What changed in this filing

/stocks — the workspaceLOADING

Item 1. Financial Statements

2025-10-28 compared with 2025-08-01 · 164 added, 103 removed, 643 unchanged (29% of the section changed)

3 unchanged sentences

(In millions, except per share data)

June 30, December 31,

September 30, December 31,

Current assets:

45 unchanged sentences

Three Months Ended

Six Months Ended

September 30,

Nine Months Ended

September 30,

Statements of Operations

8 unchanged sentences

Cost of collaboration and contract manufacturing 240.6 228.8 694.0 644.6

Other operating expense (income), net

Other operating (income) expense, net

( 10.0 ) 8.0 ( 10.0 ) 37.9

18 unchanged sentences

Unrealized gain on debt securities 15.7 128.2 75.9 139.6

Gain (loss) on foreign currency translation

Gain on foreign currency translation

0.8 1.9 1.0 1.5

30 unchanged sentences

1.8 — 136.2 0.1 13,490.8 33,680.2 52.5 ( 31.6 ) ( 17,284.7 ) 29,938.9

Issuance of Common Stock for equity awards granted under long-term incentive plans — — 0.1 — 39.8 — — — — 39.8

Common Stock tendered upon exercise of stock options and vesting of restricted stock for employee tax obligations — — ( 0.1 ) — ( 3.0 ) — — — — ( 3.0 )

Issuance/distribution of Common Stock for 401(k) Savings Plan — — — — 17.7 — — — 3.3 21.0

Repurchases of Common Stock — — — — — — — ( 1.1 ) ( 663.0 ) ( 663.0 )

Dividends declared — — — — 1.0 ( 94.4 ) — — — ( 93.4 )

Stock-based compensation charges — — — — 241.0 — — — — 241.0

Net income — — — — — 1,460.0 — — — 1,460.0

Other comprehensive income, net of tax — — — — — — 16.5 — — 16.5

Balance, September 30, 2025

1.8 $ — 136.2 $ 0.1 $ 13,787.3 $ 35,045.8 $ 69.0 ( 32.7 ) $ ( 17,944.4 ) $ 30,957.8

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (Unaudited) (continued)

22 unchanged sentences

Balance, June 30, 2024 1.8 — 134.8 0.1 12,316.9 29,414.6 ( 69.9 ) ( 26.4 ) ( 13,455.9 ) 28,205.8

Issuance of Common Stock for equity awards granted under long-term incentive plans — — 0.6 — 255.7 — — — — 255.7

Common Stock tendered upon exercise of stock options and vesting of restricted stock for employee tax obligations — — ( 0.1 ) — ( 120.2 ) — — — — ( 120.2 )

Issuance/distribution of Common Stock for 401(k) Savings Plan — — — — 20.0 — — — 1.8 21.8

Repurchases of Common Stock — — — — — — — ( 0.6 ) ( 738.3 ) ( 738.3 )

Stock-based compensation charges — — — — 230.4 — — — — 230.4

Net income — — — — — 1,340.6 — — — 1,340.6

Other comprehensive income, net of tax

— — — — — — 130.1 — — 130.1

Balance, September 30, 2024

1.8 $ — 135.3 $ 0.1 $ 12,702.8 $ 30,755.2 $ 60.2 ( 27.0 ) $ ( 14,192.4 ) $ 29,325.9

The accompanying notes are an integral part of the financial statements.

2 unchanged sentences

(In millions)

Six Months Ended

Nine Months Ended

September 30,

Cash flows from operating activities:

12 unchanged sentences

(Decrease) increase in deferred revenue ( 48.6 ) 249.0

( 125.2 ) 206.0

Increase in accounts payable, accrued expenses, and other liabilities 761.5 509.5

9 unchanged sentences

Acquisitions, net of cash acquired

Net cash used in investing activities

( 3.0 ) ( 5.0 )

Net cash used in investing activities ( 849.4 ) ( 2,818.7 )

Cash flows from financing activities:

3 unchanged sentences

Dividends paid

Net cash used in financing activities

( 10.3 ) ( 33.4 )

Net cash used in financing activities ( 2,935.3 ) ( 1,065.0 )

Effect of exchange rate changes on cash, cash equivalents, and restricted cash 0.6 —

Net decrease in cash, cash equivalents, and restricted cash

Net increase (decrease) in cash, cash equivalents, and restricted cash

24.1 ( 726.0 )

27 unchanged sentences

Three Months Ended

June 30, Six Months Ended

September 30, Nine Months Ended

September 30,

(In millions) 2025 2024 2025 2024

10 unchanged sentences

42.8 32.4 114.9 87.6

Rest of world

— 35.6 — 36.6

As of June 30, 2025 and December 31, 2024, the Company had $ 3.581 billion and $ 4.278 billion, respectively, of trade accounts receivable that were recorded within Accounts receivable, net.

The Company had product sales to certain customers that each accounted for more than 10% of total gross product revenue for the three and six months ended June 30, 2025 and 2024.

Other products

$ 1,587.7 $ 1,946.4 $ 4,634.3 $ 5,626.3

As of September 30, 2025 and December 31, 2024, the Company had $ 3.471 billion and $ 4.278 billion, respectively, of trade accounts receivable that were recorded within Accounts receivable, net.

The Company had product sales to certain customers that each accounted for more than 10% of total gross product revenue for the three and nine months ended September 30, 2025 and 2024.

Sales to each of these customers as a percentage of the Company's total gross product revenue are as follows:

Three Months Ended

Six Months Ended

September 30,

Nine Months Ended

September 30,

2025 2024 2025 2024

6 unchanged sentences

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

As of June 30, 2025, the Company's contingent reimbursement obligation to Sanofi in connection with the development balance was approximately $ 1.2 billion.

As of September 30, 2025, the Company's contingent reimbursement obligation to Sanofi in connection with the development balance was approximately $ 905 million.

Sanofi leads commercialization activities for products under the collaboration, subject to the Company's right to co-commercialize such products.

3 unchanged sentences

Statement of Operations Classification Three Months Ended

Six Months Ended

September 30,

Nine Months Ended

September 30,

(In millions) 2025 2024 2025 2024

7 unchanged sentences

The following table summarizes contract balances in connection with the Company's Sanofi collaboration:

June 30, December 31,

September 30, December 31,

(In millions) 2025

8 unchanged sentences

Statement of Operations Classification Three Months Ended

Six Months Ended

September 30,

Nine Months Ended

September 30,

(In millions) 2025 2024 2025 2024

6 unchanged sentences

The following table summarizes contract balances in connection with the Company's Bayer collaboration:

June 30, December 31,

September 30, December 31,

(In millions) 2025

2 unchanged sentences

$ 317.0 $ 216.3

In addition to the collaboration and license agreements discussed above, the Company has other collaboration and license agreements that are not individually significant to its operating results or financial condition at this time.

In addition to the collaboration and license agreements discussed above, the Company has collaboration and license agreements that are not individually significant to its operating results or financial condition at this time.

Pursuant to the terms of those agreements, the Company may (i) incur, and/or get reimbursed for, research and development costs, and/or (ii) be required to pay, and/or may receive, additional amounts contingent upon the occurrence of various future events (e.g., upon the achievement of development and commercial milestones), which in the aggregate could be significant.

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

During the three and nine months ended September 30, 2025, the Company recorded to Acquired IPR&D expense an $ 80.0 million up-front payment in connection with its license agreement with Hansoh Pharmaceuticals Group Company Limited to acquire development and commercial rights outside mainland China, Hong Kong, and Macau for HS-20094 (a dual GLP-1/GIP receptor agonist currently in Phase 3 clinical development in China).

During the three and nine months ended September 30, 2024, the Company recorded to Acquired IPR&D expense a $ 45.0 million development milestone in connection with its collaboration agreement with Sonoma Biotherapeutics, Inc.

In June 2025, the Company purchased an FDA Rare Pediatric Disease Priority Review Voucher from a third party for $ 155.0 million (which was recorded as an indefinite-lived intangible asset).

In July 2025, the Company's license agreement with Hansoh Pharmaceuticals Group Company Limited to acquire development and commercial rights outside 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.

Under the terms of the agreement, the Company made an $ 80.0 million up-front payment (which will be recorded to Acquired in-process research and development expense in the third quarter of 2025).

Net Income Per Share

1 unchanged sentence

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,

(Shares in millions) 2025 2024 2025 2024

2 unchanged sentences

Marketable Securities

Marketable securities as of June 30, 2025 and December 31, 2024 consist of both available-for-sale debt securities of investment grade issuers (see below and Note 6) as well as equity securities of publicly traded companies (see Note 6).

Marketable securities as of September 30, 2025 and December 31, 2024 consist of both available-for-sale debt securities of investment grade issuers (see below and Note 6) as well as equity securities of publicly traded companies (see Note 6).

The following tables summarize the Company's investments in available-for-sale debt securities:

(In millions) Amortized Unrealized Fair

As of June 30, 2025

As of September 30, 2025

Cost Basis Gains Losses Value

15 unchanged sentences

The Company classifies its investments in available-for-sale debt securities based on their contractual maturity dates.

The available-for-sale debt securities as of June 30, 2025 mature at various dates through July 2030.

The available-for-sale debt securities as of September 30, 2025 mature at various dates through February 2038.

The fair values of available-for-sale debt securities by contractual maturity consist of the following:

June 30, December 31,

September 30, December 31,

(In millions) 2025

6 unchanged sentences

(In millions)

As of June 30, 2025

As of September 30, 2025

Fair Value Unrealized Losses

3 unchanged sentences

government and government agency obligations 4,541.8 ( 0.4 ) 161.5 ( 0.1 ) 4,703.3 ( 0.5 )

Commercial paper

Sovereign bonds

56.0 ( 0.1 ) 14.2 — 70.2 ( 0.1 )

Asset-backed securities 365.2 ( 0.1 ) 7.0 — 372.2 ( 0.1 )

$ 13,898.1 $ ( 2.0 ) $ 573.1 $ ( 4.0 ) $ 14,471.2 $ ( 6.0 )

5 unchanged sentences

$ 12,179.8 $ ( 21.0 ) $ 1,219.5 $ ( 18.0 ) $ 13,399.3 $ ( 39.0 )

With respect to marketable securities, for the three and six months ended June 30, 2025 and 2024, amounts reclassified from Accumulated other comprehensive income (loss) into Other income (expense), net were related to realized gains/losses on sales of available-for-sale debt securities.

For the three and six months ended June 30, 2025 and 2024, realized gains/losses on sales of marketable securities were not material.

Amounts reclassified from Accumulated other comprehensive income (loss) into Other income (expense), net, related to realized gains/losses on sales of available-for-sale debt securities;

such amounts were not material for the three and nine months ended September 30, 2025 and 2024.

Fair Value Measurements

5 unchanged sentences

(In millions) Fair Value Measurements at Reporting Date

As of June 30, 2025

As of September 30, 2025

Fair Value Level 1 Level 2 Level 3

26 unchanged sentences

$ 52.3 $ — $ — $ 52.3

(a) Includes equity securities of $ 34.7 million and $ 43.2 million as of June 30, 2025 and December 31, 2024, respectively, that are subject to transfer restrictions expiring in April 2026

(a) Includes equity securities of $ 63.9 million and $ 43.2 million as of September 30, 2025 and December 31, 2024, respectively, that are subject to transfer restrictions expiring in April 2026

In addition to the investments summarized in the table above, the Company classified the following investments within Other noncurrent assets:

• As of June 30, 2025 and December 31, 2024, $ 316.8 million and $ 159.8 million, respectively, of equity securities that do not have a readily determinable fair value.

• As of September 30, 2025 and December 31, 2024, $ 316.8 million and $ 159.8 million, respectively, of equity securities that do not have a readily determinable fair value.

The change in carrying value of such investments was a result of additional purchases.

• As of June 30, 2025 and December 31, 2024, equity securities held through ownership interest in an investment fund of $ 92.3 million and $ 52.0 million, respectively, which are measured at fair value based on Level 3 inputs.

• As of September 30, 2025 and December 31, 2024, equity securities held through ownership interest in an investment fund of $ 98.4 million and $ 52.0 million, respectively, which are measured at fair value based on Level 3 inputs.

The change in carrying value was primarily the result of additional investments by the fund.

Other income (expense), net included net unrealized gains on equity securities of $ 249.8 million and $ 389.5 million for the three and six months ended June 30, 2025, respectively, and $ 392.5 million and $ 196.3 million for the three and six months ended June 30, 2024, respectively.

The fair value of the Company's long-term debt, which was determined based on Level 2 inputs, was estimated to be $ 1.538 billion and $ 1.484 billion as of June 30, 2025 and December 31, 2024, respectively.

Amounts recognized in Other income (expense), net, related to the Company's investments in public equity securities consist of the following:

Three Months Ended

September 30, Nine Months Ended

September 30,

(In millions)

2025 2024 2025 2024

Net gains recognized during the period

$ 581.5 $ 134.5 $ 978.1 $ 330.8

Net gains recognized on investments sold during the period

370.9 — 650.4 —

Net unrealized gains recognized on investments still held as of period end date

$ 210.6 $ 134.5 $ 327.7 $ 330.8

The fair value of the Company's long-term debt, which was determined based on Level 2 inputs, was estimated to be $ 1.568 billion and $ 1.484 billion as of September 30, 2025 and December 31, 2024, respectively, and the carrying value was $ 1.986 billion and $ 1.984 billion as of September 30, 2025 and December 31, 2024, respectively.

Inventories consist of the following:

September 30,

(In millions) 2025

7 unchanged sentences

federal, state, and foreign income taxes.

The Company's effective tax rate was 8.4 % and 12.0 % for the three months ended June 30, 2025 and 2024, respectively, and 9.2 % and 7.5 % for the six months ended June 30, 2025 and 2024, respectively.

The Company's 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 liabilities for uncertain tax positions recognized upon the effective settlement of the IRS audit of the Company's 2017 and 2018 federal income tax returns.

The Company's 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.

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.

2 unchanged sentences

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.

The Company is in the process of evaluating the impact of the OBBBA on its financial statements.

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

net deferred tax assets.

The Company's effective tax rate was 17.2 % and 10.2 % for the three months ended September 30, 2025 and 2024, respectively, and 12.6 % and 8.6 % for the nine months ended September 30, 2025 and 2024, respectively.

The Company's 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, the Company's 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 the Company's 2017 and 2018 federal income tax returns in the second quarter of 2025, which reduced the Company's effective tax rate for the nine months ended September 30, 2025 by 1.4 %.

The Company's 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.

The Company's effective tax rate for the nine months ended September 30, 2024 was negatively impacted by the remeasurement of uncertain tax positions.

Stockholders' Equity

1 unchanged sentence

In January 2023, the Company's board of directors authorized a share repurchase program for up to $ 3.0 billion of the Company's Common Stock.

In each of April 2024 and February 2025, the Company's board of directors authorized share

repurchase programs for up to an additional $ 3.0 billion (up to $ 6.0 billion in the aggregate).

In each of April 2024 and February 2025, the Company's board of directors authorized an additional share repurchase program for up to $ 3.0 billion (up to $ 6.0 billion in the aggregate).

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

1 unchanged sentence

Three Months Ended

Six Months Ended

September 30,

Nine Months Ended

September 30,

(In millions) 2025 2024

1 unchanged sentence

Total cost of shares $ 663.0 $ 738.3 $ 2,785.3 $ 1,637.7

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, the Company's board of directors declared quarterly cash dividends of $ 0.88 per share on its 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, the Company's board of directors declared quarterly cash dividends of $ 0.88 per share on its Common Stock and Class A Stock.

Each quarterly dividend was paid to the Company's shareholders in the quarter in which the dividend was declared.

Additionally, in July 2025, the Company's board of directors declared a cash dividend of $ 0.88 per share on its Common Stock and Class A Stock.

The dividend will be payable to the Company's shareholders in September 2025.

Additionally, in October 2025, the Company's board of directors declared a cash dividend of $ 0.88 per share on its Common Stock and Class A Stock.

The dividend will be payable to the Company's shareholders in December 2025.

Statement of Cash Flows

The following provides a reconciliation of cash, cash equivalents, and restricted cash reported within the Condensed Consolidated Balance Sheets to the total of the same such amounts shown in the Condensed Consolidated Statements of Cash Flows:

September 30,

(In millions) 2025

5 unchanged sentences

Supplemental disclosure of non-cash investing and financing activities

June 30, December 31, June 30, December 31,

September 30, December 31, September 30, December 31,

(In millions) 2025

8 unchanged sentences

Three Months Ended

Six Months Ended

September 30,

Nine Months Ended

September 30,

(In millions) 2025 2024 2025 2024

20 unchanged sentences

The Company recognizes gain contingencies associated with such proceedings when the award or recovery is realized or realizable and loss contingencies when it is probable that a liability will be incurred and the amount of loss can be reasonably estimated.

As of June 30, 2025 and December 31, 2024, the Company's accruals for loss contingencies were not material.

As of September 30, 2025 and December 31, 2024, the Company's accruals for loss contingencies were not material.

There are certain loss contingencies that the Company deems reasonably possible for which the possible loss or range of possible loss is not estimable at this time.

9 unchanged sentences

("Biocon"), as successor-in-interest to the aflibercept 2 mg biosimilar, was joined as a defendant to the lawsuit.

A trial was held in June 2023 concerning certain claims of the '601 Patent, the '572 Patent, and the Company's U.S.

11,084,865 (the "'865 Patent").

On December 27, 2023, the court issued a decision finding that (i) the asserted claims of the '865 Patent were valid and infringed by Mylan and Biocon and (ii) the asserted claims of the '601 and '572 Patents were infringed by Mylan and Biocon but were invalid as obvious.

On December 27, 2023, following a trial, the court issued a decision finding that (i) the asserted claims of the Company's U.S.

11,084,865 (the "'865 Patent") were valid and infringed by Mylan and Biocon and (ii) the asserted claims of two other Company patents were infringed by Mylan and Biocon but were invalid as obvious.

On June 11, 2024, the court granted the Company's motion for a permanent injunction, enjoining Mylan and Biocon from selling in the United States their aflibercept 2 mg biosimilar until the expiration of the '865 Patent.

On June 21, 2024, Mylan and Biocon filed a notice of appeal of the court's December 27, 2023 and June 11, 2024 decisions to the Federal Circuit.

An oral hearing concerning Mylan and Biocon's appeal was held on February 7, 2025.

On April 14, 2025, the parties entered into a settlement agreement, pursuant to which Mylan and Biocon's appeal to the Federal Circuit and all related litigation have been dismissed and Biocon is precluded from launching its aflibercept 2 mg biosimilar until the second half of 2026.

5 unchanged sentences

On June 14, June 21, and June 28, 2024, respectively, the court granted the Company's motions for preliminary injunctions against Samsung Bioepis, Formycon, and Celltrion;

each of these decisions was appealed to the Federal Circuit.

On January 29, 2025, the Federal Circuit affirmed the lower court's preliminary injunction decisions against Samsung Bioepis and Formycon;

and on March 5, 2025, the Federal Circuit affirmed the lower court's preliminary injunction decision against Celltrion.

On May 23, 2025, Formycon petitioned the lower court to revoke the preliminary injunction.

each of these decisions was affirmed by the Federal Circuit on appeal.

On May 23, 2025, Formycon petitioned the district court to revoke the preliminary injunction.

On September 28, 2025, the Company and Formycon entered into a settlement agreement, pursuant to which Formycon's motion to revoke the preliminary injunction and all related litigation have been dismissed and Formycon is precluded from launching its aflibercept 2 mg biosimilar until the fourth quarter of 2026.

On October 20, 2025, the Company and Celltrion entered into a settlement agreement, pursuant to which all litigation in the United States related to Celltrion's aflibercept 2 mg biosimilar has been dismissed and Celltrion is precluded from launching such biosimilar until December 31, 2026.

On January 10, 2024, the Company filed a patent infringement lawsuit against Amgen Inc.

4 unchanged sentences

On October 22, 2024, the Federal Circuit denied the Company's temporary injunction motion and lifted the administrative stay.

On March 14, 2025, the Federal Circuit affirmed the lower court's preliminary injunction decision.

On June 17, 2025, the Company filed an additional patent infringement lawsuit against Amgen in the United States District Court for the Central District of California

alleging that Amgen's continued commercialization of its aflibercept 2 mg biosimilar infringes the Company's U.S.

On March 14, 2025, the Federal Circuit affirmed the district court's preliminary injunction decision.

On June 17, 2025, the Company filed an additional patent infringement lawsuit against Amgen in the United States District Court for the Central District of California alleging that Amgen's continued commercialization of its aflibercept 2 mg biosimilar infringes the Company's U.S.

On August 26, 2024, the Company filed a patent infringement lawsuit against Sandoz Inc.

("Sandoz") in the United States District Court for the District of New Jersey alleging that Sandoz's filing for FDA approval of an aflibercept 2 mg biosimilar infringed certain Company patents.

On September 12, 2024, the United States Judicial Panel on Multidistrict Litigation granted the Company's motion to transfer this lawsuit to the United States District Court for the Northern District of West Virginia for coordinated and consolidated pretrial proceedings with the lawsuits described in the preceding paragraphs.

On July 11, 2025, the Company filed a motion for a preliminary injunction against Sandoz based on the '865 Patent.

On September 8, 2025, the Company and Sandoz entered into a settlement agreement, pursuant to which the Company's preliminary injunction motion and all related litigation have been dismissed and Sandoz is precluded from launching its aflibercept 2 mg biosimilar until the fourth quarter of 2026.

Post-Grant Proceedings Before the USPTO

8 unchanged sentences

On March 11, 2025, the Company appealed the OD's decision.

Oral hearings concerning the '992 and '049 Patents have been scheduled for October and December 2025, respectively.

On October 22, 2025, following an oral hearing, the OD upheld the validity of the '992 Patent's claims in amended form.

An oral hearing concerning the '049 Patent has been scheduled for December 2025.

Country-Specific Proceedings

1 unchanged sentence

2,364,691 (the "'691 Patent") and/or a declaration that its aflibercept 2 mg biosimilar would not infringe these patents in several European national courts (including those in Belgium, France, Germany, Italy, the Netherlands, and the United Kingdom).

In the United Kingdom, the Company has filed a preemptive counterclaim against Formycon, Klinge Biopharma GmbH, and Samsung Bioepis UK Limited for infringement of the '306 Patent and the '691 Patent.

In April 2025, the Company and Amgen entered into a settlement agreement, pursuant to which Amgen is no longer party to the United Kingdom proceedings.

In Germany, following a trial held in June 2025, the German Federal Patent Court upheld the '691 Patent as valid and dismissed the revocation proceeding brought by Samsung Bioepis.

In the United Kingdom, trials concerning the '691 and '306 Patents were held in June 2025, and the '992 Patent proceedings are stayed pending resolution of the EPO proceedings concerning this patent.

In the Netherlands, a trial concerning the '691 and '306 Patents was held on July 18, 2025.

In certain of these proceedings, the Company has filed a preemptive counterclaim for infringement of one or more of such patents.

In the United Kingdom, following trials held in June 2025, the High Court of England and Wales issued a decision in October 2025 that found that Formycon and Samsung Bioepis's aflibercept 2 mg biosimilar products do not infringe the '691 and '306 Patents;

upheld the '691 Patent as valid;

and invalidated the '306 Patent.

Proceedings in the United Kingdom concerning the '992 Patent are stayed pending resolution of the EPO proceedings concerning this patent.

In Germany, following a June 2025 trial concerning the revocation proceeding brought by Samsung Bioepis, the German Federal Patent Court upheld the '691 Patent as valid.

In addition, in October 2025, the Munich Regional Court issued a decision that found that Formycon's aflibercept biosimilar product infringes the '691 Patent and granted the Company's motion for a permanent injunction, enjoining Formycon from selling its aflibercept 2 mg biosimilar in Germany and several other EU countries (including Spain and the Netherlands) until the expiration of the '691 Patent.

In the Netherlands, following a trial held in July 2025, the District Court of the Hague issued a decision in October 2025 that upheld the '691 and '306 Patents as valid;

found that Samsung Bioepis's aflibercept 2 mg biosimilar product infringes the '691 and '306 Patents;

and granted the Company's request for a permanent injunction, enjoining Samsung Bioepis from selling its aflibercept 2 mg biosimilar in the Netherlands until the expiration of the '691 and '306 Patents.

The Company has commenced proceedings in Belgium against various parties, including Amgen, Celltrion, Sterigenics (Petit-Rechain) NV, and Sandoz GmbH, for infringement of the Company's European Patent No.

9 unchanged sentences

3,129,193 (the "'193 Patent"), 2,965,495 (the "'495 Patent"), and 2,906,768 (the "'768 Patent"), respectively.

constructing, using, or selling of an aflibercept 2 mg biosimilar would directly or indirectly infringe one or more claims of the Company's '510 Patent and '276 Patent, respectively.

On June 28, 2024, Amgen Canada filed a motion to delist the '276 Patent from the Canada Patent Register;

and on November 20, 2024, the court granted Amgen Canada's motion.

That decision has been appealed by the Company and Bayer.

A trial concerning the '510 Patent and the '276 Patent was held in May–June 2025;

and a trial concerning the '315 Patent and the '193 Patent has been scheduled for August–September 2025.

On October 11, 2023, the Company, Bayer Inc., and Bayer Healthcare LLC filed two separate patent infringement lawsuits against Amgen Canada in the Federal Court of Canada seeking a declaration that the making, constructing, using, or selling of an aflibercept 2 mg biosimilar would directly or indirectly infringe one or more claims of the Company's '510 Patent and '276 Patent, respectively.

A trial concerning the '510 Patent and the '276 Patent was held in May–

On August 15, 2025, the Company, Bayer Inc., Bayer Healthcare LLC, and Amgen Canada entered into a settlement agreement concerning these patent infringement lawsuits, pursuant to which each such lawsuit has been dismissed.

As a result of the settlement agreement, the Company, Bayer Inc., and Bayer Healthcare LLC are no longer seeking a declaration that Amgen Canada's aflibercept 2 mg biosimilar infringes the patents referenced in this paragraph.

Proceedings against Sandoz

2 unchanged sentences

3,137,326 (the "'326 Patent").

A trial concerning the '510 Patent, the '276 Patent, the '315 Patent, and the '326 Patent has been scheduled for October–November 2026.

On August 15, 2025, the Company, Bayer Inc., Bayer Healthcare LLC, and Sandoz Canada Inc.

entered into a settlement agreement concerning these patent infringement lawsuits, pursuant to which each such lawsuit has been dismissed.

As a result of the settlement agreement, the Company, Bayer Inc., and Bayer Healthcare LLC are no longer seeking a declaration that Sandoz Canada Inc.'s aflibercept 2 mg biosimilar infringes the patents referenced in this paragraph.

On December 13, 2022, Samsung Bioepis initiated invalidation proceedings before the Intellectual Property Trial and Appeal Board of the Korean Intellectual Property Office ("KIPO") against the Company's Korean Patent No.

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and a request for a preliminary injunction in the Federal Court of Australia alleging that the importing, selling, supplying, or otherwise disposing of an aflibercept 2 mg biosimilar would infringe one or more claims of the Company's Australian Patent No.

An oral hearing to consider the preliminary injunction request has been scheduled for August 14, 2025.

On September 3, 2025, the court denied the Company's request for a preliminary injunction, and this ruling has been appealed.

Proceedings Relating to EYLEA (aflibercept) Injection Pre-filled Syringe

On July 17, 2020, the Company filed an antitrust lawsuit (as amended on January 25, 2021) against Novartis Pharma AG, Novartis Pharmaceuticals Corporation, and Novartis Technology LLC (collectively, "Novartis") and Vetter Pharma International GmbH in the United States District Court for the Southern District of New York seeking a judgment that the defendants' conduct relating to Novartis's attempt to assert its U.S.

9,220,631 against Regeneron in 2020 violated Sections 1 and 2 of the Sherman Antitrust Act of 1890, as amended (the "Sherman Antitrust Act"), and constituted tortious interference with contract.

9,220,631 against Regeneron in 2020 violated Sections 1 and 2 of the Sherman Antitrust Act of 1890, as amended, and constituted tortious interference with contract.

The Company is also seeking injunctive relief and treble damages.

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Also on June 20, 2025, the Company filed a post-trial motion for (i) permanent injunctive relief, (ii) a constructive trust, and (iii) prejudgment interest.

An oral hearing on Amgen's and Regeneron's respective post-trial motions has been scheduled for August 27, 2025.

An oral hearing on Amgen's and Regeneron's respective post-trial motions was held on August 27, 2025.

On June 1, 2023, Sanofi filed an action in the Munich Central Division of the Unified Patent Court (the "UPC") seeking revocation of Amgen's European Patent No.

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On September 16, 2024, Amgen appealed the decision of the Munich Central Division of the UPC to the Court of Appeal of the UPC.

An oral hearing before the Court of Appeal of the UPC has been scheduled for August 2025.

An oral hearing before the Court of Appeal of the UPC was held in August 2025.

Also on June 1, 2023, Amgen filed a lawsuit against the Company and certain of Sanofi's affiliated entities in the Munich Local Division of the UPC alleging infringement of the '797 Patent.

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Department of Justice Matters

In January 2017, the Company received a subpoena from the U.S.

Attorney's Office for the District of Massachusetts requesting documents relating to its support of 501(c)(3) organizations that provide financial assistance to patients;

documents concerning its provision of financial assistance to patients with respect to products sold or developed by Regeneron (including EYLEA, Praluent, ARCALYST ® , and ZALTRAP ® );

and certain other related documents and communications.

On June 24, 2020, the U.S.

Attorney's Office for the District of Massachusetts filed a civil complaint in the U.S.

District Court for the District of Massachusetts alleging violations of the federal Anti-Kickback Statute, and asserting causes of action under the federal False Claims Act and state law (the "June 2020 Civil Complaint").

District Court for the District of Massachusetts alleging violations of the federal Anti-Kickback Statute and asserting causes of action under the federal False Claims Act and state law (the "June 2020 Civil Complaint") relating to the Company's support of 501(c)(3) organizations that provide financial assistance to patients.

On September 27, 2023, the court (i) denied in part and granted in part the Company's motion for summary judgment and (ii) denied in its entirety the motion for partial summary judgment filed by the U.S.

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Court of Appeals for the First Circuit affirmed the portion of the court's September 27, 2023 order that had been certified for interlocutory appeal.

On October 1, 2025, the U.S.

Attorney's Office for the District of Massachusetts filed a second motion for partial summary judgment.

In September 2019, the Company and Regeneron Healthcare Solutions, Inc., a wholly-owned subsidiary of the Company, each received a civil investigative demand ("CID") from the U.S.

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On June 3, 2021, the United States District Court for the Central District of California unsealed a qui tam complaint filed against the Company, Regeneron Healthcare Solutions, Inc., and Sanofi-Aventis U.S.

LLC by two qui tam plaintiffs (known as relators) purportedly on behalf of the United States and various states (the "State Plaintiffs"), asserting causes of action under

the federal False Claims Act and state law.

LLC by two qui tam plaintiffs (known as relators) purportedly on behalf of the United States and various states (the "State Plaintiffs"), asserting causes of action under the federal False Claims Act and state law.

Also on June 3, 2021, the United States and the State Plaintiffs notified the court of their decision to decline to intervene in the case.

On October 29, 2021, the qui tam plaintiffs filed an amended complaint in this matter.

On October 29, 2021, the qui tam plaintiffs filed an amended complaint in this

On January 14, 2022, the Company filed a motion to dismiss the amended complaint in its entirety.

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On August 26, 2024, the qui tam plaintiffs filed a notice of appeal.

Oral argument on the appeal has been scheduled for November 18, 2025.

In June 2021, the Company received a CID from the U.S.

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Also on March 28, 2024, the U.S.

District Court of the District of Massachusetts unsealed a qui tam complaint against the Company, AmerisourceBergen, and Besse Medical by two qui tam plaintiffs (known as relators) purportedly on behalf of the United States and various states and municipalities, asserting causes of action under the federal False Claims Act and state and local laws, and alleging violations of the federal Anti-Kickback statute.

District Court for the District of Massachusetts unsealed a qui tam complaint against the Company, AmerisourceBergen, and Besse Medical by two qui tam plaintiffs (known as relators) purportedly on behalf of the United States and various states and municipalities, asserting causes of action under the federal False Claims Act and state and local laws, and alleging violations of the federal Anti-Kickback statute.

On June 25, 2024, the States of Colorado, Georgia, Michigan, North Carolina, Texas, and Washington filed a civil complaint in partial intervention (the "June 2024 Civil Complaint") in the U.S.

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On July 23, 2025, the Company filed its answer and counterclaims to the June 2025 Civil Complaint.

On August 14, 2025, the Company moved to amend its answer and assert counterclaims to the March 2024 Civil Complaint and June 2024 Civil Complaint.

Proceedings Initiated by Other Payors

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On June 6, 2025, two purported shareholders filed separate shareholder derivative complaints in the New York Supreme Court against members of the Company's board of directors and certain current and former executive officers of the Company as defendants and Regeneron as a nominal defendant.

These actions make similar allegations to the ones filed on January 16 and January 22, 2025.

These complaints make similar allegations to the 2025 derivative complaints referenced above.

On June 16, 2025, the Company filed notices of removal, removing both of the newly filed actions from the New York Supreme Court to the U.S.

District Court of the Southern District of New York.

District Court for the Southern District of New York.

On July 16, 2025, the purported shareholders each filed a motion to remand their respective actions back to the New York Supreme Court.

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District Court for the Southern District of New York against members of the Company's board of directors and certain current and former executive officers of the Company as defendants and Regeneron as a nominal defendant.

This complaint makes similar allegations to the ones filed on January 16, 2025, January 22, 2025, and June 5, 2025.

This complaint makes similar allegations to the 2025 derivative complaints referenced above.

On September 2, 2025, a purported shareholder filed another shareholder derivative complaint in the New York Supreme Court against members of the Company's board of directors and certain current and former executive officers of the Company as defendants and Regeneron as a nominal defendant.

This complaint makes similar allegations to the 2025 derivative complaints referenced above.

On September 11, 2025, the Company filed a notice of removal, removing this action from the New York Supreme Court to the U.S.

District Court for the Southern District of New York.

On October 14, 2025, the purported shareholder filed a motion to remand the action back to the New York Supreme Court.

Shareholder Derivative Complaint – Director Compensation

On July 22, 2025, an alleged shareholder filed a shareholder derivative complaint in the New York Supreme Court, naming the current non-employee members of our board of directors, and the co-Chairs of our board of directors (who also serve as our President and Chief Executive Officer and our President and Chief Scientific Officer, respectively) as defendants and Regeneron as a nominal defendant.

The complaint asserts that the individual defendants breached their fiduciary duties and/or were unjustly enriched when they approved and/or received allegedly excessive non-employee director compensation in 2024 and 2025, and that this allegedly excessive compensation was a waste of corporate assets.

The complaint asserts that the individual defendants breached their fiduciary duties and/or

were unjustly enriched when they approved and/or received allegedly excessive non-employee director compensation in 2024 and 2025, and that this allegedly excessive compensation was a waste of corporate assets.

The complaint seeks damages in favor of Regeneron for the alleged breaches of fiduciary duties, unjust enrichment, and waste of corporate assets;

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and award of the costs of the action, including attorneys' fees.

On September 25, 2025, the Company filed a motion to dismiss the complaint.

Class Action Civil Complaint

On January 7, 2025, a purported shareholder filed a putative class action civil complaint, on behalf of himself and all others similarly situated, in the U.S.

On January 7, 2025 (as amended on September 8, 2025), a purported shareholder filed a putative class action civil complaint, on behalf of himself and all others similarly situated, in the U.S.

District Court for the Southern District of New York against the Company and certain current and former executive officers of the Company.

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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 1. Financial Statements