What changed in this filing

/stocks — the workspaceLOADING

Item 2. Management’s Discussion and Analysis

2025-08-01 compared with 2025-04-29 · 156 added, 103 removed, 513 unchanged (34% of the section changed)

34 unchanged sentences

Three Months Ended

Six Months Ended

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

27 unchanged sentences

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

Bullous pemphigoid

Libtayo ® (cemiplimab) Injection

13 unchanged sentences

Polyarticular juvenile idiopathic arthritis ("pJIA")

REGEN-COV ®(d)

Evkeeza ® (evinacumab) Injection (e)

Evkeeza ® (evinacumab) Injection (d)

HoFH (in adults, adolescents, and pediatrics)

10 unchanged sentences

Disease Territory

ARCALYST ® (rilonacept) Injection (f)

ARCALYST ® (rilonacept) Injection (e)

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

1 unchanged sentence

Recurrent pericarditis (in adults and adolescents)

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

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

Metastatic colorectal cancer ("mCRC") a a a

4 unchanged sentences

(b) In collaboration with Sanofi

(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.

(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

(c) The Company is 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) The Company is 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

(e) Kiniksa is responsible for the development and commercialization of ARCALYST

(f) Sanofi is responsible for the development and commercialization of ZALTRAP

The table below includes net product sales of Regeneron-discovered products.

18 unchanged sentences

$ 42.1 $ 30.0 $ 72.1 $ 30.9 $ 21.9 $ 52.8 37 %

Six Months Ended

2025 2024 % Change

(In millions) U.S.

ROW Total (Total Sales)

$ 700.0 $ 388.1 $ 1,088.1 $ 504.2 $ 74.3 $ 578.5 88 %

$ 1,490.3 $ 1,447.4 $ 2,937.7 $ 2,432.1 $ 1,682.9 $ 4,115.0 (29 %)

Total EYLEA HD and EYLEA

$ 2,190.3 $ 1,835.5 $ 4,025.8 $ 2,936.3 $ 1,757.2 $ 4,693.5 (14 %)

$ 5,834.4 $ 2,175.8 $ 8,010.2 $ 4,828.2 $ 1,805.0 $ 6,633.2 21 %

$ 440.3 $ 221.3 $ 661.6 $ 341.6 $ 219.7 $ 561.3 18 %

$ 122.6 $ 292.7 $ 415.3 $ 126.1 $ 267.1 $ 393.2 6 %

$ 168.5 $ 100.1 $ 268.6 $ 115.1 $ 88.7 $ 203.8 32 %

Other products (e)

$ 73.2 $ 53.5 $ 126.7 $ 56.2 $ 40.8 $ 97.0 31 %

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

23 unchanged sentences

–Pre-filled syringe (U.S.)

–RVO (U.S.) (p)

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

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

–Presented positive three-year data from extension study of Phase 3 wAMD trial at Angiogenesis, Exudation, and Degeneration ("Angiogenesis") 2025 annual meeting

1 unchanged sentence

–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 (target action date of August 19, 2025)

–FDA decision on sBLA for every 4-week dosing regimen (target action date of August 19, 2025)

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

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

Pozelimab (f) (REGN3918)

6 unchanged sentences

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

–Bullous pemphigoid (c)

–Chronic pruritus of unknown origin ("CPUO")

2 unchanged sentences

–CSU in adults and adolescents (EU)

–Bullous pemphigoid (U.S.

–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

2 unchanged sentences

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

–FDA decision on sBLA (target action date of June 20, 2025) and EC decision on regulatory submission (first half 2026) for bullous pemphigoid

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

Clinical Program (continued)

4 unchanged sentences

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

–Approved by FDA for bullous pemphigoid

Kevzara (sarilumab) (b)

6 unchanged sentences

–Chronic rhinosinusitis without nasal polyposis ("CRSsNP")

–Report results from Phase 3 AERIFY-1 and AERIFY-2 trials in COPD (mid-2025)

–Reported that Phase 3 trial (AERIFY-1) in COPD met its primary endpoint;

second Phase 3 trial (AERIFY-2) did not meet same primary endpoint

REGN5713-5715

14 unchanged sentences

–Adjuvant CSCC (U.S.

–Reported positive interim data from Phase 3 study in adjuvant CSCC

–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 and EC decision on regulatory submission for adjuvant CSCC

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

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 (2025)

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

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

Clinical Program (continued)

2 unchanged sentences

Select Upcoming

Fianlimab (f) (REGN3767)

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)

2 unchanged sentences

Bispecific antibody targeting MUC16 and CD3

–Platinum-resistant ovarian cancer

–Ovarian cancer

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

Bispecific antibody targeting MUC16 and CD28

–Ovarian cancer

Nezastomig (REGN5678)

11 unchanged sentences

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

–Report results from Phase 3 cemdisiran combination study in myasthenia gravis (second half 2025)

–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

Ordspono (odronextamab)

3 unchanged sentences

–DLBCL (c)(e)

–FDA decision on BLA for relapsed/refractory FL (target action date of July 30, 2025)

Clinical Program (continued)

Phase 2 Phase 3 Regulatory

2025 Events to Date

Select Upcoming

Lynozyfic (linvoseltamab) (f) (REGN5458)

–FDA issued CRL for BLA for relapsed/refractory FL

Lynozyfic (linvoseltamab) (f)

Bispecific antibody targeting BCMA and CD3

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

–Earlier (pre-malignant) multiple myeloma

2 unchanged sentences

–Multiple myeloma (c)(e)

–Relapsed/refractory multiple myeloma (U.S.)

–Approved by EC for relapsed/refractory multiple myeloma

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

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

–FDA decision on BLA for relapsed/refractory multiple myeloma (target action date of July 10, 2025)

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

2 unchanged sentences

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

Antibody to Factor XI

–Initiate Phase 3 program (2025)

Antibody to Factor XI

–Initiate Phase 3 program (2025)

Antibody to Factor XI (A2 domain)

–Initiate randomized Phase 2 study (second half 2025)

Antibody to Factor XI (catalytic domain)

–Venous thromboembolism after total knee replacement surgery

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

Antibody to IL2Rg

–Aplastic anemia

–Discontinued study in aplastic anemia

Antibody to TMPRSS6

6 unchanged sentences

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

Trevogrumab (f) (REGN1033)

Antibody to myostatin (GDF8)

–Report results from Phase 2 study in obesity (second half 2025)

Clinical Program (continued)

2 unchanged sentences

Select Upcoming

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)

Mibavademab (f)(o) (REGN4461)

13 unchanged sentences

–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 (mid-2025)

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

4 unchanged sentences

(e) FDA granted Fast Track designation

(f) Sanofi did not opt-in to or elected not to continue to co-develop the product candidate.

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

(f) Sanofi is entitled to receive royalties on sales of the product, if any

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

8 unchanged sentences

(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

(p) Used priority review voucher in connection with this regulatory review

(p) Studied in combination with ubamatamab

Additional Information - Clinical Development Programs

On April 18, 2025, the FDA issued a CRL regarding the sBLA for the addition of extended dosing intervals.

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 the FDA's decision.

The FDA issued a CRL for the EYLEA HD pre-filled syringe on April 23, 2025.

The Company held several teleconferences with the FDA to better understand the contents of the CRL, and believes the key outstanding issue relates to a question posed by the FDA to a third-party component supplier.

This component supplier has expeditiously responded to FDA requests for information.

The CRL did not identify any issues with the safety or efficacy of EYLEA HD, the usability of the device, proposed labelling, or pre-approval inspection findings.

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 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.

A second Phase 3 trial, AERIFY-2, did not meet the same primary endpoint, although a benefit was seen earlier in the trial.

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.

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.

2 unchanged sentences

No new safety signals were observed in either study.

Ordspono (odronextamab)

On July 30, 2025, the FDA issued a CRL for the BLA for odronextamab in relapsed/refractory follicular lymphoma after two or more lines of systemic therapy, which was also impacted by the Catalent Indiana LLC site inspection (as described in the "EYLEA HD" section above).

Collaboration, License, and Other Agreements

3 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 March 31, 2025, the total amount of our contingent reimbursement obligation to Sanofi (i.e., "development balance") in connection with such development expenses was approximately $1.453 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.

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.

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.

We co-commercialize Dupixent in the United States and in certain countries outside the United States.

11 unchanged sentences

Following designation of a lead candidate, the parties may further advance such lead candidate under either a co-development and co-commercialization agreement or a license agreement.

The initial target nomination and discovery period of five years has been automatically extended until the earlier of seven years from the effective date of the collaboration or the achievement of certain

milestones (the "Research Term").

In addition, we have an option to extend the Research Term for an additional five-year period for a research extension fee of $300.0 million.

3 unchanged sentences

We have the right to select targets under the license and collaboration agreement until April 2026.

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

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

Each company has the opportunity to lead potential development and commercialization of product candidates for a 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.

1 unchanged sentence

If nex-z is commercialized, Intellia will lead commercialization activities and we will be entitled to 25% of any profits.

In July 2025, our license agreement with Hansoh Pharmaceuticals Group Company Limited to acquire development and commercial rights outside of mainland China, Hong Kong, and Macau for HS-20094 (a dual GLP-1/GIP receptor agonist currently in Phase 3 clinical development in China) became effective.

In-licensing a late-stage GLP1/GIP agonist enables us to study combinations with our products and product candidates in order to address muscle loss and potentially other comorbidities of obesity, such as cardiovascular diseases, diabetes, and liver conditions.

Under the terms of the agreement, we made an $80.0 million up-front payment in July 2025.

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.

2 unchanged sentences

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 scope and progress of our research and

development efforts;

the timing of certain expenses;

4 unchanged sentences

Three Months Ended

Six Months Ended

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

4 unchanged sentences

Income before income taxes 1,518.7 1,628.1 2,423.7 2,328.8

Income tax expense (benefit)

Income tax expense

127.1 195.8 223.4 174.5

Net income $ 1,391.6 $ 1,432.3 $ 2,200.3 $ 2,154.3

1 unchanged sentence

Three Months Ended

(In millions) 2025 2024 $ Change

Six Months Ended

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

Net product sales:

14 unchanged sentences

Inmazeb - ROW

— — — — 1.0 (1.0)

Total net product sales $ 1,631.0 $ 1,918.6 $ (287.6) $ 3,046.6 $ 3,679.9 $ (633.3)

6 unchanged sentences

Net Product Sales

Net product sales of EYLEA HD increased for the three months ended March 31, 2025, compared to the same period in 2024, primarily due to higher sales volumes.

Net product sales of EYLEA for the three months ended March 31, 2025, compared to the same period in 2024, were negatively impacted by (i) lower volume 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.

In addition, total EYLEA and EYLEA HD net product sales were negatively impacted by lower wholesaler inventory levels at the end of the first quarter of 2025 compared to the end of the fourth quarter of 2024.

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.

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.

The magnitude and duration of such impact is presently unknown.

For more information, see Part I, Item 1A.

For more information, see Part II, Item 1A.

"Risk Factors - Risks Related to Commercialization of Our Marketed Products, Product Candidates, and New Indications for Our Marketed Products - We are substantially dependent on the success of EYLEA, EYLEA HD, and Dupixent " and " The commercial success of our products and product candidates is subject to significant competition - Marketed Products." In addition, if independent not-for-profit patient assistance funds that provide copay assistance are unable to support eligible patients, this will likely have a continued negative impact on patient affordability resulting in lower utilization of higher-cost anti-VEGF agents.

2 unchanged sentences

Three Months Ended

Six Months Ended

(In millions) 2025 2024 2025 2024

2 unchanged sentences

Reimbursement for manufacturing of commercial supplies (a)

161.5 157.3 326.6 263.1

Total Sanofi collaboration revenue $ 1,443.6 $ 1,145.6 $ 2,626.8 $ 2,055.4

3 unchanged sentences

Three Months Ended

Six Months Ended

(In millions) 2025 2024 2025 2024

7 unchanged sentences

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

29% 27% 28% 26%

(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 months ended March 31, 2025, compared to the same period in 2024, was driven by higher profits associated with Dupixent sales.

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.

Bayer Collaboration Revenue

Three Months Ended

Six Months Ended

(In millions) 2025 2024 2025 2024

2 unchanged sentences

Reimbursement for manufacturing of commercial supplies (a)

31.6 22.1 58.2 44.2

Total Bayer collaboration revenue $ 415.0 $ 375.1 $ 758.9 $ 731.1

3 unchanged sentences

Three Months Ended

Six Months Ended

(In millions) 2025 2024 2025 2024

EYLEA 8 mg and EYLEA net product sales outside the United States $ 977.7 $ 907.8 $ 1,835.5 $ 1,757.2

$ 857.8 $ 849.4

Regeneron's share of collaboration profit from sales outside the United States

5 unchanged sentences

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

39% 39% 38% 39%

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

Other Revenue

Other revenue decreased for the three months ended March 31, 2025, compared to the same period in 2024, primarily due to lower reimbursements for manufacturing commercial supplies as a result of timing of shipments, partially offset by higher royalties and share of profits earned in connection with license agreements.

Other revenue for the three months ended March 31, 2025 and 2024 included $69.9 million and $47.4 million, respectively, of royalties and share of profits earned in connection with license agreements.

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.

Operating Expenses

Three Months Ended

(In millions, except headcount data) 2025 2024 Change

Six Months Ended

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

Research and development (a)

11 unchanged sentences

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

Operating expenses for the three months ended March 31, 2025 and 2024 included $255.7 million and $230.1 million, respectively, of stock-based compensation expense related to equity awards granted under our long-term incentive plans.

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.

Research and Development Expenses

6 unchanged sentences

Three Months Ended

Six Months Ended

(In millions) 2025 2024 *

$ Change 2025 2024* $ Change

Direct research and development expenses:

Fianlimab $ 51.5 $ 64.0 $ (12.5)

Lynozyfic (linvoseltamab)

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

EYLEA HD (aflibercept) 8 mg

30.3 21.9 8.4

28.3 19.3 9.0

Fianlimab 47.9 51.0 (3.1) 99.4 115.0 (15.6)

Ordspono (odronextamab)

42.8 34.3 8.5 69.0 60.3 8.7

34.5 24.2 10.3 62.8 43.6 19.2

Dupixent (dupilumab) 28.1 28.8 (0.7) 53.6 65.1 (11.5)

23.6 5.1 18.5 39.1 12.2 26.9

EYLEA HD (aflibercept) 8 mg

22.6 25.1 (2.5) 52.9 47.1 5.8

Libtayo (cemiplimab) 18.5 20.2 (1.7) 39.3 42.8 (3.5)

16 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 $141.0 million and $123.0 million for the three months ended March 31, 2025 and 2024, respectively.

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.

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 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.

2 unchanged sentences

Selling, General, and Administrative Expenses

Selling, general, and administrative expenses decreased for the three months ended March 31, 2025, compared to the same period in 2024, due to lower charitable contributions to an independent not-for-profit patient assistance organization and lower costs associated with the estimated amount payable for the Branded Prescription Drug Fee.

Selling, general, and administrative expenses also included stock-based compensation expense of $95.2 million and $86.2 million for the three months ended March 31, 2025 and 2024, respectively.

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.

Cost of Goods Sold

Three Months Ended

Six Months Ended

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

2025 2024 2025 2024

Cost of goods sold

1 unchanged sentence

Gross margin on net product sales (a)

83% 87% 82% 86%

(a) Gross margin on net product sales represents gross profit expressed as a percentage of total net product sales recorded by the Company.

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 months ended March 31, 2025, compared to the same period in 2024, primarily due to higher inventory write-offs and reserves.

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 months ended March 31, 2024 reflected a charge of $15.3 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 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.

Other Income (Expense)

Three Months Ended

Six Months Ended

(In millions) 2025 2024 2025 2024

Unrealized gains (losses) on equity securities, net $ 139.7 $ (196.2)

Unrealized gains on equity securities, net

$ 249.8 $ 392.5 $ 389.5 $ 196.3

Interest income 174.8 179.4 348.3 340.9

4 unchanged sentences

Three Months Ended

Six Months Ended

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

Income tax expense (benefit)

Income tax expense

$ 127.1 $ 195.8 $ 223.4 $ 174.5

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8.4 % 12.0 % 9.2 % 7.5 %

Our effective tax rate for the three months ended March 31, 2025 was positively impacted, compared to the U.S.

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 and federal tax credits for research activities.

Our effective tax rate increased for the three months ended March 31, 2025, compared to the same period in 2024, due to lower tax benefits from less stock option exercises.

Our 2017 and 2018 federal income tax returns are currently under audit by the IRS, and we expect to be effectively settled with the IRS during the second quarter of 2025.

The unrecognized tax benefits for the years under examination exceed the expected payment amount;

therefore, we expect to recognize a net tax benefit upon conclusion of such examinations.

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.

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.

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.

Liquidity and Capital Resources

Our financial condition is summarized as follows:

March 31, December 31,

June 30, December 31,

(In millions) 2025 2024 $ Change

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Finance lease liabilities $ 720.0 $ 720.0 $ —

As of March 31, 2025, 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, 2025 and 2024

Three Months Ended

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

(In millions) 2025 2024 $ Change

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

Cash flows provided by (used in) investing activities

Cash flows used in investing activities

$ (446.5) $ (2,244.3) $ 1,797.8

Cash flows (used in) provided by financing activities

Cash flows used in financing activities

$ (2,217.4) $ (431.0) $ (1,786.4)

Cash Flows from Investing Activities

Capital expenditures for the three months ended March 31, 2025 included costs incurred in connection with the expansion of our research, preclinical manufacturing, and support facilities at our Tarrytown, New York corporate headquarters.

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.

Cash Flows from Financing Activities

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

As of March 31, 2025, an aggregate of $3.874 billion remained available for share repurchases under the programs.

In February 2025, our board of directors declared our first quarterly cash dividend.

In March 2025, we paid a dividend of $0.88 per share on our Common Stock and Class A Stock to our shareholders.

Additionally, in April 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 June 6, 2025 to shareholders of record as of May 20, 2025.

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.

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.

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, 2024 (filed February 5, 2025).

There have been no material changes to critical accounting estimates during the three months ended March 31, 2025.

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

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