What changed in this filing

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Item 1. Business

2021-02-08 compared with 2020-02-07 · 729 added, 410 removed, 404 unchanged (74% 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 nature, timing, and possible success and therapeutic applications of products marketed by us and/or our collaborators (collectively, "Regeneron's Products") and our 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, fasinumab, evinacumab, REGN-EB3, garetosmab, pozelimab, and REGN1979;

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

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

the likelihood and timing of possible regulatory approval and commercial launch of our late-stage product candidates and new indications for Regeneron's Products, including without limitation EYLEA, Dupixent, Libtayo, Praluent, Kevzara, fasinumab, evinacumab, REGN-EB3, garetosmab, pozelimab, and REGN1979;

the extent to which the results from the research and development programs conducted by us or our collaborators may be replicated in other studies and lead to therapeutic applications;

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 (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 (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, Inmazeb TM (atoltivimab, maftivimab, and odesivimab-ebgn), REGEN-COV™ (casirivimab and imdevimab), fasinumab, Evkeeza TM (evinacumab), garetosmab, pozelimab, odronextamab, itepekimab, REGN5458, 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;

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 EYLEA, Dupixent, Libtayo, Praluent, Kevzara, REGEN-COV, fasinumab, Evkeeza, garetosmab, pozelimab, odronextamab, itepekimab, REGN5458, and REGN5713-5714-5715;

the extent to which the results from the research and development programs conducted by us and/or our collaborators may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval;

ongoing regulatory obligations and oversight impacting Regeneron's Products (such as EYLEA, Dupixent, Libtayo, Praluent, and Kevzara), research and clinical programs, and business, including those relating to patient privacy;

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

competing drugs and product candidates that may be superior to Regeneron's Products and product candidates;

uncertainty of market acceptance and commercial success of Regeneron's Products and product candidates;

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

competing drugs and product candidates that may be superior to, or more cost effective than, Regeneron's Products and Regeneron's Product Candidates;

uncertainty of market acceptance and commercial success of Regeneron's Products and Regeneron's Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary) on the commercial success of Regeneron's Products and Regeneron's Product Candidates;

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

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

coverage and reimbursement determinations by third-party payors, including Medicare and Medicaid;

the availability and extent of reimbursement of Regeneron’s Products from third-party payors, including private payor healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid (including the impact of the recently issued "most-favored-nation" interim final rule);

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

unanticipated expenses;

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the potential for any license or collaboration agreement, including our agreements with Sanofi, Bayer, and Teva Pharmaceutical Industries Ltd.

(or their respective affiliated companies, as applicable), to be cancelled or terminated without any further product success;

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 relating to Dupixent and Praluent described further in Note 16 to our Consolidated Financial Statements included in this report), other litigation and other proceedings and governmental 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.

(or their respective affiliated companies, as applicable), as well as Regeneron's agreement with Roche relating to REGEN-COV, 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 relating to EYLEA, Dupixent, Praluent, and REGEN-COV described further in Note 15 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 15 to our Consolidated Financial Statements included in this report), the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on our business, prospects, operating results, and financial condition.

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

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

We do not undertake any obligation to update publicly any forward-looking statement, whether as a result of new information, future events, or otherwise.

We do not undertake any obligation to update (publicly or otherwise) any forward-looking statement, whether as a result of new information, future events, or otherwise.

Regeneron Pharmaceuticals, Inc.

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(In millions, except per share data) 2020 2019 *

Revenues $ 8,497.1 $ 6,557.6 $ 5,145.6

Net income $ 3,513.2 $ 2,115.8 $ 2,444.4

Net income per share - diluted $ 30.52 $ 18.46 $ 21.29

In December 2019, we and Sanofi announced our intent to restructure the antibody collaboration for Kevzara and Praluent;

completion of the proposed arrangement is expected to be finalized in the first quarter of 2020.

Refer to "Collaboration Agreements - Collaborations with Sanofi - Antibody " section below for further details.

Marketed Products

We currently have seven products that have received marketing approval, which are currently marketed by us, Bayer, and/or Sanofi:

Disease Area (1)

* Certain revisions have been made to the previously reported revenues for the years ended December 31, 2019 and 2018.

See Note 1 to our Consolidated Financial Statements for further details.

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

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

Product Disease Area Territory

EU Japan ROW (4)

EYLEA (aflibercept) Injection (1)

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

Diabetic macular edema ("DME")

- 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")

Diabetic retinopathy

- Myopic choroidal neovascularization ("mCNV") a a a

- Diabetic retinopathy a

- Neovascular glaucoma ("NVG") a

Dupixent (dupilumab) Injection (2)

- Atopic dermatitis (in adults and adolescents) (5)

Asthma (in adults and adolescents)

Chronic rhinosinusitis with nasal polyposis ("CRSwNP")

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

- Asthma (in adults and adolescents) a a a a

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

Libtayo (cemiplimab) Injection (2)

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

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

Product (continued)

Disease Area Territory

EU Japan ROW (4)

Praluent (alirocumab) Injection (3)

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

Cardiovascular risk reduction in patients with established cardiovascular disease

- LDL-lowering in heterozygous familial hypercholesterolemia ("HeFH") or clinical atherosclerotic cardiovascular disease ("ASCVD") (in adults) a a (7)

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

Kevzara (sarilumab) Solution for Subcutaneous Injection (2)

Rheumatoid arthritis ("RA") (in adults)

- Rheumatoid arthritis ("RA") (in adults) a a a a

Inmazeb (atoltivimab, maftivimab, and odesivimab-ebgn) Injection - Infection caused by Zaire ebolavirus

ARCALYST ® (rilonacept) Injection for Subcutaneous Use (8)

Cryopyrin-Associated Periodic Syndromes ("CAPS"), including Familial Cold Auto-inflammatory Syndrome ("FCAS") and Muckle-Wells Syndrome ("MWS")

- Cryopyrin-Associated Periodic Syndromes ("CAPS"), including Familial Cold Auto-inflammatory Syndrome ("FCAS") and Muckle-Wells Syndrome ("MWS") a

- Deficiency of Interleukin-1 Receptor Antagonist ("DIRA") (in adults and pediatrics) a

ZALTRAP ® (ziv-aflibercept) Injection for Intravenous Infusion (6)

Metastatic colorectal cancer ("mCRC")

(1) Refer to label information in each territory for specific indication

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

Refer to "Net Product Sales of Regeneron-Discovered Products" section below for information regarding whether net product sales for a particular product are recorded by us, Bayer, or Sanofi

Refer to product label in each territory for specific information

(1) In collaboration with Bayer (outside the United States)

(2) In collaboration with Sanofi

(4) Marketed as Libtayo (cemiplimab-rwlc) Injection in the United States

(5) Pursuant to a 2015 amended and restated ZALTRAP agreement, Sanofi is solely responsible for the development and commercialization of ZALTRAP, and Sanofi pays us a percentage of aggregate net sales of ZALTRAP

(3) In collaboration with Sanofi prior to April 2020.

Effective April 2020, 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.

Pursuant to the April 2020 agreement, Sanofi pays us a royalty on net product sales of Praluent outside the United States.

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

(4) Rest of world.

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(5) Approval in Japan is for adults and adolescents 15 years of age and older

(6) Pursuant to a 2015 amended and restated ZALTRAP agreement, Sanofi is solely responsible for the development and commercialization of ZALTRAP, and Sanofi pays us a percentage of aggregate net product sales of ZALTRAP

(7) No longer marketed by Sanofi in Japan due to injunction (see Note 15 to our Consolidated Financial Statements for further details)

(8) Pursuant to a 2017 license agreement with Kiniksa Pharmaceuticals, Ltd., we granted Kiniksa the right to develop and commercialize certain new indications for ARCALYST.

We currently maintain exclusive rights to ARCALYST in the United States for existing indications.

Commencing with the receipt of marketing approval by Kiniksa for the first new indication of ARCALYST in the United States, we will grant U.S.

commercial rights to ARCALYST for all approved indications and Kiniksa will pay us a share of ARCALYST profits.

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

Additional Information - Product Updates

Inmazeb is a cocktail of three fully-human monoclonal antibodies that each bind to the Ebola virus at different points, which may serve to increase efficacy, reduce the development of viral sequences that lead to resistance, and potentially enable utility in future outbreaks as viruses continue to evolve.

In October 2020, the U.S.

Food and Drug Administration ("FDA") approved Inmazeb for the treatment of infection caused by Zaire ebolavirus in adult and pediatric patients, including newborns of mothers who have tested positive for the infection.

In connection with this approval, we were also granted a material threat medical countermeasure priority review voucher by the FDA.

REGEN-COV - Emergency Use Authorization

In November 2020, REGEN-COV (antibody cocktail casirivimab and imdevimab administered together) received Emergency Use Authorization ("EUA") from the FDA for the treatment of mild to moderate COVID-19 in adults, as well as in pediatric patients at least 12 years of age and weighing at least 40 kg, who have received positive results of direct SARS-CoV-2 viral testing and are

at high risk for progressing to severe COVID-19 and/or hospitalization.

The EUA is temporary and does not replace a formal Biologics License Application ("BLA") submission review and approval process.

This use is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use, unless terminated or revoked sooner.

See information regarding ongoing clinical trials of REGEN-COV below.

Net Product Sales of Regeneron-Discovered Products

Year Ended December 31,

(In millions)

Net product sales recorded by Regeneron

Net product sales recorded by Sanofi (1) :

(1) Bayer records net product sales of EYLEA outside the U.S., and Sanofi records net product sales of Libtayo outside the U.S.

and global net product sales of Dupixent, Praluent, Kevzara, and ZALTRAP.

Refer to "Collaboration Agreements" section below for further details.

Net Product Sales Recorded by Regeneron Year Ended December 31,

2020 2019 2018

(In millions) U.S.

ROW Total U.S.

$ 4,947.2 $ 2,961.5 $ 7,908.7 $ 4,644.2 $ 2,897.4 $ 7,541.6 $ 4,076.7 $ 2,668.9 $ 6,745.6

$ 3,226.2 $ 818.6 $ 4,044.8 $ 1,871.2 $ 444.4 $ 2,315.6 $ 776.3 $ 145.7 $ 922.0

$ 270.7 $ 77.5 $ 348.2 $ 175.7 $ 18.1 $ 193.8 $ 14.8 — $ 14.8

$ 186.0 $ 172.8 $ 358.8 $ 126.0 $ 162.7 $ 288.7 $ 181.3 $ 125.5 $ 306.8

Kevzara (b) $ 141.6 $ 128.3 $ 269.9 $ 129.0 $ 77.7 $ 206.7 $ 74.7 $ 21.9 $ 96.6

REGEN-COV (d)

$ 185.7 — $ 185.7 — — — — — —

ZALTRAP (b) $ 5.8 $ 97.9 $ 103.7 $ 7.3 $ 101.1 $ 108.4 $ 9.0 $ 98.8 $ 107.8

ARCALYST U.S.

$ 13.1 — $ 13.1 $ 14.5 — $ 14.5 $ 14.7 — $ 14.7

(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 within Bayer collaboration revenue.

(b) Regeneron records net product sales of Libtayo in the United States.

Sanofi records net product sales of Libtayo outside the United States and global net product sales of Dupixent, Kevzara, and ZALTRAP.

The Company records its share of profits/losses within Sanofi collaboration revenue in connection with (i) sales of Libtayo outside the United States, and (ii) global sales of Dupixent and Kevzara.

Sanofi pays the Company a percentage of net sales of ZALTRAP.

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 within Sanofi collaboration revenue.

Refer to "Products" section above and "Collaboration, License, and Other Agreements - Sanofi" section below for further details.

(d) Regeneron records net product sales of REGEN-COV in connection with its agreements with the U.S.

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

Government" below for further details.

Programs in Clinical Development

All 22 of our product candidates in clinical development, including the five U.S.

Food and Drug Administration ("FDA") approved products which we are investigating in additional indications, were discovered in our research laboratories and are summarized in the table below.

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

We believe that our ability to develop product candidates is enhanced by the application of our VelociSuite ® technology platforms (refer to "Research and Development Technologies - VelociSuite " section below).

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The planning, execution, and results of our clinical programs are significant factors that can affect our operating and financial results.

We and our collaborators conduct clinical trials in multiple countries across the world.

The COVID-19 pandemic and the restrictions adopted around the globe to reduce the spread of the disease have impacted and will continue to impact our clinical development programs.

We continue to evaluate the impact of the COVID-19 pandemic on an individual trial basis and oversee trial management while also working to ensure patient safety and provide sufficient supply of product candidates for the studies.

At this time, we expect fully enrolled clinical studies to remain generally on track.

However, the ongoing pandemic continues to impact clinical trial execution in many regions across the world for us and our collaborators.

The ultimate impact (including possible delays in recruiting and/or obtaining data) resulting from the COVID-19 pandemic will depend, among other factors, on the extent of the pandemic in the areas with study sites and patient populations.

It is possible that the COVID-19 pandemic may cause clinical disruptions beyond those we have described.

In addition, there may be delays in the timing of regulatory review and other projected milestones discussed in the table below.

Refer to Part I, Item 1A.

"Risk Factors" for a description of these and other risks and uncertainties that may affect our clinical programs.

Clinical Program

Regulatory Review (i)

2019 and 2020 Events to Date

Select Upcoming Milestones

"Risk Factors" for a description of these and other risks and uncertainties that may affect our clinical programs, including those related to the COVID-19 pandemic.

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

2020 and 2021

Events to Date Select Upcoming Milestones (k)

Ophthalmology

–High-dose formulation in wet AMD –Retinopathy of prematurity ("ROP") (c)

–High-dose formulation in wet AMD

Retinopathy of prematurity

Approved by FDA for the treatment of diabetic retinopathy

Initiate Phase 3 studies of a high-dose formulation of aflibercept in wet AMD and DME (mid-2020)

Pre-filled syringe approved by FDA

Immunology & Inflammatory Diseases

–High-dose formulation in DME

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

–Pre-filled syringe approved by European Commission ("EC") –Report results from Phase 2 study for high-dose formulation in wet AMD (second half 2021)

Immunology & Inflammation

Dupixent (dupilumab) (a)

Antibody to IL-4R alpha subunit

Grass allergy

Atopic dermatitis in pediatrics (6 months–5 years of age) (Phase 2/3) (d)

Atopic dermatitis in pediatrics (6–11 years of age) (U.S.

Approved by FDA and European Commission ("EC") for expanded atopic dermatitis indication in adolescent patients (12–17 years of age)

FDA decision (target action date of May 26, 2020) on supplemental Biologics License Application ("sBLA") and EC decision (second half 2020) for expanded atopic dermatitis indication in pediatric patients (6–11 years of age)

–Peanut allergy

–Grass allergy –Atopic dermatitis in pediatrics (6 months–5 years of age) (Phase 2/3) (d)

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

CRSwNP (Japan)

Eosinophilic esophagitis

Auto-injector for 300 mg dose (U.S.

Reported that Phase 3 study in pediatric patients (6–11 years of age) with severe atopic dermatitis met its primary and secondary endpoints

–Eosinophilic esophagitis ("EoE") (c) in adults (d) , adolescents (d) , and pediatrics

–Chronic obstructive pulmonary disease ("COPD")

Report results from Phase 3 study for atopic dermatitis in pediatric patients (6 months–5 years of age) (2022)

–Bullous pemphigoid (Phase 2/3) (c)

Approved by EC for treatment of asthma in adults and adolescents

–Chronic spontaneous urticaria

Report results from Phase 3 study for asthma in pediatric patients (6–11 years of age) (second half 2020)

–Prurigo nodularis

Approved by FDA and EC for CRSwNP

EU approval for 200 mg and 300 mg auto-injector

Japan decision on application for CRSwNP (first half 2020)

FDA issued Complete Response Letter ("CRL") on sBLA for 200 mg auto-injector

FDA decision on application for 300 mg auto-injector (target action date of March 20, 2020)

Completed Phase 2a trial in grass allergy

Resubmit sBLA for 200 mg auto-injector (first half 2020)

Present results from Phase 2a trial in grass allergy at medical meeting (first half 2020)

–Allergic bronchopulmonary aspergillosis ("ABPA")

–Chronic inducible urticaria

–Asthma in pediatrics (6–11 years of age) (U.S.)

–Asthma longer term efficacy and safety (U.S.)

–200 mg auto-injector (U.S.)

–Approved by FDA and EC for expanded atopic dermatitis indication in pediatrics (6–11 years of age)

–Approved by National Medical Products Administration ("NMPA") in China for adults with atopic dermatitis

–Reported that Phase 3 trial for asthma in children aged 6 to 11 years met its primary and key secondary endpoints

–Approved by MHLW for CRSwNP in Japan

–Approved by FDA and MHLW for 300 mg auto-injector

–Reported that Part A of the Phase 3 trial in adult and adolescent patients with EoE met both co-primary endpoints

–Report results from Phase 3 study for atopic dermatitis in pediatric patients (6 months–5 years of age) (2022)

–FDA decision on supplemental BLA ("sBLA") for asthma in pediatrics (6–11 years of age) (second half 2021)

–FDA decision on sBLA for asthma longer term efficacy and safety label update (second half 2021)

–Submit Marketing Authorization Application ("MAA") for asthma in pediatrics (6–11 years of age) (first quarter 2021)

–Report results from Part B of the Phase 3 study in adults and adolescents with EoE (second half 2021)

–Report results from Phase 2 monotherapy study in peanut allergy (second half 2021)

Clinical Program (continued)

Regulatory Review (i)

2019 and 2020 Events to Date

Select Upcoming Milestones

Report results from Phase 2 study in peanut allergy (first half 2021)

Initiate Phase 3 study in pediatric patients with EOE (second half 2020)

Report results from Phase 2 portion of Phase 2/3 study in EOE (mid-2020)

Initiate Phase 3 studies in hand and foot atopic dermatitis and allergic bronchopulmonary aspergillosis ("ABPA") (first half 2020)

Phase 1 Phase 2 Phase 3 Regulatory Review (i)

2020 and 2021

Events to Date Select Upcoming Milestones (k)

Dupixent (dupilumab) (a)

–Chronic sinusitis without nasal polyposis

–Allergic fungal rhinosinusitis –Reported that Phase 2 trial of Dupixent in combination with Aimmune Therapeutics' AR101, an oral immunotherapy, in pediatric patients with peanut allergy met its primary and key secondary endpoint

–Presented results from Phase 2a trial in grass allergy

–Initiated second confirmatory Phase 3 trial in COPD

–FDA decision on sBLA for 200 mg auto-injector (mid-2021)

–Report results from Phase 3 chronic spontaneous urticaria and prurigo nodularis studies (second half 2021)

–Initiate Phase 3 study in hand and foot atopic dermatitis (first half 2021)

Kevzara (sarilumab) (a)

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

Polymyalgia rheumatica ("PMR")

Systemic juvenile idiopathic arthritis ("sJIA")

Giant cell arteritis ("GCA")

–Systemic juvenile idiopathic arthritis ("sJIA") –Reported that Phase 3 studies in COVID-19 patients did not meet primary and key secondary endpoints

–Discontinued clinical development in polymyalgia rheumatica and giant cell arteritis

Itepekimab (a) (REGN3500)

Antibody to IL-33

Studied as monotherapy and in combination with Dupixent.

Reported that Phase 2 study in asthma met its primary and key secondary endpoints

Report results from Phase 2 study in atopic dermatitis (second half 2020)

Atopic dermatitis

Sanofi reported that Phase 2 study in COPD demonstrated reduced exacerbations in the overall study population, but results were not statistically significant

Initiate Phase 2b study in asthma (second half 2020)

–COPD –Discontinued further clinical development in atopic dermatitis due to lack of efficacy

REGN1908-1909 (f)

Multi-antibody therapy to Feld1

Report results from Phase 2 study in cat allergic asthmatics (first half 2020)

–Cat allergy –Report results from Phase 2 study in cat allergic asthmatics (first half 2021)

REGN5713-5714-5715

Antibody to Betv1

Multi-antibody therapy to Betv1

–Birch allergy

Antibody to IL-36R

–Palmo-plantar pustulosis

Clinical Program (continued)

Regulatory Review (i)

2019 and 2020 Events to Date

Select Upcoming Milestones

Phase 1 Phase 2 Phase 3 Regulatory Review (i)

2020 and 2021

Events to Date Select Upcoming Milestones (k)

Solid Organ Oncology

Libtayo (cemiplimab) (a)(h)

Antibody to PD-1

Solid tumors and advanced hematologic malignancies

–Basal cell carcinoma ("BCC")

(potentially pivotal study)

First-line non-small cell lung cancer ("NSCLC")

Conditionally approved by EC for treatment of advanced CSCC

Report results from potentially pivotal Phase 2 study in BCC (mid-2020)

(pivotal study)

–Metastatic or locally advanced CSCC (d)

Second-line cervical cancer (e)

Independent data monitoring committee conducted an interim analysis for overall survival in a Phase 3 NSCLC trial, and recommended trial continue as planned

Report results from Phase 3 study in cervical cancer (first half 2021)

–Neoadjuvant CSCC

–First-line non-small cell lung cancer ("NSCLC"), monotherapy

–First-line NSCLC, chemotherapy combination

–Second-line cervical cancer (e)

–Adjuvant CSCC

Interim analysis of overall survival from Phase 3 NSCLC monotherapy study (2020)

Bispecific antibody targeting CD20 and CD3

Certain B-cell malignancies (c)

B-cell non-Hodgkin lymphoma ("B-NHL") (potentially pivotal study)

Reported updated results from Phase 1 trial in B-cell malignancies

Report updated results from initial study in certain B-cell malignancies (2020)

Continued to expand potentially pivotal Phase 2 program with different subtypes of NHL

Continue to expand potentially pivotal Phase 2 study (2020)

Bispecific antibody targeting BCMA and CD3

Multiple myeloma

Reported positive preliminary results from Phase 1 trial in multiple myeloma

Report updated results from initial study in multiple myeloma (2020)

Bispecific antibody targeting BCMA and CD3

Multiple myeloma

–First-line NSCLC, monotherapy (U.S.

–Advanced BCC (U.S.

and EU) –Reported that Phase 3 monotherapy trial in first-line NSCLC met primary endpoint.

Independent Data Monitoring Committee ("IDMC") recommended stopping the trial early due to highly significant improvement in overall survival

–Completed patient enrollment in Phase 3 first-line NSCLC chemotherapy combination study

–Reported that Phase 2 study in BCC demonstrated clinically-meaningful and durable responses

–Presented positive data from pivotal NSCLC monotherapy and BCC studies at the European Society for Medical Oncology ("ESMO") Virtual Congress 2020

–Adjuvant CSCC program under internal review –FDA decision on sBLA (target action date of February 28, 2021) and EC decision on regulatory submission (mid-2021) for first-line NSCLC, monotherapy

–Interim analysis from Phase 3 study in first-line NSCLC, chemotherapy combination (second half 2021)

–FDA decision on sBLA (target action date of March 3, 2021) and EC decision on regulatory submission (mid-2021) for advanced BCC

–Interim analysis from Phase 3 study in cervical cancer (2021)

Bispecific antibody targeting MUC16 and CD3

Platinum-resistant ovarian cancer

–Platinum-resistant ovarian cancer –Report results from Phase 1 study in platinum-resistant ovarian cancer (2022)

Bispecific antibody targeting MUC16 and CD28

–Ovarian cancer

Bispecific antibody targeting PSMA and CD28

Prostate cancer

–Prostate cancer –Report results from Phase 1 study in prostate cancer (2022)

Clinical Program (continued)

Phase 1 Phase 2 Phase 3 Regulatory Review (i)

2020 and 2021

Events to Date Select Upcoming Milestones (k)

Bispecific antibody targeting two distinct MET epitopes

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–Solid tumors and advanced hematologic malignancies

Antibody to GITR

–Solid tumors –Dosing and enrollment in Phase 1 trial temporarily suspended due to a serious adverse event

Bispecific antibody targeting EGFR and CD28

–Solid tumors

Odronextamab (REGN1979)

Bispecific antibody targeting CD20 and CD3

–Certain B-cell malignancies (c)

–B-cell non-Hodgkin lymphoma ("B-NHL") (potentially pivotal study) –Expanded potentially pivotal Phase 2 program with different subtypes of NHL

–Paused new enrollment of patients with B-NHL in compliance with FDA partial clinical hold –Finalize protocol amendment and resume patient enrollment (first half 2021)

–Complete patient enrollment in potentially pivotal Phase 2 study in B-NHL (second half 2021)

–Initiate Phase 3 program (2021)

Bispecific antibody targeting BCMA and CD3

–Multiple myeloma (potentially pivotal study) –Presented updated results from Phase 1 study in multiple myeloma at ASH –Complete patient enrollment in potentially pivotal Phase 2 study in multiple myeloma (second half 2021)

–Initiate pivotal trials in earlier lines of multiple myeloma therapy (second half 2021)

Bispecific antibody targeting BCMA and CD3

–Multiple myeloma

Clinical Program (continued)

Regulatory Review (i)

2019 and 2020 Events to Date

Select Upcoming Milestones

Cardiovascular/Metabolic Diseases

Praluent (alirocumab) (a)

Phase 1 Phase 2 Phase 3 Regulatory Review (i)

2020 and 2021

Events to Date Select Upcoming Milestones (k)

Pozelimab (f) (REGN3918)

Antibody to C5

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

–PNH, monotherapy (c)

–CD55-deficient protein-losing enteropathy (c)

–Initiate Phase 3 study in myasthenia gravis (second half 2021)

Cemdisiran (p)

siRNA therapeutic targeting C5

–Immunoglobulin A nephropathy

Antibody to IL2Rg

–Aplastic anemia

NTLA-2001 (o)

TTR gene knockout using CRISPR/Cas9

–Hereditary transthyretin amyloidosis with polyneuropathy

General Medicine

REGEN-COV (casirivimab and imdevimab) (g)(n)

Multi-antibody therapy to SARS-CoV-2 virus

–COVID-19 multi-dose safety study –COVID-19 dose-ranging virology study in non-hospitalized patients –COVID-19 treatment in non-hospitalized patients

–COVID-19 treatment in hospitalized patients

–COVID-19 treatment in hospitalized patients (UK-based RECOVERY trial)

–COVID-19 prevention (m)

–European Medicines Agency ("EMA") Rolling Review of casirivimab and imdevimab data –Reported results from first 799 non-hospitalized COVID-19 patients in Phase 2/3 trial showing that trial met primary and key secondary endpoints

–Received EUA from FDA for mild to moderate COVID-19 in high risk non-hospitalized patients

–Reported data from Phase 1/2/3 trial in hospitalized COVID-19 patients requiring low-flow oxygen and that Phase 3 program will continue based on passing futility analysis

–IDMC recommended further enrollment of hospitalized patients requiring high-flow oxygen or mechanical ventilation be placed on hold –Report additional data from Phase 3 portion of COVID-19 study in non-hospitalized patients (first half 2021)

–Report results for lower 1,200 mg dose from Phase 3 portion of COVID-19 study in non-hospitalized patients (first half 2021)

–Report additional data from Phase 3 portion of COVID-19 prevention study (second quarter 2021)

–Data to be reported from Phase 3 RECOVERY trial in hospitalized patients (first half 2021)

Clinical Program (continued)

Phase 1 Phase 2 Phase 3 Regulatory Review (i)

2020 and 2021

Events to Date Select Upcoming Milestones (k)

REGEN-COV (casirivimab and imdevimab) (g)(n)

–Reported positive initial results from Phase 3 portion of COVID-19 prevention study

–Papers published in Science and New England Journal of Medicine ("NEJM") describing REGEN-COV and initial trial results

–Report data from Phase 2 dose-ranging virology study in non-hospitalized patients (first half 2021)

–Submit BLA and MAA for COVID-19 (mid-2021)

Praluent (alirocumab) (j)

Antibody to PCSK9

Homozygous familial hypercholesterolemia ("HoFH") (c) in adults and pediatrics

Approved by EC for a new indication to reduce cardiovascular risk in adults with established ASCVD

Report results from Phase 3 study in HoFH and submit sBLA (2020)

–Homozygous familial hypercholesterolemia ("HoFH") (c) in pediatrics

–HeFH in pediatrics

Approved by FDA for a new indication to reduce the risk of heart attack, stroke and unstable angina requiring hospitalization in adults with established CV disease

Approved by FDA for treatment of adults with primary hyperlipidemia (including HeFH) to reduce low-density lipoprotein cholesterol ("LDL-C")

Evinacumab (f) (REGN1500)

–HoFH in adults (U.S.) –Reported results from Phase 3 study in adult patients with HoFH –FDA decision on sBLA for HoFH in adults (target action date of April 4, 2021)

–Report interim results from Phase 3 study for HeFH in pediatrics (first half 2021)

Fasinumab (l)(f) (REGN475)

Antibody to NGF

–Osteoarthritis pain of the knee or hip (e)

–Reported top-line results from Phase 3 trials in osteoarthritis pain of the knee or hip

–Discontinued actively treating patients following recommendation from the IDMC that the program should be terminated –Report additional longer-term safety results from Phase 3 studies in osteoarthritis pain of the knee or hip (first half 2021)

–Continue discussions with regulatory authorities and determine next steps for the program (first half 2021)

Evkeeza (evinacumab) (f)

Antibody to ANGPTL3

Refractory hypercholesterolemia (both HeFH and non-FH)

Reported positive top-line results from Phase 3 trial in HoFH

Submit BLA and Marketing Authorization Application ("MAA") for HoFH (2020)

Severe hypertriglyceridemia

Pozelimab (f) (REGN3918)

Antibody to C5

Paroxysmal nocturnal hemoglobinuria ("PNH") (c)

Reported positive top-line results from Phase 2 trial in PNH

Initiate combination program with Alnylam's cemdisiran (second half 2020)

Initiate Phase 3 program in PNH (second half 2020)

–Severe hypertriglyceridemia –HoFH (U.S.

and EU) (c)(d)

– NEJM published positive results from Phase 3 trial in HoFH

–FDA decision on BLA (target action date of February 11, 2021) and EC decision on MAA for HoFH (first half 2021)

Garetosmab (f) (REGN2477)

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–Fibrodysplasia ossificans progressiva

("FOP") (c)(e) (potentially pivotal study)

("FOP") (c)(d)(e) (potentially pivotal study)

–Reported results from Phase 2 study in FOP

Discuss regulatory submission for FOP with regulatory authorities (first half 2020)

–Paused dosing in the open-label portion of the Phase 2 study in FOP based on reports of serious adverse events –Further review trial data and determine next steps for the program (first half 2021)

Agonist antibody to leptin receptor ("LEPR")

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Clinical Program (continued)

Regulatory Review (i)

2019 and 2020 Events to Date

Select Upcoming Milestones

Fasinumab (b)(f) (REGN475)

Antibody to NGF

Osteoarthritis pain of the knee or hip (e)

Report results from Phase 3 studies in osteoarthritis pain of the knee or hip (mid-2020)

Antibody to GFRα3

Osteoarthritis pain of the knee (e)

Report results from Phase 2 study in osteoarthritis pain of the knee (second half 2020)

Infectious Diseases

REGN-EB3 (f)(g) (REGN3470-3471-3479)

Multi-antibody therapy to Ebola virus infection ("Ebola")

Ebola (U.S.) (c)(d)(j)

Investigational trial in the Democratic Republic of Congo was stopped early based on data showing that REGN-EB3 was superior to ZMapp in preventing death

Complete rolling BLA submission for Ebola (first half 2020)

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

We have discontinued further clinical development of REGN4659, an antibody to CTLA4, which was previously being studied in advanced NSCLC

Phase 1 Phase 2 Phase 3 Regulatory Review (i)

2020 and 2021

Events to Date Select Upcoming Milestones (k)

Agonist antibody to NPR1

–Heart failure

RNAi therapeutic targeting HSD17B13

–Nonalcoholic steatohepatitis

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 REGN5069, an antibody to GFRα3, which was previously being studied in osteoarthritis pain of the knee

(a) In collaboration with Sanofi

(b) In collaboration with Teva and Mitsubishi Tanabe Pharma

(b) In collaboration with Bayer outside of the United States

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

Department of Health and Human Services ("HHS") are parties to agreements whereby HHS provides certain funding to support research, development, and manufacturing of these antibodies.

Department of Health and Human Services ("HHS") are parties to agreements whereby HHS provides certain funding to support research and development of this product candidate

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

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

(j) Included as part of the Extension Phase of a trial coordinated by World Health Organization

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

(j) In collaboration with Sanofi prior to April 2020.

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

(k) As described in the section preceding the table above and Part I, Item 1A.

"Risk Factors," development timelines may be further subject to change as a result of the impact of the COVID-19 pandemic

(l) In collaboration with Teva and Mitsubishi Tanabe Pharma

(m) Conducted with the National Institute of Allergy and Infectious Diseases ("NIAID"), part of the National Institutes of Health ("NIH")

(n) In collaboration with Roche

(o) In collaboration with Intellia

(p) In collaboration with Alnylam

Additional Information - Clinical Programs

Clinical Development Program Updates

REGEN-COV (casirivimab and imdevimab)

In April 2020, the Company moved its leading neutralizing antibodies into preclinical and clinical-scale cell production lines, and in June 2020, initiated its first clinical trial of REGEN-COV.

Following a positive review from the IDMC of the REGEN-COV Phase 1 safety results in an initial cohort, the program advanced to late-stage clinical trials (see table above for further details).

The REGEN-COV clinical program consists of the following separate study populations:

non-hospitalized symptomatic and asymptomatic COVID-19 patients, hospitalized COVID-19 patients, uninfected people with close exposure to a COVID-19 patient (such as the patient's housemate), and healthy volunteers.

In October 2020, we announced positive results from the first 799 patients in the ongoing Phase 2/3 seamless trial in non-hospitalized patients with COVID-19, showing that REGEN-COV significantly reduced viral load and patient medical visits (hospitalizations, emergency room, urgent care visits, and/or physician office/telemedicine visits).

The trial met the primary and key secondary endpoints.

In September 2020, we had announced initial data from the trial showing that the antibody cocktail reduced viral load and time to alleviate symptoms.

In October 2020, the IDMC for the REGEN-COV treatment trials for COVID-19 recommended that the current hospitalized patient trial be modified.

Specifically, based on a potential safety signal and an unfavorable risk/benefit profile at this time, the IDMC recommended that further enrollment of patients requiring high-flow oxygen or mechanical ventilation be placed on hold pending collection and analysis of further data on patients already enrolled.

The IDMC also recommended continuing enrollment of hospitalized patients requiring either no or low-flow oxygen as the risk/benefit remains acceptable in these cohorts.

Finally, the IDMC recommended continuation of the outpatient trial (described further above) without modification.

In December 2020, we announced initial data from the ongoing Phase 1/2/3 trial in hospitalized COVID-19 patients requiring low-flow oxygen.

The primary clinical objective of this initial analysis was to determine if there was sufficient efficacy in these patients to warrant continuing the trial ( i.e.

, futility analysis).

The Phase 3 program in hospitalized patients requiring low-flow oxygen will continue based on passing futility analysis, as seronegative patients (patients who did not have antibodies at baseline) treated with the antibody cocktail had a lower risk of death or receiving mechanical ventilation.

In September 2020, we and the University of Oxford announced that the RECOVERY trial in the United Kingdom will evaluate REGEN-COV.

The RECOVERY trial, which is a Phase 3 open-label trial in patients hospitalized with COVID-19, will compare the effects of adding the antibody cocktail to the usual standard-of-care versus standard-of-care on its own.

The trial is being coordinated by researchers at the University of Oxford.

The RECOVERY IDMC is aware of the IDMC recommendations made in connection with the REGEN-COV treatment trials (described above), and advised that they saw no cogent reason to modify the protocol or intake to the study and recommended continuing recruitment of eligible patients to all study arms.

In January 2021, the Company announced positive initial results from an ongoing Phase 3 trial evaluating REGEN-COV used as a passive vaccine for the prevention of COVID-19 in people at high risk of infection (due to household exposure to a COVID-19 patient).

An exploratory analysis was conducted on the first approximately 400 evaluable individuals enrolled in the trial, who were randomized to receive passive vaccination with REGEN-COV (1,200 mg via subcutaneous injections) or placebo.

As described further under "Products - REGEN-COV - Emergency Use Authorization" above, in November 2020, REGEN-COV received EUA from the FDA for the treatment of mild to moderate COVID-19 who have received positive results of direct SARS-CoV-2 viral testing and are at high risk for progressing to severe COVID-19 and/or hospitalization.

The EUA is temporary and does not replace a formal BLA submission review and approval process.

Evaluation of the antibody cocktail's safety and efficacy is ongoing in multiple clinical trials, and data from these trials would be used to support a future BLA submission.

Under the EUA, the current authorized dose is 2,400 mg, and we are currently evaluating the safety and efficacy of a lower 1,200 mg dose in an ongoing Phase 3 trial in non-hospitalized patients.

In February 2021, the EMA announced it had commenced a Rolling Review of data for the casirivimab and imdevimab antibody cocktail.

Data on the safety, tolerability, and efficacy of the antibody cocktail will be shared with the EMA as they become available in the coming months.

In August 2020, we announced that two Phase 3 trials, FACT OA1 and FACT OA2, achieved the co-primary endpoints for fasinumab 1 mg monthly, demonstrating significant improvements in pain and physical function over placebo at week 16 and week 24, respectively.

Fasinumab 1 mg monthly also showed nominally significant benefits in physical function in both trials and pain in one trial, when compared to the maximum FDA-approved prescription doses of non-steroidal anti-inflammatory drugs for osteoarthritis.

The FACT OA1 trial included an additional treatment arm, fasinumab 1 mg every two months, which showed numerical benefit over placebo, but did not reach statistical significance.

In initial safety analyses from the Phase 3 trials, there was an increase in arthropathies reported with fasinumab.

In a sub-group of patients from one Phase 3 long-term safety trial, there was an increase in joint replacement with fasinumab 1 mg monthly treatment during the off-drug follow-up period, although this increase was not seen in the other trials to date.

In August 2020, we also announced that we discontinued actively treating patients with fasinumab, which at such time only involved dosing in an optional second-year extension phase of one trial.

This followed a recommendation from the fasinumab program's IDMC that the program should be terminated, based on available evidence to date.

We will continue to gather long-term safety data, which we expect to report in 2021, along with our decision on next steps for the program.

In December 2020, we announced that we are pausing new enrollment of patients with B-NHL in our trials for odronextamab in compliance with an FDA partial clinical hold.

The FDA requested that we amend the trial protocols in order to further reduce the incidence of ≥Grade 3 cytokine release syndrome ("CRS") during step-up dosing.

In October 2020, we notified clinical investigators to pause dosing of garetosmab in the ongoing Phase 2 LUMINA-1 trial in patients with the ultra-rare genetic disorder FOP.

The decision was based on reports of fatal serious adverse events in the trial during the open-label portion during which all patients received active treatment.

These deaths are being further investigated to understand if they are related to garetosmab treatment.

During the 28-week double-blind treatment period, there were no deaths in the trial.

We also shared this update with the trial's IDMC and relevant regulatory authorities, and will conduct a review of the trial data to date to better understand the benefit/risk profile of garetosmab in people with FOP.

The Company announced top-line 28-week results from the LUMINA-1 trial earlier this year;

this is the only active trial evaluating garetosmab.

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

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

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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.

Libtayo (cemiplimab) and REGN1979

Regeneron is developing a diverse and comprehensive oncology portfolio, including Libtayo, which is being studied as monotherapy and in combination with other anti-cancer agents in various indications.

Libtayo (cemiplimab)

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

The PD-1/PD-L1 immune checkpoint pathway has emerged as a major mechanism by which cancers evade immune destruction.

Libtayo is also being studied by other companies in combination with their proprietary assets.

REGN1979 is an investigational bispecific monoclonal antibody designed to bridge T-cells and tumor cells.

Regeneron is studying Libtayo as monotherapy and in combination with other anti-cancer agents in various indications.

It is also being studied by other companies in combination with their proprietary assets.

Odronextamab is an investigational bispecific monoclonal antibody designed to bridge T-cells and tumor cells.

It is designed to trigger tumor killing by binding to both a protein expressed on B-cell cancers (CD20) and a component of the T-cell receptor ("TCR") complex (CD3).

At the tumor site, it activates T-cells by engaging their CD3 molecules and promotes T-cell mediated killing of the cancer cells.

REGN5458 is an investigational bispecific monoclonal antibody designed to bind to BCMA on multiple myeloma cells and the CD3 receptor on T-cells in order to bridge them together and activate T-cells to kill the cancer cells.

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 and CD55-deficient protein-losing enteropathy.

Pozelimab is being studied as monotherapy and also in combination with Alnylam’s siRNA investigational therapy, cemdisiran.

REGEN-COV (casirivimab and imdevimab)

REGEN-COV is an investigational cocktail of two fully-human monoclonal antibodies designed to prevent and treat infection from the SARS-CoV-2 virus.

The two potent, virus-neutralizing antibodies that form the cocktail bind non-competitively to the critical receptor binding domain of the virus's spike protein, which diminishes the ability of mutant viruses to escape treatment and protects against spike variants that have arisen in the human population.

Praluent (alirocumab)

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

Evinacumab is an investigational, fully-human monoclonal antibody that specifically binds to and blocks ANGPTL3.

Fasinumab is an investigational, fully-human monoclonal antibody that targets NGF, a protein that plays a central role in the regulation of pain signaling, and is a potential new way to manage pain without resorting to opioids.

Evkeeza (evinacumab)

Evkeeza is an investigational, fully-human monoclonal antibody that specifically binds to and blocks ANGPTL3.

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

Pozelimab is an investigational, fully-human monoclonal antibody designed to block complement factor C5 and prevent the destruction of red blood cells that cause the symptoms of PNH and other diseases mediated by abnormal complement pathway activity.

PNH is an ultra-rare, chronic, life-threatening disease where genetic mutations cause hemolysis, resulting in a range of symptoms including fatigue, shortness of breath, and blood clots.

Pozelimab binds with high affinity to wild-type and variant human C5 and blocks its activity.

Garetosmab is an investigational, fully-human monoclonal antibody that binds and neutralizes Activin A, which is required for the development of additional bone outside the normal skeleton in patients with the ultra-rare genetic disorder, FOP.

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Garetosmab reduces the formation of heterotopic bone lesions by neutralizing the Activin A protein.

Fasinumab is an investigational, fully-human monoclonal antibody that targets NGF, a protein that plays a central role in the regulation of pain signaling.

NGF expression is elevated in many acute and chronic pain conditions and NGF blockade has demonstrated efficacy in clinical trials.

Targeting NGF is a potential new way to manage pain without resorting to opioids.

REGN-EB3 is an investigational cocktail of three fully-human monoclonal antibodies that each bind to the Ebola virus at different points, which may serve to increase efficacy, reduce the development of viral sequences that lead to resistance, and potentially enable utility in future outbreaks as viruses continue to evolve.

REGN-EB3 is being developed, tested, and manufactured through contracts awarded in 2015 and 2017 by BARDA, under the Assistant Secretary for Preparedness and Response within the U.S.

Department of Health and Human Services.

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, including in COPD.

REGN5713-5714-5715

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

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

Other Programs

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

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

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

The VelocImmune mouse platform is utilized to produce fully human antibodies.

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VelocImmune and our entire VelociSuite offer the potential to increase the speed and efficiency through which human antibody therapeutics may be discovered and validated, thereby improving the overall efficiency of our early stage drug development activities.

We are utilizing the VelocImmune technology to produce our next generation of drug candidates for preclinical and clinical development.

We are utilizing the VelocImmune technology to produce our next generation of therapeutic antibody drug candidates for preclinical and clinical development.

Our VelociGene platform allows custom and precise manipulation of very large sequences of DNA to produce highly customized alterations of a specified target gene, or genes, and accelerates the production of knock-out and transgenic expression models without using either positive/negative selection or isogenic DNA.

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We have also developed our VelociMab platform for the rapid screening of antibodies and rapid generation of expression cell lines for our Traps and our VelocImmune human antibodies.

We have utilized our VelociSuite technologies to develop a class of potential drug candidates, known as bi-specific antibodies.

Veloci-Bi allows for the generation of full-length bi-specific antibodies similar to native antibodies that are amenable to production by standard antibody manufacturing techniques, and are likely to have favorable antibody-like pharmacokinetic properties.

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

Our first such CD3 bi-specific antibody, REGN1979, targets CD20.

exploring additional indications and applications for our bi-specific technologies, such as other CD3 bi-specific antibodies to MUC16 (REGN4018) and BCMA (REGN5458 and REGN5459), as well as a new class of CD28 co-stimulatory bi-specifics, including an antibody that targets PSMA (REGN5678).

We have utilized our VelociSuite technologies to develop a class of potential drug candidates, known as bispecific antibodies.

Veloci-Bi allows for the generation of full-length bispecific antibodies similar to native antibodies that are amenable to production by standard antibody manufacturing techniques, and are likely to have favorable antibody-like pharmacokinetic properties.

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

Our first such CD3 bispecific antibody, odronextamab, targets CD20.

We are exploring additional indications and applications for our bispecific technologies, such as other CD3 bispecific antibodies, as well as a new class of CD28 costimulatory bispecifics.

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

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

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.

VelociHum is our immunodeficient mouse platform that can be used to accurately test human therapeutics against human immune cells and to study human tumor models.

Through genetic humanizations, VelociHum mice have been optimized to allow for better development of human immune cells in vivo , as well as to allow for engraftment of primary patient-derived tumors that do not take in other commercially available mice.

Regeneron Genetics Center ®

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RGC utilizes laboratory automation and innovative approaches to cloud computing to achieve high-quality throughput.

Central to the work of RGC is a collaboration with the Geisinger Health System of Pennsylvania.

Geisinger collects samples from consented patient volunteers, while RGC performs sequencing and genotyping to generate de-identified genomic data.

In addition, RGC has expanded on its foundational population-based collaboration with Geisinger with a growing number of other organizations worldwide.

In addition, RGC has formed a consortium to fund the generation of genetic exome sequence data from 500,000 volunteer participants who make up the UK Biobank health resource.

The current members of the consortium consist of AbbVie Inc., Alnylam Pharmaceuticals Inc., AstraZeneca PLC, Biogen Inc., Pfizer Inc., Millennium Pharmaceuticals, Inc.

(a subsidiary of Takeda Pharmaceutical Company Unlimited), and Bristol-Myers Squibb.

The consortium members have each committed up to $10.0 million in funding for Regeneron to sequence the UK Biobank's samples, which is performed at the RGC facility.

Consortium members have a limited period of exclusive access to the sequencing data before the data are made available to other health researchers by UK Biobank.

Researchers from the RGC discovered a potential new therapeutic target to reduce the risk of chronic liver disease and progression to more advanced stages of disease, such as nonalcoholic steatohepatitis ("NASH"), by analyzing extensive genetic sequencing data linked with electronic health records.

In 2018, we announced a publication describing this discovery in the New England Journal of Medicine , which identified for the first time a variant in the HSD17B13 gene that is associated with reduced risk of, or protection from, various chronic liver diseases for which there are currently no approved therapeutics.

We are collaborating with Alnylam to discover RNA interference ("RNAi") therapeutics for NASH and potentially other related diseases.

Collaboration Agreements

Collaborations with Sanofi

We are collaborating with Sanofi on the global development and commercialization of Dupixent, Praluent, Kevzara, and REGN3500 (the "Antibody Collaboration").

Under the terms of the Antibody License and Collaboration Agreement (the "LCA"), following receipt of the first positive Phase 3 trial results for a co-developed drug candidate, subsequent Phase 3 trial-related costs for that drug candidate are shared 80% by Sanofi and 20% by us.

All other agreed-upon development costs incurred by both companies are funded 100% by Sanofi.

We are obligated to reimburse Sanofi for 50% of worldwide development expenses that were fully funded by Sanofi and 30% of shared Phase 3 trial-related costs based on our share of collaboration profits from commercialization of collaboration products.

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

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

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

The RGC has completed genetic analysis of over 1.3 million samples as of December 31, 2020.

The Company is currently advancing multiple drug discovery and development programs that have benefited from RGC's research effort.

Agreements Related to COVID-19

In the first quarter of 2020, the Company announced an expansion of its Other Transaction Agreement ("OTA") with BARDA, pursuant to which HHS was obligated to fund certain of our costs incurred for research and development activities related to COVID-19 treatments.

In July 2020, the Company also announced 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.

This agreement, as subsequently amended, could result in 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.

See "Results of Operations - Revenues " below for REGEN-COV net product sales recognized in connection with this agreement during 2020.

In January 2021, the Company announced an agreement with an entity acting on behalf of 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 is obligated to purchase all filled and finished doses of drug product delivered by June 30, 2021, and may accept doses during the period from July 1, 2021 through September 30, 2021 at its discretion.

government has agreed to acquire up to 1.25 million doses at the lowest treatment dose authorized or approved by the FDA for the indication authorized under the EUA (as described under "Products - REGEN-COV - Emergency Use Authorization" above), resulting in payments to the Company of up to $2.625 billion in the aggregate.

A number of factors may impact available filled and finished supply by June 30, 2021, including manufacturing considerations and authorized dose levels.

In August 2020, we entered into a collaboration agreement with Roche to develop, manufacture, and distribute REGEN-COV.

We will continue to lead global development activities for REGEN-COV, and the parties will jointly fund certain on-going studies, as well as any mutually agreed additional new global studies to evaluate further the potential of REGEN-COV in treating or preventing COVID-19.

Following the initial EMA approval (if any), Roche will be responsible for securing regulatory approvals outside the United States and conducting any additional studies specifically required for approval by regulators outside the United States.

Under the terms of the agreement, each party is obligated to dedicate a certain amount of manufacturing capacity to REGEN-COV each year.

We will distribute the product in the United States and Roche will distribute the product outside of the United States.

The parties will 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.

Any profit sharing will commence after product manufactured by Roche receives regulatory authorization.

Collaboration, License, and Other Agreements

In May 2020, a secondary offering of 13,014,646 shares of our Common Stock held by Sanofi was completed.

We also purchased 9,806,805 shares directly from Sanofi for an aggregate purchase amount of $5 billion.

Pursuant to the offering and purchase, Sanofi disposed of all of its shares of common stock in Regeneron, other than 400,000 shares that it retained as of the closing of these transactions (see further details below regarding Sanofi's use of these shares for the funding of certain development costs).

In January 2018, we and Sanofi entered into a letter agreement (the "Letter Agreement") amending the LCA in connection with, among other matters, the allocation of additional funds to certain proposed activities relating to dupilumab and itepekimab (collectively, the "Dupilumab/Itepekimab Eligible Investments").

Pursuant to the Letter Agreement, we agreed to allow Sanofi to satisfy in whole or in part its funding obligations with respect to the Dupilumab/Itepekimab Eligible Investments for quarterly periods ending on September 30, 2020 by selling certain shares of our Common Stock directly or indirectly owned by Sanofi.

Under the Letter Agreement, we also agreed to allow Sanofi to satisfy in whole or in part its funding obligation with respect to Libtayo development costs for quarterly periods and ending on September 30, 2020 by selling certain shares of our Common Stock.

If Sanofi desired to sell shares of our Common Stock during the term of the Letter Agreement to satisfy a portion or all of its funding obligations for the Libtayo development and/or Dupilumab/Itepekimab Eligible Investments, we were able to elect to purchase, in whole or in part, such shares from Sanofi.

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

See discussion below for updates related to the development and commercialization of Praluent effective April 1, 2020.

Under the terms of the Antibody License and Collaboration Agreement (the "LCA"), Sanofi is generally responsible for funding 80%–100% of agreed-upon development costs.

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

However, we are only required to apply 10% of our share of the profits from the Antibody Collaboration in any calendar quarter to reimburse Sanofi for these development costs.

In January 2018, we and Sanofi entered into a letter agreement (the "Letter Agreement") amending the LCA in connection with, among other matters, the allocation of additional funds to certain proposed activities relating to dupilumab and REGN3500 (collectively, the "Dupilumab/REGN3500 Eligible Investments").

Pursuant to the Letter Agreement, we have agreed to allow Sanofi to satisfy in whole or in part its funding obligations with respect to the Dupilumab/REGN3500 Eligible Investments for the quarterly periods commencing on January 1, 2018 and ending on September 30, 2020 by selling up to an aggregate of 600,000 shares (of which 495,948 currently remains available) of our Common Stock directly or indirectly owned by Sanofi.

Refer to the " Immuno-Oncology " section below for further details regarding the Letter Agreement.

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

We have exercised our option to co-commercialize Dupixent, Praluent, and Kevzara in the United States, and have exercised our option to co-commercialize Dupixent in certain countries outside the United States.

We currently anticipate commencing co-commercialization of Dupixent outside the United States at the end of 2020.

We co-commercialize Dupixent in the United States, and have exercised our option to co-commercilaize Dupixent in certain countries outside the United States.

We currently anticipate commencing co-commercialization of Dupixent in such countries outside the United States in 2021.

We supply certain commercial bulk product to Sanofi.

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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 addition to profit and loss sharing, we are entitled to receive up to an aggregate of $250.0 million in milestone payments upon achievement of specified aggregate annual sales of antibodies (subject to this agreement) outside the United States on a rolling twelve-month basis.

The Company will be entitled to receive the first sales milestone payment from Sanofi, in the amount of $50.0 million, when such sales outside the United States exceed $1.0 billion.

In December 2019, we and Sanofi announced our intent to restructure the Antibody Collaboration for Kevzara and Praluent and enter into a royalty-based arrangement.

Under the proposed terms of the agreement, Sanofi is expected to gain sole global rights to Kevzara and sole rights to Praluent outside of the United States.

Regeneron is expected to gain sole U.S.

rights to Praluent.

Under the proposed terms, each party will be solely responsible for funding development and commercialization expenses in their respective territories.

In connection with the proposed agreement, the Company has eliminated certain commercialization activities and related headcount.

The proposed agreement, which is expected to be finalized in the first quarter of 2020, will not impact the companies' existing collaboration relating to Dupixent and REGN3500.

In addition to profit and loss sharing, we are entitled to receive sales milestone payments from Sanofi.

In the third quarter of 2020, the Company earned, and recognized as revenue, the first $50.0 million sales-based milestone from Sanofi, upon aggregate annual sales of antibodies outside the United States (including Praluent) exceeding $1.0 billion on a rolling twelve-month basis.

We are entitled to receive up to an aggregate of $200.0 million in additional milestone payments from Sanofi, including the second sales milestone in the amount of $50.0 million, when such sales outside the United States exceed $1.5 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, is 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 will pay the Company a 5% royalty on Sanofi’s net product sales of Praluent outside the United States until March 31, 2032.

The Company will 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.

Immuno-Oncology

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Under the terms of the Amended IO Discovery Agreement, the Company is required to conduct development activities with respect to (i) the BCMAxCD3 Program through the earlier of clinical proof-of-concept or the expenditure of $70.0 million (the "BCMAxCD3 Program Costs Cap") and (ii) the MUC16xCD3 Program through the earlier of clinical proof-of-concept or the expenditure of $50.0 million (the "MUC16xCD3 Program Costs Cap").

provided that under certain circumstances, Sanofi will have the option to increase the MUC16xCD3 Program Costs Cap to $70.0 million by making a payment to the Company in the amount of $20.0 million.

Pursuant to the Amended IO Discovery Agreement, we are primarily responsible for conducting the IO Development Activities (other than certain clinical trials that may be funded separately by Sanofi), including antibody development, preclinical activities, toxicology studies, manufacture of clinical supplies, filing of Investigational New Drug Applications ("INDs"), and clinical development through proof-of-concept.

We are obligated to reimburse Sanofi for half of the development costs they funded that are attributable to clinical development of antibody product candidates under the Amended IO Discovery Agreement from our share of profits from commercialized IO Collaboration products.

With regard to the BCMAxCD3 Program and the MUC16xCD3 Program, when (i) clinical proof-of-concept is established, (ii) the applicable Program Costs Cap is reached, or (iii) in certain other limited circumstances, Sanofi will have the option to license rights to the product candidate and other antibodies targeting the same targets for, with regard to BCMAxCD3, immuno-oncology indications, and with regard to MUC16xCD3, all indications, pursuant to the IO License and Collaboration Agreement, as amended.

Given the applicable Program Costs Cap for the BCMAxCD3 Program and MUC16xCD3 Program has been reached, we expect Sanofi to provide its decision on whether it will exercise its option to license rights to these product candidates in early 2021.

If Sanofi does not exercise its option to license rights to a product candidate, we will retain the exclusive right to develop and commercialize such product candidate and Sanofi will receive a royalty on sales.

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and (ii) if Sanofi exercises its option with respect to a MUC16xCD3 Program antibody, (x) we will lead the development of such MUC16xCD3 Program antibody and commercialization of such MUC16xCD3 Program antibody within the United States and (y) Sanofi will lead the commercialization of such MUC16xCD3 Program antibody outside of the United States.

In connection with the IO License and Collaboration Agreement, Sanofi made a $375.0 million non-refundable up-front payment to us.

If Sanofi exercises its option to license rights to a BCMAxCD3 Program antibody or MUC16xCD3 Program antibody thereunder, it will co-develop these drug candidates with us through product approval under the terms of the IO License and Collaboration Agreement.

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We are obligated to use commercially reasonable efforts to supply clinical requirements of each drug candidate under the IO License and Collaboration Agreement until commercial supplies of that IO drug candidate are being manufactured.

Under the terms of the IO License and Collaboration Agreement, the parties are also co-developing and co-commercializing Libtayo (cemiplimab), an antibody targeting PD-1.

Under the terms of the IO License and Collaboration Agreement, the parties are also co-developing and co-commercializing Libtayo, an antibody targeting PD-1.

We have principal control over the development of Libtayo, and the parties share equally, on an ongoing basis, development and commercialization expenses for Libtayo.

Under the Letter Agreement, we have agreed to allow Sanofi to satisfy in whole or in part its funding obligation with respect to Libtayo development costs for the quarterly periods commencing on October 1, 2017 and ending on September 30, 2020 by selling up to an aggregate of 800,000 shares (of which 373,880 currently remains available) of our Common Stock directly or indirectly owned by Sanofi.

If Sanofi desires to sell shares of our Common Stock during the term of the Letter Agreement to satisfy a portion or all of its funding obligations for the Libtayo development and/or, as noted above, Dupilumab/REGN3500 Eligible Investments, we may elect to purchase, in whole or in part, such shares from Sanofi.

If we do not elect to purchase such shares, Sanofi may sell the applicable number of shares (subject to certain daily and quarterly limits) in one or more open-market transactions.

Refer to the "Antibody" section above for a description of share transactions related to Dupilumab/REGN3500 Eligible Investments.

With regard to Libtayo, we lead commercialization activities in the United States, while Sanofi leads commercialization activities outside of the United States and the parties equally share profits from worldwide sales.

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We will be entitled to a milestone payment of $375.0 million in the event that global sales of certain licensed products targeting PD-1 (including Libtayo), together with sales of any other products licensed under the IO License and Collaboration Agreement and sold for use in combination with any of such licensed products targeting PD-1, equal or exceed $2.0 billion in any consecutive twelve-month period.

Collaboration with Bayer

EYLEA outside the United States

Since 2006, we and Bayer have been parties to a license and collaboration agreement for the global development and commercialization outside the United States of EYLEA.

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

Under the agreement, we and Bayer collaborate on, and share the costs of, the development of EYLEA.

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

Collaboration with Teva

In 2016, we entered into a collaboration agreement with Teva to develop and commercialize fasinumab globally, excluding certain Asian countries that are subject to our collaboration agreement with Mitsubishi Tanabe Pharma Corporation ("MTPC").

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 Mitsubishi Tanabe Pharma Corporation ("MTPC").

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

We lead global development activities, and the parties will share equally, on an ongoing basis, development costs under a global development plan.

As of December 31, 2019, we had earned an aggregate of $120.0 million of development milestones from Teva, and we are entitled to receive up to an aggregate of $340.0 million in additional development milestones and up to an aggregate of $1,890.0 million in contingent payments upon achievement of specified annual net sales amounts.

We lead global development activities, and the parties share equally, on an ongoing basis, development costs under a global development plan.

As of December 31, 2020, we had earned an aggregate of $120.0 million of development milestones from Teva, and we are entitled to receive up to an aggregate of $340.0 million in additional development milestones and up to an aggregate of $1.890 billion in contingent payments upon achievement of specified annual net sales amounts.

We are responsible for the manufacture and supply of fasinumab globally.

Within the United States, we will lead commercialization activities, and the parties will share equally in any profits or losses in connection with commercialization of fasinumab.

In the territory outside of the United States, Teva will lead commercialization

activities and we will supply product to Teva at a tiered purchase price, which is calculated as a percentage of net sales of the product (subject to adjustment in certain circumstances).

Collaboration with Alnylam

In April 2019, we and Alnylam Pharmaceuticals, Inc.

entered into a global, strategic collaboration to discover, develop, and commercialize RNAi therapeutics for a broad range of diseases by addressing therapeutic disease targets expressed in the eye and central nervous system ("CNS"), in addition to a select number of targets expressed in the liver.

In the territory outside of the United States, Teva will lead commercialization activities and we will supply product to Teva at a tiered purchase price, which is calculated as a percentage of net sales of the product (subject to adjustment in certain circumstances).

Odronextamab (REGN1979)

In April 2020, we entered into an agreement with Zai Lab Limited to develop and commercialize odronextamab in mainland China, Hong Kong, Taiwan, and Macau (the "Zai Territories").

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

We will continue to lead global development activities for odronextamab, and Zai will be responsible for funding a portion of the global development costs for certain clinical trials.

We are responsible for the manufacture and supply of clinical and commercial product of odronextamab to Zai.

If odronextamab is commercialized in the Zai Territories, we will supply the product to Zai 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 up to $160.0 million in additional regulatory and sales milestone payments.

In 2018, we and Alnylam Pharmaceuticals, Inc.

entered into a collaboration to discover 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 Phase 1 clinical development).

ALN-HSD is being co-developed with Alnylam with terms generally consistent with the form of a Co-Commercialization Collaboration Agreement in connection with the 2019 collaboration agreement as described below.

Alnylam is conducting the Phase 1 clinical trial for ALN-HSD and Regeneron will be responsible for all other development as the lead party.

The parties share equally, on an ongoing basis, development expenses for ALN-HSD.

In April 2019, we and Alnylam entered into an additional 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.

The collaboration is governed by a Master Collaboration Agreement (the "Master Agreement") (including the form of a License Agreement and a Co-Commercialization Collaboration Agreement).

Under the terms of the Master Agreement, we made an up-front payment of $400.0 million to Alnylam.

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

For each program, we will 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 or CNS programs.

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

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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 INDs (or their equivalent in certain other countries) for programs in the eye and CNS.

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.

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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 pay to the licensor certain development and/or commercialization milestone payments totaling up to $150.0 million for each collaboration product.

In addition, following the first commercial sale of the applicable collaboration product under a License Agreement, the licensee is required to make certain tiered royalty payments, ranging from low double-digits up to 20%, to the licensor based on the aggregate annual net sales of the collaboration product, subject to customary reductions.

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.

For CNS programs and liver programs, as soon as a party is designated as a lead party, the other company has rights to opt-in to a Co-Commercialization Collaboration Agreement as a participating party.

Under a Co-Commercialization Collaboration Agreement, the party designated as the lead party has operational responsibility and final decision-making authority on 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.

If a party exercises its co-funding opt-out right, the lead party will be required to make certain tiered royalty payments, ranging from low double-digits up to 20%, 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, subject to customary reductions.

Under a Co-Commercialization 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.

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.

If the non-lead party does not initially opt-in to a Co-Commercialization Collaboration Agreement, the lead party has the right to take the program forward under a License Agreement structure.

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Pursuant to the terms of the Stock Purchase Agreement, we purchased 4,444,445 shares of Alnylam common stock for aggregate cash consideration of $400.0 million.

In August 2019, the parties entered into a Co-Commercialization Collaboration Agreement for a silencing RNA ("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 product consisting of such siRNA therapeutic and a fully human monoclonal antibody targeting C5 being developed by us, with us as the licensee.

The C5 siRNA Co-Commercialization Collaboration Agreement is consistent with the financial terms contained in the form of the existing Co-Commercialization Collaboration Agreement with Alnylam.

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

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.

NTLA-2001, which is in Phase 1 clinical development, is subject to a co-development and co-commercialization arrangement pursuant to which Intellia will lead development and commercialization activities and the parties share an agreed-upon percentage of development expenses and profits (if commercialized).

In May 2020, we expanded our existing collaboration with Intellia Therapeutics, Inc.

to provide us with rights to develop products for additional in vivo CRISPR/Cas9-based therapeutic targets and for the companies to jointly develop potential products for the treatment of hemophilia A and B, with Regeneron leading development and commercialization activities.

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

In connection with the May 2020 agreement, we made a $70.0 million up-front payment and purchased 925,218 shares of Intellia common stock for an aggregate purchase price of $30.0 million.

The up-front payment and the amount paid in excess of the fair market value of the shares purchased, or $15.0 million, were recorded to Research and development expense in the second quarter of 2020.

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 July 2020, HHS exercised its option under an existing agreement to provide up to $344.6 million of 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.

As described under "Products" above, pursuant to a 2017 license agreement, we granted Kiniksa the right to develop and commercialize certain new indications for ARCALYST.

Commencing with the receipt of marketing approval by Kiniksa for the first new indication of ARCALYST in the United States, Kiniksa will be solely responsible for the U.S.

development and commercialization of ARCALYST in all approved indications .

During 2020, an sBLA for Kiniksa's first new indication for ARCALYST, recurrent pericarditis, was submitted and is currently under regulatory review, with a target action date of March 21, 2021.

If the new indication is approved by the FDA, we are entitled to receive an additional $20.0 million milestone payment from Kiniksa, and Kiniksa will pay Regeneron 50% of its profits from sales of ARCALYST.

The parties will not share in any losses incurred by Kiniksa in connection with commercialization of ARCALYST.

Manufacturing

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Manufacturing establishments, both foreign and domestic, are also subject to inspections by or under the authority of the FDA and by other national, federal, state, and local agencies.

Sales and Marketing

We have a New Products Marketing and Planning group, a Market Research group, and a Market Access group to evaluate commercial opportunities for our targets and drug candidates, assess the competitive environment, analyze the commercial potential of our product portfolio, and prepare for market launch of new products.

These groups are fully functional to support our product and product candidates that we are independently developing and/or commercializing, and work closely with our collaborators for co-developed products to create marketing plans and forecasts and to establish and execute pre-launch market development programs.

We also have a full-service commercialization group to handle various aspects of our commercial programs.

The group includes experienced professionals in the fields of marketing, communications, professional education, patient education and advocacy, reimbursement and market access, trade and distribution, commercial operations, commercial analytics, market research, and forecasting.

Moreover, for our marketed products, we have hired, trained, and deployed a field-based organization including regional directors, medical specialists, and reimbursement managers, each typically with a number of years of experience in the biopharmaceutical industry in a variety of therapeutic areas including oncology, ophthalmology, inflammation, and cardiovascular.

We have approximately 500 field-based employees in the United States.

We sell EYLEA and Libtayo in the United States to several distributors and specialty pharmacies.

We sell ARCALYST in the United States to two specialty pharmacies.

Under these distribution models, the distributors and specialty pharmacies generally take physical delivery of the product.

For EYLEA and Libtayo, the distributors and specialty pharmacies generally sell the product directly to healthcare providers, whereas for ARCALYST, the specialty pharmacies sell the product directly to patients.

Our medicines are marketed through our commercial group, which includes experienced professionals in the fields of marketing, professional education, patient education, reimbursement and market access, trade and distribution, commercial operations, commercial analytics, market research, and forecasting.

We sell our marketed products in the United States 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, 2020.

On a combined basis, our product sales to these customers accounted for approximately 90% of our gross product revenue for the year ended December 31, 2019.

We are also a party to collaboration agreements with Bayer and Sanofi, whereby our collaborator is responsible for recording product sales of EYLEA outside the United States and global sales of Dupixent, Praluent, and Kevzara, respectively (refer to "Collaboration Agreements" section above for additional information).

On a combined basis, our product sales to these customers accounted for 83% of our total gross product revenue for the year ended December 31, 2020.

We promote approved medicines to healthcare professionals via our team of U.S.-based field employees, as well medical journals, medical exhibitions, distribution of literature and samples, and online channels.

In addition, we advertise certain products directly to U.S.

consumers and maintain websites with information about our medicines.

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

Additionally, we are a party to several collaboration agreements, whereby our collaborator is responsible for recording product sales of certain products either solely outside the United States or globally.

We have exercised our option to co-commercialize some products in accordance with such collaboration agreements.

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

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

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"Risk Factors - Risks Related to Commercialization of Our Marketed Products, Product Candidates, and New Indications for Our Marketed Products - The commercial success of our products and product candidates is subject to significant competition.

Marketed Product

Competitor Product

Territory (1)

Lucentis ® (ranibizumab)

Novartis AG and Genentech/Roche

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

Avastin ® (bevacizumab)

(off-label and repackaged)

Genentech/Roche

Wet AMD, DME, and macular edema following RVO

Beovu ® (brolucizumab)

United States

Marketed Product Competitor Product Competitor Indication Territory (1)

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

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

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

Beovu ® (brolucizumab) Injection

Novartis Wet AMD Worldwide

Ozurdex ® (dexamethasone intravitreal implant)

Allergan, PLC

Allergan, PLC DME, RVO Worldwide

Iluvien ® (fluocinolone acetonide intravitreal implant)

Alimera Sciences, Inc.

Chengdu Kanghong Pharmaceutical Group Co., Ltd.

Wet AMD, mCNV

(crisaborole)

Mild-to-moderate atopic dermatitis

United States

Roche/Novartis

DME Worldwide

Conbercept Chengdu Kanghong Pharmaceutical Group Co., Ltd.

Wet AMD, mCNV China

Dupixent Eucrisa ® /Staquis ® (crisaborole)

Pfizer Mild-to-moderate atopic dermatitis United States, EU

Olumiant ® (baricitinib)

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

Xolair ® (omalizumab)

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

United States, EU (nasal polyps)

Nucala ® (mepolizumab)

GlaxoSmithKline ("GSK")

GlaxoSmithKline ("GSK") Asthma Worldwide

Cinqair ® (reslizumab)

United States, EU

Teva Asthma United States, EU

Fasenra ® (benralizumab)

Keytruda ® (pembrolizumab)

AstraZeneca Asthma Worldwide

Marketed Product (continued)

Competitor Product Competitor Indication Territory (1)

Libtayo Keytruda ® (pembrolizumab)

Merck & Co., Inc.

Various cancers

Various cancers Worldwide

Opdivo ® (nivolumab)

Bristol-Myers Squibb

Various cancers

Bristol-Myers Squibb Various cancers Worldwide

Tecentriq ® (atezolizumab)

Various cancers

Roche Various cancers Worldwide

Imfinzi ® (durvalumab)

Various cancers

AstraZeneca Various cancers Worldwide

Bavencio ® (avelumab)

Pfizer/Merck KGaA

Various cancers

Repatha ® (evolocumab)

(1) Reduce the risk of myocardial infarction, stroke, and coronary revascularization in adults with established cardiovascular disease, (2) primary hyperlipidemia, and (3) HoFH

Actemra ® (tocilizumab)

Pfizer/Merck KGaA Various cancers Worldwide

Praluent Repatha ® (evolocumab)

Amgen (1) Reduce the risk of myocardial infarction, stroke, and coronary revascularization in adults with established cardiovascular disease, (2) primary hyperlipidemia, and (3) HoFH Worldwide

Leqvio ® (inclisiran)

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

Kevzara Actemra ® (tocilizumab)

Genentech/Roche/Chugai Pharmaceutical Co., Ltd.

Rheumatoid arthritis

Rheumatoid arthritis Worldwide

Orencia ® (abatacept)

Bristol-Myers Squibb

Rheumatoid arthritis

Bristol-Myers Squibb Rheumatoid arthritis Worldwide

Xeljanz ® (tofacitinib)

Rheumatoid arthritis

Pfizer Rheumatoid arthritis Worldwide

Olumiant ® (baricitinib)

Eli Lilly/Incyte

Rheumatoid arthritis

Eli Lilly/Incyte Rheumatoid arthritis Worldwide

Rinvoq ® (upadacitinib)

Rheumatoid arthritis

AbbVie Rheumatoid arthritis Worldwide

Jyseleca ® (filgotinib)

Gilead Sciences, Inc./Galapagos NV

Rheumatoid arthritis EU, Japan

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

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

Antibodies in Development

Our antibody-based clinical candidates in development are all fully-human antibodies which were generated using our VelocImmune technology.

Our antibody generation technologies and clinical candidates face competition from many pharmaceutical and biotechnology companies using various technologies.

Numerous other companies are developing therapeutic antibody products.

Companies have generated therapeutic products that are currently in development or on the market that are derived from recombinant DNA that comprise human antibody sequences.

Product Candidates

Our late-stage and earlier-stage clinical candidates (including those being developed in collaboration with our collaborators) face competition from many pharmaceutical and biotechnology companies.

For example, we are aware of other pharmaceutical and biotechnology companies actively engaged in the research and development of antibody-based products against targets that are also the targets of our early- and late-stage product candidates.

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 RNA interference (RNAi) and chimeric antigen receptor T cell (CAR-T cell) 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.

For additional information regarding our antibody programs and the substantial competition they face, see also Part I, Item 1A.

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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In these and related areas, intellectual property rights have been sought and certain rights have been granted to competitors and potential competitors of ours, and we may be at a substantial competitive disadvantage in such areas as a result of, among other things, our lack of experience, trained personnel, and expertise.

A number of corporate and academic competitors are involved in the discovery and development of novel therapeutics that are the focus of other research or development programs we are now conducting.

A number of corporate and

academic competitors are involved in the discovery and development of novel therapeutics that are the focus of other research or development programs we are now conducting.

Some of these competitors are currently conducting advanced preclinical and clinical research programs in these areas.

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The following table describes our U.S.

patents and European patents ("EP") that we currently consider of primary importance to our marketed products, including the territory, patent number, general subject matter class, and expected expiration dates.

patents and European patents ("EP") that we currently consider of primary importance to products marketed or otherwise commercialized by us and/or our collaborators, including the territory, patent number, general subject matter class, and expected expiration dates.

The noted expiration dates include any patent term adjustments.

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

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

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

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

General Subject Matter Class

Composition of Matter

June 16, 2023 *

June 21, 2027

Methods of Treatment

Method of Manufacturing

March 22, 2026

Composition of Matter

May 23, 2020 **

Supplementary Protection Certificate

(May 23, 2025) **

June 14, 2027

Methods of Treatment

Composition of Matter

March 28, 2031 ****

October 17, 2032

Methods of Treatment

April 17, 2028

Methods of Treatment

October 2, 2027

Methods of Treatment

July 10, 2034

Methods of Treatment

December 22, 2033

Composition of Matter

October 27, 2029 **

Supplementary Protection Certificate

(September 28, 2032) **

Composition of Matter

September 18, 2035

Composition of Matter

December 15, 2029

Composition of Matter

December 15, 2029

July 27, 2032

Methods of Treatment

December 21, 2029

Methods of Treatment

December 15, 2029

Methods of Treatment

January 15, 2031

Composition of Matter

December 15, 2029 **

Supplementary Protection Certificate

(September 25, 2030) **

Composition of Matter

January 4, 2028

September 19, 2031

Methods of Treatment

Composition of Matter

June 1, 2027 **

Supplementary Protection Certificate

(June 1, 2032) **

Methods of Treatment

October 10, 2032

Product Molecule Territory Patent No.

General Subject Matter Class Expiration

aflibercept US 7,070,959 Composition of Matter June 16, 2023 *

US 8,092,803 Formulation June 21, 2027

US 10,464,992 Formulation June 14, 2027

US 10,857,231 Formulation March 22, 2026

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

US 10,857,205 Methods of Treatment January 11, 2032

US 10,828,345 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) **

EP 2364691 Formulation June 14, 2027

dupilumab US 7,608,693 Composition of Matter March 28, 2031 ****

US 8,945,559 Formulation October 17, 2032

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

US 8,337,839 Methods of Treatment October 2, 2027

US 9,290,574 Methods of Treatment July 10, 2034

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

US 10,485,844 Methods of Treatment September 21, 2037

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

EP 2356151 Composition of Matter October 27, 2029 **

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

EP 3010539 Methods of Treatment June 20, 2034

EP 2624865 Formulation October 5, 2031

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

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

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

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

EP 2358756 Composition of Matter December 15, 2029 **

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

EP 2756004 Methods of Treatment September 12, 2032

EP 3055333 Methods of Treatment October 10, 2034

EP 3169353 Methods of Treatment July 16, 2035

EP 3169362 Methods of Treatment July 16, 2035

Kevzara sarilumab US 7,582,298 Composition of Matter May 22, 2031 *****

US 10,072,086 Formulation September 19, 2031

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

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

EP 2041177 Composition of Matter June 1, 2027 **

Product (continued)

Molecule Territory Patent No.

General Subject Matter Class Expiration

Kevzara (continued)

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

EP 2766039 Methods of Treatment October 10, 2032

EP 3071230 Methods of Treatment November 21, 2034

EP 3409269 Formulation January 7, 2031

REGEN-COV ***

casirivimab and imdevimab US 10,787,501 Composition of Matter June 25, 2040

* A patent term extension has been granted by the U.S.

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** 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.

*** See Note 16 to our Consolidated Financial Statements for information regarding the patent infringement proceedings relating to Dupixent and Praluent.

*** See Note 15 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 Dupixent, Praluent, and REGEN-COV.

**** A patent term extension has been granted by the U.S.

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

***** A patent term extension has been granted by the U.S.

Patent and Trademark Office, extending the original patent term (January 4, 2028), insofar as it covers Kevzara, to May 22, 2031.

In addition, 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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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 damage awards 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 damage awards if we are found to have infringed such patents or rights ";

and Note 15 to our Consolidated Financial Statements).

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Preclinical Requirements

The activities required before a product candidate may be marketed in the United States begin with preclinical tests.

Preclinical tests include laboratory evaluations and animal studies to assess the potential safety and efficacy of the product candidate and its formulations.

Certain preclinical trials must comply with the FDA's Good Laboratory Practice requirements ("GLPs") and the U.S.

The activities required before a product candidate may be marketed in the United States or elsewhere begin with preclinical tests.

Preclinical tests include laboratory evaluations of, among other things, product chemistry and formulation and toxicological and pharmacological studies in animal species to assess the toxicity and dosing of the product candidate.

In the United States, certain preclinical trials must comply with the FDA's Good Laboratory Practice requirements ("GLPs") and the U.S.

Department of Agriculture's Animal Welfare Act.

The results of these studies must be submitted to the FDA as part of an IND, which must be reviewed by the FDA before proposed clinical testing can begin.

In other countries, the data are reviewed by regulatory authorities as part of clinical trial applications.

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

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.

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.

Product Approval

All of our product candidates require regulatory approval before they can be commercialized.

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 and foreign authorities.

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

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

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

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

In addition, each clinical trial must be reviewed and approved by, and conducted under the auspices of, an Institutional Review Board ("IRB") for each clinical site within the United States or, where applicable, an Ethics Committee and/or the competent authority for clinical sites outside the United States.

Companies sponsoring the clinical trials, investigators, and IRBs/Ethics Committees also must comply with, as applicable, regulations and guidelines for obtaining informed consent from the study patients, following the protocol and investigational plan, adequately monitoring the clinical trial, and timely reporting of adverse events.

Foreign studies conducted under an IND must meet the same requirements that apply to studies being conducted in the United States.

Data from a foreign study not conducted under an IND may be submitted in support of a BLA if the study was conducted in accordance with GCPs and the FDA is able to validate the data.

Typically, clinical testing involves a three-phase process.

In Phase 1, trials are usually conducted with a small number of healthy volunteers to determine the early safety profile of the product candidate.

In Phase 2, clinical trials are conducted with subjects afflicted with a specific disease or disorder to provide enough data to evaluate the preliminary safety, tolerability, and efficacy of different potential doses of the product candidate.

In Phase 3, larger clinical trials are conducted with patients afflicted with the specific disease or disorder in order to provide enough data to understand the efficacy and safety profile of the product candidate, as required by the FDA.

Phase 1 trials are usually conducted with a small number of healthy volunteers to determine the early safety profile, metabolism, and pharmacological actions of the product candidate, the side effects associated with increasing doses, and, if possible, to gain early evidence of effectiveness.

Phase 2 clinical trials are conducted with a relatively small sample of the intended patient population to provide enough data to evaluate the preliminary safety, tolerability, and efficacy of different potential doses of the product candidate.

Phase 3 clinical trials are larger trials conducted with patients with the target disease or disorder intended to gather additional information about dosage, safety, and effectiveness necessary to evaluate the drug's overall risk-benefit profile, and to provide a basis 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 program.

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, which can exceed $2 million per filing.

In responding to a BLA, the FDA may grant marketing approval, request additional information, or deny the application.

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

exceed $2 million per filing for new applications with clinical data review required, subject to certain limited deferrals, waivers, and reductions.

The FDA reviews applications to determine, among other things, whether a product is safe and effective for its intended use and whether the manufacturing controls are adequate to assure and preserve the product's identity, strength, quality, and purity.

For some BLAs, the FDA may convene an advisory committee to seek insights and recommendations on issues relevant to approval of the application.

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.

The FDA also can audit the sponsor of the BLA to determine if the clinical studies were conducted in compliance with current Good Clinical Practice, or cGCP, requirements.

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

After review of a BLA, the FDA may grant marketing approval, request additional information, or issue a complete response letter ("CRL") outlining the deficiencies in the submission.

The CRL may require additional testing or information, including additional preclinical or clinical data, for the FDA to reconsider the application.

Even if such additional information and data are submitted, the FDA may decide that the BLA still does not meet the standards for approval.

Data from clinical trials are not always conclusive and the FDA may interpret data differently than the sponsor.

If FDA grants approval, an approval letter authorizes commercial marketing of the product candidate with specific prescribing information for specific indications.

Any approval required by the FDA for any of our product candidates may not be obtained on a timely basis, or at all.

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Approval by a regulatory authority in one jurisdiction does not guarantee approval by comparable regulatory authorities in other jurisdictions.

In the European Economic Area ("EEA") (which is comprised of 27 Member States of the EU plus Norway, Iceland, and Liechtenstein), medicinal products can only be commercialized after a related Marketing Authorization has been granted.

Marketing authorization for biologics must be obtained through a centralized, mutual recognition procedure, which allows a company to submit a single application to the EMA.

If a related positive opinion is provided by the EMA, the EC will grant a centralized marketing authorization that is valid in the EEA.

In many jurisdictions, pediatric data or an approved Pediatric Investigation Plan ("PIP"), or a waiver of such studies, is required to have been approved by regulatory authorities prior to submission of a marketing application.

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, 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.

Various federal, state, and foreign statutes and regulations also govern or influence the research, manufacture, safety, labeling, storage, record keeping, marketing, transport, and other aspects of developing and commercializing pharmaceutical product candidates.

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The FDA has the explicit authority to require postmarketing studies (also referred to as post-approval or Phase 4 studies), labeling changes based on new safety information, and compliance with FDA-approved risk evaluation and mitigation strategies.

Following approval, the FDA regulates the marketing and promotion of our products, which must comply with the Food, Drug, and Cosmetic Act and applicable FDA regulations and standards thereunder.

The FDA's review of promotional activities includes, but is not limited to, healthcare provider-directed and direct-to-consumer advertising as well as sales representatives' communications.

The FDA may take enforcement action for promoting unapproved uses of a product or other violations of its advertising and promotion laws and regulations.

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.

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.

This could subject a company to a range of penalties that could have a significant commercial impact, including civil and criminal fines and agreements that materially restrict the manner in which a company promotes or distributes a drug.

See Part I, Item 1A.

"Risk Factors - Regulatory and Litigation Risks - If we market and sell approved products in a way that violates federal or state healthcare laws, we may be subject to civil or criminal penalties ."

"Risk Factors - Other Regulatory and Litigation Risks - Our business activities have been, and may in the future be, challenged under federal or state healthcare laws, which may subject us to civil or criminal proceedings, investigations, or penalties ."

Adverse-event reporting and submission of periodic reports are required following marketing approval.

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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.

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

This includes requirements to conduct pharmacovigilance, or the assessment and monitoring of the safety of medicinal products.

Marketing authorization holders are required to maintain a Pharmacovigilance System Master File ("PSMF") which supports and documents the compliance of the marketing authorization holder with the requirements of EU pharmacovigilance legislation.

Marketing authorization holders are also required to have a Qualified Person for Pharmacovigilance ("QPPV") who, among other things, maintains the PSMF.

A QPPV must reside in the EEA and must also prepare pharmacovigilance reports, respond to potential requests from competent authorities concerning pharmacovigilance on a 24 hour basis, and provide competent authorities with any other information that may be relevant to the safety of the medicinal product in accordance with Good Pharmacovigilance Practices.

The EC can also require marketing authorization holders to conduct post-authorization safety and/or efficacy studies.

A post-authorization safety study ("PASS") is a study that is carried out after a medicinal product has been authorized to obtain further information on a medicinal product's safety, or to measure the effectiveness of risk-management measures.

Such studies may be clinical trials or non-interventional studies.

A post-authorization efficacy study ("PAES") is a study that is carried out for complimenting available efficacy data in the light of well-reasoned scientific uncertainties on aspects of the evidence of benefits that is to be or only can be addressed post-authorization.

The EC may, in particular, impose a PASS and/or PAES on marketing authorization holders when a marketing authorization is granted upon conditions.

The EC may grant conditional marketing authorizations in the interest of public health, when there is less comprehensive clinical data available than would be required, if the EC considers that the benefit of immediate availability may outweigh the risk that the absence of the required clinical data poses.

In addition, we and our third-party suppliers are required to maintain compliance with cGMPs, and are subject to inspections by the FDA or comparable regulatory authorities in other jurisdictions to confirm such compliance.

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

Failure to comply with these laws and regulations may lead the FDA and comparable regulatory authorities in other jurisdictions to take regulatory action, which could include ordering the suspension of manufacturing or withdrawing FDA approval of a product.

Failure to comply with these laws, regulations, and conditions of product approval may lead the FDA and comparable regulatory authorities in other jurisdictions to take regulatory action or seek sanctions, including fines, issuance of warning letters, civil penalties, injunctions, suspension of manufacturing operations, operating restrictions, withdrawal of FDA approval of a product, seizure or recall of products, and criminal prosecution.

Pricing and Reimbursement

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

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

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.

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 to the states for our drugs under Medicaid and Part B of the Medicare program.

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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.

On December 21, 2020, CMS issued a final rule that modified Medicaid Drug Rebate program regulations to permit reporting multiple best price figures with regard to value‑based purchasing arrangements (beginning in 2022);

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);

and revise best price and average manufacturer price exclusions of manufacturer-sponsored patient benefit programs, specifically regarding inapplicability of such exclusions in the context of pharmacy benefit manager "accumulator" programs (beginning in 2023).

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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are provided in connection with certain durable medical equipment;

or consist of certain oral anti-cancer drugs and certain oral immunosuppressive drugs.

or are certain oral anti-cancer drugs and certain oral immunosuppressive drugs.

Medicare Part B pays for such drugs under a payment methodology based on the average sales price of the drugs.

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

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 " for a discussion of recent actions at the federal level intended to reform Medicare Part B, including the "most-favored-nation" interim final rule issued in November 2020 by HHS, acting through CMS.

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.

Such conduct also could be grounds for CMS to terminate our Medicaid drug rebate agreement, in which case federal payments may not be available under Medicaid or Medicare Part B for our covered outpatient drugs.

Federal law requires that any company that participates in the Medicaid Drug Rebate program also participate in the Public Health Service's 340B drug pricing program (the "340B program") in order for federal funds to be available for the manufacturer's drugs under Medicaid and Medicare Part B.

under Medicaid and Medicare Part B.

The 340B program, which is administered by the Health Resources and Services Administration, or HRSA, requires participating manufacturers to agree to charge statutorily defined covered entities no more than the 340B "ceiling price" for the manufacturer's covered outpatient drugs.

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.

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.

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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.

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

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.

HRSA also implemented a new price reporting system during the first quarter of 2019, under which manufacturers are now required to report their 340B ceiling prices to HRSA on a quarterly basis.

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.

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

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

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

In addition, legislation may be introduced that, if passed, 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.

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Other Regulatory Requirements

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

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

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

Federal false claims laws prohibit any person from knowingly presenting, or causing to be presented, a false claim for payment to the federal government, or knowingly making, or causing to be made, a false statement to get a false claim paid.

Federal false claims laws prohibit any person from knowingly presenting, or causing to be presented, a false claim for payment of government funds, or knowingly making, or causing to be made, a false statement to get a false claim paid.

See Part I, Item 1A.

"Risk Factors - Regulatory and Litigation Risks - If we market and sell approved products in a way that violates federal or state healthcare laws, we may be subject to civil or criminal penalties ."

We are subject to the Foreign Corrupt Practices Act, or FCPA, and similar anti-bribery or anti-corruption laws, regulations or rules of other countries in which we operate, including the U.K.

See Part I, Item 1A.

"Risk Factors - Regulatory and Litigation

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

In the United States, there are federal and state privacy laws that regulate specific categories of personal data.

The information privacy laws address state and federal health information, consumer protection, and children's personal data.

There are also data protection laws that govern data breach notification and information security.

Most health care providers, including research institutions from which we or our collaborators obtain patient health information, are subject to privacy and security regulations promulgated under the Health Insurance Portability and Accountability Act of 1996, or HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act.

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

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

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

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

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

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

Compliance with these laws requires a flexible privacy framework as they are constantly evolving.

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

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

HIPAA imposes privacy and security obligations on covered entity health care providers, health plans, and health care clearinghouses, as well as their "business associates" – independent contractors or agents of covered entities that receive or obtain protected health information in connection with providing a service on behalf of a covered entity.

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

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

To the extent we collect California resident personal data for marketing activities, we are also subject to the California Consumer Privacy Act of 2018 (the "CCPA").

The CCPA became effective on January 1, 2020 and provides California residents with certain rights concerning the use of their personal data.

The obligations to comply with the CCPA require us, among other things, to update our notices and develop new processes internally and with our partners.

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

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

The GDPR became effective on May 25, 2018, increasing our responsibility and liability in relation to the processing of personal data of EU subjects.

To the extent we collect California resident personal data for marketing and human resource activities, we are also subject to the CCPA.

The CCPA, which became effective on January 1, 2020, establishes certain requirements for data use and sharing transparency and provides California residents certain rights concerning the use, disclosure, and retention of their personal data.

The CCPA and its implementing regulations have already been amended multiple times since their enactment.

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.

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

The obligations to comply with the CCPA and evolving legislation require us, among other things, to update our notices and develop new processes internally and with our partners to facilitate data subject rights requests.

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

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

The GDPR became effective in May 2018, increasing our responsibility and liability in relation to the processing of personal data of EU subjects.

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

In particular, these obligations and restrictions concern the consent of the individuals to whom the personal data relates, the information provided to the individuals, 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 breaches of the data protection obligations.

Data protection authorities from the different EU member states may promulgate national privacy laws that impose additional requirements, which add to the complexity of processing personal data in the EU.

In particular, these obligations and restrictions concern the consent of the individuals to whom the personal data relates, 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.

Data protection authorities from the different EU member states have promulgated national privacy laws that impose additional requirements, which add to the complexity of processing and transferring personal data in the EU.

Some countries outside of the EU have reacted to the GDPR by promulgating and enacting new privacy legislation that reflects similar principals and obligations on companies that operate and process their subject's 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 flow data globally.

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

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

See Part I, Item 1A.

"Risk Factors - Regulatory and Litigation Risks - We face potential liability related to the personal information we collect from individuals, data brokers, or research institutions or obtain from clinical trials sponsored by us or our collaborators ."

"Risk Factors - Other Regulatory and Litigation Risks - We face potential liability related to the personal information we collect from individuals, data brokers, or research institutions or obtain from clinical trials sponsored by us or our collaborators ."

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

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"Selected Financial Data" and our Consolidated Financial Statements and related notes.

As of December 31, 2019, we had approximately 8,100 full-time employees.

We believe that we have been successful in attracting skilled and experienced personnel in a highly competitive environment;

however, competition for these personnel is intense.

Our management considers its relations with our employees to be good.

Human Capital Resources

We compete in the highly competitive biotechnology and pharmaceuticals industries.

Attracting, developing, and retaining skilled and experienced employees in research and development, manufacturing, sales and marketing, and other positions is crucial to our ability to compete effectively.

Our ability to recruit and retain such employees depends on a number of factors, including our corporate culture and work environment, informed by our values and behaviors (which we call The Regeneron Way) and our corporate philosophy of "Doing Well by Doing Good," talent development and career opportunities, and compensation and benefits.

Employee Profile

As of December 31, 2020, we had 9,123 full-time employees, consisting of 7,630 employed in the United States, 1,412 employed in Ireland, and 81 employed in the United Kingdom and other countries.

Of these employees, 1,784 were within our research and preclinical development organization, 1,144 were within our global clinical development organization, and 4,445 were within our industrial operations and product supply organization.

Company-wide, more than 1,000 of our full-time employees hold a Ph.D.

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

Diversity, Equity, and Inclusion

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

A key component of our corporate culture is our commitment to the promotion of diversity, equity, and inclusion ("DE&I").

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 DE&I principles are reflected in our recruitment practices, our performance management processes, and our employee training.

In addition, we support employee-led advocacy and interest groups that foster inclusion and provide meaningful professional development opportunities for our workforce, including Women in Science and Engineering at Regeneron and our Black Employee Resource Group.

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

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

To this end, we appointed an interim DE&I leader in July 2020 and hired our permanent Chief Diversity, Equity & Inclusion Officer in January 2021 to advance our DE&I strategy.

We also recently established a DE&I steering committee of senior leaders to provide oversight and guidance as we implement additional programs to increase diversity and promote inclusion.

2020 Workforce Diversity Representation *

Female Representation (Global)

Minority Representation (U.S.

* Based on full-time employees as of December 31, 2020

** Represents the percentage of our full-time employees employed in the United States that self-identified as belonging to a racial or ethnic minority group.

The denominator used in this calculation includes employees who did not disclose information related to their race or ethnicity.

Excluding those that did not disclose such information, the percentage shown in this table would be 31.5%.

Externally, we support DE&I efforts in our community.

For example, through our partnership with the Society for Science, we contribute a substantial amount annually to science, technology, engineering, and mathematics ("STEM") equity and outreach programs to help increase access to science research education and bridge opportunity gaps among students historically underrepresented in the sciences.

Employee Wellness, Health, and Safety

The wellbeing of our employees is a primary focus as we believe that the most productive people are those who are at their best, both physically and mentally.

We provide several programs related to employee health and wellness, including onsite amenities and programs such as meditation rooms, gyms, and farmers' markets.

We also provide support for work-life balance through flex-time, remote working arrangements, child and elder care, and paid parental leave, among others.

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.

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

In response to the COVID-19 pandemic, we implemented changes in our business beginning in March 2020 to protect our employees and support appropriate health and safety protocols.

For example, we have implemented work-from-home policies for a significant portion of our employees.

For these remote employees, we provide ergonomic evaluations of at-home workstations, support information technology needs, and provide guidance for managers to ensure that employees remain connected and maintain physical, mental, and emotional wellbeing.

For our essential employees who remain onsite in our laboratories and manufacturing facilities, we provide personal protective equipment and require masks to be worn;

we have also implemented increased physical distancing in workspaces and enhanced cleaning protocols.

We currently administer COVID-19 tests to all onsite employees and contractors weekly and have been regularly administering these tests for designated employees since the spring of 2020.

For any employee who contracts or is exposed to COVID-19, we provide full pay for their entire recovery and quarantine time.

Employee Growth and Development

We invest significant resources to develop talent with the right capabilities to deliver the growth and innovation needed to support our continued success.

Our Talent Development department is dedicated to promoting individual, leader, team, and organizational development through a number of tools and services.

We offer a variety of professional development courses for our employees and support employee continuing education, including through educational reimbursement and tuition forgiveness programs.

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 2020, nearly 25% of job openings were filled by existing employees who were seeking career development opportunities.

Employee Engagement

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

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

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

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

The success of our employee engagement efforts is demonstrated by our employee retention rate of 94.4% in 2020, as well as the fact that approximately 92% of our employees who responded to our annual engagement survey said Regeneron is a great place to work.

Additionally, for the sixth consecutive year, we were recognized on the Fortune "100 Best Companies to Work For" list in 2020.

In addition, we have placed either first or second for the past ten years in Science magazine’s annual "Top Employers Survey" of the global biotechnology and pharmaceutical industry, including a first-place finish in 2020.

Compensation and Benefits

We are committed to rewarding and supporting our employees in order to continue to attract and retain top talent.

We believe this commitment supports our core strategy of creating and advancing a high-quality product pipeline.

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

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

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

Total employee compensation packages (which varies by country and region) include market-competitive pay (with the opportunity to receive above-market rewards), broad-based grants of equity-based awards, healthcare benefits, retirement savings options, and matching contributions.

Corporate Information

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What changed 10-K

Item 1. Business