 to our Consolidated Financial Statements).
Business Segments We manage our business as one segment which includes all activities related to the discovery, development, and commercialization of medicines for serious diseases. For financial information related to our one segment, see our Consolidated Financial Statements and related notes. Human Capital Resources We compete in the highly competitive biotechnology and pharmaceuticals industries.
Business Segments We manage our business as one segment which includes all activities related to the discovery, development, and commercialization of medicines for serious diseases. For additional information related to our one segment, see our Consolidated Financial Statements and related notes. Human Capital Resources We compete in the highly competitive biotechnology and pharmaceuticals industries.
This could subject a company to a range of penalties that could have a significant commercial impact, including civil and criminal fines and agreements that materially restrict the manner in which a company promotes or distributes a drug. See Part I, Item 1A.
This could subject a company to a range of penalties that could have a significant commercial impact, including civil and criminal fines and agreements that materially restrict the manner in which a company promotes or distributes a drug or biologic. See Part I, Item 1A.
Through a novel formulation, it is designed to deliver a concentrated dose of aflibercept to block VEGF-A and PLGF and inhibit the growth of new blood vessels and decrease vascular permeability to treat various retinal diseases, including wAMD, DME, and DR.
Through a novel formulation, it is designed to deliver a concentrated dose of aflibercept to block VEGF-A and PLGF and inhibit the growth of new blood vessels and decrease vascular permeability to treat various retinal diseases, including wAMD, DME, DR, and RVO.
Phase 3 clinical trials are larger trials conducted with patients with the target disease or disorder intended to gather additional information about dosage, safety, and effectiveness necessary to evaluate the drug's overall risk-benefit profile.
Phase 3 clinical trials are larger trials conducted with patients with the target disease or disorder intended to gather additional information about dosage, safety, and effectiveness necessary to evaluate the drug's or biologic's overall risk-benefit profile.
"Risk Factors - Risks Related to Maintaining Approval of Our Marketed Products and the Development and Obtaining Approval of Our Product Candidates and New Indications for Our Marketed Products - Obtaining and maintaining regulatory approval for drug products is costly, time-consuming, and highly uncertain.
"Risk Factors - Risks Related to Maintaining Approval of Our Marketed Products and the Development and Obtaining Approval of Our Product Candidates and New Indications for Our Marketed Products - Obtaining and maintaining regulatory approval for drug and biologic products is costly, time-consuming, and highly uncertain.
In addition, we and our third-party suppliers are required to maintain compliance with cGMP, and are subject to inspections by the FDA or comparable regulatory authorities in other jurisdictions to confirm such compliance.
In addition, we and our third-party suppliers are required to maintain compliance with cGMP, and are subject to inspections by the FDA or comparable regulatory authorities in other jurisdictions to seek to confirm such compliance.
Through genetic humanizations, VelociHum mice have been optimized to allow for better development of human immune cells in vivo , as well as to allow for engraftment of primary patient-derived tumors that do not take in other commercially available mice. 15 Table of Contents Regeneron Genetics Center ® Regeneron Genetics Center LLC (RGC ® ), a wholly owned subsidiary of Regeneron Pharmaceuticals, Inc., leverages de-identified clinical, genomic, and other types of molecular data from properly consented human volunteers from around the world to identify medically relevant associations in a blinded fashion designed to preserve a patient's privacy while uncovering the unique characteristics of their health and wellness.
Through genetic humanizations, VelociHum mice have been optimized to allow for better development of human immune cells in vivo , as well as to allow for engraftment of primary patient-derived tumors that do not take in other commercially available mice. 17 Table of Contents Regeneron Genetics Center ® Regeneron Genetics Center LLC (RGC ® ), a wholly owned subsidiary of Regeneron Pharmaceuticals, Inc., leverages de-identified clinical, genomic, proteomic, and other types of molecular data from properly consented human volunteers from around the world to identify medically relevant associations in a blinded fashion designed to preserve a patient's privacy while uncovering the unique characteristics of their health and wellness.
In January 2025, it was announced that RGC was selected by UK Biobank consortium members to complete proteomic assay data generation for the recently announced UK Biobank Pharma Proteomics Project.
In January 2025, it was announced that RGC was selected by UK Biobank consortium members to complete proteomic assay data generation for the UK Biobank Pharma Proteomics Project.
RGC is undertaking multiple collaborative approaches to study design and implementation, including large population-based efforts that engage study participants to more discrete disease specific and founder populations with data on strategic phenotypes of interest. RGC utilizes laboratory automation and innovative approaches to cloud computing to achieve high-quality throughput, attaining nearly 3 million samples sequenced to date.
RGC is undertaking multiple collaborative approaches to study design and implementation, including large population-based efforts that engage study participants to more discrete disease specific and founder populations with data on strategic phenotypes of interest. RGC utilizes laboratory automation and innovative approaches to cloud computing to achieve high-quality throughput, attaining over 3 million samples sequenced to date.
Through our Regeneron Genetics Medicines initiative, we are currently advancing these targets using either our VelociSuite technologies or other technologies, such as siRNA gene silencing, genome editing, and targeted viral-based gene delivery and expression. See the "Collaboration, License, and Other Agreements" section below for descriptions of our collaborations with Alnylam Pharmaceuticals, Inc. and Intellia Therapeutics, Inc.
Through our Regeneron Genetics Medicines initiative, we are currently advancing many of these targets using either our VelociSuite technologies or other technologies, such as siRNA gene silencing, genome editing, and targeted viral-based gene delivery and expression. See the "Collaboration, License, and Other Agreements" section below for descriptions of our agreements with Alnylam Pharmaceuticals, Inc. and Intellia Therapeutics, Inc.
In particular, human therapeutic products are subject to rigorous preclinical and clinical trials and other pre-market approval requirements by the FDA, European Medicines Agency ("EMA"), and regulatory authorities of other countries. The structure and substance of the FDA and other countries' pharmaceutical regulatory practices may evolve over time. The ultimate outcome and impact of such developments cannot be predicted.
In particular, human therapeutic products are subject to rigorous preclinical and clinical trials and other pre-market approval requirements by the FDA, European Medicines Agency ("EMA"), and regulatory authorities of other jurisdictions. The structure and substance of the FDA and other countries' pharmaceutical regulatory practices may evolve over time. The ultimate outcome and impact of such developments cannot be predicted.
Pozelimab Pozelimab is a fully human monoclonal antibody designed to block complement factor C5 in order to treat diseases mediated by abnormal complement pathway activity, and is approved by the FDA for CHAPLE. Pozelimab is being studied in investigational combinations with an investigational small interfering RNA ("siRNA") therapy, cemdisiran, in PNH, myasthenia gravis, and geographic atrophy.
Pozelimab Pozelimab is a fully human monoclonal antibody designed to block complement factor C5 in order to treat diseases mediated by abnormal complement pathway activity, and is approved by the FDA for CHAPLE. Pozelimab is being studied in investigational combinations with an investigational small interfering RNA ("siRNA") therapy, cemdisiran, in PNH and geographic atrophy.
These patents cover, among other things, proteins, DNA and RNA molecules, manufacturing patents, method of use patents, and pharmaceutical compositions and formulations. 21 Table of Contents The following table describes our U.S. patents, European patents ("EP"), and Japanese patents ("JP") that are of particular relevance to key products marketed or otherwise commercialized by us and/or our collaborators.
These patents cover, among other things, proteins, DNA and RNA molecules, manufacturing patents, method of use patents, and pharmaceutical compositions and formulations. The following table describes our U.S. patents, European patents ("EP"), and Japanese patents ("JP") that are of particular relevance to key products marketed or otherwise commercialized by us and/or our collaborators.
Our ability to recruit and retain such employees depends on a number of factors, including our corporate culture and work environment, informed by our values and behaviors (which we call "The Regeneron Way") and our philosophy of "Doing Well by Doing Good"; talent development and career opportunities; and compensation and benefits. Integrity is a core value at Regeneron.
Our ability to recruit and retain such employees depends on a number of factors, including our corporate culture, informed by our values and behaviors (which we call "The Regeneron Way") and our philosophy of "Doing Well by Doing Good"; talent development and career opportunities; and compensation and benefits. Integrity is a core value at Regeneron.
The targeted action date can be 6 months after the 60-day filing date (or 8 months after BLA submission) for product candidates that are granted priority review designation because they are intended to treat serious or life-threatening conditions and demonstrate the potential to address unmet medical needs.
The targeted action date can be 6 months after the 60-day filing date (or 8 months after application submission) for product candidates that are granted priority review designation because they are intended to treat serious or life-threatening conditions and demonstrate the potential to address unmet medical needs.
Approval of a product candidate by comparable regulatory authorities in countries outside the United States is generally required prior to commencement of marketing of the product in those countries. The approval procedure varies among countries and may involve different or additional testing, and the time required to obtain such approval may differ from that required for FDA approval.
Approval of a product candidate by comparable regulatory authorities in jurisdictions outside the United States is generally required prior to commencement of marketing of the product in those jurisdictions. The approval procedure varies among jurisdictions and may involve different or additional testing, and the time required to obtain such approval may differ from that required for FDA approval.
Our strategy is rooted in the understanding that a better workplace drives better science and that better science drives a better world. We believe that by fostering an inclusive culture and bringing diverse voices and perspectives to the discourse, we improve our ability to fulfill our mission to repeatedly bring important medicines to patients with serious diseases.
Our strategy is rooted in the understanding that a better workplace drives better science and that better science drives a better world. We believe that by fostering an inclusive culture and bringing different voices and perspectives to the discourse, we improve our ability to fulfill our mission to repeatedly bring important medicines to patients with serious diseases.
Clinical trials involve the administration of a drug to healthy human volunteers or to patients under the supervision of a qualified investigator.
Clinical trials involve the administration of a drug or biologic to healthy human volunteers or to patients under the supervision of a qualified investigator.
The FDA has other programs to expedite development and review of product candidates that address serious or life-threatening conditions. For some BLAs, the FDA may convene an advisory committee to seek insights and recommendations on issues relevant to approval of the application.
The FDA has other programs to expedite development and review of product candidates that address serious or life-threatening conditions. For some applications, the FDA may convene an advisory committee to seek insights and recommendations on issues relevant to approval of the application.
The FDA has the explicit authority to require postmarketing studies (also referred to as post-approval or Phase 4 studies) and labeling changes based on new safety information, and may impose and enforce a REMS at the time of approval or after the product is on the market.
The FDA has the explicit authority to require postmarketing studies (also referred to as post-approval studies) and labeling changes based on new safety information and may impose and enforce a REMS at the time of approval or after the product is on the market.
Culture and Development Our employees represent a broad range of backgrounds, just like the people who take our medicines, and bring a wide array of perspectives and experiences that have helped us achieve our leadership position in the biotechnology and pharmaceuticals industries and the global marketplace.
Culture and Development Our employees represent a broad range of backgrounds, just like the people who take our medicines, and bring a wide array of perspectives and experiences that have helped us maintain our leadership position in the biotechnology and pharmaceuticals industries and the global marketplace.
Rules that are equivalent in scope but which vary in application apply in other countries. 25 Table of Contents Product Approval All of our product candidates require regulatory approval by relevant government authorities before they can be commercialized.
Rules that are equivalent in scope but which vary in application apply in other countries. 27 Table of Contents Product Approval All of our product candidates require regulatory approval by relevant government authorities before they can be commercialized.
RGC continues to publish results from its research efforts in journals and publications in partnership with its collaborators to advance the field of genomics. These efforts at RGC have led to the identification of more than 30 novel genetic targets.
RGC continues to publish results from its research efforts in journals and publications in partnership with its collaborators to advance the field of genomics. These efforts at RGC have led to the identification of more than 40 novel genetic targets.
After review of a BLA, the FDA may grant marketing approval, request additional information, or issue a CRL outlining the deficiencies in the submission. The CRL may require additional testing or information, including additional preclinical or clinical data, for the FDA to reconsider the application.
After review of an NDA or BLA, the FDA may grant marketing approval, request additional information, or issue a CRL outlining the deficiencies in the submission. The CRL may require additional testing or information, including additional preclinical or clinical data, for the FDA to reconsider the application.
The reimbursement payment in any quarter will equal 5% of the then outstanding repayment obligation, but never more than our share of the collaboration profits in the quarter unless we elect to reimburse Bayer at a faster rate. Within the United States, we retain exclusive commercialization rights and are entitled to all profits from such sales.
The reimbursement payment in any quarter will equal 5% of the then outstanding repayment 18 Table of Contents obligation, but never more than our share of the collaboration profits in the quarter unless we elect to reimburse Bayer at a faster rate. Within the United States, we retain exclusive commercialization rights and are entitled to all profits from such sales.
We are committed to meeting or exceeding all environmental, health, safety ("EHS") and security regulations and have a range of programs, policies, and procedures to ensure the safety of all people who come to work at Regeneron. In addition, our 2025 global responsibility goals include a commitment to focus on workplace injury prevention in our drive toward zero incidents.
We are committed to meeting or exceeding all environmental, health, safety ("EHS") and security regulations and have a range of programs, policies, and procedures to ensure the safety of all people who come to work at Regeneron. In addition, our global responsibility goals included a commitment to focus on workplace injury prevention in our drive toward zero incidents.
Even if such additional information and data are submitted, the FDA may decide that the BLA still does not meet the standards for approval. Data from clinical trials are not always conclusive and the FDA may interpret data differently than the sponsor.
Even if such additional information and data are submitted, the FDA may decide that the application still does not meet the standards for approval. Data from clinical trials are not always conclusive and the FDA may interpret data differently than the sponsor.
Prescription drug manufacturers in the U.S. must comply with applicable provisions of the Drug Supply Chain Security Act and provide and receive product tracing information, maintain appropriate licenses, ensure they only work with other properly licensed entities, and have procedures in place to identify and 28 Table of Contents properly handle suspect and illegitimate products.
Prescription drug manufacturers in the U.S. must comply with applicable provisions of the Drug Supply Chain Security Act and provide and receive product tracing information, maintain appropriate licenses, ensure they only work with other properly licensed entities, and have procedures in place to identify and properly handle suspect and illegitimate products.
Before approving a new drug or biologic product, the FDA 26 Table of Contents also requires that the facilities at which the product will be manufactured or advanced through the supply chain be in compliance with current Good Manufacturing Practices, or cGMP, requirements and regulations governing, among other things, the manufacture, shipment, and storage of the product.
Before approving a new drug or biologic product, the FDA also requires that the facilities at which the product will be manufactured or advanced through the supply chain be in compliance with current Good Manufacturing Practices, or cGMP, requirements and regulations governing, among other things, the manufacture, shipment, and storage of the product.
Manufacturers that fail to pay refunds could be subject to civil monetary penalties. Further, the Inflation Reduction Act ("IRA") has established a Medicare Part B inflation rebate scheme under which, generally speaking, manufacturers owe rebates if the average sales price of a Part B drug increases faster than the pace of inflation.
Manufacturers that fail to pay refunds could be subject to civil monetary penalties. Further, the Inflation Reduction Act ("IRA") has established a Medicare Part B inflation rebate scheme under which, generally speaking, manufacturers owe rebates if the average sales price of 31 Table of Contents a Part B drug increases faster than the pace of inflation.
Each company will have the opportunity to lead potential development and commercialization of product candidates for one target, and the company that is not leading development and commercialization will have the option to enter into a co-development and co-commercialization agreement for the target.
Each company has the opportunity to lead potential development and commercialization of product candidates for a target, and the company that is not leading development and commercialization will have the option to enter into a co-development and co-commercialization agreement for the target.
"Risk Factors - Risks Related to Commercialization of Our Marketed Products, Product Candidates, and New Indications for Our Marketed Products - The commercial success of our products and product candidates is subject to significant competition ." Other Areas Many pharmaceutical and biotechnology companies are attempting to discover new therapeutics for indications in which we invest substantial time and resources.
"Risk Factors - Risks Related to Commercialization of Our Marketed Products, Product Candidates, and New Indications for Our Marketed Products - The commercial success of our products and product candidates is subject to significant competition ." 22 Table of Contents Other Areas Many pharmaceutical and biotechnology companies are attempting to discover new therapeutics for indications in which we invest substantial time and resources.
The FTC also has the power to enforce the Health Breach Notification Rule, which imposes notification obligations on companies for breaches of certain health information contained in personal health records. Enforcement by the FTC under the FTC Act and Health Breach Notification Rule can result in civil penalties or enforcement actions.
The FTC also has the power to enforce the Health Breach Notification Rule, which imposes notification obligations on companies for breaches of certain health information contained in personal health records. Enforcement by the FTC under the FTC Act and Health Breach Notification Rule can result in civil penalties or 33 Table of Contents enforcement actions.
We expect to continue, when appropriate, to file product and process applications with respect to our inventions. However, we may not file any such 24 Table of Contents applications or, if filed, the patents may not be issued. Patents issued to or licensed by us may be infringed by the products or processes of others.
We expect to continue, when appropriate, to file product and process applications with respect to our inventions. However, we may not file any such applications or, if filed, the patents may not be issued. Patents issued to or licensed by us may be infringed by the products or processes of others.
(f) Included in this line item are products which are sold by us and others. Refer to Part II, Item 7. "Management's Discussion and Analysis of Financial Condition and Results of Operations - Results of Operations - Revenues" for a complete listing of net product sales recorded by us.
(e) Included in this line item are products which are sold by us and others. Refer to Part II, Item 7. "Management's Discussion and Analysis of Financial Condition and Results of Operations - Results of Operations - Revenues" for a listing of net product sales recorded by us.
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 these parties that includes the right to develop and sell Libtayo.
Squibb & Sons, L.L.C., and Ono Pharmaceutical Co., Ltd. to obtain a license under 26 Table of Contents certain patents owned and/or exclusively licensed by one or more of these parties that includes the right to develop and sell Libtayo.
Cat allergy is primarily caused by exposure to Fel d 1, the major allergen in cat dander produced by all cats. 13 Table of Contents Libtayo (cemiplimab) Libtayo is a fully human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T-cells. The PD-1/PD-L1 immune checkpoint pathway is a well-known mechanism by which cancers evade immune destruction.
Cat allergy is primarily caused by exposure to Fel d 1, the major allergen in cat dander produced by all cats. Libtayo (cemiplimab) Libtayo is a fully human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T-cells. The PD-1/PD-L1 immune checkpoint pathway is a well-known mechanism by which cancers evade immune destruction.
The FDA requires BLA holders to employ a system for obtaining and reviewing safety information, adverse events, and product complaints associated with each drug and to submit safety reports to the FDA, with expedited reporting timelines in certain situations.
The FDA requires NDA and BLA holders to employ a system for obtaining and reviewing safety information, adverse events, and product complaints associated with each drug or biologic and to submit safety reports to the FDA, with expedited reporting timelines in certain situations.
The GDPR also confers a private right of action on data subjects and 31 Table of Contents consumer associations to file complaints with data protection authorities, seek judicial remedies, and obtain compensation for damages resulting from violations of the GDPR.
The GDPR also confers a private right of action on data subjects and consumer associations to file complaints with data protection authorities, seek judicial remedies, and obtain compensation for damages resulting from violations of the GDPR.
When a BLA is submitted, the FDA makes an initial determination as to whether the application is sufficiently complete to be accepted for review. If the application is not, the FDA may refuse to accept the BLA for filing and request additional information.
When an NDA or BLA is submitted, the FDA makes an initial determination as to whether the application is sufficiently complete to be accepted for review. If the application is not, the FDA may refuse to accept the application for filing and request additional information.
Not included in this line item are net product sales of ARCALYST, which are recorded by Kiniksa. (g) Rest of world ("ROW") Programs in Clinical Development Product candidates in Phase 2 and Phase 3 clinical development, which are being developed by us and/or our collaborators, are summarized in the table below.
Not included in this line item are net product sales of ARCALYST, which are recorded by Kiniksa. (f) Rest of world ("ROW") 5 Table of Contents Programs in Clinical Development Product candidates in Phase 2 and Phase 3 clinical development, which are being developed by us and/or our collaborators, are summarized in the table below.
Failure to timely pay a Part B inflation rebate is subject to a civil monetary penalty. 29 Table of Contents The IRA also created a drug price negotiation program requiring the government to set prices for select high-expenditure drugs covered under Medicare Parts B and D.
Failure to timely pay a Part B inflation rebate is subject to a civil monetary penalty. The IRA also created a drug price negotiation program requiring the government to set prices for select high-expenditure drugs covered under Medicare Parts B and D.
FDA performance goals generally provide for action on a BLA within 10 months of the 60-day filing date (or within 12 months of the BLA submission). That deadline can be extended by FDA under certain circumstances, including by the FDA's requests for additional information.
FDA performance goals generally provide for action on an NDA or BLA within 10 months of the 60-day filing date (or within 12 months of the application submission). That deadline can be extended by FDA under certain circumstances, including by the FDA's requests for additional information.
A refusal to file, which requires resubmission of the BLA with the requested additional information, delays review of the application.
A refusal to file, which requires resubmission of the NDA or BLA with the requested additional information, delays review of the application.
We are obligated to reimburse Sanofi for 30% to 50% of worldwide development expenses that were funded by Sanofi based on our share of collaboration profits; however, we are only required to apply 20% of our share of profits from the collaboration each calendar quarter to reimburse Sanofi for these development expenses.
We are obligated to reimburse Sanofi for 30% to 50% of development expenses that were funded by Sanofi (i.e., "development balance") based on our share of collaboration profits; however, we are only required to apply 20% of our share of profits from the collaboration each calendar quarter to reimburse Sanofi for these development expenses.
The FDA will typically inspect such facilities for compliance with these requirements and regulations prior to approving a BLA. The FDA also can audit the sponsor of the BLA to determine if the clinical studies were conducted in compliance with current GCPs.
The FDA will typically inspect such facilities for compliance with these requirements and regulations prior to approving a marketing application. The FDA also can audit the sponsor of the NDA or BLA to determine if the clinical studies were conducted in compliance with current GCPs.
The EC may grant conditional marketing authorizations in the interest of public health, when there is less comprehensive clinical data available than would be required, if the EC considers that the benefit of immediate availability may outweigh the risk that the absence of the required clinical data poses.
The EC may grant a conditional marketing authorization in the interest of public health, when there is less comprehensive clinical data available than typically would be required, if the EC considers that the benefit of immediate availability may outweigh the risk that the absence of the required clinical data poses.
VelocImmune was generated by leveraging our VelociGene technology (see below), in a process in which six megabases of mouse immunoglobulin gene loci were replaced, or "humanized," with corresponding human immunoglobulin gene loci. VelocImmune mice can be used efficiently to generate fully human antibodies to targets of therapeutic interest.
The VelocImmune mouse platform is utilized to produce fully human antibodies. VelocImmune was generated by leveraging our VelociGene technology (see below), in a process in which six megabases of mouse immunoglobulin gene loci were replaced, or "humanized," with corresponding human immunoglobulin gene loci. VelocImmune mice can be used efficiently to generate fully human antibodies to targets of therapeutic interest.
These statements concern, and these risks and uncertainties include, among others: • the nature, timing, and possible success and therapeutic applications of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, "Regeneron's Products") and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, "Regeneron's Product Candidates") and research and clinical programs now underway or planned, including without limitation those discussed or referenced in this report, Regeneron's and its collaborators' earlier-stage programs, and the use of human genetics in Regeneron's research programs; • the likelihood and timing of achieving any of our anticipated development milestones referenced in this report; • safety issues resulting from the administration of Regeneron's Products and Regeneron's Product Candidates in patients, including serious complications or side effects in connection with the use of Regeneron's Products and Regeneron's Product Candidates in clinical trials; • the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron's Product Candidates and new indications for Regeneron's Products, including without limitation those discussed or referenced in this report; • the extent to which the results from the research and development programs conducted by us and/or our collaborators may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; • ongoing regulatory obligations and oversight impacting Regeneron's Products, research and clinical programs, and business, including those relating to patient privacy; • determinations by regulatory and administrative governmental authorities which may delay or restrict our ability to continue to develop or commercialize Regeneron's Products and Regeneron's Product Candidates; • competing drugs and product candidates that may be superior to, or more cost effective than, Regeneron's Products and Regeneron's Product Candidates (including biosimilar versions of Regeneron's Products); • uncertainty of the utilization, market acceptance, and commercial success of Regeneron's Products and Regeneron's Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary) or recommendations and guidelines from governmental authorities and other third parties on the commercial success of Regeneron's Products and Regeneron's Product Candidates; • our ability to manufacture and manage supply chains for multiple products and product candidates; • the ability of our collaborators, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regeneron's Products and Regeneron's Product Candidates; • the availability and extent of reimbursement of Regeneron's Products from third-party payors, including private payor healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; • coverage and reimbursement determinations by such payors and new policies and procedures adopted by such payors; • changes in laws, regulations, and policies affecting the healthcare industry; • the costs of developing, producing, and selling products or unanticipated expenses; • our ability to meet any of our financial projections or guidance, including without limitation capital expenditures, and changes to the assumptions underlying those projections or guidance; • the potential for any license or collaboration agreement, including our agreements with Sanofi and Bayer (or their respective affiliated companies, as applicable), to be cancelled or terminated; • the impact of public health outbreaks, epidemics, or pandemics on our business; and • risks associated with litigation and other proceedings and government investigations relating to the Company and/or its operations (including without limitation those described in Note 16 to our Consolidated Financial Statements included in this report), risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings described further in Note 16 to our Consolidated Financial Statements included in this report), the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on our business, prospects, operating results, and financial condition.
These statements concern, and these risks and uncertainties include, among others: • competing products and product candidates (including biosimilar products) that may be superior to, or more cost effective than, products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, "Regeneron's Products") and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, "Regeneron's Product Candidates"); • uncertainty of the utilization, market acceptance, and commercial success of Regeneron's Products and Regeneron's Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary) or recommendations and guidelines from governmental authorities and other third parties or other factors beyond Regeneron's control on the commercial success of Regeneron's Products and Regeneron's Product Candidates; • the nature, timing, and possible success and therapeutic applications of Regeneron's Products and Regeneron's Product Candidates and research and clinical programs now underway or planned, including without limitation those discussed or referenced in this report, Regeneron's and its collaborators' earlier-stage programs, and the use of human genetics in Regeneron's research programs; • the likelihood and timing of achieving any of our anticipated development milestones referenced in this report; • safety issues resulting from the administration of Regeneron's Products and Regeneron's Product Candidates in patients, including serious complications or side effects in connection with the use of Regeneron's Products and Regeneron's Product Candidates in clinical trials; • the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron's Product Candidates and new indications for Regeneron's Products, including without limitation those discussed or referenced in this report; • the extent to which the results from the research and development programs conducted by us and/or our collaborators may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; • ongoing regulatory obligations and oversight impacting Regeneron's Products, research and clinical programs, and business, including those relating to patient privacy; • determinations by regulatory and administrative governmental authorities which may delay or restrict our ability to continue to develop or commercialize Regeneron's Products and Regeneron's Product Candidates; • our ability to manufacture and manage supply chains for multiple products and product candidates and risks associated with tariffs and other trade restrictions; • the ability of our collaborators, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regeneron's Products and Regeneron's Product Candidates; • the availability and extent of reimbursement or copay assistance for Regeneron's Products from third-party payors and other third parties, including private payor healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; • coverage and reimbursement determinations by such payors and other third parties and new policies and procedures adopted by such payors and other third parties; • changes to drug pricing regulations and requirements and our drug pricing strategy; • other changes in laws, regulations, and policies affecting the healthcare industry; • the costs of developing, producing, and selling products or unanticipated expenses; • our ability to meet any of our financial projections or guidance and changes to the assumptions underlying those projections or guidance; • the potential for any license or collaboration agreement, including our agreements with Sanofi and Bayer (or their respective affiliated companies, as applicable), to be cancelled or terminated; • the impact of public health outbreaks, epidemics, or pandemics on our business; and • risks associated with litigation and other proceedings and government investigations relating to the Company and/or its operations (including without limitation those described in Note 16 to our Consolidated Financial Statements included in this report), risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings described further in Note 16 to our Consolidated Financial Statements included in this report), the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on our business, prospects, operating results, and financial condition. 2 Table of Contents These statements are made based on management's current beliefs and judgment, and the reader is cautioned not to rely on any such statements.
Selected financial information is summarized as follows: Year Ended December 31, (In millions, except per share data) 2024 2023 2022 Revenues $ 14,202.0 $ 13,117.2 $ 12,172.9 Net income $ 4,412.6 $ 3,953.6 $ 4,338.4 Net income per share - diluted $ 38.34 $ 34.77 $ 38.22 For purposes of this report, references to our products encompass products commercialized by us and/or our collaborators or licensees and references to our product candidates encompass product candidates in development by us and/or our collaborators or licensees (in the case of collaborated or licensed products or product candidates under the terms of the applicable collaboration or license agreements), unless otherwise stated or required by the context.
Selected financial information is summarized as follows: Year Ended December 31, (In millions, except per share data) 2025 2024 2023 Revenues $ 14,342.9 $ 14,202.0 $ 13,117.2 Net income $ 4,504.9 $ 4,412.6 $ 3,953.6 Net income per share - diluted $ 41.48 $ 38.34 $ 34.77 For purposes of this report, references to our products encompass products commercialized by us and/or our collaborators or licensees and references to our product candidates encompass product candidates in development by us and/or our collaborators or licensees (in the case of collaborated or licensed products or product candidates under the terms of the applicable collaboration or license agreements), unless otherwise stated or required by the context.
(d) We record net product sales of Praluent in the United States. Sanofi records net product sales of Praluent outside the United States and pays us a royalty on such sales, which is recorded within Other revenue.
(c) We record global net product sales of Libtayo and pay Sanofi a royalty on such sales (d) We record net product sales of Praluent in the United States. Sanofi records net product sales of Praluent outside the United States and pays us a royalty on such sales, which is recorded within Other revenue.
Changes of suppliers or modifications of methods of manufacturing may require amending our application(s) to the FDA or such comparable foreign regulatory authorities and acceptance of the change by the FDA or such comparable foreign regulatory authorities prior to release of product(s).
Changes of suppliers or modifications in methods of manufacturing may require amending our application(s) to the FDA or such comparable foreign 30 Table of Contents regulatory authorities and acceptance of the change by the FDA or such comparable foreign regulatory authorities prior to release of product(s).
Marketing authorization holders are required to maintain a Pharmacovigilance System Master File ("PSMF"), which supports and documents the compliance of the marketing authorization holder with the requirements of EU pharmacovigilance legislation. Marketing authorization holders are also required to have a Qualified Person for Pharmacovigilance ("QPPV"), who, among other things, maintains the PSMF.
Marketing authorization holders are required to maintain a Pharmacovigilance System Master File ("PSMF"), which seeks to support and document compliance of the marketing authorization holder with the requirements of EU pharmacovigilance legislation. Marketing authorization holders are also required to have a Qualified Person for Pharmacovigilance ("QPPV"), who, among other things, maintains the PSMF.
Although the FDA is not bound by the recommendation of an advisory committee, the agency considers such recommendations carefully when making decisions.
Although the FDA is not bound by the recommendation of an advisory committee, the agency 28 Table of Contents considers such recommendations carefully when making decisions.
EU Japan EYLEA HD ® (aflibercept) Injection 8 mg (a) Wet age-related macular degeneration ("wAMD") a a a Diabetic macular edema ("DME") a a a Diabetic retinopathy ("DR") a EYLEA ® (aflibercept) Injection (a) wAMD a a a DME a a a DR a Macular edema following retinal vein occlusion ("RVO"), which includes macular edema following central retinal vein occlusion ("CRVO") and macular edema following branch retinal vein occlusion ("BRVO") a a a Myopic choroidal neovascularization ("mCNV") a a Neovascular glaucoma ("NVG") a Retinopathy of prematurity ("ROP") a a a Dupixent ® (dupilumab) Injection (b) Atopic dermatitis (in adults, adolescents, and pediatrics aged 6 months and older) a a a Asthma (in adults and adolescents) a a a 3 Table of Contents Product (continued) Disease Territory U.S.
EU Japan EYLEA HD ® (aflibercept) Injection 8 mg (a) Wet age-related macular degeneration ("wAMD") a a a Diabetic macular edema ("DME") a a a Diabetic retinopathy ("DR") a Macular edema following retinal vein occlusion ("RVO") a a EYLEA ® (aflibercept) Injection (a) wAMD a a a DME a a a DR a RVO a a a Myopic choroidal neovascularization ("mCNV") a a Neovascular glaucoma ("NVG") a Retinopathy of prematurity ("ROP") a a a Dupixent ® (dupilumab) Injection (b) Atopic dermatitis (in patients aged 6 months and older) a a a Asthma (in adults and adolescents) a a a Asthma (in pediatrics 6–11 years of age) a a a 3 Table of Contents Product (continued) Disease Territory U.S.
The prescription drug plans negotiate pricing with manufacturers and pharmacies, and may condition formulary placement on the availability of manufacturer discounts.
The prescription drug plans negotiate 32 Table of Contents pricing with manufacturers and pharmacies, and may condition formulary placement on the availability of manufacturer discounts.
Collaboration, License, and Other Agreements Sanofi We are collaborating with Sanofi on the global development and commercialization of Dupixent, Kevzara, and itepekimab (the "Antibody Collaboration"). Under the terms of the Antibody Collaboration, Sanofi is generally responsible for funding 80% to 100% of agreed-upon development costs.
Collaboration, License, and Other Agreements Sanofi We are collaborating with Sanofi on the global development and commercialization of Dupixent, Kevzara, and itepekimab. Under the terms of the collaboration, Sanofi is generally responsible for funding 80% to 100% of agreed-upon development expenses as incurred.
Post-approval modifications to 27 Table of Contents the drug, such as changes in indications, labeling, or manufacturing processes or facilities, may require a sponsor to develop additional data or conduct additional preclinical studies or clinical trials, to be submitted in a new or supplemental BLA, which would require FDA approval.
Post-approval modifications to the drug or biologic, such as changes in indications, labeling, or manufacturing processes or facilities, may require a sponsor to develop additional data or conduct additional preclinical studies or clinical trials, to be submitted in a new or supplemental NDA or BLA, which would require FDA approval.
Failure to timely pay a Part D inflation rebate or otherwise comply with obligations under the Medicare Part D inflation rebate scheme is subject to a civil monetary penalty.
Failure to timely pay a Part D manufacturer discount program amount or inflation rebate or otherwise comply with obligations under the Medicare Part D inflation rebate scheme is subject to a civil monetary penalty.
However, a pediatric study plan is not required for orphan products and the timing of the submission is subject to negotiation with FDA, but such plan cannot be submitted later than submission of a BLA.
However, a pediatric study plan is not required for orphan products and the timing of the submission is subject to negotiation with FDA, but such plan cannot be submitted later than submission of an application for marketing approval.
Federal false claims laws prohibit any person from knowingly presenting, or causing to be presented, a false claim for payment of government funds, or knowingly making, or causing to be made, a false statement to get a false claim paid. See Part I, Item 1A.
Federal false claims laws prohibit any person from knowingly presenting, or causing to be presented, a false claim for payment of government funds, or knowingly making, or causing to be made, a false statement to get a false claim paid.
Agreed-upon development expenses incurred by the Company and Bayer are generally shared equally. Bayer is responsible for commercialization activities outside the United States, and the companies share equally in profits from such sales. We are obligated to reimburse Bayer for 50% of the development costs that it has incurred under the agreement from our share of the collaboration profits.
Bayer is responsible for commercialization activities outside the United States, and the companies share equally in profits from such sales. We are obligated to reimburse Bayer for 50% of the development expenses that it has incurred under the agreement from our share of the collaboration profits.
CSCC United States (a) This table focuses on products that have received marketing approval in one or more of the specified indications in the United States, EU, and/or Japan. Certain products listed in this table have also received marketing approval in countries outside the United States, EU, and Japan.
CSCC United States (a) Except as noted in footnote (b) below, this table focuses on products that have received marketing approval in one or more of the specified indications in the United States, EU, and/or Japan. Certain products listed in this table have also received marketing approval in countries outside the United States, EU, and Japan.
The EC can also require marketing authorization holders to conduct post-authorization safety and/or efficacy studies. A post-authorization safety study ("PASS") is a study that is carried out after a medicinal product has been authorized to obtain further information on a medicinal product's safety, or to measure the effectiveness of risk-management measures. Such studies may be clinical trials or non-interventional studies.
The EC can also require marketing authorization holders to conduct post-authorization safety and/or efficacy studies. A post-authorization safety study ("PASS") is a study that is carried out after a medicinal product has been authorized for marketing to obtain further information on a medicinal product's safety, or to measure the effectiveness of risk-management measures.
Other Programs Our preclinical research programs include the areas of oncology/immuno-oncology, angiogenesis, ophthalmology, metabolic and related diseases, muscle diseases and disorders, inflammation and immune diseases, bone and cartilage, pain and neurobiology, auditory conditions, enzyme replacement therapy, cardiovascular diseases, infectious diseases, and diseases related to aging.
Other Programs Our preclinical research programs include the areas of oncology/immuno-oncology, angiogenesis, ophthalmology, metabolic and related diseases, muscle diseases and disorders, inflammation and immune diseases, bone and cartilage, pain and neurobiology, auditory conditions, enzyme replacement therapy, cardiovascular diseases, infectious diseases, and diseases related to aging. These preclinical research programs include both rare diseases and those involving broader populations.
The results of the preclinical and clinical testing of a biologic product candidate are then submitted to the FDA in the form of a BLA for evaluation to determine whether the product candidate may be approved for commercial sale under the Public Health Service Act.
The results of the preclinical and clinical testing of a drug or biologic product candidate are then submitted to the FDA in the form of an NDA for a drug or a BLA for a biologic for evaluation to determine whether the product candidate may be approved for commercial sale under the Federal Food, Drug, and Cosmetic Act or Public Health Service Act.
In 2024, we were named to the Civic 50 of most community-minded companies in the United States for the eighth consecutive year.
In 2025, we were named to the Civic 50 of most community-minded companies in the United States for the ninth consecutive year.
The success of our employee engagement efforts is demonstrated by our employee retention rate of 94% in 2024, as well as the fact that 88% of our employees who responded to our annual engagement survey said Regeneron is a great place to work.
The success of our employee engagement efforts is demonstrated by our employee retention rate of nearly 93% in 2025, as well as the fact that 81% of our employees who responded to our annual engagement survey said Regeneron is a great place to work.
A post-authorization efficacy study ("PAES") is a study that is carried out for complementing available efficacy data in the light of well-reasoned scientific uncertainties on aspects of the evidence of benefits that is to be or only can be addressed post-authorization.
Such studies may be clinical trials or non-interventional studies. A post-authorization efficacy study ("PAES") is a study that is carried out for complementing available efficacy data in the light of well-reasoned scientific uncertainties on aspects of the evidence of benefits that are to be or only can be addressed post-authorization.
Moderate-to-severe atopic dermatitis United States, EU, Japan Cibinqo ® (abrocitinib) Pfizer Moderate-to-severe atopic dermatitis United States, EU, Japan Tezspire ™ (tezepelumab-ekko) AstraZeneca/Amgen Asthma United States, EU, Japan Fasenra ® (benralizumab) AstraZeneca Asthma United States, EU, Japan Nucala ® (mepolizumab) GlaxoSmithKline ("GSK") Asthma, nasal polyps United States, EU, Japan Xolair ® (omalizumab) Roche/Novartis Asthma, nasal polyps, CSU United States, EU, Japan Libtayo Keytruda ® (pembrolizumab) Merck & Co., Inc.
Moderate-to-severe atopic dermatitis United States, EU, Japan Cibinqo ® (abrocitinib) Pfizer Moderate-to-severe atopic dermatitis United States, EU, Japan Tezspire ™ (tezepelumab-ekko) AstraZeneca/Amgen Asthma, nasal polyps United States, EU, Japan Fasenra ® (benralizumab) AstraZeneca Asthma United States, EU, Japan Nucala ® (mepolizumab) GlaxoSmithKline ("GSK") Asthma, nasal polyps, COPD United States, EU, Japan Exdensur ® (depemokimab) GSK Asthma, CRSwNP United States, Japan Xolair ® (omalizumab) Roche/Novartis Asthma, nasal polyps, CSU United States, EU, Japan Omlyclo ® (biosimilar referencing Xolair) Celltrion Asthma, nasal polyps, CSU United States, EU Rhapsido ® Novartis AG CSU United States Libtayo Keytruda ® (pembrolizumab) Merck & Co., Inc.
The EC may, in particular, impose a PASS and/or PAES on marketing authorization holders when a marketing authorization is granted upon conditions.
The EC may, in particular, impose a PASS and/or PAES on a marketing authorization holder when a marketing authorization is granted subject to conditions.
For example, we are aware of other pharmaceutical and biotechnology companies actively engaged in the research and development of antibody-based products against targets that are also the targets of our early- and late-stage product candidates.
For example, we are aware of other pharmaceutical and biotechnology companies actively engaged in the research and development of antibody-based products (including bispecific antibodies, multispecific antibodies, and/or antibody-drug conjugates) and gene therapy-based products against targets that are also the targets of our early- and late-stage product candidates.
General Subject Matter Class Expiration EYLEA HD aflibercept (8 mg) US 11,066,458 Formulation June 14, 2027 US 11,084,865 Formulation June 14, 2027 US 11,103,552 Formulation May 15, 2039 US 10,828,345 Methods of Treatment January 11, 2032 US 12,168,036 Methods of Treatment May 15, 2039 JP 7,235,770 Formulation May 10, 2039 EYLEA (a) aflibercept (2 mg) US 8,092,803 Formulation June 21, 2027 US 11,066,458 Formulation June 14, 2027 US 11,084,865 Formulation June 14, 2027 US 11,732,024 Formulation June 14, 2027 US 10,828,345 Methods of Treatment January 11, 2032 US 11,559,564 Methods of Treatment January 11, 2032 US 11,707,506 Methods of Treatment January 11, 2032 US 11,730,794 Methods of Treatment January 11, 2032 EP 1183353 Composition of Matter (Supplementary Protection Certificate) (May 23, 2025) (b) /(November 23, 2025) (c) EP 2364691 Formulation June 14, 2027 EP 2944306 Formulation June 14, 2027 (b) EP 2944306 Formulation (Supplementary Protection Certificate) (May 25, 2028) (b) JP 5,216,002 Formulation February 27, 2028 – October 1, 2029 (d) Dupixent dupilumab US 7,608,693 Composition of Matter March 28, 2031 (e) US 8,735,095 Composition of Matter October 2, 2027 US 8,945,559 Formulation October 17, 2032 US 9,238,692 Formulation October 5, 2031 US 10,435,473 Formulation October 5, 2031 US 11,059,896 Formulation October 5, 2031 US 11,926,670 Formulation October 5, 2031 US 8,075,887 Methods of Treatment April 17, 2028 US 8,337,839 Methods of Treatment October 2, 2027 US 9,290,574 Methods of Treatment July 10, 2034 US 9,574,004 Methods of Treatment December 22, 2033 US 10,066,017 Methods of Treatment January 21, 2036 US 11,421,036 Methods of Treatment July 10, 2034 US 10,137,193 Methods of Treatment March 18, 2036 US 10,485,844 Methods of Treatment September 21, 2037 US 10,059,771 Methods of Treatment June 20, 2034 US 11,214,621 Methods of Treatment January 21, 2036 22 Table of Contents Product (continued) Molecule Territory Patent No.
General Subject Matter Class Expiration EYLEA HD (continued) US 10,828,345 Methods of Treatment January 11, 2032 US 12,168,036 Methods of Treatment May 10, 2039 EP 4,185,318 Methods of Treatment May 16, 2042 JP 7,235,770 Formulation March 30, 2040 EYLEA (a) aflibercept (2 mg) US 8,092,803 Formulation June 21, 2027 US 11,066,458 Formulation June 14, 2027 US 11,084,865 Formulation June 14, 2027 US 11,732,024 Formulation June 14, 2027 US 12,331,099 Formulation June 14, 2027 US 10,828,345 Methods of Treatment January 11, 2032 US 11,559,564 Methods of Treatment January 11, 2032 US 11,707,506 Methods of Treatment January 11, 2032 US 11,730,794 Methods of Treatment January 11, 2032 US 11,986,511 Methods of Treatment January 11, 2032 EP 2364691 Formulation June 14, 2027 EP 2944306 Formulation June 14, 2027 (b) EP 2944306 Formulation (Supplementary Protection Certificate) (May 25, 2028) (b) JP 5,216,002 Formulation February 27, 2028 – October 1, 2029 (d) JP 7,733,706 Methods of Treatment January 11, 2032 Dupixent dupilumab US 7,608,693 Composition of Matter March 28, 2031 (e) US 8,735,095 Composition of Matter October 2, 2027 US 8,945,559 Formulation October 17, 2032 US 9,238,692 Formulation October 5, 2031 US 10,435,473 Formulation October 5, 2031 US 11,059,896 Formulation October 5, 2031 US 11,926,670 Formulation October 5, 2031 US 8,075,887 Methods of Treatment April 17, 2028 US 8,337,839 Methods of Treatment October 2, 2027 US 9,290,574 Methods of Treatment July 10, 2034 US 9,574,004 Methods of Treatment December 22, 2033 US 10,066,017 Methods of Treatment January 21, 2036 US 10,730,948 Methods of Treatment July 10, 2034 US 11,421,036 Methods of Treatment July 10, 2034 US 10,137,193 Methods of Treatment March 18, 2036 US 10,485,844 Methods of Treatment September 21, 2037 US 10,059,771 Methods of Treatment June 20, 2034 US 11,214,621 Methods of Treatment January 21, 2036 US 11,167,004 Methods of Treatment September 21, 2037 US 11,034,768 Methods of Treatment March 28, 2039 US 11,292,847 Methods of Treatment May 10, 2039 US 11,845,800 Methods of Treatment December 22, 2033 US 12,090,201 Methods of Treatment February 3, 2043 US 12,291,571 Methods of Treatment December 25, 2034 US 12,398,212 Methods of Treatment July 5, 2042 24 Table of Contents Product (continued) Molecule Territory Patent No.
Of these employees, 2,562 were within our research and preclinical development organization, 2,151 were within our global clinical development and regulatory affairs organization, and 6,846 were within our industrial operations and product supply organization. Company-wide, nearly 1,700 of our full-time employees hold a Ph.D. and/or M.D.
Of these employees, 2,591 were within our research and preclinical development organization, 2,274 were within our global clinical development and regulatory affairs organization, and 6,717 were within our industrial operations and product supply organization. Company-wide, over 1,800 of our full-time employees hold a Ph.D. and/or M.D.
Alnylam In 2019, we and Alnylam entered into a collaboration to discover, develop, and commercialize RNAi therapeutics for a broad range of diseases by addressing therapeutic disease targets expressed in the eye and central nervous system ("CNS"), in addition to a select number of targets expressed in the liver.
Alnylam We and Alnylam Pharmaceuticals, Inc. are parties to a collaboration to discover, develop, and commercialize RNAi the rapeutics for a broad range of diseases by addressing therapeutic disease targets expressed in the eye and central nervous system, in addition to a select number of targets expressed in the liver.
General Subject Matter Class Expiration Libtayo (continued) US 10,457,725 Methods of Treatment May 12, 2037 US 11,292,842 Methods of Treatment July 18, 2038 US 11,505,600 Methods of Treatment July 2, 2038 US 11,926,668 Methods of Treatment February 20, 2038 EP 3097119 Composition of Matter January 23, 2035 EP 3606504 Formulation March 23, 2038 EP 3455258 Methods of Treatment May 12, 2037 EP 3932951 Methods of Treatment May 12, 2037 JP 6,425,730 Composition of Matter January 23, 2035 – March 15, 2039 (d) JP 6,711,883 Composition of Matter January 23, 2035 – August 13, 2037 (d) JP 7,174,009 Composition of Matter January 23, 2035 – March 9, 2035 (d) JP 7,229,171 Formulation March 23, 2038 JP 7,240,512 Methods of Treatment May 25, 2041 (a) See Note 16 to our Consolidated Financial Statements for information regarding inter partes review and post-grant review petitions filed in the U.S.
General Subject Matter Class Expiration Dupixent (continued) JP 7,609,901 Methods of Treatment August 20, 2033 JP 7,630,012 Methods of Treatment February 20, 2035 JP 7,736,667 Methods of Treatment August 5, 2040 Libtayo cemiplimab US 9,987,500 Composition of Matter September 18, 2035 US 10,737,113 Composition of Matter April 10, 2035 US 11,603,407 Formulation March 21, 2038 US 10,457,725 Methods of Treatment May 12, 2037 US 11,292,842 Methods of Treatment July 18, 2038 US 11,505,600 Methods of Treatment July 2, 2038 US 11,926,668 Methods of Treatment February 20, 2038 EP 3097119 Composition of Matter January 23, 2035 EP 3606504 Formulation March 23, 2038 EP 4249512 Formulation March 23, 2038 EP 3455258 Methods of Treatment May 12, 2037 EP 3932951 Methods of Treatment May 12, 2037 JP 6,425,730 Composition of Matter January 23, 2035 – March 15, 2039 (d) JP 6,711,883 Composition of Matter January 23, 2035 – August 13, 2037 (d) JP 7,174,009 Composition of Matter January 23, 2035 – March 9, 2035 (d) JP 7,562,606 Composition of Matter January 23, 2035 JP 7,229,171 Formulation March 23, 2038 JP 7,240,512 Methods of Treatment May 25, 2041 JP 7,324,710 Methods of Treatment February 20, 2038 JP 7,384,949 Methods of Treatment February 20, 2038 JP 7,656,012 Methods of Treatment February 20, 2038 (a) See Note 16 to our Consolidated Financial Statements for information regarding inter partes review and post-grant review petitions filed in the U.S.
Year Ended December 31, 2024 2023 2022 (In millions) U.S. ROW (g) Total U.S. ROW Total U.S.
Year Ended December 31, 2025 2024 2023 (In millions) U.S. ROW (f) Total U.S. ROW Total U.S.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

249 edited+76 added−29 removed282 unchanged
Biggest changeRisks Related to Our Reliance on or Transactions with Third Parties • If our collaborations with Sanofi or Bayer or other third parties are terminated or breached, our ability to develop, manufacture, and commercialize certain of our products and product candidates in the time expected, or at all, may be materially harmed. • Our collaborators and service providers may fail to perform adequately in their efforts to support the development, manufacture, and commercialization of our drug candidates and current and future products. • We have undertaken and may in the future undertake strategic acquisitions, and any difficulties from integrating such acquisitions or failure to realize the expected benefits from such acquisitions could adversely affect our business, operating results, and financial condition.
Biggest changeBribery Act. • Our operations are subject to environmental, health, and safety laws and regulations, including those governing the use of hazardous materials. • Changes in laws, regulations, and policies affecting the healthcare industry could adversely affect our business. • Tax liabilities, tariffs and other trade restrictions, and other risks associated with our operations outside the United States could adversely affect our business. • We face risks related to the personal data we collect, process, and share. 37 Table of Contents Risks Related to Our Reliance on or Transactions with Third Parties • If our collaborations with Sanofi or Bayer or other third parties are terminated or breached, our ability to develop, manufacture, and commercialize certain of our products and product candidates in the time expected, or at all, may be materially harmed. • Our collaborators and service providers may fail to perform adequately in their efforts to support the development, manufacture, and commercialization of our drug candidates and current and future products. • We have undertaken and may in the future undertake strategic acquisitions, and any difficulties from integrating such acquisitions or failure to realize the expected benefits from such acquisitions could adversely affect our business, operating results, and financial condition.
Commercialization of EYLEA and EYLEA HD in the United States and elsewhere is subject to significant competition (as described further below under " The commercial success of our products and product candidates is subject to significant competition "), which we expect to continue to increase in the future.
Commercialization of EYLEA HD and EYLEA in the United States and elsewhere is subject to significant competition (as described further below under " The commercial success of our products and product candidates is subject to significant competition "), which we expect to continue to increase in the future.
"Business - Patents, Trademarks, and Trade Secrets"). Ophthalmologists are also using off-label, third-party repackaged versions of Genentech/Roche's approved VEGF antagonist, bevacizumab, for the treatment of certain of EYLEA's and EYLEA HD's respective indications, and we are aware of another company developing an ophthalmic formulation of such product that has been approved in the EU.
"Business - Patents, Trademarks, and Trade Secrets"). Ophthalmologists are also using off-label, third-party repackaged versions of Genentech/Roche's approved VEGF antagonist, bevacizumab, for the treatment of certain of EYLEA HD's and EYLEA's respective indications, and we are aware of another company developing an ophthalmic formulation of such product that has been approved in the EU.
We are also aware of a number of companies working on the development of product candidates and extended delivery devices for the potential treatment of one or more of EYLEA's and EYLEA HD's respective indications, including those that act by blocking VEGF and VEGF receptors (including therapies designed to extend the treatment interval) and/or other targets.
We are also aware of a number of companies working on the development of product candidates and extended delivery devices for the potential treatment of one or more of EYLEA HD's and EYLEA's respective indications, including those that act by blocking VEGF and VEGF receptors (including therapies designed to extend the treatment interval) and/or other targets.
Dupixent . The market for Dupixent's current and potential future indications is also increasingly competitive. In atopic dermatitis, there are systemic JAK inhibitors and antibodies against IL-13 and IL-4Ra approved or in development for atopic dermatitis. There is also an antibody against IL-31R approved for atopic dermatitis and prurigo nodularis.
Dupixent . The market for Dupixent's current and potential future indications is also increasingly competitive. There are systemic JAK inhibitors and antibodies against IL-13 and IL-4Ra approved or in development for atopic dermatitis. There is also an antibody against IL-31R approved for atopic dermatitis and prurigo nodularis.
If we or our collaborators do not maintain regulatory approval for our marketed products, and obtain regulatory approval for our product candidates or new indications of our marketed products (or are materially delayed in doing so), the value of our Company and our business, prospects, operating results, and financial condition may be materially harmed.
If we or our collaborators do not maintain regulatory approval for our marketed products, or obtain regulatory approval for our product candidates or new indications of our marketed products (or are materially delayed in doing so), the value of our Company and our business, prospects, operating results, and financial condition may be materially harmed.
It is not possible to determine what impact (if any) the Antibody Collaboration Litigation may have on the Antibody Collaboration and our business relationship with Sanofi, or whether we will be successful in the Antibody Collaboration Litigation.
It is not possible to determine what impact (if any) the Antibody Collaboration Litigation may have on the Antibody Collaboration and our business relationship with Sanofi, or whether we will be successful in the Antibody Collaboration Litigation.
We also have outsourced significant elements of our information technology infrastructure and operations to third parties, which may allow them to access our confidential information and may also make our systems vulnerable to service interruptions or to security breaches from inadvertent or intentional actions by such third parties or others.
We have outsourced significant elements of our information technology infrastructure and operations to third parties, which may allow them to access our confidential information and may also make our systems vulnerable to service interruptions or to security breaches from inadvertent or intentional actions by such third parties or others.
We would be unable to obtain these raw materials, other products, or services for an indeterminate period of time if any of these third parties were to cease or interrupt production or otherwise fail to supply these materials, products, or services to us for any reason, including due to regulatory requirements or actions (including recalls), adverse financial developments at or affecting the supplier, failure by the supplier to comply with cGMPs, contaminations, business interruptions, or labor shortages or disputes (in each case, including as a result of the armed conflict between Russia and Ukraine or public health outbreaks, epidemics, or pandemics or other geopolitical developments).
We would be unable to obtain these raw materials, other products, or services for an indeterminate period of time if any of these third parties were to cease or interrupt production or otherwise fail to supply these materials, products, or services to us for any reason, including due to regulatory requirements or actions (including recalls), adverse financial developments at or affecting the supplier, failure by the supplier to comply with cGMPs, contaminations, business interruptions, or labor shortages or disputes (in each case, including as a result of public health outbreaks, epidemics, or pandemics or other geopolitical developments, such as the armed conflict between Russia and Ukraine).
If we or our collaborators fail to maintain regulatory compliance or satisfy other obligations for such products' currently approved indications (including because the product does not meet the relevant endpoints of any required post-approval studies (such as those required under an accelerated approval by the FDA or other similar type of approval), or for any of the reasons discussed below under "Risks Related to Maintaining Approval of Our Marketed Products and the Development and Obtaining Approval of Our Product Candidates and New Indications for Our Marketed Products - Obtaining and maintaining regulatory approval for drug products is costly, time-consuming, and highly uncertain.
If we or our collaborators fail to maintain regulatory compliance or satisfy other obligations for such products' currently approved indications (including because the product does not meet the relevant endpoints of any required post-approval studies (such as those required under an accelerated approval by the FDA or other similar type of approval), or for any of the reasons discussed below under "Risks Related to Maintaining Approval of Our Marketed Products and the Development and Obtaining Approval of Our Product Candidates and New Indications for Our Marketed Products - Obtaining and maintaining regulatory approval for drug and biologic products is costly, time-consuming, and highly uncertain.
Our sales of products we commercialize in the United States and our collaborators' sales of products they commercialize or co-commercialize with us under our collaboration agreements with them in the United States and other countries (which impact our share of any profits or losses from the commercialization of these products under the relevant collaboration agreements and, therefore, our results of operations) may be reduced if the applicable product is imported into those countries from lower priced markets, whether legally or illegally (a practice known as parallel trading or reimportation).
Our sales of products we commercialize in the United States and our collaborators' sales of products they commercialize or co-commercialize with us under our collaboration agreements with them in the United States and other countries (which impact our share of any profits from the commercialization of these products under the relevant collaboration agreements and, therefore, our results of operations) may be reduced if the applicable product is imported into those countries from lower priced markets, whether legally or illegally (a practice known as parallel trading or reimportation).
Foreign regulatory authorities may ask for additional data in order to begin a clinical study, including Phase 3 clinical trials required to submit a MAA in the EU. In addition, such authorities often have the authority to require post-approval studies, such as a PASS and/or PAES, which involve various risks similar to those described above.
Foreign regulatory authorities may ask for additional data in order to begin a clinical study, including Phase 3 clinical trials required to submit an MAA in the EU. In addition, such authorities often have the authority to require post-approval studies, such as a PASS and/or a PAES, which involve various risks similar to those described above.
Our ability to generate and grow sales of these products will depend, in part, on the extent to which our distributor customers are able to provide adequate distribution of these products to healthcare providers. Although we believe we can find additional distributors, if necessary, our revenue during any period of disruption could suffer and we might incur additional costs.
Our ability to generate and grow sales of our products will depend, in part, on the extent to which our distributor customers are able to provide adequate distribution of our products to healthcare providers. Although we believe we can find additional distributors, if necessary, our revenue during any period of disruption could suffer and we might incur additional costs.
Although we believe, based on an assessment of the relevant facts available to us, that none of these incidents has had a material adverse impact on our operations, there can be no assurance that a future incident would not result in material harm to our business, prospects, operating results, and financial condition.
Although we believe, based on an assessment of the relevant facts available to us, that none of these incidents has had a material adverse impact on our operations to date, there can be no assurance that a future incident would not result in material harm to our business, prospects, operating results, and financial condition.
Biosimilar versions of EYLEA have been recently approved in the United States, EU, and other jurisdictions, with additional biosimilar versions of EYLEA and/or EYLEA HD in development, as discussed further under "Risks Related to Commercialization of Our Marketed Products, Product Candidates, and New Indications for Our Marketed Products - The commercial success of our products and product candidates is subject to significant competition - Marketed Products" above.
Biosimilar versions of EYLEA have been recently approved and/or launched in the United States, EU, and other jurisdictions, with additional biosimilar versions of EYLEA and/or EYLEA HD in development, as discussed further under "Risks Related to Commercialization of Our Marketed Products, Product Candidates, and New Indications for Our Marketed Products - The commercial success of our products and product candidates is subject to significant competition - Marketed Products" above.
Sales of our marketed products in the United States are dependent, in large part, on the availability and extent of reimbursement from third-party payors, including private payor healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies ("PBMs"), and government programs such as Medicare and Medicaid.
Sales of our marketed products in the United States are dependent, in large part, on the availability and extent of coverage and reimbursement from third-party payors, including private payor healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies ("PBMs"), and government programs such as Medicare and Medicaid.
The extent to which the policy changes described above will ultimately impact reimbursement levels of our marketed products, including those covered under Medicare Part B (such as EYLEA and EYLEA HD), or our product candidates that may be covered under Medicare Part B or Medicare Part D in the future, is currently unclear.
The full extent to which the policy changes described above will ultimately impact reimbursement levels of our marketed products, including those covered under Medicare Part B (such as EYLEA HD and EYLEA), or our product candidates that may be covered under Medicare Part B or Medicare Part D in the future, is currently unclear.
While the FDA has performance goals that provide for action on BLA submissions by certain deadlines, the FDA's review goals are subject to change and the duration of the FDA's review depends on a number of factors, including the number and types of other applications that are submitted to the FDA around the same time period or are pending.
While the FDA has performance goals that provide for action on NDA and BLA submissions by certain deadlines, the FDA's review goals are subject to change and the duration of the FDA's review depends on a number of factors, including the number and types of other applications that are submitted to the FDA around the same time period or are pending.
We also rely on Sanofi for sales, marketing, and distribution of Dupixent in many countries outside the United States. While we exercised our option under the Antibody Collaboration to co-commercialize Dupixent in certain jurisdictions outside the United States, we will continue to rely in considerable part on Sanofi's sales and marketing organization in such jurisdictions.
We also rely on Sanofi for sales, marketing, and distribution of Dupixent in many countries outside the United States. While we exercised our option under the Antibody Collaboration to co-commercialize Dupixent in certain jurisdictions outside the United States, we continue to rely in considerable part on Sanofi's sales and marketing organization in such jurisdictions.
Other Risks Related to Our Business We are dependent on our key personnel and if we cannot recruit and retain leaders in our research, development, manufacturing, and commercial organizations, our business will be harmed. We are highly dependent on certain of our executive officers and other key members of our senior management team.
Other Risks Related to Our Business We are dependent on our key personnel and if we cannot recruit or retain leaders in our research, development, manufacturing, and commercial organizations, our business will be harmed. We are highly dependent on certain of our executive officers and other key members of our senior management team.
In certain instances (such as when we use a biomarker-based test to identify and enroll specific patients in a clinical trial), regulatory approval of a companion diagnostic to our therapeutic product candidate may be required as a condition to regulatory approval of the therapeutic product candidate.
In certain instances (such as when we use a biomarker-based test to identify and enroll specific patients in a clinical trial), regulatory approval of a companion diagnostic to our therapeutic product candidate may be required as a condition for regulatory approval of the therapeutic product candidate.
We rely heavily on Bayer with respect to the commercialization of EYLEA HD and EYLEA outside the United States. Bayer is responsible for obtaining and maintaining regulatory approval outside the United States, as well as providing all sales, marketing, and commercial support for the product outside the United States.
We rely on Bayer with respect to the commercialization of EYLEA HD and EYLEA outside the United States. Bayer is responsible for obtaining and maintaining regulatory approval outside the United States, as well as providing all sales, marketing, and commercial support for the product outside the United States.
Unexpected refunds to the government, and/or response to a government investigation or enforcement action, would be expensive and time-consuming, and could have a material adverse effect on our business, financial condition, results of operations, and future prospects.
Unexpected refunds to the government, and/or response to a government investigation or enforcement action, could be expensive and time-consuming, and could have a material adverse effect on our business, financial condition, results of operations, and future prospects.
Any delay, interruption, or other issue that arises in the manufacture, fill/finish, packaging, or storage of any drug product or product candidate as a result of a failure of our facilities or the facilities or operations of our collaborators or other third parties to pass any regulatory agency inspection or maintain cGMP compliance could significantly impair our ability to develop, obtain approval for, and successfully commercialize our products, which would substantially harm our business, prospects, operating results, and financial condition.
Any delay, interruption, or other issue that arises in the manufacture, fill/finish, packaging, or storage of any drug product or product candidate as a result of a failure of our facilities or the facilities or operations of our collaborators, contract manufacturers, or other third parties to pass any regulatory agency inspection or maintain cGMP compliance could significantly impair our ability to develop, obtain approval for, and successfully commercialize our products, which would substantially harm our business, prospects, operating results, and financial condition.
Under our arrangement with Bayer, pricing and reimbursement for EYLEA HD and EYLEA outside the United States is the responsibility of Bayer. Similarly, under our Antibody Collaboration with Sanofi, pricing and reimbursement for the products commercialized or co-commercialized thereunder outside the United States are the responsibility of Sanofi.
Under our arrangement with Bayer, pricing and reimbursement for EYLEA HD and EYLEA outside the United States are the responsibility of Bayer. Similarly, under our Antibody Collaboration with Sanofi, pricing and reimbursement for the products commercialized or co-commercialized thereunder outside the United States are the responsibility of Sanofi.
As we increase our production in response to higher product demand or in anticipation of a potential regulatory approval, our current manufacturing capacity will likely not be sufficient, and our dependence on our collaborators and/or contract manufacturers may increase, to produce adequate quantities of drug material for both commercial and clinical purposes. • Expanding our manufacturing capacity and establishing fill/finish capabilities has been and will continue to be costly and we may be unsuccessful in doing so in a timely manner, which could delay or prevent the launch and successful commercialization of our products approved for marketing and could jeopardize our clinical development programs. • Our ability to manufacture products may be impaired if any of our or our collaborators' manufacturing activities, or the activities of other third parties involved in our manufacture and supply chain, are found to infringe patents of others. • If sales of our marketed products do not meet the levels currently expected, or if the launch of any of our product candidates is delayed or unsuccessful, we may face costs related to excess inventory or unused capacity at our manufacturing facilities and at the facilities of third parties or our collaborators. • Third-party service or supply failures, failures at our manufacturing facilities in Rensselaer, New York and Limerick, Ireland, or failures at the facilities of any other party participating in the supply chain would adversely affect our ability to supply our products. 35 Table of Contents • Our or our collaborators' failure to meet the stringent requirements of governmental regulation in the manufacture of drug products or product candidates could result in incurring substantial remedial costs, delays in the development or approval of our product candidates or new indications for our marketed products and/or in their commercial launch if regulatory approval is obtained, and a reduction in sales.
As we increase our production in response to higher product demand or in anticipation of potential regulatory approvals, our current manufacturing capacity will likely not be sufficient, and our dependence on our collaborators and/or contract manufacturers may increase, to produce adequate quantities of drug material for both commercial and clinical purposes. • Expanding our manufacturing capacity and establishing fill/finish capabilities has been and will continue to be costly and we may be unsuccessful in doing so in a timely manner, which could delay or prevent the launch and successful commercialization of our products approved for marketing and could jeopardize our clinical development programs. • Our ability to manufacture products may be impaired if any of our or our collaborators' manufacturing activities, or the activities of other third parties involved in our manufacture and supply chain, are found to infringe patents of others. • If sales of our marketed products do not meet the levels currently expected, or if the launch of any of our product candidates is delayed or unsuccessful, we may face costs related to excess inventory or unused capacity at our manufacturing facilities and at the facilities of third parties or our collaborators. • Third-party service or supply failures, failures at our manufacturing facilities in Rensselaer, New York and Limerick, Ireland, or failures at the facilities of any other party participating in the supply chain would adversely affect our ability to supply our products. • Our or our collaborators' or contract manufacturers' failure to meet the stringent requirements of governmental regulation in the manufacture of drug products or product candidates could result in incurring substantial remedial costs, delays in the development or approval of our product candidates or new indications for our marketed products and/or in their commercial launch if regulatory approval is obtained, and a reduction in sales.
Risks Related to Maintaining Approval of Our Marketed Products and the Development and Obtaining Approval of Our Product Candidates and New Indications for Our Marketed Products Obtaining and maintaining regulatory approval for drug products is costly, time-consuming, and highly uncertain.
Risks Related to Maintaining Approval of Our Marketed Products and the Development and Obtaining Approval of Our Product Candidates and New Indications for Our Marketed Products Obtaining and maintaining regulatory approval for drug and biologic products is costly, time-consuming, and highly uncertain.
Our ability to continue to manufacture products in our Rensselaer, New York and Limerick, Ireland facilities and at additional facilities (if any) in the future (including our ability to conduct any fill/finish activities in the future), the ability of our collaborators to manufacture products at their facilities, and our ability to utilize other third parties to produce our products, to supply raw materials or other products, or to perform fill/finish services or other steps in our manufacture and supply chain, depends on our and their ability to operate without infringing the patents or other intellectual property rights of others.
Our ability to continue to manufacture products in our Rensselaer, New York and Limerick, Ireland facilities and at additional facilities (if any) in the future (including our ability to conduct any fill/finish activities in the future), the ability of our collaborators or contract manufacturers to manufacture products at their facilities, and our ability to utilize other third parties to produce our products, to supply raw materials or other products, or to perform fill/finish services or other steps in our manufacture and supply chain, depends on our and their ability to operate without infringing the patents or other intellectual property rights of others.
Even if obtained, such designations may not result in faster development processes, reviews, or approvals compared to drugs considered for approval under conventional FDA procedures.
Even if obtained, such designations may not result in faster development processes, reviews, or approvals compared to drugs or biologics considered for approval under conventional FDA procedures.
See also "Risks Related to Manufacturing and Supply - Our or our collaborators' failure to meet the stringent requirements of governmental regulation in the manufacture of drug products or product candidates could result in incurring substantial remedial costs, delays in the development or approval of our product candidates or new indications for our marketed products and/or in their commercial launch if regulatory approval is obtained, and a reduction in sales " below.
See also "Risks Related to Manufacturing and Supply - Our or our collaborators' or contract manufacturers' failure to meet the stringent requirements of governmental regulation in the manufacture of drug products or product candidates could result in incurring substantial remedial costs, delays in the development or approval of our product candidates or new indications for our marketed products and/or in their commercial launch if regulatory approval is obtained, and a reduction in sales " below.
For additional information, see "Risks Related to Manufacturing and Supply - Our or our collaborators' failure to meet the stringent requirements of governmental regulation in the manufacture of drug products or product candidates could result in incurring substantial remedial costs, delays in the development or approval of our product candidates or new indications for our marketed products and/or in their commercial launch if regulatory approval is obtained, and a reduction in sales.
For additional information, see "Risks Related to Manufacturing and Supply - Our or our collaborators' or contract manufacturers' failure to meet the stringent requirements of governmental regulation in the manufacture of drug products or product candidates could result in incurring substantial remedial costs, delays in the development or approval of our product candidates or new indications for our marketed products and/or in their commercial launch if regulatory approval is obtained, and a reduction in sales.
For example, during each of the years ended December 31, 2022 and 2021, we recorded a charge to write down inventory related to REGEN-COV.
For example, during each of the years ended December 31, 2022 and 2021, we recorded a substantial charge to write down inventory related to REGEN-COV ® .
We and our collaborators would be unable to manufacture these materials if the relevant facility were to cease production due to regulatory requirements or actions, business interruptions, labor shortages or disputes, supply chain interruptions or constraints (including with respect to natural gas and other raw materials), contaminations, fire, climate change, natural disasters, acts of war or terrorism, or other problems.
We and our collaborators and contract manufacturers would be unable to manufacture these materials if the relevant facility were to cease production due to regulatory requirements or actions, business interruptions, labor shortages or disputes, supply chain interruptions or constraints (including with respect to natural gas and other raw materials), contaminations, fire, climate change, natural disasters, acts of war or terrorism, or other problems.
See also "Risks Related to Manufacturing and Supply - Our or our collaborators' failure to meet the stringent requirements of governmental regulation in the manufacture of drug products or product candidates could result in incurring substantial remedial costs, delays in the development or approval of our product candidates or new indications for our marketed products and/or in their commercial launch if regulatory approval is obtained, and a reduction in sales.
See also "Risks Related to Manufacturing and Supply - Our or our collaborators' or contract manufacturers' failure to meet the stringent requirements of governmental regulation in the manufacture of drug products or product candidates could result in incurring substantial remedial costs, delays in the development or approval of our product candidates or new indications for our marketed products and/or in their commercial launch if regulatory approval is obtained, and a reduction in sales.
Congressional inquiries and recently approved or proposed federal and state legislation, regulations, and policies (in addition to those already in effect) designed to, among other things, bring more transparency to drug pricing, review the relationship between pricing and manufacturer patient programs, reduce the out-of-pocket cost of prescription drugs, and reform government program reimbursement methodologies for drugs.
Congressional inquiries, executive orders, and recently approved or proposed federal and state legislation, regulations, and policies (in addition to those already in effect) designed to, among other things, bring more transparency to drug pricing, review the relationship between pricing and manufacturer patient programs, reduce the out-of-pocket cost of prescription drugs, and reform government program reimbursement methodologies for drugs.
For example, in the past we have experienced, and expect to continue to experience, various types of cybersecurity incidents, including unauthorized access to our IT systems, data security breaches, malware incursions, denial-of-service attacks, phishing campaigns, and other similar disruptions. Similar incidents have been experienced and may in the future be experienced by certain third parties on which we rely.
For example, in the past we have experienced, and may experience in the future, various types of cybersecurity incidents, including unauthorized access to our IT systems, data security breaches, malware incursions, denial-of-service attacks, phishing campaigns, and other similar disruptions. Similar incidents have been experienced and may in the future be experienced by certain third parties on which we rely.
Our or our collaborators' failure to meet the stringent requirements of governmental regulation in the manufacture of drug products or product candidates could result in incurring substantial remedial costs, delays in the development or approval of our product candidates or new indications for our marketed products and/or in their commercial launch if regulatory approval is obtained, and a reduction in sales.
Our or our collaborators' or contract manufacturers' failure to meet the stringent requirements of governmental regulation in the manufacture of drug products or product candidates could result in incurring substantial remedial costs, delays in the development or approval of our product candidates or new indications for our marketed products and/or in their commercial launch if regulatory approval is obtained, and a reduction in sales.
Serious complications or side effects in connection with the use of our products and in clinical trials for our product candidates and new indications for our marketed products could cause our regulatory approvals to be revoked or limited or lead to delay or discontinuation of development of our product candidates or new indications for our marketed products, which could severely harm our business, prospects, operating results, and financial condition.
Serious complications or side effects in connection with the use or development of our products or product candidates could cause our regulatory approvals to be revoked or limited or lead to delay or discontinuation of development of our product candidates or new indications for our marketed products, which could severely harm our business, prospects, operating results, and financial condition.
The degree to which EYLEA HD net product sales may offset further potential decrease in EYLEA net product sales, resulting from the factors discussed above or otherwise, is uncertain. We also are substantially dependent on our share of profits from the commercialization of Dupixent under our Antibody Collaboration with Sanofi.
The degree to which EYLEA HD net product sales may offset further potential decreases in EYLEA net product sales, resulting from the factors discussed above or otherwise, is uncertain. We also are substantially dependent on our share of profits from the commercialization of Dupixent under our collaboration with Sanofi (the "Antibody Collaboration").
In addition, as EYLEA HD does not benefit from regulatory exclusivity in the United States, market exclusivity for EYLEA HD in the United States is based solely on our patent rights pertaining to this product (which are subject to the risks and uncertainties discussed above under " If we cannot protect the confidentiality of our trade secrets, or our patents or other means of defending our intellectual property are insufficient to protect our proprietary rights, our business and competitive position will be harmed.
In addition, as EYLEA HD does not benefit from regulatory exclusivity in the United States, market exclusivity for EYLEA HD in the United States is based solely on our patent rights pertaining to this product (which are subject to the risks and uncertainties discussed above under " If we cannot protect the confidentiality of our trade secrets, or our patents or other means of defending our intellectual property are insufficient to protect our proprietary rights, our 54 Table of Contents business and competitive position will be harmed.
If we fail to realize the expected benefits from acquisitions we have consummated or may consummate in the future, whether as a result of unidentified risks or liabilities, integration difficulties, product development or regulatory setbacks (including those relating to 62 Table of Contents issues that may have arisen before we completed the transaction in question), litigation with current or former employees and other events, our business, operating results, and financial condition could be adversely affected.
If we fail to realize the expected benefits from acquisitions we have consummated or may consummate in the future, whether as a result of unidentified risks or liabilities, integration difficulties, product development or regulatory setbacks (including those relating to issues that may have arisen before we completed the transaction in question), litigation with current or former employees and other events, our business, operating results, and financial condition could be adversely affected.
In asthma, competitors to Dupixent include antibodies against the IL-5 ligand or the IL-5 receptor, immunoglobulin E, or thymic stromal lymphopoietin ("TSLP"); and some of these antibodies are either approved or in development for indications that also compete or may compete in the future with Dupixent in CRSwNP, EoE, and COPD.
In asthma, competitors to Dupixent include antibodies against the IL-5 ligand or the IL-5 receptor, immunoglobulin E, or thymic stromal lymphopoietin ("TSLP"); and some of these antibodies are either approved or in development for indications that also compete or may compete in the future with Dupixent in CRSwNP, EoE, COPD, and CSU where approved.
Furthermore, we are subject to extensive pharmacovigilance reporting and other pharmacovigilance requirements, which may differ in the numerous countries in which we conduct clinical trials or commercialize a product. Failure to comply with any such requirements may result in the premature closure of the clinical trials and other enforcement actions by the relevant regulatory authorities.
Furthermore, we are subject to extensive pharmacovigilance reporting and other pharmacovigilance requirements, which may differ in the numerous jurisdictions in which we conduct clinical trials or commercialize a product. Failure to comply with any such requirements may result in the premature closure of the clinical trials and other enforcement actions by the relevant regulatory authorities.
Future sales of our Common Stock by our significant shareholders or us may depress our stock price and impair our ability to raise funds in new share offerings. A small number of our shareholders beneficially own a substantial amount of our Common Stock. As of December 31, 2024, our five largest shareholders plus Dr.
Future sales of our Common Stock by our significant shareholders or us may depress our stock price and impair our ability to raise funds in new share offerings. A small number of our shareholders beneficially own a substantial amount of our Common Stock. As of December 31, 2025, our five largest shareholders plus Dr.
In addition, a number of states have legislation requiring pharmaceutical companies to establish marketing compliance programs, file periodic reports with the state, or make periodic public disclosures on sales, marketing, pricing, clinical trials, and other activities; restrict when pharmaceutical companies may provide meals or gifts to prescribers or engage in other marketing-related activities; require identification or licensing of sales representatives; and restrict the ability of manufacturers to offer co-pay support to patients for certain prescription drugs.
In addition, a number of states have legislation requiring pharmaceutical companies to establish marketing compliance programs, file periodic reports with the state, or make periodic public disclosures on sales, marketing, pricing, clinical trials, and other activities; restrict when pharmaceutical companies may provide meals or gifts to prescribers or engage in other marketing-related activities; require identification or licensing of sales representatives; and restrict the ability of manufacturers to offer copay support to patients for certain prescription drugs.
Advertising and promotional materials must comply with FDA regulations and those of foreign regulatory authorities and may be subject to other potentially applicable federal and state laws. The applicable regulations in countries outside the U.S. grant similar powers to the competent authorities and impose similar obligations on companies.
Advertising and promotional materials must comply with FDA regulations and those of foreign regulatory authorities and may be subject to other potentially applicable federal and state laws. The applicable regulations in jurisdictions outside the U.S. grant similar powers to the competent authorities and impose similar obligations on companies.
Regulatory and Development Risks • Drug development and obtaining and maintaining regulatory approval for drug products is costly, time-consuming, and highly uncertain. • Serious complications or side effects in connection with the use or development of our products or product candidates could cause our regulatory approvals to be revoked or limited or lead to delay or discontinuation of development of our product candidates or new indications for our marketed products. • We may be unable to formulate or manufacture our product candidates in a way that is suitable for clinical or commercial use, which would delay or prevent continued development of such candidates and/or receipt of regulatory approval or commercial sale. • Many of our products are intended to be used in combination with drug-delivery devices, which may result in additional regulatory, commercialization, and other risks.
Regulatory and Development Risks • Drug development and obtaining and maintaining regulatory approval for drug and biologic products is costly, time-consuming, and highly uncertain. • Serious complications or side effects in connection with the use or development of our products or product candidates could cause our regulatory approvals to be revoked or limited or lead to delay or discontinuation of development of our product candidates or new indications for our marketed products. 36 Table of Contents • We may be unable to formulate or manufacture our product candidates in a way that is suitable for clinical or commercial use, which would delay or prevent continued development of such candidates and/or receipt of regulatory approval or commercial sale. • Many of our products are intended to be used in combination with drug-delivery devices, which may result in additional regulatory, commercialization, and other risks.
Commercialization of any of our marketed products may 43 Table of Contents also be adversely impacted by vertical integration of private payor healthcare and insurance programs, health maintenance organizations, and PBMs, or further consolidation among the healthcare providers served or operated by our distributor customers if, for example, one or more consolidated groups of healthcare providers determines not to use (or decides to switch from) such marketed product in favor of a competing product.
Commercialization of any of our marketed products may also be adversely impacted by vertical integration of private payor healthcare and insurance programs, health maintenance organizations, and PBMs, or further consolidation among the healthcare providers served or operated by our distributor customers if, for example, one or more consolidated groups of healthcare providers determines not to use (or decides to switch from) such marketed product in favor of a competing product.
Additionally, the United States and other government actions related to Russia's invasion of Ukraine may limit or prevent filing, prosecution, and maintenance of patent applications in Russia. These actions could result in abandonment or lapse of our patents or patent applications, resulting in partial or complete loss of patent rights in Russia.
Additionally, the United States' and other government actions related to Russia's invasion of Ukraine may limit or prevent filing, prosecution, and maintenance of patent applications in Russia. These actions could result in abandonment or lapse of our patents or patent applications, resulting in partial or complete loss of patent rights in Russia.
In addition, if we or our collaborators experience excess inventory, it may be necessary to write down or write off such excess inventory or incur an impairment charge with respect to the facility where such product is manufactured, which could adversely affect our operating results.
In addition, if we or our collaborators carry excess inventory, it may be necessary to write down or write off such excess inventory or incur an impairment charge with respect to the facility where such product is manufactured, which could adversely affect our operating results.
Data security breaches could lead to the loss of trade secrets or other intellectual property, result in demands for ransom or other forms of blackmail, or lead to the public exposure of personal information (including sensitive personal information) of our employees, clinical trial patients, customers, and others.
Data security breaches could lead to the loss of trade secrets or other intellectual property, result in demands for ransom or other forms of extortion, or lead to the public exposure of personal information (including sensitive personal information) of our employees, clinical trial patients, customers, and others.
Other Risks Related to Our Business and Our Common Stock • Our business is dependent on our key personnel and will be harmed if we cannot recruit and retain key members of our senior management team, including leaders in our research, development, manufacturing, and commercial organizations. • Significant disruptions of information technology systems or breaches of data security could adversely affect our business. • Public health outbreaks, epidemics, or pandemics (such as the COVID-19 pandemic) have adversely affected and may in the future adversely affect our business. • Our indebtedness could adversely impact our business. • Our stock price is extremely volatile. • Our existing shareholders may be able to exert substantial influence over matters requiring shareholder approval and over our management. * * * Risks Related to Commercialization of Our Marketed Products, Product Candidates, and New Indications for Our Marketed Products We are substantially dependent on the success of EYLEA, EYLEA HD, and Dupixent.
Other Risks Related to Our Business and Our Common Stock • Our business is dependent on our key personnel and will be harmed if we cannot recruit or retain key members of our senior management team, including leaders in our research, development, manufacturing, and commercial organizations. • Significant disruptions of information technology systems or breaches of data security could adversely affect our business. • Public health outbreaks, epidemics, or pandemics have adversely affected and may in the future adversely affect our business. • Our indebtedness could adversely impact our business. • Our stock price is extremely volatile. • Our existing shareholders may be able to exert substantial influence over matters requiring shareholder approval and over our management. * * * Risks Related to Commercialization of Our Marketed Products, Product Candidates, and New Indications for Our Marketed Products We are substantially dependent on the success of EYLEA HD, EYLEA, and Dupixent.
Due to the uncertainties associated with developing biopharmaceutical products, we may not be the first to obtain marketing approval for a product against any particular target, which may have a material adverse effect on our business or future prospects.
Due to the uncertainties associated with developing pharmaceutical products, we may not be the first to obtain marketing approval for a product against any particular target, which may have a material adverse effect on our business or future prospects.
If the FDA does not accept our application for review or approve our application, it may require that we conduct additional clinical, preclinical, or manufacturing validation studies or additional analyses of data from existing studies and submit the data before it will reconsider our application.
If the FDA does not accept from us an application for review or approve our application, it may require that we conduct additional clinical, preclinical, or manufacturing validation studies or additional analyses of data from existing studies and submit the data before it will reconsider our application.
We expect that the degree of commercial success of our marketed products will continue to depend on many factors, including the following (as applicable): • effectiveness of the commercial strategy in and outside the United States for the marketing of our products, including pricing strategy; • sufficient coverage of, and reimbursement for, our marketed products by third-party payors, including Medicare and Medicaid in the United States and other government and private payors in the United States and foreign jurisdictions, as well as U.S. and foreign payor restrictions on eligible patient populations and the reimbursement process (including drug price control measures that have been or may be enacted or introduced in the United States by various federal and state authorities); • our ability and our collaborators' ability to maintain sales of our marketed products in the face of competitive products and to differentiate our marketed products from competitive products, including as applicable product candidates currently in clinical development; and, in the case of EYLEA and EYLEA HD, the existing and potential new branded and biosimilar competition (discussed further under " The commercial success of our products and product candidates is subject to significant competition - Marketed Products" below) and the willingness of retinal specialists and patients to start or continue treatment with such products or to switch from a competitive product to one of our products; • the safety and efficacy of our marketed products (particularly those launched recently, such as EYLEA HD) seen in a broader patient group (i.e., real-world use); • the effect of existing and new healthcare laws and regulations currently being considered or implemented in the United States and globally, including measures requiring the U.S. government in the future to negotiate the prices of certain drugs and price reporting and other disclosure requirements and the potential impact of such requirements on physician prescribing practices and payor coverage; • serious complications or side effects in connection with the use of our marketed products, as discussed under "Risks Related to Maintaining Approval of Our Marketed Products and the Development and Obtaining Approval of Our Product Candidates and New Indications for Our Marketed Products - Serious complications or side effects in connection with the use of our products and in clinical trials for our product candidates and new indications for our marketed products could cause our regulatory approvals to be revoked or limited or lead to delay or discontinuation of 37 Table of Contents development of our product candidates or new indications for our marketed products, which could severely harm our business, prospects, operating results, and financial condition " below; • maintaining and successfully monitoring commercial manufacturing arrangements for our marketed products with third parties who perform fill/finish or other steps in the manufacture of such products to ensure that they meet our standards and those of regulatory authorities, including the FDA, which extensively regulate and monitor pharmaceutical manufacturing facilities; • our ability to meet the demand for commercial supplies of our marketed products; • the outcome of the pending proceedings relating to EYLEA (described further in Note 16 to our Consolidated Financial Statements included in this report), as well as other risks relating to our marketed products and product candidates associated with intellectual property of other parties and pending or future litigation relating thereto (as discussed under "Risks Related to Intellectual Property and Market Exclusivity" below); • the outcome of the pending government proceedings and investigations and other matters described in Note 16 to our Consolidated Financial Statements included in this report (including the civil proceedings initiated or joined by the U.S.
We expect that the degree of commercial success of our marketed products will continue to depend on many factors, including the following (as applicable): • effectiveness of the commercial strategy in and outside the United States for the marketing of our products, including pricing strategy; • sufficient coverage of, and reimbursement or copay assistance for, our marketed products by third-party payors and other third parties, including Medicare and Medicaid in the United States and other government and private payors in the United States and foreign jurisdictions, as well as U.S. and foreign payor restrictions on eligible patient populations and the reimbursement process (including drug price control measures that have been or may be enacted or introduced in the United States by various federal and state authorities); • our ability and our collaborators' ability to maintain sales of our marketed products in the face of competitive products and to differentiate our marketed products from competitive products, including as applicable product candidates currently in clinical development; and, in the case of EYLEA HD and EYLEA, the existing and potential new branded and biosimilar competition (discussed further under " The commercial success of our products and product candidates is subject to significant competition - Marketed Products" below) and the willingness of retinal specialists and patients to start or continue treatment with such products or to switch from a competitive product to one of our products; • the safety and efficacy of our marketed products seen in a broader patient group (i.e., real-world use); • the effect of existing and new healthcare laws and regulations currently being considered or implemented in the United States and globally, including measures requiring the U.S. government in the future to negotiate the prices of certain drugs and price reporting and other disclosure requirements and the potential impact of such requirements on physician prescribing practices and payor coverage; • serious complications or side effects in connection with the use of our marketed products, as discussed under "Risks Related to Maintaining Approval of Our Marketed Products and the Development and Obtaining Approval of Our Product Candidates and New Indications for Our Marketed Products - Serious complications or side effects in connection with the use or development of our products or product candidates could cause our regulatory approvals to be revoked or limited or lead to delay or discontinuation of development of our product candidates or new indications for our marketed products, which could severely harm our business, prospects, operating results, and financial condition " below; • maintaining and successfully monitoring commercial manufacturing arrangements for our marketed products with third parties who perform fill/finish and bulk product manufacturing or other steps in the manufacture of such products to ensure that they meet our standards and those of regulatory authorities, including the FDA, which extensively regulate and monitor, and have been increasing their focus on, pharmaceutical manufacturing facilities; • our ability to meet the demand for commercial supplies of our marketed products; • the outcome of the pending proceedings relating to EYLEA (described further in Note 16 to our Consolidated Financial Statements included in this report), as well as other risks relating to our marketed products and product candidates associated with intellectual property of other parties and pending or future litigation relating thereto (as discussed under "Risks Related to Intellectual Property and Market Exclusivity" below); • the outcome of the pending government proceedings and investigations and other matters described in Note 16 to our Consolidated Financial Statements included in this report (including the civil proceedings initiated or joined by the U.S.
Third-party service or supply failures, or other failures, business interruptions, or other disasters affecting our manufacturing facilities in Rensselaer, New York and Limerick, Ireland, the manufacturing facilities of our collaborators, or the facilities of any other party participating in the supply chain, would adversely affect our ability to supply our products.
Third-party service or supply failures, or other failures, business interruptions, or other disasters affecting our manufacturing facilities in Rensselaer, New York and Limerick, Ireland, the manufacturing facilities of our collaborators or contract manufacturers, or the facilities of any other party participating in the supply chain, would adversely affect our ability to supply our products.
Other parties may allege that our or our collaborators' manufacturing activities, or the activities of other third parties involved in our manufacture and supply chain (which may be located in jurisdictions outside the United States), infringe patents or other intellectual property rights.
Other parties may allege that our or our collaborators' manufacturing activities, or the activities of contract manufacturers or other third parties involved in our manufacture and supply chain (which may be located in jurisdictions outside the United States), infringe patents or other intellectual property rights.
The recommended termination or material modification of any of our ongoing late-stage clinical trials by an IDMC could negatively impact the future development of our product candidate(s), and our business, prospects, operating results, and financial condition may be materially harmed. We are studying our product candidates in a wide variety of indications in clinical trials.
The recommended termination or material modification of any of our ongoing late-stage clinical trials by an IDMC could negatively impact the future development of our product candidate(s), and our business, prospects, operating results, and financial condition may be materially harmed. 50 Table of Contents We are studying our product candidates in a wide variety of indications in clinical trials.
For example, there are several companies that are marketing and/or developing antibodies or other molecules (such as small interfering RNA molecules, or siRNAs) against PCSK9, ANGPTL3 and IL-6 and/or IL-6R, which currently (or, for product candidates in development, may in the future if approved) treat the same conditions as Praluent, Evkeeza, and Kevzara, respectively.
In addition, there are several companies that are marketing and/or developing antibodies or other molecules (such as small interfering RNA molecules, or siRNAs, and oral small molecules) against PCSK9, ANGPTL3 and IL-6 and/or IL-6R, which currently (or, for product candidates in development, may in the future if approved) treat the same conditions as Praluent, Evkeeza, and Kevzara, respectively.
Before approving a new drug or biologic product, the FDA and such comparable foreign regulatory authorities require that the facilities at which the product will be manufactured or advanced through the supply chain be in compliance with current Good Manufacturing Practices, or cGMP, requirements and regulations governing the manufacture, shipment, and storage of the 45 Table of Contents product.
Before approving a new drug or biologic product, the FDA and such comparable foreign regulatory authorities require that the facilities at which the product will be manufactured or advanced through the supply chain be in compliance with current Good Manufacturing Practices, or cGMP, requirements and regulations governing the manufacture, shipment, and storage of the product.
However, the term of regulatory exclusivity may not remain at 12 years in the United States and could be shortened if, for example, the PPACA is amended. A number of jurisdictions outside the United States have also established abbreviated pathways for regulatory approval of biological products that are biosimilar to earlier versions of biological products.
However, the term of regulatory exclusivity may not remain at 12 years in the United States and could be shortened if, for example, the PPACA is amended. A number of jurisdictions outside the United States (such as the EU) have also established abbreviated pathways for regulatory approval of biological products that are biosimilar to earlier versions of biological products.
Whether or not we obtain FDA approval for a product in the United States, we must obtain approval of the product by the comparable regulatory authorities in countries outside the United States before we can market that product or any other product in those countries.
Whether or not we obtain FDA approval for a product in the United States, we must obtain approval of the product by the comparable regulatory authorities in jurisdictions outside the United States before we can market that product or any other product in those jurisdictions.
A judicial or regulatory decision in favor of one or more parties making such allegations could 53 Table of Contents directly or indirectly preclude the manufacture of our products to which those intellectual property rights apply on a temporary or permanent basis, which could materially harm our business, prospects, operating results, and financial condition.
A judicial or regulatory decision in favor of one or more parties making such allegations could directly or indirectly preclude the manufacture of our products to which those intellectual property rights apply on a temporary or permanent basis, which could materially harm our business, prospects, operating results, and financial condition.
The PPACA provides a regulatory mechanism that allows for FDA approval of biologic drugs that are similar to innovative drugs on the basis of less extensive data than is required by a full BLA. Under this regulation, an application for approval of a biosimilar may be filed four years after approval of the innovator product.
The PPACA provides a regulatory mechanism that allows for FDA approval of biologics that are similar to innovative biologics on the basis of less extensive data than is required by a full BLA. Under this regulation, an application for approval of a biosimilar may be filed four years after approval of the innovator product.
These activities subject us to additional data protection authority oversight and require us to comply with stringent local and regional data privacy laws. Such laws include the GDPR, which has a wide range of compliance obligations relating to the processing and protection of personal data. Violations of the GDPR carry significant financial penalties for noncompliance.
These activities subject us to additional data protection authority oversight and require us to comply with stringent local and regional data privacy laws. Such laws include the GDPR, which has a wide range of compliance obligations relating to the processing and protection of personal data. Violations of the GDPR carry significant financial penalties for 63 Table of Contents noncompliance.
We and our collaborators and other third-party providers are required to maintain compliance with cGMPs, and are subject to inspections by the FDA or comparable agencies in other jurisdictions to confirm such compliance.
We and our collaborators, contract manufacturers, and other third-party providers are required to maintain compliance with cGMPs, and are subject to inspections by the FDA or comparable agencies in other jurisdictions to confirm such compliance.
If any licenses are required, we may not be able to obtain such licenses on commercially reasonable terms, if at all. The failure to obtain any such license could prevent us from developing or commercializing any one or more of our products or product candidates, which could severely harm our business.
If any licenses are required, we may not be able to obtain such licenses on commercially reasonable terms, if at 53 Table of Contents all. The failure to obtain any such license could prevent us from developing or commercializing any one or more of our products or product candidates, which could severely harm our business.
As we increase our production in anticipation of potential regulatory approval for our product candidates, our current manufacturing capacity will likely not be 52 Table of Contents sufficient, and our dependence on our collaborators and/or contract manufacturers may increase, to produce adequate quantities of drug material for both commercial and clinical purposes.
As we increase our production in anticipation of potential regulatory approval for our product candidates, our current manufacturing capacity will likely not be sufficient, and our dependence on our collaborators and/or contract manufacturers may increase, to produce adequate quantities of drug material for both commercial and clinical purposes.
FDA guidance relating to accelerated approval of oncology therapeutics indicates that a confirmatory trial for a particular oncology product candidate should be underway when the related BLA is submitted to the FDA and also states that the FDA may require that a confirmatory trial for a particular oncology product candidate be well underway, if not fully enrolled, by the time of the accelerated approval action.
FDA guidance relating to accelerated approval of oncology therapeutics indicates that a confirmatory trial for a particular oncology product candidate should be underway when the related marketing application is submitted to the FDA and also states that the FDA may require that a confirmatory trial for a particular oncology product candidate be well underway, if not fully enrolled, by the time of the accelerated approval action.
Additionally, manufacturers of biological products and their facilities are subject to payment of substantial user fees and continual review and periodic inspections by the FDA and other regulatory authorities for compliance with cGMP regulations and adherence to any commitments made in the applicable BLA.
Additionally, manufacturers of drugs and biological products and their facilities are subject to payment of substantial user fees and continual review and periodic inspections by the FDA and other regulatory authorities for compliance with cGMP regulations and adherence to any commitments made in the applicable NDA or BLA.
Further, other factors may adversely affect our effective tax rate, including changes in the mix of our 59 Table of Contents profitability from country to country, tax effects of stock-based compensation (which depend in part on the price of our stock and, therefore, are beyond our control), and changes in tax laws or regulations.
Further, other factors may adversely affect our effective tax rate, including changes in the mix of our profitability from country to country, tax effects of stock-based compensation (which depend in part on the price of our stock and, therefore, are beyond our control), and changes in tax laws or regulations.
As our currently marketed products and most of our product candidates are biologics, bringing them to market may cost more than bringing traditional, small-molecule drugs to market due to the complexity 38 Table of Contents associated with the research, development, production, supply, and regulatory review of such products.
As our currently marketed products and most of our product candidates are biologics, bringing them to market may cost more than bringing traditional, small-molecule drugs to market due to the complexity associated with the research, development, production, supply, and regulatory review of such products.
Obligations equivalent in scope, but which can vary widely in application, apply in countries outside the United States. According to the FDA policies under the Prescription Drug User Fee Act, the FDA system of review times for new drugs includes standard review and priority review.
Obligations equivalent in scope, but which can vary widely in application, apply in jurisdictions outside the United States. According to the FDA policies under the Prescription Drug User Fee Act, the FDA system of review times for new drugs and biologics includes standard review and priority review.
The holder of an approved BLA or foreign equivalent is obligated to monitor and report adverse events and any failure of a product to meet the specifications in the BLA.
The holder of an approved NDA, BLA, or foreign equivalent is obligated to monitor and report adverse events and any failure of a product to meet the specifications in the application.
We have been in the past, are currently, and may in the future be involved in patent litigation and other proceedings involving patents and other intellectual property. For example, we are currently party to patent infringement and other proceedings relating to EYLEA, as described in Note 16 to our Consolidated Financial Statements.
We have been in the past, are currently, and may in the future be involved in patent litigation and other proceedings involving patents and other intellectual property. For example, we are currently party to patent infringement and other proceedings relating to EYLEA, as described in Note 16 to our Consolidated Financial Statements included in this report.
Our patent rights may not provide us with a proprietary position or competitive advantages against competitors. Furthermore, even if the outcome is favorable to us, the enforcement of our intellectual property rights can be extremely expensive and time consuming.
Our patent rights may not provide us with a proprietary position or competitive advantages against 52 Table of Contents competitors. Furthermore, even if the outcome is favorable to us, the enforcement of our intellectual property rights can be extremely expensive and time consuming.
If we are unable to continue to develop suitable product formulations or manufacturing processes to support large-scale clinical testing of our product candidates, including our antibody-based product candidates, we may be unable to supply necessary materials for our clinical trials, which would delay or prevent the development of our product candidates.
If we are unable to continue to develop suitable product formulations or manufacturing processes to support large-scale clinical testing of our product candidates, we may be unable to supply necessary materials for our clinical trials, which would delay or prevent the development of our product candidates.
In the United States, each component of a combination product is subject to the requirements established by the FDA for that type of component, whether a drug, biologic, or device. The determination whether a product is a combination product or two 49 Table of Contents separately regulated products is made by the FDA on a case-by-case basis.
In the United States, each component of a combination product is subject to the requirements established by the FDA for that type of component, whether a drug, biologic, or device. The determination whether a product is a combination product or two separately regulated products is made by the FDA on a case-by-case basis.
More detailed information about the risks related to the commercialization of our marketed products is provided in the risk factors below. We and our collaborators are subject to significant ongoing regulatory obligations and oversight with respect to the products we or our collaborators commercialize.
More detailed information about the risks related to the commercialization of our marketed products is provided in the risk factors below. 39 Table of Contents We and our collaborators are subject to significant ongoing regulatory obligations and oversight with respect to the products we or our collaborators commercialize.
In addition, we rely on certain third parties or our collaborators to perform filling, finishing, distribution, laboratory testing, and other services related to the manufacture of our marketed products and product candidates, and to supply various raw materials and other products.
In addition, we rely on certain third parties or our collaborators to perform filling, finishing, distribution, laboratory testing, and other services related to the manufacture of our marketed products and product candidates, and to supply various raw materials and other 56 Table of Contents products.

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

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Biggest changeWe have also 67 Table of Contents developed a process to conduct due diligence on third parties with which we work to oversee and identify material risks from cybersecurity threats associated with our use of those third parties' services, including those that perform cybersecurity services.
Biggest changeWe have also developed a process to conduct due diligence on third parties with which we work to oversee and identify material risks from cybersecurity threats associated with our use of those third parties' services, including those that perform cybersecurity services.
The Company's Chief Information Security Officer ("CISO"), in coordination with the Chief Information Officer and the Technology Risk Management Committee, is responsible for the establishment and maintenance of our cybersecurity program, as well as the assessment and management of cybersecurity risks.
The Company's Chief Information Security Officer ("CISO"), in coordination with the Chief Digital & Technology Officer and the Technology Risk Management Committee, is responsible for the establishment and maintenance of our cybersecurity program, as well as the assessment and management of cybersecurity risks.

Item 2. Properties

Properties — owned and leased real estate

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Biggest changeLocation Approximate Square Feet Use Leased/Owned Tarrytown, New York 1,500,000 Corporate headquarters, laboratory, and office space Leased (a) Rensselaer, New York 1,600,000 Manufacturing, warehouse, laboratory, fill/finish (b) , and office space Owned Limerick, Ireland 850,000 Manufacturing, warehouse, laboratory, and office space Owned (a) Refer to Part II, Item 7.
Biggest changeA summary of our significant owned and leased properties is provided below. 71 Table of Contents Location Approximate Square Feet Use Leased/Owned Tarrytown, New York 1,800,000 Corporate headquarters, laboratory, and office space Leased or Owned (a) Rensselaer, New York 1,600,000 Manufacturing, warehouse, laboratory, fill/finish (b) , and office space Owned Limerick, Ireland 950,000 Manufacturing, warehouse, laboratory, and office space Owned (a) Approximately 1,500,000 square feet is leased pursuant to a lease financing facility and approximately 300,000 square feet is owned.
Item 2. Properties We conduct our research, development, manufacturing, and administrative activities at our owned and leased facilities. A summary of our significant owned and leased properties is provided below.
Item 2. Properties We conduct our research, development, manufacturing, and administrative activities at our owned and leased facilities.
In addition to the properties summarized in the table above, we own an approximate 100-acre parcel of land adjacent to our Tarrytown, New York location, which we are in the process of developing, primarily to expand our research, preclinical manufacturing, and support facilities to accommodate our growth.
(b) Our fill/finish facility in Rensselaer, New York is currently undergoing process validation and has yet to be approved for commercial production In addition to the properties summarized in the table above, we own an approximate 100-acre parcel of land adjacent to our Tarrytown, New York location, which we are in the process of developing, primarily to expand our research and support facilities to accommodate our growth.
In September 2024, we also acquired an approximate 1,000,000 square foot facility in Saratoga Springs, New York. Item 3. Legal Proceedings The information called for by this item is incorporated herein by reference to the information set forth in Note 16 to our Consolidated Financial Statements included in this report. Item 4.
Legal Proceedings The information called for by this item is incorporated herein by reference to the information set forth in Note 16 to our Consolidated Financial Statements included in this report. Item 4. Mine Safety Disclosures Not applicable. PART II
"Management's Discussion and Analysis of Financial Condition and Results of Operations - Liquidity and Capital Resources - Tarrytown, New York Corporate Headquarters Lease " for further details. (b) Our fill/finish facility in Rensselaer, New York is currently undergoing process validation as required by regulatory authorities.
Refer to Part II, Item 7. "Management's Discussion and Analysis of Financial Condition and Results of Operations - Liquidity and Capital Resources - Tarrytown, New York Corporate Headquarters Lease " for further details regarding the lease financing facility.
Removed
Mine Safety Disclosures Not applicable. 68 Table of Contents PART II
Added
In 2024, we also acquired an approximate 1,000,000 square foot facility in Saratoga Springs, New York, and we are in the process of designing and developing this property for production support activities and expanding our manufacturing capacity. Item 3.

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Biggest changeIn February 2025, our board of directors approved the initiation of a quarterly cash dividend program and declared a cash dividend of $0.88 per share on our 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.
Biggest changeIn January 2026, our board of directors declared a cash dividend of $0.94 per share on our Common Stock and Class A stock, which will be payable to our shareholders in March 2026.
Item 5. Market for Registrant's Common Equity, Related Stockholder Matters, and Issuer Purchases of Equity Securities Market for Registrant's Common Equity Our Common Stock, par value $.001 per share, is quoted on The NASDAQ Global Select Market under the symbol "REGN." Our Class A Stock, par value $.001 per share, is not publicly quoted or traded.
Item 5. Market for Registrant's Common Equity, Related Stockholder Matters, and Issuer Purchases of Equity Securities Market Information Our Common Stock, par value $.001 per share, is quoted on The NASDAQ Global Select Market under the symbol "REGN." Our Class A Stock, par value $.001 per share, is not publicly quoted or traded.
Issuer Purchases of Equity Securities The table below reflects shares of Common Stock we repurchased under our share repurchase programs, as well as Common Stock withheld by us for employees to satisfy their tax withholding obligations arising upon the vesting of restricted stock granted under one of our long-term incentive plans, during the three months ended December 31, 2024.
Issuer Purchases of Equity Securities The table below reflects shares of Common Stock we repurchased under our share repurchase programs, as well as Common Stock withheld by us for employees to satisfy their tax withholding obligations arising upon the vesting of restricted stock granted under one of our long-term incentive plans, during the three months ended December 31, 2025.
The comparison assumes that $100 was invested on December 31, 2019 in our Common Stock and in both of the foregoing indices. All values assume reinvestment of the pre-tax value of dividends paid by companies included in these indices.
The comparison assumes that $100 was invested on December 31, 2020 in our Common Stock and in both of the foregoing indices. All values assume reinvestment of the pre-tax value of dividends paid by companies included in these indices.
STOCK PERFORMANCE GRAPH Set forth below is a line graph comparing the cumulative total shareholder return on Regeneron's Common Stock with the cumulative total return of (i) the NASDAQ US Benchmark Pharmaceuticals Total Return Index ("NQ US Pharma TR Index"), and (ii) Standard & Poor's 500 Stock Index ("S&P 500") for the period from December 31, 2019 through December 31, 2024.
Stock Performance Graph Set forth below is a line graph comparing the cumulative total shareholder return on Regeneron's Common Stock with the cumulative total return of (i) the NASDAQ US Benchmark Pharmaceuticals Total Return Index ("NQ US Pharma TR Index"), and (ii) Standard & Poor's 500 Stock Index ("S&P 500") for the period from December 31, 2020 through December 31, 2025.
The historical stock price performance of our Common Stock shown in the graph below is not necessarily indicative of future stock price performance. 12/31/2019 12/31/2020 12/31/2021 12/31/2022 12/31/2023 12/31/2024 Regeneron $ 100.00 $ 128.66 $ 168.19 $ 192.15 $ 233.91 $ 189.71 S&P 500 $ 100.00 $ 116.26 $ 147.52 $ 118.84 $ 147.64 $ 182.05 NQ US Pharma TR Index $ 100.00 $ 110.52 $ 137.47 $ 153.08 $ 159.01 $ 172.62 69 Table of Contents This performance graph shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or incorporated by reference into any filing of ours under the Securities Act of 1933, as amended, or the Securities Exchange Act, except as shall be expressly set forth by specific reference in such filing.
The historical stock price performance of our Common Stock shown in the graph below is not necessarily indicative of future stock price performance. 72 Table of Contents 12/31/2020 12/31/2021 12/31/2022 12/31/2023 12/31/2024 12/31/2025 Regeneron $ 100.00 $ 130.72 $ 149.34 $ 181.80 $ 147.45 $ 159.77 S&P 500 $ 100.00 $ 126.89 $ 102.22 $ 126.99 $ 156.59 $ 182.25 NQ US Pharma TR Index $ 100.00 $ 124.39 $ 138.51 $ 143.88 $ 156.19 $ 200.89 This performance graph shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or incorporated by reference into any filing of ours under the Securities Act of 1933, as amended, or the Securities Exchange Act, except as shall be expressly set forth by specific reference in such filing.
Period Total Number of Shares Purchased Average Price Paid per Share Total Number of Shares Purchased as Part of Publicly Announced Programs Approximate Dollar Value of Shares that May Yet Be Purchased Under the Programs (b) (In millions) 10/1/2024–10/31/2024 316,483 $ 982.90 316,431 $ 2,581.9 11/1/2024–11/30/2024 404,299 $ 782.08 395,051 $ 2,273.3 12/1/2024–12/31/2024 748,201 $ 744.67 483,956 $ 1,916.7 Total 1,468,983 (a) 1,195,438 (a) (a) The difference between the total number of shares purchased and the total number of shares purchased as part of publicly announced programs relates to Common Stock withheld by us for employees to satisfy their tax withholding obligations arising upon the vesting of restricted stock granted under one of our long-term incentive plans.
Period Total Number of Shares Purchased Average Price Paid per Share Total Number of Shares Purchased as Part of Publicly Announced Programs Approximate Dollar Value of Shares that May Yet Be Purchased Under the Programs (In millions) 10/1/2025–10/31/2025 394,828 $ 592.94 394,828 $ 1,922.3 11/1/2025–11/30/2025 330,630 $ 689.69 325,234 $ 1,697.9 12/1/2025–12/31/2025 594,493 $ 735.19 283,758 $ 1,486.0 Total (a) 1,319,951 1,003,820 (a) The difference between the total number of shares purchased and the total number of shares purchased as part of publicly announced programs relates to Common Stock withheld by us for employees to satisfy their tax withholding obligations arising upon the vesting of restricted stock granted under one of our long-term incentive plans 73 Table of Contents Item 6. [Reserved]
As of January 23, 2025, there were 149 shareholders of record of our Common Stock and 14 shareholders of record of our Class A Stock. Prior to 2025, no dividends on our Common Stock or Class A Stock had been declared or paid.
Holders As of January 22, 2026, there were 150 shareholders of record of our Common Stock and 14 shareholders of record of our Class A Stock. Dividends In 2025, we initiated a quarterly cash dividend program.
Removed
(b) In February 2025, our board of directors authorized a share repurchase program to repurchase up to an additional $3.0 billion of our Common Stock. See Part II, Item 7. "Management's Discussion and Analysis of Financial Condition and Results of Operations - Liquidity and Capital Resources - Share Repurchase Programs" for further details. Item 6. [Reserved]
Added
We currently intend to continue to pay a quarterly cash dividend, although the amount and timing of any future dividends are subject to authorization by our board of directors and will depend on various factors. Refer to Part II, Item 7.
Added
"Management's Discussion and Analysis of Financial Condition and Results of Operations - Liquidity and Capital Resources - Dividends" for further details.

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

53 edited+23 added−22 removed54 unchanged
Biggest changeOperating Expenses Year Ended December 31, Change (In millions, except headcount data) 2024 2023 2022 2024 vs. 2023 2023 vs. 2022 Research and development (a) $ 5,132.0 $ 4,439.0 $ 3,592.5 $ 693.0 $ 846.5 Acquired in-process research and development 101.0 186.1 255.1 (85.1) (69.0) Selling, general, and administrative (a) 2,954.4 2,631.3 2,115.9 323.1 515.4 Cost of goods sold 1,087.3 932.1 800.0 155.2 132.1 Cost of collaboration and contract manufacturing (b) 883.2 883.7 760.4 (0.5) 123.3 Other operating expense (income), net 53.4 (2.1) (89.9) 55.5 87.8 Total operating expenses $ 10,211.3 $ 9,070.1 $ 7,434.0 $ 1,141.2 $ 1,636.1 Average headcount 14,383 12,698 11,115 1,685 1,583 (a) Includes costs incurred net of any cost reimbursements from collaborators (b) Includes costs incurred in connection with manufacturing drug supplies for collaborators and others Operating expenses in 2024 and 2023 included a total of $982.8 million and $885.0 million, respectively, of stock-based compensation expense related to equity awards granted under our long-term incentive plans.
Biggest changeOther Revenue Year Ended December 31, (In millions) 2025 2024 2023 Royalties on sales of Novartis' Ilaris ® (canakinumab) (a) $ 274.8 $ 177.5 $ 153.8 Regeneron's share of profits from sales of ARCALYST (b) 231.2 115.2 60.4 Other (c) 196.6 222.3 321.9 Total other revenue $ 702.6 $ 515.0 $ 536.1 (a) In connection with our agreement with Novartis, the tiered royalty rates start at 4% and reach 15% after annual sales exceed $1.5 billion (b) In connection with our license agreement with Kiniksa Pharmaceuticals, Ltd., we are entitled to receive 50% of Kiniksa's profits from sales of ARCALYST (c) Consists primarily of amounts earned in connection with manufacturing product for others; corresponding costs incurred by the Company in connection with such manufacturing is recorded within Cost of collaboration and contract manufacturing 80 Table of Contents Operating Expenses Year Ended December 31, Change (In millions, except headcount data) 2025 2024 2023 2025 vs. 2024 2024 vs. 2023 Research and development (a) $ 5,850.2 $ 5,132.0 $ 4,439.0 $ 718.2 $ 693.0 Acquired in-process research and development 124.1 101.0 186.1 23.1 (85.1) Selling, general, and administrative (a) 2,700.0 2,954.4 2,631.3 (254.4) 323.1 Cost of goods sold 1,140.8 1,087.3 932.1 53.5 155.2 Cost of collaboration and contract manufacturing (b) 959.9 883.2 883.7 76.7 (0.5) Other operating (income) expense, net (10.0) 53.4 (2.1) (63.4) 55.5 Total operating expenses $ 10,765.0 $ 10,211.3 $ 9,070.1 $ 553.7 $ 1,141.2 Average headcount 15,261 14,383 12,698 878 1,685 (a) Includes costs incurred net of any cost reimbursements from collaborators (b) Includes costs incurred in connection with manufacturing drug supplies for collaborators and others Operating expenses in 2025 and 2024 included stock-based compensation expense of $993.7 million and $982.8 million, respectively.
Item 7. Management's Discussion and Analysis of Financial Condition and Results and Results of Operations The following discussion should be read in conjunction with the consolidated financial statements and related notes included elsewhere in this report.
Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations The following discussion should be read in conjunction with the consolidated financial statements and related notes included elsewhere in this report.
The amount of funding that will be required for our clinical programs depends upon the results of our research and preclinical programs and early-stage clinical trials, regulatory requirements, the duration and results of clinical trials underway and of additional clinical trials that we decide to initiate, and the various factors that affect the cost of each trial, including the size of trials, fees charged for services provided by clinical trial investigators and other third parties, the costs for manufacturing the product candidate for use in the trials, and other expenses.
The amount of funding that will be required depends upon the results of our research and preclinical programs and early-stage clinical trials, regulatory requirements, the duration and results of clinical trials underway and of additional clinical trials that we decide to initiate, and the various factors that affect the cost of each trial, including the size of trials, fees charged for services provided by clinical trial investigators and other third parties, the costs for manufacturing the product candidate for use in the trials, and other expenses.
We believe that our existing capital resources, borrowing availability under the Credit Facility, funds generated by anticipated product sales, and funding for reimbursement of research and development costs that we are entitled to receive under our collaboration agreements, will enable us to meet our anticipated operating needs for the foreseeable future.
We believe that our existing capital resources, borrowing availability under the Credit Facility, funds generated by anticipated product sales, and funding for reimbursement of research and development expenses that we are entitled to receive under our collaboration agreements, will enable us to meet our anticipated operating needs for the foreseeable future.
Refer to Part II, Item 7 in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023 (filed with the SEC on February 5, 2024) for additional discussion of our financial condition and results of operations for the year ended December 31, 2022, as well as our financial condition and results of operations for the year ended December 31, 2023 compared to the year ended December 31, 2022.
Refer to Part II, Item 7 in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024 (filed with the SEC on February 5, 2025) for additional discussion of our financial condition and results of operations for the year ended December 31, 2023, as well as our financial condition and results of operations for the year ended December 31, 2024 compared to the year ended December 31, 2023.
We adjust the amount of the liability to reflect any subsequent changes in the relevant facts and circumstances surrounding the uncertain tax positions. 72 Table of Contents Inventories We capitalize inventory costs associated with our 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.
We adjust the amount of the liability to reflect any subsequent changes in the relevant facts and circumstances surrounding the uncertain tax positions. Inventories We capitalize inventory costs associated with our 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.
We enter into collaboration and licensing agreements that may require us to pay (i) 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, and/or (ii) royalties calculated based on a percentage of net product sales.
We enter into collaboration and licensing agreements that may require us to pay (i) amounts contingent upon the occurrence of various future events (e.g., upon the achievement of various development and commercial milestones), which, in the aggregate, 87 Table of Contents could be significant, and/or (ii) royalties calculated based on a percentage of net product sales.
We 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. We were in compliance with all covenants of the Credit Agreement as of December 31, 2024.
We had no borrowings outstanding under the Credit Facility as of December 31, 2025. The Credit Agreement contains operating covenants and a maximum total leverage ratio financial covenant. We were in compliance with all covenants of the Credit Agreement as of December 31, 2025.
Our ability to generate profits and to generate positive cash flow from operations over the next several years depends significantly on the success in commercializing EYLEA HD, EYLEA, and Dupixent.
Our ability to generate profits and to generate positive cash flow from operations over the next several years depends significantly on the success in commercializing our products, including EYLEA HD and Dupixent.
We expect that expenses related to the filing, prosecution, defense, and enforcement of patents and other intellectual property will be substantial. Liabilities for unrecognized tax benefits totaled $1.314 billion as of December 31, 2024. Due to their nature, there is a high degree of uncertainty regarding the period and amounts of potential future cash settlement with tax authorities.
We expect that expenses related to the filing, prosecution, defense, and enforcement of patents and other intellectual property will be substantial. Liabilities for unrecognized tax benefits totaled $1.578 billion as of December 31, 2025. Due to their nature, there is a high degree of uncertainty regarding the period and amounts of potential future cash settlement with tax authorities.
Collaborative Arrangements We have entered into various collaborative arrangements to research, develop, manufacture, and commercialize products and/or product candidates. Our collaboration agreements may require us to deliver various rights, services, and/or goods across the entire life cycle of a product or product candidate.
Collaborative Arrangements We have entered into various collaborative arrangements to research, develop, manufacture, and commercialize products and/or product candidates. Our collaboration agreements may require us to deliver various rights, services, and/or goods across the entire 74 Table of Contents life cycle of a product or product candidate.
Using this model, fair value is calculated based on assumptions with respect to (i) expected volatility of our Common Stock price, (ii) the periods of time over which employees and members of our board of directors are expected to hold their options prior to exercise (expected lives), (iii) expected dividend yield on our Common Stock, and (iv) risk-free interest rates, which are based on quoted U.S.
Using this model, fair value is calculated based on assumptions with respect to (i) expected volatility of our Common Stock price, (ii) the periods of time over which employees and members of our board of directors are expected to hold their options prior to exercise (expected lives), (iii) expected dividend yield on our Common Stock, which is based on our historical practice and expectation of future dividend payments, and (iv) risk-free interest rates, which are based on quoted U.S.
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 Exchange Act), privately negotiated transactions, accelerated share repurchases, block trades, and other transactions in compliance with Rule 10b-18 of the Exchange Act.
The share repurchase programs permit 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 Exchange Act), privately negotiated transactions, accelerated share repurchases, block trades, and other transactions in compliance with Rule 10b-18 of the Exchange Act.
The cash dividend will be payable on March 20, 2025 to shareholders of record as of February 20, 2025. We currently intend to continue to pay a quarterly cash dividend on our outstanding Common Stock and Class A Stock.
The dividend will be payable on March 5, 2026 to our shareholders of record as of February 20, 2026. We currently intend to continue to pay a quarterly cash dividend on our outstanding Common Stock and Class A Stock.
Our research and development efforts have led to numerous approved products that have received marketing approval and approximately 40 product candidates in clinical development (including a number of marketed products for which we are investigating additional indications), most of which were homegrown in our laboratories.
Our research and development efforts have led to numerous products that have received marketing approval and approximately 45 product candidates currently in clinical development (including a number of marketed products for which we are investigating additional indications), most of which were homegrown in our laboratories.
Repurchases may be made from time to time at management's discretion, and the timing and amount of any such repurchases will be determined based on share price, market conditions, legal requirements, and other relevant factors. The program has no time limit and can be discontinued at any time.
Repurchases may be made from time to time at management's discretion, and the timing and amount of any such repurchases will be determined based on share price, market conditions, legal requirements, and other relevant factors. The programs have no time limit and can be discontinued at any time.
In arrangements where we: • supply commercial product to our collaborator, we may be reimbursed for our 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 our collaborator to third-party customers); • share in any profits or losses arising from the commercialization of such products, we record our 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; • receive royalties and/or sales-based milestone payments from our collaborator, we recognize such amounts in the period earned. 71 Table of Contents Our collaborators provide us with estimates of product sales and our share of profits or losses, as applicable, for each quarter.
In arrangements where we: • supply commercial product to our collaborator, we may be reimbursed for our 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 our collaborator to third-party customers); • share in any profits or losses arising from the commercialization of such products, we record our 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; and • receive royalties and/or sales-based milestone payments from our collaborator, we recognize such amounts in the period earned.
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 our debt rating and total leverage ratio.
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 our debt rating and total leverage ratio. The agreements governing the Lease financing contain financial and operating covenants.
Cash Flows from Financing Activities Proceeds from issuances of Common Stock, in connection with exercises of employee stock options, were $1.465 billion during 2024, compared to $1.146 billion during 2023 and $1.520 billion during 2022.
Cash Flows from Financing Activities Proceeds from issuances of Common Stock, in connection with exercises of employee stock options, were $635.9 million during 2025, compared to $1.465 billion during 2024 and $1.146 billion during 2023.
We expect to continue to incur significant costs in connection with our research and development activities (including preclinical and clinical programs).
We expect to continue to incur significant costs in connection with our research and development activities.
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 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.
We expect to recognize this stock-based compensation expense related to stock options and restricted stock over a weighted-average period of 1.9 years. 77 Table of Contents Research and Development Expenses The following table summarizes our direct research and development expenses by clinical development program and other significant categories of research and development expenses.
We expect to recognize this stock-based compensation expense related to stock options and restricted stock over weighted-average periods of 1.7 years and 2.3 years, respectively. 81 Table of Contents Research and Development Expenses The following table summarizes our direct research and development expenses by clinical development program and other significant categories of research and development expenses.
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.
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 76 Table of Contents the Company of being achieved.
We were in compliance with all such covenants as of December 31, 2024. Additional Funding Requirements The amount required to fund operations will depend on various factors, including the potential regulatory approval and commercialization of our product candidates and the timing thereof and the extent and cost of our research and development programs.
Additional Funding Requirements The amount required to fund operations will depend on various factors, including the potential regulatory approval and commercialization of our product candidates and the timing thereof and the extent and cost of our research and development programs.
In February 2025, our board of directors authorized a share repurchase program to repurchase up to an additional $3.0 billion of our Common Stock.
Share Repurchase Programs Our board of directors has authorized share repurchase programs, including a share repurchase program for up to $3.0 billion of our Common Stock which was authorized in February 2025.
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 Sanofi Collaboration Revenue Year Ended December 31, (In millions) 2024 2023 2022 Antibody: Regeneron's share of profits $ 3,923.5 $ 3,136.5 $ 2,082.0 Sales-based milestones earned — 50.0 100.0 Reimbursement for manufacturing of commercial supplies (a) 607.9 613.0 633.7 Other — — 28.7 Total Antibody 4,531.4 3,799.5 2,844.4 Total Immuno-oncology (b) — — 11.3 Total Sanofi collaboration revenue $ 4,531.4 $ 3,799.5 $ 2,855.7 (a) Corresponding costs incurred by the Company in connection with such manufacturing is recorded within Cost of collaboration and contract manufacturing.
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, 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 Provisions 2,751.7 421.1 119.7 3,292.5 Credits/payments (2,659.2) (400.7) (122.2) (3,182.1) Balance as of December 31, 2025 $ 631.6 $ 148.2 $ 91.0 $ 870.8 Sanofi Collaboration Revenue Year Ended December 31, (In millions) 2025 2024 2023 Regeneron's share of profits $ 5,241.6 $ 3,923.5 $ 3,136.5 Sales-based milestones earned — — 50.0 Reimbursement for manufacturing of commercial supplies (a) 642.4 607.9 613.0 Total Sanofi collaboration revenue $ 5,884.0 $ 4,531.4 $ 3,799.5 (a) Corresponding costs incurred by the Company in connection with such manufacturing is recorded within Cost of collaboration and contract manufacturing Global net product sales of Dupixent and Kevzara are recorded by Sanofi, and we and Sanofi share profits on such sales.
Year Ended December 31, $ Change (In millions) 2024 2023 * 2022 * 2024 vs. 2023 2023 vs. 2022 Direct research and development expenses: Fianlimab $ 215.5 $ 112.2 $ 43.4 $ 103.3 $ 68.8 Linvoseltamab 141.9 78.7 45.5 63.2 33.2 Ordspono (odronextamab) 129.4 96.3 66.0 33.1 30.3 Dupixent (dupilumab) 128.8 168.0 156.5 (39.2) 11.5 EYLEA HD (aflibercept) 8 mg 98.3 96.2 67.9 2.1 28.3 Itepekimab 96.2 70.3 26.5 25.9 43.8 Pozelimab 79.4 60.2 72.4 19.2 (12.2) Libtayo (cemiplimab) 79.1 105.3 138.0 (26.2) (32.7) Other product candidates in clinical development and other research programs 620.2 508.4 426.7 111.8 81.7 Total direct research and development expenses 1,588.8 1,295.6 1,042.9 293.2 252.7 Indirect research and development expenses: Payroll and benefits 1,681.7 1,537.0 1,195.5 144.7 341.5 Lab supplies and other research and development costs 241.5 210.6 181.0 30.9 29.6 Occupancy and other operating costs 614.9 518.2 508.5 96.7 9.7 Total indirect research and development expenses 2,538.1 2,265.8 1,885.0 272.3 380.8 Clinical manufacturing costs 1,195.9 1,053.9 938.3 142.0 115.6 Reimbursement of research and development expenses by collaborators (190.8) (176.3) (273.7) (14.5) 97.4 Total research and development expenses $ 5,132.0 $ 4,439.0 $ 3,592.5 $ 693.0 $ 846.5 * Certain prior year amounts have been reclassified to conform to the current year's presentation. 78 Table of Contents Research and development expenses included stock-based compensation expense of $543.8 million and $488.7 million in 2024 and 2023, respectively.
Year Ended December 31, $ Change (In millions) 2025 2024 * 2023 * 2025 vs. 2024 2024 vs. 2023 Direct research and development expenses: Fianlimab $ 207.9 $ 215.5 $ 112.2 $ (7.6) $ 103.3 Lynozyfic (linvoseltamab) 166.0 141.9 78.7 24.1 63.2 Ordspono (odronextamab) 165.4 129.4 96.3 36.0 33.1 Itepekimab 111.8 96.2 70.3 15.6 25.9 Dupixent (dupilumab) 111.2 128.8 168.0 (17.6) (39.2) EYLEA HD (aflibercept) 8 mg 90.4 98.3 96.2 (7.9) 2.1 Libtayo (cemiplimab) 76.1 79.1 105.3 (3.0) (26.2) Trevogrumab 73.7 33.0 1.5 40.7 31.5 Pozelimab/cemdisiran 67.2 79.4 60.2 (12.2) 19.2 Other product candidates in clinical development and other research programs 688.4 587.2 506.9 101.2 80.3 Total direct research and development expenses 1,758.1 1,588.8 1,295.6 169.3 293.2 Indirect research and development expenses: Payroll and benefits 1,800.8 1,681.7 1,537.0 119.1 144.7 Lab supplies and other research and development costs 258.2 241.5 210.6 16.7 30.9 Occupancy and other operating costs 635.4 614.9 518.2 20.5 96.7 Total indirect research and development expenses 2,694.4 2,538.1 2,265.8 156.3 272.3 Clinical manufacturing costs 1,391.2 1,195.9 1,053.9 195.3 142.0 Priority review voucher 155.0 — — 155.0 — Reimbursement of research and development expenses by collaborators (148.5) (190.8) (176.3) 42.3 (14.5) Total research and development expenses $ 5,850.2 $ 5,132.0 $ 4,439.0 $ 718.2 $ 693.0 * Certain prior year amounts have been reclassified to conform to the current year's presentation 82 Table of Contents Research and development expenses included stock-based compensation expense of $545.4 million and $543.8 million in 2025 and 2024, respectively.
As of December 31, 2024, unrecognized stock-based compensation expense related to unvested stock options and unvested restricted stock (including performance-based restricted stock units) was $626.7 million and $1.271 billion, respectively.
As of December 31, 2025, unrecognized stock-based compensation expense related to unvested stock options and unvested restricted stock was $385.8 million and $1.493 billion, respectively.
For information related to repurchases of Common Stock, see " Share Repurchase Programs " section below. 81 Table of Contents 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").
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").
In addition, payments in connection with Common Stock tendered for employee tax obligations were $1.029 billion during 2024, compared to $700.6 million during 2023 and $445.7 million during 2022.
In addition, payments in connection with Common Stock tendered for employee tax obligations were $532.1 million during 2025, compared to $1.029 billion during 2024 and $700.6 million during 2023. For information related to repurchases of Common Stock, see "Share Repurchase Programs" section below.
Regeneron's share of profits in connection with commercialization of EYLEA 8 mg and EYLEA outside the United States is summarized below: Year Ended December 31, (In millions) 2024 2023 2022 EYLEA 8 mg and EYLEA net product sales outside the United States $ 3,576.8 $ 3,495.2 $ 3,382.8 Regeneron's share of collaboration profit from sales outside the United States $ 1,469.7 $ 1,436.1 $ 1,375.1 Reimbursement of development expenses incurred by Bayer in accordance with Regeneron's payment obligation (a) (66.4) (59.7) (57.7) Regeneron's share of profits $ 1,403.3 $ 1,376.4 $ 1,317.4 Regeneron's share of profits as a percentage of EYLEA 8 mg and EYLEA net product sales outside the United States 39% 39% 39% (a) See "Liquidity and Capital Resources - Additional Funding Requirements" below for additional details on our contingent reimbursement obligation. 76 Table of Contents Roche Collaboration Revenue Year Ended December 31, (In millions) 2024 2023 2022 Regeneron's share of profits $ 1.4 $ 224.3 $ 627.3 Other — (13.3) — Total Roche collaboration revenue $ 1.4 $ 211.0 $ 627.3 Roche distributes and records net product sales of Ronapreve outside the United States, and the parties share gross profits from sales based on a pre-specified formula.
Regeneron's share of profits in connection with commercialization of EYLEA 8 mg and EYLEA outside the United States is summarized below: Year Ended December 31, (In millions) 2025 2024 2023 EYLEA 8 mg and EYLEA net product sales outside the United States $ 3,506.3 $ 3,576.8 $ 3,495.2 Regeneron's share of collaboration profit from sales outside the United States $ 1,347.3 $ 1,469.7 $ 1,436.1 Reimbursement of development expenses incurred by Bayer in accordance with Regeneron's payment obligation (a) (64.6) (66.4) (59.7) Regeneron's share of profits $ 1,282.7 $ 1,403.3 $ 1,376.4 Regeneron's share of profits as a percentage of EYLEA 8 mg and EYLEA net product sales outside the United States 37% 39% 39% (a) See "Liquidity and Capital Resources - Additional Funding Requirements" below for additional details on our contingent reimbursement obligation The decrease in our share of profits for the year ended December 31, 2025, compared to the same period in 2024, was primarily driven by lower profits associated with a decrease in EYLEA sales outside the United States.
If we subsequently determine 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. See Note 13 to our Consolidated Financial Statements for stock-based compensation expense and related assumptions used in determining the fair value of our awards.
If we subsequently determine 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.
We are unable to reasonably estimate if our product candidates in clinical development will generate material product revenues and net cash inflows. Acquired In-process Research and Development ("IPR&D") Expenses Acquired IPR&D expense in 2024 included a $45.0 million development milestone in connection with our collaboration agreement with Sonoma Biotherapeutics, Inc.
We are unable to reasonably estimate if our product candidates in clinical development will generate material product revenues and net cash inflows. Acquired In-Process Research and Development ("IPR&D") Expenses Acquired IPR&D expenses in 2025 included an $80.0 million up-front payment in connection with our license agreement with Hansoh Pharmaceuticals Group Company Limited.
As of December 31, 2024, our contingent reimbursement obligation to Sanofi in connection with the companies' Antibody Collaboration was approximately $1.635 billion and our contingent reimbursement obligation to Bayer was approximately $315 million.
As of December 31, 2025, our contingent reimbursement obligation to Sanofi in connection with the development balance was approximately $595 million and our contingent reimbursement obligation to Bayer was approximately $296 million.
Net product sales of Ronapreve outside the United States declined as a result of new variants of the SARS-CoV-2 virus emerging that are not susceptible to the treatment. Other Revenue Other revenue in 2024 and 2023 included $328.6 million and $247.6 million, respectively, of royalties and share of profits earned in connection with license agreements.
Net product sales of Ronapreve outside the United States declined as a result of new variants of the SARS-CoV-2 virus emerging that are not susceptible to the treatment.
The estimates are revised, if necessary, in subsequent periods if our actual share of profits or losses differ from those estimates. Stock-based Compensation We recognize stock-based compensation expense for equity grants under our long-term incentive plans to employees and non-employee members of our board of directors (as applicable) based on the grant-date fair value of those awards.
Stock-based Compensation We recognize stock-based compensation expense for equity grants under our long-term incentive plans to employees and non-employee members of our board of directors 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.
Antibody Global net product sales of Dupixent and Kevzara are recorded by Sanofi, and we and Sanofi share profits on such sales. 75 Table of Contents Regeneron's share of profits in connection with the commercialization of Dupixent and Kevzara is summarized below: Year Ended December 31, (In millions) 2024 2023 2022 Dupixent and Kevzara net product sales $ 14,606.7 $ 11,974.0 $ 9,039.2 Regeneron's share of collaboration profits in connection with commercialization of antibodies 4,527.2 3,596.3 2,405.5 Reimbursement of development expenses incurred by Sanofi in accordance with Regeneron's payment obligation (a) (603.7) (459.8) (266.6) One-time payment in connection with amendment to the Antibody License and Collaboration Agreement — — (56.9) Regeneron's share of profits $ 3,923.5 $ 3,136.5 $ 2,082.0 Regeneron's share of profits as a percentage of Dupixent and Kevzara net product sales 27% 26% 23% (a) See "Liquidity and Capital Resources - Additional Funding Requirements" below for additional details on our contingent reimbursement obligation.
Regeneron's share of profits in connection with the commercialization of Dupixent and Kevzara is summarized below: Year Ended December 31, (In millions) 2025 2024 2023 Dupixent and Kevzara net product sales $ 18,381.3 $ 14,606.7 $ 11,974.0 Regeneron's share of collaboration profits in connection with commercialization of antibodies 6,171.3 4,527.2 3,596.3 Reimbursement of development expenses incurred by Sanofi in accordance with Regeneron's payment obligation (a) (929.7) (603.7) (459.8) Regeneron's share of profits $ 5,241.6 $ 3,923.5 $ 3,136.5 Regeneron's share of profits as a percentage of Dupixent and Kevzara net product sales 29% 27% 26% (a) See "Liquidity and Capital Resources - Additional Funding Requirements" below for additional details on our contingent reimbursement obligation The increase in our share of profits during the year ended December 31, 2025, compared to 2024, was driven by higher profits primarily associated with an increase in Dupixent sales. 79 Table of Contents Bayer Collaboration Revenue Year Ended December 31, (In millions) 2025 2024 2023 Regeneron's share of profits $ 1,282.7 $ 1,403.3 $ 1,376.4 Reimbursement for manufacturing of commercial supplies (a) 139.7 95.7 111.1 Total Bayer collaboration revenue $ 1,422.4 $ 1,499.0 $ 1,487.5 (a) Corresponding costs incurred by the Company in connection with such manufacturing is recorded within Cost of collaboration and contract manufacturing Bayer records net product sales of EYLEA 8 mg and EYLEA outside the United States, and we and Bayer share profits on such sales.
Income Taxes We recognize deferred tax assets and liabilities 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.
See Note 13 to our Consolidated Financial Statements for stock-based compensation expense and related assumptions used in determining the fair value of our awards. 75 Table of Contents Income Taxes We recognize deferred tax assets and liabilities 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 Net CFC Tested Income (“NCTI”) (formerly known as global intangible low-taxed income ("GILTI")) inclusions.
We continue to evaluate additional guidance released by the OECD, along with the pending legislative adoption by additional countries. 80 Table of Contents Liquidity and Capital Resources Our financial condition is summarized as follows: As of December 31, (In millions) 2024 2023 $ Change Financial assets: Cash and cash equivalents $ 2,488.2 $ 2,730.0 $ (241.8) Marketable securities - current 6,524.3 8,114.8 (1,590.5) Marketable securities - noncurrent 8,900.1 5,396.5 3,503.6 $ 17,912.6 $ 16,241.3 $ 1,671.3 Working capital: Current assets $ 18,660.9 $ 19,479.2 $ (818.3) Current liabilities 3,944.3 3,423.4 520.9 $ 14,716.6 $ 16,055.8 $ (1,339.2) Borrowings and finance lease liabilities: Long-term debt $ 1,984.4 $ 1,982.9 $ 1.5 Finance lease liabilities $ 720.0 $ 720.0 $ — As of December 31, 2024, we also had borrowing availability of $750.0 million under a revolving credit facility (see further description under " Credit Facility " below).
Our effective tax rate for 2024 was positively impacted, compared to the U.S. federal statutory rate, primarily by stock-based compensation, income earned in foreign jurisdictions with tax rates lower than the U.S. federal statutory rate, and federal tax credits for research activities. 84 Table of Contents Liquidity and Capital Resources Our financial condition is summarized as follows: As of December 31, (In millions) 2025 2024 $ Change Financial assets: Cash and cash equivalents $ 3,118.1 $ 2,488.2 $ 629.9 Marketable securities - current 5,487.1 6,524.3 (1,037.2) Marketable securities - noncurrent 10,260.6 8,900.1 1,360.5 $ 18,865.8 $ 17,912.6 $ 953.2 Working capital: Current assets $ 18,021.9 $ 18,660.9 $ (639.0) Current liabilities 4,368.4 3,944.3 424.1 $ 13,653.5 $ 14,716.6 $ (1,063.1) Borrowings and finance lease liabilities: Long-term debt $ 1,985.9 $ 1,984.4 $ 1.5 Finance lease liabilities $ 720.0 $ 720.0 $ — As of December 31, 2025, we also had borrowing availability of $750.0 million under a revolving credit facility (see further description under " Credit Facility " below).
There is uncertainty surrounding whether or when new products or new indications for marketed products will receive regulatory approval or, if any such approval is received, whether we will be able to successfully commercialize such products and whether or when they may become profitable. 70 Table of Contents Critical Accounting Estimates The preparation of financial statements in accordance with accounting principles generally accepted in the United States of America ("GAAP") requires management to make estimates and assumptions that affect reported amounts and related disclosures in the financial statements.
There is uncertainty surrounding whether or when new products or new indications for marketed products will receive regulatory approval or, if any such approval is received, whether we will be able to successfully commercialize such products and whether or when they may become profitable.
The assumptions used in computing the fair value of equity awards reflect our best estimates but involve uncertainties related to market and other conditions, many of which are outside our control. Changes in any of these assumptions may materially affect the fair value of awards granted and the amount of stock-based compensation recognized in future periods.
This estimate is reviewed at least annually and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. The assumptions used in computing the fair value of equity awards reflect our best estimates but involve uncertainties related to market and other conditions, many of which are outside our control.
As additional information becomes available, or, based on specific events such as the outcome of litigation or settlement of claims, we reassess the potential liability related to pending claims and litigation, and may change our estimates. 73 Table of Contents Results of Operations Net Income Year Ended December 31, (In millions, except per share data) 2024 2023 2022 Revenues $ 14,202.0 $ 13,117.2 $ 12,172.9 Operating expenses 10,211.3 9,070.1 7,434.0 Income from operations 3,990.7 4,047.1 4,738.9 Other income (expense) 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 - diluted $ 38.34 $ 34.77 $ 38.22 Revenues Year Ended December 31, $ Change (In millions) 2024 2023 2022 2024 vs. 2023 2023 vs. 2022 Net product sales: EYLEA HD - U.S. $ 1,201.1 $ 165.8 $ — $ 1,035.3 $ 165.8 EYLEA - U.S. 4,767.1 5,719.6 6,264.6 (952.5) (545.0) Total EYLEA HD and EYLEA - U.S. 5,968.2 5,885.4 6,264.6 82.8 (379.2) Libtayo - U.S. 787.3 538.8 374.5 248.5 164.3 Libtayo - ROW (a) 429.5 324.3 73.0 105.2 251.3 Total Libtayo - Global 1,216.8 863.1 447.5 353.7 415.6 Praluent - U.S. 241.7 182.4 130.0 59.3 52.4 Evkeeza - U.S. 125.7 77.3 48.6 48.4 28.7 Inmazeb - U.S. 76.8 69.8 3.0 7.0 66.8 Total net product sales $ 7,629.2 $ 7,078.0 $ 6,893.7 $ 551.2 $ 184.3 Collaboration revenue: Sanofi $ 4,531.4 $ 3,799.5 $ 2,855.7 $ 731.9 $ 943.8 Bayer 1,499.0 1,487.5 1,430.7 11.5 56.8 Roche 1.4 211.0 627.3 (209.6) (416.3) Other 26.0 5.1 0.4 20.9 4.7 Other revenue 515.0 536.1 365.1 (21.1) 171.0 Total revenues $ 14,202.0 $ 13,117.2 $ 12,172.9 $ 1,084.8 $ 944.3 (a) Effective July 1, 2022, we obtained the exclusive right to develop, commercialize, and manufacture Libtayo worldwide under an Amended and Restated Immuno-oncology License and Collaboration Agreement with Sanofi ("A&R IO LCA") and, as a result, we began recording net product sales of Libtayo outside the United States as of such date.
Results of Operations Net Income Year Ended December 31, (In millions, except per share data) 2025 2024 2023 Revenues $ 14,342.9 $ 14,202.0 $ 13,117.2 Operating expenses 10,765.0 10,211.3 9,070.1 Income from operations 3,577.9 3,990.7 4,047.1 Other income (expense) 1,652.8 789.2 152.2 Income before income taxes 5,230.7 4,779.9 4,199.3 Income tax expense 725.8 367.3 245.7 Net income $ 4,504.9 $ 4,412.6 $ 3,953.6 Net income per share - diluted $ 41.48 $ 38.34 $ 34.77 77 Table of Contents Revenues Year Ended December 31, $ Change (In millions) 2025 2024 2023 2025 vs. 2024 2024 vs. 2023 Net product sales: EYLEA HD - U.S. $ 1,636.9 $ 1,201.1 $ 165.8 $ 435.8 $ 1,035.3 EYLEA - U.S. 2,747.8 4,767.1 5,719.6 (2,019.3) (952.5) Total EYLEA HD and EYLEA - U.S. 4,384.7 5,968.2 5,885.4 (1,583.5) 82.8 Libtayo - U.S. 944.7 787.3 538.8 157.4 248.5 Libtayo - ROW 507.5 429.5 324.3 78.0 105.2 Total Libtayo - Global 1,452.2 1,216.8 863.1 235.4 353.7 Praluent - U.S. 262.5 241.7 182.4 20.8 59.3 Evkeeza - U.S. 162.2 125.7 77.3 36.5 48.4 Inmazeb - U.S. 37.4 76.8 69.8 (39.4) 7.0 Other products - Global 10.1 — — 10.1 — Total net product sales $ 6,309.1 $ 7,629.2 $ 7,078.0 $ (1,320.1) $ 551.2 Collaboration revenue: Sanofi $ 5,884.0 $ 4,531.4 $ 3,799.5 $ 1,352.6 $ 731.9 Bayer 1,422.4 1,499.0 1,487.5 (76.6) 11.5 Roche — 1.4 211.0 (1.4) (209.6) Other 24.8 26.0 5.1 (1.2) 20.9 Other revenue 702.6 515.0 536.1 187.6 (21.1) Total revenues $ 14,342.9 $ 14,202.0 $ 13,117.2 $ 140.9 $ 1,084.8 Net Product Sales Net product sales of EYLEA HD increased in 2025 compared to 2024, due to higher sales volumes, partly offset by a lower net selling price.
We use the Black-Scholes model to compute the estimated fair value of stock option awards.
Changes in any of these assumptions may materially affect the fair value of awards granted and the amount of stock-based compensation recognized in future periods. We use the Black-Scholes model to compute the estimated fair value of stock option 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.
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.
The share repurchase program was approved under terms substantially similar to the repurchase programs described above. 82 Table of Contents Dividend In February 2025, our board of directors declared our first quarterly cash dividend, in the amount of $0.88 per share on our Common Stock and Class A Stock.
Each quarterly dividend was paid to our shareholders in the quarter in which the dividend was declared. 86 Table of Contents Additionally, in January 2026, our board of directors declared a cash dividend of $0.94 per share on our Common Stock and Class A Stock.
Other Operating Expense (Income) Other operating expense (income), net, in 2024 reflected a charge of $53.4 million related to the increase in the estimated fair value of the contingent consideration liability recognized in connection with our 2023 acquisition of Decibel Therapeutics, Inc. 79 Table of Contents Other Income (Expense) Other income (expense) consists of the following: Year Ended December 31, (In millions) 2024 2023 2022 Unrealized gains (losses) on equity securities, net $ 117.7 $ (237.8) $ (39.8) Interest income 711.4 495.9 160.1 Foreign currency (losses) gains, net (0.5) (12.9) 50.2 Other 15.8 (20.0) 8.8 Other income (expense), net 844.4 225.2 179.3 Interest expense (55.2) (73.0) (59.4) Total other income (expense) $ 789.2 $ 152.2 $ 119.9 Income Taxes Year Ended December 31, (In millions, except effective tax rate) 2024 2023 2022 Income tax expense $ 367.3 $ 245.7 $ 520.4 Effective tax rate 7.7% 5.9% 10.7% Our effective tax rate for 2024 and 2023 was positively impacted, compared to the U.S. federal statutory rate, primarily by stock-based compensation, income earned in foreign jurisdictions with tax rates lower than the U.S. federal statutory rate, and federal tax credits for research activities.
Other Operating (Income) Expense Other operating (income) expense, net, in 2024 reflected a charge of $53.4 million related to the increase in the estimated fair value of the contingent consideration liability recognized in connection with our 2023 acquisition of Decibel Therapeutics, Inc. 83 Table of Contents Other Income (Expense) Year Ended December 31, (In millions) 2025 2024 * 2023 * Gains (losses) on marketable and other securities, net $ 946.1 $ 118.3 $ (266.4) Interest income 716.8 711.4 495.9 Other 33.7 14.7 (4.3) Other income (expense), net 1,696.6 844.4 225.2 Interest expense (43.8) (55.2) (73.0) Total other income (expense) $ 1,652.8 $ 789.2 $ 152.2 * Certain prior year amounts have been reclassified to conform to the current year's presentation Income Taxes Year Ended December 31, (In millions, except effective tax rate) 2025 2024 2023 Income tax expense $ 725.8 $ 367.3 $ 245.7 Effective tax rate 13.9% 7.7% 5.9% On July 4, 2025, bill H.R. 1, commonly referred to as the "One Big Beautiful Bill Act" or "OBBBA," was signed into law, with certain provisions effective in 2025 and other provisions becoming effective in 2026.
In addition, in September 2024, we acquired an approximate 1,000,000 square foot facility in Saratoga Springs, New York. We expect to incur capital expenditures of $850 million to $975 million in 2025, including in connection with the continued expansion of our facilities in Tarrytown, New York.
We expect to incur capital expenditures of $1.100 billion to $1.300 billion in 2026, including in connection with the continued expansion of our facilities in Tarrytown, New York and developing our property in Saratoga Springs, New York for production support activities and additional manufacturing capacity.
Acquired IPR&D expense in 2023 included a $100.0 million development milestone in connection with our collaboration agreement with Alnylam Pharmaceuticals, Inc., a $45.0 million up-front payment in connection with our collaboration agreement with Sonoma, and a $30.0 million charge to extend the period for selecting targets under our collaboration agreement with Intellia Therapeutics, Inc.
Acquired IPR&D expenses in 2024 included a $45.0 million development milestone in connection with our collaboration agreement with Sonoma Biotherapeutics, Inc.
Sources and Uses of Cash for the Years Ended December 31, 2024, 2023, and 2022 Year Ended December 31, $ Change (In millions) 2024 2023 2022 2024 vs. 2023 2023 vs. 2022 Cash flows provided by operating activities $ 4,420.5 $ 4,594.0 $ 5,014.9 $ (173.5) $ (420.9) Cash flows used in investing activities $ (2,468.1) $ (3,185.1) $ (3,784.6) $ 717.0 $ 599.5 Cash flows used in financing activities $ (2,200.5) $ (1,790.1) $ (1,009.0) $ (410.4) $ (781.1) Cash Flows from Investing Activities Capital expenditures in 2024 included costs incurred in connection with the expansion of our research, preclinical manufacturing, and support facilities at our Tarrytown, New York corporate headquarters, as well as costs associated with the expansion of our manufacturing facilities in Rensselaer, New York (including the fill/finish facility).
Sources and Uses of Cash Year Ended December 31, $ Change (In millions) 2025 2024 2023 2025 vs. 2024 2024 vs. 2023 Cash flows provided by (used in): Operating activities $ 4,978.9 $ 4,420.5 $ 4,594.0 $ 558.4 $ (173.5) Investing activities $ (629.1) $ (2,468.1) $ (3,185.1) $ 1,839.0 $ 717.0 Financing activities $ (3,715.4) $ (2,200.5) $ (1,790.1) $ (1,514.9) $ (410.4) Cash Flows from Operating Activities In 2025, Other, net included a $155.0 million charge in connection with a fourth quarter 2025 decision to utilize a PRV for a regulatory submission; such amount was previously capitalized as an intangible asset as described in the " Cash Flows from Investing Activities " section below.
The Lease is classified as a finance lease as we have 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 our Credit Agreement.
Such financial covenants and certain of the operating covenants are substantially similar to the covenants set forth in our Credit Agreement. We were in compliance with all such covenants as of December 31, 2025.
We expect continued significant capital expenditures over the next several years related to this expansion. Payments for the Libtayo intangible asset of $125.7 million, $207.8 million, and $1.027 billion in 2024, 2023, and 2022, respectively, related to our acquisition (including contingent consideration paid) of the exclusive right to develop, commercialize, and manufacture Libtayo worldwide.
In addition, payments for intangible assets in 2025, 2024, and 2023 included $160.3 million, $125.7 million, and $207.8 million, respectively, for contingent consideration paid to Sanofi in connection with our acquisition of worldwide rights to Libtayo in 2022.
Selling, general, and administrative expenses also included stock-based compensation expense of $355.0 million and $307.1 million in 2024 and 2023, respectively. Cost of Goods Sold Cost of goods sold increased in 2024, compared to 2023, primarily due to higher start-up costs for our Rensselaer, New York fill/finish facility.
We have also recently committed to matching donations for up to a total of $200 million during 2026. Selling, general, and administrative expenses included stock-based compensation expense of $362.9 million and $355.0 million in 2025 and 2024, respectively.
There can be no assurance as to the timing or number of shares of any repurchases in the future. The table below summarizes the shares of our Common Stock that we repurchased and the cost of such shares, which were recorded as Treasury Stock.
There can be no assurance as to the timing or number of shares of any repurchases in the future. As of December 31, 2025, $1.486 billion remained available for share repurchases under our share repurchase programs. Dividends In 2025, our board of directors declared quarterly cash dividends of $0.88 per share on our Common Stock and Class A Stock.
Removed
When we have a combined unit of account which includes a license and providing research and development services to our collaborator, recognition of up-front payments and development milestones earned from our 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 our research and development costs incurred relative to the total expected cost which determines the extent of our progress toward completion.
Added
Critical Accounting Estimates The preparation of financial statements in accordance with accounting principles generally accepted in the United States of America ("GAAP") requires management to make estimates and assumptions that affect reported amounts and related disclosures in the financial statements.
Removed
We review our estimates each period and make revisions to such estimates as necessary.
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Our collaborators provide us with estimates of product sales and our share of profits or losses, as applicable, for each quarter. The estimates are revised, if necessary, in subsequent periods if our actual share of profits or losses differ from those estimates.
Removed
Due to the variability in the scope of activities and length of time necessary to develop a drug product, potential delays in development programs, changes to development plans and budgets as programs progress, including if we and our collaborators decide to expand or contract our clinical plans for a drug candidate in various disease indications, and uncertainty in the ultimate requirements to obtain governmental approval for commercialization, revisions to our estimates are likely to occur periodically, potentially resulting in material changes to amounts recognized.
Added
Payments to acquire intangible assets in an asset acquisition may include up-front payments and contingent consideration.
Removed
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.
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As additional information becomes available, or, based on specific events such as the outcome of litigation or settlement of claims, we reassess the potential liability related to pending claims and litigation, and may change our estimates.
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Net Product Sales Total EYLEA HD and EYLEA net product sales in the U.S. increased in 2024 compared to 2023. EYLEA HD was approved by the FDA in August 2023 and net product sales in 2024 were driven by the transition of patients from other anti-VEGF products, including EYLEA, as well as new patients naïve to anti-VEGF therapy.
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EYLEA HD was approved by the FDA in August 2023.
Removed
Net product sales of EYLEA HD and EYLEA in 2024 were adversely impacted by a lower net selling price compared to 2023. 74 Table of Contents Total EYLEA HD and EYLEA net product sales for the fourth quarter of 2024 were favorably impacted by approximately $85 million as a result of higher wholesaler inventory levels for EYLEA, partially offset by lower wholesaler inventory levels for EYLEA HD, at the end of the fourth quarter of 2024 compared to the end of the third quarter of 2024.
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Net product sales of EYLEA decreased in 2025 compared to 2024, due to (i) lower sales volumes as a result of continued competitive pressures (as described below), loss in market share to compounded bevacizumab due to patient affordability constraints, and the continued transition of patients to EYLEA HD, and (ii) a lower net selling price.
Removed
Revenue from product sales is recorded net of applicable provisions for rebates, chargebacks, and discounts; distribution-related fees; and other sales-related deductions.
Added
EYLEA net product sales have been, and are likely to continue to be, negatively impacted by increased competition from other anti-VEGF products, including biosimilars, as well as the transition of patients from EYLEA to EYLEA HD. The magnitude and duration of such impact is presently unknown. For more information, see Part I, Item 1A.
Removed
(b) As the A&R IO LCA became effective July 1, 2022, the six months ended June 30, 2022 was the last period in which Sanofi collaboration revenue was recognized in connection with the Immuno-oncology collaboration.
Added
"Risk Factors - Risks Related to Commercialization of Our Marketed Products, Product Candidates, and New Indications for Our Marketed Products - We are substantially dependent on the success of EYLEA HD, EYLEA, and Dupixent" and "The commercial success of our products and product candidates is subject to significant competition - Marketed Products." In addition, if independent not-for-profit patient assistance funds that provide copay assistance are unable to support eligible patients, this will likely have a continued negative impact on patient affordability resulting in lower utilization of higher-cost anti-VEGF agents. 78 Table of Contents Revenue from product sales is recorded net of applicable provisions for rebates, chargebacks, and discounts; distribution-related fees; and other sales-related deductions.
Removed
The increase in our share of profits during the year ended December 31, 2024, compared to 2023, was driven by higher profits associated with Dupixent sales.
Added
Roche Collaboration Revenue Under the terms of the Roche collaboration, Roche distributed and recorded net product sales of Ronapreve ™ outside the United States, and the parties shared gross profits from sales based on a pre-specified formula. In 2023, total Roche collaboration revenue was $211.0 million.
Removed
During the year ended December 31, 2023, we 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.
Added
Research and development expenses in 2025 included $155.0 million related to an FDA Rare Pediatric Disease Priority Review Voucher ("PRV"). During the fourth quarter of 2025, we made the decision to utilize the PRV for a regulatory submission; this PRV was purchased by us, and capitalized as an intangible asset, in the second quarter of 2025.
Removed
Bayer Collaboration Revenue Year Ended December 31, (In millions) 2024 2023 2022 Regeneron's share of profits $ 1,403.3 $ 1,376.4 $ 1,317.4 Reimbursement for manufacturing of ex-U.S. commercial supplies (a) 95.7 111.1 91.4 One-time payment in connection with change in Japan arrangement (b) — — 21.9 Total Bayer collaboration revenue $ 1,499.0 $ 1,487.5 $ 1,430.7 (a) Corresponding costs incurred by the Company in connection with such manufacturing is recorded within Cost of collaboration and contract manufacturing.
Added
Selling, General, and Administrative Expenses Selling, general, and administrative expenses decreased in 2025, compared to 2024, primarily due to lower charitable contributions to Good Days, an independent non-profit patient assistance organization with a Retinal Vascular and Neovascular Disease Fund (the "Fund").
Removed
(b) Effective January 1, 2022, the Company and Bayer commenced sharing equally in profits based on sales from Bayer to its distributor in Japan. Previously, the Company received from Bayer a tiered percentage of sales based on sales by Bayer's distributor in Japan. Bayer records net product sales of EYLEA 8 mg and EYLEA outside the United States.
Added
In July 2025, we launched a matching program for donations made to the Fund and committed to quarterly matching donations through the end of 2025. During the fourth quarter of 2025, we recognized approximately $60 million in connection with matching donations made to the Fund.
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Selling, General, and Administrative Expenses Selling, general, and administrative expenses increased in 2024, compared to 2023, due to higher commercialization-related expenses to support our launch of EYLEA HD and higher headcount and headcount-related costs partly related to our international commercial expansion.
Added
Cost of Goods Sold Year Ended December 31, (In millions, except gross margin on net product sales) 2025 2024 2023 Cost of goods sold $ 1,140.8 $ 1,087.3 $ 932.1 Gross margin on net product sales (a) 82% 86% 87% (a) Gross margin on net product sales represents gross profit expressed as a percentage of total net product sales recorded by the Company.
Removed
Certain countries in which we have operations, including Ireland, have adopted legislation influenced by the Organization for Economic Co-operation and Development ("OECD") Global Anti-Base Erosion Model Rules ("Pillar Two") framework, including a minimum tax rate of 15%.

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Item 7A. Quantitative and Qualitative Disclosures About Market Risk

Market Risk — interest-rate, FX, commodity exposure

8 edited+0 added−3 removed5 unchanged
Biggest changeOur investments in equity securities primarily include companies with which we have entered into collaboration arrangements. As of December 31, 2024, our marketable securities included $1.095 billion of equity securities. Changes in the fair value of our equity securities are included in Other income (expense), net on the Statements of Operations.
Biggest changeOur investments in equity securities include companies with which we have entered into collaboration and other strategic arrangements. As of December 31, 2025 and 2024, the carrying value of our investments in equity securities was $515.8 million and $1.307 billion, respectively.
We also incur worldwide development expenses for clinical products we are developing independently, incur expenses outside the United States in connection with our international operations, and record product sales of Libtayo outside the United States.
We also incur worldwide development expenses for product candidates we are developing independently, incur expenses outside the United States in connection with our international operations, and record product sales for certain products outside the United States.
We estimate that a 100 basis point, or 1%, unfavorable change in interest rates would have resulted in approximately a $163.0 million and $98.7 million decrease in the fair value of our investment portfolio as of December 31, 2024 and 2023, respectively.
We estimate that a 100 basis point, or 1%, unfavorable change in interest rates would have resulted in a $198.3 million and $163.0 million decrease in the fair value of our investment portfolio as of December 31, 2025 and 2024, respectively.
Foreign Exchange Risk Significant changes in foreign exchange rates of the countries outside the United States where our products are sold, where development expenses are incurred by us or our collaborators, or where we incur operating expenses may impact our operating results and financial condition. 84 Table of Contents As discussed further above, our collaborators market certain products outside the United States, and we share in profits and losses with these collaborators from commercialization of products.
Foreign Exchange Risk Significant changes in foreign exchange rates of the countries outside the United States where our products are sold or where operating expenses are incurred may impact our operating results and financial condition. Our collaborators market certain products outside the United States, and we share in profits with these collaborators from commercialization of products.
We have exposure to market risk for changes in interest rates, including the interest rate risk relating to our variable rate Tarrytown, New York lease (as described in Part II, Item 7. "Management's Discussion and Analysis of Financial Condition and Results of Operations - Liquidity and Capital Resources - Tarrytown, New York Corporate Headquarters Lease ").
In addition to our investments in marketable securities, we also have exposure to changes in interest rates in connection with our variable rate Tarrytown, New York lease (as described in Part II, Item 7. "Management's Discussion and Analysis of Financial Condition and Results of Operations - Liquidity and Capital Resources - Tarrytown, New York Corporate Headquarters Lease ").
Our interest rate exposure is offset by our investments in marketable securities. We continue to monitor our interest rate risk and may utilize derivative instruments and/or other strategies in the future to further mitigate our interest rate exposure.
Our interest rate exposure is offset by our investments in marketable securities. We continue to monitor our interest rate risk and may utilize derivative instruments and/or other strategies in the future to further mitigate our interest rate exposure. Credit Quality Risk We have an investment policy that includes guidelines on acceptable investment securities, minimum credit quality, maturity parameters, and diversification.
Credit Quality Risk We have an investment policy that includes guidelines on acceptable investment securities, minimum credit quality, maturity parameters, and concentration and diversification. Nonetheless, deterioration of the credit quality of an investment security subsequent to purchase may subject us to the risk of not being able to recover the full principal value of the security.
Nonetheless, deterioration of the credit quality of an investment security subsequent to purchase may subject us to the risk of not being able to recover the full principal value of the security.
We recorded $117.7 million of net unrealized gains and $237.8 million of net unrealized losses on equity securities in Other income (expense), net in 2024 and 2023, respectively. Item 8. Financial Statements and Supplementary Data The information required by this Item is set forth beginning on page F-1 of this report and is incorporated herein by reference. Item 9.
Changes in the fair value of our equity securities are included in Other income (expense), net on the Statements of Operations. 88 Table of Contents Item 8. Financial Statements and Supplementary Data The information required by this Item is set forth beginning on page F-1 of this report and is incorporated herein by reference. Item 9.
Removed
In 2024 and 2023, we did not recognize any charges for credit-related losses of our available-for-sale debt securities. We are subject to credit risk associated with the receivables due from our collaborators, including Sanofi and Bayer. We are also subject to credit risk in connection with trade accounts receivable due from our customers from our product sales.
Removed
As of December 31, 2024, two customers accounted on a combined basis for 79% of our net trade accounts receivables. We have contractual payment terms with each of our collaborators and customers, and also monitor financial performance and credit worthiness so that we can properly assess and respond to any changes in collaborator and/or customer credit profiles.
Removed
In 2024 and 2023, we did not recognize any charges for write-offs and allowances of accounts receivable related to credit risk for our collaborators or customers.

Other REGN 10-K year-over-year comparisons