What changed in this filing

/stocks — the workspaceLOADING

Item 2. Management’s Discussion and Analysis

2024-05-02 compared with 2023-11-02 · 213 added, 378 removed, 380 unchanged (61% 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, 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;

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 those discussed or referenced in this report, 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;

• safety issues resulting from the administration of Regeneron's Products and Regeneron's Product Candidates in patients, including serious complications or side effects in connection with the use of Regeneron's Products and Regeneron's Product Candidates in clinical trials;

the likelihood, timing, and scope of possible regulatory approval and commercial launch of our late-stage product candidates and new indications for Regeneron's Products, including without limitation those listed above;

• the likelihood, timing, and scope of possible regulatory approval and commercial launch of our late-stage product candidates and new indications for Regeneron's Products, including without limitation those discussed or referenced in this report;

• the extent to which the results from the research and development programs conducted by us and/or our collaborators may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval;

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• the impact of public health outbreaks, epidemics, or pandemics (such as the COVID-19 pandemic) on our business;

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 11 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 11 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.

• 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 11 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 11 to our Condensed Consolidated Financial Statements included in this report), the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on our business, prospects, operating results, and financial condition.

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

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

In evaluating such statements, shareholders and potential investors should specifically consider the various

factors identified under Part II, Item 1A.

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

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Three Months Ended

September 30, Nine Months Ended

September 30,

(In millions, except per share data) 2024 2023

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Product Disease Territory

EYLEA (aflibercept) Injection (a)

EYLEA ® HD (aflibercept) Injection 8 mg (a)

Wet age-related macular degeneration ("wAMD")

Diabetic macular edema ("DME") a a a

Diabetic macular edema ("DME")

Diabetic retinopathy ("DR")

EYLEA ® (aflibercept) Injection (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

Diabetic retinopathy ("DR") a

Neovascular glaucoma ("NVG") a

Retinopathy of prematurity ("ROP")

EYLEA HD (aflibercept) Injection 8 mg (a)

Dupixent ® (dupilumab) Injection (b)

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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

Dupixent (dupilumab) Injection (b) (continued)

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

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

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

EoE (in pediatrics 1–11 years of age)

Prurigo nodularis a a a

Libtayo (cemiplimab) Injection (c)

Chronic spontaneous urticaria ("CSU") (in adults and adolescents)

Libtayo ® (cemiplimab) Injection

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

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Metastatic or recurrent second-line cervical cancer

Praluent (alirocumab) Injection (d)

Praluent ® (alirocumab) Injection (c)

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

HeFH in pediatrics and adolescents (8–17 years of age)

Cardiovascular risk reduction in patients with established cardiovascular disease a a

Homozygous familial hypercholesterolemia ("HoFH") a

REGEN-COV ®(e)

Kevzara (sarilumab) Injection (b)

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Polymyalgia rheumatica ("PMR")

Evkeeza (evinacumab) Injection (f)

HoFH (in adults and adolescents) a a

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

REGEN-COV ®(d)

Evkeeza ® (evinacumab) Injection (e)

HoFH (in adults, adolescents, and pediatrics aged 5 years and older)

Inmazeb ® (atoltivimab, maftivimab, and odesivimab) Injection

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

ARCALYST ® (rilonacept) Injection (g)

ARCALYST ® (rilonacept) Injection (f)

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

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Recurrent pericarditis (in adults and adolescents)

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

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

Metastatic colorectal cancer ("mCRC") a a a

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(a) In collaboration with Bayer outside the United States.

Aflibercept 8 mg is known as EYLEA HD in the United States and EYLEA 8 mg in other countries.

(b) In collaboration with Sanofi

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

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

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

(e) In collaboration with Roche.

(c) 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 the United States.

(d) 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.

(e) 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 the United States.

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

(g) 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,

2024 2023 % Change

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ROW Total (Total Sales)

$ 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 %

$ 144.1 $ 88.3 $ 232.4 $ 94.7 $ 48.5 $ 143.2 62 %

$ 40.4 $ 125.1 $ 165.5 $ 29.7 $ 84.0 $ 113.7 46 %

REGEN-COV (e)

$ — $ — $ — $ — $ 22.8 $ 22.8 (100 %)

$ 52.4 $ 43.3 $ 95.7 $ 53.1 $ 35.0 $ 88.1 9 %

Other products (f)

EYLEA HD and EYLEA (a)

$ 1,401.6 $ 849.4 $ 2,251.0 $ 1,433.8 $ 847.1 $ 2,280.9 (1 %)

Nine Months Ended

September 30,

2023 2022 % Change

(In millions) U.S.

ROW Total U.S.

ROW Total (Total Sales)

$ 2,218.0 $ 858.8 $ 3,076.8 $ 1,898.1 $ 586.9 $ 2,485.0 24 %

$ 42.7 $ — $ 42.7 $ — $ — $ — (h)

$ 159.2 $ 104.7 $ 263.9 $ 109.7 $ 72.9 $ 182.6 45 %

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$ — $ 1.2 $ 1.2 $ — $ 613.2 $ 613.2 (100 %)

$ 148.5 $ 125.2 $ 273.7 $ 153.1 $ 123.7 $ 276.8 (1 %)

Other products (f)

$ 25.3 $ 17.7 $ 43.0 $ 18.1 $ 16.5 $ 34.6 24 %

(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.

The Company records its share of profits/losses in connection with sales of EYLEA outside the United States.

(b) Sanofi records global net product sales of Dupixent and Kevzara.

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

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

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

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

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

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).

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

The Company records its share of profits in connection with sales outside the United States.

(b) Sanofi records global net product sales of Dupixent and Kevzara, and the Company records its share of profits in connection with global sales of such products.

(c) 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.

Included in this line item for the first quarter of 2023 is approximately $6 million of 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).

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

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

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

The parties share gross profits from global sales of REGEN-COV and Ronapreve based on a pre-specified formula.

(e) Roche records net product sales outside the United States and the parties share gross profits from sales based on a pre-specified formula.

(f) Included in this line item are products which are sold by the Company and others.

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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 $54 million for the second quarter of 2023.

net product sales of ARCALYST were $71 million for the fourth quarter of 2023.

(g) Rest of world ("ROW")

(h) Percentage not meaningful

Programs in Clinical Development

Product candidates in clinical development, which are being developed by us and/or our collaborators, are summarized in the table below.

Product candidates in Phase 2 and Phase 3 clinical development, which are being developed by us and/or our collaborators, are summarized in the table below.

There are numerous uncertainties associated with drug development, including uncertainties related to safety and efficacy data from each phase of drug development (including any post-approval studies), uncertainties related to the enrollment and performance of clinical trials, changes in regulatory requirements, changes to drug pricing and reimbursement regulations and requirements, and changes in the competitive landscape affecting a product candidate.

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Any of such risks and uncertainties may, among other matters, negatively impact the development timelines set forth in the table below.

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

2023 Events to Date Select Upcoming Milestones

Clinical Program Phase 2 Phase 3 Regulatory

2024 Events to Date

Select Upcoming

Ophthalmology

EYLEA HD (aflibercept) 8 mg (a)

–wAMD and DME (EU and Japan)

–Approved by U.S.

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

–Approved by European Commission ("EC") and Japan's Ministry of Health, Labour and Welfare ("MHLW") for wAMD and DME

–Initiate Phase 3 study in RVO (mid-2024) to enable U.S.

Food and Drug Administration ("FDA") submission

–Submit supplemental Biologics License Application ("sBLA") with two-year data for wAMD and DME (mid-2024)

Pozelimab (f) (REGN3918)

Antibody to C5

–Initiate Phase 3 study in combination with cemdisiran in geographic atrophy (second half 2024)

Immunology & Inflammation

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–Eosinophilic gastroenteritis (Phase 2/3)

–EoE in pediatrics (c)

–Asthma in pediatrics (2–5 years of age)

–Chronic obstructive pulmonary disease

–Bullous pemphigoid (c)

–Chronic spontaneous urticaria ("CSU")

–Chronic pruritus of unknown origin

–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

–Approved by MHLW for prurigo nodularis

–Reported that Phase 3 trial in COPD with evidence of type 2 inflammation met its primary and all key secondary endpoints;

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

–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)

–EoE in pediatrics (1–11 years of age) (EU)

–COPD with type 2 inflammatory phenotype (U.S., EU, and Japan)

–CSU in adults and adolescents (EU)

–Approved by FDA for EoE in pediatrics (1–11 years of age)

–Approved by MHLW for CSU in adults and adolescents

–EC decision on regulatory submission for EoE in pediatrics (second half 2024)

–FDA decision on sBLA (target action date of June 27, 2024) and EC decision on regulatory submission (second half 2024) for COPD with type 2 inflammatory phenotype

–EC decision on regulatory submission for CSU in adults and adolescents (first half 2025)

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

–Report results from Phase 3 trial in bullous pemphigoid (second half 2024)

Clinical Program (continued)

Phase 1 Phase 2 Phase 3 Regulatory Review (h)

2023 Events to Date Select Upcoming Milestones

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

Phase 2 Phase 3 Regulatory

2024 Events to Date

Select Upcoming

Kevzara (sarilumab) (b)

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

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

–Approved by FDA for PMR

–Systemic juvenile idiopathic arthritis ("sJIA") (pivotal study) –PMR (EU)

–EC decision on regulatory submission for PMR (second half 2024)

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

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Antibody to IL-33

–Phase 3 COPD program passed interim futility analysis conducted by Independent Data Monitoring Committee ("IDMC")

–Non-cystic fibrosis bronchiectasis ("NCFB")

–Report results from Phase 3 study in COPD (2025)

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–Neoadjuvant CSCC

–First-line NSCLC, BNT116 (r) combination

–First-line NSCLC, BNT116 (i) combination

–Neoadjuvant hepatocellular carcinoma ("HCC")

–Adjuvant CSCC

–Approved by EC for first-line NSCLC, chemotherapy combination

Clinical Program (continued)

Phase 1 Phase 2 Phase 3 Regulatory Review (h)

2023 Events to Date Select Upcoming Milestones

–Conduct interim analysis from Phase 3 study in adjuvant CSCC (second half 2024)

Fianlimab (f) (REGN3767)

Antibody to LAG-3

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

–First-line advanced NSCLC (Phase 2/3) (pivotal study)

–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 potentially pivotal Phase 2 study (in combination with Libtayo) in perioperative melanoma (first half 2024)

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

–Initiate Phase 2 study (in combination with Libtayo) in perioperative head and neck squamous cell carcinoma (2025)

–Initiate Phase 3 study (in combination with Libtayo) in first-line metastatic melanoma versus the combination of relatlimab and nivolumab (second half 2024)

Clinical Program (continued)

Phase 2 Phase 3 Regulatory

2024 Events to Date

Select Upcoming

Fianlimab (f) (REGN3767)

–Report results from Phase 3 study in first-line metastatic melanoma (2025)

–Report initial data from Phase 2/3 study in first-line advanced NSCLC (second half 2024)

Immune activator targeting TLR9

–Solid tumors

–Solid tumors –Company paused enrollment in Phase 2 study related to drug supply

Ubamatamab (f) (REGN4018)

Bispecific antibody targeting MUC16 and CD3

–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

–Platinum-resistant ovarian cancer

Bispecific antibody targeting PSMA and CD28

–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)

Nezastomig (REGN5678)

Bispecific antibody targeting PSMA and CD28

–Prostate cancer

Davutamig (REGN5093)

Bispecific antibody targeting two distinct MET epitopes

–MET-altered advanced NSCLC

REGN5093-M114

Bispecific antibody-drug conjugate targeting two distinct MET epitopes

–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

–Solid tumors

–Initiate cohorts in combination with REGN4336 (PSMAxCD3) in metastatic castration-resistant prostate cancer (first half 2024)

Bispecific antibody targeting EGFR and CD28

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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)

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

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

Odronextamab (m) (REGN1979)

Bispecific antibody targeting CD20 and CD3

–Certain B-cell malignancies (c)

–B-cell non-Hodgkin lymphoma

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–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

–Relapsed/refractory FL and DLBCL (EU)

–FDA issued Complete Response Letters ("CRLs") for BLA for relapsed/refractory FL and DLBCL due to enrollment status of confirmatory Phase 3 trials

–EC decision on Marketing Authorization Application ("MAA") for relapsed/refractory FL and DLBCL (second half 2024)

Linvoseltamab (f) (REGN5458)

Bispecific antibody targeting BCMA and CD3

–Multiple myeloma (c)(e)

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

–Earlier (pre-malignant) multiple myeloma

–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

–Relapsed/refractory multiple myeloma (U.S.

–FDA decision on BLA (target action date of August 22, 2024) and EC decision on MAA (first half 2025) for relapsed/refractory multiple myeloma

Clinical Program (continued)

Phase 1 Phase 2 Phase 3 Regulatory Review (h)

2023 Events to Date Select Upcoming Milestones

Antibody to IL2Rg

–Aplastic anemia

Phase 2 Phase 3 Regulatory

2024 Events to Date

Select Upcoming

NTLA-2001 (j)

TTR gene knockout using CRISPR/Cas9

–Transthyretin ("ATTR") amyloidosis (c)

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

Antibody to Factor XI

–Transthyretin amyloidosis (c) with cardiomyopathy ("ATTR-CM")

Antibody to Factor XI

Antibody to TMPRSS6

–Transfusion dependent iron overload

–Thrombosis –Report results from Phase 2 study in thrombosis (second half 2024)

Internal Medicine/Genetic Medicines

Praluent (alirocumab)

Antibody to PCSK9

–HeFH in pediatrics and adolescents

–HeFH in pediatrics and adolescents (8–17 years of age) (U.S.)

–FDA decision on sBLA for HeFH in pediatrics and adolescents (target action date of March 10, 2024)

Evkeeza (evinacumab) (f)(l)

Antibody to ANGPTL3

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

–HoFH in adults, adolescents, and pediatrics (5–11 years of age) (Japan)

–Approved by FDA for HoFH in pediatrics (5–11 years of age)

Garetosmab (f) (REGN2477)

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

Trevogrumab (f) (REGN1033)

Antibody to myostatin (GDF8)

–Healthy volunteers

–Initiate Phase 2 obesity study of trevogrumab in combination with semaglutide with and without garetosmab (mid-2024)

Mibavademab (f) (REGN4461)

Agonist antibody to leptin receptor ("LEPR")

–Generalized lipodystrophy (e)

–Partial lipodystrophy

Clinical Program (continued)

Phase 1 Phase 2 Phase 3 Regulatory Review (h)

2023 Events to Date Select Upcoming Milestones

REGN5381/REGN9035

Agonist antibody to NPR1/reversal agent to REGN5381

–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

–Generalized lipodystrophy (d)(e)

Agonist antibody to NPR1

–Heart failure

RNAi therapeutic targeting HSD17B13

–Nonalcoholic steatohepatitis

("NASH") –NASH

RNAi therapeutic targeting PNPLA3

RNAi therapeutic targeting APP

–Early-onset Alzheimer’s disease (q)

–Reported positive interim data from single dose part of Phase 1 trial in early-onset Alzheimer’s disease

AAV-based gene therapy

–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)

–Cerebral amyloid angiopathy ("CAA")

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

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

(i) In collaboration with Zai Lab in mainland China, Hong Kong, Taiwan, and Macau

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

(j) In collaboration with Intellia

(k) In collaboration with Alnylam

(l) In collaboration with Ultragenyx outside the United States

(l) 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.

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

(n) Studied in combination with ubamatamab

(n) Company is seeking accelerated approval in the United States

(o) Alnylam elected to opt-out of the product candidate.

Under the terms of our agreement, Alnylam is entitled to receive royalties on sales of the product, if any.

(p) Studied in combination with odronextamab

(q) Part B of the study (multi-dose regimen) has been placed on partial clinical hold in the U.S.

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

(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

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.

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 EYLEA HD.

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)

• 84% maintaining ≥16-week dosing intervals through two years, compared to 89% maintaining a 16-week dosing interval through one year

• 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

• 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.

In this trial, patients receiving Dupixent experienced a 30% reduction in moderate or severe acute COPD exacerbations (rapid and acute worsening of respiratory symptoms) over 52 weeks, while also demonstrating significant improvements in lung function, quality of life, and COPD respiratory symptoms.

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 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.

In 2024, a Phase 1 study of linvoseltamab, in combination with dupilumab, in severe food allergy was initiated.

A Phase 1/2 study of DB-OTO, an AAV-based gene therapy, in children with profound genetic hearing loss due to mutations of the oteoferlin gene is ongoing.

The Company will present updated data from the Phase 1/2 trial at the May 2024 American Society of Gene and Cell Therapy ("ASGCT") annual conference.

Collaboration, License, and Other Agreements

We are collaborating with Sanofi on the global development and commercialization of Dupixent, Kevzara, and itepekimab (the "Antibody Collaboration").

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

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

as of December 31, 2022, the total amount of our contingent reimbursement obligation to Sanofi in connection with such development expenses was approximately $2.9 billion.

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

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

Under the terms of the collaboration, Sanofi is generally responsible for funding 80% to 100% of agreed-upon development costs.

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

however, we are only required to apply 20% of our share of profits from the collaboration each calendar quarter to reimburse Sanofi for these development expenses.

As of March 31, 2024, the total amount of our contingent reimbursement obligation to Sanofi (i.e., "development balance") in connection with such development expenses was approximately $2.200 billion.

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

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We supply certain commercial bulk product to Sanofi.

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

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

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

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.

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

We 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.

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

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

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

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

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 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.

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 (aflibercept) and aflibercept 8 mg outside the United States.

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

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

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

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

Bayer is responsible for commercialization activities outside the United States, and the companies share equally in profits and losses from such sales.

Bayer is responsible for commercialization activities outside the United States, and the companies share equally in profits from such sales.

We are obligated to reimburse Bayer for 50% of the development costs that it has incurred under the agreement from our share of the collaboration profits.

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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.

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.

During 2023, we paid a $100.0 million development milestone to Alnylam upon the achievement of specified proof-of-principle criteria for the ALN-APP program and 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.

The initial target nomination and discovery period is five years (which may under certain situations automatically be extended for up to seven years in the aggregate) (the "Research Term").

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For CNS programs and liver programs, under a Co-Co Collaboration Agreement, the party designated as the lead party will lead development and commercialization of the program and the parties will split profits and share costs equally, subject to certain co-funding opt-outs at specified clinical trial phases or under other conditions.

Alnylam is the lead party for ALN-APP, and we are the lead party for ALN-PNP.

In addition, during 2019, the parties entered a License Agreement for a combination consisting of cemdisiran (a small interfering RNA ("siRNA") therapeutic targeting the C5 component of the human complement pathway being developed by Alnylam) and pozelimab, with us as the licensee.

Under the License Agreement, we as the licensee are responsible for our own costs and expenses.

Alnylam is the lead party for ALN-APP.

Under a license agreement, the lead party is designated as the licensee and has the right to develop and commercialize the collaboration product under such program.

The licensee will be responsible for its own costs and expenses incurred.

licensee will pay to the licensor certain development and/or commercialization milestone payments, as well as certain tiered royalty payments to the licensor based on the aggregate annual net sales of the collaboration product.

The parties have entered into various license agreements, including for a combination consisting of cemdisiran (a small interfering RNA ("siRNA") therapeutic targeting the C5 component of the human complement pathway being developed by Alnylam) and pozelimab, with us as the licensee.

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

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

In 2020, we expanded our existing collaboration with Intellia to provide us with rights to develop products for additional in vivo CRISPR/Cas9-based therapeutic targets and for the companies to jointly develop potential products for the treatment of hemophilia A and B, with Regeneron leading development and commercialization activities.

The collaboration was expanded in 2020 to provide us with rights to develop products for additional in vivo CRISPR/Cas9-based therapeutic targets and for the companies to jointly develop potential products for the treatment of hemophilia A and B, with Regeneron leading development and commercialization activities.

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 to Intellia.

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.

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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 addition, 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 made a $30.0 million extension payment to Intellia.

In March 2024, Intellia elected to opt-out of further development activities pursuant to the Factor IX co-development and co-commercialization agreement;

as a result, we retain the right to develop and commercialize products directed to Factor IX, and Intellia will be entitled to receive milestone payments and royalties on sales (if any).

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.

In August 2023, we acquired Decibel by paying $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, entitling them to receive up to an additional $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.

In 2018, we entered into a collaboration agreement with bluebird bio, Inc.

(which subsequently spun out 2seventy bio, Inc.

in 2021) to research, develop, and commercialize novel cell therapy approaches to address cancer.

In April 2024, we acquired full development and commercialization rights to 2seventy bio's oncology and autoimmune preclinical and clinical stage cell therapy pipeline.

Under the terms of the agreement, we made a $5.0 million up-front payment, and have assumed ongoing program, infrastructure, and personnel costs related to the product candidates acquired.

In addition, we are obligated to pay 2seventy bio a regulatory milestone upon the first major market approval of the first approved product;

and, with respect to any approved product, a low single-digit percent royalty on sales.

Our ability to generate profits and to generate positive cash flow from operations over the next several years depends significantly on the success in commercializing EYLEA HD, EYLEA, and Dupixent.

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.

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

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

Our financial results may fluctuate from quarter to quarter and will depend on, among other factors, the net

sales of our products;

the scope and progress of our research and development efforts;

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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.

We cannot predict whether or when new products or new indications for marketed products will receive regulatory approval or, if any such approval is received, whether we will be able to successfully commercialize such product(s) and whether or when they may become profitable.

Corporate Information

6 unchanged sentences

Results of Operations

Three and Nine Months Ended September 30, 2023 and 2022

Three Months Ended

September 30, Nine Months Ended

September 30,

(In millions, except per share data) 2024 2023

4 unchanged sentences

Income before income taxes 700.7 858.0

Income tax expense 103.0 194.1 257.7 392.8

Income tax (benefit) expense

Net income $ 722.0 $ 817.8

1 unchanged sentence

Three Months Ended

September 30, Nine Months Ended

September 30,

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

(In millions) 2024 2023 $ Change

Net product sales:

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

EYLEA HD - U.S.

$ 200.0 $ — $ 200.0

1,201.6 1,433.8 (232.2)

Total EYLEA HD and EYLEA - U.S.

1,401.6 1,433.8 (32.2)

Libtayo - U.S.

1 unchanged sentence

Libtayo - ROW 104.7 67.2 37.5

Total Libtayo - Global

263.9 176.9 87.0

Praluent - U.S.

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24.8 14.9 9.9

Inmazeb - U.S.

Inmazeb - Global

1.0 2.2 (1.2)

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Total revenues $ 3,145.0 $ 3,162.1 $ (17.1)

* Not meaningful

Net Product Sales

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.

In August 2023, the FDA approved EYLEA HD in the United States.

Net product sales of EYLEA in the United States decreased for the three months ended March 31, 2024, compared to the same period in 2023, primarily due to changing market dynamics, resulting in lower volumes and a lower net selling price.

Collaboration Revenue

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Three Months Ended

September 30, Nine Months Ended

September 30,

(In millions) 2024 2023

Regeneron's share of profits in connection with commercialization of antibodies $ 804.0 $ 636.5

Sales-based milestones earned 50.0 — 50.0 50.0

Reimbursement for manufacturing of commercial supplies (a)

151.5 160.5 506.0 466.8

Other — (0.2) — 28.7

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

Total Immuno-oncology (b)

Total Sanofi collaboration revenue $ 909.8 $ 798.4

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

(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%.

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

Three Months Ended

September 30, Nine Months Ended

September 30,

(In millions) 2024 2023

4 unchanged sentences

(121.9) (74.9)

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

$ 804.0 $ 636.5

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

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.

Regeneron's share of profits as a percentage of Dupixent and Kevzara net product sales

The increase in our share of profits in connection with commercialization of antibodies for the three months ended March 31, 2024, compared to the same periods in 2023, was driven by higher profits associated with Dupixent sales.

Bayer Collaboration Revenue

Three Months Ended

September 30, Nine Months Ended

September 30,

(In millions) 2024 2023

Regeneron's share of profits in connection with commercialization of EYLEA outside the United States $ 349.9 $ 315.3 $ 1,031.0 $ 993.4

Regeneron's share of profits in connection with commercialization of EYLEA 8 mg and EYLEA outside the United States

$ 333.9 $ 331.6

Reimbursement for manufacturing of ex-U.S.

commercial supplies (a)

27.2 17.5 79.7 60.3

One-time payment in connection with change in Japan arrangement (b)

Total Bayer collaboration revenue $ 356.0 $ 356.9

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

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

Previously, the Company received from Bayer a tiered percentage of sales based on sales by Bayer's distributor in Japan.

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

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

Bayer records net product sales of EYLEA 8 mg and EYLEA outside the United States.

Regeneron's share of profits in connection with commercialization of EYLEA 8 mg and EYLEA outside the United States is summarized below:

Three Months Ended

September 30, Nine Months Ended

September 30,

(In millions) 2024 2023

EYLEA net product sales outside the United States

EYLEA 8 mg and EYLEA net product sales outside the United States

$ 849.4 $ 847.1

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(16.6) (15.3)

Regeneron's share of profits in connection with commercialization of EYLEA outside the United States $ 349.9 $ 315.3 $ 1,031.0 $ 993.4

Regeneron's share of profits as a percentage of EYLEA net product sales outside the United States 40% 39% 40% 39%

Regeneron's share of profits in connection with commercialization of EYLEA 8 mg and EYLEA outside the United States

$ 333.9 $ 331.6

Regeneron's share of profits as a percentage of EYLEA 8 mg and EYLEA net product sales outside the United States

Roche Collaboration Revenue

Three Months Ended

September 30, Nine Months Ended

September 30,

(In millions) 2023 2022 2023 2022

Global gross profit payment from Roche in connection with sales of Ronapreve $ — $ 6.4 $ 222.2 $ 230.9

Other (5.7) — (9.5) —

Total Roche collaboration revenue $ (5.7) $ 6.4 $ 212.7 $ 230.9

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.

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

For the three months ended March 31, 2024 and 2023, our share of gross profits in connection with sales of Ronapreve outside the United States was $0.5 million and $222.2 million, respectively.

Three Months Ended

September 30, Nine Months Ended

September 30,

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

(In millions, except headcount data) 2024 2023 Change

Research and development (a)

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193.4 249.1 (55.7)

Other operating (income) expense, net (0.5) (45.7) 45.2 (1.6) (83.3) 81.7

Other operating expense (income), net 15.3 (0.5) 15.8

Total operating expenses $ 2,393.6 $ 2,215.4 $ 178.2

2 unchanged sentences

(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.

Operating expenses for the three months ended March 31, 2024 and 2023 included a total of $230.1 million and $238.7 million, respectively, of stock-based compensation expense related to equity awards granted under our long-term incentive plans.

Research and Development Expenses

The following table summarizes our estimates of direct research and development expenses by clinical development program and other significant categories of research and development expenses.

The following table summarizes our direct research and development expenses by clinical development program and other significant categories of research and development expenses.

Direct research and development expenses are comprised primarily of costs paid to third parties for clinical and product development activities, including costs related to preclinical research activities, clinical trials, and the portion of research and development expenses incurred by our collaborators that we are obligated to reimburse.

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Three Months Ended

September 30, Nine Months Ended

September 30,

(In millions) 2024 2023 *

$ Change 2023 2022 *

Direct research and development expenses:

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

Fianlimab $ 64.0 $ 34.8 $ 29.2

Linvoseltamab 63.3 14.8 48.5

Dupixent (dupilumab) 36.3 49.2 (12.9)

Odronextamab 26.1 22.1 4.0

Libtayo (cemiplimab) 22.6 32.9 (10.3)

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

21.9 25.7 (3.8)

19.3 19.4 (0.1)

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 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.

Research and development expenses included stock-based compensation expense of $123.0 million and $139.5 million for the three months ended March 31, 2024 and 2023, 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.

"Risk Factors." There is also variability in the duration and costs necessary to develop a pharmaceutical product, potential opportunities and/or uncertainties related to future indications to be studied, and the estimated cost and scope of the projects.

The lengthy process of seeking FDA and other applicable approvals, and subsequent compliance with applicable statutes and regulations, require the expenditure of substantial resources.

"Risk Factors." There is also variability in the duration and costs necessary to develop a product candidate, potential opportunities and/or uncertainties related to future indications to be studied, and the estimated cost and scope of the projects.

The lengthy process of seeking FDA and other applicable approvals, and subsequent compliance with

applicable statutes and regulations, require the expenditure of substantial resources.

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

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

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.

Acquired IPR&D for the three months ended March 31, 2023 included a $45.0 million up-front payment in connection with our collaboration agreement with Sonoma Biotherapeutics, Inc.

Selling, General, and Administrative Expenses

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.

Selling, general, and administrative expenses increased for the three months ended March 31, 2024, compared to the same period in 2023, due to an increase in commercialization-related expenses to support our launch of EYLEA HD and higher headcount and headcount-related costs primarily related to the international expansion in support of Libtayo and hematology product launch preparations.

Selling, general, and administrative expenses also included stock-based compensation expense of $86.2 million and $76.8 million for the three months ended March 31, 2024 and 2023, respectively.

Cost of Goods Sold

Cost of goods sold increased for the three months ended March 31, 2024, compared to the same period in 2023, primarily due to higher start-up costs for our Rensselaer, New York fill/finish facility.

Cost of Collaboration and Contract Manufacturing

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 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.

Cost of collaboration and contract manufacturing decreased for the three months ended March 31, 2024, compared to the same period in 2023, primarily due to the recognition of lower Dupixent manufacturing costs as a result of the transition to a higher-yielding manufacturing process.

Other Operating Expense (Income)

Other operating expense (income), net, for the three months ended March 31, 2024 reflects a $15.3 million charge related to the increase in the estimated fair value of the contingent consideration liability recognized in connection with our 2023 acquisition of Decibel Therapeutics, Inc.

Other Income (Expense)

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Three Months Ended

September 30, Nine Months Ended

September 30,

(In millions) 2024 2023

Unrealized (losses) gains on equity securities, net $ (100.3) $ 254.3 $ (295.9) $ (120.6)

Unrealized losses on equity securities, net

$ (196.2) $ (164.7)

Interest income 161.5 95.2

Other 0.1 (1.2)

Other income (expense), net 17.6 301.4 32.2 (16.0)

Other (expense) income, net (34.6) (70.7)

Interest expense (16.1) (18.0)

Total other income (expense) $ (50.7) $ (88.7)

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

September 30, Nine Months Ended

September 30,

(In millions, except effective tax rate) 2024 2023

Income tax expense

Income tax (benefit) expense

$ (21.3) $ 40.2

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(3.0 %) 4.7 %

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.

federal statutory rate and, to a lesser extent, stock-based compensation and federal tax credits for research activities.

The Company's effective tax rate for the three months ended March 31, 2024 was positively impacted, compared to the U.S.

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

federal statutory rate.

The effective tax rate for the three months ended March 31, 2024 was positively impacted, compared to the same period in 2023, primarily by additional stock-based compensation.

Certain countries in which we have operations, including Ireland, have adopted legislation influenced by the Organization for Economic Co-operation and Development ("OECD") Global Anti-Base Erosion Model Rules ("Pillar Two") framework, including a minimum tax rate of 15%.

The adoption of the Pillar Two framework did not have a material impact on our effective tax rate for the three months ended March 31, 2024.

It is uncertain whether the United States will enact legislation to adopt the Pillar Two framework.

We continue to evaluate additional guidance released by the OECD, along with the pending legislative adoption by additional individual countries.

Liquidity and Capital Resources

Our financial condition is summarized as follows:

September 30, December 31,

March 31, December 31,

(In millions) 2024 2023 $ Change

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Finance lease liabilities $ 720.0 $ 720.0 $ —

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,

As of March 31, 2024, we also had borrowing availability of $750.0 million under a revolving credit facility.

Sources and Uses of Cash for the Three Months Ended March 31, 2024 and 2023

Three Months Ended

(In millions) 2024 2023 $ Change

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Cash flows used in investing activities $ (1,687.1) $ (235.7) $ (1,451.4)

Cash flows used in financing activities $ (1,344.0) $ (761.4) $ (582.6)

Cash flows provided by (used in) financing activities

$ 47.1 $ (322.5) $ 369.6

Cash Flows from Investing Activities

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 $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.

Capital expenditures for the three months ended March 31, 2024 included costs incurred in connection with the expansion of our research, preclinical manufacturing, and support facilities at our Tarry town, New York location, as well as costs associated

with the expansion of our manufacturing facilities in Rensselaer, New York (including equipment related to the fill/finish facility).

We expect to incur capital expenditures of $780 million to $880 million for the full year of 2024 primarily in connection with the continued expansion of our facilities in Tarrytown and Rensselaer (including the fill/finish facility).

Payments for the Libtayo intangible asset of $27.9 million and $100.9 million for the three months ended March 31, 2024 and 2023, respectively, were related to contingent consideration in connection with our acquisition of the exclusive right to develop, commercialize, and manufacture Libtayo worldwide.

Cash Flows from Financing Activities

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.

Proceeds from issuances of Common Stock, in connection with exercises of employee stock options, were $682.1 million for the three months ended March 31, 2024, compared to $485.2 million for the three months ended March 31, 2023.

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

Share Repurchase Programs

In November 2021, our board of directors authorized a share repurchase program to repurchase up to $3.0 billion of our Common Stock.

As of June 30, 2023, the Company had repurchased the entire $3.0 billion of its Common Stock it was authorized to repurchase under the program.

In January 2023, our board of directors authorized an additional share repurchase program to repurchase up to $3.0 billion of our Common Stock.

In January 2023, our board of directors authorized a share repurchase program to repurchase up to $3.0 billion of our Common Stock.

The share repurchase program permits the Company to make repurchases through a variety of methods, including open-market transactions (including pursuant to a trading plan adopted in accordance with Rule 10b5-1 of the Exchange Act), privately negotiated transactions, accelerated share repurchases, block trades, and other transactions in compliance with Rule 10b-18 of the Exchange Act.

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

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

As of March 31, 2024, $1.233 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.

Nine Months Ended

September 30,

Three Months Ended

(In millions) 2024 2023

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Total cost of shares $ 298.0 $ 693.9

In April 2024, our board of directors authorized a new share repurchase program to repurchase up to an additional $3.0 billion of our Common Stock.

The share repurchase program was approved under terms substantially similar to the share repurchase program described above.

Critical Accounting Estimates

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"Management's Discussion and Analysis of Financial Condition and Results of Operations" of our Annual Report on Form 10-K for the fiscal year ended December 31, 2023 (filed February 5, 2024).

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

There have been no material changes to critical accounting estimates during the three months ended March 31, 2024.

Future Impact of Recently Issued Accounting Standards

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.

See Note 1 to our Condensed Consolidated Financial Statements for a summary of recently issued accounting standards.

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