What changed in this filing

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Item 2. Management’s Discussion and Analysis

2024-10-31 compared with 2024-08-01 · 174 added, 127 removed, 543 unchanged (36% of the section changed)

7 unchanged sentences

• 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 discussed or referenced in this report;

• the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron's 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;

1 unchanged sentence

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

• competing drugs and product candidates that may be superior to, or more cost effective than, Regeneron's Products and Regeneron's Product Candidates;

• competing drugs and product candidates that may be superior to, or more cost effective than, Regeneron's Products and Regeneron's Product Candidates (including biosimilar versions of Regeneron's Products);

• uncertainty of the utilization, market acceptance, and commercial success of Regeneron's Products and Regeneron's Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary) or recommendations and guidelines from governmental authorities and other third parties on the commercial success of Regeneron's Products and Regeneron's Product Candidates;

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Three Months Ended

Six Months Ended

September 30,

Nine Months Ended

September 30,

(In millions, except per share data) 2024 2023 2024 2023

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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

Chronic rhinosinusitis with nasal polyposis ("CRSwNP") (in adults)

CRSwNP (in adolescents)

Chronic obstructive pulmonary disease

21 unchanged sentences

HoFH (in adults, adolescents, and pediatrics)

Ordspono ™ (odronextamab)

Follicular lymphoma ("FL")

Diffuse large B-cell lymphoma ("DLBCL")

Inmazeb ® (atoltivimab, maftivimab, and odesivimab) Injection

4 unchanged sentences

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, adolescents, and pediatrics) a

Product (continued)

1 unchanged sentence

ARCALYST (rilonacept) Injection (f) (continued)

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

Recurrent pericarditis (in adults and adolescents)

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Three Months Ended

September 30,

2024 2023 % Change

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$ 68.2 $ 23.2 $ 91.4 $ 23.4 $ 15.5 $ 38.9 135 %

Six Months Ended

Nine Months Ended

September 30,

2024 2023 % Change

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Prior to July 1, 2022, Sanofi recorded net product sales of Libtayo outside the United States.

Included in this line item for the six months ended June 30, 2023 is approximately $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).

Included in this line item for the nine months ended September 30, 2023 is approximately $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).

(d) We record net product sales of Praluent in the United States.

Sanofi records net product sales of Praluent outside the United States and pays us a royalty on such sales, which is recorded within Other revenue.

(e) Roche records net product sales outside the United States and we record our share of gross profits from sales based on a pre-specified formula, which is recorded within Collaboration revenue.

(e) Roche records net product sales outside the United States and we record our share of gross profits from sales, which is recorded within Collaboration revenue.

Refer to "Results of Operations - Revenues - Roche Collaboration Revenue" below for such amounts.

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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 $79 million for the first quarter of 2024.

net product sales of ARCALYST were $103 million for the second quarter of 2024.

(g) Rest of world ("ROW")

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–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 (second half 2024) to enable U.S.

Food and Drug Administration ("FDA") submission

–FDA decision on supplemental Biologics License Application ("sBLA") with two-year data for wAMD and DME (first half 2025)

–Pre-filled syringe approved by European Medicines Agency ("EMA")

–Presented positive three-year data from extension study of Phase 3 DME trial at American Academy of Ophthalmology ("AAO") Annual Meeting

–Report results from Phase 3 QUASAR study in RVO (fourth quarter 2024) to enable global regulatory submissions

Food and Drug Administration ("FDA") decision on supplemental Biologics License Application ("sBLA") with two-year data for wAMD and DME (first half 2025)

Pozelimab (f) (REGN3918)

Antibody to C5

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

–Geographic atrophy, cemdisiran combination (l)

Immunology & Inflammation

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–Bullous pemphigoid (c)

–Chronic pruritus of unknown origin

–Chronic pruritus of unknown origin ("CPUO")

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

–CRSwNP in adolescents

–COPD with type 2 inflammatory phenotype (U.S.

–CSU in adults and adolescents (EU)

–COPD with type 2 inflammatory phenotype (Japan)

–CSU in adults and adolescents (U.S.

–Approved by FDA for CRSwNP in adolescents

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

–EMA's Committee for Medicinal Products for Human Use ("CHMP") adopted positive opinion for EoE in pediatrics (1–11 years of age)

–Results from Phase 3 trial in pediatrics (1–11 years of age) with EoE published in New England Journal of Medicine (" NEJM ")

–Approved by MHLW for CSU in adults and adolescents

–Approved by EC for uncontrolled COPD characterized by raised blood eosinophils

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

results presented at 2024 American Thoracic Society International Conference and published in NEJM

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

–FDA decision on sBLA

for CRSwNP in

adolescents (target action date of September 15, 2024)

–FDA decision on sBLA for COPD with type 2 inflammatory phenotype (target action date of September 27, 2024)

–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)

–EC decision on regulatory submission for EoE in pediatrics (fourth quarter 2024)

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

–Submit sBLA for bullous pemphigoid (fourth quarter 2024)

Clinical Program (continued)

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Select Upcoming

Dupixent (dupilumab) (b)

–FDA extended by three months target action date of its priority review of sBLA for COPD with type 2 inflammatory phenotype

Dupixent (dupilumab) (b) (continued)

–Approved by MHLW for CSU in adults and adolescents

–Reported that second Phase 3 trial in CSU in biologic-naïve patients met its primary and key secondary endpoints

–Approved by FDA, EC, and National Medical Products Administration ("NMPA") in China for uncontrolled COPD and an eosinophilic phenotype

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

results presented at 2024 American Thoracic Society International Conference and published in NEJM

–Reported that Phase 3 trial in bullous pemphigoid met its primary and all key secondary endpoints

–Reported that first Phase 3 trial in CPUO did not achieve statistical significance in its primary itch responder endpoint

Kevzara (sarilumab) (b)

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–Approved by FDA for pJIA

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

–EMA's CHMP adopted positive opinion for PMR

–EC decision on regulatory submission for PMR (fourth quarter 2024)

–EC decision on regulatory submission for pJIA (first half 2025)

Clinical Program (continued)

Phase 2 Phase 3 Regulatory

2024 Events to Date

Select Upcoming

Itepekimab (b) (REGN3500)

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–First-line NSCLC, BNT116 (i) combination

–Neoadjuvant NSCLC

–Neoadjuvant hepatocellular carcinoma ("HCC")

–Adjuvant CSCC

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

–Submit regulatory application in Japan for NSCLC, monotherapy and chemotherapy combination (second half 2024)

–First-line NSCLC, monotherapy and chemotherapy combination (Japan)

–Presented positive five-year survival data from Phase 3 NSCLC monotherapy trial at IASLC 2024 World Conference on Lung Cancer

–Conduct interim analysis from Phase 3 study in adjuvant CSCC (fourth quarter 2024)

–MHLW decision on regulatory submission for NSCLC, monotherapy and chemotherapy combination (second half 2025)

Fianlimab (f) (REGN3767)

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–First-line metastatic melanoma (e)

–First-line adjuvant melanoma

–Adjuvant melanoma

–First-line metastatic melanoma versus the combination of relatlimab and nivolumab

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

–Presented positive two-year data from Phase 1 trial (in combination with Libtayo) in advanced melanoma at European Society for Medical Oncology ("ESMO") Annual Meeting

–Initiate Phase 2 study (in combination with Libtayo) in first-line metastatic head and neck squamous cell carcinoma (2025)

–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 (fourth quarter 2024)

Clinical Program (continued)

Phase 2 Phase 3 Regulatory

2024 Events to Date

Select Upcoming

Immune activator targeting TLR9

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–Prostate cancer

Clinical Program (continued)

Phase 2 Phase 3 Regulatory

2024 Events to Date

Select Upcoming

Bispecific antibody targeting EGFR and CD28

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–Presented positive results from dose escalation portion of Phase 1/2 trial (in combination with Libtayo) in advanced solid tumors at American Society of Clinical Oncology ("ASCO") 2024 Annual Meeting

Davutamig (REGN5093)

Bispecific antibody targeting two distinct MET epitopes

–MET-altered advanced NSCLC

Pozelimab (f) (REGN3918)

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

Odronextamab (m) (REGN1979)

Ordspono (odronextamab) (m)

Bispecific antibody targeting CD20 and CD3

1 unchanged sentence

("B-NHL") (pivotal study)

–Follicular lymphoma ("FL")

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

–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

–European Medicines Agency's ("EMA") Committee for Medicinal Products for Human Use ("CHMP") adopted positive opinion for relapsed/refractory FL and DLBCL

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

Clinical Program (continued)

Phase 2 Phase 3 Regulatory

2024 Events to Date

Select Upcoming

–Approved by EC for relapsed/refractory FL and DLBCL

Linvoseltamab (f) (REGN5458)

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–Multiple myeloma (c)(e)

–Relapsed/refractory multiple myeloma (U.S.

–Relapsed/refractory multiple myeloma (EU)

–FDA issued CRL for BLA for relapsed/refractory multiple myeloma due to findings resulting from an inspection at third-party fill/finish manufacturer

–FDA and EC decisions on regulatory applications for relapsed/refractory multiple myeloma pending resolution of a third-party fill/finish manufacturing issue

Clinical Program (continued)

Phase 2 Phase 3 Regulatory

2024 Events to Date

Select Upcoming

Linvoseltamab (f) (REGN5458) (continued)

–Presented 14-month median follow-up data from pivotal Phase 1/2 trial in multiple myeloma at European Hematology Association ("EHA") Congress 2024 and published these data in Journal of Clinical Oncology

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

NTLA-2001 (j)

Nexiguran ziclumeran (NTLA-2001) (j)

TTR gene knockout using CRISPR/Cas9

1 unchanged sentence

Antibody to Factor XI

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

–Thrombosis –Report top-line results from Phase 2 study in thrombosis (fourth quarter 2024)

Antibody to Factor XI

–Report top-line results from Phase 2 study in thrombosis (fourth quarter 2024)

Antibody to IL2Rg

–Aplastic anemia

Antibody to TMPRSS6

–Iron overload in beta-thalassemia

Internal Medicine/Genetic Medicines

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

–Report results from Phase 3 study in FOP (second half 2025)

Trevogrumab (f) (REGN1033)

Antibody to myostatin (GDF8)

Mibavademab (f)(p) (REGN4461)

–Complete enrollment in Phase 2 study in obesity (fourth quarter 2024)

Mibavademab (f)(o) (REGN4461)

Agonist antibody to leptin receptor ("LEPR")

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RNAi therapeutic targeting HSD17B13

–Nonalcoholic steatohepatitis

–Metabolic dysfunction-associated steatohepatitis ("MASH")

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

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

(o) Studied in combination with semaglutide with and without garetosmab

(p) A Phase 2 study, sponsored by Eli Lilly, is also ongoing and testing the combination of tirzepatide and mibavademab compared with tirzepatide alone in patients with obesity.

(n) Studied in combination with semaglutide with and without garetosmab

(o) A Phase 2 study, sponsored by Eli Lilly, is also ongoing and testing the combination of tirzepatide and mibavademab compared with tirzepatide alone in patients with obesity.

Additional Information - Clinical Development Programs

Dupixent (dupilumab)

In May 2024, the FDA extended by three months the target action date of its priority review of the sBLA for Dupixent as an add-on maintenance treatment in certain adult patients with uncontrolled COPD.

The FDA had requested additional analyses on the efficacy of Dupixent in the BOREAS and NOTUS pivotal trials.

Based on the submission of these analyses, the agency determined that this additional information constituted a major amendment to the sBLA and extended the target action date accordingly.

The revised target action date is September 27, 2024.

Linvoseltamab

During its review of the linvoseltamab BLA for relapsed/refractory multiple myeloma, the FDA informed us that the third-party fill/finish provider for linvoseltamab had unresolved findings from a pre-approval inspection for another company's product candidate, which is to be filled on the same manufacturing line as linvoseltamab.

Although this third-party fill/finish provider communicated to us and the FDA that they believe these findings have been successfully remediated, the FDA has indicated that a re-inspection will be required before these issues are considered resolved and any new products filled on this line can be approved, including linvoseltamab.

Therefore, we believe that any potential FDA approval of the linvoseltamab BLA will be delayed beyond the August 22, 2024 target action date.

The FDA has not informed us of any approvability issues for linvoseltamab related to safety, efficacy, or the status of our confirmatory trial.

In August 2024, the FDA issued a CRL for the BLA for linvoseltamab in relapsed/refractory multiple myeloma that has progressed after at least three prior therapies.

The sole approvability issue identified is related to findings from a pre-approval inspection at a third-party fill/finish manufacturer.

Resolution of this issue will be required for both FDA and EC regulatory approvals.

In September 2024, the Company and Sanofi announced that the first Phase 3 trial (Study A) of Dupixent in adults with uncontrolled and severe CPUO did not achieve statistical significance in its primary itch responder endpoint (despite favorable numerical improvements), but showed nominally significant improvements in all other itch endpoints.

The Dupixent Phase 3 program in CPUO consists of Study A and Study B.

Study B is planned to initiate as a subsequent pivotal trial.

Early-Stage Clinical Development Updates

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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 otoferlin gene is ongoing.

In May 2024, the Company presented updated data from the Phase 1/2 trial at the American Society of Gene and Cell Therapy ("ASGCT") annual conference and announced that DB-OTO improved hearing to normal levels in one child and that initial hearing improvements were observed in a second child.

In May 2024, we presented updated data from the Phase 1/2 trial at the American Society of Gene and Cell Therapy ("ASGCT") annual conference and announced that DB-OTO improved hearing to normal levels in one child and that initial hearing improvements were observed in a second child.

Additionally, the FDA granted DB-OTO Regenerative Medicine Advanced Therapy ("RMAT") designation.

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

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

Under the terms of the Antibody 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 June 30, 2024, the total amount of our contingent reimbursement obligation to Sanofi (i.e., "development balance") in connection with such development expenses was approximately $2.013 billion.

As of September 30, 2024, the total amount of our contingent reimbursement obligation to Sanofi (i.e., "development balance") in connection with such development expenses was approximately $1.810 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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are parties to a 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.

During 2023, we paid a $100.0 million development milestone to Alnylam upon the achievement of specified proof-of-principle criteria for a CNS program (ALN-APP) and Alnylam is eligible to receive an additional $100.0 million clinical proof-of-principle milestone in connection with an eye program.

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

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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 development milestones for DB-OTO within specified time periods.

In July 2024, a development milestone contemplated by the CVRs was achieved, and, as a result, we became obligated to pay $55.1 million to the holders of the CVRs.

The holders of the CVRs may be entitled to receive an additional $42.0 million if an additional milestone contemplated by the CVRs is achieved.

During the third quarter of 2024, a development milestone contemplated by the CVRs was achieved, and, as a result, we paid $55.1 million to the holders of the CVRs.

The holders of the CVRs will be entitled to receive an additional $42.0 million if an additional milestone contemplated by the CVRs is achieved.

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

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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.

obligated to pay 2seventy bio a regulatory milestone upon the first major market approval of the first approved product;

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.

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Our principal executive offices are located at 777 Old Saw Mill River Road, Tarrytown, New York 10591, and our telephone number at that address is (914) 847-7000.

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").

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 Securities Exchange Act of 1934, as amended (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://investor.regeneron.com ) and our social media channels to publish important information about Regeneron, including information that may be deemed material to investors.

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Three Months Ended

Six Months Ended

September 30,

Nine Months Ended

September 30,

(In millions, except per share data) 2024 2023 2024 2023

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Six Months Ended

September 30,

Nine Months Ended

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(In millions) 2024 2023 $ Change 2024 2023 $ Change

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Total EYLEA HD and EYLEA net product sales in the U.S.

increased for the three and six months ended June 30, 2024, compared to the same periods in 2023.

EYLEA HD was approved by the FDA in August 2023 and EYLEA HD net product sales for the three and six months ended June 30, 2024 were driven by the transition of patients from other anti-VEGF products, including EYLEA, to EYLEA HD, as well as new patients naïve to anti-VEGF therapy.

Net product sales of EYLEA in the United States decreased for the three and six months ended June 30, 2024, compared to the same periods in 2023, primarily due to (i) the aforementioned approval and transition of certain patients to EYLEA HD, and (ii) other market dynamics that resulted in lower volumes and a lower net selling price.

increased for the three and nine months ended September 30, 2024 compared to the same periods in 2023.

EYLEA HD was approved by the FDA in August 2023 and net product sales for the three and nine months ended September 30, 2024 were driven by the transition of patients from other anti-VEGF products, including EYLEA, as well as new patients naïve to anti-VEGF therapy.

Net product sales of EYLEA for the three and nine months ended September 30, 2024 were adversely impacted by a lower net selling price compared to the same periods in 2023.

In addition, for the three months ended September 30, 2024 total EYLEA HD and EYLEA net product sales were favorably impacted by approximately $40 million as a result of higher wholesaler inventory levels for EYLEA HD at the end of the third quarter of 2024 compared to the end of the second quarter of 2024, partially offset by lower wholesaler inventory levels for EYLEA.

Collaboration Revenue

1 unchanged sentence

Three Months Ended

Six Months Ended

September 30,

Nine Months Ended

September 30,

(In millions) 2024 2023 2024 2023

1 unchanged sentence

$ 1,088.3 $ 863.0 $ 2,880.6 $ 2,250.6

Sales-based milestones earned

— 50.0 — 50.0

Reimbursement for manufacturing of commercial supplies (a)

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Three Months Ended

Six Months Ended

September 30,

Nine Months Ended

September 30,

(In millions) 2024 2023 2024 2023

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28% 27% 27% 26%

The increase in our share of profits for the three and six months ended June 30, 2024, compared to the same periods in 2023, was driven by higher profits associated with Dupixent sales.

The increase in our share of profits for the three and nine months ended September 30, 2024, compared to the same periods in 2023, was driven by higher profits associated with Dupixent sales.

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 exceeding $3.0 billion on a rolling twelve-month basis.

Bayer Collaboration Revenue

Three Months Ended

Six Months Ended

September 30,

Nine Months Ended

September 30,

(In millions) 2024 2023 2024 2023

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Six Months Ended

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Nine Months Ended

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(In millions) 2024 2023 2024 2023

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Six Months Ended

September 30,

Nine Months Ended

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(In millions)

2024 2023 2024 2023

Global gross profit payment from Roche in connection with sales of Ronapreve $ 0.4 $ — $ 0.9 $ 222.2

Global gross profits earned in connection with sales of Ronapreve

$ 0.5 $ — $ 1.4 $ 222.2

— (5.7) — (9.5)

Total Roche collaboration revenue

1 unchanged sentence

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

Net product sales of Ronapreve outside the United States declined as a result of new variants of the SARS-CoV-2 virus emerging that are not susceptible to the treatment.

Three Months Ended

Six Months Ended

September 30,

Nine Months Ended

September 30,

(In millions, except headcount data) 2024 2023 Change 2024 2023 Change

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(a) Includes costs incurred net of any cost reimbursements from collaborators

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

Operating expenses included stock-based compensation of $223.2 million and $202.0 million for the three months ended June 30, 2024 and 2023, respectively, and $453.3 million and $440.7 million for the six months ended June 30, 2024 and 2023, respectively.

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

Operating expenses included stock-based compensation of $225.1 million and $203.9 million for the three months ended September 30, 2024 and 2023, respectively, and $678.4 million and $644.6 million for the nine months ended September 30, 2024 and 2023, respectively.

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

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Three Months Ended

Six Months Ended

September 30,

Nine Months Ended

September 30,

(In millions) 2024 2023 *

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Fianlimab $ 53.4 $ 27.6 $ 25.8 $ 168.4 $ 80.5 $ 87.9

Ordspono (odronextamab)

33.8 24.9 8.9 94.1 66.6 27.5

Dupixent (dupilumab) 31.3 32.7 (1.4) 96.4 132.0 (35.6)

Odronextamab 34.3 19.6 14.7 60.3 41.8 18.5

EYLEA HD (aflibercept) 8 mg

28.9 18.3 10.6 76.0 71.9 4.1

24.2 12.7 11.5 43.6 32.1 11.5

Linvoseltamab 25.4 23.3 2.1 111.8 64.3 47.5

24.2 22.0 2.2 67.8 54.1 13.7

Libtayo (cemiplimab) 17.9 23.9 (6.0) 60.7 82.2 (21.5)

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

Research and development expenses included stock-based compensation expense of $122.4 million and $109.1 million for the three months ended June 30, 2024 and 2023, respectively, and $245.4 million and $248.6 million for the six months ended June 30, 2024 and 2023, respectively.

Research and development expenses included stock-based compensation expense of $123.7 million and $107.4 million for the three months ended September 30, 2024 and 2023, respectively, and $369.1 million and $356.0 million for the nine months ended September 30, 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.

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

Acquired IPR&D for the three and six months ended June 30, 2024 primarily included up-front payments, as well as a premium on equity securities purchased, in connection with collaboration and licensing agreements.

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 nine months ended September 30, 2024 included a $45.0 million development milestone in connection with our collaboration agreement with Sonoma Biotherapeutics, Inc.

Acquired IPR&D for the three and nine months ended September 30, 2023 included a $100.0 million development milestone in connection with our collaboration agreement with Alnylam Pharmaceuticals, Inc.

The nine months ended September 30, 2023 also included a $45.0 million up-front payment in connection with our collaboration agreement with Sonoma.

Selling, General, and Administrative Expenses

Selling, general, and administrative expenses increased for the three and six months ended June 30, 2024, compared to the same periods in 2023, due to higher commercialization-related expenses to support our launch of EYLEA HD and higher headcount and headcount-related costs partly related to our international commercial expansion.

Selling, general, and administrative expenses also included stock-based compensation expense of $82.6 million and $73.3 million for the three months ended June 30, 2024 and 2023, respectively, and $168.8 million and $150.1 million for the six months ended June 30, 2024 and 2023, respectively.

Selling, general, and administrative expenses increased for the three and nine months ended September 30, 2024, compared to the same periods in 2023, due to higher commercialization-related expenses to support our launch of EYLEA HD and higher headcount and headcount-related costs partly related to our international commercial expansion.

Selling, general, and administrative expenses also included stock-based compensation expense of $83.1 million and $74.4 million for the three months ended September 30, 2024 and 2023, respectively, and $251.9 million and $224.5 million for the nine months ended September 30, 2024 and 2023, respectively.

Cost of Goods Sold

Cost of goods sold increased for the three and six months ended June 30, 2024, compared to the same periods 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 decreased for the six months ended June 30, 2024, compared to the same period in 2023, partly due to the recognition of lower Dupixent manufacturing costs as a result of the transition to a higher-yielding manufacturing process.

Cost of goods sold increased for the three and nine months ended September 30, 2024, compared to the same periods in 2023, primarily due to higher start-up costs for our Rensselaer, New York fill/finish facility.

Other Operating Expense (Income)

Other operating expense (income), net, reflected charges of $14.6 million and $29.9 million, for the three and six months ended June 30, 2024, respectively, 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 operating expense (income), net, reflected charges of $8.0 million and $37.9 million for the three and nine months ended September 30, 2024, respectively, 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

Six Months Ended

September 30,

Nine Months Ended

September 30,

(In millions) 2024 2023 2024 2023

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Three Months Ended

Six Months Ended

September 30,

Nine Months Ended

September 30,

(In millions, except effective tax rate) 2024 2023 2024 2023

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10.2 % 9.3 % 8.6 % 8.4 %

Our effective tax rate for the three and six months ended June 30, 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, partly offset by the remeasurement of existing uncertain tax positions.

Our effective tax rate for the three and nine months ended September 30, 2024 was positively impacted, compared to the U.S.

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

federal statutory rate and stock-based compensation.

Our effective tax rate for the nine months ended September 30, 2024 was negatively impacted by the remeasurement of existing uncertain tax positions.

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 and six months ended June 30, 2024.

The adoption of the Pillar Two framework did not have a material impact on our effective tax rate for the three and nine months ended September 30, 2024.

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

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Our financial condition is summarized as follows:

June 30, December 31,

September 30, December 31,

(In millions) 2024 2023 $ Change

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Finance lease liabilities $ 720.0 $ 720.0 $ —

As of June 30, 2024, 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, 2024 and 2023

Six Months Ended

As of September 30, 2024, 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, 2024 and 2023

Nine Months Ended

September 30,

(In millions) 2024 2023 $ Change

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Cash flows used in financing activities $ (1,065.0) $ (1,344.0) $ 279.0

$ (431.0) $ (936.7) $ 505.7

Cash Flows from Investing Activities

Capital expenditures for the six months ended June 30, 2024 included costs incurred in connection with the expansion of our research, preclinical manufacturing, and support facilities at our Tarry town, N ew York location, as well as costs associated with the expansion of our manufacturing facilities in Rensselaer, New York (including the fill/finish facility).

We expect to incur

capital expenditures of $750 million to $820 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 $58.3 million and $121.8 million for the six months ended June 30, 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.

Capital expenditures for the nine months ended September 30, 2024 included costs incurred in connection with the expansion of our research, preclinical manufacturing, and support facilities at our Tarrytown, New York location, as well as costs associated

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

In addition, in September 2024, we acquired a 1,100,000 square foot facility in Saratoga Springs, New York.

We expect to incur capital expenditures of $700 million to $740 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 $58.3 million and $145.7 million for the nine months ended September 30, 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 $1.120 billion for the six months ended June 30, 2024, compared to $575.9 million for the six months ended June 30, 2023.

In addition, payments in connection with Common Stock tendered for employee tax obligations were $655.5 million for the six months ended June 30, 2024, compared to $113.1 million for the six months ended June 30, 2023.

Proceeds from issuances of Common Stock, in connection with exercises of employee stock options, were $1.374 billion for the nine months ended September 30, 2024, compared to $844.5 million for the nine months ended September 30, 2023.

In addition, payments in connection with Common Stock tendered for employee tax obligations were $775.7 million for the nine months ended September 30, 2024, compared to $242.5 million for the nine months ended September 30, 2023.

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

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

As of September 30, 2024, the Company had repurchased the entire $3.0 billion of its Common Stock it was authorized to repurchase under the program.

In April 2024, our board of directors authorized a share repurchase program to repurchase up to an additional $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.

In April 2024, our board of directors authorized a 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.

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

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

Nine Months Ended

September 30,

(In millions) 2024 2023

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Total cost of shares $ 1,637.7 $ 1,923.8

As of June 30, 2024, an aggregate of $3.631 billion remained available for share repurchases under the programs.

As of September 30, 2024, $2.893 billion remained available for share repurchases under the April 2024 program.

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 six months ended June 30, 2024.

There have been no material changes to critical accounting estimates during the nine months ended September 30, 2024.

Future Impact of Recently Issued Accounting Standards

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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