What changed in this filing

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Item 1. Business

2026-02-04 compared with 2025-02-05 · 437 added, 389 removed, 724 unchanged (53% of the section changed)

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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;

• competing products and product candidates (including biosimilar products) that may be superior to, or more cost effective than, products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, "Regeneron's Products") and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, "Regeneron's Product Candidates");

• uncertainty of the utilization, market acceptance, and commercial success of Regeneron's Products and Regeneron's Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary) or recommendations and guidelines from governmental authorities and other third parties or other factors beyond Regeneron's control on the commercial success of Regeneron's Products and Regeneron's Product Candidates;

• the nature, timing, and possible success and therapeutic applications of Regeneron's Products and Regeneron's Product Candidates and research and clinical programs now underway or planned, including without limitation those discussed or referenced in this report, Regeneron's and its collaborators' earlier-stage programs, and the use of human genetics in Regeneron's research programs;

• the likelihood and timing of achieving any of our anticipated development milestones referenced in this report;

4 unchanged sentences

• 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;

• our ability to manufacture and manage supply chains for multiple products and product candidates and risks associated with tariffs and other trade restrictions;

• the ability of our collaborators, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regeneron's Products and Regeneron's Product Candidates;

• the availability and extent of reimbursement 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 availability and extent of reimbursement or copay assistance for Regeneron's Products from third-party payors and other third parties, including private payor healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid;

• coverage and reimbursement determinations by such payors and other third parties and new policies and procedures adopted by such payors and other third parties;

• changes to drug pricing regulations and requirements and our drug pricing strategy;

• other changes in laws, regulations, and policies affecting the healthcare industry;

• the costs of developing, producing, and selling products or unanticipated expenses;

• our ability to meet any of our financial projections or guidance, including without limitation capital expenditures, and changes to the assumptions underlying those projections or guidance;

• our ability to meet any of our financial projections or guidance and changes to the assumptions underlying those projections or guidance;

• the potential for any license or collaboration agreement, including our agreements with Sanofi and Bayer (or their respective affiliated companies, as applicable), to be cancelled or terminated;

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These statements are made based on management's current beliefs and judgment, and the reader is cautioned not to rely on any such statements.

In evaluating such statements, shareholders and potential investors should specifically consider the various

factors identified under Part I, Item 1A.

In evaluating such statements, shareholders and potential investors should specifically consider the various factors identified under Part I, Item 1A.

"Risk Factors," which could cause actual events and results to differ materially from those indicated by such forward-looking statements.

19 unchanged sentences

Diabetic retinopathy ("DR")

Macular edema following retinal vein occlusion ("RVO")

EYLEA ® (aflibercept) Injection (a)

Macular edema following retinal vein occlusion ("RVO"), which includes macular edema following central retinal vein occlusion ("CRVO") and macular edema following branch retinal vein occlusion ("BRVO")

Myopic choroidal neovascularization ("mCNV") a a

2 unchanged sentences

Dupixent ® (dupilumab) Injection (b)

Atopic dermatitis (in adults, adolescents, and pediatrics aged 6 months and older)

Atopic dermatitis (in patients aged 6 months and older)

Asthma (in adults and adolescents) a a a

Asthma (in pediatrics 6–11 years of age) a a a

Product (continued)

1 unchanged sentence

Dupixent ® (dupilumab) Injection (b) (continued)

Asthma (in pediatrics 6–11 years of age) a a

Chronic rhinosinusitis with nasal polyposis ("CRSwNP") (in adults)

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Chronic obstructive pulmonary disease ("COPD")

Eosinophilic esophagitis ("EoE") (in adults, adolescents, and pediatrics aged 1 year and older)

Eosinophilic esophagitis ("EoE") (in patients aged 1 year and older)

Prurigo nodularis a a a

Chronic spontaneous urticaria ("CSU") (in adults and adolescents)

Bullous pemphigoid

Libtayo ® (cemiplimab) Injection

Metastatic or locally advanced first-line non-small cell lung cancer ("NSCLC")

Metastatic or locally advanced first-line NSCLC (in combination with chemotherapy)

Metastatic or locally advanced first-line non-small cell lung cancer ("NSCLC"), monotherapy and in combination with chemotherapy

Metastatic or locally advanced basal cell carcinoma ("BCC")

Metastatic or locally advanced cutaneous squamous cell carcinoma ("CSCC") a a

Adjuvant CSCC

Metastatic or recurrent second-line cervical cancer

Praluent ® (alirocumab) Injection (c)

LDL-lowering in heterozygous familial hypercholesterolemia ("HeFH") or clinical atherosclerotic cardiovascular disease ("ASCVD") a a

HeFH in pediatrics and adolescents (8–17 years of age)

Cardiovascular risk reduction in patients with established cardiovascular disease a a

Cardiovascular risk reduction in patients at increased risk of cardiovascular events

Hypercholesterolemia

Heterozygous familial hypercholesterolemia ("HeFH") (in patients aged 8 years and older)

Homozygous familial hypercholesterolemia ("HoFH") a

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Polyarticular juvenile idiopathic arthritis ("pJIA")

REGEN-COV ®(d)

Evkeeza ® (evinacumab) Injection (e)

Evkeeza ® (evinacumab) Injection (d)

HoFH (in adults, adolescents, and pediatrics)

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Diffuse large B-cell lymphoma ("DLBCL")

Lynozyfic ™ (linvoseltamab)

Relapsed/refractory multiple myeloma

Inmazeb ® (atoltivimab, maftivimab, and odesivimab) Injection

1 unchanged sentence

Veopoz ® (pozelimab) Injection

CD55-deficient protein-losing enteropathy ("CHAPLE") (in adults, adolescents, and pediatrics aged 1 year and older)

Product (continued)

ARCALYST ® (rilonacept) Injection (f)

CD55-deficient protein-losing enteropathy ("CHAPLE") (in patients aged 1 year and older)

ARCALYST ® (rilonacept) Injection (e)

Cryopyrin-associated periodic syndromes ("CAPS"), including familial cold auto-inflammatory syndrome ("FCAS") and Muckle-Wells syndrome ("MWS") (in adults and adolescents) a

1 unchanged sentence

Recurrent pericarditis (in adults and adolescents)

ZALTRAP ® (ziv-aflibercept) Injection for Intravenous Infusion (g)

ZALTRAP ® (ziv-aflibercept) Injection for Intravenous Infusion (f)

Metastatic colorectal cancer ("mCRC") a a a

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(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.

(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.

(g) Sanofi is solely responsible for the development and commercialization of ZALTRAP.

(c) The Company is 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) The Company is 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

(e) Kiniksa is responsible for the development and commercialization of ARCALYST

(f) Sanofi is responsible for the development and commercialization of ZALTRAP

The table below includes net product sales of Regeneron-discovered products.

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ROW Total U.S.

EYLEA HD and EYLEA (a)

$ 1,636.9 $ 932.7 $ 2,569.6 $ 1,201.1 $ 239.9 $ 1,441.0 $ 165.8 $ — $ 165.8

$ 2,747.8 $ 2,573.6 $ 5,321.4 $ 4,767.1 $ 3,336.9 $ 8,104.0 $ 5,719.6 $ 3,495.2 $ 9,214.8

Total EYLEA HD and EYLEA

$ 4,384.7 $ 3,506.3 $ 7,891.0 $ 5,968.2 $ 3,576.8 $ 9,545.0 $ 5,885.4 $ 3,495.2 $ 9,380.6

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$ 944.7 $ 507.5 $ 1,452.2 $ 787.3 $ 429.5 $ 1,216.8 $ 538.8 $ 330.0 $ 868.8

REGEN-COV (e)

$ 262.5 $ 594.3 $ 856.8 $ 241.7 $ 523.3 $ 765.0 $ 182.4 $ 456.5 $ 638.9

Other products (f)

$ 371.4 $ 203.2 $ 574.6 $ 270.2 $ 188.5 $ 458.7 $ 214.7 $ 171.2 $ 385.9

Other products (e)

$ 210.0 $ 113.3 $ 323.3 $ 202.9 $ 90.0 $ 292.9 $ 150.5 $ 686.2 $ 836.7

(a) We record net product sales of EYLEA HD and EYLEA in the United States, and Bayer records net product sales outside the United States.

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Prior to July 1, 2022, Sanofi recorded net product sales of Libtayo outside the United States.

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).

(d) We record net product sales of Praluent in the United States.

Sanofi records net product sales of Praluent outside the United States and pays us a royalty on such sales, which is recorded within Other revenue.

(e) Roche records net product sales outside the United States and we record our share of gross profits from sales, which is recorded within Collaboration revenue.

Refer to Part II, Item 7.

"Management's Discussion and Analysis of Financial Condition and Results of Operations -Results of Operations - Revenues - Roche Collaboration Revenue" for such amounts.

(f) Included in this line item are products which are sold by us and others.

(e) Included in this line item are products which are sold by us and others.

Refer to Part II, Item 7.

"Management's Discussion and Analysis of Financial Condition and Results of Operations - Results of Operations - Revenues" for a complete listing of net product sales recorded by us.

"Management's Discussion and Analysis of Financial Condition and Results of Operations - Results of Operations - Revenues" for a listing of net product sales recorded by us.

Not included in this line item are net product sales of ARCALYST, which are recorded by Kiniksa.

(g) Rest of world ("ROW")

(f) Rest of world ("ROW")

Programs in Clinical Development

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EYLEA HD (aflibercept) 8 mg (a)

–Two-year data for wAMD and DME (U.S.)

–Pre-filled syringe (U.S.)

–Approved by European Commission ("EC") and Japan's Ministry of Health, Labour and Welfare ("MHLW") for wAMD and DME

–Pre-filled syringe approved by European Medicines Agency ("EMA")

–Presented positive three-year data from extension study of Phase 3 DME trial at American Academy of Ophthalmology ("AAO") Annual Meeting

–Reported that Phase 3 QUASAR trial in RVO met its primary endpoint

Food 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)

–Presented positive three-year data from extension study of Phase 3 wAMD trial at Angiogenesis, Exudation, and Degeneration ("Angiogenesis") 2025 annual meeting

–Presented positive data from Phase 3 QUASAR trial in RVO at Angiogenesis 2025 annual meeting

–Approved by FDA and European Commission ("EC") for RVO

–Approved by FDA for every 4-week dosing regimen for approved indications

–FDA issued Complete Response Letters ("CRLs") for supplemental Biologics License Application ("sBLA") for addition of extended dosing intervals and for regulatory application for pre-filled syringe

–Submitted regulatory application for pre-filled syringe in U.S.

–Approved EC for extended dosing intervals up to 6 months (24 weeks) in wAMD and DME

Food and Drug Administration ("FDA") decision for pre-filled syringe (second quarter 2026)

Clinical Program (continued)

Phase 2 Phase 3 Regulatory

2025 and 2026

Events to Date

Select Upcoming

Pozelimab (f) (antibody to C5) + cemdisiran (l) (siRNA therapeutic targeting C5)

–Geographic atrophy (q)

–Report initial results from lead-in cohort of Phase 3 study in geographic atrophy (combination and cemdisiran monotherapy) (second half 2026)

Immunology & Inflammation

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Antibody to IL-4R alpha subunit

–Ulcerative colitis

–Asthma in pediatrics (2–5 years of age)

–Bullous pemphigoid (c)

–Chronic pruritus of unknown origin ("CPUO")

–Lichen simplex chronicus

–COPD with type 2 inflammatory phenotype (Japan)

–CSU in adults and adolescents (U.S.

–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)

Clinical Program (continued)

Phase 2 Phase 3 Regulatory

2024 and 2025

Events to Date

Select Upcoming

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

–CSU in pediatrics (2–11 years of age) (U.S., EU, and Japan)

–Bullous pemphigoid (EU and Japan)

–Allergic fungal rhinosinusitis ("AFRS") (U.S.)

–Approved by Japan's Ministry of Health, Labour and Welfare ("MHLW") for asthma in pediatrics (6–11 years of age)

–Approved by MHLW for COPD

–Approved by FDA and EC for CSU in adults and adolescents

–Presented positive data from Phase 2/3 bullous pemphigoid trial at 2025 American Academy of Dermatology ("AAD") Annual Meeting

–Approved by FDA for bullous pemphigoid

–Reported that Phase 3 trial in AFRS met its primary and key secondary endpoints

–EC decision on regulatory submission for bullous pemphigoid (first half 2026)

–FDA decision on sBLA for AFRS (February 2026)

Kevzara (sarilumab) (b)

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–Systemic juvenile idiopathic arthritis ("sJIA") (pivotal study)

–Approved by FDA and EC for pJIA

–Approved by EC for PMR

–Approved by EC for pJIA

Itepekimab (b) (REGN3500)

Antibody to IL-33

–Chronic rhinosinusitis without nasal polyposis ("CRSsNP")

–Reported that Phase 3 trial (AERIFY-1) in COPD met its primary endpoint;

second Phase 3 trial (AERIFY-2) did not meet same primary endpoint

Clinical Program (continued)

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Select Upcoming

Itepekimab (b) (REGN3500)

Antibody to IL-33

–Non-cystic fibrosis bronchiectasis ("NCFB")

–Chronic rhinosinusitis without nasal polyposis ("CRSsNP")

–Report results from Phase 3 study in COPD (second half 2025)

–Initiate additional Phase 3 studies (first half 2025)

Itepekimab (b) (REGN3500) (continued)

–Discontinued Phase 2 study in non-cystic fibrosis bronchiectasis ("NCFB")

REGN5713-5715

Multi-antibody therapy to Bet v 1

–Birch allergy

–Birch allergy –Reported that Phase 3 trial in birch allergy met its primary and key secondary endpoints

–Initiated second Phase 3 trial in birch allergy

REGN1908-1909 (f)

Multi-antibody therapy to Fel d 1

–Reported that Phase 3 trial in cat allergy met its primary and key secondary endpoints

–Initiate second Phase 3 study in cat allergy (first half 2026)

Solid Organ Oncology

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–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)

–Adjuvant CSCC (Japan)

–Approved by FDA and EC for adjuvant CSCC

–Reported positive data from Phase 3 trial in adjuvant CSCC;

results presented at 2025 American Society of Clinical Oncology ("ASCO") Annual Meeting and published in New England Journal of Medicine ("NEJM")

–Approved by MHLW for NSCLC, monotherapy and chemotherapy combination

–Reported positive five-year follow-up data from Phase 3 trial in combination with chemotherapy for NSCLC;

results presented at IASLC 2025 World Conference on Lung Cancer ("WCLC")

Fianlimab (f) (REGN3767)

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–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)

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)

–Report results from Phase 3 study versus pembrolizumab in first-line metastatic melanoma (first half 2026)

Clinical Program (continued)

3 unchanged sentences

Select Upcoming

Fianlimab (f) (REGN3767) (continued)

–Perioperative melanoma

–Based on pre-planned interim analysis of two Phase 2/3 studies in first-line advanced NSCLC, Phase 2 portion of the studies will continue unchanged

–Report Phase 2 data in first-line advanced NSCLC (first half 2026)

Immune activator targeting TLR9

Ubamatamab (f) (REGN4018)

Bispecific antibody targeting MUC16 and CD3

–Ovarian cancer

–Presented additional data from Phase 2 study in platinum-resistant ovarian cancer at European Society for Medical Oncology ("ESMO") 2025 Meeting

Bispecific antibody targeting MUC16 and CD28

–Ovarian cancer

Nezastomig (REGN5678)

Bispecific antibody targeting PSMA and CD28

–Prostate cancer

–Report additional data from study in prostate cancer (2025)

–Prostate cancer –Reported additional data from study in prostate cancer at American Association for Cancer Research ("AACR") Annual Meeting

Marlotamig (REGN7075)

Bispecific antibody targeting EGFR and CD28

–Solid tumors

–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)

1 unchanged sentence

–MET-altered advanced NSCLC

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)

Pozelimab (f) (antibody to C5) + cemdisiran (l) (siRNA therapeutic targeting C5)

–Paroxysmal nocturnal hemoglobinuria ("PNH") (c)

–Report results from Phase 3 study in PNH (fourth quarter 2026/first quarter 2027)

Ordspono (odronextamab)

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("B-NHL") (pivotal study)

–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)

–Lymphoma (c)(e) (multiple lines and settings)

–FDA issued CRL for BLA for relapsed/refractory FL

Lynozyfic (linvoseltamab) (f)

Bispecific antibody targeting BCMA and CD3

–Multiple myeloma precursor and related conditions

–Multiple myeloma (c)(e) (multiple lines and settings)

–Approved by FDA and EC for relapsed/refractory multiple myeloma –Initiate additional Phase 3 studies in multiple myeloma and precursor conditions (2026)

Clinical Program (continued)

3 unchanged sentences

Select Upcoming

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.

–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

Lynozyfic (linvoseltamab) (f) (continued)

–Completed enrollment in Phase 3 confirmatory trial (LINKER-MM3) in relapsed/refractory multiple myeloma

Nexiguran ziclumeran (Nex-z, NTLA-2001) (j)

TTR gene knockout using CRISPR/Cas9

–Transthyretin amyloidosis with cardiomyopathy ("ATTR-CM") (c)

–Transthyretin amyloidosis with cardiomyopathy ("ATTR-CM") (c)(m)

–Hereditary transthyretin amyloidosis with polyneuropathy ("ATTRv-PN") (c)(m)

Antibody to Factor XI

–Thrombosis –Reported positive results from Phase 2 trial in thrombosis

–Initiate Phase 3 program (2025)

Antibody to Factor XI

–Reported positive results from Phase 2 trial in thrombosis

–Initiate Phase 3 program (2025)

–Phase 3 ATTR-CM trial enrollment on FDA clinical hold

Antibody to Factor XI (catalytic domain)

–Thrombosis –Venous thromboembolism after total knee replacement surgery

–Initiate additional Phase 3 studies in anticoagulation (first half 2026)

Antibody to Factor XI (A2 domain)

–Initiate Phase 3 studies in anticoagulation (first half 2026)

Antibody to IL2Rg

–Aplastic anemia

–Discontinued study in aplastic anemia

Antibody to TMPRSS6

–Iron overload in beta-thalassemia

Internal Medicine/Genetic Medicines

Internal Medicine/Neurology/Rare Diseases

Garetosmab (f) (REGN2477)

2 unchanged sentences

("FOP") (c)(d)(e)

–Report results from Phase 3 study in FOP (second half 2025)

–Reported that Phase 3 trial in FOP met its primary endpoint

–FDA decision on BLA and EC decision on Marketing Authorization Application ("MAA") for FOP (second half 2026)

Cemdisiran (l)

siRNA therapeutic targeting C5

–Myasthenia gravis (c)

–Reported that Phase 3 trial in myasthenia gravis met its primary and key secondary endpoints

–Submit New Drug Application ("NDA") for myasthenia gravis (first quarter 2026)

Mibavademab (f)(o) (REGN4461)

Agonist antibody to leptin receptor ("LEPR")

–Functional hypothalamic amenorrhea

–Generalized lipodystrophy (c)(d)(e)

Trevogrumab (f) (REGN1033)

Antibody to myostatin (GDF8)

–Completed enrollment in Phase 2 study in obesity

–Report results from Phase 2 study in obesity (second half 2025)

–Reported 26-week results from Phase 2 study in obesity

–Report additional data from Phase 2 study in obesity (2026)

Clinical Program (continued)

3 unchanged sentences

Select Upcoming

Mibavademab (f)(o) (REGN4461)

Agonist antibody to leptin receptor ("LEPR")

–Generalized lipodystrophy (d)(e)

Agonist antibody to NPR1

–Heart failure

Antagonist antibody to NPR1

–Postural orthostatic tachycardia syndrome ("POTS")

–Sepsis-induced hypotension

Rapirosiran (ALN-HSD) (k)

1 unchanged sentence

–Metabolic dysfunction-associated steatohepatitis ("MASH")

ALN-ANG3 (k)(r)

RNAi therapeutic targeting ANGPTL3

–Diabetic kidney disease

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)

–Hearing deficit due to variants of otoferlin gene (c)(e)(m) (Phase 1/2) (pivotal study)

–Hearing deficit due to variants of otoferlin gene (U.S.)

–Presented updated data from Phase 1/2 trial and published in NEJM

–FDA granted Commissioner's National Priority Voucher

–FDA decision on BLA for hearing deficit due to variants of otoferlin gene (first half 2026)

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

We have discontinued further clinical development of REGN5381, an agonist antibody to NPR1, which was previously being studied in heart failure and uncontrolled hypertension

(a) In collaboration with Bayer outside the United States

(b) In collaboration with Sanofi

(d) FDA granted Breakthrough Therapy designation

(e) FDA granted Fast Track designation

(f) Sanofi did not opt-in to or elected not to continue to co-develop the product candidate.

Under the terms of our agreement, Sanofi is entitled to receive royalties on sales of the product, if any.

(d) FDA granted Breakthrough Therapy designation for one or more indications

(e) FDA granted Fast Track designation for one or more indications

(f) Sanofi is entitled to receive royalties on sales of the product

(g) Studied as monotherapy and in combination with other antibodies and treatments

(h) Information in this column captures submissions to U.S., EU, and Japan regulatory authorities

(h) Information in this column captures submissions to U.S., EU, and/or Japan regulatory authorities

(i) BioNTech's BNT116 is an mRNA cancer vaccine

(j) In collaboration with Intellia

(k) Alnylam elected to opt-out of the product candidate.

Under the terms of our agreement, Alnylam is entitled to receive royalties on sales of the product, if any.

(l) Under the terms of our license agreement for cemdisiran, Alnylam is entitled to receive royalties on sales (if any), as well as sales milestones.

(m) FDA granted Regenerative Medicine Advanced Therapy ("RMAT") designation

(k) Alnylam is entitled to receive royalties on sales of the product

(l) Under the terms of our license agreement for cemdisiran, Alnylam is entitled to receive royalties on sales, as well as milestone payments

(m) FDA granted Regenerative Medicine Advanced Therapy ("RMAT") designation for one or more indications

(n) Studied in combination with semaglutide with and without garetosmab

(o) A Phase 2 study, sponsored by Eli Lilly, is also ongoing and testing the combination of tirzepatide and mibavademab compared with tirzepatide alone in patients with obesity

(p) Studied in combination with ubamatamab or fianlimab

(q) Geographic atrophy also studied with cemdisiran monotherapy

(r) Studied as monotherapy and in combination with Evkeeza (evinacumab)

Additional Information - Clinical Development Programs

Linvoseltamab

In August 2024, the FDA issued a CRL for the BLA for linvoseltamab in relapsed/refractory multiple myeloma that has progressed after at least three prior therapies.

The sole approvability issue identified related to findings from a pre-approval inspection at a third-party fill/finish manufacturer.

In January 2025, the Company resubmitted the BLA following resolution of third-party manufacturing issues, and an FDA decision on the BLA is anticipated by mid-2025.

In September 2024, the Company and Sanofi announced that the first Phase 3 trial (Study A) of Dupixent in adults with uncontrolled and severe CPUO did not achieve statistical significance in its primary itch responder endpoint (despite favorable numerical improvements), but showed nominally significant improvements in all other itch endpoints.

The Dupixent Phase 3 program in CPUO consists of Study A and Study B.

Study B recently initiated as a subsequent pivotal trial.

Select Early-Stage Clinical Development Updates

In 2024, a Phase 1 study of linvoseltamab, in combination with dupilumab, in severe food allergy was initiated.

In 2024, a Phase 1 combination cohort of nezastomig and REGN4336 (bispecific antibody targeting PSMA and CD3) in metastatic castration-resistant prostate cancer was initiated.

In August 2025, the FDA extended the target action dates for the Company's FDA applications for EYLEA HD (pre-filled syringe, every-four-week dosing, and for the treatment of RVO).

The delay resulted from observations from a July 2025 FDA general site inspection (not specific to EYLEA HD) at Catalent Indiana, LLC ("Catalent"), part of Novo Nordisk A/S, the manufacturing filler in the EYLEA HD BLA.

The FDA extended the review periods after determining that the information submitted by the manufacturing filler in August 2025 to address the observations constituted a major amendment to each regulatory application.

In October 2025, the Company was notified by Catalent that they received an official action indicated ("OAI") letter from the FDA citing unresolved issues related to a July 2025 FDA general site inspection.

On October 27, 2025, the FDA issued a CRL for the pre-filled syringe sBLA.

The sole approvability issue cited in the CRL relates to unresolved inspection findings at Catalent.

In December 2025, the Company submitted a regulatory application seeking approval of the EYLEA HD pre-filled syringe using a new manufacturer.

The application has been accepted for review, a standard pre-licensing inspection has been scheduled, and an FDA decision on the Company's filing is expected in the second quarter of 2026.

In November 2025, the FDA approved EYLEA HD for the treatment of patients with RVO and for an every 4-week dosing option across approved indications.

In addition, in December 2025, the FDA approved the addition of a new manufacturer to fill vials for EYLEA HD.

In May 2025, the Company and Sanofi announced that a Phase 3 trial, AERIFY-1, in adults who were former smokers with inadequately controlled COPD met the primary endpoint of significantly reducing moderate or severe acute exacerbations by 27% compared to placebo at week 52, a clinically meaningful benefit.

A second Phase 3 trial, AERIFY-2, did not meet the same primary endpoint, although a benefit was seen earlier in the trial.

The safety profile of itepekimab observed in the Phase 3 trials was consistent with prior clinical trials.

The Company and Sanofi are evaluating next steps.

In April 2025, a pre-planned interim analysis was conducted on two ongoing Phase 2/3 studies evaluating the combination of fianlimab and cemiplimab in first-line advanced NSCLC.

Due to limited follow-up, the Phase 2 portion of the studies will continue unchanged until additional data are available.

The next analyses for these studies are expected in the first half of 2026, at which time a decision whether to advance to Phase 3 is expected to be made.

No new safety signals were observed in either study.

Ordspono (odronextamab)

On July 30, 2025, the FDA issued a CRL for the BLA for odronextamab in relapsed/refractory follicular lymphoma after two or more lines of systemic therapy, which was also impacted by the Catalent Indiana LLC site inspection (as described in the "EYLEA HD" section above).

Descriptions of Marketed Products Studied in Additional Indications and Product Candidates in Late-Stage Clinical Development

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EYLEA HD is a soluble fusion protein that acts as a vascular endothelial growth factor ("VEGF") inhibitor.

Through a novel formulation, it is designed to deliver a concentrated dose of aflibercept to block VEGF-A and PLGF and inhibit the growth of new blood vessels and decrease vascular permeability to treat various retinal diseases, including wAMD, DME, and DR.

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.

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, bullous pemphigoid, and potentially other chronic allergic and inflammatory diseases.

Kevzara (sarilumab)

Kevzara is a fully human monoclonal antibody that binds specifically to the IL-6 receptor and inhibits IL-6-mediated signaling.

IL-6 is an immune system protein produced in increased quantities in patients with RA and has been associated with disease activity, joint destruction, and other systemic problems.

Itepekimab is an investigational, fully human monoclonal antibody that inhibits IL-33, a protein that is believed to play a key role in lung inflammation in COPD.

IL-6 is an immune system protein produced in increased quantities in patients with inflammatory diseases such as RA and has been associated with disease activity, joint destruction, and other systemic problems.

Itepekimab is an investigational, fully human monoclonal antibody that inhibits IL-33, a protein that is believed to play a key role in inflammation in COPD and CRSwNP.

REGN5713-5715

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The PD-1/PD-L1 immune checkpoint pathway is a well-known mechanism by which cancers evade immune destruction.

Regeneron is studying Libtayo as monotherapy and in combination with either conventional or novel therapeutic approaches in various solid tumors and blood cancers.

Regeneron is studying Libtayo as a monotherapy and in combination with either conventional or novel therapeutic approaches in various solid tumors and blood cancers.

It is also being studied in combination with proprietary anti-cancer assets of other companies.

Libtayo has also been approved by regulatory authorities in a number of cancer indications, including advanced NSCLC, BCC, CSCC, and cervical cancer.

Libtayo has also been approved by regulatory authorities in a number of cancer indications, including as a treatment for advanced NSCLC, BCC, CSCC, and cervical cancer, and as an adjuvant treatment for patients with CSCC with a high risk of recurrence after surgery and radiation.

Fianlimab is an investigational, fully human monoclonal antibody targeting the immune checkpoint receptor LAG-3 on T-cells.

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Pozelimab is a fully human monoclonal antibody designed to block complement factor C5 in order to treat diseases mediated by abnormal complement pathway activity, and is approved by the FDA for CHAPLE.

Pozelimab is being studied in investigational combinations with an investigational small interfering RNA ("siRNA") therapy, cemdisiran, in PNH, myasthenia gravis, and geographic atrophy.

Pozelimab is being studied in investigational combinations with an investigational small interfering RNA ("siRNA") therapy, cemdisiran, in PNH and geographic atrophy.

Cemdisiran is an investigational siRNA therapy that reduces circulating levels of C5.

Cemdisiran, as a monotherapy and in combination with pozelimab (C5 antibody), is being evaluated in trials for complement-mediated disorders, including myasthenia gravis, PNH, and geographic atrophy.

Ordspono (odronextamab)

Odronextamab is a bispecific monoclonal antibody designed to bridge CD20 on cancer cells with CD3-expressing T cells to facilitate local T-cell activation and cancer-cell killing.

We are studying odronextamab 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.

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.

We are also studying linvoseltamab in precursor conditions to multiple myeloma, including high-risk MGUS and high-risk smoldering myeloma.

Ordspono is a bispecific monoclonal antibody designed to bridge CD20 on cancer cells with CD3-expressing T cells to facilitate local T-cell activation and cancer-cell killing.

We are studying Ordspono in several types of B-cell non-Hodgkin lymphoma, including in frontline settings.

Lynozyfic (linvoseltamab)

Lynozyfic is a bispecific monoclonal antibody designed to bind to CD3 while also binding and bridging T-cells to the BCMA protein on multiple myeloma cells.

This may help to activate T-cells via their CD3 receptors and trigger targeted, T-cell mediated killing of multiple myeloma.

Lynozyfic has been approved by regulatory authorities for relapsed or refractory multiple myeloma, and continues to be studied in multiple lines and settings of multiple myeloma.

Nex-z is an investigational CRISPR-based therapy to be systemically delivered to edit genes inside the human body and is being studied as a treatment for ATTR amyloidosis.

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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.

REGN7508 and REGN9933

We are advancing a robust factor XI program to assess two mechanistically-distinct antibodies, REGN7508 (catalytic domain) and/or REGN9933 (A2 domain), across a variety of indications.

These two antibodies were prospectively designed to have distinct profiles – with one designed to provide stronger anticoagulation and the other offering a lower risk of bleeding – potentially allowing physicians to tailor anticoagulation therapy for patients with different risk profiles.

Garetosmab is an investigational, fully human monoclonal antibody that binds to and neutralizes Activin A, which drives the abnormal bone formation that is the main pathology of the ultra-rare genetic disorder FOP.

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We are studying mibavademab as a potential treatment for generalized lipodystrophy.

DB-OTO is an investigational cell-selective, dual AAV vector gene therapy designed to provide durable, physiological hearing to individuals with profound, congenital hearing loss caused by variants of the otoferlin gene.

The treatment aims to deliver a working copy of the otoferlin gene to replace the non-functional otoferlin protein using a modified, non-pathogenic virus that is delivered via an infusion into the cochlea under general anesthesia (similar to the procedure used for cochlear implantation).

In this gene therapy, the newly introduced otoferlin gene is under the control of a proprietary cell-specific Myo15 promoter, which is intended to restrict expression only to hair cells that normally express otoferlin.

Other Programs

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VelociSuite ® is our second technology platform, which is used for discovering, developing, and producing fully human antibodies that can address both secreted and cell-surface targets.

We also leverage VelociSuite to produce new classes of bispecific antibodies.

We also leverage VelociSuite to produce new classes of bispecific antibodies, antibody-protein fusions, and antibody conjugates.

Additionally, we use genetic medicine platforms as complementary approaches to these core technologies to potentially treat or cure diseases.

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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.

Regeneron Genetics Center LLC (RGC ® ), a wholly owned subsidiary of Regeneron Pharmaceuticals, Inc., leverages de-identified clinical, genomic, proteomic, and other types of molecular data from properly consented human volunteers from around the world to identify medically relevant associations in a blinded fashion designed to preserve a patient's privacy while uncovering the unique characteristics of their health and wellness.

The objective of RGC is to expand the use of human genetics for discovering and validating genetic factors that cause or influence a range of diseases where there are major unmet medical needs, with the prospect of improving the drug discovery and development process and to advance innovation in clinical care design.

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.

In January 2025, it was announced that RGC was selected by UK Biobank consortium members to complete proteomic assay data generation for the recently announced UK Biobank Pharma Proteomics Project.

RGC utilizes laboratory automation and innovative approaches to cloud computing to achieve high-quality throughput, attaining over 3 million samples sequenced to date.

In January 2025, it was announced that RGC was selected by UK Biobank consortium members to complete proteomic assay data generation for the UK Biobank Pharma Proteomics Project.

In January 2025, RGC entered into an agreement with Truveta Inc.

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These efforts at RGC have led to the identification of more than 40 novel genetic targets.

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.

Through our Regeneron Genetics Medicines initiative, we are currently advancing many of these targets using either our VelociSuite technologies or other technologies, such as siRNA gene silencing, genome editing, and targeted viral-based gene delivery and expression.

See the "Collaboration, License, and Other Agreements" section below for descriptions of our agreements with Alnylam Pharmaceuticals, Inc.

and Intellia Therapeutics, Inc.

Collaboration, License, and Other Agreements

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 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;

We are collaborating with Sanofi on the global development and commercialization of Dupixent, Kevzara, and itepekimab.

Under the terms of the collaboration, Sanofi is generally responsible for funding 80% to 100% of agreed-upon development expenses as incurred.

We are obligated to reimburse Sanofi for 30% to 50% of development expenses that were funded by Sanofi (i.e., "development balance") based on our share of collaboration profits;

however, we are only required to apply 20% of our share of profits from the collaboration each calendar quarter to reimburse Sanofi for these development expenses.

As of December 31, 2024, the total amount of our contingent reimbursement obligation (i.e., "development balance") to Sanofi in connection with such development expenses was approximately $1.635 billion.

Under our collaboration agreement, Sanofi records product sales for commercialized products, and Regeneron has the right to co-commercialize such products on a country-by-country basis.

As of December 31, 2025, the total amount of our contingent reimbursement obligation to Sanofi in connection with the development balance was approximately $595 million.

Under our collaboration agreement, Sanofi records product sales for commercialized products, and we have the right to co-commercialize such products on a country-by-country basis.

We co-commercialize Dupixent in the United States and in certain countries outside the United States.

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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.

The reimbursement payment in any quarter will equal 5% of the then outstanding repayment obligation, but never more than our share of the collaboration profits in the quarter unless we elect to reimburse Bayer at a faster rate.

We are obligated to reimburse Bayer for 50% of the development expenses that it has incurred under the agreement from our share of the collaboration profits.

The reimbursement payment in any quarter will equal 5% of the then outstanding repayment

obligation, but never more than our share of the collaboration profits in the quarter unless we elect to reimburse Bayer at a faster rate.

Within the United States, we retain exclusive commercialization rights and are entitled to all profits from such sales.

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.

For each program, we provide Alnylam with a specified amount of funding at program initiation and at lead candidate designation.

During 2023, we paid a $100.0 million development milestone to Alnylam (in connection with a CNS program) and Alnylam is eligible to receive an additional $100.0 million clinical proof-of-principle milestone in connection with an eye program.

We and Alnylam Pharmaceuticals, Inc.

are parties to a collaboration to discover, develop, and commercialize RNAi the rapeutics for a broad range of diseases by addressing therapeutic disease targets expressed in the eye and central nervous system, in addition to a select number of targets expressed in the liver.

For each target nominated, we provide Alnylam with a specified amount of funding at program initiation and at lead candidate designation.

Under the terms of the collaboration, the parties perform discovery research until designation of lead candidates.

Following designation of a lead candidate, the parties may further advance such lead candidate under either a co-development/co-commercialization collaboration agreement ("Co-Co Collaboration Agreement") or a license agreement structure.

The initial target nomination and discovery period of five years has been automatically extended until the earlier of seven years from the effective date of the collaboration or the achievement of certain milestones (the "Research Term").

In addition, we have an option to extend the Research Term for an additional five-year period for a research extension fee of $300.0 million.

Following designation of a lead candidate, the parties may further advance such lead candidate under either a co-development and co-commercialization collaboration agreement ("Co-Co Collaboration Agreement") or a license agreement.

The target nomination period of the collaboration agreement ends in May 2026.

For CNS programs and liver programs, under a Co-Co Collaboration Agreement, the party designated as the lead party will lead development and commercialization of the program and the parties will split profits and share costs equally, subject to certain co-funding opt-outs at specified clinical trial phases or under other conditions.

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.

The licensee will pay to the licensor certain development and/or commercialization milestone payments, as well as certain tiered royalty payments to the licensor based on the aggregate annual net sales of the collaboration product.

We have entered into various license agreements with Alnylam, with us as the licensee, including for cemdisiran as a monotherapy and for a combination consisting of cemdisiran and pozelimab.

During the second quarter of 2024, we elected to no longer co-develop ALN-APP pursuant to a Co-Co Collaboration Agreement;

as a result, Alnylam retains the right to develop and commercialize such product and we will receive a royalty on sales (if any).

We have also entered into various license agreements with Alnylam, with us as the licensee, including for cemdisiran as a monotherapy and for a combination consisting of cemdisiran and pozelimab.

Under a license agreement, the lead party is designated as the licensee and has the right to develop and commercialize the product under such program.

The licensee will be responsible for its own expenses incurred.

The licensee will pay to the licensor certain development and/or commercialization milestone payments, as well as tiered royalty payments to the licensor based on the aggregate annual sales of the product.

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.

Nex-z, which is in clinical development, is subject to a co-development and co-commercialization arrangement pursuant to which Intellia will lead development and commercialization activities and the parties share an agreed-upon percentage of development expenses and profits (if commercialized).

In addition, we also have non-exclusive rights to independently develop and commercialize ex vivo gene edited products.

In September 2023, we expanded the license and collaboration agreement to develop additional in vivo CRISPR-based gene editing therapies focused on neurological and muscular diseases.

Intellia will lead the design of the editing methodology, we will lead the design of the targeted viral vector delivery approach, and the parties share costs equally.

Each company will have the opportunity to lead potential development and commercialization of product candidates for one target, and the company that is not leading development and commercialization will have the option to enter into a co-development and co-commercialization agreement for the target.

In addition, in October 2023, we elected to extend the period for selecting targets under the license and collaboration agreement for an additional two years until April 2026;

as a result, we made a $30.0 million extension payment to Intellia.

In March 2024, Intellia elected to opt-out of further development activities pursuant to the Factor IX co-development and co-commercialization agreement;

as a result, we retain the right to develop and commercialize products directed to Factor IX (which is currently in Phase 1 clinical development), and Intellia will be entitled to receive milestone payments and royalties on sales (if any).

In 2017, we entered into an agreement with Decibel Therapeutics, Inc.

to discover and develop new potential therapeutics to protect, repair and restore hearing (including DB-OTO, which is currently in clinical development, and preclinical programs for GJB2-related and stereocilin-related hearing loss).

In 2023, we acquired Decibel by paying $101.3 million in cash (or $4.00 per share of Decibel common stock).

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.

As a result, we have paid an aggregate amount of $97.1 million, which was the maximum amount that holders of the CVRs were entitled to receive (including the payment in respect of the second development milestone made in 2025).

In 2018, we entered into a collaboration agreement with bluebird bio, Inc.

(which subsequently spun out 2seventy bio, Inc.

in 2021) to research, develop, and commercialize novel cell therapy approaches to address cancer.

In April 2024, we acquired full development and commercialization rights to 2seventy bio's oncology and autoimmune preclinical and clinical stage cell therapy pipeline.

Under the terms of the agreement, we made a $5.0 million up-front payment, and have assumed ongoing program, infrastructure, and personnel costs related to the product candidates acquired.

We are obligated to pay 2seventy bio a regulatory milestone upon the first major market approval of the first approved product;

and, with respect to any approved product, a low single-digit percent royalty on sales.

In addition, we separately entered into sublease agreements for a portion of 2seventy bio's facilities.

are parties to a license and collaboration agreement to advance CRISPR/Cas9 gene-editing technology for in vivo therapeutic development, including therapies focused on neurological and muscular diseases.

We have the right to select targets under the license and collaboration agreement until April 2026.

Intellia leads the design of the editing methodology, we lead the design of the targeted viral vector delivery approach, and the parties share costs.

Each company has the opportunity to lead potential development and commercialization of product candidates for a target, and the company that is not leading development and commercialization will have the option to enter into a co-development and co-commercialization agreement for the target.

Nex-z, which is in clinical development, is subject to a co-development and co-commercialization arrangement pursuant to which Intellia leads development activities and the parties share development expenses 75% (Intellia)/25% (us).

If nex-z is commercialized, Intellia will lead commercialization activities and we will share in 25% of any profits or losses.

In July 2025, our license agreement with Hansoh Pharmaceuticals Group Company Limited to acquire development and commercial rights outside of mainland China, Hong Kong, and Macau for HS-20094 (a dual GLP-1/GIP receptor agonist currently in Phase 3 clinical development in China) became effective.

In-licensing a late-stage GLP-1/GIP agonist enables us to study combinations with our products and product candidates in order to address muscle loss and potentially other comorbidities of obesity, such as cardiovascular diseases, diabetes, and liver conditions.

Under the terms of the agreement, we made an $80.0 million up-front payment in July 2025.

In addition, we are obligated to make additional payments upon achievement of development, regulatory, and sales milestones, as well as a low double-digit royalty on sales.

In January 2026, our collaboration agreement with Tessera Therapeutics, Inc.

to develop and commercialize TSRA-196 (Tessera's investigational program for the treatment of alpha-1 antitrypsin deficiency ("AATD")) became effective.

Tessera will lead the initial first-in-human trial, while we will lead subsequent global development and commercialization.

The parties will share worldwide development expenses and, if commercialized, any future profits or losses equally.

Under the terms of the agreement, the Company made aggregate payments of $150.0 million in January 2026, consisting of an up-front payment and the purchase of Tessera preferred stock.

In addition, we are obligated to make additional payments upon achievement of certain development milestones.

Manufacturing

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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.

In addition, we have constructed a fill/finish facility in Rensselaer, New York that is undergoing process validation and has yet to be approved for commercial production.

We currently have approximately 100,000 liters of cell culture capacity at our Rensselaer facility and approximately 120,000 liters of cell culture capacity at our Limerick facility.

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Manufacturing establishments, both foreign and domestic, are also subject to inspections by or under the authority of the FDA and by other national, federal, state, and local agencies.

Our medicines are marketed through our commercial group, which includes experienced professionals in the fields of marketing, sales, professional education, patient education, reimbursement and market access, trade and distribution, commercial operations, commercial analytics, and market research.

In the United States, we sell our marketed products primarily to wholesalers and specialty distributors that serve pharmacies, hospitals, government agencies, physicians, and other healthcare providers.

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.

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 commercialize our products both in the United States and other countries through our commercial group, which includes experienced professionals in the fields of marketing, sales, professional education, patient education, reimbursement and market access, trade and distribution, commercial operations, commercial analytics, and market research.

In addition, we also co-commercialize certain products sold by our collaborators in the United States and other countries.

We sell our marketed products primarily to wholesalers, specialty distributors, pharmacies, hospitals, government agencies, physicians, and other healthcare providers.

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.

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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 and with obtaining the rights, in 2022, to commercialize Libtayo outside the United States.

For the year ended December 31, 2025, we had sales to two customers that each accounted for more than 10% of total gross product revenue.

On a combined basis, our product sales to these customers accounted for 77% of our total gross product revenue for the year ended December 31, 2025.

We face substantial competition from pharmaceutical and biotechnology companies.

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EYLEA HD and EYLEA (b)

Pavblu ® (aflibercept-ayyh) (biosimilar referencing EYLEA)

wAMD, DME, macular edema following RVO (including CRVO and BRVO), and DR

United States

Branded Competitor Products

Vabysmo ™ (faricimab-svoa)

Genentech/Roche wAMD, DME, and macular edema following RVO

Genentech/Roche wAMD, DME, RVO, and choroidal neovascularization ("CNV") with angioid streaks

United States, EU, Japan

Avastin ® (bevacizumab) (off-label and repackaged)

Genentech/Roche wAMD, DME, and macular edema following RVO

Avastin ® (bevacizumab)

Genentech/Roche wAMD, DME, and RVO (for each used off-label and repackaged)

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

Novartis AG and Genentech/Roche wAMD, DME, RVO, DR, CNV, 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

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

Lytenava ™ (bevacizumab gamma)

Outlook Therapeutics, Inc.

Susvimo ® (ranibizumab ocular implant)

Genentech/Roche wAMD, DME

Genentech/Roche wAMD, DME, DR

United States

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Allergan/AbbVie Inc.

DME, RVO United States, EU

DME, RVO United States, EU, Japan

Iluvien ® (fluocinolone acetonide intravitreal implant)

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DME United States, EU

Biosimilar Competitor Products

Pavblu ® (aflibercept-ayyh) (biosimilar referencing EYLEA)

wAMD, DME, RVO, and DR

United States, EU (c)

Afqlir ® (aflibercept) (biosimilar referencing EYLEA)

wAMD, DME, RVO, and mCNV

Eiyzey (aflibercept) (biosimilar referencing EYLEA)

Sam Chun Dang

wAMD, DME, RVO, and mCNV

Byooviz ™ (ranibizumab-nuna) (biosimilar referencing Lucentis)

Samsung Bioepis Co., Ltd.

and Harrow, Inc.

wAMD, DME, RVO, DR, and CNV

United States, EU, Japan

Ximluci ® (ranibizumab) (biosimilar referencing Lucentis)

Xbrane Biopharma AB and STADA Arzneimittel AG

wAMD, DME, RVO, proliferative DR, and CNV

Cimerli ™ (ranibizumab-eqrn) (biosimilar referencing Lucentis)

Formycon AG, Bioeq AG, Sandoz, and Teva Ltd.

wAMD, DME, RVO, DR, and CNV

United States, EU

Nufymco ® (ranibizumab-leyk) (biosimilar referencing Lucentis)

Formycon AG, Bioeq AG, and Zydus Lifesciences Limited

wAMD, DME, RVO, DR, and mCNV

United States

Ebglyss ® (lebrikizumab)

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Moderate-to-severe atopic dermatitis, pruritus associated with atopic dermatitis, prurigo nodularis

United States, Japan

United States, EU, Japan

Marketed Product (continued)

Competitor Product Competitor Indication Territory (a)

Dupixent (continued)

Adbry ™ /Adtralza ® (tralokinumab)

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Tezspire ™ (tezepelumab-ekko)

AstraZeneca/Amgen Asthma United States, EU, Japan

AstraZeneca/Amgen Asthma, nasal polyps

United States, EU, Japan

Fasenra ® (benralizumab)

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Nucala ® (mepolizumab)

GlaxoSmithKline ("GSK") Asthma, nasal polyps United States, EU, Japan

Xolair ® (omalizumab)

Roche/Novartis Asthma, nasal polyps, CSU

GlaxoSmithKline ("GSK") Asthma, nasal polyps, COPD

United States, EU, Japan

Exdensur ® (depemokimab)

Asthma, CRSwNP

United States, Japan

Xolair ® (omalizumab)

Roche/Novartis Asthma, nasal polyps, CSU United States, EU, Japan

Omlyclo ® (biosimilar referencing Xolair)

Celltrion Asthma, nasal polyps, CSU United States, EU

United States

Libtayo Keytruda ® (pembrolizumab)

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United States

(a) This table focuses on products that have received marketing approval in one or more of the specified indications in the United States, EU, and/or Japan.

(a) Except as noted in footnote (b) below, this table focuses on products that have received marketing approval in one or more of the specified indications in the United States, EU, and/or Japan.

Certain products listed in this table have also received marketing approval in countries outside the United States, EU, and Japan.

(b) In addition to the products listed in this table, certain other biosimilar products referencing EYLEA have received marketing approval in the United States, EU, and/or Japan but have not yet launched in such jurisdictions.

The timing of any launch of these biosimilar products will depend on, among other factors, the outcome of the pending patent litigation proceedings described in Note 16 to our Consolidated Financial Statements and the expiration of the patents protecting EYLEA (including those set forth under "Patents, Trademarks, and Trade Secrets" below).

The timing of any launch of these biosimilar products will depend on, among other factors, the outcome of the pending patent litigation proceedings and the settlement terms of the previously pending litigation proceedings described in Note 16 to our Consolidated Financial Statements and the expiration of the patents protecting EYLEA (including those set forth under "Patents, Trademarks, and Trade Secrets" below).

Product Candidates

Our late-stage and earlier-stage clinical candidates (including those being developed in collaboration with our collaborators) face competition from many pharmaceutical and biotechnology companies.

For example, we are aware of other pharmaceutical and biotechnology companies actively engaged in the research and development of antibody-based products against targets that are also the targets of our early- and late-stage product candidates.

These companies are using various technologies in competition with our VelocImmune technology and our other antibody generation technologies, including their own antibody generation technologies and other approaches such as RNAi, chimeric antigen receptor T cell (CAR-T cell), and gene therapy technologies.

Our late-stage and earlier-stage clinical candidates (including those being developed pursuant to agreements with our collaborators) face competition from many pharmaceutical and biotechnology companies.

For example, we are aware of other pharmaceutical and biotechnology companies actively engaged in the research and development of antibody-based products (including bispecific antibodies, multispecific antibodies, and/or antibody-drug conjugates) and gene therapy-based products against targets that are also the targets of our early- and late-stage product candidates.

We are also aware of other companies developing or marketing small molecules that may compete with our antibody product candidates in various indications, if such product candidates obtain regulatory approval in those indications.

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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.

However, we continue to file patent applications directed to improvements to these technology platforms.

Our patent portfolio includes granted patents and pending patent applications covering our VelociSuite technologies, including our VelocImmune mouse platform (used to generate fully human antibodies).

Patent protection for certain of our VelociSuite technologies extends to 2042 based on remaining issued patents, and we continue to file new patent applications directed to improvements to these technology platforms.

Our patent portfolio also includes issued patents and pending applications relating to commercialized products and our product candidates in clinical development.

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US 11,103,552 Formulation May 15, 2039

Product (continued)

Molecule Territory Patent No.

General Subject Matter Class Expiration

EYLEA HD (continued)

US 10,828,345 Methods of Treatment January 11, 2032

Methods of Treatment May 10, 2039

JP 7,235,770 Formulation May 10, 2039

Methods of Treatment

JP 7,235,770 Formulation March 30, 2040

aflibercept (2 mg)

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US 11,732,024 Formulation June 14, 2027

June 14, 2027

US 10,828,345 Methods of Treatment January 11, 2032

2 unchanged sentences

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)

Methods of Treatment

January 11, 2032

EP 2364691 Formulation June 14, 2027

3 unchanged sentences

February 27, 2028 – October 1, 2029 (d)

Methods of Treatment

January 11, 2032

Dupixent dupilumab US 7,608,693 Composition of Matter March 28, 2031 (e)

10 unchanged sentences

US 10,066,017 Methods of Treatment January 21, 2036

Methods of Treatment

July 10, 2034

US 11,421,036 Methods of Treatment July 10, 2034

3 unchanged sentences

US 11,214,621 Methods of Treatment January 21, 2036

Product (continued)

Molecule Territory Patent No.

General Subject Matter Class Expiration

Dupixent (continued)

US 11,167,004 Methods of Treatment September 21, 2037

3 unchanged sentences

US 12,090,201 Methods of Treatment February 3, 2043

12,291,571 Methods of Treatment December 25, 2034

12,398,212 Methods of Treatment July 5, 2042

Product (continued)

Molecule Territory Patent No.

General Subject Matter Class Expiration

Dupixent (continued)

EP 2356151 Composition of Matter October 27, 2029 (b)

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EP 3515465 Methods of Treatment September 21, 2037

EP 3889181 Methods of Treatment September 4, 2033

Methods of Treatment

June 20, 2034

EP 3973987 Methods of Treatment February 20, 2035

Methods of Treatment

September 4, 2033

EP 2624865 Formulation October 5, 2031

1 unchanged sentence

Composition of Matter October 27, 2029 – October 27, 2034 (d)

JP 5,844,772 Composition of Matter October 27, 2029 – February 22, 2034

Composition of Matter

October 27, 2029

October 5, 2031 – September 14, 2035 (d)

JP 6,231,605 Formulation October 5, 2031 – March 3, 2034

October 5, 2031 – October 5, 2036

JP 5,844,772 Methods of Treatment

October 27, 2029 – February 22, 2034

Methods of Treatment

3 unchanged sentences

Methods of Treatment

September 4, 2033

Methods of Treatment

February 20, 2035

5 unchanged sentences

JP 6,893,265 Methods of Treatment February 20, 2035

Methods of Treatment

June 20, 2034

Methods of Treatment

September 4, 2033

Methods of Treatment

August 20, 2033

JP 7,164,530 Methods of Treatment September 21, 2037

4 unchanged sentences

JP 7,343,547 Methods of Treatment February 20, 2035

Libtayo cemiplimab US 9,987,500 Composition of Matter September 18, 2035

US 10,737,113 Composition of Matter April 10, 2035

US 11,603,407 Formulation March 21, 2038

Product (continued)

1 unchanged sentence

General Subject Matter Class Expiration

Libtayo (continued)

Dupixent (continued)

Methods of Treatment

August 20, 2033

Methods of Treatment

February 20, 2035

Methods of Treatment

August 5, 2040

Libtayo cemiplimab US 9,987,500 Composition of Matter September 18, 2035

US 10,737,113 Composition of Matter April 10, 2035

US 11,603,407 Formulation March 21, 2038

US 10,457,725 Methods of Treatment May 12, 2037

4 unchanged sentences

EP 3606504 Formulation March 23, 2038

March 23, 2038

EP 3455258 Methods of Treatment May 12, 2037

3 unchanged sentences

JP 7,174,009 Composition of Matter January 23, 2035 – March 9, 2035 (d)

Composition of Matter

January 23, 2035

JP 7,229,171 Formulation March 23, 2038

JP 7,240,512 Methods of Treatment May 25, 2041

Methods of Treatment

February 20, 2038

Methods of Treatment

February 20, 2038

Methods of Treatment

February 20, 2038

(a) See Note 16 to our Consolidated Financial Statements for information regarding inter partes review and post-grant review petitions filed in the U.S.

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Squibb & Sons, L.L.C., and Ono Pharmaceutical Co., Ltd.

to obtain a license under certain patents owned and/or exclusively licensed by one or more of these parties that includes the right to develop and sell Libtayo.

to obtain a license under

certain patents owned and/or exclusively licensed by one or more of these parties that includes the right to develop and sell Libtayo.

Under the agreement, we paid royalties of 8.0% on worldwide sales of Libtayo through December 31, 2023, and are obligated to pay royalties of 2.5% from January 1, 2024 through December 31, 2026.

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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.

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.

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All of our product candidates require regulatory approval by relevant government authorities before they can be commercialized.

In particular, human therapeutic products are subject to rigorous preclinical and clinical trials and other pre-market approval requirements by the FDA, European Medicines Agency ("EMA"), and regulatory authorities of other countries.

The structure and substance of the FDA and other countries' pharmaceutical regulatory practices may evolve over time.

The ultimate outcome and impact of such developments cannot be predicted.

Clinical trials involve the administration of a drug to healthy human volunteers or to patients under the supervision of a qualified investigator.

Clinical trials involve the administration of a drug or biologic to healthy human volunteers or to patients under the supervision of a qualified investigator.

The 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.

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Foreign studies conducted under an IND must meet the same requirements that apply to studies being conducted in the United States.

Data from a foreign study not conducted under an IND may be submitted in support of a BLA if the study was conducted in accordance with GCPs and the FDA is able to validate the data.

Data from a foreign study not conducted under an IND generally may be submitted in support of an application for marketing approval if the study was conducted in accordance with GCPs and the FDA is able to validate the data.

The sponsor of a clinical trial or the sponsor's designated responsible party may be required to register certain information about the trial and disclose certain results on government or independent registry websites, such as clinicaltrials.gov.

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Phase 2 clinical trials are conducted with a relatively small sample of the intended patient population to provide enough data to evaluate the preliminary safety, tolerability, and efficacy of different potential doses of the product candidate.

Phase 3 clinical trials are larger trials conducted with patients with the target disease or disorder intended to gather additional information about dosage, safety, and effectiveness necessary to evaluate the drug's overall risk-benefit profile.

Phase 3 data often form the core basis on which the FDA and comparable foreign regulatory authorities evaluate a product candidate's safety and effectiveness when considering the product application for regulatory approval.

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The sponsoring company, the FDA or other regulatory authorities, or the IRB or Ethics Committee and competent authority may suspend or terminate a clinical trial at any time on various grounds, including a finding that the patients are being exposed to an unacceptable health risk.

The results of the preclinical and clinical testing of a biologic product candidate are then submitted to the FDA in the form of a BLA for evaluation to determine whether the product candidate may be approved for commercial sale under the Public Health Service Act.

When a BLA is submitted, the FDA makes an initial determination as to whether the application is sufficiently complete to be accepted for review.

If the application is not, the FDA may refuse to accept the BLA for filing and request additional information.

A refusal to file, which requires resubmission of the BLA with the requested additional information, delays review of the application.

The results of the preclinical and clinical testing of a drug or biologic product candidate are then submitted to the FDA in the form of an NDA for a drug or a BLA for a biologic for evaluation to determine whether the product candidate may be approved for commercial sale under the Federal Food, Drug, and Cosmetic Act or Public Health Service Act.

When an NDA or BLA is submitted, the FDA makes an initial determination as to whether the application is sufficiently complete to be accepted for review.

If the application is not, the FDA may refuse to accept the application for filing and request additional information.

A refusal to file, which requires resubmission of the NDA or BLA with the requested additional information, delays review of the application.

If the application is accepted for review, the FDA reviews the application to determine, among other things, whether a product is safe and effective for its intended use and whether the manufacturing controls are adequate to assure and preserve the product's identity, strength, quality, and purity.

FDA performance goals generally provide for action on a BLA within 10 months of the 60-day filing date (or within 12 months of the BLA submission).

FDA performance goals generally provide for action on an NDA or BLA within 10 months of the 60-day filing date (or within 12 months of the application submission).

That deadline can be extended by FDA under certain circumstances, including by the FDA's requests for additional information.

The targeted action date can be 6 months after the 60-day filing date (or 8 months after BLA submission) for product candidates that are granted priority review designation because they are intended to treat serious or life-threatening conditions and demonstrate the potential to address unmet medical needs.

The targeted action date can be 6 months after the 60-day filing date (or 8 months after application submission) for product candidates that are granted priority review designation because they are intended to treat serious or life-threatening conditions and demonstrate the potential to address unmet medical needs.

The FDA has other programs to expedite development and review of product candidates that address serious or life-threatening conditions.

For some BLAs, the FDA may convene an advisory committee to seek insights and recommendations on issues relevant to approval of the application.

Although the FDA is not bound by the recommendation of an advisory committee, the agency considers such recommendations carefully when making decisions.

Before approving a new drug or biologic product, the FDA

also requires that the facilities at which the product will be manufactured or advanced through the supply chain be in compliance with current Good Manufacturing Practices, or cGMP, requirements and regulations governing, among other things, the manufacture, shipment, and storage of the product.

The FDA will typically inspect such facilities for compliance with these requirements and regulations prior to approving a BLA.

The FDA also can audit the sponsor of the BLA to determine if the clinical studies were conducted in compliance with current GCPs.

After review of a BLA, the FDA may grant marketing approval, request additional information, or issue a CRL outlining the deficiencies in the submission.

For some applications, the FDA may convene an advisory committee to seek insights and recommendations on issues relevant to approval of the application.

Although the FDA is not bound by the recommendation of an advisory committee, the agency

considers such recommendations carefully when making decisions.

Before approving a new drug or biologic product, the FDA also requires that the facilities at which the product will be manufactured or advanced through the supply chain be in compliance with current Good Manufacturing Practices, or cGMP, requirements and regulations governing, among other things, the manufacture, shipment, and storage of the product.

The FDA will typically inspect such facilities for compliance with these requirements and regulations prior to approving a marketing application.

The FDA also can audit the sponsor of the NDA or BLA to determine if the clinical studies were conducted in compliance with current GCPs.

After review of an NDA or BLA, the FDA may grant marketing approval, request additional information, or issue a CRL outlining the deficiencies in the submission.

The CRL may require additional testing or information, including additional preclinical or clinical data, for the FDA to reconsider the application.

Even if such additional information and data are submitted, the FDA may decide that the BLA still does not meet the standards for approval.

Even if such additional information and data are submitted, the FDA may decide that the application still does not meet the standards for approval.

Data from clinical trials are not always conclusive and the FDA may interpret data differently than the sponsor.

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Additionally, as a condition of approval, the FDA may impose restrictions that could affect the commercial prospects of a product and increase our costs, such as a Risk Evaluation and Mitigation Strategy ("REMS") to mitigate certain specific safety risks, and/or post-approval commitments or requirements to conduct additional clinical trials or non-clinical studies or to conduct surveillance programs to monitor the product's effects.

Approval of a product candidate by comparable regulatory authorities in countries outside the United States is generally required prior to commencement of marketing of the product in those countries.

The approval procedure varies among countries and may involve different or additional testing, and the time required to obtain such approval may differ from that required for FDA approval.

Approval of a product candidate by comparable regulatory authorities in jurisdictions outside the United States is generally required prior to commencement of marketing of the product in those jurisdictions.

The approval procedure varies among jurisdictions and may involve different or additional testing, and the time required to obtain such approval may differ from that required for FDA approval.

Approval by a regulatory authority in one jurisdiction does not guarantee approval by comparable regulatory authorities in other jurisdictions.

In the European Economic Area ("EEA") (which is comprised of 27 Member States of the EU plus Norway, Iceland, and Liechtenstein), medicinal products can only be commercialized after a related Marketing Authorization has been granted.

Marketing authorization for biologics must be obtained through a centralized procedure, which allows a company to submit a single application to the EMA.

Marketing authorization for certain drugs and biologics (including medicinal products that are derived from biotechnology processes) that contain a new active substance indicated for the treatment of certain diseases (such as cancer, diabetes, neurodegenerative diseases, or autoimmune and other immune dysfunctions) or that are designated orphan medicines must be obtained through a centralized procedure, which allows a company to submit a single application to the EMA.

If a related positive opinion is provided by the EMA, the EC will grant a centralized marketing authorization that is valid in the EEA.

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In the United States, under the Pediatric Research Equity Act ("PREA"), certain applications for approval must include an assessment, generally based on clinical study data, of the safety and effectiveness of the subject product in relevant pediatric populations, unless a waiver or deferral is granted.

However, a pediatric study plan is not required for orphan products and the timing of the submission is subject to negotiation with FDA, but such plan cannot be submitted later than submission of a BLA.

Various federal, state, and foreign statutes and regulations also govern or influence the research, manufacture, safety, labeling, storage, record keeping, marketing, transport, and other aspects of developing and commercializing pharmaceutical product candidates.

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and foreign regulatory approval processes and requirements, see Part I, Item 1A.

"Risk Factors - Risks Related to Maintaining Approval of Our Marketed Products and the Development and Obtaining Approval of Our Product Candidates and New Indications for Our Marketed Products - Obtaining and maintaining regulatory approval for drug products is costly, time-consuming, and highly uncertain.

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.

"Risk Factors - Risks Related to Maintaining Approval of Our Marketed Products and the Development and Obtaining Approval of Our Product Candidates and New Indications for Our Marketed Products - Obtaining and maintaining regulatory approval for drug and biologic products is costly, time-consuming, and highly uncertain.

If we or our collaborators do not maintain regulatory approval for our marketed products, or obtain regulatory approval for our product candidates, we will not be able to market or sell them;

and if we do not obtain approvals for new indications for our marketed products, we may not be able to realize the full commercial potential of such products.

Any of the foregoing may materially and negatively impact our business, prospects, operating results, and financial condition.

Post-Approval Regulation

The FDA and comparable regulatory authorities in other jurisdictions may also require us to conduct additional clinical trials or to make certain changes related to a product after granting approval of the product.

The FDA has the explicit authority to require postmarketing studies (also referred to as post-approval or Phase 4 studies) and labeling changes based on new safety information, and may impose and enforce a REMS at the time of approval or after the product is on the market.

Post-approval modifications to

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.

The FDA has the explicit authority to require postmarketing studies (also referred to as post-approval studies) and labeling changes based on new safety information and may impose and enforce a REMS at the time of approval or after the product is on the market.

Post-approval modifications to the drug or biologic, such as changes in indications, labeling, or manufacturing processes or facilities, may require a sponsor to develop additional data or conduct additional preclinical studies or clinical trials, to be submitted in a new or supplemental NDA or BLA, which would require FDA approval.

Following approval, the FDA and comparable regulatory authorities outside the United States regulate the marketing and promotion of our products, which must comply with the Food, Drug, and Cosmetic Act and applicable FDA regulations and standards thereunder and equivalent foreign laws.

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Failure to comply with applicable FDA and comparable foreign regulatory authorities' requirements and restrictions in this area may subject a company to adverse publicity and enforcement action by the FDA, the Department of Justice, or the Office of the Inspector General of the Department of Health and Human Services, as well as state authorities and comparable regulatory authorities outside the United States.

This could subject a company to a range of penalties that could have a significant commercial impact, including civil and criminal fines and agreements that materially restrict the manner in which a company promotes or distributes a drug.

See Part I, Item 1A.

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Adverse-event reporting and submission of periodic reports are required following marketing approval.

The FDA requires BLA holders to employ a system for obtaining and reviewing safety information, adverse events, and product complaints associated with each drug and to submit safety reports to the FDA, with expedited reporting timelines in certain situations.

Based on new safety information after approval, the FDA can, among other things, mandate product labeling changes, require new post-marketing studies, impose or modify a risk evaluation and mitigation strategy for the product, or suspend or withdraw approval of the product.

We may be subject to audits by the FDA and other regulatory authorities to ensure that we are complying with the applicable requirements.

Rules that are equivalent in scope but which vary in application apply in countries outside the United States in which we conduct clinical trials.

The FDA requires NDA and BLA holders to employ a system for obtaining and reviewing safety information, adverse events, and product complaints associated with each drug or biologic and to submit safety reports to the FDA, with expedited reporting timelines in certain situations.

Based on new safety information after approval, the FDA can, among other things, mandate product labeling changes, require new post-marketing studies, impose or modify a REMS for the product, or suspend or withdraw approval of the product.

We may be subject to audits by the FDA and other regulatory authorities to determine whether we are complying with the applicable requirements.

Rules that are equivalent in scope but which vary in application apply in jurisdictions outside the United States in which we sell products.

The holder of an EU marketing authorization for a medicinal product must also comply with the EU's pharmacovigilance legislation.

This includes requirements to conduct pharmacovigilance, or the assessment and monitoring of the safety of medicinal products.

Marketing authorization holders are required to maintain a Pharmacovigilance System Master File ("PSMF"), which supports and documents the compliance of the marketing authorization holder with the requirements of EU pharmacovigilance legislation.

Marketing authorization holders are required to maintain a Pharmacovigilance System Master File ("PSMF"), which seeks to support and document compliance of the marketing authorization holder with the requirements of EU pharmacovigilance legislation.

Marketing authorization holders are also required to have a Qualified Person for Pharmacovigilance ("QPPV"), who, among other things, maintains the PSMF.

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The EC can also require marketing authorization holders to conduct post-authorization safety and/or efficacy studies.

A post-authorization safety study ("PASS") is a study that is carried out after a medicinal product has been authorized to obtain further information on a medicinal product's safety, or to measure the effectiveness of risk-management measures.

A post-authorization safety study ("PASS") is a study that is carried out after a medicinal product has been authorized for marketing to obtain further information on a medicinal product's safety, or to measure the effectiveness of risk-management measures.

Such studies may be clinical trials or non-interventional studies.

A post-authorization efficacy study ("PAES") is a study that is carried out for complementing available efficacy data in the light of well-reasoned scientific uncertainties on aspects of the evidence of benefits that is to be or only can be addressed post-authorization.

The EC may, in particular, impose a PASS and/or PAES on marketing authorization holders when a marketing authorization is granted upon conditions.

The EC may grant conditional marketing authorizations in the interest of public health, when there is less comprehensive clinical data available than would be required, if the EC considers that the benefit of immediate availability may outweigh the risk that the absence of the required clinical data poses.

In addition, we and our third-party suppliers are required to maintain compliance with cGMP, and are subject to inspections by the FDA or comparable regulatory authorities in other jurisdictions to confirm such compliance.

Changes of suppliers or modifications of methods of manufacturing may require amending our application(s) to the FDA or such comparable foreign regulatory authorities and acceptance of the change by the FDA or such comparable foreign regulatory authorities prior to release of product(s).

A post-authorization efficacy study ("PAES") is a study that is carried out for complementing available efficacy data in the light of well-reasoned scientific uncertainties on aspects of the evidence of benefits that are to be or only can be addressed post-authorization.

The EC may, in particular, impose a PASS and/or PAES on a marketing authorization holder when a marketing authorization is granted subject to conditions.

The EC may grant a conditional marketing authorization in the interest of public health, when there is less comprehensive clinical data available than typically would be required, if the EC considers that the benefit of immediate availability may outweigh the risk that the absence of the required clinical data poses.

Changes of suppliers or modifications in methods of manufacturing may require amending our application(s) to the FDA or such comparable foreign

regulatory authorities and acceptance of the change by the FDA or such comparable foreign regulatory authorities prior to release of product(s).

FDA regulations also require investigation and correction of any deviations from cGMP and impose reporting and documentation requirements upon us and our third-party suppliers.

Prescription drug manufacturers in the U.S.

must comply with applicable provisions of the Drug Supply Chain Security Act and provide and receive product tracing information, maintain appropriate licenses, ensure they only work with other properly licensed entities, and have procedures in place to identify and

properly handle suspect and illegitimate products.

We may also be subject to state regulations related to the manufacturing and distribution of our products.

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See Part I, Item 1A.

"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 - Product reimbursement and coverage policies and practices, pricing regulations and requirements, and our pricing strategy could change due to various factors beyond our control, which may adversely impact our business, prospects, operating results, and financial condition.

We participate in, and have certain price reporting obligations to, the Medicaid Drug Rebate program, state Medicaid supplemental rebate program(s), and other governmental pricing programs.

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The amount of the rebate is adjusted upward if the average manufacturer price increases more than inflation (measured by reference to the Consumer Price Index - Urban).

Effective January 1, 2024, the rebate is no longer capped at 100% of the average manufacturer price and, as a result, the rebate liability of manufacturers could increase.

If we become aware that our Medicaid reporting for a prior quarter was incorrect, or has changed as a result of recalculation of the pricing data, we are obligated to resubmit the corrected data for up to three years after those data originally were due, which revisions could affect our rebate liability for prior quarters.

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Manufacturers that fail to pay refunds could be subject to civil monetary penalties.

Further, the Inflation Reduction Act ("IRA") has established a Medicare Part B inflation rebate scheme under which, generally speaking, manufacturers owe rebates if the average sales price of a Part B drug increases faster than the pace of inflation.

Further, the Inflation Reduction Act ("IRA") has established a Medicare Part B inflation rebate scheme under which, generally speaking, manufacturers owe rebates if the average sales price of

a Part B drug increases faster than the pace of inflation.

Failure to timely pay a Part B inflation rebate is subject to a civil monetary penalty.

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See Part I, Item 1A.

Civil monetary penalties can be applied if we are found to have knowingly submitted any false pricing or other information to the government, if we are found to have made a misrepresentation in the reporting of our average sales price, or if we fail to submit the required data on a timely basis.

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government and, subject to detailed program rules and government oversight, each drug plan establishes its own Medicare Part D formulary for prescription drug coverage and pricing, which the drug plan may modify from time to time.

The prescription drug plans negotiate pricing with manufacturers and pharmacies, and may condition formulary placement on the availability of manufacturer discounts.

In addition, manufacturers, including us, are required to provide to CMS a 70% discount on brand name prescription drugs utilized by Medicare Part D beneficiaries when those beneficiaries are in the coverage gap phase of the Part D benefit design.

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 prescription drug plans negotiate

pricing with manufacturers and pharmacies, and may condition formulary placement on the availability of manufacturer discounts.

In addition, effective January 1, 2025, the IRA replaced the coverage gap discount program with a new manufacturer discount program under which manufacturers, including us, are required to provide to CMS a 10% discount on covered Part D drugs utilized by Medicare Part D beneficiaries when those beneficiaries are in the initial phase of the Part D benefit design (i.e., the phase during which the beneficiary must pay a copayment or coinsurance amount) and a 20% discount when those beneficiaries are in the catastrophic phase of Part D coverage (i.e., the phase after the beneficiary incurs costs above the initial phase's annual out-of-pocket limit).

In addition, the IRA has established a Medicare Part D inflation rebate scheme under which, generally speaking, manufacturers will owe additional rebates if the average manufacturer price of a Part D drug increases faster than the pace of inflation.

Failure to timely pay a Part D inflation rebate or otherwise comply with obligations under the Medicare Part D inflation rebate scheme is subject to a civil monetary penalty.

Failure to timely pay a Part D manufacturer discount program amount or inflation rebate or otherwise comply with obligations under the Medicare Part D inflation rebate scheme is subject to a civil monetary penalty.

Private payor healthcare and insurance providers, health maintenance organizations, and pharmacy benefit managers in the United States are adopting more aggressive utilization management techniques and are increasingly requiring significant discounts and rebates from manufacturers as a condition to including products on formulary with favorable coverage and copayment/coinsurance.

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Federal false claims laws prohibit any person from knowingly presenting, or causing to be presented, a false claim for payment of government funds, or knowingly making, or causing to be made, a false statement to get a false claim paid.

We are also subject to federal and state transparency laws that require manufacturers to report transfers of value made to certain healthcare professionals and healthcare organizations.

We also have similar reporting obligations in other countries based on laws, regulations, and/or industry trade association requirements.

See Part I, Item 1A.

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The FTC also has the power to enforce the Health Breach Notification Rule, which imposes notification obligations on companies for breaches of certain health information contained in personal health records.

Enforcement by the FTC under the FTC Act and Health Breach Notification Rule can result in civil penalties or enforcement actions.

Enforcement by the FTC under the FTC Act and Health Breach Notification Rule can result in civil penalties or

enforcement actions.

In addition, at the state level, many state consumer privacy laws recently went into effect and many other consumer privacy laws are expected to go into effect in the near future.

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Violations of the GDPR carry significant financial penalties for noncompliance.

The GDPR also confers a private right of action on data subjects and

consumer associations to file complaints with data protection authorities, seek judicial remedies, and obtain compensation for damages resulting from violations of the GDPR.

The GDPR also confers a private right of action on data subjects and consumer associations to file complaints with data protection authorities, seek judicial remedies, and obtain compensation for damages resulting from violations of the GDPR.

Many other jurisdictions outside the United States have adopted and continue to adopt varying privacy and data protection legislation, the continued emergence of which has increased the costs and complexity of compliance.

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We manage our business as one segment which includes all activities related to the discovery, development, and commercialization of medicines for serious diseases.

For financial information related to our one segment, see our Consolidated Financial Statements and related notes.

For additional information related to our one segment, see our Consolidated Financial Statements and related notes.

Human Capital Resources

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Attracting, developing, and retaining skilled and experienced employees in research and development, manufacturing, sales and marketing, and other positions is crucial to our ability to compete effectively.

Our ability to recruit and retain such employees depends on a number of factors, including our corporate culture and work environment, informed by our values and behaviors (which we call "The Regeneron Way") and our philosophy of "Doing Well by Doing Good";

Our ability to recruit and retain such employees depends on a number of factors, including our corporate culture, informed by our values and behaviors (which we call "The Regeneron Way") and our philosophy of "Doing Well by Doing Good";

talent development and career opportunities;

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Our Code of Business Conduct and Ethics brings together Regeneron's key policy principles and establishes the Company's expectations for all of our employees to act in accordance with applicable laws, rules, and regulations.

Employee Profile

Workforce Profile

As of December 31, 2025, we had 15,410 full-time employees, consisting of 11,961 employed in the United States, 2,149 employed in Ireland, and 1,300 employed in other countries (primarily in the United Kingdom, Japan, and Germany).

Of these employees, 2,591 were within our research and preclinical development organization, 2,274 were within our global clinical development and regulatory affairs organization, and 6,717 were within our industrial operations and product supply organization.

Company-wide, nearly 1,700 of our full-time employees hold a Ph.D.

Company-wide, over 1,800 of our full-time employees hold a Ph.D.

We also supplement our workforce with independent contractors, contingent workers, and temporary workers, as needed.

None of our employees are represented by a labor union, and our management considers its relations with our employees to be good.

Outside the United States, some of our employees are represented by works councils.

Our management considers its relations with our employees to be good.

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.

Our employees represent a broad range of backgrounds, just like the people who take our medicines, and bring a wide array of perspectives and experiences that have helped us maintain our leadership position in the biotechnology and pharmaceuticals industries and the global marketplace.

Our strategy is rooted in the understanding that a better workplace drives better science and that better science drives a better world.

We believe that by fostering an inclusive culture and bringing diverse voices and perspectives to the discourse, we improve our ability to fulfill our mission to repeatedly bring important medicines to patients with serious diseases.

We empower employee-led cross-functional resource groups, functional/site-level councils, and other interest groups, who connect around a common passion to build a culture of inclusion and collaboration.

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 early 2021, we launched a global strategy to advance diversity, focused on creating a better workplace, better science, and better world;

and implemented a new governance model that includes councils comprised of senior leaders who provide oversight and guidance on our diversity efforts and support the execution of our strategy.

In order to better understand our employees' perspectives, we also measure inclusion and belonging as part of our annual employee engagement survey.

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.

2024 Workforce Diversity Representation *

Female Representation (Global)

People of Color Representation (U.S.

* 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.

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.

For example, as part of our $100 million, 10-year commitment to support the Regeneron Science Talent Search ("STS"), we allocate $3.1 million annually to fund the Society for Science’s science, technology, engineering, and math ("STEM") outreach and equity programs.

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.

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.

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.

We also continue to take steps to further integrate diversity considerations into the design and selection of sites for our clinical studies to make sure they reflect the diversity of patients with the diseases under investigation.

Employee Wellness, Health, and Safety

The wellbeing of our employees is a primary focus as we believe that the most productive people are those who are at their best, both physically and mentally.

We provide several programs related to employee health and wellness, including onsite amenities and programs such as meditation and prayer rooms and fitness centers.

We also prioritize mental health initiatives and have taken further action to reduce or remove barriers to quality mental healthcare for our employees and their family members.

In addition, we provide support for work-life balance through flex-time, remote working arrangements, child and elder care, and paid parental leave, among others.

Occupational health and safety is critical to our success.

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.

Employee Growth and Development

We believe that by fostering an inclusive culture and bringing different voices and perspectives to the discourse, we improve our ability to fulfill our mission to repeatedly bring important medicines to patients with serious diseases.

Our employee-led cross-functional resource groups, open to all, help colleagues to connect around common interests and support our culture of inclusion and collaboration.

In recent years, we have expanded our mentoring program and inclusive leadership workshops for senior leaders and new managers to increase leadership skills and connection among employees.

In addition, in order to better understand our employees' perspectives, we measure inclusion and belonging as part of our annual employee engagement survey.

We invest significant resources to develop talent with the right capabilities to deliver the growth and innovation needed to support our continued success.

Our Talent department is dedicated to promoting individual, leader, team, and organizational development through a number of tools and services.

Our Talent department is dedicated to promoting individual, leader, team, and organizational development

through a number of tools and services.

We offer a variety of professional development courses for our employees and support employee continuing education, including through educational reimbursement and tuition forgiveness programs.

In addition, we continue to invest in our current and future leaders through a number of leadership development courses and programs and feedback and coaching opportunities.

In 2024, nearly 30% of job openings were filled by existing employees who were seeking career development opportunities.

In 2025, approximately 25% of job openings were filled by existing employees who were seeking career development opportunities.

We continue to invest in the science, engineering, technology, and math ("STEM") talent pipeline with our most significant philanthropic investments in science education, a commitment we call STEM-Fueled ™ – our long-standing collection of programs and partnerships that fuel future scientific innovators to pursue bold ideas and advance world-changing solutions.

This commitment includes our $100 million, 10-year commitment to support the Regeneron Science Talent Search ("STS"), the oldest and most prestigious high school science and mathematics competition in the United States, and $34 million, 5-year title sponsorship of the Regeneron International Science and Engineering Fair ("ISEF"), the world's largest global science competition for high school students.

Employee Engagement

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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.

Supporting our communities is at the heart of Regeneron's culture and we encourage community involvement to foster employee engagement.

We are committed to fostering employee volunteerism and continue to deliver on our global responsibility goal to drive employee volunteer levels above national standards.

Employees are encouraged and empowered to support organizations and causes that are important to them including through, among other things, our matching gift program, volunteer-time-off policy, and our annual company-wide service event, Day for Doing Good .

In 2024, over 7,800 employees volunteered approximately 45,400 hours,

including approximately 49% of our employees who volunteered nearly 27,400 hours to approximately 220 nonprofits during our Day for Doing Good .

Additionally, through our Matching Gift Program, we matched approximately $2.3 million in employee contributions in 2024, supporting over 2,300 charities.

In 2024, we were named to the Civic 50 of most community-minded companies in the United States for the eighth consecutive year.

The success of our employee engagement efforts is demonstrated by our employee retention rate of 94% in 2024, as well as the fact that 88% of our employees who responded to our annual engagement survey said Regeneron is a great place to work.

In 2025, over 7,600 employees volunteered nearly 42,000 hours, including approximately 47% of our employees who volunteered nearly 28,700 hours to approximately 230 nonprofits during our Day for Doing Good .

Additionally, through our Matching Gift Program, we matched approximately $2.4 million in employee contributions in 2025, supporting nearly 2,500 charities.

In 2025, we were named to the Civic 50 of most community-minded companies in the United States for the ninth consecutive year.

The success of our employee engagement efforts is demonstrated by our employee retention rate of nearly 93% in 2025, as well as the fact that 81% of our employees who responded to our annual engagement survey said Regeneron is a great place to work.

Additionally, we have placed in the top five for the past 15 years in Science magazine's annual "Top Employers Survey" of the global biotechnology and pharmaceutical industry.

Employee Wellness, Health, and Safety

The wellbeing of our employees is a primary focus as we believe that the most productive people are those who are at their best, both physically and mentally.

We provide several programs related to employee health and wellness, including onsite amenities and programs such as meditation and prayer rooms and fitness centers.

We also prioritize mental health initiatives and have taken further action to reduce or remove barriers to quality mental healthcare for our employees and their family members.

In addition, we provide support for work-life balance through flex-time, remote working arrangements, child and elder care, and paid parental leave, among others.

Occupational health and safety is critical to our success.

In addition, our global responsibility goals included a commitment to focus on workplace injury prevention in our drive toward zero incidents.

Compensation and Benefits

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business