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What changed in Regeneron Pharmaceuticals's 10-K — 2023 vs 2024

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Paragraph-level year-over-year comparison of Regeneron Pharmaceuticals's 2023 and 2024 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 2024 report.

+544 added−569 removedSource: 10-K (2025-02-05) vs 10-K (2024-02-05)

Top changes in Regeneron Pharmaceuticals's 2024 10-K

544 paragraphs added · 569 removed · 427 edited across 7 sections

Item 1. Business

Business — how the company describes what it does

134 edited+42 added−72 removed186 unchanged
Biggest changeFood and Drug Administration ("FDA") for wAMD, DME, and DR –Approved by European Commission ("EC") and Japan's Ministry of Health, Labour and Welfare ("MHLW") for wAMD and DME –Reported positive two-year data from Phase 3 studies in wAMD and DME –Initiate Phase 3 study in RVO (mid-2024) to enable FDA submission EYLEA (aflibercept) (a) –Approved by FDA for ROP Pozelimab (f) (REGN3918) Antibody to C5 –Initiate Phase 3 study in combination with cemdisiran in geographic atrophy (second half 2024) Immunology & Inflammation Dupixent (dupilumab) (b) Antibody to IL-4R alpha subunit –Ulcerative colitis –Eosinophilic gastroenteritis (Phase 2/3) –Chronic obstructive pulmonary disease ("COPD") (d) –Bullous pemphigoid (c) –Chronic spontaneous urticaria ("CSU") –Chronic pruritus of unknown origin –EoE in pediatrics (1–11 years of age) (EU) –COPD with type 2 inflammatory phenotype (U.S. and EU) –CSU in adults and adolescents (Japan) –Approved by EC for atopic dermatitis in pediatrics (6 months–5 years of age) –Approved by MHLW for atopic dermatitis in pediatrics and adolescents (6 months–14 years of age) –Approved by FDA for EoE in pediatrics (1–11 years of age) –Approved by EC for EoE in adults and adolescents –Approved by MHLW for prurigo nodularis –EC decision on regulatory submission for EoE in pediatrics (second half 2024) –FDA decision on supplemental Biologics License Application ("sBLA") (mid/second half 2024) and EC decision on regulatory submission (second half 2024) for COPD with type 2 inflammatory phenotype 7 Table of Contents Clinical Program (continued) Phase 1 Phase 2 Phase 3 Regulatory Review (h) 2023 and 2024 Events to Date Select Upcoming Milestones Dupixent (dupilumab) (b) (continued) –Reported that Phase 3 BOREAS trial in COPD with evidence of type 2 inflammation met its primary and all key secondary endpoints; presented at 2023 American Thoracic Society International Conference and published in New England Journal of Medicine –Reported that results from interim analysis of replicate Phase 3 NOTUS trial in COPD with evidence of type 2 inflammation met its primary endpoint –FDA issued Complete Response Letter ("CRL") for sBLA for CSU due to requirement for additional efficacy data –Phase 3 trial in chronic cold induced urticaria did not meet its required efficacy endpoints –Discontinued further clinical development in allergic fungal rhinosinusitis and chronic rhinosinusitis without nasal polyposis –MHLW decision on regulatory submission for CSU in adults and adolescents (first half 2024) –Report results from ongoing Phase 3 trial in CSU (in biologic-naïve patients) (fourth quarter 2024) –Report results from Phase 3 trial in bullous pemphigoid (second half 2024) –Initiate Phase 1 study in severe food allergy following transient linvoseltamab treatment (2024) Kevzara (sarilumab) (b) Antibody to IL-6R –Polyarticular-course juvenile idiopathic arthritis ("pcJIA") (pivotal study) –Systemic juvenile idiopathic arthritis ("sJIA") (pivotal study) –PMR (EU) –pcJIA (U.S. and EU) –Approved by FDA for PMR –EC decision on regulatory submission for PMR (second half 2024) –FDA decision on sBLA (target action date of June 10, 2024) and EC decision (second half 2024) on regulatory submission for pcJIA 8 Table of Contents Clinical Program (continued) Phase 1 Phase 2 Phase 3 Regulatory Review (h) 2023 and 2024 Events to Date Select Upcoming Milestones Itepekimab (b) (REGN3500) Antibody to IL-33 –COPD (e) –Phase 3 COPD program passed interim futility analysis conducted by Independent Data Monitoring Committee ("IDMC") –Report results from Phase 3 study in COPD (2025) REGN5713-5714-5715 Multi-antibody therapy to Bet v 1 –Birch allergy Solid Organ Oncology Libtayo (cemiplimab) (g) Antibody to PD-1 –Neoadjuvant CSCC –First-line NSCLC, BNT116 (r) combination –Adjuvant CSCC –Approved by EC for first-line NSCLC, chemotherapy combination –Conduct interim analysis from Phase 3 study in adjuvant CSCC (second half 2024) Fianlimab (f) (REGN3767) Antibody to LAG-3 –Solid tumors and advanced hematologic malignancies –First-line advanced NSCLC (Phase 2/3) (pivotal study) –First-line metastatic melanoma (e) –First-line adjuvant melanoma –Presented positive data from Phase 1 trial (in combination with Libtayo) in advanced melanoma at 2023 American Society of Clinical Oncology ("ASCO") Annual Meeting –Initiate potentially pivotal Phase 2 study (in combination with Libtayo) in perioperative melanoma (first half 2024) –Initiate Phase 2 study (in combination with Libtayo) in perioperative NSCLC (first half 2024) –Initiate Phase 2 study (in combination with Libtayo) in perioperative head and neck squamous cell carcinoma (2024) –Report potentially pivotal initial results from Phase 2/3 study in first-line metastatic melanoma (second half 2024) –Report initial data from Phase 2/3 study in first-line advanced NSCLC (second half 2024) Vidutolimod Immune activator targeting TLR9 –Solid tumors 9 Table of Contents Clinical Program (continued) Phase 1 Phase 2 Phase 3 Regulatory Review (h) 2023 and 2024 Events to Date Select Upcoming Milestones Ubamatamab (f) (REGN4018) Bispecific antibody targeting MUC16 and CD3 –Platinum-resistant ovarian cancer –Presented results from Phase 1/2 study (in combination with Libtayo) in platinum-resistant ovarian cancer at European Society for Medical Oncology ("ESMO") Congress REGN5668 (n) Bispecific antibody targeting MUC16 and CD28 –Platinum-resistant ovarian cancer REGN5678 Bispecific antibody targeting PSMA and CD28 –Prostate cancer –Discontinued enrollment in cohorts in combination with full-dose Libtayo (cemiplimab) –Expanded enrollment in monotherapy cohort –Initiate cohorts in combination with REGN4336 in metastatic castration-resistant prostate cancer (first half 2024) REGN4336 Bispecific antibody targeting PSMA and CD3 –Prostate cancer Davutamig (REGN5093) Bispecific antibody targeting two distinct MET epitopes –MET-altered advanced NSCLC REGN5093-M114 Bispecific antibody-drug conjugate targeting two distinct MET epitopes –MET overexpressing advanced cancer REGN6569 Antibody to GITR –Solid tumors REGN7075 Bispecific antibody targeting EGFR and CD28 –Solid tumors –Initiate dose-expansion cohorts (in combination with Libtayo) in EGFR-high tumors (first half 2024) 10 Table of Contents Clinical Program (continued) Phase 1 Phase 2 Phase 3 Regulatory Review (h) 2023 and 2024 Events to Date Select Upcoming Milestones Hematology Pozelimab (f) (REGN3918) Antibody to C5 –Myasthenia gravis, cemdisiran combination (c)(s) –Paroxysmal nocturnal hemoglobinuria ("PNH"), cemdisiran combination (c)(s) –Veopoz (pozelimab) approved by FDA for CHAPLE in adults and children aged 1 year and older, monotherapy Odronextamab (m) (REGN1979) Bispecific antibody targeting CD20 and CD3 –Certain B-cell malignancies (c) –B-cell non-Hodgkin lymphoma ("B-NHL") (pivotal study) –Follicular lymphoma ("FL") –Diffuse large B-cell lymphoma ("DLBCL") –Relapsed/refractory FL and DLBCL (U.S. and EU) –Presented updated data from trials in patients with relapsed/refractory FL and DLBCL at American Society of Hematology ("ASH") Annual Meeting –FDA decision on BLA (target action date of March 31, 2024) and EC decision on regulatory submission (second half 2024) for relapsed/refractory FL and DLBCL REGN5837 (p) Bispecific antibody targeting CD22 and CD28 –B-NHL Linvoseltamab (f) (REGN5458) Bispecific antibody targeting BCMA and CD3 –Multiple myeloma (c)(e) –Multiple myeloma (pivotal study) (c)(e) –Earlier (pre-malignant) multiple myeloma –Multiple myeloma (c)(e) –Relapsed/refractory multiple myeloma (U.S. and EU) –Presented updated positive data from pivotal trial in multiple myeloma at ASCO and ASH Annual Meetings –FDA decision on BLA (second half 2024) and EC decision on regulatory submission (first half 2025) for relapsed/refractory multiple myeloma REGN5459 (f) Bispecific antibody targeting BCMA and CD3 –Transplant desensitization in patients with chronic kidney disease REGN7257 Antibody to IL2Rg –Aplastic anemia NTLA-2001 (j) TTR gene knockout using CRISPR/Cas9 –Transthyretin ("ATTR") amyloidosis (c) –ATTR amyloidosis with cardiomyopathy ("ATTR-CM") REGN9933 Antibody to Factor XI –Thrombosis –Report results from Phase 2 study in thrombosis (second half 2024) REGN7508 Antibody to Factor XI –Thrombosis 11 Table of Contents Clinical Program (continued) Phase 1 Phase 2 Phase 3 Regulatory Review (h) 2023 and 2024 Events to Date Select Upcoming Milestones REGN7999 Antibody to TMPRSS6 –Transfusion dependent iron overload Internal Medicine/Genetic Medicines Praluent (alirocumab) Antibody to PCSK9 –HeFH in pediatrics and adolescents –HeFH in pediatrics and adolescents (8–17 years of age) (U.S.) –Approved by EC for HeFH in pediatrics and adolescents (8–17 years of age) –FDA decision on sBLA for HeFH in pediatrics and adolescents (target action date of March 10, 2024) Evkeeza (f)(l) (evinacumab) Antibody to ANGPTL3 –Approved by FDA and EC for HoFH in pediatrics (5–11 years of age) and MHLW for HoFH in adults, adolescents, and pediatrics Garetosmab (f) (REGN2477) Antibody to Activin A –Fibrodysplasia ossificans progressiva ("FOP") (c)(d)(e) Trevogrumab (f) (REGN1033) Antibody to myostatin (GDF8) –Initiate Phase 2 study in combination with semaglutide with and without garetosmab (mid-2024) Mibavademab (f) (REGN4461) Agonist antibody to leptin receptor ("LEPR") –Generalized lipodystrophy (d)(e) –Presented results from Phase 2 study in generalized lipodystrophy at ENDO 2023 REGN5381/REGN9035 Agonist antibody to NPR1/reversal agent to REGN5381 –Reversal agent in healthy volunteers –Heart failure –Resumed enrollment in previously paused Phase 1 and Phase 2 studies following protocol amendments –Reported positive initial data from Phase 1 trial in healthy volunteers REGN7544 Antagonist antibody to NPR1 –Healthy volunteers ALN-HSD (o) RNAi therapeutic targeting HSD17B13 –Nonalcoholic steatohepatitis ("NASH") 12 Table of Contents Clinical Program (continued) Phase 1 Phase 2 Phase 3 Regulatory Review (h) 2023 and 2024 Events to Date Select Upcoming Milestones ALN-PNP (k) RNAi therapeutic targeting PNPLA3 –NASH ALN-APP (k) RNAi therapeutic targeting APP –Early-onset Alzheimer’s disease (q) –Reported positive interim data from single dose part of Phase 1 trial in early-onset Alzheimer’s disease DB-OTO AAV-based gene therapy –Hearing loss in pediatrics (c) (Phase 1/2) –Reported preliminary, positive safety and efficacy results from first patient dosed in Phase 1/2 trial in pediatrics with hearing loss "Next Generation" Covid Antibody (i) Antibody to SARS-CoV-2 variants –Healthy volunteers REGN13335 Antagonist antibody to PDGF-B –Healthy volunteers 13 Table of Contents Note: For purposes of the table above, a program is classified in Phase 1, 2, or 3 clinical development after recruitment for the corresponding study or studies has commenced.
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.
The 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 the 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 30 novel genetic targets.
"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).
"Risk Factors - Risks Related to Commercialization of Our Marketed Products, Product Candidates, and New Indications for Our Marketed Products - Changes to product reimbursement and coverage policies and practices may materially harm our business, prospects, operating results, and financial condition.
"Risk Factors - Risks Related to Commercialization of Our Marketed Products, Product Candidates, and New Indications for Our Marketed Products - Changes to product reimbursement and coverage policies and practices may materially harm our business, prospects, operating results, and financial condition.
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 and Intellia Therapeutics, Inc.
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.
General Regeneron Pharmaceuticals, Inc. is a fully integrated biotechnology company that invents, develops, manufactures, and commercializes medicines for people with serious diseases. Our products and product candidates in development are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, hematologic conditions, infectious diseases, and rare diseases.
General Regeneron Pharmaceuticals, Inc. is a fully integrated biotechnology company that invents, develops, manufactures, and commercializes medicines for people with serious diseases. Our products and product candidates in development are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases, and rare diseases.
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. 18 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. 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.
Manufacturers must pay refunds to Medicare for single-source drugs or biological products, or biosimilar biological products, reimbursed under Medicare Part B and packaged in single-dose containers or single-use packages for units of discarded drug reimbursed by Medicare Part B in excess of 10 percent of total allowed charges under Medicare Part B for that drug.
Manufacturers must pay refunds to Medicare for single-source drugs or biological products, or biosimilar biological products, reimbursed under Medicare Part B and packaged in single-dose containers or single-use packages for units of discarded drug reimbursed by Medicare Part B in excess of 10% of total allowed charges under Medicare Part B for that drug.
Furthermore, the RGC has deployed bulk RNA sequencing, whole genome sequencing, and an O-LINK proteomic assay to complement whole exome sequencing and genotyping. In addition, the RGC leverages organoid models, siRNA, and CRISPR knockout models to validate genetic associations that lead to new therapeutic targets.
Furthermore, RGC has deployed bulk RNA sequencing, whole genome sequencing, and an O-LINK proteomic assay to complement whole exome sequencing and genotyping. In addition, RGC leverages organoid models, siRNA, and CRISPR knockout models to validate genetic associations that lead to new therapeutic targets.
We make available free of charge on or through our Internet website ( http://www.regeneron.com ) our Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, and, if applicable, amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Exchange Act, as soon as reasonably practicable after we electronically file such material with, or furnish it to, the Securities and Exchange Commission ("SEC").
Corporate Information We make available free of charge on or through our Internet website ( http://www.regeneron.com ) our Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, and, if applicable, amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Exchange Act, as soon as reasonably practicable after we electronically file such material with, or furnish it to, the Securities and Exchange Commission ("SEC").
HRSA also implemented a price reporting system under which we are required to report our 340B ceiling prices to HRSA on a quarterly basis, which then publishes those prices to 340B covered entities.
HRSA has also implemented a price reporting system under which we are required to report our 340B ceiling prices to HRSA on a quarterly basis, which then publishes those prices to 340B covered entities.
We are committed to meeting or exceeding all environmental, health, safety ("EHS") and security regulations and have a range of programs, plans, 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 2025 global responsibility goals include a commitment to focus on workplace injury prevention in our drive toward zero incidents.
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 our late-stage 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; • 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; • unanticipated expenses; • the costs of developing, producing, and selling products; 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 (such as the COVID-19 pandemic) on our business; and • 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), other 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), 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: • 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.
The conduct of clinical trials is subject to extensive regulation, including compliance with the FDA's bioresearch monitoring regulations and Good Clinical Practice requirements ("GCPs"), which establish standards for conducting, recording data from, and reporting the results of, clinical trials, and are intended to assure that the data and reported results are credible and accurate, and that the rights, safety, and well-being of study participants are protected.
The conduct of clinical trials is subject to extensive regulation, including compliance with the FDA's bioresearch monitoring regulations and Good Clinical Practice requirements ("GCPs"), which establish standards for recruiting for, conducting, recording data from, and reporting the results of, clinical trials, and are intended to assure that the data and reported results are credible, representative, and accurate, and that the rights, safety, and well-being of study participants are protected.
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 31 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 28 Table of Contents properly handle suspect and illegitimate products.
Before approving a new drug or biologic product, the FDA 29 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 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.
Total employee compensation packages (which vary by country and region) include market-competitive pay (with the opportunity to receive above-market rewards), broad-based grants of equity-based awards, comprehensive healthcare benefits, parental leave, child and elder care support, retirement savings options, and matching contributions in connection with employee savings plans.
Total employee compensation packages (which vary by country and region) include market-competitive pay (with the opportunity to receive above-market rewards), broad-based grants of stock-based awards, comprehensive healthcare benefits, parental leave, child and elder care support, retirement savings options, and matching contributions in connection with employee savings plans.
In 2023, the Together for CHANGE TM ("Changing Healthcare for People of African Ancestry through InterNational Genomics & Equity") initiative was launched by a coalition of Meharry Medical College, the Regeneron Genetics Center, AstraZeneca, Novo Nordisk, and Roche to improve health outcomes for people of African ancestry and enhance representation in STEM careers.
Also in 2023, the Together for CHANGE TM ("Changing Healthcare for People of African Ancestry through InterNational Genomics & Equity") initiative was launched by a coalition of Meharry Medical College, the Regeneron Genetics Center, AstraZeneca, Novo Nordisk, and Roche to improve health outcomes for people of African ancestry and enhance their representation in STEM careers.
We are also exploring a variety of alternative antibody formats (Altibodies ™ ) that can bring binding partners together in restrained geometries. The VelociT mouse extends our research and drug discovery capabilities into cell-mediated immunity and therapeutic TCRs for oncology and other indications.
We are also exploring a variety of alternative antibody formats (Altibodies ™ ) that can bring binding partners together in restrained geometries. The VelociT mouse extends our research and drug discovery capabilities into cell-mediated immunity and therapeutic T-cell receptors ("TCRs") for oncology and other indications.
Failure to timely pay a Part B inflation rebate is subject to a civil monetary penalty. 32 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. 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.
Post-approval modifications to 30 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 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.
Additionally, we have placed in the top five for the past 13 years in Science magazine’s annual "Top Employers Survey" of the global biotechnology and pharmaceutical industry. Compensation and Benefits We are committed to rewarding and supporting our employees in order to continue to attract and retain top talent.
Additionally, we have placed in the top five for the past 14 years in Science magazine’s annual "Top Employers Survey" of the global biotechnology and pharmaceutical industry. Compensation and Benefits We are committed to rewarding and supporting our employees in order to continue to attract and retain top talent.
Collaboration, License, and Other Agreements Sanofi Antibody 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 License and Collaboration Agreement (the "LCA"), 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 (the "Antibody Collaboration"). Under the terms of the Antibody Collaboration, Sanofi is generally responsible for funding 80% to 100% of agreed-upon development costs.
We had sales to two customers (Besse Medical, a subsidiary of Cencora, Inc., and McKesson Corporation) that each accounted for more than 10% of total gross product revenue for the year ended December 31, 2023.
We had sales to two customers (Besse Medical, a subsidiary of Cencora, Inc., and McKesson Corporation) that each accounted for more than 10% of total gross product revenue for the year ended December 31, 2024.
Rules that are equivalent in scope but which vary in application apply in other countries. 28 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. 25 Table of Contents Product Approval All of our product candidates require regulatory approval by relevant government authorities before they can be commercialized.
Medicare Part B generally covers drugs that must be administered by physicians or other health care practitioners; are provided in connection with certain durable medical equipment; or are certain oral anti-cancer drugs and certain oral immunosuppressive drugs. Medicare Part B pays for such drugs under a payment methodology based on the average sales price of the drugs.
Medicare Part B generally covers drugs that must be administered by physicians or other healthcare practitioners; are provided in connection with certain durable medical equipment; or are certain oral anti-cancer drugs and certain oral immunosuppressive drugs. Medicare Part B pays for such drugs under a payment methodology based on the average sales price of the drugs.
We communicate frequently and transparently with our employees through a variety of communication methods, including video and written communications, company forums and summits, annual engagement surveys, and pulse surveys. We are also committed to fostering employee volunteerism to reach our 2025 global responsibility goal of driving employee volunteer levels above national standards.
We communicate frequently and transparently with our employees through a variety of communication methods, including video and written communications, company forums and town halls, annual engagement surveys, and pulse surveys. We are also committed to fostering employee volunteerism to reach our 2025 global responsibility goal of driving employee volunteer levels above national standards.
The primary underpinning of our pay philosophy is to award equity-based pay to all eligible employees to ensure that when we deliver for patients and for shareholders, everyone shares in the upside growth. Our practice, therefore, has been to award initial equity grants to all new hires, in addition to our comprehensive annual equity program.
The primary underpinning of our pay philosophy is to award stock-based pay to all eligible employees to ensure that when we deliver for patients and for shareholders, everyone shares in the upside growth. Our practice, therefore, has been to award initial stock-based grants to all new hires, in addition to our comprehensive annual stock-based compensation program.
In the area of immunotherapies in oncology, we are exploring the use of bispecific antibodies that target tumor antigens and the CD3 receptor on T-cells to harness the oncolytic properties of T-cells. We are exploring additional indications and applications for our bispecific technologies, including a new class of CD28 and 4-1BB costimulatory bispecifics.
In the area of immunotherapies in oncology, we are exploring the use of bispecific antibodies that target tumor antigens and the CD3 receptor on T-cells to harness the oncolytic properties of T-cells. We are exploring additional indications and applications for our bispecific technologies, including CD28 and 4-1BB costimulatory bispecifics.
ATTR amyloidosis is a progressive and fatal disorder resulting from deposition of insoluble amyloid fibrils into multiple organs and tissues leading to systemic failure. Delivered with in vivo technology, NTLA-2001 offers the possibility of halting and reversing the disease by driving a deep, consistent, and potentially lifelong reduction in transthyretin ("TTR") protein after a single dose.
ATTR amyloidosis is a progressive and fatal disorder resulting from deposition of insoluble amyloid fibrils into multiple organs and tissues leading to systemic failure. Delivered with in vivo technology, nex-z offers the possibility of halting and reversing the disease by driving a deep, consistent, and potentially lifelong reduction in transthyretin ("TTR") protein after a single dose.
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 more than 2 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 nearly 3 million samples sequenced to date.
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.
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.
Dupixent (dupilumab) Dupixent is a fully human monoclonal antibody that inhibits signaling of the IL-4 and IL-13 pathways, and is not an immunosuppressant. IL-4 and IL-13 are key and central drivers of the type 2 inflammation that plays a major role in atopic dermatitis, asthma, CRSwNP, EoE, prurigo nodularis, and potentially other chronic allergic and inflammatory diseases, including COPD.
Dupixent (dupilumab) Dupixent is a fully human monoclonal antibody that inhibits signaling of the IL-4 and IL-13 pathways, and is not an immunosuppressant. IL-4 and IL-13 are key and central drivers of the type 2 inflammation that play a major role in atopic dermatitis, asthma, CRSwNP, COPD, EoE, prurigo nodularis, CSU, and potentially other chronic allergic and inflammatory diseases.
On a combined basis, our product sales to these customers accounted for 76% of our total gross product revenue for the year ended December 31, 2023. We promote approved medicines to healthcare professionals via our team of field employees, as well as medical journals, medical exhibitions, distribution of literature and samples, and online channels.
On a combined basis, our product sales to these customers accounted for 74% of our total gross product revenue for the year ended December 31, 2024. We promote approved medicines to healthcare professionals via our team of field employees, as well as medical journals, medical exhibitions, distribution of literature and samples, and online channels.
In 2023, we expanded our mentoring program and inclusive leadership workshops for senior leaders and new managers, focusing on our diverse talent base to increase leadership skills, connection, and visibility of underrepresented talent. While we are proud of our workforce diversity representation shown in the table below, we seek to continuously improve in this area.
In recent years, we have expanded our mentoring program and inclusive leadership workshops for senior leaders and new managers, focusing on our diverse talent base to increase leadership skills, connection, and visibility of underrepresented talent. While we are proud of our workforce diversity representation shown in the table below, we seek to continuously improve in this area.
In addition, we have developed a STEM pilot program with post-primary-school and high-school students in the New York State Capital Region and Limerick, Ireland that aspires to build long-term relationships with students from disadvantaged socio-economic groups, to encourage and support them in their studies, to inspire them to attend college, and, ultimately, to build a deeper more diverse talent pipeline.
Among our other efforts, we have developed a STEM pilot program with post-primary-school and high-school students in the New York State Capital Region and Limerick, Ireland that aspires to build long-term relationships with students from disadvantaged socio-economic groups, to encourage and support them in their studies, to inspire them to attend college, and, ultimately, to build a deeper more diverse talent pipeline.
(d) The Company is solely responsible for the development and commercialization of Praluent in the United States and Sanofi is responsible for the development and commercialization of Praluent outside the United States. (e) In collaboration with Roche. Product is known as REGEN-COV in the United States and Ronapreve ™ in other countries.
(b) In collaboration with Sanofi (c) The Company is solely responsible for the development and commercialization of Praluent in the United States and Sanofi is responsible for the development and commercialization of Praluent outside the United States. (d) In collaboration with Roche. Product is known as REGEN-COV in the United States and Ronapreve ™ in other countries.
Alnylam In 2019, we and Alnylam Pharmaceuticals, Inc. entered into a global, strategic 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 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.
Other Regulatory Requirements We are subject to health care "fraud and abuse" laws, such as the federal civil False Claims Act, the anti-kickback provisions of the federal Social Security Act, and other state and federal laws and regulations.
Other Regulatory Requirements We are subject to healthcare "fraud and abuse" laws, such as the federal civil False Claims Act, the anti-kickback provisions of the federal Social Security Act, and other state and federal laws and regulations.
Only) ** 30.5% * Based on full-time employees as of December 31, 2023 ** Represents the percentage of our full-time employees in the United States that self-identified as belonging to a racial or ethnic minority group. The denominator used in this calculation includes employees who did not disclose information related to their race or ethnicity.
Only) ** 31.6% * Based on full-time employees as of December 31, 2024 ** Represents the percentage of our full-time employees in the United States that self-identified as belonging to a racial or ethnic minority group. The denominator used in this calculation includes employees who did not disclose information related to their race or ethnicity.
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.
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.
In addition, we hold an ownership interest in thousands of patent applications in the United States and other countries. Our patent portfolio includes granted patents and pending patent applications covering our VelociSuite technologies, including our VelocImmune mouse platform which produces fully human antibodies. Our issued patents covering these technologies generally expire between 2022 and 2032.
In addition, we hold an ownership interest in thousands of patent applications in the United States and other countries. Our patent portfolio includes granted patents and pending patent applications covering our VelociSuite technologies, including our VelocImmune mouse platform which produces fully human antibodies. Our remaining issued patents covering these technologies will expire between 2025 and 2032.
Diversity, Equity, and Inclusion 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 achieve our leadership position in the biotechnology and pharmaceuticals industries and the global marketplace.
Certain of these patents may also be entitled to term extensions. We continue to pursue additional patents and patent term extensions in the United States and other jurisdictions covering various aspects of our products that may, if issued, extend exclusivity beyond the expiration of the patents listed in the table below.
We continue to pursue additional patents and patent term extensions in the United States and other jurisdictions covering various aspects of our products that may, if issued, extend exclusivity beyond the expiration of the patents listed in the table below.
The prescription drug plans negotiate pricing with manufacturers and pharmacies, and may condition formulary placement on the availability of manufacturer 33 Table of Contents discounts.
The prescription drug plans negotiate pricing with manufacturers and pharmacies, and may condition formulary placement on the availability of manufacturer discounts.
The success of our employee engagement efforts is demonstrated by our employee retention rate of 93.6% in 2023, 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 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.
In 2023, over 25% of job openings were filled by existing employees who were seeking career development opportunities. Employee Engagement We believe engaging our employees, from their first day and throughout their career, is key to fostering new ideas and driving commitment and productivity.
In 2024, nearly 30% of job openings were filled by existing employees who were seeking career development opportunities. Employee Engagement We believe engaging our employees, from their first day and throughout their career, is key to fostering new ideas and driving commitment and productivity.
Central to the work of RGC is the portfolio of collaborations with over 100 academic and clinical collaborators around the world, including the University of Colorado, Geisinger Health System, Mayo Clinic, University of Pennsylvania, UCLA Medical Center, UK Biobank, University of Oxford, University of Cambridge, and the University of Helsinki.
In addition, central to the ongoing work of RGC is the portfolio of collaborations with over 150 academic and clinical collaborators around the world, including the University of Colorado, Geisinger Health System, Mayo Clinic, University of Pennsylvania, UCLA Medical Center, UK Biobank, University of Oxford, and the University of Cambridge.
"Risk Factors - Risks Related to Intellectual Property and Market Exclusivity - Loss or limitation of patent rights, and regulatory pathways for biosimilar competition, could reduce the duration of market exclusivity for our products ").
"Risk Factors - Risks Related to Intellectual Property and Market Exclusivity - Loss or limitation of patent rights, and regulatory pathways for biosimilar competition, have in the past reduced and could reduce in the future the duration of market exclusivity for our products ").
The PPACA expanded the list of covered entities to include certain free-standing cancer hospitals, critical access hospitals, rural referral centers, and sole community hospitals, but exempts "orphan drugs" from the ceiling price requirements for these covered entities.
The federal Patient Protection and Affordable Care Act (the "PPACA") expanded the list of covered entities to include certain free-standing cancer hospitals, critical access hospitals, rural referral centers, and sole community hospitals, but exempts "orphan drugs" from the ceiling price requirements for these covered entities.
The IRA includes a sunset provision with respect to the coverage gap discount program starting in 2025 and replaces it with a new manufacturer discount program.
The IRA includes a sunset provision with respect to the coverage gap discount program starting in 2025 and replaces it 30 Table of Contents with a new manufacturer discount program.
Selected financial information is summarized as follows: Year Ended December 31, (In millions, except per share data) 2023 2022 2021 Revenues $ 13,117.2 $ 12,172.9 $ 16,071.7 Net income $ 3,953.6 $ 4,338.4 $ 8,075.3 Net income per share - diluted $ 34.77 $ 38.22 $ 71.97 For purposes of this report, references to our products encompass products marketed or otherwise 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) 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.
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.
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.
Alnylam is the lead party for ALN-APP, and we are the lead party for ALN-PNP. Under a license agreement, the lead party is designated as the licensee and has the right to develop and commercialize the collaboration product under such program. The licensee will be responsible for its own costs and expenses incurred.
Under a license agreement, the lead party is designated as the licensee and has the right to develop and commercialize the collaboration product under such program. The licensee will be responsible for its own costs and expenses incurred.
Excluding those that did not disclose such information, the percentage shown in this table would be 34.9%. Externally, we support DEI efforts in our community, including by supporting young scientific talent in underrepresented communities.
Excluding those that did not disclose such information, the percentage shown in this table would be 35.5%. Externally, we support diversity efforts in our community, including by supporting young scientific talent in underrepresented communities.
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.
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.
" Marketed Product Competitor Product Competitor Indication Territory (a) EYLEA HD and EYLEA Yesafili ® (aflibercept) (biosimilar referencing EYLEA) Biocon Biologics Ltd wAMD, DME, macular edema following RVO (including CRVO and BRVO), and mCNV EU Lucentis ® (ranibizumab injection) Novartis AG and Genentech/Roche wAMD, DME, macular edema following RVO (including CRVO and BRVO), DR, mCNV, and ROP United States, EU, Japan 22 Table of Contents Marketed Product (continued) Competitor Product Competitor Indication Territory (a) EYLEA HD and EYLEA (continued) Byooviz ™ (ranibizumab-nuna) (biosimilar referencing Lucentis) Samsung Bioepis Co., Ltd. and Biogen Inc. wAMD, DME, macular edema following RVO (including CRVO and BRVO), DR, and mCNV United States, EU Ximluci ® (ranibizumab) (biosimilar referencing Lucentis) Xbrane Biopharma AB and Bausch + Lomb wAMD, DME, macular edema following RVO (including CRVO and BRVO), DR, and CNV EU Cimerli ™ (ranibizumab-eqrn) (biosimilar referencing Lucentis) Formycon AG, Bioeq AG, Coherus BioSciences, Inc., and Teva Ltd. wAMD, DME, macular edema following RVO (including CRVO and BRVO), DR, and mCNV United States, EU Susvimo ® (ranibizumab ocular implant) Genentech/Roche wAMD United States Vabysmo ™ (faricimab-svoa) Genentech/Roche wAMD, DME, and macular edema following RVO United States, EU, Japan Avastin ® (bevacizumab) (off-label and repackaged) Genentech/Roche wAMD, DME, and macular edema following RVO United States, EU, Japan Beovu ® (brolucizumab) Injection Novartis AG wAMD, DME United States, EU, Japan Ozurdex ® (dexamethasone intravitreal implant) Allergan/AbbVie Inc.
" Marketed Product Competitor Product Competitor Indication Territory (a) EYLEA HD and EYLEA (b) Pavblu ® (aflibercept-ayyh) (biosimilar referencing EYLEA) Amgen Inc. wAMD, DME, macular edema following RVO (including CRVO and BRVO), and DR United States Vabysmo ™ (faricimab-svoa) Genentech/Roche wAMD, DME, and macular edema following RVO United States, EU, Japan Avastin ® (bevacizumab) (off-label and repackaged) Genentech/Roche wAMD, DME, and macular edema following RVO United States, EU, Japan Lucentis ® (ranibizumab injection) Novartis AG and Genentech/Roche wAMD, DME, macular edema following RVO (including CRVO and BRVO), DR, mCNV, and ROP United States, EU, Japan Byooviz ™ (ranibizumab-nuna) (biosimilar referencing Lucentis) Samsung Bioepis Co., Ltd. and Biogen Inc. wAMD, DME, macular edema following RVO (including CRVO and BRVO), DR, and mCNV United States, EU Ximluci ® (ranibizumab) (biosimilar referencing Lucentis) Xbrane Biopharma AB and STADA Arzneimittel AG wAMD, DME, macular edema following RVO (including CRVO and BRVO), DR, and CNV EU 19 Table of Contents Marketed Product (continued) Competitor Product Competitor Indication Territory (a) EYLEA HD and EYLEA (continued) Cimerli ™ (ranibizumab-eqrn) (biosimilar referencing Lucentis) Formycon AG, Bioeq AG, Sandoz, and Teva Ltd. wAMD, DME, macular edema following RVO (including CRVO and BRVO), DR, and mCNV United States, EU Susvimo ® (ranibizumab ocular implant) Genentech/Roche wAMD, DME United States Beovu ® (brolucizumab) Injection Novartis AG wAMD, DME United States, EU, Japan Ozurdex ® (dexamethasone intravitreal implant) Allergan/AbbVie Inc.
In 2023, we were named to the Civic 50 of most community-minded companies in the United States for the seventh consecutive year.
In 2024, we were named to the Civic 50 of most community-minded companies in the United States for the eighth consecutive year.
We are studying whether odronextamab may help to activate T-cells via their CD3 receptors and trigger targeted, T-cell mediated killing of cancerous cells in several types of B-cell non-Hodgkin lymphoma. Linvoseltamab Linvoseltamab is an investigational bispecific monoclonal antibody designed to bind to CD3 while also binding and bridging T-cells to the BCMA protein on multiple myeloma cells.
Linvoseltamab Linvoseltamab is an investigational bispecific monoclonal antibody designed to bind to CD3 while also binding and bridging T-cells to the BCMA protein on multiple myeloma cells. We are studying whether linvoseltamab may help to activate T-cells via their CD3 receptors and trigger targeted, T-cell mediated killing of multiple myeloma.
(f) The Company is solely responsible for the development and commercialization of Evkeeza in the United States and Ultragenyx is responsible for the development and commercialization of Evkeeza outside the United States. (g) Kiniksa is solely responsible for the development and commercialization of ARCALYST. (h) Sanofi is solely responsible for the development and commercialization of ZALTRAP.
(e) The Company is solely responsible for the development and commercialization of Evkeeza in the United States and Ultragenyx is responsible for the development and commercialization of Evkeeza outside the United States. (f) Kiniksa is solely responsible for the development and commercialization of ARCALYST.
Of these employees, 2,393 were within our research and preclinical development organization, 2,002 were within our global clinical development and regulatory affairs organization, and 6,124 were within our industrial operations and product supply organization. Company-wide, over 1,500 of our full-time employees hold a Ph.D. and/or M.D.
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.
These facilities consist of owned and leased research, manufacturing, office, laboratory, and warehouse space. In addition, we have constructed a fill/finish facility in Rensselaer, New York that is undergoing process validation as required by regulatory authorities.
Manufacturing We currently manufacture bulk drug materials and products at our manufacturing facilities in Rensselaer, New York and Limerick, Ireland. These facilities consist of owned and leased manufacturing, office, laboratory, and warehouse space. In addition, we have constructed a fill/finish facility in Rensselaer, New York that is undergoing process validation as required by regulatory authorities.
We co-commercialize Dupixent in the United States and in certain countries outside the United States. We supply certain commercial bulk product to Sanofi. We and Sanofi equally share profits from sales within the United States.
We co-commercialize Dupixent in the United States and in certain countries outside the United States. We supply certain commercial bulk product to Sanofi.
These institutions are becoming more active in seeking patent and other intellectual property protection and licensing arrangements to 24 Table of Contents collect royalties or other consideration for use of the technology they have developed. Products developed in this manner may compete directly with products we develop.
These institutions have become more active in seeking patent and other intellectual property protection and licensing arrangements to collect royalties or other consideration for use of the technology they have developed. Products developed in this manner may compete directly with products we develop. We also compete with others in acquiring technology from these institutions, agencies, and organizations.
We have also been the title sponsor of the Regeneron International Science and Engineering Fair ("ISEF") since 2019 and recently announced an additional $34 million, 5-year commitment.
We have also been the title sponsor of the Regeneron International Science and Engineering Fair ("ISEF") since 2019 and made an additional $34 million, 5-year commitment to this program in 2023.
Included in this line item for the years ended December 31, 2023 and 2022 is approximately $6 million and $34 million, respectively, of net product sales recorded by Sanofi in connection with sales in certain markets outside the United States (Sanofi recorded net product sales in such markets during a transition period until inventory on hand as of July 1, 2022 had been sold through to the end customers).
Included in this line item for the years ended December 31, 2023 and 2022 is approximately $6 million and $34 million, respectively, of net product sales recorded by Sanofi in connection with sales in certain markets outside the United States (Sanofi recorded net product sales in such markets during a transition period).
In addition, we rely on our collaborators or third parties to perform packaging, filling, finishing, labeling, distribution, laboratory testing, and other services related to the manufacture of our products and product candidates, and to 21 Table of Contents supply various raw materials and other products. See Part I, Item 1A.
In addition, we rely on our collaborators or third parties to perform packaging, filling, finishing, labeling, distribution, laboratory testing, and other services related to the manufacture of our products and product candidates. See Part I, Item 1A. "Risk Factors - Risks Related to Manufacturing and Supply" for further information.
We also compete with others in acquiring technology from these institutions, agencies, and organizations. Patents, Trademarks, and Trade Secrets We rely on a combination of intellectual property laws, including patent, trademark, copyright, trade secret, and domain name protection laws, as well as confidentiality and license agreements, to protect our intellectual property and proprietary rights.
Patents, Trademarks, and Trade Secrets We rely on a combination of intellectual property laws, including patent, trademark, copyright, trade secret, and domain name protection laws, as well as confidentiality and license agreements, to protect our intellectual property and proprietary rights.
For additional information regarding the substantial competition these marketed products face, including potential future competition from product candidates in clinical development, see also Part I, Item 1A.
The table below is provided for illustrative purposes only and is not exhaustive. For additional information regarding the substantial competition these marketed products face, including potential future competition from product candidates in clinical development, see also Part I, Item 1A.
It is currently unclear how HRSA will apply its enforcement authority under this regulation. Moreover, HRSA has established an administrative dispute resolution ("ADR") process for claims by covered entities that a manufacturer has engaged in overcharging, and by manufacturers that a covered entity violated the prohibitions against diversion or duplicate discounts.
Moreover, HRSA has established an administrative dispute resolution ("ADR") process for claims by covered entities that a manufacturer has engaged in overcharging, and by manufacturers that a covered entity violated the prohibitions against diversion or duplicate discounts.
The Company has since expanded enrollment in a REGN5678 monotherapy cohort and plans to explore other REGN5678 combinations. Descriptions of Marketed Products Studied in Additional Indications and Product Candidates in Late-Stage Clinical Development EYLEA HD (aflibercept) 8 mg EYLEA HD is a soluble fusion protein that acts as a vascular endothelial growth factor ("VEGF") inhibitor.
Descriptions of Marketed Products Studied in Additional Indications and Product Candidates in Late-Stage Clinical Development EYLEA HD (aflibercept) 8 mg EYLEA HD is a soluble fusion protein that acts as a vascular endothelial growth factor ("VEGF") inhibitor.
Intellia In 2016, we entered into a license and collaboration agreement with Intellia to advance CRISPR/Cas9 gene-editing technology for in vivo therapeutic development.
Intellia We and Intellia Therapeutics, Inc. are parties to a license and collaboration agreement to advance CRISPR/Cas9 gene-editing technology for in vivo therapeutic development.
Under the terms of our agreement, Sanofi is entitled to receive royalties on sales of the product, if any. (g) Studied as monotherapy and in combination with other antibodies and treatments (h) Information in this column relates to U.S., EU, and Japan regulatory submissions only (i) We and the Biomedical Advanced Research and Development Authority ("BARDA") of the U.S.
Under the terms of our agreement, Sanofi is entitled to receive royalties on sales of the product, if any. (g) Studied as monotherapy and in combination with other antibodies and treatments (h) Information in this column captures submissions to U.S., EU, and Japan regulatory authorities (i) BioNTech's BNT116 is an mRNA cancer vaccine.
In addition, we advertise certain products directly to consumers and maintain websites with information about our medicines. The commercial group also evaluates opportunities for our targets and product candidates and prepares for market launches of new medicines. We have established certain commercial capabilities outside the United States in connection with co-commercializing Dupixent in accordance with our Sanofi collaboration agreement.
In addition, we advertise certain products directly to consumers and maintain websites with information about our medicines. The commercial group also evaluates opportunities for our targets and product candidates and prepares for market launches of new medicines.
Our board of directors receives a detailed update on our DEI efforts at least once a year and continues to monitor our progress. 36 Table of Contents 2023 Workforce Diversity Representation * Female Representation (Global) 49.9% People of Color Representation (U.S.
Our board of directors and/or an appropriate committee thereof receives a detailed update on our efforts at least once a year and continues to monitor our progress. 32 Table of Contents 2024 Workforce Diversity Representation * Female Representation (Global) 50.0% People of Color Representation (U.S.
Various cancers United States, EU, Japan Opdivo ® (nivolumab) Bristol-Myers Squibb Various cancers United States, EU, Japan Tecentriq ® (atezolizumab) Roche Various cancers United States, EU, Japan Imfinzi ® (durvalumab) AstraZeneca Various cancers United States, EU, Japan Bavencio ® (avelumab) Pfizer/Merck KGaA Various cancers United States, EU, Japan Jemperli ® (dostarlimab) GSK Various cancers United States, EU (a) This table focuses on the United States, EU, and Japan.
Various cancers United States, EU, Japan Opdivo ® (nivolumab) Bristol-Myers Squibb Various cancers United States, EU, Japan Tecentriq ® (atezolizumab) Roche Various cancers United States, EU, Japan Imfinzi ® (durvalumab) AstraZeneca Various cancers United States, EU, Japan Bavencio ® (avelumab) Pfizer/Merck KGaA Various cancers United States, EU, Japan Jemperli ® (dostarlimab) GSK Various cancers United States, EU Unloxcyt™ (cosibelimab) Checkpoint Therapeutics, Inc.
General Subject Matter Class Expiration EYLEA (a) (continued) US 11,253,572 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 8,945,559 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 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 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 March 11, 2036 US 11,167,004 Methods of Treatment September 21, 2037 US 11,034,768 Methods of Treatment March 23, 2039 US 11,292,847 Methods of Treatment May 10, 2039 EP 2356151 Composition of Matter October 27, 2029 (b) EP 2356151 Composition of Matter (Supplementary Protection Certificate) (September 28, 2032) (b )/(March 28, 2033) (c) EP 3010539 Methods of Treatment June 20, 2034 EP 2888281 Methods of Treatment August 20, 2033 EP 3064511 Methods of Treatment October 27, 2029 EP 3107575 Methods of Treatment February 20, 2035 EP 3470432 Methods of Treatment August 20, 2033 EP 3019191 Methods of Treatment July 10, 2034 EP 3703818 Methods of Treatment October 29, 2038 EP 4011915 Methods of Treatment August 20, 2033 EP 2624865 Formulation October 5, 2031 EP 3354280 Formulation October 5, 2031 JP 5,291,802 Composition of Matter October 27, 2029 – October 27, 2034 (d) JP 5,918,246 Formulation October 5, 2031 – September 14, 2035 (d) 26 Table of Contents Product (continued) Molecule Territory Patent No.
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.
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 from commercialization of collaboration products.
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.
"Risk Factors - Other Regulatory and Litigation Risks - Risks from the improper conduct of employees, agents, contractors, or collaborators could adversely affect our reputation and our business, prospects, operating results, and financial condition ." In the United States, there are numerous federal and state laws and regulations governing data privacy of personal data and the collection, use, disclosure, and protection of health data, genetic data, consumer data, and children's data.
"Risk Factors - Other Regulatory and Litigation Risks - Risks from the improper conduct of employees, agents, contractors, or collaborators could adversely affect our reputation and our business, prospects, operating results, and financial condition ." We are subject to privacy and data protection laws in the United States and abroad, including health privacy laws, data breach notification laws, consumer protection laws, data localization laws, biometric privacy laws, and genetic privacy laws.
In addition, Decibel shareholders received one non-tradeable contingent value right ("CVR") per share of Decibel common stock, which entitles the holder to receive up to $3.50 per share in cash upon achievement of certain clinical development and regulatory milestones for DB-OTO within specified time periods.
In addition, Decibel shareholders received one non-tradeable contingent value right ("CVR") per share of Decibel common stock, entitling them to receive up to an additional $3.50 per share in cash upon achievement of certain development milestones for DB-OTO within specified time periods. During 2024, the first and second (final) development milestones contemplated by the CVRs were achieved.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

200 edited+53 added−39 removed307 unchanged
Biggest changeThese factors include, by way of example: • net product sales of our marketed products (as recorded by us or our collaborators), in particular EYLEA HD, EYLEA, Dupixent, and Libtayo, as well as our overall operating results; • if any of our product candidates or our new indications for our marketed products receive regulatory approval, net product sales of, and profits from, these product candidates and new indications; • market acceptance of, and the market share for, our marketed products, especially EYLEA HD, EYLEA, Dupixent, and Libtayo; • whether our net product sales and net profits underperform, meet, or exceed the expectations of investors or analysts; • announcement of actions by the FDA or foreign regulatory authorities or their respective advisory committees regarding our, or our collaborators', or our competitors', currently pending or future application(s) for regulatory approval of product candidate(s) or new indications for marketed products; • announcement of submission of an application for regulatory approval of one or more of our, or our competitors', product candidates or new indications for marketed products; • progress, delays, or results in clinical trials of our or our competitors' product candidates or new indications for marketed products; • announcement of technological innovations or product candidates by us or competitors; • claims by others that our products or technologies infringe their patents; • challenges by others to our patents in the EPO and in the USPTO; • public concern as to the safety or effectiveness of any of our marketed products or product candidates or new indications for our marketed products; • pricing or reimbursement actions, decisions, or recommendations by government authorities, insurers, or other organizations (such as health maintenance organizations and PBMs) affecting the coverage, reimbursement, or use of any of our marketed products or competitors' products; • our ability to raise additional capital as needed on favorable terms; • developments in our relationships with collaborators or key customers; • developments in the biotechnology industry or in government regulation of healthcare, including those relating to compounding (i.e., a practice in which a pharmacist, a physician, or, in the case of an outsourcing facility, a person under the supervision of a pharmacist, combines, mixes, or alters ingredients of a drug to create a medication tailored to the needs of an individual patient); • large sales of our Common Stock by our executive officers or other employees, directors, or significant shareholders (or the expectation of any such sales); • changes in tax rates, laws, or interpretation of tax laws; • arrivals and departures of key personnel; • general market conditions; • impact of public health outbreaks, epidemics, or pandemics (such as the COVID-19 pandemic) on our business; • our ability to repurchase our Common Stock under any share repurchase program on favorable terms or at all; • trading activity that results from the rebalancing of stock indices in which our Common Stock is included, or the inclusion or exclusion of our Common Stock from such indices; • other factors identified in these "Risk Factors"; and • the perception by the investment community or our shareholders of any of the foregoing factors. 68 Table of Contents The trading price of our Common Stock has been, and could continue to be, subject to wide fluctuations in response to these and other factors, including the sale or attempted sale of a large amount of our Common Stock in the market.
Biggest changeThese factors include, by way of example: • net product sales of our marketed products (as recorded by us or our collaborators), in particular EYLEA HD, EYLEA, Dupixent, and Libtayo, 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, and our overall operating results; • if any of our product candidates or our new indications for our marketed products receive regulatory approval, net product sales of, and profits from, these product candidates and new indications; • market acceptance of, and the market share for, our marketed products, especially EYLEA HD, EYLEA, Dupixent, and Libtayo; • whether our net product sales and net profits underperform, meet, or exceed the expectations of investors or analysts; • U.S. or other major market launch of a biosimilar version of one of our key marketed products (such as EYLEA or EYLEA HD); • announcement of actions by the FDA or foreign regulatory authorities or their respective advisory committees regarding our, or our collaborators', or our competitors', currently pending or future application(s) for regulatory approval of product candidate(s) or new indications for marketed products; • announcement of submission of an application for regulatory approval of one or more of our, or our competitors', product candidates or new indications for marketed products; • progress, delays, or results in clinical trials of our or our competitors' product candidates or new indications for marketed products; • announcement of technological innovations or product candidates by us or competitors; • claims by others that our products or technologies infringe their patents; • challenges by others to our patents in the EPO and in the USPTO and developments relating to patent litigation and other proceedings and government investigations relating to our Company and operations; • public concern as to the safety or effectiveness of any of our marketed products or product candidates or new indications for our marketed products; • pricing or reimbursement actions, decisions, or recommendations by government authorities, insurers, or other organizations (such as health maintenance organizations and PBMs) affecting the coverage, reimbursement, or use of any of our marketed products or competitors' products; • developments in our relationships with collaborators or key customers; • developments in the biotechnology industry or in government regulation of healthcare, including those relating to compounding (i.e., a practice in which a pharmacist, a physician, or, in the case of an outsourcing facility, a person under the supervision of a pharmacist, combines, mixes, or alters ingredients of a drug to create a medication tailored to the needs of an individual patient); • large sales of our Common Stock by our executive officers or other employees, directors, or significant shareholders (or the expectation of any such sales); • changes in tax rates, laws, or interpretation of tax laws; • arrivals and departures of key personnel; • general market conditions, including as a result of changes in trade, economic, and other policies of the United States or other countries; • impact of public health outbreaks, epidemics, or pandemics (such as the COVID-19 pandemic) on our business; • our ability to repurchase our Common Stock under any share repurchase program on favorable terms or at all and our ability to continue to declare cash dividends on our Common Stock and Class A Stock; • trading activity that results from the rebalancing of stock indices in which our Common Stock is included, or the inclusion or exclusion of our Common Stock from such indices; • other factors identified in these "Risk Factors"; and • the perception by the investment community or our shareholders of any of the foregoing factors.
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 for our marketed products, we will not be able to market or sell them, which would materially and negatively impact our business, prospects, operating results, and financial condition.
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 for our marketed products, we will not be able to market or sell them, which would materially and negatively impact our business, prospects, operating results, and financial condition.
The COVID-19 pandemic previously adversely affected, and the COVID-19 pandemic or other actual or threatened public health outbreaks, epidemics, or pandemics may in the future adversely affect, among other things, the economic and financial markets and labor resources of the countries in which we operate; our manufacturing and supply chain operations, research and development efforts, commercial operations and sales force, administrative personnel, third-party service providers, and business partners and customers; and the demand for our marketed products.
The COVID-19 pandemic previously adversely affected, and actual or threatened public health outbreaks, epidemics, or pandemics may in the future adversely affect, among other things, the economic and financial markets and labor resources of the countries in which we operate; our manufacturing and supply chain operations, research and development efforts, commercial operations and sales force, administrative personnel, third-party service providers, and business partners and customers; and the demand for our marketed products.
These tests and trials may not achieve favorable results for many reasons, including, among others, failure of the product candidate to demonstrate safety or efficacy, the development of serious or life-threatening adverse events (or side effects) caused by or connected with exposure to the product candidate (or prior or concurrent exposure to other products or product candidates), difficulty in enrolling and maintaining subjects in a clinical trial, clinical trial design that may not make it possible to enroll or retain a sufficient number of patients to achieve a statistically significant result or the desired level of statistical significance for the endpoint in question, lack of sufficient supplies of the product candidate or comparator drug, and the failure of clinical investigators, trial monitors, contractors, consultants, or trial subjects to comply with the trial plan, protocol, or applicable regulations related to the FDA's GLPs or GCPs.
These tests and trials may not achieve favorable results for many reasons, including, among others, failure of the product candidate to demonstrate safety or efficacy; the development of serious or life-threatening adverse events (or side effects) caused by or connected with exposure to the product candidate (or prior or concurrent exposure to other products or product candidates); difficulty in enrolling and maintaining subjects in a clinical trial; clinical trial design that may not make it possible to enroll or retain a sufficient number of patients to achieve a statistically significant result or the desired level of statistical significance for the endpoint in question; lack of sufficient supplies of the product candidate or comparator drug; and the failure of clinical investigators, trial monitors, contractors, consultants, or trial subjects to comply with the trial plan, protocol, or applicable regulations related to GLPs or GCPs.
In order to commercialize or co-commercialize any products outside the United States beyond what we have done so far, we must build our sales, marketing, distribution, regulatory, managerial, and other capabilities in the relevant markets or make arrangements with third parties to perform these services, any of which will likely be expensive and time consuming and could delay product launch or the co-commercialization of a product in one or more markets outside the United States.
In order to commercialize or co-commercialize any products outside the United States beyond what we have done so far, we must build or enhance our sales, marketing, distribution, regulatory, managerial, and other capabilities in the relevant markets or make arrangements with third parties to perform these services, any of which will likely be expensive and time consuming and could delay product launch or the co-commercialization of a product in one or more markets outside the United States.
For example, certain of our U.S. patents (including those pertaining to our key products, such as EYLEA) have been and may in the future be challenged by parties who file a request for post-grant review or inter partes review under the America Invents Act of 2011 or ex parte reexamination, as described in Note 16 to our Consolidated Financial Statements included in this report.
For example, certain of our U.S. patents (including those pertaining to our key products, such as EYLEA) have been and may in the future be challenged by parties who file a request for post-grant review or inter partes review under the America Invents Act of 2011 or ex parte reexamination, as further described in Note 16 to our Consolidated Financial Statements included in this report.
All aspects of our business, including research and development, manufacturing, marketing, pricing, sales, intellectual property rights, and the framework for dispute resolution and asserting our rights against others, are subject to extensive legislation and regulation. Changes in applicable U.S. federal, state, and foreign laws and agency regulations could have a materially negative impact on our business.
All aspects of our business, including research and development, manufacturing, marketing, pricing, sales, intellectual property rights, and the framework for dispute resolution and asserting our rights against others, are subject to extensive legislation and regulation. Changes in applicable U.S. federal, state, and foreign laws and agency regulations and policies could have a materially negative impact on our business.
Bribery Act. • Our operations are subject to environmental, health, and safety laws and regulations, including those governing the use of hazardous materials. • Changes in laws and regulations affecting the healthcare industry could adversely affect our business. • Tax liabilities and 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.
Bribery 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 and 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.
There is the potential that our systems may be directly or indirectly affected as nation-states conduct global cyberwarfare, including in connection with the current Russia-Ukraine or Hamas-Israel armed conflict. Due to the nature of some of these attacks, there is a risk that an attack may remain undetected for a period of time.
There is also the potential that our systems may be directly or indirectly affected as nation-states conduct global cyberwarfare, including in connection with the current Russia-Ukraine or Hamas-Israel armed conflict. Due to the nature of some of these attacks, there is a risk that an attack may remain undetected for a period of time.
Such attacks are of ever-increasing levels of sophistication and are made by groups and individuals with a wide range of motives (including industrial espionage or extortion) and expertise, including by organized criminal groups, "hacktivists," nation states, and others. As a company with an increasingly global presence, our systems are subject to frequent attacks.
Such attacks are of ever-increasing levels of sophistication and are made by groups and individuals with a wide range of motives (including industrial espionage or extortion) and expertise, including by organized criminal groups, "hacktivists," nation states, and others. As a company with an increasingly global presence, our systems are subject to frequent attacks and incidents.
In addition, we are aware of several other companies developing biosimilar versions of EYLEA and other approved anti-VEGF treatments. Other potentially competitive products in development include products for use in combination with EYLEA and/or other anti-VEGF treatments, small-molecule tyrosine kinase inhibitors, gene therapies, and other eye-drop formulations, devices, and oral therapies.
In addition, we are aware of several other companies developing biosimilar versions of EYLEA, EYLEA HD, and/or other approved anti-VEGF treatments. Other potentially competitive products in development include products for use in combination with EYLEA and/or other anti-VEGF treatments, small-molecule tyrosine kinase inhibitors, gene therapies, and other eye-drop formulations, devices, and oral therapies.
The use of AI solutions by our employees or third parties on which we rely may continue to increase and may lead to the public disclosure of confidential information (including personal data and proprietary information) in contravention of our internal policies, data protection laws, other applicable laws, or contractual requirements.
The use of AI solutions by our employees or third parties on which we rely may continue to increase and may lead to the impermissible use or public disclosure of confidential information (including personal data and proprietary information) in contravention of our internal policies, data protection laws, other applicable laws, or contractual requirements.
If we and Sanofi fail to coordinate our sales and marketing efforts effectively, sales of Dupixent may be materially affected. Sanofi also maintains other important responsibilities relating to Dupixent. For example, Sanofi records product sales for Dupixent in the United States and leads negotiations with payors relating to this product.
If we and Sanofi fail to coordinate our sales and marketing efforts effectively, sales of Dupixent may be materially adversely affected. Sanofi also maintains other important responsibilities relating to Dupixent. For example, Sanofi records product sales for Dupixent in the United States and leads negotiations with payors relating to this product.
We are also highly dependent on the expertise and services of other senior management members leading our research, development, manufacturing, and commercialization efforts. There is intense competition in the biotechnology industry for qualified scientists and managerial personnel in the research, development, manufacture, and commercialization of drugs.
We are also highly dependent on the expertise and services of other senior management members leading our research, development, manufacturing, and commercialization efforts. There is intense competition in the biotechnology industry for qualified scientists and managerial personnel in the research, development, manufacturing, and commercialization of drugs.
Sanctions under these federal and state laws may include civil monetary penalties, damages, exclusion of a manufacturer's products from reimbursement under government programs, criminal fines, and imprisonment for individuals and the curtailment or restructuring of operations.
Sanctions under these federal and state laws may include civil monetary penalties, administrative fines and penalties, damages, exclusion of a manufacturer's products from reimbursement under government programs, criminal fines, and imprisonment for individuals and the curtailment or restructuring of operations.
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 will 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. 39 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 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.
Our inability, or the inability of our collaborators and third-party fill/finish or other service providers, to demonstrate ongoing cGMP compliance could require us to engage in lengthy and expensive remediation efforts, withdraw or recall product, halt or interrupt clinical trials, and/or interrupt commercial supply of any marketed products, and could also delay or prevent our obtaining regulatory approval for our product candidates or new indications for our marketed products.
Our inability, or the inability of our collaborators and third-party fill/finish or other service providers, to demonstrate ongoing cGMP compliance could require us to engage in lengthy and expensive remediation efforts, identify and onboard new service providers, withdraw or recall product, halt or interrupt clinical trials, and/or interrupt commercial supply of any marketed products, and could also delay or prevent our obtaining regulatory approval for our product candidates or new indications for our marketed products.
If we or our suppliers and/or service providers fail to maintain or protect our information technology systems and data security effectively and in compliance with U.S. and foreign laws, or fail to anticipate, plan for, or manage significant disruptions to these systems, we or our suppliers and/or service providers could have difficulty preventing, detecting, or controlling such disruptions or security breaches, which could result in legal proceedings, liability under U.S. and foreign laws that protect the privacy of personal information, disruptions to our operations, government investigations, breach of contract claims, and damage to our reputation (in each case in the U.S. or globally), which could have a material adverse effect on our business, prospects, operating results, and financial condition.
If we or our suppliers and/or service providers fail to maintain or protect our information technology systems and data security effectively and in compliance with U.S. and foreign laws, or fail to anticipate, plan for, or manage significant disruptions to these 63 Table of Contents systems, we or our suppliers and/or service providers could have difficulty preventing, detecting, or controlling such disruptions or security breaches, which could result in legal proceedings, liability under U.S. and foreign laws that protect the privacy of personal information, disruptions to our operations, government investigations, breach of contract claims, and damage to our reputation (in each case in the U.S. or globally), which could have a material adverse effect on our business, prospects, operating results, and financial condition.
These cGMP requirements and regulations are not prescriptive instructions on how to manufacture products, but rather a series of principles that must be observed during manufacturing; as a result, the manner in which such principles are implemented may not be specifically delineated, which can present a challenging environment as the FDA and comparable foreign regulatory authorities increasingly scrutinize compliance with these requirements and regulations.
These cGMP requirements and regulations are not prescriptive instructions on how to manufacture products, but rather a series of principles that must be observed during manufacturing; as a result, the manner in which such principles are implemented may not be specifically delineated, which can be challenging as the FDA and comparable foreign regulatory authorities increasingly scrutinize compliance with these requirements and regulations.
In this section, we first provide a summary of the more significant risks and uncertainties we face and then provide a full set of risk factors and discuss them in greater detail. 38 Table of Contents Summary of Risk Factors As noted above, we are subject to a number of risks that if realized could materially harm our business, prospects, operating results, and financial condition.
In this section, we first provide a summary of the more significant risks and uncertainties we face and then provide a full set of risk factors and discuss them in greater detail. 34 Table of Contents Summary of Risk Factors As noted above, we are subject to a number of risks that if realized could materially harm our business, prospects, operating results, and financial condition.
If we provide payments or other remuneration to a healthcare professional to induce the prescribing of our products, we could face liability under state and federal anti-kickback laws. The Bipartisan Budget Act of 2018 has increased the criminal and civil penalties that can be imposed for violating certain federal health care laws, including the federal anti-kickback statute.
If we provide payments or other remuneration to a healthcare professional to induce the prescribing of our products, we could face liability under state and federal anti-kickback laws. The Bipartisan Budget Act of 2018 has increased the criminal and civil penalties that can be imposed for violating certain federal healthcare laws, including the federal anti-kickback statute.
"Management's Discussion and Analysis of Financial Condition and Results of Operations – Liquidity and Capital Resources" for information about expected capital expenditures relating to this and other projects).
"Management's Discussion and Analysis of Financial Condition and Results of Operations – Liquidity and Capital Resources" for information about capital expenditures relating to this and other projects).
Recent FDA draft 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 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.
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, 2023, 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, 2024, our five largest shareholders plus Dr.
In addition, several 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 co-pay support to patients for certain prescription drugs.
It is likely that federal and state legislatures and health agencies will continue to focus on additional health care reform measures in the future that will impose additional constraints on prices and reimbursements for our marketed products. Further, there have been several recent U.S.
It is likely that federal and state legislatures and health agencies will continue to focus on additional healthcare reform measures in the future that will impose additional constraints on prices and reimbursements for our marketed products. Further, there have been several recent U.S.
We are also required to report the 340B ceiling prices for our covered outpatient drugs to HRSA, which then publishes them to 340B covered entities. Any charge by HRSA that we have violated the requirements of the program or the regulation could negatively impact our financial results.
We are also required to report the 340B ceiling prices for our covered outpatient drugs to HRSA, which then publishes them to 340B covered entities. Any charge by HRSA that we have violated the requirements of the program or the regulation could negatively impact our operating results.
If our clinical candidates are discontinued or their clinical development is delayed, if the launch of new indications for our marketed products or new product candidates is delayed or does not occur, or if such products are launched and the launch is unsuccessful or the product is subsequently recalled or marketing approval is rescinded, we may have to absorb one hundred percent of related overhead costs and inefficiencies, as well as similar costs of third-party contract manufacturers performing services for us.
If our clinical candidates are discontinued or their clinical development is delayed, if the launch of new indications for our marketed products or new product candidates is delayed or does not occur, or if such products are launched and the launch is unsuccessful or the product is subsequently recalled or marketing approval is rescinded, we may have to absorb related overhead costs and inefficiencies, as well as similar costs of third-party contract manufacturers performing services for us.
In addition, we may experience significant charges to earnings in connection with our efforts, if any, to consummate acquisitions. For transactions that are ultimately not consummated, these charges may include fees and expenses for investment bankers, attorneys, accountants, and other advisors in connection with our efforts.
In addition, we may experience significant charges to earnings in connection with our efforts to consummate acquisitions. For transactions that are ultimately not consummated, these charges may include fees and expenses for investment bankers, attorneys, accountants, and other advisors in connection with our efforts.
Risks associated with our operations outside the United States could adversely affect our business. We have operations and conduct business in several countries outside the United States and have been significantly expanding the scope of these activities in existing and/or additional countries, including EU countries and Japan.
Risks associated with our operations outside the United States could adversely affect our business. We have operations and conduct business in many countries outside the United States and have been significantly expanding the scope of these activities in existing and/or additional countries, including EU countries and Japan.
If we were to experience difficulty with the commercialization of EYLEA HD or EYLEA in the United States or if 40 Table of Contents Bayer were to experience any difficulty with the commercialization of EYLEA HD or EYLEA outside the United States, if EYLEA net product sales experience a sustained decline in or outside the United States without an offset from EYLEA HD net product sales, or if we and Bayer are unable to maintain or obtain marketing approvals of these products (as applicable), we may experience a reduction in revenue and may not be able to stay profitable at the levels we previously achieved or at all, and our business, prospects, operating results, and financial condition may be materially harmed.
If we experience difficulty with the commercialization of EYLEA HD or EYLEA in the United States or if Bayer experiences any difficulty with the 36 Table of Contents commercialization of EYLEA HD or EYLEA outside the United States, if EYLEA net product sales experience a sustained decline in or outside the United States without an offset from EYLEA HD net product sales, or if we and Bayer are unable to maintain or obtain marketing approvals of these products (as applicable), we may experience a reduction in revenue and may not be able to stay profitable at the levels we previously achieved or at all, and our business, prospects, operating results, and financial condition may be materially harmed.
We and our collaborators are subject to significant ongoing regulatory obligations and oversight with respect to the products we or they commercialize for the products' currently approved indications in the United States, EU, Japan, and other countries where such products are approved.
We and our collaborators are subject to significant ongoing regulatory obligations and oversight with respect to the products we or they commercialize for the products' currently approved indications in the United States, EU, Japan, and other countries.
Foreign regulatory authorities may ask for additional data in order to begin a clinical study, including Phase 3 clinical trials required to submit a Marketing Authorization Application ("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 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.
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.
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.
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 health care 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 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; 41 Table of Contents • our ability to meet the demand for commercial supplies of our marketed products; • the outcome of the pending proceedings relating to EYLEA and REGEN-COV (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 complaint filed against us on June 24, 2020 in 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 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.
In addition, in order for private insurance and governmental payors (such as Medicare and Medicaid in the United States) to reimburse the cost of our marketed products, we must maintain, among other things, our FDA registration and our National Drug 42 Table of Contents Code, formulary approval by PBMs, and recognition by insurance companies and CMS.
In addition, in order for private insurance and governmental payors (such as Medicare and Medicaid in the United States) to reimburse the cost of our marketed products, we must maintain, among other things, our FDA registration and our National Drug Code, formulary approval by PBMs, and recognition by insurance companies and CMS.
Notably, in 2022 the U.S. Congress passed the IRA, which includes, among other items, provisions regarding the following: • Implementation of a Medicare Drug Price Negotiation Program (the "Medicare Drug Price Negotiation Program"). The Medicare Drug Price Negotiation Program requires the government to set prices for select high-expenditure drugs covered under Medicare Parts B and D.
Notably, in 2022 the U.S. Congress passed the Inflation Reduction Act ("IRA"), which includes, among other items, provisions regarding the following: • Implementation of a Medicare Drug Price Negotiation Program (the "Medicare Drug Price Negotiation Program"). The Medicare Drug Price Negotiation Program requires the government to set prices for select high-expenditure drugs covered under Medicare Parts B and D.
Parallel traders (who may repackage or otherwise alter the original product or sell it through alternative channels such as mail order or the Internet) take advantage of the price differentials between markets arising from factors including sales costs, market conditions (such as intermediate trading stages), tax rates, or national regulation of prices.
Parallel traders (who may repackage or otherwise alter the original product or sell it through alternative channels such as mail order or the Internet) take advantage of the price differentials between markets arising from factors including sales costs, market conditions, tax rates, or national regulation of prices.
Loss of regulatory approval or clearance of a device that is used with our product may also result in the removal of our product from the 52 Table of Contents market. Further, failure to successfully develop or supply and manufacture these devices, or to gain or maintain their approval, could adversely affect sales of the related products.
Loss of regulatory approval or clearance of a device that is used with our product may also result in the removal of our product from the market. Further, failure to successfully develop or supply and manufacture these devices, or to gain or maintain their approval, could adversely affect sales of the related products.
If these service providers do not perform their services adequately, sales of our marketed products will suffer. 65 Table of Contents We have undertaken and may in the future undertake strategic acquisitions, and any difficulties from integrating such acquisitions could adversely affect our business, operating results, and financial condition.
If these service providers do not perform their services adequately, sales of our marketed products will suffer. We have undertaken and may in the future undertake strategic acquisitions, and any difficulties from integrating such acquisitions could adversely affect our business, operating results, and financial condition.
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.
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.
We participate in the Medicaid Drug Rebate program, the 340B program (which is administered by HRSA), the VA FSS pricing program, the Tricare Retail Pharmacy Program, and other federal and state government pricing programs. Such programs often require us to provide discounts and/or pay rebates to certain government payors and/or private purchasers.
We participate in the Medicaid Drug Rebate program, the Public Health Service's 340B program (which is administered by HRSA), the VA FSS pricing program, the Tricare Retail Pharmacy Program, and other federal and state government pricing programs. Such programs often require us to provide discounts and/or pay rebates to certain government payors and/or private purchasers.
If we are not able to retain (or for any other reason lose the services of) any of these persons, our business may suffer. In particular, we depend on the services of Leonard S. Schleifer, M.D., Ph.D., our President and Chief Executive Officer, and George D. Yancopoulos, M.D., Ph.D., our President and Chief Scientific Officer.
If we are not able to retain (or for any other reason lose the services of) any of these persons, our business may suffer. In particular, we depend on the services of Leonard S. Schleifer, M.D., Ph.D., our Board co-Chair, President and Chief Executive Officer, and George D. Yancopoulos, M.D., Ph.D., our Board co-Chair, President and Chief Scientific Officer.
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 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 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.
District Court for the District of Massachusetts by the U.S. Attorney's Office for the District of Massachusetts); and • the results of post-approval studies, whether conducted by us or by others and whether mandated by regulatory agencies or voluntary, and studies of other products that could implicate an entire class of products or are perceived to do so.
Department of Justice and the U.S. Attorney's Office for the District of Massachusetts); and • the results of post-approval studies, whether conducted by us or by others and whether mandated by regulatory agencies or voluntary, and studies of other products that could implicate an entire class of products or are perceived to do so.
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.
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.
As part of our efforts to acquire companies, businesses, products, or product candidates or to enter into other significant transactions, we will conduct business, legal, and financial due diligence with the goal of identifying and evaluating material risks involved in the transaction.
As part of our efforts to acquire companies, businesses, products, or product candidates or to enter into other significant transactions, we will conduct business, legal, research and development, regulatory, and financial due diligence with the goal of identifying and evaluating material risks involved in the transaction.
Expanding our manufacturing capacity and establishing fill/finish capabilities will 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 marketed products and product candidates or other indications for our marketed products if they are approved for marketing and could jeopardize our current and future clinical development programs.
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 marketed products and product candidates or other indications for our marketed products if they are approved for marketing and could jeopardize our current and future clinical development programs.
In addition, these five shareholders plus our Chief Executive Officer held approximately 46.5% of the combined voting power of our outstanding shares of Common Stock and Class A Stock, assuming the exercise of all options held by our Chief Executive Officer which are exercisable within 60 days of December 31, 2023. 69 Table of Contents The anti-takeover effects of provisions of our charter, by-laws, and of New York corporate law, as well as the contractual provisions in our investor and collaboration agreements and certain provisions of our compensation plans and agreements, could deter, delay, or prevent an acquisition or other "change of control" of us and could adversely affect the price of our Common Stock.
In addition, these five shareholders plus our Chief Executive Officer held approximately 46.2% of the combined voting power of our outstanding shares of Common Stock and Class A Stock, assuming the exercise of all options held by our Chief Executive Officer which are exercisable within 60 days of December 31, 2024. 66 Table of Contents The anti-takeover effects of provisions of our charter, by-laws, and of New York corporate law, as well as the contractual provisions in our investor and collaboration agreements and certain provisions of our compensation plans and agreements, could deter, delay, or prevent an acquisition or other "change of control" of us and could adversely affect the price of our Common Stock.
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.
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.
Data security breaches could lead to the loss of trade secrets or other intellectual property, 66 Table of Contents 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 blackmail, or lead to the public exposure of personal information (including sensitive personal information) of our employees, clinical trial patients, customers, and others.
Because of the breadth of these laws and the narrowness of the safe harbors, it is possible that some of our business activities could be challenged under one or more of such laws. As described further in Note 16 to our Consolidated Financial Statements included in this report, we are party to civil litigation initiated in 2020 by the U.S.
Because of the breadth of these laws and the narrowness of the safe harbors, it is possible that some of our business activities could be challenged under one or more of such laws. As described further in Note 16 to our Consolidated Financial Statements included in this report, we are party to civil proceedings initiated or joined by the U.S.
While we have some commercial presence outside the United States, our commercial capabilities outside the United States are still limited and would need to be further developed or outsourced for products commercialized under our Antibody Collaboration (see also "Risks Related to Commercialization of Our Marketed Products, Product Candidates, and New Indications for Our Marketed Products - If we are unable to establish commercial capabilities outside the United States for Libtayo, Dupixent, and any other products we intend to commercialize or co-commercialize outside the United States, our business, prospects, operating results, and financial condition may be adversely affected " above).
While we have some commercial presence outside the United States, our commercial capabilities outside the United States are still limited and would need to be further developed or outsourced for products commercialized under our Antibody Collaboration (see also "Risks Related to Commercialization of Our Marketed Products, Product Candidates, and New Indications for Our Marketed Products - If we are unable to establish sufficient commercial capabilities outside the United States for products we intend to commercialize or co-commercialize outside the United States, our business, prospects, operating results, and financial condition may be adversely affected " above).
Given cost sensitivities in many health care systems, our currently marketed products and product candidates are likely to be subject to continued pricing pressures, which may have an adverse impact on our business, prospects, operating results, and financial condition.
Given cost sensitivities in many healthcare systems, our currently marketed products and product candidates are likely to be subject to continued pricing pressures, which may have an adverse impact on our business, prospects, operating results, and financial condition.
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.
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.
As a result, the public float of our Common Stock (i.e., the portion of our Common Stock held by public investors, as opposed to the Common Stock held by our directors, officers, and principal shareholders) may be lower than the public float of other large public companies with broader public ownership.
As a result, the public float of our Common Stock (i.e., the portion of our Common Stock held by public investors, as opposed to the Common Stock held by our directors, officers, and principal shareholders) may be lower than the 65 Table of Contents public float of other large public companies with broader public ownership.
Unexpected refunds to the government, and/or response to a government investigation or enforcement 60 Table of Contents 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, would be expensive and time-consuming, and could have a material adverse effect on our business, financial condition, results of operations, and future prospects.
Problems with these manufacturing processes, even minor deviations from the normal process or from the materials used in the manufacturing process (which may not be detectable by us or our collaborators in a timely manner), could lead to product defects or manufacturing failures, resulting in lot failures, product recalls, product liability claims, and insufficient inventory.
Problems with these manufacturing processes, even minor deviations from the normal process or from the materials used in the manufacturing process (which may not be detectable by us or our collaborators in a timely manner), have led in the past and could lead in the future to product defects or manufacturing failures, resulting in lot failures, product recalls, product liability claims, and/or insufficient inventory.
The FDA regulates the marketing and promotion of our products, which must comply with the Food, Drug, and Cosmetic Act and applicable FDA implementing standards. The FDA's review of promotional activities includes healthcare provider-directed and direct-to-consumer advertising, communications regarding unapproved uses, industry-sponsored scientific and educational activities, and sales representatives' communications.
The FDA regulates the marketing and promotion of our products, which must comply with the Food, Drug, and Cosmetic Act and applicable FDA implementing standards. The FDA's review of promotional activities includes healthcare provider-directed and direct-to-consumer advertising, certain communications regarding unapproved uses, industry-sponsored scientific and educational 55 Table of Contents activities, and sales representatives' communications.
Our indebtedness could adversely impact our business. We have certain indebtedness and contingent liabilities, including milestone and royalty payment obligations. As of December 31, 2023, we had an aggregate of $2.703 billion of outstanding indebtedness under our senior unsecured notes and the lease financing facility. We may also incur additional debt in the future.
Our indebtedness could adversely impact our business. We have certain indebtedness and contingent liabilities, including milestone and royalty payment obligations. As of December 31, 2024, we had an aggregate of $2.704 billion of outstanding indebtedness under our senior unsecured notes and the lease financing facility. We may also incur additional debt in the future.
A REMS may include various elements, ranging from a medication guide or patient package 47 Table of Contents insert to limitations on who may prescribe or dispense the drug, depending on what the FDA considers necessary for the safe use of the drug.
A REMS may include various elements, ranging from a medication guide or patient package insert to limitations on who may prescribe or dispense the drug, depending on what the FDA considers necessary for the safe use of the drug.
Starting in 2023 and 2026, the government is authorized to select Part D and Part B drugs, respectively, for inclusion in the Medicare Drug Price Negotiation Program, with established prices to go into effect for selected Part D drugs in 2026 and for selected Part B drugs in 2028, in each case absent certain disqualifying events. 43 Table of Contents • Medicare Inflation Based Rebates .
Starting in 2023 and 2026, the government is authorized to select Part D and Part B drugs, respectively, for inclusion in the Medicare Drug Price Negotiation Program, with established prices to go into effect for selected Part D drugs in 2026 and for selected Part B drugs in 2028, in each case absent certain disqualifying events. • Medicare Inflation Based Rebates .
The IRA includes measures requiring manufacturers to pay rebates where the average sales price or average manufacturer price of drugs covered under Medicare Parts B and D, respectively, exceeds the rate of inflation. • Medicare Part D Program Redesign .
The IRA includes measures requiring manufacturers to pay rebates where increases to the average sales price or average manufacturer price of drugs covered under Medicare Parts B and D, respectively, exceed the rate of inflation. • Medicare Part D Program Redesign .
We may not successfully expand or establish sufficient manufacturing or any future fill/finish capabilities or manufacture our products economically or in compliance with cGMPs and other regulatory requirements, and we and our collaborators may not be able to build or procure additional capacity in the required timeframe to meet commercial demand for our product candidates if they receive regulatory approval, and to continue to meet the requirements of our clinical programs.
We may not successfully expand or establish sufficient manufacturing or any future fill/finish capabilities or manufacture our products in a cost-effective manner or in compliance with cGMPs and other regulatory requirements, and we and our collaborators may not be able to build or procure additional capacity in the required timeframe to meet commercial demand for our product candidates if they receive regulatory approval, and to continue to meet the requirements of our clinical programs.
The degree to which EYLEA HD net product sales may offset any potential decrease in EYLEA net product sales, resulting from the factors discussed above or otherwise, is uncertain. In addition, we 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 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.
We have limited commercial capabilities outside the United States and would have to develop or outsource these capabilities (see also "Risks Related to Commercialization of Our Marketed Products, Product Candidates, and New Indications for Our Marketed Products - If we are unable to establish commercial capabilities outside the United States for Libtayo, Dupixent, and any other products we intend to commercialize or co-commercialize outside the United States, our business, prospects, operating results, and financial condition may be adversely affected " above).
We have limited commercial capabilities outside the United States and would have to develop or outsource these capabilities (see also "Risks Related to Commercialization of Our Marketed Products, Product Candidates, and New Indications for Our Marketed Products - If we are unable to establish sufficient commercial capabilities outside the United States for products we intend to commercialize or co-commercialize outside the United States, our business, prospects, operating results, and financial condition may be adversely affected " above).
In asthma, competitors to Dupixent include antibodies against the IL-5 ligand or the IL-5 receptor, immunoglobulin E, or thymic stromal lymphopoietin 44 Table of Contents ("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 and EoE.
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.
Schleifer, our Chief Executive Officer, beneficially owned approximately 39.3% of our outstanding shares of Common Stock, assuming, in the case of our Chief Executive Officer, the conversion of his Class A Stock into Common Stock and the exercise of all options held by him which are exercisable within 60 days of December 31, 2023.
Schleifer, our Chief Executive Officer, beneficially owned approximately 39.0% of our outstanding shares of Common Stock, assuming, in the case of our Chief Executive Officer, the conversion of his Class A Stock into Common Stock and the exercise of all options held by him which are exercisable within 60 days of December 31, 2024.
Schleifer, our Chief Executive Officer, beneficially owned approximately 39.3% of our outstanding shares of Common Stock, assuming, in the case of our Chief Executive Officer, the conversion of his Class A Stock into Common Stock and the exercise of all options held by him which are exercisable within 60 days December 31, 2023.
Schleifer, our Chief Executive Officer, beneficially owned approximately 39.0% of our outstanding shares of Common Stock, assuming, in the case of our Chief Executive Officer, the conversion of his Class A Stock into Common Stock and the exercise of all options held by him which are exercisable within 60 days of December 31, 2024.
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 COVID-19 pandemic and the armed conflict between Russia and Ukraine, which have exacerbated many of these issues, or other public health outbreaks, epidemics, or pandemics or 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 the armed conflict between Russia and Ukraine or public health outbreaks, epidemics, or pandemics or other geopolitical developments).
We may also be subject to claims by patients who use our approved products, or our product candidates if those product candidates receive regulatory approval and become commercially available, that they have been injured by a side effect associated with the drug.
We have previously been subject to, and may in the future be subject to, claims by patients who use our approved products, or our product candidates if those product candidates receive regulatory approval and become commercially available, that they have been injured by a side effect associated with the drug.
We are aware of claims by third parties, including those based on published clinical data, alleging that ZALTRAP may be safely administered to the eye. EYLEA HD was approved by the FDA in August 2023 for the treatment of wAMD, DME, and DR. As a newly approved product, EYLEA HD has entered the highly competitive environment described above.
We are aware of claims by third parties, including those based on published clinical data, alleging that ZALTRAP may be safely administered to the eye. EYLEA HD was approved by the FDA in August 2023 for the treatment of wAMD, DME, and DR and entered the highly competitive environment described above.
Product Candidates Our VelocImmune ® technology, other antibody generation technologies, and late-stage and earlier-stage clinical candidates face competition from many pharmaceutical and biotechnology companies using various technologies, including antibody generation technologies and other approaches such as RNAi, chimeric antigen receptor T cell (CAR-T cell), and gene therapy technologies.
Product Candidates Our VelocImmune ® technology, other antibody generation technologies, and late-stage and earlier-stage clinical candidates face competition from many pharmaceutical and biotechnology companies using various technologies, including antibody generation 41 Table of Contents technologies and other approaches such as RNAi, chimeric antigen receptor T cell (CAR-T cell), and gene therapy technologies.
Changes of suppliers or 57 Table of Contents modifications of methods of manufacturing may require amending our application(s) to the FDA or such comparable foreign agencies and acceptance of the change by the FDA or such comparable foreign agencies prior to release of product(s).
Changes of suppliers or modifications of methods of manufacturing may require amending our application(s) to the FDA or such comparable foreign agencies and acceptance of the change by the FDA or such comparable foreign agencies prior to release of product(s).
It is possible that as we test our drug candidates or new indications in larger, longer, and more extensive clinical programs, or as use of these drugs becomes more widespread if they receive regulatory approval, illnesses, injuries, and discomforts that were observed in earlier trials, as well as conditions that did not occur or went undetected in previous trials, will be reported by patients.
It is possible that as we test our drug candidates or new indications in larger, longer, and more extensive or complex clinical programs (including those evaluating combination therapies), or as use of these drugs becomes more widespread if they receive regulatory approval, illnesses, injuries, and discomforts that were observed in earlier trials, as well as conditions that did not occur or went undetected in previous trials, will be reported by patients.
For the years ended December 31, 2023 and 2022, our product sales to two distributor customers accounted on a combined basis for 76% and 83% of our total gross product revenue, respectively. We expect significant distributor customer concentration to continue for the foreseeable future.
For the years ended December 31, 2024 and 2023, our product sales to two distributor customers accounted on a combined basis for 74% and 76% of our total gross product revenue, respectively. We expect significant distributor customer concentration to continue for the foreseeable future.
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) compete with Praluent, Evkeeza, and Kevzara, respectively.
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.
The commercial success of our products and product candidates is subject to significant competition. Marketed Products There is substantial competition in the biotechnology and pharmaceutical industries from biotechnology, pharmaceutical, and chemical companies. Many of our competitors have substantially greater research, preclinical and clinical product development and manufacturing capabilities, as well as financial, marketing, and human resources, than we do.
The commercial success of our products and product candidates is subject to significant competition. Marketed Products We face substantial competition from pharmaceutical and biotechnology companies. Many of our competitors have substantially greater research, preclinical and clinical product development, and manufacturing capabilities, as well as financial, marketing, and human resources, than we do.
If Bayer and, in Japan, Santen do not perform their obligations in a timely manner, or at all, our ability to commercialize EYLEA HD and EYLEA outside the United States will be significantly adversely affected.
If Bayer and, in Japan, Santen do not perform their obligations in a 61 Table of Contents timely manner, or at all, our ability to commercialize EYLEA HD and EYLEA outside the United States will be significantly adversely affected.
In particular, our business activities outside the United States (which have recently increased, and are expected to continue to increase, due to, in part, our efforts to establish our commercialization and co-commercialization capabilities in certain jurisdictions outside the United States) are subject to the Foreign Corrupt Practices Act, or FCPA, and similar anti-bribery or anti-corruption laws, regulations or rules of other countries in which we operate, including the U.K.
In particular, our business activities outside the United States (which have recently expanded and continue to expand due to, in part, our efforts to establish further commercialization and co-commercialization capabilities in certain jurisdictions outside the United States) are subject to the Foreign Corrupt Practices Act, or FCPA, and similar anti-bribery or anti-corruption laws, regulations or rules of other countries in which we operate, including the U.K.

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

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Biggest changeCybersecurity threats, including those resulting from any previous cybersecurity incidents, have not materially affected our Company, including our business strategy, results of operations, or financial condition. We do not believe that cybersecurity threats resulting from any previous cybersecurity incidents of which we are aware are reasonably likely to materially affect our Company.
Biggest changeTo date, the Company is not aware of risks from cybersecurity threats, including those resulting from any previous cybersecurity incidents, that have materially affected or are reasonably likely to materially affect our Company, including our business strategy, results of operations, or financial condition.
Our Technology Risk Management Committee, which is comprised of representatives from our business operations and support functions (e.g., legal, finance, internal audit, commercial, privacy), assesses risks based on probability and potential impact to key business systems and processes. Risks that are considered high are incorporated into our overall risk management program.
Our Technology Risk Management Committee, which is comprised of representatives from our business operations and support functions (e.g., legal, finance, internal audit, commercial, privacy), assesses cybersecurity risks based on probability and potential impact to key business systems and processes. Cybersecurity risks that are considered high are incorporated into our overall risk management program.
Refer to the risk factor captioned " Significant disruptions of information technology systems or breaches of data security could adversely affect our business " in Part I, Item 1A. "Risk Factors" for additional description of cybersecurity risks and potential related impacts on our Company.
Refer to the risk factor captioned " Significant disruptions of information technology systems or breaches of data security could adversely affect our business " in Part I, Item 1A. "Risk Factors" for additional information regarding cybersecurity risks and potential related impacts on our Company.
A mitigation plan is developed for each identified high risk, with progress reported to the Technology Risk Management Committee and tracked as part of our overall risk management program overseen by the Audit Committee of our board of directors. We collaborate with third parties to assess the effectiveness of our cybersecurity prevention and response systems and processes.
A mitigation plan is developed for each identified high risk, with progress on risk mitigation reported to the Technology Risk Management Committee and tracked as part of our overall risk management program, which is overseen by the Audit Committee of our board of directors.
The current CISO has over 35 years of experience in information security and possesses the requisite education, skills, experience, and industry certifications expected of an individual assigned to these duties. The CISO provides periodic updates on our cybersecurity risk profile to management's Technology Risk Management Committee, the Audit Committee of our board of directors, and the Audit Committee chair.
The current CISO has over 35 years of experience in technology and information security, including operating in the role of the CISO for several large companies in the pharmaceutical and healthcare industries, and possesses the requisite education, skills, experience, and industry certifications expected of an individual assigned to these duties.
These include cybersecurity assessors, consultants, and other external cybersecurity experts to assist in the identification, verification, and validation of cybersecurity risks, as well as to support associated mitigation plans when necessary. We have also 70 Table of Contents developed a third-party cybersecurity risk management process to conduct due diligence on external entities, including those that perform cybersecurity services.
We collaborate with third parties to assess the effectiveness of our cybersecurity prevention and response systems and processes. These include cybersecurity assessors, consultants, and other external cybersecurity experts to assist in the identification, verification, and validation of cybersecurity risks, as well as to support associated mitigation plans when necessary.
Added
We 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.
Added
The CISO provides periodic updates on our cybersecurity risk profile to management's Technology Risk Management Committee and the Audit Committee of our board of directors.

Item 2. Properties

Properties — owned and leased real estate

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Biggest changeWe also own an approximate 100-acre parcel of land adjacent to our Tarrytown, New York location, which we are in the process of developing, primarily in connection with expanding our research and support facilities to accommodate our growth. Rensselaer, New York We own facilities in Rensselaer, New York totaling approximately 1,260,000 square feet of manufacturing, research, office, and warehouse space.
Biggest changeIn 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.
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. Tarrytown, New York At our Tarrytown, New York location, we lease approximately 1,467,000 square feet of laboratory and office space. Refer to Part II, Item 7.
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.
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. 71 Table of Contents PART II
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.
"Management's Discussion and Analysis of Financial Condition and Results of Operations - Liquidity and Capital Resources - Tarrytown, New York Leases " for further details.
"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.
Removed
In addition, we have constructed an approximately 341,000 square foot fill/finish facility in Rensselaer, New York that is undergoing process validation as required by regulatory authorities. Limerick, Ireland We own a facility in Limerick, Ireland totaling approximately 555,000 square feet of manufacturing, warehouse, laboratory, and office space. Item 3.
Added
Location 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.
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Mine Safety Disclosures Not applicable. 68 Table of Contents PART II

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Biggest changeThe historical stock price performance of our Common Stock shown in the graph below is not necessarily indicative of future stock price performance. 12/31/2018 12/31/2019 12/31/2020 12/31/2021 12/31/2022 12/31/2023 Regeneron $ 100.00 $ 100.53 $ 129.35 $ 169.08 $ 193.17 $ 235.15 S&P 500 $ 100.00 $ 128.88 $ 149.83 $ 190.13 $ 153.16 $ 190.27 NQ US Pharma TR Index $ 100.00 $ 114.51 $ 126.56 $ 157.42 $ 175.29 $ 182.08 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 to such filing. 72 Table of Contents 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, 2023.
Biggest changeThe 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 comparison assumes that $100 was invested on December 31, 2018 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, 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.
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, 2018 through December 31, 2023.
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.
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) 11/1/2023–11/30/2023 272,952 $ 802.55 269,976 $ 1,609.1 12/1/2023–12/31/2023 558,642 $ 849.22 93,108 $ 1,530.6 Total 831,594 (a) 363,084 (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 (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.
As of January 25, 2024, there were 153 shareholders of record of our Common Stock and 14 shareholders of record of our Class A Stock. We have never paid cash dividends on our Common Stock or Class A Stock and do not currently have plans to do so.
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.
Added
In 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.
Added
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.
Added
(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]

Item 7. Management's Discussion & Analysis

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

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Biggest changeResults of Operations Net Income Year Ended December 31, (In millions, except per share data) 2023 2022 2021 Revenues $ 13,117.2 $ 12,172.9 $ 16,071.7 Operating expenses 9,070.1 7,434.0 7,124.9 Income from operations 4,047.1 4,738.9 8,946.8 Other income (expense) 152.2 119.9 379.0 Income before income taxes 4,199.3 4,858.8 9,325.8 Income tax expense 245.7 520.4 1,250.5 Net income $ 3,953.6 $ 4,338.4 $ 8,075.3 Net income per share - diluted $ 34.77 $ 38.22 $ 71.97 77 Table of Contents Revenues Year Ended December 31, $ Change (In millions) 2023 2022 2021 2023 vs. 2022 2022 vs. 2021 Net product sales: EYLEA HD - U.S. $ 165.8 $ — $ — $ 165.8 $ — EYLEA - U.S. 5,719.6 6,264.6 5,792.3 (545.0) 472.3 Total EYLEA HD and EYLEA - U.S. 5,885.4 6,264.6 5,792.3 (379.2) 472.3 Libtayo - U.S. 538.8 374.5 306.3 164.3 68.2 Libtayo - ROW * 324.3 73.0 — 251.3 73.0 Total Libtayo - Global 863.1 447.5 306.3 415.6 141.2 Praluent - U.S. 182.4 130.0 170.0 52.4 (40.0) REGEN-COV - U.S. — — 5,828.0 — (5,828.0) Evkeeza - U.S. 77.3 48.6 18.4 28.7 30.2 Inmazeb - U.S. 69.8 3.0 — 66.8 3.0 ARCALYST - U.S. ** — — 2.2 — (2.2) Total net product sales $ 7,078.0 $ 6,893.7 $ 12,117.2 $ 184.3 $ (5,223.5) Collaboration revenue: Sanofi $ 3,799.5 $ 2,855.7 $ 1,902.2 $ 943.8 $ 953.5 Bayer 1,487.5 1,430.7 1,409.3 56.8 21.4 Roche 211.0 627.3 361.8 (416.3) 265.5 Other 5.1 0.4 — 4.7 0.4 Other revenue 536.1 365.1 281.2 171.0 83.9 Total revenues $ 13,117.2 $ 12,172.9 $ 16,071.7 $ 944.3 $ (3,898.8) * Effective July 1, 2022, the Company became solely responsible for the research, development, and commercialization of Libtayo worldwide and began recording net product sales of Libtayo outside the United States. ** Effective April 1, 2021, Kiniksa records net product sales of ARCALYST in the United States.
Biggest changeAs 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.
Therefore, we continue to expect that a portion of our share of profits from sales under our collaborations with Bayer and Sanofi will be used to reimburse our collaborators for these obligations. Future Impact of Recently Issued Accounting Standards See Note 1 to our Consolidated Financial Statements for a description of recently issued accounting standards.
Therefore, we continue to expect that a portion of our share of profits from sales under our collaborations with Sanofi and Bayer will be used to reimburse our collaborators for these obligations. Future Impact of Recently Issued Accounting Standards See Note 1 to our Consolidated Financial Statements for a description of recently issued accounting standards.
The 2022 Credit Agreement includes an option for the Company to elect to increase the commitments under the 2022 Credit Facility and/or to enter into one or more tranches of term loans in the aggregate principal amount of up to $500.0 million, subject to the consent of the lenders providing the additional commitments or term loans, as applicable, and certain other conditions.
The Credit Agreement includes an option for the Company to elect to increase the commitments under the Credit Facility and/or to enter into one or more tranches of term loans in the aggregate principal amount of up to $500.0 million, subject to the consent of the lenders providing the additional commitments or term loans, as applicable, and certain other conditions.
We believe that our existing capital resources, borrowing availability under the 2022 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 costs that we are entitled to receive under our collaboration agreements, will enable us to meet our anticipated operating needs for the foreseeable future.
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. 74 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; • 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.
Proceeds of the loans under the 2022 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 2022 Credit Facility.
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 adjust the amount of the liability to reflect any subsequent changes in the relevant facts and circumstances surrounding the uncertain tax positions. 75 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 the 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. 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.
"Risk Factors." There is also variability in the duration and costs necessary to develop a pharmaceutical product, potential opportunities and/or uncertainties related to future indications to be studied, and the estimated cost and scope of the projects.
"Risk Factors." There is also variability in the duration and costs necessary to develop a product candidate, potential opportunities and/or uncertainties related to future indications to be studied, and the estimated cost and scope of the projects.
Clinical manufacturing costs primarily consist of costs to manufacture bulk drug product for clinical development purposes as well as related drug filling, packaging, and labeling costs. Clinical manufacturing costs also includes pre-launch commercial supplies which did not meet the criteria to be capitalized as inventory (see "Critical Accounting Policies and Use of Estimates - Inventories" above).
Clinical manufacturing costs primarily consist of costs to manufacture bulk drug product for clinical development purposes as well as related drug filling, packaging, and labeling costs. Clinical manufacturing costs also include pre-launch commercial supplies which did not meet the criteria to be capitalized as inventory (see "Critical Accounting Estimates - Inventories" above).
Refer to Part II, Item 7 in our Annual Report on Form 10-K for the fiscal year ended December 31, 2022 (filed with the SEC on February 6, 2023) for additional discussion of our financial condition and results of operations for the year ended December 31, 2021, as well as our financial condition and results of operations for the year ended December 31, 2022 compared to the year ended December 31, 2021.
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.
During the year ended December 31, 2023, the Company earned the final $50.0 million sales-based milestone from Sanofi, upon aggregate annual sales of antibodies outside the United States (including Praluent) exceeding $3.0 billion on a rolling twelve-month basis.
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.
We also have the option prior to the end of the term of the Third Amended and Restated Lease to (a) purchase the Facility by paying an amount equal to the outstanding principal amount of the Participants' advances under the Third Amended and Restated Participation Agreement, all accrued and unpaid yield thereon, and all other outstanding amounts under the Third Amended and Restated Participation Agreement, Third Amended and Restated Lease, and certain related documents or (b) sell the Facility to a third party on behalf of BAL.
We also have the option to (a) purchase the Facility by paying an amount equal to the outstanding principal amount of the Participants' advances under the Participation Agreement, all accrued and unpaid yield thereon, and all other outstanding amounts under the Participation Agreement, Lease, and certain related documents or (b) sell the Facility to a third party on behalf of BAL.
(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. 80 Table of Contents Bayer records net product sales of EYLEA outside the United States.
(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.
We periodically analyze our inventory levels to identify inventory that may expire prior to expected sale or has a cost basis in excess of its estimated realizable value, and write down such inventories as appropriate. In addition, our products are subject to strict quality control and monitoring which we perform throughout the manufacturing process.
We periodically analyze our inventory levels to identify inventory that may expire prior to expected sale or has a cost basis in excess of its estimated realizable value. In addition, our products are subject to strict quality control and monitoring which we perform throughout the manufacturing process.
We cannot predict 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 product(s) and whether or when they may become profitable. 73 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. 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.
As of June 30, 2023, the Company had repurchased the entire $3.0 billion of its Common Stock that it was authorized to repurchase under the program. In January 2023, our board of directors authorized an additional share repurchase program to repurchase up to $3.0 billion of our Common Stock.
In January 2023, our board of directors authorized a share repurchase program to repurchase up to an additional $3.0 billion of our Common Stock. As of September 30, 2024, the Company had repurchased the entire $3.0 billion of its Common Stock it was authorized to repurchase under the program.
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. 88 Table of Contents We also anticipate continuing to incur substantial commercialization costs for our marketed products.
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.
(b) As the A&R IO LCA became effective July 1, 2022, the three months ended June 30, 2022 was the last quarter in which Sanofi collaboration revenue was recognized in connection with the IO Collaboration.
(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.
Bayer Collaboration Revenue Year Ended December 31, (In millions) 2023 2022 2021 Regeneron's share of profits in connection with commercialization of EYLEA outside the United States $ 1,376.4 $ 1,317.4 $ 1,349.2 Reimbursement for manufacturing of ex-U.S. commercial supplies (a) 111.1 91.4 60.1 One-time payment in connection with change in Japan arrangement (b) — 21.9 — Total Bayer collaboration revenue $ 1,487.5 $ 1,430.7 $ 1,409.3 (a) Corresponding costs incurred by the Company in connection with such production is recorded within Cost of collaboration and contract manufacturing.
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.
Our ability to generate profits and to generate positive cash flow from operations over the next several years depends significantly on the continued success in commercializing EYLEA and Dupixent, as well as whether we are successful in commercializing EYLEA HD.
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.
We expect to recognize this stock-based compensation expense related to stock options and restricted stock over weighted-average periods of 1.8 years and 2.3 years, respectively. 82 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 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.
This estimate is revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. In addition, we reassess our forfeiture rate assumptions at least annually, considering both historical forfeiture experience and an estimate of future forfeitures for currently outstanding unvested awards.
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.
As of December 31, 2021, the Company had repurchased the entire $1.5 billion of its Common Stock that it was authorized to repurchase under the program. In November 2021, our board of directors authorized a share repurchase program to repurchase up to $3.0 billion of our Common Stock.
Share Repurchase Programs In November 2021, our board of directors authorized a share repurchase program to repurchase up to $3.0 billion of our Common Stock. As of June 30, 2023, the Company had repurchased the entire $3.0 billion of its Common Stock it was authorized to repurchase under the program.
(In millions) Rebates, Chargebacks, and Discounts Distribution- Related Fees Other Sales- Related Deductions Total Balance as of December 31, 2020 $ 202.2 $ 77.2 $ 44.8 $ 324.2 Provisions 1,047.1 363.6 150.4 1,561.1 Credits/payments (1,034.7) (360.8) (127.6) (1,523.1) 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 Sanofi Collaboration Revenue Year Ended December 31, (In millions) 2023 2022 2021 Antibody: Regeneron's share of profits in connection with commercialization of antibodies $ 3,136.5 $ 2,082.0 $ 1,363.0 Sales-based milestones earned 50.0 100.0 50.0 Reimbursement for manufacturing of commercial supplies (a) 613.0 633.7 488.8 Other — 28.7 — Total Antibody 3,799.5 2,844.4 1,901.8 Total Immuno-oncology (b) — 11.3 0.4 Total Sanofi collaboration revenue $ 3,799.5 $ 2,855.7 $ 1,902.2 (a) Corresponding costs incurred by the Company in connection with such production 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, 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.
"Collaboration, License, and Other Agreements - Sanofi - Immuno-Oncology " above). Acquisitions, net of cash acquired, of $54.9 million and $230.3 million in 2023 and 2022 was related to our acquisitions of Decibel Therapeutics, Inc. and Checkmate Pharmaceuticals, Inc., respectively.
Acquisitions, net of cash acquired, of $54.9 million and $230.3 million in 2023 and 2022 was related to our acquisitions of Decibel Therapeutics, Inc. and Checkmate Pharmaceuticals, Inc., respectively.
As of December 31, 2023, unrecognized stock-based compensation expense related to unvested stock options and unvested restricted stock (including performance-based restricted stock units) was $589.6 million and $1.127 billion, 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, 2023, our contingent reimbursement obligation to Bayer was approximately $293 million and our contingent reimbursement obligation to Sanofi in connection with the companies' Antibody Collaboration was approximately $2.330 billion.
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.
The Third Amended and Restated Lease and Third Amended and Restated Participation Agreement provide for a March 2027 maturity date of the $720.0 million lease financing (previously advanced by the Participants in March 2017 in connection with the acquisition by BAL of the Facility and our lease of the Facility from BAL) and the end of the term of our lease of the Facility from BAL, at which time all amounts outstanding thereunder will become due and payable in full.
The Lease, Participation Agreement, and certain related agreements provide for $720.0 million of lease financing (previously advanced by the Participants in March 2017 in connection with the acquisition by BAL of the Facility and our lease of the Facility from BAL), which matures when the term of the Lease expires in March 2027, at which time all amounts outstanding thereunder will become payable in full.
The Third Amended and Restated Participation Agreement and Third Amended and Restated Lease include an option for us to elect to further extend the maturity date of the Third Amended and Restated Participation Agreement and the term of the Third Amended and Restated Lease for an additional five-year period, subject to the consent of all the Participants and certain other conditions.
We have the option to further extend the maturity date of the Participation Agreement and the term of the Lease for an additional five-year period, subject to the consent of the Participants and certain other conditions.
Acquired In-process Research and Development ("IPR&D") Acquired IPR&D in 2023 included: • $100.0 million charge in connection with a development milestone for the Phase 1 ALN-APP program, which is in collaboration with Alnylam; • $45.0 million up-front payment in connection with our collaboration agreement with Sonoma Biotherapeutics, Inc.; and • $30.0 million charge to extend the period for selecting targets under our collaboration agreement with Intellia.
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.
As set forth in the 2022 Credit Agreement, we have the option to amend the 2022 Credit Agreement to establish environmental, social, and governance targets which will be used to adjust pricing under the 2022 Credit Facility, subject to parameters to be provided in the 2022 Credit Agreement.
The Credit Agreement also provides a $50.0 million sublimit for letters of credit. As set forth in the Credit Agreement, we have the option to amend the Credit Agreement to establish environmental, social, and governance targets which will be used to adjust pricing under the Credit Facility, subject to parameters to be provided in the Credit Agreement.
We expect to continue to incur substantial expenses related to our research and development activities, a portion of which we expect to be reimbursed by our collaborators. In addition, our research and development activities and related costs which are not reimbursed are expected to expand and require additional resources.
We expect to continue to incur substantial expenses related to our research and development activities, and our research and development activities and related costs which are not reimbursed by collaborators are expected to expand and require additional resources. We also expect to incur substantial costs related to the commercialization of our marketed products.
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.
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.
The increase in our share of profits in connection with commercialization of antibodies during the year ended December 31, 2023, compared to 2022, was driven by higher profits associated with Dupixent sales, partly offset by the impact of the amendment to the LCA.
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.
Regeneron's share of profits in connection with commercialization of EYLEA outside the United States is summarized below: Year Ended December 31, (In millions) 2023 2022 2021 EYLEA net product sales outside the United States $ 3,495.2 $ 3,382.8 $ 3,450.9 Regeneron's share of collaboration profit from sales outside the United States $ 1,436.1 $ 1,375.1 $ 1,408.3 Reimbursement of development expenses incurred by Bayer in accordance with Regeneron's payment obligation (a) (59.7) (57.7) (59.1) Regeneron's share of profits in connection with commercialization of EYLEA outside the United States $ 1,376.4 $ 1,317.4 $ 1,349.2 Regeneron's share of profits as a percentage of 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.
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.
We expect continued significant capital expenditures over the next several years in connection with the planned expansion of our Tarrytown, New York campus. 86 Table of Contents Payments for the Libtayo intangible asset of $207.8 million and $1.027 billion in 2023 and 2022, respectively, were related to our acquisition (including contingent consideration paid) of the exclusive right to develop, commercialize, and manufacture Libtayo worldwide (as described in Part I, Item 1.
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.
The Third Amended and Restated 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 Third Amended and Restated Lease financing contain financial and operating covenants.
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.
"Collaboration, License, and Other Agreements," under our collaborations with Bayer and Sanofi, we and our collaborator share profits in connection with commercialization of drug products. If the applicable collaboration is profitable, we have contingent contractual obligations to reimburse Bayer and Sanofi for a defined percentage (generally 50%) of agreed-upon development expenses funded by Bayer and Sanofi (i.e., "development balance").
If the applicable collaboration is profitable, we have contingent contractual obligations to reimburse Sanofi and Bayer for a defined percentage (generally 50%) of agreed-upon development expenses funded by Sanofi and Bayer (i.e., "development balance").
The expected dividend yield is zero as we have never paid dividends and do not currently have plans to do so. We use a Monte Carlo simulation to compute the estimated fair value of performance-based restricted stock units that are subject to vesting based on the Company's attainment of pre-established criteria that include a market condition.
We use a Monte Carlo simulation to compute the estimated fair value of performance-based restricted stock units that are subject to vesting based on the Company's attainment of pre-established criteria that include a market condition.
Cash Flows from Financing Activities Proceeds from issuances of Common Stock, in connection with exercises of employee stock options, were $1.146 billion during 2023, compared to $1.520 billion during 2022 and $1.672 billion during 2021. For information related to repurchases of Common Stock, see " Share Repurchase Programs " section below.
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.
"Business - Collaboration, License, and Other Agreements - Sanofi - Antibody", on July 1, 2022, an amendment to the LCA became effective, pursuant to which the percentage of Regeneron's share of profits in any calendar quarter used to reimburse Sanofi for development costs which were funded by Sanofi increased from 10% to 20%. 79 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) 2023 2022 2021 Dupixent and Kevzara net product sales $ 11,974.0 $ 9,039.2 $ 6,536.3 Regeneron's share of collaboration profits 3,596.3 2,405.5 1,511.5 Reimbursement of development expenses incurred by Sanofi in accordance with Regeneron's payment obligation (a) (459.8) (266.6) (148.5) One-time payment in connection with amendment to the Antibody License and Collaboration Agreement — (56.9) — Regeneron's share of profits in connection with commercialization of antibodies $ 3,136.5 $ 2,082.0 $ 1,363.0 Regeneron's share of profits as a percentage of Dupixent and Kevzara net product sales 26% 23% 21% (a) See "Liquidity and Capital Resources - Additional Funding Requirements" below for additional details on our contingent reimbursement obligation.
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.
Commercialization costs over the next few years will depend on, among other things, the market potential for product candidates, whether commercialization costs are shared with a collaborator, and regulatory approval of additional product candidates. We expect that expenses related to the filing, prosecution, defense, and enforcement of patents and other intellectual property will be substantial.
We also anticipate continuing to incur substantial commercialization costs for our marketed products. Commercialization costs over the next few years will depend on, among other things, the market potential for product candidates, whether commercialization costs are shared with a collaborator, and regulatory approval of additional product candidates.
The 2022 Credit Agreement includes an option for us to elect to extend the maturity date of the 2022 Credit Facility beyond December 2027, subject to the consent of the extending lenders and certain other conditions.
The Credit Agreement includes an option for us to elect to extend the maturity date of the Credit Facility beyond December 2027, subject to the consent of the extending lenders and certain other conditions. Amounts borrowed under the Credit Facility may be prepaid, and the commitments under the Credit Facility may be terminated, at any time without premium or penalty.
While we do not expect the adoption of the Pillar Two framework to have a material impact on our effective tax rate, we are continuing to evaluate additional guidance released by the OECD, along with the pending legislative adoption by additional individual countries. 85 Table of Contents Liquidity and Capital Resources Our financial condition is summarized as follows: As of December 31, (In millions) 2023 2022 $ Change Financial assets: Cash and cash equivalents $ 2,730.0 $ 3,105.9 $ (375.9) Marketable securities - current 8,114.8 4,636.4 3,478.4 Marketable securities - noncurrent 5,396.5 6,591.8 (1,195.3) $ 16,241.3 $ 14,334.1 $ 1,907.2 Working capital: Current assets $ 19,479.2 $ 15,884.1 $ 3,595.1 Current liabilities 3,423.4 3,141.3 282.1 $ 16,055.8 $ 12,742.8 $ 3,313.0 Borrowings and finance lease liabilities: Long-term debt $ 1,982.9 $ 1,981.4 $ 1.5 Finance lease liabilities $ 720.0 $ 720.0 $ — As of December 31, 2023, we also had borrowing availability of $750.0 million under a revolving credit facility (see further description under " Credit Facility " below).
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).
Year Ended December 31, $ Change (In millions) 2023 2022 * 2021 * 2023 vs. 2022 2022 vs. 2021 Direct research and development expenses: Dupixent (dupilumab) $ 168.0 $ 156.5 $ 146.4 $ 11.5 $ 10.1 Fianlimab 112.2 43.4 8.7 68.8 34.7 Libtayo (cemiplimab) 105.3 138.0 146.2 (32.7) (8.2) Odronextamab 96.3 66.0 34.9 30.3 31.1 EYLEA HD (aflibercept) 8 mg 96.2 67.9 73.5 28.3 (5.6) Linvoseltamab 78.7 45.5 18.7 33.2 26.8 Itepekimab 70.3 26.5 — 43.8 26.5 Pozelimab 60.2 72.4 28.3 (12.2) 44.1 REGEN-COV (5.6) 32.8 309.8 (38.4) (277.0) Other product candidates in clinical development and other research programs 514.0 393.9 429.7 120.1 (35.8) Total direct research and development expenses 1,295.6 1,042.9 1,196.2 252.7 (153.3) Indirect research and development expenses: Payroll and benefits 1,537.0 1,195.5 981.4 341.5 214.1 Lab supplies and other research and development costs 210.6 181.0 142.0 29.6 39.0 Occupancy and other operating costs 518.2 508.5 414.9 9.7 93.6 Total indirect research and development expenses 2,265.8 1,885.0 1,538.3 380.8 346.7 Clinical manufacturing costs 1,053.9 938.3 621.7 115.6 316.6 Reimbursement of research and development expenses by collaborators (176.3) (273.7) (496.1) 97.4 222.4 Total research and development expenses $ 4,439.0 $ 3,592.5 $ 2,860.1 $ 846.5 $ 732.4 * Certain prior year amounts have been reclassified to conform to the current year's presentation. 83 Table of Contents Total research and development expenses increased in 2023, compared to 2022, partially due to the impact of the amendments to the Sanofi collaboration agreements (which were effective July 1, 2022) described above in Part I, Item 1.
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.
We are also required to make monthly payments of basic rent during the remaining term of the Third Amended and Restated Lease to satisfy the yield payable to the Participants on their outstanding advances under the Third Amended and Restated Participation Agreement.
Pursuant to the Lease, we pay all maintenance, insurance, taxes, and other costs arising out of the use of the Facility. We are also required to make monthly payments of basic rent to satisfy the yield payable to the Participants on their outstanding advances under the Participation Agreement.
In addition, Other revenue increased in 2023, compared to 2022, primarily due to the following: • higher reimbursements for the manufacture of commercial supplies for Sanofi related to Praluent outside the United States; • higher share of profits earned in connection with sales of ARCALYST pursuant to our license agreement with Kiniksa Pharmaceuticals, Ltd.; and • royalties earned in connection with our license agreement with Novartis, under which we receive royalties on worldwide sales of Novartis' Ilaris ® (canakinumab). 81 Table of Contents Expenses Year Ended December 31, Change (In millions, except headcount data) 2023 2022 2021 2023 vs. 2022 2022 vs. 2021 Research and development (a) $ 4,439.0 $ 3,592.5 $ 2,860.1 $ 846.5 $ 732.4 Acquired in-process research and development 186.1 255.1 48.0 (69.0) 207.1 Selling, general, and administrative (a) 2,631.3 2,115.9 1,824.9 515.4 291.0 Cost of goods sold 932.1 800.0 1,773.1 132.1 (973.1) Cost of collaboration and contract manufacturing (b) 883.7 760.4 664.4 123.3 96.0 Other operating (income) expense, net (2.1) (89.9) (45.6) 87.8 (44.3) Total operating expenses $ 9,070.1 $ 7,434.0 $ 7,124.9 $ 1,636.1 $ 309.1 Average headcount 12,698 11,115 9,884 1,583 1,231 (a) Includes costs incurred net of any cost reimbursements from collaborators who are not deemed to be our customers (b) Includes costs incurred in connection with producing commercial drug supplies for collaborators and others Operating expenses in 2023 and 2022 included a total of $885.0 million and $725.0 million, respectively, of stock-based compensation expense related to equity awards granted under our long-term incentive plans.
Operating 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.
Year Ended December 31, (In millions) 2023 2022 2021 Number of shares 2.9 3.3 3.0 Total cost of shares $ 2,214.6 $ 2,099.8 $ 1,655.0 Tarrytown, New York Lease We are party to a Third Amended and Restated Lease and Remedies Agreement, dated March 27, 2023 (the "Third Amended and Restated Lease") with BA Leasing BSC, LLC, an affiliate of Banc of America Leasing & Capital, LLC ("BAL"), as lessor, which relates to our lease of laboratory and office facilities in Tarrytown, New York (the "Facility"); and a Third Amended and Restated Participation Agreement, dated March 27, 2023 (the "Third Amended and Restated Participation Agreement") with Bank of America, N.A., as administrative agent (the "Administrative Agent"), and a syndicate of lenders (collectively with BAL, the "Participants"), as rent assignees.
"Risk Factors." Tarrytown, New York Corporate Headquarters Lease We lease laboratory and office facilities for our corporate headquarters in Tarrytown, New York (the "Facility") under the Third Amended and Restated Lease and Remedies Agreement (the "Lease") with BA Leasing BSC, LLC, an affiliate of Banc of America Leasing & Capital, LLC ("BAL"), as lessor, and the Third Amended and Restated Participation Agreement (the "Participation Agreement") with Bank of America, N.A., as administrative agent, and a syndicate of lenders (collectively with BAL, the "Participants"), as rent assignees.
There can be significant judgment involved in determining the estimated fair values of such assets and liabilities. Amounts allocated to acquired in-process research and development are capitalized as indefinite-lived intangible assets. Any excess of the purchase price (consideration transferred) over the fair values of net assets acquired is recorded as goodwill.
Amounts allocated to acquired in-process research and development are capitalized as indefinite-lived intangible assets. Any excess of the purchase price (consideration transferred) over the fair values of net assets acquired is recorded as goodwill. Contingent consideration obligations are recorded at fair value as of the acquisition date and remeasured each subsequent reporting period until the contingencies have been resolved.
Certain countries in which we have operations, including Ireland, have adopted legislation influenced by the OECD Pillar Two rules, including a minimum tax rate of 15%. It is uncertain whether the United States will enact legislation to adopt the Pillar Two framework.
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%.
Amounts borrowed under the 2022 Credit Facility may be prepaid, and the commitments under the 2022 Credit Facility may be terminated, at any time without premium or penalty. We had no borrowings outstanding under the 2022 Credit Facility as of December 31, 2023. The 2022 Credit Agreement contains operating covenants and a maximum total leverage ratio financial covenant.
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.
Acquisitions We make certain judgments to determine whether a transaction should be accounted for as a business combination or as an asset acquisition. In a business combination, the acquisition method of accounting generally requires that the assets acquired and liabilities assumed be recorded as of the date of the acquisition at their respective fair values.
In a business combination, the acquisition method of accounting generally requires that the assets acquired and liabilities assumed be recorded as of the date of the acquisition at their respective fair values. There can be significant judgment involved in determining the estimated fair values of such assets and liabilities.
There can be no assurance as to the timing or number of shares of any repurchases in the future.
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.
In a business combination, contingent consideration obligations are recorded at fair value as of the acquisition date and remeasured each subsequent reporting period until the contingencies have been resolved. The fair value of contingent consideration liabilities is determined using inputs that may include the probability of achieving certain milestones and estimated discount rates.
The fair value of contingent consideration liabilities is determined using inputs that may include the probability of achieving certain milestones and estimated discount rates.
If the projected undiscounted cash flows of the intangible asset are less than the carrying amount, the intangible asset is written down to its fair value in the period in which the impairment occurs. 76 Table of Contents Contingencies We accrue, based on management's judgment, for an estimated loss when the potential loss from claims or legal proceedings is considered probable and the amount can be reasonably estimated.
Contingencies We accrue, based on management's judgment, for an estimated loss when the potential loss from claims or legal proceedings is considered probable and the amount can be reasonably estimated.
If certain batches or units of product no longer meet quality specifications or become obsolete due to expiration, we record a charge to write down such inventory to its estimated realizable value. See "Results of Operations - Expenses - Cost of Goods Sold" below for further information related to our inventory write-offs and reserves.
If certain batches or units of product no longer meet quality specifications or become obsolete due to expiration, we record a charge to write down such inventory to its estimated realizable value. Acquisitions We make certain judgments to determine whether a transaction should be accounted for as a business combination or as an asset acquisition.
We are unable to reasonably estimate if our product candidates in clinical development will generate material product revenues and net cash inflows.
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.
Liabilities for unrecognized tax benefits totaled $696.4 million as of December 31, 2023. Due to their nature, there is a high degree of uncertainty regarding the period and amounts of potential future cash settlement with tax authorities. See Note 15 to our Consolidated Financial Statements.
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.
Overview Regeneron Pharmaceuticals, Inc. is a fully integrated biotechnology company that invents, develops, manufactures, and commercializes medicines for people with serious diseases. Our research and development efforts have led to eleven FDA-approved products that have received marketing approval and approximately 35 product candidates in clinical development, almost all of which were homegrown in our laboratories.
Overview Regeneron Pharmaceuticals, Inc. is a fully integrated biotechnology company that invents, develops, manufactures, and commercializes medicines for people with serious diseases.
Other Income (Expense) Other income (expense) consists of the following: Year Ended December 31, (In millions) 2023 2022 2021 Unrealized (losses) gains on equity securities, net $ (237.8) $ (39.8) $ 386.1 Interest income 495.9 160.1 45.8 Foreign currency (losses) gains (12.9) 50.2 0.4 Other (20.0) 8.8 4.0 Other income (expense), net 225.2 179.3 436.3 Interest expense (73.0) (59.4) (57.3) Total other income (expense) $ 152.2 $ 119.9 $ 379.0 The increase in interest income in 2023, compared to 2022, was primarily driven by higher interest rates.
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.
We expect to incur capital expenditures of $825 million to $950 million in 2024 primarily in connection with the continued expansion of our research, preclinical manufacturing, and support facilities at our Tarrytown, New York campus and our manufacturing facilities.
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.
The payment of these amounts, however, is contingent upon the occurrence of various future events, which have a high degree of uncertainty of occurring and for which the specific timing cannot be predicted. See Note 3 to our Consolidated Financial Statements. As described in Part I, Item 1.
The specific timing of these contingent payments cannot be predicted. See Note 3 to our Consolidated Financial Statements. As described in Part I, Item 1. "Collaboration, License, and Other Agreements," under our collaborations with Sanofi and Bayer, we and our collaborator share profits in connection with commercialization of drug products.
Sources and Uses of Cash for the Years Ended December 31, 2023, 2022, and 2021 Year Ended December 31, $ Change (In millions) 2023 2022 2021 2023 vs. 2022 2022 vs. 2021 Cash flows provided by operating activities $ 4,594.0 $ 5,014.9 $ 7,081.3 $ (420.9) $ (2,066.4) Cash flows used in investing activities $ (3,185.1) $ (3,784.6) $ (5,384.7) $ 599.5 $ 1,600.1 Cash flows used in financing activities $ (1,790.1) $ (1,009.0) $ (1,005.8) $ (781.1) $ (3.2) Cash Flows from Operating Activities As of December 31, 2023 and 2022, deferred tax assets increased by $837.8 million and $746.4 million, respectively, primarily related to the impact of the Tax Cuts and Jobs Act of 2017, which requires, for tax purposes, the capitalization and amortization of research and development expenses effective for years beginning after December 31, 2021.
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).
Selling, general, and administrative expenses also included $307.1 million and $256.4 million of stock-based compensation expense in 2023 and 2022, respectively.
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.
Credit Facility In December 2022, we entered into an agreement with a syndicate of lenders (the "2022 Credit Agreement") which provides for a $750.0 million senior unsecured five-year revolving credit facility (the "2022 Credit Facility") and replaced the then-existing credit agreement, which was contemporaneously terminated.
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").
We were in compliance with all covenants of the 2022 Credit Agreement as of December 31, 2023. Share Repurchase Programs In January 2021, our board of directors authorized a share repurchase program to repurchase up to $1.5 billion of our Common Stock.
In April 2024, our board of directors authorized a share repurchase program to repurchase up to an additional $3.0 billion of our Common Stock.
As of December 31, 2021, the Company had completed its final deliveries of drug product under its agreements with the U.S. government; as a result, there were no net product sales of REGEN-COV in the United States recorded during the years ended December 31, 2023 and 2022. 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.
Revenue from product sales is recorded net of applicable provisions for rebates, chargebacks, and discounts; distribution-related fees; and other sales-related deductions.
Removed
We also expect to incur substantial costs related to the commercialization of our marketed products.
Added
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.
Removed
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.
Added
If the projected undiscounted cash flows of the intangible asset are less than the carrying amount, the intangible asset is written down to its fair value in the period in which the impairment occurs.
Removed
Previously, the Company recorded net product sales of ARCALYST in the United States. Net Product Sales Net product sales of EYLEA in the United States decreased in 2023, compared to 2022, primarily due to changing market dynamics, resulting in a lower net selling price and lower volumes.
Added
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.
Removed
EYLEA volumes in 2023 were impacted by the August 2023 launch of EYLEA HD and subsequent transition of EYLEA patients to EYLEA HD. During the year ended December 31, 2021, we recorded net product sales of REGEN-COV in connection with our agreements with the U.S. government.
Added
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.
Removed
The following table summarizes the provisions, and credits/payments, for sales-related deductions.
Added
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.
Removed
Antibody Global net product sales of Dupixent and Kevzara are recorded by Sanofi in connection with the Antibody Collaboration, and we and Sanofi share profits on such sales. As described in Part I, Item 1.
Added
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.
Removed
During the year ended December 31, 2022, the Company earned two $50.0 million sales-based milestones from Sanofi, upon aggregate annual sales of antibodies outside the United States (including Praluent) exceeding $2.0 billion and $2.5 billion, respectively, on a rolling twelve-month basis.

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Item 7A. Quantitative and Qualitative Disclosures About Market Risk

Market Risk — interest-rate, FX, commodity exposure

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Biggest changeItem 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 and Disagreements with Accountants on Accounting and Financial Disclosure None.
Biggest changeWe 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.
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 Leases ").
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 ").
As sales outside the United States continue to grow, and as we expand our international operations, we will continue to assess potential steps, including foreign currency hedging and other strategies, to mitigate our foreign exchange risk. Market Price Risk We are exposed to price risk on equity securities included in our investment portfolio.
As sales outside the United States continue to grow, and as we expand our international operations, we will continue to assess and implement strategies, including foreign currency hedging, to mitigate our foreign exchange risk. Market Price Risk We are exposed to price risk on equity securities included in our investment portfolio.
In 2023, 2022, and 2021, we did not recognize any charges for write-offs and allowances of accounts receivable related to credit risk for our collaborators or customers.
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.
We estimate that a 100 basis point, or 1%, unfavorable change in interest rates would have resulted in approximately a $98.7 million and $102.7 million decrease in the fair value of our investment portfolio as of December 31, 2023 and 2022, respectively.
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.
In 2023, 2022, and 2021, we did not record any charges for credit-related impairments of our available-for-sale debt securities. We are subject to credit risk associated with the receivables due from our collaborators, including Bayer and Sanofi. We are also subject to credit risk in connection with trade accounts receivable due from our customers from our product sales.
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.
In addition, pursuant to the applicable terms of the agreements with our collaborators, we also share in certain worldwide development expenses incurred by our collaborators.
In addition, pursuant to the applicable terms of the agreements with our collaborators, we also share in certain worldwide development and/or commercialization-related expenses incurred by our collaborators.
We have contractual payment terms with each of our collaborators and customers. We 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.
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.
Therefore, 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.
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.
Our investments include equity securities of companies with which we have entered into collaboration arrangements. Changes in the fair value of our equity investments are included in Other income (expense), net on the Statements of Operations. We recorded $237.8 million and $39.8 million of net unrealized losses on equity securities in Other income (expense), net in 2023 and 2022, respectively.
Our 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.
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, effective July 1, 2022, market Libtayo outside the United States as a result of obtaining worldwide rights to Libtayo under an A&R IO LCA with Sanofi.
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.
Removed
As of December 31, 2023, two customers accounted on a combined basis for 83% of our net trade accounts receivables. 89 Table of Contents Foreign Exchange Risk 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.
Added
Changes in and Disagreements with Accountants on Accounting and Financial Disclosure None.

Other REGN 10-K year-over-year comparisons