What changed in this filing

/stocks — the workspaceLOADING

Item 2. Management’s Discussion and Analysis

2021-11-04 compared with 2021-08-05 · 203 added, 160 removed, 612 unchanged (37% of the section changed)

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

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

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

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

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

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

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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 the casirivimab and imdevimab antibody cocktail (known as REGEN-COV in the United States and Ronapreve ™ in other countries), to be cancelled or terminated;

government, 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.

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

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

"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 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.

is a fully integrated biotechnology company that discovers, invents, develops, manufactures, and commercializes medicines for 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, hematologic conditions, infectious diseases, and rare diseases.

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Three Months Ended

June 30, Six Months Ended

September 30, Nine Months Ended

September 30,

(In millions, except per share data) 2021 2020 2021 2020

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Net income per share - diluted $ 14.33 $ 7.39 $ 52.29 $ 20.36

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

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

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

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Dupixent (dupilumab) Injection (2)

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

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

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

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

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

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

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Praluent (alirocumab) Injection (3)

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

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

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

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REGEN-COV (5)

- COVID-19 treatment a

- COVID-19 a a

Kevzara (sarilumab) Solution for Subcutaneous Injection (2)

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

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

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

(7) No longer marketed by Sanofi in Japan

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

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

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

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

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

REGEN-COV - Emergency and Temporary Use Authorizations

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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.

Emergency or temporary pandemic use authorizations are currently in place in certain other countries outside the United States, including within the European Union, India, Switzerland, and Canada.

In August 2021, the United Kingdom's ("UK") Medicines and Healthcare products Regulatory Agency ("MHRA") granted Conditional Marketing Authorization for the casirivimab and imdevimab antibody cocktail in England, Scotland, and Wales to prevent and treat acute COVID-19 infection.

In addition, the MHRA authorized emergency supply of the antibody cocktail to prevent and treat acute COVID-19 infection in Northern Ireland.

Emergency or temporary pandemic use authorizations are also currently in place in certain other countries outside the United States, including within the European Union, India, Switzerland, and Canada.

Net Product Sales of Regeneron-Discovered Products

Three Months Ended

September 30,

2021 2020 % Change

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$ 1.2 $ 20.9 $ 22.1 $ 1.7 $ 22.5 $ 24.2 (9 %)

Six Months Ended

Nine Months Ended

September 30,

2021 2020 % Change

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

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

2021 Events to Date Select Upcoming Milestones (j)

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

2021 Events to Date Select Upcoming Milestones (i)

Ophthalmology

EYLEA (aflibercept) (b)

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

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–High-dose formulation in DME

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

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

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

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–Completed enrollment in Phase 3 studies for high-dose formulation in wet AMD and DME

–Submit supplemental BLA ("sBLA") for every-16-weeks dosing regimen in patients with NPDR (Q4 2021)

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

–Reported that Phase 2 trial of high-dose formulation in wet AMD met its primary safety and efficacy endpoints

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

–Report results from Phase 3 studies for high-dose formulation in wet AMD and DME (second half 2022)

Immunology & Inflammation

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

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

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

–Chronic obstructive pulmonary disease ("COPD")

–Bullous pemphigoid (Phase 2/3) (c)

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

–Asthma longer term efficacy and safety in adults and adolescents (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

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

–EoE in adults and adolescents (U.S.)

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

–Initiated Phase 3 study in hand and foot atopic dermatitis

–Report results from Phase 3 study for atopic dermatitis in pediatric patients (6 months–5 years of age) (Q3 2021)

–FDA decision on 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 (Q4 2021)

–Submit sBLA (Q4 2021) and Marketing Authorization Application ("MAA") (first half 2022) for atopic dermatitis in pediatric patients (6 months–5 years of age)

Clinical Program (continued)

Phase 1 Phase 2 Phase 3 Regulatory Review (i)

2021 Events to Date Select Upcoming Milestones (j)

Phase 1 Phase 2 Phase 3 Regulatory Review (h)

2021 Events to Date Select Upcoming Milestones (i)

Dupixent (dupilumab) (a)

–Chronic obstructive pulmonary disease ("COPD")

–Bullous pemphigoid (Phase 2/3) (c)

–Chronic spontaneous urticaria ("CSU")

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–Allergic fungal rhinosinusitis

–Presented additional positive results from Phase 3 trial for asthma in pediatrics (6–11 years of age) at American Thoracic Society International Conference

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

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

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

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

–Approved by FDA for 200 mg auto-injector

–Report results from Part B of the Phase 3 study in adults and adolescents with EoE (Q4 2021)

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

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

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

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

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

–Report results from prurigo nodularis study (second half 2021)

–Report results from additional Phase 3 prurigo nodularis study (first half 2022)

Kevzara (sarilumab) (a)

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

Clinical Program (continued)

Phase 1 Phase 2 Phase 3 Regulatory Review (h)

2021 Events to Date Select Upcoming Milestones (i)

REGN5713-5714-5715

Multi-antibody therapy to Bet v 1

–Birch allergy –Report results from initial Phase 3 study in birch allergy (Q4 2021)

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

Antibody to IL-36R

–Palmo-plantar pustulosis

Clinical Program (continued)

Phase 1 Phase 2 Phase 3 Regulatory Review (i)

2021 Events to Date Select Upcoming Milestones (j)

Solid Organ Oncology

Libtayo (cemiplimab) (a)(h)

Libtayo (cemiplimab) (a)(g)

Antibody to PD-1

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–Adjuvant CSCC

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

–Second-line cervical cancer (U.S.) –Approved by FDA and EC for first-line NSCLC, monotherapy

–Approved by FDA and EC for BCC

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

trial stopped early based on IDMC recommendation –Submit sBLA and Marketing Authorization Application ("MAA") for cervical cancer (second half 2021)

trial stopped early based on IDMC recommendation –FDA decision on sBLA for cervical cancer (target action date of January 30, 2022)

–Submit MAA for cervical cancer (Q4 2021)

–Submit sBLA (Q4 2021) and MAA (Q1 2022) for NSCLC, chemotherapy combination

Bispecific antibody targeting MUC16 and CD3

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

Clinical Program (continued)

Phase 1 Phase 2 Phase 3 Regulatory Review (h)

2021 Events to Date Select Upcoming Milestones (i)

Bispecific antibody targeting two distinct MET epitopes

–MET-altered advanced NSCLC

Clinical Program (continued)

Phase 1 Phase 2 Phase 3 Regulatory Review (i)

2021 Events to Date Select Upcoming Milestones (j)

REGN5093-M114

Bispecific antibody-drug conjugate targeting two distinct MET epitopes

–MET overexpressing advanced cancer

Fianlimab (f)

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Bispecific antibody targeting BCMA and CD3

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

–Multiple myeloma (potentially pivotal study) –Expand into earlier lines of multiple myeloma therapy (first half 2022)

Bispecific antibody targeting BCMA and CD3

–Multiple myeloma

Clinical Program (continued)

Phase 1 Phase 2 Phase 3 Regulatory Review (h)

2021 Events to Date Select Upcoming Milestones (i)

Pozelimab (f) (REGN3918)

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

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

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

–Myasthenia gravis, cemdisiran combination (n)

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

–Initiate Phase 3 study in PNH, cemdisiran combination (2022)

–Initiate Phase 3 study in myasthenia gravis, cemdisiran combination (Q4 2021)

Cemdisiran (o)

Cemdisiran (n)

siRNA therapeutic targeting C5

–Immunoglobulin A nephropathy

Clinical Program (continued)

Phase 1 Phase 2 Phase 3 Regulatory Review (i)

2021 Events to Date Select Upcoming Milestones (j)

Antibody to IL2Rg

–Aplastic anemia

NTLA-2001 (n)

NTLA-2001 (m)

TTR gene knockout using CRISPR/Cas9

–Hereditary transthyretin amyloidosis with polyneuropathy

("ATTRv-PN") –Reported positive interim data from Phase 1 trial in ATTRv-PN

("ATTRv-PN") (c)

–Reported positive interim data from Phase 1 trial in ATTRv-PN

Antibody to Factor XI

General Medicine

REGEN-COV (casirivimab and imdevimab) (e)(g)(l)(m)

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

Multi-antibody therapy to SARS-CoV-2 virus

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–COVID-19 treatment in hospitalized patients

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

–COVID-19 prevention

–COVID-19 prevention in immunocompromised patients

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

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

– New England Journal of Medicine published positive results from Phase 3 trial in non-hospitalized COVID-19 patients

–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

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

–Approved by Ministry of Health, Labour and Welfare ("MHLW") for COVID-19 treatment in Japan –Complete rolling BLA and MAA submissions for COVID-19 treatment and prevention (second half 2021)

–FDA decision on BLA (target action date of April 13, 2022) and EC decision on regulatory submission (Q4 2021) for COVID-19 treatment of non-hospitalized patients and prevention

–Submit BLA (Q4 2021) and MAA (Q1 2022) for COVID-19 treatment in hospitalized patients

Clinical Program (continued)

Phase 1 Phase 2 Phase 3 Regulatory Review (i)

2021 Events to Date Select Upcoming Milestones (j)

REGEN-COV (casirivimab and imdevimab) (e) (g) (l)(m)

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

Phase 1 Phase 2 Phase 3 Regulatory Review (h)

2021 Events to Date Select Upcoming Milestones (i)

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

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

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

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

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

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

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

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–HeFH in pediatrics –Approved by FDA for HoFH

Fasinumab (k)(f) (REGN475)

Clinical Program (continued)

Phase 1 Phase 2 Phase 3 Regulatory Review (h)

2021 Events to Date Select Upcoming Milestones (i)

Fasinumab (j)(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 (second half 2021)

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

–Report additional longer-term safety results from Phase 3 studies in osteoarthritis pain of the knee or hip (Q4 2021)

–Continue discussions with regulatory authorities and determine next steps for the program (Q4 2021)

Evkeeza (evinacumab) (f)

Antibody to ANGPTL3

–Severe hypertriglyceridemia –Approved by FDA and EC for HoFH

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

–Completed Phase 2 study in severe hypertriglyceridemia

Garetosmab (f) (REGN2477)

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

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

–Further review trial data and determine next steps for the program (2022)

Agonist antibody to leptin receptor ("LEPR")

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

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

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

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

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

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

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

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

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

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

(k) In collaboration with Teva and Mitsubishi Tanabe Pharma

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

(m) In collaboration with Roche

(n) In collaboration with Intellia

(o) In collaboration with Alnylam

(j) In collaboration with Teva and Mitsubishi Tanabe Pharma

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

(l) In collaboration with Roche

(m) In collaboration with Intellia

(n) 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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We also expect to incur substantial costs related to the commercialization of our marketed products.

Our financial results may fluctuate from quarter to quarter and will depend on, among other factors, the net sales of our marketed products;

Our financial results may fluctuate from quarter to quarter and will depend on, among other factors, the net sales of our products;

the scope and progress of our research and development efforts;

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We have shared these data with regulatory authorities and requested that the EUA be expanded to include COVID-19 treatment for appropriate hospitalized patients.

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

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

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

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

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

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

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

The FDA is currently reviewing the Company's request to expand the EUA to include treatment in hospital settings.

Prevention Study

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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.

During the third quarter of 2021, we also initiated a Phase 2 trial in high-risk children aged 12 years and under to assess the safety and tolerability of REGEN-COV.

Agreements Related to COVID-19

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.

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

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

In July 2020, the Company announced a $466 million agreement with entities acting at the direction of BARDA and the U.S.

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

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Pursuant to the agreement, the U.S.

government was obligated to purchase all filled and finished doses of drug product delivered by June 30, 2021, 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 and Temporary Use Authorizations" above).

government was obligated to purchase all filled and finished doses of drug product delivered by June 30, 2021, up to 1.25 million doses, at the lowest treatment dose authorized or approved by the FDA for the indication authorized under the EUA, resulting in payments to the Company of $2.625 billion (as described under "Products - REGEN-COV - Emergency and Temporary Use Authorizations" above).

The Company has completed its final deliveries of drug product under the agreements described above.

See "Results of Operations - Revenues" below for REGEN-COV net product sales recognized during the three and six months ended June 30, 2021 in connection with these agreements.

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

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

Pursuant to the agreement, the U.S.

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

A number of factors may impact the quantity and timing of filled and finished drug product supply, including manufacturing considerations.

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

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

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

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

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

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

We supply certain commercial bulk product to Sanofi.

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

In the third quarter of 2020, the Company earned, and

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

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

In the third quarter of 2020, the Company earned 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.

In the third quarter of 2021, the Company earned the second $50.0 million sales-based milestone from Sanofi, upon aggregate annual sales of antibodies outside the United States (including Praluent) exceeding $1.5 billion on a rolling twelve-month basis.

We are entitled to receive up to an aggregate of $150.0 million in additional sales milestone payments from Sanofi.

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.

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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").

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.

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

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

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

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

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

As of June 30, 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.

As of September 30, 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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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.

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.

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

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

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

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Our principal executive offices are located at 777 Old Saw Mill River Road, Tarrytown, New York 10591, and our telephone number at that address is (914) 847-7000.

We make available free of charge on or through our Internet website ( http://www.regeneron.com ) our Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, and, if applicable, amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Exchange Act, as soon as reasonably practicable after we electronically file such material with, or furnish it to, the Securities and Exchange Commission ("SEC").

furnished pursuant to Section 13(a) or 15(d) of the Exchange Act, as soon as reasonably practicable after we electronically file such material with, or furnish it to, the Securities and Exchange Commission ("SEC").

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

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Results of Operations

Three and Six Months Ended June 30, 2021 and 2020

Three and Nine Months Ended September 30, 2021 and 2020

Three Months Ended

June 30, Six Months Ended

September 30, Nine Months Ended

September 30,

(In millions, except per share data) 2021 2020 2021 2020

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Three Months Ended

June 30, Six Months Ended

September 30, Nine Months Ended

September 30,

(In millions) 2021 2020 $ Change 2021 2020 $ Change

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Net Product Sales

Net product sales of EYLEA in the United States increased for the three and six months ended June 30, 2021, compared to the same periods in 2020, primarily due to higher sales volume (including the adverse impact of the COVID-19 pandemic on U.S.

Net product sales of EYLEA in the United States increased for the three and nine months ended September 30, 2021, compared to the same periods in 2020, primarily due to higher sales volume (including the adverse impact of the COVID-19 pandemic on U.S.

EYLEA demand during the three months ended June 30, 2020), partly offset by an increase in sales-related deductions.

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

During the three and six months ended June 30, 2021, net product sales of REGEN-COV were recorded in connection with our agreements with the U.S.

During the three and nine months ended September 30, 2021 and 2020, net product sales of REGEN-COV were recorded in connection with our agreements with the U.S.

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

Government " section above for further details.

Effective April 1, 2021, Kiniksa records net product sales of ARCALYST in the United States.

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

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

Collaboration Revenue

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Three Months Ended

June 30, Six Months Ended

September 30, Nine Months Ended

September 30,

(In millions) 2021 2020 2021 2020

Regeneron's share of profits in connection with commercialization of antibodies $ 387.0 $ 212.8 $ 975.2 $ 555.6

Sales-based milestone earned

50.0 50.0 50.0 50.0

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Regeneron's share of losses in connection with commercialization of Libtayo outside the United States (3.0) (4.7) (12.6) (17.3)

(3.5) (6.4) (9.6) (12.6)

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 six months ended June 30, 2021, the change in our share of profits in connection with commercialization of antibodies, compared to the same periods of 2020, was driven by higher Dupixent profits.

During the three and nine months ended September 30, 2021, the increase in our share of profits in connection with commercialization of antibodies, compared to the same periods 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

June 30, Six Months Ended

September 30, Nine Months Ended

September 30,

(In millions) 2021 2020 2021 2020

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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.

During the three months ended September 30, 2021 and 2020, the Company earned $50.0 million sales-based milestones from Sanofi, upon aggregate annual sales of antibodies outside the United States (including Praluent) exceeding $1.5 billion and $1.0 billion, respectively, on a rolling twelve-month basis.

Bayer Collaboration Revenue

Three Months Ended

June 30, Six Months Ended

September 30, Nine Months Ended

September 30,

(In millions) 2021 2020 2021 2020

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Three Months Ended

June 30, Six Months Ended

September 30, Nine Months Ended

September 30,

(In millions) 2021 2020 2021 2020

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Roche Collaboration Revenue

During the three and six months ended June 30, 2021, Regeneron's share of gross profits in connection with sales of casirivimab and imdevimab outside the United States was $167.9 million and $234.7 million, respectively.

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.

As described above under "Agreements Related to COVID-19 - Roche ", Roche distributes and records net product sales of the casirivimab and imdevimab antibody cocktail outside the United States, and the parties share gross profits from worldwide sales, depending on the amount of manufactured product supplied by each party to the market.

Each quarter, a single payment is due from one party to the other to true-up the global gross profits between the parties.

If Regeneron is to receive a true-up payment from Roche, such amount will be recorded to Collaboration revenue.

If Regeneron is to make a true-up payment to Roche, such amount will be recorded to Cost of goods sold.

During the three and nine months ended September 30, 2021, true-up payments owed from Roche in connection with this agreement were $127.1 million and $361.8 million, respectively.

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

these estimates are reconciled to actual results in the subsequent fiscal quarter, and the true-up of global gross profits is adjusted accordingly, as necessary.

Other Revenue

Other revenue decreased during the three and six months ended June 30, 2021, compared to the same periods of 2020, primarily due to lower amounts recognized in connection with our agreement with BARDA related to funding of certain development activities for antibodies for the treatment of COVID-19, and, to a lesser extent, Inmazeb.

In addition, a $30.0 million up-front payment from Zai Lab was recorded in Other revenue in the second quarter of 2020 in connection with our collaboration agreement.

This decrease in Other revenue for the six months ended June 30, 2021 was partly offset by a $20.0 million milestone payment received from Kiniksa during 2021 in connection with our ARCALYST license agreement.

Other revenue decreased during the three and nine months ended September 30, 2021, compared to the same periods of 2020, primarily due to lower amounts recognized in connection with our agreement with BARDA related to funding of certain development activities for COVID-19 antibodies, and, to a lesser extent, Inmazeb.

Three Months Ended

June 30, Six Months Ended

September 30, Nine Months Ended

September 30,

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

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214.4 143.0 71.4 493.5 454.5 39.0

Other operating (income) expense, net (31.3) (50.2) 18.9 (71.8) (90.6) 18.8

Other operating expense (income), net 42.0 (44.6) 86.6 (29.8) (135.2) 105.4

Total operating expenses $ 1,605.6 $ 1,240.9 $ 364.7 $ 4,812.9 $ 3,664.6 $ 1,148.3

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(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 $145.5 million and $103.5 million for the three months ended June 30, 2021 and 2020, respectively, and $276.4 million and $209.3 million for the six months ended June 30, 2021 and 2020, respectively, of non-cash compensation expense related to equity awards granted under our long-term incentive plans.

Operating expenses included a total of $136.9 million and $101.2 million for the three months ended September 30, 2021 and 2020, respectively, and $413.3 million and $310.5 million for the nine months ended September 30, 2021 and 2020, 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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Three Months Ended

June 30, Six Months Ended

September 30, Nine Months Ended

September 30,

(In millions) 2021 2020 *

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Direct research and development expenses:

$ 97.2 $ 14.1 $ 83.1 $ 305.9 $ 14.1 $ 291.8

Libtayo (cemiplimab) $ 34.6 $ 46.9 $ (12.3) $ 112.6 $ 118.4 $ (5.8)

1 unchanged sentence

EYLEA 23.5 19.7 3.8 78.3 48.5 29.8

15.4 70.2 (54.8) 320.1 84.3 235.8

Fasinumab 6.6 39.9 (33.3) 58.3 123.6 (65.3)

17 unchanged sentences

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

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

Research and development expenses for the nine months ended September 30, 2020 included the $70.0 million up-front payment and the amount paid in excess of the fair value of the shares purchased, or $15.0 million, in connection with our collaboration agreement with Intellia (see "Collaboration and License Agreements - Intellia" above).

Direct research and development expenses in 2020 also include costs incurred in connection with Kevzara for the treatment of COVID-19 patients (included within "Other product candidates in clinical development and other research programs" in the table above).

Reimbursement of research and development expenses by collaborators included $41.0 million and $127.8 million of reimbursements from Roche related to REGEN-COV for the three and six months ended June 30, 2021, respectively.

There were no reimbursements of research and development expenses by collaborators related to REGEN-COV during the three and six months ended June 30, 2020.

Research and development expenses included non-cash compensation expense of $70.9 million and $56.9 million for the three months ended June 30, 2021 and 2020, respectively, and $140.6 million and $113.6 million for the six months ended June 30, 2021 and 2020, respectively.

Reimbursement of research and development expenses by collaborators included reimbursements from Roche related to REGEN-COV of $10.5 million and $138.3 million for the three and nine months ended September 30, 2021, respectively, and $9.5 million for both the three and nine months ended September 30, 2020.

Research and development expenses included non-cash compensation expense of $73.1 million and $55.9 million for the three months ended September 30, 2021 and 2020, respectively, and $213.7 million and $169.5 million for the nine months ended September 30, 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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The lengthy process of seeking FDA and other applicable approvals, and subsequent compliance with applicable statutes and regulations, require the expenditure of substantial resources.

Any failure by us to obtain, or delay in obtaining, regulatory approvals could materially

adversely affect our business.

Any failure by us to obtain, or delay in obtaining, regulatory approvals could materially adversely affect our business.

We are unable to reasonably estimate if our product candidates in clinical development will generate material product revenues and net cash inflows.

Selling, General, and Administrative Expenses

Selling, general, and administrative expenses increased for the three and six months ended June 30, 2021, compared to the same periods in 2020, primarily due to higher headcount-related costs, and an increase in commercialization-related expenses for EYLEA and Libtayo.

In addition, the three months ended June 30, 2021 included costs associated with educational campaigns related to COVID-19.

Selling, general, and administrative expenses also included non-cash compensation expense of $49.6 million and $38.2 million for the three months ended June 30, 2021 and 2020, respectively, and $100.4 million and $78.5 million for the six months ended June 30, 2021 and 2020, respectively.

Selling, general, and administrative expenses increased for the three and nine months ended September 30, 2021, compared to the same periods in 2020, primarily due to higher headcount-related costs and an increase in commercialization-related expenses for EYLEA, including direct-to-consumer advertising.

In addition, the nine months ended September 30, 2021 included increased commercialization-related expenses for Libtayo and costs associated with educational campaigns related to COVID-19.

Selling, general, and administrative expenses also included non-cash compensation expense of $48.7 million and $35.9 million for the three months ended September 30, 2021 and 2020, respectively, and $149.1 million and $114.4 million for the nine months ended September 30, 2021 and 2020, respectively.

Cost of Goods Sold

Cost of goods sold increased for the three and six months ended June 30, 2021, compared to the same periods in 2020, primarily due to the recognition of manufacturing costs in connection with product sales of REGEN-COV (refer to "Agreements Related to COVID-19 - U.S.

Government " section above for further details).

In addition, Cost of goods sold included inventory write-offs and reserves totaling $139.9 million and $149.3 million for the three and six months ended June 30, 2021, respectively, primarily related to REGEN-COV.

For the three and six months ended June 30, 2020, such amounts were not material.

Cost of goods sold increased for the three and nine months ended September 30, 2021, compared to the same periods in 2020, primarily due to the recognition of manufacturing costs in connection with product sales of REGEN-COV.

In addition, Cost of goods sold included inventory write-offs and reserves totaling $38.7 million and $188.0 million for the three and nine months ended September 30, 2021, respectively (primarily related to REGEN-COV for the nine months ended September 30, 2021).

Inventory write-offs and reserves were $11.8 million and $23.6 million for the three and nine months ended September 30, 2020, respectively.

Cost of Collaboration and Contract Manufacturing

Cost of collaboration and contract manufacturing decreased for the three and six months ended June 30, 2021, compared to the same periods in 2020, primarily due to the recognition of process validation costs during 2020 in connection with manufacturing Inmazeb under our BARDA agreement;

Cost of collaboration and contract manufacturing increased for the three and nine months ended September 30, 2021, compared to the same periods in 2020, primarily due to the recognition of manufacturing costs associated with higher sales of Dupixent.

The increase for the nine months ended September 30, 2021 was partly offset by the recognition of process validation costs during 2020 in connection with manufacturing Inmazeb under our BARDA agreement;

such costs did not recur during 2021.

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

Other Operating (Income) Expense

Other operating (income) expense, net, includes recognition of a portion of amounts previously deferred in connection with up-front and development milestone payments, as applicable, received in connection with Sanofi IO, Teva, and MTPC collaborative arrangements.

Other Operating Expense (Income)

Other operating expense (income), net, includes recognition of a portion of amounts previously deferred in connection with up-front and development milestone payments, as applicable, received in connection with Sanofi IO, Teva, and MTPC collaborative arrangements.

During the three months ended September 30, 2021, we updated our estimate of the total research and development costs expected to be incurred (which resulted in a change to the estimate of the stage of completion) in connection with the Sanofi IO Collaboration, and, as a result, recorded a cumulative catch-up adjustment of $66.9 million as a reduction to other operating income.

Other Income (Expense)

Other income (expense), net, for the three and six months ended June 30, 2021, compared to the same periods in 2020, was primarily impacted by the recognition of higher unrealized gains on equity securities.

Other income (expense), net, for the nine months ended September 30, 2021, compared to the same period in 2020, was primarily impacted by the recognition of higher unrealized gains on equity securities.

Three Months Ended

June 30, Six Months Ended

September 30, Nine Months Ended

September 30,

(In millions, except effective tax rate) 2021 2020 2021 2020

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10.2 % 15.6 % 14.3 % 8.6 %

Our effective tax rate for the three and six months ended June 30, 2021 was positively impacted, compared to the U.S.

federal statutory rate, primarily by income earned in foreign jurisdictions with tax rates lower than the U.S.

federal statutory rate and federal tax credits for research activities.

In addition, the effective tax rate for the six months ended June 30, 2021 was positively impacted by the reversal of liabilities related to uncertain tax positions.

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

Our effective tax rate for the three and nine months ended September 30, 2021 was positively impacted, compared to the U.S.

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

federal statutory rate, the foreign-derived intangible income deduction, and federal tax credits for research activities.

In addition, the effective tax rate for the nine months ended September 30, 2021 was positively impacted by the reversal of liabilities related to uncertain tax positions.

Our effective tax rate for the three and nine months ended September 30, 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.

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Our financial condition is summarized as follows:

June 30, December 31,

September 30, December 31,

(In millions) 2021 2020 $ Change

9 unchanged sentences

$ 10,060.6 $ 7,081.7 $ 2,978.9

As of June 30, 2021, we also had borrowing availability of $750.0 million under a revolving credit facility.

Sources and Uses of Cash for the Six Months Ended June 30, 2021 and 2020

As of June 30,

As of September 30, 2021, 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, 2021 and 2020

As of September 30,

(In millions) 2021 2020 $ Change

2 unchanged sentences

Cash flows used in financing activities $ (99.2) $ (1,665.2) $ 1,566.0

Cash Flows from Operating Activities

Our net income for the six months ended June 30, 2021 included $552.9 million related to unrealized gains (net) on equity securities.

As of June 30, 2021, Accounts receivable increased by $2.884 billion, compared to December 31, 2020, primarily due to REGEN-COV sales in connection with our agreement to supply drug product to the U.S.

Cash Flows from Investing Activities

Capital expenditures during the six months ended June 30, 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.

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, 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 $545 million to $575 million for the full year of 2021 primarily in connection with the continued expansion of our manufacturing facilities, including the fill/finish facility.

1 unchanged sentence

Cash Flows from Financing Activities

Proceeds from issuances of Common Stock, in connection with exercises of employee stock options, were $308.2 million during the six months ended June 30, 2021, compared to $2.168 billion during the six months ended June 30, 2020.

For additional information related to cash flows from financing activities, see "Share Repurchase Program" and "Secondary Offering and Purchase of Regeneron Common Stock Held by Sanofi" sections below.

Proceeds from issuances of Common Stock, in connection with exercises of employee stock options, were $1.130 billion during the nine months ended September 30, 2021, compared to $2.471 billion during the nine months ended September 30, 2020.

For additional information related to cash flows from financing activities, see "Share Repurchase Program", "Secondary Offering and Purchase of Regeneron Common Stock Held by Sanofi", and "Issuance of Senior Notes" sections below.

Share Repurchase Program

1 unchanged sentence

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.

In January 2021, our board of directors authorized an additional 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.

3 unchanged sentences

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

During the six months ended June 30, 2021, we repurchased 1,272,143 shares of our Common Stock under the January 2021 program and recorded the cost of the shares received, or $612.1 million, as Treasury Stock.

As of June 30, 2021, $887.9 million remained available for share repurchases under the program.

During the nine months ended September 30, 2021, we repurchased 1,567,555 shares of our Common Stock under the January 2021 program and recorded the cost of the shares received, or $802.7 million, as Treasury Stock.

As of September 30, 2021, $697.3 million remained available for share repurchases under the program.

Secondary Offering and Purchase of Regeneron Common Stock Held by Sanofi

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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.

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).

There have been no material changes to our critical accounting policies and use of estimates during the six months ended June 30, 2021.

There have been no material changes to our critical accounting policies and use of estimates during the nine months ended September 30, 2021.

Future Impact of Recently Issued Accounting Standards

As of June 30, 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.

As of September 30, 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.

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

What changed 10-Q

Item 2. Management’s Discussion and Analysis