What changed in this filing

/stocks — the workspaceLOADING

Item 2. Management’s Discussion and Analysis

2021-05-06 compared with 2020-11-05 · 336 added, 379 removed, 371 unchanged (66% of the section changed)

4 unchanged sentences

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 our product candidates and research and clinical programs now underway or planned, including without limitation EYLEA ® (aflibercept) Injection, Dupixent ® (dupilumab) Injection, Libtayo ® (cemiplimab) Injection, Praluent ® (alirocumab) Injection, Kevzara ® (sarilumab) Injection, Inmazeb TM (atoltivimab, maftivimab, and odesivimab-ebgn), REGN-COV2, fasinumab, evinacumab, garetosmab, pozelimab, Regeneron's oncology programs (including its costimulatory bispecific portfolio), Regeneron's earlier-stage programs, and the use of human genetics in Regeneron's research programs;

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, Evkeeza TM (evinacumab), Inmazeb TM (atoltivimab, maftivimab, and odesivimab-ebgn), REGEN-COV™ (casirivimab with imdevimab), fasinumab, garetosmab, pozelimab, odronextamab, itepekimab, REGN5458, REGN5713-5714-5715, Regeneron's other oncology programs (including its costimulatory bispecific portfolio), Regeneron's and its collaborators' earlier-stage programs, and the use of human genetics in Regeneron's research programs;

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

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

the likelihood, 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, Inmazeb, REGN-COV2, fasinumab, evinacumab, garetosmab, pozelimab, and odronextamab;

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

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

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

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

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

ongoing regulatory obligations and oversight impacting Regeneron's Products (such as EYLEA, Dupixent, Libtayo, Praluent, Kevzara, Evkeeza, and Inmazeb), 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 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 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;

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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 REGN-COV2, 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, and Praluent described further in Note 12 to our Condensed Consolidated Financial Statements included in this report), other litigation and other proceedings and government investigations relating to the Company and/or its operations (including without limitation those described in Note 12 to our Condensed Consolidated Financial Statements included in this report), the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on our business, prospects, operating results, and financial condition.

(or their respective affiliated companies, as applicable), as well as Regeneron's agreement with Roche relating to the casirivimab with imdevimab antibody cocktail (known as REGEN-COV in the United States), 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 12 to our Condensed Consolidated Financial Statements included in this report), other litigation and other proceedings and government investigations relating to the Company and/or its operations (including without limitation those described in Note 12 to our Condensed Consolidated Financial Statements included in this report), the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on our business, prospects, operating results, and financial condition.

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

1 unchanged sentence

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

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

We do not undertake any

obligation to update (publicly or otherwise) any forward-looking statement, whether as a result of new information, future events, or otherwise.

Regeneron Pharmaceuticals, Inc.

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.

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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Three Months Ended

September 30, Nine Months Ended

September 30,

(In millions, except per share data) 2021 2020

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Net income per share - diluted $ 10.09 $ 5.43

* Certain revisions have been made to the previously reported revenues for the periods ended September 30, 2019.

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

Product Disease Area (1)

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

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

Product Disease Area Territory

EU Japan ROW (4)

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

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

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

3 unchanged sentences

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

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

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

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

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

Libtayo (cemiplimab) Injection (3)(4)

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

Product (continued)

Disease Area (1)

Disease Area 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 (9)

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

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

- Homozygous familial hypercholesterolemia ("HoFH") 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 - HoFH (in adults and adolescents) a

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

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

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

- Recurrent pericarditis (in adults and adolescents)

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

- 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

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

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

Product is approved for use in adults, unless otherwise noted, in the disease area described above

(1) In collaboration with Bayer outside the United States

(2) In collaboration with Sanofi

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

(5) 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" section below for further details.

(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.

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(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

(9) No longer marketed by Sanofi in Japan due to injunction (see Note 12 to our Condensed Consolidated Financial Statements for further details)

(7) No longer marketed by Sanofi in Japan

(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.

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.

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

REGEN-COV - Emergency Use Authorization

In November 2020, the antibody cocktail casirivimab with 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.

Net Product Sales of Regeneron-Discovered Products

Net Product Sales Recorded by Regeneron Three Months Ended

September 30,

Three Months Ended

2021 2020 % Change

(In millions) U.S.

ROW Total U.S.

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$ 43.3 $ 61.3 $ 104.6 $ 35.1 $ 44.7 $ 79.8 31 %

Kevzara (b) $ 33.2 $ 36.8 $ 70.0 $ 36.5 $ 18.3 $ 54.8 28 %

REGN-COV2 (d)

$ 40.2 — $ 40.2 — — — (e)

ZALTRAP (b) $ 1.7 $ 22.5 $ 24.2 $ 3.1 $ 25.3 $ 28.4 (15 %)

ARCALYST U.S.

$ 30.7 $ 38.4 $ 69.1 $ 35.3 $ 24.8 $ 60.1 15 %

Net Product Sales Recorded by Regeneron Nine Months Ended

September 30,

2020 2019 % Change

ROW Total U.S.

ROW Total (Total Sales)

$ 3,604.0 $ 2,102.7 $ 5,706.7 $ 3,422.1 $ 2,114.9 $ 5,537.0 3 %

Dupixent (b) $ 2,300.6 $ 572.2 $ 2,872.8 $ 1,266.0 $ 298.1 $ 1,564.1 84 %

$ 196.6 $ 54.3 $ 250.9 $ 115.2 $ 3.9 $ 119.1 111 %

REGEN-COV (e)

$ 262.2 $ 176.6 $ 438.8 — — — (h)

$ 0.5 — $ 0.5 — — — (h)

$ 1.4 $ 23.0 $ 24.4 $ 1.5 $ 26.5 $ 28.0 (13 %)

Kevzara (b) $ 105.0 $ 93.4 $ 198.4 $ 91.4 $ 55.6 $ 147.0 35 %

REGN-COV2 (d)

$ 40.2 — $ 40.2 — — — (e)

ZALTRAP (b) $ 4.9 $ 74.0 $ 78.9 $ 4.9 $ 74.6 $ 79.5 (1 %)

ARCALYST U.S.

$ 2.2 — $ 2.2 $ 3.0 — $ 3.0 (27 %)

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

(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 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.

(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.

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

(d) Regeneron records net product sales of REGN-COV2 in connection with our agreement with the U.S.

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

(e) Percentage not meaningful

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.

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

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

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

Prior to April 1, 2021, Regeneron recorded net product sales of ARCALYST in the United States.

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

(h) Percentage not meaningful

Programs in Clinical Development

All 24 of our product candidates in clinical development, including the five U.S.

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

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

We believe that our ability to develop product candidates is enhanced by the application of our VelociSuite ® technology platforms.

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.

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

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

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

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.

6 unchanged sentences

Ophthalmology

- High-dose formulation in wet AMD - Retinopathy of prematurity

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

- High-dose formulation in wet AMD - Pre-filled syringe approved by European Commission ("EC")

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

–High-dose formulation in wet AMD

–High-dose formulation in DME

Immunology & Inflammatory Diseases

–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

–Submit sBLA for every-16-weeks dosing regimen in patients with NPDR (second half 2021)

–Report results from Phase 2 study for high-dose formulation in wet AMD (second half 2021)

–Complete enrollment in Phase 3 high-dose formulation studies (second half 2021)

Immunology & Inflammation

Dupixent (dupilumab) (a)

Antibody to IL-4R alpha subunit

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

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

- Approved by FDA for expanded atopic dermatitis indication in pediatrics (6–11 years of age) - EC decision for expanded atopic dermatitis indication in pediatrics (6–11 years of age) (fourth quarter 2020)

–Peanut allergy

- Asthma in pediatrics (6–11 years of age) - Approved by National Medical Products Administration ("NMPA") in China for adults with atopic dermatitis - Report results from Phase 3 study for atopic dermatitis in pediatric patients (6 months–5 years of age) (2022)

- Eosinophilic esophagitis

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

- European Medicines Agency's Committee for Medicinal Products for Human Use ("CHMP") recommended approval for an additional indication in children aged 6 to 11 with atopic dermatitis - Submit supplemental Biologics License Application ("sBLA") and Marketing Authorization Application ("MAA") for asthma in pediatrics (6–11 years of age) (first quarter 2021)

–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

–Chronic obstructive pulmonary disease ("COPD")

–Bullous pemphigoid (Phase 2/3) (c)

- Chronic spontaneous urticaria - Reported that Phase 3 trial for asthma in children aged 6 to 11 years met its primary and key secondary endpoints - Report results from Part B of the Phase 3 study in adults and adolescents with EoE (2022)

–Chronic spontaneous urticaria

–Prurigo nodularis

- Allergic bronchopulmonary aspergillosis ("ABPA") - Report results from Phase 2 study in peanut allergy (fourth quarter 2020)

- Approved by MHLW for CRSwNP in Japan

- Approved by FDA and MHLW for 300 mg auto-injector - Resubmit sBLA for 200 mg auto-injector (fourth quarter 2020)

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

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

–200 mg auto-injector (U.S.)

–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

–Initiated Phase 3 study in hand and foot atopic dermatitis

–Report results from Phase 3 study for atopic dermatitis in pediatric patients (6 months–5 years of age) (second half 2021)

–FDA decision on supplemental BLA ("sBLA") (target action date of October 21, 2021) and European Commission ("EC") decision on regulatory submission (first half 2022) for asthma in pediatrics (6–11 years of age)

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

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

Clinical Program (continued)

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2021 Events to Date Select Upcoming Milestones (k)

- 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 chronic spontaneous urticaria and prurigo nodularis studies (second half 2021)

- Presented results from Phase 2a trial in grass allergy - Initiate Phase 3 studies in chronic inducible urticaria, chronic sinusitis without nasal polyposis, and allergic fungal rhinosinusitis (fourth quarter 2020)

- Initiated second confirmatory Phase 3 trial in COPD

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

Dupixent (dupilumab) (a)

–Allergic bronchopulmonary aspergillosis ("ABPA")

–Chronic inducible urticaria

–Chronic sinusitis without nasal polyposis

–Allergic fungal rhinosinusitis

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

–FDA decision on sBLA for 200 mg auto-injector (target action date of June 15, 2021)

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

Kevzara (sarilumab) (a)

Antibody to IL-6R

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

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

–Systemic juvenile idiopathic arthritis ("sJIA")

- Discontinued clinical development in polymyalgia rheumatica and giant cell arteritis

Itepekimab (a) (REGN3500)

Antibody to IL-33

- Asthma - Discontinued further clinical development in atopic dermatitis due to lack of efficacy - Initiate Phase 3 study in COPD (fourth quarter 2020)

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

–Initiate Phase 3 study in cat allergic asthmatics (second half 2021)

REGN5713-5714-5715

Antibody to Betv1

- Birch allergy - Initiate Phase 3 study in birch allergy (first half 2021)

Antibody to IL2Rg

- Aplastic anemia

Clinical Program (continued)

Phase 1 Phase 2 Phase 3 Regulatory Review (i)

2020 Events to Date Select Upcoming Milestones (k)

Multi-antibody therapy to Bet v 1

–Birch allergy –Report results from initial Phase 3 study in birch allergy (second half 2021)

Antibody to IL-36R

–Palmo-plantar pustulosis

Solid Organ Oncology

Libtayo (cemiplimab) (a)(h)

Antibody to PD-1

- Solid tumors and advanced hematologic malignancies - Basal cell carcinoma ("BCC")

(potentially pivotal study) - First-line non-small cell lung cancer ("NSCLC"), monotherapy - First-line NSCLC, monotherapy (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.

- FDA decision on sBLA (target action date of February 28, 2021) and EC decision on regulatory submission (mid-2021) for first-line NSCLC, monotherapy

–BCC (pivotal study)

–Metastatic or locally advanced CSCC (d)

- First-line NSCLC, chemotherapy combination - Advanced BCC (U.S.

- Neoadjuvant CSCC - Second-line cervical cancer (e)

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

- Adjuvant CSCC - 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 - Interim analysis from Phase 3 study in cervical cancer (2021)

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

Odronextamab (REGN1979)

Bispecific antibody targeting CD20 and CD3

- Certain B-cell malignancies (c)

- B-cell non-Hodgkin lymphoma ("B-NHL") (potentially pivotal study) - Expanded potentially pivotal Phase 2 program with different subtypes of NHL - Report updated results from initial study in certain B-cell malignancies (fourth quarter 2020)

Bispecific antibody targeting BCMA and CD3

- Multiple myeloma - Report updated results from initial study in multiple myeloma (fourth quarter 2020)

Bispecific antibody targeting BCMA and CD3

- Multiple myeloma

Bispecific antibody targeting MUC16 and CD3

- Platinum-resistant ovarian cancer

–Neoadjuvant CSCC

–First-line NSCLC, chemotherapy combination

–Second-line cervical cancer (e)

–First-line NSCLC, monotherapy (EU)

–Advanced BCC (EU) –Approved by FDA for first-line NSCLC, monotherapy

–Approved by FDA for BCC

–EC decision on regulatory submission for first-line NSCLC, monotherapy (mid-2021)

Clinical Program (continued)

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2021 Events to Date Select Upcoming Milestones (k)

Libtayo (cemiplimab) (a)(h)

–Adjuvant CSCC

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

trial stopped early based on Independent Data Monitoring Committee ("IDMC") recommendation –Interim analysis from Phase 3 study in first-line NSCLC, chemotherapy combination (second half 2021)

–EC decision on regulatory submission for advanced BCC (mid-2021)

–Submit sBLA and Marketing Authorization Application ("MAA") for cervical cancer (second half 2021)

Bispecific antibody targeting MUC16 and CD3

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

Bispecific antibody targeting MUC16 and CD28

–Ovarian cancer

Bispecific antibody targeting PSMA and CD28

- Prostate cancer

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

Bispecific antibody targeting two distinct MET epitopes

–MET-altered advanced NSCLC

Fianlimab (f)

Antibody to LAG-3

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Antibody to GITR

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

Bispecific antibody targeting EGFR and CD28

–Solid tumors

Cardiovascular/Metabolic Diseases

Clinical Program (continued)

Phase 1 Phase 2 Phase 3 Regulatory Review (i)

2021 Events to Date Select Upcoming Milestones (k)

Odronextamab (REGN1979)

Bispecific antibody targeting CD20 and CD3

–Certain B-cell malignancies (c)

(partial clinical hold)

–B-cell non-Hodgkin lymphoma ("B-NHL") (potentially pivotal study) (partial clinical hold) –Finalize protocol amendment for B-NHL trials and resume patient enrollment (first half 2021)

–Initiate Phase 3 program

Bispecific antibody targeting BCMA and CD3

–Multiple myeloma (potentially pivotal study) –Expand into earlier lines of multiple myeloma therapy (second half 2021)

Bispecific antibody targeting BCMA and CD3

–Multiple myeloma

Pozelimab (f) (REGN3918)

Antibody to C5;

studied as monotherapy and in combination with cemdisiran

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

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

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

Cemdisiran (p)

siRNA therapeutic targeting C5

–Immunoglobulin A nephropathy

Antibody to IL2Rg

–Aplastic anemia

NTLA-2001 (o)

TTR gene knockout using CRISPR/Cas9

–Hereditary transthyretin amyloidosis with polyneuropathy

General Medicine

REGEN-COV (casirivimab with imdevimab) (e)(g)(m)(n)

Multi-antibody therapy to SARS-CoV-2 virus

–COVID-19 multi-dose safety study –COVID-19 dose-ranging virology study in non-hospitalized patients –COVID-19 treatment in non-hospitalized patients –European Medicines Agency ("EMA") Rolling Review of casirivimab with imdevimab data –Reported that Phase 3 trials in non-hospitalized COVID-19 patients met primary and key secondary endpoints –Data to be reported from Phase 3 RECOVERY trial in hospitalized patients (first half 2021)

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

Clinical Program (continued)

Phase 1 Phase 2 Phase 3 Regulatory Review (i)

2021 Events to Date Select Upcoming Milestones (k)

REGEN-COV (casirivimab with imdevimab) (e)(g)(m)(n)

–COVID-19 treatment in hospitalized patients

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

–COVID-19 prevention

–EUA amendment for lower 1,200 mg dose (treatment)

–EUA amendment to add COVID-19 prevention –NIH COVID-19 Treatment Guidelines updated to strongly recommend REGEN-COV be used in non-hospitalized COVID-19 patients at high risk of clinical progression

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

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

Praluent (alirocumab) (j)

Antibody to PCSK9

- Homozygous familial hypercholesterolemia ("HoFH") (c) 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)

- HeFH in pediatrics

Evinacumab (f) (REGN1500)

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

Fasinumab (l)(f) (REGN475)

Antibody to NGF

–Osteoarthritis pain of the knee or hip (e)

–Report additional longer-term safety results from Phase 3 studies in osteoarthritis pain of the knee or hip (2021)

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

Evkeeza (evinacumab) (f)

Antibody to ANGPTL3

- Refractory hypercholesterolemia (both HeFH and non-FH) - HoFH (U.S.

and EU) (c)(d)

- New England Journal of Medicine 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)

- Severe hypertriglyceridemia

Pozelimab (f) (REGN3918)

Antibody to C5

- Paroxysmal nocturnal hemoglobinuria ("PNH") (c)

- Initiate combination program with Alnylam's cemdisiran (fourth quarter 2020)

- CD55-deficient protein-losing enteropathy (c)

- Initiate Phase 3 program in PNH (next 12 months)

–Severe hypertriglyceridemia –HoFH (EU) (c)(d)

–Approved by FDA for HoFH

–EMA's Committee for Medicinal Products for Human Use ("CHMP") recommended approval for HoFH –EC decision on MAA for HoFH (first half 2021)

Clinical Program (continued)

Phase 1 Phase 2 Phase 3 Regulatory Review (i)

2021 Events to Date Select Upcoming Milestones (k)

Garetosmab (f) (REGN2477)

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

- Reported results from Phase 2 study in FOP - Further review trial data and determine next steps for the program

- Paused dosing in the open-label portion of the Phase 2 study in FOP based on reports of serious adverse events

Clinical Program (continued)

Phase 1 Phase 2 Phase 3 Regulatory Review (i)

2020 Events to Date Select Upcoming Milestones (k)

–Further review trial data and determine next steps for the program (first half 2021)

Agonist antibody to leptin receptor ("LEPR")

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–Heart failure

Fasinumab (l)(f) (REGN475)

Antibody to NGF

- Osteoarthritis pain of the knee or hip (e)

- Reported top-line results from Phase 3 trials in osteoarthritis pain of the knee or hip - Report additional longer-term safety results from Phase 3 studies in osteoarthritis pain of the knee or hip (first half 2021)

- Discontinued actively treating patients following recommendation from the IDMC that the program should be terminated - Continue discussions with regulatory authorities and determine next steps for the program (first half 2021)

Infectious Diseases

REGN-COV2 (g) (n) (REGN10933-10987)

Multi-antibody therapy to SARS-CoV-2 virus

- COVID-19 multi-dose safety study - COVID-19 treatment in non-hospitalized patients (Phase 2/3) - COVID-19 prevention (m)

- Adults with mild-to-moderate COVID-19 who are at high risk for poor outcomes - Reported that Phase 2/3 trial in non-hospitalized patients with COVID-19 met primary and key secondary endpoints - FDA decision on EUA for COVID-19 (fourth quarter 2020)

- COVID-19 treatment in hospitalized patients (Phase 2/3) - COVID-19 treatment in hospitalized patients (RECOVERY trial) - Submitted request to FDA for an Emergency Use Authorization ("EUA") for COVID-19 - Complete Phase 3 portion of COVID-19 study in non-hospitalized patients and submit BLA (first half 2021)

- IDMC recommended further enrollment of hospitalized patients requiring high-flow oxygen or mechanical ventilation be placed on hold

- Two papers published in Science describing REGN-COV2

RNAi therapeutic targeting HSD17B13

–Nonalcoholic steatohepatitis

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

We have discontinued further clinical development of REGN5069, an antibody to GFRα3, which was previously being studied in osteoarthritis pain of the knee

(a) In collaboration with Sanofi

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

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

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

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(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")

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

(n) In collaboration with Roche

(o) In collaboration with Intellia

(p) In collaboration with Alnylam

Our ability to generate profits and to generate positive cash flow from operations over the next several years depends significantly on the continued success in commercializing EYLEA and Dupixent.

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Additional Information - Clinical Development Programs

We are using our end-to-end antibody technologies to discover and develop brand new therapeutic antibodies for COVID-19.

The Company is advancing REGN-COV2, a novel investigational antibody "cocktail" treatment designed to prevent and treat infection from the SARS-CoV-2 virus.

The use of our two-antibody "cocktail" is intended to diminish the risk of viral escape by effectively binding to the virus's critical spike protein in two separate, non-overlapping locations.

In April 2020, the Company moved its leading neutralizing antibodies into pre-clinical and clinical-scale cell production lines, and in June 2020, initiated its first clinical trial of REGN-COV2.

Following a positive review from the IDMC of REGN-COV2 Phase 1 safety results in an initial cohort, the program advanced to late-stage clinical trials (see table above for further details).

The REGN-COV2 clinical program consists of the following separate study populations:

hospitalized COVID-19 patients, non-hospitalized symptomatic and asymptomatic 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 submitted a request to the FDA for an EUA for REGN-COV2 in patients with mild-to-moderate COVID-19 who are at high risk for poor outcomes.

In October 2020, we announced positive results from the ongoing Phase 2/3 seamless trial in non-hospitalized patients with COVID-19, showing that REGN-COV2 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 REGN-COV2 reduced viral load and time to alleviate symptoms.

In October 2020, the IDMC for the REGN-COV2 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 September 2020, we and the University of Oxford announced that the RECOVERY trial in the UK will evaluate REGN-COV2.

The RECOVERY trial, which is a Phase 3 open-label trial in patients hospitalized with COVID-19, will compare the effects of adding REGN-COV2 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 REGN-COV2 treatment trials (described above), and will be discussing the impact, if any, on the RECOVERY trial.

In October 2020, the 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.

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 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.

REGEN-COV (casirivimab with imdevimab)

In February 2021, the IDMC for the REGEN-COV Phase 3 trial in non-hospitalized patients with COVID-19 found clear clinical efficacy for reducing the rate of hospitalization and death with both the 1,200 mg and 2,400 mg doses of REGEN-COV compared to placebo, and recommended stopping enrollment in the placebo group.

In March 2021, we announced positive top-line results from the Phase 3 trial in non-hospitalized COVID-19 patients.

The trial met its primary endpoint, showing that REGEN-COV reduced the risk of hospitalization or death by 70% (1,200 mg dose (intravenous ("IV")) and 71% (2,400 mg dose IV) compared to placebo.

The trial also met key secondary endpoints, including the ability to reduce symptom duration.

Based on these results, we submitted a request to the FDA to update the EUA to the lower 1,200 mg dose (refer to "Products - REGEN-COV - Emergency Use Authorization" above for further details about the EUA).

In March 2021, the Company also announced that all tested doses (IV:

2,400 mg, 1,200 mg, 600 mg and 300 mg;

subcutaneous injections:

1,200 mg and 600 mg) in the Phase 2 dose-ranging trial in non-hospitalized COVID-19 patients met the primary endpoint.

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

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

Additionally in February 2021, the EMA's CHMP issued a positive opinion, recommending the antibody cocktail can be used to treat COVID-19 patients who do not require supplemental oxygen and are at high risk of progressing to severe COVID-19.

The CHMP's positive opinion can be used by EU member states when making decisions on the possible use of the antibody cocktail at a national level prior to a market authorization.

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.

We shared this data with the FDA and requested that the EUA be expanded to include COVID-19 prevention for appropriate populations.

In April 2021, the Company also announced positive data from the Phase 3 treatment trial in recently infected asymptomatic COVID-19 patients.

The trial was also being jointly run with the NIAID and met all primary and key secondary endpoints.

The trial demonstrated that the 1,200 mg subcutaneous injection of REGEN-COV reduced the risk of progressing to symptomatic COVID-19 by 31% (primary endpoint), and by 76% after the third day.

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 is obligated to fund 80% of certain of our costs incurred for certain research and development activities related to COVID-19 treatments.

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

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

Department of Defense to manufacture and deliver filled and finished REGN-COV2 to the U.S.

This agreement could result in payments to the Company of up to $450.2 million in the aggregate for bulk manufacturing of the drug substance, as well as fill/finish and storage activities.

See "Results of Operations - Revenues " below for REGN-COV2 net product sales recognized in connection with this agreement during the three months ended September 30, 2020.

In August 2020, we entered into a collaboration agreement with Roche to develop, manufacture, and distribute REGN-COV2.

We will continue to lead global development activities for REGN-COV2, and the parties will jointly fund the ongoing Phase 3 prevention and Phase 1 healthy volunteer safety studies, as well as any mutually agreed additional new global studies to evaluate further the potential of REGN-COV2 in treating or preventing COVID-19.

Roche will be responsible for securing regulatory approvals outside the United States, following the initial EMA approval (if any), 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 REGN-COV2 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 delivered by each party.

Any profit sharing will commence after product manufactured by Roche receives regulatory approval and is supplied to the market.

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

During the first quarter of 2021, the Company completed its final deliveries of drug product under this agreement.

See "Results of Operations - Revenues" below for REGEN-COV net product sales recognized in connection with this agreement during the three months ended March 31, 2021.

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

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

Pursuant to the agreement, the U.S.

government is obligated to purchase all filled and finished doses of drug product delivered by June 30, 2021, and may accept doses during the period from July 1, 2021 through September 30, 2021 at its discretion.

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

A number of factors may impact the quantity of filled and finished product supplied by June 30, 2021, including manufacturing considerations and authorized dose levels.

See also Part II, Item 1A.

"Risk Factors - We face risks related to the development, manufacturing, and commercialization of REGEN-COV ."

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

We continue to lead global development activities for casirivimab with imdevimab, and the parties jointly fund certain on-going studies, as well as any mutually agreed additional new global studies to evaluate further the potential of casirivimab with imdevimab 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 casirivimab with 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).

As of September 30, 2020, we were collaborating with Sanofi on the global development and commercialization of Dupixent, Kevzara, and itepekimab (the "Antibody Collaboration").

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"), following receipt of the first positive Phase 3 trial results for a co-developed drug candidate, subsequent Phase 3 trial-related costs for that drug candidate are generally shared 80% by Sanofi and 20% by us.

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

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

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

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

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

In 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 have agreed to allow Sanofi to satisfy in whole or in part its funding obligations with respect to the Dupilumab/Itepekimab Eligible Investments for the quarterly periods commencing on January 1, 2018 and ending on September 30, 2020 by selling certain shares of our Common Stock directly or indirectly owned by Sanofi.

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

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

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

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

We supply certain commercial bulk product to Sanofi.

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

We are entitled to receive up to an aggregate of $200.0 million in additional milestone payments from Sanofi, including the second sales milestone in the amount of $50.0 million, when such sales outside the United States exceed $1.5 billion on a rolling twelve-month basis.

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

We are entitled to receive

up to an aggregate of $200.0 million in additional milestone payments from Sanofi, including the second sales milestone in the amount of $50.0 million, when such sales outside the United States exceed $1.5 billion on a rolling twelve-month basis.

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

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

1 unchanged sentence

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

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

litigation proceedings against up to 50% of any Praluent royalty payment owed to Regeneron).

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

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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");

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

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

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.

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 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 candidate 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, an antibody targeting PD-1.

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

Under the Letter Agreement, we have agreed to allow Sanofi to satisfy in whole or in part its funding obligation with respect to Libtayo development costs for the quarterly

periods commencing on October 1, 2017 and ending on September 30, 2020 by selling certain shares of our Common Stock directly or indirectly owned by Sanofi.

As of September 30, 2020, 279,766 shares of our Common Stock remained eligible for sale by Sanofi in order to satisfy its funding obligations with respect to Libtayo development costs and/or, as noted above, Dupilumab/Itepekimab Eligible Investments.

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

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

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

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

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.

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 outside the United States

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

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

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

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

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

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

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

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

As of September 30, 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 March 31, 2021, we had earned an aggregate of $120.0 million of development milestones from Teva and we are entitled to receive up to an aggregate of $340.0 million in additional development milestones and up to an aggregate of $1.890 billion in contingent payments upon achievement of specified annual net sales amounts.

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

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

Odronextamab (REGN1979)

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

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

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

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

If odronextamab is commercialized in the Zai Territories, we will supply the product to Zai at a tiered purchase price, which is calculated as a percentage of net sales of the product (subject to adjustment in certain circumstances), and are eligible to receive up to $160.0 million in additional regulatory and sales milestone payments.

In 2018, we and Alnylam Pharmaceuticals, Inc.

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

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

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

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

In 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.

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.

In addition, during 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.

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.

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

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

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

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

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

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

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

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

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

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

In 2015, we and BARDA entered into an agreement pursuant to which HHS provides certain funding to develop, test, and manufacture a treatment for Ebola virus infection.

In July 2020, HHS exercised its option under the existing agreement to provide up to $344.6 million of additional funding for the manufacture and supply of Inmazeb.

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

In July 2020, HHS exercised its option under an existing agreement to provide up to $344.6 million of additional funding for the manufacture and supply of Inmazeb.

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

See "Agreements Related to COVID-19 - BARDA" section above for information related to our COVID-19 agreement.

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

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

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

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 is the last quarter for which the Company will record 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.

Corporate Information

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Results of Operations

Three and Nine Months Ended September 30, 2020 and 2019

Certain revisions have been made to the previously reported September 30, 2019 amounts below in connection with changing the presentation of certain amounts earned from collaborators;

see Note 1 to our Condensed Consolidated Financial Statements for further details.

Three Months Ended March 31, 2021 and 2020

Three Months Ended

September 30, Nine Months Ended

September 30,

(In millions, except per share data) 2021 2020

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Income from operations 1,112.7 700.1

Other (expense) income, net (54.8) 30.0 176.2 5.2

Other income (expense) 140.3 (31.5)

Income before income taxes 1,253.0 668.6

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Three Months Ended

September 30, Nine Months Ended

September 30,

(In millions) 2021 2020 $ Change *

2020 2019 $ Change *

Net product sales in the United States:

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Praluent 43.3 *

REGN-COV2 40.2 — 40.2 40.2 — 40.2

REGEN-COV 262.2 — 262.2

Evkeeza 0.5 — 0.5

ARCALYST 2.2 3.0 (0.8)

Sanofi and Bayer collaboration revenue:

Collaboration revenue:

Sanofi 364.8 246.9 117.9

Bayer 322.8 281.4 41.4

Roche 66.8 — 66.8

Other revenue 50.0 63.2 (13.2)

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Net Product Sales

Net product sales of EYLEA in the United States increased for the three and nine months ended September 30, 2020, compared to the same periods in 2019, due to higher sales volume partly offset by an increase in sales-related deductions primarily due to higher rebates and discounts.

EYLEA demand was lower in April 2020 due to the impact of the COVID-19 pandemic compared to the same period of 2019.

While we observed an increase in U.S.

EYLEA demand during the subsequent months of the second and third quarters of 2020 relative to April 2020, we are unable to predict whether there will be additional adverse impact on net product sales if shelter-in-place, social distancing, and other similar measures are reintroduced or imposed in additional geographies.

Effective April 1, 2020, the Company is solely responsible for the development and commercialization of Praluent in the United States and records net product sales of Praluent in the United States.

Net product sales of EYLEA in the United States increased for the three months ended March 31, 2021, compared to the same period in 2020, due to higher sales volume partly offset by an increase in sales-related deductions primarily due to higher rebates and discounts.

Effective April 1, 2020, the Company became solely responsible for the development and commercialization of Praluent in the United States and records net product sales of Praluent in the United States.

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

During the three months ended September 30, 2020, net product sales of REGN-COV2 were recorded in connection with our agreement with the U.S.

Refer to "Agreements Related to COVID-19 - BARDA " section above for further details.

During the three months ended March 31, 2021, net product sales of REGEN-COV were recorded in connection with our July 2020 agreement with the U.S.

government and the Company completed its final deliveries of drug product under this agreement.

In January 2021, the Company announced an additional agreement to manufacture and deliver additional filled and finished drug product of REGEN-COV to the U.S.

The Company expects to commence deliveries of drug product under this agreement during the second quarter of 2021.

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

Government " section above for further details.

Collaboration Revenue

Sanofi Collaboration Revenue

Three Months Ended

September 30, Nine Months Ended

September 30,

(In millions) 2021 2020

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$ 260.6 $ 170.9

Sales-based milestone earned 50.0 — 50.0 —

Reimbursement for manufacturing of commercial supplies (1)

94.3 85.4 275.0 143.8

Total Antibody 366.2 251.0

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Regeneron's share of losses in connection with commercialization of Libtayo outside the United States

(4.7) (4.6) (17.3) (16.2)

Reimbursement for manufacturing of commercial supplies (1)

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these estimates are reconciled to actual results in the subsequent fiscal quarter, and our portion of the profits or losses is adjusted accordingly, as necessary.

During the three and nine months ended September 30, 2020, the change in our share of profits in connection with commercialization of antibodies, compared to the same periods of 2019, was driven by higher Dupixent profits and, to a lesser extent, our new agreement with Sanofi under which, effective April 1, 2020, we are no longer sharing in losses with Sanofi in connection with the commercialization of Praluent (see further information below).

The increase in reimbursements for manufacturing of commercial supplies is primarily driven by higher Dupixent sales, as revenue recognition for such cost reimbursements is deferred until the product is sold by Sanofi to third-party customers.

During the three months ended March 31, 2021, the change in our share of profits in connection with commercialization of antibodies, compared to the same period of 2020, was driven by higher Dupixent profits.

Regeneron's share of profits in connection with the commercialization of Dupixent, Praluent (through March 31, 2020), and Kevzara is summarized below:

Three Months Ended

September 30, Nine Months Ended

September 30,

(In millions) 2021 2020

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Regeneron's share of collaboration profits as a percentage of Dupixent, Praluent, and Kevzara net product sales 20% 17%

19 % 12 % 18 % 5 %

(1) Global net product sales of Dupixent and Kevzara are recorded by Sanofi.

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therefore, the quarter ended March 31, 2020 was the last quarter for which net product sales of Praluent were included in the table above.

As described above under "Collaboration, License, and Other Agreements - Sanofi - Antibody ", effective April 1, 2020, the Company is solely responsible for the development and commercialization of Praluent in the United States.

Under the new agreement, Sanofi is solely responsible for the development and commercialization of Praluent outside of the United States, and will pay the Company a 5% royalty on Sanofi’s net product sales of Praluent outside the United States.

As described above under "Collaboration, License, and Other Agreements - Sanofi - Antibody ", effective April 1, 2020, the Company became solely responsible for the development and commercialization of Praluent in the United States.

Under the new agreement, Sanofi is solely responsible for the development and commercialization of Praluent outside of the United States, and pays the Company a 5% royalty on Sanofi’s net product sales of Praluent outside the United States.

Bayer Collaboration Revenue

Three Months Ended

September 30, Nine Months Ended

September 30,

(In millions) 2021 2020

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Reimbursement for manufacturing of commercial supplies (1)

12.0 18.6 52.9 41.5

Total Bayer collaboration revenue $ 322.8 $ 281.4

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Three Months Ended

September 30, Nine Months Ended

September 30,

(In millions) 2021 2020

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Regeneron's net profit as a percentage of EYLEA net product sales outside the United States

37 % 38 % 37 % 38 %

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

Bayer provides us with an estimate of our share of the profit, including the percentage of sales in Japan that we earned, from commercialization of EYLEA outside the United States for the most recent fiscal quarter;

these estimates are reconciled to actual results in the subsequent fiscal quarter, and our portion of the profit or loss is adjusted accordingly, as necessary.

these estimates are reconciled to actual results in the subsequent fiscal quarter, and our portion of the profit is adjusted accordingly, as necessary.

Roche Collaboration Revenue

As described above under "Agreements Related to COVID-19 - Roche ", Roche distributes and records net product sales of the casirivimab with imdevimab antibody cocktail outside the United States.

Roche provides us with an estimate of our share of the gross profits for the most recent fiscal quarter;

these estimates are reconciled to actual results in the subsequent fiscal quarter, and our portion of the profits is adjusted accordingly, as necessary.

Other Revenue

Other revenue increased during the three and nine months ended September 30, 2020, compared to the same periods of 2019, primarily due to:

• recognition of revenue in connection with our agreements with BARDA related to funding of certain development activities for antibodies for the treatment of COVID-19 and Inmazeb for the treatment of Ebola;

Other revenue decreased during the three months ended March 31, 2021, compared to the same period of 2020, primarily due to lower amounts recognized in connection with our agreement with BARDA related to funding of certain development activities for Inmazeb for the treatment of Ebola.

This decrease was partly offset by the following items included within Other revenue for the three months ended March 31, 2021:

• a $20.0 million milestone payment received from Kiniksa in connection with our ARCALYST license agreement;

• effective April 1, 2020, Sanofi's reimbursement for manufacturing commercial supplies of Praluent and royalties of 5% on Sanofi’s net product sales of Praluent outside the United States.

Three Months Ended

September 30, Nine Months Ended

September 30,

(In millions, except headcount data) 2020 2019 $ Change 2020 2019 $ Change

(In millions, except headcount data) 2021 2020 $ Change

Research and development (1)

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(1) Includes costs incurred as well as cost reimbursements from collaborators who are not deemed to be our customers

(2) Cost of goods sold includes costs in connection with producing commercial supplies for products that are sold by Regeneron in the United States ( i.e., for which we record net product sales) and any royalties we are obligated to pay on such sales, period costs for our Limerick manufacturing facility, and amounts we are obligated to pay to Sanofi for its share of Libtayo U.S.

(2) Cost of goods sold primarily includes costs in connection with producing commercial supplies for products that are sold by Regeneron in the United States ( i.e., for which we record net product sales), any royalties we are obligated to pay on such sales, and amounts we are obligated to pay to Sanofi for its share of Libtayo U.S.

gross profits

(3) Cost of collaboration and contract manufacturing includes costs we incur in connection with producing commercial drug supplies for collaborators and others

Operating expenses included a total of $101.2 million and $117.1 million for the three months ended September 30, 2020 and 2019, respectively, and $310.5 million and $330.8 million for the nine months ended September 30, 2020 and 2019, respectively, of non-cash compensation expense related to equity awards granted under our long-term incentive plans.

Operating expenses for the three months ended March 31, 2021 and 2020 included a total of $130.9 million and $105.8 million, respectively, of non-cash compensation expense related to equity awards granted under our long-term incentive plans.

Research and Development Expenses

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Clinical manufacturing costs also includes pre-launch commercial supplies which did not meet the criteria to be capitalized as inventory.

The table below also includes reimbursements of research and development expenses by collaborators, as when we are entitled to reimbursement of all or a portion of such expenses that we incur under a collaboration, we record those reimbursable amounts in the period in which such costs are incurred.

Three Months Ended

September 30, Nine Months Ended

September 30,

(In millions) 2021 2020 *

$ Change 2020 2019 *

Direct research and development expenses:

REGEN-COV (casirivimab with imdevimab)

$ 208.8 — $ 208.8

Libtayo (cemiplimab) 39.8 $ 36.0 3.8

Dupixent (dupilumab) 31.3 22.6 8.7 97.4 67.9 29.5

REGN-COV2 70.2 — 70.2 84.3 — 84.3

Fasinumab 31.5 40.4 (8.9)

EYLEA 28.1 17.6 10.5

Evinacumab 8.0 9.6 (1.6) 26.8 24.6 2.2

Kevzara (sarilumab) 6.9 4.6 2.3 66.3 11.0 55.3

Up-front payments related to license and collaboration agreements

— — — 85.0 400.0 (315.0)

Dupixent (dupilumab) 27.4 34.4 (7.0)

Other product candidates in clinical development and other research programs

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Reimbursement of research and development expenses by collaborators (172.4) (155.0) (17.4)

(146.3) (137.4) (8.9) (443.2) (455.9) 12.7

Total research and development expenses

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

Research and development expenses for the nine months ended September 30, 2020 included $85.0 million in aggregate up-front payments made in connection with our collaboration agreement with Intellia (see "Collaboration, License, and Other Agreements - Intellia " above).

Research and development expenses for the nine months ended September 30, 2019 included a $400.0 million up-front payment to Alnylam.

Research and development expenses included non-cash compensation expense of $55.9 million and $60.0 million for the three months ended September 30, 2020 and 2019, respectively, and $169.5 million and $178.0 million for the nine months ended September 30, 2020 and 2019, respectively.

Research and development expenses included non-cash compensation expense of $69.7 million and $56.7 million for the three months ended March 31, 2021 and 2020, respectively.

There are numerous uncertainties associated with drug development, including uncertainties related to safety and efficacy data from each phase of drug development, uncertainties related to the enrollment and performance of clinical trials, changes in regulatory requirements, changes in the competitive landscape affecting a product candidate, and other risks and uncertainties described in Part II, Item 1A.

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Selling, General, and Administrative Expenses

Selling, general, and administrative expenses increased for the nine months ended September 30, 2020, compared to the same period in 2019, primarily due to higher headcount-related costs, an increase in commercialization-related expenses for EYLEA and Libtayo, higher contributions to independent not-for-profit patient assistance organizations, additional accruals for loss contingencies associated with ongoing litigation, and, effective April 1, 2020, no longer receiving Praluent-related cost reimbursements from Sanofi for Regeneron-incurred expenses.

Selling, general, and administrative expenses also included non-cash compensation expense of $35.9 million and $40.8 million for the three months ended September 30, 2020 and 2019, respectively, and $114.4 million and $122.3 million for the nine months ended September 30, 2020 and 2019, respectively.

Selling, general, and administrative expenses increased for the three months ended March 31, 2021, compared to the same period in 2020, primarily due to higher headcount-related costs, an increase in commercialization-related expenses for Libtayo, and an increase in expenditures related to new products.

Selling, general, and administrative expenses also included non-cash compensation expense of $50.8 million and $40.3 million for the three months ended March 31, 2021 and 2020, respectively.

Cost of Goods Sold

Cost of goods sold increased for the nine months ended September 30, 2020, compared to the same period in 2019, primarily in connection with higher product sales including (i) our obligation to pay Sanofi its share of Libtayo U.S.

gross profits and (ii) third-party royalties.

These increases were partly offset by lower period costs for our Limerick commercial manufacturing facility.

Cost of goods sold increased for the three months ended March 31, 2021, compared to the same period in 2020, primarily due to the recognition of manufacturing costs in connection with product sales of REGEN-COV (which commenced in the third quarter of 2020) and Praluent in the United States (which were recorded by Sanofi prior to April 1, 2020).

Cost of Collaboration and Contract Manufacturing

Cost of collaboration and contract manufacturing increased for the three and nine months ended September 30, 2020, compared to the same periods in 2019, primarily due to the recognition of manufacturing costs associated with higher sales of Dupixent and recognition of costs in connection with manufacturing ex-U.S.

commercial supplies of Praluent for Sanofi under our new agreement (see "Collaboration, License, and Other Agreements - Sanofi - Antibody " above for further details).

In addition, Cost of collaboration and contract manufacturing increased for the nine months ended September 30, 2020, compared to the same period in 2019, due to process validation costs in connection with manufacturing Inmazeb under our BARDA agreement.

Cost of collaboration and contract manufacturing decreased for the three months ended March 31, 2021, compared to the same period in 2020, primarily due to the recognition of process validation costs during the three months ended March 31, 2020 in connection with manufacturing Inmazeb under our BARDA agreement;

such costs did not recur during the three months ended March 31, 2021.

This decrease was largely offset by the recognition of manufacturing costs associated with higher sales of Dupixent.

Other Operating (Income) Expense

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Other Income (Expense)

Other income (expense), net, for the three months ended September 30, 2020, compared to the same period in 2019, was negatively impacted by the recognition of unrealized losses on equity securities.

In addition, interest expense for the three months ended September 30, 2020, compared to the same period in 2019, increased as a result of the 2020 bridge loan facility and issuance of senior notes (as described below).

Other income (expense), net, for the nine months ended September 30, 2020, compared to the same period in 2019, was primarily affected by the positive impact of the recognition of unrealized gains on equity securities.

Other income (expense), net, for the three months ended March 31, 2021, compared to the same period in 2020, was positively impacted by the recognition of unrealized gains on equity securities.

Three Months Ended

September 30, Nine Months Ended

September 30,

(In millions, except effective tax rate) 2021 2020

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Effective tax rate

15.6 % 12.9 % 8.6 % 14.0 %

Our effective tax rate for the three and nine months ended September 30, 2020 was positively impacted, compared to the U.S.

Our effective tax rate for the three months ended March 31, 2021 was positively impacted, compared to the U.S.

federal statutory rate, primarily by the reversal of liabilities related to uncertain tax positions, stock-based compensation, income earned in foreign jurisdictions with tax rates lower than the U.S.

federal statutory rate, and federal tax credits for research activities.

Our effective tax rate for the three months ended March 31, 2020 was positively impacted, compared to the U.S.

federal statutory rate, primarily by stock-based compensation, and, to a lesser extent, income earned in foreign jurisdictions with tax rates lower than the U.S.

federal statutory rate and federal tax credits for research activities.

Our effective tax rate for the three and nine months ended September 30, 2019 was positively impacted, compared to the U.S.

federal statutory rate, primarily by federal tax credits for research activities, the foreign-derived intangible income deduction, and income earned in foreign jurisdictions with tax rates lower than the U.S.

federal statutory rate, partly offset by the taxation of certain global intangible low-taxed income and the non-deductible Branded Prescription Drug Fee.

Liquidity and Capital Resources

Our financial condition is summarized as follows:

September 30, December 31,

March 31, December 31,

(In millions) 2021 2020 $ Change

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$ 7,047.5 $ 6,722.6 $ 324.9

Long-term debt $ 1,978.9 $ 1,978.5 $ 0.4

Working capital:

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$ 6,837.3 $ 7,081.7 $ (244.4)

As of September 30, 2020, we also had borrowing availability of $750.0 million under a revolving credit facility.

Sources and Uses of Cash for the Nine Months Ended September 30, 2020 and 2019

September 30, September 30,

As of March 31, 2021, we also had borrowing availability of $750.0 million under a revolving credit facility.

Sources and Uses of Cash for the Three Months Ended March 31, 2021 and 2020

As of March 31,

(In millions) 2021 2020 $ Change

Cash flows provided by operating activities $ 668.5 $ 698.0 $ (29.5)

Cash flows provided by (used in) investing activities $ 234.4 $ (1,819.1) $ 2,053.5

Cash flows used in investing activities $ (1,059.0) $ (443.2) $ (615.8)

Cash flows (used in) provided by financing activities $ (366.4) $ 335.6 $ (702.0)

Cash Flows from Operating Activities

Our net income for the nine months ended September 30, 2020 included a $50.0 million sales-based milestone related to Sanofi sales of antibodies outside the United States (see "Collaboration, License, and Other Agreements - Sanofi - Antibody " above for further details) and $85.0 million up-front payments made to Intellia pursuant to our collaboration agreements.

Our net income for the nine months ended September 30, 2020 also included $133.8 million related to unrealized gains (net) on equity securities (included in other non-cash items).

As of September 30, 2020, Sanofi, trade, and other accounts receivables increased by $1.275 billion, compared to December 31, 2019, primarily as a result of extending payment terms to certain of our EYLEA customers due to the COVID-19 pandemic.

Deferred taxes as of September 30, 2020 decreased by $117.9 million, compared to December 31, 2019, primarily due to non-cash compensation expense and unrealized gains (net) on equity securities as described above.

Our net income for the three months ended March 31, 2021 included $143.9 million related to net unrealized gains on equity securities (included in other non-cash items).

Inventories increased as of March 31, 2021, compared to December 31, 2020, partially (i) due to REGEN-COV production in connection with our agreement to supply drug product to the U.S.

government, and (ii) as a result of purchasing additional raw materials in anticipation of potential disruptions to our supply chain due to the COVID-19 pandemic and additional production at our manufacturing facilities.

Cash Flows from Investing Activities

Sales of marketable securities during the nine months ended September 30, 2020 included proceeds in connection with funding our stock repurchase from Sanofi (as described below).

Capital expenditures during the nine months ended September 30, 2020 included costs associated with (i) the expansion of our manufacturing facilities in Rensselaer, New York and Limerick, Ireland, including construction of a fill/finish facility and related equipment, and (ii) laboratory expansion and renovations at our Tarrytown, New York facilities.

We expect to incur capital expenditures of $570 million to $600 million for the full year of 2020 primarily in connection with these projects.

Capital expenditures during the three months ended March 31, 2021 included costs associated with the expansion of our manufacturing facilities in Rensselaer, New York and Limerick, Ireland, including construction of a fill/finish facility and related equipment.

We expect to incur capital expenditures of $585 million to $650 million for the full year of 2021 primarily in connection with the continued expansion of our manufacturing facilities, including the fill/finish facility, and the expansion of our research facilities.

Cash Flows from Financing Activities

During the nine months ended September 30, 2020, we paid an aggregate of $5.5 billion to purchase shares of our Common Stock, a portion of which was funded with the proceeds from a $1.5 billion senior unsecured 364-day bridge loan facility.

See additional information under " Secondary Offering and Purchase of Regeneron Common Stock Held by Sanofi " below.

During the three months ended September 30, 2020, we issued and sold $2.0 billion aggregate principal amount of senior unsecured notes and used a portion of the net proceeds to repay in full the bridge loan facility.

See additional information under " Issuance of Senior Notes " below.

Proceeds from issuances of Common Stock, in connection with exercises of employee stock options, were $2.5 billion during the nine months ended September 30, 2020, compared to $163.5 million during the nine months ended September 30, 2019.

Share Repurchase Program

Proceeds from issuances of Common Stock, in connection with exercises of employee stock options, were $95.0 million during the three months ended March 31, 2021, compared to $811.4 million during the three months ended March 31, 2020.

In November 2019, our board of directors authorized a share repurchase program to repurchase up to $1.0 billion of our Common Stock.

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

As of December 31, 2020, the Company had repurchased the entire $1.0 billion of its Common Stock that it was authorized to repurchase under this program.

In January 2021, our board of directors authorized a new share repurchase program to repurchase up to $1.5 billion of our Common Stock.

The share repurchase program was approved under terms substantially similar to the November 2019 share repurchase program.

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

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We plan to finance the share repurchase program with available cash.

During the nine months ended September 30, 2020, we repurchased 898,991 shares of our Common Stock under the program and recorded the cost of the shares received, or $373.3 million, as Treasury Stock.

As of September 30, 2020, the Company had $372.7 million which remained available for share repurchases under the program.

Sanofi Funding of Certain Development Costs

As described above in "Collaboration, License, and Other Agreements - Sanofi ," effective January 7, 2018, we agreed to allow Sanofi to satisfy in whole or in part its funding obligations with respect to Libtayo development and/or Dupilumab/Itepekimab Eligible Investments incurred in periods through September 30, 2020 by selling shares (of which 279,766 shares remained available to be sold as of September 30, 2020) of our Common Stock directly or indirectly owned by Sanofi.

During the nine months ended September 30, 2020, Sanofi elected to sell, and we elected to purchase (by issuing a credit towards the amount owed by Sanofi), 77,677 shares of the Company's Common Stock to satisfy Sanofi's funding obligation related to Libtayo development costs.

Consequently, we recorded $41.7 million related to the shares received as Treasury Stock during the nine months ended September 30, 2020.

In addition, during the nine months ended September 30, 2020, Sanofi elected to sell, and we elected to purchase (in cash), 171,471 shares of the Company's Common Stock in connection with Sanofi's funding obligation for Dupilumab/Itepekimab Eligible Investments.

Consequently, we recorded the cost of the shares received, or $93.3 million, as Treasury Stock during the nine months ended September 30, 2020.

Secondary Offering and Purchase of Regeneron Common Stock Held by Sanofi

As described above in "Collaboration, License, and Other Agreements - Sanofi ," in May 2020, a secondary offering of 13,014,646 shares of our Common Stock (the "Secondary Offering") held by Sanofi was completed.

In connection with the Secondary Offering, we also purchased 9,806,805 shares of our Common Stock directly from Sanofi for an aggregate purchase amount of $5 billion (the "Stock Purchase").

As a result of the Secondary Offering and the Stock Purchase, Sanofi disposed of all of its shares of our Common Stock, other than 400,000 shares that it retained as of the closing of the Secondary Offering and the Stock Purchase (which Sanofi has used, and may continue to use, for the funding of certain Libtayo development costs and/or Dupilumab/Itepekimab Eligible Investments as described above).

We funded the Stock Purchase with a combination of cash on hand, proceeds from the sale of marketable securities, and proceeds from loans under a $1.5 billion senior unsecured 364-day bridge loan facility (the "Bridge Facility") which was entered into in May 2020.

The loans under the Bridge Facility bore interest at a variable interest rate based on either the London Interbank Offered Rate or the alternate base rate, plus an applicable margin that varied with our debt rating and total leverage ratio.

As described below, the Bridge Facility was repaid in August 2020 following the issuance and sale of the Company's senior unsecured notes.

Issuance of Senior Notes

In August 2020, we issued and sold $1.250 billion aggregate principal amount of senior unsecured notes due 2030 (the "2030 Notes") and $750 million aggregate principal amount of senior unsecured notes due 2050 (the "2050 Notes" and, together with the 2030 Notes, the "Notes").

Net proceeds from the issuance and sale of the Notes (after deducting underwriting discounts and offering expenses) were used in part to repay in full the Bridge Facility described above, including accrued interest and related fees and expenses in connection therewith.

The 2030 Notes accrue interest at the rate of 1.750% per year and will mature on September 15, 2030.

The 2050 Notes accrue interest at the rate of 2.800% per year and will mature on September 15, 2050.

Interest on each series of Notes is payable semi-annually in arrears on March 15 and September 15 of each year, commencing on March 15, 2021, until their respective maturity dates.

The Notes may be redeemed at the Company’s option at any time at 100% of the principal amount plus accrued and unpaid interest, and, until a specified period before maturity, a specified make-whole amount.

The Notes contain a change-of-control provision that, under certain circumstances, may require the Company to offer to repurchase the Notes at a price equal to 101% of the principal amount plus accrued and unpaid interest.

The Notes also contain certain limitations on the Company’s ability to incur liens and enter into sale and leaseback transactions, as well as customary events of default.

During the three months ended March 31, 2021, we repurchased 690,265 shares of our Common Stock under the January 2021 program and recorded the cost of the shares received, or $323.5 million, as Treasury Stock.

As of March 31, 2021, $1.177 billion remained available for share repurchases under the program.

Critical Accounting Policies and Use of Estimates

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"Management's Discussion and Analysis of Financial Condition and Results of Operations" of our Annual Report on Form 10-K for the fiscal year ended December 31, 2020 (filed February 8, 2021).

Except as described in Note 1 to our Condensed Consolidated Financial Statements included in this report, there were no material changes to our critical accounting policies and use of estimates during the nine months ended September 30, 2020.

There have been no material changes to our critical accounting policies and use of estimates during the three months ended March 31, 2021.

Future Impact of Recently Issued Accounting Standards

As of September 30, 2020, the future adoption of recently issued accounting standards is not expected to have a material impact on the Company's financial position or results of operations.

As of March 31, 2021, the future adoption of recently issued accounting standards is not expected to have a material impact on the Company's financial position or results of operations.

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What changed 10-Q

Item 2. Management’s Discussion and Analysis