REGENERON PHARMACEUTICALS, INC. 10-Q

Item 1. Financial Statements REGENERON PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) (In millions, except per share data) September 30, December 31, 2025 2024 ASSETS Current assets: Cash and cash equivalents $ 2,506.4 $ 2,488.2 Marketable securities 5,937.2 6,524.3 Accounts receivable, net 5,687.1 6,211.9 Inventories 3,254.4 3,087.3 Prepaid expenses and other current assets 595.6 349.2 Total current assets 17,980.7 18,660.9 Marketable securities 10,285.7 8,900.1 Property, plant, and equipment, net 5,002.3 4,599.7 Intangible assets, net 1,380.9 1,148.6 Deferred tax assets 3,846.7 3,314.1 Other noncurrent assets 1,673.1 1,136.0 Total assets $ 40,169.4 $ 37,759.4 LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable $ 903.8 $ 789.5 Accrued expenses and other current liabilities 2,975.7 2,527.1 Deferred revenue 545.6 627.7 Total current liabilities 4,425.1 3,944.3 Long-term debt 1,985.5 1,984.4 Finance lease liabilities 720.0 720.0 Deferred revenue 219.2 185.7 Other noncurrent liabilities 1,861.8 1,571.4 Total liabilities 9,211.6 8,405.8 Stockholders' equity: Preferred Stock, par value $ .01 per share; 30.0 shares authorized; shares issued and outstanding - no ne — — Class A Stock, convertible, par value $ .001 per share; 40.0 shares authorized; shares issued and outstanding - 1.8 in 2025 and 2024 — — Common Stock, par value $ .001 per share; 320.0 shares authorized; shares issued - 136.2 in 2025 and 136.0 in 2024 0.1 0.1 Additional paid-in capital 13,787.3 12,855.9 Retained earnings 35,045.8 31,672.9 Accumulated other comprehensive income (loss) 69.0 ( 7.9 ) Treasury Stock, at cost; 32.7 shares in 2025 and 28.2 shares in 2024 ( 17,944.4 ) ( 15,167.4 ) Total stockholders' equity 30,957.8 29,353.6 Total liabilities and stockholders' equity $ 40,169.4 $ 37,759.4 The accompanying notes are an integral part of the financial statements. 2 Table of Contents REGENERON PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (Unaudited) (In millions, except per share data) Three Months Ended September 30, Nine Months Ended September 30, 2025 2024 2025 2024 Statements of Operations Revenues: Net product sales $ 1,587.7 $ 1,946.4 $ 4,634.3 $ 5,626.3 Collaboration revenue 1,968.4 1,660.1 5,360.3 4,450.9 Other revenue 198.2 114.2 464.0 335.6 3,754.3 3,720.7 10,458.6 10,412.8 Expenses: Research and development 1,475.0 1,271.5 4,224.1 3,719.9 Acquired in-process research and development 83.1 56.2 105.4 87.2 Selling, general, and administrative 657.8 714.4 1,925.0 2,162.2 Cost of goods sold 281.0 262.3 822.1 760.5 Cost of collaboration and contract manufacturing 240.6 228.8 694.0 644.6 Other operating (income) expense, net ( 10.0 ) 8.0 ( 10.0 ) 37.9 2,727.5 2,541.2 7,760.6 7,412.3 Income from operations 1,026.8 1,179.5 2,698.0 3,000.5 Other income (expense): Other income (expense), net 755.8 327.3 1,520.6 866.0 Interest expense ( 19.3 ) ( 13.8 ) ( 31.6 ) ( 44.7 ) 736.5 313.5 1,489.0 821.3 Income before income taxes 1,763.3 1,493.0 4,187.0 3,821.8 Income tax expense 303.3 152.4 526.7 326.9 Net income $ 1,460.0 $ 1,340.6 $ 3,660.3 $ 3,494.9 Net income per share - basic $ 14.09 $ 12.40 $ 34.83 $ 32.36 Net income per share - diluted $ 13.62 $ 11.54 $ 33.61 $ 30.23 Weighted average shares outstanding - basic 103.6 108.1 105.1 108.0 Weighted average shares outstanding - diluted 107.2 116.2 108.9 115.6 Statements of Comprehensive Income Net income $ 1,460.0 $ 1,340.6 $ 3,660.3 $ 3,494.9 Other comprehensive income (loss), net of tax: Unrealized gain on debt securities 15.7 128.2 75.9 139.6 Gain on foreign currency translation 0.8 1.9 1.0 1.5 Comprehensive income $ 1,476.5 $ 1,470.7 $ 3,737.2 $ 3,636.0 The accompanying notes are an integral part of the financial statements. 3 Table of Contents REGENERON PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (Unaudited) (In millions) Class A Stock Common Stock Additional Paid-in Capital Retained Earnings Accumulated Other Comprehensive Income (Loss) Treasury Stock Total Stockholders' Equity Shares Amount Shares Amount Shares Amount Balance, December 31, 2024 1.8 $ — 136.0 $ 0.1 $ 12,855.9 $ 31,672.9 $ ( 7.9 ) ( 28.2 ) $ ( 15,167.4 ) $ 29,353.6 Issuance of Common Stock for equity awards granted under long-term incentive plans — — 0.1 — 62.9 — — — — 62.9 Common Stock tendered upon exercise of stock options and vesting of restricted stock for employee tax obligations — — — — ( 4.4 ) — — — — ( 4.4 ) Issuance/distribution of Common Stock for 401(k) Savings Plan — — — — 17.8 — — — 1.7 19.5 Repurchases of Common Stock — — — — — — — ( 1.5 ) ( 1,052.4 ) ( 1,052.4 ) Dividends declared — — — — 1.0 ( 97.2 ) — — — ( 96.2 ) Stock-based compensation charges — — — — 258.9 — — — — 258.9 Net income — — — — — 808.7 — — — 808.7 Other comprehensive income, net of tax — — — — — — 37.0 — — 37.0 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 — — 0.1 — 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 Issuance of Common Stock for equity awards granted under long-term incentive plans — — 0.1 — 39.8 — — — — 39.8 Common Stock tendered upon exercise of stock options and vesting of restricted stock for employee tax obligations — — ( 0.1 ) — ( 3.0 ) — — — — ( 3.0 ) Issuance/distribution of Common Stock for 401(k) Savings Plan — — — — 17.7 — — — 3.3 21.0 Repurchases of Common Stock — — — — — — — ( 1.1 ) ( 663.0 ) ( 663.0 ) Dividends declared — — — — 1.0 ( 94.4 ) — — — ( 93.4 ) Stock-based compensation charges — — — — 241.0 — — — — 241.0 Net income — — — — — 1,460.0 — — — 1,460.0 Other comprehensive income, net of tax — — — — — — 16.5 — — 16.5 Balance, September 30, 2025 1.8 $ — 136.2 $ 0.1 $ 13,787.3 $ 35,045.8 $ 69.0 ( 32.7 ) $ ( 17,944.4 ) $ 30,957.8 4 Table of Contents 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 1.8 $ — 133.1 $ 0.1 $ 11,354.0 $ 27,260.3 $ ( 80.9 ) ( 25.5 ) $ ( 12,560.4 ) $ 25,973.1 Issuance of Common Stock for equity awards granted under long-term incentive plans — — 1.5 — 672.4 — — — — 672.4 Common Stock tendered upon exercise of stock options and vesting of restricted stock for employee tax obligations — — ( 0.4 ) — ( 335.9 ) — — — — ( 335.9 ) Issuance/distribution of Common Stock for 401(k) Savings Plan — — — — 18.8 — — — 1.7 20.5 Repurchases of Common Stock — — — — — — — ( 0.3 ) ( 298.0 ) ( 298.0 ) 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 1.8 $ — 135.3 $ 0.1 $ 12,702.8 $ 30,755.2 $ 60.2 ( 27.0 ) $ ( 14,192.4 ) $ 29,325.9 The accompanying notes are an integral part of the financial statements. 5 Table of Contents REGENERON PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited) (In millions) Nine Months Ended September 30, 2025 2024 Cash flows from operating activities: Net income $ 3,660.3 $ 3,494.9 Adjustments to reconcile net income to net cash provided by operating activities: Depreciation and amortization 398.7 356.5 Stock-based compensation expense 744.4 678.4 Gains on marketable and other securities, net ( 967.6 ) ( 331.2 ) Other, net ( 1.4 ) ( 31.9 ) Deferred income taxes ( 552.9 ) ( 477.1 ) Changes in assets and liabilities: Decrease (increase) in accounts receivable 549.3 ( 436.2 ) Increase in inventories ( 277.4 ) ( 502.0 ) Increase in prepaid expenses and other assets ( 458.1 ) ( 352.2 ) (Decrease) increase in deferred revenue ( 48.6 ) 249.0 Increase in accounts payable, accrued expenses, and other liabilities 761.5 509.5 Total adjustments 147.9 ( 337.2 ) Net cash provided by operating activities 3,808.2 3,157.7 Cash flows from investing activities: Purchases of marketable and other securities ( 8,914.6 ) ( 14,664.5 ) Sales or maturities of marketable and other securities 8,991.2 12,445.3 Capital expenditures ( 649.7 ) ( 556.3 ) Payments for intangible assets ( 273.3 ) ( 58.3 ) Proceeds from sale of property, plant, and equipment — 20.1 Acquisitions, net of cash acquired ( 3.0 ) ( 5.0 ) Net cash used in investing activities ( 849.4 ) ( 2,818.7 ) Cash flows from financing activities: Proceeds from issuance of Common Stock 132.4 1,374.4 Payments in connection with Common Stock tendered for employee tax obligations ( 12.9 ) ( 775.7 ) Repurchases of Common Stock ( 2,766.9 ) ( 1,630.3 ) Dividends paid ( 277.6 ) — Other ( 10.3 ) ( 33.4 ) Net cash used in financing activities ( 2,935.3 ) ( 1,065.0 ) Effect of exchange rate changes on cash, cash equivalents, and restricted cash 0.6 — Net increase (decrease) in cash, cash equivalents, and restricted cash 24.1 ( 726.0 ) Cash, cash equivalents, and restricted cash at beginning of period 2,489.0 2,737.8 Cash, cash equivalents, and restricted cash at end of period $ 2,513.1 $ 2,011.8 The accompanying notes are an integral part of the financial statements. 6 Table of Contents REGENERON PHARMACEUTICALS, INC. NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) 1. Interim Financial Statements Basis of Presentation The interim Condensed Consolidated Financial Statements of Regeneron Pharmaceuticals, Inc. and its subsidiaries ("Regeneron," "Company," "we," "us," and "our") have been prepared in accordance with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all information and disclosures necessary for a presentation of the Company's financial position, results of operations, and cash flows in conformity with accounting principles generally accepted in the United States of America. In the opinion of management, these financial statements reflect all normal recurring adjustments and accruals necessary for a fair statement of the Company's condensed consolidated financial statements for such periods. The results of operations for any interim period are not necessarily indicative of the results for the full year. The December 31, 2024 Condensed Consolidated Balance Sheet data were derived from audited financial statements, but do not include all disclosures required by accounting principles generally accepted in the United States of America. These financial statements should be read in conjunction with the financial statements and notes thereto contained in the Company's Annual Report on Form 10-K for the year ended December 31, 2024. Recently Issued Accounting Standards Standard/Description Effective Date Impact of Adoption on the Company's Financial Statements ASU 2023-09: 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 ASU 2024-03: 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 7 Table of Contents 2. Product Sales Net product sales consist of the following: Three Months Ended September 30, Nine Months Ended September 30, (In millions) 2025 2024 2025 2024 EYLEA HD ® U.S. $ 430.6 $ 392.3 $ 1,130.6 $ 896.5 EYLEA ® U.S. 680.6 1,144.6 2,170.9 3,576.7 Total EYLEA HD and EYLEA U.S. 1,111.2 1,536.9 3,301.5 4,473.2 Libtayo ® U.S. 219.1 194.5 659.4 536.1 Libtayo Rest of world 146.1 94.1 367.4 313.8 Total Libtayo Global 365.2 288.6 1,026.8 849.9 Praluent ® U.S. 67.7 52.9 190.3 179.0 Evkeeza ® U.S. 42.8 32.4 114.9 87.6 Inmazeb ® U.S. — 35.6 — 36.6 Other products Global 0.8 — 0.8 — $ 1,587.7 $ 1,946.4 $ 4,634.3 $ 5,626.3 As of September 30, 2025 and December 31, 2024, the Company had $ 3.471 billion and $ 4.278 billion, respectively, of trade accounts receivable that were recorded within Accounts receivable, net. The Company had product sales to certain customers that each accounted for more than 10% of total gross product revenue for the three and nine months ended September 30, 2025 and 2024. Sales to each of these customers as a percentage of the Company's total gross product revenue are as follows: Three Months Ended September 30, Nine Months Ended September 30, 2025 2024 2025 2024 Customer A 49 % 51 % 51 % 51 % Customer B 30 % 24 % 26 % 24 % 3. Collaboration, License, and Other Agreements a. Sanofi The Company is party to a global, strategic collaboration with Sanofi to research, develop, and commercialize fully human monoclonal antibodies, which currently consists of Dupixent ® (dupilumab), Kevzara ® (sarilumab), and itepekimab . Sanofi is generally responsible for funding 80 % to 100 % of agreed-upon development costs. 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, 2025, the Company's contingent reimbursement obligation to Sanofi in connection with the development balance was approximately $ 905 million. Sanofi leads commercialization activities for products under the collaboration, subject to the Company's right to co-commercialize such products. 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). 8 Table of Contents 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 2025 2024 Regeneron's share of profits Collaboration revenue $ 1,455.5 $ 1,088.3 $ 3,755.7 $ 2,880.6 Reimbursement for manufacturing of commercial supplies Collaboration revenue $ 161.5 $ 175.1 $ 488.1 $ 438.2 Regeneron's obligation for its share of Sanofi R&D expenses, net of reimbursement of R&D expenses (R&D expense) $ ( 23.5 ) $ ( 7.8 ) $ ( 56.9 ) $ ( 35.5 ) Reimbursement of commercialization-related expenses Reduction of SG&A expense $ 182.6 $ 169.0 $ 535.8 $ 459.3 The following table summarizes contract balances in connection with the Company's Sanofi collaboration: September 30, December 31, (In millions) 2025 2024 Accounts receivable, net $ 1,493.9 $ 1,216.2 Deferred revenue $ 423.5 $ 571.7 b. Bayer The Company is party to a license and collaboration agreement with Bayer for the global development and commercialization of EYLEA 8 mg (aflibercept 8 mg) and EYLEA (aflibercept) outside the United States. Agreed-upon development expenses incurred by the Company and Bayer are generally shared equally. Bayer is responsible for commercialization activities outside the United States, and the companies share equally in profits from such sales. Within the United States, the Company is responsible for commercialization and retains profits from such sales. Amounts recognized in the Company's Statements of Operations in connection with its Bayer collaboration are as follows: Statement of Operations Classification Three Months Ended September 30, Nine Months Ended September 30, (In millions) 2025 2024 2025 2024 Regeneron's share of profits Collaboration revenue $ 311.9 $ 367.6 $ 1,012.6 $ 1,054.5 Reimbursement for manufacturing of commercial supplies Collaboration revenue $ 32.9 $ 23.2 $ 91.1 $ 67.4 Regeneron's obligation for its share of Bayer R&D expenses, net of reimbursement of R&D expenses (R&D expense) $ ( 3.9 ) $ ( 11.8 ) $ ( 18.9 ) $ ( 35.2 ) The following table summarizes contract balances in connection with the Company's Bayer collaboration: September 30, December 31, (In millions) 2025 2024 Accounts receivable, net $ 363.2 $ 349.9 Deferred revenue $ 317.0 $ 216.3 c. Other In addition to the collaboration and license agreements discussed above, the Company has collaboration and license agreements that are not individually significant to its operating results or financial condition at this time. Pursuant to the terms of those agreements, the Company may (i) incur, and/or get reimbursed for, research and development costs, and/or (ii) be required to pay, and/or may receive, additional amounts contingent upon the occurrence of various future events (e.g., upon the achievement of development and commercial milestones), which in the aggregate could be significant. 9 Table of Contents Acquired In-Process Research and Development ("IPR&D") Expenses During the three and nine months ended September 30, 2025, the Company recorded to Acquired IPR&D expense an $ 80.0 million up-front payment in connection with its license agreement with Hansoh Pharmaceuticals Group Company Limited to acquire development and commercial rights outside mainland China, Hong Kong, and Macau for HS-20094 (a dual GLP-1/GIP receptor agonist currently in Phase 3 clinical development in China). During the three and nine months ended September 30, 2024, the Company recorded to Acquired IPR&D expense a $ 45.0 million development milestone in connection with its collaboration agreement with Sonoma Biotherapeutics, Inc. Other 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). 4. Net Income Per Share 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 2025 2024 Net income - basic and diluted $ 1,460.0 $ 1,340.6 $ 3,660.3 $ 3,494.9 Weighted average shares - basic 103.6 108.1 105.1 108.0 Effect of dilutive securities: Stock options 1.5 5.3 1.8 5.2 Restricted stock awards and restricted stock units 2.1 2.8 2.0 2.4 Weighted average shares - diluted 107.2 116.2 108.9 115.6 Net income per share - basic $ 14.09 $ 12.40 $ 34.83 $ 32.36 Net income per share - diluted $ 13.62 $ 11.54 $ 33.61 $ 30.23 Shares which have been excluded from diluted per share amounts because their effect would have been antidilutive include the following: Three Months Ended September 30, Nine Months Ended September 30, (Shares in millions) 2025 2024 2025 2024 Stock options 6.3 0.1 6.3 1.5 Restricted stock awards and restricted stock units 0.9 — 1.0 — 10 Table of Contents 5. Marketable Securities Marketable securities as of September 30, 2025 and December 31, 2024 consist of both available-for-sale debt securities of investment grade issuers (see below and Note 6) as well as equity securities of publicly traded companies (see Note 6). The following tables summarize the Company's investments in available-for-sale debt securities: (In millions) Amortized Unrealized Fair As of September 30, 2025 Cost Basis Gains Losses Value Corporate bonds $ 9,624.3 $ 78.8 $ ( 5.4 ) $ 9,697.7 U.S. government and government agency obligations 4,691.7 12.1 ( 0.5 ) 4,703.3 Commercial paper 445.1 0.2 — 445.3 Certificates of deposit 310.2 0.2 — 310.4 Asset-backed securities 293.8 1.4 — 295.2 Sovereign bonds 69.8 0.5 ( 0.1 ) 70.2 $ 15,434.9 $ 93.2 $ ( 6.0 ) $ 15,522.1 As of December 31, 2024 Corporate bonds $ 8,226.9 $ 25.1 $ ( 31.4 ) $ 8,220.6 U.S. government and government agency obligations 4,820.5 3.4 ( 6.9 ) 4,817.0 Commercial paper 548.3 0.4 — 548.7 Certificates of deposit 380.6 0.5 — 381.1 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, 2025 mature at various dates through February 2038. The fair values of available-for-sale debt securities by contractual maturity consist of the following: September 30, December 31, (In millions) 2025 2024 Maturities within one year $ 5,937.2 $ 6,524.3 Maturities after one year through five years 9,518.9 7,804.8 Maturities after five years 66.0 — $ 15,522.1 $ 14,329.1 11 Table of Contents The following table shows the fair value and gross unrealized losses by category and disaggregated by the length of time that the Company's available-for-sale debt securities have been in a continuous unrealized loss position. Less than 12 Months 12 Months or Greater Total (In millions) As of September 30, 2025 Fair Value Unrealized Losses Fair Value Unrealized Losses Fair Value Unrealized Losses Corporate bonds $ 9,300.3 $ ( 1.5 ) $ 397.4 $ ( 3.9 ) $ 9,697.7 $ ( 5.4 ) U.S. government and government agency obligations 4,541.8 ( 0.4 ) 161.5 ( 0.1 ) 4,703.3 ( 0.5 ) Sovereign bonds 56.0 ( 0.1 ) 14.2 — 70.2 ( 0.1 ) $ 13,898.1 $ ( 2.0 ) $ 573.1 $ ( 4.0 ) $ 14,471.2 $ ( 6.0 ) As of December 31, 2024 Corporate bonds $ 7,175.8 $ ( 14.2 ) $ 1,044.8 $ ( 17.2 ) $ 8,220.6 $ ( 31.4 ) U.S. government and government agency obligations 4,675.3 ( 6.2 ) 141.7 ( 0.7 ) 4,817.0 ( 6.9 ) 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 ) Amounts reclassified from Accumulated other comprehensive income (loss) into Other income (expense), net, related to realized gains/losses on sales of available-for-sale debt securities; such amounts were not material for the three and nine months ended September 30, 2025 and 2024. 12 Table of Contents 6. Fair Value Measurements The table below summarizes the Company's assets and liabilities which are measured at fair value on a recurring basis. The following fair value hierarchy is used to classify assets and liabilities, based on inputs to valuation techniques utilized to measure fair value: • Level 1 - Quoted prices in active markets for identical assets or liabilities • Level 2 - Significant other observable inputs, such as quoted market prices for similar instruments in active markets, quoted prices for identical or similar instruments in markets that are not active, or model-based valuations in which significant inputs used are observable • Level 3 - Significant other unobservable inputs (In millions) Fair Value Measurements at Reporting Date As of September 30, 2025 Fair Value Level 1 Level 2 Level 3 Assets: Cash equivalents $ 1,162.5 $ 378.3 $ 784.2 $ — Available-for-sale debt securities: Corporate bonds 9,697.7 — 9,697.7 — U.S. government and government agency obligations 4,703.3 — 4,703.3 — Commercial paper 445.3 — 445.3 — Certificates of deposit 310.4 — 310.4 — Asset-backed securities 295.2 — 295.2 — Sovereign bonds 70.2 — 70.2 — Equity securities (a) 700.8 700.8 — — Total assets $ 17,385.4 $ 1,079.1 $ 16,306.3 $ — Liabilities: Contingent consideration $ 10.3 $ — $ — $ 10.3 As of December 31, 2024 Assets: Cash equivalents $ 1,452.2 $ 1,264.2 $ 188.0 $ — Available-for-sale debt securities: Corporate bonds 8,220.6 — 8,220.6 — U.S. government and government agency obligations 4,817.0 — 4,817.0 — Commercial paper 548.7 — 548.7 — Certificates of deposit 381.1 — 381.1 — Asset-backed securities 279.3 — 279.3 — Sovereign bonds 82.4 — 82.4 — Equity securities (a) 1,095.3 1,095.3 — — Total assets $ 16,876.6 $ 2,359.5 $ 14,517.1 $ — Liabilities: Contingent consideration $ 52.3 $ — $ — $ 52.3 (a) Includes equity securities of $ 63.9 million and $ 43.2 million as of September 30, 2025 and December 31, 2024, respectively, that are subject to transfer restrictions expiring in April 2026 13 Table of Contents In addition to the investments summarized in the table above, the Company classified the following investments within Other noncurrent assets: • As of September 30, 2025 and December 31, 2024, $ 316.8 million and $ 159.8 million, respectively, of equity securities that do not have a readily determinable fair value. The change in carrying value of such investments was a result of additional purchases. • As of September 30, 2025 and December 31, 2024, equity securities held through ownership interest in an investment fund of $ 98.4 million and $ 52.0 million, respectively, which are measured at fair value based on Level 3 inputs. The change in carrying value was primarily the result of additional investments by the fund. Amounts recognized in Other income (expense), net, related to the Company's investments in public equity securities consist of the following: Three Months Ended September 30, Nine Months Ended September 30, (In millions) 2025 2024 2025 2024 Net gains recognized during the period $ 581.5 $ 134.5 $ 978.1 $ 330.8 Less: Net gains recognized on investments sold during the period 370.9 — 650.4 — Net unrealized gains recognized on investments still held as of period end date $ 210.6 $ 134.5 $ 327.7 $ 330.8 The fair value of the Company's long-term debt, which was determined based on Level 2 inputs, was estimated to be $ 1.568 billion and $ 1.484 billion as of September 30, 2025 and December 31, 2024, respectively, and the carrying value was $ 1.986 billion and $ 1.984 billion as of September 30, 2025 and December 31, 2024, respectively. 7. Inventories Inventories consist of the following: September 30, December 31, (In millions) 2025 2024 Raw materials $ 710.0 $ 879.5 Work-in-process 1,565.9 1,342.3 Finished goods 169.7 139.8 Deferred costs 808.8 725.7 $ 3,254.4 $ 3,087.3 Deferred costs represent the costs of product manufactured and shipped to the Company's collaborators for which recognition of revenue has been deferred. 8. Income Taxes The Company is subject to U.S. federal, state, and foreign income taxes. On July 4, 2025, bill H.R. 1, commonly referred to as the "One Big Beautiful Bill Act" or "OBBBA," was signed into law, with certain provisions effective in 2025 and others in 2026. The OBBBA significantly revises U.S. 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. As a result of the OBBBA being signed into law, the Company recognized a charge of $ 44.5 million in the third quarter of 2025 related to the re-measurement of the Company's U.S. net deferred tax assets. 14 Table of Contents The Company's effective tax rate was 17.2 % and 10.2 % for the three months ended September 30, 2025 and 2024, respectively, and 12.6 % and 8.6 % for the nine months ended September 30, 2025 and 2024, respectively. The Company's effective tax rate for the three and nine months ended September 30, 2025 was positively impacted, compared to the U.S. federal statutory rate, primarily by income earned in foreign jurisdictions with tax rates lower than the U.S. federal statutory rate and federal tax credits for research activities, partially offset by the impact of the OBBBA being signed into law. In addition, the Company's effective tax rate for the nine months ended September 30, 2025 was positively impacted by the release of liabilities for uncertain tax positions recognized upon the effective settlement of the IRS audit of the Company's 2017 and 2018 federal income tax returns in the second quarter of 2025, which reduced the Company's effective tax rate for the nine months ended September 30, 2025 by 1.4 %. The Company's effective tax rate for the three and nine months ended September 30, 2024 was positively impacted, compared to the U.S. federal statutory rate, primarily by income earned in foreign jurisdictions with tax rates lower than the U.S. federal statutory rate and stock-based compensation. The Company's effective tax rate for the nine months ended September 30, 2024 was negatively impacted by the remeasurement of uncertain tax positions. 9. Stockholders' Equity a. 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 an additional share repurchase program for up to $ 3.0 billion (up to $ 6.0 billion in the aggregate). The programs have no time limit and can be discontinued at any time. 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 2025 2024 Number of shares 1.1 0.6 4.5 1.5 Total cost of shares $ 663.0 $ 738.3 $ 2,785.3 $ 1,637.7 As of September 30, 2025, $ 2.156 billion remained available for share repurchases under the programs. b. Dividends In each of the first, second, and third quarters of 2025, the Company's board of directors declared quarterly cash dividends of $ 0.88 per share on its Common Stock and Class A Stock. Each quarterly dividend was paid to the Company's shareholders in the quarter in which the dividend was declared. Additionally, in October 2025, the Company's board of directors declared a cash dividend of $ 0.88 per share on its Common Stock and Class A Stock. The dividend will be payable to the Company's shareholders in December 2025. 10. 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 2024 Cash and cash equivalents $ 2,506.4 $ 2,011.8 Restricted cash included in Other current assets 6.7 — Total cash, cash equivalents, and restricted cash shown in the Condensed Consolidated Statements of Cash Flows $ 2,513.1 $ 2,011.8 Restricted cash consists of amounts held pursuant to contractual arrangements and for dividends payable on certain equity awards. 15 Table of Contents Supplemental disclosure of non-cash investing and financing activities September 30, December 31, September 30, December 31, (In millions) 2025 2024 2024 2023 Accrued capital expenditures $ 176.9 $ 151.6 $ 94.0 $ 75.4 Accrued contingent consideration in connection with acquisitions $ 52.5 $ 62.7 $ 88.0 $ 71.6 11. 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 September 30, Nine Months Ended September 30, (In millions) 2025 2024 2025 2024 Direct research and development expenses (a) $ 454.3 $ 386.4 $ 1,296.7 $ 1,158.5 Indirect research and development expenses: Payroll and benefits 438.3 407.8 1,339.5 1,249.2 Lab supplies and other research and development costs 67.5 63.0 192.4 175.4 Occupancy and other operating costs 166.3 158.7 479.2 434.9 Total indirect research and development expenses 672.1 629.5 2,011.1 1,859.5 Clinical manufacturing costs 381.4 306.6 1,028.8 841.3 Reimbursement of research and development expenses by collaborators ( 32.8 ) ( 51.0 ) ( 112.5 ) ( 139.4 ) Total research and development expenses $ 1,475.0 $ 1,271.5 $ 4,224.1 $ 3,719.9 (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 12. Legal Matters From time to time, the Company is a party to legal proceedings in the course of the Company's business. The outcome of any such proceedings, regardless of the merits, is inherently uncertain. If the Company is unable to prevail in one or more of such proceedings, its consolidated financial position, results of operations, and future cash flows may be materially adversely impacted. Costs associated with the Company's involvement in legal proceedings are expensed as incurred. The Company recognizes gain contingencies associated with such proceedings when the award or recovery is realized or realizable and loss contingencies when it is probable that a liability will be incurred and the amount of loss can be reasonably estimated. As of September 30, 2025 and December 31, 2024, the Company's accruals for loss contingencies were not material. There are certain loss contingencies that the Company deems reasonably possible for which the possible loss or range of possible loss is not estimable at this time. 16 Table of Contents 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"), 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 U.S. Patent Litigation 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 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. On December 27, 2023, following a trial, the court issued a decision finding that (i) the asserted claims of the Company's U.S. Patent No. 11,084,865 (the "'865 Patent") were valid and infringed by Mylan and Biocon and (ii) the asserted claims of two other Company patents were infringed by Mylan and Biocon but were invalid as obvious. On June 11, 2024, the court granted the Company's motion for a permanent injunction, enjoining Mylan and Biocon from selling in the United States their aflibercept 2 mg biosimilar until the expiration of the '865 Patent. On 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. ("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 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; each of these decisions was affirmed by the Federal Circuit on appeal. On May 23, 2025, Formycon petitioned the district court to revoke the preliminary injunction. On September 28, 2025, the Company and Formycon entered into a settlement agreement, pursuant to which Formycon's motion to revoke the preliminary injunction and all related litigation have been dismissed and Formycon is precluded from launching its aflibercept 2 mg biosimilar until the fourth quarter of 2026. On October 20, 2025, the Company and Celltrion entered into a settlement agreement, pursuant to which all litigation in the United States related to Celltrion's aflibercept 2 mg biosimilar has been dismissed and Celltrion is precluded from launching such biosimilar until December 31, 2026. On January 10, 2024, the Company filed a patent infringement lawsuit against Amgen Inc. ("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 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. On March 14, 2025, the Federal Circuit affirmed the district court's preliminary injunction decision. On June 17, 2025, the Company filed an additional patent infringement lawsuit against Amgen in the United States District Court for the Central District of California alleging that Amgen's continued commercialization of its aflibercept 2 mg biosimilar infringes the Company's U.S. Patent No. 12,331,099. On August 26, 2024, the Company filed a patent infringement lawsuit against Sandoz Inc. ("Sandoz") in the United States District Court for the District of New Jersey alleging that Sandoz's filing for FDA approval of an aflibercept 2 mg biosimilar infringed certain Company patents. On September 12, 2024, the United States Judicial Panel on Multidistrict Litigation granted the Company's motion to transfer this lawsuit to the United States District Court for the Northern District of West Virginia for coordinated and consolidated pretrial proceedings with the lawsuits described in the preceding two paragraphs. On July 11, 2025, the Company filed a motion for a preliminary injunction against Sandoz based on the '865 Patent. On September 8, 2025, the Company and Sandoz entered into a settlement agreement, pursuant to which the Company's preliminary injunction motion and all related litigation have been dismissed and Sandoz is precluded from launching its aflibercept 2 mg biosimilar until the fourth quarter of 2026. 17 Table of Contents 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. Patent No. 10,828,345 (the "'345 Patent"), seeking a declaration that the '865 Patent and '345 Patent are invalid. Europe 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 ("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. On October 22, 2025, following an oral hearing, the OD upheld the validity of the '992 Patent's claims in amended form. An oral hearing concerning the '049 Patent has been scheduled for December 2025. Country-Specific Proceedings 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 certain of these proceedings, the Company has filed a preemptive counterclaim for infringement of one or more of such patents. In the United Kingdom, following trials held in June 2025, the High Court of England and Wales issued a decision in October 2025 that found that Formycon and Samsung Bioepis's aflibercept 2 mg biosimilar products do not infringe the '691 and '306 Patents; upheld the '691 Patent as valid; and invalidated the '306 Patent. Proceedings in the United Kingdom concerning the '992 Patent are stayed pending resolution of the EPO proceedings concerning this patent. In Germany, following a June 2025 trial concerning the revocation proceeding brought by Samsung Bioepis, the German Federal Patent Court upheld the '691 Patent as valid. In addition, in October 2025, the Munich Regional Court issued a decision that found that Formycon's aflibercept biosimilar product infringes the '691 Patent and granted the Company's motion for a permanent injunction, enjoining Formycon from selling its aflibercept 2 mg biosimilar in Germany and several other EU countries (including Spain and the Netherlands) until the expiration of the '691 Patent. In the Netherlands, following a trial held in July 2025, the District Court of the Hague issued a decision in October 2025 that upheld the '691 and '306 Patents as valid; found that Samsung Bioepis's aflibercept 2 mg biosimilar product infringes the '691 and '306 Patents; and granted the Company's request for a permanent injunction, enjoining Samsung Bioepis from selling its aflibercept 2 mg biosimilar in the Netherlands until the expiration of the '691 and '306 Patents. The Company has commenced proceedings in Belgium against various parties, including Amgen, Celltrion, Sterigenics (Petit-Rechain) NV, and Sandoz GmbH, for infringement of the Company's European Patent No. 1,183,353 (as extended by Supplementary Protection Certificate 2013C/029). Canada Proceedings against Amgen Canada On May 9, 2023, Amgen Canada Inc. ("Amgen Canada") filed invalidation proceedings against the Company in the Federal Court of Canada seeking revocation of the Company's Canadian Patent Nos. 2,654,510 (the "'510 Patent") and 3,007,276 (the "'276 Patent"). On September 14, 2023, the Company, Bayer Inc., and Bayer Healthcare LLC filed 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 Bayer Healthcare LLC's Canadian Patent No. 2,970,315 (the "'315 Patent"). On September 14, 2023, the Company and Bayer Inc. filed three 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 Canadian Patent Nos. 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. A trial concerning the '510 Patent and the '276 Patent was held in May– 18 Table of Contents June 2025. On August 15, 2025, the Company, Bayer Inc., Bayer Healthcare LLC, and Amgen Canada entered into a settlement agreement concerning these patent infringement lawsuits, pursuant to which each such lawsuit has been dismissed. As a result of the settlement agreement, the Company, Bayer Inc., and Bayer Healthcare LLC are no longer seeking a declaration that Amgen Canada's aflibercept 2 mg biosimilar infringes the patents referenced in this paragraph. Proceedings against Sandoz 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 August 15, 2025, the Company, Bayer Inc., Bayer Healthcare LLC, and Sandoz Canada Inc. entered into a settlement agreement concerning these patent infringement lawsuits, pursuant to which each such lawsuit has been dismissed. As a result of the settlement agreement, the Company, Bayer Inc., and Bayer Healthcare LLC are no longer seeking a declaration that Sandoz Canada Inc.'s aflibercept 2 mg biosimilar infringes the patents referenced in this paragraph. South Korea 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; 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. (collectively, "Samsung"), Sam Chun Dang Pharm. Co., Ltd. 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. Australia 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. 2012205599. On September 3, 2025, the court denied the Company's request for a preliminary injunction, and this ruling has been appealed. Proceedings Relating to EYLEA (aflibercept) Injection Pre-filled Syringe On July 17, 2020, the Company filed an antitrust lawsuit (as amended on January 25, 2021) against Novartis Pharma AG, Novartis Pharmaceuticals Corporation, and Novartis Technology LLC (collectively, "Novartis") and Vetter Pharma International GmbH in the United States District Court for the Southern District of New York seeking a judgment that the defendants' conduct relating to Novartis's attempt to assert its U.S. Patent No. 9,220,631 against Regeneron in 2020 violated Sections 1 and 2 of the Sherman Antitrust Act of 1890, as amended, and constituted tortious interference with contract. The Company is also seeking injunctive relief and treble damages. 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. Court of Appeals for the Second Circuit (the "Second Circuit"). 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. 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. 19 Table of Contents 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 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 was held on August 27, 2025. Europe 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 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 was held in August 2025. Also on June 1, 2023, Amgen filed a lawsuit against the Company and certain of Sanofi's affiliated entities in the Munich Local Division of the UPC alleging infringement of the '797 Patent. 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). The Company and Sanofi are also seeking revocation of the '797 Patent at the EPO. 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 On June 24, 2020, the U.S. Attorney's Office for the District of Massachusetts filed a civil complaint in the U.S. District Court for the District of Massachusetts alleging violations of the federal Anti-Kickback Statute and asserting causes of action under the federal False Claims Act and state law (the "June 2020 Civil Complaint") relating to the Company's support of 501(c)(3) organizations that provide financial assistance to patients. On September 27, 2023, the court (i) denied in part and granted in part the Company's motion for summary judgment and (ii) denied in its entirety the motion for partial summary judgment filed by the U.S. Attorney's Office for the District of Massachusetts. 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. 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. On October 1, 2025, the U.S. Attorney's Office for the District of Massachusetts filed a second motion for partial summary judgment. In September 2019, the Company and Regeneron Healthcare Solutions, Inc., a wholly-owned subsidiary of the Company, each received a civil investigative demand ("CID") from the U.S. Department of Justice pursuant to the federal False Claims Act relating to remuneration paid to physicians in the form of consulting fees, advisory boards, speaker fees, and payment or reimbursement for travel and entertainment allegedly in violation of the federal Anti-Kickback Statute. The CIDs relate to EYLEA, Praluent, Dupixent, ZALTRAP, ARCALYST, and Kevzara and cover the period from January 2015 to the present. 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. Also on June 3, 2021, the United States and the State Plaintiffs notified the court of their decision to decline to intervene in the case. On October 29, 2021, the qui tam plaintiffs filed an amended complaint in this 20 Table of Contents matter. On January 14, 2022, the Company filed a motion to dismiss the amended complaint in its entirety. On July 25, 2023, the court granted in part and denied in part the Company's motion to dismiss. On September 1, 2023, the Company filed a second motion to dismiss the amended complaint or, in the alternative, a motion for judgment on the pleadings. On July 31, 2024 and August 15, 2024, respectively, the District Court granted the Company's second motion to dismiss the amended complaint with respect to the remaining causes of action under federal law and declined to exercise supplemental jurisdiction over the remaining causes of action under state law. On August 26, 2024, the qui tam plaintiffs filed a notice of appeal. Oral argument on the appeal has been scheduled for November 18, 2025. In June 2021, the Company received a CID from the U.S. Department of Justice pursuant to the federal False Claims Act. The CID states that the investigation concerns allegations that the Company (i) violated the False Claims Act by paying kickbacks to distributors and ophthalmology practices to induce purchase of EYLEA, including through discounts, rebates, credit card fees, free units of EYLEA, and inventory management systems; and (ii) inflated reimbursement rates for EYLEA by excluding applicable discounts, rebates, and benefits from the average sales price reported to the Centers for Medicare & Medicaid Services. The CID covers the period from January 2011 through June 2021. On November 29, 2023, the U.S. Department of Justice informed the Company that it had filed a notice of partial intervention in this matter. On March 28, 2024, the Department of Justice and the U.S. 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. Also on March 28, 2024, the U.S. District Court for the District of Massachusetts unsealed a qui tam complaint against the Company, AmerisourceBergen, and Besse Medical by two qui tam plaintiffs (known as relators) purportedly on behalf of the United States and various states and municipalities, asserting causes of action under the federal False Claims Act and state and local laws, and alleging violations of the federal Anti-Kickback statute. On June 25, 2024, the States of Colorado, Georgia, Michigan, North Carolina, Texas, and Washington filed a civil complaint in partial intervention (the "June 2024 Civil Complaint") in the U.S. District Court for the District of Massachusetts asserting causes of action under various state laws. 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 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. On August 14, 2025, the Company moved to amend its answer and assert counterclaims to the March 2024 Civil Complaint and June 2024 Civil Complaint. Proceedings Initiated by Other Payors The Company is party to several lawsuits relating to the conduct alleged in the June 2020 Civil Complaint discussed under "Department of Justice Matters" above. These lawsuits were filed by UnitedHealthcare Insurance Company and United Healthcare Services, Inc. (collectively, "UHC") and Humana Inc. ("Humana") in the United States District Court for the Southern District of New York on December 17, 2020 and July 22, 2021, respectively; and by Blue Cross and Blue Shield of Massachusetts, Inc. and Blue Cross and Blue Shield of Massachusetts HMO Blue, Inc. (collectively, "BCBS"), Medical Mutual of Ohio ("MMO"), Horizon Healthcare Services, Inc. d/b/a Horizon Blue Cross Blue Shield of New Jersey ("Horizon"), and Local 464A United Food and Commercial Workers Union Welfare Service Benefit Fund ("Local 464A") in the U.S. District Court for the District of Massachusetts on December 20, 2021, February 23, 2022, April 4, 2022, and June 17, 2022, respectively. These lawsuits allege causes of action under state law and the federal Racketeer Influenced and Corrupt Organizations Act ("RICO") and seek monetary damages and equitable relief. The MMO and Local 464A lawsuits are putative class action lawsuits. On December 29, 2021, the lawsuits filed by UHC and Humana were stayed by the United States District Court for the Southern District of New York 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. On September 27, 2022, the lawsuits filed by BCBS, MMO, and Horizon were stayed by the U.S. District Court for the District of Massachusetts pending resolution of the proceedings before the same court concerning the allegations in the June 2020 Civil Complaint; and, in light of these stays, the parties to the Local 464A action have also agreed to stay that matter. On June 24, 2024, a group of plaintiffs purporting to be assignees of claims by various Medicare Advantage plans and related entities filed a putative class action complaint in the U.S. District Court for the District of Columbia on behalf of Medicare Advantage plans and other payors. The lawsuit relates to the conduct alleged in the June 2020 Civil Complaint, March 2024 Civil Complaint, and June 2024 Civil Complaint discussed under "Department of Justice Matters" above. The lawsuit alleges causes of action under state law and RICO and seeks monetary damages and equitable relief. On October 22, 2024, the Company filed a motion to transfer the proceedings to the U.S. District Court for the District of Massachusetts or, in the alternative, to stay the proceedings or dismiss the proceedings. 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 21 Table of Contents 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. 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. The complaint seeks an award of damages allegedly sustained by the Company; an order requiring Regeneron to take all necessary actions to reform and improve its corporate governance and internal procedures; disgorgement from the individual defendants of all profits and benefits obtained by them resulting from their sales of Regeneron stock; and costs and disbursements of the action, including attorneys' fees. On July 28, 2021, the defendants filed a notice of removal, removing the case from the New York Supreme Court to the U.S. District Court for the Southern District of New York. On September 23, 2021, the plaintiff moved to remand the case to the New York Supreme Court. Also on September 23, 2021, the individual defendants moved to dismiss the complaint in its entirety. On December 19, 2022, the U.S. 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. 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. 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. 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 June 3, 2025, the court consolidated the two separate shareholder derivative complaints pursuant to a joint stipulation by the parties. On June 6, 2025, two purported shareholders filed separate shareholder derivative complaints in the New York Supreme Court against members of the Company's board of directors and certain current and former executive officers of the Company as defendants and Regeneron as a nominal defendant. These complaints make similar allegations to the 2025 derivative complaints referenced above. On June 16, 2025, the Company filed notices of removal, removing both of the newly filed actions from the New York Supreme Court to the U.S. District Court for the Southern District of New York. On July 16, 2025, the purported shareholders each filed a motion to remand their respective actions back to the New York Supreme Court. 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 2025 derivative complaints referenced above. On September 2, 2025, a purported shareholder filed another shareholder derivative complaint in the New York Supreme Court against members of the Company's board of directors and certain current and former executive officers of the Company as defendants and Regeneron as a nominal defendant. This complaint makes similar allegations to the 2025 derivative complaints referenced above. On September 11, 2025, the Company filed a notice of removal, removing this action from the New York Supreme Court to the U.S. District Court for the Southern District of New York. On October 14, 2025, the purported shareholder filed a motion to remand the action back to the New York Supreme Court. Shareholder Derivative Complaint – Director Compensation On July 22, 2025, an alleged shareholder filed a shareholder derivative complaint in the New York Supreme Court, naming the current non-employee members of our board of directors, and the co-Chairs of our board of directors (who also serve as our President and Chief Executive Officer and our President and Chief Scientific Officer, respectively) as defendants and Regeneron as a nominal defendant. The complaint asserts that the individual defendants breached their fiduciary duties and/or 22 Table of Contents 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. On September 25, 2025, the Company filed a motion to dismiss the complaint. Class Action Civil Complaint On January 7, 2025 (as amended on September 8, 2025), a purported shareholder filed a putative class action civil complaint, on behalf of himself and all others similarly situated, in the U.S. District Court for the Southern District of New York against the Company and certain current and former executive officers of the Company. 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. On July 10, 2025, the court appointed a lead plaintiff and lead counsel for the action. 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. On July 3, 2025, Sanofi filed a motion to dismiss the complaint. 23 Table of Contents