What changed in this filing

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Item 1. Business

2022-02-07 compared with 2021-02-08 · 587 added, 483 removed, 650 unchanged (62% of the section changed)

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

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

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

the nature, timing, and possible success and therapeutic applications of Regeneron's Products and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, "Regeneron's Product Candidates") and research and clinical programs now underway or planned, including without limitation EYLEA ® (aflibercept) Injection, Dupixent ® (dupilumab) Injection, Libtayo ® (cemiplimab) Injection, Praluent ® (alirocumab) Injection, Kevzara ® (sarilumab) Injection, Evkeeza ® (evinacumab), Inmazeb ® (atoltivimab, maftivimab, and odesivimab-ebgn), REGEN-COV ® (casirivimab and imdevimab), aflibercept 8 mg, fasinumab, pozelimab, odronextamab, itepekimab, REGN5458, REGN5713-5714-5715, REGN1908-1909, 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;

ongoing regulatory obligations and oversight impacting Regeneron's Products, research and clinical programs, and business, including those relating to patient privacy;

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

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;

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

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

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

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

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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), as well as Regeneron's agreement with Roche relating to REGEN-COV, to be cancelled or terminated;

(or their respective affiliated companies, as applicable), as well as Regeneron's agreement with Roche relating to the casirivimab and imdevimab antibody cocktail (known as REGEN-COV in the United States and Ronapreve ™ in other countries), 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.

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Regeneron Pharmaceuticals, Inc.

is a fully integrated biotechnology company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious diseases.

Our commercialized medicines and product candidates in development are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, pain, infectious diseases, and rare diseases.

is a fully integrated biotechnology company that discovers, invents, develops, manufactures, and commercializes medicines for serious diseases.

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

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Net income per share - diluted $ 71.97 $ 30.52 $ 18.46

* 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.

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

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

Product Disease Area Territory

Product Disease Territory

EU Japan ROW (4)

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Dupixent (dupilumab) Injection (2)

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

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

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

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

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

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

Libtayo (cemiplimab) Injection (2)

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

Product (continued)

Disease Area Territory

Disease Territory

EU Japan ROW (4)

Libtayo (cemiplimab) Injection (2)

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

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

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

Praluent (alirocumab) Injection (3)

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

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

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

- Homozygous familial hypercholesterolemia ("HoFH") a

REGEN-COV (5)

- COVID-19 a a a

Kevzara (sarilumab) Solution for Subcutaneous Injection (2)

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

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

Evkeeza (evinacumab) Injection (6)

- HoFH (in adults and adolescents) a a

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

ARCALYST ® (rilonacept) Injection for Subcutaneous Use (7)

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

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

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

- Recurrent pericarditis (in adults and adolescents)

ZALTRAP ® (ziv-aflibercept) Injection for Intravenous Infusion (8)

- 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

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 or others.

In addition, unless otherwise noted, products in the table above are approved for use in adults in the above-referenced diseases.

(1) In collaboration with Bayer outside the United States

(2) In collaboration with Sanofi

(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.

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

(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.

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

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

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

(5) Known as REGEN-COV in the United States and Ronapreve in other countries

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

Ultragenyx pays us a percentage of net product sales of Evkeeza outside the United States and the Company is also eligible to receive regulatory and sales milestone payments.

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

In March 2021, Kiniksa received marketing approval for its first new indication of ARCALYST in the United States;

consequently we granted U.S.

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

(8) Sanofi is solely responsible for the development and commercialization of ZALTRAP, and Sanofi pays us a percentage of aggregate net product sales of ZALTRAP.

REGEN-COV - Emergency and Temporary Use Authorizations

In November 2020, the antibody cocktail casirivimab and imdevimab administered together, known as REGEN-COV in the United States, received Emergency Use Authorization ("EUA") from the U.S.

Food and Drug Administration ("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.

In June 2021, the FDA updated the EUA for REGEN-COV, lowering the dose to 1,200 mg (which is half the dose originally authorized) and allowing for subcutaneous injections as an alternative when intravenous ("IV") infusion is not feasible and would lead to a delay in treatment.

In July 2021, the FDA also expanded the EUA to include post-exposure prophylaxis in people at high risk for progression to severe COVID-19, who are not fully vaccinated or are not expected to mount an adequate response to vaccination, and who have been exposed to a SARS-CoV-2 infected individual or are at high risk of exposure to an infected individual because of infection occurring in the same institutional setting (such as in nursing homes or prisons).

Based on laboratory data that showed markedly decreased binding to the Omicron spike protein, REGEN-COV is highly unlikely to be active against the Omicron variant.

In January 2022, the FDA revised the EUA for REGEN-COV to exclude its use in geographic regions where, based on available information including variant susceptibility and regional variant frequency, infection or exposure is likely due to a variant such as Omicron (B.1.1.529) that is not susceptible to the treatment.

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

states, territories, or jurisdictions, since Omicron is currently the dominant variant across the United States.

If, in the future, patients in certain geographic regions are likely to be infected or exposed to a variant that is susceptible to REGEN-COV, then the limitation on use may be revised in these areas.

Emergency or temporary pandemic use authorizations are also currently in place in numerous other countries outside the United States.

Net Product Sales of Regeneron-Discovered Products

Net Product Sales Recorded by Regeneron Year Ended December 31,

Year Ended December 31,

2021 2020 2019

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$ 170.0 $ 251.1 $ 421.1 $ 186.0 $ 172.8 $ 358.8 $ 126.0 $ 162.7 $ 288.7

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

REGEN-COV (d)

REGEN-COV (e)

$ 5,828.0 $ 1,745.9 $ 7,573.9 $ 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.

$ 161.9 $ 176.1 $ 338.0 $ 141.6 $ 128.3 $ 269.9 $ 129.0 $ 77.7 $ 206.7

$ 18.4 — $ 18.4 — — — — — —

$ 2.2 — $ 2.2 $ 13.1 — $ 13.1 $ 14.5 — $ 14.5

$ 5.3 $ 86.4 $ 91.7 $ 5.8 $ 97.9 $ 103.7 $ 7.3 $ 101.1 $ 108.4

(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.

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

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

The Company records its share of profits/losses in connection with global sales of Dupixent and Kevzara, and Sanofi pays the Company a percentage of net sales of ZALTRAP.

(c) Regeneron records net product sales of Libtayo in the United States and Sanofi records net product sales of Libtayo outside the United States.

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

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

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

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

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

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

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

Roche records net product sales of the antibody cocktail outside the United States and the parties share gross profits from global sales based on a pre-specified formula.

Refer to "Agreements Related to COVID-19" below for further details.

(f) Regeneron records net product sales of Evkeeza in the United States.

Pursuant to the January 2022 agreement, Ultragenyx will record net product sales of Evkeeza outside of the United States and will pay the Company a percentage of such sales.

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

(g) Amounts reflected in the table above represent net product sales recorded by Regeneron.

Effective April 1, 2021, Kiniksa records net product sales of ARCALYST in the United States and pays us a share of ARCALYST profits, if any.

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

Programs in Clinical Development

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

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).

We continue to invest in the development of enabling technologies to assist in our efforts to identify, develop, manufacture, and commercialize new product candidates.

There are numerous uncertainties associated with drug development, including uncertainties related to safety and efficacy data from each phase of drug development (including any post-approval studies), uncertainties related to the enrollment and performance of clinical trials, changes in regulatory requirements, changes to drug pricing and reimbursement regulations and requirements, and changes in the competitive landscape affecting a product candidate.

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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.

The COVID-19 pandemic and the restrictions adopted around the globe to reduce the spread of the disease have impacted and may 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.

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"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)

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

2021 and 2022

Events to Date Select Upcoming Milestones (k)

Events to Date Select Upcoming Milestones (i)

Ophthalmology

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

–High-dose formulation in wet AMD

–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)

EYLEA (aflibercept) (b)

–Retinopathy of prematurity ("ROP") (c)

–ROP (EU and Japan) –Initial results from National Institutes of Health ("NIH")-sponsored Protocol W trial in non-proliferative diabetic retinopathy ("NPDR") were announced;

data confirmed results from Company-sponsored PANORAMA trial and demonstrated reduced risk of developing vision-threatening complications with every-16-weeks dosing regimen

–Completed enrollment in Phase 3 study for ROP

–Submit supplemental BLA ("sBLA") for every-16-weeks dosing regimen in patients with NPDR (first half 2022)

–Report results from Phase 3 study in ROP (second half 2022)

Aflibercept 8 mg (b)

–Wet AMD –Wet AMD

–Completed enrollment in Phase 3 studies in wet AMD and DME

–Reported initial data from Phase 2 trial in wet AMD and that trial met its primary safety and efficacy endpoints

–Report detailed results from Phase 2 trial in wet AMD (first quarter 2022)

–Report results from Phase 3 studies in wet AMD and DME (second half 2022)

Immunology & Inflammation

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

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

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

–Atopic dermatitis in pediatrics (6 months–5 years of age) (U.S.)

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

–EoE in adults and adolescents (U.S.)

–Reported that Phase 3 trial for atopic dermatitis in pediatrics (6 months–5 years of age) met its primary and key secondary endpoints

–Initiated Phase 3 study in hand and foot atopic dermatitis

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

–FDA decision on sBLA for atopic dermatitis in pediatric patients (6 months–5 years of age) (mid-2022)

–Submit regulatory application in the EU for atopic dermatitis in pediatric patients (6 months–5 years of age) (first half 2022)

Clinical Program (continued)

Phase 1 Phase 2 Phase 3 Regulatory Review (h)

2021 and 2022

Events to Date Select Upcoming Milestones (i)

Dupixent (dupilumab) (a)

–Chronic obstructive pulmonary disease ("COPD")

–Bullous pemphigoid (Phase 2/3) (c)

–Chronic spontaneous urticaria

–Chronic spontaneous urticaria ("CSU")

–Prurigo nodularis

–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)

–Chronic inducible urticaria - cold

–Chronic rhinosinusitis without nasal polyposis

–Allergic fungal rhinosinusitis

–European Medicines Agency's ("EMA") Committee for Medicinal Products for Human Use adopted a positive opinion for severe asthma in pediatrics (6–11 years of age)

– New England Journal of Medicine ("NEJM") published positive results from Phase 3 trial in pediatrics (6–11 years of age) with moderate-to-severe asthma

–Reported that Phase 3 trial in CSU met its primary and key secondary endpoints

–Reported that two Phase 3 trials in prurigo nodularis met their respective primary and key secondary endpoints

–Reported that Part B of the Phase 3 trial in adults and adolescents with EoE met its co-primary endpoints

–Approved by FDA for 200 mg auto-injector

–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

–European Commission ("EC") decision on regulatory submission for asthma in pediatrics (6–11 years of age) (first half 2022)

–Complete rolling sBLA submission for EoE in adults and adolescents (first quarter 2022)

–Report results from Phase 2 study in peanut allergy (second half 2022)

–Report results from additional Phase 3 CSU study (second half 2022)

–Submit sBLA for prurigo nodularis (first half 2022)

–Report results from Phase 3 study in chronic inducible urticaria - cold (second half 2022)

Clinical Program (continued)

Phase 1 Phase 2 Phase 3 Regulatory Review (i)

Phase 1 Phase 2 Phase 3 Regulatory Review (h)

2021 and 2022

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)

Events to Date Select Upcoming Milestones (i)

Kevzara (sarilumab) (a)

1 unchanged sentence

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

–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

–Systemic juvenile idiopathic arthritis ("sJIA")

Itepekimab (a) (REGN3500)

Antibody to IL-33

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

REGN1908-1909 (f)

Multi-antibody therapy to Feld1

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

Multi-antibody therapy to Fel d 1

–Cat allergy –Reported that Phase 2 study in cat allergic patients with mild asthma met its primary and key secondary endpoints

REGN5713-5714-5715

Multi-antibody therapy to Betv1

–Birch allergy

Multi-antibody therapy to Bet v 1

–Birch allergy –Initial Phase 3 study in birch allergic patients with allergic rhinoconjunctivitis met its primary endpoint

Antibody to IL-36R

–Palmo-plantar pustulosis

Clinical Program (continued)

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)

Libtayo (cemiplimab) (a)(g)

Antibody to PD-1

–Basal cell carcinoma ("BCC")

(pivotal study)

–Metastatic or locally advanced CSCC (d)

–Neoadjuvant CSCC

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

–Second-line cervical cancer, ISA101b combination

–First-line NSCLC, chemotherapy combination

1 unchanged sentence

–Adjuvant CSCC

–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)

–Second-line cervical cancer (EU)

–First-line NSCLC, chemotherapy combination (U.S.

–Approved by FDA and EC for first-line NSCLC, monotherapy

–Approved by FDA and EC for BCC

–Reported Phase 3 chemotherapy combination trial in NSCLC met its overall survival primary endpoint;

trial stopped early based on Independent Data Monitoring Committee ("IDMC") recommendation –FDA decision on sBLA (target action date of September 19, 2022) and EC decision on regulatory submission for NSCLC, chemotherapy combination (second half 2022)

–EC decision on regulatory submission for cervical cancer (second half 2022)

Clinical Program (continued)

Phase 1 Phase 2 Phase 3 Regulatory Review (h)

2021 and 2022

Events to Date Select Upcoming Milestones (i)

Libtayo (cemiplimab) (a)(g)

–Reported positive results from Phase 3 trial in cervical cancer, demonstrating an overall survival benefit;

trial stopped early based on IDMC recommendation

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

Bispecific antibody targeting MUC16 and CD3

4 unchanged sentences

–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 PSMA and CD3

–Prostate cancer

Bispecific antibody targeting two distinct MET epitopes

–MET-altered advanced NSCLC

REGN5093-M114

Bispecific antibody-drug conjugate targeting two distinct MET epitopes

–MET overexpressing advanced cancer

Fianlimab (f)

Antibody to LAG-3

–Solid tumors and advanced hematologic malignancies

–Solid tumors and advanced hematologic malignancies –Presented positive data from Phase 1 trial in combination with Libtayo in advanced melanoma at American Society of Clinical Oncology Annual Meeting

–Initiate Phase 3 study in first-line metastatic melanoma (first half 2022)

Antibody to GITR

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

–Solid tumors

Clinical Program (continued)

Phase 1 Phase 2 Phase 3 Regulatory Review (h)

2021 and 2022

Events to Date Select Upcoming Milestones (i)

Bispecific antibody targeting EGFR and CD28

3 unchanged sentences

–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)

–B-cell non-Hodgkin lymphoma ("B-NHL") (potentially pivotal study) –Resumed enrollment of patients with follicular lymphoma ("FL") and diffuse large B-cell lymphoma ("DLBCL") following protocol amendments –Report additional results from potentially pivotal Phase 2 study in B-NHL (2022)

–Initiate Phase 3 program (second half 2022)

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)

–Multiple myeloma (potentially pivotal study) –Presented results for higher dose level cohorts from Phase 1 trial in multiple myeloma at American Society of Hematology ("ASH") Annual Meeting –Complete enrollment in potentially pivotal Phase 2 study in multiple myeloma (first quarter 2022)

–Report results from potentially pivotal Phase 2 study in multiple myeloma (second half 2022)

–Expand into earlier lines of multiple myeloma therapy (first half 2022)

Bispecific antibody targeting BCMA and CD3

–Multiple myeloma

Clinical Program (continued)

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)

studied as monotherapy and in combination with cemdisiran

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

–Myasthenia gravis, cemdisiran combination (n)

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

–Submit BLA for CD55-deficient protein-losing enteropathy, monotherapy (second half 2022)

Cemdisiran (n)

siRNA therapeutic targeting C5

2 unchanged sentences

–Aplastic anemia

NTLA-2001 (o)

Clinical Program (continued)

Phase 1 Phase 2 Phase 3 Regulatory Review (h)

2021 and 2022

Events to Date Select Upcoming Milestones (i)

NTLA-2001 (m)

TTR gene knockout using CRISPR/Cas9

–Hereditary transthyretin amyloidosis with polyneuropathy

–Transthyretin amyloidosis

–Reported positive interim data from Phase 1 trial in hereditary transthyretin amyloidosis with polyneuropathy

Antibody to Factor XI

General Medicine

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

REGEN-COV (casirivimab and imdevimab) (e)(k)(l)

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)

–COVID-19 prevention

–COVID-19 treatment and prevention (U.S.)

–EUA amendment to add COVID-19 treatment for hospitalized patients and pre-exposure prophylaxis –Reported that Phase 3 trials in non-hospitalized COVID-19 patients met primary and key secondary endpoints

–Reported that Phase 3 trial in hospitalized COVID-19 patients met its primary endpoint

–Positive results reported from Phase 3 RECOVERY trial in hospitalized patients

–Reported that all tested doses in Phase 2 dose-ranging study in non-hospitalized patients met its primary endpoint

–FDA updated EUA, lowering dose to 1,200 mg, allowing for subcutaneous injections in certain circumstances, and to include post-exposure prophylaxis

–FDA revised EUA to exclude use in geographic regions where infection or exposure is likely due to a variant that is not susceptible to the treatment –FDA decision on BLA (target action date of April 13, 2022) for COVID-19 treatment of non-hospitalized patients and prevention

–Submit sBLA and Marketing Authorization Application ("MAA") for COVID-19 treatment of hospitalized patients (first half 2022)

Clinical Program (continued)

Phase 1 Phase 2 Phase 3 Regulatory Review (i)

Phase 1 Phase 2 Phase 3 Regulatory Review (h)

2021 and 2022

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)

Events to Date Select Upcoming Milestones (i)

REGEN-COV (casirivimab and imdevimab) (e)(k)(l)

–Approved by EC for COVID-19 treatment of non-hospitalized patients and prevention and by Ministry of Health, Labour and Welfare ("MHLW") for COVID-19 treatment in Japan

–Reported that Phase 3 prevention trial in uninfected household contacts of SARS-CoV-2 infected individuals met its primary and key secondary endpoints

–Reported positive longer-term results from Phase 3 prevention trial

Praluent (alirocumab)

Antibody to PCSK9

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

–HeFH in pediatrics

–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)

–HeFH in pediatrics –Approved by FDA for HoFH

Fasinumab (j)(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)

–Continue discussions with regulatory authorities and determine next steps for the program (mid-2022)

Evkeeza (evinacumab) (f)(o)

Antibody to ANGPTL3

–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)

–Acute pancreatitis prevention –Approved by FDA and EC for HoFH

–Completed Phase 2 study in severe hypertriglyceridemia

Garetosmab (f) (REGN2477)

1 unchanged sentence

–Fibrodysplasia ossificans progressiva

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

–Reported results from Phase 2 study in FOP

–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)

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

–Determine next steps for the program (2022)

Agonist antibody to leptin receptor ("LEPR")

–Generalized lipodystrophy (e)

Clinical Program (continued)

Phase 1 Phase 2 Phase 3 Regulatory Review (i)

2020 and 2021

Events to Date Select Upcoming Milestones (k)

–Partial lipodystrophy

–Report results from Phase 2 study in generalized lipodystrophy (first half 2022)

Agonist antibody to NPR1

3 unchanged sentences

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

4 unchanged sentences

(f) Sanofi did not opt-in to or elected not to continue to co-develop the product candidate.

Under the terms of our agreement, Sanofi is entitled to receive royalties on any future sales of the product candidate.

(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 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) 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.

Under the terms of our agreement, Sanofi is entitled to receive royalties on sales of the product, if any.

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

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

(i) 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

(j) In collaboration with Teva and Mitsubishi Tanabe Pharma

(k) Certain trials conducted with the National Institute of Allergy and Infectious Diseases ("NIAID"), part of the NIH

(l) In collaboration with Roche outside of the United States

(m) In collaboration with Intellia

(n) In collaboration with Alnylam

(o) In collaboration with Ultragenyx outside of the United States

Additional Information - Clinical Development Programs

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.

Based on laboratory data that showed markedly decreased binding to the Omicron spike protein, REGEN-COV is highly unlikely to be active against the Omicron variant.

See "REGEN-COV - Emergency and Temporary Use Authorizations" above for further information.

The Company has completed or discontinued dosing with REGEN-COV in all COVID-19 treatment and prevention studies.

However, the Company continues to progress "next generation" antibodies that are active against Omicron, Delta, and other variants of concern.

Pending regulatory discussions, new therapeutic candidates could enter clinical development in the coming months.

REGEN-COV Treatment Study - Hospitalized Patients

The Phase 3 UK-based RECOVERY trial in hospitalized patients with severe COVID-19 found that adding REGEN-COV to usual care reduced the risk of death by 20% in patients who had not mounted a natural antibody response on their own against SARS-CoV-2, compared to usual care alone.

We were subsequently notified by the sponsor of the RECOVERY trial of a Good Clinical Practices ("GCPs") inspection of the trial by the UK MHRA, which found certain deviations from GCP compliance.

The MHRA report stated that it found no evidence that the identified issues had impacted the overall data integrity to such an extent that the data would be unreliable based on those findings.

However, it noted that certain aspects of data quality could not be fully assured and requested that certain corrective and preventative actions be taken;

the sponsor of the trial has been in discussions with the MHRA and is responding to these findings.

We have shared this information with the FDA.

In the Company-sponsored Phase 2/3 study in hospitalized patients, REGEN-COV met the primary virologic endpoint, showing that REGEN-COV reduced viral load in these hospitalized patients, but did not achieve statistical significance in the pre-specified primary clinical endpoint:

reduction in mechanical ventilation or death from day 6 to day 29 in patients with high viral load at baseline.

However, the study showed a reduction in mechanical ventilation or death from day 1 to day 29 in all patients who were SARS-CoV-2 PCR-positive at baseline.

In addition, an approximately 36% reduction in all-cause mortality was seen from day 1 to day 29, supporting the results of the RECOVERY trial.

In September 2021, the Company announced that a Phase 3 trial in patients hospitalized with COVID-19 met its primary endpoint.

The trial showed that REGEN-COV significantly reduced viral load within 7 days of treatment in patients who entered the trial without having mounted their own antibody response (seronegative) and required low-flow or no supplemental oxygen.

Patients who received REGEN-COV in this trial experienced a 36% reduced risk of death within 29 days of receiving treatment, and in patients who were seronegative when they entered the trial the risk of death was reduced by 56%.

REGEN-COV Prevention Study

In April 2021, we announced positive results from the Phase 3 COVID-19 prevention trial in household contacts of SARS-CoV-2 infected individuals.

The trial, which was jointly run with the NIAID, part of the NIH, met its primary and key secondary endpoints, showing that REGEN-COV 1,200 mg subcutaneous injection reduced the risk of symptomatic infections by 81% in those who were not infected.

In November 2021, we announced additional positive results from the Phase 3 COVID-19 prevention trial jointly run with the NIAID, showing the a single dose of REGEN-COV reduced the risk of contracting COVID-19 by 81.6% during the pre-specified follow-up period (months 2–8), maintaining the risk reduction reported during the first month after administration, which is described above.

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.

EYLEA (aflibercept)

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

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

Aflibercept 8 mg

Aflibercept 8 mg is an investigational soluble fusion protein that acts as a VEGF inhibitor (see related description under "EYLEA (aflibercept)" above).

This concentrated aflibercept formulation is being studied in wet AMD and DME, investigating dosing intervals of every 12 weeks and every 16 weeks.

Dupixent (dupilumab)

Dupixent is a fully-human monoclonal antibody that inhibits the signaling pathway of IL-4 and IL-13.

Data from Dupixent clinical trials have shown that IL-4 and IL-13 are key drivers of the type 2 inflammation that plays a major role in atopic dermatitis, asthma, and CRSwNP, as well as other immunological and inflammatory diseases.

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

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

Kevzara (sarilumab)

1 unchanged sentence

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.

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

REGN1908-1909

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

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

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 nuts and fruits such as apples, pears, and cherries.

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.

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.

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

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

Regeneron is studying Libtayo as monotherapy and in combination with either conventional or novel therapeutic approaches in various solid tumors and blood cancers.

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

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

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

REGN5458 is an investigational bispecific monoclonal antibody designed to bind to CD3 while also binding and bridging T-cells to the BCMA protein on multiple myeloma cells.

We are studying whether REGN5458 may help to activate T-cells via their CD3 receptors and trigger targeted, T-cell mediated killing of multiple myeloma.

Pozelimab is an investigational, fully human monoclonal antibody designed to block complement factor C5 in order to treat diseases mediated by abnormal complement pathway activity, including PNH, CD55-deficient protein-losing enteropathy, and myasthenia gravis.

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

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.

Praluent (alirocumab)

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Evkeeza (evinacumab)

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

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

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

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.

The abnormal bone formation in soft tissue outside of the normal skeleton, a process known as heterotopic ossification, leads to loss of mobility and premature death in FOP patients.

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

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

Our preclinical research programs include the areas of oncology/immuno-oncology, angiogenesis, ophthalmology, metabolic and related diseases, muscle diseases and disorders, inflammation and immune diseases, bone and cartilage, pain and neurobiology, cardiovascular diseases, infectious diseases, and diseases related to aging.

Research and Development Technologies

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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.

In producing knock-out models, a color or fluorescent marker may be substituted in place of the actual gene sequence, allowing for high-resolution visualization of precisely where the gene is active in the body during normal body functioning as well as in disease processes.

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Furthermore, mice developed using our VelociMouse technology are suitable for direct phenotyping or other studies.

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 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 bispecific antibodies.

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

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.

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

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

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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.

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

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.

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Regeneron Genetics Center (RGC ™ ), a wholly owned subsidiary of Regeneron Pharmaceuticals, Inc., leverages de-identified clinical, genomic, and molecular data from human volunteers to identify medically relevant associations in a blinded fashion designed to preserve patients' privacy.

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

RGC is undertaking multiple approaches, including large population-based efforts as well as family- and founder-based approaches.

RGC is undertaking multiple collaborative approaches to study design and implementation, including large population-based efforts as well as family- and founder-based approaches.

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

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.

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

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.

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

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

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

These efforts at the RGC have led to the identification of more than 10 novel genetic targets.

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

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

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.

In the first quarter of 2020, the Company announced an expansion of its Other Transaction Agreement with the Biomedical Advanced Research Development Authority ("BARDA"), pursuant to which the U.S.

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

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

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

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.

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

In January 2021, the Company announced an agreement with an entity acting on behalf of the U.S.

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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.

government was obligated to purchase 1.25 million doses of drug product, resulting in payments to the Company of $2.625 billion (as described under "Products - REGEN-COV - Emergency and Temporary Use Authorizations" above).

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

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

Pursuant to the agreement, the U.S.

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

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

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

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

See "Results of Operations - Revenues" below for REGEN-COV net product sales recognized in connection with these agreements.

In August 2020, we entered into a collaboration agreement with Roche to develop, manufacture, and distribute the casirivimab and imdevimab antibody cocktail.

We lead global development activities for casirivimab and imdevimab, and the parties jointly fund certain ongoing studies, as well as any mutually agreed additional new global studies to evaluate further the potential of casirivimab and imdevimab in treating or preventing COVID-19.

Under the terms of the agreement, each party is obligated to dedicate a certain amount of manufacturing capacity to casirivimab and imdevimab each year.

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

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

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.

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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 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 co-commercialize Dupixent in the United States and in certain countries outside the United States.

We supply certain commercial bulk product to Sanofi.

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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 each of 2020 and 2021, the Company earned a $50.0 million sales-based milestone from Sanofi, upon aggregate annual sales of antibodies outside the United States (including Praluent) exceeding $1.0 billion and $1.5 billion, respectively, on a rolling twelve-

We are entitled to receive up to an aggregate of $150.0 million in additional sales milestone payments from Sanofi, which includes the next sales milestone payment of $50.0 million that would be earned when such sales outside the United States exceed $2.0 billion on a rolling twelve-month basis.

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

The parties also entered into a Praluent Cross License & Commercialization Agreement (the "Praluent Agreement") pursuant to which, effective April 1, 2020, the Company, at its sole cost, 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.

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

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

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We are collaborating with Sanofi on the development and commercialization of antibody-based cancer treatments in the field of immuno-oncology (the "IO Collaboration").

The IO Collaboration is governed by an Amended and Restated Immuno-oncology Discovery and Development Agreement (the "Amended IO Discovery Agreement"), and an Immuno-oncology License and Collaboration Agreement (the "IO License and Collaboration Agreement").

Effective December 31, 2018, the Company and Sanofi entered into the Amended IO Discovery Agreement, which narrowed the scope of the existing discovery and development activities conducted by the Company ("IO Development Activities") under the original 2015 Immuno-oncology Discovery and Development Agreement (the "2015 IO Discovery Agreement") to developing therapeutic bispecific antibodies targeting (i) BCMA and CD3 (the "BCMAxCD3 Program") and (ii) MUC16 and CD3 (the "MUC16xCD3 Program") through clinical proof-of-concept.

The Amended IO Discovery Agreement provided for Sanofi's payment of $461.9 million to the Company as consideration for (x) the termination of the 2015 IO Discovery Agreement, (y) the prepayment for certain IO Development Activities regarding the BCMAxCD3 Program and the MUC16xCD3 Program, and (z) the reimbursement of costs incurred by the Company under the 2015 IO Discovery Agreement during the fourth quarter of 2018.

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").

Effective December 31, 2018, the Company and Sanofi entered into an Amended and Restated Immuno-oncology Discovery and Development Agreement (the "Amended IO Discovery Agreement"), which narrowed the scope of the existing discovery and development activities conducted by the Company ("IO Development Activities") under the original 2015 Immuno-oncology Discovery and Development Agreement (the "2015 IO Discovery Agreement") to developing therapeutic bispecific antibodies targeting (i) BCMA and CD3 (the "BCMAxCD3 Program") and (ii) MUC16 and CD3 (the "MUC16xCD3 Program") through clinical proof-of-concept.

The Amended IO Discovery Agreement provided for, among other things, Sanofi's prepayment for certain IO Development Activities regarding the BCMAxCD3 Program and the MUC16xCD3 Program.

Under the terms of the Amended IO Discovery Agreement, the Company was 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").

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.

Pursuant to the Amended IO Discovery Agreement, the parties agreed that (i) if Sanofi exercises its option with respect to a BCMAxCD3 Program antibody, Sanofi will lead the development and global commercialization of such BCMAxCD3 Program antibody;

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.

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.

Sanofi will fund development costs up front for a BCMAxCD3 Program antibody and we will reimburse half of the total development costs for such antibody from our share of future IO Collaboration profits to the extent they are sufficient for this purpose.

In addition, we and Sanofi will share equally, on an ongoing basis, the development costs for a MUC16xCD3 Program antibody.

Each party will have the right to co-commercialize licensed products in countries where it is not the lead commercialization party.

The parties will share equally in profits and losses in connection with the commercialization of collaboration products.

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, an antibody targeting PD-1.

With regard to the BCMAxCD3 Program and the MUC16xCD3 Program, when the applicable Program Costs Cap was reached, Sanofi had 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 Immuno-oncology License and Collaboration Agreement (the "IO License and Collaboration Agreement"), as amended.

During the first quarter of 2021, Sanofi did not exercise its options to license rights to these product candidates;

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

Under the terms of the IO License and Collaboration Agreement, the parties are co-developing and co-commercializing Libtayo.

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

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Sanofi has exercised its option to co-commercialize Libtayo in the United States.

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.

EYLEA outside the United States

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.

Bayer markets EYLEA outside the United States, where, for countries other than Japan, the companies share equally in profits and losses from sales of EYLEA.

In Japan, we are entitled to receive a tiered percentage of between 33.5% and 40.0% of EYLEA net sales through 2021, and thereafter, the companies will share equally in profits and losses from the sales of EYLEA.

We will be entitled to a milestone payment of $375.0 million in the event that global sales of Libtayo equal or exceed $2.0 billion in any consecutive twelve-month period.

EYLEA and aflibercept 8 mg outside the United States

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

All agreed-upon development expenses incurred by the Company and Bayer are shared equally.

Bayer markets EYLEA outside the United States, where, for countries other than Japan, the companies share equally in profits and losses from sales.

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

We are obligated to reimburse Bayer for 50% of the development costs that it has incurred under the agreement from our share of the collaboration profits (including payments to us based on sales in Japan).

The reimbursement payment in any quarter will equal 5% of the then outstanding repayment obligation, but never more than our share of the collaboration profits in the quarter unless we elect to reimburse Bayer at a faster rate.

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

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

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

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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.

As of December 31, 2021, we had received an aggregate $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.

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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 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 continue to lead global development activities for odronextamab, and Zai is 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.

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 we 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).

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

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 an aggregate of $200.0 million in clinical proof-of-principle milestones for eye or CNS programs.

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

In 2019, we and Alnylam entered into a global, strategic collaboration to discover, develop, and commercialize RNAi therapeutics for a broad range of diseases by addressing therapeutic disease targets expressed in the eye and central nervous system ("CNS"), in addition to a select number of targets expressed in the liver.

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

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;

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.

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

In connection with the collaboration, we and Alnylam also entered into a Stock Purchase Agreement.

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 cemdisiran and pozelimab, 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 connection with the collaboration, we also purchased shares of Alnylam common stock for aggregate cash consideration of $400.0 million.

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

Under the C5 siRNA Co-Commercialization Collaboration agreement, the parties share costs equally and will split profits (if commercialized);

and under the License Agreement, the licensee is responsible for its own costs and expenses.

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).

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

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

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In connection with the May 2020 agreement, we made a $70.0 million up-front payment and purchased 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.

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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.

As described under "Products" above, pursuant to a 2017 license agreement, we granted Kiniksa Pharmaceuticals, Ltd.

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

During the first quarter of 2021, Kiniksa received marketing approval in the United States for a new indication of ARCALYST, recurrent pericarditis, and, as a result, we received a $20.0 million milestone payment from Kiniksa.

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

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

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

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

As described under "Products" above, in January 2022 we entered into a license and collaboration agreement for Ultragenyx Pharmaceutical Inc.

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

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

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

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

We have also granted Ultragenyx an exclusive option to negotiate a separate agreement to collaborate on the development and commercialization of garetosmab outside of the United States under terms to be agreed upon by both companies.

Manufacturing

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We currently have approximately 100,000 liters of cell culture capacity at our Rensselaer facility, and are approved by the FDA and other regulatory agencies to manufacture our bulk drug materials and products.

In addition, we currently have approximately 130,000 liters of cell culture capacity at our Limerick facility which has received certain manufacturing approvals by regulatory agencies, including the FDA, and is in the process of further validation, as required by regulatory authorities, for the manufacture of our bulk drug materials and products.

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

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On a combined basis, our product sales to these customers accounted for 48% of our total gross product revenue for the year ended December 31, 2021.

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.

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

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

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

Many of our competitors have substantially greater research, preclinical and clinical product development, manufacturing capabilities, and financial, marketing, and human resources than we do.

Competition from smaller competitors may also be or become more significant if those competitors acquire or discover patentable inventions, form collaborative arrangements, or merge with large pharmaceutical or biotechnology companies.

Even if we are able to commercialize additional product candidates, one or more of our competitors may have brought a competitive product to market earlier than us or may have patent protection that dominates or adversely affects our activities or products.

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

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

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

Marketed Products

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

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

Samsung Bioepis Co., Ltd./Biogen Inc.

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

Susvimo ® (ranibizumab ocular implant)

Genentech/Roche Wet AMD United States

Vabysmo ™ (faricimab-svoa)

Genentech/Roche Wet AMD, DME United States

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

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

Marketed Product (continued)

Competitor Product Competitor Indication Territory (1)

Beovu ® (brolucizumab) Injection

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Ozurdex ® (dexamethasone intravitreal implant)

Allergan, PLC DME, RVO Worldwide

Allergan/AbbVie Inc.

DME, RVO United States, EU

Iluvien ® (fluocinolone acetonide intravitreal implant)

Alimera Sciences, Inc.

DME Worldwide

DME United States, EU

Conbercept Chengdu Kanghong Pharmaceutical Group Co., Ltd.

Wet AMD, mCNV China

Wet AMD, DME, mCNV China

Dupixent Eucrisa ® /Staquis ® (crisaborole)

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

Mild-to-moderate atopic dermatitis United States, EU

Olumiant ® (baricitinib)

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

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

Cibinqo ® (abrocitinib)

Pfizer Moderate-to-severe atopic dermatitis Worldwide

Rinvoq ® (upadacitinib)

AbbVie Moderate-to-severe atopic dermatitis Worldwide

Adbry ™ /Adtralza ® (tralokinumab)

LEO Pharma Inc.

Moderate-to-severe atopic dermatitis United States, EU

Corectim ® (delgocitinib)

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

Atopic dermatitis Japan

Xolair ® (omalizumab)

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Nucala ® (mepolizumab)

GlaxoSmithKline ("GSK") Asthma Worldwide

GlaxoSmithKline ("GSK") Asthma, nasal polyps Worldwide (asthma);

United States, EU (nasal polyps)

Cinqair ® (reslizumab)

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AstraZeneca Asthma Worldwide

Marketed Product (continued)

Competitor Product Competitor Indication Territory (1)

Tezspire ™ (tezepelumab-ekko)

AstraZeneca/Amgen Asthma United States

Libtayo Keytruda ® (pembrolizumab)

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Pfizer/Merck KGaA Various cancers Worldwide

Jemperli ® (dostarlimab)

GSK Various cancers United States, EU

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

Marketed Product (continued)

Competitor Product Competitor Indication Territory (1)

Leqvio ® (inclisiran)

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

United States, EU

Kevzara Actemra ® (tocilizumab)

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(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.

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

Product Candidates

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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.

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

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

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Many pharmaceutical and biotechnology companies are attempting to discover new therapeutics for indications in which we invest substantial time and resources.

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.

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 inferior intellectual property position or 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.

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

These and other competitors may have established substantial intellectual property and other competitive advantages.

These and other competitors also may have established substantial intellectual property and other competitive advantages.

If any of these or other competitors announces a successful clinical study involving a product that may be competitive with one of our product candidates or the grant of marketing approval by a regulatory agency for a competitive product, such developments may have an adverse effect on our business, operating results, financial condition, cash flows, or future prospects.

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

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

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

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

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

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Our success depends, in part, on our ability to obtain patents, maintain trade secret protection, and operate without infringing on the proprietary 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 awards of damages if we are found to have infringed such patents or rights ";

and Note 15 to our Consolidated Financial Statements).

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The following table describes our U.S.

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.

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

The noted expiration dates include any patent term adjustments.

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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.

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

Product Molecule Territory Patent No.

General Subject Matter Class Expiration

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

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

US 8,092,803 Formulation June 21, 2027

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US 10,857,231 Formulation March 22, 2026

US 11,066,458 Formulation June 14, 2027

US 11,084,865 Formulation June 14, 2027

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

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

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

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

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

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

EP 2364691 Formulation June 14, 2027

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

EP 2944306 Formulation June 14, 2027

Composition of Matter

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

Methods of Treatment

June 24, 2022

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

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

US 8,945,559 Formulation October 17, 2032

Product (continued)

Molecule Territory Patent No.

General Subject Matter Class Expiration

Dupixent (a) (continued)

US 10,435,473 Formulation October 5, 2031

US 11,059,896 Formulation October 5, 2031

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

4 unchanged sentences

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) **

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

US 11,034,768 Methods of Treatment March 23, 2039

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

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

EP 3010539 Methods of Treatment June 20, 2034

EP 2888281 Methods of Treatment August 20, 2033

EP 3064511 Methods of Treatment October 27, 2029

EP 3107575 Methods of Treatment February 20, 2035

EP 3470432 Methods of Treatment August 20, 2033

EP 2624865 Formulation October 5, 2031

EP 3354280 Formulation October 5, 2031

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

October 5, 2031 – September 15, 2034 (d)

Methods of Treatment

August 20, 2033 – August 29, 2034 (d)

Methods of Treatment

September 4, 2033

Methods of Treatment

February 20, 2035

Methods of Treatment

June 20, 2034

Methods of Treatment

November 13, 2035

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

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

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

EP 3097119 Composition of Matter January 23, 2035

EP 3455258 Methods of Treatment May 12, 2037

Composition of Matter January 23, 2035

Praluent (a)(f)

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

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

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

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

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

Product (continued)

Molecule Territory Patent No.

General Subject Matter Class Expiration

Praluent (a)(f)

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

EP 3156422 Composition of Matter December 15, 2029

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

EP 2756004 Methods of Treatment September 12, 2032

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EP 3169362 Methods of Treatment July 16, 2035

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

EP 3004171 Methods of Treatment June 6, 2034

EP 3068803 Methods of Treatment November 12, 2034

EP 3395836 Methods of Manufacturing January 27, 2032

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

US 10,072,086 Formulation September 19, 2031

US 11,098,127 Formulation January 7, 2031

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

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

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) **

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

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

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

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

EP 2766039 Methods of Treatment October 10, 2032

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EP 3409269 Formulation January 7, 2031

REGEN-COV ***

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

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

Methods of Treatment

October 10, 2032 – March 29, 2033 (d)

Methods of Treatment November 21, 2034

REGEN-COV (a)

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

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

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

** 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 15 to our Consolidated Financial Statements for information regarding inter partes review and post-grant review petitions filed in the U.S.

US 10,975,139 Composition of Matter June 25, 2040

(a) 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.

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

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

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

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

This may result in multiple PTE approvals for a given patent, each with its own expiration date.

In this table, date ranges are shown for the expiration of Japanese patents for which multiple PTEs have been granted, with the later date indicating the latest expiring PTE for the corresponding patent.

(e) 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.

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

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

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

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

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

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

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

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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 awards of damages if we are found to have infringed such patents or rights ";

and Note 15 to our Consolidated Financial Statements).

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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.

The sponsor of a clinical trial or the sponsor's designated responsible party may be required to register certain information about the trial and disclose certain results on government or independent registry websites, such as clinicaltrials.gov.

Typically, clinical testing involves a three-phase process, which may overlap or be subdivided in some cases.

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.

Although Phase 1 trials are typically conducted in healthy human subjects, in some instances, the trial subjects are patients with the targeted disease or condition.

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.

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

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

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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 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.

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

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

If the application is not, the FDA may refuse to accept the BLA for filing and request additional information.

A refusal to file, which requires resubmission of the BLA with the requested additional information, delays review of the application.

If the application is accepted for review, the FDA reviews the application 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.

FDA performance goals generally provide for action on a BLA within 10 months of the 60-day filing date (or within 12 months of the BLA submission).

That deadline can be extended by FDA under certain circumstances, including by the FDA's requests for additional information.

The targeted action date can be 6 months after the 60-day filing date (or 8 months after BLA submission) for product candidates that are granted priority review designation because they are intended to treat serious or life-threatening conditions and demonstrate the potential to address unmet medical needs.

The FDA has other programs to expedite development and review of product candidates that address serious or life-threatening conditions.

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.

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 GCPs.

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The results of preclinical studies or early stage clinical trials may not predict long-term safety or efficacy of our compounds when they are tested or used more broadly in humans.

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

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

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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.

Marketing authorization for biologics must be obtained through a centralized 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.

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

In the United States, 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.

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

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

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

Emergency Use Authorization

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

The COVID-19 pandemic has been designated as such a national emergency.

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

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

The FDA expects EUA holders to work toward submission of full

applications, such as a BLA, as soon as possible.

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

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

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

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

Post-Approval Regulation

The FDA and comparable regulatory authorities in other jurisdictions may also require us to conduct additional clinical trials or to make certain changes related to a product after granting approval of the product.

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.

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

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

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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.

A post-authorization efficacy study ("PAES") is a study that is carried out for complementing 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.

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 cGMP, and are subject to inspections by the FDA or comparable regulatory authorities in other jurisdictions to confirm such compliance.

Changes of suppliers or modifications of methods of manufacturing may require amending our application(s) to the FDA or such comparable foreign regulatory authorities and acceptance of the change by the FDA or such comparable foreign regulatory authorities prior to release of product(s).

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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.

We also have obligations to report the average sales price for certain drugs to the Medicare program as part of our agreement to participate in the Medicaid Drug Rebate program.

For calendar quarters beginning January 1, 2022, we will be required to report the average sales price for certain drugs under the Medicare program regardless of whether we participate in the Medicaid Drug Rebate Program.

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

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

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

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

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

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

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

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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).

and revise best price and average manufacturer price exclusions of manufacturer-sponsored patient benefit programs, particularly regarding potential 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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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.

Starting in 2023, manufacturers must pay refunds to Medicare for single-source drugs or biological products, or biosimilar biological products, reimbursed under Medicare Part B and packaged in single-dose containers or single-use packages for units of discarded drug reimbursed by Medicare Part B in excess of 10 percent of total allowed charges under Medicare Part B for that drug.

Manufacturers that fail to pay refunds could be subject to civil monetary penalties of 125 percent of the refund amount.

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.

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.

The 340B program, which is administered by the Health Resources and Services Administration ("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.

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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.

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

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

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

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The governing statute provides for civil monetary penalties for failure to provide information timely or for knowing submission of false information to the government.

Medicare Part D provides coverage to enrolled Medicare patients for self-administered drugs ( i.e.

, drugs that are not administered by a physician).

Medicare Part D provides coverage to enrolled Medicare patients for self-administered drugs (i.e., drugs that are not administered by a physician).

Medicare Part D is administered by private prescription drug plans approved by the U.S.

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

In addition, for 2021, manufacturers, including us, are required to provide to CMS a 70% discount on brand name prescription drugs utilized by Medicare Part D beneficiaries when those beneficiaries are in the coverage gap phase of the Part D benefit design.

In addition, for 2021, manufacturers, including us, are required to provide to CMS a 70% discount on brand name

prescription drugs utilized by Medicare Part D beneficiaries when those beneficiaries are in the coverage gap phase of the Part D benefit design.

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

As a consequence, these payors may not cover or adequately reimburse for use of our products or may do so at levels that disadvantage them relative to competitive products.

These payors may not cover or adequately reimburse for use of our products or may do so at levels that disadvantage them relative to competitive products.

Outside the United States, within the EU, our products are paid for by a variety of payors, with governments being the primary source of payment.

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Negotiating prices with governmental authorities can delay commercialization of our products.

Governments may use a variety of cost-containment measures to control the cost of products, including price cuts, mandatory rebates, value-based pricing, and reference pricing ( i.e.

, referencing prices in other countries or prices of competitive products and using those reference prices to set a price).

Governments may use a variety of cost-containment measures to control the cost of products, including price cuts, mandatory rebates, value-based pricing, and reference pricing (i.e., referencing prices in other countries or prices of competitive products and using those reference prices to set a price).

Budgetary pressures in many EU countries are continuing to cause governments to consider or implement various cost-containment measures, such as price freezes, increased price cuts and rebates, and expanded generic substitution and patient cost-sharing.

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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.

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

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

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

HIPAA imposes privacy and security obligations on covered entity health care providers, health plans, and health care clearinghouses, as well as their "business associates" – 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.

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

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

Although we are not directly subject to HIPAA other than with respect to providing certain employee benefits, we could potentially be subject to criminal penalties if we, our affiliates, or our agents knowingly 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 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.

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

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

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

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

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

Failure to comply with the CCPA

may result in, among other things, significant civil penalties and injunctive relief, or statutory or actual damages.

In addition, California residents have the right to bring a private right of action in connection with certain types of incidents.

These claims may result in significant liability and damages.

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

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.

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

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

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

In particular, these obligations and restrictions 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.

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

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

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

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

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

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

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See Part I, Item 1A.

"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 ."

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

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.

Business Segments

We manage our business as one segment which includes all activities related to the discovery, development, and commercialization of medicines for the treatment of serious diseases.

For financial information related to our one segment, see Part II, Item 6.

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

We manage our business as one segment which includes all activities related to the discovery, development, and commercialization of medicines for serious diseases.

For financial information related to our one segment, see our Consolidated Financial Statements and related notes.

Human Capital Resources

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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.

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.

As of December 31, 2021, we had 10,368 full-time employees, consisting of 8,564 employed in the United States, 1,648 employed in Ireland, and 156 employed in other countries (including the United Kingdom, Germany, the Netherlands, and Canada).

Of these employees, 1,936 were within our research and preclinical development organization, 1,300 were within our global clinical development organization, and 5,037 were within our industrial operations and product supply organization.

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

Company-wide, nearly 1,200 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.

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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").

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

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

Our 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.

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

We empower employee-led cross-functional resource groups ("ERGs") and interest groups, who connect around a common passion to build a culture of inclusion and collaborate to support under-served science and global communities.

In 2021, we launched several new ERGs, all of which align their objectives to our global DEI strategy and provide meaningful professional development opportunities for our workforce, with support from senior leaders as executive sponsors.

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.

Making progress toward this goal, in 2020, we established a DEI steering committee of senior leaders to provide oversight and guidance on our DEI efforts.

In 2021, we hired our Chief DEI Officer;

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

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

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

In order to better understand our employees' perspectives, we also conducted an employee engagement survey and launched an objective measure for inclusion and belonging.

Our board of directors received a detailed update on our DEI efforts in 2021 and continues to monitor our progress.

2021 Workforce Diversity Representation *

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* Based on full-time employees as of December 31, 2021

** 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.

** Represents the percentage of our full-time employees 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 31.0%.

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

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

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.

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

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 provide several programs related to employee health and wellness, including onsite amenities and programs such as meditation and prayer rooms and fitness centers.

Throughout the COVID-19 pandemic, we have continued to prioritize mental health initiatives and take further action to reduce or remove barriers to quality mental healthcare for our employees and their family members.

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

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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.

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, such as work-from-home policies for a significant portion of our employees, increased physical distancing in workspaces, and regular testing.

As the dynamics of the COVID-19 pandemic continue to evolve, we adjust and tailor our approach based on public health guidance and local community case rates.

For our essential employees who remain onsite in our laboratories and manufacturing facilities, we provide personal protective equipment

and require masks to be worn.

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

In addition, we have established a workforce reintegration plan to facilitate our large-scale return to office.

The reintegration plan includes safety measures and procedures in compliance with local, state, and federal mandates.

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.

Our Talent 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.

In 2021, over 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.

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

In order to make progress on this goal during the COVID-19 pandemic, we transitioned volunteer programs to virtual formats to continue to support our non-profit partners while safeguarding health and safety.

The success of our employee engagement efforts is demonstrated by our employee retention rate of 92.2% in 2021, as well as the fact that nearly 90% of our employees who responded to our annual engagement survey said Regeneron is a great place to work, of which we are especially proud since over 30% of our current workforce was onboarded during the COVID-19 pandemic.

Additionally, for the seventh consecutive year, we were recognized on the Fortune "100 Best Companies to Work For" list in 2021.

We have also placed in the top five for the past 11 years in Science magazine’s annual "Top Employers Survey" of the global biotechnology and pharmaceutical industry.

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.

We believe this commitment supports our core strategy of creating and advancing a high-quality product pipeline and delivering medicines to people in need.

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

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

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

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

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

Corporate Information

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

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

We encourage investors and other interested parties to review the

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

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

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

What changed 10-K

Item 1. Business