Regeneron Pharmaceuticals · 10-Q · Item 2 MD&A

Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations

This Quarterly Report on Form 10-Q contains forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. (where applicable, together with its subsidiaries, "Regeneron," "Company," "we," "us," and "our"), and actual events or results may differ materially from these forward-looking statements. Words such as "anticipate," "expect," "intend," "plan," "believe," "seek," "estimate," variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others:

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

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

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

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

•safety issues resulting from the administration of Regeneron's Products and Regeneron's Product Candidates in patients, including serious complications or side effects in connection with the use of Regeneron's Products and Regeneron's Product Candidates in clinical trials;

•the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron's Product Candidates and new indications for Regeneron's Products, including without limitation those discussed or referenced in this report;

•the extent to which the results from the research and development programs conducted by us and/or our collaborators may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval;

•ongoing regulatory obligations and oversight impacting Regeneron's Products, research and clinical programs, and business, including those relating to patient privacy;

•determinations by regulatory and administrative governmental authorities which may delay or restrict our ability to continue to develop or commercialize Regeneron's Products and Regeneron's Product Candidates;

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

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

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

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

•changes to drug pricing regulations and requirements and our drug pricing strategy, 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 and changes to the assumptions underlying those projections or guidance;

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

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

•risks associated with litigation and other proceedings and government investigations relating to the Company and/or its operations (including without limitation those described in Note 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

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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. In evaluating such statements, shareholders and potential investors should specifically consider the various factors identified under Part II, Item 1A. "Risk Factors," which could cause actual events and results to differ materially from those indicated by such forward-looking statements. We do not undertake any obligation to update (publicly or otherwise) any forward-looking statement, whether as a result of new information, future events, or otherwise.

Overview

Regeneron Pharmaceuticals, Inc. is a fully integrated biotechnology company that invents, develops, manufactures, and commercializes medicines for people with serious diseases. Our products and product candidates in development are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases, and rare diseases.

Our core business strategy is to maintain a strong foundation in scientific research and drug development using our proprietary technologies, and to build on that foundation with our clinical development, manufacturing, and commercial capabilities. Our objective is to continue to advance as an integrated, multi-product biotechnology company that provides patients and medical professionals with important medicines for preventing and treating human diseases.

Selected financial information is summarized as follows:

Three Months Ended

Six Months Ended

(In millions, except per share data)

Revenues

$

$

$

$

Net income

$

$

$

$

Net income per share - diluted

$

$

$

$

For purposes of this report, references to our products encompass products commercialized by us and/or our collaborators or licensees and references to our product candidates encompass product candidates in development by us and/or our collaborators or licensees (in the case of collaborated or licensed products or product candidates under the terms of the applicable collaboration or license agreements), unless otherwise stated or required by the context.

Products

Products that have received marketing approval are summarized in the table below. Certain products have also received marketing approval in countries outside the United States, European Union ("EU"), or Japan.

Product

Disease

Territory

U.S.

EU

Japan

EYLEA HD® (aflibercept) Injection 8 mg(a)

Wet age-related macular degeneration ("wAMD")

a

a

a

Diabetic macular edema ("DME")

a

a

a

Diabetic retinopathy ("DR")

a

Macular edema following retinal vein occlusion ("RVO")

a

a

EYLEA® (aflibercept) Injection(a)

wAMD

a

a

a

DME

a

a

a

DR

a

RVO

a

a

a

Myopic choroidal neovascularization ("mCNV")

a

a

Neovascular glaucoma ("NVG")

a

Retinopathy of prematurity ("ROP")

a

a

a

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Product (continued)

Disease

Territory

U.S.

EU

Japan

Dupixent® (dupilumab) Injection(b)

Atopic dermatitis (in patients aged 6 months and older)

a

a

a

Asthma (in patients aged 6 years and older)

a

a

a

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

a

a

a

CRSwNP (in adolescents)

a

Chronic obstructive pulmonary disease ("COPD")

a

a

a

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

a

a

Prurigo nodularis

a

a

a

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

a

a

a

CSU (in pediatrics 2–11 years of age)

a

a

Bullous pemphigoid

a

a

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

a

Libtayo® (cemiplimab) Injection

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

a

a

a

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

a

a

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

a

a

Adjuvant CSCC

a

a

Metastatic or recurrent second-line cervical cancer

a

a

Praluent® (alirocumab) Injection(c)

Cardiovascular risk reduction in patients at increased risk of cardiovascular events

a

a

Hypercholesterolemia

a

a

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

a

a

Homozygous familial hypercholesterolemia ("HoFH")

a

Kevzara® (sarilumab) Injection(b)

Rheumatoid arthritis ("RA")

a

a

a

Polymyalgia rheumatica ("PMR")

a

a

Polyarticular juvenile idiopathic arthritis ("pJIA")

a

a

Evkeeza® (evinacumab) Injection(d)

HoFH (in adults, adolescents, and pediatrics)

a

a

a

Ordspono™ (odronextamab)

Follicular lymphoma ("FL")

a

Diffuse large B-cell lymphoma ("DLBCL")

a

Lynozyfic® (linvoseltamab)

Relapsed/refractory multiple myeloma

a

a

Inmazeb® (atoltivimab, maftivimab, and odesivimab) Injection

Infection caused by Zaire ebolavirus

a

Veopoz® (pozelimab) Injection

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

a

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Product (continued)

Disease

Territory

U.S.

EU

Japan

Otarmeni™ (lunsotogene parvec)

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

a

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

Deficiency of interleukin-1 receptor antagonist ("DIRA") (in adults, adolescents, and pediatrics)

a

Recurrent pericarditis (in adults and adolescents)

a

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

Metastatic colorectal cancer ("mCRC")

a

a

a

Note: Refer to table below (net product sales of Regeneron-discovered products) for information regarding whether net product sales for a particular product are recorded by us or others. In addition, unless otherwise noted, products in the table above are generally approved for use in adults in the above-referenced diseases.

(a) In collaboration with Bayer outside the United States. Aflibercept 8 mg is known as EYLEA HD in the United States and EYLEA 8 mg in other countries.

(b) In collaboration with Sanofi

(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. Such net product sales are recorded by us or others, as further described in the footnotes to the table. We believe the information in the table is useful to investors as it demonstrates our pipeline productivity and our ability to innovate, discover, and develop new products, and bring those products to market either alone or based on contractual arrangements with other parties, which has a direct impact on our results of operations and financial condition. The table also shows the degree to which we, a collaborator, and/or a licensee is currently commercializing the products discovered by Regeneron. In addition, this information allows management and investors to assess the commercial trends and developments impacting Regeneron-discovered products.

In arrangements where our collaborator or licensee is currently commercializing such products and is recording net product sales as a result, the net product sales shown in the table also are an important metric for management's review and assessment of (i) the revenues we record for our share of profits and/or royalties from such sales and (ii) the impact of our obligation to supply commercial product to certain of these collaborators or licensees.

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Three Months Ended

% Change

(In millions)

U.S.

ROW(f)

Total

U.S.

ROW

Total

(Total Sales)

Dupixent(a)

$

$

$

$

$

$

%

EYLEA HD(b)

$

$

$

$

$

$

%

EYLEA(b)

$

$

$

$

$

$

%)

Total EYLEA HD and EYLEA

$

$

$

$

$

$

%)

Libtayo(c)

$

$

$

$

$

$

%

Praluent(d)

$

$

$

$

$

$

%

Kevzara(a)

$

$

$

$

$

$

%

Lynozyfic

$

$

$

$

—

$

—

$

—

*

Other products(e)

$

$

$

$

$

$

%

Six Months Ended

% Change

(In millions)

U.S.

ROW

Total

U.S.

ROW

Total

(Total Sales)

Dupixent(a)

$

$

$

$

$

$

%

EYLEA HD(b)

$

$

$

$

$

$

%

EYLEA(b)

$

$

$

$

$

$

%)

Total EYLEA HD and EYLEA

$

$

$

$

$

$

%)

Libtayo(c)

$

$

$

$

$

$

%

Praluent(d)

$

$

$

$

$

$

%

Kevzara(a)

$

$

$

$

$

$

%

Lynozyfic

$

$

$

$

—

$

—

$

—

*

Other products(e)

$

$

$

$

$

$

%

* Percentage not meaningful or greater than 100%

(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.

(c) We record global net product sales of Libtayo and pay Sanofi a royalty on such sales

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

(e) Included in this line item are products which are sold by us and others. Refer to "Results of Operations - Revenues" below 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.

(f) Rest of world ("ROW")

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Programs in Clinical Development

Product candidates in Phase 2 and Phase 3 clinical development, which are being developed by us and/or our collaborators, are summarized in the table below. 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. The planning, execution, and results of our clinical programs are significant factors that can affect our operating and financial results.

Refer to Part II, Item 1A. "Risk Factors" for a description of risks and uncertainties that may affect our clinical programs. Any of such risks and uncertainties may, among other matters, negatively impact the development timelines set forth in the table below.

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Clinical Program

Phase 2

Phase 3

Regulatory

Review(h)

Select Upcoming

Milestones

Ophthalmology

EYLEA HD (aflibercept) 8 mg(a)

–Pre-filled syringe (U.S.)

–RVO (Japan)

–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) (RNAi 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

Dupixent (dupilumab)(b)

Antibody to IL-4R alpha subunit

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

–Chronic pruritus of unknown origin ("CPUO")

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

–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

–Withdrew regulatory application in EU for bullous pemphigoid

–Phase 3 studies in lichen simplex chronicus did not meet primary endpoints

Kevzara (sarilumab)(b)

Antibody to IL-6R

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

Multi-antibody therapy to Bet v 1

–Birch allergy

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Clinical Program (continued)

Phase 2

Phase 3

Regulatory

Review(h)

Select Upcoming

Milestones

Multi-antibody therapy to Fel d 1

–Cat allergy

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

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")

–Early-stage CSCC (intralesional)

–Adjuvant and advanced CSCC (Japan)

(antibody to LAG-3) + Libtayo (cemiplimab)(f)

–Perioperative NSCLC

–Perioperative melanoma

–First-line metastatic head and neck squamous cell carcinoma

–First-line metastatic melanoma(e)

–Adjuvant melanoma

–Reported that Phase 3 study versus pembrolizumab in first-line metastatic melanoma did not reach statistical significance for primary endpoint

–Phase 3 adjuvant melanoma study passed both pre-planned interim analyses conducted by Independent Data Monitoring Committee; study will continue to final analysis

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

–Report results from Phase 3 study versus pembrolizumab in adjuvant melanoma (fourth quarter 2026)

Vidutolimod

Immune activator targeting TLR9

Bispecific antibody targeting MUC16 and CD3

–Serous ovarian cancer

–Advanced NSCLC(l)

Bispecific antibody targeting MUC16 and CD28

–Ovarian cancer

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Clinical Program (continued)

Phase 2

Phase 3

Regulatory

Review(h)

Select Upcoming

Milestones

Bispecific antibody targeting PSMA and CD28

–Prostate cancer

Bispecific antibody targeting EGFR and CD28

–Solid tumors

Bispecific antibody targeting two distinct MET epitopes

–MET-altered advanced NSCLC

Hematology-Oncology

Ordspono (odronextamab)

Bispecific antibody targeting CD20 and CD3

–B-cell non-Hodgkin lymphoma

("B-NHL") (pivotal study)

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

Lynozyfic (linvoseltamab)(f)

Bispecific antibody targeting BCMA and CD3

–Multiple myeloma precursor and related conditions

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

–Reported positive data from Phase 1/2 trial in amyloid light chain amyloidosis; results presented at American Society of Clinical Oncology ("ASCO") 2026 Annual Meeting

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")

–Peripheral artery disease ("PAD")

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

Antibody to Factor XI (A2 domain)

–Thrombosis

–SPAF

–PAD

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

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Clinical Program (continued)

Phase 2

Phase 3

Regulatory

Review(h)

Select Upcoming

Milestones

Mibavademab(f)(o) (REGN4461)

Agonist antibody to leptin receptor ("LEPR")

–Functional hypothalamic amenorrhea

Antibody to myostatin (GDF8)

–Obesity(n)

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

GLP-1/GIP receptor agonist

–Obesity

–Initiate Phase 3 program in obesity in patients with and without Type 2 diabetes (second half 2026)

Antagonist antibody to NPR1

–Postural orthostatic tachycardia syndrome ("POTS")

–Sepsis-induced hypotension

Rapirosiran (ALN-HSD)(k)

RNAi therapeutic targeting HSD17B13

–Metabolic dysfunction-associated steatohepatitis ("MASH")

ALN-CIDEB(k)

RNAi therapeutic targeting CIDEB

–MASH(e)

ALN-PNP(k)

RNAi therapeutic targeting PNPLA3

–MASH

ALN-ANG3(k)(r)

RNAi therapeutic targeting ANGPTL3

–Diabetic kidney disease

Antagonist antibody to PDGF-B

–Pulmonary arterial

hypertension

("PAH")(c)

Neurology/Rare Diseases

Antibody to Activin A

–Fibrodysplasia ossificans progressiva

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

–FOP (U.S. and EU)

–FDA decision on Biologics License Application ("BLA") (August 2026) and EC decision on Marketing Authorization Application ("MAA") (first half 2027) for FOP

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Clinical Program (continued)

Phase 2

Phase 3

Regulatory

Review(h)

Select Upcoming

Milestones

Cemdisiran(k)

RNAi therapeutic targeting C5

–Generalized myasthenia gravis ("gMG")(c)

–gMG (U.S. and EU)

–FDA decision on New Drug Application ("NDA") (November 2026) and EC decision on MAA (second half 2027) for gMG

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

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

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

Agonist antibody to leptin receptor ("LEPR")

–Generalized lipodystrophy(c)(d)(e)

–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 loss due to variants of otoferlin ("OTOF") gene(c)(e)(m) (pivotal study)

–Hearing loss associated with variants in OTOF gene (EU and Japan)

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

–EC decision on MAA for hearing loss associated with variants in OTOF gene (first quarter 2027)

ALN-SOD(s)

RNAi therapeutic targeting SOD1

–Amyotrophic lateral sclerosis (ALS)

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Note: We and Sanofi have discontinued further clinical development of itepekimab, an antibody to IL-33, in COPD, CRSwNP, and chronic rhinosinusitis without nasal polyposis ("CRSsNP"). In addition, we have discontinued further clinical development of REGN7999, an antibody to TMPRSS6, which was previously being studied in iron overload in beta-thalassemia.

(a) In collaboration with Bayer outside the United States

(b) In collaboration with Sanofi

(c) FDA granted Orphan Drug designation for one or more indications

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

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

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

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

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

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

(j) In collaboration with Intellia

(k) 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 or fianlimab

(q) In-licensed from Hansoh

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

(s) In collaboration with Alnylam. Study on clinical hold in the U.S. by the FDA; continuing to enroll ex-U.S.

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Additional Information - Clinical Development Programs

EYLEA HD

The Company is working with the FDA and multiple third-party filling manufacturers to potentially achieve regulatory approval for the pre-filled syringe by the end of 2026.

Select Early-Stage Clinical Development Updates

In 2026, a Phase 1 study for REGN20423, a long-acting IL-13 antibody, in healthy volunteers and patients with atopic dermatitis was initiated.

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 prices no greater than prices determined based on benchmarking 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 prices no greater than 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.

T1The U.S. 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

Sanofi

We are party to a global collaboration with Sanofi to research, develop, and commercialize fully human monoclonal antibodies, which currently consists of Dupixent, Kevzara, and itepekimab. As described above, during 2026 we and Sanofi discontinued further clinical development of itepekimab.

Agreed-upon development expenses incurred by the parties are generally shared equally. 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. We also supply certain commercial bulk product to Sanofi. We and Sanofi equally share profits from sales within the United States, and share profits outside the United States on a sliding scale based on sales starting at 65% (Sanofi)/35% (us) and ending at 55% (Sanofi)/45% (us).

Bayer

We and Bayer are parties to a license and collaboration agreement for the development and commercialization of EYLEA 8 mg and EYLEA. Agreed-upon development expenses incurred by the parties are generally shared equally. Bayer is responsible for commercialization activities outside the United States, and the companies share equally in profits from such sales.

We are obligated to reimburse Bayer for 50% of the development 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.

Alnylam

We and Alnylam Pharmaceuticals, Inc. 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 collaboration agreement ("Co-Co Collaboration Agreement") or a license agreement. The target nomination period of the collaboration agreement ended in May 2026.

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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.

Intellia

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

Hansoh

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 pay a low double-digit royalty on sales.

Tessera

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.

Parabilis

In May 2026, we entered into a collaboration agreement with Parabilis Medicines to discover and develop multiple therapeutic candidates based on Parabilis’ Helicon™ peptide platform. Under the terms of the agreement, we made a $50.0 million up-front payment and purchased $75.0 million of Parabilis common stock. We will lead development and commercialization, and Parabilis will be eligible to receive milestone payments for development, regulatory and commercial milestones, as well as tiered royalties up to low double-digits on sales. Under the terms of the agreement, additional targets may be pursued upon additional option payments made by us.

General

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 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; the scope and progress of our research and development efforts; the timing of certain expenses; the continuation of our collaborations, in particular with Sanofi and Bayer, including our share of collaboration profits from sales of commercialized products and the amount of reimbursement of our research and development expenses that we receive from collaborators; and the amount of income tax expense we incur, which is partly dependent on the profits or losses in each of the countries in which we operate. There is uncertainty surrounding whether or when new products

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or new indications for marketed products will receive regulatory approval or, if any such approval is received, whether we will be able to successfully commercialize such products and whether or when they may become profitable.

Results of Operations

Net Income

Three Months Ended

Six Months Ended

(In millions, except per share data)

Revenues

$

$

$

$

Operating expenses

Income from operations

Other income (expense)

Income before income taxes

Income tax expense

Net income

$

$

$

$

Net income per share - diluted

$

$

$

$

Revenues

Three Months Ended

Six Months Ended

(In millions)

$ Change

$ Change

Net product sales:

EYLEA HD - U.S.

$

$

$

$

$

$

EYLEA - U.S.

Total EYLEA HD and EYLEA - U.S.

Libtayo - U.S.

Libtayo - ROW

Total Libtayo - Global

Praluent - U.S.

Evkeeza - U.S.

Lynozyfic - Global

—

—

Other products - Global

—

—

—

—

Total net product sales

$

$

$

$

$

$

Collaboration revenue:

Sanofi

$

$

$

$

$

$

Bayer

Other

Other revenue

Total revenues

$

$

$

$

$

$

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Net Product Sales

Net product sales of EYLEA HD increased for the three and six months ended June 30, 2026, compared to the same periods in 2025, primarily due to higher sales volumes, partly offset by a lower net selling price.

Net product sales of EYLEA decreased for the three and six months ended June 30, 2026, compared to the same periods 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. The magnitude and duration of such impact is presently unknown. 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 revenues derived from net product sales of EYLEA HD, EYLEA, and Dupixent" and "The commercial success of our products and product candidates is subject to significant competition - Marketed Products."

Global net product sales of Libtayo increased for the three and six months ended June 30, 2026, compared to the same periods in 2025, primarily due to higher sales volumes.

Collaboration Revenue

Sanofi Collaboration Revenue

Three Months Ended

Six Months Ended

(In millions)

Regeneron's share of profits

$

$

$

$

Reimbursement for manufacturing of commercial supplies(a)

Total Sanofi collaboration revenue

$

$

$

$

(a) Corresponding costs incurred by the Company in connection with such manufacturing is recorded within Cost of collaboration and contract manufacturing

Global net product sales of Dupixent and Kevzara are recorded by Sanofi, and we and Sanofi share profits on such sales.

Regeneron's share of profits in connection with the commercialization of Dupixent and Kevzara is summarized below:

Three Months Ended

Six Months Ended

(In millions)

Dupixent and Kevzara net product sales

$

$

$

$

Regeneron's share of collaboration profits in connection with commercialization of antibodies

$

$

$

$

Reimbursement of development expenses incurred by Sanofi in accordance with Regeneron's payment obligation(a)

Regeneron's share of profits

$

$

$

$

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

(a) The Sanofi development balance, which represented our obligation to reimburse Sanofi for development expenses that were previously funded by Sanofi, was fully repaid as of June 30, 2026 and will no longer reduce our share of profits beginning in the third quarter of 2026

T2The increase in our share of profits for the three and six months ended June 30, 2026, compared to the same periods in 2025, was driven by higher profits primarily associated with an increase in Dupixent net product sales.

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Bayer Collaboration Revenue

Three Months Ended

Six Months Ended

(In millions)

Regeneron's share of profits

$

$

$

$

Reimbursement for manufacturing of commercial supplies(a)

Total Bayer collaboration revenue

$

$

$

$

(a) Corresponding costs incurred by the Company in connection with such manufacturing is recorded within Cost of collaboration and contract manufacturing

Bayer records net product sales of EYLEA 8 mg and EYLEA outside the United States, and we and Bayer share profits on such sales.

Regeneron's share of profits in connection with commercialization of EYLEA 8 mg and EYLEA outside the United States is summarized below:

Three Months Ended

Six Months Ended

(In millions)

EYLEA 8 mg and EYLEA net product sales outside the United States

$

$

$

$

Regeneron's share of collaboration profit from sales outside the United States

$

$

$

$

Reimbursement of development expenses incurred by Bayer in accordance with Regeneron's payment obligation(a)

Regeneron's share of profits

$

$

$

$

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

(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 six months ended June 30, 2026, compared to the same periods in 2025, was driven by lower profits primarily associated with a decrease in EYLEA sales outside the United States.

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Other Revenue

Three Months Ended

Six Months Ended

(In millions)

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

$

$

$

$

Other(a)

Total other revenue

$

$

$

$

(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

Six Months Ended

(In millions)

$ Change

$ Change

Research and development(a)

$

$

$

$

$

$

Acquired in-process research and development

Selling, general, and administrative(a)

Cost of goods sold

Cost of collaboration and contract manufacturing(b)

Total operating expenses

$

$

$

$

$

$

(a) Includes costs incurred net of any cost reimbursements from collaborators

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

Operating expenses included stock-based compensation expense of $243.0 million and $251.7 million for the three months ended June 30, 2026 and 2025, respectively, and $500.4 million and $507.4 million for the six months ended June 30, 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 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. Clinical manufacturing costs primarily consist of costs to manufacture bulk drug product for clinical development purposes as well as related drug filling, packaging, and labeling costs.

Clinical manufacturing costs also include pre-launch commercial supplies which did not meet the criteria to be capitalized as inventory. The table below also includes reimbursements of research and development expenses by collaborators, as when we are entitled to reimbursement of all or a portion of such expenses that we incur under a collaboration, we record those reimbursable amounts in the period in which such costs are incurred.

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Three Months Ended

Six Months Ended

(In millions)

$ Change

$ Change

Direct research and development expenses:

Fianlimab

$

$

$

$

$

$

Lynozyfic (linvoseltamab)

Ordspono (odronextamab)

Cenvacibart & amrecibart

Dupixent (dupilumab)

—

Pozelimab/cemdisiran

Itepekimab

Libtayo (cemiplimab)

Trevogrumab

Other product candidates in clinical development and other research programs

Total direct research and development expenses

Indirect research and development expenses:

Payroll and benefits

Lab supplies and other research and development costs

Occupancy and other operating costs

Total indirect research and development expenses

Clinical manufacturing costs

Reimbursement of research and development expenses by collaborators

Total research and development expenses

$

$

$

$

$

$

* 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 $130.8 million and $139.0 million for the three months ended June 30, 2026 and 2025, respectively, and $265.9 million and $280.0 million for the six months ended June 30, 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. "Risk Factors." There is also variability in the duration and costs necessary to develop a product candidate, potential opportunities and/or uncertainties related to future indications to be studied, and the estimated cost and scope of the projects. The lengthy process of seeking FDA and other applicable approvals, and subsequent compliance with applicable statutes and regulations, require the expenditure of substantial resources.

Any failure by us to obtain, or delay in obtaining, regulatory approvals could materially adversely affect our business. We are unable to reasonably estimate if our product candidates in clinical development will generate material product revenues and net cash inflows.

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

Acquired IPR&D expenses for the three and six months ended June 30, 2026 included up-front and opt-in payments in connection with collaboration and licensing agreements. In addition, Acquired IPR&D expenses for the six months ended June 30, 2026 included the premium on equity securities purchased and development milestone payments in connection with collaboration and licensing agreements.

Selling, General, and Administrative Expenses

Selling, general, and administrative expenses increased for the six months ended June 30, 2026, compared to the same period in 2025, partly due to an increase in commercialization-related expenses and higher headcount and headcount-related costs, offset in part by lower charitable contributions to an independent non-profit patient assistance organization. Selling, general, and administrative expenses included stock-based compensation expense of $85.5 million and $91.8 million for the three months ended June 30, 2026 and 2025, respectively, and $174.7 million and $187.0 million for the six months ended June 30, 2026 and 2025, respectively.

Cost of Goods Sold

Three Months Ended

Six Months Ended

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

Cost of goods sold

$

$

$

$

Gross margin on net product sales(a)

(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.

T3Gross margin on net product sales decreased for the three and six months ended June 30, 2026, compared to the same periods in 2025, primarily due to unabsorbed manufacturing costs 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. As of June 30, 2026, bulk manufacturing production returned to normal levels. The interruption did not 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

Six Months Ended

(In millions)

Gains on marketable and other securities, net

$

$

$

$

Interest income

Other

Other income (expense), net

Interest expense

Total other income (expense)

$

$

$

$

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

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Income Taxes

Three Months Ended

Six Months Ended

(In millions, except effective tax rate)

Income tax expense

$

$

$

$

Effective tax rate

%

%

%

%

Our effective tax rate for the three and six months ended June 30, 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, to a lesser extent, tax benefits from cross-border tax laws and federal tax credits for research activities, partly offset by changes in unrecognized tax benefits. In addition, our effective tax rate increased for the three and six months ended June 30, 2026, compared to the same periods in 2025, primarily due to the release of liabilities associated with unrecognized tax benefits upon the settlement of an IRS audit.

Liquidity and Capital Resources

Our financial condition is summarized as follows:

(In millions)

$ Change

Financial assets:

Cash and cash equivalents

$

$

$

Marketable securities - current

Marketable securities - noncurrent

$

$

$

Working capital:

Current assets

$

$

$

Current liabilities

*

$

$

$

Borrowings and finance lease liabilities:

Long-term debt

$

$

$

Finance lease liabilities

$

*

$

$

—

* The $720.0 million related to finance lease liabilities is classified within current liabilities as of June 30, 2026

As of June 30, 2026, we also had borrowing availability of $750.0 million under a revolving credit facility.

Sources and Uses of Cash

Six Months Ended

(In millions)

$ Change

Cash flows provided by (used in):

Operating activities

$

$

$

Investing activities

$

$

$

Financing activities

$

$

$

Cash Flows from Investing Activities

Capital expenditures for the six months ended June 30, 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

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expansion of our manufacturing facilities. T4We expect to incur capital expenditures of $1.030 billion to $1.100 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

T5Our 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 April 2026. The programs have no time limit and can be discontinued at any time. As of June 30, 2026, $2.534 billion remained available for share repurchases under the program.

Dividends

In each of the first and second quarters of 2026, our board of directors declared a quarterly cash dividend of $0.94 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 July 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 August 31, 2026 to our shareholders of record as of August 18, 2026.

Critical Accounting Estimates

A summary of critical accounting estimates is presented in Part II, Item 7. "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 six months ended June 30, 2026.

Future Impact of Recently Issued Accounting Standards

See Note 1 to our Condensed Consolidated Financial Statements included in this report for a description of recently issued accounting standards.