What changed in this filing

/stocks — the workspaceLOADING

Item 2. Management’s Discussion and Analysis

2023-11-02 compared with 2023-08-03 · 237 added, 184 removed, 521 unchanged (45% of the section changed)

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

These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, "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;

These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, "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, EYLEA HD (aflibercept) Injection 8 mg, Dupixent ® (dupilumab) Injection, Libtayo ® (cemiplimab) Injection, Praluent ® (alirocumab) Injection, Kevzara ® (sarilumab) Injection, Evkeeza ® (evinacumab) Injection, Veopoz ™ (pozelimab) Injection, 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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is a fully integrated biotechnology company that invents, develops, manufactures, and commercializes medicines for people with serious diseases.

Our products and product candidates in development are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, pain, hematologic conditions, infectious diseases, and rare diseases.

Our products and product candidates in development are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, hematologic conditions, infectious diseases, and rare diseases.

Our core business strategy is to maintain a strong foundation in basic scientific research and discovery-enabling technologies, and to build on that foundation with our clinical development, manufacturing, and commercial capabilities.

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Three Months Ended

June 30, Six Months Ended

September 30, Nine Months Ended

September 30,

(In millions, except per share data) 2023 2022 2023 2022

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

Certain products have also received marketing approval in countries outside the United States, European Union ("EU"), or Japan.

Product Disease Territory

EU Japan Other (e)

EYLEA (aflibercept) Injection (a)

Neovascular age-related macular degeneration ("wet AMD") a a a a

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

Wet age-related macular degeneration ("wAMD")

Diabetic macular edema ("DME") a a a

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

Myopic choroidal neovascularization ("mCNV") a a a

Myopic choroidal neovascularization ("mCNV") a a

Diabetic retinopathy ("DR") a

1 unchanged sentence

Retinopathy of prematurity ("ROP")

EYLEA HD (aflibercept) Injection 8 mg (a)

Dupixent (dupilumab) Injection (b)

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

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

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

Asthma (in adults and adolescents) a a a a

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

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

Atopic dermatitis (in adults, adolescents, and pediatrics aged 6 months and older)

Asthma (in adults and adolescents) a a a

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

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

Product (continued)

Disease Territory

EU Japan Other (e)

Dupixent (dupilumab) Injection (b) (continued)

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

Prurigo nodularis a a a a

Prurigo nodularis a a a

Libtayo (cemiplimab) Injection (c)

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Metastatic or locally advanced basal cell carcinoma ("BCC")

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

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

Metastatic or recurrent second-line cervical cancer

Praluent (alirocumab) Injection (d)

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

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

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

Cardiovascular risk reduction in patients with established cardiovascular disease a a

Homozygous familial hypercholesterolemia ("HoFH") a

REGEN-COV ®(f)

COVID-19 a a a

Kevzara (sarilumab) Solution for Subcutaneous Injection (b)

Rheumatoid arthritis ("RA") a a a a

REGEN-COV ®(e)

Kevzara (sarilumab) Injection (b)

Rheumatoid arthritis ("RA") a a a

Polymyalgia rheumatica ("PMR")

Evkeeza (evinacumab) Injection (g)

HoFH (in adults and adolescents) a a a

Evkeeza (evinacumab) Injection (f)

HoFH (in adults and adolescents) a a

HoFH (in pediatrics 5–11 years of age) a

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

Inmazeb ® (atoltivimab, maftivimab, and odesivimab) Injection

Infection caused by Zaire ebolavirus

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

Veopoz (pozelimab) Injection

CD55-deficient protein-losing enteropathy ("CHAPLE") (in adults, adolescents, and pediatrics aged 1 year and older)

ARCALYST ® (rilonacept) Injection (g)

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

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

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

Recurrent pericarditis (in adults and adolescents)

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

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

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

Metastatic colorectal cancer ("mCRC") a a a

Refer to table below (net product sales of Regeneron-discovered products) for information regarding whether net product sales for a particular product are recorded by us or others.

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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) 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.

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

(g) The Company is solely responsible for the development and commercialization of Evkeeza in the United States and Ultragenyx is responsible for the development and commercialization of 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.

(d) The Company is solely responsible for the development and commercialization of Praluent in the United States and Sanofi is responsible for the development and commercialization of Praluent outside of the United States.

(e) In collaboration with Roche.

Product is known as REGEN-COV in the United States and Ronapreve ™ in other countries.

(f) The Company is solely responsible for the development and commercialization of Evkeeza in the United States and Ultragenyx is responsible for the development and commercialization of 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.

Net product sales of Regeneron-discovered products consist of the following:

Three Months Ended

September 30,

2023 2022 % Change

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$ 1,448.2 $ 872.2 $ 2,320.4 $ 1,629.4 $ 816.9 $ 2,446.3 (5 %)

$ 42.7 $ — $ 42.7 $ — $ — $ — (h)

$ 2,366.3 $ 731.3 $ 3,097.6 $ 1,824.0 $ 506.1 $ 2,330.1 33 %

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$ 23.4 $ 15.5 $ 38.9 $ 17.5 $ 14.7 $ 32.2 21 %

Six Months Ended

Nine Months Ended

September 30,

2023 2022 % Change

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$ 4,382.1 $ 2,605.6 $ 6,987.7 $ 4,768.2 $ 2,544.2 $ 7,312.4 (4 %)

$ 42.7 $ — $ 42.7 $ — $ — $ — (h)

$ 6,369.6 $ 2,002.4 $ 8,372.0 $ 4,731.7 $ 1,500.6 $ 6,232.3 34 %

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$ 64.0 $ 48.9 $ 112.9 $ 39.5 $ 54.1 $ 93.6 21 %

(a) Regeneron records net product sales of EYLEA in the United States.

(a) Regeneron records net product sales of EYLEA and EYLEA HD in the United States.

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

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

Included in this line item for the six months ended June 30, 2023 is $6 million of first quarter 2023 net product sales recorded by Sanofi in connection with sales in certain markets outside the United States (Sanofi recorded net product sales in such markets during a transition period until inventory on hand as of July 1, 2022 had been sold through to the end customers).

Included in this line item for the nine months ended September 30, 2023 is $6 million of first quarter 2023 net product sales recorded by Sanofi in connection with sales in certain markets outside the United States (Sanofi recorded net product sales in such markets during a transition period until inventory on hand as of July 1, 2022 had been sold through to the end customers).

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

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Not included in this line item are net product sales of ARCALYST, which are recorded by Kiniksa;

net product sales of ARCALYST were $43 million for the first quarter of 2023.

net product sales of ARCALYST were $54 million for the second quarter of 2023.

(g) Rest of world ("ROW")

(h) Percentage not meaningful

Programs in Clinical Development

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Ophthalmology

EYLEA (aflibercept) (a)

EYLEA HD (aflibercept) 8 mg (a)

–wAMD and DME (EU and Japan)

–Approved by U.S.

Food and Drug Administration ("FDA") for ROP

Aflibercept 8 mg (a)

–Wet AMD and DME (U.S., EU, and Japan)

–FDA issued Complete Response Letter ("CRL") for Biologics License Application ("BLA") for wet AMD, DME, and DR due to unresolved observations resulting from an inspection at third-party contract manufacturer

–Resubmitted BLA for wet AMD, DME, and DR

–Reported positive two-year data from Phase 3 study in DME

–FDA decision on BLA for wet AMD, DME, and DR

–European Commission ("EC") and Japan's Ministry of Health, Labour and Welfare ("MHLW") decision on regulatory submissions for wet AMD and DME (fourth quarter 2023/first half 2024)

–Report two-year data from Phase 3 study in wet AMD (third quarter 2023)

Food and Drug Administration ("FDA") for wAMD, DME, and DR

–Reported positive two-year data from Phase 3 studies in wAMD and DME

–European Commission ("EC") and Japan's Ministry of Health, Labour and Welfare ("MHLW") decision on regulatory submissions for wAMD and DME (first half 2024)

EYLEA (aflibercept) (a)

–Approved by FDA for ROP

Immunology & Inflammation

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–EoE in pediatrics (c)

–Chronic obstructive pulmonary disease ("COPD") (d)

–Chronic obstructive pulmonary disease

–Bullous pemphigoid (c)

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–Chronic pruritus of unknown origin

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

–CSU in adults and adolescents (U.S.

–EoE in pediatrics (1–11 years of age) (U.S.)

–CSU in adults and adolescents (Japan)

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

–Approved by MHLW for atopic dermatitis in pediatrics and adolescents (6 months–14 years of age)

–Approved by EC for EoE in adults and adolescents

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presented at 2023 American Thoracic Society International Conference and published in New England Journal of Medicine

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

–Supplemental BLA ("sBLA") filing acceptance and submission of regulatory application in the EU for EoE in pediatrics (second half 2023)

–Report results from replicate Phase 3 trial in COPD (mid-2024)

–FDA decision on supplemental Biologics License Application ("sBLA") for EoE in pediatrics (target action date of January 31, 2024)

–Submit regulatory application in the EU for EoE in pediatrics (fourth quarter 2023)

–Interim analysis from replicate Phase 3 trial in COPD (fourth quarter 2023)

–MHLW decision on regulatory submission for CSU in adults and adolescents (first half 2024)

–Report results from ongoing Phase 3 trial in CSU (in biologic-naïve patients) (fourth quarter 2024)

Clinical Program (continued)

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Dupixent (dupilumab) (b)

–FDA issued Complete Response Letter ("CRL") for sBLA for CSU due to requirement for additional efficacy data

–Phase 3 trial in chronic cold induced urticaria did not meet its required efficacy endpoints

–Discontinued further clinical development in allergic fungal rhinosinusitis and chronic rhinosinusitis without nasal polyposis

–FDA decision on sBLA (target action date of October 22, 2023) and MHLW decision on regulatory submission (first half 2024) for CSU in adults and adolescents

Kevzara (sarilumab) (b)

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

–Systemic juvenile idiopathic arthritis ("sJIA") (pivotal study) –Approved by FDA for PMR

–Submit sBLA and regulatory application in the EU for pcJIA (second half 2023)

–Systemic juvenile idiopathic arthritis ("sJIA") (pivotal study) –pcJIA (U.S.

–Approved by FDA for PMR

–FDA decision on sBLA (target action date of June 10, 2024) and EC decision (second half 2024) on regulatory submission for pcJIA

Itepekimab (b) (REGN3500)

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–Neoadjuvant CSCC

–Second-line cervical cancer, ISA101b combination

–First-line NSCLC, BNT116 (s) combination

–First-line NSCLC, BNT116 (r) combination

–Adjuvant CSCC

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–Solid tumors and advanced hematologic malignancies –First-line advanced NSCLC (Phase 2/3) (pivotal study)

–First-line metastatic melanoma

–First-line adjuvant melanoma –Presented positive data from Phase 1 trial (in combination with Libtayo) in advanced melanoma at 2023 American Society of Clinical Oncology ("ASCO") Annual Meeting

–Initiate potentially pivotal Phase 2 study (in combination with Libtayo) in perioperative melanoma (second half 2023)

–Initiate Phase 2 study (in combination with Libtayo) in perioperative NSCLC (second half 2023)

–First-line metastatic melanoma (e)

–First-line adjuvant melanoma

–Presented positive data from Phase 1 trial (in combination with Libtayo) in advanced melanoma at 2023 American Society of Clinical Oncology ("ASCO") Annual Meeting

–Initiate potentially pivotal Phase 2 study (in combination with Libtayo) in perioperative melanoma (fourth quarter 2023)

–Initiate Phase 2 study (in combination with Libtayo) in perioperative NSCLC (first half 2024)

Immune activator targeting TLR9

–Solid tumors

Ubamatamab (f)

Ubamatamab (f) (REGN4018)

Bispecific antibody targeting MUC16 and CD3

–Platinum-resistant ovarian cancer

–Report results from Phase 1/2 study (in combination with Libtayo) in platinum-resistant ovarian cancer (second half 2023)

–Platinum-resistant ovarian cancer –Presented results from Phase 1/2 study (in combination with Libtayo) in platinum-resistant ovarian cancer at European Society for Medical Oncology ("ESMO") Congress

Bispecific antibody targeting MUC16 and CD28

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Bispecific antibody targeting PSMA and CD28

–Prostate cancer –Discontinued enrollment in cohorts in combination with full-dose Libtayo

–Prostate cancer –Discontinued enrollment in cohorts in combination with full-dose Libtayo (cemiplimab)

–Expanded enrollment in monotherapy cohort

–Report additional results from Phase 1/2 study (in combination with Libtayo) in prostate cancer (2024)

–Initiate cohorts in combination with lower doses of cemiplimab (first quarter 2024)

Bispecific antibody targeting PSMA and CD3

–Prostate cancer

Davutamig (REGN5093)

Bispecific antibody targeting two distinct MET epitopes

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–MET overexpressing advanced cancer

Clinical Program (continued)

Phase 1 Phase 2 Phase 3 Regulatory Review (h)

2023 Events to Date Select Upcoming Milestones

Antibody to GITR

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–Solid tumors

Clinical Program (continued)

Phase 1 Phase 2 Phase 3 Regulatory Review (h)

2023 Events to Date Select Upcoming Milestones

Odronextamab (i) (REGN1979)

Pozelimab (f) (REGN3918)

Antibody to C5

–Myasthenia gravis, cemdisiran combination (c)(s)

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

–Veopoz (pozelimab) approved by FDA for CHAPLE in adults and children aged 1 year and older, monotherapy

Odronextamab (i)(m) (REGN1979)

Bispecific antibody targeting CD20 and CD3

–Certain B-cell malignancies (c)(m)

–Certain B-cell malignancies (c)

–B-cell non-Hodgkin lymphoma

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

–Relapsed/refractory FL and DLBCL (EU) –Initiate Phase 3 studies in follicular lymphoma ("FL") and diffuse large B-cell lymphoma ("DLBCL"), including earlier lines of therapy (second half 2023)

–BLA filing acceptance for relapsed/refractory FL and DLBCL (second half 2023)

("B-NHL") (pivotal study)

–Follicular lymphoma ("FL")

–Diffuse large B-cell lymphoma ("DLBCL")

–Relapsed/refractory FL and DLBCL (U.S.

–FDA decision on BLA (target action date of March 31, 2024) and EC decision on regulatory submission (second half 2024) for relapsed/refractory FL and DLBCL

Bispecific antibody targeting CD22 and CD28

Linvoseltamab (f)

Linvoseltamab (f) (REGN5458)

Bispecific antibody targeting BCMA and CD3

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–Multiple myeloma (pivotal study) (c)(e)

–Presented updated positive data from pivotal trial in multiple myeloma at ASCO Annual Meeting –Initiate Phase 3 study in multiple myeloma, including earlier lines of therapy (third quarter 2023)

–Present data from pivotal study in multiple myeloma (fourth quarter 2023)

–Submit BLA for relapsed/refractory multiple myeloma (fourth quarter 2023)

–Multiple myeloma (c)(e)

–Presented updated positive data from pivotal trial in multiple myeloma at ASCO Annual Meeting –Present data from pivotal study in multiple myeloma (fourth quarter 2023/first half 2024)

–Submit BLA (fourth quarter 2023) and Marketing Authorization Application ("MAA") (first quarter 2024) for relapsed/refractory multiple myeloma

Bispecific antibody targeting BCMA and CD3

–Transplant desensitization in patients with chronic kidney disease

Pozelimab (f) (REGN3918)

Antibody to C5;

studied as monotherapy and in combination with cemdisiran

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

–Myasthenia gravis, cemdisiran combination (t)

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

–CHAPLE, monotherapy (adults and children aged 1 year and older) (U.S.)

–FDA decision on BLA for pozelimab monotherapy for CHAPLE (target action date of August 20, 2023)

Clinical Program (continued)

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–Transthyretin ("ATTR") amyloidosis (c)

–Initiate Phase 3 study in ATTR amyloidosis with cardiomyopathy ("ATTR-CM") (fourth quarter 2023)

Antibody to Factor XI

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–Transfusion dependent iron overload

General Medicine

"Next Generation" Covid Antibodies

Antibodies to SARS-CoV-2 variants

–Initiate clinical development of "next generation" antibody (second half 2023)

Internal Medicine/Genetic Medicines

Praluent (alirocumab)

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

Mibavademab (f)

Mibavademab (f) (REGN4461)

Agonist antibody to leptin receptor ("LEPR")

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Agonist antibody to NPR1/reversal agent to REGN5381

–Reversal agent in healthy volunteers –Heart failure –Paused enrollment in Phase 1 and Phase 2 studies pending protocol amendment

–Report initial data in healthy volunteers (second half 2023)

–Reversal agent in healthy volunteers –Heart failure –Paused enrollment in Phase 2 study pending protocol amendment

–Resumed enrollment in previously paused Phase 1 study

–Report initial data in healthy volunteers (fourth quarter 2023)

Antagonist antibody to NPR1

–Healthy volunteers

RNAi therapeutic targeting HSD17B13

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–Hearing loss in pediatrics (c) (Phase 1/2)

–Reported preliminary, positive safety and efficacy results from first patient dosed in Phase 1/2 trial in pediatrics with hearing loss

"Next Generation" Covid Antibodies (t)

Antibodies to SARS-CoV-2 variants

–Initiate clinical development of "next generation" antibody (fourth quarter 2023)

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.

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by the FDA due to findings observed in prior non-clinical chronic toxicology studies.

(r) In collaboration with Decibel

(s) BioNTech's BNT116 is an mRNA cancer vaccine

(t) Under the terms of our license agreement for the combination consisting of cemdisiran and pozelimab, Alnylam is entitled to receive royalties on sales of the combination (if any), as well as sales milestones.

(r) BioNTech's BNT116 is an mRNA cancer vaccine

(s) Under the terms of our license agreement for the combination consisting of cemdisiran and pozelimab, Alnylam is entitled to receive royalties on sales of the combination (if any), as well as sales milestones.

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

Department of Health and Human Services ("HHS") are parties to an agreement whereby HHS provides certain funding to support research and development activities.

Additional Information - Clinical Development Programs

Aflibercept 8 mg

In June 2023, the FDA issued a CRL for the BLA for aflibercept 8 mg for the treatment of patients with wet AMD, DME, and DR.

The CRL was issued solely due to unresolved observations resulting from a May 2023 FDA inspection at a third-party contract manufacturing organization, Catalent, that the Company engaged to complete vial-filling for aflibercept 8 mg.

The CRL did not identify any issues with the aflibercept 8 mg clinical efficacy or safety profile, trial design, labeling, or drug substance manufacturing, and no additional clinical data or trials have been requested.

The May 2023 inspection was conducted as part of the FDA review process for both the aflibercept 8 mg BLA and the pending BLA for pozelimab, as both product candidates are filled on the same manufacturing line in Catalent's facility.

Catalent has already provided certain manufacturing data and other information to the FDA, and expects to be able to provide the remaining required data and information in August 2023.

The FDA has stated that its review of the Catalent manufacturing data in the context of the pozelimab BLA will support actions for both the pozelimab BLA and the aflibercept 8 mg BLA resubmission.

The FDA has also informed the Company that it will strive to complete its review prior to the target action date for the pozelimab BLA (August 20, 2023), and, if unable to do so, may extend its review by up to 3 months while still continuing to prioritize the review.

Based on this information, the Company anticipates the FDA will act on the pozelimab and aflibercept 8 mg BLAs before the end of the third quarter 2023.

In June 2023, the Company announced top-line, two-year (96 weeks) data for aflibercept 8 mg from the pivotal PHOTON trial in patients with DME.

In addition, in July 2023, the results were presented at the American Society of Retina Specialists annual meeting.

During the trial, aflibercept 8 mg patients were initially randomized to either 12- or 16-week dosing intervals (after three initial monthly doses) and were able to shorten or extend dosing intervals if pre-specified criteria were met.

The longer-term data among aflibercept 8 mg patients who completed the trial demonstrated that the vast majority of patients were able to maintain or further extend these dosing intervals through two years with:

EYLEA HD (aflibercept) 8 mg

In August 2023, the FDA approved the BLA for EYLEA HD for the treatment of patients with wAMD, DME, and DR.

Previously, in June 2023, the FDA issued a CRL for the EYLEA HD BLA.

With the approval of EYLEA HD, the pre-approval inspection issues related to the BLA had been addressed.

In June 2023 and August 2023, the Company announced top-line, two-year (96 weeks) data for EYLEA HD from the pivotal PHOTON trial in patients with DME and the pivotal PULSAR trial in patients with wAMD, respectively.

In addition, in July 2023, the results from the PHOTON trial were presented at the American Society of Retina Specialists annual meeting.

During both trials, EYLEA HD patients were initially randomized to either 12- or 16-week dosing intervals (after three initial monthly doses) and were able to shorten or extend dosing intervals if pre-specified criteria were met.

The longer-term data among EYLEA HD patients who completed the trials demonstrated that the vast majority of patients were able to maintain or further extend these dosing intervals through two years with:

• 89% maintaining ≥12-week dosing intervals through two years, compared to 93% through one year (48 weeks)

1 unchanged sentence

• 44% meeting the criteria for ≥20-week dosing intervals by week 96, including 17% and 27% who were eligible for 20- and 24-week dosing intervals, respectively

The visual gains for aflibercept 8 mg remained consistent with the first year of the trial.

In PHOTON, the safety of aflibercept 8 mg also continued to be similar to EYLEA through two years and remained consistent with the known safety profile of EYLEA from previous clinical trials for DME.

In May 2023, Bayer announced that it initiated a Phase 3 study to evaluate the efficacy and safety of aflibercept 8 mg at extended dosing intervals compared to the standard of care, EYLEA, in RVO to support potential future regulatory submissions outside the United States.

• 88% on a ≥12-week dosing interval at the end of two years

• 78% maintaining ≥12-week dosing intervals through two years, compared to 83% throughout the first year of study (48 weeks)

• 71% meeting the extension criteria for even longer dosing intervals, including 47% for ≥20-week intervals and 28% for 24-week intervals

• those assigned to ≥16-week dosing regimen at baseline, 70% maintaining ≥16-week dosing intervals throughout the two-year study period;

at the end of two years, 78% were eligible for ≥16-week dosing, with 53% eligible for ≥20-dosing week intervals.

The visual gains for EYLEA HD remained consistent with the first year of the trials.

In both PHOTON and PULSAR, the safety of EYLEA HD also continued to be similar to EYLEA through two years and remained consistent with the known safety profile of EYLEA from previous clinical trials for DME and wAMD.

In May 2023, Bayer announced that it initiated a Phase 3 study to evaluate the efficacy and safety of EYLEA HD at extended dosing intervals compared to the standard of care, EYLEA, in RVO to support potential future regulatory submissions outside the United States.

In March 2023, the Company and Sanofi announced that the primary and all key secondary endpoints were met in the BOREAS trial (the first of two Phase 3 trials) in adults currently on maximal standard-of-care inhaled therapy (triple therapy) with uncontrolled COPD and evidence of type 2 inflammation.

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The safety results were generally consistent with the known safety profile of Dupixent in its approved indications.

Based on recent feedback from the FDA, in addition to the positive results of the BOREAS study, a positive interim analysis of the replicate Phase 3 NOTUS study would enable an sBLA submission.

The independent data monitoring committee will conduct an interim analysis of the NOTUS study later this year.

In October 2023, the FDA issued a CRL for the sBLA for Dupixent in CSU.

The CRL states that additional efficacy data are required to support an approval;

it did not identify any issues with safety or manufacturing.

An ongoing Phase 3 clinical trial (in biologic-naïve patients) continues to enroll patients, with results expected in late 2024.

In the ongoing Phase 1 study of REGN5678, the Company has observed antitumor activity in combination with Libtayo as well as with REGN5678 monotherapy.

Due to the emerging safety profile, including two immune-mediated Grade 5 adverse events (death), one of which occurred in July 2023, the Company has discontinued enrollment of patients receiving the combination of REGN5678 and full-dose Libtayo.

The Company plans to explore REGN5678 combinations with lower doses of Libtayo.

The Company also plans to enroll patients in a REGN5678 monotherapy cohort, as well as in combination with other immunotherapy modalities.

In April 2023, the Company and Alnylam Pharmaceuticals, Inc.

reported positive interim data from the single dose portion of the Phase 1 study of ALN-APP in early-onset Alzheimer’s disease.

Alnylam announced incremental data at the 2023

Alzheimer’s Association International Conference ("AAIC") in July 2023.

The Phase 1 trial is ongoing, with safety and efficacy trends to be further evaluated as more data are gathered.

As described in the "Collaboration, License, and Other Agreements - Alnylam" section below, Alnylam is eligible to receive a $100.0 million development milestone from us upon achieving specified clinical proof-of-principle criteria for a central nervous system ("CNS") program (including the ALN-APP program).

Due to the emerging safety profile, including two immune-mediated Grade 5 adverse events (death), one of which occurred in July 2023, the Company discontinued enrollment of patients receiving the combination of REGN5678 and full-dose Libtayo (cemiplimab).

The Company has since expanded enrollment in a REGN5678 monotherapy cohort and plans to explore REGN5678 combinations with lower doses of cemiplimab, as well as in combination with other immunotherapy modalities.

Collaboration, License, and Other Agreements

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In 2022, we earned two additional $50.0 million sales-based milestones, upon aggregate annual sales of antibodies outside the United States (including Praluent) exceeding $2.0 billion and $2.5 billion, respectively, on a rolling twelve-month basis.

We are entitled to receive the final sales milestone payment of $50.0 million when such sales outside the United States exceed $3.0 billion on a rolling twelve-month basis.

During the three months ended September 30, 2023, the Company earned the final $50.0 million sales-based milestone from Sanofi, upon aggregate annual sales of antibodies outside the United States (including Praluent) exceeding $3.0 billion on a rolling twelve-month basis.

Immuno-Oncology

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In connection with the A&R IO LCA, in 2022, the Company made a $900.0 million up-front payment to Sanofi, as well as a $100.0 million regulatory milestone payment.

In addition, Sanofi earned a $65.0 million sales-based milestone upon the achievement of a specified amount of worldwide net product sales of Libtayo in 2022 and is eligible to receive an additional $35.0 million sales-based milestone upon the achievement of a specified amount of worldwide net product sales of Libtayo in 2023.

In addition, Sanofi was eligible to earn an aggregate of $100.0 million in Libtayo sales-based milestones under the terms of the A&R IO LCA, of which they earned $65.0 million in 2022 and $35.0 million in 2023.

We 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.

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.

Under the Amended and Restated Immuno-oncology Discovery and Development Agreement, we were obligated to reimburse Sanofi for half of the development costs it funded that were attributable to clinical development of product candidates 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 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.

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

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

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

In 2019, we and Alnylam entered into a global, strategic collaboration to discover, develop, and commercialize RNAi therapeutics for a broad range of diseases by addressing therapeutic disease targets expressed in the eye and central nervous system, in addition to a select number of targets expressed in the liver.

In 2019, we and Alnylam Pharmaceuticals, Inc.

entered into a global, strategic collaboration to discover, develop, and commercialize RNAi therapeutics for a broad range of diseases by addressing therapeutic disease targets expressed in the eye and central nervous system ("CNS"), in addition to a select number of targets expressed in the liver.

In connection with the collaboration, the Company made an up-front payment of $400.0 million to Alnylam, and also purchased shares of Alnylam common stock for $400.0 million.

For each program, we provide Alnylam with a specified amount of funding at program initiation and at lead candidate designation, and Alnylam is eligible to receive two $100.0 million clinical proof-of-principle milestones for each of the eye and CNS programs (an aggregate of $200.0 million in development milestones).

Under the terms of the collaboration, the parties plan to perform discovery research until designation of lead candidates.

For each program, we provide Alnylam with a specified amount of funding at program initiation and at lead candidate designation.

During the three months ended September 30, 2023, the Company became obligated to pay Alnylam a $100.0 million development milestone upon the achievement of specified proof-of-principle criteria for the ALN-APP program.

Alnylam is eligible to receive an additional $100.0 million clinical proof-of-principle milestone in connection with an eye program.

Under the terms of the collaboration, the parties perform discovery research until designation of lead candidates.

Following designation of a lead candidate, the parties may further advance such lead candidate under either a co-development/co-commercialization collaboration agreement ("Co-Co Collaboration Agreement") (under which the parties are advancing ALN-APP and ALN-PNP, which are currently in clinical development) or a license agreement ("License Agreement") structure.

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

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, as well as on whether we are able to obtain regulatory approval for aflibercept 8 mg and are successful in commercializing it.

In September 2023, we further expanded our existing collaboration to develop additional in vivo CRISPR-based gene editing therapies focused on neurological and muscular diseases.

Intellia will lead the design of the editing methodology, we will lead the design of the targeted viral vector delivery approach, and the parties share costs equally.

Each company will have the opportunity to lead potential development and commercialization of product candidates for one target, and the company that is not leading development and commercialization will have the option to enter into a co-development and co-commercialization agreement for the target.

In October 2023, we elected to extend the period for selecting targets under the 2016 license and collaboration agreement for an additional two years until April 2026;

as a result, we became obligated to make a $30.0 million extension payment to Intellia.

In 2017, we entered into an agreement with Decibel Therapeutics, Inc.

to discover and develop new potential therapeutics to protect, repair and restore hearing (including DB-OTO, which is currently in clinical development, and preclinical programs for GJB2-related and stereocilin-related hearing loss).

In August 2023, we entered into an Agreement and Plan of Merger to acquire Decibel, and in September 2023, we completed the acquisition of Decibel.

We paid $101.3 million in cash (or $4.00 per share of Decibel common stock).

In addition, Decibel shareholders received one non-tradeable contingent value right ("CVR") per share of Decibel common stock, which entitles the holder to receive up to $3.50 per share in cash upon achievement of certain clinical development and regulatory milestones for DB-OTO within specified time periods.

The maximum aggregate amount that holders of the CVRs may be entitled to receive if all the milestones contemplated by the CVRs are achieved is approximately $97 million.

In August 2023, we expanded our Other Transaction Agreement ("OTA") with BARDA, pursuant to which the HHS is obligated to fund up to 70% of our costs incurred for certain development activities related to a next-generation COVID-19 monoclonal antibody therapy for the prevention of SARS-CoV-2 infection.

The agreement could result in payments to the Company of up to approximately $326 million in the aggregate to support clinical development, clinical manufacturing, and the regulatory licensure process.

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, as well as whether we are successful in commercializing EYLEA HD.

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.

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.

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

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

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

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

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

We encourage investors and other interested parties to review the information we may publish through our media and investor relations website and the social media channels listed on our media and investor relations website, in addition to our SEC filings, press releases, conference calls, and webcasts.

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Results of Operations

Three and Six Months Ended June 30, 2023 and 2022

Three and Nine Months Ended September 30, 2023 and 2022

Three Months Ended

June 30, Six Months Ended

September 30, Nine Months Ended

September 30,

(In millions, except per share data) 2023 2022 2023 2022

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Three Months Ended

June 30, Six Months Ended

September 30, Nine Months Ended

September 30,

(In millions) 2023 2022 $ Change 2023 2022 $ Change

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$ 1,448.2 $ 1,629.4 $ (181.2) $ 4,382.1 $ 4,768.2 $ (386.1)

EYLEA HD - U.S.

Libtayo - U.S.

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Net Product Sales

Net product sales of EYLEA in the United States decreased for the three and six months ended June 30, 2023, compared to the same periods in 2022, primarily due to a lower net selling price resulting from increased competition.

Net product sales of EYLEA in the United States decreased for the three and nine months ended September 30, 2023, compared to the same periods in 2022, primarily due to a lower net selling price resulting from increased competition.

In August 2023, the FDA approved EYLEA HD for the treatment of patients with wAMD, DME, and DR.

As described in "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.

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Three Months Ended

June 30, Six Months Ended

September 30, Nine Months Ended

September 30,

(In millions) 2023 2022 2023 2022

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Total Antibody 1,064.5 711.4 2,806.6 2,008.5

Total Immuno-oncology — 6.5 — 11.3

Total Immuno-oncology (b)

Total Sanofi collaboration revenue $ 1,064.5 $ 711.4 $ 2,806.6 $ 2,019.8

(a) Corresponding costs incurred by the Company in connection with such production is recorded within Cost of collaboration and contract manufacturing.

Global net product sales of Dupixent and Kevzara are recorded by Sanofi in connection with the Antibody Collaboration.

(b) As the A&R IO LCA became effective July 1, 2022, the three months ended June 30, 2022 was the last period in which Sanofi collaboration revenue was recognized in connection with the IO Collaboration.

Global net product sales of Dupixent and Kevzara are recorded by Sanofi in connection with the Antibody Collaboration, and we and Sanofi share profits on such sales.

As described above under "Collaboration, License, and Other Agreements - Sanofi - Antibody ", on July 1, 2022, an amendment to the LCA 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 six months ended June 30, 2023, compared to the same periods in 2022, was driven by higher profits associated with Dupixent sales, partly offset by the impact of the amendment to the LCA.

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) 2023 2022 2023 2022

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(132.6) (78.7) (314.2) (180.7)

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

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Regeneron's share of collaboration profits as a percentage of Dupixent and Kevzara net product sales 27% 23% 26% 22%

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.

As the A&R IO LCA became effective July 1, 2022, the three months ended June 30, 2022 was the last period in which Sanofi collaboration revenue was recognized in connection with the IO Collaboration.

The increase in our share of profits in connection with commercialization of antibodies during the three and nine months ended September 30, 2023, compared to the same periods in 2022, was driven by higher profits associated with Dupixent sales, partly offset by the impact of the amendment to the LCA.

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.

Bayer Collaboration Revenue

Three Months Ended

June 30, Six Months Ended

September 30, Nine Months Ended

September 30,

(In millions) 2023 2022 2023 2022

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Three Months Ended

June 30, Six Months Ended

September 30, Nine Months Ended

September 30,

(In millions) 2023 2022 2023 2022

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Three Months Ended

June 30, Six Months Ended

September 30, Nine Months Ended

September 30,

(In millions) 2023 2022 2023 2022

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Roche distributes and records net product sales of Ronapreve outside the United States, and the parties share gross profits from worldwide sales.

Other Revenue

Other revenue during the three and nine months ended September 30, 2023 included the recognition of $34.2 million of revenue in connection with our August 2023 agreement with BARDA to fund certain costs for a next-generation COVID-19 monoclonal antibody therapy for the prevention of SARS-CoV-2 infection.

Three Months Ended

June 30, Six Months Ended

September 30, Nine Months Ended

September 30,

(In millions, except headcount data) 2023 2022 Change 2023 2022 Change

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(a) Includes costs incurred net of any cost reimbursements from collaborators who are not deemed to be our customers

(b) Includes costs we incur in connection with producing commercial drug supplies for collaborators and others

Operating expenses included stock-based compensation of $202.0 million and $159.8 million for the three months ended June 30, 2023 and 2022, respectively, and $440.7 million and $326.7 million for the six months ended June 30, 2023 and 2022, respectively.

(b) Includes costs incurred in connection with producing commercial drug supplies for collaborators and others

Operating expenses included stock-based compensation of $203.9 million and $166.3 million for the three months ended September 30, 2023 and 2022, respectively, and $644.6 million and $493.0 million for the nine months ended September 30, 2023 and 2022, respectively.

Stock-based compensation expense relates to equity awards granted under our long-term incentive plans.

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Three Months Ended

June 30, Six Months Ended

September 30, Nine Months Ended

September 30,

(In millions) 2023 2022 *

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Dupixent (dupilumab) $ 32.7 $ 37.1 $ (4.4) $ 132.0 $ 109.3 $ 22.7

Aflibercept 8 mg 27.9 13.6 14.3 53.6 33.8 19.8

Linvoseltamab 26.3 11.7 14.6 41.1 17.1 24.0

Libtayo (cemiplimab) 25.4 37.2 (11.8) 58.3 75.8 (17.5)

Odronextamab 19.6 13.9 5.7 41.8 25.3 16.5

Fianlimab 27.6 8.9 18.7 80.5 16.9 63.6

Odronextamab 24.9 17.5 7.4 66.6 42.9 23.7

Libtayo (cemiplimab) 23.9 31.3 (7.4) 82.2 107.1 (24.9)

Linvoseltamab 23.3 12.4 10.9 64.3 29.5 34.8

22.0 13.2 8.8 54.1 11.6 42.5

19.9 17.6 2.3 42.6 35.0 7.6

EYLEA HD (aflibercept) 8 mg

18.3 10.8 7.5 71.9 44.6 27.3

Other product candidates in clinical development and other research programs

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

Total research and development expenses increased for the three and six months ended June 30, 2023, compared to the same periods in 2022, partially due to the impact of the amendments to the Sanofi collaboration agreements (which were effective July 1, 2022) described under the "Collaboration, License, and Other Agreements" section above, as (i) Sanofi is no longer reimbursing us for 50% of Libtayo development costs (such reimbursements were previously included in Reimbursement of research and development expenses by collaborators in the table above) and (ii) we recognize our 50% share of research and development expenses in connection with the Sanofi Antibody Collaboration.

Clinical manufacturing costs for the three and six months ended June 30, 2023 increased due to manufacturing activity associated with our earlier-stage product candidates.

Research and development expenses included stock-based compensation expense of $109.1 million and $89.7 million for the three months ended June 30, 2023 and 2022, respectively, and $248.6 million and $182.1 million for the six months ended June 30, 2023 and 2022, respectively.

Total research and development expenses increased for the nine months ended September 30, 2023, compared to the same period in 2022, partially due to the impact of the amendments to the Sanofi collaboration agreements (which were effective July 1, 2022) described under the "Collaboration, License, and Other Agreements" section above, as (i) Sanofi is no longer reimbursing us for 50% of Libtayo development costs (such reimbursements were previously included in Reimbursement of research and development expenses by collaborators in the table above) and (ii) we recognize our 50% share of research and development expenses in connection with the Sanofi Antibody Collaboration.

Research and development expenses included stock-based compensation expense of $107.4 million and $93.7 million for the three months ended September 30, 2023 and 2022, respectively, and $356.0 million and $275.8 million for the nine months ended September 30, 2023 and 2022, 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 six months ended June 30, 2023 included a $45.0 million up-front payment in connection with our collaboration agreement with Sonoma Biotherapeutics, 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 Pharmaceuticals, Inc.

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 three months ended September 30, 2023 was related to a $100.0 million charge in connection with a development milestone for the Phase 1 ALN-APP program which is in collaboration with Alnylam.

In addition to this Alnylam development milestone, Acquired IPR&D for the nine months ended September 30, 2023 also included a $45.0 million up-front payment in connection with our collaboration agreement with Sonoma Biotherapeutics, Inc.

Acquired IPR&D for the nine months ended September 30, 2022 included a $195.0 million charge related to our acquisition of Checkmate Pharmaceuticals, Inc and 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, 2023, compared to the same periods in 2022, primarily due to an increase in commercialization-related expenses and integration costs for Libtayo outside the United States (as effective July 1, 2022, the Company became solely responsible for the commercialization of Libtayo worldwide), higher headcount and headcount-related costs, and higher contributions to an independent not-for-profit patient assistance organization.

Selling, general, and administrative expenses included stock-based compensation expense of $73.3 million and $57.5 million for the three months ended June 30, 2023 and 2022, respectively, and $150.1 million and $118.2 million for the six months ended June 30, 2023 and 2022, respectively.

Selling, general, and administrative expenses increased for the three and nine months ended September 30, 2023, compared to the same periods in 2022, primarily due to higher headcount and headcount-related costs and higher contributions to an independent not-for-profit patient assistance organization.

Selling, general, and administrative expenses also increased for the nine months ended September 30, 2023 due to higher commercialization-related expenses and integration costs for Libtayo outside the United States (as effective July 1, 2022, the Company became solely responsible for the commercialization of Libtayo worldwide).

Selling, general, and administrative expenses included stock-based compensation expense of $74.4 million and $59.8 million for the three months ended September 30, 2023 and 2022, respectively, and $224.5 million and $178.0 million for the nine months ended September 30, 2023 and 2022, respectively.

Cost of Collaboration and Contract Manufacturing

Cost of collaboration and contract manufacturing increased for the three and six months ended June 30, 2023, compared to the same periods in 2022, primarily due to the recognition of costs in connection with manufacturing commercial supplies of Dupixent.

Cost of collaboration and contract manufacturing for the six months ended June 30, 2023 also increased due to the recognition of costs in connection with manufacturing commercial supplies for Sanofi related to Praluent outside the United States.

Cost of collaboration and contract manufacturing increased for the nine months ended September 30, 2023, compared to the same period in 2022, primarily due to the recognition of costs in connection with manufacturing commercial supplies for Sanofi related to Dupixent, Praluent outside the United States, and for Bayer related to EYLEA outside the United States.

Other Operating (Income) Expense

Other operating (income) expense, net, for the three and six months ended June 30, 2022 included recognition of amounts previously deferred in connection with up-front and development milestone payments, as applicable, received in connection with our Sanofi IO, Teva, and Mitsubishi Tanabe Pharma Corporation ("MTPC") collaborative arrangements.

Other operating (income) expense, net, for the nine months ended September 30, 2022 included recognition of amounts previously deferred in connection with up-front and development milestone payments, as applicable, received in connection with our Sanofi IO, Teva, and Mitsubishi Tanabe Pharma Corporation ("MTPC") collaborative arrangements.

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, the three months ended June 30, 2022 was the last period in which such amounts were recognized in connection with our Sanofi IO Collaboration.

In addition, during the three months ended September 30, 2022, the Company discontinued further clinical development of fasinumab, and, as a result, we deemed our obligation to provide development services in connection with the Teva and MTPC collaborative arrangements to be complete.

Other Income (Expense)

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Three Months Ended

June 30, Six Months Ended

September 30, Nine Months Ended

September 30,

(In millions) 2023 2022 2023 2022

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Total other income (expense) $ (0.2) $ 286.1 $ (22.5) $ (58.0)

The increase in interest income for the three and nine months ended September 30, 2023, compared to the same periods in 2022, was primarily driven by higher interest rates.

Three Months Ended

June 30, Six Months Ended

September 30, Nine Months Ended

September 30,

(In millions, except effective tax rate) 2023 2022 2023 2022

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9.3 % 12.9 % 8.4 % 11.1 %

The Company's effective tax rate for the three and six months ended June 30, 2023 was positively impacted, compared to the U.S.

The Company's effective tax rate for the three and nine months ended September 30, 2023 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.

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Our financial condition is summarized as follows:

June 30, December 31,

September 30, December 31,

(In millions) 2023 2022 $ Change

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Finance lease liabilities $ 720.0 $ 720.0 $ —

As of June 30, 2023, 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, 2023 and 2022

Six Months Ended

As of September 30, 2023, 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, 2023 and 2022

Nine Months Ended

September 30,

(In millions) 2023 2022 $ Change

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Cash Flows from Investing Activities

Capital expenditures during the six months ended June 30, 2023 included costs incurred in connection with the expansion of our Tarrytown, New York campus, as well 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).

Additionally, capital expenditures for the six months ended June 30, 2023 is net of grant proceeds of $60.0 million primarily related to the expansion of our facilities in New York.

Capital expenditures during the nine months ended September 30, 2023 included costs incurred in connection with the expansion of our Tarrytown, New York campus, as well 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).

Additionally, capital expenditures for the nine months ended September 30, 2023 is net of grant proceeds of $60.0 million primarily related to the expansion of our facilities in New York.

We expect to incur capital expenditures of $660 million to $700 million for the full year of 2023 primarily in connection with the continued expansion of our research, preclinical manufacturing, and support facilities at our Tarrytown campus and our Rensselaer manufacturing facility (including the fill/finish facility).

Payments for Libtayo intangible asset of $121.8 million during the six months ended June 30, 2023 were related to contingent consideration in connection with 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 six months ended June 30, 2022 was related to our acquisition of Checkmate.

Payments for Libtayo intangible asset of $145.7 million during the nine months ended September 30, 2023 were related to contingent consideration in connection with 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).

Payments for Libtayo intangible asset of $926.8 million during the nine months ended September 30, 2022 were related to our acquisition of the Libtayo rights as described above.

Acquisitions, net of cash acquired, of $51.1 million during the nine months ended September 30, 2023 was related to our acquisition of Decibel (as described in "Collaboration, License, and Other Agreements - Decibel " above).

Acquisitions, net of cash acquired, of $230.3 million during the nine months ended September 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 $575.9 million during the six months ended June 30, 2023, compared to $828.4 million during the six months ended June 30, 2022.

Proceeds from issuances of Common Stock, in connection with exercises of employee stock options, were $844.5 million during the nine months ended September 30, 2023, compared to $1.147 billion during the nine months ended September 30, 2022.

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

7 unchanged sentences

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

As of June 30, 2023, $2.332 billion remained available for share repurchases under the program.

As of September 30, 2023, $1.826 billion remained available for share repurchases under the program.

The table below summarizes the shares of our Common Stock we repurchased and the cost of the shares, which were recorded as Treasury Stock.

Six Months Ended

Nine Months Ended

September 30,

(In millions) 2023 2022

4 unchanged sentences

"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, 2022 (filed February 6, 2023).

There have been no material changes to critical accounting estimates during the six months ended June 30, 2023.

There have been no material changes to critical accounting estimates during the nine months ended September 30, 2023.

Future Impact of Recently Issued Accounting Standards

As of June 30, 2023, 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, 2023, 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