What changed in this filing

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Item 1. Financial Statements

2025-04-29 compared with 2024-10-31 · 220 added, 397 removed, 431 unchanged (59% of the section changed)

3 unchanged sentences

(In millions, except per share data)

September 30, December 31,

March 31, December 31,

Current assets:

35 unchanged sentences

Accumulated other comprehensive income (loss) 29.1 ( 7.9 )

60.2 ( 80.9 )

Treasury Stock, at cost;

8 unchanged sentences

Three Months Ended

September 30,

Nine Months Ended

September 30,

Statements of Operations

10 unchanged sentences

2,437.0 2,393.6

2,541.2 2,251.7 7,412.3 6,608.7

Income from operations 591.7 751.4

5 unchanged sentences

Income before income taxes 905.0 700.7

Income tax expense

Income tax expense (benefit)

96.3 ( 21.3 )

8 unchanged sentences

Unrealized gain on debt securities

128.2 21.3 139.6 62.8

Gain (loss) on foreign currency translation

1.9 ( 0.4 ) 1.5 ( 0.8 )

(Loss) gain on foreign currency translation

Comprehensive income $ 845.7 $ 725.7

12 unchanged sentences

Repurchases of Common Stock — — — — — — — ( 1.5 ) ( 1,052.4 ) ( 1,052.4 )

Stock-based compensation charges — — — — 233.3 — — — — 233.3

Net income — — — — — 722.0 — — — 722.0

Other comprehensive income, net of tax

— — — — — — 3.7 — — 3.7

Balance, March 31, 2024

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

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

Dividends declared

— — — — 1.0 ( 97.2 ) — — — ( 96.2 )

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, 2022 1.8 $ — 130.4 $ 0.1 $ 9,949.3 $ 23,306.7 $ ( 238.8 ) ( 22.6 ) $ ( 10,353.3 ) $ 22,664.0

Issuance of Common Stock for equity awards granted under long-term incentive plans — — 1.1 — 491.3 — — — — 491.3

Common Stock tendered upon exercise of stock options and vesting of restricted stock for employee tax obligations — — ( 0.1 ) — ( 99.2 ) — — — — ( 99.2 )

Issuance/distribution of Common Stock for 401(k) Savings Plan — — — — 18.9 — — — 1.7 20.6

Repurchases of Common Stock — — — — — — — ( 0.9 ) ( 693.9 ) ( 693.9 )

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

1 unchanged sentence

Other comprehensive income, net of tax — — — — — — 37.0 — — 37.0

— — — — — — 57.2 — — 57.2

Balance, March 31, 2025

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 — — 0.2 — 80.7 — — — — 80.7

Common Stock tendered upon exercise of stock options and vesting of restricted stock for employee tax obligations — — — — ( 14.0 ) — — — — ( 14.0 )

Issuance/distribution of Common Stock for 401(k) Savings Plan — — — — 16.1 — — — 2.4 18.5

Repurchases of Common Stock — — — — — — — ( 1.0 ) ( 722.8 ) ( 722.8 )

Stock-based compensation charges — — — — 208.0 — — — — 208.0

Net income — — — — — 968.4 — — — 968.4

Other comprehensive loss, net of tax

— — — — — — ( 16.1 ) — — ( 16.1 )

Balance, June 30, 2023

Balance, December 31, 2023

1.8 $ — 133.1 $ 0.1 $ 11,354.0 $ 27,260.3 $ ( 80.9 ) ( 25.5 ) $ ( 12,560.4 ) $ 25,973.1

7 unchanged sentences

— — — — — — 3.7 — — 3.7

Balance, September 30, 2023

Balance, March 31, 2024

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

3 unchanged sentences

(In millions)

Nine Months Ended

September 30,

Three Months Ended

Cash flows from operating activities:

7 unchanged sentences

Changes in assets and liabilities:

Increase in accounts receivable

( 436.2 ) ( 256.1 )

Decrease in accounts receivable

Increase in inventories ( 152.3 ) ( 155.8 )

Increase in prepaid expenses and other assets

Increase (decrease) in deferred revenue 249.0 ( 5.1 )

Increase in accounts payable, accrued expenses, and other liabilities 509.5 737.3

( 179.5 ) ( 77.9 )

Increase in deferred revenue

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

( 214.1 ) 110.5

Total adjustments 236.4 790.5

4 unchanged sentences

Capital expenditures ( 229.3 ) ( 133.9 )

Proceeds from sale of property, plant, and equipment

Payments for Libtayo intangible asset ( 42.2 ) ( 27.9 )

Acquisitions, net of cash acquired

Net cash provided by (used in) in investing activities

647.5 ( 1,687.1 )

Net cash used in investing activities ( 2,818.7 ) ( 3,118.9 )

Cash flows from financing activities:

2 unchanged sentences

Repurchases of Common Stock ( 1,041.4 ) ( 291.3 )

Net cash used in financing activities ( 1,065.0 ) ( 1,344.0 )

Dividends paid

Net cash (used in) provided by financing activities

( 1,089.2 ) 47.1

Effect of exchange rate changes on cash, cash equivalents, and restricted cash 0.6 ( 0.5 )

Net decrease in cash, cash equivalents, and restricted cash ( 726.0 ) ( 959.2 )

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

604.0 ( 128.0 )

Cash, cash equivalents, and restricted cash at beginning of period 2,489.0 2,737.8

1 unchanged sentence

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

Table of Conte nts

REGENERON PHARMACEUTICALS, INC.

10 unchanged sentences

Recently Issued Accounting Standards

In November 2023, the Financial Accounting Standards Board ("FASB") issued Accounting Standards Update No.

2023-07, Segment Reporting - Improvements to Reportable Segment Disclosures .

The amendments require disclosure of incremental segment information on an annual and interim basis.

The amendments also require companies with a single reportable segment to provide all disclosures required by this amendment and all existing segment disclosures in Accounting Standards Codification 280, Segment Reporting .

The amendments are effective for fiscal years beginning after December 15, 2023, and interim periods beginning after December 15, 2024.

The Company does not expect the adoption of the amendments to have a significant impact on its financial statements.

In December 2023, the FASB issued Accounting Standards Update No.

2023-09, Income Taxes - Improvements to Income Tax Disclosures .

The amendments require (i) enhanced disclosures in connection with an entity's effective tax rate reconciliation and (ii) income taxes paid disaggregated by jurisdiction.

The amendments are effective for annual periods beginning after December 15, 2024.

The Company does not expect the adoption of the amendments to have a significant impact on its financial statements.

Standard/Description

Effective Date

Impact of Adoption on the Company's Financial Statements

In December 2023, the FASB issued amended guidance related to improvements to income tax disclosures .

The amendments require annually (i) enhanced disclosures in connection with an entity's effective tax rate reconciliation and (ii) income taxes paid disaggregated by jurisdiction.

January 1, 2025

No significant impact expected

In November 2024, the FASB issued new guidance which requires disclosure of disaggregated income statement expense information about specific categories (including purchases of inventory, employee compensation, depreciation, and intangible asset amortization) in the notes to financial statements.

January 1, 2027 for annual reporting periods and January 1, 2028 for interim reporting periods

Currently evaluating impact

Product Sales

1 unchanged sentence

Three Months Ended

September 30, Nine Months Ended

September 30,

(In millions) 2025 2024

3 unchanged sentences

1,042.8 1,401.6

194.5 144.1 536.1 384.0

Rest of world

94.1 88.3 313.8 235.3

Total Libtayo

288.6 232.4 849.9 619.3

52.9 40.4 179.0 121.1

32.4 19.1 87.6 53.3

35.6 3.3 36.6 7.7

Rest of world

$ 1,415.6 $ 1,761.3

As of September 30, 2024 and December 31, 2023, the Company had $ 4.142 billion and $ 3.888 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, 2024 and 2023.

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.

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

Three Months Ended

September 30,

Nine Months Ended

September 30,

2024 2023 2024 2023

Besse Medical, a subsidiary of Cencora, Inc.

51 % 53 % 51 % 52 %

McKesson Corporation 24 % 24 % 24 % 25 %

Collaboration, License, and Other Agreements

1 unchanged sentence

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

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

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;

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 September 30, 2024, the Company's contingent reimbursement obligation to Sanofi under the collaboration was approximately $ 1.810 billion.

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

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

During the three months ended September 30, 2023, the Company earned the final $ 50.0 million sales-based milestone from Sanofi upon aggregate annual sales of antibodies outside the United States exceeding $ 3.0 billion on a rolling twelve-month basis.

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).

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

September 30,

Nine Months Ended

September 30,

(In millions) 2025 2024

1 unchanged sentence

Collaboration revenue $ 1,018.2 $ 804.0

Sales-based milestones earned

Collaboration revenue

$ — $ 50.0 $ — $ 50.0

Reimbursement for manufacturing of commercial supplies Collaboration revenue $ 165.0 $ 105.8

1 unchanged sentence

$ ( 15.5 ) $ ( 18.6 )

Reimbursement of commercialization-related expenses Reduction of SG&A expense $ 169.0 $ 135.5 $ 459.3 $ 384.0

Reimbursement of commercialization-related expenses

Reduction of SG&A expense $ 159.2 $ 139.5

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

September 30, December 31,

March 31, December 31,

(In millions) 2025

8 unchanged sentences

Statement of Operations Classification Three Months Ended

September 30,

Nine Months Ended

September 30,

(In millions) 2025 2024

1 unchanged sentence

Collaboration revenue $ 317.3 $ 333.9

Reimbursement for manufacturing of ex-U.S.

commercial supplies Collaboration revenue $ 23.2 $ 27.2 $ 67.4 $ 79.7

Reimbursement for manufacturing of commercial supplies

Collaboration revenue $ 26.6 $ 22.1

Regeneron's obligation for its share of Bayer R&D expenses, net of reimbursement of R&D expenses (R&D expense)

1 unchanged sentence

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

September 30, December 31,

March 31, December 31,

(In millions) 2025

2 unchanged sentences

$ 260.0 $ 216.3

The Company is a party to a collaboration agreement with Roche to develop, manufacture, and distribute the casirivimab and imdevimab antibody cocktail (known as REGEN-COV ® in the United States and Ronapreve ™ in other countries).

Under the terms of the collaboration agreement, the Company has the right to distribute the product in the United States while Roche has the right to distribute the product outside the United States.

The parties share gross profits from worldwide sales.

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

Statement of Operations Classification Three Months Ended

September 30,

Nine Months Ended

September 30,

(In millions) 2024 2023 2024

Global gross profits earned in connection with sales of Ronapreve

Collaboration revenue $ 0.5 $ — $ 1.4 $ 222.2

Collaboration revenue $ — $ ( 5.7 ) $ — $ ( 9.5 )

Contract balances in the Company's Balance Sheets in connection with the Roche collaboration were not material as of September 30, 2024 and December 31, 2023.

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 be required to pay, or it 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.

The Company may also incur, or get reimbursed for, significant research and development costs.

During the three and nine months ended September 30, 2024, the Company recorded to Acquired in-process research and development expense a $ 45.0 million development milestone in connection with the Company's collaboration agreement with Sonoma Biotherapeutics, Inc.

During the three and nine months ended September 30, 2023, the Company recorded to Acquired in-process research and development expense a $ 100.0 million development milestone in connection with the Company's collaboration agreement with Alnylam Pharmaceuticals, Inc.

Acquired in-process research and development expense for the nine months ended September 30, 2023 also included a $ 45.0 million u p-front payment in connection with the Company's collaboration agreement with Sonoma.

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.

Net Income Per Share

Basic net income per share is computed by dividing net income by the weighted average number of shares of Common Stock and Class A Stock outstanding.

Net income per share is presented on a combined basis, inclusive of Common Stock and Class A Stock outstanding, as each class of stock has equivalent economic rights.

Diluted net income per share includes the potential dilutive effect of other securities as if such securities were converted or exercised during the period, when the effect is dilutive.

The calculations of basic and diluted net income per share are as follows:

Three Months Ended

September 30,

Nine Months Ended

September 30,

(In millions, except per share data) 2025 2024

9 unchanged sentences

Three Months Ended

September 30,

Nine Months Ended

September 30,

(Shares in millions) 2025 2024

Stock options 4.8 1.5

Restricted stock awards and restricted stock units

Marketable Securities

Marketable securities as of September 30, 2024 and December 31, 2023 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 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).

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

(In millions) Amortized Unrealized Fair

As of September 30, 2024

As of March 31, 2025

Cost Basis Gains Losses Value

1 unchanged sentence

government and government agency obligations 3,531.8 5.7 ( 2.3 ) 3,535.2

Sovereign bonds 66.7 0.4 ( 0.2 ) 66.9

Commercial paper 393.6 0.2 — 393.8

1 unchanged sentence

Asset-backed securities 321.2 0.7 ( 0.2 ) 321.7

Sovereign bonds 60.0 0.3 ( 0.1 ) 60.2

$ 13,261.6 $ 57.0 $ ( 17.7 ) $ 13,300.9

2 unchanged sentences

government and government agency obligations 4,820.5 3.4 ( 6.9 ) 4,817.0

Sovereign bonds 58.1 — ( 0.9 ) 57.2

Commercial paper 548.3 0.4 — 548.7

1 unchanged sentence

Asset-backed securities 279.0 0.6 ( 0.3 ) 279.3

Sovereign bonds 82.7 0.1 ( 0.4 ) 82.4

$ 14,338.0 $ 30.1 $ ( 39.0 ) $ 14,329.1

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 September 30, 2024 mature at various dates through October 2029.

The available-for-sale debt securities as of March 31, 2025 mature at various dates through January 2030.

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

September 30, December 31,

March 31, December 31,

(In millions) 2025

1 unchanged sentence

Maturities after one year through five years 8,041.7 7,804.8

Maturities after five years 0.8 4.6

$ 13,300.9 $ 14,329.1

2 unchanged sentences

(In millions)

As of September 30, 2024

As of March 31, 2025

Fair Value Unrealized Losses

3 unchanged sentences

government and government agency obligations 3,473.9 ( 1.9 ) 61.3 ( 0.4 ) 3,535.2 ( 2.3 )

Sovereign bonds 46.0 — 20.9 ( 0.2 ) 66.9 ( 0.2 )

Asset-backed securities 310.7 ( 0.2 ) 11.0 — 321.7 ( 0.2 )

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

$ 11,826.9 $ ( 6.3 ) $ 665.8 $ ( 11.4 ) $ 12,492.7 $ ( 17.7 )

2 unchanged sentences

government and government agency obligations 4,675.3 ( 6.2 ) 141.7 ( 0.7 ) 4,817.0 ( 6.9 )

Sovereign bonds 12.4 ( 0.1 ) 44.8 ( 0.8 ) 57.2 ( 0.9 )

Commercial paper

636.8 ( 0.2 ) — — 636.8 ( 0.2 )

Asset-backed securities 265.4 ( 0.3 ) 13.9 — 279.3 ( 0.3 )

Sovereign bonds 63.3 ( 0.3 ) 19.1 ( 0.1 ) 82.4 ( 0.4 )

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

The unrealized losses on corporate bonds were primarily driven by changes in interest rates.

The Company has reviewed its portfolio of available-for-sale debt securities and determined that the decline in fair value below cost did not result from credit-related factors.

In addition, the Company does not intend to sell, and it is not more likely than not that the Company will be required to sell, such securities before recovery of their amortized cost bases.

With respect to marketable securities, for the three and nine months ended September 30, 2024 and 2023, 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 nine months ended September 30, 2024 and 2023, realized gains/losses on sales of marketable securities were not material.

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.

Fair Value Measurements

5 unchanged sentences

(In millions) Fair Value Measurements at Reporting Date

As of September 30, 2024

As of March 31, 2025

Fair Value Level 1 Level 2 Level 3

3 unchanged sentences

government and government agency obligations 3,535.2 — 3,535.2 —

Sovereign bonds 66.9 — 66.9 —

Commercial paper 393.8 — 393.8 —

1 unchanged sentence

Asset-backed securities 321.7 — 321.7 —

Equity securities (unrestricted) 1,232.1 1,232.1 — —

Equity securities (restricted) (a)

Sovereign bonds 60.2 — 60.2 —

Equity securities (a)

1,234.6 1,234.6 — —

7 unchanged sentences

government and government agency obligations 4,817.0 — 4,817.0 —

Sovereign bonds 57.2 — 57.2 —

Commercial paper 548.7 — 548.7 —

1 unchanged sentence

Asset-backed securities 279.3 — 279.3 —

Equity securities (unrestricted) 864.5 864.5 — —

Equity securities (restricted) 112.9 112.9 — —

Sovereign bonds 82.4 — 82.4 —

Equity securities (a)

1,095.3 1,095.3 — —

$ 16,876.6 $ 2,359.5 $ 14,517.1 $ —

Contingent consideration

$ 52.3 $ — $ — $ 52.3

(a) Includes equity securities which are subject to transfer restrictions that expire in April 2026

In addition to the investments summarized in the table above, as of September 30, 2024 and December 31, 2023, the Company had $ 159.8 million and $ 74.3 million, respectively, in equity investments that do not have a readily determinable fair value.

These investments are recorded within Other noncurrent assets.

Also recorded within Other noncurrent assets as of September 30, 2024 were equity investments of $ 47.0 million which are measured at fair value based on Level 3 inputs;

no such investments were held by the Company as of December 31, 2023.

During the three and nine months ended September 30, 2024, the Company recorded $ 134.5 million and $ 330.8 million of net unrealized gains, respectively, on equity securities in Other income (expense), net;

and during the three and nine months ended September 30, 2023, the Company recorded $ 100.3 million and $ 295.9 million of net unrealized losses, respectively, on equity securities in Other income (expense), net.

In addition, during the three months ended September 30, 2023, the Company recorded a write-down of $ 29.0 million in Other income (expense), net related to the Company's investments in private companies.

The fair value of the Company's long-term debt, which was determined based on Level 2 inputs, was estimated to be $ 1.577 billion and $ 1.528 billion as of September 30, 2024 and December 31, 2023, respectively.

(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

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.

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.

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 10.2 % and 9.3 % for the three months ended September 30, 2024 and 2023, respectively, and 8.6 % and 8.4 % for the nine months ended September 30, 2024 and 2023, respectively.

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 existing uncertain tax positions.

The Company's effective tax rate for the three and nine months ended September 30, 2023 was positively impacted, compared to the U.S.

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.

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, stock-based compensation and federal tax credits for research activities.

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.

Stockholders' Equity

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

As of September 30, 2024, the Company had repurchased the entire $ 3.0 billion of its Common Stock it was authorized to repurchase under the program.

In April 2024, 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 permits the Company to make repurchases through a variety of methods, including open-market transactions (including pursuant to a trading plan adopted in accordance with Rule 10b5-1 of the Securities Exchange Act of 1934, as amended (the "Exchange Act")), privately negotiated transactions, accelerated share repurchases, block trades, and other transactions in compliance with Rule 10b-18 of the Exchange Act.

Share Repurchase Programs

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).

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

The table below summarizes the shares of the Company's Common Stock that the Company repurchased and the cost of such shares, which were recorded as Treasury Stock.

Three Months Ended

September 30,

Nine Months Ended

September 30,

(In millions) 2025 2024

1 unchanged sentence

Total cost of shares $ 1,052.4 $ 298.0

As of September 30, 2024, $ 2.893 billion remained available for share repurchases under the April 2024 program.

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.

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

Cash and cash equivalents $ 3,090.2 $ 2,602.0

Restricted cash included in Other current assets

Restricted cash included in Other noncurrent assets

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$ 3,093.0 $ 2,609.8

Restricted cash consisted of amounts held by financial institutions pursuant to contractual arrangements.

Restricted cash consists of amounts held pursuant to contractual arrangements and for dividends payable on certain equity awards.

Supplemental disclosure of non-cash investing and financing activities

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

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

(In millions) 2025

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$ 43.1 $ 62.7 $ 88.8 $ 71.6

Segment Information

The Company operates in one business segment, which includes all activities related to the discovery, development, and commercialization of medicines for serious diseases.

The determination of a single business segment is consistent with the consolidated financial information regularly provided to the Company’s chief operating decision maker (“CODM”).

The Company’s CODM is its Chief Executive Officer, who reviews and evaluates consolidated net income for purposes of assessing performance, making operating decisions, allocating resources, and planning and forecasting for future periods.

In addition to the significant expense categories included within consolidated net income presented on the Company's Condensed Consolidated Statements of Operations, see below for disaggregated amounts that comprise research and development expenses:

Three Months Ended

(In millions) 2025 2024

Direct research and development expenses (a)

$ 388.4 $ 408.3

Indirect research and development expenses:

Payroll and benefits 451.6 418.9

Lab supplies and other research and development costs

Occupancy and other operating costs 154.4 134.6

Total indirect research and development expenses

Clinical manufacturing costs

Reimbursement of research and development expenses by collaborators ( 37.3 ) ( 43.8 )

Total research and development expenses

$ 1,327.4 $ 1,248.4

(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

Legal Matters

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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 September 30, 2024 and December 31, 2023, the Company's accruals for loss contingencies were not material.

As of March 31, 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.

Proceedings Relating to Praluent (alirocumab) Injection

United States

On May 27, 2022, the Company filed a lawsuit against Amgen Inc.

in the United States District Court for the District of Delaware, alleging that, beginning in 2020, Amgen engaged in an anticompetitive bundling scheme which was designed to exclude Praluent from the market in violation of federal and state laws.

The lawsuit seeks damages for harm caused by the alleged scheme, as well as injunctive relief restraining Amgen from continuing its alleged anticompetitive conduct.

On August 1 and 11, 2022, Amgen filed a motion to dismiss the complaint and a motion to stay these proceedings, respectively.

On February 10, 2023, the court denied Amgen's motion to stay;

and on March 21, 2023, the court denied Amgen's motion to dismiss.

On August 28, 2023, the Company filed an amended complaint in this matter;

and, as part of its response, on September 20, 2023, Amgen filed a counterclaim alleging that the Company engaged in unfair business practices in violation of state law.

On May 22, 2024, Amgen filed a motion for summary judgment.

An oral hearing on Amgen's motion for summary judgment has been scheduled for November 20, 2024.

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.

3,666,797 (the "'797 Patent").

The '797 Patent is a divisional patent of European Patent No.

2,215,124 (the "'124 Patent") (i.e., a patent that shares the same priority date, disclosure, and patent term of the parent '124 Patent), which was previously invalidated by Technical Board of Appeal (the "TBA") of the European Patent Office (the "EPO").

A trial on the revocation action before the Munich Central Division of the UPC was held on June 4, 2024.

On July 16, 2024, the Munich Central Division of the UPC issued a decision revoking the '797 Patent in its entirety.

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

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.

The lawsuit seeks, among other things, a permanent injunction in several countries in Europe and monetary damages.

On July 29, 2024, the Munich Local Division of the UPC ordered a stay of the infringement lawsuit in light of the decision of the Munich Central Division of the UPC to revoke the '797 Patent in its entirety (discussed above).

Proceedings Relating to EYLEA (aflibercept) Injection

Certain of the Company's patents pertaining to EYLEA are subject to post-grant proceedings before the United States Patent and Trademark Office ("USPTO"), EPO, or other comparable foreign authorities, including those described in greater detail below.

Certain of the Company's patents pertaining to EYLEA are subject to post-grant proceedings before the United States Patent and Trademark Office ("USPTO"), the European Patent Office (the "EPO"), or other comparable foreign authorities, including those described in greater detail below.

In addition, the Company has filed patent infringement lawsuits in several jurisdictions alleging infringement of certain Company patents pertaining to EYLEA, including those described in greater detail below.

United States

Post-Grant Proceedings Before USPTO

Company Patent(s)

Challenger(s)

Type of Challenge

Date of Challenge

Latest Events/Current Status

9,254,338 (the "'338 Patent") and 9,669,069 (the "'069 Patent") Mylan Pharmaceuticals Inc., joined by Apotex Inc.

and Celltrion

IPR petitions seeking declarations of invalidity

On November 9, 2022, the USPTO issued final written decisions finding that the challenged claims of the '338 and '069 Patents are unpatentable and, therefore, invalid.

On January 10, 2023, the Company filed notices of appeal of these decisions to the United States Court of Appeals for the Federal Circuit (the "Federal Circuit").

On July 9, 2024, the Company's appeal was voluntarily dismissed.

10,130,681 (the "'681 Patent") and 10,888,601 (the "'601 Patent")

Mylan, joined by Celltrion ('601 and '681 Patents) and Samsung Bioepis Co., Ltd.

('601 Patent)

IPR petitions seeking declarations of invalidity

On January 9, 2024, the USPTO issued final written decisions finding that that the challenged claims of the '681 and '601 Patents are unpatentable and, therefore, invalid.

On March 12, 2024, the Company filed notices of appeal of these decisions to the Federal Circuit.

On August 20, 2024, the Company's appeal was voluntarily dismissed.

Samsung Bioepis, joined by Biocon Biologics Inc.

('601 Patent)

IPR petitions seeking declarations of invalidity

January 6, 2023 ('681 Patent)

March 26, 2023 ('601 Patent)

On July 19, 2023 and October 20, 2023, the USPTO instituted IPR proceedings concerning the '681 Patent and the '601 Patent, respectively.

On June 14, 2024, the USPTO issued a final written decision finding that the challenged claims of the '681 Patent are unpatentable and, therefore, invalid.

11,253,572 (the "'572 Patent") Samsung Bioepis

IPR petition seeking declaration of invalidity

April 27, 2023

On November 17, 2023, the USPTO instituted IPR proceedings concerning the '572 Patent.

On July 11, 2024, the Company filed a Notice of Disclaimer with the USPTO, disclaiming all claims of the '572 Patent.

Patent Litigation

On August 2, 2022, the Company filed a patent infringement lawsuit against Mylan, a wholly-owned subsidiary of Viatris Inc., in the United States District Court for the Northern District of West Virginia alleging that Mylan's filing for U.S.

On August 2, 2022, the Company filed a patent infringement lawsuit against Mylan Pharmaceuticals Inc.

("Mylan"), a wholly-owned subsidiary of Viatris Inc., in the United States District Court for the Northern District of West Virginia alleging that Mylan's filing for U.S.

Food and Drug Administration ("FDA") approval of an aflibercept 2 mg biosimilar infringes certain Company patents.

On April 20, 2023, Mylan filed a motion for summary judgment or partial summary judgment concerning four of the asserted patents.

On April 26, 2023, the Company filed a stipulation accepting summary judgment of noninfringement of all asserted claims of the Company's U.S.

On June 5, 2023, Biocon, as successor-in-interest to the aflibercept 2 mg biosimilar, was joined as a defendant to the lawsuit.

On June 5, 2023, Biocon Biologics Inc.

("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.

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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.

On November 8, November 22, and November 29, 2023, respectively, the Company filed patent infringement lawsuits against Celltrion, Samsung Bioepis, and Formycon AG 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.

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

("Celltrion"), Samsung Bioepis Co., Ltd.

("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's filing for FDA approval of an aflibercept 2 mg biosimilar infringes certain Company patents.

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.

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.

An oral hearing concerning the respective notices of appeal of Samsung Bioepis and Formycon has been scheduled for December 5, 2024.

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

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 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.

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.

An oral hearing before the United States District Court for the Northern District of West Virginia was held on August 13, 2024.

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 October 22, 2024, the Federal Circuit denied the Company's temporary injunction motion, lifted the administrative stay, and indicated that an expedited oral hearing on the Company's appeal to the Federal Circuit will be held in January 2025.

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

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 infringes 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.

Post-Grant Proceedings

Authority/Court

Company Patent(s)

Challenger(s)

Type of Challenge

Date of Challenge

Latest Events/Current Status

European Patent No.

2,944,306 (the "'306 Patent") Anonymous parties Opposition proceedings October 26 and October 27, 2021 Oral hearing scheduled for November 2024

European Patent No.

3,716,992 (the "'992 Patent")

Amgen and three anonymous parties Opposition proceedings May 5–10, 2023

Oral hearing to be scheduled

EPO European Patent No.

3,384,049 (the "'049 Patent") Amgen and anonymous parties

Opposition proceedings April 22–30, 2024

Oral hearing to be scheduled

German Federal Patent Court

German designation of European Patent No.

2,364,691 (the "'691 Patent") Samsung Bioepis NL B.V.

Invalidation proceedings June 22, 2023 Trial has been scheduled to begin in June 2025

High Court of Justice of England and Wales United Kingdom designations of the '691 Patent and '306 Patent

Formycon AG and Klinge Biopharma GmbH Invalidation proceedings and declaration of non-infringement by challengers' aflibercept 2 mg biosimilar

April 18, 2024 Trial has been scheduled to begin in June 2025

Invalidation proceedings and declaration of non-infringement by challenger's aflibercept 2 mg biosimilar

September 11, 2024

Trial has been scheduled to begin in June 2025

Samsung Bioepis UK Limited

Invalidation proceedings and declaration of non-infringement by challenger's aflibercept 2 mg biosimilar

October 2, 2024

Trial has been scheduled to begin in June 2025

High Court of Justice of England and Wales United Kingdom designation of the '992 Patent

Amgen Invalidation proceedings May 13, 2024 Stayed pending final resolution of the '992 Patent EPO opposition proceedings listed above

District Court of The Hague, the Netherlands Dutch designation of the '691 Patent and '306 Patent Samsung Bioepis NL B.V.

Invalidation proceedings July 17, 2024

Trial for both patents has been scheduled for July 18, 2025

High Court of Justice of England and Wales

United Kingdom designation of the '992 Patent

Samsung Bioepis UK Limited

Invalidation proceedings

July 24, 2024

Stayed pending final resolution of the '992 Patent EPO opposition proceedings listed above

Judicial Court of Paris

French designation of the '691 Patent and '306 Patent Formycon AG Invalidation proceedings and declaration of non-infringement by challenger's aflibercept 2 mg biosimilar August 19, 2024 Trial to be scheduled

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.

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.

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

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

Country-Specific Proceedings

Various parties, including Samsung Bioepis and Formycon and/or their affiliated entities, are seeking revocation of the '306 Patent, the '992 Patent, and the Company's European Patent No.

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, 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.

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.

1,183,353 (as extended by Supplementary Protection Certificate 2013C/029).

Proceedings against Amgen Canada

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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 filed a summary trial motion with respect to the '510 Patent and a motion to delist the '276 Patent from the Canada Patent Register.

A hearing on the motion to delist the '276 Patent has been scheduled for November 2024.

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.

Proceedings against Samsung

On August 1, 2024, the Company, Bayer Inc., and Bayer Healthcare LLC filed patent infringement lawsuits against Samsung Bioepis Co., Ltd.

Proceedings against Sandoz

On January 24, 2025, the Company, Bayer Inc., and Bayer Healthcare LLC filed patent infringement lawsuits against Sandoz Canada Inc.

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 '510 Patent, the '276 Patent, the '495 Patent, the '768 Patent, the '193 Patent, the '315 Patent, and Canadian Patent No.

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

On October 28, 2024, the Company, Bayer Inc., Bayer Healthcare LLC, and Samsung Bioepis Co., Ltd.

entered into a settlement agreement concerning these patent infringement lawsuits, pursuant to which each such lawsuit will be dismissed and Samsung will generally be precluded from launching its aflibercept 2 mg biosimilar product in Canada until July 1, 2025.

On October 31, 2022 and December 13, 2022, Samsung Bioepis Co., Ltd.

initiated invalidation proceedings before the Intellectual Property Trial and Appeal Board of the Korean Intellectual Property Office against the Company's Korean Patent Nos.

1131429 and 1406811 (the "'811 Patent"), respectively, seeking revocation of each such patent in its entirety.

Set forth below is a summary of patent infringement lawsuits filed by the Company and, as applicable, Bayer Consumer Care AG before the Seoul Central District Court based on allegations that the making, constructing, using, or selling of an aflibercept 2 mg biosimilar by the relevant defendant(s) would infringe one or more claims of the Company's patents listed below.

Company Patent(s)

Relief Sought

Date of Action

Korean Patent No.

659477 (the "'477 Patent")

Samsung Bioepis Co., Ltd.

and its parent company Samsung Biologics Co., Ltd.

January 16, 2023

Sam Chun Dang Pharm.

and OPTUS Pharmaceutical Co., Ltd

January 8, 2024

'477 Patent, '811 Patent, and Korean Patent No.

2519234 (the "'234 Patent")

Celltrion Inc.

Damages and injunctive relief

January 10, 2024

'811 Patent and '234 Patent

Sam Chun Dang Pharm.

and OPTUS Pharmaceutical Co., Ltd

Damages and injunctive relief

Samsung Bioepis Co., Ltd., its parent company Samsung Biologics Co., Ltd., and Samil Pharmaceuticals Co., Ltd

Injunctive relief

Samsung Bioepis Co., Ltd., its parent company Samsung Biologics Co., Ltd., and Samil Pharmaceuticals Co., Ltd.

Injunctive relief

July 30, 2024

Celltrion Inc.

and Kukje Pharmaceuticals, Inc.

Injunctive relief

July 30, 2024

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.

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.

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.

(collectively, "Samsung"), Sam Chun Dang Pharm.

and OPTUS Pharmaceutical Co., Ltd, and Celltrion.

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 relevant defendant(s) would infringe one or more claims of the '811 Patent and/or the Company's Korean Patent Nos.

659477 (the "'477 Patent") and 2519234 (the "'234 Patent").

On February 7, 2025, the Seoul Central District Court granted the Company's preliminary injunction request against Samsung on the basis of the '811 Patent;

Samsung has appealed that decision.

The preliminary injunction against Samsung prohibits Samsung from manufacturing and selling its aflibercept 2 mg biosimilar in South Korea.

Also on February 7, 2025, the Seoul Central District Court denied Regeneron's preliminary injunction request against Celltrion;

Regeneron has appealed that decision.

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

On June 19, 2020, Novartis Pharma AG, Novartis Pharmaceuticals Corporation, and Novartis Technology LLC (collectively, "Novartis") filed a patent infringement lawsuit (as amended on August 2, 2021) in the U.S.

District Court for the Northern District of New York asserting claims of Novartis's U.S.

9,220,631 (the "'631 Patent") and seeking preliminary and permanent injunctions to prevent the Company from continuing to infringe the '631 Patent.

Novartis also seeks a judgment of patent infringement of the '631 Patent, monetary damages (together with interest), an order of willful infringement of the '631 Patent (which would allow the court in its discretion to award damages up to three times the amount assessed), costs and expenses of the lawsuits, and attorneys' fees.

On November 7, 2022, the Company and Novartis entered into a stipulation staying the lawsuit in light of the decision in the IPR proceeding discussed below.

On July 16, 2020, the Company initiated two IPR petitions in the USPTO seeking a declaration of invalidity of the '631 Patent on two separate grounds.

On October 26, 2021, the USPTO issued a decision instituting the IPR proceeding.

An oral hearing was held on July 21, 2022.

On October 25, 2022, the Patent Trial and Appeal Board ("PTAB") of the USPTO issued a final written decision invalidating all claims of the '631 Patent.

On December 23, 2022, Novartis filed a notice of appeal of the PTAB's decision to the Federal Circuit.

An oral hearing was held on August 6, 2024.

On September 23, 2024, the Federal Circuit affirmed the PTAB's decision invalidating all claims of the '631 Patent.

On July 17, 2020, the Company filed an antitrust lawsuit against Novartis and Vetter Pharma International Gmbh ("Vetter") in the United States District Court for the Southern District of New York seeking a declaration that the '631 Patent is unenforceable and a judgment that the defendants' conduct violates Sections 1 and 2 of the Sherman Antitrust Act of 1890, as amended (the "Sherman Antitrust Act").

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.

The Company is also seeking injunctive relief and treble damages.

On September 4, 2020, Novartis filed, and Vetter moved to join, a motion to dismiss the complaint, to transfer the lawsuit to the Northern District of New York, or to stay the lawsuit;

and on October 19, 2020, Novartis filed, and Vetter moved to join, a second motion to dismiss the complaint on different grounds.

On January 25, 2021, the Company filed an amended complaint seeking a

judgment that Novartis's conduct violates Section 2 of the Sherman Antitrust Act based on additional grounds, as well as a judgment of tortious interference with contract.

On February 22, 2021, Novartis filed, and Vetter moved to join, a motion to dismiss the amended complaint.

On September 21, 2021, the court granted Novartis and Vetter's motion to transfer this lawsuit to the Northern District of New York.

As a result, this lawsuit was transferred to the same judge that had been assigned to the patent infringement lawsuit discussed above.

On January 31, 2022, the court granted Novartis and Vetter's motion to dismiss the amended complaint.

On September 21, 2021, this lawsuit was transferred to the Northern District of New York.

On June 10, 2022, the Company filed an appeal of the District Court's decision to dismiss the amended complaint with the U.S.

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On March 18, 2024, the Second Circuit reversed the District Court's decision to dismiss the amended complaint and remanded the lawsuit to the District Court for further proceedings consistent with the Second Circuit's opinion.

Proceedings Relating to REGEN-COV (casirivimab and imdevimab)

On October 5, 2020, Allele Biotechnology and Pharmaceuticals, Inc.

("Allele") filed a lawsuit (as amended on April 8, 2021 and December 12, 2022) against the Company in the United States District Court for the Southern District of New York, asserting infringement of U.S.

On November 19, 2024, the Company moved to transfer the lawsuit back to the Southern District of New York, which motion was granted on December 5, 2024.

Proceedings Relating to Praluent (alirocumab) Injection

United States

On May 27, 2022, the Company filed a lawsuit against Amgen in the United States District Court for the District of Delaware, alleging that, beginning in 2020, Amgen engaged in an anticompetitive bundling scheme which was designed to exclude Praluent from the market in violation of federal and state laws.

The lawsuit seeks damages for harm caused by the alleged scheme, as well as injunctive relief restraining Amgen from continuing its alleged anticompetitive conduct.

On February 10, 2023, the court denied Amgen's motion to stay these proceedings;

and on March 21, 2023, the court denied Amgen's motion to dismiss the complaint.

On August 28, 2023, the Company filed an amended complaint in this matter;

and, as part of its response, on September 20, 2023, Amgen filed a counterclaim alleging that the Company engaged in unfair business practices in violation of state law.

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

A trial has been scheduled to begin in May 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.

3,666,797 (the "'797 Patent").

Allele seeks a judgment of patent infringement of the '221 Patent, an award of monetary damages (together with interest), an order of willful infringement of the '221 Patent (which would allow the court in its discretion to award damages up to three times the amount assessed), costs and expenses of the lawsuit, and attorneys' fees.

On July 16, 2021, the Company filed a motion to dismiss the complaint, which motion was denied on March 2, 2022.

On September 18, 2023, the parties entered into a stipulation that narrowed the case to (i) whether any safe harbor defense under federal law applies to Regeneron's use of the invention covered, based on the court's claim construction, by the '221 Patent;

(ii) damages for any use by Regeneron found to not be covered by such safe harbor defense;

and (iii) whether any use referred to in clause (ii) above was willful.

On October 4, 2024, the court granted Allele's motion for summary judgment and found that the safe harbor defense under federal law does not apply to Regeneron's use of the invention covered, based on the court's claim construction, by the '221 Patent.

A trial date has not yet been scheduled.

The '797 Patent is a divisional patent of European Patent No.

2,215,124 (the "'124 Patent") (i.e., a patent that shares the same priority date, disclosure, and patent term of the parent '124 Patent), which was previously invalidated by the Technical Board of Appeal of the EPO.

On July 16, 2024, following a trial, the Munich Central Division of the UPC issued a decision revoking the '797 Patent in its entirety.

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.

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.

The lawsuit seeks, among other things, a permanent injunction in several countries in Europe and monetary damages.

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.

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

Department of Justice Matters

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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").

On August 24, 2020, the Company filed a motion to dismiss the June 2020 Civil Complaint in its entirety.

On December 4, 2020, the court denied the motion to dismiss.

On December 28, 2022, the U.S.

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

On January 31, 2023, the Company filed a motion for summary judgment.

An oral hearing on the parties' respective motions for summary judgment was held on July 21, 2023.

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.

1 unchanged sentence

On October 25, 2023, the court certified for interlocutory appeal a portion of the court's September 27, 2023 order that addressed the causation standard applicable to the alleged violations of the federal Anti-Kickback Statute and federal False Claims Act.

and on December 11, 2023, the U.S.

Court of Appeals for the First Circuit certified for appeal (i.e., accepted for review) the court's September 27, 2023 order.

An oral hearing concerning the appeal to the U.S.

Court of Appeals for the First Circuit was held on July 22, 2024.

On February 18, 2025, the U.S.

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.

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.

8 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 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.

8 unchanged sentences

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.

3 unchanged sentences

On July 18, 2024, the Company filed a motion to dismiss the March 2024 Civil Complaint and the June 2024 Civil Complaint.

An oral hearing has been scheduled for December 16, 2024.

California Department of Insurance Subpoena

In September 2022, the Company received a subpoena from the Insurance Commissioner for the State of California pursuant to the California Insurance Code.

The subpoena seeks information relating to the marketing, sale, and distribution of EYLEA, including (i) discounts, rebates, credit card fees, and inventory management systems;

(ii) Regeneron's relationships with distributors;

(iii) price reporting;

(iv) speaker programs;

and (v) patient support programs.

The subpoena covers the period from January 1, 2014 through August 1, 2021.

The Company is cooperating with this investigation.

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

Proceedings Initiated by Other Payors

21 unchanged sentences

District Court for the District of Massachusetts or, in the alternative, to stay the proceedings or dismiss the proceedings.

Proceedings Relating to Shareholder Derivative Complaint

On June 29, 2021, an alleged shareholder filed a shareholder derivative complaint in the New York Supreme Court, naming the current and certain former 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.

On January 28, 2025, pursuant to a stipulation among the parties, the proceedings were transferred to the U.S.

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 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.

The complaint asserts that the individual defendants breached their fiduciary duties in relation to the allegations in the June 2020 Civil Complaint discussed under "Department of Justice Matters" above.

9 unchanged sentences

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

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

The complaints each allege that the individual defendants, among other things, breached their fiduciary duties to the Company by failing to properly manage and oversee the Company in connection with the conduct alleged in the March 2024 Civil Complaint discussed under "Department of Justice Matters" above.

The complaints also each allege that the individual defendants breached the federal securities laws, wasted corporate assets, and unjustly enriched themselves at the expense of the Company.

The complaints each seek, among other things, an award of damages allegedly sustained by the Company as a result of the alleged misconduct of the individual defendants;

an order requiring the individual defendants to take all necessary actions to reform and improve the Company’s corporate governance and internal procedures;

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.

Sanofi Litigation

On November 18, 2024, the Company filed a lawsuit (as amended on December 20, 2024) in the United States District Court for the Southern District of New York against Sanofi and certain of its affiliated entities.

The lawsuit alleges that the defendants breached certain provisions of the parties' Amended and Restated License and Collaboration Agreement, dated as of November 10, 2009 (as amended, the "Collaboration Agreement"), concerning Sanofi's obligation to provide Regeneron with full access to material information relating to the commercialization of Dupixent or other products commercialized pursuant to the Collaboration Agreement and Regeneron's audit rights under the Collaboration Agreement.

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

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