What changed in this filing

/stocks — the workspaceLOADING

Item 2. Management’s Discussion and Analysis

2026-04-29 compared with 2025-10-28 · 219 added, 302 removed, 421 unchanged (55% of the section changed)

4 unchanged sentences

These statements concern, and these risks and uncertainties include, among others:

• competing drugs and product candidates 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") (including biosimilar versions of Regeneron's Products);

• 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;

10 unchanged sentences

• 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;

• changes to drug pricing regulations and requirements and our drug pricing strategy, including in connection with our April 2026 agreements with the U.S.

government discussed in this report;

• 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;

• the impact of public health outbreaks, epidemics, or pandemics on our business;

• risks associated with litigation and other proceedings and government investigations relating to the Company and/or its operations (including without limitation those described in Note 12 to our Condensed Consolidated Financial Statements included in this report), risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings described further in Note 12 to our Condensed Consolidated Financial Statements included in this report), the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on our business, prospects, operating results, and financial condition.

of any such proceedings and investigations, and the impact any of the foregoing may have on our business, prospects, operating results, and financial condition.

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

9 unchanged sentences

Three Months Ended

September 30,

Nine Months Ended

September 30,

(In millions, except per share data) 2026 2025

10 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

4 unchanged sentences

Dupixent ® (dupilumab) Injection (b)

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

Asthma (in adults and adolescents) a a a

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

Atopic dermatitis (in patients aged 6 months and older)

Asthma (in patients aged 6 years and older)

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

1 unchanged sentence

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

CSU (in pediatrics 2–11 years of age)

Bullous pemphigoid a a

Allergic fungal rhinosinusitis ("AFRS") (in patients aged 6 years and older)

Libtayo ® (cemiplimab) Injection

5 unchanged sentences

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

13 unchanged sentences

Veopoz ® (pozelimab) Injection

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

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

Product (continued)

Disease Territory

Otarmeni ™ (lunsotogene parvec)

Hearing loss associated with variants in the OTOF gene (in adults, adolescents, and pediatrics)

ARCALYST ® (rilonacept) Injection (e)

20 unchanged sentences

Three Months Ended

September 30,

2026 2025 % Change

3 unchanged sentences

$ 468.4 $ 332.5 $ 800.9 $ 306.8 $ 146.4 $ 453.2 77 %

Total EYLEA HD and EYLEA

$ 473.1 $ 396.2 $ 869.3 $ 736.0 $ 711.4 $ 1,447.4 (40 %)

$ 3,618.8 $ 1,238.2 $ 4,857.0 $ 2,824.7 $ 992.5 $ 3,817.2 27 %

$ 219.1 $ 146.1 $ 365.2 $ 194.5 $ 94.1 $ 288.6 27 %

$ 67.7 $ 148.0 $ 215.7 $ 52.9 $ 138.5 $ 191.4 13 %

$ 102.9 $ 51.1 $ 154.0 $ 72.7 $ 47.4 $ 120.1 28 %

Other products (e)

$ 43.9 $ 28.0 $ 71.9 $ 68.2 $ 24.4 $ 92.6 (22 %)

Nine Months Ended

September 30,

2025 2024 % Change

(In millions) U.S.

ROW Total (Total Sales)

$ 1,130.6 $ 620.5 $ 1,751.1 $ 896.5 $ 149.5 $ 1,046.0 67 %

$ 2,170.9 $ 2,068.8 $ 4,239.7 $ 3,576.7 $ 2,539.4 $ 6,116.1 (31 %)

Total EYLEA HD and EYLEA

3 unchanged sentences

$ 100.5 $ 44.3 $ 144.8 $ 72.8 $ 43.6 $ 116.4 24 %

$ 271.4 $ 151.2 $ 422.6 $ 187.8 $ 136.1 $ 323.9 30 %

Lynozyfic $ 10.7 $ 0.5 $ 11.2 $ — $ — $ — *

Other products (e)

$ 77.1 $ 29.3 $ 106.4 $ 31.1 $ 23.5 $ 54.6 95 %

(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.

* Percentage not meaningful

(a) Sanofi records global net product sales of Dupixent and Kevzara, and we record our share of profits in connection with global sales of such products within Collaboration revenue.

Refer to "Results of Operations - Revenues - Sanofi Collaboration Revenue" below for such amounts.

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

We record our share of profits in connection with sales outside the United States within Collaboration revenue;

refer to "Results of Operations - Revenues - Bayer Collaboration Revenue" below for such amounts.

(b) Sanofi records global net product sales of Dupixent and Kevzara, and we record our share of profits in connection with global sales of such products within Collaboration revenue.

Refer to "Results of Operations - Revenues - Sanofi Collaboration Revenue" below for such amounts.

7 unchanged sentences

Product candidates in Phase 2 and Phase 3 clinical development, which are being developed by us and/or our collaborators, are summarized in the table below.

A program is classified in Phase 2 or 3 clinical development after enrollment for the corresponding study or studies has commenced.

There are numerous uncertainties associated with drug development, including uncertainties related to safety and efficacy data from each phase of drug development (including any post-approval studies), uncertainties related to the enrollment and performance of clinical trials, changes in regulatory requirements, changes to drug pricing and reimbursement regulations and requirements, and changes in the competitive landscape affecting a product candidate.

8 unchanged sentences

EYLEA HD (aflibercept) 8 mg (a)

–RVO (U.S., EU, and Japan)

–Every 4-week dosing regimen for approved indications (U.S.)

–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

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

–Approved by European Commission ("EC") for extended dosing intervals up to 6 months (24 weeks) in wAMD and DME –U.S.

Food and Drug Administration ("FDA") decision on supplemental Biologics License Application ("sBLA") for RVO (November 2025) (r)

–FDA decision on sBLA for every 4-week dosing regimen (November 2025) (r)

Pozelimab (f) (REGN3918)

Antibody to C5

–Geographic atrophy, cemdisiran combination (l)(q)

–Pre-filled syringe (U.S.)

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

–Approved by U.S.

Food and Drug Administration ("FDA") for extension of dosing intervals up to 20 weeks in wAMD and DME

–FDA decisions for pre-filled syringe

Cemdisiran (k) (siRNA therapeutic targeting C5) ± pozelimab (f) (antibody to C5)

–Geographic atrophy

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

Immunology & Inflammation

4 unchanged sentences

–Lichen simplex chronicus

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

–CSU in adults and adolescents (EU)

–Approved by Japan's Ministry of Health, Labour and Welfare ("MHLW") for COPD

–Approved by FDA for CSU in adults and adolescents

–EC decision on regulatory submission for CSU in adults and adolescents (fourth quarter 2025)

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

Clinical Program (continued)

Phase 2 Phase 3 Regulatory

2025 Events to Date

Select Upcoming

Dupixent (dupilumab) (b) (continued)

–CSU in pediatrics (2–11 years of age) (U.S.

–Bullous pemphigoid (EU and Japan)

–Allergic fungal rhinosinusitis ("AFRS")

– European Medicines Agency's ("EMA") Committee for Medicinal Products for Human Use ("CHMP") adopted positive opinion 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

–CSU in pediatrics (2–11 years of age) (Japan)

–Bullous pemphigoid (EU)

–Approved by FDA for AFRS

–Approved by FDA and EC for CSU in pediatrics

–Approved by Japan's Ministry of Health, Labour and Welfare ("MHLW") for bullous pemphigoid

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

–Report results from Phase 3 study in lichen simplex chronicus (second half 2026)

Kevzara (sarilumab) (b)

1 unchanged sentence

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

–Approved by EC for pJIA

Itepekimab (b) (REGN3500)

Antibody to IL-33

–Non-cystic fibrosis bronchiectasis ("NCFB")

–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

REGN5713-5715

Multi-antibody therapy to Bet v 1

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

–Initiate additional Phase 3 study in birch allergy (fourth quarter 2025)

–Birch allergy –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 additional Phase 3 study in cat allergy (first half 2026)

Solid Organ Oncology

Libtayo (cemiplimab) (g)

Antibody to PD-1

–Neoadjuvant CSCC

–First-line NSCLC, BNT116 (i) combination

–Neoadjuvant NSCLC

–Early-stage CSCC (intralesional)

–Adjuvant CSCC (EU)

–Approved by FDA for adjuvant CSCC

–EMA's CHMP adopted positive opinion for adjuvant CSCC

–EC decision on regulatory submission for adjuvant CSCC (fourth quarter 2025)

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

Clinical Program (continued)

2 unchanged sentences

Select Upcoming

Libtayo (cemiplimab) (g) (continued)

Solid Tumor Oncology

Libtayo (cemiplimab) (f)(g)

Antibody to PD-1

–Neoadjuvant CSCC

–First-line NSCLC, BNT116 (i) combination

–Neoadjuvant NSCLC

–Neoadjuvant hepatocellular carcinoma ("HCC")

–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")

–Early-stage CSCC (intralesional)

–Adjuvant and advanced CSCC (Japan)

Fianlimab (f) (REGN3767)

Antibody to LAG-3

–First-line advanced NSCLC (Phase 2/3)

–Perioperative NSCLC

–Perioperative melanoma

–First-line metastatic head and neck squamous cell carcinoma

–First-line metastatic melanoma (e)

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

–Report data from Phase 2/3 studies in first-line advanced NSCLC (first half 2026)

–Initiate Phase 2 study (in combination with Libtayo) in first-line metastatic head and neck squamous cell carcinoma (first half 2026)

–Phase 2 data in first-line advanced NSCLC did not support advancement to Phase 3

–Phase 3 adjuvant melanoma study passed first interim analysis conducted by Independent Data Monitoring Committee;

study will continue as planned

–Report results from Phase 3 study in combination with Libtayo versus pembrolizumab in first-line metastatic melanoma (second quarter 2026)

–Report results from Phase 3 study in combination with Libtayo versus pembrolizumab in adjuvant melanoma (second half 2026)

Immune activator targeting TLR9

1 unchanged sentence

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

Clinical Program (continued)

Phase 2 Phase 3 Regulatory

2025 Events to Date

Select Upcoming

–Serous ovarian cancer

–Advanced NSCLC (l)

Bispecific antibody targeting MUC16 and CD28

2 unchanged sentences

Bispecific antibody targeting PSMA and CD28

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

–Prostate cancer

Marlotamig (REGN7075)

Bispecific antibody targeting EGFR and CD28

–Solid tumors

–Report additional data from study in solid tumors (first half 2026)

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)

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

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), pending discussions with FDA

Clinical Program (continued)

Phase 2 Phase 3 Regulatory

2026 Events to Date

Select Upcoming

Hematology-Oncology

Ordspono (odronextamab)

2 unchanged sentences

("B-NHL") (pivotal study)

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

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

–FDA issued CRL for BLA for relapsed/refractory FL

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

Lynozyfic (linvoseltamab) (f)

Bispecific antibody targeting BCMA and CD3

–Earlier (pre-malignant) multiple myeloma

–Monoclonal gammopathy of undetermined significance ("MGUS")

–Multiple myeloma precursor and related conditions

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

–Approved by FDA and EC for relapsed/refractory multiple myeloma

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

–Initiate additional Phase 3 studies in multiple myeloma and precursor conditions (2026)

Cardiometabolic/Internal Medicine

Antibody to Factor XI (catalytic domain)

–Thrombosis –Venous thromboembolism ("VTE") after total knee replacement surgery

–Cancer-associated VTE

–Stroke prevention in atrial fibrillation ("SPAF")

–Initiate additional Phase 3 studies in anticoagulation (mid-2026)

Antibody to Factor XI (A2 domain)

–Thrombosis –SPAF

–Initiate additional Phase 3 studies in anticoagulation (mid- 2026)

Mibavademab (f)(o) (REGN4461)

Agonist antibody to leptin receptor ("LEPR")

–Functional hypothalamic amenorrhea

Trevogrumab (f) (REGN1033)

Antibody to myostatin (GDF8)

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

Olatorepatide (q) (HS-20094)

GLP-1/GIP receptor agonist

Antagonist antibody to NPR1

–Postural orthostatic tachycardia syndrome ("POTS")

–Sepsis-induced hypotension

Rapirosiran (ALN-HSD) (k)

RNAi therapeutic targeting HSD17B13

–Metabolic dysfunction-associated steatohepatitis ("MASH")

Clinical Program (continued)

2 unchanged sentences

Select Upcoming

Lynozyfic (linvoseltamab) (f) (continued)

–Light chain amyloidosis ("ALA") (Phase 1/2)

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

TTR gene knockout using CRISPR/Cas9

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

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

–Intellia temporarily paused dosing and screening in Phase 3 ATTR-CM and ATTRv-PN trials due to a Grade 4 adverse event involving the liver

Antibody to Factor XI (A2 domain)

–Initiate Phase 3 studies (first half 2026)

Antibody to Factor XI (catalytic domain)

–Venous thromboembolism after total knee replacement surgery

–Initiate additional Phase 3 studies (first half 2026)

Antibody to IL2Rg

–Discontinued study in aplastic anemia

Antibody to TMPRSS6

–Iron overload in beta-thalassemia

Internal Medicine/Genetic Medicines

ALN-ANG3 (k)(r)

RNAi therapeutic targeting ANGPTL3

–Diabetic kidney disease

Neurology/Rare Diseases

Garetosmab (f) (REGN2477)

2 unchanged sentences

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

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

–Submit BLA for FOP (fourth quarter 2025)

Trevogrumab (f) (REGN1033)

Antibody to myostatin (GDF8)

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

Mibavademab (f)(o) (REGN4461)

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

Cemdisiran (k)

siRNA therapeutic targeting C5

–Myasthenia gravis (c)

–Myasthenia gravis (U.S.)

–Submitted New Drug Application ("NDA") utilizing FDA Rare Pediatric Disease Priority Review Voucher

–FDA decision on NDA for myasthenia gravis (fourth quarter 2026)

Cemdisiran (k) (siRNA therapeutic targeting C5) + pozelimab (f) (antibody to C5)

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

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

Mibavademab (f) (REGN4461)

Agonist antibody to leptin receptor ("LEPR")

–Generalized lipodystrophy (c)(d)(e)

Agonist antibody to NPR1

–Discontinued Phase 2 studies in heart failure and uncontrolled hypertension

Clinical Program (continued)

Phase 2 Phase 3 Regulatory

2025 Events to Date

Select Upcoming

Antagonist antibody to NPR1

–Postural orthostatic tachycardia syndrome ("POTS")

–Sepsis-induced hypotension

Rapirosiran (ALN-HSD) (k)

RNAi therapeutic targeting HSD17B13

–Metabolic dysfunction-associated steatohepatitis ("MASH")

–Monogenic obesity

Nexiguran ziclumeran (nex-z) (j)

TTR gene knockout using CRISPR/Cas9

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

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

–FDA removed clinical hold on Phase 3 trials in ATTR-CM and ATTRv-PN

Otarmeni (lunsotogene parvec, formerly known as DB-OTO)

AAV-based gene therapy

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

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

–FDA granted Commissioner's National Priority Voucher

–Submit BLA for hearing deficit due to variants of the otoferlin gene (fourth quarter 2025)

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

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

–Approved by FDA for hearing loss associated with variants in OTOF gene

Antibody to TMPRSS6

–Iron overload in beta-thalassemia

Antibody to IL2Rg

(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 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

2 unchanged sentences

(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 milestone payments

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

(k) In-licensed from Alnylam

(l) Also studied in combination with marlotamig

(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

(q) Geographic atrophy also studied with cemdisiran monotherapy

(r) Refer to "Additional Information - Clinical Development Programs - EYLEA HD" for further details

(p) Studied in combination with ubamatamab or fianlimab

(q) In-licensed from Hansoh

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

Additional Information - Clinical Development Programs

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.

The Company is planning to submit by January 2026 an application to include a new pre-filled syringe manufacturing filler in the EYLEA HD BLA.

In addition, the Company has submitted an application to include an additional vial filler, should this be needed for approval of every-four-week dosing and RVO label enhancements, with an FDA decision regarding this new vial filler expected by late December 2025.

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).

The Company resubmitted its application seeking FDA approval for filling of the EYLEA HD pre-filled syringe ("PFS") at Catalent Indiana, where the FDA has recently conducted a site re-inspection.

In addition, the FDA did not act by the April 2026 PDUFA date on the Company's regulatory application for a second contract manufacturer for the PFS;

therefore, this application remains pending.

The Company and both third-party filling manufacturers are working closely with the FDA to resolve all outstanding issues, and the Company anticipates a regulatory decision on one or both applications during the second quarter of 2026.

Recent Developments – U.S.

Government Agreements

In April 2026, we announced agreements with the U.S.

government (the "U.S.

Government Agreements") pursuant to which we have agreed, among other matters, to provide certain of our products that we wholly own in the United States to the Medicaid program at or below prices benchmarked against a defined group of other developed countries ("Most-Favored-Nation Pricing").

We have also agreed to price certain future medicines in the United States at or below Most-Favored-Nation Pricing;

to participate in a direct purchasing platform, TrumpRx.gov, that will allow eligible patients to purchase Praluent directly;

and to provide our recently FDA-approved gene therapy Otarmeni™ for free in the United States.

Government Agreements further provide that Regeneron's products will not face tariffs as a result of the U.S.

Department of Commerce's recent investigation under Section 232 of the Trade Expansion Act of 1962, as amended, through January 2029 so long as the Company continues its commitments to invest in manufacturing and research and development infrastructure in the United States.

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 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 September 30, 2025, the total amount of our contingent reimbursement obligation to Sanofi (i.e., "development balance") in connection with such development expenses was approximately $905 million.

As of March 31, 2026, the total amount of our contingent reimbursement obligation to Sanofi in connection with such development expenses was approximately $278 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.

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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.

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.

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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.

are parties to 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, 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 and co-commercialization agreement or a license agreement.

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.

We have also entered into various license agreements with Alnylam, with us as the licensee, including for cemdisiran (a small interfering RNA ("siRNA") therapeutic ta rgeting the C5 component of the human complement pathway) as a monotherapy and for a combination consisting of cemdisiran and pozelimab.

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.

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, including therapies focused on neurological and muscular diseases.

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

We had 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.

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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 be entitled to 25% of any profits.

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.

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

We have licensed from Hansoh Pharmaceuticals Group Company Limited the development and commercial rights for olatorepatide (a dual GLP-1/GIP receptor agonist) outside of mainland China, Hong Kong, and Macau.

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 the first quarter of 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.

Our ability to generate profits and to generate positive cash flow from operations over the next several years depends significantly on the success in commercializing our products, including EYLEA HD and Dupixent.

We expect to continue to incur substantial expenses related to our research and development activities, and our research and development activities and related costs which are not reimbursed by collaborators are expected to expand and require additional resources.

We expect to continue to incur substantial expenses related to our research and development activities, and our research and development activities and related costs are expected to expand and require additional resources.

We also expect to incur substantial costs related to the commercialization of our marketed products.

Our financial results may fluctuate from

quarter to quarter and will depend on, among other factors, the net sales of our products;

Our financial results may fluctuate from quarter to quarter and will depend on, among other factors, the net sales of our products;

the scope and progress of our research and development efforts;

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Three Months Ended

September 30,

Nine Months Ended

September 30,

(In millions, except per share data) 2026 2025

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Income tax expense

303.3 152.4 526.7 326.9

Net income $ 727.2 $ 808.7

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Three Months Ended

September 30,

Nine Months Ended

September 30,

(In millions) 2025 2024 $ Change 2025 2024 $ Change

(In millions) 2026 2025 $ Change

Net product sales:

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Total Libtayo - Global 438.2 285.1 153.1

365.2 288.6 76.6 1,026.8 849.9 176.9

Praluent - U.S.

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45.7 30.9 14.8

Inmazeb - U.S.

— 35.6 (35.6) — 36.6 (36.6)

Lynozyfic - Global

Other products - Global 31.3 — 31.3

0.8 — 0.8 0.8 — 0.8

Total net product sales $ 1,534.5 $ 1,415.6 $ 118.9

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Net Product Sales

Net product sales of EYLEA HD increased for the three and nine months ended September 30, 2025, compared to the same periods in 2024, due to higher sales volumes, partly offset by a lower net selling price.

Net product sales of EYLEA for the three and nine months ended September 30, 2025, compared to the same periods in 2024, were negatively impacted by (i) lower sales volumes as a result of continued competitive pressures (as described below), loss in market share to compounded bevacizumab due to patient affordability constraints, and the continued transition of patients to EYLEA HD, and (ii) a lower net selling price.

Net product sales of EYLEA HD increased for the three months ended March 31, 2026, compared to the same period in 2025, due to higher sales volumes, partly offset by a lower net selling price.

In addition, EYLEA HD net product sales were negatively impacted by lower wholesaler inventory levels at the end of the first quarter of 2026 compared to the end of the fourth quarter of 2025.

Net product sales of EYLEA decreased for the three months ended March 31, 2026, compared to the same period in 2025, due to (i) lower sales volumes as a result of continued competitive pressures (as described below) and the continued transition of patients to EYLEA HD, and (ii) a lower net selling price.

EYLEA net product sales have been, and are likely to continue to be, negatively impacted by increased competition from other anti-VEGF products, including biosimilars, as well as the transition of patients from EYLEA to EYLEA HD.

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For more information, see Part II, Item 1A.

"Risk Factors - Risks Related to Commercialization of Our Marketed Products, Product Candidates, and New Indications for Our Marketed Products - We are substantially dependent on the success of EYLEA, EYLEA HD, and Dupixent " and " The commercial success of our products and product candidates is subject to significant competition - Marketed Products." In addition, if independent not-for-profit patient assistance funds that provide copay assistance are unable to support eligible patients, this will likely have a continued negative impact on patient affordability resulting in lower utilization of higher-cost anti-VEGF agents.

Collaboration Revenue

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Three Months Ended

September 30,

Nine Months Ended

September 30,

(In millions) 2026 2025

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Reimbursement for manufacturing of commercial supplies (a)

161.5 175.1 488.1 438.2

Total Sanofi collaboration revenue $ 1,605.1 $ 1,183.2

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Three Months Ended

September 30,

Nine Months Ended

September 30,

(In millions) 2026 2025

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Regeneron's share of profits as a percentage of Dupixent and Kevzara net product sales

29% 28% 28% 27%

(a) See "Collaboration, License, and Other Agreements - Sanofi" above for additional details on our contingent reimbursement obligation.

The increase in our share of profits for the three and nine months ended September 30, 2025, compared to the same periods in 2024, was driven by higher profits associated with an increase in Dupixent sales.

We expect our contingent reimbursement obligation to be fully repaid by the end of the second quarter of 2026.

The increase in our share of profits for the three months ended March 31, 2026, compared to the same period in 2025, was driven by higher profits primarily associated with an increase in Dupixent sales.

Bayer Collaboration Revenue

Three Months Ended

September 30,

Nine Months Ended

September 30,

(In millions) 2026 2025

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Reimbursement for manufacturing of commercial supplies (a)

32.9 23.2 91.1 67.4

Total Bayer collaboration revenue $ 287.3 $ 343.9

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Three Months Ended

September 30,

Nine Months Ended

September 30,

(In millions) 2026 2025

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Regeneron's share of profits as a percentage of EYLEA 8 mg and EYLEA net product sales outside the United States

37% 39% 38% 39%

(a) See "Collaboration, License, and Other Agreements - Bayer" above for additional details on our contingent reimbursement obligation

The decrease in our share of profits for the three and nine months ended September 30, 2025, compared to the same periods in 2024, was driven by lower profits associated with a decrease in EYLEA sales outside the United States.

The decrease in our share of profits for the three months ended March 31, 2026, compared to the same period in 2025, was driven by lower profits primarily associated with a decrease in EYLEA sales outside the United States.

Other Revenue

Other revenue increased for the three and nine months ended September 30, 2025, compared to the same periods in 2024.

Other revenue included royalties and share of profits earned in connection with license agreements of $165.4 million and $90.7 million for the three months ended September 30, 2025 and 2024, respectively, and $353.0 million and $207.5 million for the nine months ended September 30, 2025 and 2024, respectively.

Three Months Ended

(In millions) 2026 2025

Share of profits and royalties in connection with license and other agreements

$ 100.7 $ 63.4

Total other revenue $ 171.2 $ 81.9

(a) Consists primarily of amounts earned in connection with manufacturing product for others;

corresponding costs incurred by the Company in connection with such manufacturing is recorded within Cost of collaboration and contract manufacturing

Operating Expenses

Three Months Ended

September 30,

Nine Months Ended

September 30,

(In millions, except headcount data) 2025 2024 Change 2025 2024 Change

(In millions, except headcount data) 2026 2025 Change

Research and development (a)

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296.0 198.8 97.2

Other operating (income) expense, net (10.0) 8.0 (18.0) (10.0) 37.9 (47.9)

Total operating expenses $ 2,962.5 $ 2,437.0 $ 525.5

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(b) Includes costs incurred in connection with manufacturing drug supplies for collaborators and others

Operating expenses included stock-based compensation expense of $237.0 million and $225.1 million for the three months ended September 30, 2025 and 2024, respectively, and $744.4 million and $678.4 million for the nine months ended September 30, 2025 and 2024, respectively.

Operating expenses included stock-based compensation expense of $257.4 million and $255.7 million for the three months ended March 31, 2026 and 2025, respectively.

Research and Development Expenses

The following table summarizes our direct research and development expenses by clinical development program and other significant categories of research and development expenses.

Direct research and development expenses are comprised primarily of costs paid to third parties for clinical and product development activities, including costs related to preclinical research activities, clinical trials, and the portion of research and development expenses incurred by our collaborators that we are obligated to reimburse.

Direct research and development expenses are comprised primarily of costs paid to third parties for clinical development activities, including costs related to preclinical research activities, clinical trials, and the portion of research and development expenses incurred by our collaborators that we are obligated to reimburse.

Indirect research and development expenses have not been allocated directly to each program, and primarily consist of costs to compensate personnel, overhead and infrastructure costs to maintain our facilities, and other costs related to activities that benefit multiple projects.

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Three Months Ended

September 30,

Nine Months Ended

September 30,

(In millions) 2026

$ Change 2025 2024 *

Direct research and development expenses:

Fianlimab $ 55.8 $ 53.4 $ 2.4 $ 155.3 $ 168.4 $ (13.1)

Lynozyfic (linvoseltamab) $ 73.8 $ 31.7 $ 42.1

Ordspono (odronextamab)

48.6 26.2 22.4

Lynozyfic (linvoseltamab) 32.8 25.4 7.4 118.1 111.8 6.3

Fianlimab 42.2 51.5 (9.3)

REGN7508 & REGN9933

33.2 9.0 24.2

Dupixent (dupilumab) 29.3 25.5 3.8

EYLEA HD (aflibercept) 8 mg

21.8 28.3 (6.5)

Libtayo (cemiplimab) 19.7 20.8 (1.1)

Pozelimab/cemdisiran

17.5 12.8 4.7

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* Certain prior year amounts have been reclassified to conform to the current year's presentation

Research and development expenses included stock-based compensation expense of $125.1 million and $123.7 million for the three months ended September 30, 2025 and 2024, respectively, and $405.1 million and $369.1 million for the nine months ended September 30, 2025 and 2024, respectively.

Research and development expenses included stock-based compensation expense of $135.1 million and $141.0 million for the three months ended March 31, 2026 and 2025, respectively.

There are numerous uncertainties associated with drug development, including uncertainties related to safety and efficacy data from each phase of drug development, uncertainties related to the enrollment and performance of clinical trials, changes in regulatory requirements, changes in the competitive landscape affecting a product candidate, and other risks and uncertainties described in Part II, Item 1A.

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Acquired In-Process Research and Development ("IPR&D") Expenses

Acquired IPR&D expenses for the three and nine months ended September 30, 2025 included an $80.0 million up-front payment in connection with our license agreement with Hansoh Pharmaceuticals Group Company Limited.

Acquired IPR&D expenses for the three and nine months ended September 30, 2024 included a $45.0 million development milestone in connection with our collaboration agreement with Sonoma Biotherapeutics, Inc.

Acquired IPR&D expenses for the three months ended March 31, 2026 primarily related to the premium on equity securities purchased, as well as development milestone and up-front payments, in connection with collaboration and licensing agreements.

Selling, General, and Administrative Expenses

Selling, general, and administrative expenses decreased for the three and nine months ended September 30, 2025, compared to the same periods in 2024, primarily due to lower charitable contributions to an independent not-for-profit patient assistance organization.

Selling, general, and administrative expenses included stock-based compensation expense of $92.0 million and $83.1 million for the three months ended September 30, 2025 and 2024, respectively, and $279.0 million and $251.9 million for the nine months ended September 30, 2025 and 2024, respectively.

Selling, general, and administrative expenses increased for the three months ended March 31, 2026, compared to the same period in 2025, primarily due to an increase in commercialization-related expenses for EYLEA HD and Libtayo and higher headcount and headcount-related costs, partly offset by lower charitable contributions to an independent non-profit patient assistance organization.

Selling, general, and administrative expenses included stock-based compensation expense of $89.2 million and $95.2 million for the three months ended March 31, 2026 and 2025, respectively.

Cost of Goods Sold

Three Months Ended

September 30,

Nine Months Ended

September 30,

(In millions, except gross margin on net product sales)

2025 2024 2025 2024

Cost of goods sold

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Gross margin on net product sales (a)

82% 87% 82% 86%

(a) Gross margin on net product sales represents gross profit expressed as a percentage of total net product sales recorded by the Company.

Gross profit is calculated as net product sales (see "Net Product Sales" section above) less cost of goods sold.

Gross margin on net product sales decreased for the three and nine months ended September 30, 2025, compared to the same periods in 2024, partly due to ongoing investments to support our manufacturing operations.

In addition, gross margin on net product sales decreased due to higher amortization expense associated with our Libtayo intangible asset as each quarter we record additions to the intangible asset related to royalties due to Sanofi.

Other Operating (Income) Expense

Other operating (income) expense, net, for the nine months ended September 30, 2024 reflected a charge of $37.9 million related to the increase in the estimated fair value of the contingent consideration liability recognized in connection with our 2023 acquisition of Decibel Therapeutics, Inc.

Gross margin on net product sales decreased for the three months ended March 31, 2026, compared to the same period in 2025, primarily due to unabsorbed manufacturing costs and higher inventory write-offs and reserves as a result of a temporary interruption of bulk manufacturing production at our facility in Limerick, Ireland, due to unanticipated facility repairs that commenced during the first quarter of 2026.

We resumed initial production at the facility in the second quarter of 2026;

however, gross margin will continue to be negatively impacted until production returns to normal levels, which is expected by the end of the second quarter of 2026.

The interruption has not impacted, nor is it expected to impact, the availability of any of our products.

See Part II, Item 1A.

"Risk Factors - Risks Related to Manufacturing and Supply - Third-party service or supply failures, or other failures, business interruptions, or other disasters affecting our manufacturing facilities in Rensselaer, New York and Limerick, Ireland, the manufacturing facilities of our collaborators or contract manufacturers, or the facilities of any other party participating in the supply chain, could adversely affect our ability to supply our products.

Other Income (Expense)

Three Months Ended

September 30,

Nine Months Ended

September 30,

(In millions) 2026 2025

Gains on marketable and other securities, net $ 25.0 $ 139.9

$ 577.7 $ 134.7 $ 967.6 $ 331.2

Interest income 183.5 173.5

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Three Months Ended

September 30,

Nine Months Ended

September 30,

(In millions, except effective tax rate) 2026 2025

3 unchanged sentences

12.5 % 10.6 %

On July 4, 2025, bill H.R.

1, commonly referred to as the "One Big Beautiful Bill Act" or "OBBBA," was signed into law, with certain provisions effective in 2025 and others in 2026.

The OBBBA significantly revises U.S.

corporate income tax laws by, among other things, restoring the option for immediate expense recognition for U.S.-based research and development expenditures and making permanent the ability to claim first-year bonus depreciation on qualified property.

The OBBBA also modifies U.S.

taxation on foreign earnings by, among other things, changing the tax rates for global intangible low-taxed income (now known as Net CFC Tested Income) and foreign-derived intangible income (now known as foreign-derived deduction eligible income), modifying the allocation of expenses in calculating foreign tax credits, as well as changing foreign tax credit limitations.

As a result of the OBBBA being signed into law, we recognized a charge of $44.5 million in the third quarter of 2025 related to the re-measurement of our U.S.

net deferred tax assets.

Our effective tax rate for the three and nine months ended September 30, 2025 was positively impacted, compared to the U.S.

Our effective tax rate for the three months ended March 31, 2026 and 2025 was positively impacted, compared to the U.S.

federal statutory rate, primarily by income earned in foreign jurisdictions with tax rates lower than the U.S.

federal statutory rate and federal tax credits for research activities, partially offset by the impact of the OBBBA being signed into law.

In addition, our effective tax rate for the nine months ended September 30, 2025 was positively impacted by the release of liabilities for uncertain tax positions recognized upon the effective settlement of the IRS audit of our 2017 and 2018 federal income tax returns in the second quarter of 2025, which reduced our effective tax rate for the nine months ended September 30, 2025 by 1.4%.

The increase in our effective tax rate for the three and nine months ended September 30, 2025, compared to the same periods in 2024, was primarily impacted by the net change in uncertain tax positions, as well as lower tax benefits from less stock option exercises and the enactment of the OBBBA.

federal statutory rate and, to a lesser extent, federal tax credits for research activities, partly offset by changes in unrecognized tax benefits.

In addition, our effective tax rate increased for the three months ended March 31, 2026, compared to the same period in 2025, primarily due to lower tax benefits from cross-border tax laws and federal tax credits for research activities.

Liquidity and Capital Resources

Our financial condition is summarized as follows:

September 30, December 31,

March 31, December 31,

(In millions) 2026 2025 $ Change

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Finance lease liabilities $ 720.0 * $ 720.0 $ —

As of September 30, 2025, we also had borrowing availability of $750.0 million under a revolving credit facility.

Sources and Uses of Cash for the Nine Months Ended September 30, 2025 and 2024

Nine Months Ended

September 30,

* The $720.0 million related to finance lease liabilities is classified within current liabilities as of March 31, 2026

As of March 31, 2026, we also had borrowing availability of $750.0 million under a revolving credit facility.

Sources and Uses of Cash

Three Months Ended

(In millions) 2026 2025 $ Change

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Cash Flows from Investing Activities

Capital expenditures for the nine months ended September 30, 2025 included costs incurred in connection with the expansion of our research, preclinical manufacturing, and support facilities at our Tarrytown, New York corporate headquarters.

We expect to incur capital expenditures of $850 million to $890 million for the full year of 2025.

Payments for intangible assets for the nine months ended September 30, 2025 included $155.0 million related to our purchase of an FDA Rare Pediatric Disease Priority Review Voucher from a third party in the second quarter of 2025.

Capital expenditures for the three months ended March 31, 2026 included costs incurred in connection with the expansion of our research and support facilities at our Tarrytown, New York corporate headquarters, as well as costs associated with the expansion of our manufacturing facilities.

We expect to incur capital expenditures of $1.100 billion to $1.200 billion for the full

year of 2026, including in connection with the continued expansion of our facilities in Tarrytown, New York, and the continued expansion of our manufacturing facilities, including in connection with developing our property in Saratoga Springs, New York for production support activities and additional manufacturing capacity.

Cash Flows from Financing Activities

Share Repurchase Programs

In each of April 2024 and February 2025, our board of directors authorized an additional share repurchase program for up to $3.0 billion of our Common Stock (up to $6.0 billion in the aggregate).

Our board of directors has authorized share repurchase programs, including a share repurchase program for up to $3.0 billion of our Common Stock which was authorized in February 2025.

The programs have no time limit and can be discontinued at any time.

As of September 30, 2025, $2.156 billion remained available for share repurchases under the programs.

In each of the first, second, and third quarters of 2025, our board of directors declared quarterly cash dividends of $0.88 per share on our Common Stock and Class A Stock.

Each quarterly dividend was paid to our shareholders in the quarter in which the dividend was declared.

Additionally, in October 2025, our board of directors declared a cash dividend of $0.88 per share on our Common Stock and Class A Stock.

The dividend will be payable on December 5, 2025 to our shareholders of record as of November 20, 2025.

As of March 31, 2026, $688.2 million remained available for share repurchases under the programs.

In April 2026, our board of directors authorized a share repurchase program to repurchase up to an additional $3.0 billion of our Common Stock.

The share repurchase program was approved under terms substantially similar to the share repurchase programs described above.

In January 2026, our board of directors declared a quarterly cash dividend of $0.94 per share on our Common Stock and Class A Stock, which was paid to our shareholders in March 2026.

Additionally, in April 2026, our board of directors declared a cash dividend of $0.94 per share on our Common Stock and Class A Stock.

The dividend will be payable on June 4, 2026 to our shareholders of record as of May 20, 2026.

Critical Accounting Estimates

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"Management's Discussion and Analysis of Financial Condition and Results of Operations" of our Annual Report on Form 10-K for the fiscal year ended December 31, 2025 (filed February 4, 2026).

There have been no material changes to critical accounting estimates during the nine months ended September 30, 2025.

There have been no material changes to critical accounting estimates during the three months ended March 31, 2026.

Future Impact of Recently Issued Accounting Standards

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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-Q

Item 2. Management’s Discussion and Analysis