Regeneron Pharmaceuticals Inc.

10/28/2025 | Press release | Distributed by Public on 10/28/2025 04:57

Quarterly Report for Quarter Ending September 30, 2025 (Form 10-Q)

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 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);
•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, including without limitation capital expenditures, and changes to the assumptions underlying those projections or guidance;
•the potential for any license or collaboration agreement, including our agreements with Sanofi and Bayer (or their respective affiliated companies, as applicable), to be cancelled or terminated;
•the impact of public health outbreaks, epidemics, or pandemics on our business; and
•risks associated with litigation and other proceedings and government investigations relating to the Company and/or its operations (including without limitation those described in Note 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.
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
September 30,
Nine Months Ended
September 30,
(In millions, except per share data) 2025 2024 2025 2024
Revenues $ 3,754.3 $ 3,720.7 $ 10,458.6 $ 10,412.8
Net income $ 1,460.0 $ 1,340.6 $ 3,660.3 $ 3,494.9
Net income per share - diluted $ 13.62 $ 11.54 $ 33.61 $ 30.23
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
EYLEA®(aflibercept) Injection(a)
wAMD
a a a
DME
a a a
DR
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")
a a a
Myopic choroidal neovascularization ("mCNV") a a
Neovascular glaucoma ("NVG") a
Retinopathy of prematurity ("ROP")
a a a
Product (continued)
Disease Territory
U.S. EU Japan
Dupixent®(dupilumab) Injection(b)
Atopic dermatitis (in adults, adolescents, and pediatrics aged 6 months and older)
a a a
Asthma (in adults and adolescents) a a a
Asthma (in pediatrics 6-11 years of age) 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 adults, adolescents, and pediatrics aged 1 year and older)
a a
Prurigo nodularis a a a
Chronic spontaneous urticaria ("CSU") (in adults and adolescents)
a a
Bullous pemphigoid
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
Metastatic or recurrent second-line cervical cancer
a a
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)
a a
Cardiovascular risk reduction in patients with established cardiovascular disease 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 adults, adolescents, and pediatrics aged 1 year and older)
a
Product (continued)
Disease Territory
U.S. EU Japan
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.
Three Months Ended
September 30,
2025 2024 % Change
(In millions) U.S.
ROW(f)
Total U.S. ROW Total (Total Sales)
EYLEA HD(a)
$ 430.6 $ 232.4 $ 663.0 $ 392.3 $ 75.2 $ 467.5 42 %
EYLEA(a)
$ 680.6 $ 621.4 $ 1,302.0 $ 1,144.6 $ 856.5 $ 2,001.1 (35 %)
Total EYLEA HD and EYLEA
$ 1,111.2 $ 853.8 $ 1,965.0 $ 1,536.9 $ 931.7 $ 2,468.6 (20 %)
Dupixent(b)
$ 3,618.8 $ 1,238.2 $ 4,857.0 $ 2,824.7 $ 992.5 $ 3,817.2 27 %
Libtayo(c)
$ 219.1 $ 146.1 $ 365.2 $ 194.5 $ 94.1 $ 288.6 27 %
Praluent(d)
$ 67.7 $ 148.0 $ 215.7 $ 52.9 $ 138.5 $ 191.4 13 %
Kevzara(b)
$ 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 U.S. ROW Total (Total Sales)
EYLEA HD(a)
$ 1,130.6 $ 620.5 $ 1,751.1 $ 896.5 $ 149.5 $ 1,046.0 67 %
EYLEA(a)
$ 2,170.9 $ 2,068.8 $ 4,239.7 $ 3,576.7 $ 2,539.4 $ 6,116.1 (31 %)
Total EYLEA HD and EYLEA
$ 3,301.5 $ 2,689.3 $ 5,990.8 $ 4,473.2 $ 2,688.9 $ 7,162.1 (16 %)
Dupixent(b)
$ 9,453.2 $ 3,414.0 $ 12,867.2 $ 7,652.9 $ 2,797.5 $ 10,450.4 23 %
Libtayo(c)
$ 659.4 $ 367.4 $ 1,026.8 $ 536.1 $ 313.8 $ 849.9 21 %
Praluent(d)
$ 190.3 $ 440.7 $ 631.0 $ 179.0 $ 405.6 $ 584.6 8 %
Kevzara(b)
$ 271.4 $ 151.2 $ 422.6 $ 187.8 $ 136.1 $ 323.9 30 %
Other products(e)
$ 117.1 $ 81.5 $ 198.6 $ 124.4 $ 65.2 $ 189.6 5 %
(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. 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.
(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.
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.
Clinical Program Phase 2 Phase 3
Regulatory
Review(h)
2025 Events to Date
Select Upcoming
Milestones
Ophthalmology
EYLEA HD (aflibercept) 8 mg(a)
-RVO
-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)
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
-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
Review(h)
2025 Events to Date
Select Upcoming
Milestones
Dupixent (dupilumab)(b)(continued)
-CSU in pediatrics (2-11 years of age) (U.S. and EU)
-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
Kevzara (sarilumab)(b)
Antibody to IL-6R
-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")
-COPD(e)
-CRSwNP
-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)
REGN1908-1909(f)
Multi-antibody therapy to Fel d 1
-Cat allergy
-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)
Clinical Program (continued)
Phase 2 Phase 3
Regulatory
Review(h)
2025 Events to Date
Select Upcoming
Milestones
Libtayo (cemiplimab)(g) (continued)
-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")
Fianlimab(f) (REGN3767)
Antibody to LAG-3
-First-line advanced NSCLC (Phase 2/3)
-Perioperative NSCLC
-Perioperative melanoma
-First-line metastatic melanoma(e)
-Adjuvant melanoma
-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)
Vidutolimod
Immune activator targeting TLR9
Ubamatamab(f) (REGN4018)
Bispecific antibody targeting MUC16 and CD3
-Ovarian cancer
-Presented additional data from Phase 2 study in platinum-resistant ovarian cancer at European Society for Medical Oncology ("ESMO") 2025 Meeting
Clinical Program (continued)
Phase 2 Phase 3
Regulatory
Review(h)
2025 Events to Date
Select Upcoming
Milestones
REGN5668(p)
Bispecific antibody targeting MUC16 and CD28
-Ovarian cancer
Nezastomig (REGN5678)
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
REGN7075
Bispecific antibody targeting EGFR and CD28
-Solid tumors
-Report additional data from study in solid tumors (first half 2026)
Davutamig (REGN5093)
Bispecific antibody targeting two distinct MET epitopes
-MET-altered advanced NSCLC
Hematology
Pozelimab(f) (REGN3918)
Antibody to C5
-Myasthenia gravis, cemdisiran combination(c)(l)
-Paroxysmal nocturnal hemoglobinuria ("PNH"), cemdisiran combination(c)(l)
-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
Ordspono (odronextamab)
Bispecific antibody targeting CD20 and CD3
-B-cell non-Hodgkin lymphoma
("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
Lynozyfic (linvoseltamab)(f)
Bispecific antibody targeting BCMA and CD3
-Earlier (pre-malignant) multiple myeloma
-Monoclonal gammopathy of undetermined significance ("MGUS")
-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
Clinical Program (continued)
Phase 2 Phase 3
Regulatory
Review(h)
2025 Events to Date
Select Upcoming
Milestones
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
REGN9933
Antibody to Factor XI (A2 domain)
-Thrombosis
-Initiate Phase 3 studies (first half 2026)
REGN7508
Antibody to Factor XI (catalytic domain)
-Thrombosis
-Venous thromboembolism after total knee replacement surgery
-Initiate additional Phase 3 studies (first half 2026)
REGN7257
Antibody to IL2Rg
-Discontinued study in aplastic anemia
REGN7999
Antibody to TMPRSS6
-Iron overload in beta-thalassemia
Internal Medicine/Genetic Medicines
Garetosmab(f) (REGN2477)
Antibody to Activin A
-Fibrodysplasia ossificans progressiva
("FOP")(c)(d)(e)
-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)
-Obesity(n)
-Reported 26-week results from Phase 2 study in obesity
Mibavademab(f)(o) (REGN4461)
Agonist antibody to leptin receptor ("LEPR")
-Generalized lipodystrophy(c)(d)(e)
REGN5381
Agonist antibody to NPR1
-Discontinued Phase 2 studies in heart failure and uncontrolled hypertension
Clinical Program (continued)
Phase 2 Phase 3
Regulatory
Review(h)
2025 Events to Date
Select Upcoming
Milestones
REGN7544
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")
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)
Note: For purposes of the table above, a program is classified in Phase 2 or 3 clinical development after recruitment for the corresponding study or studies has commenced
(a)In collaboration with Bayer outside the United States
(b)In collaboration with Sanofi
(c)FDA granted Orphan Drug designation
(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
(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)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
(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
Additional Information - Clinical Development Programs
EYLEA HD
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.
Itepekimab
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.
Fianlimab
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).
Collaboration, License, and Other Agreements
Sanofi
We are collaborating with Sanofi on the global development and commercialization of Dupixent, Kevzara, and itepekimab (the "Antibody Collaboration"). Under the terms of the Antibody Collaboration, Sanofi is generally responsible for funding 80% to 100% of agreed-upon development costs. We are obligated to reimburse Sanofi for 30% to 50% of development expenses that were funded by Sanofi based on our share of collaboration profits; however, we are only required to apply 20% of our share of profits from the collaboration each calendar quarter to reimburse Sanofi for these development expenses. 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.
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 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 global development and commercialization of EYLEA 8 mg and EYLEA outside the United States. Agreed-upon development expenses incurred by the Company and Bayer are generally shared equally. Bayer is responsible for commercialization activities outside the United States, and the companies share equally in profits from such sales.
We are obligated to reimburse Bayer for 50% of the development costs that it has incurred under the agreement from our share of the collaboration profits. 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.
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 targeting the C5 component of the human complement pathway) as a monotherapy and for a combination consisting of cemdisiran and pozelimab.
Intellia
We and Intellia Therapeutics, Inc. are parties to a license and collaboration agreement to advance CRISPR/Cas9 gene-editing technology for in vivotherapeutic development, including therapies focused on neurological and muscular diseases. We have the right to select targets under the license and collaboration agreement until April 2026.
Intellia leads the design of the editing methodology, we lead the design of the targeted viral vector delivery approach, and the parties share costs. Each company has the opportunity to lead potential development and commercialization of product candidates for a target, and the company that is not leading development and commercialization will have the option to enter into a co-development and co-commercialization agreement for the target.
Nex-z, which is in clinical development, is subject to a co-development and co-commercialization arrangement pursuant to which Intellia leads development activities and the parties share development expenses 75% (Intellia)/25% (us). If nex-z is commercialized, Intellia will lead commercialization activities and we will be entitled to 25% of any profits.
Hansoh
In July 2025, our license agreement with Hansoh Pharmaceuticals Group Company Limited to acquire development and commercial rights outside of mainland China, Hong Kong, and Macau for HS-20094 (a dual GLP-1/GIP receptor agonist currently in Phase 3 clinical development in China) became effective. In-licensing a late-stage GLP-1/GIP agonist enables us to study combinations with our products and product candidates in order to address muscle loss and potentially other comorbidities of obesity, such as cardiovascular diseases, diabetes, and liver conditions. Under the terms of the agreement, we made an $80.0 million up-front payment in July 2025. In addition, we are obligated to make additional payments upon achievement of development, regulatory, and sales milestones, as well as a low double-digit royalty on sales.
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 which are not reimbursed by collaborators are expected to expand and require additional resources. We also expect to incur substantial costs related to the commercialization of our marketed products. 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 we earn in each of the countries in which we operate. There is uncertainty surrounding whether or when new products or new indications for marketed products will receive regulatory approval or, if any such approval is received, whether we will be able to successfully commercialize such products and whether or when they may become profitable.
Results of Operations
Net Income
Three Months Ended
September 30,
Nine Months Ended
September 30,
(In millions, except per share data) 2025 2024 2025 2024
Revenues $ 3,754.3 $ 3,720.7 $ 10,458.6 $ 10,412.8
Operating expenses 2,727.5 2,541.2 7,760.6 7,412.3
Income from operations 1,026.8 1,179.5 2,698.0 3,000.5
Other income (expense) 736.5 313.5 1,489.0 821.3
Income before income taxes 1,763.3 1,493.0 4,187.0 3,821.8
Income tax expense
303.3 152.4 526.7 326.9
Net income $ 1,460.0 $ 1,340.6 $ 3,660.3 $ 3,494.9
Net income per share - diluted $ 13.62 $ 11.54 $ 33.61 $ 30.23
Revenues
Three Months Ended
September 30,
Nine Months Ended
September 30,
(In millions) 2025 2024 $ Change 2025 2024 $ Change
Net product sales:
EYLEA HD - U.S.
$ 430.6 $ 392.3 $ 38.3 $ 1,130.6 $ 896.5 $ 234.1
EYLEA - U.S. 680.6 1,144.6 (464.0) 2,170.9 3,576.7 (1,405.8)
Total EYLEA HD and EYLEA - U.S.
1,111.2 1,536.9 (425.7) 3,301.5 4,473.2 (1,171.7)
Libtayo - U.S. 219.1 194.5 24.6 659.4 536.1 123.3
Libtayo - ROW 146.1 94.1 52.0 367.4 313.8 53.6
Total Libtayo - Global
365.2 288.6 76.6 1,026.8 849.9 176.9
Praluent - U.S. 67.7 52.9 14.8 190.3 179.0 11.3
Evkeeza - U.S. 42.8 32.4 10.4 114.9 87.6 27.3
Inmazeb - U.S.
- 35.6 (35.6) - 36.6 (36.6)
Other products - Global
0.8 - 0.8 0.8 - 0.8
Total net product sales $ 1,587.7 $ 1,946.4 $ (358.7) $ 4,634.3 $ 5,626.3 $ (992.0)
Collaboration revenue:
Sanofi $ 1,617.0 $ 1,263.4 $ 353.6 $ 4,243.8 $ 3,318.8 $ 925.0
Bayer 344.8 390.8 (46.0) 1,103.7 1,121.9 (18.2)
Other 6.6 5.9 0.7 12.8 10.2 2.6
Other revenue 198.2 114.2 84.0 464.0 335.6 128.4
Total revenues $ 3,754.3 $ 3,720.7 $ 33.6 $ 10,458.6 $ 10,412.8 $ 45.8
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.
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 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
Sanofi Collaboration Revenue
Three Months Ended
September 30,
Nine Months Ended
September 30,
(In millions) 2025 2024 2025 2024
Regeneron's share of profits
$ 1,455.5 $ 1,088.3 $ 3,755.7 $ 2,880.6
Reimbursement for manufacturing of commercial supplies(a)
161.5 175.1 488.1 438.2
Total Sanofi collaboration revenue $ 1,617.0 $ 1,263.4 $ 4,243.8 $ 3,318.8
(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
September 30,
Nine Months Ended
September 30,
(In millions) 2025 2024 2025 2024
Dupixent and Kevzara net product sales $ 5,011.0 $ 3,937.3 $ 13,289.8 $ 10,774.3
Regeneron's share of collaboration profits in connection with commercialization of antibodies
$ 1,723.6 $ 1,263.4 $ 4,400.5 $ 3,338.5
Reimbursement of development expenses incurred by Sanofi in accordance with Regeneron's payment obligation(a)
(268.1) (175.1) (644.8) (457.9)
Regeneron's share of profits
$ 1,455.5 $ 1,088.3 $ 3,755.7 $ 2,880.6
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.
Bayer Collaboration Revenue
Three Months Ended
September 30,
Nine Months Ended
September 30,
(In millions) 2025 2024 2025 2024
Regeneron's share of profits
$ 311.9 $ 367.6 $ 1,012.6 $ 1,054.5
Reimbursement for manufacturing of commercial supplies(a)
32.9 23.2 91.1 67.4
Total Bayer collaboration revenue $ 344.8 $ 390.8 $ 1,103.7 $ 1,121.9
(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
September 30,
Nine Months Ended
September 30,
(In millions) 2025 2024 2025 2024
EYLEA 8 mg and EYLEA net product sales outside the United States $ 853.8 $ 931.7 $ 2,689.3 $ 2,688.9
Regeneron's share of collaboration profit from sales outside the United States
$ 328.0 $ 384.2 $ 1,061.5 $ 1,103.7
Reimbursement of development expenses incurred by Bayer in accordance with Regeneron's payment obligation(a)
(16.1) (16.6) (48.9) (49.2)
Regeneron's share of profits
$ 311.9 $ 367.6 $ 1,012.6 $ 1,054.5
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.
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.
Operating Expenses
Three Months Ended
September 30,
Nine Months Ended
September 30,
(In millions, except headcount data) 2025 2024 Change 2025 2024 Change
Research and development(a)
$ 1,475.0 $ 1,271.5 $ 203.5 $ 4,224.1 $ 3,719.9 $ 504.2
Acquired in-process research and development 83.1 56.2 26.9 105.4 87.2 18.2
Selling, general, and administrative(a)
657.8 714.4 (56.6) 1,925.0 2,162.2 (237.2)
Cost of goods sold 281.0 262.3 18.7 822.1 760.5 61.6
Cost of collaboration and contract manufacturing(b)
240.6 228.8 11.8 694.0 644.6 49.4
Other operating (income) expense, net (10.0) 8.0 (18.0) (10.0) 37.9 (47.9)
Total operating expenses $ 2,727.5 $ 2,541.2 $ 186.3 $ 7,760.6 $ 7,412.3 $ 348.3
Average headcount 15,301 14,642 659 15,222 14,165 1,057
(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 $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.
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. 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.
Three Months Ended
September 30,
Nine Months Ended
September 30,
(In millions) 2025
2024*
$ Change 2025
2024*
$ Change
Direct research and development expenses:
Fianlimab $ 55.8 $ 53.4 $ 2.4 $ 155.3 $ 168.4 $ (13.1)
Ordspono (odronextamab)
50.1 33.8 16.3 119.1 94.1 25.0
Lynozyfic (linvoseltamab) 32.8 25.4 7.4 118.1 111.8 6.3
Itepekimab
28.1 24.2 3.9 90.9 67.8 23.1
Dupixent (dupilumab) 27.6 31.3 (3.7) 81.1 96.4 (15.3)
EYLEA HD (aflibercept) 8 mg
21.1 28.9 (7.8) 73.9 76.0 (2.1)
Libtayo (cemiplimab) 18.0 17.9 0.1 57.3 60.7 (3.4)
Trevogrumab
17.9 6.4 11.5 57.0 18.7 38.3
Pozelimab
16.5 17.6 (1.1) 45.6 49.3 (3.7)
Other product candidates in clinical development and other research programs
186.4 147.5 38.9 498.4 415.3 83.1
Total direct research and development expenses 454.3 386.4 67.9 1,296.7 1,158.5 138.2
Indirect research and development expenses:
Payroll and benefits 438.3 407.8 30.5 1,339.5 1,249.2 90.3
Lab supplies and other research and development costs
67.5 63.0 4.5 192.4 175.4 17.0
Occupancy and other operating costs 166.3 158.7 7.6 479.2 434.9 44.3
Total indirect research and development expenses
672.1 629.5 42.6 2,011.1 1,859.5 151.6
Clinical manufacturing costs
381.4 306.6 74.8 1,028.8 841.3 187.5
Reimbursement of research and development expenses by collaborators (32.8) (51.0) 18.2 (112.5) (139.4) 26.9
Total research and development expenses
$ 1,475.0 $ 1,271.5 $ 203.5 $ 4,224.1 $ 3,719.9 $ 504.2
*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.
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.
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.
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.
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
$ 281.0 $ 262.3 $ 822.1 $ 760.5
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.
Other Income (Expense)
Three Months Ended
September 30,
Nine Months Ended
September 30,
(In millions) 2025 2024 2025 2024
Gains on marketable and other securities, net
$ 577.7 $ 134.7 $ 967.6 $ 331.2
Interest income 175.1 187.4 523.5 528.3
Other 3.0 5.2 29.5 6.5
Other income (expense), net 755.8 327.3 1,520.6 866.0
Interest expense (19.3) (13.8) (31.6) (44.7)
Total other income (expense) $ 736.5 $ 313.5 $ 1,489.0 $ 821.3
Income Taxes
Three Months Ended
September 30,
Nine Months Ended
September 30,
(In millions, except effective tax rate) 2025 2024 2025 2024
Income tax expense
$ 303.3 $ 152.4 $ 526.7 $ 326.9
Effective tax rate
17.2 % 10.2 % 12.6 % 8.6 %
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. 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.
Liquidity and Capital Resources
Our financial condition is summarized as follows:
September 30, December 31,
(In millions) 2025 2024 $ Change
Financial assets:
Cash and cash equivalents $ 2,506.4 $ 2,488.2 $ 18.2
Marketable securities - current 5,937.2 6,524.3 (587.1)
Marketable securities - noncurrent 10,285.7 8,900.1 1,385.6
$ 18,729.3 $ 17,912.6 $ 816.7
Working capital:
Current assets $ 17,980.7 $ 18,660.9 $ (680.2)
Current liabilities 4,425.1 3,944.3 480.8
$ 13,555.6 $ 14,716.6 $ (1,161.0)
Borrowings and finance lease liabilities:
Long-term debt $ 1,985.5 $ 1,984.4 $ 1.1
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,
(In millions) 2025 2024 $ Change
Cash flows provided by (used in):
Operating activities
$ 3,808.2 $ 3,157.7 $ 650.5
Investing activities
$ (849.4) $ (2,818.7) $ 1,969.3
Financing activities
$ (2,935.3) $ (1,065.0) $ (1,870.3)
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.
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). 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.
Dividends
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.
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, 2024 (filed February 5, 2025). There have been no material changes to critical accounting estimates during the nine months ended September 30, 2025.
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.
Regeneron Pharmaceuticals Inc. published this content on October 28, 2025, and is solely responsible for the information contained herein. Distributed via Edgar on October 28, 2025 at 10:57 UTC. If you believe the information included in the content is inaccurate or outdated and requires editing or removal, please contact us at [email protected]