What changed in this filing

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Item 2. Management’s Discussion and Analysis

2022-11-03 compared with 2022-08-03 · 211 added, 174 removed, 578 unchanged (40% 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), 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), aflibercept 8 mg, pozelimab, odronextamab, itepekimab, fianlimab, garetosmab, linvoseltamab, REGN5713-5714-5715, Regeneron's other oncology programs (including its costimulatory bispecific portfolio), Regeneron's and its collaborators' earlier-stage programs, and the use of human genetics in Regeneron's research programs;

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

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our ability to meet any of our financial projections or guidance, including without limitation capital expenditures, and changes to the assumptions underlying those projections or guidance;

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), 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.

the potential for any license or collaboration agreement, including our agreements with Sanofi and Bayer (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 described further in Note 14 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 14 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.

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Three Months Ended

June 30, Six Months Ended

September 30, Nine Months Ended

September 30,

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

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- Neovascular glaucoma ("NVG") a

- Retinopathy of prematurity ("ROP")

Dupixent (dupilumab) Injection (b)

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

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

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

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

Product (continued)

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Dupixent (dupilumab) Injection (b) (continued)

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

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

- Prurigo nodularis a a

Libtayo (cemiplimab) Injection (c)

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Evkeeza (evinacumab) Injection (g)

- HoFH (in adults and adolescents) a a

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

- HoFH (in adults and adolescents) a a a

Inmazeb ® (atoltivimab, maftivimab, and odesivimab-ebgn) Injection

- Infection caused by Zaire ebolavirus

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

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Three Months Ended

September 30,

2022 2021 % Change

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$ 17.5 $ 14.7 $ 32.2 $ 7.8 $ 20.9 $ 28.7 12 %

Six Months Ended

Nine Months Ended

September 30,

2022 2021 % Change

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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.

Effective July 1, 2022, the Company began recording net product sales of Libtayo outside the United States and pays Sanofi a royalty on global sales.

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

Included in this line item is approximately $17 million of net product sales recorded by Sanofi in the third quarter of 2022 in connection with sales in certain markets (Sanofi will record net product sales in such markets during a transition period until inventory on hand as of July 1, 2022 is sold through to the end customers).

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

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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 $22.2 million for the first quarter of 2022.

net product sales of ARCALYST were $27 million for the second quarter of 2022.

Programs in Clinical Development

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EYLEA (aflibercept) (a)

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

–ROP (EU and Japan)

–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)

–ROP (U.S., EU)

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

Food and Drug Administration ("FDA") in connection with ROP study, extending period of EYLEA U.S.

market exclusivity by six months through May 17, 2024

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

–FDA decision on supplemental Biologics License Application ("sBLA") for ROP (target action date of February 11, 2023)

–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)

–Reported detailed results from Phase 2 trial in wet AMD

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

–Reported that Phase 3 trials in wet AMD and DME met their primary endpoints

–Submit BLA for wet AMD and DME (fourth quarter 2022)

Immunology & Inflammation

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–Chronic spontaneous urticaria ("CSU")

–Prurigo nodularis

–Allergic bronchopulmonary aspergillosis ("ABPA")

–Chronic inducible urticaria - cold

–Chronic rhinosinusitis without nasal polyposis

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

–Allergic fungal rhinosinusitis

–Atopic dermatitis in pediatrics (6 months–5 years of age) (EU) and in pediatrics and adolescents (6 months–14 years of age (Japan)

–EoE in adults and adolescents (EU)

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

–Prurigo nodularis (EU and Japan)

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

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–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

–Approved by FDA for prurigo nodularis

–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)

–MHLW decision on regulatory submission for atopic dermatitis in pediatrics and adolescents (6 months–14 years of age) in Japan (second half 2023)

–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)

–Submit sBLA for EoE in pediatrics (mid-2023)

Clinical Program (continued)

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Dupixent (dupilumab) (b)

–Allergic fungal rhinosinusitis

–Chronic pruritis of unknown origin

–Chronic pruritus of unknown origin

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

–Initiated additional Phase 3 trial in CSU (in biologic-naïve patients)

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

–EC decision on regulatory submission for prurigo nodularis (first half 2023)

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

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Antibody to IL-33

REGN1908-1909 (f)

Multi-antibody therapy to Fel d 1

REGN5713-5714-5715

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Solid Organ Oncology

Libtayo (cemiplimab) (o)(g)

Libtayo (cemiplimab) (n)(g)

Antibody to PD-1

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–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)

–European Medicines Agency's Committee for Medicinal Products for Human Use ("CHMP") adopted positive opinion for cervical cancer

–Voluntarily withdrew sBLA for cervical cancer due to inability to align with FDA on certain post-marketing studies –FDA decision on sBLA (fourth quarter 2022) (o) and EC decision on regulatory submission (first half 2023) for NSCLC, chemotherapy combination

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

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2022 Events to Date Select Upcoming Milestones

Libtayo (cemiplimab) (n)(g)

–Positive data from Phase 2 trial in neoadjuvant CSCC presented at European Society for Medical Oncology ("ESMO") Congress 2022 and published in New England Journal of Medicine

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)

–Solid tumors and advanced hematologic malignancies –First-line metastatic melanoma –Presented positive data from Phase 1 trial (in combination with Libtayo) in advanced melanoma at ESMO Congress 2022

–Initiate Phase 3 study in first-line adjuvant melanoma (fourth quarter 2022)

Immune activator targeting TLR9

–CSCC and Merkel cell carcinoma

–CSCC and Merkel cell carcinoma –Initiate Phase 2 study in melanoma and other solid tumors

Ubamatamab (f)

Bispecific antibody targeting MUC16 and CD3

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

–Platinum-resistant ovarian cancer –Presented positive initial data from monotherapy dose escalation portion of Phase 1/2 study in platinum-resistant ovarian cancer at ESMO Congress 2022

Bispecific antibody targeting MUC16 and CD28

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Bispecific antibody targeting two distinct MET epitopes

–MET-altered advanced NSCLC –Report results from Phase 1 study in MET-altered advanced NSCLC (second half 2022)

–MET-altered advanced NSCLC –Presented positive initial data from dose escalation portion of Phase 1/2 study in MET-altered advanced NSCLC at ESMO Congress 2022

Clinical Program (continued)

Phase 1 Phase 2 Phase 3 Regulatory Review (h)

2022 Events to Date Select Upcoming Milestones

REGN5093-M114

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Bispecific antibody targeting CD20 and CD3

–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)

Clinical Program (continued)

Phase 1 Phase 2 Phase 3 Regulatory Review (h)

2022 Events to Date Select Upcoming Milestones

Odronextamab (REGN1979)

–Certain B-cell malignancies (c)(m)

–B-cell non-Hodgkin lymphoma

("B-NHL") (m) (potentially pivotal study)

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

–Submit BLA for B-NHL (second half 2023)

–Initiate Phase 3 program (first half 2023)

Linvoseltamab (f)

Bispecific antibody targeting BCMA and CD3

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–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)

–Completed enrollment in potentially pivotal Phase 2 study in multiple myeloma –Report results from potentially pivotal Phase 2 study in multiple myeloma (fourth quarter 2022)

Bispecific antibody targeting BCMA and CD3

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studied as monotherapy and in combination with cemdisiran

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

–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 (l)

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

–Myasthenia gravis, cemdisiran combination (k)

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

–Submit BLA for CD55-deficient protein-losing enteropathy, monotherapy (fourth quarter 2022)

Cemdisiran (k)

siRNA therapeutic targeting C5

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

Clinical Program (continued)

Phase 1 Phase 2 Phase 3 Regulatory Review (h)

2022 Events to Date Select Upcoming Milestones

Antibody to IL2Rg

–Aplastic anemia

NTLA-2001 (k)

NTLA-2001 (j)

TTR gene knockout using CRISPR/Cas9

–Transthyretin ("ATTR") amyloidosis (c)

–Reported updated positive interim data from Phase 1 trial in ATTR

–Reported positive interim data from Phase 1 trial in ATTR

Antibody to Factor XI

Clinical Program (continued)

Phase 1 Phase 2 Phase 3 Regulatory Review (h)

2022 Events to Date Select Upcoming Milestones

Antibody to TMPRSS6

–Transfusion dependent iron overload

General Medicine

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

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

Multi-antibody therapy to SARS-CoV-2 virus

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–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)

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

"Next Generation" Covid Antibodies

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–HeFH in pediatrics

Fasinumab (i)(f) (REGN475)

Antibody to NGF

–Osteoarthritis pain of the knee or hip (e)

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

Evkeeza (evinacumab) (f)(m)

Evkeeza (evinacumab) (f)(l)

Antibody to ANGPTL3

–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)

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

Garetosmab (f) (REGN2477)

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

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

Mibavademab (f)

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–Partial lipodystrophy

REGN5381/REGN9035

Agonist antibody to NPR1/reversal agent to REGN5381

–Reversal agent in healthy volunteers –Heart failure

Clinical Program (continued)

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2022 Events to Date Select Upcoming Milestones

REGN5381/REGN9035

Agonist antibody to NPR1/reversal agent to REGN5381

–Reversal agent in healthy volunteers –Heart failure

RNAi therapeutic targeting HSD17B13

–Nonalcoholic steatohepatitis

("NASH") –Reported preliminary data from Phase 1 study in NASH

–Initiate Phase 2 study in NASH (fourth quarter 2022)

RNAi therapeutic targeting APP

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

We have discontinued further clinical development of REGN6490, an antibody to IL-36R, which was previously being studied in palmo-plantar pustulosis.

We have discontinued further clinical development of fasinumab (REGN475), an antibody to NGF, which was previously being studied in osteoarthritis pain of the knee or hip in collaboration with Teva and Mitsubishi Tanabe Pharma Corporation ("MTPC");

and REGN6490, an antibody to IL-36R, which was previously being studied in palmo-plantar pustulosis.

We have discontinued the Phase 3 study of REGN1908-1909, a multi-antibody therapy to Fel d 1, in cat allergy, due to futility.

(a) In collaboration with Bayer outside the United States

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

(i) In collaboration with Teva and Mitsubishi Tanabe Pharma

(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.

(i) In collaboration with Roche outside the United States

(j) In collaboration with Intellia

(k) In collaboration with Alnylam

(l) In collaboration with Ultragenyx outside the United States

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

(n) 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.

(o) An FDA travel complication related to scheduling a routine clinical trial site inspection in eastern Europe has delayed the FDA's decision on the NSCLC chemotherapy combination sBLA until after the September 19, 2022 target action date.

(p) Studied in combination with ubamatamab

Additional Information - Clinical Development Programs

Aflibercept 8 mg

In September 2022, the Company announced that the primary endpoints were met in two pivotal trials investigating aflibercept 8 mg with 12- and 16-week dosing regimens in patients with DME and wet AMD.

The PHOTON trial in DME and the PULSAR trial in wet AMD both demonstrated that aflibercept 8 mg 12- and 16-week dosing regimens achieved non-inferiority in vision gains compared to the EYLEA 8-week dosing regimen.

Furthermore, of the patients randomized to 12- and 16-week dosing intervals, 91% and 89% of DME patients, respectively, and 79% and 77% of wet AMD patients, respectively, maintained those intervals through 48 weeks.

The safety of aflibercept 8 mg was similar to EYLEA in both trials, and consistent with the known safety profile of EYLEA from previous clinical trials.

The Company intends to use a priority review voucher in connection with the submission of the BLA for DME and wet AMD, which is currently planned for late 2022.

REGEN-COV (casirivimab and imdevimab)

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.

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.

REGEN-COV previously received 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.

Based on laboratory data, 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.

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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.

The FDA has 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

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

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

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

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

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

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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 the three and six months ended June 30, 2021.

See "Results of Operations - Revenues" below for REGEN-COV net product sales recognized during the three and nine months ended September 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).

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Immuno-oncology

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

The Company previously collaborated 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.

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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.

Under the A&R IO LCA, the amount of development costs incurred under the IO Collaboration for which we are obligated to reimburse Sanofi was $35.0 million as of the effective date of the A&R IO LCA, and we pay 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.

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

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

We and Teva are parties to a collaboration agreement to develop and commercialize fasinumab globally, excluding certain Asian countries that are subject to our collaboration agreement with MTPC.

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

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

As of 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.

Within the United States, we will lead commercialization activities, and the parties will share equally in any profits or losses in connection with commercialization of fasinumab.

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

We led global development activities, including the manufacturing of fasinumab, and the parties shared development costs equally.

As of September 30, 2022, we had received an aggregate $120.0 million of development milestones from Teva.

During the third quarter of 2022, we discontinued further clinical development of fasinumab.

In 2018, we and Alnylam Pharmaceuticals, Inc.

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

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

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

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

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

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

In connection with the 2020 agreement, we made a $70.0 million up-front payment to Intellia.

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

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

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

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

18 unchanged sentences

We expect to continue to incur substantial expenses related to our research and development activities, a portion of which we expect to be reimbursed by our collaborators.

Also, our research and development activities outside our collaborations, the costs of which are not reimbursed, are expected to expand and require additional resources.

In addition, our research and development activities and related costs which are not reimbursed, are expected to expand and require additional resources.

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

2 unchanged sentences

the timing of certain expenses;

the continuation of our collaborations, in particular with Sanofi and Bayer, including our share of collaboration profits or losses from sales of commercialized products and the amount of reimbursement of our research and development expenses that we receive from collaborators;

the continuation of our collaborations, in particular with Sanofi and Bayer, including our share of collaboration profits from sales of commercialized products and the amount of reimbursement of our research and development expenses that we receive from collaborators;

and the amount of income tax expense we incur, which is partly dependent on the profits or losses we earn in each of the countries in which we operate.

8 unchanged sentences

Results of Operations

Three and Six Months Ended June 30, 2022 and 2021

Three and Nine Months Ended September 30, 2022 and 2021

Three Months Ended

June 30, Six Months Ended

September 30, Nine Months Ended

September 30,

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

8 unchanged sentences

Three Months Ended

June 30, Six Months Ended

September 30, Nine Months Ended

September 30,

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

Net product sales in the United States:

EYLEA $ 1,621.2 $ 1,424.7 $ 196.5 $ 3,138.8 $ 2,771.7 $ 367.1

Libtayo 90.9 78.0 12.9 169.8 147.1 22.7

Praluent 31.2 41.9 (10.7) 64.8 85.2 (20.4)

REGEN-COV — 2,591.2 (2,591.2) — 2,853.4 (2,853.4)

Evkeeza 11.1 2.0 9.1 19.6 2.5 17.1

ARCALYST — * — * *

Net product sales:

$ 1,629.4 $ 1,473.4 $ 156.0 $ 4,768.2 $ 4,245.1 $ 523.1

Libtayo - U.S.

94.7 78.4 16.3 264.5 225.5 39.0

Libtayo - ROW 31.0 — *

Praluent - U.S.

29.7 44.8 (15.1) 94.5 130.0 (35.5)

REGEN-COV - U.S.

— 676.7 (676.7) — 3,530.1 (3,530.1)

Evkeeza - U.S.

13.6 6.6 7.0 33.2 9.1 24.1

Inmazeb - U.S.

3.0 — 3.0 3.0 — 3.0

ARCALYST ** - U.S.

Collaboration revenue:

5 unchanged sentences

Total revenues $ 2,936.2 $ 3,452.8 $ (516.6) $ 8,758.5 $ 11,120.0 $ (2,361.5)

* Percentage not meaningful

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

1 unchanged sentence

Net Product Sales

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.

Net product sales of EYLEA in the United States increased for the three and nine months ended September 30, 2022, compared to the same periods in 2021, due to higher sales volume partly offset by an increase in sales-related deductions.

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 worldwide and began recording net product sales of Libtayo outside the United States.

During the three and nine months ended September 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 and six months ended June 30, 2022.

as a result, there were no net product sales of REGEN-COV in the United States recorded during the three and nine months ended September 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

1 unchanged sentence

Three Months Ended

June 30, Six Months Ended

September 30, Nine Months Ended

September 30,

(In millions) 2022 2021 2022 2021

1 unchanged sentence

Sales-based milestone earned

— 50.0 50.0 50.0

Reimbursement for manufacturing of commercial supplies (a)

13 unchanged sentences

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 and six months ended June 30, 2022, compared to the same periods in 2021, was driven by higher Dupixent profits.

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%.

The increase in our share of profits in connection with commercialization of antibodies during the three and nine months ended September 30, 2022, compared to the same periods in 2021, was driven by higher Dupixent profits, partly offset by a one-time payment, recorded during the third quarter of 2022, in connection with this amendment.

In addition, given the recent U.S.

dollar strengthening against several foreign currencies, including the Japanese yen and the euro, the amount of the share of profits we receive in connection with commercialization of antibodies outside the United States was impacted in the third quarter of 2022.

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

September 30, Nine Months Ended

September 30,

(In millions) 2022 2021 2022 2021

4 unchanged sentences

(78.7) (38.8) (180.7) (105.0)

One-time payment in connection with amendment to the Antibody License and Collaboration Agreement (56.9) — (56.9) —

Regeneron's share of profits in connection with commercialization of antibodies

1 unchanged sentence

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

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.

During the nine months ended September 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.

During the three months ended September 30, 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 $1.5 billion on a rolling twelve-month basis.

Bayer Collaboration Revenue

Three Months Ended

June 30, Six Months Ended

September 30, Nine Months Ended

September 30,

(In millions) 2022 2021 2022 2021

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

In addition, given the recent U.S.

dollar strengthening against several foreign currencies, including the Japanese yen and the euro, the amount of the share of profits we receive in connection with commercialization of EYLEA outside the United States was impacted in the third quarter of 2022.

Regeneron's share of profits in connection with commercialization of EYLEA outside the United States is summarized below:

Three Months Ended

June 30, Six Months Ended

September 30, Nine Months Ended

September 30,

(In millions) 2022 2021 2022 2021

17 unchanged sentences

Three Months Ended

June 30, Six Months Ended

September 30, Nine Months Ended

September 30,

(In millions) 2022 2021 2022 2021

2 unchanged sentences

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

Other Revenue

Other revenue 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

June 30, Six Months Ended

September 30, Nine Months Ended

September 30,

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

4 unchanged sentences

529.1 445.0 84.1 1,455.4 1,265.3 190.1

Cost of goods sold (b)

149.2 539.4 (390.2) 356.5 722.6 (366.1)

Cost of collaboration and contract manufacturing (c)

Cost of goods sold 141.3 238.8 (97.5) 497.8 961.4 (463.6)

Cost of collaboration and contract manufacturing (b)

176.5 214.4 (37.9) 522.0 493.5 28.5

3 unchanged sentences

(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 (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 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.

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

Operating expenses included a total of $166.3 million and $136.9 million for the three months ended September 30, 2022 and 2021, respectively, and $493.0 million and $413.3 million for the nine months ended September 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

6 unchanged sentences

Three Months Ended

June 30, Six Months Ended

September 30, Nine Months Ended

September 30,

(In millions) 2022 2021 *

3 unchanged sentences

Libtayo (cemiplimab) 31.3 34.6 (3.3) 107.1 112.6 (5.5)

EYLEA 16.3 26.7 (10.4) 40.7 54.8 (14.1)

Aflibercept 14.3 23.5 (9.2) 54.9 78.3 (23.4)

12.2 15.4 (3.2) 25.8 320.1 (294.3)

15 unchanged sentences

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

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.

Total research and development expenses increased during the three months ended September 30, 2022 partially due to the impact of the amendments to the Sanofi collaboration agreements described under the "Collaboration, License, and Other Agreements" section above, including Sanofi no longer reimbursing us for 50% of Libtayo development costs incurred.

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

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

Research and development expenses included stock-based compensation expense of $93.7 million and $73.1 million for the three months ended September 30, 2022 and 2021, respectively, and $275.8 million and $213.7 million for the nine months ended September 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.

5 unchanged sentences

Acquired In-process Research and Development ("IPR&D")

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.

Acquired IPR&D for the nine months ended September 30, 2022 included a $195.0 million charge related to the Company's second quarter 2022 acquisition of Checkmate.

Additionally, Acquired IPR&D for the nine months ended September 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 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.

Selling, general, and administrative expenses increased for the three and nine months ended September 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 Libtayo.

The increase in Selling, general, and administrative expenses for the nine months ended September 30, 2022 was also due to higher 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 $59.8 million and $48.7 million for the three months ended September 30, 2022 and 2021, respectively, and $178.0 million and $149.1 million for the nine months ended September 30, 2022 and 2021, respectively.

Cost of Goods Sold

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 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.

Cost of goods sold decreased for the three and nine months ended September 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 also decreased for the three and nine months ended September 30, 2022 since effective July 1, 2022, as a result of the A&R IO LCA described above, we are no longer obligated to pay Sanofi for their share of Libtayo U.S.

gross profits.

During the six months ended June 30, 2022, Cost of goods sold included $70.1 million related to Regeneron's obligation for Sanofi's share of Libtayo U.S.

gross profits.

Cost of goods sold for the nine months ended September 30, 2022 also decreased, compared to the same period in 2021, due to lower inventory write-offs and reserves ($101.3 million for the nine months ended September 30, 2022 compared to $188.0 million for the nine months ended September 30, 2021) primarily related to REGEN-COV.

Other Operating (Income) Expense

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

During the three months ended September 30, 2022, the Company discontinued further clinical development of fasinumab and, as a result, recorded $44.4 million (as an increase to other operating income) related to our Teva and MTPC collaborative arrangements as we deemed our obligation to provide development services in connection with these collaborative arrangements to be complete.

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 was the last period in which such amounts were recognized in connection with our Sanofi immuno-oncology collaborative arrangement.

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

Other Income (Expense)

Other income (expense) 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.

Other income (expense) for the three and nine months ended September 30, 2022, compared to the same periods in 2021, was primarily impacted by the recognition of net unrealized gains on equity securities of $254.3 million and net unrealized losses of $120.6 million for the three and nine months ended September 30, 2022, respectively, compared to $29.1 million of net unrealized losses and $523.8 million of net unrealized gains for the three and nine months ended September 30, 2021, respectively.

Three Months Ended

June 30, Six Months Ended

September 30, Nine Months Ended

September 30,

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

3 unchanged sentences

12.9 % 10.2 % 11.1 % 14.3 %

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.

The effective tax rate for the three months ended September 30, 2022, compared to the same period in 2021, included a lower benefit from stock-based compensation and a higher benefit from the proportion of income earned in foreign jurisdictions with tax rates lower than the U.S.

federal statutory rate (mainly due to no sales of REGEN-COV in the United States during 2022).

The effective tax rate for the nine months ended September 30, 2022, compared to the same period in 2021, included a favorable benefit from the proportion of income earned in foreign jurisdictions with tax rates lower than the U.S.

federal statutory rate (including the impact from REGEN-COV income in 2021 described above), and, to a lesser extent, stock-based compensation.

Liquidity and Capital Resources

Our financial condition is summarized as follows:

June 30, December 31,

September 30, December 31,

(In millions) 2022 2021 $ Change

13 unchanged sentences

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

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

As of September 30, 2022, we also had borrowing availability of $750.0 million under a revolving credit facility.

Sources and Uses of Cash for the Nine Months Ended September 30, 2022 and 2021

Nine Months Ended

September 30,

(In millions) 2022 2021 $ Change

3 unchanged sentences

Cash Flows from Operating Activities

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.

As of September 30, 2022, Accounts receivable had decreased by $488.2 million, compared to December 31, 2021, driven by 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 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.

As of September 30, 2022, deferred tax assets increased by $466.7 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 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.

Capital expenditures during the nine months ended September 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 $580 million to $615 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.

Payments for Libtayo intangible asset of $926.8 million during the nine months ended September 30, 2022 were related to our acquisition of the exclusive right to develop, commercialize, and manufacture Libtayo worldwide (as described in "Collaboration, License, and Other Agreements - Sanofi - Immuno-oncology " above).

Asset acquisition, net of cash acquired, of $230.3 million during the nine months ended September 30, 2022 was related to our second quarter 2022 acquisition of Checkmate.

Cash Flows from Financing Activities

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.

Proceeds from issuances of Common Stock, in connection with exercises of employee stock options, were $1.147 billion during the nine months ended September 30, 2022, compared to $1.130 billion during the nine months ended September 30, 2021.

For information related to repurchases of Common Stock, see the " Share Repurchase Program " section below.

Share Repurchase Program

4 unchanged sentences

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

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.

During the nine months ended September 30, 2022, we repurchased 2,721,305 shares of our Common Stock under the program and recorded the cost of the shares, or $1.659 billion, as Treasury Stock.

As of September 30, 2022, $1.186 billion remained available for share repurchases under the program.

Tarrytown, New York Leases

3 unchanged sentences

In accordance with the terms of the Restated Lease, we continue to pay all maintenance, insurance, taxes, and other costs arising out of the use of the Facility.

We are also required to make monthly payments of basic rent during the term of the Restated Lease in an amount equal to a variable rate per annum, which was modified in connection with the Restated Lease, to be an adjusted one-month forward-looking term rate based on the Secured Overnight Financing Rate ("SOFR"), plus an applicable margin that varies with our debt rating and total leverage ratio.

rate based on the Secured Overnight Financing Rate ("SOFR"), plus an applicable margin that varies with our debt rating and total leverage ratio.

The Restated Participation Agreement and Restated Lease include an option for us to elect to further extend the maturity date of the Restated Participation Agreement and the term of the Restated Lease for an additional five-year period, subject to the consent of all the Participants and certain other conditions.

3 unchanged sentences

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 June 30, 2022.

Critical Accounting Policies and Use of Estimates

A summary of our critical accounting policies and use of estimates are presented in Part II, Item 7.

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

Critical Accounting Estimates

A summary of critical accounting estimates is presented in Part II, Item 7.

"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 six months ended June 30, 2022.

There have been no material changes to critical accounting estimates during the nine months ended September 30, 2022.

Future Impact of Recently Issued Accounting Standards

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.

As of September 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