Item 1. Financial Statements
Item 1. Financial Statements
REGENERON PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited)
(In millions, except per share data)
March 31, December 31,
2025 2024
ASSETS
Current assets:
Cash and cash equivalents $ 3,090.2 $ 2,488.2
Marketable securities 5,259.2 6,524.3
Accounts receivable, net 5,561.0 6,211.9
Inventories 3,192.4 3,087.3
Prepaid expenses and other current assets 468.9 349.2
Total current assets 17,571.7 18,660.9
Marketable securities 9,276.3 8,900.1
Property, plant, and equipment, net 4,694.2 4,599.7
Intangible assets, net 1,167.0 1,148.6
Deferred tax assets 3,442.9 3,314.1
Other noncurrent assets 1,393.1 1,136.0
Total assets $ 37,545.2 $ 37,759.4
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $ 705.5 $ 789.5
Accrued expenses and other current liabilities 2,241.8 2,527.1
Deferred revenue 619.3 627.7
Total current liabilities 3,566.6 3,944.3
Long-term debt 1,984.8 1,984.4
Finance lease liabilities 720.0 720.0
Deferred revenue 211.8 185.7
Other noncurrent liabilities 1,674.4 1,571.4
Total liabilities 8,157.6 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 - 136.1 in 2025 and 136.0 in 2024
0.1 0.1
Additional paid-in capital 13,192.1 12,855.9
Retained earnings 32,384.4 31,672.9
Accumulated other comprehensive income (loss) 29.1 ( 7.9 )
Treasury Stock, at cost; 29.7 shares in 2025 and 28.2 shares in 2024
( 16,218.1 ) ( 15,167.4 )
Total stockholders' equity 29,387.6 29,353.6
Total liabilities and stockholders' equity $ 37,545.2 $ 37,759.4
The accompanying notes are an integral part of the financial statements.
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REGENERON PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (Unaudited)
(In millions, except per share data)
Three Months Ended
March 31,
2025
2024
Statements of Operations
Revenues:
Net product sales $ 1,415.6 $ 1,761.3
Collaboration revenue 1,531.2 1,266.8
Other revenue 81.9 116.9
3,028.7 3,145.0
Expenses:
Research and development 1,327.4 1,248.4
Acquired in-process research and development 12.3 7.1
Selling, general, and administrative 633.0 689.0
Cost of goods sold 265.5 240.4
Cost of collaboration and contract manufacturing 198.8 193.4
Other operating expense (income), net
— 15.3
2,437.0 2,393.6
Income from operations 591.7 751.4
Other income (expense):
Other income (expense), net
322.0 ( 34.6 )
Interest expense ( 8.7 ) ( 16.1 )
313.3 ( 50.7 )
Income before income taxes 905.0 700.7
Income tax expense (benefit)
96.3 ( 21.3 )
Net income $ 808.7 $ 722.0
Net income per share - basic $ 7.58 $ 6.70
Net income per share - diluted $ 7.27 $ 6.27
Weighted average shares outstanding - basic 106.7 107.8
Weighted average shares outstanding - diluted 111.2 115.1
Statements of Comprehensive Income
Net income $ 808.7 $ 722.0
Other comprehensive income (loss), net of tax:
Unrealized gain on debt securities
38.1 3.5
(Loss) gain on foreign currency translation
( 1.1 ) 0.2
Comprehensive income $ 845.7 $ 725.7
The accompanying notes are an integral part of the financial statements.
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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
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
The accompanying notes are an integral part of the financial statements.
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REGENERON PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited)
(In millions)
Three Months Ended
March 31,
2025
2024
Cash flows from operating activities:
Net income $ 808.7 $ 722.0
Adjustments to reconcile net income to net cash provided by operating activities:
Depreciation and amortization 126.9 114.1
Stock-based compensation expense 255.7 230.1
(Gains) losses on marketable and other securities, net ( 139.9 ) 196.1
Other non-cash items, net 3.2 0.1
Deferred income taxes ( 139.1 ) ( 190.4 )
Changes in assets and liabilities:
Decrease in accounts receivable
657.8 446.8
Increase in inventories ( 152.3 ) ( 155.8 )
Increase in prepaid expenses and other assets
( 179.5 ) ( 77.9 )
Increase in deferred revenue
17.7 116.9
(Decrease) increase in accounts payable, accrued expenses, and other liabilities
( 214.1 ) 110.5
Total adjustments 236.4 790.5
Net cash provided by operating activities 1,045.1 1,512.5
Cash flows from investing activities:
Purchases of marketable and other securities ( 2,539.3 ) ( 5,657.5 )
Sales or maturities of marketable and other securities 3,458.3 4,132.2
Capital expenditures ( 229.3 ) ( 133.9 )
Payments for Libtayo intangible asset ( 42.2 ) ( 27.9 )
Net cash provided by (used in) in investing activities
647.5 ( 1,687.1 )
Cash flows from financing activities:
Proceeds from issuance of Common Stock 60.6 682.1
Payments in connection with Common Stock tendered for employee tax obligations ( 4.3 ) ( 343.7 )
Repurchases of Common Stock ( 1,041.4 ) ( 291.3 )
Dividends paid
( 93.8 ) —
Other
( 10.3 ) —
Net cash (used in) provided by financing activities
( 1,089.2 ) 47.1
Effect of exchange rate changes on cash, cash equivalents, and restricted cash 0.6 ( 0.5 )
Net increase (decrease) in cash, cash equivalents, and restricted cash
604.0 ( 128.0 )
Cash, cash equivalents, and restricted cash at beginning of period 2,489.0 2,737.8
Cash, cash equivalents, and restricted cash at end of period $ 3,093.0 $ 2,609.8
The accompanying notes are an integral part of the financial statements.
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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
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2. Product Sales
Net product sales consist of the following:
Three Months Ended
March 31,
(In millions) 2025 2024
EYLEA HD ®
U.S. $ 306.8 $ 200.0
EYLEA ®
U.S. 736.0 1,201.6
Total EYLEA HD and EYLEA U.S. 1,042.8 1,401.6
Libtayo ®
U.S. 192.5 159.2
Libtayo
Rest of world
92.6 104.7
Total Libtayo
Global
285.1 263.9
Praluent ®
U.S. 56.8 70.0
Evkeeza ®
U.S. 30.9 24.8
Inmazeb ®
Rest of world
— 1.0
$ 1,415.6 $ 1,761.3
As of March 31, 2025 and December 31, 2024, the Company had $ 3.760 billion and $ 4.278 billion, respectively, of trade accounts receivable that were recorded within Accounts receivable, net.
The Company had product sales to certain customers that each accounted for more than 10% of total gross product revenue for the three months ended March 31, 2025 and 2024. Sales to each of these customers as a percentage of the Company's total gross product revenue are as follows:
Three Months Ended
March 31,
2025 2024
Customer A
51 % 51 %
Customer B
25 % 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 March 31, 2025, the Company's contingent reimbursement obligation to Sanofi in connection with the development balance was approximately $ 1.453 billion.
Sanofi leads commercialization activities for products under the collaboration, subject to the Company's right to co-commercialize such products. 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).
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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
March 31,
(In millions) 2025 2024
Regeneron's share of profits
Collaboration revenue $ 1,018.2 $ 804.0
Reimbursement for manufacturing of commercial supplies Collaboration revenue $ 165.0 $ 105.8
Regeneron's obligation for its share of Sanofi R&D expenses, net of reimbursement of R&D expenses (R&D expense)
$ ( 15.5 ) $ ( 18.6 )
Reimbursement of commercialization-related expenses
Reduction of SG&A expense $ 159.2 $ 139.5
The following table summarizes contract balances in connection with the Company's Sanofi collaboration:
March 31, December 31,
(In millions) 2025
2024
Accounts receivable, net $ 1,192.8 $ 1,216.2
Deferred revenue
$ 549.5 $ 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
March 31,
(In millions) 2025 2024
Regeneron's share of profits
Collaboration revenue $ 317.3 $ 333.9
Reimbursement for manufacturing of commercial supplies
Collaboration revenue $ 26.6 $ 22.1
Regeneron's obligation for its share of Bayer R&D expenses, net of reimbursement of R&D expenses (R&D expense)
$ ( 9.4 ) $ ( 8.7 )
The following table summarizes contract balances in connection with the Company's Bayer collaboration:
March 31, December 31,
(In millions) 2025
2024
Accounts receivable, net $ 373.2 $ 349.9
Deferred revenue
$ 260.0 $ 216.3
c. 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 (i) incur, and/or get reimbursed for, research and development costs, and/or (ii) be required to pay, and/or may receive, additional amounts contingent upon the occurrence of various future events (e.g., upon the achievement of various development and commercial milestones), which in the aggregate could be significant.
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4. Net Income Per Share
The calculations of basic and diluted net income per share are as follows:
Three Months Ended
March 31,
(In millions, except per share data) 2025 2024
Net income - basic and diluted $ 808.7 $ 722.0
Weighted average shares - basic 106.7 107.8
Effect of dilutive securities:
Stock options 2.5 5.3
Restricted stock awards and restricted stock units 2.0 2.0
Weighted average shares - diluted 111.2 115.1
Net income per share - basic $ 7.58 $ 6.70
Net income per share - diluted $ 7.27 $ 6.27
Shares which have been excluded from diluted per share amounts because their effect would have been antidilutive include the following:
Three Months Ended
March 31,
(Shares in millions) 2025 2024
Stock options 4.8 1.5
Restricted stock awards and restricted stock units
1.0 —
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5. Marketable Securities
Marketable securities as of March 31, 2025 and December 31, 2024 consist of both available-for-sale debt securities of investment grade issuers (see below and Note 6) as well as equity securities of publicly traded companies (see Note 6).
The following tables summarize the Company's investments in available-for-sale debt securities:
(In millions) Amortized Unrealized Fair
As of March 31, 2025
Cost Basis Gains Losses Value
Corporate bonds $ 8,540.9 $ 49.8 $ ( 15.1 ) $ 8,575.6
U.S. government and government agency obligations 3,531.8 5.7 ( 2.3 ) 3,535.2
Commercial paper 393.6 0.2 — 393.8
Certificates of deposit 414.1 0.3 — 414.4
Asset-backed securities 321.2 0.7 ( 0.2 ) 321.7
Sovereign bonds 60.0 0.3 ( 0.1 ) 60.2
$ 13,261.6 $ 57.0 $ ( 17.7 ) $ 13,300.9
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 March 31, 2025 mature at various dates through January 2030. The fair values of available-for-sale debt securities by contractual maturity consist of the following:
March 31, December 31,
(In millions) 2025
2024
Maturities within one year $ 5,259.2 $ 6,524.3
Maturities after one year through five years 8,041.7 7,804.8
$ 13,300.9 $ 14,329.1
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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 March 31, 2025
Fair Value Unrealized Losses
Fair Value Unrealized Losses
Fair Value Unrealized Losses
Corporate bonds $ 7,982.1 $ ( 4.1 ) $ 593.5 $ ( 11.0 ) $ 8,575.6 $ ( 15.1 )
U.S. government and government agency obligations 3,473.9 ( 1.9 ) 61.3 ( 0.4 ) 3,535.2 ( 2.3 )
Asset-backed securities 310.7 ( 0.2 ) 11.0 — 321.7 ( 0.2 )
Sovereign bonds 60.2 ( 0.1 ) — — 60.2 ( 0.1 )
$ 11,826.9 $ ( 6.3 ) $ 665.8 $ ( 11.4 ) $ 12,492.7 $ ( 17.7 )
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 )
With respect to marketable securities, for the three months ended March 31, 2025 and 2024, amounts reclassified from Accumulated other comprehensive income (loss) into Other income (expense), net were related to realized gains/losses on sales of available-for-sale debt securities. For the three months ended March 31, 2025 and 2024, realized gains/losses on sales of marketable securities were not material.
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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 March 31, 2025
Fair Value Level 1 Level 2 Level 3
Assets:
Cash equivalents $ 1,865.0 $ 660.1 $ 1,204.9 $ —
Available-for-sale debt securities:
Corporate bonds 8,575.6 — 8,575.6 —
U.S. government and government agency obligations 3,535.2 — 3,535.2 —
Commercial paper 393.8 — 393.8 —
Certificates of deposit 414.4 — 414.4 —
Asset-backed securities 321.7 — 321.7 —
Sovereign bonds 60.2 — 60.2 —
Equity securities (a)
1,234.6 1,234.6 — —
Total assets
$ 16,400.5 $ 1,894.7 $ 14,505.8 $ —
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 $ 26.3 million and $ 43.2 million as of March 31, 2025 and December 31, 2024, respectively, that are subject to transfer restrictions expiring in April 2026
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In addition to the investments summarized in the table above, the Company classified the following investments within Other noncurrent assets:
• As of March 31, 2025 and December 31, 2024, the Company had $ 316.8 million and $ 159.8 million, respectively, in equity securities that do not have a readily determinable fair value. The change in carrying value of such investments was a result of additional purchases.
• As of March 31, 2025 and December 31, 2024, the Company had equity securities held through ownership interest in an investment fund of $ 72.3 million and $ 52.0 million, respectively, which are measured at fair value based on Level 3 inputs.
During the three months ended March 31, 2025 and 2024, the Company recorded $ 139.7 million of net unrealized gains and $ 196.2 million of net unrealized losses, respectively, on equity securities in Other income (expense), net.
The fair value of the Company's long-term debt, which was determined based on Level 2 inputs, was estimated to be $ 1.511 billion and $ 1.484 billion as of March 31, 2025 and December 31, 2024, respectively.
7. Inventories
Inventories consist of the following:
March 31,
December 31,
(In millions) 2025
2024
Raw materials $ 838.5 $ 879.5
Work-in-process 1,470.0 1,342.3
Finished goods 110.0 139.8
Deferred costs 773.9 725.7
$ 3,192.4 $ 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. The Company's effective tax rate was 10.6 % and ( 3.0 %) for the three months ended March 31, 2025 and 2024, respectively. The Company's effective tax rate for the three months ended March 31, 2025 and 2024 was positively impacted, compared to the U.S. federal statutory rate, primarily by income earned in foreign jurisdictions with tax rates lower than the U.S. federal statutory rate and federal tax credits for research activities. The Company's effective tax rate for the three months ended March 31, 2024 was also positively impacted by stock-based compensation.
The Company's 2017 and 2018 federal income tax returns are currently under audit by the IRS, and the Company expects to be effectively settled with the IRS during the second quarter of 2025. The unrecognized tax benefits for the years under examination exceed the expected payment amount; therefore, the Company expects to recognize a net tax benefit upon conclusion of such examinations.
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 share repurchase programs for up to an additional $ 3.0 billion (up to $ 6.0 billion in the aggregate). The programs have no time limit and can be discontinued at any time.
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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
March 31,
(In millions) 2025 2024
Number of shares 1.5 0.3
Total cost of shares $ 1,052.4 $ 298.0
As of March 31, 2025, an aggregate of $ 3.874 billion remained available for share repurchases under the programs.
b. Dividends
In February 2025, the Company's board of directors declared the Company's first quarterly cash dividend. In March 2025, the Company paid a dividend of $ 0.88 per share on its Common Stock and Class A Stock to its shareholders.
Additionally, in April 2025, the Company's board of directors declared a cash dividend of $ 0.88 per share on its Common Stock and Class A Stock. The dividend will be payable to shareholders in June 2025.
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:
March 31,
(In millions) 2025
2024
Cash and cash equivalents $ 3,090.2 $ 2,602.0
Restricted cash included in Other current assets
2.8 —
Restricted cash included in Other noncurrent assets
— 7.8
Total cash, cash equivalents, and restricted cash shown in the Condensed Consolidated Statements of Cash Flows
$ 3,093.0 $ 2,609.8
Restricted cash consists of amounts held pursuant to contractual arrangements and for dividends payable on certain equity awards.
Supplemental disclosure of non-cash investing and financing activities
March 31, December 31, March 31, December 31,
(In millions) 2025
2024
2024
2023
Accrued capital expenditures $ 105.9 $ 151.6 $ 108.0 $ 75.4
Accrued contingent consideration in connection with acquisitions
$ 43.1 $ 62.7 $ 88.8 $ 71.6
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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
March 31,
(In millions) 2025 2024
Direct research and development expenses (a)
$ 388.4 $ 408.3
Indirect research and development expenses:
Payroll and benefits 451.6 418.9
Lab supplies and other research and development costs
60.0 55.9
Occupancy and other operating costs 154.4 134.6
Total indirect research and development expenses
666.0 609.4
Clinical manufacturing costs
310.3 274.5
Reimbursement of research and development expenses by collaborators ( 37.3 ) ( 43.8 )
Total research and development expenses
$ 1,327.4 $ 1,248.4
(a) Direct research and development expenses are comprised primarily of costs paid to third parties for clinical and product development activities, and the portion of research and development expenses incurred by our collaborators that we are obligated to reimburse
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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 accruals for loss contingencies associated with such proceedings when it is probable that a liability will be incurred and the amount of loss can be reasonably estimated. As of March 31, 2025 and December 31, 2024, the Company's accruals for loss contingencies were not material. There are certain loss contingencies that the Company deems reasonably possible for which the possible loss or range of possible loss is not estimable at this time.
Proceedings Relating to 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. 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. An oral hearing concerning Mylan and Biocon's appeal was held on February 7, 2025. On April 14, 2025, the parties entered into a settlement agreement, pursuant to which Mylan and Biocon's appeal to the Federal Circuit and all related litigation have been dismissed and Biocon will be precluded from launching its aflibercept 2 mg biosimilar until the second half of 2026.
On November 8, November 22, and November 29, 2023, respectively, the Company filed patent infringement lawsuits against Celltrion, Inc. ("Celltrion"), Samsung Bioepis Co., Ltd. ("Samsung Bioepis"), and Formycon AG ("Formycon") in the United States District Court for the Northern District of West Virginia following service on Regeneron of each company's notice of commercial marketing. The lawsuits allege that each company has infringed certain Company patents, including based on each company's filing for FDA approval of an aflibercept 2 mg biosimilar. On December 27, 2023, the Company filed a second patent infringement lawsuit against Samsung Bioepis in the United States District Court for the Northern District of West Virginia alleging that Samsung Bioepis's filing for FDA approval of an aflibercept 2 mg biosimilar infringes certain Company patents. On June 14, June 21, and June 28, 2024, respectively, the court granted the Company's motions for preliminary injunctions against Samsung Bioepis, Formycon, and Celltrion. On June 14, June 25, and July 8, 2024, respectively, Samsung Bioepis, Formycon, and Celltrion filed notices of appeal of the court's preliminary injunction decisions to the Federal Circuit. On January 29, 2025, the Federal Circuit affirmed the lower court's preliminary injunction decisions against Samsung Bioepis and Formycon; and on March 5, 2025, the Federal Circuit affirmed the lower court's preliminary injunction decision against Celltrion.
On January 10, 2024, the Company filed a patent infringement lawsuit against Amgen Inc. ("Amgen") in the United States District Court for the Central District of California alleging that Amgen's filing for FDA approval of an aflibercept 2 mg biosimilar infringes certain Company patents. On April 11, 2024, the United States Judicial Panel on Multidistrict Litigation granted the Company's motion to transfer this lawsuit to the United States District Court for the Northern District of West Virginia for coordinated and consolidated pretrial proceedings with the lawsuits described in the preceding paragraph. On June 7, 2024, the Company filed a motion for a preliminary injunction against Amgen. On September 23, 2024, the court denied the Company's motion for a preliminary injunction, and the Company filed (i) a notice of appeal of such decision to the Federal Circuit, (ii) a motion for an immediate administrative stay, and (iii) a motion for a temporary injunction preventing Amgen from launching its aflibercept 2 mg biosimilar during the pendency of such appeal. On September 25, 2024, the Federal Circuit
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issued an administrative stay pending its review of the Company's temporary injunction motion. On October 22, 2024, the Federal Circuit denied the Company's temporary injunction motion and lifted the administrative stay. An expedited oral hearing concerning the Company's appeal of the court's preliminary injunction decision was held on January 14, 2025. On March 14, 2025, the Federal Circuit affirmed the lower court's preliminary injunction decision.
On August 26, 2024, the Company filed a patent infringement lawsuit against Sandoz Inc. ("Sandoz") in the United States District Court for the District of New Jersey alleging that Sandoz's filing for FDA approval of an aflibercept 2 mg biosimilar infringes certain Company patents. On September 12, 2024, the United States Judicial Panel on Multidistrict Litigation granted the Company's motion to transfer this lawsuit to the United States District Court for the Northern District of West Virginia for coordinated and consolidated pretrial proceedings with the lawsuits described in the preceding paragraphs.
Post-Grant Proceedings 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.
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 of the EPO. On November 26, 2024, following an oral hearing, the Opposition Division ("OD") of the EPO announced its decision to revoke the '306 Patent. On March 11, 2025, the Company appealed the OD's decision. An oral hearing concerning the '992 Patent has been scheduled for October 2025.
Country-Specific Proceedings
Various parties, including Samsung Bioepis and Formycon and/or their affiliated entities, are seeking revocation of the '306 Patent, the '992 Patent, and the Company's European Patent No. 2,364,691 (the "'691 Patent") and/or a declaration that its aflibercept 2 mg biosimilar would not infringe these patents in several European national courts (including those in Belgium, France, Germany, Italy, the Netherlands, and the United Kingdom). In the United Kingdom, the Company has filed a preemptive counterclaim against Formycon, Klinge Biopharma GmbH, and Samsung Bioepis UK Limited for infringement of the '306 Patent and the '691 Patent. In April 2025, the Company and Amgen entered into a settlement agreement, pursuant to which Amgen is no longer party to the United Kingdom proceedings. In Germany, a trial concerning the '691 Patent has been scheduled to begin in June 2025. In the United Kingdom, trials concerning the '691 and '306 Patents have been scheduled to begin in June 2025, and the '992 Patent proceedings are stayed pending resolution of the EPO proceedings concerning this patent. In the Netherlands, a trial concerning the '691 and '306 Patents has been scheduled to begin in July 2025.
The Company has commenced proceedings in Belgium against various parties, including Amgen, Celltrion, Sterigenics (Petit-Rechain) NV, and Sandoz GmbH, for infringement of the Company's European Patent No. 1,183,353 (as extended by Supplementary Protection Certificate 2013C/029).
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. On May 7, 2024 and June 28, 2024, respectively, Amgen Canada filed a summary trial motion with respect to the '510 Patent and a motion to delist the '276 Patent from the Canada Patent Register. On
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November 20, 2024, the court granted Amgen Canada's motion to delist the '276 Patent from the Canada Patent Register, which decision has been appealed by the Company and Bayer. A trial for the lawsuits concerning the '510 Patent and the '276 Patent has been scheduled for May–June 2025; and a trial for the lawsuits concerning the '315 Patent and the '193 Patent has been scheduled for August–September 2025.
Proceedings against 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"). A trial for the lawsuits concerning the '510 Patent, the '276 Patent, the '315 Patent, and the '326 Patent has been scheduled for October–November 2026.
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, and Samsung Bioepis appealed this decision on November 6, 2024.
The Company and, as applicable, Bayer Consumer Care AG, have also filed patent infringement lawsuits in the Seoul Central District Court against various parties including Samsung Bioepis and its parent company Samsung Biologics Co., Ltd. (collectively, "Samsung"), Sam Chun Dang Pharm. 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.
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 (the "Sherman Antitrust Act"), 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.
Proceedings Relating to Praluent (alirocumab) Injection
United States
On May 27, 2022, the Company filed a lawsuit against Amgen in the United States District Court for the District of Delaware, alleging that, beginning in 2020, Amgen engaged in an anticompetitive bundling scheme which was designed to exclude Praluent from the market in violation of federal and state laws. The lawsuit seeks damages for harm caused by the alleged scheme, as well as injunctive relief restraining Amgen from continuing its alleged anticompetitive conduct. On February 10, 2023, the court denied Amgen's motion to stay these proceedings; and on March 21, 2023, the court denied Amgen's motion to dismiss the complaint. On August 28, 2023, the Company filed an amended complaint in this matter; and, as part of its response, on September 20, 2023, Amgen filed a counterclaim alleging that the Company engaged in unfair business practices in violation of state law. On April 10, 2025, the court denied Amgen's motion for summary judgment. A trial has been scheduled to begin in May 2025.
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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, originally scheduled for May 2025, has been postponed.
Also on June 1, 2023, Amgen filed a lawsuit against the Company and certain of Sanofi's affiliated entities in the Munich Local Division of the UPC alleging infringement of the '797 Patent. The lawsuit seeks, among other things, a permanent injunction in several countries in Europe and monetary damages. 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 Opposition Division of the EPO upheld the '797 Patent as valid. The Company and Sanofi have appealed this decision to the Technical Board of Appeal of the EPO.
Department of Justice Matters
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 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.
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 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.
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
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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 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.
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 parties jointly filed a stipulation to stay the action pending resolution of the proceedings before the same court concerning the allegations in the June 2020 Civil Complaint.
2021 Shareholder Derivative Complaint
On June 29, 2021, an alleged shareholder filed a shareholder derivative complaint in the New York Supreme Court, naming the then-current and certain former members of the Company's board of directors and certain then-current and former executive officers of the Company as defendants and Regeneron as a nominal defendant. The complaint asserts that the individual defendants breached their fiduciary duties in relation to the allegations in the June 2020 Civil Complaint discussed under "Department of Justice Matters" above. 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
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the allegations in the June 2020 Civil Complaint. As a result of the stay, the court also terminated the Company's motion to dismiss the complaint without prejudice. The Company can therefore renew the motion to dismiss upon conclusion of the stay.
Class Action Civil Complaint
On January 7, 2025, a purported shareholder filed a putative class action civil complaint, on behalf of himself and all others similarly situated, in the U.S. District Court for the Southern District of New York against the Company and certain current and former executive officers of the Company. The complaint asserts violations of federal securities laws in connection with statements or disclosures purportedly related to the conduct alleged in the March 2024 Civil Complaint discussed under "Department of Justice Matters" above.
2025 Shareholder Derivative Complaints
On January 16 and January 22, 2025, purported shareholders filed two separate shareholder derivative complaints in the U.S. District Court for the Southern District of New York against members of the Company's board of directors and certain current and former executive officers of the Company as defendants and Regeneron as a nominal defendant. The complaints each allege that the individual defendants, among other things, breached their fiduciary duties to the Company by failing to properly manage and oversee the Company in connection with the conduct alleged in the March 2024 Civil Complaint discussed under "Department of Justice Matters" above. The complaints also each allege that the individual defendants breached the federal securities laws, wasted corporate assets, and unjustly enriched themselves at the expense of the Company. The complaints each seek, among other things, an award of damages allegedly sustained by the Company as a result of the alleged misconduct of the individual defendants; an order requiring the individual defendants to take all necessary actions to reform and improve the Company’s corporate governance and internal procedures; and costs and disbursements of the applicable action, including attorneys' fees. On February 11, 2025, the parties filed a joint stipulation to consolidate the two separate shareholder derivative complaints.
Sanofi Litigation
On November 18, 2024, the Company filed a lawsuit (as amended on December 20, 2024) in the United States District Court for the Southern District of New York against Sanofi and certain of its affiliated entities. The lawsuit alleges that the defendants breached certain provisions of the parties' Amended and Restated License and Collaboration Agreement, dated as of November 10, 2009 (as amended, the "Collaboration Agreement"), concerning Sanofi's obligation to provide Regeneron with full access to material information relating to the commercialization of Dupixent or other products commercialized pursuant to the Collaboration Agreement and Regeneron's audit rights under the Collaboration Agreement. The lawsuit seeks a declaratory judgment, injunctive relief, damages, and other relief.
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Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.