What changed in this filing

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Item 1. Financial Statements

2025-08-01 compared with 2025-04-29 · 189 added, 94 removed, 557 unchanged (34% of the section changed)

3 unchanged sentences

(In millions, except per share data)

March 31, December 31,

June 30, December 31,

Current assets:

45 unchanged sentences

Three Months Ended

Six Months Ended

Statements of Operations

10 unchanged sentences

— 14.6 — 29.9

2,596.1 2,477.5 5,033.1 4,871.1

Income from operations 1,079.5 1,069.6 1,671.2 1,821.0

5 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

8 unchanged sentences

Unrealized gain on debt securities 22.1 7.9 60.2 11.4

(Loss) gain on foreign currency translation

Gain (loss) on foreign currency translation

1.3 ( 0.6 ) 0.2 ( 0.4 )

Comprehensive income $ 1,415.0 $ 1,439.6 $ 2,260.7 $ 2,165.3

19 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

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, 2023

10 unchanged sentences

1.8 — 134.2 0.1 11,942.6 27,982.3 ( 77.2 ) ( 25.8 ) ( 12,856.7 ) 26,991.1

Issuance of Common Stock for equity awards granted under long-term incentive plans — — 1.0 — 436.5 — — — — 436.5

Common Stock tendered upon exercise of stock options and vesting of restricted stock for employee tax obligations — — ( 0.4 ) — ( 311.8 ) — — — — ( 311.8 )

Issuance/distribution of Common Stock for 401(k) Savings Plan — — — — 19.6 — — — 2.2 21.8

Repurchases of Common Stock — — — — — — — ( 0.6 ) ( 601.4 ) ( 601.4 )

Stock-based compensation charges — — — — 230.0 — — — — 230.0

Net income — — — — — 1,432.3 — — — 1,432.3

Other comprehensive income, net of tax — — — — — — 7.3 — — 7.3

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

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:

3 unchanged sentences

Stock-based compensation expense 507.4 453.3

(Gains) losses on marketable and other securities, net ( 139.9 ) 196.1

Other non-cash items, net 3.2 0.1

Gains on marketable and other securities, net

( 389.9 ) ( 196.5 )

( 17.7 ) ( 2.9 )

Deferred income taxes ( 274.3 ) ( 308.5 )

Changes in assets and liabilities:

Decrease in accounts receivable

Decrease (increase) in accounts receivable 629.6 ( 47.3 )

Increase in inventories ( 194.8 ) ( 337.6 )

Increase in prepaid expenses and other assets ( 410.2 ) ( 604.2 )

( 179.5 ) ( 77.9 )

Increase in deferred revenue

(Decrease) increase in accounts payable, accrued expenses, and other liabilities

(Decrease) increase in deferred revenue

( 125.2 ) 206.0

Increase in accounts payable, accrued expenses, and other liabilities

Total adjustments ( 10.8 ) ( 287.8 )

4 unchanged sentences

Capital expenditures ( 448.3 ) ( 314.4 )

Payments for Libtayo intangible asset ( 42.2 ) ( 27.9 )

Net cash provided by (used in) in investing activities

Payments for intangible assets

( 230.0 ) ( 58.3 )

Proceeds from sale of property, plant, and equipment

Acquisitions, net of cash acquired

Net cash used in investing activities

( 446.5 ) ( 2,244.3 )

Cash flows from financing activities:

3 unchanged sentences

Dividends paid

Net cash (used in) provided by financing activities

Net cash used in financing activities

( 2,217.4 ) ( 431.0 )

Effect of exchange rate changes on cash, cash equivalents, and restricted cash 1.0 ( 0.8 )

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

Net decrease in cash, cash equivalents, and restricted cash

( 473.4 ) ( 809.6 )

2 unchanged sentences

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

Table of Conte nts

REGENERON PHARMACEUTICALS, INC.

23 unchanged sentences

Three Months Ended

June 30, Six Months Ended

(In millions) 2025 2024 2025 2024

3 unchanged sentences

1,147.5 1,534.7 2,190.3 2,936.3

247.8 182.4 440.3 341.6

Rest of world

128.7 115.0 221.3 219.7

Total Libtayo

376.5 297.4 661.6 561.3

65.8 56.1 122.6 126.1

41.2 30.4 72.1 55.2

Rest of world

$ 1,631.0 $ 1,918.6 $ 3,046.6 $ 3,679.9

As of March 31, 2025 and December 31, 2024, the Company had $ 3.760 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 months ended March 31, 2025 and 2024.

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.

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

2025 2024 2025 2024

52 % 51 % 52 % 51 %

24 % 24 % 24 % 24 %

Collaboration, License, and Other Agreements

3 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 March 31, 2025, the Company's contingent reimbursement obligation to Sanofi in connection with the development balance was approximately $ 1.453 billion.

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

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

(In millions) 2025 2024 2025 2024

7 unchanged sentences

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

March 31, December 31,

June 30, December 31,

(In millions) 2025

8 unchanged sentences

Statement of Operations Classification Three Months Ended

Six Months Ended

(In millions) 2025 2024 2025 2024

6 unchanged sentences

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

March 31, December 31,

June 30, December 31,

(In millions) 2025

2 unchanged sentences

$ 261.9 $ 216.3

In addition to the collaboration and license agreements discussed above, the Company has various other 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 various development and commercial milestones), which in the aggregate could be significant.

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.

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.

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

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

9 unchanged sentences

Three Months Ended

Six Months Ended

(Shares in millions) 2025 2024 2025 2024

2 unchanged sentences

Marketable Securities

Marketable securities as of March 31, 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 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).

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

(In millions) Amortized Unrealized Fair

As of March 31, 2025

As of June 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 March 31, 2025 mature at various dates through January 2030.

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

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) 2025

1 unchanged sentence

Maturities after one year through five years 8,572.4 7,804.8

Maturities after five years

$ 14,046.6 $ 14,329.1

2 unchanged sentences

(In millions)

As of March 31, 2025

As of June 30, 2025

Fair Value Unrealized Losses

3 unchanged sentences

government and government agency obligations 3,640.7 ( 1.2 ) 23.2 ( 0.1 ) 3,663.9 ( 1.3 )

Commercial paper

573.2 ( 0.1 ) — — 573.2 ( 0.1 )

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

Sovereign bonds 60.2 ( 0.1 ) — — 60.2 ( 0.1 )

$ 13,080.1 $ ( 2.9 ) $ 488.7 $ ( 7.3 ) $ 13,568.8 $ ( 10.2 )

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 months ended March 31, 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 months ended March 31, 2025 and 2024, realized gains/losses on sales of marketable securities were not material.

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.

Fair Value Measurements

5 unchanged sentences

(In millions) Fair Value Measurements at Reporting Date

As of March 31, 2025

As of June 30, 2025

Fair Value Level 1 Level 2 Level 3

26 unchanged sentences

$ 52.3 $ — $ — $ 52.3

(a) Includes equity securities of $ 26.3 million and $ 43.2 million as of March 31, 2025 and December 31, 2024, respectively, that are subject to transfer restrictions expiring in April 2026

(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

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

• As of March 31, 2025 and December 31, 2024, the Company had $ 316.8 million and $ 159.8 million, respectively, in equity securities that do not have a readily determinable fair value.

• 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.

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

• As of March 31, 2025 and December 31, 2024, the Company had equity securities held through ownership interest in an investment fund of $ 72.3 million and $ 52.0 million, respectively, which are measured at fair value based on Level 3 inputs.

During the three months ended March 31, 2025 and 2024, the Company recorded $ 139.7 million of net unrealized gains and $ 196.2 million of net unrealized losses, respectively, on equity securities in Other income (expense), net.

The fair value of the Company's long-term debt, which was determined based on Level 2 inputs, was estimated to be $ 1.511 billion and $ 1.484 billion as of March 31, 2025 and December 31, 2024, respectively.

• 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.

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.

Inventories consist of the following:

8 unchanged sentences

federal, state, and foreign income taxes.

The Company's effective tax rate was 10.6 % and ( 3.0 %) for the three months ended March 31, 2025 and 2024, respectively.

The Company's effective tax rate for the three months ended March 31, 2025 and 2024 was positively impacted, compared to the U.S.

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 and federal tax credits for research activities.

The Company's effective tax rate for the three months ended March 31, 2024 was also positively impacted by stock-based compensation.

The Company's 2017 and 2018 federal income tax returns are currently under audit by the IRS, and the Company expects 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, the Company expects 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 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.

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 ability to claim first-year bonus depreciation on qualified property.

The OBBBA also modifies U.S.

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

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

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 share

repurchase programs for up to an additional $ 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

(In millions) 2025 2024

1 unchanged sentence

Total cost of shares $ 1,069.9 $ 601.4 $ 2,122.3 $ 899.4

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

In February 2025, the Company's board of directors declared the Company's first quarterly cash dividend.

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

Additionally, in April 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 shareholders in June 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, 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.

Statement of Cash Flows

3 unchanged sentences

Restricted cash included in Other current assets

Restricted cash included in Other noncurrent assets

Total cash, cash equivalents, and restricted cash shown in the Condensed Consolidated Statements of Cash Flows

2 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) 2025

8 unchanged sentences

Three Months Ended

Six Months Ended

(In millions) 2025 2024 2025 2024

4 unchanged sentences

Lab supplies and other research and development costs

64.9 56.5 124.9 112.4

Occupancy and other operating costs 158.6 141.6 313.0 276.1

Total indirect research and development expenses

672.9 620.6 1,339.0 1,229.9

Clinical manufacturing costs

337.0 260.1 647.3 534.6

Reimbursement of research and development expenses by collaborators ( 42.3 ) ( 44.6 ) ( 79.7 ) ( 88.4 )

7 unchanged sentences

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

The Company recognizes accruals for loss contingencies associated with such proceedings when it is probable that a liability will be incurred and the amount of loss can be reasonably estimated.

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

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.

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 from June 12, 2023 through June 23, 2023 concerning certain claims of the '601 Patent, the '572 Patent, and the Company's U.S.

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").

3 unchanged sentences

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 will be precluded from launching its aflibercept 2 mg biosimilar until the second half of 2026.

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.

On November 8, November 22, and November 29, 2023, respectively, the Company filed patent infringement lawsuits against Celltrion, Inc.

1 unchanged sentence

("Samsung Bioepis"), and Formycon AG ("Formycon") in the United States District Court for the Northern District of West Virginia following service on Regeneron of each company's notice of commercial marketing.

The lawsuits allege that each company has infringed certain Company patents, including based on each company's filing for FDA approval of an aflibercept 2 mg biosimilar.

On December 27, 2023, the Company filed a second patent infringement lawsuit against Samsung Bioepis in the United States District Court for the Northern District of West Virginia alleging that Samsung Bioepis's filing for FDA approval of an aflibercept 2 mg biosimilar infringes certain Company patents.

The lawsuits alleged that each company had infringed certain Company patents, including based on each company's filing for FDA approval of an aflibercept 2 mg biosimilar.

On December 27, 2023, the Company filed a second patent infringement lawsuit against Samsung Bioepis.

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;

On June 14, June 25, and July 8, 2024, respectively, Samsung Bioepis, Formycon, and Celltrion filed notices of appeal of the court's preliminary injunction decisions to the Federal Circuit.

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.

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

("Amgen") in the United States District Court for the Central District of California alleging that Amgen's filing for FDA approval of an aflibercept 2 mg biosimilar infringes certain Company patents.

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

On April 11, 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 paragraph.

On June 7, 2024, the Company filed a motion for a preliminary injunction against Amgen.

On September 23, 2024, the court denied the Company's motion for a preliminary injunction, and the Company filed (i) a notice of appeal of such decision to the Federal Circuit, (ii) a motion for an immediate administrative stay, and (iii) a motion for a temporary injunction preventing Amgen from launching its aflibercept 2 mg biosimilar during the pendency of such appeal.

On September 25, 2024, the Federal Circuit

issued an administrative stay pending its review of the Company's temporary injunction motion.

On September 23, 2024, the court denied the Company's motion for a preliminary injunction;

and on September 25, 2024, the Federal Circuit issued an administrative stay pending its review of the Company's temporary injunction motion.

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

An expedited oral hearing concerning the Company's appeal of the court's preliminary injunction decision was held on January 14, 2025.

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 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 infringes certain Company patents.

("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.

Post-Grant Proceedings Before the USPTO

On November 20, 2024, November 29, 2024, and January 15, 2025, Samsung Bioepis, Formycon, and Celltrion, respectively, filed inter partes review ("IPR") petitions in the USPTO against the '865 Patent, each seeking a declaration that the '865 Patent is invalid.

On June 6, 2025, the USPTO denied institution of Samsung and Formycon's respective IPR petitions, and on June 25, 2025, the USPTO denied institution of Celltrion's IPR petition.

On July 14, 2025, Fresenius Kabi SwissBioSim GmbH filed IPR petitions in the USPTO against the '865 Patent and U.S.

10,828,345 (the "'345 Patent"), seeking a declaration that the '865 Patent and '345 Patent are invalid.

EPO Post-Grant Proceedings

Various parties, including Amgen and other, anonymous parties, are seeking revocation of the Company's European Patent Nos.

2,944,306 (the "'306 Patent"), 3,716,992 (the "'992 Patent"), and 3,384,049 (the "'049 Patent") before the Opposition Division of the EPO.

On November 26, 2024, following an oral hearing, the Opposition Division ("OD") of the EPO announced its decision to revoke the '306 Patent.

2,944,306 (the "'306 Patent"), 3,716,992 (the "'992 Patent"), and 3,384,049 (the "'049 Patent") before the Opposition Division ("OD") of the EPO.

On November 26, 2024, following an oral hearing, the OD announced its decision to revoke the '306 Patent.

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

An oral hearing concerning the '992 Patent has been scheduled for October 2025.

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

Country-Specific Proceedings

3 unchanged sentences

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, a trial concerning the '691 Patent has been scheduled to begin in June 2025.

In the United Kingdom, trials concerning the '691 and '306 Patents have been scheduled to begin 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 has been scheduled to begin in July 2025.

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.

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.

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.

On May 7, 2024 and June 28, 2024, respectively, Amgen Canada filed a summary trial motion with respect to the '510 Patent and a motion to delist the '276 Patent from the Canada Patent Register.

November 20, 2024, the court granted Amgen Canada's motion to delist the '276 Patent from the Canada Patent Register, which decision has been appealed by the Company and Bayer.

A trial for the lawsuits concerning the '510 Patent and the '276 Patent has been scheduled for May–June 2025;

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

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.

Proceedings against Sandoz

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

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

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

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.

1406811 (the "'811 Patent"), seeking revocation of the '811 Patent in its entirety.

On October 23, 2024, the KIPO maintained the '811 Patent as valid, and Samsung Bioepis appealed this decision on November 6, 2024.

On October 23, 2024, the KIPO maintained the '811 Patent as valid;

Samsung Bioepis has appealed that decision.

The Company and, as applicable, Bayer Consumer Care AG, have also filed patent infringement lawsuits in the Seoul Central District Court against various parties including Samsung Bioepis and its parent company Samsung Biologics Co., Ltd.

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Regeneron has appealed that decision.

On June 4, 2025, the Company, Bayer Consumer Care AG, and Bayer Australia filed a patent infringement lawsuit against Sandoz Pty Ltd.

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.

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

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On April 10, 2025, the court denied Amgen's motion for summary judgment.

A trial has been scheduled to begin in May 2025.

A trial was held in May 2025.

On May 15, 2025, the jury reached a verdict in Regeneron's favor on nine of the ten counts submitted to it and awarded Regeneron $ 135.6 million in compensatory damages and $ 271.2 million in punitive damages.

On June 20, 2025, Amgen filed a post-trial motion for judgment as a matter of law or, in the alternative, for a new trial.

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.

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, originally scheduled for May 2025, has been postponed.

An oral hearing before the Court of Appeal of the UPC has been scheduled for 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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The Company and Sanofi are also seeking revocation of the '797 Patent at the EPO.

On April 3, 2025, the Opposition Division of the EPO upheld the '797 Patent as valid.

On April 3, 2025, the OD upheld the '797 Patent as valid.

The Company and Sanofi have appealed this decision to the Technical Board of Appeal of the EPO.

An oral hearing before the Technical Board of Appeal of the EPO has been scheduled for April 2026.

Department of Justice Matters

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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.

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Attorney's Office for the District of Massachusetts filed a civil complaint intervention (the "March 2024 Civil Complaint") in the U.S.

District Court for the District of Massachusetts asserting causes of action under the

federal False Claims Act and a claim for unjust enrichment.

District Court for the District of Massachusetts asserting causes of action under the federal False Claims Act and a claim for unjust enrichment.

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

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An oral hearing on the Company's motion to dismiss was held on December 16, 2024.

On April 29, 2025, the court denied the Company's motion to dismiss.

On May 27, 2025, the Company filed its answers to the March 2024 Civil Complaint and the June 2024 Civil Complaint.

On June 17, 2025, the court granted a motion by the States of Maine, Nebraska, Ohio, Oregon, and Wyoming to intervene in the action.

On June 18, 2025, those states filed a consolidated complaint asserting causes of action under their respective state laws (the "June 2025 Civil Complaint").

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

Proceedings Initiated by Other Payors

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District Court for the District of Massachusetts.

On February 1, 2025, the parties jointly filed a stipulation to stay the action pending resolution of the proceedings before the same court concerning the allegations in the June 2020 Civil Complaint.

2021 Shareholder Derivative Complaint

On February 1, 2025, the

parties jointly filed a stipulation to stay the action pending resolution of the proceedings before the same court concerning the allegations in the June 2020 Civil Complaint.

Shareholder Derivative Complaint – Department of Justice June 2020 Civil Complaint Matters

On June 29, 2021, an alleged shareholder filed a shareholder derivative complaint in the New York Supreme Court, naming the then-current and certain former members of the Company's board of directors and certain then-current and former executive officers of the Company as defendants and Regeneron as a nominal defendant.

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District Court for the Southern District of New York denied the plaintiff's motion to remand the case and granted a motion to stay the case pending resolution of the proceedings before the U.S.

District Court for the District of Massachusetts concerning

the allegations in the June 2020 Civil Complaint.

District Court for the District of Massachusetts concerning the allegations in the June 2020 Civil Complaint.

As a result of the stay, the court also terminated the Company's motion to dismiss the complaint without prejudice.

The Company can therefore renew the motion to dismiss upon conclusion of the stay.

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.

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

The complaint asserts violations of federal securities laws in connection with statements or disclosures purportedly related to the conduct alleged in the March 2024 Civil Complaint discussed under "Department of Justice Matters" above.

2025 Shareholder Derivative Complaints

Shareholder Derivative Complaints – Department of Justice March 2024 Civil Complaint Matters

On January 16 and January 22, 2025, purported shareholders filed two separate shareholder derivative complaints in the U.S.

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and costs and disbursements of the applicable action, including attorneys' fees.

On February 11, 2025, the parties filed a joint stipulation to consolidate the two separate shareholder derivative complaints.

On June 3, 2025, the court consolidated the two separate shareholder derivative complaints pursuant to a joint stipulation by the parties.

On June 5, 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.

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.

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

On July 30, 2025, a purported shareholder filed another shareholder derivative complaint in the U.S.

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.

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

improvements to Regeneron's corporate governance and internal procedures;

equitable relief, including restitution from the individual defendants;

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

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.

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

On July 10, 2025, the court appointed a lead plaintiff and lead counsel for the action.

Sanofi Litigation

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The lawsuit seeks a declaratory judgment, injunctive relief, damages, and other relief.

On July 3, 2025, Sanofi filed a motion to dismiss the complaint.

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