REGENERON PHARMACEUTICALS, INC. 10-Q

Item 1. Financial Statements REGENERON PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) (In millions, except per share data) June 30, December 31, 2024 2023 ASSETS Current assets: Cash and cash equivalents $ 1,920.7 $ 2,730.0 Marketable securities 7,888.3 8,114.8 Accounts receivable, net 5,717.1 5,667.3 Inventories 2,873.6 2,580.5 Prepaid expenses and other current assets 681.9 386.6 Total current assets 19,081.6 19,479.2 Marketable securities 7,722.4 5,396.5 Property, plant, and equipment, net 4,305.9 4,146.4 Intangible assets, net 1,102.2 1,038.6 Deferred tax assets 2,880.9 2,575.4 Other noncurrent assets 993.8 444.1 Total assets $ 36,086.8 $ 33,080.2 LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable $ 561.7 $ 606.6 Accrued expenses and other current liabilities 2,360.9 2,357.9 Deferred revenue 586.0 458.9 Total current liabilities 3,508.6 3,423.4 Long-term debt 1,983.6 1,982.9 Finance lease liabilities 720.0 720.0 Deferred revenue 205.6 126.7 Other noncurrent liabilities 1,463.2 854.1 Total liabilities 7,881.0 7,107.1 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 2024 and 2023 — — Common Stock, par value $ .001 per share; 320.0 shares authorized; shares issued - 134.8 in 2024 and 133.1 in 2023 0.1 0.1 Additional paid-in capital 12,316.9 11,354.0 Retained earnings 29,414.6 27,260.3 Accumulated other comprehensive loss ( 69.9 ) ( 80.9 ) Treasury Stock, at cost; 26.4 shares in 2024 and 25.5 shares in 2023 ( 13,455.9 ) ( 12,560.4 ) Total stockholders' equity 28,205.8 25,973.1 Total liabilities and stockholders' equity $ 36,086.8 $ 33,080.2 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 June 30, Six Months Ended June 30, 2024 2023 2024 2023 Statements of Operations Revenues: Net product sales $ 1,918.6 $ 1,772.1 $ 3,679.9 $ 3,440.1 Collaboration revenue 1,524.0 1,316.7 2,790.8 2,694.8 Other revenue 104.5 69.3 221.4 185.3 3,547.1 3,158.1 6,692.1 6,320.2 Expenses: Research and development 1,200.0 1,085.3 2,448.4 2,186.5 Acquired in-process research and development 23.9 — 31.0 56.1 Selling, general, and administrative 758.8 652.0 1,447.8 1,253.1 Cost of goods sold 257.8 192.4 498.2 400.8 Cost of collaboration and contract manufacturing 222.4 212.5 415.8 461.6 Other operating expense (income), net 14.6 ( 0.6 ) 29.9 ( 1.1 ) 2,477.5 2,141.6 4,871.1 4,357.0 Income from operations 1,069.6 1,016.5 1,821.0 1,963.2 Other income (expense): Other income (expense), net 573.3 85.3 538.7 14.6 Interest expense ( 14.8 ) ( 18.9 ) ( 30.9 ) ( 36.9 ) 558.5 66.4 507.8 ( 22.3 ) Income before income taxes 1,628.1 1,082.9 2,328.8 1,940.9 Income tax expense 195.8 114.5 174.5 154.7 Net income $ 1,432.3 $ 968.4 $ 2,154.3 $ 1,786.2 Net income per share - basic $ 13.25 $ 9.05 $ 19.95 $ 16.69 Net income per share - diluted $ 12.41 $ 8.50 $ 18.68 $ 15.68 Weighted average shares outstanding - basic 108.1 107.0 108.0 107.0 Weighted average shares outstanding - diluted 115.4 113.9 115.3 113.9 Statements of Comprehensive Income Net income $ 1,432.3 $ 968.4 $ 2,154.3 $ 1,786.2 Other comprehensive income (loss), net of tax: Unrealized gain (loss) on debt securities 7.9 ( 15.7 ) 11.4 41.5 Loss on foreign currency translation ( 0.6 ) ( 0.4 ) ( 0.4 ) ( 0.4 ) Comprehensive income $ 1,439.6 $ 952.3 $ 2,165.3 $ 1,827.3 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, 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 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, 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 — — — — 237.4 — — — — 237.4 Net income — — — — — 817.8 — — — 817.8 Other comprehensive income, net of tax — — — — — — 57.2 — — 57.2 Balance, March 31, 2023 1.8 — 131.4 0.1 10,597.7 24,124.5 ( 181.6 ) ( 23.5 ) ( 11,045.5 ) 23,495.2 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 1.8 $ — 131.6 $ 0.1 $ 10,888.5 $ 25,092.9 $ ( 197.7 ) ( 24.5 ) $ ( 11,765.9 ) $ 24,017.9 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) Six Months Ended June 30, 2024 2023 Cash flows from operating activities: Net income $ 2,154.3 $ 1,786.2 Adjustments to reconcile net income to net cash provided by operating activities: Depreciation and amortization 234.8 202.6 Stock-based compensation expense 453.3 440.7 (Gains) losses on marketable and other securities, net ( 196.5 ) 197.5 Other non-cash items, net ( 2.9 ) 29.2 Deferred income taxes ( 308.5 ) ( 425.8 ) Changes in assets and liabilities: (Increase) decrease in accounts receivable ( 47.3 ) 207.4 Increase in inventories ( 337.6 ) ( 147.2 ) Increase in prepaid expenses and other assets ( 604.2 ) ( 8.9 ) Increase (decrease) in deferred revenue 206.0 ( 50.4 ) Increase in accounts payable, accrued expenses, and other liabilities 315.1 158.7 Total adjustments ( 287.8 ) 603.8 Net cash provided by operating activities 1,866.5 2,390.0 Cash flows from investing activities: Purchases of marketable and other securities ( 10,073.4 ) ( 6,271.1 ) Sales or maturities of marketable and other securities 8,186.7 4,061.5 Capital expenditures ( 314.4 ) ( 291.2 ) Proceeds from sale of property, plant, and equipment 20.1 — Payments for Libtayo intangible asset ( 58.3 ) ( 121.8 ) Acquisitions, net of cash acquired ( 5.0 ) — Net cash used in investing activities ( 2,244.3 ) ( 2,622.6 ) Cash flows from financing activities: Proceeds from issuance of Common Stock 1,119.7 575.9 Payments in connection with Common Stock tendered for employee tax obligations ( 655.5 ) ( 113.1 ) Repurchases of Common Stock ( 895.2 ) ( 1,399.5 ) Net cash used in financing activities ( 431.0 ) ( 936.7 ) Effect of exchange rate changes on cash, cash equivalents, and restricted cash ( 0.8 ) ( 0.4 ) Net decrease in cash, cash equivalents, and restricted cash ( 809.6 ) ( 1,169.7 ) Cash, cash equivalents, and restricted cash at beginning of period 2,737.8 3,119.4 Cash, cash equivalents, and restricted cash at end of period $ 1,928.2 $ 1,949.7 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, 2023 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, 2023. 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. 7 Table of Contents 2. Product Sales Net product sales consist of the following: Three Months Ended June 30, Six Months Ended June 30, (In millions) 2024 2023 2024 2023 EYLEA ® HD U.S. $ 304.2 $ — $ 504.2 $ — EYLEA ® U.S. 1,230.5 1,500.1 2,432.1 2,933.9 Total EYLEA HD and EYLEA U.S. 1,534.7 1,500.1 2,936.3 2,933.9 Libtayo ® U.S. 182.4 130.2 341.6 239.9 Libtayo Rest of world 115.0 79.8 219.7 147.0 Total Libtayo Global 297.4 210.0 561.3 386.9 Praluent ® U.S. 56.1 40.5 126.1 80.7 Evkeeza ® U.S. 30.4 19.3 55.2 34.2 Inmazeb ® Global — 2.2 1.0 4.4 $ 1,918.6 $ 1,772.1 $ 3,679.9 $ 3,440.1 As of June 30, 2024 and December 31, 2023, the Company had $ 3.958 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 six months ended June 30, 2024 and 2023. Sales to each of these customers as a percentage of the Company's total gross product revenue are as follows: Three Months Ended June 30, Six Months Ended June 30, 2024 2023 2024 2023 Besse Medical, a subsidiary of Cencora, Inc. 51 % 51 % 51 % 51 % McKesson Corporation 24 % 25 % 24 % 25 % 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 worldwide 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 June 30, 2024, the Company's contingent reimbursement obligation to Sanofi under the collaboration was approximately $ 2.013 billion. Sanofi leads commercialization activities for products under the collaboration, subject to the Company's right to co-commercialize such products. 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 June 30, Six Months Ended June 30, (In millions) 2024 2023 2024 2023 Regeneron's share of profits Collaboration revenue $ 988.3 $ 751.1 $ 1,792.3 $ 1,387.6 Reimbursement for manufacturing of commercial supplies Collaboration revenue $ 157.3 $ 192.6 $ 263.1 $ 354.5 Regeneron's obligation for its share of Sanofi R&D expenses, net of reimbursement of R&D expenses (R&D expense) $ ( 9.1 ) $ ( 14.5 ) $ ( 27.7 ) $ ( 40.9 ) Reimbursement of commercialization-related expenses Reduction of SG&A expense $ 150.8 $ 130.9 $ 290.3 $ 248.5 The following table summarizes contract balances in connection with the Company's Sanofi collaboration: June 30, December 31, (In millions) 2024 2023 Accounts receivable, net $ 1,133.0 $ 1,029.1 Deferred revenue $ 601.9 $ 427.7 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. Within the United States, the Company is responsible for commercialization and retains profits from such sales. Bayer is responsible for commercialization activities outside the United States, and the companies share equally in 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 June 30, Six Months Ended June 30, (In millions) 2024 2023 2024 2023 Regeneron's share of profits Collaboration revenue $ 353.0 $ 349.5 $ 686.9 $ 681.1 Reimbursement for manufacturing of ex-U.S. commercial supplies Collaboration revenue $ 22.1 $ 27.2 $ 44.2 $ 52.5 Regeneron's obligation for its share of Bayer R&D expenses, net of reimbursement of R&D expenses (R&D expense) $ ( 14.7 ) $ ( 12.0 ) $ ( 23.4 ) $ ( 25.4 ) The following table summarizes contract balances in connection with the Company's Bayer collaboration: June 30, December 31, (In millions) 2024 2023 Accounts receivable, net $ 373.4 $ 381.7 Deferred revenue $ 171.1 $ 138.2 9 Table of Contents c. Roche 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 based on a pre-specified formula, depending on the amount of manufactured product supplied by each party to the market. 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 June 30, Six Months Ended June 30, (In millions) 2024 2023 2024 2023 Global gross profit payment from Roche in connection with sales of Ronapreve Collaboration revenue $ 0.4 $ — $ 0.9 $ 222.2 Other Collaboration revenue $ — $ ( 3.8 ) $ — $ ( 3.8 ) Contract balances in the Company's Balance Sheets in connection with the Roche collaboration were not material as of June 30, 2024 and December 31, 2023. d. Other 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 six months ended June 30, 2024, the Company recorded to Acquired in-process research and development expense $ 23.9 million and $ 31.0 million, respectively, which primarily related to up-front payments, as well as a premium on equity securities purchased, in connection with collaboration and licensing agreements. During the six months ended June 30, 2023, the Company recorded to Acquired in-process research and development expense $ 56.1 million, which included a $ 45.0 million u p-front payment in connection with the Company's collaboration agreement with Sonoma Biotherapeutics, Inc. 4. 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 June 30, Six Months Ended June 30, (In millions, except per share data) 2024 2023 2024 2023 Net income - basic and diluted $ 1,432.3 $ 968.4 $ 2,154.3 $ 1,786.2 Weighted average shares - basic 108.1 107.0 108.0 107.0 Effect of dilutive securities: Stock options 5.0 4.8 5.1 4.9 Restricted stock awards and restricted stock units 2.3 2.1 2.2 2.0 Weighted average shares - diluted 115.4 113.9 115.3 113.9 Net income per share - basic $ 13.25 $ 9.05 $ 19.95 $ 16.69 Net income per share - diluted $ 12.41 $ 8.50 $ 18.68 $ 15.68 10 Table of Contents Shares which have been excluded from diluted per share amounts because their effect would have been antidilutive include the following: Three Months Ended June 30, Six Months Ended June 30, (Shares in millions) 2024 2023 2024 2023 Stock options 1.5 1.7 1.5 1.7 5. Marketable Securities Marketable securities as of June 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). The following tables summarize the Company's investments in available-for-sale debt securities: (In millions) Amortized Unrealized Fair As of June 30, 2024 Cost Basis Gains Losses Value Corporate bonds $ 7,362.2 $ 3.8 $ ( 69.6 ) $ 7,296.4 U.S. government and government agency obligations 5,787.1 0.2 ( 19.8 ) 5,767.5 Sovereign bonds 54.0 — ( 0.7 ) 53.3 Commercial paper 785.3 — ( 0.4 ) 784.9 Certificates of deposit 384.3 0.1 ( 0.1 ) 384.3 Asset-backed securities 151.6 — ( 1.1 ) 150.5 $ 14,524.5 $ 4.1 $ ( 91.7 ) $ 14,436.9 As of December 31, 2023 Corporate bonds $ 6,492.5 $ 10.4 $ ( 104.9 ) $ 6,398.0 U.S. government and government agency obligations 4,839.6 2.4 ( 8.6 ) 4,833.4 Sovereign bonds 58.1 — ( 0.9 ) 57.2 Commercial paper 636.8 0.2 ( 0.2 ) 636.8 Certificates of deposit 520.8 0.6 — 521.4 Asset-backed securities 88.2 0.1 ( 1.2 ) 87.1 $ 12,636.0 $ 13.7 $ ( 115.8 ) $ 12,533.9 The Company classifies its investments in available-for-sale debt securities based on their contractual maturity dates. The available-for-sale debt securities as of June 30, 2024 mature at various dates through June 2029. The fair values of available-for-sale debt securities by contractual maturity consist of the following: June 30, December 31, (In millions) 2024 2023 Maturities within one year $ 7,888.3 $ 8,114.8 Maturities after one year through five years 6,548.6 4,414.5 Maturities after five years — 4.6 $ 14,436.9 $ 12,533.9 11 Table of Contents The following table shows the fair value of the Company's available-for-sale debt securities that have unrealized losses, aggregated by investment category and length of time that the individual securities have been in a continuous loss position. Less than 12 Months 12 Months or Greater Total (In millions) As of June 30, 2024 Fair Value Unrealized Loss Fair Value Unrealized Loss Fair Value Unrealized Loss Corporate bonds $ 4,835.6 $ ( 16.3 ) $ 2,460.8 $ ( 53.3 ) $ 7,296.4 $ ( 69.6 ) U.S. government and government agency obligations 4,803.5 ( 6.1 ) 964.0 ( 13.7 ) 5,767.5 ( 19.8 ) Sovereign bonds 26.7 ( 0.1 ) 26.6 ( 0.6 ) 53.3 ( 0.7 ) Commercial paper 784.9 ( 0.4 ) — — 784.9 ( 0.4 ) Certificates of deposit 384.3 ( 0.1 ) — — 384.3 ( 0.1 ) Asset-backed securities 81.7 ( 0.2 ) 68.8 ( 0.9 ) 150.5 ( 1.1 ) $ 10,916.7 $ ( 23.2 ) $ 3,520.2 $ ( 68.5 ) $ 14,436.9 $ ( 91.7 ) As of December 31, 2023 Corporate bonds $ 2,363.3 $ ( 2.4 ) $ 4,034.7 $ ( 102.5 ) $ 6,398.0 $ ( 104.9 ) U.S. government and government agency obligations 4,780.6 ( 6.0 ) 52.7 ( 2.6 ) 4,833.3 ( 8.6 ) 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 61.8 ( 0.3 ) 25.3 ( 0.9 ) 87.1 ( 1.2 ) $ 7,854.9 $ ( 9.0 ) $ 4,157.5 $ ( 106.8 ) $ 12,012.4 $ ( 115.8 ) The unrealized losses on corporate bonds as of June 30, 2024 were primarily driven by increased 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 six months ended June 30, 2024 and 2023, amounts reclassified from Accumulated other comprehensive loss into Other income (expense), net were related to realized gains/losses on sales of available-for-sale debt securities. For the three and six months ended June 30, 2024 and 2023, realized gains/losses on sales of marketable securities were not material. 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 June 30, 2024 Fair Value Level 1 Level 2 Level 3 Assets: Cash equivalents $ 781.8 $ 94.8 $ 687.0 $ — Available-for-sale debt securities: Corporate bonds 7,296.4 — 7,296.4 — U.S. government and government agency obligations 5,767.5 — 5,767.5 — Sovereign bonds 53.3 — 53.3 — Commercial paper 784.9 — 784.9 — Certificates of deposit 384.3 — 384.3 — Asset-backed securities 150.5 — 150.5 — Equity securities (unrestricted) 1,090.9 1,090.9 — — Equity securities (restricted) 82.9 82.9 — — Total assets $ 16,392.5 $ 1,268.6 $ 15,123.9 $ — Liabilities: Contingent consideration $ 90.4 $ — $ — $ 90.4 As of December 31, 2023 Assets: Cash equivalents $ 928.1 $ 6.4 $ 921.7 $ — Available-for-sale debt securities: Corporate bonds 6,398.0 — 6,398.0 — U.S. government and government agency obligations 4,833.4 — 4,833.4 — Sovereign bonds 57.2 — 57.2 — Commercial paper 636.8 — 636.8 — Certificates of deposit 521.4 — 521.4 — Asset-backed securities 87.1 — 87.1 — Equity securities (unrestricted) 864.5 864.5 — — Equity securities (restricted) 112.9 112.9 — — Total assets $ 14,439.4 $ 983.8 $ 13,455.6 $ — Liabilities: Contingent consideration $ 43.7 $ — $ — $ 43.7 The Company held certain restricted equity securities as of June 30, 2024 which are subject to transfer restrictions that expire in April 2026. 13 Table of Contents During the three and six months ended June 30, 2024, the Company recorded $ 392.5 million and $ 196.3 million of net unrealized gains, respectively, on equity securities in Other income (expense), net; and during the three and six months ended June 30, 2023, the Company recorded $ 30.9 million and $ 195.6 million of net unrealized losses, respectively, on equity securities in Other income (expense), net. In addition to the investments summarized in the table above, as of June 30, 2024 and December 31, 2023, the Company had $ 196.8 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. The fair value of the Company's long-term debt, which was determined based on Level 2 inputs, was estimated to be $ 1.485 billion and $ 1.528 billion as of June 30, 2024 and December 31, 2023, respectively. 7. Inventories Inventories consist of the following: June 30, December 31, (In millions) 2024 2023 Raw materials $ 843.6 $ 789.3 Work-in-process 1,154.9 1,121.8 Finished goods 154.4 147.3 Deferred costs 720.7 522.1 $ 2,873.6 $ 2,580.5 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. The Company's effective tax rate was 12.0 % and 10.6 % for the three months ended June 30, 2024 and 2023, respectively, and 7.5 % and 8.0 % for the six months ended June 30, 2024 and 2023, respectively. The Company's effective tax rate for the three and six months ended June 30, 2024 was positively impacted, compared to the U.S. federal statutory rate, primarily by stock-based compensation and income earned in foreign jurisdictions with tax rates lower than the U.S. federal statutory rate, partly offset by the remeasurement of existing uncertain tax positions. The Company's effective tax rate for the three and six months ended June 30, 2023 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. 9. 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. 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 Exchange Act), privately negotiated transactions, accelerated share repurchases, block trades, and other transactions in compliance with Rule 10b-18 of the Exchange Act. Repurchases may be made from time to time at management's discretion, and the timing and amount of any such repurchases will be determined based on share price, market conditions, legal requirements, and other relevant factors. The program has no time limit and can be discontinued at any time. There can be no assurance as to the timing or number of shares of any repurchases in the future. 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 was approved under terms substantially similar to the share repurchase program described above. 14 Table of Contents The table below summarizes the shares of the Company's Common Stock the Company repurchased and the cost of the shares, which were recorded as Treasury Stock. Three Months Ended June 30, Six Months Ended June 30, (In millions) 2024 2023 2024 2023 Number of shares 0.6 1.0 0.9 1.9 Total cost of shares $ 601.4 $ 722.8 $ 899.4 $ 1,416.7 As of June 30, 2024, an aggregate of $ 3.631 billion remained available for share repurchases under the programs. 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: June 30, (In millions) 2024 2023 Cash and cash equivalents $ 1,920.7 $ 1,937.2 Restricted cash included in Prepaid expenses and other current assets 7.5 5.5 Restricted cash included in Other noncurrent assets — 7.0 Total cash, cash equivalents, and restricted cash shown in the Condensed Consolidated Statements of Cash Flows $ 1,928.2 $ 1,949.7 Restricted cash consists of amounts held by financial institutions pursuant to contractual arrangements. Supplemental disclosure of non-cash investing and financing activities June 30, December 31, June 30, December 31, (In millions) 2024 2023 2023 2022 Accrued capital expenditures $ 112.6 $ 75.4 $ 107.5 $ 70.8 Accrued contingent consideration in connection with acquisitions $ 95.1 $ 71.6 $ 60.8 $ 135.5 11. 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 were unable to prevail in any such proceedings, its consolidated financial position, results of operations, and future cash flows may be materially impacted. Costs associated with the Company's involvement in legal proceedings are expensed as incurred. The Company recognizes accruals for loss contingencies associated with such proceedings when it is probable that a liability will be incurred and the amount of loss can be reasonably estimated. As of June 30, 2024 and December 31, 2023, 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. 15 Table of Contents 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. A trial has been scheduled to begin in November 2024. 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 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. 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. 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. 16 Table of Contents United States Post-Grant Proceedings Before USPTO Company Patent(s) Challenger(s) Type of Challenge Date of Challenge Latest Events/Current Status U.S. Patent Nos. 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 May 5, 2021 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. U.S. Patent Nos. 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 July 1, 2022 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. 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. U.S. Patent No. 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. U.S. 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 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. Patent No. 11,104,715. On June 5, 2023, 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. Patent No. 11,084,865 (the "'865 Patent"). On December 27, 2023, the court issued a decision finding that (i) the asserted claims of the '865 Patent were valid and infringed by Mylan and Biocon and (ii) the asserted claims of the '601 and '572 Patents were infringed by Mylan and Biocon but were invalid as obvious. On June 11, 2024, the court granted the Company's motion for a permanent injunction, enjoining Mylan and Biocon from selling in the United States their aflibercept 2 mg biosimilar until the expiration of the '865 Patent. On June 21, 2024, Mylan and Biocon filed a notice of appeal of the court's December 27, 2023 and June 11, 2024 decisions to the Federal Circuit. 17 Table of Contents 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. 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 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. 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 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 has been scheduled for August 13, 2024. Europe Post-Grant Proceedings Authority/Court Company Patent(s) Challenger(s) Type of Challenge Date of Challenge Latest Events/Current Status EPO 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. EPO 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. 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 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 Trial to be scheduled. 18 Table of Contents Canada Proceedings against Viatris Canada and BCIL On March 1, 2024, the Company, Bayer Inc., Bayer Healthcare LLC, BGP Pharma ULC d.b.a. Viatris Canada ("Viatris Canada"), Biosimilar Collaborations Ireland Limited ("BCIL"), and Biocon Biologics Limited entered into a settlement agreement concerning the previously disclosed patent infringement lawsuits. Pursuant to the settlement agreement, each of such lawsuits has been dismissed and BCIL is generally precluded from launching its aflibercept 2 mg biosimilar product in Canada until July 1, 2025. 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. 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. Hearings for both motions have been scheduled for November 2024. 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 Celltrion On January 15, 2024, the Company and Bayer Inc. filed patent infringement lawsuits against Celltrion, Inc., Celltrion Healthcare Co, Ltd., Celltrion Pharma Inc., and Celltrion Healthcare Canada Ltd. 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, and the '315 Patent. On July 2, 2024, the Company, Bayer Inc., Bayer Healthcare LLC, and Celltrion, Inc. entered into a settlement agreement concerning these patent infringement lawsuits, pursuant to which each such lawsuit has been dismissed and Celltrion is generally precluded from launching its aflibercept 2 mg biosimilar product in Canada until July 1, 2025. Proceedings against Apotex On March 6, 2024, the Company, Bayer Inc., and Bayer Healthcare LLC filed patent infringement lawsuits against Apotex 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, and the '315 Patent. On June 21, 2024, the Company, Bayer Inc., Bayer Healthcare LLC, and Apotex Inc. entered into a settlement agreement concerning these patent infringement lawsuits, pursuant to which each such lawsuit has been dismissed and Apotex is generally precluded from launching its aflibercept 2 mg biosimilar product in Canada until July 1, 2025. South Korea 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 of such patents in its entirety. On January 8, 2024, the Company and Bayer Consumer Care AG filed a patent infringement lawsuit against Sam Chun Dang Pharm. Co., Ltd. and OPTUS Pharmaceutical Co., Ltd before the Seoul Central District Court seeking damages based on an 19 Table of Contents allegation that offering to sell an aflibercept 2 mg biosimilar would infringe one or more claims of the Company's Korean Patent No. 659477 (the "'477 Patent"). On January 10, 2024, the Company and Bayer Consumer Care AG filed a patent infringement lawsuit against Celltrion Inc. before the Seoul Central District Court seeking damages and injunctive relief based on an allegation that the making, constructing, using, or selling of an aflibercept 2 mg biosimilar would infringe one or more claims of the '477 Patent, the '811 Patent, and Korean Patent No. 2519234 (the "'234 Patent"). On January 16, 2023, the Company filed a patent infringement lawsuit against Samsung Bioepis Co., Ltd. and its parent company Samsung Biologics Co., Ltd. before the Seoul Central District Court seeking damages based on an allegation that the making, constructing, using, or selling of an aflibercept 2 mg biosimilar would infringe one or more claims of the '477 Patent. On May 8, 2024, the Company and Bayer Consumer Care AG filed a patent infringement lawsuit against Sam Chun Dang Pharm. Co., Ltd. and OPTUS Pharmaceutical Co., Ltd before the Seoul Central District Court seeking damages and injunctive relief based on an allegation that the making, constructing, using, or selling of an aflibercept 2 mg biosimilar would infringe one or more claims of the '811 patent and the '234 Patent. On May 14, 2024, the Company and Bayer Consumer Care AG filed a patent infringement lawsuit against Samsung Bioepis Co., Ltd., its parent company Samsung Biologics Co., Ltd., and Samil Pharmaceuticals Co., Ltd. before the Seoul Central District Court seeking injunctive relief based on an allegation that the making, constructing, using, or selling of an aflibercept 2mg biosimilar would infringe one or more claims of the '811 Patent and the '234 Patent. 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. Patent No. 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 has been scheduled for August 6, 2024. 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"). 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 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. 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. Patent No. 10,221,221 (the "'221 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 20 Table of Contents 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. Department of Justice Matters In January 2017, the Company received a subpoena from the U.S. Attorney's Office for the District of Massachusetts requesting documents relating to its support of 501(c)(3) organizations that provide financial assistance to patients; documents concerning its provision of financial assistance to patients with respect to products sold or developed by Regeneron (including EYLEA, Praluent, ARCALYST ® , and ZALTRAP ® ); and certain other related documents and communications. On June 24, 2020, the U.S. Attorney's Office for the District of Massachusetts filed a civil complaint in the U.S. District Court for the District of Massachusetts alleging violations of the federal Anti-Kickback Statute, and asserting causes of action under the federal False Claims Act and state law (the "June 2020 Civil Complaint"). 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. 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; 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. 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 matter. On January 14, 2022, the Company filed a motion to dismiss the amended complaint in its entirety. On July 25, 2023, the court in part granted and in part denied 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. A trial has been scheduled for April 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 of the District of Massachusetts unsealed a qui tam complaint against the Company, AmerisourceBergen, and Besse Medical by two qui tam plaintiffs (known as relators) purportedly on behalf of the United States and various states and municipalities, asserting causes of action under the federal False Claims Act and state and local laws, and alleging violations of the federal Anti-Kickback statute. 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 states laws. On July 18, 2024, the Company filed a motion to dismiss the March 2024 Civil Complaint and the June 2024 Civil Complaint. 21 Table of Contents 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. 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. 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. 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. 22 Table of Contents