What changed in this filing

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Item 1. Business

2024-02-05 compared with 2023-02-06 · 456 added, 511 removed, 740 unchanged (57% of the section changed)

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Words such as "anticipate," "expect," "intend," "plan," "believe," "seek," "estimate," variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words.

These statements concern, and these risks and uncertainties include, among others, the impact of SARS-CoV-2 (the virus that has caused the COVID-19 pandemic) on Regeneron's business and its employees, collaborators, and suppliers and other third parties on which Regeneron relies, Regeneron's and its collaborators’ ability to continue to conduct research and clinical programs, Regeneron's ability to manage its supply chain, net product sales of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, "Regeneron’s Products"), and the global economy;

the nature, timing, and possible success and therapeutic applications of Regeneron's Products and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, "Regeneron's Product Candidates") and research and clinical programs now underway or planned, including without limitation EYLEA ® (aflibercept) Injection, Dupixent ® (dupilumab) Injection, Libtayo ® (cemiplimab) Injection, Praluent ® (alirocumab) Injection, Kevzara ® (sarilumab) Injection, Evkeeza ® (evinacumab), aflibercept 8 mg, pozelimab, odronextamab, itepekimab, fianlimab, garetosmab, linvoseltamab, REGN5713-5714-5715, Regeneron's other oncology programs (including its costimulatory bispecific portfolio), Regeneron's and its collaborators' earlier-stage programs, and the use of human genetics in Regeneron's research programs;

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

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

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

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

the likelihood, timing, and scope of possible regulatory approval and commercial launch of our late-stage product candidates and new indications for Regeneron's Products, including without limitation those listed above;

• 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 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;

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• 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;

and 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 (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.

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

In evaluating such statements, shareholders and potential investors should specifically consider the various factors identified under Part I, Item 1A.

In evaluating such statements, shareholders and potential investors should specifically consider the various

factors identified under Part I, Item 1A.

"Risk Factors," which could cause actual events and results to differ materially from those indicated by such forward-looking statements.

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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, pain, hematologic conditions, infectious diseases, and rare 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 objective is to continue to be an integrated, multi-product biotechnology company that provides patients and medical professionals with important medicines for preventing and treating human diseases.

Our objective is to continue to advance as an integrated, multi-product biotechnology company that provides patients and medical professionals with important medicines for preventing and treating human diseases.

Selected financial information is summarized as follows:

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

Certain products have also received marketing approval in countries outside the United States, European Union ("EU"), or Japan.

Product Disease Territory

EU Japan ROW (e)

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

Wet age-related macular degeneration ("wAMD")

Diabetic macular edema ("DME")

Diabetic retinopathy ("DR")

EYLEA ® (aflibercept) Injection (a)

Neovascular age-related macular degeneration ("wet AMD") a a a a

Diabetic macular edema ("DME") a a a a

Macular edema following retinal vein occlusion ("RVO"), which includes macular edema following central retinal vein occlusion ("CRVO") and macular edema following branch retinal vein occlusion ("BRVO")

Myopic choroidal neovascularization ("mCNV") a a a

Diabetic retinopathy ("DR") a

Myopic choroidal neovascularization ("mCNV") a a

Neovascular glaucoma ("NVG") a

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Dupixent ® (dupilumab) Injection (b)

Atopic dermatitis (in adults and adolescents) a a a a

Atopic dermatitis (in pediatrics 6–11 years of age) a a a

Atopic dermatitis (in pediatrics 6 months–5 years of age) a a

Asthma (in adults and adolescents) a a a a

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

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

Atopic dermatitis (in adults, adolescents, and pediatrics aged 6 months and older)

Asthma (in adults and adolescents) a a a

Product (continued)

Disease Territory

EU Japan ROW (e)

Dupixent (dupilumab) Injection (b) (continued)

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)

Prurigo nodularis a a a

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

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

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

Metastatic or recurrent second-line cervical cancer

Praluent ® (alirocumab) Injection (d)

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

Cardiovascular risk reduction in patients with established cardiovascular disease a a a

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

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

Cardiovascular risk reduction in patients with established cardiovascular disease a a

Homozygous familial hypercholesterolemia ("HoFH") a

REGEN-COV ®(f)

COVID-19 a a a

Kevzara (sarilumab) Solution for Subcutaneous Injection (b)

Rheumatoid arthritis ("RA") a a a a

Evkeeza (evinacumab) Injection (g)

HoFH (in adults and adolescents) a a a

Inmazeb ® (atoltivimab, maftivimab, and odesivimab-ebgn) Injection

REGEN-COV ®(e)

Kevzara (sarilumab) Injection (b)

Rheumatoid arthritis ("RA") a a a

Polymyalgia rheumatica ("PMR")

Evkeeza ® (evinacumab) Injection (f)

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

Inmazeb ® (atoltivimab, maftivimab, and odesivimab) Injection

Infection caused by Zaire ebolavirus

ARCALYST ® (rilonacept) Injection for Subcutaneous Use (h)

Veopoz ™ (pozelimab) Injection

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

ARCALYST ® (rilonacept) Injection (g)

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 and pediatrics) a

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

Recurrent pericarditis (in adults and adolescents)

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

Metastatic colorectal cancer ("mCRC") a a a a

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

Metastatic colorectal cancer ("mCRC") a a a

Refer to table below (net product sales of Regeneron-discovered products) for information regarding whether net product sales for a particular product are recorded by us or others.

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(a) In collaboration with Bayer outside the United States.

Aflibercept 8 mg is known as EYLEA HD in the United States and EYLEA 8 mg in other countries.

(b) In collaboration with Sanofi

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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 solely responsible for the development and commercialization of Praluent outside of the United States.

(e) Rest of world ("ROW").

A checkmark in this column indicates that the product has received marketing approval in at least one country outside of the United States, European Union ("EU"), or Japan.

(f) Known as REGEN-COV in the United States and Ronapreve ™ in other countries.

(g) The Company is solely responsible for the development and commercialization of Evkeeza in the United States.

In January 2022, the Company entered into a license and collaboration agreement for Ultragenyx to develop and commercialize Evkeeza outside of the United States.

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

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

(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.

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:

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ROW Total U.S.

$ 165.8 $ — $ 165.8 $ — $ — $ — $ — $ — $ —

$ 5,719.6 $ 3,495.2 $ 9,214.8 $ 6,264.6 $ 3,382.8 $ 9,647.4 $ 5,792.3 $ 3,450.9 $ 9,243.2

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

$ 8,855.6 $ 2,732.5 $ 11,588.1 $ 6,668.0 $ 2,013.2 $ 8,681.2 $ 4,713.0 $ 1,485.3 $ 6,198.3

$ 538.8 $ 330.0 $ 868.8 $ 374.5 $ 203.5 $ 578.0 $ 306.3 $ 151.9 $ 458.2

$ 182.4 $ 456.5 $ 638.9 $ 130.0 $ 337.4 $ 467.4 $ 170.0 $ 251.1 $ 421.1

REGEN-COV (e)

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$ 150.5 $ 67.4 $ 217.9 $ 56.1 $ 69.1 $ 125.2 $ 25.9 $ 86.4 $ 112.3

* Effective January 1, 2022, the Company and Bayer commenced sharing equally in profits and losses based on sales from Bayer to its distributor in Japan.

Previously, the Company received from Bayer a tiered percentage of sales based on sales by Bayer's distributor in Japan.

Consequently, the prior year net product sales amount has been revised for comparability purposes.

(a) Regeneron records net product sales of EYLEA in the United States.

Bayer records net product sales of EYLEA outside the United States.

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

(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/losses in connection with global 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.

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

Included in this line item is approximately $34 million of net product sales recorded by Sanofi in the second half of 2022 in connection with sales in certain markets (Sanofi will record net product sales in such markets during a transition period until inventory on hand as of July 1, 2022 is sold through to the end customers).

(d) Effective April 1, 2020, Regeneron records net product sales of Praluent in the United States.

Also effective April 1, 2020, Sanofi records net product sales of Praluent outside the United States and pays the Company a royalty on such sales.

Previously, Sanofi recorded global net product sales of Praluent and the Company recorded its share of profits/losses in connection with such sales.

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.

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

(g) Rest of world ("ROW")

Programs in Clinical Development

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2023 and 2024

Events to Date Select Upcoming Milestones

Events to Date

Select Upcoming Milestones

Ophthalmology

EYLEA HD (aflibercept) 8 mg (a)

–Approved by U.S.

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

–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)

–ROP (U.S.) –Granted pediatric exclusivity by U.S.

Food and Drug Administration ("FDA") in connection with ROP study, extending period of EYLEA U.S.

market exclusivity by six months through May 17, 2024

–Approved by European Commission ("EC") for ROP

–Approved by Ministry of Health, Labour and Welfare ("MHLW") for ROP in Japan

–Withdrew supplemental Biologics License Application ("sBLA") for every-16-weeks dosing regimen in patients with DR

–FDA decision on sBLA for ROP (target action date of February 11, 2023)

Aflibercept 8 mg (a)

–Wet AMD and DME (U.S.)

–Reported that Phase 3 trials in wet AMD and DME met their primary endpoints

–FDA decision on BLA for wet AMD and DME (third quarter 2023)

–Submit regulatory application in the EU for wet AMD and DME (first quarter 2023)

–Report two-year data from Phase 3 studies in wet AMD and DME (third quarter 2023)

Clinical Program (continued)

Phase 1 Phase 2 Phase 3 Regulatory Review (h)

2022 and 2023

Events to Date Select Upcoming Milestones

–Approved by FDA for ROP

Pozelimab (f) (REGN3918)

Antibody to C5

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

Immunology & Inflammation

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Antibody to IL-4R alpha subunit

–EoE in pediatrics (c)

–Chronic obstructive pulmonary disease ("COPD")

–Bullous pemphigoid (Phase 2/3) (c)

–Ulcerative colitis

–Eosinophilic gastroenteritis (Phase 2/3)

–Chronic obstructive pulmonary disease

–Bullous pemphigoid (c)

–Chronic spontaneous urticaria ("CSU")

–Chronic inducible urticaria - cold

–Chronic rhinosinusitis without nasal polyposis

–Allergic fungal rhinosinusitis

–Chronic pruritus of unknown origin

–Atopic dermatitis in pediatrics (6 months–5 years of age) (EU) and in pediatrics and adolescents (6 months–14 years of age (Japan)

–Prurigo nodularis (Japan)

–CSU in adults and adolescents (U.S.)

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

–European Medicines Agency's ("EMA") Committee for Medicinal Products for Human Use ("CHMP") adopted positive opinion for atopic dermatitis in pediatrics (6 months–5 years of age)

–Approved by EC for severe asthma in pediatrics (6–11 years of age)

–Approved by FDA and EC for EoE in adults and adolescents

–Reported that Phase 3 trial in EoE in pediatrics (1–11 years of age) met its primary endpoint

–Approved by FDA and EC for prurigo nodularis

–Stopped one of the Phase 3 trials in CSU (in patients refractory to omalizumab) due to futility, based on pre-specified interim analysis

–Initiated additional Phase 3 trial in CSU (in biologic-naïve patients)

–Discontinued further clinical development in peanut allergy

–EC decision on regulatory submission for atopic dermatitis in pediatrics (6 months–5 years of age) (first half 2023)

–MHLW decision on regulatory submission for atopic dermatitis in pediatrics and adolescents (6 months–14 years of age) in Japan (second half 2023)

–Submit sBLA for EoE in pediatrics (mid-2023)

–Report results from first Phase 3 study in COPD (first half 2023)

–FDA decision on sBLA for CSU in adults and adolescents (second half 2023)

–Report results from Phase 3 study in chronic inducible urticaria - cold (first half 2023)

–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

Clinical Program (continued)

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2023 and 2024

Events to Date Select Upcoming Milestones

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)

Kevzara (sarilumab) (b)

Antibody to IL-6R

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

–Systemic juvenile idiopathic arthritis ("sJIA") –Polymyalgia rheumatica ("PMR") (U.S.) –FDA decision on sBLA for PMR (target action date of February 28, 2023)

–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

Clinical Program (continued)

Phase 1 Phase 2 Phase 3 Regulatory Review (h)

2023 and 2024

Events to Date

Select Upcoming Milestones

Itepekimab (b) (REGN3500)

Antibody to IL-33

–COPD –Report results from Phase 3 study in COPD (2024)

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

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

REGN5713-5714-5715

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Solid Organ Oncology

Libtayo (cemiplimab) (n)(g)

Libtayo (cemiplimab) (g)

Antibody to PD-1

–Neoadjuvant CSCC

–Second-line cervical cancer, ISA101b combination

–First-line NSCLC, BNT116 (r) combination

–Adjuvant CSCC

–First-line NSCLC, chemotherapy combination (EU)

–Approved by FDA in combination with chemotherapy for NSCLC

–Approved by EC and MHLW for cervical cancer

–Voluntarily withdrew sBLA for cervical cancer due to inability to align with FDA on certain post-marketing studies

–Positive data from Phase 2 trial in neoadjuvant CSCC presented at European Society for Medical Oncology ("ESMO") Congress 2022 and published in New England Journal of Medicine

–EC decision on regulatory submission for NSCLC, chemotherapy combination (first half 2023)

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

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

Fianlimab (f) (REGN3767)

Antibody to LAG-3

–Solid tumors and advanced hematologic malignancies –First-line metastatic melanoma

–First-line adjuvant melanoma –Presented positive data from Phase 1 trial (in combination with Libtayo) in advanced melanoma at ESMO Congress 2022

–Initiate Phase 3 study (in combination with Libtayo) in perioperative melanoma (mid-2023)

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

–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)

Immune activator targeting TLR9

–Solid tumors

Clinical Program (continued)

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2023 and 2024

Events to Date Select Upcoming Milestones

Fianlimab (f)

–Positive initial data from Phase 1 trial (in combination with Libtayo) in NSCLC presented at ESMO Immuno-Oncology Congress 2022

–Initiate Phase 2/3 studies (in combination with Libtayo) in first-line advanced NSCLC (first half 2023)

–Initiate Phase 2 study (in combination with Libtayo) in perioperative NSCLC (second half 2023)

Immune activator targeting TLR9

–Solid tumors –Initiate Phase 2 study in melanoma

Ubamatamab (f)

Events to Date

Select Upcoming Milestones

Ubamatamab (f) (REGN4018)

Bispecific antibody targeting MUC16 and CD3

–Platinum-resistant ovarian cancer –Presented positive initial data from monotherapy dose escalation portion of Phase 1/2 study in platinum-resistant ovarian cancer at ESMO Congress 2022

–Report results from Phase 1/2 study (in combination with Libtayo) in platinum-resistant ovarian cancer (2023)

–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

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Bispecific antibody targeting PSMA and CD28

–Prostate cancer –Reported preliminary data from dose escalation portion of Phase 1/2 study (in combination with Libtayo) in prostate cancer

–Report additional results from Phase 1/2 study (in combination with Libtayo) in prostate cancer (2023)

–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)

Bispecific antibody targeting PSMA and CD3

–Prostate cancer

Davutamig (REGN5093)

Bispecific antibody targeting two distinct MET epitopes

–MET-altered advanced NSCLC –Presented positive initial data from dose escalation portion of Phase 1/2 study in MET-altered advanced NSCLC at ESMO Congress 2022

–MET-altered advanced NSCLC

REGN5093-M114

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–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)

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2023 and 2024

Events to Date Select Upcoming Milestones

Bispecific antibody targeting EGFR and CD28

–Solid tumors

Odronextamab (i) (REGN1979)

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)

Bispecific antibody targeting CD20 and CD3

–Certain B-cell malignancies (c)(m)

–Certain B-cell malignancies (c)

–B-cell non-Hodgkin lymphoma

("B-NHL") (m) (pivotal study)

–Presented positive data from two cohorts of pivotal Phase 2 study in patients with diffuse large B-cell lymphoma ("DLBCL") and follicular lymphoma ("FL") at American Society of Hematology ("ASH") Annual Meeting

–Initiate Phase 3 studies in FL and DLBCL, including earlier lines of therapy (first half 2023)

–Submit BLA for relapsed/refractory FL and DLBCL (second half 2023)

Linvoseltamab (f)

("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

Linvoseltamab (f) (REGN5458)

Bispecific antibody targeting BCMA and CD3

–Multiple myeloma (c)

–Multiple myeloma (pivotal study) (c)

–Completed enrollment in pivotal Phase 2 study in multiple myeloma

–Presented positive data from pivotal Phase 2 study in multiple myeloma at ASH Annual Meeting

–Initiate Phase 3 study in multiple myeloma, including earlier lines of therapy (first half 2023)

–Submit BLA for relapsed/refractory multiple myeloma (second half 2023)

–Multiple myeloma (c)(e)

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

–Earlier (pre-malignant) multiple myeloma

–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

Pozelimab (f) (REGN3918)

Antibody to C5;

studied as monotherapy and in combination with cemdisiran

–CD55-deficient protein-losing enteropathy ("CHAPLE"), monotherapy (c)(e) (potentially pivotal study)

–Myasthenia gravis, cemdisiran combination (k)

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

–CHAPLE, monotherapy (U.S.)

–FDA decision on BLA for CHAPLE, monotherapy (second half 2023)

Antibody to IL2Rg

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–Transthyretin ("ATTR") amyloidosis (c)

–Reported positive interim data from Phase 1 trial in ATTR

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

Antibody to Factor XI

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

Antibody to Factor XI

Clinical Program (continued)

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2023 and 2024

Events to Date Select Upcoming Milestones

Antibody to Factor XI

Events to Date

Select Upcoming Milestones

Antibody to TMPRSS6

–Transfusion dependent iron overload

General Medicine

"Next Generation" Covid Antibodies

Antibodies to SARS-CoV-2 variants

–Initiate clinical development of "next generation" antibody

Internal Medicine/Genetic Medicines

Praluent (alirocumab)

Antibody to PCSK9

–HeFH in pediatrics –Submit sBLA for HeFH in pediatrics (mid-2023)

Evkeeza (evinacumab) (f)(l)

–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

–HoFH in pediatrics (5–11 years of age) (U.S.)

–Reported that Phase 3 trial for HoFH in pediatrics (5–11 years of age) met its primary endpoint

–FDA decision on sBLA for HoFH in pediatrics (5–11 years of age) (target action date of March 30, 2023)

–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)

Mibavademab (f)

Trevogrumab (f) (REGN1033)

Antibody to myostatin (GDF8)

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

Mibavademab (f) (REGN4461)

Agonist antibody to leptin receptor ("LEPR")

–Generalized lipodystrophy (e)

–Partial lipodystrophy

–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 –Report initial data in healthy volunteers (2023)

–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

Antagonist antibody to NPR1

–Healthy volunteers

RNAi therapeutic targeting HSD17B13

–Nonalcoholic steatohepatitis

("NASH") –Reported preliminary data from Phase 1 study in NASH

–Initiate Phase 2 study in NASH (first quarter 2023)

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 –Report results from Phase 1 study in early-onset Alzheimer’s disease (mid-2023)

–Early-onset Alzheimer’s disease (q)

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

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

For purposes of the table above, a program is classified in Phase 1, 2, or 3 clinical development after recruitment for the corresponding study or studies has commenced.

We have discontinued further clinical development of fasinumab (REGN475), an antibody to NGF, which was previously being studied in osteoarthritis pain of the knee or hip in collaboration with Teva and Mitsubishi Tanabe Pharma Corporation ("MTPC");

REGN6490, an antibody to IL-36R, which was previously being studied in palmo-plantar pustulosis;

and the Phase 3 study of REGN1908-1909, a multi-antibody therapy to Fel d 1, in cat allergy, due to futility.

(a) In collaboration with Bayer outside the United States

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

(i) In collaboration with Zai Lab in mainland China, Hong Kong, Taiwan, and Macau

(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.

(j) In collaboration with Intellia

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

(n) In collaboration with Sanofi prior to July 2022.

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

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

(o) Studied in combination with ubamatamab

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

(n) Studied in combination with ubamatamab

(o) 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.

Additional Information - Clinical Development Programs

Aflibercept 8 mg

In September 2022, the Company announced that the primary endpoints were met in two pivotal trials investigating aflibercept 8 mg with 12- and 16-week dosing regimens in patients with DME and wet AMD.

The PHOTON trial in DME and the PULSAR trial in wet AMD both demonstrated that aflibercept 8 mg 12- and 16-week dosing regimens achieved non-inferiority in vision gains compared to the EYLEA 8-week dosing regimen.

Furthermore, of the patients randomized to 12- and 16-week dosing intervals, 91% and 89% of DME patients, respectively, and 79% and 77% of wet AMD patients, respectively, maintained those intervals through 48 weeks.

The safety of aflibercept 8 mg was similar to EYLEA in both trials, and consistent with the known safety profile of EYLEA from previous clinical trials.

The Company is utilizing a priority review voucher in connection with the December 2022 submission of the BLA for DME and wet AMD.

REGEN-COV (casirivimab and imdevimab)

REGEN-COV, a multi-antibody therapy to SARS-CoV-2 virus, previously received an EUA for use in certain post-exposure prophylaxis settings and as a treatment for people with mild to moderate COVID-19 who are at high risk of serious consequences from COVID-19.

Based on laboratory data, in January 2022, the FDA revised the EUA for REGEN-COV to exclude its use in geographic regions where, based on available information including variant susceptibility and regional variant frequency, infection or exposure is likely due to a variant such as an Omicron-lineage variant that is not susceptible to the treatment.

With this EUA revision, REGEN-COV is not currently authorized for use in any U.S.

states, territories, or jurisdictions, since Omicron-lineage variants are currently dominant across the United States.

In December 2022, the FDA issued a complete response letter ("CRL") on the BLA for REGEN-COV to treat COVID-19 in non-hospitalized patients and as prophylaxis in certain individuals.

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.

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

EYLEA (aflibercept)

EYLEA is a soluble fusion protein that acts as a vascular endothelial growth factor ("VEGF") inhibitor, formulated as a 2 mg intravitreal injection for the eye.

It is designed to block the growth of new blood vessels and decrease the ability of fluid to pass through blood vessels (vascular permeability) in the eye by blocking VEGF-A and PLGF, two growth factors involved in angiogenesis.

Aflibercept 8 mg

Aflibercept 8 mg is an investigational soluble fusion protein that acts as a VEGF inhibitor.

Through a novel formulation, it is designed to deliver a concentrated dose of aflibercept to block VEGF-A and PLGF and inhibit the growth of new blood vessels and decrease vascular permeability.

Aflibercept 8 mg is being studied in wet AMD and DME using extended dosing intervals of every 12 weeks and every 16 weeks.

EYLEA HD (aflibercept) 8 mg

EYLEA HD is a soluble fusion protein that acts as a vascular endothelial growth factor ("VEGF") inhibitor.

Through a novel formulation, it is designed to deliver a concentrated dose of aflibercept to block VEGF-A and PLGF and inhibit the growth of new blood vessels and decrease vascular permeability to treat various retinal diseases, including wAMD, DME, and DR.

Dupixent (dupilumab)

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.

Kevzara (sarilumab)

Kevzara is a fully human monoclonal antibody that binds specifically to the IL-6 receptor and inhibits IL-6-mediated signaling.

IL-6 is a signaling protein produced in increased quantities in patients with RA and has been associated with disease activity, joint destruction, and other systemic problems.

IL-6 is an immune system protein produced in increased quantities in patients with RA and has been associated with disease activity, joint destruction, and other systemic problems.

Itepekimab is an investigational, fully human monoclonal antibody that inhibits IL-33, a protein that is believed to play a key role in lung inflammation in COPD.

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Libtayo (cemiplimab)

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

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.

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

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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).

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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.

Pozelimab is an investigational, fully human monoclonal antibody designed to block complement factor C5 in order to treat diseases mediated by abnormal complement pathway activity, including PNH, CHAPLE, and myasthenia gravis.

Pozelimab is being studied as monotherapy and also in combination with Alnylam’s investigational small interfering RNA ("siRNA") therapy, cemdisiran.

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.

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)

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Our scientists have developed two different technologies to make protein therapeutics that potently and specifically block, activate, or inhibit the action of specific cell surface or secreted molecules.

The first technology fuses receptor components to the constant region of an antibody molecule to make a class of drugs we call "Traps".

EYLEA, ZALTRAP, and ARCALYST are drugs generated using our Trap technology.

The first technology fuses receptor components to the constant region of an antibody molecule to make a class of drugs we call "Traps." EYLEA HD, EYLEA, ZALTRAP, and ARCALYST are drugs generated using our Trap technology.

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.

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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.

As a result, VelociT mice generate fully human TCRs, providing for customized modeling of T-cell function in different diseases and a powerful platform for the discovery of unique TCR-based therapies.

As a result, VelociT mice can be utilized to produce fully human TCRs, providing for customized modeling of T-cell function in different diseases and a powerful platform for the discovery of unique TCR-based therapies.

We are also able to produce antibodies that recognize intracellular peptides bound in the groove of human leukocyte antigen ("HLA"), enabling the targeting of intracellular proteins in cancer cells.

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Regeneron Genetics Center ®

Regeneron Genetics Center LLC (RGC ™ ), a wholly owned subsidiary of Regeneron Pharmaceuticals, Inc., leverages de-identified clinical, genomic, and other types of molecular data from properly consented human volunteers from around the world to identify medically relevant associations in a blinded fashion designed to preserve a patients' privacy while uncovering the unique characteristics of their health and wellness.

Regeneron Genetics Center LLC (RGC ® ), a wholly owned subsidiary of Regeneron Pharmaceuticals, Inc., leverages de-identified clinical, genomic, and other types of molecular data from properly consented human volunteers from around the world to identify medically relevant associations in a blinded fashion designed to preserve a patient's privacy while uncovering the unique characteristics of their health and wellness.

The objective of RGC is to expand the use of human genetics for discovering and validating genetic factors that cause or influence a range of diseases where there are major unmet medical needs, with the prospect of improving the drug discovery and development process and to advance innovation in clinical care design.

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 approximately 2 million samples sequenced to date.

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.

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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.

Agreements Related to COVID-19

In 2020, the Company expanded its Other Transaction Agreement with the Biomedical Advanced Research Development Authority ("BARDA"), pursuant to which the U.S.

Department of Health and Human Services ("HHS") was obligated to fund certain of our costs incurred for research and development activities related to COVID-19 treatments.

In 2020, the Company also entered into an agreement with entities acting at the direction of BARDA and the U.S.

Department of Defense to manufacture and deliver filled and finished drug product of REGEN-COV to the U.S.

The agreement, as subsequently amended, provided for payments to the Company of up to $465.9 million in the aggregate for bulk manufacturing of the drug substance, as well as fill/finish, storage, and other activities.

In January 2021, the Company entered into an agreement with the U.S.

Department of Defense and HHS to manufacture and deliver additional filled and finished drug product of REGEN-COV to the U.S.

Pursuant to the agreement, the U.S.

government was obligated to purchase 1.25 million doses of drug product, resulting in payments to the Company of $2.625 billion.

In September 2021, the Company entered into an amendment to its January 2021 agreement to supply the U.S.

government with an additional 1.4 million doses of REGEN-COV.

Pursuant to the agreement, the U.S.

government was obligated to purchase all filled and finished doses of such additional drug product delivered by January 31, 2022, resulting in payments to the Company of $2.940 billion in the aggregate.

Additionally, Roche supplied a portion of the doses to Regeneron to fulfill our agreement with the U.S.

government (see "Roche" section below for further details regarding our collaboration agreement with Roche).

As of December 31, 2021, the Company had completed its final deliveries of drug product under the agreements described above.

In 2020, we entered into a collaboration agreement with Roche to develop, manufacture, and distribute the casirivimab and imdevimab antibody cocktail (known as REGEN-COV in the United States and Ronapreve in other countries).

We have the right to distribute the product in the United States and Roche has the right to distribute the product outside of the United States.

The parties share gross profits from worldwide sales based on a pre-specified formula, depending on the amount of manufactured product supplied by each party to the market.

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

Collaboration, License, and Other Agreements

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We supply certain commercial bulk product to Sanofi.

We and Sanofi equally share profits and losses 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), and share losses outside the United States 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) exceeding $1.0 billion and $1.5 billion, respectively, on a rolling twelve-month basis.

We are entitled to receive the final sales milestone payment of $50.0 million when such sales outside the United States exceed $3.0 billion on a rolling twelve-month basis.

In April 2020, the Company and Sanofi entered into an amendment to the LCA in connection with, among other things, the removal of Praluent from the LCA such that (i) effective April 1, 2020, the LCA no longer governs the development, manufacture, or commercialization of Praluent and (ii) the quarterly period ended March 31, 2020 was the last quarter for which Sanofi and the Company shared profits and losses for Praluent under the LCA.

The parties also entered into a Praluent Cross License & Commercialization Agreement (the "Praluent Agreement") pursuant to which, effective April 1, 2020, the Company, at its sole cost, became solely responsible for the development and commercialization of Praluent in the United States, and Sanofi, at its sole cost, is solely responsible for the development and commercialization of Praluent outside of the United States.

Under the Praluent Agreement, Sanofi pays the Company a 5% royalty on Sanofi’s net product sales of Praluent outside the United States until March 31, 2032.

The Company does not owe Sanofi royalties on the Company’s net product sales of Praluent in the United States.

Although each party will be responsible for manufacturing Praluent for its respective territory, the parties have entered into definitive supply agreements under which, for a certain transitional period, the Company will continue to supply drug substance to Sanofi and Sanofi will continue to supply finished product to Regeneron.

With respect to any intellectual property or product liability litigation relating to Praluent, the parties have agreed that, effective April 1, 2020, Regeneron and Sanofi each will be solely responsible for any such litigation (including damages and other costs and expenses thereof) in the United States and outside the United States, respectively, arising out of Praluent sales or other activities on or after April 1, 2020 (subject to Sanofi's right to set off a portion of any third-party royalty payments resulting from certain patent litigation proceedings against up to 50% of any Praluent royalty payment owed to Regeneron).

The parties will each bear 50% of any damages arising out of Praluent sales or other activities prior to April 1, 2020.

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

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

The parties shared equally, on an ongoing basis, 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 of the United States.

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, the Company 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").

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 earned a $65.0 million sales-based milestone upon the achievement of a specified amount of worldwide net product sales of Libtayo in 2022, and is eligible to receive an additional $35.0 million sales-based milestone upon the achievement of a specified amount of worldwide net product sales of Libtayo in 2023.

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 Regeneron certain transition, distribution, and manufacturing services, respectively.

Under the Amended and Restated Immuno-oncology Discovery and Development Agreement, 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.

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 Bayer are parties to a license and collaboration agreement for the global development and commercialization of EYLEA and aflibercept 8 mg outside the United States.

We and Bayer are parties to a license and collaboration agreement for the global development and commercialization of EYLEA 8 mg and EYLEA outside the United States.

Agreed-upon development expenses incurred by the Company and Bayer are generally shared equally.

Bayer markets EYLEA outside the United States, and the companies share equally in profits and losses from such sales.

In Japan, we were entitled to receive a tiered percentage of between 33.5% and 40.0% of EYLEA net sales through 2021, and, effective January 1, 2022, the companies share equally in profits and losses from sales.

Bayer is responsible for commercialization activities outside the United States, and the companies share equally in profits from such sales.

We are obligated to reimburse Bayer for 50% of the development costs that it has incurred under the agreement from our share of the collaboration profits.

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

We and Teva are parties to a collaboration agreement to develop and commercialize fasinumab globally, excluding certain Asian countries that are subject to our collaboration agreement with MTPC.

In connection with the agreement, Teva made a $250.0 million non-refundable up-front payment in 2016.

We led global development activities, including the manufacturing of fasinumab, and the parties shared development costs equally.

As of December 31, 2022, we had received an aggregate $120.0 million of development milestones from Teva.

During the third quarter of 2022, we discontinued further clinical development of fasinumab.

In 2019, we and Alnylam Pharmaceuticals, Inc.

entered into a collaboration to discover RNA interference ("RNAi") therapeutics for NASH and potentially other related diseases, as well as to research, co-develop and commercialize any therapeutic product candidates that emerge from these discovery efforts (including ALN-HSD, which is currently in clinical development).

Under the terms of the collaboration agreement, the parties share development costs equally.

During the fourth quarter of 2022, Alnylam elected to opt-out of further development activities related to ALN-HSD;

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

In 2019, we and Alnylam 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.

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.

For each program, we provide Alnylam with a specified amount of funding at program initiation and at lead candidate designation, and Alnylam is eligible to receive up to an aggregate of $200.0 million in clinical proof-of-principle milestones for eye and CNS programs.

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

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.

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").

In addition, we have an option to extend the Research Term for an additional five-year period for a research extension fee ranging from $200.0 million to $400.0 million;

the actual amount of the fee will be determined based on the acceptance of one or more Investigational New Drug Applications ("INDs") (or their equivalent in certain other countries) for programs in the eye and CNS.

At the stage of designation of a lead candidate for CNS programs and liver programs, the parties have alternating rights to be a lead party for collaboration products.

At the stage of designation of a lead candidate for eye programs, we have the sole right to take the product forward as a licensee.

The lead party is required to take the program forward under the License Agreement structure unless the other party exercises its rights to opt-in to a Co-Co Collaboration Agreement as a participating party, in which case the lead party is required to take the program forward under the Co-Co Collaboration Agreement structure.

Alnylam does not have rights to opt-in to a Co-Co Collaboration Agreement for eye programs.

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.

The licensee will be responsible for its own costs and expenses incurred in connection with the development and commercialization of the collaboration products under the License Agreement.

The licensee will be responsible for its own costs and expenses incurred.

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.

If a party exercises its co-funding opt-out right, the lead party will be required to make certain tiered royalty payments to the other party based on the aggregate annual net sales of the collaboration product and the timing of the exercise of the co-funding opt-out right.

Under the collaboration, when we are the licensee under a License Agreement or the lead party under a Co-Co Collaboration Agreement, Alnylam will be responsible for the manufacture and supply of the product to us for Phase 1 and Phase 2 clinical trials.

In addition, during 2019, the parties entered into a Co-Co Collaboration Agreement for cemdisiran, an siRNA therapeutic targeting the C5 component of the human complement pathway being developed by Alnylam, with Alnylam as the lead party, and a License Agreement for a combination consisting of cemdisiran and pozelimab, with us as the licensee.

Under the C5 siRNA Co-Co Collaboration Agreement, the parties shared costs equally, and under the License Agreement, we as the licensee are responsible for our own costs and expenses.

The C5 siRNA License Agreement contains a flat low double-digit royalty payable to Alnylam on potential future net sales of the combination only subject to customary reductions, as well as up to $325.0 million in sales milestones.

During the fourth quarter of 2022, we elected to opt-out of further development activities pursuant to the Co-Co Collaboration Agreement for cemdisiran as a monotherapy;

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

In 2016, we entered into a license and collaboration agreement with Intellia Therapeutics, Inc.

to advance CRISPR/Cas9 gene-editing technology for in vivo therapeutic development.

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).

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

We and BARDA are parties to agreements pursuant to which HHS provided certain funding to develop, test, and manufacture a treatment for Ebola virus infection.

In 2020, HHS exercised its option under an existing agreement to provide additional funding for the manufacture and supply of Inmazeb.

We expect to deliver a pre-specified number of Inmazeb treatment doses over the course of approximately six years.

See "Agreements Related to COVID-19 - U.S.

Government" section above for information related to our COVID-19 agreements.

Pursuant to a 2017 license agreement, we granted Kiniksa Pharmaceuticals, Ltd.

the right to develop and commercialize certain new indications for ARCALYST.

During the first quarter of 2021, Kiniksa received marketing approval in the United States for a new indication of ARCALYST, recurrent pericarditis.

The quarterly period ended March 31, 2021 was the last quarter for which the Company recorded net product sales of ARCALYST.

Following this approval, Kiniksa is solely responsible for the U.S.

development and commercialization of ARCALYST in all approved indications, and Regeneron will continue to supply clinical and commercial product to Kiniksa.

Kiniksa will pay Regeneron 50% of its profits from sales of ARCALYST and the parties will not share in any losses incurred by Kiniksa in connection with commercialization of ARCALYST.

In January 2022, we entered into a license and collaboration agreement for Ultragenyx Pharmaceutical Inc.

to develop and commercialize Evkeeza in countries outside of the United States.

In connection with the agreement, Ultragenyx made a $30.0 million non-refundable up-front payment to the Company.

Ultragenyx will share in certain costs for global trials led by the Company and also have the right to continue to clinically develop Evkeeza in countries outside of the U.S.

We will supply commercial product to Ultragenyx at a tiered purchase price, which is calculated as a percentage of net sales of the product (subject to adjustment in certain circumstances), and are eligible to receive additional regulatory and sales milestone payments.

In May 2022, the Company completed its acquisition of Checkmate Pharmaceuticals, Inc.

for a total equity value of approximately $250 million.

In connection with the acquisition, the Company obtained the rights to vidutolimod, which is in clinical development for oncology.

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.

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 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.

Manufacturing

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

In addition, the construction of a fill/finish facility in Rensselaer, New York is in process.

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

We currently have approximately 100,000 liters of cell culture capacity at our Rensselaer facility and approximately 120,000 liters of cell culture capacity at our Limerick facility.

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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.

supply various raw materials and other products.

See Part I, Item 1A.

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In the United States, we sell our marketed products primarily to wholesalers and specialty distributors that serve pharmacies, hospitals, government agencies, physicians, and other healthcare providers.

We had sales to two customers (Besse Medical, a subsidiary of AmerisourceBergen Corporation, and McKesson Corporation) that each accounted for more than 10% of total gross product revenue for the year ended December 31, 2022.

We had sales to two customers (Besse Medical, a subsidiary of Cencora, Inc., and McKesson Corporation) that each accounted for more than 10% of total gross product revenue for the year ended December 31, 2023.

On a combined basis, our product sales to these customers accounted for 76% of our total gross product revenue for the year ended December 31, 2023.

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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 some products in accordance with our collaboration agreements.

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.

Refer to "Collaboration, License, and Other Agreements" section above for additional information related to these agreements.

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

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Marketed Products

The table below provides an overview of the current competitive landscape for the key products marketed by us and/or our collaborators in such products' currently approved indications.

The table below provides an overview of the current competitive landscape for key products marketed by us and/or our collaborators in such products' currently approved indications.

The table below is provided for illustrative purposes only and is not exhaustive.

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Marketed Product Competitor Product Competitor Indication Territory (a)

EYLEA Lucentis ® (ranibizumab injection)

Novartis AG and Genentech/Roche Wet AMD, DME, macular edema following RVO (including CRVO and BRVO), diabetic retinopathy, mCNV, and ROP Worldwide

EYLEA HD and EYLEA

Yesafili ® (aflibercept) (biosimilar referencing EYLEA)

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

Lucentis ® (ranibizumab injection)

Novartis AG and Genentech/Roche wAMD, DME, macular edema following RVO (including CRVO and BRVO), DR, mCNV, and ROP

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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and Biogen Inc.

Wet AMD, DME, macular edema following RVO (including CRVO and BRVO), diabetic retinopathy, and mCNV United States, EU

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

United States, EU

Ximluci ® (ranibizumab) (biosimilar referencing Lucentis)

Xbrane Biopharma AB, Bausch + Lomb, and STADA Arzneimittel AG Wet AMD, DME, macular edema following RVO (including CRVO and BRVO), diabetic retinopathy, and CNV EU

Xbrane Biopharma AB and Bausch + Lomb

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

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

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

Wet AMD, DME, macular edema following RVO (including CRVO and BRVO), diabetic retinopathy, and CNV United States, EU

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

United States, EU

Susvimo ® (ranibizumab ocular implant)

Genentech/Roche Wet AMD United States

Genentech/Roche wAMD

United States

Vabysmo ™ (faricimab-svoa)

Genentech/Roche Wet AMD, DME Worldwide

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

United States, EU, Japan

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

Genentech/Roche Wet AMD, DME, and macular edema following RVO Worldwide

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

United States, EU, Japan

Beovu ® (brolucizumab) Injection

Novartis AG Wet AMD, DME Worldwide

Novartis AG wAMD, DME

United States, EU, Japan

Ozurdex ® (dexamethasone intravitreal implant)

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DME, RVO United States, EU

Marketed Product (continued)

Competitor Product Competitor Indication Territory (a)

EYLEA (continued)

Iluvien ® (fluocinolone acetonide intravitreal implant)

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DME United States, EU

Conbercept Chengdu Kanghong Pharmaceutical Group Co., Ltd.

Wet AMD, DME, mCNV China

Dupixent Eucrisa ® /Staquis ® (crisaborole)

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Cibinqo ® (abrocitinib)

Pfizer Moderate-to-severe atopic dermatitis Worldwide

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

Rinvoq ® (upadacitinib)

AbbVie Moderate-to-severe atopic dermatitis Worldwide

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

Adbry ™ /Adtralza ® (tralokinumab)

LEO Pharma Inc.

Moderate-to-severe atopic dermatitis Worldwide

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

Ebglyss ® (lebrikizumab)

Almirall S.A.

Moderate-to-severe atopic dermatitis EU

Corectim ® (delgocitinib)

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Xolair ® (omalizumab)

Roche/Novartis Asthma, nasal polyps Worldwide (asthma);

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 Worldwide (asthma);

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

United States, EU (nasal polyps)

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Fasenra ® (benralizumab)

AstraZeneca Asthma Worldwide

Asthma United States, EU, Japan

Tezspire ™ (tezepelumab-ekko)

AstraZeneca/Amgen Asthma Worldwide

AstraZeneca/Amgen Asthma United States, EU, Japan

Libtayo Keytruda ® (pembrolizumab)

Merck & Co., Inc.

Various cancers Worldwide

Various cancers United States, EU, Japan

Opdivo ® (nivolumab)

Bristol-Myers Squibb Various cancers Worldwide

Bristol-Myers Squibb Various cancers United States, EU, Japan

Tecentriq ® (atezolizumab)

Roche Various cancers Worldwide

Roche Various cancers United States, EU, Japan

Imfinzi ® (durvalumab)

AstraZeneca Various cancers Worldwide

AstraZeneca Various cancers United States, EU, Japan

Bavencio ® (avelumab)

Pfizer/Merck KGaA Various cancers Worldwide

Pfizer/Merck KGaA Various cancers United States, EU, Japan

Jemperli ® (dostarlimab)

GSK Various cancers United States, EU

Praluent Repatha ® (evolocumab)

Amgen Reduce the risk of myocardial infarction, stroke, and coronary revascularization in adults with established cardiovascular disease;

primary hyperlipidemia;

and HoFH Worldwide

Marketed Product (continued)

Competitor Product Competitor Indication Territory (a)

Praluent ( continued)

Leqvio ® (inclisiran)

Novartis Primary hypercholesterolemia (heterozygous familial and non-familial) or mixed dyslipidemia

United States, EU

Kevzara Actemra ® (tocilizumab)

Genentech/Roche/Chugai Pharmaceutical Co., Ltd.

Rheumatoid arthritis Worldwide

Orencia ® (abatacept)

Bristol-Myers Squibb Rheumatoid arthritis Worldwide

Xeljanz ® (tofacitinib)

Pfizer Rheumatoid arthritis Worldwide

Olumiant ® (baricitinib)

Eli Lilly/Incyte Rheumatoid arthritis Worldwide

Rinvoq ® (upadacitinib)

AbbVie Rheumatoid arthritis Worldwide

Jyseleca ® (filgotinib)

Gilead Sciences, Inc./Galapagos NV

Rheumatoid arthritis EU, Japan

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

"Worldwide" indicates that the relevant product is approved in the United States, EU, Japan, and at least one other country.

(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.

Product Candidates

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These companies are using various technologies in competition with our VelocImmune technology and our other antibody generation technologies, including their own antibody generation technologies and other approaches such as RNAi, chimeric antigen receptor T cell (CAR-T cell), and gene therapy technologies.

We are also aware of several companies developing or marketing small molecules that may compete with our antibody product candidates in various indications, if such product candidates obtain regulatory approval in those indications.

We are also aware of other companies developing or marketing small molecules that may compete with our antibody product candidates in various indications, if such product candidates obtain regulatory approval in those indications.

For additional information regarding our product candidates (including those being developed in collaboration with our collaborators) and the substantial competition they face, see also Part I, Item 1A.

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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 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.

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

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Our policy is to file patent applications to protect technology, inventions, and improvements that we consider important to our business and operations.

We hold an ownership interest in a number of issued patents in the United States and foreign countries with respect to our products and technologies.

In addition, we hold an ownership interest in thousands of patent applications in the United States and foreign countries.

We hold an ownership interest in a number of issued patents in the United States and other countries with respect to our products and technologies.

In addition, we hold an ownership interest in thousands of patent applications in the United States and other countries.

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

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One or more patents with the same or earlier expiry date may fall under the same "general subject matter class" for certain products and may not be separately listed.

We also own various patents with claims relating to methods of making, formulating, and/or using the active molecules contained within our key products, but that do not cover indications, methods of use or processes currently approved by regulatory agencies or used by us and/or our collaborators.

Such patents are not listed in the following table.

Product Molecule Territory Patent No.

General Subject Matter Class Expiration

aflibercept US 7,070,959 Composition of Matter June 16, 2023 (b)

aflibercept (8 mg)

US 10,066,458 Formulation June 14, 2027

US 11,084,865 Formulation June 14, 2027

US 10,857,231 Formulation March 22, 2026

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 10,130,681 Methods of Treatment January 11, 2032

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

JP 7,235,770 Formulation May 10, 2039

aflibercept (2 mg)

US 8,092,803 Formulation June 21, 2027

US 11,066,458 Formulation June 14, 2027

US 11,084,865 Formulation June 14, 2027

US 11,732,024 Formulation June 14, 2027

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

3 unchanged sentences

US 10,888,601 Methods of Treatment January 11, 2032

US 10,406,226 Method of Manufacturing March 22, 2026

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

EP 2364691 Formulation June 14, 2027

EP 2944306 Formulation June 14, 2027

Composition of Matter

December 29, 2022 – December 25, 2023 (d)

Methods of Treatment

June 24, 2022

February 27, 2028 – October 1, 2029 (d)

Product (continued)

1 unchanged sentence

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)

EP 2364691 Formulation June 14, 2027

EP 2944306 Formulation June 14, 2027 (b)

EP 2944306 Formulation (Supplementary Protection Certificate)

(May 25, 2028) (b)

February 27, 2028 – October 1, 2029 (d)

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

15 unchanged sentences

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

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

EP 2356151 (Supplementary Protection Certificate) (September 28, 2032) (c)

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

EP 2356151 Composition of Matter (Supplementary Protection Certificate)

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

EP 3010539 Methods of Treatment June 20, 2034

4 unchanged sentences

EP 3019191 Methods of Treatment July 10, 2034

EP 3703818 Methods of Treatment October 29, 2038

EP 4011915 Methods of Treatment August 20, 2033

EP 2624865 Formulation October 5, 2031

2 unchanged sentences

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

Product (continued)

Molecule Territory Patent No.

General Subject Matter Class Expiration

Dupixent (continued)

Methods of Treatment

9 unchanged sentences

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

JP 7,216,122 Methods of Treatment November 13, 2035

JP 7,216,157 Methods of Treatment August 20, 2033

JP 7,256,231 Methods of Treatment September 4, 2033

JP 7,315,545 Methods of Treatment October 29, 2038

JP 7,343,547 Methods of Treatment February 20, 2035

Libtayo cemiplimab US 9,987,500 Composition of Matter September 18, 2035

US 10,737,113 Composition of Matter April 10, 2035

US 11,603,407 Formulation March 21, 2038

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

2 unchanged sentences

EP 3097119 Composition of Matter January 23, 2035

EP 3606504 Formulation March 23, 2038

EP 3455258 Methods of Treatment May 12, 2037

EP 3932951 Methods of Treatment May 12, 2037

Composition of Matter January 23, 2035

Product (continued)

Molecule Territory Patent No.

General Subject Matter Class Expiration

Libtayo (continued)

Composition of Matter January 23, 2035 – March 15, 2039 (d)

JP 6,711,883 Composition of Matter January 23, 2035 – August 13, 2037 (d)

JP 7,174,009 Composition of Matter January 23, 2035 – March 9, 2035 (d)

JP 7,229,171 Formulation March 23, 2038

JP 6,999,577 Methods of Treatment May 12, 2037

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

Praluent (a)(f)

alirocumab US 8,062,640 Composition of Matter December 15, 2029

US 10,023,654 Composition of Matter December 15, 2029

US 10,472,425 Formulation July 27, 2032

US 8,357,371 Methods of Treatment December 21, 2029

US 9,550,837 Methods of Treatment December 15, 2029

US 9,724,411 Methods of Treatment January 15, 2031

US 11,246,925 Methods of Treatment April 11, 2032

US 11,306,155 Methods of Treatment July 16, 2035

US 10,428,157 Methods of Treatment December 26, 2037

US 10,544,232 Methods of Treatment March 13, 2035

US 10,995,150 Methods of Treatment June 6, 2034

US 11,116,839 Methods of Treatment June 14, 2033

EP 2358756 Composition of Matter December 15, 2029 (c)

EP 2358756 (Supplementary Protection Certificate) (September 25, 2030) (c)

EP 3156422 Composition of Matter December 15, 2029

EP 2756004 Methods of Treatment September 12, 2032

EP 3055333 Methods of Treatment October 10, 2034

EP 3689913 Methods of Treatment October 10, 2034

EP 3169353 Methods of Treatment July 16, 2035

EP 3169362 Methods of Treatment July 16, 2035

EP 3004171 Methods of Treatment June 6, 2034

EP 3068803 Methods of Treatment November 12, 2034

EP 3395836 Methods of Manufacturing January 27, 2032

Kevzara sarilumab US 7,582,298 Composition of Matter May 22, 2031 (g)

US 10,072,086 Formulation September 19, 2031

US 11,098,127 Formulation January 7, 2031

US 8,080,248 Methods of Treatment June 1, 2027

US 8,568,721 Methods of Treatment June 1, 2027

US 9,943,594 Methods of Treatment December 28, 2033

US 10,927,435 Methods of Treatment October 10, 2032

EP 2041177 Composition of Matter June 1, 2027 (c)

EP 2041177 (Supplementary Protection Certificate) (June 1, 2032) (c)

EP 2766039 Methods of Treatment October 10, 2032

EP 3071230 Methods of Treatment November 21, 2034

EP 3409269 Formulation January 7, 2031

EP 3756652 Formulation January 7, 2031

Composition of Matter June 1, 2027 – August 22, 2031 (d)

January 7, 2031 – October 24, 2031 (d)

Methods of Treatment

October 10, 2032 – March 29, 2033 (d)

JP 7,025,477 Methods of Treatment October 10, 2032

Product (continued)

Molecule Territory Patent No.

General Subject Matter Class Expiration

Kevzara (continued)

Methods of Treatment November 21, 2034

JP 7,166,925 Methods of Treatment March 7, 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.

Patent and Trademark Office relating to EYLEA and patent infringement proceedings relating to Praluent.

(b) A patent term extension has been granted by the U.S.

Patent and Trademark Office, extending the original patent term (May 23, 2020), insofar as it covers EYLEA, to June 16, 2023.

(c) Supplementary protection certificates ("SPCs") are pending and/or have been granted in various European countries, extending the original patent terms in those countries, where granted, to the applicable dates indicated in parentheses.

Patent and Trademark Office and patent infringement proceedings relating to EYLEA.

(b) Supplementary protection certificates ("SPCs") are pending or have been granted in various European countries, extending the original patent terms in those countries, where granted, to the applicable dates indicated in parentheses.

(c) SPC term extensions are pending or have been granted in various European countries based on the completion of a pediatric investigation program, extending the term of the SPC in those countries, where granted, an additional 6 months to the applicable dates indicated in parentheses.

(d) The patent term extension ("PTE") system in Japan allows for a patent to be extended more than once provided the later approval is directed to a different indication from that of the previous approval.

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Patent and Trademark Office, extending the original patent term (October 2, 2027), insofar as it covers Dupixent, to March 28, 2031.

(f) This table excludes Japanese patents related to Praluent because Praluent is not being commercialized in Japan at this time.

(g) A patent term extension has been granted by the U.S.

Patent and Trademark Office, extending the original patent term (June 1, 2027), insofar as it covers Kevzara, to May 22, 2031.

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.

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to obtain a license under certain patents owned and/or exclusively licensed by one or more of these parties that includes the right to develop and sell Libtayo.

Under the agreement, we pay royalties of 8.0% on worldwide sales of Libtayo through December 31, 2023, and royalties of 2.5% from January 1, 2024 through December 31, 2026.

Under the agreement, we paid royalties of 8.0% on worldwide sales of Libtayo through December 31, 2023, and are obligated to pay royalties of 2.5% from January 1, 2024 through December 31, 2026.

Patent law relating to the patentability and scope of claims in the biotechnology field is evolving and our patent rights are subject to this additional uncertainty.

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It is possible that patents issued or licensed to us will be successfully challenged, that a court may find that we are infringing validly issued patents of third parties, or that we may have to alter or discontinue the development of our products or pay licensing fees to take into account patent rights of third parties (see Part I, Item 1A.

"Risk Factors - Risks Related to Intellectual Property

and Market Exclusivity - We may be restricted in our development, manufacturing, and/or commercialization activities by patents or other proprietary rights of others, and could be subject to awards of damages if we are found to have infringed such patents or rights ";

"Risk Factors - Risks Related to Intellectual Property and Market Exclusivity - We may be restricted in our development, manufacturing, and/or commercialization activities by patents or other proprietary rights of others, and could be subject to awards of damages if we are found to have infringed such patents or rights ";

and Note 16 to our Consolidated Financial Statements).

Government Regulation

Regulation by government authorities in the United States and foreign countries is a significant factor in the research, development, manufacture, and marketing of our products and our product candidates.

Regulation by government authorities in the United States and other countries is a significant factor in the research, development, manufacture, and marketing of our products and our product candidates.

A summary of the primary areas of government regulation that are relevant to our business is provided below.

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Department of Agriculture's Animal Welfare Act.

The results of these studies must be submitted to the FDA or the relevant regulatory authority outside the United States as part of an IND or clinical trial application (as applicable), which must be reviewed by the FDA or the relevant government authority before proposed clinical testing can begin in the applicable country or jurisdiction.

The results of these studies must be submitted to the FDA or the relevant regulatory authority outside the United States as part of an IND or other clinical trial application (as applicable), which must be reviewed by the FDA or the relevant government authority before proposed clinical testing can begin in the applicable country or jurisdiction.

In the United States, unless the FDA raises concerns, the IND becomes effective 30 days following its receipt by the FDA, and the clinical trial proposed in the IND may begin.

The FDA or other regulatory authorities may ask for additional data in order to begin a clinical trial.

Rules that are equivalent in scope but which vary in application apply in foreign countries.

Rules that are equivalent in scope but which vary in application apply in other countries.

Product Approval

All of our product candidates require regulatory approval by relevant government authorities before they can be commercialized.

In particular, human therapeutic products are subject to rigorous preclinical and clinical trials and other pre-market approval requirements by the FDA, EMA, and other foreign regulatory authorities.

The structure and substance of the FDA and foreign pharmaceutical regulatory practices may evolve over time.

In particular, human therapeutic products are subject to rigorous preclinical and clinical trials and other pre-market approval requirements by the FDA, European Medicines Agency ("EMA"), and regulatory authorities of other countries.

The structure and substance of the FDA and other countries' pharmaceutical regulatory practices may evolve over time.

The ultimate outcome and impact of such developments cannot be predicted.

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Phase 3 data often form the core basis on which the FDA and comparable foreign regulatory authorities evaluate a product candidate's safety and effectiveness when considering the product application for regulatory approval.

If concerns arise about the safety of the product candidate, the FDA or other regulatory authorities can stop clinical trials by placing them on a "clinical hold" pending receipt of additional data, which can result in a delay or termination of a clinical development

The sponsoring company, the FDA or other regulatory authorities, or the IRB or Ethics Committee and competent authority may suspend or terminate a clinical trial at any time on various grounds, including a finding that the patients are being exposed to an unacceptable health risk.

The results of the preclinical and clinical testing of a biologic product candidate are then submitted to the FDA in the form of a BLA for evaluation to determine whether the product candidate may be approved for commercial sale under the Public Health Service Act.

Under the Prescription Drug User Fee Act, we typically must pay fees to the FDA for review of any BLA.

When a BLA is submitted, the FDA makes an initial determination as to whether the application is sufficiently complete to be accepted for review.

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Although the FDA is not bound by the recommendation of an advisory committee, the agency considers such recommendations carefully when making decisions.

Before approving a new drug or biologic product, the FDA also requires that the facilities at which the product will be manufactured or advanced through the supply chain be in compliance with current Good Manufacturing Practices, or cGMP, requirements and regulations governing, among other things, the manufacture, shipment, and storage of the product.

Before approving a new drug or biologic product, the FDA

also requires that the facilities at which the product will be manufactured or advanced through the supply chain be in compliance with current Good Manufacturing Practices, or cGMP, requirements and regulations governing, among other things, the manufacture, shipment, and storage of the product.

The FDA will typically inspect such facilities for compliance with these requirements and regulations prior to approving a BLA.

The FDA also can audit the sponsor of the BLA to determine if the clinical studies were conducted in compliance with current GCPs.

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Additionally, as a condition of approval, the FDA may impose restrictions that could affect the commercial prospects of a product and increase our costs, such as a Risk Evaluation and Mitigation Strategy ("REMS") to mitigate certain specific safety risks, and/or post-approval commitments or requirements to conduct additional clinical trials or non-clinical studies or to conduct surveillance programs to monitor the product's effects.

Approval of a product candidate by comparable regulatory authorities in foreign countries is generally required prior to commencement of marketing of the product in those countries.

Approval of a product candidate by comparable regulatory authorities in countries outside the United States is generally required prior to commencement of marketing of the product in those countries.

The approval procedure varies among countries and may involve different or additional testing, and the time required to obtain such approval may differ from that required for FDA approval.

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In some EU countries, we may also be required to have an approved PIP before we can begin enrolling pediatric patients in a clinical trial.

In the United States, under the Pediatric Research Equity Act ("PREA"), certain applications for approval must include an assessment, generally based on clinical study data, of the safety and effectiveness of the subject product in relevant pediatric populations, unless a waiver or

deferral is granted.

However, a pediatric study plan is not required for orphan products and the timing of the submission is subject to negotiation with FDA, but such plan cannot be submitted later than submission of a BLA.

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"Risk Factors - Risks Related to Maintaining Approval of Our Marketed Products and the Development and Obtaining Approval of Our Product Candidates and New Indications for Our Marketed Products - Obtaining and maintaining regulatory approval for drug products is costly, time-consuming, and highly uncertain.

Emergency Use Authorization

The Secretary of HHS may authorize unapproved medical products to be marketed in the context of an actual or potential emergency that has been designated by the U.S.

The COVID-19 pandemic has been designated as such a national emergency, with such designation currently expected to expire on May 11, 2023.

After an emergency has been announced, the Secretary of HHS may authorize the issuance of, and the FDA Commissioner may issue, EUAs for the use of specific products based on criteria established by the Food, Drug, and Cosmetic Act, including that the product at issue may be effective in diagnosing, treating, or preventing serious or life-threatening diseases when there are no adequate, approved, and available alternatives.

Although the criteria of an EUA differ from the criteria for approval of a BLA, EUAs nevertheless require the development and submission of data to satisfy the relevant FDA standards, as well as a number of ongoing compliance obligations.

The FDA expects EUA holders to work toward submission of full applications, such as a BLA, as soon as possible.

An EUA is also subject to additional conditions and restrictions and is product-specific.

An EUA terminates when the emergency determination underlying the EUA terminates.

An EUA is not a long-term alternative to obtaining FDA approval, licensure, or clearance for a product.

The FDA may revoke, revise, or restrict an EUA for a variety of reasons, including where it is determined that the underlying health emergency no longer exists or warrants such authorization or the medical product is no longer effective in diagnosing, treating, or preventing the underlying health emergency .

If we or our collaborators do not maintain regulatory approval for our marketed products, and obtain regulatory approval for our product candidates or new indications for our marketed products, we will not be able to market or sell them, which would materially and negatively impact our business, prospects, operating results, and financial condition.

Post-Approval Regulation

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The FDA has the explicit authority to require postmarketing studies (also referred to as post-approval or Phase 4 studies) and labeling changes based on new safety information, and may impose and enforce a REMS at the time of approval or after the product is on the market.

Post-approval modifications to the drug, such as changes in indications, labeling, or manufacturing processes or facilities, may require a sponsor to develop additional data or conduct additional preclinical studies or clinical trials, to be submitted in a new or supplemental BLA, which would require FDA approval.

Post-approval modifications to

the drug, such as changes in indications, labeling, or manufacturing processes or facilities, may require a sponsor to develop additional data or conduct additional preclinical studies or clinical trials, to be submitted in a new or supplemental BLA, which would require FDA approval.

Following approval, the FDA and comparable regulatory authorities outside the United States regulate the marketing and promotion of our products, which must comply with the Food, Drug, and Cosmetic Act and applicable FDA regulations and standards thereunder and equivalent foreign laws.

The review of promotional activities by the FDA and comparable regulatory authorities outside the United States includes, but is not limited to, healthcare provider-directed and direct-to-consumer advertising, communications regarding unapproved uses, industry-sponsored scientific and educational activities, promotional activities involving the Internet, and sales representatives' communications.

After approval, product promotion can include only those claims relating to safety and effectiveness that are consistent with the labeling approved by the FDA and comparable foreign regulatory authorities.

FDA and comparable foreign regulatory authorities' regulations impose restrictions on manufacturers' communications regarding unapproved uses, but under certain conditions may engage in non-promotional, balanced, scientific communication regarding such use.

FDA and comparable foreign regulatory authorities' regulations impose restrictions on manufacturers' communications regarding unapproved uses, but under certain conditions manufacturers may engage in non-promotional, balanced, scientific communication regarding such use.

Failure to comply with applicable FDA and comparable foreign regulatory authorities' requirements and restrictions in this area may subject a company to adverse publicity and enforcement action by the FDA, the Department of Justice, or the Office of the Inspector General of the Department of Health and Human Services, as well as state authorities and comparable regulatory authorities outside the United States.

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We may be subject to audits by the FDA and other regulatory authorities to ensure that we are complying with the applicable requirements.

Rules that are equivalent in scope but which vary in application apply in foreign countries in which we conduct clinical trials.

Rules that are equivalent in scope but which vary in application apply in countries outside the United States in which we conduct clinical trials.

The holder of an EU marketing authorization for a medicinal product must also comply with the EU's pharmacovigilance legislation.

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Prescription drug manufacturers in the U.S.

must comply with applicable provisions of the Drug Supply Chain Security Act and provide and receive product tracing information, maintain appropriate licenses, ensure they only work with other properly licensed entities, and have procedures in place to identify and properly handle suspect and illegitimate products.

properly handle suspect and illegitimate products.

We may also be subject to state regulations related to the manufacturing and distribution of our products.

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See Part I, Item 1A.

"Risk Factors - Risks Related to Commercialization of Our Marketed Products, Product Candidates, and New Indications for Our Marketed Products - Sales of our marketed products are dependent on the availability and extent of reimbursement from third-party payors, and changes to such reimbursement may materially harm our business, prospects, operating results, and financial condition.

"Risk Factors - Risks Related to Commercialization of Our Marketed Products, Product Candidates, and New Indications for Our Marketed Products - Changes to product reimbursement and coverage policies and practices may materially harm our business, prospects, operating results, and financial condition.

We participate in, and have certain price reporting obligations to, the Medicaid Drug Rebate program, state Medicaid supplemental rebate program(s), and other governmental pricing programs.

We also have obligations to report the average sales price for certain drugs to the Medicare program.

Medicaid program as a condition of having federal funds being made available for our drugs under Medicaid and Part B of the Medicare program.

Under the Medicaid Drug Rebate program, we are required to pay a rebate to each state Medicaid program for our covered outpatient drugs that are dispensed to Medicaid beneficiaries and paid for by a state Medicaid program as a condition of having federal funds being made available for our drugs under Medicaid and Part B of the Medicare program.

Medicaid is a joint federal and state program that is administered by the states for low-income and disabled beneficiaries.

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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).

Currently, the rebate is capped at 100 percent of the average manufacturer price, but effective January 1, 2024, this cap on the rebate will be removed, and our rebate liability could increase accordingly.

If we become aware that our 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.

The federal Patient Protection and Affordable Care Act (the "PPACA") made significant changes to the Medicaid Drug Rebate program, and CMS issued a final regulation, which became effective on April 1, 2016, to implement the changes to the Medicaid Drug Rebate program under the PPACA.

CMS recently 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 (beginning in 2022).

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.

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.

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.

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

Starting in 2023, 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 percent of total allowed charges under Medicare Part B for that drug.

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

Further, starting in 2023, the Inflation Reduction Act ("IRA") establishes a Medicare Part B inflation rebate scheme under which, generally speaking, manufacturers will owe rebates if the average sales price of a Part B drug increases faster than the pace of inflation.

Further, the Inflation Reduction Act ("IRA") has established a Medicare Part B inflation rebate scheme under which, generally speaking, manufacturers owe rebates if the average sales price of a Part B drug increases faster than the pace of inflation.

Failure to timely pay a Part B inflation rebate is subject to a civil monetary penalty.

The IRA also creates a drug price negotiation program under which, after being on the market for a certain period of time, the prices for certain high Medicare spending drugs and biological products provided to Medicare patients without generic or biosimilar competition will be capped by reference to, among other things, a specified non-federal average manufacturer price, starting in 2026.

The IRA also created a drug price negotiation program requiring the government to set prices for select high-expenditure drugs covered under Medicare Parts B and D.

Starting in 2023 and 2026, the government is authorized to select Part D and Part B drugs, respectively, for inclusion in the drug price negotiation program, with established prices to go into effect for selected Part D drugs in 2026 and for selected Part B drugs in 2028, in each case absent certain disqualifying events.

Failure to comply with requirements under the drug price negotiation program is subject to an excise tax and a civil monetary penalty.

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See Part I, Item 1A.

Civil monetary penalties can be applied if we are found to have knowingly submitted any false pricing or other information to the government, if we are found to have made a misrepresentation in the reporting of our average sales price, or if we fail to submit the required data on a timely basis.

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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 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.

In general, products subject to Medicaid price reporting and rebate liability are also subject to the 340B ceiling price calculation and discount requirement.

HRSA issued a final regulation regarding the calculation of the 340B ceiling price and the imposition of civil monetary penalties on manufacturers that knowingly and intentionally overcharge covered entities, which became effective on January 1, 2019.

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.

Any charge by HRSA that we have violated the requirements of the regulation could result in civil monetary penalties.

Moreover, under a final regulation effective January 13, 2021, HRSA established a new 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.

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.

Such claims are to be resolved through an ADR panel of government officials rendering a decision that could be appealed only in federal court.

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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.

In addition, legislation could be passed that would further expand the 340B program to additional covered entities or would require participating manufacturers to agree to provide 340B discounted pricing on drugs used in an inpatient setting.

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 discounts.

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

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.

In addition, as of October 2022, the IRA 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.

Failure to timely pay a Part D inflation rebate is subject to a civil monetary penalty.

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.

Failure to timely pay a Part D inflation rebate or otherwise comply with obligations under the Medicare Part D inflation rebate scheme is subject to a civil monetary penalty.

Private payor healthcare and insurance providers, health maintenance organizations, and pharmacy benefit managers in the United States are adopting more aggressive utilization management techniques and are increasingly requiring significant discounts and rebates from manufacturers as a condition to including products on formulary with favorable coverage and copayment/coinsurance.

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

The CCPA, which became effective on January 1, 2020, created new transparency requirements and granted California residents several new rights with regard to their personal data.

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 go into effect on January 1, 2023, and new implementing regulations are expected to be introduced by the CPPA.

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

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.

For example, states such as Virginia, Colorado, and Utah have enacted similar privacy laws that impose new obligations or limitations in areas affecting our business, and efforts at the federal level to enact similar laws have been ongoing.

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.

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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.

With respect to the transfer of personal data outside of the EU, while there are legal mechanisms available to lawfully transfer personal data outside of the EU, including to the United States, there are certain unsettled legal issues regarding such data transfers, the resolution of which may adversely affect our ability to transfer personal data or otherwise may cause us to incur significant costs to come into compliance with applicable data transfer impact assessments and implementation of legal data transfer mechanisms.

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

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 EU-U.S.

data privacy safeguards.

The European Commission is now expected to review the executive order and could propose an adequacy decision concerning the level of personal data protection in the United States under which personal data could flow freely from the EU to the United States.

Some countries outside of 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.

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.

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Employee Profile

As of December 31, 2022, we had 11,851 full-time employees, consisting of 9,843 employed in the United States, 1,721 employed in Ireland, and 287 employed in other countries (primarily in the United Kingdom and Germany).

Of these employees, 2,174 were within our research and preclinical development organization, 1,669 were within our global clinical development and

regulatory affairs organization, and 5,534 were within our industrial operations and product supply organization.

Company-wide, nearly 1,400 of our full-time employees hold a Ph.D.

As of December 31, 2023, we had 13,450 full-time employees, consisting of 10,875 employed in the United States, 1,939 employed in Ireland, and 636 employed in other countries (primarily in the United Kingdom, Japan, and Germany).

Of these employees, 2,393 were within our research and preclinical development organization, 2,002 were within our global clinical development and regulatory affairs organization, and 6,124 were within our industrial operations and product supply organization.

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

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

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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 DEI principles are reflected in our efforts in building a better workplace where employees can be themselves and succeed, advance medicine for all with better science, and use their voice and influence to create a better world.

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 collaborate to support under-served science and global communities.

In 2022, we introduced inclusive leadership education for some of our most senior leaders and launched a pilot mentorship program focused on our diverse talent base to increase visibility, connection, and the leadership skills of underrepresented talent.

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.

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.

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

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Externally, we support DEI 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, we allocate $3.1 million annually to fund the Society for Science’s science, technology, engineering, and math ("STEM") outreach and equity programs.

In 2022, we also continued our $24 million, 5-year title sponsorship of Regeneron International Science and Engineering Fair, with representation from over 1,700 student scientists representing 63 countries and 49 U.S.

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.

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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, plans, 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 2022, nearly 30% of job openings were filled by existing employees who were seeking career development opportunities.

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

Employee Engagement

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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 2022, nearly 7,000 employees volunteered approximately 31,200 hours, including approximately 55% of our employees who volunteered nearly 20,000 hours to approximately 190 nonprofits during our Day for Doing Good .

Additionally, through our Matching Gift Program, we matched over $2 million in employee contributions in 2022, supporting over 2,000 charities.

In 2022, we were named to the Civic 50 of most community-minded companies in the United States for the sixth consecutive year.

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.

The success of our employee engagement efforts is demonstrated by our employee retention rate of 93.6% in 2023, 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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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 varies 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.

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.

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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").

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

We encourage investors and other interested parties to review the

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

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

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

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

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