What changed in this filing

/stocks — the workspaceLOADING

Item 2. Management’s Discussion and Analysis

2021-08-05 compared with 2021-05-06 · 226 added, 161 removed, 546 unchanged (41% 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 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 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;

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

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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, Kevzara, Evkeeza, and Inmazeb), research and clinical programs, and business, including those relating to patient privacy;

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

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

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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 with imdevimab antibody cocktail (known as REGEN-COV in the United States), to be cancelled or terminated;

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

and risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA, Dupixent, Praluent, and REGEN-COV described further in Note 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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"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.

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

Regeneron Pharmaceuticals, Inc.

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Three Months Ended

June 30, Six Months Ended

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

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- Homozygous familial hypercholesterolemia ("HoFH") a

REGEN-COV (9)

- COVID-19 treatment a

Kevzara (sarilumab) Solution for Subcutaneous Injection (2)

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

Evkeeza (evinacumab) Injection - HoFH (in adults and adolescents) a

Evkeeza (evinacumab) Injection - HoFH (in adults and adolescents) a a

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

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

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

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

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

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

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

(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

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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.

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

REGEN-COV - Emergency and Temporary Use Authorizations

United States

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

Food and Drug Administration ("FDA") for the treatment of mild to moderate COVID-19 in adults, as well as in pediatric patients at least 12 years of age and weighing at least 40 kg, who have received positive results of direct SARS-CoV-2 viral testing and are at high risk for progressing to severe COVID-19 and/or hospitalization.

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

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

For people who are not expected to mount an adequate immune response to vaccination, REGEN-COV can also now be administered monthly for the duration of ongoing exposure to SARS-CoV-2.

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.

See information regarding ongoing clinical trials of REGEN-COV in the "Programs in Clinical Development" section below.

Outside the United States

In February 2021, the European Medicines Agency's ("EMA") Committee for Medicinal Products for Human Use ("CHMP") issued a positive opinion, recommending that the casirivimab and imdevimab antibody cocktail 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.

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.

Net Product Sales of Regeneron-Discovered Products

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$ 41.9 $ 57.5 $ 99.4 $ 47.2 $ 39.4 $ 86.6 15 %

REGEN-COV (e)

$ 2,591.2 $ 470.2 $ 3,061.4 — — — (h)

$ 30.7 $ 36.0 $ 66.7 $ 36.5 $ 31.8 $ 68.3 (2 %)

$ 2.0 — $ 2.0 — — — (h)

$ 7.7 — $ 7.7 $ 2.7 — $ 2.7 185 %

$ 1.3 $ 22.2 $ 23.5 $ 1.7 $ 25.0 $ 26.7 (12 %)

Six Months Ended

2021 2020 % Change

(In millions) U.S.

ROW Total U.S.

ROW Total (Total Sales)

$ 2,771.7 $ 1,728.1 $ 4,499.8 $ 2,285.7 $ 1,322.7 $ 3,608.4 25 %

$ 2,108.1 $ 653.8 $ 2,761.9 $ 1,449.4 $ 350.8 $ 1,800.2 53 %

$ 147.1 $ 70.6 $ 217.7 $ 125.0 $ 29.8 $ 154.8 41 %

$ 85.2 $ 118.8 $ 204.0 $ 82.3 $ 84.1 $ 166.4 23 %

REGEN-COV (e)

$ 2,853.4 $ 654.4 $ 3,507.8 — — — (h)

$ 61.4 $ 74.4 $ 135.8 $ 71.8 $ 56.6 $ 128.4 6 %

$ 2.5 — $ 2.5 — — — (h)

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(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.

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

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

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

2021 Events to Date Select Upcoming Milestones (k)

2021 Events to Date Select Upcoming Milestones (j)

Ophthalmology

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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)

–Completed enrollment in Phase 3 study for ROP

–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)

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

Immunology & Inflammation

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–Bullous pemphigoid (Phase 2/3) (c)

–Chronic spontaneous urticaria

–Prurigo nodularis

–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)

–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)

Clinical Program (continued)

Phase 1 Phase 2 Phase 3 Regulatory Review (i)

2021 Events to Date Select Upcoming Milestones (k)

2021 Events to Date Select Upcoming Milestones (j)

Dupixent (dupilumab) (a)

–Chronic spontaneous urticaria ("CSU")

–Prurigo nodularis

–Allergic bronchopulmonary aspergillosis ("ABPA")

–Chronic inducible urticaria

–Chronic sinusitis without nasal polyposis

–Chronic rhinosinusitis 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)

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

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

–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)

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

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

REGN5713-5714-5715

Multi-antibody therapy to Bet v 1

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

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

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

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Antibody to PD-1

–BCC (pivotal study)

–Metastatic or locally advanced CSCC (d)

–Neoadjuvant CSCC

–Second-line cervical cancer, ISA101b combination

–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)

Phase 1 Phase 2 Phase 3 Regulatory Review (i)

2021 Events to Date Select Upcoming Milestones (k)

Libtayo (cemiplimab) (a)(h)

–Adjuvant CSCC

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

–Approved by FDA and EC for BCC

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

trial stopped early based on Independent Data Monitoring Committee ("IDMC") recommendation

–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)

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

Bispecific antibody targeting MUC16 and CD3

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–MET-altered advanced NSCLC

Clinical Program (continued)

Phase 1 Phase 2 Phase 3 Regulatory Review (i)

2021 Events to Date Select Upcoming Milestones (j)

Fianlimab (f)

Antibody to LAG-3

–Solid tumors and advanced hematologic malignancies

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

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

Antibody to GITR

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

–Solid tumors

Bispecific antibody targeting EGFR and CD28

–Solid tumors

Clinical Program (continued)

Phase 1 Phase 2 Phase 3 Regulatory Review (i)

2021 Events to Date Select Upcoming Milestones (k)

Odronextamab (REGN1979)

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–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

–B-cell non-Hodgkin lymphoma ("B-NHL") (potentially pivotal study) –Resumed enrollment of patients with follicular lymphoma ("FL") and diffuse large B-cell lymphoma ("DLBCL") following protocol amendments –Initiate Phase 3 program

Bispecific antibody targeting BCMA and CD3

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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)

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

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

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

Cemdisiran (o)

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 (o)

NTLA-2001 (n)

TTR gene knockout using CRISPR/Cas9

–Hereditary transthyretin amyloidosis with polyneuropathy

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

General Medicine

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

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

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

–COVID-19 treatment in hospitalized patients

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–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

–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

–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)

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

Praluent (alirocumab) (j)

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

Praluent (alirocumab)

Antibody to PCSK9

–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)

–HeFH in pediatrics –Approved by FDA for HoFH

Fasinumab (k)(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)

–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)

Evkeeza (evinacumab) (f)

Antibody to ANGPTL3

–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)

–Severe hypertriglyceridemia –Approved by FDA and EC for HoFH

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 (first half 2021)

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

Agonist antibody to leptin receptor ("LEPR")

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

(j) 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.

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.

(j) 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

(l) In collaboration with Teva and Mitsubishi Tanabe Pharma

(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

(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

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

REGEN-COV (casirivimab with imdevimab)

REGEN-COV (casirivimab and imdevimab)

Treatment Study - Non-Hospitalized Patients

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 met its primary endpoint, showing that REGEN-COV reduced the risk of hospitalization or death by 70% (1,200 mg dose 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 unchanged sentences

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

The trial was 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.

Treatment Study - Hospitalized Patients

In June 2021, positive results were reported from the Phase 3 UK-based RECOVERY trial in hospitalized patients with severe COVID-19.

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

We 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.

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

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

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

We have shared this information with the FDA.

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

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

However, four out of five secondary clinical endpoints of the study were nominally significant including an endpoint preferred by the FDA:

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

The relative risk reduction with REGEN-COV versus placebo ranged from approximately 24% to 47% on these various clinical endpoints.

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.

Prevention Study

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

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

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

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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.

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Pursuant to the agreement, the U.S.

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

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

A number of factors may impact 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.

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).

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

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

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

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

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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, and

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

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

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

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

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

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

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

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

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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 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).

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.

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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 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.

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.

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

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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.

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

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

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

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

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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.

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

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

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Results of Operations

Three Months Ended March 31, 2021 and 2020

Three and Six Months Ended June 30, 2021 and 2020

Three Months Ended

June 30, Six Months Ended

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

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Three Months Ended

(In millions) 2021 2020 $ Change *

June 30, Six Months Ended

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

Net product sales in the United States:

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ARCALYST — ** 2.7 **

2.2 ** 5.7 **

Collaboration revenue:

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* Net product sales of Praluent in the United States were recorded by Sanofi prior to April 1, 2020

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

Net Product Sales

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.

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.

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

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 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.

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.

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

(In millions) 2021 2020 2021 2020

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Reimbursement for manufacturing of commercial supplies (1)

110.9 100.6 216.5 180.7

Total Antibody 438.5 272.5 804.7 523.5

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

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

Reimbursement for manufacturing of commercial supplies (1)

2.7 3.0 7.4 5.1

Total Immuno-oncology (0.8) (3.4) (2.2) (7.5)

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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 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.

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.

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

(In millions) 2021 2020 2021 2020

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Three Months Ended

June 30, Six Months Ended

(In millions) 2021 2020 2021 2020

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Reimbursement for manufacturing of commercial supplies (1)

13.7 13.3 27.6 40.9

Total Bayer collaboration revenue $ 349.1 $ 244.2 $ 671.9 $ 525.6

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Three Months Ended

June 30, Six Months Ended

(In millions) 2021 2020 2021 2020

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

37% 36% 37% 37%

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

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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.

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.

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;

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Other Revenue

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.

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.

Three Months Ended

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

June 30, Six Months Ended

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

Research and development (1)

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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 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.

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.

Research and Development Expenses

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Three Months Ended

June 30, Six Months Ended

(In millions) 2021 2020 *

$ Change 2021 2020 *

Direct research and development expenses:

REGEN-COV (casirivimab with imdevimab)

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

Libtayo (cemiplimab) 38.2 35.4 2.8 78.0 71.4 6.6

Fasinumab 31.5 40.4 (8.9)

EYLEA 28.1 17.6 10.5

Dupixent (dupilumab) 37.0 31.7 5.3 64.4 66.2 (1.8)

EYLEA 26.7 11.2 15.5 54.8 28.8 26.0

Fasinumab 20.2 43.2 (23.0) 51.7 83.7 (32.0)

Up-front payments related to license and collaboration agreements — 85.0 (85.0) — 85.0 (85.0)

Other product candidates in clinical development and other research programs

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

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.

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).

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.

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 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.

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.

Cost of Goods Sold

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 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 Collaboration and Contract Manufacturing

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.

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;

such costs did not recur during 2021.

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

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Other Income (Expense)

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.

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.

Three Months Ended

June 30, Six Months Ended

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

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Effective tax rate

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.

17.4 % 2.4 % 15.8 % 4.1 %

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.

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

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.

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:

March 31, December 31,

June 30, December 31,

(In millions) 2021 2020 $ Change

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$ 9,605.2 $ 7,081.7 $ 2,523.5

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,

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,

(In millions) 2021 2020 $ Change

Cash flows provided by operating activities $ 1,295.2 $ 1,641.4 $ (346.2)

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 (used in) provided by investing activities $ (933.2) $ 1,010.2 $ (1,943.4)

Cash flows used in financing activities $ (484.6) $ (2,277.2) $ 1,792.6

Cash Flows from Operating Activities

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.

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 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.

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.

We expect to incur capital expenditures of $590 million to $640 million for the full year of 2021 primarily in connection with the continued expansion of our manufacturing facilities, including the fill/finish facility.

Capital expenditures expected to be incurred during the remainder of 2021 also include costs related to plans to expand our research, preclinical manufacturing, and support facilities at our Tarrytown, New York campus.

Cash Flows from Financing Activities

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.

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.

Share Repurchase Program

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

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

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.

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.

Secondary Offering and Purchase of Regeneron Common Stock Held by 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 $5.0 billion (the "Stock Purchase").

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 bridge loan facility (the "Bridge Facility") which was entered into in May 2020.

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

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 three months ended March 31, 2021.

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

Future Impact of Recently Issued Accounting Standards

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.

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.

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