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,
2026 2025
ASSETS
Current assets:
Cash and cash equivalents $ 2,962.6 $ 3,118.1
Marketable securities 5,791.1 5,487.1
Accounts receivable, net 5,731.0 5,741.1
Inventories 3,103.6 3,200.8
Prepaid expenses and other current assets 620.9 474.8
Total current assets 18,209.2 18,021.9
Marketable securities 9,786.0 10,260.6
Property, plant, and equipment, net 5,266.1 5,120.4
Intangible assets, net 1,286.9 1,257.4
Deferred tax assets 4,190.9 4,077.2
Other noncurrent assets 2,129.7 1,821.2
Total assets $ 40,868.8 $ 40,558.7
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $ 1,027.1 $ 939.0
Accrued expenses and other current liabilities 2,724.4 2,876.4
Finance lease liabilities 720.0 —
Deferred revenue 636.2 553.0
Total current liabilities 5,107.7 4,368.4
Long-term debt 1,986.2 1,985.9
Finance lease liabilities — 720.0
Deferred revenue 225.1 208.7
Other noncurrent liabilities 2,126.2 2,018.8
Total liabilities 9,445.2 9,301.8
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 2026 and 2025
— —
Common Stock, par value $ .001 per share; 320.0 shares authorized; shares issued - 137.9 in 2026 and 137.6 in 2025
0.1 0.1
Additional paid-in capital 14,401.3 13,995.0
Retained earnings 36,423.8 35,797.1
Accumulated other comprehensive income
11.9 77.5
Treasury Stock, at cost; 34.7 shares in 2026 and 33.7 shares in 2025
( 19,413.5 ) ( 18,612.8 )
Total stockholders' equity 31,423.6 31,256.9
Total liabilities and stockholders' equity $ 40,868.8 $ 40,558.7
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,
2026
2025
Statements of Operations
Revenues:
Net product sales $ 1,534.5 $ 1,415.6
Collaboration revenue 1,899.7 1,531.2
Other revenue 171.2 81.9
3,605.4 3,028.7
Expenses:
Research and development 1,543.5 1,327.4
Acquired in-process research and development 101.9 12.3
Selling, general, and administrative 647.7 633.0
Cost of goods sold 373.4 265.5
Cost of collaboration and contract manufacturing 296.0 198.8
2,962.5 2,437.0
Income from operations 642.9 591.7
Other income (expense):
Other income (expense), net
201.2 322.0
Interest expense ( 12.9 ) ( 8.7 )
188.3 313.3
Income before income taxes 831.2 905.0
Income tax expense
104.0 96.3
Net income $ 727.2 $ 808.7
Net income per share - basic $ 6.99 $ 7.58
Net income per share - diluted $ 6.75 $ 7.27
Weighted average shares outstanding - basic 104.0 106.7
Weighted average shares outstanding - diluted 107.7 111.2
Statements of Comprehensive Income
Net income $ 727.2 $ 808.7
Other comprehensive income (loss), net of tax:
Unrealized (loss) gain on debt securities
( 65.8 ) 38.1
Gain (loss) on foreign currency translation 0.2 ( 1.1 )
Comprehensive income $ 661.6 $ 845.7
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, 2025
1.8 $ — 137.6 $ 0.1 $ 13,995.0 $ 35,797.1 $ 77.5 ( 33.7 ) $ ( 18,612.8 ) $ 31,256.9
Issuance of Common Stock for equity awards granted under long-term incentive plans — — 0.3 — 167.0 — — — — 167.0
Common Stock tendered upon exercise of stock options and vesting of restricted stock for employee tax obligations — — — — ( 29.1 ) — — — — ( 29.1 )
Issuance/distribution of Common Stock for 401(k) Savings Plan — — — — 21.5 — — — 2.5 24.0
Repurchases of Common Stock — — — — — — — ( 1.0 ) ( 803.2 ) ( 803.2 )
Dividends declared
— — — — — ( 100.5 ) — — — ( 100.5 )
Stock-based compensation charges — — — — 246.9 — — — — 246.9
Net income — — — — — 727.2 — — — 727.2
Other comprehensive loss, net of tax
— — — — — — ( 65.6 ) — — ( 65.6 )
Balance, March 31, 2026
1.8 $ — 137.9 $ 0.1 $ 14,401.3 $ 36,423.8 $ 11.9 ( 34.7 ) $ ( 19,413.5 ) $ 31,423.6
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
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,
2026
2025
Cash flows from operating activities:
Net income $ 727.2 $ 808.7
Adjustments to reconcile net income to net cash provided by operating activities:
Depreciation and amortization 123.2 126.9
Stock-based compensation expense 257.4 255.7
Gains on marketable and other securities, net ( 25.0 ) ( 139.9 )
Other, net
55.6 3.2
Deferred income taxes ( 96.0 ) ( 139.1 )
Changes in assets and liabilities:
Decrease in accounts receivable
1.2 657.8
Decrease (increase) in inventories
26.6 ( 152.3 )
Increase in prepaid expenses and other assets ( 198.6 ) ( 179.5 )
Increase in deferred revenue
99.6 17.7
Increase (decrease) in accounts payable, accrued expenses, and other liabilities
107.7 ( 214.1 )
Total adjustments 351.7 236.4
Net cash provided by operating activities 1,078.9 1,045.1
Cash flows from investing activities:
Purchases of marketable and other securities ( 2,755.9 ) ( 2,539.3 )
Sales or maturities of marketable and other securities 2,606.5 3,458.3
Capital expenditures ( 230.6 ) ( 229.3 )
Payments for intangible assets
( 48.9 ) ( 42.2 )
Net cash (used in) provided by investing activities
( 428.9 ) 647.5
Cash flows from financing activities:
Proceeds from issuance of Common Stock 163.1 60.6
Payments in connection with Common Stock tendered for employee tax obligations ( 73.2 ) ( 4.3 )
Repurchases of Common Stock ( 794.3 ) ( 1,041.4 )
Dividends paid
( 97.8 ) ( 93.8 )
Other
— ( 10.3 )
Net cash used in financing activities ( 802.2 ) ( 1,089.2 )
Effect of exchange rate changes on cash, cash equivalents, and restricted cash ( 0.9 ) 0.6
Net (decrease) increase in cash, cash equivalents, and restricted cash
( 153.1 ) 604.0
Cash, cash equivalents, and restricted cash at beginning of period 3,123.7 2,489.0
Cash, cash equivalents, and restricted cash at end of period $ 2,970.6 $ 3,093.0
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, 2025 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, 2025.
Recently Issued Accounting Standards
Standard/Description
Effective Date
Impact of Adoption on the Company's Financial Statements
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) 2026 2025
EYLEA HD ®
U.S. $ 468.4 $ 306.8
EYLEA ®
U.S. 473.1 736.0
Total EYLEA HD and EYLEA U.S. 941.5 1,042.8
Libtayo ®
U.S. 286.1 192.5
Libtayo
Rest of world
152.1 92.6
Total Libtayo
Global
438.2 285.1
Praluent ®
U.S. 66.6 56.8
Evkeeza ®
U.S. 45.7 30.9
Lynozyfic ®
Global
11.2 —
Other products
Global
31.3 —
$ 1,534.5 $ 1,415.6
As of March 31, 2026 and December 31, 2025, the Company had $ 3.529 billion and $ 3.458 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, 2026 and 2025. 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,
2026 2025
Customer A
45 % 51 %
Customer B
30 % 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 expenses as incurred. 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. The Company is required to apply 20 % of its share of profits from the collaboration each calendar quarter to reimburse Sanofi for these development expenses. The Company's contingent reimbursement obligation to Sanofi in connection with the development balance was approximately $ 278 million as of March 31, 2026.
Sanofi leads commercialization activities for products under the collaboration, subject to the Company's right to co-commercialize such products. The Company co-commercializes Dupixent in the United States and in certain countries outside the United States. The Company supplies certain commercial bulk product to Sanofi. 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) 2026 2025
Regeneron's share of profits
Collaboration revenue $ 1,450.8 $ 1,018.2
Reimbursement for manufacturing of commercial supplies Collaboration revenue $ 154.3 $ 165.0
Regeneron's obligation for its share of Sanofi R&D expenses, net of reimbursement of R&D expenses (R&D expense)
$ ( 16.7 ) $ ( 15.5 )
Reimbursement of commercialization-related expenses
Reduction of SG&A expense $ 184.1 $ 159.2
The following table summarizes contract balances in connection with the Company's Sanofi collaboration:
March 31, December 31,
(In millions) 2026
2025
Accounts receivable, net $ 1,713.2 $ 1,610.6
Deferred revenue
$ 545.4 $ 442.3
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. The Company is also obligated to use commercially reasonable efforts to supply clinical and commercial bulk product to Bayer.
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) 2026 2025
Regeneron's share of profits
Collaboration revenue $ 240.0 $ 317.3
Reimbursement for manufacturing of commercial supplies
Collaboration revenue $ 47.3 $ 26.6
Reimbursement of R&D expenses, net of Regeneron's obligation for its share of Bayer R&D expenses
Reduction of R&D expense/(R&D expense)
$ 1.0 $ ( 9.4 )
The following table summarizes contract balances in connection with the Company's Bayer collaboration:
March 31, December 31,
(In millions) 2026
2025
Accounts receivable, net $ 241.1 $ 287.6
Deferred revenue
$ 291.7 $ 295.7
c. Other
In addition to the collaboration and license agreements discussed above, the Company has collaboration and license agreements that are not individually significant to its operating results or financial condition at this time. Pursuant to the terms of those agreements, the Company may (i) incur, and/or get reimbursed for, research and development expenses, and/or (ii) be required to pay, and/or may receive, additional amounts contingent upon the occurrence of various future events (e.g., upon the achievement of development and commercial milestones), which in the aggregate could be significant.
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Acquired In-Process Research and Development ("IPR&D") Expenses
Acquired IPR&D expenses for the three months ended March 31, 2026 primarily related to the premium on equity securities purchased, as well as development milestone and up-front payments, in connection with collaboration and licensing agreements.
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) 2026 2025
Net income - basic and diluted $ 727.2 $ 808.7
Weighted average shares - basic 104.0 106.7
Effect of dilutive securities:
Stock options 2.6 2.5
Restricted stock awards and restricted stock units 1.1 2.0
Weighted average shares - diluted 107.7 111.2
Net income per share - basic $ 6.99 $ 7.58
Net income per share - diluted $ 6.75 $ 7.27
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) 2026 2025
Stock options 3.7 4.8
Restricted stock awards and restricted stock units
— 1.0
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5. Marketable Securities
Marketable securities as of March 31, 2026 and December 31, 2025 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, 2026
Cost Basis Gains Losses Value
Corporate bonds $ 10,606.9 $ 35.3 $ ( 22.6 ) $ 10,619.6
U.S. government and government agency obligations 3,667.9 4.7 ( 5.0 ) 3,667.6
Commercial paper 689.3 — ( 0.2 ) 689.1
Certificates of deposit 248.2 — ( 0.2 ) 248.0
Asset-backed securities 219.2 0.6 ( 0.1 ) 219.7
Sovereign bonds 84.3 0.3 ( 0.2 ) 84.4
$ 15,515.8 $ 40.9 $ ( 28.3 ) $ 15,528.4
As of December 31, 2025
Corporate bonds $ 10,141.0 $ 80.9 $ ( 2.4 ) $ 10,219.5
U.S. government and government agency obligations 4,352.2 15.2 ( 0.1 ) 4,367.3
Commercial paper 540.8 0.3 — 541.1
Certificates of deposit 265.7 0.2 — 265.9
Asset-backed securities 241.4 1.4 — 242.8
Sovereign bonds 76.3 0.5 — 76.8
$ 15,617.4 $ 98.5 $ ( 2.5 ) $ 15,713.4
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, 2026 mature at various dates through December 2032. The fair values of available-for-sale debt securities by contractual maturity consist of the following:
March 31, December 31,
(In millions) 2026
2025
Maturities within one year $ 5,791.1 $ 5,487.1
Maturities after one year through five years 9,638.9 10,224.8
Maturities after five years 98.4 1.5
$ 15,528.4 $ 15,713.4
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6. Fair Value Measurements
The table below summarizes the Company's assets 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
Fair Value Measurements at Reporting Date
As of March 31, 2026
Value
Level 1 Level 2
Cash equivalents $ 1,865.3 $ 613.3 $ 1,252.0
Available-for-sale debt securities:
Corporate bonds 10,619.6 — 10,619.6
U.S. government and government agency obligations 3,667.6 — 3,667.6
Commercial paper 689.1 — 689.1
Certificates of deposit 248.0 — 248.0
Asset-backed securities 219.7 — 219.7
Sovereign bonds 84.4 — 84.4
Equity securities (a)
48.7 48.7 —
$ 17,442.4 $ 662.0 $ 16,780.4
As of December 31, 2025
Cash equivalents $ 2,121.6 $ 1,127.7 $ 993.9
Available-for-sale debt securities:
Corporate bonds 10,219.5 — 10,219.5
U.S. government and government agency obligations 4,367.3 — 4,367.3
Commercial paper 541.1 — 541.1
Certificates of deposit 265.9 — 265.9
Asset-backed securities 242.8 — 242.8
Sovereign bonds 76.8 — 76.8
Equity securities (a)
34.3 34.3 —
$ 17,869.3 $ 1,162.0 $ 16,707.3
(a) Includes equity securities of $ 47.5 million and $ 33.3 million as of March 31, 2026 and December 31, 2025, respectively, which were subject to transfer restrictions that expired in April 2026
In addition to the investments summarized in the table above, the Company recorded the following investments within Other noncurrent assets:
• As of March 31, 2026 and December 31, 2025, $ 571.6 million and $ 334.0 million, respectively, of equity securities that do not have a readily determinable fair value. The change in carrying value of such investments was primarily the result of additional purchases.
• As of March 31, 2026 and December 31, 2025, equity securities held through ownership interest in an investment fund of $ 169.9 million and $ 147.5 million, respectively, which are measured at fair value based on Level 3 inputs. The change in carrying value was primarily the result of additional purchases by the fund.
During the three months ended March 31, 2026 and 2025, the Company recognized $ 24.0 million and $ 139.7 million of net unrealized gains, respectively, in Other income (expense), net, related to investments in equity securities that were still held as of the period end date.
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Other Fair Value Disclosures
The fair value of the Company's long-term debt, which was determined based on Level 2 inputs, was estimated to be $ 1.564 billion and $ 1.576 billion as of March 31, 2026 and December 31, 2025, respectively. The carrying value was $ 1.986 billion as of March 31, 2026 and December 31, 2025.
7. Inventories
Inventories consist of the following:
March 31,
December 31,
(In millions) 2026
2025
Raw materials $ 630.7 $ 641.5
Work-in-process 1,524.5 1,641.6
Finished goods 160.5 190.2
Deferred costs 787.9 727.5
$ 3,103.6 $ 3,200.8
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's effective tax rate was 12.5 % and 10.6 % for the three months ended March 31, 2026 and 2025, respectively. The Company's effective tax rate for the three months ended March 31, 2026 and 2025 was positively impacted, compared to the U.S. federal statutory rate, primarily by income earned in foreign jurisdictions with tax rates lower than the U.S. federal statutory rate and, to a lesser extent, federal tax credits for research activities, partly offset by changes in unrecognized tax benefits.
9. Stockholders' Equity
a. Share Repurchase Programs
The Company's board of directors has authorized share repurchase programs, including a share repurchase program for up to $ 3.0 billion of the Company's Common Stock which was authorized in February 2025. The programs have no time limit and can be discontinued at any time.
The table below summarizes the shares of the Company's Common Stock that the Company repurchased under its share repurchase programs and the cost of such shares, which were recorded as Treasury Stock.
Three Months Ended
March 31,
(In millions) 2026 2025
Number of shares 1.0 1.5
Total cost of shares $ 803.2 $ 1,052.4
As of March 31, 2026, $ 688.2 million remained available for share repurchases under the Company's share repurchase programs.
In April 2026, 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 repurchase programs described above.
b. Dividends
In January 2026, the Company's board of directors declared a quarterly cash dividend of $ 0.94 per share on its Common Stock and Class A Stock, which was paid to the Company's shareholders in March 2026.
Additionally, in April 2026, the Company's board of directors declared a cash dividend of $ 0.94 per share on its Common Stock and Class A Stock. The dividend will be payable to the Company's shareholders in June 2026.
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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) 2026
2025
Cash and cash equivalents $ 2,962.6 $ 3,090.2
Restricted cash included in Other current assets
8.0 2.8
Total cash, cash equivalents, and restricted cash shown in the Condensed Consolidated Statements of Cash Flows
$ 2,970.6 $ 3,093.0
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) 2026
2025
2025
2024
Accrued capital expenditures $ 162.5 $ 178.8 $ 105.9 $ 151.6
Accrued contingent consideration in connection with acquisitions
$ 60.7 $ 58.9 $ 43.1 $ 62.7
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:
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Three Months Ended
March 31,
(In millions) 2026 2025
Direct research and development expenses (a)
$ 498.6 $ 388.4
Indirect research and development expenses:
Payroll and benefits 484.2 451.6
Lab supplies and other research and development costs
59.3 60.0
Occupancy and other operating costs 170.9 154.4
Total indirect research and development expenses
714.4 666.0
Clinical manufacturing costs
364.1 310.3
Reimbursement of research and development expenses by collaborators ( 33.6 ) ( 37.3 )
Total research and development expenses
$ 1,543.5 $ 1,327.4
(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
12. Legal Matters
From time to time, the Company is a party to legal proceedings in the course of the Company's business. The outcome of any such proceedings, regardless of the merits, is inherently uncertain. If the Company is unable to prevail in one or more of such proceedings, its consolidated financial position, results of operations, and future cash flows may be materially adversely impacted. Costs associated with the Company's involvement in legal proceedings are expensed as incurred. The Company recognizes gain contingencies associated with such proceedings when the award or recovery is realized or realizable and loss contingencies when it is probable that a liability will be incurred and the amount of loss can be reasonably estimated. As of March 31, 2026 and December 31, 2025, 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.
a. Proceedings Relating to EYLEA (aflibercept) Injection
(1) United States
As described in greater detail below, the Company has filed patent infringement lawsuits against various parties in the United States alleging infringement of certain Company patents pertaining to EYLEA, and certain of these patents have also been subject to post-grant proceedings before the United States Patent and Trademark Office ("USPTO").
On February 11, 2026, the Company entered into a settlement agreement resulting in the dismissal of the previously disclosed patent infringement lawsuit before the United States District Court for the Northern District of West Virginia against Samsung Bioepis Co., Ltd. ("Samsung Bioepis"). The lawsuit alleged infringement of certain Company patents, including the Company's U.S. Patent No. 11,084,865. Pursuant to the settlement agreement, Samsung Bioepis is precluded from launching its aflibercept 2 mg biosimilar until January 2027.
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On January 10, 2024, the Company filed a patent infringement lawsuit (as amended on January 7, 2026) against Amgen Inc. ("Amgen") in the United States District Court for the Central District of California (subsequently transferred to the United States District Court for the Northern District of West Virginia) alleging that Amgen's filing for U.S. Food and Drug Administration ("FDA") approval of an aflibercept 2 mg biosimilar infringed certain Company patents (as amended, the "2024 lawsuit"). On September 23, 2024, the court denied the Company's motion for a preliminary injunction, which decision was affirmed by the Federal Circuit on March 14, 2025. On June 17, 2025, the Company filed an additional patent infringement lawsuit against Amgen in the United States District Court for the Central District of California alleging that Amgen's continued commercialization of its aflibercept 2 mg biosimilar infringes the Company's U.S. Patent No. 12,331,099 (the "2025 lawsuit"). On September 12, 2025, Amgen filed its answer and counterclaims in the 2025 lawsuit alleging, among other things, that the Company obtained numerous patents fraudulently, rendering them unenforceable, and that obtaining and enforcing certain Company patents violated Section 2 of the Sherman Antitrust Act of 1890, as amended (the "Sherman Antitrust Act"). On November 12, 2025, the Company filed a motion to dismiss certain of Amgen's affirmative defenses and counterclaims in the 2025 lawsuit, and an oral hearing on the motion was held on April 7, 2026. On March 9, 2026, Amgen filed its answer and counterclaims in the 2024 lawsuit; and, on April 20, 2026, the Company filed a motion to dismiss certain of Amgen's affirmative defenses and counterclaims in the 2024 lawsuit.
(2) Outside the United States
As described in greater detail below, the Company has filed patent infringement lawsuits against various parties in several jurisdictions outside the United States alleging infringement of certain Company patents pertaining to EYLEA, and certain of these patents have also been subject to post-grant proceedings before the European Patent Office (the "EPO") and/or other comparable foreign authorities.
(i) Multijurisdictional Settlement – Formycon . On February 23, 2026, the Company and Bayer entered into a settlement agreement with Formycon AG ("Formycon") in respect of Europe and certain markets in Latin America and the Asia-Pacific region. Pursuant to the settlement agreement, all pending judicial and administrative proceedings related to Formycon's aflibercept 2 mg biosimilar product have been dismissed, and Formycon is permitted to launch its product in the United Kingdom and, starting in May 2026, the rest of Europe and the other jurisdictions covered by the settlement.
(ii) Europe
(I) EPO Post-Grant Proceedings
Various parties, including Amgen and other, anonymous parties, are seeking revocation of the Company's European Patent Nos. 2,944,306 (the "'306 Patent"), 3,716,992 (the "'992 Patent"), and 3,384,049 (the "'049 Patent") before the Opposition Division ("OD") of the EPO. On November 26, 2024, following an oral hearing, the OD announced its decision to revoke the '306 Patent. An oral hearing concerning the Company's appeal of this decision has been scheduled for October 2026. On October 22, 2025, following an oral hearing, the OD upheld the validity of the '992 Patent's claims in amended form, which decision has been appealed by Amgen. On April 21, 2026, following an oral hearing, the OD invalidated the '049 Patent.
(II) Country-Specific Proceedings
The Company is also party to proceedings against various parties, including Sandoz Inc. ("Sandoz"), Sam Chun Dang Pharm. Co., Ltd ("Sam Chun Dang"), and/or their affiliated entities, before several European national courts. In Germany, in a January 2026 preliminary injunction proceeding, the Munich Regional Court issued a decision that found that Sandoz's aflibercept 2 mg biosimilar product infringes the Company's European Patent No. 2,364,691 (the "'691 Patent") and granted the Company's motion for a preliminary injunction, enjoining Sandoz from selling its aflibercept 2 mg biosimilar in Germany until the expiration of the '691 Patent. Following an appeal by Sandoz, in February 2026 the Munich Higher Regional Court suspended enforcement of, and the Company subsequently withdrew its request for, the preliminary injunction. On March 31, 2026, the Company initiated a patent infringement lawsuit in the Munich Regional Court against Sandoz alleging its aflibercept 2 mg biosimilar infringes the '691 Patent. In addition, on April 1, 2026, the Company initiated a patent infringement lawsuit in the Munich Regional Court against Sam Chun Dang alleging its aflibercept 2 mg biosimilar infringes the '691 Patent.
(iii) South Korea
The Company and Bayer Consumer Care AG have filed patent infringement lawsuits in the Seoul Central District Court against Sam Chun Dang and OPTUS Pharmaceutical Co., Ltd. These lawsuits seek damages and/or injunctive relief and allege that the
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making, constructing, using, or selling of an aflibercept 2 mg biosimilar by the defendants would infringe one or more claims of the Company's Korean Patent Nos. 1406811, 659477, and 2519234.
(iv) Japan
On October 10, 2025, the Company filed a patent infringement lawsuit in the Osaka District Court against Fuji Pharma Co., Ltd. alleging that the making, constructing, using, or selling of an aflibercept 2 mg biosimilar by the defendant would infringe one or more claims of the Company's Japanese Patent No. 7,733,706. On January 28, 2026, the parties entered into a settlement agreement, pursuant to which this lawsuit has been dismissed.
b. 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 (the "SDNY") 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, 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 SDNY, which motion was granted on December 5, 2024.
c. Proceedings Relating to Praluent (alirocumab) Injection
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. A trial was held in May 2025. On May 15, 2025, the jury reached a verdict in Regeneron's favor on nine of the ten counts submitted to it and awarded Regeneron $ 135.6 million in compensatory damages and $ 271.2 million in punitive damages. On June 20, 2025, Amgen filed a post-trial motion for judgment as a matter of law or, in the alternative, for a new trial. Also on June 20, 2025, the Company filed a post-trial motion for (i) permanent injunctive relief, (ii) a constructive trust, and (iii) prejudgment interest. An oral hearing on Amgen's and Regeneron's respective post-trial motions was held on August 27, 2025.
d. Department of Justice Matters
On June 24, 2020, the U.S. Attorney's Office for the District of Massachusetts filed a civil complaint in the U.S. District Court for the District of Massachusetts alleging violations of the federal Anti-Kickback Statute and asserting causes of action under the federal False Claims Act and state law (the "June 2020 Civil Complaint") relating to the Company's support of 501(c)(3) organizations that provide financial assistance to patients. On September 27, 2023, the court (i) denied in part and granted in part the Company's motion for summary judgment and (ii) denied in its entirety the motion for partial summary judgment filed by the U.S. Attorney's Office for the District of Massachusetts. On October 25, 2023, the court certified for interlocutory appeal a portion of the court's September 27, 2023 order that addressed the causation standard applicable to the alleged violations of the federal Anti-Kickback Statute and federal False Claims Act. On February 18, 2025, the U.S. Court of Appeals for the First Circuit affirmed the portion of the court's September 27, 2023 order that had been certified for interlocutory appeal. On October 1, 2025, the U.S. Attorney's Office for the District of Massachusetts filed a second motion for partial summary judgment.
On June 3, 2021, the United States District Court for the Central District of California unsealed a qui tam complaint (as amended on October 29, 2021) 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"). The amended complaint alleges violations of the federal Anti-Kickback Statute and asserts causes of action under the federal False Claims Act and state law relating to allegedly unlawful remuneration and assistance provided to prescribers. 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 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
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remaining causes of action under state law. On August 26, 2024, the qui tam plaintiffs filed a notice of appeal. Oral argument on the appeal was held on November 18, 2025.
In June 2021, the Company received a civil investigative demand ("CID") from the U.S. Department of Justice pursuant to the federal False Claims Act relating to, among other things, alleged 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. On March 28, 2024, the U.S. District Court for the District of Massachusetts unsealed a qui tam complaint against the Company and others by two qui tam plaintiffs, 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 related to, among other things, the alleged conduct described above. Also on March 28, 2024, the U.S. Department of Justice and the U.S. Attorney's Office for the District of Massachusetts filed a civil complaint in partial intervention (the "March 2024 Civil Complaint") of the qui tam action, in the same court, asserting causes of action under the federal False Claims Act and a claim for unjust enrichment related to the alleged conduct described above. 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 same court asserting causes of action under various state laws related to the same alleged conduct. On April 29, 2025, the court denied the Company's motion to dismiss the March 2024 Civil Complaint and the June 2024 Civil Complaint. On June 18, 2025, the States of Maine, Nebraska, Ohio, Oregon, and Wyoming intervened in the action and filed a consolidated complaint asserting causes of action under their respective state laws.
e. 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 "d. 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 SDNY 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 SDNY 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 "d. 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.
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f. Shareholder Derivative Complaint – Department of Justice June 2020 Civil Complaint Matters
On June 29, 2021, an alleged shareholder filed a shareholder derivative complaint in the Supreme Court of the State of New York (the "NY 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 "d. 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 NY Supreme Court to the SDNY. On September 23, 2021, the plaintiff moved to remand the case to the NY Supreme Court. Also on September 23, 2021, the individual defendants moved to dismiss the complaint in its entirety. On December 19, 2022, the SDNY 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.
g. Shareholder Derivative Complaints – Department of Justice March 2024 Civil Complaint Matters
In 2025, various purported shareholders of the Company filed several shareholder derivative complaints in the SDNY or the NY Supreme Court against members of the Company's board of directors and certain current and former executive officers of the Company as defendants and Regeneron as a nominal defendant. The complaints 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 "d. Department of Justice Matters" above, and one lawsuit also alleges a breach of fiduciary duty relating to the conduct alleged in the second amended putative class action civil complaint discussed under "i. Class Action Civil Complaint" below. The complaints also 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 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. The cases filed in the SDNY were consolidated and stayed pending resolution of the motion to dismiss filed in the putative class action discussed under "i. Class Action Civil Complaint" below. The shareholder derivative complaints filed in the NY Supreme Court were removed to the SDNY, and the purported shareholders filed motions to remand. On March 16, 2026, the SDNY denied the motions to remand and consolidated the cases with the other shareholder derivative lawsuits pending in the SDNY (which, as noted above, are subject to a stay).
h. Shareholder Derivative Complaint – Director Compensation
On July 22, 2025, an alleged shareholder filed a shareholder derivative complaint in the NY Supreme Court, naming the current non-employee members of our board of directors, and the co-Chairs of our board of directors (who also serve as our President and Chief Executive Officer and our President and Chief Scientific Officer, respectively) as defendants and Regeneron as a nominal defendant. The complaint asserts that the individual defendants breached their fiduciary duties and/or were unjustly enriched when they approved and/or received allegedly excessive non-employee director compensation in 2024 and 2025, and that this allegedly excessive compensation was a waste of corporate assets. The complaint seeks damages in favor of Regeneron for the alleged breaches of fiduciary duties, unjust enrichment, and waste of corporate assets; improvements to Regeneron's corporate governance and internal procedures; equitable relief, including restitution from the individual defendants; and award of the costs of the action, including attorneys' fees. An oral hearing on the Company's motion to dismiss the complaint was held on April 17, 2026.
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i. Class Action Civil Complaint
On January 7, 2025 (as amended on September 8, 2025 and October 30, 2025), a purported shareholder filed a putative class action civil complaint, on behalf of himself and all others similarly situated, in the SDNY against the Company and certain current and former executive officers of the Company. The second amended 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 "d. Department of Justice Matters" above as well as allegations relating to the launch of EYLEA HD. On July 10, 2025, the court appointed a lead plaintiff and lead counsel for the action. On November 17, 2025, the Company filed a motion to dismiss the second amended complaint.
j. Sanofi Litigation
On November 18, 2024, the Company filed a lawsuit (as amended on December 20, 2024) in the SDNY against Sanofi and certain of its affiliated entities (collectively, "Sanofi"). The lawsuit alleges that the defendants breached certain provisions of the parties' Amended and Restated License and Collaboration Agreement, dated as of November 10, 2009 (as amended, the "Collaboration Agreement"), concerning Sanofi's obligation to provide Regeneron with full access to material information relating to the commercialization of Dupixent or other products commercialized pursuant to the Collaboration Agreement and Regeneron's audit rights under the Collaboration Agreement. The lawsuit seeks a declaratory judgment, injunctive relief, damages, and other relief. On March 17, 2026, the court denied Sanofi's motion to dismiss the complaint.
k. Dupixent Product Liability Litigation
Since 2025, a number of product liability lawsuits have been filed in various U.S. district and state courts against the Company and certain of Sanofi's affiliated entities claiming that Dupixent either caused or exacerbated the patients' T-cell lymphoma, and asserting causes of action under various state laws. On February 13, 2026, several of the plaintiffs filed a motion with the United States Judicial Panel on Multidistrict Litigation seeking to consolidate these lawsuits for coordinated pretrial proceedings.
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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.