Regeneron Pharmaceuticals, Inc. (REGN)

Item 1. Business

This Annual Report on Form 10-K 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;

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

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

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

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

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

•risks associated with litigation and other proceedings and government investigations relating to the Company and/or its operations (including without limitation those described in Note 16 to our Consolidated Financial Statements included in this report), risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings described further in Note 16 to our Consolidated Financial Statements included in this report), the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on our business, prospects, operating results, and financial condition.

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These statements are made based on management's current beliefs and judgment, and the reader is cautioned not to rely on any such statements. In evaluating such statements, shareholders and potential investors should specifically consider the various factors identified under Part I, Item 1A. "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.

General

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

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:

	Year Ended December 31,
(In millions, except per share data)	2025		2024		2023
Revenues	$	14,342.9	$	14,202.0	$	13,117.2
Net income	$	4,504.9	$	4,412.6	$	3,953.6
Net income per share - diluted	$	41.48	$	38.34	$	34.77

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

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.

Japan

EYLEA HD

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Financial statements

data from SEC XBRL filings. Values are as-reported; restatements supersede originals. Values reported in .

From 10-Q filed 2026-04-29 (period ending 2026-03-31).

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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:

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

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

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

•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

Selected financial information is summarized as follows:

	Three Months Ended March 31,
(In millions, except per share data)	2026		2025
Revenues	$	3,605.4	$	3,028.7
Net income	$	727.2	$	808.7
Net income per share - diluted	$	6.75	$	7.27

Products

Product

Disease

Territory

U.S.

Japan

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

Wet age-related macular degeneration ("wAMD")

Diabetic macular edema ("DME")

Diabetic retinopathy ("DR")

Macular edema following retinal vein occlusion ("RVO")

EYLEA® (aflibercept) Injection(a)

wAMD

DME

RVO

Myopic choroidal neovascularization ("mCNV")

Neovascular glaucoma ("NVG")

Retinopathy of prematurity ("ROP")

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Product (continued)

Disease

Territory

U.S.

Japan

Dupixent® (dupilumab) Injection(b)

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)

CRSwNP (in adolescents)

Chronic obstructive pulmonary disease ("COPD")

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

Prurigo nodularis

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

CSU (in pediatrics 2–11 years of age)

Bullous pemphigoid

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

Libtayo® (cemiplimab) Injection

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

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

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

Adjuvant CSCC

Metastatic or recurrent second-line cervical cancer

Praluent® (alirocumab) Injection(c)

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")

Kevzara® (sarilumab) Injection(b)

Rheumatoid arthritis ("RA")

Polymyalgia rheumatica ("PMR")

Polyarticular juvenile idiopathic arthritis ("pJIA")

Evkeeza® (evinacumab) Injection(d)

HoFH (in adults, adolescents, and pediatrics)

Ordspono™ (odronextamab)

Follicular lymphoma ("FL")

Diffuse large B-cell lymphoma ("DLBCL")

Lynozyfic® (linvoseltamab)

Relapsed/refractory multiple myeloma

Inmazeb® (atoltivimab, maftivimab, and odesivimab) Injection

Infection caused by Zaire ebolavirus

Veopoz® (pozelimab) Injection

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

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Product (continued)

Disease

Territory

U.S.

Japan

Otarmeni™ (lunsotogene parvec)

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

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)

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

Recurrent pericarditis (in adults and adolescents)

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

Metastatic colorectal cancer ("mCRC")

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

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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.

	Three Months Ended March 31,
	2026						2025						% Change
(In millions)	U.S.		ROW(f)		Total		U.S.		ROW		Total		(Total Sales)
Dupixent(a)	$	3,558.4	$	1,321.7	$	4,880.1	$	2,629.4	$	1,036.2	$	3,665.6	33	%
EYLEA HD(b)	$	468.4	$	332.5	$	800.9	$	306.8	$	146.4	$	453.2	77	%
EYLEA(b)	$	473.1	$	396.2	$	869.3	$	736.0	$	711.4	$	1,447.4	(40	%)
Total EYLEA HD and EYLEA	$	941.5	$	728.7	$	1,670.2	$	1,042.8	$	857.8	$	1,900.6	(12	%)
Libtayo(c)	$	286.1	$	152.1	$	438.2	$	192.5	$	92.6	$	285.1	54	%
Praluent(d)	$	66.6	$	179.1	$	245.7	$	56.8	$	136.5	$	193.3	27	%
Kevzara(a)	$	100.5	$	44.3	$	144.8	$	72.8	$	43.6	$	116.4	24	%
Lynozyfic	$	10.7	$	0.5	$	11.2	$	—	$	—	$	—	*
Other products(e)	$	77.1	$	29.3	$	106.4	$	31.1	$	23.5	$	54.6	95	%
* 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.
(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")

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)

2026 Events to Date

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) (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

Dupixent (dupilumab)(b)

Antibody to IL-4R alpha subunit

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

–Chronic pruritus of unknown origin ("CPUO")

–Lichen simplex chronicus

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

Antibody to IL-6R

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

Itepekimab(b) (REGN3500)

Antibody to IL-33

–Chronic rhinosinusitis without nasal polyposis ("CRSsNP")

–COPD(e)

–CRSwNP

REGN5713-5715

Multi-antibody therapy to Bet v 1

–Birch allergy

–Initiated second Phase 3 trial in birch allergy

REGN1908-1909(f)

Multi-antibody therapy to Fel d 1

–Cat allergy

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

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Clinical Program (continued)

Phase 2

Phase 3

Regulatory

Review(h)

2026 Events to Date

Select Upcoming

Milestones

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)

Fianlimab(f) (REGN3767)

Antibody to LAG-3

–Perioperative NSCLC

–Perioperative melanoma

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Held by

holders ( registered funds via N-PORT, institutional investors via 13F). Showing top by dollar value.

Holder	Type	ETF	MF	Position ($)	% of holder	Δ % of holder	Holder AUM

Recent insider activity

Last 90 days. Open-market trades (purchases & sales) by directors, officers, and 10%+ owners. 3 transactions across 1 insider. Net: -300 shares, -$226,801.

Date	Insider	Role	Action	Shares	Price	Value
2026-05-01	RYAN ARTHUR F	Director	Sell	-100 ×12	$705.24	-$70,524
2026-04-01	RYAN ARTHUR F	Director	Sell	-100 ×9	$777.27	-$77,727
2026-03-02	RYAN ARTHUR F	Director	Sell	-100 ×13	$785.50	-$78,550

Source: SEC Form 4 filings.

Next expected filings

~2026-07-31 10-Q expected by 2026-08-08 (in 66 days)
~2026-10-27 10-Q expected by 2026-11-04 (in 154 days)
~2027-02-03 10-K expected by 2027-02-25 (in 253 days)
~2027-04-28 10-Q expected by 2027-05-06 (in 337 days)

Predicted from historical filing cadence; not an SEC commitment.

Recent SEC filings

2026-04-29 8-K Earnings Release; Financial Statements and Exhibits
2026-04-29 10-Q Quarterly Report
2026-04-24 DEF 14A Proxy Statement
2026-04-08 8-K Earnings Release
2026-02-04 10-K Annual Report
2026-01-30 8-K Earnings Release; Financial Statements and Exhibits
2026-01-12 8-K Earnings Release; Regulation FD Disclosure; Financial Statements and Exhibits
2025-10-28 10-Q Quarterly Report
2025-10-28 8-K Earnings Release; Financial Statements and Exhibits
2025-10-06 8-K Earnings Release
2025-08-01 10-Q Quarterly Report
2025-08-01 8-K Earnings Release; Financial Statements and Exhibits
2025-04-29 10-Q Quarterly Report
2025-04-29 8-K Earnings Release; Financial Statements and Exhibits
2025-02-05 10-K Annual Report

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