What changed in this filing

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Item 1. Financial Statements

2026-07-30 compared with 2026-04-29 · 127 added, 83 removed, 489 unchanged (30% of the section changed)

3 unchanged sentences

(In millions, except per share data)

March 31, December 31,

June 30, December 31,

Current assets:

35 unchanged sentences

Retained earnings 37,621.4 35,797.1

Accumulated other comprehensive income

Accumulated other comprehensive (loss) income ( 35.8 ) 77.5

Treasury Stock, at cost;

8 unchanged sentences

Three Months Ended

June 30, Six Months Ended

Statements of Operations

12 unchanged sentences

Other income (expense), net

245.3 442.8 446.5 764.8

Interest expense ( 11.0 ) ( 3.6 ) ( 23.9 ) ( 12.3 )

234.3 439.2 422.6 752.5

Income before income taxes 1,527.8 1,518.7 2,359.0 2,423.7

Income tax expense

230.9 127.1 334.9 223.4

Net income $ 1,296.9 $ 1,391.6 $ 2,024.1 $ 2,200.3

7 unchanged sentences

Unrealized (loss) gain on debt securities ( 48.0 ) 22.1 ( 113.8 ) 60.2

( 65.8 ) 38.1

Gain (loss) on foreign currency translation 0.2 ( 1.1 )

Gain on foreign currency translation 0.3 1.3 0.5 0.2

Comprehensive income $ 1,249.2 $ 1,415.0 $ 1,910.8 $ 2,260.7

20 unchanged sentences

1.8 — 137.9 0.1 14,401.3 36,423.8 11.9 ( 34.7 ) ( 19,413.5 ) 31,423.6

Issuance of Common Stock for equity awards granted under long-term incentive plans — — 0.1 — 43.4 — — — — 43.4

Common Stock tendered upon exercise of stock options and vesting of restricted stock for employee tax obligations — — — — ( 7.7 ) — — — — ( 7.7 )

Issuance/distribution of Common Stock for 401(k) Savings Plan — — — — 21.1 — — — 3.1 24.2

Repurchases of Common Stock — — — — — — — ( 1.7 ) ( 1,164.5 ) ( 1,164.5 )

Dividends declared — — — — — ( 99.3 ) — — — ( 99.3 )

Stock-based compensation charges — — — — 242.5 — — — — 242.5

Net income — — — — — 1,296.9 — — — 1,296.9

Other comprehensive loss, net of tax — — — — — — ( 47.7 ) — — ( 47.7 )

Balance, June 30, 2026 1.8 $ — 138.0 $ 0.1 $ 14,700.6 $ 37,621.4 $ ( 35.8 ) ( 36.4 ) $ ( 20,574.9 ) $ 31,711.4

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

Class A Stock Common Stock Additional

Paid-in Capital Retained Earnings Accumulated Other Comprehensive Income (Loss) Treasury Stock Total Stockholders' Equity

Shares Amount Shares Amount Shares Amount

Balance, December 31, 2024

5 unchanged sentences

Dividends declared

— — — — 1.0 ( 97.2 ) — — — ( 96.2 )

Stock-based compensation charges — — — — 258.9 — — — — 258.9

3 unchanged sentences

1.8 — 136.1 0.1 13,192.1 32,384.4 29.1 ( 29.7 ) ( 16,218.1 ) 29,387.6

Issuance of Common Stock for equity awards granted under long-term incentive plans — — 0.1 — 28.9 — — — — 28.9

Common Stock tendered upon exercise of stock options and vesting of restricted stock for employee tax obligations — — — — ( 5.4 ) — — — — ( 5.4 )

Issuance/distribution of Common Stock for 401(k) Savings Plan — — — — 19.2 — — — 3.3 22.5

Repurchases of Common Stock — — — — — — — ( 1.9 ) ( 1,069.9 ) ( 1,069.9 )

Dividends declared — — — — 1.1 ( 95.8 ) — — — ( 94.7 )

Stock-based compensation charges — — — — 254.9 — — — — 254.9

Net income — — — — — 1,391.6 — — — 1,391.6

Other comprehensive income, net of tax — — — — — — 23.4 — — 23.4

Balance, June 30, 2025 1.8 $ — 136.2 $ 0.1 $ 13,490.8 $ 33,680.2 $ 52.5 ( 31.6 ) $ ( 17,284.7 ) $ 29,938.9

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

2 unchanged sentences

(In millions)

Three Months Ended

Six Months Ended

Cash flows from operating activities:

4 unchanged sentences

Gains on marketable and other securities, net ( 86.9 ) ( 389.9 )

110.5 ( 17.7 )

Deferred income taxes ( 290.4 ) ( 274.3 )

Changes in assets and liabilities:

Decrease in accounts receivable

Decrease (increase) in inventories

26.6 ( 152.3 )

(Increase) decrease in accounts receivable ( 837.3 ) 629.6

Increase in inventories ( 1.6 ) ( 194.8 )

Increase in prepaid expenses and other assets ( 517.7 ) ( 410.2 )

Increase in deferred revenue

Increase (decrease) in accounts payable, accrued expenses, and other liabilities

107.7 ( 214.1 )

Increase (decrease) in deferred revenue 143.5 ( 125.2 )

Increase in accounts payable, accrued expenses, and other liabilities 600.4 2.3

Total adjustments ( 132.2 ) ( 10.8 )

6 unchanged sentences

( 99.9 ) ( 230.0 )

Net cash (used in) provided by investing activities

( 428.9 ) 647.5

Net cash used in investing activities ( 521.6 ) ( 446.5 )

Cash flows from financing activities:

6 unchanged sentences

Effect of exchange rate changes on cash, cash equivalents, and restricted cash ( 1.2 ) 1.0

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

( 153.1 ) 604.0

Net decrease in cash, cash equivalents, and restricted cash ( 657.7 ) ( 473.4 )

Cash, cash equivalents, and restricted cash at beginning of period 3,123.7 2,489.0

21 unchanged sentences

Three Months Ended

June 30, Six Months Ended

(In millions) 2026 2025 2026 2025

$ 596.3 $ 393.2 $ 1,064.7 $ 700.0

412.2 754.3 885.3 1,490.3

Total EYLEA HD and EYLEA U.S.

1,008.5 1,147.5 1,950.0 2,190.3

342.6 247.8 628.7 440.3

Rest of world

146.8 128.7 298.9 221.3

Total Libtayo

489.4 376.5 927.6 661.6

74.7 65.8 141.3 122.6

53.3 41.2 99.0 72.1

16.5 — 27.7 —

Other products

$ 1,642.4 $ 1,631.0 $ 3,176.9 $ 3,046.6

As of March 31, 2026 and December 31, 2025, the Company had $ 3.529 billion and $ 3.458 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 months ended March 31, 2026 and 2025.

As of June 30, 2026 and December 31, 2025, the Company had $ 3.784 billion and $ 3.458 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, 2026 and 2025.

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

Three Months Ended

June 30, Six Months Ended

2026 2025 2026 2025

45 % 52 % 45 % 52 %

32 % 24 % 31 % 24 %

Collaboration, License, and Other Agreements

The Company is party to a global, strategic collaboration with Sanofi to research, develop, and commercialize fully human monoclonal antibodies, which currently consists of Dupixent ® (dupilumab), Kevzara ® (sarilumab), and itepekimab .

Sanofi is generally responsible for funding 80 % to 100 % of agreed-upon development expenses as incurred.

The Company is obligated to reimburse Sanofi for 30 % to 50 % of development expenses that were funded by Sanofi (i.e., "development balance") based on the Company's share of collaboration profits.

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

The Company's contingent reimbursement obligation to Sanofi in connection with the development balance was approximately $ 278 million as of March 31, 2026.

The Company is party to a global collaboration with Sanofi to research, develop, and commercialize fully human monoclonal antibodies, which currently consists of Dupixent ® (dupilumab), Kevzara ® (sarilumab), and itepekimab .

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

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

The Company co-commercializes Dupixent in the United States and in certain countries outside the United States.

The Company supplies certain commercial bulk product to Sanofi.

The parties equally share profits from sales within the United States.

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

The Company also supplies certain commercial bulk product to Sanofi.

The parties equally share profits from sales within the United States, and share profits outside the United States on a sliding scale based on sales starting at 65 % (Sanofi)/ 35 % (Regeneron) and ending at 55 % (Sanofi)/ 45 % (Regeneron).

Amounts recognized in the Company's Statements of Operations in connection with its Sanofi collaboration are as follows:

Statement of Operations Classification Three Months Ended

June 30, Six Months Ended

(In millions) 2026 2025 2026 2025

6 unchanged sentences

Reduction of SG&A expense $ 188.8 $ 194.0 $ 372.9 $ 353.2

As of June 30, 2026, the "development balance," which represented the Company's obligation to reimburse Sanofi for development expenses that were previously funded by Sanofi, was fully repaid and will no longer reduce Sanofi collaboration revenue beginning in the third quarter of 2026.

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

March 31, December 31,

June 30, December 31,

(In millions) 2026

2 unchanged sentences

$ 607.5 $ 442.3

The Company is party to a license and collaboration agreement with Bayer for the global development and commercialization of EYLEA 8 mg (aflibercept 8 mg) and EYLEA (aflibercept) outside the United States.

The Company is party to a license and collaboration agreement with Bayer for the development and commercialization of EYLEA 8 mg (aflibercept 8 mg) and EYLEA (aflibercept).

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

4 unchanged sentences

Statement of Operations Classification Three Months Ended

June 30, Six Months Ended

(In millions) 2026 2025 2026 2025

3 unchanged sentences

Collaboration revenue $ 48.9 $ 31.6 $ 96.2 $ 58.2

Reimbursement of R&D expenses, net of Regeneron's obligation for its share of Bayer R&D expenses

Reduction of R&D expense/(R&D expense)

$ 1.0 $ ( 9.4 )

Regeneron's obligation for its share of Bayer R&D expenses, net of reimbursement of R&D expenses (R&D expense)/Reduction of R&D expense $ ( 0.6 ) $ ( 5.6 ) $ 0.4 $ ( 15.0 )

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

March 31, December 31,

June 30, December 31,

(In millions) 2026

5 unchanged sentences

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

Acquired IPR&D expenses for the three months ended March 31, 2026 primarily related to the premium on equity securities purchased, as well as development milestone and up-front payments, in connection with collaboration and licensing agreements.

Acquired IPR&D expenses for the three and six months ended June 30, 2026 were $ 127.0 million and $ 228.9 million, respectively, and included up-front and opt-in payments in connection with collaboration and licensing agreements.

In addition, Acquired IPR&D expenses for the six months ended June 30, 2026 included the premium on equity securities purchased and development milestone payments in connection with collaboration and licensing agreements.

Net Income Per Share

1 unchanged sentence

Three Months Ended

June 30, Six Months Ended

(In millions, except per share data) 2026 2025 2026 2025

9 unchanged sentences

Three Months Ended

June 30, Six Months Ended

(Shares in millions) 2026 2025 2026 2025

2 unchanged sentences

Marketable Securities

Marketable securities as of March 31, 2026 and December 31, 2025 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 June 30, 2026 and December 31, 2025 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 March 31, 2026

As of June 30, 2026

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 March 31, 2026 mature at various dates through December 2032.

The available-for-sale debt securities as of June 30, 2026 mature at various dates through December 2032.

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

March 31, December 31,

June 30, December 31,

(In millions) 2026

4 unchanged sentences

Fair Value Measurements

The table below summarizes the Company's assets which are measured at fair value on a recurring basis.

The following fair value hierarchy is used to classify assets and liabilities, based on inputs to valuation techniques utilized to measure fair value:

2 unchanged sentences

• Level 3 - Significant other unobservable inputs

The following tables summarize the Company's assets that are measured at fair value on a recurring basis:

(In millions) Fair

Fair Value Measurements at Reporting Date

As of March 31, 2026

As of June 30, 2026

Level 1 Level 2

9 unchanged sentences

177.9 177.9 —

$ 16,703.1 $ 1,383.2 $ 15,319.9

As of December 31, 2025

7 unchanged sentences

Sovereign bonds 76.8 — 76.8

Equity securities (a)

Equity securities 34.3 34.3 —

$ 17,869.3 $ 1,162.0 $ 16,707.3

(a) Includes equity securities of $ 47.5 million and $ 33.3 million as of March 31, 2026 and December 31, 2025, respectively, which were subject to transfer restrictions that expired in April 2026

(a) Includes equity securities of $ 114.0 million as of June 30, 2026 which were subject to transfer restrictions that expire in December 2026

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

• As of March 31, 2026 and December 31, 2025, $ 571.6 million and $ 334.0 million, respectively, of equity securities that do not have a readily determinable fair value.

• As of June 30, 2026 and December 31, 2025, $ 597.3 million and $ 334.0 million, respectively, of equity securities that do not have a readily determinable fair value.

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

• As of March 31, 2026 and December 31, 2025, equity securities held through ownership interest in an investment fund of $ 169.9 million and $ 147.5 million, respectively, which are measured at fair value based on Level 3 inputs.

• As of June 30, 2026 and December 31, 2025, equity and other securities held through ownership interest in an investment fund of $ 203.9 million and $ 147.5 million, respectively, which are primarily measured at fair value based on Level 3 inputs.

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

During the three months ended March 31, 2026 and 2025, the Company recognized $ 24.0 million and $ 139.7 million of net unrealized gains, respectively, in Other income (expense), net, related to investments in equity securities that were still held as of the period end date.

Other income (expense), net included net unrealized gains related to investments in equity securities that were still held as of the period end date of $ 61.4 million and $ 85.4 million for the three and six months ended June 30, 2026, respectively, and $ 249.8 million and $ 389.5 million for the three and six months ended June 30, 2025, respectively.

Other Fair Value Disclosures

The fair value of the Company's long-term debt, which was determined based on Level 2 inputs, was estimated to be $ 1.564 billion and $ 1.576 billion as of March 31, 2026 and December 31, 2025, respectively.

The carrying value was $ 1.986 billion as of March 31, 2026 and December 31, 2025.

The fair value of the Company's long-term debt, which was determined based on Level 2 inputs, was estimated to be $ 1.561 billion and $ 1.576 billion as of June 30, 2026 and December 31, 2025, respectively.

The carrying value was $ 1.987 billion as of June 30, 2026 and $ 1.986 billion as of December 31, 2025.

Inventories consist of the following:

June 30, December 31,

(In millions) 2026

5 unchanged sentences

Deferred costs represent the costs of product manufactured and shipped to the Company's collaborators for which recognition of revenue has been deferred.

The Company's effective tax rate was 12.5 % and 10.6 % for the three months ended March 31, 2026 and 2025, respectively.

The Company's effective tax rate for the three months ended March 31, 2026 and 2025 was positively impacted, compared to the U.S.

The Company's effective tax rate was 15.1 % and 8.4 % for the three months ended June 30, 2026 and 2025, respectively, and 14.2 % and 9.2 % for the six months ended June 30, 2026 and 2025, respectively.

The Company's effective tax rate for the three and six months ended June 30, 2026 and 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, to a lesser extent, federal tax credits for research activities, partly offset by changes in unrecognized tax benefits.

federal statutory rate and, to a lesser extent, tax benefits from cross-border tax laws and federal tax credits for research activities, partly offset by changes in unrecognized tax benefits.

In addition, the Company's effective tax rate for the three and six months ended June 30, 2025 was positively impacted by the release of liabilities associated with unrecognized tax benefits upon the settlement of the IRS audit of the Company's 2017 and 2018 federal income tax returns.

Stockholders' Equity

Share Repurchase Programs

The Company's board of directors has authorized share repurchase programs, including a share repurchase program for up to $ 3.0 billion of the Company's Common Stock which was authorized in February 2025.

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

1 unchanged sentence

Three Months Ended

June 30, Six Months Ended

(In millions) 2026 2025

1 unchanged sentence

Total cost of shares $ 1,164.5 $ 1,069.9 $ 1,967.7 $ 2,122.3

As of March 31, 2026, $ 688.2 million remained available for share repurchases under the Company's share repurchase programs.

In April 2026, the Company's board of directors authorized a share repurchase program to repurchase up to an additional $ 3.0 billion of the Company's Common Stock.

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

In January 2026, the Company's board of directors declared a quarterly cash dividend of $ 0.94 per share on its Common Stock and Class A Stock, which was paid to the Company's shareholders in March 2026.

Additionally, in April 2026, the Company's board of directors declared a cash dividend of $ 0.94 per share on its Common Stock and Class A Stock.

The dividend will be payable to the Company's shareholders in June 2026.

As of June 30, 2026, $ 2.534 billion remained available for share repurchases under the Company's share repurchase programs.

In each of the first and second quarters of 2026, the Company's board of directors declared a quarterly cash dividend of $ 0.94 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 2026, the Company's board of directors declared a cash dividend of $ 0.94 per share on its Common Stock and Class A Stock.

The dividend will be payable to the Company's shareholders in August 2026.

Statement of Cash Flows

7 unchanged sentences

Supplemental disclosure of non-cash investing and financing activities

March 31, December 31, March 31, December 31,

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

(In millions) 2026

8 unchanged sentences

Three Months Ended

June 30, Six Months Ended

(In millions) 2026 2025 2026 2025

4 unchanged sentences

Lab supplies and other research and development costs

71.5 64.9 130.8 124.9

Occupancy and other operating costs 182.0 158.6 352.9 313.0

Total indirect research and development expenses

713.9 672.9 1,428.2 1,339.0

Clinical manufacturing costs

404.7 337.0 768.9 647.3

Reimbursement of research and development expenses by collaborators ( 26.2 ) ( 42.3 ) ( 59.8 ) ( 79.7 )

1 unchanged sentence

$ 1,631.6 $ 1,421.7 $ 3,175.1 $ 2,749.1

(a) Direct research and development expenses are comprised primarily of costs paid to third parties for clinical and product development activities, and the portion of research and development expenses incurred by our collaborators that we are obligated to reimburse

(a) Direct research and development expenses are comprised primarily of costs paid to third parties for clinical development activities, and the portion of research and development expenses incurred by our collaborators that we are obligated to reimburse

Legal Matters

From time to time, the Company is a party to legal proceedings in the course of the Company's business.

The Company is a party to legal proceedings that arise in the ordinary course of its business.

The outcome of any such proceedings, regardless of the merits, is inherently uncertain.

If the Company is unable to prevail in one or more of such proceedings, its consolidated financial position, results of operations, and future cash flows may be materially adversely impacted.

Costs associated with the Company's involvement in legal proceedings are expensed as incurred.

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 March 31, 2026 and December 31, 2025, the Company's accruals for loss contingencies were not material.

As of June 30, 2026 and December 31, 2025, 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.

Costs associated with the Company's involvement in legal proceedings are expensed as incurred.

Proceedings Relating to EYLEA (aflibercept) Injection

(1) United States

As described in greater detail below, the Company has filed patent infringement lawsuits against various parties in the United States alleging infringement of certain Company patents pertaining to EYLEA, and certain of these patents have also been subject to post-grant proceedings before the United States Patent and Trademark Office ("USPTO").

On February 11, 2026, the Company entered into a settlement agreement resulting in the dismissal of the previously disclosed patent infringement lawsuit before the United States District Court for the Northern District of West Virginia against Samsung Bioepis Co., Ltd.

("Samsung Bioepis").

The lawsuit alleged infringement of certain Company patents, including the Company's U.S.

Pursuant to the settlement agreement, Samsung Bioepis is precluded from launching its aflibercept 2 mg biosimilar until January 2027.

In addition to the patent infringement proceedings in the United States alleging infringement of certain Company patents pertaining to EYLEA discussed below, certain of these patents have also been subject to post-grant proceedings before the United States Patent and Trademark Office.

On January 10, 2024, the Company filed a patent infringement lawsuit (as amended on January 7, 2026) against Amgen Inc.

8 unchanged sentences

and, on April 20, 2026, the Company filed a motion to dismiss certain of Amgen's affirmative defenses and counterclaims in the 2024 lawsuit.

On July 7, 2026, the court granted the Company's motion to dismiss Amgen's affirmative defenses and counterclaims challenged in the 2025 lawsuit with the exception of Amgen's prosecution delay affirmative defense and counterclaim.

(2) Outside the United States

As described in greater detail below, the Company has filed patent infringement lawsuits against various parties in several jurisdictions outside the United States alleging infringement of certain Company patents pertaining to EYLEA, and certain of these patents have also been subject to post-grant proceedings before the European Patent Office (the "EPO") and/or other comparable foreign authorities.

(i) Multijurisdictional Settlement – Formycon .

On February 23, 2026, the Company and Bayer entered into a settlement agreement with Formycon AG ("Formycon") in respect of Europe and certain markets in Latin America and the Asia-Pacific region.

Pursuant to the settlement agreement, all pending judicial and administrative proceedings related to Formycon's aflibercept 2 mg biosimilar product have been dismissed, and Formycon is permitted to launch its product in the United Kingdom and, starting in May 2026, the rest of Europe and the other jurisdictions covered by the settlement.

(I) EPO Post-Grant Proceedings

12 unchanged sentences

Following an appeal by Sandoz, in February 2026 the Munich Higher Regional Court suspended enforcement of, and the Company subsequently withdrew its request for, the preliminary injunction.

On March 31, 2026, the Company initiated a patent infringement lawsuit in the Munich Regional Court against Sandoz alleging its aflibercept 2 mg biosimilar infringes the '691 Patent.

In addition, on April 1, 2026, the Company initiated a patent infringement lawsuit in the Munich Regional Court against Sam Chun Dang alleging its aflibercept 2 mg biosimilar infringes the '691 Patent.

(iii) South Korea

In March–June 2026, the Company initiated patent infringement lawsuits in the Munich Regional Court against each of Sandoz and Sam Chun Dang alleging that their respective aflibercept 2 mg biosimilars infringe the '691 Patent and seeking damages for past infringement and injunctions to enjoin such parties and their commercialization partners from continuing to sell their respective aflibercept 2 mg biosimilars in Germany and several other countries in the European Union.

(ii) South Korea

The Company and Bayer Consumer Care AG have filed patent infringement lawsuits in the Seoul Central District Court against Sam Chun Dang and OPTUS Pharmaceutical Co., Ltd.

These lawsuits seek damages and/or injunctive relief and allege that the

making, constructing, using, or selling of an aflibercept 2 mg biosimilar by the defendants would infringe one or more claims of the Company's Korean Patent Nos.

These lawsuits seek damages and/or injunctive relief and allege that the making, constructing, using, or selling of an aflibercept 2 mg biosimilar by the defendants would infringe one or more claims of the Company's Korean Patent Nos.

1406811, 659477, and 2519234.

On October 10, 2025, the Company filed a patent infringement lawsuit in the Osaka District Court against Fuji Pharma Co., Ltd.

alleging that the making, constructing, using, or selling of an aflibercept 2 mg biosimilar by the defendant would infringe one or more claims of the Company's Japanese Patent No.

On January 28, 2026, the parties entered into a settlement agreement, pursuant to which this lawsuit has been dismissed.

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 (the "SDNY") seeking a judgment that the defendants' conduct relating to Novartis's attempt to assert its U.S.

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, and constituted tortious interference with contract.

31 unchanged sentences

On September 1, 2023, the Company filed a second motion to dismiss the amended complaint or, in the alternative, a motion for judgment on the pleadings.

On July 31, 2024 and August 15, 2024, respectively, the District Court granted the Company's second motion to dismiss the amended complaint with respect to the remaining causes of action under federal law and declined to exercise supplemental jurisdiction over the

remaining causes of action under state law.

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

7 unchanged sentences

Attorney's Office for the District of Massachusetts filed a civil complaint in partial intervention (the "March 2024 Civil Complaint") of the qui tam action, in the same court, asserting causes of action under the federal False Claims Act and a claim for unjust enrichment related to the alleged conduct described above.

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 same court asserting causes of action under various state laws related to the same alleged conduct.

the same alleged conduct.

On April 29, 2025, the court denied the Company's motion to dismiss the March 2024 Civil Complaint and the June 2024 Civil Complaint.

On June 18, 2025, the States of Maine, Nebraska, Ohio, Oregon, and Wyoming intervened in the action and filed a consolidated complaint asserting causes of action under their respective state laws.

On January 20, 2026, a qui tam plaintiff filed a complaint under seal against the Company and other pharmaceutical companies purportedly on behalf of the United States and various states.

The complaint alleges violations of the federal Anti-Kickback Statute and other laws and asserts causes of action under the federal False Claims Act and various state laws relating to allegedly unlawful remuneration and assistance provided to prescribers.

On May 22, 2026 and June 17, 2026, respectively, the United States and the applicable states notified the court of their decisions to decline to intervene in the case.

On June 18, 2026, the United States District Court for the Central District of California unsealed the qui tam complaint.

On July 20, 2026, the plaintiff filed an amended complaint.

Proceedings Initiated by Other Payors

55 unchanged sentences

Shareholder Derivative Complaint – Director Compensation

On July 22, 2025, an alleged shareholder filed a shareholder derivative complaint in the NY 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.

On July 22, 2025, an alleged shareholder filed a shareholder derivative complaint in the NY Supreme Court, naming the current non-employee members of the Company's board of directors, and the co-Chairs of the Company's board of directors (who also serve as Regeneron's President and Chief Executive Officer and Regeneron's 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.

4 unchanged sentences

An oral hearing on the Company's motion to dismiss the complaint was held on April 17, 2026.

Class Action Civil Complaint

On June 22, 2026, plaintiff's counsel filed a motion to substitute the named plaintiff.

Class Action Civil Complaints

On January 7, 2025 (as amended on September 8, 2025 and October 30, 2025), a purported shareholder filed a putative class action civil complaint, on behalf of himself and all others similarly situated, in the SDNY against the Company and certain current and former executive officers of the Company.

3 unchanged sentences

On November 17, 2025, the Company filed a motion to dismiss the second amended complaint.

An oral hearing on the Company's motion to dismiss was held on June 25, 2026.

On July 16, 2026, a purported shareholder filed a putative class action civil complaint, on behalf of herself and all others similarly situated, in the SDNY against the Company and certain employees of the Company.

The complaint asserts violations of federal securities laws in connection with statements or disclosures purportedly related to the Company's fianlimab clinical development program.

Sanofi Litigation

6 unchanged sentences

district and state courts against the Company and certain of Sanofi's affiliated entities claiming that Dupixent either caused or exacerbated the patients' T-cell lymphoma, and asserting causes of action under various state laws.

On February 13, 2026, several of the plaintiffs filed a motion with the United States Judicial Panel on Multidistrict Litigation seeking to consolidate these lawsuits for coordinated pretrial proceedings.

On February 13, 2026, several of the plaintiffs filed a motion with the United States Judicial Panel on Multidistrict Litigation (the "JPML") seeking to consolidate the federal lawsuits for coordinated pretrial proceedings.

On June 4, 2026, the JPML issued an order transferring the federal lawsuits to the District of New Jersey for coordinated pretrial proceedings.

On July 17, 2026, two plaintiffs filed a putative class action lawsuit in the United States District Court for the District of Maryland, alleging that the Company failed to warn that Dupixent allegedly causes or is linked to the development of cutaneous T-cell lymphoma.

The complaint asserts causes of action under various state laws and seeks damages and equitable relief, including the creation of a fund to finance Dupixent medical monitoring and treatment services.

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