What changed in this filing

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Item 1. Business

2025-02-05 compared with 2024-02-05 · 395 added, 478 removed, 718 unchanged (55% of the section changed)

6 unchanged sentences

• 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 our late-stage product candidates and new indications for Regeneron's Products, including without limitation those discussed or referenced in this report;

• 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;

1 unchanged sentence

• 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;

• 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;

3 unchanged sentences

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

• unanticipated expenses;

• the costs of developing, producing, and selling products;

• 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 (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 16 to our 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 16 to our Consolidated Financial Statements included in this report), the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on our business, prospects, operating results, and financial condition.

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

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

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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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Net income per share - diluted $ 38.34 $ 34.77 $ 38.22

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.

17 unchanged sentences

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

Chronic rhinosinusitis with nasal polyposis ("CRSwNP") a a a

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

EoE (in pediatrics 1–11 years of age)

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

CRSwNP (in adolescents)

Chronic obstructive pulmonary disease ("COPD")

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

Prurigo nodularis a a a

Libtayo ® (cemiplimab) Injection (c)

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

Libtayo ® (cemiplimab) Injection

Metastatic or locally advanced first-line non-small cell lung cancer ("NSCLC")

3 unchanged sentences

Metastatic or recurrent second-line cervical cancer

Praluent ® (alirocumab) Injection (d)

Praluent ® (alirocumab) Injection (c)

LDL-lowering in heterozygous familial hypercholesterolemia ("HeFH") or clinical atherosclerotic cardiovascular disease ("ASCVD") a a

2 unchanged sentences

Homozygous familial hypercholesterolemia ("HoFH") a

REGEN-COV ®(e)

Kevzara ® (sarilumab) Injection (b)

1 unchanged sentence

Polymyalgia rheumatica ("PMR")

Evkeeza ® (evinacumab) Injection (f)

HoFH (in adults, adolescents, and pediatrics aged 5 years and older)

Polyarticular juvenile idiopathic arthritis ("pJIA")

REGEN-COV ®(d)

Evkeeza ® (evinacumab) Injection (e)

HoFH (in adults, adolescents, and pediatrics)

Ordspono ™ (odronextamab)

Follicular lymphoma ("FL")

Diffuse large B-cell lymphoma ("DLBCL")

Inmazeb ® (atoltivimab, maftivimab, and odesivimab) Injection

2 unchanged sentences

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

ARCALYST ® (rilonacept) Injection (g)

Product (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)

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

Recurrent pericarditis (in adults and adolescents)

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

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

Metastatic colorectal cancer ("mCRC") a a a

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(b) In collaboration with Sanofi

Effective July 2022, the Company is solely responsible for the development, commercialization, and manufacturing of Libtayo.

Refer to "Collaboration, License, and Other Agreements" section below for further details.

(d) The Company is solely 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.

(e) In collaboration with Roche.

(c) The Company is solely 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) In collaboration with Roche.

Product is known as REGEN-COV in the United States and Ronapreve ™ in other countries.

(f) The Company is solely 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.

(g) Kiniksa is solely responsible for the development and commercialization of ARCALYST.

(h) Sanofi is solely responsible for the development and commercialization of ZALTRAP.

Net product sales of Regeneron-discovered products consist of the following:

(e) The Company is solely 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.

(f) Kiniksa is solely responsible for the development and commercialization of ARCALYST.

(g) Sanofi is solely 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.

Year Ended December 31,

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ROW Total U.S.

EYLEA HD and EYLEA (a)

$ 5,968.2 $ 3,576.8 $ 9,545.0 $ 5,885.4 $ 3,495.2 $ 9,380.6 $ 6,264.6 $ 3,382.8 $ 9,647.4

$ 10,398.7 $ 3,749.3 $ 14,148.0 $ 8,855.6 $ 2,732.5 $ 11,588.1 $ 6,668.0 $ 2,013.2 $ 8,681.2

Total EYLEA HD and EYLEA $ 5,885.4 $ 3,495.2 $ 9,380.6 $ 6,264.6 $ 3,382.8 $ 9,647.4 $ 5,792.3 $ 3,450.9 $ 9,243.2

$ 787.3 $ 429.5 $ 1,216.8 $ 538.8 $ 330.0 $ 868.8 $ 374.5 $ 203.5 $ 578.0

3 unchanged sentences

$ — $ 3.5 $ 3.5 $ — $ 618.8 $ 618.8 $ — $ 1,769.6 $ 1,769.6

$ 214.7 $ 171.2 $ 385.9 $ 199.7 $ 158.3 $ 358.0 $ 161.9 $ 176.1 $ 338.0

Other products (f)

$ 202.9 $ 86.5 $ 289.4 $ 150.5 $ 67.4 $ 217.9 $ 56.1 $ 69.1 $ 125.2

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

The Company records its share of profits in connection with sales outside the United States.

(b) Sanofi records global net product sales of Dupixent and Kevzara.

The Company records its share of profits in connection with global sales of Dupixent and Kevzara.

(c) Prior to July 1, 2022, Regeneron recorded net product sales of Libtayo in the United States and Sanofi recorded net product sales of Libtayo outside the United States.

The parties equally shared profits/losses in connection with global sales of Libtayo.

Effective July 1, 2022, the Company began recording net product sales of Libtayo outside the United States and pays Sanofi a royalty on global sales.

Refer to "Collaboration, License, and Other Agreements" section below for further details.

Included in this line item for the years ended December 31, 2023 and 2022 is approximately $6 million and $34 million, respectively, of 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 until inventory on hand as of July 1, 2022 had been sold through to the end customers).

(d) Regeneron records net product sales of Praluent in the United States.

Sanofi records net product sales of Praluent outside the United States and pays the Company a royalty on such sales.

(e) Regeneron records net product sales of REGEN-COV in the United States and Roche records net product sales of Ronapreve outside the United States.

The parties share gross profits from global sales of REGEN-COV and Ronapreve based on a pre-specified formula.

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

(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 Part II, Item 7.

"Management's Discussion and Analysis of Financial Condition and Results of Operations - Results of Operations - Revenues" for a complete listing of net product sales recorded by the Company.

Not included in this line item are net product sales of ARCALYST subsequent to the first quarter of 2021, which are recorded by Kiniksa.

"Management's Discussion and Analysis of Financial Condition and Results of Operations - Results of Operations - Revenues - Bayer Collaboration Revenue" 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 Part II, Item 7.

"Management's Discussion and Analysis of Financial Condition and Results of Operations - Results of Operations - Revenues - Sanofi Collaboration Revenue" for such amounts.

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

(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 Part II, Item 7.

"Management's Discussion and Analysis of Financial Condition and Results of Operations -Results of Operations - Revenues - Roche Collaboration Revenue" for such amounts.

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

Refer to Part II, Item 7.

"Management's Discussion and Analysis of Financial Condition and Results of Operations - Results of Operations - Revenues" 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.

(g) Rest of world ("ROW")

Programs in Clinical Development

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

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.

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Any of such risks and uncertainties may, among other matters, negatively impact the development timelines set forth in the table below.

Clinical Program Phase 1 Phase 2 Phase 3 Regulatory Review (h)

Clinical Program Phase 2 Phase 3 Regulatory

2024 and 2025

Events to Date

Select Upcoming Milestones

Select Upcoming

Ophthalmology

EYLEA HD (aflibercept) 8 mg (a)

–Approved by U.S.

Food and Drug Administration ("FDA") for wAMD, DME, and DR

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

–Pre-filled syringe (U.S.)

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

–Reported positive two-year data from Phase 3 studies in wAMD and DME

–Initiate Phase 3 study in RVO (mid-2024) to enable FDA submission

EYLEA (aflibercept) (a)

–Approved by FDA for ROP

–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

–Reported that Phase 3 QUASAR trial in RVO met its primary endpoint

Food and Drug Administration ("FDA") decision on supplemental Biologics License Application ("sBLA") with two-year data for wAMD and DME (target action date of April 20, 2025)

–FDA decision for pre-filled syringe (mid-2025)

–Submit sBLA for RVO (first quarter 2025)

–Submit sBLA for every 4-week dosing regimen (first quarter 2025)

Pozelimab (f) (REGN3918)

Antibody to C5

–Initiate Phase 3 study in combination with cemdisiran in geographic atrophy (second half 2024)

–Geographic atrophy, cemdisiran combination (l)

Immunology & Inflammation

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–Ulcerative colitis

–Eosinophilic gastroenteritis (Phase 2/3)

–Chronic obstructive pulmonary disease

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

–Bullous pemphigoid (c)

–Chronic spontaneous urticaria ("CSU")

–Chronic pruritus of unknown origin

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

–COPD with type 2 inflammatory phenotype (U.S.

–CSU in adults and adolescents (Japan)

–Approved by EC for atopic dermatitis in pediatrics (6 months–5 years of age)

–Approved by MHLW for atopic dermatitis in pediatrics and adolescents (6 months–14 years of age)

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

–Approved by EC for EoE in adults and adolescents

–Approved by MHLW for prurigo nodularis

–EC decision on regulatory submission for EoE in pediatrics (second half 2024)

–FDA decision on supplemental Biologics License Application ("sBLA") (mid/second half 2024) and EC decision on regulatory submission (second half 2024) for COPD with type 2 inflammatory phenotype

–Chronic pruritus of unknown origin ("CPUO")

–Lichen simplex chronicus

–COPD with type 2 inflammatory phenotype (Japan)

–CSU in adults and adolescents (U.S.

–Bullous pemphigoid (U.S.)

–Approved by FDA for CRSwNP in adolescents

–Approved by FDA and EC 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 ")

–MHLW decision on regulatory submission for COPD (first half 2025)

–FDA decision on sBLA (target action date of April 18, 2025) and EC decision on regulatory submission (first half 2025) for CSU in adults and adolescents

–FDA decision on sBLA for bullous pemphigoid (second half 2025)

–Submit regulatory application in the EU for bullous pemphigoid (first half 2025)

Clinical Program (continued)

Phase 1 Phase 2 Phase 3 Regulatory Review (h)

Phase 2 Phase 3 Regulatory

2024 and 2025

Events to Date

Select Upcoming Milestones

Dupixent (dupilumab) (b)

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

presented at 2023 American Thoracic Society International Conference and published in New England Journal of Medicine

–Reported that results from interim analysis of replicate Phase 3 NOTUS trial in COPD with evidence of type 2 inflammation met its primary endpoint

–FDA issued Complete Response Letter ("CRL") for sBLA for CSU due to requirement for additional efficacy data

–Phase 3 trial in chronic cold induced urticaria did not meet its required efficacy endpoints

–Discontinued further clinical development in allergic fungal rhinosinusitis and chronic rhinosinusitis without nasal polyposis

–MHLW decision on regulatory submission for CSU in adults and adolescents (first half 2024)

–Report results from ongoing Phase 3 trial in CSU (in biologic-naïve patients) (fourth quarter 2024)

–Report results from Phase 3 trial in bullous pemphigoid (second half 2024)

–Initiate Phase 1 study in severe food allergy following transient linvoseltamab treatment (2024)

Select Upcoming

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

Kevzara (sarilumab) (b)

Antibody to IL-6R

–Polyarticular-course juvenile idiopathic arthritis ("pcJIA") (pivotal study)

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

–Approved by FDA for PMR

–EC decision on regulatory submission for PMR (second half 2024)

–FDA decision on sBLA (target action date of June 10, 2024) and EC decision (second half 2024) on regulatory submission for pcJIA

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

–Approved by FDA and EC for pJIA

–Approved by EC for PMR

Clinical Program (continued)

Phase 1 Phase 2 Phase 3 Regulatory Review (h)

Phase 2 Phase 3 Regulatory

2024 and 2025

Events to Date

Select Upcoming Milestones

Select Upcoming

Itepekimab (b) (REGN3500)

Antibody to IL-33

–Phase 3 COPD program passed interim futility analysis conducted by Independent Data Monitoring Committee ("IDMC")

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

–Non-cystic fibrosis bronchiectasis ("NCFB")

–Chronic rhinosinusitis without nasal polyposis ("CRSsNP")

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

–Initiate additional Phase 3 studies (first half 2025)

REGN5713-5715

1 unchanged sentence

–Birch allergy

REGN1908-1909 (f)

Multi-antibody therapy to Fel d 1

Solid Organ Oncology

2 unchanged sentences

–Neoadjuvant CSCC

–First-line NSCLC, BNT116 (r) combination

–First-line NSCLC, BNT116 (i) combination

–Neoadjuvant NSCLC

–Neoadjuvant hepatocellular carcinoma ("HCC")

–Adjuvant CSCC

–Approved by EC for first-line NSCLC, chemotherapy combination

–Conduct interim analysis from Phase 3 study in adjuvant CSCC (second half 2024)

–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

–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)

–Submit sBLA for adjuvant CSCC (first half 2025)

Fianlimab (f) (REGN3767)

Antibody to LAG-3

–Solid tumors and advanced hematologic malignancies –First-line advanced NSCLC (Phase 2/3) (pivotal study)

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

–Perioperative NSCLC

–Perioperative melanoma

–First-line metastatic melanoma (e)

–First-line adjuvant melanoma

–Presented positive data from Phase 1 trial (in combination with Libtayo) in advanced melanoma at 2023 American Society of Clinical Oncology ("ASCO") Annual Meeting

–Initiate potentially pivotal Phase 2 study (in combination with Libtayo) in perioperative melanoma (first half 2024)

–Initiate Phase 2 study (in combination with Libtayo) in perioperative NSCLC (first half 2024)

–Initiate Phase 2 study (in combination with Libtayo) in perioperative head and neck squamous cell carcinoma (2024)

–Report potentially pivotal initial results from Phase 2/3 study in first-line metastatic melanoma (second half 2024)

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

–Adjuvant melanoma

–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

–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 versus pembrolizumab in first-line metastatic melanoma (second half 2025)

–Report initial data from Phase 2/3 study in first-line advanced NSCLC (first half 2025)

Immune activator targeting TLR9

–Solid tumors

Clinical Program (continued)

Phase 1 Phase 2 Phase 3 Regulatory Review (h)

2023 and 2024

Events to Date

Select Upcoming Milestones

–Company discontinued Phase 2 study due to drug supply

Ubamatamab (f) (REGN4018)

Bispecific antibody targeting MUC16 and CD3

–Platinum-resistant ovarian cancer –Presented results from Phase 1/2 study (in combination with Libtayo) in platinum-resistant ovarian cancer at European Society for Medical Oncology ("ESMO") Congress

Bispecific antibody targeting MUC16 and CD28

–Platinum-resistant ovarian cancer

Bispecific antibody targeting PSMA and CD28

–Prostate cancer –Discontinued enrollment in cohorts in combination with full-dose Libtayo (cemiplimab)

–Expanded enrollment in monotherapy cohort

–Initiate cohorts in combination with REGN4336 in metastatic castration-resistant prostate cancer (first half 2024)

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

Clinical Program (continued)

Phase 2 Phase 3 Regulatory

2024 and 2025

Events to Date

Select Upcoming

Nezastomig (REGN5678)

Bispecific antibody targeting PSMA and CD28

–Prostate cancer

–Report additional data from study in prostate cancer (2025)

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 (2025)

Davutamig (REGN5093)

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–MET-altered advanced NSCLC

REGN5093-M114

Bispecific antibody-drug conjugate targeting two distinct MET epitopes

–MET overexpressing advanced cancer

Antibody to GITR

–Solid tumors

Bispecific antibody targeting EGFR and CD28

–Solid tumors –Initiate dose-expansion cohorts (in combination with Libtayo) in EGFR-high tumors (first half 2024)

Clinical Program (continued)

Phase 1 Phase 2 Phase 3 Regulatory Review (h)

2023 and 2024

Events to Date

Select Upcoming Milestones

Pozelimab (f) (REGN3918)

Antibody to C5

–Myasthenia gravis, cemdisiran combination (c)(s)

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

–Veopoz (pozelimab) approved by FDA for CHAPLE in adults and children aged 1 year and older, monotherapy

Odronextamab (m) (REGN1979)

–Myasthenia gravis, cemdisiran combination (c)(l)

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

–Presented positive updated data from Phase 3 trial (in combination with cemdisiran) in PNH at American Society of Hematology ("ASH") Annual Meeting

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

Ordspono (odronextamab)

Bispecific antibody targeting CD20 and CD3

–Certain B-cell malignancies (c)

–B-cell non-Hodgkin lymphoma

("B-NHL") (pivotal study)

–Follicular lymphoma ("FL")

–Diffuse large B-cell lymphoma ("DLBCL")

–Relapsed/refractory FL and DLBCL (U.S.

–Presented updated data from trials in patients with relapsed/refractory FL and DLBCL at American Society of Hematology ("ASH") Annual Meeting

–FDA decision on BLA (target action date of March 31, 2024) and EC decision on regulatory submission (second half 2024) for relapsed/refractory FL and DLBCL

Bispecific antibody targeting CD22 and CD28

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

subsequently resubmitted BLA for FL

–Approved by EC for relapsed/refractory FL and DLBCL

–Presented new and updated data for several B-NHL subtypes across earlier lines of treatment at ASH Annual Meeting

–FDA decision on BLA for relapsed/refractory FL (second half 2025)

Clinical Program (continued)

Phase 2 Phase 3 Regulatory

2024 and 2025

Events to Date

Select Upcoming

Linvoseltamab (f) (REGN5458)

Bispecific antibody targeting BCMA and CD3

–Multiple myeloma (c)(e)

–Multiple myeloma (pivotal study) (c)(e)

–Earlier (pre-malignant) multiple myeloma

–Monoclonal gammopathy of undetermined significance ("MGUS")

–Light chain amyloidosis ("ALA")

–Multiple myeloma (c)(e)

–Relapsed/refractory multiple myeloma (U.S.

–Presented updated positive data from pivotal trial in multiple myeloma at ASCO and ASH Annual Meetings

–FDA decision on BLA (second half 2024) and EC decision on regulatory submission (first half 2025) for relapsed/refractory multiple myeloma

Bispecific antibody targeting BCMA and CD3

–Transplant desensitization in patients with chronic kidney disease

Antibody to IL2Rg

–Aplastic anemia

NTLA-2001 (j)

–Resubmitted BLA for relapsed/refractory multiple myeloma following resolution of third-party manufacturing issues

–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

–FDA decision on BLA (mid-2025) and EC decision on regulatory application (first half 2025) for relapsed/refractory multiple myeloma

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

TTR gene knockout using CRISPR/Cas9

–Transthyretin ("ATTR") amyloidosis (c)

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

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

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

Antibody to Factor XI

–Thrombosis –Report results from Phase 2 study in thrombosis (second half 2024)

–Thrombosis –Reported positive results from Phase 2 trial in thrombosis

–Initiate Phase 3 program (2025)

Antibody to Factor XI

Clinical Program (continued)

Phase 1 Phase 2 Phase 3 Regulatory Review (h)

2023 and 2024

Events to Date

Select Upcoming Milestones

–Reported positive results from Phase 2 trial in thrombosis

–Initiate Phase 3 program (2025)

Antibody to IL2Rg

–Aplastic anemia

Antibody to TMPRSS6

–Transfusion dependent iron overload

–Iron overload in beta-thalassemia

Internal Medicine/Genetic Medicines

Praluent (alirocumab)

Antibody to PCSK9

–HeFH in pediatrics and adolescents

–HeFH in pediatrics and adolescents (8–17 years of age) (U.S.)

–Approved by EC for HeFH in pediatrics and adolescents (8–17 years of age)

–FDA decision on sBLA for HeFH in pediatrics and adolescents (target action date of March 10, 2024)

Evkeeza (f)(l) (evinacumab)

Antibody to ANGPTL3

–Approved by FDA and EC for HoFH in pediatrics (5–11 years of age) and MHLW for HoFH in adults, adolescents, and pediatrics

Garetosmab (f) (REGN2477)

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

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

Trevogrumab (f) (REGN1033)

Antibody to myostatin (GDF8)

–Initiate Phase 2 study in combination with semaglutide with and without garetosmab (mid-2024)

Mibavademab (f) (REGN4461)

–Completed enrollment in Phase 2 study in obesity

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

Clinical Program (continued)

Phase 2 Phase 3 Regulatory

2024 and 2025

Events to Date

Select Upcoming

Mibavademab (f)(o) (REGN4461)

Agonist antibody to leptin receptor ("LEPR")

–Generalized lipodystrophy (d)(e)

–Presented results from Phase 2 study in generalized lipodystrophy at ENDO 2023

REGN5381/REGN9035

Agonist antibody to NPR1/reversal agent to REGN5381

–Reversal agent in healthy volunteers –Heart failure –Resumed enrollment in previously paused Phase 1 and Phase 2 studies following protocol amendments

–Reported positive initial data from Phase 1 trial in healthy volunteers

Agonist antibody to NPR1

–Heart failure

Antagonist antibody to NPR1

–Healthy volunteers

–Postural orthostatic tachycardia syndrome ("POTS")

Rapirosiran (ALN-HSD) (k)

RNAi therapeutic targeting HSD17B13

–Nonalcoholic steatohepatitis

Clinical Program (continued)

Phase 1 Phase 2 Phase 3 Regulatory Review (h)

2023 and 2024

Events to Date

Select Upcoming Milestones

RNAi therapeutic targeting PNPLA3

RNAi therapeutic targeting APP

–Early-onset Alzheimer’s disease (q)

–Reported positive interim data from single dose part of Phase 1 trial in early-onset Alzheimer’s disease

–Metabolic dysfunction-associated steatohepatitis ("MASH")

AAV-based gene therapy

–Hearing loss in pediatrics (c) (Phase 1/2)

–Reported preliminary, positive safety and efficacy results from first patient dosed in Phase 1/2 trial in pediatrics with hearing loss

"Next Generation" Covid Antibody (i)

Antibody to SARS-CoV-2 variants

–Healthy volunteers

Antagonist antibody to PDGF-B

–Healthy volunteers

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

–Presented updated data from Phase 1/2 trial at American Society of Gene and Cell Therapy ("ASGCT") annual conference

–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.

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(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

(i) We and the Biomedical Advanced Research and Development Authority ("BARDA") of the U.S.

Department of Health and Human Services ("HHS") are parties to an agreement whereby HHS provides certain funding to support research and development activities.

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

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

(j) In collaboration with Intellia

(k) In collaboration with Alnylam

(l) In collaboration with Ultragenyx outside the United States

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

(n) Studied in combination with ubamatamab

(o) Alnylam elected to opt-out of the product candidate.

(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.

(p) Studied in combination with odronextamab

(q) Part B of the study (multi-dose regimen) placed on partial clinical hold in the U.S.

by the FDA due to findings observed in prior non-clinical chronic toxicology studies

(r) BioNTech's BNT116 is an mRNA cancer vaccine.

(s) Under the terms of our license agreement for the combination consisting of cemdisiran and pozelimab, Alnylam is entitled to receive royalties on sales of the combination (if any), as well as sales milestones.

(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 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.

Additional Information - Clinical Development Programs

EYLEA HD (aflibercept) 8 mg

In August 2023, the FDA approved the BLA for EYLEA HD for the treatment of patients with wAMD, DME, and DR.

Previously, in June 2023, the FDA issued a CRL for the EYLEA HD BLA.

The CRL was issued solely due to unresolved observations resulting from a May 2023 FDA inspection at a third-party contract manufacturing organization, Catalent, that the Company engaged to complete vial-filling for EYLEA HD.

With the approval of EYLEA HD, the pre-approval inspection issues related to the BLA had been addressed.

In June 2023 and August 2023, the Company announced top-line, two-year (96 weeks) data for EYLEA HD from the pivotal PHOTON trial in patients with DME and the pivotal PULSAR trial in patients with wAMD, respectively.

In addition, in July 2023, the results from the PHOTON trial were presented at the American Society of Retina Specialists annual meeting.

During both trials, EYLEA HD patients were initially randomized to either 12- or 16-week dosing intervals (after three initial monthly doses) and were able to shorten or extend dosing intervals if pre-specified criteria were met.

The longer-term data among EYLEA HD patients who completed the trials demonstrated that the vast majority of patients were able to maintain or further extend these dosing intervals through two years with:

• 89% maintaining ≥12-week dosing intervals through two years, compared to 93% through one year (48 weeks)

• 84% maintaining ≥16-week dosing intervals through two years, compared to 89% maintaining a 16-week dosing interval through one year

• 44% meeting the criteria for ≥20-week dosing intervals by week 96, including 17% and 27% who were eligible for 20- and 24-week dosing intervals, respectively

• 88% on a ≥12-week dosing interval at the end of two years

• 78% maintaining ≥12-week dosing intervals through two years, compared to 83% throughout the first year of study (48 weeks)

• 71% meeting the extension criteria for even longer dosing intervals, including 47% for ≥20-week intervals and 28% for 24-week intervals

• those assigned to ≥16-week dosing regimen at baseline, 70% maintaining ≥16-week dosing intervals throughout the two-year study period;

at the end of two years, 78% were eligible for ≥16-week dosing, with 53% eligible for ≥20-dosing week intervals.

The visual gains for EYLEA HD remained consistent with the first year of the trials.

In both PHOTON and PULSAR, the safety of EYLEA HD also continued to be similar to EYLEA through two years and remained consistent with the known safety profile of EYLEA from previous clinical trials for DME and wAMD.

In May 2023, Bayer announced that it initiated a Phase 3 study to evaluate the efficacy and safety of EYLEA HD at extended dosing intervals compared to the standard of care, EYLEA, in RVO to support potential future regulatory submissions outside the United States.

In March 2023, the Company and Sanofi announced that the primary and all key secondary endpoints were met in the BOREAS trial (the first of two Phase 3 trials) in adults currently on maximal standard-of-care inhaled therapy (triple therapy) with uncontrolled COPD and evidence of type 2 inflammation.

In this trial, patients receiving Dupixent experienced a 30% reduction in moderate or severe acute COPD exacerbations (rapid and acute worsening of respiratory symptoms) compared to placebo over 52 weeks, while also demonstrating significant improvements in lung function, quality of life, and COPD respiratory symptoms.

In November 2023, the Company and Sanofi announced that the replicate Phase 3 NOTUS trial met its primary endpoint, showing Dupixent significantly reduced exacerbations by 34% compared to placebo over 52 weeks in patients with moderate-to-severe COPD with evidence of type 2 inflammation, confirming results from the BOREAS pivotal trial.

Given the overwhelming positive efficacy of the primary endpoint in the interim analysis from the NOTUS trial, the results will be considered the primary analysis of the trial.

In December 2023, the Company and Sanofi submitted the data from this interim analysis of the NOTUS trial, along with the results from the Phase 3 BOREAS trial, to the FDA.

The safety results for the BOREAS and NOTUS trials were generally consistent with the known safety profile of Dupixent in its approved indications.

In October 2023, the FDA issued a CRL for the sBLA for Dupixent in CSU.

The CRL states that additional efficacy data are required to support an approval;

it did not identify any issues with safety or manufacturing.

An ongoing Phase 3 clinical trial (in biologic-naïve patients) continues to enroll patients, with results expected in late 2024.

In the ongoing Phase 1 study of REGN5678, the Company has observed antitumor activity in combination with Libtayo as well as with REGN5678 monotherapy.

Due to the emerging safety profile, including two immune-mediated Grade 5 adverse events (death), the Company discontinued enrollment of patients receiving the combination of REGN5678 and full-dose Libtayo (cemiplimab).

The Company has since expanded enrollment in a REGN5678 monotherapy cohort and plans to explore other REGN5678 combinations.

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 related to findings from a pre-approval inspection at a third-party fill/finish manufacturer.

In January 2025, the Company resubmitted the BLA following resolution of third-party manufacturing issues, and an FDA decision on the BLA is anticipated by mid-2025.

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 recently initiated as a subsequent pivotal trial.

Select Early-Stage Clinical Development Updates

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

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.

Descriptions of Marketed Products Studied in Additional Indications and Product Candidates in Late-Stage Clinical Development

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Dupixent is a fully human monoclonal antibody that inhibits signaling of the IL-4 and IL-13 pathways, and is not an immunosuppressant.

IL-4 and IL-13 are key and central drivers of the type 2 inflammation that plays a major role in atopic dermatitis, asthma, CRSwNP, EoE, prurigo nodularis, and potentially other chronic allergic and inflammatory diseases, including COPD.

IL-4 and IL-13 are key and central drivers of the type 2 inflammation that play a major role in atopic dermatitis, asthma, CRSwNP, COPD, EoE, prurigo nodularis, CSU, and potentially other chronic allergic and inflammatory diseases.

Kevzara (sarilumab)

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REGN5713-5715

REGN5713-5714-5715 is an investigational combination of three fully human monoclonal antibodies designed to treat allergic inflammatory conditions caused by the allergen Betv1, which is the main allergen responsible for birch pollen allergies.

REGN5713-5715 is an investigational combination of two fully human monoclonal antibodies designed to treat allergic inflammatory conditions caused by the allergen Bet v 1, which is the main allergen responsible for birch pollen allergies.

Birch pollen allergy is one of the most common causes of seasonal allergies that occur in the spring, and is also believed to trigger "oral allergy syndrome" food reactions to related allergens found in nuts and fruits such as apples, pears, and cherries.

REGN1908-1909

REGN1908-1909 is an investigational combination of two fully human monoclonal antibodies that is designed to specifically bind and block the Fel d 1 allergen, thus preventing it from binding and triggering the endogenous antibodies that cause allergies (i.e., immunoglobulin E antibodies).

Cat allergy is primarily caused by exposure to Fel d 1, the major allergen in cat dander produced by all cats.

Libtayo (cemiplimab)

Libtayo is a fully human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T-cells that has been approved by regulatory authorities for five different cancers.

Libtayo is a fully human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T-cells.

The PD-1/PD-L1 immune checkpoint pathway is a well-known mechanism by which cancers evade immune destruction.

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It is also being studied in combination with proprietary anti-cancer assets of other companies.

Libtayo has also been approved by regulatory authorities in a number of cancer indications, including advanced NSCLC, BCC, CSCC, and cervical cancer.

Fianlimab is an investigational, fully human monoclonal antibody targeting the immune checkpoint receptor LAG-3 on T-cells.

In melanoma, LAG-3 expression in the tumor microenvironment may be associated with therapeutic resistance to PD-1 inhibitors.

In melanoma and NSCLC, LAG-3 expression in the tumor microenvironment may be associated with therapeutic resistance to PD-1 inhibitors.

Fianlimab is being investigated in combination with Libtayo to determine whether concurrent blockade of LAG-3 and PD-1 can help overcome this resistance and release the brakes on T-cell activation.

Pozelimab is a fully human monoclonal antibody designed to block complement factor C5 in order to treat diseases mediated by abnormal complement pathway activity, and is approved by the FDA for CHAPLE.

Pozelimab is being studied in investigational combinations with an investigational small interfering RNA ("siRNA") therapy, cemdisiran, in PNH and myasthenia gravis.

Odronextamab is an investigational bispecific monoclonal antibody designed to bind to a component of the T-cell receptor ("TCR") complex (CD3), while also binding and bridging T-cells to a protein expressed on B-cells (CD20).

We are studying whether odronextamab may help to activate T-cells via their CD3 receptors and trigger targeted, T-cell mediated killing of cancerous cells in several types of B-cell non-Hodgkin lymphoma.

Pozelimab is being studied in investigational combinations with an investigational small interfering RNA ("siRNA") therapy, cemdisiran, in PNH, myasthenia gravis, and geographic atrophy.

Ordspono (odronextamab)

Odronextamab is a bispecific monoclonal antibody designed to bridge CD20 on cancer cells with CD3-expressing T cells to facilitate local T-cell activation and cancer-cell killing.

We are studying odronextamab in several types of B-cell non-Hodgkin lymphoma.

Linvoseltamab

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We are studying whether linvoseltamab may help to activate T-cells via their CD3 receptors and trigger targeted, T-cell mediated killing of multiple myeloma.

NTLA-2001 is an investigational CRISPR-based therapy to be systemically delivered to edit genes inside the human body and is being studied as a treatment for ATTR amyloidosis.

We are also studying linvoseltamab in precursor conditions to multiple myeloma, including high-risk MGUS and high-risk smoldering myeloma.

Nex-z is an investigational CRISPR-based therapy to be systemically delivered to edit genes inside the human body and is being studied as a treatment for ATTR amyloidosis.

ATTR amyloidosis is a progressive and fatal disorder resulting from deposition of insoluble amyloid fibrils into multiple organs and tissues leading to systemic failure.

Delivered with in vivo technology, NTLA-2001 offers the possibility of halting and reversing the disease by driving a deep, consistent, and potentially lifelong reduction in transthyretin ("TTR") protein after a single dose.

Praluent (alirocumab)

Praluent is a fully human monoclonal antibody that inhibits the binding of PCSK9 to the LDL receptor.

Through inhibiting PCSK9, Praluent increases the number of available LDL receptors on the surface of liver cells to clear LDL, which lowers LDL cholesterol levels in the blood.

Evkeeza (evinacumab)

Evkeeza is a fully human monoclonal antibody that specifically binds to and blocks ANGPTL3.

ANGPTL3 plays a key role in regulating plasma lipid levels, including triglycerides, LDL cholesterol, and HDL cholesterol, through inhibition of lipase enzymes (lipoprotein lipase and endothelial lipase).

Delivered with in vivo technology, nex-z offers the possibility of halting and reversing the disease by driving a deep, consistent, and potentially lifelong reduction in transthyretin ("TTR") protein after a single dose.

Garetosmab is an investigational, fully human monoclonal antibody that binds to and neutralizes Activin A, which drives the abnormal bone formation that is the main pathology of the ultra-rare genetic disorder FOP.

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Garetosmab is being investigated to determine whether it can help reduce and/or prevent the formation of heterotopic bone lesions by neutralizing the Activin A protein.

Mibavademab is an investigational, fully human monoclonal antibody that binds to and activates the leptin receptor, which modulates the control of food intake, energy expenditure, and glucose/lipid metabolism.

We are studying mibavademab as a potential treatment for generalized lipodystrophy.

Other Programs

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VelociSuite ® is our second technology platform, which is used for discovering, developing, and producing fully human antibodies that can address both secreted and cell-surface targets.

We also leverage VelociSuite to produce new classes of bispecific antibodies.

Additionally, we use genetic medicine platforms as complementary approaches to these core technologies to potentially treat or cure diseases.

VelociSuite consists of VelocImmune ® , VelociGene ® , VelociMouse ® , VelociMab ® , Veloci-Bi ® , VelociT ® , VelociHum ® , and other related technologies.

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In the area of immunotherapies in oncology, we are exploring the use of bispecific antibodies that target tumor antigens and the CD3 receptor on T-cells to harness the oncolytic properties of T-cells.

We are exploring additional indications and applications for our bispecific technologies, including a new class of CD28 and 4-1BB costimulatory bispecifics.

We are exploring additional indications and applications for our bispecific technologies, including CD28 and 4-1BB costimulatory bispecifics.

We are also exploring a variety of alternative antibody formats (Altibodies ™ ) that can bring binding partners together in restrained geometries.

The VelociT mouse extends our research and drug discovery capabilities into cell-mediated immunity and therapeutic TCRs for oncology and other indications.

The VelociT mouse extends our research and drug discovery capabilities into cell-mediated immunity and therapeutic T-cell receptors ("TCRs") for oncology and other indications.

VelociT was developed by using our VelociGene technology to humanize genes encoding TCRα and TCRβ variable sequences, CD4 and CD8 co-receptors, β2m, and class-I and -II major histocompatibility complexes.

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RGC is undertaking multiple collaborative approaches to study design and implementation, including large population-based efforts that engage study participants to more discrete disease specific and founder populations with data on strategic phenotypes of interest.

RGC utilizes laboratory automation and innovative approaches to cloud computing to achieve high-quality throughput, attaining more than 2 million samples sequenced to date.

Central to the work of RGC is the portfolio of collaborations with over 100 academic and clinical collaborators around the world, including the University of Colorado, Geisinger Health System, Mayo Clinic, University of Pennsylvania, UCLA Medical Center, UK Biobank, University of Oxford, University of Cambridge, and the University of Helsinki.

RGC utilizes laboratory automation and innovative approaches to cloud computing to achieve high-quality throughput, attaining nearly 3 million samples sequenced to date.

In January 2025, it was announced that RGC was selected by UK Biobank consortium members to complete proteomic assay data generation for the recently announced UK Biobank Pharma Proteomics Project.

In January 2025, RGC entered into an agreement with Truveta Inc.

pursuant to which RGC will sequence exomes and conduct genotyping and imputation of up to ten million de-identified consented volunteers using biospecimens provided by Truveta health system members across the United States.

In addition, central to the ongoing work of RGC is the portfolio of collaborations with over 150 academic and clinical collaborators around the world, including the University of Colorado, Geisinger Health System, Mayo Clinic, University of Pennsylvania, UCLA Medical Center, UK Biobank, University of Oxford, and the University of Cambridge.

These collaborations provide access to biological samples and associated phenotype data from properly consented patient volunteers for purposes of genomic research.

RGC undertakes genetic sequencing of these samples to create a unique resource of de-identified genetic data and associated phenotype data for research.

Furthermore, the RGC has deployed bulk RNA sequencing, whole genome sequencing, and an O-LINK proteomic assay to complement whole exome sequencing and genotyping.

In addition, the RGC leverages organoid models, siRNA, and CRISPR knockout models to validate genetic associations that lead to new therapeutic targets.

The RGC continues to publish results from its research efforts in journals and publications in partnership with its collaborators to advance the field of genomics.

These efforts at the RGC have led to the identification of more than 30 novel genetic targets.

Furthermore, RGC has deployed bulk RNA sequencing, whole genome sequencing, and an O-LINK proteomic assay to complement whole exome sequencing and genotyping.

In addition, RGC leverages organoid models, siRNA, and CRISPR knockout models to validate genetic associations that lead to new therapeutic targets.

RGC continues to publish results from its research efforts in journals and publications in partnership with its collaborators to advance the field of genomics.

These efforts at RGC have led to the identification of more than 30 novel genetic targets.

Through our Regeneron Genetics Medicines initiative, we are currently advancing these targets using either our VelociSuite technologies or other technologies, such as siRNA gene silencing, genome editing, and targeted viral-based gene delivery and expression.

See the "Collaboration, License, and Other Agreements" section below for descriptions of our collaborations with Alnylam and Intellia Therapeutics, Inc.

See the "Collaboration, License, and Other Agreements" section below for descriptions of our collaborations with Alnylam Pharmaceuticals, Inc.

and Intellia Therapeutics, Inc.

Collaboration, License, and Other Agreements

We are collaborating with Sanofi on the global development and commercialization of Dupixent, Kevzara, and itepekimab (the "Antibody Collaboration").

Under the terms of the Antibody License and Collaboration Agreement (the "LCA"), 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 from commercialization of collaboration products.

Under the terms of the LCA, we were required to apply 10% of our share of the profits from the Antibody Collaboration in any calendar quarter to reimburse Sanofi for these development costs.

On July 1, 2022, an amendment to the LCA became effective, pursuant to which the percentage of Regeneron’s share of profits used to reimburse Sanofi for such development costs increased from 10% to 20%.

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;

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 December 31, 2024, the total amount of our contingent reimbursement obligation (i.e., "development balance") to Sanofi in connection with such development expenses was approximately $1.635 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.

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We supply certain commercial bulk product to Sanofi.

We and Sanofi equally share profits from sales within the United States.

We and Sanofi 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).

In each of 2020 and 2021, we earned a $50.0 million sales-based milestone from Sanofi, upon aggregate annual sales of antibodies outside the United States (including Praluent, which was previously included in the LCA) exceeding $1.0 billion and $1.5 billion, respectively, on a rolling twelve-month basis.

In 2022, we earned two additional $50.0 million sales-based milestones, upon aggregate annual sales of antibodies outside the United States (including Praluent) exceeding $2.0 billion and $2.5 billion, respectively, on a rolling twelve-month basis, and in 2023, we earned the final $50.0 million sales-based milestone from Sanofi, upon aggregate annual sales of antibodies outside the United States (including Praluent) exceeding $3.0 billion on a rolling twelve-month basis.

Immuno-Oncology

We previously collaborated with Sanofi for antibody-based cancer treatments in the field of immuno-oncology (the "IO Collaboration").

Under the terms of the Immuno-oncology License and Collaboration Agreement, the parties were co-developing and co-commercializing Libtayo.

The parties shared equally development and commercialization expenses for Libtayo.

We had principal control over the development of Libtayo and led commercialization activities in the United States, while Sanofi led

commercialization activities outside the United States.

The parties shared equally in profits and losses in connection with the commercialization of Libtayo.

Effective July 1, 2022, we obtained the exclusive right to develop, commercialize, and manufacture Libtayo worldwide under an Amended and Restated Immuno-oncology License and Collaboration Agreement with Sanofi (the "A&R IO LCA").

In connection with the A&R IO LCA, in 2022, the Company made a $900.0 million up-front payment to Sanofi, as well as a $100.0 million regulatory milestone payment.

In addition, Sanofi was eligible to earn an aggregate of $100.0 million in Libtayo sales-based milestones under the terms of the A&R IO LCA, of which they earned $65.0 million in 2022 and $35.0 million in 2023.

We also pay Sanofi an 11% royalty on net product sales of Libtayo through March 31, 2034.

The parties have also entered into a transition services agreement, a transitional distribution agreement, and a manufacturing services agreement, pursuant to which, during certain transitional periods, Sanofi will perform for the Company certain transition, distribution, and manufacturing services, respectively.

Under the terms of the IO Collaboration, we were obligated to reimburse Sanofi for half of the development costs it funded that were attributable to clinical development of product candidates from our share of profits from commercialized IO Collaboration products.

Under the A&R IO LCA, the amount of development costs incurred under the IO Collaboration for which we are obligated to reimburse Sanofi was $35.0 million as of the effective date of the A&R IO LCA, and we pay Sanofi a 0.5% royalty on net product sales of Libtayo until all such development costs have been reimbursed by us.

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).

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.

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Within the United States, we retain exclusive commercialization rights and are entitled to all profits from such sales.

In 2019, we and Alnylam Pharmaceuticals, Inc.

entered into a global, strategic 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.

In connection with the collaboration, the Company made an up-front payment of $400.0 million to Alnylam, and also purchased shares of Alnylam common stock for $400.0 million.

In 2019, we and Alnylam entered into 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.

For each program, we provide Alnylam with a specified amount of funding at program initiation and at lead candidate designation.

During 2023, we paid a $100.0 million development milestone to Alnylam upon the achievement of specified proof-of-principle criteria for the ALN-APP program and Alnylam is eligible to receive an additional $100.0 million clinical proof-of-principle milestone in connection with an eye program.

During 2023, we paid a $100.0 million development milestone to Alnylam (in connection with a CNS program) and Alnylam is eligible to receive an additional $100.0 million clinical proof-of-principle milestone in connection with an eye program.

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/co-commercialization collaboration agreement ("Co-Co Collaboration Agreement") (under which the parties are advancing ALN-APP and ALN-PNP, which are currently in clinical development) or a license agreement structure.

The initial target nomination and discovery period is five years (which may under certain situations automatically be extended for up to seven years in the aggregate) (the "Research Term").

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.

For CNS programs and liver programs, under a Co-Co Collaboration Agreement, the party designated as the lead party will lead development and commercialization of the program and the parties will split profits and share costs equally, subject to certain co-funding opt-outs at specified clinical trial phases or under other conditions.

Alnylam is the lead party for ALN-APP, and we are the lead party for ALN-PNP.

Under a license agreement, the lead party is designated as the licensee and has the right to develop and commercialize the collaboration product under such program.

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The licensee will pay to the licensor certain development and/or commercialization milestone payments, as well as certain tiered royalty payments to the licensor based on the aggregate annual net sales of the collaboration product.

The parties have entered into various license agreements, including for a combination consisting of cemdisiran (an siRNA therapeutic targeting the C5 component of the human complement pathway being developed by Alnylam) and pozelimab, with us as the licensee.

In 2016, we entered into a license and collaboration agreement with Intellia 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 2020, we expanded our existing collaboration with Intellia to provide us with rights to develop products for additional in vivo CRISPR/Cas9-based therapeutic targets and for the companies to jointly develop potential products for the treatment of hemophilia A and B, with Regeneron leading development and commercialization activities.

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

In connection with the 2020 agreement, we made a $70.0 million up-front payment to Intellia.

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

We have entered into various license agreements with Alnylam, with us as the licensee, including for cemdisiran as a monotherapy and for a combination consisting of cemdisiran and pozelimab.

During the second quarter of 2024, we elected to no longer co-develop ALN-APP pursuant to a Co-Co 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).

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.

Nex-z, 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 October 2023, we elected to extend the period for selecting targets under the 2016 license and collaboration agreement for an additional two years until April 2026;

as a result, we became obligated to make a $30.0 million extension payment to Intellia.

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 (which is currently in Phase 1 clinical development), 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 entered into an Agreement and Plan of Merger to acquire Decibel, and in September 2023, we completed the acquisition of Decibel.

We paid $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, which entitles the holder to receive up to $3.50 per share in cash upon achievement of certain clinical development and regulatory milestones for DB-OTO within specified time periods.

The maximum aggregate amount that holders of the CVRs may be entitled to receive if all the milestones contemplated by the CVRs are achieved is approximately $97 million.

In August 2023, we expanded our existing Other Transaction Agreement ("OTA") with BARDA, pursuant to which the HHS is obligated to fund up to 70% of our costs incurred for certain development activities related to a next-generation COVID-19 monoclonal antibody therapy for the prevention of SARS-CoV-2 infection.

Pursuant to the terms of the expanded agreement, we could receive payments of up to approximately $326 million in the aggregate to support clinical development, clinical manufacturing, and the regulatory licensure process.

In 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 2024, the first and second (final) development milestones contemplated by the CVRs were achieved.

As a result, we have paid an aggregate amount of $97.1 million, which was the maximum amount that holders of the CVRs were entitled to receive (including the payment in respect of the second development milestone made in 2025).

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.

Manufacturing

We currently manufacture bulk drug materials and products at our manufacturing facilities in Rensselaer, New York and Limerick, Ireland.

These facilities consist of owned and leased research, manufacturing, office, laboratory, and warehouse space.

These facilities consist of owned and leased manufacturing, office, laboratory, and warehouse space.

In addition, we have constructed a fill/finish facility in Rensselaer, New York that is undergoing process validation as required by regulatory authorities.

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Certain bulk drug materials and products are also manufactured by our collaborators, and certain raw materials or products necessary for the manufacture and formulation of our products and product candidates are provided by single-source unaffiliated third-party suppliers.

In addition, we rely on our collaborators or third parties to perform packaging, filling, finishing, labeling, distribution, laboratory testing, and other services related to the manufacture of our products and product candidates, and to

supply various raw materials and other products.

See Part I, Item 1A.

"Risk Factors - Risks Related to Manufacturing and Supply" for further information.

Among the conditions for regulatory marketing approval of a medicine is the requirement that the prospective manufacturer's quality control and manufacturing procedures conform to the good manufacturing practice ("GMP") regulations of the health authority.

Among the conditions for marketing approval of a new drug or biologic product is the requirement that the prospective manufacturer's quality control and manufacturing procedures conform to the good manufacturing practice ("GMP") regulations of the health authority.

In complying with standards set forth in these regulations, manufacturers must continue to expend time, money, and effort in the areas of production and quality control to ensure full technical compliance.

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The commercial group also evaluates opportunities for our targets and product candidates and prepares for market launches of new medicines.

We have established certain commercial capabilities outside the United States in connection with co-commercializing Dupixent in accordance with our Sanofi collaboration agreement.

In addition, we are in process of building additional commercial capabilities outside the United States as a result of us obtaining the rights, in 2022, to commercialize Libtayo outside the United States.

We face substantial competition from pharmaceutical, biotechnology, and chemical companies.

We have established certain commercial capabilities outside the United States in connection with co-commercializing Dupixent in accordance with our Sanofi collaboration and with obtaining the rights, in 2022, to commercialize Libtayo outside the United States.

We face substantial competition from pharmaceutical and biotechnology companies.

Our ability to compete depends, to a great extent, on how fast we can develop safe and effective product candidates, complete clinical testing and approval processes, and supply commercial quantities of the product to the market.

Competition among products approved for sale is based on efficacy, safety, reliability, availability, price, patent and other intellectual property position, and other factors.

Competition among products approved for sale is based on efficacy, safety, reliability, ease of administration, dosing frequency, availability, price, patent and other intellectual property position, and other factors.

Marketed Products

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Marketed Product Competitor Product Competitor Indication Territory (a)

EYLEA HD and EYLEA

Yesafili ® (aflibercept) (biosimilar referencing EYLEA)

Biocon Biologics Ltd wAMD, DME, macular edema following RVO (including CRVO and BRVO), and mCNV

EYLEA HD and EYLEA (b)

Pavblu ® (aflibercept-ayyh) (biosimilar referencing EYLEA)

wAMD, DME, macular edema following RVO (including CRVO and BRVO), and DR

United States

Vabysmo ™ (faricimab-svoa)

Genentech/Roche wAMD, DME, and macular edema following RVO

United States, EU, Japan

Avastin ® (bevacizumab) (off-label and repackaged)

Genentech/Roche wAMD, DME, and macular edema following RVO

United States, EU, Japan

Lucentis ® (ranibizumab injection)

1 unchanged sentence

United States, EU, Japan

Marketed Product (continued)

Competitor Product Competitor Indication Territory (a)

EYLEA HD and EYLEA (continued)

Byooviz ™ (ranibizumab-nuna) (biosimilar referencing Lucentis)

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Ximluci ® (ranibizumab) (biosimilar referencing Lucentis)

Xbrane Biopharma AB and Bausch + Lomb

Xbrane Biopharma AB and STADA Arzneimittel AG

wAMD, DME, macular edema following RVO (including CRVO and BRVO), DR, and CNV

Marketed Product (continued)

Competitor Product Competitor Indication Territory (a)

EYLEA HD and EYLEA (continued)

Cimerli ™ (ranibizumab-eqrn) (biosimilar referencing Lucentis)

Formycon AG, Bioeq AG, Coherus BioSciences, Inc., and Teva Ltd.

Formycon AG, Bioeq AG, Sandoz, and Teva Ltd.

wAMD, DME, macular edema following RVO (including CRVO and BRVO), DR, and mCNV

1 unchanged sentence

Susvimo ® (ranibizumab ocular implant)

Genentech/Roche wAMD

Genentech/Roche wAMD, DME

United States

Vabysmo ™ (faricimab-svoa)

Genentech/Roche wAMD, DME, and macular edema following RVO

United States, EU, Japan

Avastin ® (bevacizumab) (off-label and repackaged)

Genentech/Roche wAMD, DME, and macular edema following RVO

United States, EU, Japan

Beovu ® (brolucizumab) Injection

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DME United States, EU

Dupixent Eucrisa ® /Staquis ® (crisaborole)

Mild-to-moderate atopic dermatitis United States, EU

Opzelura ® (ruxolitinib)

Incyte Corporation Mild-to-moderate atopic dermatitis United States

Olumiant ® (baricitinib)

Eli Lilly and Company/Incyte Corporation Moderate-to-severe atopic dermatitis EU, Japan

Cibinqo ® (abrocitinib)

Pfizer Moderate-to-severe atopic dermatitis United States, EU, Japan

Ebglyss ® (lebrikizumab)

Almirall S.A., Eli Lilly and Company

Moderate-to-severe atopic dermatitis United States, EU, Japan

Rinvoq ® (upadacitinib)

AbbVie Moderate-to-severe atopic dermatitis United States, EU, Japan

Nemluvio ® /Mitchga ® (nemolizumab)

Maruho Co., Ltd./Chugai Pharmaceutical Co., Ltd.

Moderate-to-severe atopic dermatitis, pruritus associated with atopic dermatitis, prurigo nodularis

United States, Japan

Adbry ™ /Adtralza ® (tralokinumab)

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Moderate-to-severe atopic dermatitis United States, EU, Japan

Ebglyss ® (lebrikizumab)

Almirall S.A.

Moderate-to-severe atopic dermatitis EU

Corectim ® (delgocitinib)

Japan Tobacco Inc./Torii Pharmaceutical Co., Ltd.

Atopic dermatitis Japan

Mitchga ® (nemolizumab)

Maruho Co., Ltd./Chugai Pharmaceutical Co., Ltd.

Pruritus associated with atopic dermatitis Japan

Xolair ® (omalizumab)

Roche/Novartis Asthma, nasal polyps United States, EU, Japan (asthma);

United States, EU (nasal polyps)

Marketed Product (continued)

Competitor Product Competitor Indication Territory (a)

Dupixent (continued)

Nucala ® (mepolizumab)

GlaxoSmithKline ("GSK") Asthma, nasal polyps United States, EU, Japan (asthma);

United States, EU (nasal polyps)

Cinqair ® (reslizumab)

Teva Asthma United States, EU

Fasenra ® (benralizumab)

Asthma United States, EU, Japan

Cibinqo ® (abrocitinib)

Pfizer Moderate-to-severe atopic dermatitis United States, EU, Japan

Tezspire ™ (tezepelumab-ekko)

AstraZeneca/Amgen Asthma United States, EU, Japan

Fasenra ® (benralizumab)

Asthma United States, EU, Japan

Nucala ® (mepolizumab)

GlaxoSmithKline ("GSK") Asthma, nasal polyps United States, EU, Japan

Xolair ® (omalizumab)

Roche/Novartis Asthma, nasal polyps, CSU

United States, EU, Japan

Libtayo Keytruda ® (pembrolizumab)

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GSK Various cancers United States, EU

(a) This table focuses on the United States, EU, and Japan.

Certain products have also received marketing approval in countries outside the United States, EU, and Japan.

Unloxcyt™ (cosibelimab)

Checkpoint Therapeutics, Inc.

United States

(a) This table focuses on products that have received marketing approval in one or more of the specified indications in the United States, EU, and/or Japan.

Certain products listed in this table have also received marketing approval in countries outside the United States, EU, and Japan.

(b) In addition to the products listed in this table, certain other biosimilar products referencing EYLEA have received marketing approval in the United States, EU, and/or Japan but have not yet launched in such jurisdictions.

The timing of any launch of these biosimilar products will depend on, among other factors, the outcome of the pending patent litigation proceedings described in Note 16 to our Consolidated Financial Statements and the expiration of the patents protecting EYLEA (including those set forth under "Patents, Trademarks, and Trade Secrets" below).

Product Candidates

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We also compete with academic institutions, governmental agencies, and other public or private research organizations, which conduct research, seek patent and other intellectual property protection, and establish collaborative arrangements for the development and marketing of products that would provide royalties or other consideration for use of their technology.

These institutions are becoming more active in seeking patent and other intellectual property protection and licensing arrangements to

collect royalties or other consideration for use of the technology they have developed.

These institutions have become more active in seeking patent and other intellectual property protection and licensing arrangements to collect royalties or other consideration for use of the technology they have developed.

Products developed in this manner may compete directly with products we develop.

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Our patent portfolio includes granted patents and pending patent applications covering our VelociSuite technologies, including our VelocImmune mouse platform which produces fully human antibodies.

Our issued patents covering these technologies generally expire between 2022 and 2032.

Our remaining issued patents covering these technologies will expire between 2025 and 2032.

However, we continue to file patent applications directed to improvements to these technology platforms.

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The following table describes our U.S.

patents, European patents ("EP"), and Japanese patents ("JP") that are of particular relevance to key products marketed or otherwise commercialized by us and/or our collaborators, including the territory, patent number, general subject matter class, and expected expiration dates.

The noted expiration dates include any patent term adjustments.

Certain of these patents may also be entitled to term extensions.

patents, European patents ("EP"), and Japanese patents ("JP") that are of particular relevance to key products marketed or otherwise commercialized by us and/or our collaborators.

The noted expiration dates include any patent term adjustments, and certain of these patents may also be entitled to term extensions.

We continue to pursue additional patents and patent term extensions in the United States and other jurisdictions covering various aspects of our products that may, if issued, extend exclusivity beyond the expiration of the patents listed in the table below.

5 unchanged sentences

aflibercept (8 mg)

US 10,066,458 Formulation June 14, 2027

US 11,066,458

Formulation June 14, 2027

US 11,084,865 Formulation June 14, 2027

US 11,103,552 Formulation May 15, 2039

US 11,732,024 Formulation June 14, 2027

US 9,254,338 Methods of Treatment May 22, 2032

US 10,828,345 Methods of Treatment January 11, 2032

Methods of Treatment May 15, 2039

JP 7,235,770 Formulation May 10, 2039

4 unchanged sentences

US 11,732,024 Formulation June 14, 2027

US 9,254,338 Methods of Treatment May 22, 2032

US 10,828,345 Methods of Treatment January 11, 2032

2 unchanged sentences

US 11,730,794 Methods of Treatment January 11, 2032

Product (continued)

Molecule Territory Patent No.

General Subject Matter Class Expiration

EYLEA (a) (continued)

US 11,253,572 Methods of Treatment January 11, 2032

US 11,559,564 Methods of Treatment January 11, 2032

US 11,707,506 Methods of Treatment January 11, 2032

US 11,730,794 Methods of Treatment January 11, 2032

EP 1183353 Composition of Matter (Supplementary Protection Certificate) (May 23, 2025) (b) /(November 23, 2025) (c)

5 unchanged sentences

Dupixent dupilumab US 7,608,693 Composition of Matter March 28, 2031 (e)

US 8,735,095 Composition of Matter October 2, 2027

US 8,945,559 Formulation October 17, 2032

2 unchanged sentences

US 11,059,896 Formulation October 5, 2031

US 11,926,670 Formulation October 5, 2031

US 8,075,887 Methods of Treatment April 17, 2028

2 unchanged sentences

US 9,574,004 Methods of Treatment December 22, 2033

US 10,066,017 Methods of Treatment January 21, 2036

US 11,421,036 Methods of Treatment July 10, 2034

2 unchanged sentences

US 10,059,771 Methods of Treatment June 20, 2034

US 11,214,621 Methods of Treatment March 11, 2036

US 11,214,621 Methods of Treatment January 21, 2036

Product (continued)

Molecule Territory Patent No.

General Subject Matter Class Expiration

Dupixent (continued)

US 11,167,004 Methods of Treatment September 21, 2037

1 unchanged sentence

US 11,292,847 Methods of Treatment May 10, 2039

US 11,845,800 Methods of Treatment December 22, 2033

US 12,090,201 Methods of Treatment February 3, 2043

EP 2356151 Composition of Matter October 27, 2029 (b)

1 unchanged sentence

(September 28, 2032) (b )/(March 28, 2033) (c)

EP 3715372 Composition of Matter October 27, 2029

EP 3010539 Methods of Treatment June 20, 2034

2 unchanged sentences

EP 3107575 Methods of Treatment February 20, 2035

EP 3470432 Methods of Treatment August 20, 2033

EP 3019191 Methods of Treatment July 10, 2034

1 unchanged sentence

EP 4011915 Methods of Treatment August 20, 2033

EP 3515465 Methods of Treatment September 21, 2037

EP 3889181 Methods of Treatment September 4, 2033

EP 3973987 Methods of Treatment February 20, 2035

EP 2624865 Formulation October 5, 2031

1 unchanged sentence

Composition of Matter October 27, 2029 – October 27, 2034 (d)

JP 5,844,772 Composition of Matter October 27, 2029 – February 22, 2034

October 5, 2031 – September 14, 2035 (d)

Product (continued)

Molecule Territory Patent No.

General Subject Matter Class Expiration

Dupixent (continued)

JP 6,231,605 Formulation October 5, 2031 – March 3, 2034

Methods of Treatment

6 unchanged sentences

June 20, 2034 – September 2, 2035 (d)

JP 6,640,977 Methods of Treatment June 20, 2034 – September 6, 2034

Methods of Treatment

November 13, 2035

JP 6,893,265 Methods of Treatment February 20, 2035

JP 7,164,530 Methods of Treatment September 21, 2037

7 unchanged sentences

US 11,603,407 Formulation March 21, 2038

Product (continued)

Molecule Territory Patent No.

General Subject Matter Class Expiration

Libtayo (continued)

US 10,457,725 Methods of Treatment May 12, 2037

1 unchanged sentence

US 11,505,600 Methods of Treatment July 2, 2038

US 11,926,668 Methods of Treatment February 20, 2038

EP 3097119 Composition of Matter January 23, 2035

7 unchanged sentences

JP 7,240,512 Methods of Treatment May 25, 2041

JP 7,054,680 Methods of Treatment May 12, 2037

JP 7,240,512 Methods of Treatment May 25, 2041

(a) See Note 16 to our Consolidated Financial Statements for information regarding inter partes review and post-grant review petitions filed in the U.S.

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In addition to our patent portfolio, in the United States and certain other countries, our competitive position may be enhanced due to the availability of market exclusivity under relevant law (for additional information regarding market exclusivity, see Part I, Item 1A.

"Risk Factors - Risks Related to Intellectual Property and Market Exclusivity - Loss or limitation of patent rights, and regulatory pathways for biosimilar competition, could reduce the duration of market exclusivity for our products ").

For example, in the United States, the regulatory exclusivity period for EYLEA (i.e., the period during which no biosimilar product can be approved by the FDA) extends through May 17, 2024 following the pediatric exclusivity granted by the FDA.

"Risk Factors - Risks Related to Intellectual Property and Market Exclusivity - Loss or limitation of patent rights, and regulatory pathways for biosimilar competition, have in the past reduced and could reduce in the future the duration of market exclusivity for our products ").

The effect of expiration of a patent relating to a particular product also depends upon other factors, such as the nature of the market and the position of the product in it, the growth of the market, the complexities and economics of the process for manufacture of the active ingredient of the product, and the requirements of new drug provisions of the Federal Food, Drug and Cosmetic Act or similar laws and regulations in other countries.

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We expect to continue, when appropriate, to file product and process applications with respect to our inventions.

However, we may not file any such applications or, if filed, the patents may not be issued.

However, we may not file any such

applications or, if filed, the patents may not be issued.

Patents issued to or licensed by us may be infringed by the products or processes of others.

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Clinical trials involve the administration of a drug to healthy human volunteers or to patients under the supervision of a qualified investigator.

The conduct of clinical trials is subject to extensive regulation, including compliance with the FDA's bioresearch monitoring regulations and Good Clinical Practice requirements ("GCPs"), which establish standards for conducting, recording data from, and reporting the results of, clinical trials, and are intended to assure that the data and reported results are credible and accurate, and that the rights, safety, and well-being of study participants are protected.

The conduct of clinical trials is subject to extensive regulation, including compliance with the FDA's bioresearch monitoring regulations and Good Clinical Practice requirements ("GCPs"), which establish standards for recruiting for, conducting, recording data from, and reporting the results of, clinical trials, and are intended to assure that the data and reported results are credible, representative, and accurate, and that the rights, safety, and well-being of study participants are protected.

Clinical trials must be conducted under protocols that detail the study objectives, parameters for monitoring safety, and the efficacy criteria, if any, to be evaluated.

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in any pricing structure, calculated to include all sales and associated rebates, discounts, and other price concessions.

The amount of the rebate is adjusted upward if average manufacturer price increases more than inflation (measured by reference to the Consumer Price Index - Urban).

Until December 31, 2023, the rebate was capped at 100 percent of the average manufacturer price, but effective January 1, 2024, this cap on the rebate has been removed, and the rebate liability of manufacturers could increase accordingly.

The amount of the rebate is adjusted upward if the average manufacturer price increases more than inflation (measured by reference to the Consumer Price Index - Urban).

Effective January 1, 2024, the rebate is no longer capped at 100% of the average manufacturer price and, as a result, the rebate liability of manufacturers could increase.

If we become aware that our Medicaid reporting for a prior quarter was incorrect, or has changed as a result of recalculation of the pricing data, we are obligated to resubmit the corrected data for up to three years after those data originally were due, which revisions could affect our rebate liability for prior quarters.

If we fail to pay the required rebate amount or report pricing data on a timely basis, we may be subject to civil monetary penalties and/or termination of our Medicaid Drug Rebate program agreement, in which case federal payments may not be available under Medicaid or Medicare Part B for our covered outpatient drugs.

The federal Patient Protection and Affordable Care Act (the "PPACA") made significant changes to the Medicaid Drug Rebate program, and thereafter CMS issued a final regulation to implement the changes to the Medicaid Drug Rebate program under the PPACA.

CMS has since modified Medicaid Drug Rebate program regulations to, among other things, permit reporting multiple best price figures with regard to value‑based purchasing arrangements and provide definitions for "line extension," "new formulation," and related terms with the practical effect of expanding the scope of drugs considered to be line extensions.

For additional information regarding risks related to our price reporting and rebate payment obligations, see Part I, Item 1A.

"Risk Factors - Other Regulatory and Litigation Risks - If we fail to comply with our reporting and payment obligations under the Medicaid Drug Rebate program or other governmental pricing programs, we could be subject to additional reimbursement requirements, penalties, sanctions and fines, which could have a material adverse effect on our business, financial condition, results of operations, and future prospects ."

Medicare is a federal program that is administered by the federal government that covers individuals age 65 and over or that are disabled as well as those with certain health conditions.

Medicare Part B generally covers drugs that must be administered by physicians or other health care practitioners;

Medicare Part B generally covers drugs that must be administered by physicians or other healthcare practitioners;

are provided in connection with certain durable medical equipment;

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The manufacturer-submitted information may be used by CMS to calculate Medicare payment rates.

Manufacturers must pay refunds to Medicare for single-source drugs or biological products, or biosimilar biological products, reimbursed under Medicare Part B and packaged in single-dose containers or single-use packages for units of discarded drug reimbursed by Medicare Part B in excess of 10 percent of total allowed charges under Medicare Part B for that drug.

Manufacturers must pay refunds to Medicare for single-source drugs or biological products, or biosimilar biological products, reimbursed under Medicare Part B and packaged in single-dose containers or single-use packages for units of discarded drug reimbursed by Medicare Part B in excess of 10% of total allowed charges under Medicare Part B for that drug.

Manufacturers that fail to pay refunds could be subject to civil monetary penalties.

12 unchanged sentences

Covered entities include hospitals that serve a disproportionate share of financially needy patients, community health clinics, and other entities that receive certain types of grants under the Public Health Service Act.

The PPACA expanded the list of covered entities to include certain free-standing cancer hospitals, critical access hospitals, rural referral centers, and sole community hospitals, but exempts "orphan drugs" from the ceiling price requirements for these covered entities.

The federal Patient Protection and Affordable Care Act (the "PPACA") expanded the list of covered entities to include certain free-standing cancer hospitals, critical access hospitals, rural referral centers, and sole community hospitals, but exempts "orphan drugs" from the ceiling price requirements for these covered entities.

The 340B ceiling price is calculated using a statutory formula, which is based on the average manufacturer price and Medicaid rebate amount for the covered outpatient drug as calculated under the Medicaid Drug Rebate program.

2 unchanged sentences

If we are found to have knowingly and intentionally charged 340B covered entities more than the statutorily mandated ceiling price, we could be subject to significant civil monetary penalties and/or such failure also could be grounds for HRSA to terminate our agreement to participate in the 340B program, in which case our covered outpatient drugs would no longer be eligible for federal payment under Medicaid or Medicare Part B.

It is currently unclear how HRSA will apply its enforcement authority under this regulation.

Moreover, HRSA has established an administrative dispute resolution ("ADR") process for claims by covered entities that a manufacturer has engaged in overcharging, and by manufacturers that a covered entity violated the prohibitions against diversion or duplicate discounts.

1 unchanged sentence

An ADR proceeding could subject us to onerous procedural requirements and could result in additional liability.

On November 30, 2022, HRSA issued a notice of proposed rulemaking that proposes several changes to the ADR process;

and, following the solicitation of public comments, in October 2023 HRSA submitted a final version of the rule to the White House Office of Management and Budget for review.

HRSA also implemented a price reporting system under which we are required to report our 340B ceiling prices to HRSA on a quarterly basis, which then publishes those prices to 340B covered entities.

HRSA has also implemented a price reporting system under which we are required to report our 340B ceiling prices to HRSA on a quarterly basis, which then publishes those prices to 340B covered entities.

In order to be eligible to have our products paid for with federal funds under the Medicaid and Medicare Part B programs and purchased by certain federal agencies and grantees, we participate in the U.S.

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government and, subject to detailed program rules and government oversight, each drug plan establishes its own Medicare Part D formulary for prescription drug coverage and pricing, which the drug plan may modify from time to time.

The prescription drug plans negotiate pricing with manufacturers and pharmacies, and may condition formulary placement on the availability of manufacturer

The prescription drug plans negotiate pricing with manufacturers and pharmacies, and may condition formulary placement on the availability of manufacturer discounts.

In addition, manufacturers, including us, are required to provide to CMS a 70% discount on brand name prescription drugs utilized by Medicare Part D beneficiaries when those beneficiaries are in the coverage gap phase of the Part D benefit design.

The IRA includes a sunset provision with respect to the coverage gap discount program starting in 2025 and replaces it with a new manufacturer discount program.

The IRA includes a sunset provision with respect to the coverage gap discount program starting in 2025 and replaces it

with a new manufacturer discount program.

In addition, the IRA has established a Medicare Part D inflation rebate scheme under which, generally speaking, manufacturers will owe additional rebates if the average manufacturer price of a Part D drug increases faster than the pace of inflation.

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Other Regulatory Requirements

We are subject to health care "fraud and abuse" laws, such as the federal civil False Claims Act, the anti-kickback provisions of the federal Social Security Act, and other state and federal laws and regulations.

We are subject to healthcare "fraud and abuse" laws, such as the federal civil False Claims Act, the anti-kickback provisions of the federal Social Security Act, and other state and federal laws and regulations.

Federal and state anti-kickback laws prohibit, among other things, payments or other remuneration to induce or reward someone to purchase, prescribe, endorse, or recommend a product that is reimbursed under federal or state healthcare programs.

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"Risk Factors - Other Regulatory and Litigation Risks - Risks from the improper conduct of employees, agents, contractors, or collaborators could adversely affect our reputation and our business, prospects, operating results, and financial condition ."

We are subject to privacy and data protection laws in the United States and abroad, including health privacy laws, data breach notification laws, consumer protection laws, data localization laws, biometric privacy laws, and genetic privacy laws.

In the United States, there are numerous federal and state laws and regulations governing data privacy of personal data and the collection, use, disclosure, and protection of health data, genetic data, consumer data, and children's data.

Such laws and regulations include the Health Insurance Portability and Accountability Act of 1996 and its implementing regulations (collectively, "HIPAA"), as well as state data breach notification laws, state health information and/or genetic privacy laws, and federal and state consumer protection laws (such as Section 5 of the Federal Trade Commission Act (the "FTC Act") and the California Consumer Privacy Act (the "CCPA")).

Many of these laws differ from each other in significant ways and have different effects.

Many of the state laws enable a state attorney general to bring actions and provide private rights of action to consumers as enforcement mechanisms.

There is also heightened sensitivity around certain types of health data, which may be subject to additional protections.

The landscape of federal and state laws regulating personal data is constantly evolving.

Failure to comply with these laws and regulations could result in government enforcement actions and create liability for us (which could include civil and/or criminal penalties), private litigation, and/or adverse publicity.

Federal regulators, state attorneys general, and plaintiffs' attorneys have been active in this space.

HIPAA imposes privacy and security obligations on covered entity health care providers, health plans, and health care clearinghouses, as well as their "business associates" – certain persons or covered entities that create, receive, maintain, or transmit protected health information ("PHI") in connection with providing a specified service or performing a function on behalf of a covered entity.

Most health care providers, including research institutions from which we or our collaborators obtain clinical trial data, are subject to HIPAA.

Although we are not directly subject to HIPAA other than with respect to providing certain employee benefits, we could potentially be subject to criminal penalties if we, our affiliates, or our agents knowingly receive PHI maintained by a HIPAA-covered entity in a manner that is not permitted under HIPAA.

The Federal Trade Commission ("FTC") also sets expectations for failing to take appropriate steps to keep consumers' personal information secure, or failing to provide a level of security commensurate to promises made to individuals about the security of their personal information (such as in a privacy notice) may constitute unfair or deceptive acts or practices in violation of Section 5 of the FTC Act.

The FTC expects a company's data security measures to be reasonable and appropriate in light of the sensitivity and volume of consumer information it holds, the size and complexity of its business, and the cost of available tools to improve security and reduce vulnerabilities.

Individually identifiable health information is considered sensitive data that merit stronger safeguards.

With respect to privacy, the FTC also sets expectations that companies honor the privacy promises made to individuals about how the company handles consumers' personal information;

and any failure to honor promises, such as the statements made in a privacy policy or on a website, may also constitute unfair or deceptive acts or practices in violation of the FTC Act.

The FTC has the power to enforce promises as it interprets them, and events that we cannot fully control, such as data breaches, may result in FTC enforcement.

Enforcement by the FTC under the FTC Act can result in civil penalties or enforcement actions.

To the extent we collect California resident personal data, we are also subject to the CCPA.

The CCPA includes certain transparency requirements and grants California residents several rights with regard to their personal data.

In addition, in November 2020, California voters approved the California Privacy Rights Act ("CPRA") ballot initiative which introduced significant amendments to the CCPA and established and funded a dedicated California privacy regulator, the California Privacy Protection Agency ("CPPA").

The amendments introduced by the CPRA went into effect on January 1, 2023.

Failure to comply with such laws may result in, among other things, significant civil penalties and injunctive relief, or statutory or actual damages.

In addition, California residents have the right to bring a private right of action in connection with data privacy incidents involving certain elements of personal data.

These claims may result in significant liability and damages.

Similarly, there are a number of legislative proposals in the United States, at both the federal and state level, that could impose new obligations or limitations in the area of consumer protection.

Several additional state consumer privacy laws went into effect in 2023 and many other consumer privacy laws are expected to come into effect in the near future that have or will impose new obligations or limitations in areas affecting our business.

We may be subject to fines, penalties, or private actions in the event of non-compliance with such laws.

Outside the United States, our clinical trial programs, research collaborations, and other processing activities implicate international data protection laws, including the EU General Data Protection Regulation 2016/679 ("GDPR").

The GDPR has increased our responsibility and liability in relation to the processing of personal data of individuals located in the EU.

The GDPR, together with the national legislation of the EU member states governing the processing of personal data, impose strict obligations and restrictions on the ability to collect, analyze, and transfer personal data, including health data and samples from clinical trials and adverse event reporting.

In particular, these obligations and restrictions may concern the consent of the individuals to whom the personal data relate, the information provided to the individuals, the sharing of personal data with third parties, the transfer of personal data out of the EU, security breach notifications, security and confidentiality of the personal data and imposition of substantial potential fines for violations of the data protection obligations.

In 2021, the European Commission published new standard contractual clauses required to be incorporated into new and existing agreements in order to continue to lawfully transfer personal data outside the EU.

Different EU member states, as well as the United Kingdom and Switzerland, have promulgated national privacy laws that impose additional requirements, which add to the complexity of processing and transferring EU personal data.

In October 2022, the United States issued an executive order to implement the EU-U.S.

Data Privacy Framework, for which the European Commission adopted an adequacy decision in July 2023 concluding that personal data can flow freely from the EU to companies in the United States that participate in the EU-U.S.

Data Privacy Framework.

Some countries outside the EU have reacted to the GDPR by promulgating and enacting new privacy legislation that reflects similar principles and obligations on companies that operate and process their citizens' personal data.

Any failure or perceived failure to comply with privacy-related legal obligations, or any compromise of security of personal data, may result in governmental enforcement actions, litigation, contractual indemnity claims, or restraining orders that would impact our ability to process and share data globally.

As we expand our presence into new countries, we must continue to assess our privacy controls to enable the processing of personal data.

Guidance on implementation and compliance practices are often updated or otherwise revised.

See Part I, Item 1A.

"Risk Factors - Other Regulatory and Litigation Risks - We face risks related to the personal data we collect, process, and share ."

At the federal level, most U.S.

healthcare providers, including research institutions from which we or our collaborators obtain clinical trial data, are subject to privacy and security regulations promulgated under the Health Insurance Portability and Accountability Act of 1996, the Health Information Technology for Economic and Clinical Health Act, and their implementing regulations (collectively, "HIPAA").

While Regeneron is not directly subject to HIPAA, other than potentially with respect to providing certain employee benefits, we could be subject to criminal penalties if we, our affiliates, or our agents knowingly receive protected health information in a manner that is not permitted under HIPAA.

The Federal Trade Commission ("FTC") also sets expectations for taking appropriate steps to safeguard consumers' personal information and for providing a level of privacy or security commensurate to promises made to individuals.

Failure to meet these FTC standards may constitute unfair or deceptive acts or practices in violation of Section 5 of the FTC Act.

The FTC also has the power to enforce the Health Breach Notification Rule, which imposes notification obligations on companies for breaches of certain health information contained in personal health records.

Enforcement by the FTC under the FTC Act and Health Breach Notification Rule can result in civil penalties or enforcement actions.

In addition, at the state level, many state consumer privacy laws recently went into effect and many other consumer privacy laws are expected to go into effect in the near future.

These laws include certain transparency and other requirements to protect personal data and grant residents with certain rights regarding their personal data.

These laws and regulations are constantly evolving and may impose limitations on our business activities.

Outside the United States, our activities subject us to additional data protection authority oversight and require us to comply with stringent local and regional data privacy laws.

Such laws include the EU's General Data Protection Regulations ("GDPR"), which has a wide range of compliance obligations relating to the processing and protection of personal data.

Violations of the GDPR carry significant financial penalties for noncompliance.

The GDPR also confers a private right of action on data subjects and

consumer associations to file complaints with data protection authorities, seek judicial remedies, and obtain compensation for damages resulting from violations of the GDPR.

Many other jurisdictions outside the United States have adopted and continue to adopt varying privacy and data protection legislation, the continued emergence of which has increased the costs and complexity of compliance.

In addition to the foregoing, our present business is, and our future business may be, subject to regulation under the United States Atomic Energy Act, the Clean Air Act, the Clean Water Act, the Comprehensive Environmental Response, Compensation and Liability Act, the National Environmental Policy Act, the Toxic Substances Control Act, the Resource Conservation and Recovery Act, national restrictions, and other current and potential future local, state, federal, and foreign regulations.

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Of these employees, 2,562 were within our research and preclinical development organization, 2,151 were within our global clinical development and regulatory affairs organization, and 6,846 were within our industrial operations and product supply organization.

Company-wide, over 1,500 of our full-time employees hold a Ph.D.

Company-wide, nearly 1,700 of our full-time employees hold a Ph.D.

We also supplement our workforce with independent contractors, contingent workers, and temporary workers, as needed.

None of our employees are represented by a labor union, and our management considers its relations with our employees to be good.

Diversity, Equity, and Inclusion

Culture and Development

Our employees represent a broad range of backgrounds, just like the people who take our medicines, and bring a wide array of perspectives and experiences that have helped us achieve our leadership position in the biotechnology and pharmaceuticals industries and the global marketplace.

A key component of our culture is our commitment to diversity, equity, and inclusion ("DEI").

We believe this commitment allows us to better drive innovation and achieve our mission to repeatedly bring important new medicines to patients with serious diseases.

Our strategy is rooted in the understanding that DEI drives better science and that better science drives a better world.

We believe that by fostering an inclusive culture and bringing diverse voices and perspectives to the discourse, we improve our ability to fulfill our mission.

We empower employee-led cross-functional resource groups, functional/site-level DEI councils, and other interest groups, who connect around a common passion to build a culture of inclusion and collaboration.

In 2023, we expanded our mentoring program and inclusive leadership workshops for senior leaders and new managers, focusing on our diverse talent base to increase leadership skills, connection, and visibility of underrepresented talent.

Our strategy is rooted in the understanding that a better workplace drives better science and that better science drives a better world.

We believe that by fostering an inclusive culture and bringing diverse voices and perspectives to the discourse, we improve our ability to fulfill our mission to repeatedly bring important medicines to patients with serious diseases.

We empower employee-led cross-functional resource groups, functional/site-level councils, and other interest groups, who connect around a common passion to build a culture of inclusion and collaboration.

In recent years, we have expanded our mentoring program and inclusive leadership workshops for senior leaders and new managers, focusing on our diverse talent base to increase leadership skills, connection, and visibility of underrepresented talent.

While we are proud of our workforce diversity representation shown in the table below, we seek to continuously improve in this area.

In April 2020, we announced our 2025 global responsibility goals, including a commitment to increase diversity in leadership and foster inclusion.

Making progress toward this goal, since then we hired our Chief DEI Officer;

launched a DEI strategy focused on creating a better workplace, better science, and better world;

and implemented a new governance model that includes both an executive DEI council and a DEI leadership council.

These councils are comprised of senior leaders who provide oversight and guidance on our DEI efforts and support the execution of our DEI strategy.

In early 2021, we launched a global strategy to advance diversity, focused on creating a better workplace, better science, and better world;

and implemented a new governance model that includes councils comprised of senior leaders who provide oversight and guidance on our diversity efforts and support the execution of our strategy.

In order to better understand our employees' perspectives, we also measure inclusion and belonging as part of our annual employee engagement survey.

Our board of directors receives a detailed update on our DEI efforts at least once a year and continues to monitor our progress.

Our board of directors and/or an appropriate committee thereof receives a detailed update on our efforts at least once a year and continues to monitor our progress.

2024 Workforce Diversity Representation *

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Excluding those that did not disclose such information, the percentage shown in this table would be 35.5%.

Externally, we support DEI efforts in our community, including by supporting young scientific talent in underrepresented communities.

Externally, we support diversity efforts in our community, including by supporting young scientific talent in underrepresented communities.

For example, as part of our $100 million, 10-year commitment to support the Regeneron Science Talent Search ("STS"), we allocate $3.1 million annually to fund the Society for Science’s science, technology, engineering, and math ("STEM") outreach and equity programs.

We have also been the title sponsor of the Regeneron International Science and Engineering Fair ("ISEF") since 2019 and recently announced an additional $34 million, 5-year commitment.

In 2023, the Together for CHANGE TM ("Changing Healthcare for People of African Ancestry through InterNational Genomics & Equity") initiative was launched by a coalition of Meharry Medical College, the Regeneron Genetics Center, AstraZeneca, Novo Nordisk, and Roche to improve health outcomes for people of African ancestry and enhance representation in STEM careers.

In addition, we have developed a STEM pilot program with post-primary-school and high-school students in the New York State Capital Region and Limerick, Ireland that aspires to build long-term relationships with students from disadvantaged socio-economic groups, to encourage and support them in their studies, to inspire them to attend college, and, ultimately, to build a deeper more diverse talent pipeline.

We have also been the title sponsor of the Regeneron International Science and Engineering Fair ("ISEF") since 2019 and made an additional $34 million, 5-year commitment to this program in 2023.

Also in 2023, the Together for CHANGE TM ("Changing Healthcare for People of African Ancestry through InterNational Genomics & Equity") initiative was launched by a coalition of Meharry Medical College, the Regeneron Genetics Center, AstraZeneca, Novo Nordisk, and Roche to improve health outcomes for people of African ancestry and enhance their representation in STEM careers.

Among our other efforts, we have developed a STEM pilot program with post-primary-school and high-school students in the New York State Capital Region and Limerick, Ireland that aspires to build long-term relationships with students from disadvantaged socio-economic groups, to encourage and support them in their studies, to inspire them to attend college, and, ultimately, to build a deeper more diverse talent pipeline.

We also continue to take steps to further integrate diversity considerations into the design and selection of sites for our clinical studies to make sure they reflect the diversity of patients with the diseases under investigation.

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Occupational health and safety is critical to our success.

We are committed to meeting or exceeding all environmental, health, safety ("EHS") and security regulations and have a range of programs, plans, and procedures to ensure the safety of all people who come to work at Regeneron.

We are committed to meeting or exceeding all environmental, health, safety ("EHS") and security regulations and have a range of programs, policies, and procedures to ensure the safety of all people who come to work at Regeneron.

In addition, our 2025 global responsibility goals include a commitment to focus on workplace injury prevention in our drive toward zero incidents.

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In addition, we continue to invest in our current and future leaders through a number of leadership development courses and programs and feedback and coaching opportunities.

In 2023, over 25% of job openings were filled by existing employees who were seeking career development opportunities.

In 2024, nearly 30% of job openings were filled by existing employees who were seeking career development opportunities.

Employee Engagement

We believe engaging our employees, from their first day and throughout their career, is key to fostering new ideas and driving commitment and productivity.

We communicate frequently and transparently with our employees through a variety of communication methods, including video and written communications, company forums and summits, annual engagement surveys, and pulse surveys.

We communicate frequently and transparently with our employees through a variety of communication methods, including video and written communications, company forums and town halls, annual engagement surveys, and pulse surveys.

We are also committed to fostering employee volunteerism to reach our 2025 global responsibility goal of driving employee volunteer levels above national standards.

Employees are encouraged and empowered to support organizations and causes that are important to them including through, among other things, our matching gift program, volunteer-time-off policy, and our annual company-wide service event, Day for Doing Good .

In 2023, over 7,300 employees volunteered approximately 39,600 hours, including approximately 51% of our employees who volunteered nearly 23,600 hours to approximately 230 nonprofits during our

Day for Doing Good .

Additionally, through our Matching Gift Program, we matched approximately $2.4 million in employee contributions in 2023, supporting nearly 2,000 charities.

In 2023, we were named to the Civic 50 of most community-minded companies in the United States for the seventh consecutive year.

In 2024, over 7,800 employees volunteered approximately 45,400 hours,

including approximately 49% of our employees who volunteered nearly 27,400 hours to approximately 220 nonprofits during our Day for Doing Good .

Additionally, through our Matching Gift Program, we matched approximately $2.3 million in employee contributions in 2024, supporting over 2,300 charities.

In 2024, we were named to the Civic 50 of most community-minded companies in the United States for the eighth consecutive year.

The success of our employee engagement efforts is demonstrated by our employee retention rate of 94% in 2024, as well as the fact that 88% of our employees who responded to our annual engagement survey said Regeneron is a great place to work.

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Employee engagement, commitment, and achievements are key drivers of pipeline success and therefore our long-term performance.

The primary underpinning of our pay philosophy is to award equity-based pay to all eligible employees to ensure that when we deliver for patients and for shareholders, everyone shares in the upside growth.

Our practice, therefore, has been to award initial equity grants to all new hires, in addition to our comprehensive annual equity program.

Total employee compensation packages (which vary by country and region) include market-competitive pay (with the opportunity to receive above-market rewards), broad-based grants of equity-based awards, comprehensive healthcare benefits, parental leave, child and elder care support, retirement savings options, and matching contributions in connection with employee savings plans.

We annually review our workforce demographic and pay equity data to track our performance and inform new initiatives.

Our analysis indicates favorable performance in these areas, and we are committed to continued monitoring.

The primary underpinning of our pay philosophy is to award stock-based pay to all eligible employees to ensure that when we deliver for patients and for shareholders, everyone shares in the upside growth.

Our practice, therefore, has been to award initial stock-based grants to all new hires, in addition to our comprehensive annual stock-based compensation program.

Total employee compensation packages (which vary by country and region) include market-competitive pay (with the opportunity to receive above-market rewards), broad-based grants of stock-based awards, comprehensive healthcare benefits, parental leave, child and elder care support, retirement savings options, and matching contributions in connection with employee savings plans.

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 Exchange Act, as soon as reasonably practicable after we electronically file such material with, or furnish it to, the Securities and Exchange Commission ("SEC").

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

What changed 10-K

Item 1. Business