What changed in this filing

/stocks — the workspaceLOADING

Item 2. Management’s Discussion and Analysis

2025-10-28 compared with 2025-08-01 · 182 added, 128 removed, 541 unchanged (36% of the section changed)

17 unchanged sentences

• coverage and reimbursement determinations by such payors and other third parties and new policies and procedures adopted by such payors and other third parties;

• changes in laws, regulations, and policies affecting the healthcare industry;

• changes to drug pricing regulations and requirements and our drug pricing strategy;

• other changes in laws, regulations, and policies affecting the healthcare industry;

• the costs of developing, producing, and selling products or unanticipated expenses;

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Three Months Ended

Six Months Ended

September 30,

Nine Months Ended

September 30,

(In millions, except per share data) 2025 2024 2025 2024

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Libtayo ® (cemiplimab) Injection

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

Metastatic or locally advanced first-line NSCLC (in combination with chemotherapy)

Metastatic or locally advanced first-line non-small cell lung cancer ("NSCLC"), monotherapy and in combination with chemotherapy

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

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

Adjuvant CSCC

Metastatic or recurrent second-line cervical cancer

43 unchanged sentences

Three Months Ended

September 30,

2025 2024 % Change

11 unchanged sentences

$ 43.9 $ 28.0 $ 71.9 $ 68.2 $ 24.4 $ 92.6 (22 %)

Six Months Ended

Nine Months Ended

September 30,

2025 2024 % Change

20 unchanged sentences

(e) Included in this line item are products which are sold by us and others.

Refer to "Results of Operations - Revenues" below for a complete listing of net product sales recorded by us.

Refer to "Results of Operations - Revenues" below for a listing of net product sales recorded by us.

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

12 unchanged sentences

EYLEA HD (aflibercept) 8 mg (a)

–Pre-filled syringe (U.S.)

–RVO (U.S., EU, and Japan)

–Every 4-week dosing regimen for approved indications (U.S.)

2 unchanged sentences

–FDA issued Complete Response Letters ("CRLs") for sBLA for addition of extended dosing intervals and for regulatory application for pre-filled syringe

–Approved by EC for extended dosing intervals up to 6 months (24 weeks) in wAMD and DME

Food and Drug Administration ("FDA") decision for pre-filled syringe

–FDA decision on supplemental Biologics License Application ("sBLA") for RVO

–FDA decision on sBLA for every 4-week dosing regimen

–Approved by European Commission ("EC") for extended dosing intervals up to 6 months (24 weeks) in wAMD and DME –U.S.

Food and Drug Administration ("FDA") decision on supplemental Biologics License Application ("sBLA") for RVO (November 2025) (r)

–FDA decision on sBLA for every 4-week dosing regimen (November 2025) (r)

Pozelimab (f) (REGN3918)

Antibody to C5

–Geographic atrophy, cemdisiran combination (l)

–Geographic atrophy, cemdisiran combination (l)(q)

Immunology & Inflammation

1 unchanged sentence

Antibody to IL-4R alpha subunit

–Ulcerative colitis

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

3 unchanged sentences

–CSU in adults and adolescents (EU)

–CSU in pediatrics (2–11 years of age) (U.S.

–Bullous pemphigoid (EU and Japan)

–Approved by Japan's Ministry of Health, Labour and Welfare ("MHLW") for COPD

–Approved by FDA for CSU in adults and adolescents

–Resubmitted regulatory application for CSU in adults and adolescents in EU

–European Commission ("EC") decision on regulatory submission for CSU in adults and adolescents (second half 2025)

–EC decision on regulatory submission for CSU in adults and adolescents (fourth quarter 2025)

–EC decision on regulatory submission for bullous pemphigoid (first half 2026)

4 unchanged sentences

Dupixent (dupilumab) (b) (continued)

–CSU in pediatrics (2–11 years of age) (U.S.

–Bullous pemphigoid (EU and Japan)

–Allergic fungal rhinosinusitis ("AFRS")

– European Medicines Agency's ("EMA") Committee for Medicinal Products for Human Use ("CHMP") adopted positive opinion for CSU in adults and adolescents

–Presented positive data from Phase 2/3 bullous pemphigoid trial at 2025 American Academy of Dermatology ("AAD") Annual Meeting

12 unchanged sentences

Multi-antibody therapy to Bet v 1

–Birch allergy

–Birch allergy –Reported that Phase 3 trial in birch allergy met its primary and key secondary endpoints

–Initiate additional Phase 3 study in birch allergy (fourth quarter 2025)

REGN1908-1909 (f)

Multi-antibody therapy to Fel d 1

–Reported that Phase 3 trial in cat allergy met its primary and key secondary endpoints

–Initiate additional Phase 3 study in cat allergy (first half 2026)

Solid Organ Oncology

4 unchanged sentences

–Neoadjuvant NSCLC

–Neoadjuvant hepatocellular carcinoma ("HCC")

–Adjuvant CSCC

–Early-stage CSCC (intralesional)

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

–Adjuvant CSCC (U.S.

–Adjuvant CSCC (EU)

–Approved by FDA for adjuvant CSCC

–EMA's CHMP adopted positive opinion for adjuvant CSCC

–EC decision on regulatory submission for adjuvant CSCC (fourth quarter 2025)

Clinical Program (continued)

Phase 2 Phase 3 Regulatory

2025 Events to Date

Select Upcoming

Libtayo (cemiplimab) (g) (continued)

–Neoadjuvant hepatocellular carcinoma ("HCC")

–Reported positive data from Phase 3 trial in adjuvant CSCC;

results presented at 2025 American Society of Clinical Oncology ("ASCO") Annual Meeting and published in New England Journal of Medicine ("NEJM")

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

–FDA decision on sBLA (October 2025) and EC decision on regulatory submission (first half 2026) for adjuvant CSCC

–Approved by MHLW for NSCLC, monotherapy and chemotherapy combination

–Reported positive five-year follow-up data from Phase 3 trial in combination with chemotherapy for NSCLC;

results presented at IASLC 2025 World Conference on Lung Cancer ("WCLC")

Fianlimab (f) (REGN3767)

6 unchanged sentences

–Based on pre-planned interim analysis of two Phase 2/3 studies in first-line advanced NSCLC, Phase 2 portion of the studies will continue unchanged

–Initiate Phase 2 study (in combination with Libtayo) in first-line metastatic head and neck squamous cell carcinoma (first quarter 2026)

Clinical Program (continued)

Phase 2 Phase 3 Regulatory

2025 Events to Date

Select Upcoming

Fianlimab (f) (REGN3767) (continued)

–Report results from Phase 3 study versus pembrolizumab in first-line metastatic melanoma (fourth quarter 2025/first quarter 2026)

–Report data from Phase 2/3 studies in first-line advanced NSCLC (first quarter 2026)

–Report results from Phase 3 study versus pembrolizumab in first-line metastatic melanoma (first half 2026)

–Report data from Phase 2/3 studies in first-line advanced NSCLC (first half 2026)

–Initiate Phase 2 study (in combination with Libtayo) in first-line metastatic head and neck squamous cell carcinoma (first half 2026)

Immune activator targeting TLR9

2 unchanged sentences

–Ovarian cancer

–Report additional data from study in platinum-resistant ovarian cancer (second half 2025)

–Presented additional data from Phase 2 study in platinum-resistant ovarian cancer at European Society for Medical Oncology ("ESMO") 2025 Meeting

Clinical Program (continued)

Phase 2 Phase 3 Regulatory

2025 Events to Date

Select Upcoming

Bispecific antibody targeting MUC16 and CD28

5 unchanged sentences

–Solid tumors

–Report additional data from study in solid tumors (second half 2025)

–Report additional data from study in solid tumors (first half 2026)

Davutamig (REGN5093)

5 unchanged sentences

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

–Report results from Phase 3 cemdisiran combination study in myasthenia gravis (third quarter 2025)

Clinical Program (continued)

Phase 2 Phase 3 Regulatory

2025 Events to Date

Select Upcoming

–Reported that Phase 3 cemdisiran combination trial in myasthenia gravis met its primary and key secondary endpoints

Cemdisiran (l)

siRNA therapeutic targeting C5

–Myasthenia gravis (c)

–Reported that Phase 3 trial in myasthenia gravis met its primary and key secondary endpoints

–Submit New Drug Application ("NDA") for myasthenia gravis (first quarter 2026), pending discussions with FDA

Ordspono (odronextamab)

2 unchanged sentences

("B-NHL") (pivotal study)

–DLBCL (c)(e)

–FL (c)(e) (multiple lines and settings)

–DLBCL (c)(e) (multiple lines and settings)

–FDA issued CRL for BLA for relapsed/refractory FL

3 unchanged sentences

–Monoclonal gammopathy of undetermined significance ("MGUS")

–Light chain amyloidosis ("ALA") (Phase 1/2)

–Multiple myeloma (c)(e)

–Multiple myeloma (c)(e) (multiple lines and settings)

–Approved by FDA and EC for relapsed/refractory multiple myeloma

–Completed enrollment in Phase 3 confirmatory trial (LINKER-MM3) in relapsed/refractory multiple myeloma

Clinical Program (continued)

Phase 2 Phase 3 Regulatory

2025 Events to Date

Select Upcoming

Lynozyfic (linvoseltamab) (f) (continued)

–Light chain amyloidosis ("ALA") (Phase 1/2)

Nexiguran ziclumeran (Nex-z, NTLA-2001) (j)

2 unchanged sentences

–Hereditary transthyretin amyloidosis with polyneuropathy ("ATTRv-PN") (c)(m)

–Intellia temporarily paused dosing and screening in Phase 3 ATTR-CM and ATTRv-PN trials due to a Grade 4 adverse event involving the liver

Antibody to Factor XI (A2 domain)

–Initiate randomized Phase 2 study (second half 2025)

–Initiate Phase 3 studies (first half 2026)

Antibody to Factor XI (catalytic domain)

–Venous thromboembolism after total knee replacement surgery

–Initiate additional Phase 3 studies (second half 2025/first half 2026)

–Initiate additional Phase 3 studies (first half 2026)

Antibody to IL2Rg

7 unchanged sentences

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

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

Clinical Program (continued)

Phase 2 Phase 3 Regulatory

2025 Events to Date

Select Upcoming

–Reported that Phase 3 trial in FOP met its primary endpoint

–Submit BLA for FOP (fourth quarter 2025)

Trevogrumab (f) (REGN1033)

Antibody to myostatin (GDF8)

–Reported interim 26-week results from Phase 2 study in obesity;

final 26-week results consistent with interim results

–Present final 26-week results from Phase 2 study in obesity at upcoming conference (third quarter 2025)

–Reported 26-week results from Phase 2 study in obesity

Mibavademab (f)(o) (REGN4461)

2 unchanged sentences

Agonist antibody to NPR1

–Heart failure

–Uncontrolled hypertension

–Discontinued Phase 2 studies in heart failure and uncontrolled hypertension

Clinical Program (continued)

Phase 2 Phase 3 Regulatory

2025 Events to Date

Select Upcoming

Antagonist antibody to NPR1

5 unchanged sentences

AAV-based gene therapy

–Hearing deficit due to variants of the otoferlin gene (c)(e)(m) (Phase 1/2)

–Presented updated data from Phase 1/2 trial at Association for Research in Otolaryngology's Annual MidWinter Meeting

–Report additional data from Phase 1/2 study (second half 2025)

–Hearing deficit due to variants of the otoferlin gene (c)(e)(m) (Phase 1/2) (pivotal study)

–Presented updated data from Phase 1/2 trial and published in NEJM

–FDA granted Commissioner's National Priority Voucher

–Submit BLA for hearing deficit due to variants of the otoferlin gene (fourth quarter 2025)

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

6 unchanged sentences

(g) Studied as monotherapy and in combination with other antibodies and treatments

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

(h) Information in this column captures submissions to U.S., EU, and/or Japan regulatory authorities

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

2 unchanged sentences

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

(l) Under the terms of our license agreement for cemdisiran, Alnylam is entitled to receive royalties on sales (if any), as well as sales milestones

(l) Under the terms of our license agreement for cemdisiran, Alnylam is entitled to receive royalties on sales (if any), as well as milestone payments

(m) FDA granted Regenerative Medicine Advanced Therapy ("RMAT") designation

2 unchanged sentences

(p) Studied in combination with ubamatamab

(q) Geographic atrophy also studied with cemdisiran monotherapy

(r) Refer to "Additional Information - Clinical Development Programs - EYLEA HD" for further details

Additional Information - Clinical Development Programs

In April 2025, the FDA issued a CRL regarding the sBLA for the addition of extended dosing intervals.

The FDA indicated that the submitted data did not support extended dosing intervals greater than every 16 weeks.

The Company is evaluating next steps.

The FDA issued a CRL for the EYLEA HD pre-filled syringe in April 2025, and the FDA subsequently accepted the Company's resubmission of its regulatory application for the EYLEA HD pre-filled syringe.

However, the Company now expects regulatory approvals to be delayed for its currently pending FDA applications for EYLEA HD (pre-filled syringe, every-four-week dosing, and for the treatment of macular edema following retinal vein occlusion), which have PDUFA dates in August 2025.

The anticipated delay is related to observations from an FDA general site inspection at the filler for EYLEA HD in these regulatory applications, Catalent Indiana LLC (recently acquired by Novo Nordisk A/S).

This inspection was completed in mid-July and was not specific to EYLEA HD.

Based on the Company's review of the observations and Novo's proposed response to the FDA, along with the progress the Company has made with alternate third-party fillers, the Company anticipates an expeditious resolution of the filling issues for EYLEA HD.

In August 2025, the FDA extended the target action dates for the Company's FDA applications for EYLEA HD (pre-filled syringe, every-four-week dosing, and for the treatment of RVO).

The delay resulted from observations from a July 2025 FDA general site inspection (not specific to EYLEA HD) at Catalent Indiana, LLC ("Catalent"), part of Novo Nordisk A/S, the manufacturing filler in the EYLEA HD BLA.

The FDA extended the review periods after determining that the information submitted by the manufacturing filler in August 2025 to address the observations constituted a major amendment to each regulatory application.

In October 2025, the Company was notified by Catalent that they received an official action indicated ("OAI") letter from the FDA citing unresolved issues related to a July 2025 FDA general site inspection.

On October 27, 2025, the FDA issued a CRL for the pre-filled syringe sBLA.

The sole approvability issue cited in the CRL relates to unresolved inspection findings at Catalent.

The Company is planning to submit by January 2026 an application to include a new pre-filled syringe manufacturing filler in the EYLEA HD BLA.

In addition, the Company has submitted an application to include an additional vial filler, should this be needed for approval of every-four-week dosing and RVO label enhancements, with an FDA decision regarding this new vial filler expected by late December 2025.

In May 2025, the Company and Sanofi announced that a Phase 3 trial, AERIFY-1, in adults who were former smokers with inadequately controlled COPD met the primary endpoint of significantly reducing moderate or severe acute exacerbations by 27% compared to placebo at week 52, a clinically meaningful benefit.

1 unchanged sentence

The safety profile of itepekimab observed in the Phase 3 trials was consistent with prior clinical trials.

The Company and Sanofi are reviewing the data and will discuss with regulatory authorities to evaluate next steps.

The Company and Sanofi are evaluating next steps.

In April 2025, a pre-planned interim analysis was conducted on two ongoing Phase 2/3 studies evaluating the combination of fianlimab and cemiplimab in first-line advanced NSCLC.

Due to limited follow-up, the Phase 2 portion of the studies will continue unchanged until additional data are available.

The next analyses for these studies are expected in the first quarter of 2026, at which time a decision whether to advance to Phase 3 is expected to be made.

The next analyses for these studies are expected in the first half of 2026, at which time a decision whether to advance to Phase 3 is expected to be made.

No new safety signals were observed in either study.

6 unchanged sentences

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, 2025, the total amount of our contingent reimbursement obligation to Sanofi (i.e., "development balance") in connection with such development expenses was approximately $1.2 billion.

As of September 30, 2025, the total amount of our contingent reimbursement obligation to Sanofi (i.e., "development balance") in connection with such development expenses was approximately $905 million.

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

26 unchanged sentences

In addition, we are obligated to make additional payments upon achievement of development, regulatory, and sales milestones, as well as a low double-digit 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.

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 our products, including EYLEA HD and Dupixent.

We expect to continue to incur substantial expenses related to our research and development activities, and our research and development activities and related costs which are not reimbursed by collaborators are expected to expand and require additional resources.

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;

the scope and progress of our research and

development efforts;

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;

the timing of certain expenses;

4 unchanged sentences

Three Months Ended

Six Months Ended

September 30,

Nine Months Ended

September 30,

(In millions, except per share data) 2025 2024 2025 2024

9 unchanged sentences

Three Months Ended

Six Months Ended

September 30,

Nine Months Ended

September 30,

(In millions) 2025 2024 $ Change 2025 2024 $ Change

14 unchanged sentences

42.8 32.4 10.4 114.9 87.6 27.3

Inmazeb - ROW

Inmazeb - U.S.

— 35.6 (35.6) — 36.6 (36.6)

Other products - Global

0.8 — 0.8 0.8 — 0.8

Total net product sales $ 1,587.7 $ 1,946.4 $ (358.7) $ 4,634.3 $ 5,626.3 $ (992.0)

6 unchanged sentences

Net Product Sales

Net product sales of EYLEA HD increased for the three and six months ended June 30, 2025, compared to the same periods in 2024, due to higher sales volumes.

Net product sales of EYLEA for the three and six months ended June 30, 2025, compared to the same periods in 2024, were negatively impacted by (i) lower sales volumes as a result of continued competitive pressures (as described below), loss in market share to compounded bevacizumab due to patient affordability constraints, and the continued transition of patients to EYLEA HD, and (ii) a lower net selling price.

Net product sales of EYLEA HD increased for the three and nine months ended September 30, 2025, compared to the same periods in 2024, due to higher sales volumes, partly offset by a lower net selling price.

Net product sales of EYLEA for the three and nine months ended September 30, 2025, compared to the same periods in 2024, were negatively impacted by (i) lower sales volumes as a result of continued competitive pressures (as described below), loss in market share to compounded bevacizumab due to patient affordability constraints, and the continued transition of patients to EYLEA HD, and (ii) a lower net selling price.

EYLEA net product sales have been, and are likely to continue to be, negatively impacted by increased competition from other anti-VEGF products, including biosimilars, as well as the transition of patients from EYLEA to EYLEA HD.

5 unchanged sentences

Three Months Ended

Six Months Ended

September 30,

Nine Months Ended

September 30,

(In millions) 2025 2024 2025 2024

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Three Months Ended

Six Months Ended

September 30,

Nine Months Ended

September 30,

(In millions) 2025 2024 2025 2024

9 unchanged sentences

(a) See "Collaboration, License, and Other Agreements - Sanofi" above for additional details on our contingent reimbursement obligation

The increase in our share of profits for the three and six months ended June 30, 2025, compared to the same periods in 2024, 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, 2025, compared to the same periods in 2024, was driven by higher profits associated with an increase in Dupixent sales.

Bayer Collaboration Revenue

Three Months Ended

Six Months Ended

September 30,

Nine Months Ended

September 30,

(In millions) 2025 2024 2025 2024

5 unchanged sentences

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

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

Bayer records net product sales of EYLEA 8 mg and EYLEA outside the United States, and we and Bayer share profits on such sales.

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

Six Months Ended

September 30,

Nine Months Ended

September 30,

(In millions) 2025 2024 2025 2024

9 unchanged sentences

(a) See "Collaboration, License, and Other Agreements - Bayer" above for additional details on our contingent reimbursement obligation

The decrease in our share of profits for the three and nine months ended September 30, 2025, compared to the same periods in 2024, was driven by lower profits associated with a decrease in EYLEA sales outside the United States.

Other Revenue

Other revenue increased for the three and six months ended June 30, 2025, compared to the same periods in 2024.

Other revenue included royalties and share of profits earned in connection with license agreements of $117.8 million and $69.4 million for the three months ended June 30, 2025 and 2024, respectively, and $187.6 million and $116.9 million for the six months ended June 30, 2025 and 2024, respectively.

Other revenue increased for the three and nine months ended September 30, 2025, compared to the same periods in 2024.

Other revenue included royalties and share of profits earned in connection with license agreements of $165.4 million and $90.7 million for the three months ended September 30, 2025 and 2024, respectively, and $353.0 million and $207.5 million for the nine months ended September 30, 2025 and 2024, respectively.

Operating Expenses

Three Months Ended

Six Months Ended

September 30,

Nine Months Ended

September 30,

(In millions, except headcount data) 2025 2024 Change 2025 2024 Change

7 unchanged sentences

240.6 228.8 11.8 694.0 644.6 49.4

Other operating expense (income), net — 14.6 (14.6) — 29.9 (29.9)

Other operating (income) expense, net (10.0) 8.0 (18.0) (10.0) 37.9 (47.9)

Total operating expenses $ 2,727.5 $ 2,541.2 $ 186.3 $ 7,760.6 $ 7,412.3 $ 348.3

2 unchanged sentences

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

Operating expenses included stock-based compensation expense of $251.7 million and $223.2 million for the three months ended June 30, 2025 and 2024, respectively, and $507.4 million and $453.3 million for the six months ended June 30, 2025 and 2024, respectively.

Operating expenses included stock-based compensation expense of $237.0 million and $225.1 million for the three months ended September 30, 2025 and 2024, respectively, and $744.4 million and $678.4 million for the nine months ended September 30, 2025 and 2024, respectively.

Research and Development Expenses

6 unchanged sentences

Three Months Ended

Six Months Ended

September 30,

Nine Months Ended

September 30,

(In millions) 2025 2024 *

$ Change 2025 2024* $ Change

$ Change 2025 2024 *

Direct research and development expenses:

Lynozyfic (linvoseltamab)

$ 53.6 $ 23.1 $ 30.5 $ 85.3 $ 86.4 $ (1.1)

Fianlimab $ 55.8 $ 53.4 $ 2.4 $ 155.3 $ 168.4 $ (13.1)

1 unchanged sentence

50.1 33.8 16.3 119.1 94.1 25.0

Lynozyfic (linvoseltamab) 32.8 25.4 7.4 118.1 111.8 6.3

28.1 24.2 3.9 90.9 67.8 23.1

Dupixent (dupilumab) 27.6 31.3 (3.7) 81.1 96.4 (15.3)

23.6 5.1 18.5 39.1 12.2 26.9

EYLEA HD (aflibercept) 8 mg

2 unchanged sentences

17.9 6.4 11.5 57.0 18.7 38.3

16.5 17.6 (1.1) 45.6 49.3 (3.7)

Other product candidates in clinical development and other research programs

14 unchanged sentences

* 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 $139.0 million and $122.4 million for the three months ended June 30, 2025 and 2024, respectively, and $280.0 million and $245.4 million for the six months ended June 30, 2025 and 2024, respectively.

Research and development expenses included stock-based compensation expense of $125.1 million and $123.7 million for the three months ended September 30, 2025 and 2024, respectively, and $405.1 million and $369.1 million for the nine months ended September 30, 2025 and 2024, 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.

3 unchanged sentences

We are unable to reasonably estimate if our product candidates in clinical development will generate material product revenues and net cash inflows.

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

Acquired IPR&D expenses for the three and nine months ended September 30, 2025 included an $80.0 million up-front payment in connection with our license agreement with Hansoh Pharmaceuticals Group Company Limited.

Acquired IPR&D expenses 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.

Selling, General, and Administrative Expenses

Selling, general, and administrative expenses decreased for the three and six months ended June 30, 2025, compared to the same periods in 2024, primarily due to lower charitable contributions to an independent not-for-profit patient assistance organization.

Selling, general, and administrative expenses included stock-based compensation expense of $91.8 million and $82.6 million for the three months ended June 30, 2025 and 2024, respectively, and $187.0 million and $168.8 million for the six months ended June 30, 2025 and 2024, respectively.

Selling, general, and administrative expenses decreased for the three and nine months ended September 30, 2025, compared to the same periods in 2024, primarily due to lower charitable contributions to an independent not-for-profit patient assistance organization.

Selling, general, and administrative expenses included stock-based compensation expense of $92.0 million and $83.1 million for the three months ended September 30, 2025 and 2024, respectively, and $279.0 million and $251.9 million for the nine months ended September 30, 2025 and 2024, respectively.

Cost of Goods Sold

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September 30,

Nine Months Ended

September 30,

(In millions, except gross margin on net product sales)

6 unchanged sentences

Gross profit is calculated as net product sales (see "Net Product Sales" section above) less cost of goods sold.

Gross margin on net product sales decreased for the three and six months ended June 30, 2025, compared to the same periods in 2024, partly due to ongoing investments to support our manufacturing operations and higher inventory write-offs and reserves.

Other Operating Expense (Income)

Other operating expense (income), net, for the three and six months ended June 30, 2024 reflected a charge of $14.6 million and $29.9 million, 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.

Gross margin on net product sales decreased for the three and nine months ended September 30, 2025, compared to the same periods in 2024, partly due to ongoing investments to support our manufacturing operations.

In addition, gross margin on net product sales decreased due to higher amortization expense associated with our Libtayo intangible asset as each quarter we record additions to the intangible asset related to royalties due to Sanofi.

Other Operating (Income) Expense

Other operating (income) expense, net, for the nine months ended September 30, 2024 reflected a charge of $37.9 million 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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Six Months Ended

September 30,

Nine Months Ended

September 30,

(In millions) 2025 2024 2025 2024

Unrealized gains on equity securities, net

Gains on marketable and other securities, net

$ 577.7 $ 134.7 $ 967.6 $ 331.2

5 unchanged sentences

Three Months Ended

Six Months Ended

September 30,

Nine Months Ended

September 30,

(In millions, except effective tax rate) 2025 2024 2025 2024

3 unchanged sentences

17.2 % 10.2 % 12.6 % 8.6 %

Our effective tax rate for the three and six months ended June 30, 2025 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, federal tax credits for research activities, and, in the second quarter of 2025, the release of existing uncertain tax positions recognized upon the effective settlement of the IRS audit of our 2017 and 2018 federal income tax returns.

The release of liabilities for uncertain tax positions reduced our effective tax rate for the three and six months ended June 30, 2025 by 3.9% and 2.4%, respectively.

The change in our effective tax rate for the three and six months ended June 30, 2025, compared to the same periods in 2024, was primarily impacted by the net change in uncertain tax positions, as well as lower tax benefits from less stock option exercises.

On July 4, 2025, bill H.R.

1, commonly referred to as the "One Big Beautiful Bill Act" or "OBBBA", was signed into law.

1, commonly referred to as the "One Big Beautiful Bill Act" or "OBBBA," was signed into law, with certain provisions effective in 2025 and others in 2026.

The OBBBA significantly revises U.S.

corporate income tax laws by, among other things, restoring the option for immediate expense recognition for U.S.-based research and development expenditures and making permanent the first-year bonus depreciation on qualified property.

corporate income tax laws by, among other things, restoring the option for immediate expense recognition for U.S.-based research and development expenditures and making permanent the ability to claim first-year bonus depreciation on qualified property.

The OBBBA also modifies U.S.

taxation on foreign earnings by, among other things, changing the tax rates for global intangible low-taxed income (now known as Net CFC Tested Income) and foreign-derived intangible income (now known as foreign-derived deduction eligible income), modifying the allocation of expenses in calculating foreign tax credits, as well as changing foreign tax credit limitations.

We are in the process of evaluating the impact of the OBBBA on our financial statements.

As a result of the OBBBA being signed into law, we recognized a charge of $44.5 million in the third quarter of 2025 related to the re-measurement of our U.S.

net deferred tax assets.

Our effective tax rate for the three and nine months ended September 30, 2025 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 federal tax credits for research activities, partially offset by the impact of the OBBBA being signed into law.

In addition, our effective tax rate for the nine months ended September 30, 2025 was positively impacted by the release of liabilities for uncertain tax positions recognized upon the effective settlement of the IRS audit of our 2017 and 2018 federal income tax returns in the second quarter of 2025, which reduced our effective tax rate for the nine months ended September 30, 2025 by 1.4%.

The increase in our effective tax rate for the three and nine months ended September 30, 2025, compared to the same periods in 2024, was primarily impacted by the net change in uncertain tax positions, as well as lower tax benefits from less stock option exercises and the enactment of the OBBBA.

Liquidity and Capital Resources

Our financial condition is summarized as follows:

June 30, December 31,

September 30, December 31,

(In millions) 2025 2024 $ Change

11 unchanged sentences

Finance lease liabilities $ 720.0 $ 720.0 $ —

As of June 30, 2025, 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, 2025 and 2024

Six Months Ended

As of September 30, 2025, 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, 2025 and 2024

Nine Months Ended

September 30,

(In millions) 2025 2024 $ Change

Cash flows provided by operating activities $ 2,189.5 $ 1,866.5 $ 323.0

Cash flows used in investing activities

Cash flows provided by (used in):

Operating activities

$ 3,808.2 $ 3,157.7 $ 650.5

Cash flows used in financing activities

Investing activities

$ (849.4) $ (2,818.7) $ 1,969.3

Financing activities

$ (2,935.3) $ (1,065.0) $ (1,870.3)

Cash Flows from Investing Activities

Capital expenditures for the six months ended June 30, 2025 included costs incurred in connection with the expansion of our research, preclinical manufacturing, and support facilities at our Tarrytown, New York corporate headquarters.

We expect to incur capital expenditures of $880 million to $950 million for the full year of 2025, including in connection with the continued expansion of our facilities in Tarrytown, New York.

Payments for intangible assets for the six months ended June 30, 2025 included $155.0 million related to our purchase of an FDA Rare Pediatric Disease Priority Review Voucher from a third party in the second quarter of 2025.

Capital expenditures for the nine months ended September 30, 2025 included costs incurred in connection with the expansion of our research, preclinical manufacturing, and support facilities at our Tarrytown, New York corporate headquarters.

We expect to incur capital expenditures of $850 million to $890 million for the full year of 2025.

Payments for intangible assets for the nine months ended September 30, 2025 included $155.0 million related to our purchase of an FDA Rare Pediatric Disease Priority Review Voucher from a third party in the second quarter of 2025.

Cash Flows from Financing Activities

2 unchanged sentences

The programs have no time limit and can be discontinued at any time.

As of June 30, 2025, $2.814 billion remained available for share repurchases under the programs.

In each of the first and second quarters of 2025, our board of directors declared quarterly cash dividends of $0.88 per share on our Common Stock and Class A Stock.

As of September 30, 2025, $2.156 billion remained available for share repurchases under the programs.

In each of the first, second, and third quarters of 2025, our board of directors declared quarterly cash dividends of $0.88 per share on our Common Stock and Class A Stock.

Each quarterly dividend was paid to our shareholders in the quarter in which the dividend was declared.

Additionally, in July 2025, our board of directors declared a cash dividend of $0.88 per share on our Common Stock and Class A Stock.

The dividend will be payable on September 3, 2025 to our shareholders of record as of August 18, 2025.

Additionally, in October 2025, our board of directors declared a cash dividend of $0.88 per share on our Common Stock and Class A Stock.

The dividend will be payable on December 5, 2025 to our shareholders of record as of November 20, 2025.

Critical Accounting Estimates

1 unchanged sentence

"Management's Discussion and Analysis of Financial Condition and Results of Operations" of our Annual Report on Form 10-K for the fiscal year ended December 31, 2024 (filed February 5, 2025).

There have been no material changes to critical accounting estimates during the six months ended June 30, 2025.

There have been no material changes to critical accounting estimates during the nine months ended September 30, 2025.

Future Impact of Recently Issued Accounting Standards

1 unchanged sentence

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