What changed in this filing

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Item 2. Management’s Discussion and Analysis

2022-08-03 compared with 2022-05-04 · 216 added, 170 removed, 536 unchanged (42% of the section changed)

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

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

the likelihood that any planned or future acquisitions, business combinations, or other related transactions, such as Regeneron's planned acquisition of Checkmate Pharmaceuticals, Inc.

discussed in this report, will close within the expected time period or at all and whether and to what extent Regeneron will realize any anticipated benefits of any such transaction;

(or their respective affiliated companies, as applicable), 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 13 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 13 to our Condensed Consolidated Financial Statements included in this report), the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on our business, prospects, operating results, and financial condition.

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

In evaluating such statements, shareholders and potential investors

should specifically consider the various factors identified under Part II, Item 1A.

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.

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Three Months Ended

June 30, Six Months Ended

(In millions, except per share data) 2022 2021 2022 2021

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Product Disease Territory

EU Japan ROW (d)

EU Japan ROW (e)

EYLEA (aflibercept) Injection (a)

3 unchanged sentences

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

- Diabetic retinopathy a

- Diabetic retinopathy ("DR") a

- Neovascular glaucoma ("NVG") a

2 unchanged sentences

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

- Atopic dermatitis (in pediatrics 6 months–5 years of age) a

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

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Disease Territory

EU Japan ROW (d)

EU Japan ROW (e)

Dupixent (dupilumab) Injection (b) (continued)

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

Libtayo (cemiplimab) Injection (b)

- Eosinophilic esophagitis ("EoE") (in adults and adolescents)

Libtayo (cemiplimab) Injection (c)

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

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- Metastatic or recurrent second-line cervical cancer

Praluent (alirocumab) Injection (c)

Praluent (alirocumab) Injection (d)

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

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- Homozygous familial hypercholesterolemia ("HoFH") a

REGEN-COV (e)

REGEN-COV (f)

- COVID-19 a a a

1 unchanged sentence

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

Evkeeza (evinacumab) Injection (f)

Evkeeza (evinacumab) Injection (g)

- 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 (g)

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

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

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- Recurrent pericarditis (in adults and adolescents)

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

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

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

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(b) In collaboration with Sanofi

(c) 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.

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

Effective July 2022, the Company is solely responsible for the development, commercialization, and manufacturing of Libtayo.

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

(d) 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.

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

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

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

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

(g) Kiniksa is solely responsible for the development and commercialization of ARCALYST.

(h) Sanofi is solely responsible for the development and commercialization of ZALTRAP.

REGEN-COV - Emergency and Temporary Use Authorizations

REGEN-COV has not been approved by the U.S.

Food and Drug Administration ("FDA"), but is currently authorized under an Emergency Use Authorization ("EUA") for use in certain post-exposure prophylaxis settings and as a treatment for people with mild to moderate COVID-19 who are at high risk of serious consequences from COVID-19.

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.

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

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

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

states, territories, or jurisdictions, since Omicron-lineage variants are currently dominant across the United States.

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

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

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

Refer to "Additional Information - Clinical Development Programs" section below for further details regarding the status of the Emergency Use Authorization ("EUA") for REGEN-COV in the United States.

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

(h) Kiniksa is solely responsible for the development and commercialization of ARCALYST.

(i) Sanofi is solely responsible for the development and commercialization of ZALTRAP.

Net Product Sales of Regeneron-Discovered Products

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$ 12.1 $ 19.0 $ 31.1 $ 3.3 $ 22.2 $ 25.5 22 %

Six Months Ended

2022 2021 % Change

(In millions) U.S.

ROW Total U.S.

ROW Total (Total Sales)

$ 3,138.8 $ 1,738.3 $ 4,877.1 $ 2,771.7 $ 1,668.8 * $ 4,440.5 10 %

$ 2,907.7 $ 994.5 $ 3,902.2 $ 2,108.1 $ 653.8 $ 2,761.9 41 %

$ 169.8 $ 96.2 $ 266.0 $ 147.1 $ 70.6 $ 217.7 22 %

$ 64.8 $ 155.5 $ 220.3 $ 85.2 $ 118.8 $ 204.0 8 %

REGEN-COV (e)

$ — $ 658.4 $ 658.4 $ 2,853.4 $ 654.4 $ 3,507.8 (81 %)

$ 100.0 $ 88.7 $ 188.7 $ 61.4 $ 74.4 $ 135.8 39 %

Other products (f)

$ 22.0 $ 39.4 $ 61.4 $ 7.4 $ 45.2 $ 52.6 17 %

* Effective January 1, 2022, the Company and Bayer commenced sharing equally in profits and losses based on sales from Bayer to its distributor in Japan.

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The Company records its share of profits/losses in connection with global sales of Dupixent and Kevzara.

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

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

(c) Prior to July 1, 2022, Regeneron recorded net product sales of Libtayo in the United States and Sanofi recorded net product sales of Libtayo outside the United States.

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

Effective July 1, 2022, the Company will record global net product sales of Libtayo and pay Sanofi a royalty on such sales.

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

(d) Regeneron records net product sales of Praluent in the United States.

Sanofi records net product sales of Praluent outside the United States and pays the Company a royalty on such sales.

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

(e) Regeneron records net product sales of REGEN-COV in the United States.

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

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In addition, not included in this line item are net product sales of ARCALYST subsequent to the first quarter of 2021, which are recorded by Kiniksa;

net product sales of ARCALYST were $18.7 million for the fourth quarter of 2021.

net product sales of ARCALYST were $22.2 million for the first quarter of 2022.

Programs in Clinical Development

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–ROP (EU and Japan)

–Every-16-weeks dosing regimen in patients with non-proliferative diabetic retinopathy ("NPDR")

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

–FDA decision on supplemental BLA ("sBLA") for every-16-weeks dosing regimen in patients with NPDR (first half 2023)

–Every-16-weeks dosing regimen in patients with DR (U.S.)

–Submit supplemental Biologics License Application ("sBLA") for ROP (third quarter 2022)

Food and Drug Administration ("FDA") decision on sBLA for every-16-weeks dosing regimen in patients with DR (target action date of February 28, 2023)

Aflibercept 8 mg (a)

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Antibody to IL-4R alpha subunit

–Peanut allergy

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

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

–Grass allergy –EoE in pediatrics (c)

–Chronic obstructive pulmonary disease ("COPD")

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–Allergic bronchopulmonary aspergillosis ("ABPA")

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

–EoE in adults and adolescents (U.S.

–Prurigo nodularis (U.S.

–Chronic inducible urticaria - cold

–Chronic rhinosinusitis without nasal polyposis

–Atopic dermatitis in pediatrics (6 months–5 years of age) (EU)

–EoE in adults and adolescents (EU)

–Prurigo nodularis (U.S., EU, and Japan)

–Approved by FDA for atopic dermatitis in pediatrics (6 months–5 years of age)

–Approved by European Commission ("EC") for severe asthma in pediatrics (6–11 years of age)

–Approved by FDA for EoE in adults and adolescents

–Reported that Phase 3 trial in EoE in pediatrics (1–11 years of age) met its primary endpoint

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

–Stopped one of the Phase 3 trials in CSU (in patients refractory to omalizumab) due to futility, based on pre-specified interim analysis

–FDA decision on sBLA (target action date of June 9, 2022) and EC decision on regulatory submission (first half 2023) for atopic dermatitis in pediatric patients (6 months–5 years of age)

–Submit regulatory application in Japan for atopic dermatitis in pediatric and adolescent patients (6 months–14 years of age) (second half 2022)

–FDA decision on sBLA (target action date of August 3, 2022) and EC decision on regulatory submission (first half 2023) for EoE in adults and adolescents

–Report results from Phase 3 study for EoE in pediatrics (mid-2022)

–EC decision on regulatory submission for atopic dermatitis in pediatrics (6 months–5 years of age) (first half 2023)

–Submit regulatory application in Japan for atopic dermatitis in pediatrics and adolescents (6 months–14 years of age) (second half 2022)

–EC decision on regulatory submission for EoE in adults and adolescents (first half 2023)

–Submit sBLA for EoE in pediatrics (first half 2023)

–Report initial results from Phase 3 study in COPD (first half 2023)

Clinical Program (continued)

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Dupixent (dupilumab) (b)

–Chronic inducible urticaria - cold

–Chronic rhinosinusitis without nasal polyposis

–Allergic fungal rhinosinusitis

–Chronic pruritis of unknown origin

–Report initial results from Phase 3 study in COPD (first half 2023)

–FDA decision on sBLA (fourth quarter 2022/first quarter 2023) and EC decision on regulatory submission (first half 2023) for prurigo nodularis

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

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

–Stopped one of the Phase 3 trials in CSU (in patients refractory to omalizumab) due to futility, based on pre-specified interim analysis

–Discontinued further clinical development in peanut allergy

–FDA decision on sBLA (target action date of September 30, 2022) and EC decision on regulatory submission (first half 2023) for prurigo nodularis

–Report results from Phase 3 study in chronic inducible urticaria - cold (first half 2023)

Kevzara (sarilumab) (b)

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Solid Organ Oncology

Libtayo (cemiplimab) (b)(g)

Libtayo (cemiplimab) (o)(g)

Antibody to PD-1

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–Neoadjuvant CSCC

–Second-line cervical cancer, ISA101b combination

–First-line NSCLC, chemotherapy combination

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–Adjuvant CSCC

–Second-line cervical cancer (EU and Japan) –Voluntarily withdrew sBLA for cervical cancer due to inability to align with FDA on certain post-marketing studies –FDA decision on sBLA (target action date of September 19, 2022) and EC decision on regulatory submission for NSCLC, chemotherapy combination (second half 2022)

–Second-line cervical cancer (EU and Japan)

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

–Voluntarily withdrew sBLA for cervical cancer due to inability to align with FDA on certain post-marketing studies –FDA decision on sBLA (target action date of September 19, 2022) (p) and EC decision on regulatory submission for NSCLC, chemotherapy combination (first half 2023)

–EC decision on regulatory submission for cervical cancer (first quarter 2023)

Clinical Program (continued)

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2022 Events to Date Select Upcoming Milestones

Libtayo (cemiplimab) (b)(g)

–Second-line cervical cancer, ISA101b combination

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

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

Fianlimab (f)

Antibody to LAG-3

–Solid tumors and advanced hematologic malignancies –First-line metastatic melanoma

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

Immune activator targeting TLR9

–CSCC and Merkel cell carcinoma

Ubamatamab (f)

Bispecific antibody targeting MUC16 and CD3

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Bispecific antibody targeting PSMA and CD28

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

–Prostate cancer –Reported preliminary data from dose escalation portion of Phase 1/2 study in prostate cancer

Bispecific antibody targeting PSMA and CD3

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–MET overexpressing advanced cancer

Fianlimab (f)

Antibody to LAG-3

–Solid tumors and advanced hematologic malignancies –First-line metastatic melanoma

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

Antibody to GITR

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Bispecific antibody targeting CD20 and CD3

–Certain B-cell malignancies (c)(o)

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

–Certain B-cell malignancies (c)(n)

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

–Report additional results from potentially pivotal Phase 2 study in B-NHL and submit BLA (second half 2022)

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Odronextamab (REGN1979)

–Initiate Phase 3 program (second half 2022)

–Initiate Phase 3 program (first half 2023)

Bispecific antibody targeting BCMA and CD3

–Multiple myeloma (potentially pivotal study) –Complete enrollment in potentially pivotal Phase 2 study in multiple myeloma (second half 2022)

–Report results from potentially pivotal Phase 2 study in multiple myeloma (2023)

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

–Multiple myeloma (c)

–Multiple myeloma (potentially pivotal study) (c)

–Complete enrollment in potentially pivotal Phase 2 study in multiple myeloma (second half 2022)

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

Bispecific antibody targeting BCMA and CD3

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

–Myasthenia gravis, cemdisiran combination (m)

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

–Myasthenia gravis, cemdisiran combination (l)

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

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

Cemdisiran (m)

Cemdisiran (l)

siRNA therapeutic targeting C5

–Immunoglobulin A nephropathy

–Reported positive topline results from Phase 2 trial in immunoglobulin A nephropathy

Antibody to IL2Rg

–Aplastic anemia

NTLA-2001 (l)

NTLA-2001 (k)

TTR gene knockout using CRISPR/Cas9

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General Medicine

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

REGEN-COV (casirivimab and imdevimab) (e)(j)

Multi-antibody therapy to SARS-CoV-2 virus

–COVID-19 treatment in hospitalized patients

–COVID-19 prevention

–COVID-19 treatment of non-hospitalized patients and pre-and post-exposure prophylaxis (U.S.)

–COVID-19 treatment of hospitalized patients (EU) –Submitted additional data to the FDA from prophylaxis trial;

considered Major Amendment to the BLA and target action date extended by three months

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

–EC decision on regulatory submission for COVID-19 treatment of hospitalized patients (second half 2022)

–COVID-19 treatment of hospitalized patients (EU) –Submitted additional data to the FDA from prophylaxis trial in connection with BLA

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

–EC decision on regulatory submission for COVID-19 treatment of hospitalized patients (first half 2023)

"Next Generation" Covid Antibodies

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–Osteoarthritis pain of the knee or hip (e)

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

Evkeeza (evinacumab) (f)(n)

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

Evkeeza (evinacumab) (f)(m)

Antibody to ANGPTL3

–Acute pancreatitis prevention

–Reported that Phase 3 trial for HoFH in pediatrics (5–11 years of age) met its primary endpoint

–Submit sBLA for HoFH in pediatrics (5–11 years of age) (second half 2022)

Garetosmab (f) (REGN2477)

3 unchanged sentences

–Initiate Phase 3 study in FOP (second half 2022)

Mibavademab (f)

Agonist antibody to leptin receptor ("LEPR")

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Agonist antibody to NPR1/reversal agent to REGN5381

–Heart failure

–Reversal agent in healthy volunteers –Heart failure

Clinical Program (continued)

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(i) In collaboration with Teva and Mitsubishi Tanabe Pharma

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

(k) In collaboration with Roche outside the United States

(l) In collaboration with Intellia

(m) In collaboration with Alnylam

(n) In collaboration with Ultragenyx outside the United States

(o) FDA granted Fast Track designation for follicular lymphoma and diffuse large B-cell lymphoma

(j) In collaboration with Roche outside the United States

(k) In collaboration with Intellia

(l) In collaboration with Alnylam

(m) In collaboration with Ultragenyx outside the United States

(n) FDA granted Fast Track designation for follicular lymphoma and diffuse large B-cell lymphoma

(o) In collaboration with Sanofi prior to July 2022.

Effective July 2022, the Company is solely responsible for the research, development, and commercialization of Libtayo.

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

(p) We were recently informed that an FDA travel complication related to scheduling a routine clinical trial site inspection in eastern Europe will likely delay its decision on the NSCLC chemotherapy combination sBLA until after the September 19, 2022 target action date.

Additional Information - Clinical Development Programs

REGEN-COV (casirivimab and imdevimab)

In April 2022, the Company announced that the FDA extended by three months (with a new target action date of July 13, 2022) its review of the BLA for REGEN-COV to treat COVID-19 in non-hospitalized patients and as prophylaxis in certain individuals.

The extension is due to ongoing discussions with the FDA relating to pre-exposure prophylactic use, for which the Company has submitted additional data from its completed prophylaxis trial that the FDA has accepted for review.

REGEN-COV has not been approved by the FDA, but is currently authorized under an EUA for use in certain post-exposure prophylaxis settings and as a treatment for people with mild to moderate COVID-19 who are at high risk of serious consequences from COVID-19.

The EUA is temporary and does not replace a formal 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.

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

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

states, territories, or jurisdictions, since Omicron-lineage variants are currently dominant across the United States.

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

In April 2022, the Company announced that the FDA extended by three months (to July 2022) its review of the BLA for REGEN-COV to treat COVID-19 in non-hospitalized patients and as prophylaxis in certain individuals.

The extension was due to ongoing discussions with the FDA relating to pre-exposure prophylactic use, for which the Company has submitted additional data from its completed prophylaxis trial that the FDA has accepted for review.

In July 2022, the FDA notified the Company that its review of the BLA for REGEN-COV to treat COVID-19 in non-hospitalized patients and as prophylaxis in certain individuals is ongoing.

Agreements Related to COVID-19

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

See "Results of Operations - Revenues" below for REGEN-COV net product sales recognized during 2021.

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

In 2020, we entered into a collaboration agreement with Roche to develop, manufacture, and distribute the casirivimab and imdevimab antibody cocktail (known as REGEN-COV in the United States and Ronapreve in other countries).

We lead global development activities for casirivimab and imdevimab, and the parties jointly fund certain studies.

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

Under the terms of the agreement, the parties jointly fund certain studies and 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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We are collaborating with Sanofi on the global development and commercialization of Dupixent, Kevzara, and itepekimab (the "Antibody Collaboration").

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

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

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

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

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

As of June 30, 2022, the total amount of our contingent reimbursement obligation to Sanofi in connection with such development expenses was approximately $3.1 billion.

Under the terms of the Antibody License and Collaboration Agreement, we were required to apply 10% of our share of the profits from the Antibody Collaboration in any calendar quarter to reimburse Sanofi for these development costs.

On July 1, 2022, an amendment to the Antibody License and Collaboration Agreement became effective, pursuant to which the percentage of Regeneron’s share of profits used to reimburse Sanofi for such development costs increased from 10% to 20%.

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.

1 unchanged sentence

We supply certain commercial bulk product to Sanofi.

We and Sanofi equally share

profits and losses from sales within the United States.

We and Sanofi equally share profits and losses from sales within the United States.

We and Sanofi share profits outside the United States on a sliding scale based on sales starting at 65% (Sanofi)/35% (us) and ending at 55% (Sanofi)/45% (us), and share losses outside the United States at 55% (Sanofi)/45% (us).

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

In each of the years ended 2020 and 2021, the Company earned a $50.0 million sales-based milestone from Sanofi, upon aggregate annual sales of antibodies outside the United States (including Praluent) exceeding $1.0 billion and $1.5 billion, respectively, on a rolling twelve-month basis, and, in first quarter of 2022, the Company earned the next $50.0 million sales-based milestone upon aggregate sales of antibodies outside the United States exceeding $2.0 billion.

In each of the years ended 2020 and 2021, the Company earned a $50.0 million sales-based milestone from Sanofi, upon aggregate annual sales of antibodies outside the United States (including Praluent) exceeding $1.0 billion and $1.5 billion, respectively, on a rolling twelve-month basis, and, in first quarter of 2022, the Company earned a $50.0 million sales-based milestone upon aggregate sales of antibodies outside the United States exceeding $2.0 billion.

We are entitled to receive up to an aggregate of $100.0 million in additional sales milestone payments from Sanofi, which includes the next sales milestone payment of $50.0 million that would be earned when such sales outside the United States exceed $2.5 billion on a rolling twelve-month basis.

Immuno-oncology

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

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 and Restated Immuno-oncology Discovery and Development Agreement from our share of profits from commercialized IO Collaboration products.

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.

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

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

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

The Company has been collaborating with Sanofi for antibody-based cancer treatments in the field of immuno-oncology (the "IO Collaboration").

Under the terms of the Immuno-oncology License and Collaboration Agreement, the parties were co-developing and co-commercializing Libtayo.

The parties shared equally, on an ongoing basis, development and commercialization expenses for Libtayo.

We had principal control over the development of Libtayo and led commercialization activities in the United States, while Sanofi led commercialization activities outside of the United States.

The parties shared equally in profits and losses in connection with the commercialization of Libtayo.

Effective July 1, 2022, the Company obtained the exclusive right to develop, commercialize, and manufacture Libtayo worldwide under an Amended and Restated Immuno-oncology License and Collaboration Agreement with Sanofi (the "A&R IO LCA").

Consequently, in July 2022, we made a $900.0 million up-front payment to Sanofi, and Sanofi is eligible to receive a $100.0 million regulatory milestone and up to an aggregate of $100.0 million in sales-based milestones upon achieving certain amounts of worldwide net product sales of Libtayo through 2023.

We will also pay Sanofi an 11% royalty on net product sales of Libtayo through March 31, 2034.

The parties have also entered into a transition services agreement, a transitional distribution agreement, and a manufacturing services agreement, pursuant to which, during certain transitional periods, Sanofi will perform for Regeneron certain transition, distribution, and manufacturing services, respectively.

We were obligated to reimburse Sanofi for half of the development costs it funded that were attributable to clinical development of antibody product candidates under the Amended and Restated Immuno-oncology Discovery and Development Agreement from our share of profits from commercialized IO Collaboration products.

Under the A&R IO LCA, the amount of development costs incurred under the IO Collaboration for which we are obligated to reimburse Sanofi is $35.0 million, and we will reimburse Sanofi for such development costs by paying Sanofi a 0.5% royalty on net product sales of Libtayo until all such development costs have been reimbursed by us.

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

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

Agreed-upon development expenses incurred by the Company and Bayer are generally shared equally.

Bayer markets EYLEA outside the United States, and the companies share equally in profits and losses from such sales.

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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, 2022, we had received an aggregate $120.0 million of development milestones from Teva, and we are entitled to receive up to an aggregate of $340.0 million in additional development milestones and up to an aggregate of $1.890 billion in contingent payments upon achievement of specified annual net sales amounts.

As of June 30, 2022, we had received an aggregate $120.0 million of development milestones from Teva, and we are entitled to receive up to an aggregate of $340.0 million in additional development milestones and up to an aggregate of $1.890 billion in contingent payments upon achievement of specified annual net sales amounts.

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

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In 2018, we and Alnylam Pharmaceuticals, Inc.

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

development).

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

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

Ultragenyx will share in certain costs for global trials led by the

Company and also have the right to continue to clinically develop Evkeeza in countries outside of the U.S.

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

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

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

In April 2022, we entered into an Agreement and Plan of Merger (the "Merger Agreement") to acquire Checkmate Pharmaceuticals, Inc.

at a total equity value of approximately $250 million.

On May 2, 2022, we commenced a tender offer to acquire any and all outstanding shares of common stock of Checkmate at a price of $10.50 per share, to be paid to each shareholder tendering Checkmate shares in cash, without interest, subject to reduction for any applicable withholding taxes.

The consummation of the tender offer is subject to certain conditions, including the tender of at least a majority of the outstanding shares of Checkmate common stock, the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act and other customary closing conditions.

If the tender offer is successfully consummated, we will acquire all shares not acquired in the tender offer through a merger that does not require the vote of Checkmate shareholders.

The transaction is expected to close in mid-2022.

In May 2022, the Company completed its acquisition of Checkmate Pharmaceuticals, Inc.

for a total equity value of approximately $250 million.

In connection with the acquisition, the Company obtained the rights to vidutolimod, which is in clinical development for oncology.

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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Results of Operations

Three Months Ended March 31, 2022 and 2021

Three and Six Months Ended June 30, 2022 and 2021

Three Months Ended

June 30, Six Months Ended

(In millions, except per share data) 2022 2021 2022 2021

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Three Months Ended

(In millions) 2022 2021 $ Change

June 30, Six Months Ended

(In millions) 2022 2021 $ Change 2022 2021 $ Change

Net product sales in the United States:

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Roche 8.2 167.9 (159.7) 224.5 234.7 (10.2)

Other collaboration revenue 0.4 — 0.4 0.4 — 0.4

Other revenue 59.2 46.0 13.2 153.2 96.0 57.2

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Net Product Sales

Net product sales of EYLEA in the United States increased for the three months ended March 31, 2022, compared to the same period in 2021, due to higher sales volume.

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

Net product sales of EYLEA in the United States increased for the three and six months ended June 30, 2022, compared to the same periods in 2021, due to higher sales volume.

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

As of December 31, 2021, the Company had completed its final deliveries of drug product under its agreements with the U.S.

as a result, there were no net product sales of REGEN-COV in the United States recorded during the three months ended March 31, 2022.

as a result, there were no net product sales of REGEN-COV in the United States recorded during the three and six months ended June 30, 2022.

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

Government " section above for further details.

As described under "Collaboration, License, and Other Agreements - Sanofi - Immuno-oncology " above, effective July 1, 2022, the Company became solely responsible for the research, development, and commercialization of Libtayo and will record worldwide net product sales of Libtayo.

Collaboration Revenue

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Three Months Ended

June 30, Six Months Ended

(In millions) 2022 2021 2022 2021

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Reimbursement for manufacturing of commercial supplies (a)

145.5 110.9 306.3 216.5

Other 28.9 — 28.9 —

Total Antibody 671.0 438.5 1,297.1 804.7

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commercial supplies (a)

2.6 2.7 4.6 7.4

Total Immuno-oncology 6.5 (0.8) 11.3 (2.2)

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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.

The increase in our share of profits in connection with commercialization of antibodies during the three months ended March 31, 2022, compared to the same period of 2021, was driven by higher Dupixent profits.

The increase in our share of profits in connection with commercialization of antibodies during the three and six months ended June 30, 2022, compared to the same periods in 2021, was driven by higher Dupixent profits.

Regeneron's share of profits in connection with the commercialization of Dupixent and Kevzara is summarized below:

Three Months Ended

June 30, Six Months Ended

(In millions) 2022 2021 2022 2021

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Regeneron's share of collaboration profits as a percentage of Dupixent and Kevzara net product sales 23% 21% 22% 20%

During the three months ended March 31, 2022, the Company earned a $50.0 million sales-based milestone from Sanofi, upon aggregate annual sales of antibodies outside the United States (including Praluent) exceeding $2.0 billion on a rolling twelve-month basis.

As described above under "Collaboration, License, and Other Agreements - Sanofi - Antibody ", on July 1, 2022, an amendment to the Antibody License and Collaboration Agreement became effective, pursuant to which the percentage of Regeneron's share of profits in any calendar quarter used to reimburse Sanofi for development costs which were funded by Sanofi increased from 10% to 20%.

During the six months ended June 30, 2022, the Company earned a $50.0 million sales-based milestone from Sanofi, upon aggregate annual sales of antibodies outside the United States (including Praluent) exceeding $2.0 billion on a rolling twelve-month basis.

Bayer Collaboration Revenue

Three Months Ended

June 30, Six Months Ended

(In millions) 2022 2021 2022 2021

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commercial supplies (a)

17.8 13.7 42.8 27.6

One-time payment in connection with change in Japan arrangement

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Three Months Ended

June 30, Six Months Ended

(In millions) 2022 2021 2022 2021

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

During the three months ended March 31, 2022 and 2021, the Company recorded, within collaboration revenue, $216.3 million and $66.8 million of payments, respectively, from Roche in connection with this agreement.

Amounts recognized in Collaboration revenue in connection with the Roche collaboration agreement are as follows:

Three Months Ended

June 30, Six Months Ended

(In millions) 2022 2021 2022 2021

Global gross profit payment from Roche in connection with sales of Ronapreve $ 8.2 $ 167.9 $ 224.5 $ 234.7

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

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Other Revenue

Other revenue during the three months ended March 31, 2022 included a $30.0 million up-front payment received from Ultragenyx in connection with our license and collaboration agreement for Evkeeza outside the United States.

Other revenue during the six months ended June 30, 2022 included a $30.0 million up-front payment received from Ultragenyx in connection with our January 2022 license and collaboration agreement for Evkeeza outside the United States.

Three Months Ended

(In millions, except headcount data) 2022 2021 Change

June 30, Six Months Ended

(In millions, except headcount data) 2022 2021 Change 2022 2021 Change

Research and development (a)

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

(b) Cost of goods sold primarily includes costs in connection with producing commercial supplies for products that are sold by Regeneron in the United States (i.e.

(b) Cost of goods sold primarily includes costs in connection with producing commercial supplies for products that are sold by Regeneron (i.e.

, for which we record net product sales), any royalties we are obligated to pay on such sales, and amounts we are obligated to pay to collaborators for their share of gross profits.

(c) 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, 2022 and 2021 included a total of $166.9 million and $130.9 million, respectively, of stock-based compensation expense related to equity awards granted under our long-term incentive plans.

Operating expenses included a total of $159.8 million and $145.5 million for the three months ended June 30, 2022 and 2021, respectively, and $326.7 million and $276.4 million for the six months ended June 30, 2022 and 2021, respectively, of stock-based 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) 2022 2021 *

$ Change 2022 2021 *

Direct research and development expenses:

Libtayo (cemiplimab) $ 38.6 $ 39.8 $ (1.2)

Dupixent (dupilumab) $ 40.1 $ 37.0 $ 3.1 $ 72.2 $ 64.4 $ 7.8

Libtayo (cemiplimab) 37.2 38.2 (1.0) 75.8 78.0 (2.2)

EYLEA 16.3 26.7 (10.4) 40.7 54.8 (14.1)

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

Reimbursement of research and development expenses by collaborators included reimbursements from Roche related to REGEN-COV of $86.8 million for the three months ended March 31, 2021.

For the three months ended March 31, 2022, reimbursements from Roche related to REGEN-COV were not material.

Research and development expenses included stock-based compensation expense of $92.4 million and $69.7 million for the three months ended March 31, 2022 and 2021, respectively.

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.

For the three and six months ended June 30, 2022, reimbursements from Roche related to REGEN-COV were not material.

Research and development expenses included stock-based compensation expense of $89.7 million and $70.9 million for the three months ended June 30, 2022 and 2021, respectively, and $182.1 million and $140.6 million for the six months ended June 30, 2022 and 2021, 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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Acquired In-process Research and Development ("IPR&D")

Acquired IPR&D for the three months ended March 31, 2022 included a $20.0 million opt-in payment in connection with a product candidate under our collaboration agreement with Adicet Bio, Inc.

Acquired IPR&D for the three and six months ended June 30, 2022 included a $195.0 million charge related to the Company's acquisition of Checkmate.

Additionally, Acquired IPR&D for the six months ended June 30, 2022 included a $20.0 million opt-in payment in connection with a product candidate under our collaboration agreement with Adicet Bio, Inc.

Selling, General, and Administrative Expenses

Selling, general, and administrative expenses increased for the three months ended March 31, 2022, compared to the same period in 2021, primarily due to higher headcount and headcount-related costs and an increase in commercialization-related expenses for EYLEA.

Selling, general, and administrative expenses also included stock-based compensation expense of $60.7 million and $50.8 million for the three months ended March 31, 2022 and 2021, respectively.

Selling, general, and administrative expenses increased for the three and six months ended June 30, 2022, compared to the same periods in 2021, primarily due to higher headcount and headcount-related costs and an increase in commercialization-related expenses for EYLEA, partly offset by costs in 2021 for educational campaigns related to COVID-19 that did not recur during 2022.

Selling, general, and administrative expenses also included stock-based compensation expense of $57.5 million and $49.6 million for the three months ended June 30, 2022 and 2021, respectively, and $118.2 million and $100.4 million for the six months ended June 30, 2022 and 2021, respectively.

Cost of Goods Sold

Cost of goods sold increased for the three months ended March 31, 2022, compared to the same period in 2021, primarily due to $58.0 million of costs related to REGEN-COV, including inventory write-offs and reserves, partly offset by lower REGEN-COV manufacturing costs since there were no net product sales in the United States for the three months ended March 31, 2022.

Cost of goods sold decreased for the three and six months ended June 30, 2022, compared to the same periods in 2021, primarily due to the Company not recognizing any REGEN-COV net product sales in the United States during 2022.

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.

The six months ended June 30, 2022 included $58.0 million of costs related to REGEN-COV, including inventory write-offs and reserves.

Cost of Collaboration and Contract Manufacturing

Cost of collaboration and contract manufacturing increased for the three months ended March 31, 2022, compared to the same period in 2021, primarily due to the recognition of manufacturing costs associated with higher sales of Dupixent and an increase in shipments of commercial supplies of Praluent for Sanofi outside the United States.

Cost of collaboration and contract manufacturing increased for the six months ended June 30, 2022, compared to the same period in 2021, primarily due to the recognition of manufacturing costs associated with higher sales of Dupixent and an increase in shipments of commercial supplies of Praluent for Sanofi outside the United States.

Other Operating (Income) Expense

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 our Sanofi immuno-oncology, Teva, and MTPC collaborative arrangements.

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 our Sanofi immuno-oncology, Teva, and MTPC collaborative arrangements.

As the A&R IO LCA became effective July 1, 2022 (as further described under "Collaboration, License, and Other Agreements - Sanofi - Immuno-oncology " above), the three months ended June 30, 2022 will be the last period in which such amounts will be recognized in connection with our Sanofi immuno-oncology collaborative arrangement.

Other Income (Expense)

Other income (expense) was ($197.4) million and $140.3 million for the three months ended March 31, 2022 and 2021, respectively.

This change was primarily driven by the recognition of net unrealized losses on equity securities of $211.2 million for the three months ended March 31, 2022 compared to $143.9 million of net unrealized gains for the same period in 2021.

Other income (expense) for the three and six months ended June 30, 2022, compared to the same periods in 2021, was primarily impacted by the recognition of net unrealized losses on equity securities of $163.7 million and $374.9 million for the three and six months ended June 30, 2022, respectively, compared to $409.0 million and $552.9 million of net unrealized gains for the three and six months ended June 30, 2021, respectively.

Three Months Ended

June 30, Six Months Ended

(In millions, except effective tax rate) 2022 2021 2022 2021

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Effective tax rate

Our effective tax rate for the three months ended March 31, 2022 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 stock-based compensation.

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

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

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

11.5 % 17.4 % 9.8 % 15.8 %

The decrease in the effective tax rate for the three and six months ended June 30, 2022, compared to the same periods in 2021, was primarily driven by the proportion of income earned in foreign jurisdictions with tax rates lower than the U.S.

federal statutory rate, the impact of income earned in the United States during 2021 related to REGEN-COV, and, to a lesser extent, stock-based compensation.

Liquidity and Capital Resources

Our financial condition is summarized as follows:

March 31, December 31,

June 30, December 31,

(In millions) 2022 2021 $ Change

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$ 12,496.0 $ 10,082.4 $ 2,413.6

* Includes $719.7 million related to finance lease liabilities, which were classified within Current liabilities as of December 31, 2021.

* The $719.7 million related to finance lease liabilities was classified within current liabilities as of December 31, 2021.

See " Tarrytown, New York Leases " section below for details.

As of March 31, 2022, 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, 2022 and 2021

As of March 31,

As of June 30, 2022, 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, 2022 and 2021

Six Months Ended

(In millions) 2022 2021 $ Change

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Cash flows used in investing activities $ (2,119.2) $ (933.2) $ (1,186.0)

Cash flows provided by (used in) financing activities $ 64.7 $ (366.4) $ 431.1

Cash flows used in financing activities $ (36.4) $ (484.6) $ 448.2

Cash Flows from Operating Activities

As of March 31, 2022, Accounts receivable had decreased by $1.198 billion, compared to December 31, 2021, primarily due to the Company's collection of amounts due from the U.S.

As of June 30, 2022, Accounts receivable had decreased by $875.1 million, compared to December 31, 2021, primarily due to the Company's collection of amounts due from the U.S.

government in connection with REGEN-COV sales in the fourth quarter of 2021.

As of March 31, 2022, deferred tax assets increased by $225.0 million, compared to December 31, 2021, primarily related to the impact of the Tax Cuts and Jobs Act of 2017, which requires, for tax purposes, the capitalization and amortization of research and development expenses effective for years beginning after December 31, 2021.

As of June 30, 2022, deferred tax assets increased by $381.0 million, compared to December 31, 2021, primarily related to the impact of the Tax Cuts and Jobs Act of 2017, which requires, for tax purposes, the capitalization and amortization of research and development expenses effective for years beginning after December 31, 2021.

Cash Flows from Investing Activities

Capital expenditures during the three months ended March 31, 2022 included costs associated with the expansion of our manufacturing facilities in Rensselaer, New York (including the ongoing construction of a fill/finish facility and related equipment) and Limerick, Ireland, as well costs incurred in connection with our expansion of the Tarrytown, New York campus.

Capital expenditures during the six months ended June 30, 2022 included costs associated with the expansion of our manufacturing facilities in Rensselaer, New York (including the ongoing construction of a fill/finish facility and related equipment) and Limerick, Ireland, as well costs incurred in connection with our expansion of the Tarrytown, New York campus.

We expect to incur capital expenditures of $620 million to $670 million for the full year of 2022 primarily in connection with the continued expansion of our manufacturing facilities (including the fill/finish facility) and the expansion of our research, preclinical manufacturing, and support facilities at our Tarrytown, New York campus.

Asset acquisition, net of cash acquired, of $230.3 million during the six months ended June 30, 2022 was related to our acquisition of Checkmate.

Cash Flows from Financing Activities

Proceeds from issuances of Common Stock, in connection with exercises of employee stock options, were $521.6 million during the three months ended March 31, 2022, compared to $95.0 million during the three months ended March 31, 2021.

Proceeds from issuances of Common Stock, in connection with exercises of employee stock options, were $828.4 million during the six months ended June 30, 2022, compared to $308.2 million during the six months ended June 30, 2021.

For additional information related to cash flows from financing activities, see the " Share Repurchase Program " section below.

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There can be no assurance as to the timing or number of shares of any repurchases in the future.

During the three months ended March 31, 2022, we repurchased 566,973 shares of our Common Stock under the program and recorded the cost of the shares received, or $352.0 million, as Treasury Stock.

As of March 31, 2022, $2.493 billion remained available for share repurchases under the program.

During the six months ended June 30, 2022, we repurchased 1,227,288 shares of our Common Stock under the program and recorded the cost of the shares received, or $745.5 million, as Treasury Stock.

As of June 30, 2022, $2.099 billion remained available for share repurchases under the program.

Tarrytown, New York Leases

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Such financial covenants and certain of the operating covenants are substantially similar to the covenants set forth in our credit facility.

The Company was in compliance with all such covenants as of March 31, 2022.

The Company was in compliance with all such covenants as of June 30, 2022.

Critical Accounting Policies and Use of Estimates

1 unchanged sentence

"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, 2021 (filed February 7, 2022).

There have been no material changes to our critical accounting policies and use of estimates during the three months ended March 31, 2022.

There have been no material changes to our critical accounting policies and use of estimates during the six months ended June 30, 2022.

Future Impact of Recently Issued Accounting Standards

As of March 31, 2022, 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, 2022, 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