What changed in this filing

/stocks — the workspaceLOADING

Item 2. Management’s Discussion and Analysis

2025-04-29 compared with 2024-10-31 · 196 added, 297 removed, 420 unchanged (54% of the section changed)

4 unchanged sentences

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

• the nature, timing, and possible success and therapeutic applications of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, "Regeneron's Products") and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, "Regeneron's Product Candidates") and research and clinical programs now underway or planned, including without limitation those discussed or referenced in this report, Regeneron's and its collaborators' earlier-stage programs, and the use of human genetics in Regeneron's research programs;

• competing 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;

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

• competing drugs and product candidates that may be superior to, or more cost effective than, Regeneron's Products and Regeneron's Product Candidates (including biosimilar versions of Regeneron's Products);

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

• our ability to manufacture and manage supply chains for multiple products and product candidates;

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

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

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

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

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

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

1 unchanged sentence

• 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 (such as the COVID-19 pandemic) on our business;

• 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 11 to our Condensed Consolidated Financial Statements included in this report), other litigation and other proceedings and government investigations relating to the Company and/or its operations (including without limitation those described in Note 11 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.

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

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

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.

"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.

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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, hematologic conditions, infectious diseases, and rare diseases.

Our core business strategy is to maintain a strong foundation in basic scientific research and discovery-enabling technologies, and to build on that foundation with our clinical development, manufacturing, and commercial capabilities.

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.

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Three Months Ended

September 30,

Nine Months Ended

September 30,

(In millions, except per share data) 2025 2024

2 unchanged sentences

Net income per share - diluted $ 7.27 $ 6.27

For purposes of this report, references to our products encompass products marketed or otherwise 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.

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 that have received marketing approval are summarized in the table below.

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Retinopathy of prematurity ("ROP")

Product (continued)

Disease Territory

Dupixent ® (dupilumab) Injection (b)

1 unchanged sentence

Asthma (in adults and adolescents) a a a

Product (continued)

Dupixent (dupilumab) Injection (b) (continued)

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

1 unchanged sentence

CRSwNP (in adolescents)

Chronic obstructive pulmonary disease

Eosinophilic esophagitis ("EoE") (in adults and adolescents)

EoE (in pediatrics 1–11 years of age)

Chronic obstructive pulmonary disease ("COPD")

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

Prurigo nodularis a a a

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Diffuse large B-cell lymphoma ("DLBCL")

Lynozyfic ™ (linvoseltamab)

Relapsed/refractory multiple myeloma

Inmazeb ® (atoltivimab, maftivimab, and odesivimab) Injection

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

ARCALYST ® (rilonacept) Injection (f)

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

Product (continued)

Disease Territory

ARCALYST (rilonacept) Injection (f) (continued)

ARCALYST ® (rilonacept) Injection (f)

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

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Three Months Ended

September 30,

2025 2024 % Change

1 unchanged sentence

ROW Total (Total Sales)

EYLEA HD and EYLEA (a)

$ 306.8 $ 146.4 $ 453.2 $ 200.0 $ 15.2 $ 215.2 111 %

$ 736.0 $ 711.4 $ 1,447.4 $ 1,201.6 $ 834.2 $ 2,035.8 (29 %)

$ 194.5 $ 94.1 $ 288.6 $ 144.1 $ 88.3 $ 232.4 24 %

$ 52.9 $ 138.5 $ 191.4 $ 40.4 $ 125.1 $ 165.5 16 %

$ 72.7 $ 47.4 $ 120.1 $ 52.4 $ 43.3 $ 95.7 25 %

REGEN-COV (e)

$ — $ 1.2 $ 1.2 $ — $ — $ — *

Other products (f)

$ 68.2 $ 23.2 $ 91.4 $ 23.4 $ 15.5 $ 38.9 135 %

Nine Months Ended

September 30,

2024 2023 % Change

(In millions) U.S.

ROW Total (Total Sales)

EYLEA HD and EYLEA (a)

$ 4,473.2 $ 2,688.9 $ 7,162.1 $ 4,424.8 $ 2,605.6 $ 7,030.4 2 %

Total EYLEA HD and EYLEA

$ 1,042.8 $ 857.8 $ 1,900.6 $ 1,401.6 $ 849.4 $ 2,251.0 (16 %)

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$ 56.8 $ 136.5 $ 193.3 $ 70.0 $ 131.3 $ 201.3 (4 %)

REGEN-COV (e)

$ 72.8 $ 43.6 $ 116.4 $ 50.0 $ 44.1 $ 94.1 24 %

Other products (f)

Other products (e)

$ 31.1 $ 23.5 $ 54.6 $ 25.3 $ 18.9 $ 44.2 24 %

* Percentage not meaningful

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

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

Included in this line item for the nine months ended September 30, 2023 is approximately $6 million of first quarter 2023 net product sales recorded by Sanofi in connection with sales in certain markets outside the United States (Sanofi recorded net product sales in such markets during a transition period).

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

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

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

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

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

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

Refer to "Results of Operations - Revenues" below for a complete 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.

net product sales of ARCALYST were $103 million for the second quarter of 2024.

(g) Rest of world ("ROW")

(f) Rest of world ("ROW")

Programs in Clinical Development

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EYLEA HD (aflibercept) 8 mg (a)

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

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

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

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

–Report results from Phase 3 QUASAR study in RVO (fourth quarter 2024) to enable global regulatory submissions

Food and Drug Administration ("FDA") decision on supplemental Biologics License Application ("sBLA") with two-year data for wAMD and DME (first half 2025)

–Pre-filled syringe (U.S.)

–RVO (U.S.) (p)

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

–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

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

–FDA decision on supplemental Biologics License Application ("sBLA") for RVO (target action date of August 19, 2025)

–FDA decision on sBLA for every 4-week dosing regimen (target action date of August 19, 2025)

Pozelimab (f) (REGN3918)

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–Ulcerative colitis

–Eosinophilic gastroenteritis (Phase 2/3)

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

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–Chronic pruritus of unknown origin ("CPUO")

–EoE in pediatrics (1–11 years of age) (EU)

–COPD with type 2 inflammatory phenotype (Japan)

–CSU in adults and adolescents (U.S.

–Approved by FDA for CRSwNP in adolescents

–Approved by FDA for EoE in pediatrics (1–11 years of age)

–EMA's Committee for Medicinal Products for Human Use ("CHMP") adopted positive opinion for EoE in pediatrics (1–11 years of age)

–Results from Phase 3 trial in pediatrics (1–11 years of age) with EoE published in New England Journal of Medicine (" NEJM ")

–EC decision on regulatory submission for EoE in pediatrics (fourth quarter 2024)

–FDA decision on sBLA and EC decision on regulatory submission for CSU in adults and adolescents (first half 2025)

–Submit sBLA for bullous pemphigoid (fourth quarter 2024)

–Lichen simplex chronicus

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

–CSU in adults and adolescents (EU)

–Bullous pemphigoid (U.S.

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

–Approved by FDA for CSU in adults and adolescents

–Resubmitted regulatory application for CSU in adults and adolescents in EU

–European Commission ("EC") decision on regulatory submission for CSU in adults and adolescents (second half 2025)

–FDA decision on sBLA (target action date of June 20, 2025) and EC decision on regulatory submission (first half 2026) for bullous pemphigoid

Clinical Program (continued)

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Dupixent (dupilumab) (b) ( continued)

–Approved by MHLW for CSU in adults and adolescents

–Reported that second Phase 3 trial in CSU in biologic-naïve patients met its primary and key secondary endpoints

–Approved by FDA, EC, and National Medical Products Administration ("NMPA") in China for uncontrolled COPD and an eosinophilic phenotype

–Reported that Phase 3 NOTUS trial in COPD with evidence of type 2 inflammation met its primary and key secondary endpoints;

results presented at 2024 American Thoracic Society International Conference and published in NEJM

–Reported that Phase 3 trial in bullous pemphigoid met its primary and all key secondary endpoints

–Reported that first Phase 3 trial in CPUO did not achieve statistical significance in its primary itch responder endpoint

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

Kevzara (sarilumab) (b)

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

–Approved by FDA for pJIA

–EMA's CHMP adopted positive opinion for PMR

–EC decision on regulatory submission for PMR (fourth quarter 2024)

–EC decision on regulatory submission for pJIA (first half 2025)

Clinical Program (continued)

Phase 2 Phase 3 Regulatory

2024 Events to Date

Select Upcoming

–Approved by EC for pJIA

Itepekimab (b) (REGN3500)

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–Non-cystic fibrosis bronchiectasis ("NCFB")

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

–Chronic rhinosinusitis without nasal polyposis ("CRSsNP")

–Report results from Phase 3 AERIFY-1 and AERIFY-2 trials in COPD (mid-2025)

REGN5713-5715

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–Birch allergy

REGN1908-1909 (f)

Multi-antibody therapy to Fel d 1

Solid Organ Oncology

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–Adjuvant CSCC

–Early-stage CSCC (intralesional)

–First-line NSCLC, monotherapy and chemotherapy combination (Japan)

–Presented positive five-year survival data from Phase 3 NSCLC monotherapy trial at IASLC 2024 World Conference on Lung Cancer

–Conduct interim analysis from Phase 3 study in adjuvant CSCC (fourth quarter 2024)

–Adjuvant CSCC (U.S.

–Reported positive interim data from Phase 3 study in adjuvant CSCC

–MHLW decision on regulatory submission for NSCLC, monotherapy and chemotherapy combination (second half 2025)

–FDA decision on sBLA and EC decision on regulatory submission for adjuvant CSCC

Fianlimab (f) (REGN3767)

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–Perioperative NSCLC

–Perioperative melanoma (Phase 2/3)

–Perioperative melanoma

–First-line metastatic melanoma (e)

–Adjuvant melanoma

–First-line metastatic melanoma versus the combination of relatlimab and nivolumab

–Presented positive two-year data from Phase 1 trial (in combination with Libtayo) in advanced melanoma at European Society for Medical Oncology ("ESMO") Annual Meeting

–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

–Initiate Phase 2 study (in combination with Libtayo) in first-line metastatic head and neck squamous cell carcinoma (2025)

–Report results from Phase 3 study in first-line metastatic melanoma (2025)

–Report initial data from Phase 2/3 study in first-line advanced NSCLC (fourth quarter 2024)

–Report results from Phase 3 study versus pembrolizumab in first-line metastatic melanoma (second half 2025)

Clinical Program (continued)

Phase 2 Phase 3 Regulatory

2025 Events to Date

Select Upcoming

Fianlimab (f) (REGN3767)

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

Immune activator targeting TLR9

–Company discontinued Phase 2 study due to drug supply

Ubamatamab (f) (REGN4018)

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–Platinum-resistant ovarian cancer

–Report additional data from study in platinum-resistant ovarian cancer (second half 2025)

Nezastomig (REGN5678)

Bispecific antibody targeting PSMA and CD28

–Prostate cancer

Clinical Program (continued)

Phase 2 Phase 3 Regulatory

2024 Events to Date

Select Upcoming

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

Bispecific antibody targeting EGFR and CD28

–Solid tumors

–Presented positive results from dose escalation portion of Phase 1/2 trial (in combination with Libtayo) in advanced solid tumors at American Society of Clinical Oncology ("ASCO") 2024 Annual Meeting

–Report additional data from study in solid tumors (second half 2025)

Davutamig (REGN5093)

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–Paroxysmal nocturnal hemoglobinuria ("PNH"), cemdisiran combination (c)(l)

Ordspono (odronextamab) (m)

–Report results from Phase 3 cemdisiran combination study in myasthenia gravis (second half 2025)

Ordspono (odronextamab)

Bispecific antibody targeting CD20 and CD3

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("B-NHL") (pivotal study)

–FDA issued Complete Response Letters ("CRLs") for BLA for relapsed/refractory FL and DLBCL due to enrollment status of confirmatory Phase 3 trials

–Approved by EC for relapsed/refractory FL and DLBCL

Linvoseltamab (f) (REGN5458)

–DLBCL (c)(e)

–FDA decision on BLA for relapsed/refractory FL (target action date of July 30, 2025)

Clinical Program (continued)

Phase 2 Phase 3 Regulatory

2025 Events to Date

Select Upcoming

Lynozyfic (linvoseltamab) (f) (REGN5458)

Bispecific antibody targeting BCMA and CD3

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–Monoclonal gammopathy of undetermined significance ("MGUS")

–Light chain amyloidosis ("ALA")

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

–Multiple myeloma (c)(e)

–Relapsed/refractory multiple myeloma (EU)

–FDA issued CRL for BLA for relapsed/refractory multiple myeloma due to findings resulting from an inspection at third-party fill/finish manufacturer

–FDA and EC decisions on regulatory applications for relapsed/refractory multiple myeloma pending resolution of a third-party fill/finish manufacturing issue

Clinical Program (continued)

Phase 2 Phase 3 Regulatory

2024 Events to Date

Select Upcoming

Linvoseltamab (f) (REGN5458) (continued)

–Presented 14-month median follow-up data from pivotal Phase 1/2 trial in multiple myeloma at European Hematology Association ("EHA") Congress 2024 and published these data in Journal of Clinical Oncology

Nexiguran ziclumeran (NTLA-2001) (j)

–Relapsed/refractory multiple myeloma (U.S.)

–Approved by EC for relapsed/refractory multiple myeloma

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

–FDA decision on BLA for relapsed/refractory multiple myeloma (target action date of July 10, 2025)

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

TTR gene knockout using CRISPR/Cas9

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

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

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

Antibody to Factor XI

–Thrombosis –Report top-line results from Phase 2 study in thrombosis (fourth quarter 2024)

–Initiate Phase 3 program (2025)

Antibody to Factor XI

–Report top-line results from Phase 2 study in thrombosis (fourth quarter 2024)

–Initiate Phase 3 program (2025)

Antibody to IL2Rg

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Antibody to myostatin (GDF8)

–Complete enrollment in Phase 2 study in obesity (fourth quarter 2024)

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

Clinical Program (continued)

Phase 2 Phase 3 Regulatory

2025 Events to Date

Select Upcoming

Mibavademab (f)(o) (REGN4461)

Agonist antibody to leptin receptor ("LEPR")

–Generalized lipodystrophy (d)(e)

–Generalized lipodystrophy (c)(d)(e)

Agonist antibody to NPR1

–Heart failure

–Uncontrolled hypertension

Antagonist antibody to NPR1

–Postural orthostatic tachycardia syndrome ("POTS")

–Sepsis-induced hypotension

Rapirosiran (ALN-HSD) (k)

1 unchanged sentence

–Metabolic dysfunction-associated steatohepatitis ("MASH")

AAV-based gene therapy

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

–Presented updated data from Phase 1/2 trial at Association for Research in Otolaryngology’s Annual MidWinter Meeting

–Report additional data from Phase 1/2 study (mid-2025)

For purposes of the table above, a program is classified in Phase 2 or 3 clinical development after recruitment for the corresponding study or studies has commenced

7 unchanged sentences

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

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

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

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

3 unchanged sentences

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

(m) FDA granted Fast Track designation for follicular lymphoma and diffuse large B-cell lymphoma

(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) Used priority review voucher in connection with this regulatory review

Additional Information - Clinical Development Programs

Linvoseltamab

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

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

Resolution of this issue will be required for both FDA and EC regulatory approvals.

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

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

Study B is planned to initiate as a subsequent pivotal trial.

Early-Stage Clinical Development Updates

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

A Phase 1/2 study of DB-OTO, an AAV-based gene therapy, in children with profound genetic hearing loss due to mutations of the otoferlin gene is ongoing.

In May 2024, we presented updated data from the Phase 1/2 trial at the American Society of Gene and Cell Therapy ("ASGCT") annual conference and announced that DB-OTO improved hearing to normal levels in one child and that initial hearing improvements were observed in a second child.

Additionally, the FDA granted DB-OTO Regenerative Medicine Advanced Therapy ("RMAT") designation.

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

On April 18, 2025, the FDA issued a CRL regarding the sBLA for the addition of extended dosing intervals.

The FDA indicated that the submitted data did not support extended dosing intervals greater than every 16 weeks.

The Company is evaluating the FDA's decision.

The FDA issued a CRL for the EYLEA HD pre-filled syringe on April 23, 2025.

The Company held several teleconferences with the FDA to better understand the contents of the CRL, and believes the key outstanding issue relates to a question posed by the FDA to a third-party component supplier.

This component supplier has expeditiously responded to FDA requests for information.

The CRL did not identify any issues with the safety or efficacy of EYLEA HD, the usability of the device, proposed labelling, or pre-approval inspection findings.

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 quarter 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.

Collaboration, License, and Other Agreements

1 unchanged sentence

Under the terms of the Antibody Collaboration, Sanofi is generally responsible for funding 80% to 100% of agreed-upon development costs.

We are obligated to reimburse Sanofi for 30% to 50% of worldwide development expenses that were funded by Sanofi based on our share of collaboration profits;

We are 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, 2024, the total amount of our contingent reimbursement obligation to Sanofi (i.e., "development balance") in connection with such development expenses was approximately $1.810 billion.

As of March 31, 2025, the total amount of our contingent reimbursement obligation to Sanofi (i.e., "development balance") in connection with such development expenses was approximately $1.453 billion.

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

9 unchanged sentences

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 ("CNS"), in addition to a select number of targets expressed in the liver.

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.

During the second quarter of 2024, we elected to no longer co-develop ALN-APP pursuant to a co-development/co-commercialization collaboration agreement;

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

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

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

Following designation of a lead candidate, the parties may further advance such lead candidate under either a co-development and co-commercialization agreement or a license agreement.

The initial target nomination and discovery period of five years has been automatically extended until the earlier of seven years from the effective date of the collaboration or the achievement of certain

milestones (the "Research Term").

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

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

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.

NTLA-2001, which is in clinical development, is subject to a co-development and co-commercialization arrangement pursuant to which Intellia will lead development and commercialization activities and the parties share an agreed-upon percentage of development expenses and profits (if commercialized).

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

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

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

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

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

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

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

as a result, we retain the right to develop and commercialize products directed to Factor IX, and Intellia will be entitled to receive milestone payments and royalties on sales (if any).

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

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

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

In addition, Decibel shareholders received one non-tradeable contingent value right ("CVR") per share of Decibel common stock, entitling them to receive up to an additional $3.50 per share in cash upon achievement of certain development milestones for DB-OTO within specified time periods.

During the third quarter of 2024, a development milestone contemplated by the CVRs was achieved, and, as a result, we paid $55.1 million to the holders of the CVRs.

The holders of the CVRs will be entitled to receive an additional $42.0 million if an additional milestone contemplated by the CVRs is achieved.

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

(which subsequently spun out 2seventy bio, Inc.

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

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

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

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

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

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

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

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

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

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.

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 EYLEA HD, EYLEA, and Dupixent.

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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.

We cannot predict 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.

Corporate Information

We were incorporated in the State of New York in 1988 and publicly listed in 1991.

Our principal executive offices are located at 777 Old Saw Mill River Road, Tarrytown, New York 10591, and our telephone number at that address is (914) 847-7000.

We make available free of charge on or through our Internet website ( http://www.regeneron.com ) our Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, and, if applicable, amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), as soon as reasonably practicable after we electronically file such material with, or furnish it to, the Securities and Exchange Commission ("SEC").

Investors and other interested parties should note that we use our media and investor relations website ( http://investor.regeneron.com ) and our social media channels to publish important information about Regeneron, including information that may be deemed material to investors.

We encourage investors and other interested parties to review the information we may publish through our media and investor relations website and the social media channels listed on our media and investor relations website, in addition to our SEC filings, press releases, conference calls, and webcasts.

The information contained on our websites and social media channels is not included as a part of, or incorporated by reference into, this report.

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

Three Months Ended

September 30,

Nine Months Ended

September 30,

(In millions, except per share data) 2025 2024

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Income before income taxes 905.0 700.7

Income tax expense

152.4 103.0 326.9 257.7

Income tax expense (benefit)

Net income $ 808.7 $ 722.0

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Three Months Ended

September 30,

Nine Months Ended

September 30,

(In millions) 2024 2023 $ Change 2024 2023 $ Change

(In millions) 2025 2024 $ Change

Net product sales:

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30.9 24.8 6.1

Inmazeb - Global

35.6 3.3 32.3 36.6 7.7 28.9

Inmazeb - ROW

Total net product sales $ 1,415.6 $ 1,761.3 $ (345.7)

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Bayer 343.9 356.0 (12.1)

Roche 0.5 (5.7) 6.2 1.4 212.7 (211.3)

Other 4.1 1.0 3.1

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Net Product Sales

Total EYLEA HD and EYLEA net product sales in the U.S.

increased for the three and nine months ended September 30, 2024 compared to the same periods in 2023.

EYLEA HD was approved by the FDA in August 2023 and net product sales for the three and nine months ended September 30, 2024 were driven by the transition of patients from other anti-VEGF products, including EYLEA, as well as new patients naïve to anti-VEGF therapy.

Net product sales of EYLEA for the three and nine months ended September 30, 2024 were adversely impacted by a lower net selling price compared to the same periods in 2023.

In addition, for the three months ended September 30, 2024 total EYLEA HD and EYLEA net product sales were favorably impacted by approximately $40 million as a result of higher wholesaler inventory levels for EYLEA HD at the end of the third quarter of 2024 compared to the end of the second quarter of 2024, partially offset by lower wholesaler inventory levels for EYLEA.

Net product sales of EYLEA HD increased for the three months ended March 31, 2025, compared to the same period in 2024, primarily due to higher sales volumes.

Net product sales of EYLEA for the three months ended March 31, 2025, compared to the same period in 2024, were negatively impacted by (i) lower volume 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.

In addition, total EYLEA and EYLEA HD net product sales were negatively impacted by lower wholesaler inventory levels at the end of the first quarter of 2025 compared to the end of the fourth quarter of 2024.

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 I, 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

1 unchanged sentence

Three Months Ended

September 30,

Nine Months Ended

September 30,

(In millions) 2025 2024

1 unchanged sentence

$ 1,018.2 $ 804.0

Sales-based milestones earned

— 50.0 — 50.0

Reimbursement for manufacturing of commercial supplies (a)

175.1 151.5 438.2 506.0

Total Sanofi collaboration revenue $ 1,183.2 $ 909.8

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

(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.

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Three Months Ended

September 30,

Nine Months Ended

September 30,

(In millions) 2025 2024

2 unchanged sentences

$ 1,180.3 $ 925.9

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

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

(162.1) (121.9)

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

28% 27% 27% 26%

The increase in our share of profits for the three and nine months ended September 30, 2024, compared to the same periods in 2023, was driven by higher profits associated with Dupixent sales.

During the three months ended September 30, 2023, the Company earned the final $50.0 million sales-based milestone from Sanofi upon aggregate annual sales of antibodies outside the United States exceeding $3.0 billion on a rolling twelve-month basis.

(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 months ended March 31, 2025, compared to the same period in 2024, was driven by higher profits associated with Dupixent sales.

Bayer Collaboration Revenue

Three Months Ended

September 30,

Nine Months Ended

September 30,

(In millions) 2025 2024

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$ 317.3 $ 333.9

Reimbursement for manufacturing of ex-U.S.

commercial supplies (a)

23.2 27.2 67.4 79.7

Reimbursement for manufacturing of commercial supplies (a)

Total Bayer collaboration revenue $ 343.9 $ 356.0

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

(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.

1 unchanged sentence

Three Months Ended

September 30,

Nine Months Ended

September 30,

(In millions) 2025 2024

3 unchanged sentences

$ 333.6 $ 350.5

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

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

(16.3) (16.6)

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

39% 40% 39% 40%

Roche Collaboration Revenue

Three Months Ended

September 30,

Nine Months Ended

September 30,

(In millions)

2024 2023 2024 2023

Global gross profits earned in connection with sales of Ronapreve

$ 0.5 $ — $ 1.4 $ 222.2

— (5.7) — (9.5)

Total Roche collaboration revenue

$ 0.5 $ (5.7) $ 1.4 $ 212.7

Roche distributes and records net product sales of Ronapreve outside the United States, and the parties share gross profits from sales.

Net product sales of Ronapreve outside the United States declined as a result of new variants of the SARS-CoV-2 virus emerging that are not susceptible to the treatment.

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

Other Revenue

Other revenue decreased for the three months ended March 31, 2025, compared to the same period in 2024, primarily due to lower reimbursements for manufacturing commercial supplies as a result of timing of shipments, partially offset by higher royalties and share of profits earned in connection with license agreements.

Other revenue for the three months ended March 31, 2025 and 2024 included $69.9 million and $47.4 million, respectively, of royalties and share of profits earned in connection with license agreements.

Operating Expenses

Three Months Ended

September 30,

Nine Months Ended

September 30,

(In millions, except headcount data) 2024 2023 Change 2024 2023 Change

(In millions, except headcount data) 2025 2024 Change

Research and development (a)

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

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

Operating expenses included stock-based compensation of $225.1 million and $203.9 million for the three months ended September 30, 2024 and 2023, respectively, and $678.4 million and $644.6 million for the nine months ended September 30, 2024 and 2023, respectively.

Stock-based compensation expense relates to equity awards granted under our long-term incentive plans.

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

Operating expenses for the three months ended March 31, 2025 and 2024 included $255.7 million and $230.1 million, respectively, of stock-based compensation expense related to equity awards granted under our long-term incentive plans.

Research and Development Expenses

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Three Months Ended

September 30,

Nine Months Ended

September 30,

(In millions) 2025 2024 *

$ Change 2024 2023 *

Direct research and development expenses:

Fianlimab $ 51.5 $ 64.0 $ (12.5)

Ordspono (odronextamab)

Lynozyfic (linvoseltamab)

31.7 63.3 (31.6)

Dupixent (dupilumab) 31.3 32.7 (1.4) 96.4 132.0 (35.6)

EYLEA HD (aflibercept) 8 mg

30.3 21.9 8.4

Linvoseltamab 25.4 23.3 2.1 111.8 64.3 47.5

28.3 19.3 9.0

Ordspono (odronextamab)

26.2 26.1 0.1

Dupixent (dupilumab) 25.5 36.3 (10.8)

Libtayo (cemiplimab) 20.8 22.6 (1.8)

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

Research and development expenses included stock-based compensation expense of $123.7 million and $107.4 million for the three months ended September 30, 2024 and 2023, respectively, and $369.1 million and $356.0 million for the nine months ended September 30, 2024 and 2023, respectively.

Research and development expenses included stock-based compensation expense of $141.0 million and $123.0 million for the three months ended March 31, 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.

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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")

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

Acquired IPR&D for the three and nine months ended September 30, 2023 included a $100.0 million development milestone in connection with our collaboration agreement with Alnylam Pharmaceuticals, Inc.

The nine months ended September 30, 2023 also included a $45.0 million up-front payment in connection with our collaboration agreement with Sonoma.

Selling, General, and Administrative Expenses

Selling, general, and administrative expenses increased for the three and nine months ended September 30, 2024, compared to the same periods in 2023, due to higher commercialization-related expenses to support our launch of EYLEA HD and higher headcount and headcount-related costs partly related to our international commercial expansion.

Selling, general, and administrative expenses also included stock-based compensation expense of $83.1 million and $74.4 million for the three months ended September 30, 2024 and 2023, respectively, and $251.9 million and $224.5 million for the nine months ended September 30, 2024 and 2023, respectively.

Selling, general, and administrative expenses decreased for the three months ended March 31, 2025, compared to the same period in 2024, due to lower charitable contributions to an independent not-for-profit patient assistance organization and lower costs associated with the estimated amount payable for the Branded Prescription Drug Fee.

Selling, general, and administrative expenses also included stock-based compensation expense of $95.2 million and $86.2 million for the three months ended March 31, 2025 and 2024, respectively.

Cost of Goods Sold

Cost of goods sold increased for the three and nine months ended September 30, 2024, compared to the same periods in 2023, primarily due to higher start-up costs for our Rensselaer, New York fill/finish facility.

Three Months Ended

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

Cost of goods sold

$ 265.5 $ 240.4

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.

Gross margin on net product sales decreased for the three months ended March 31, 2025, compared to the same period in 2024, primarily due to higher inventory write-offs and reserves.

Other Operating Expense (Income)

Other operating expense (income), net, reflected charges of $8.0 million and $37.9 million for the three and nine months ended September 30, 2024, respectively, 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 operating expense (income), net, for the three months ended March 31, 2024 reflected a charge of $15.3 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)

Other income (expense) consists of the following:

Three Months Ended

September 30,

Nine Months Ended

September 30,

(In millions) 2025 2024

Unrealized gains (losses) on equity securities, net $ 139.7 $ (196.2)

$ 134.5 $ (100.3) $ 330.8 $ (295.9)

Interest income 173.5 161.5

4 unchanged sentences

Three Months Ended

September 30,

Nine Months Ended

September 30,

(In millions, except effective tax rate) 2025 2024

Income tax expense $ 152.4 $ 103.0 $ 326.9 $ 257.7

Income tax expense (benefit)

$ 96.3 $ (21.3)

Effective tax rate

10.6 % (3.0 %)

Our effective tax rate for the three and nine months ended September 30, 2024 was positively impacted, compared to the U.S.

Our effective tax rate for the three months ended March 31, 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 stock-based compensation.

Our effective tax rate for the nine months ended September 30, 2024 was negatively impacted by the remeasurement of existing uncertain tax positions.

Certain countries in which we have operations, including Ireland, have adopted legislation influenced by the Organization for Economic Co-operation and Development ("OECD") Global Anti-Base Erosion Model Rules ("Pillar Two") framework, including a minimum tax rate of 15%.

The adoption of the Pillar Two framework did not have a material impact on our effective tax rate for the three and nine months ended September 30, 2024.

It is uncertain whether the United States will enact legislation to adopt the Pillar Two framework.

We continue to evaluate additional guidance released by the OECD, along with the pending legislative adoption by additional individual countries.

federal statutory rate and federal tax credits for research activities.

Our effective tax rate increased for the three months ended March 31, 2025, compared to the same period in 2024, due to lower tax benefits from less stock option exercises.

Our 2017 and 2018 federal income tax returns are currently under audit by the IRS, and we expect to be effectively settled with the IRS during the second quarter of 2025.

The unrecognized tax benefits for the years under examination exceed the expected payment amount;

therefore, we expect to recognize a net tax benefit upon conclusion of such examinations.

Liquidity and Capital Resources

Our financial condition is summarized as follows:

September 30, December 31,

March 31, December 31,

(In millions) 2025 2024 $ Change

11 unchanged sentences

Finance lease liabilities $ 720.0 $ 720.0 $ —

As of September 30, 2024, 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, 2024 and 2023

Nine Months Ended

September 30,

As of March 31, 2025, we also had borrowing availability of $750.0 million under a revolving credit facility.

Sources and Uses of Cash for the Three Months Ended March 31, 2025 and 2024

Three Months Ended

(In millions) 2025 2024 $ Change

Cash flows provided by operating activities $ 1,045.1 $ 1,512.5 $ (467.4)

Cash flows used in investing activities $ (2,818.7) $ (3,118.9) $ 300.2

Cash flows used in financing activities $ (1,065.0) $ (1,344.0) $ 279.0

Cash flows provided by (used in) investing activities

$ 647.5 $ (1,687.1) $ 2,334.6

Cash flows (used in) provided by financing activities

$ (1,089.2) $ 47.1 $ (1,136.3)

Cash Flows from Investing Activities

Capital expenditures for the nine months ended September 30, 2024 included costs incurred in connection with the expansion of our research, preclinical manufacturing, and support facilities at our Tarrytown, New York location, as well as costs associated

with the expansion of our manufacturing facilities in Rensselaer, New York (including the fill/finish facility).

In addition, in September 2024, we acquired a 1,100,000 square foot facility in Saratoga Springs, New York.

We expect to incur capital expenditures of $700 million to $740 million for the full year of 2024 primarily in connection with the continued expansion of our facilities in Tarrytown and Rensselaer (including the fill/finish facility).

Payments for the Libtayo intangible asset of $58.3 million and $145.7 million for the nine months ended September 30, 2024 and 2023, respectively, were related to contingent consideration in connection with our acquisition of the exclusive right to develop, commercialize, and manufacture Libtayo worldwide.

Capital expenditures for the three months ended March 31, 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 $950 million for the full year of 2025, including in connection with the continued expansion of our facilities in Tarrytown, New York.

Cash Flows from Financing Activities

Proceeds from issuances of Common Stock, in connection with exercises of employee stock options, were $1.374 billion for the nine months ended September 30, 2024, compared to $844.5 million for the nine months ended September 30, 2023.

In addition, payments in connection with Common Stock tendered for employee tax obligations were $775.7 million for the nine months ended September 30, 2024, compared to $242.5 million for the nine months ended September 30, 2023.

For information related to repurchases of Common Stock, see " Share Repurchase Programs " section below.

Share Repurchase Programs

In January 2023, our board of directors authorized a share repurchase program to repurchase up to $3.0 billion of our Common Stock.

As of September 30, 2024, the Company had repurchased the entire $3.0 billion of its Common Stock it was authorized to repurchase under the program.

In April 2024, our board of directors authorized a share repurchase program to repurchase up to an additional $3.0 billion of our Common Stock.

The share repurchase program permits the Company to make repurchases through a variety of methods, including open-market transactions (including pursuant to a trading plan adopted in accordance with Rule 10b5-1 of the Exchange Act), privately negotiated transactions, accelerated share repurchases, block trades, and other transactions in compliance with Rule 10b-18 of the Exchange Act.

Repurchases may be made from time to time at management's discretion, and the timing and amount of any such repurchases will be determined based on share price, market conditions, legal requirements, and other relevant factors.

The program has no time limit and can be discontinued at any time.

There can be no assurance as to the timing or number of shares of any repurchases in the future.

The table below summarizes the shares of our Common Stock that we repurchased and the cost of such shares, which were recorded as Treasury Stock.

Nine Months Ended

September 30,

(In millions) 2024 2023

Number of shares 1.5 2.6

Total cost of shares $ 1,637.7 $ 1,923.8

As of September 30, 2024, $2.893 billion remained available for share repurchases under the April 2024 program.

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 March 31, 2025, an aggregate of $3.874 billion remained available for share repurchases under the programs.

In February 2025, our board of directors declared our first quarterly cash dividend.

In March 2025, we paid a dividend of $0.88 per share on our Common Stock and Class A Stock to our shareholders.

Additionally, in April 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 June 6, 2025 to shareholders of record as of May 20, 2025.

Critical Accounting Estimates

1 unchanged sentence

"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, 2024.

There have been no material changes to critical accounting estimates during the three months ended March 31, 2025.

Future Impact of Recently Issued Accounting Standards

See Note 1 to our Condensed Consolidated Financial Statements for a summary 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.

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

What changed 10-Q

Item 2. Management’s Discussion and Analysis