FULLTEXT DEL 1 AV 3
10-Q – 2025-10-28 – regn-20250930.htm
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended September 30, 2025
OR
☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from __________ to __________
Commission File Number: 000-19034
REGENERON PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
New York 13-3444607
(State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.)
777 Old Saw Mill River Road , Tarrytown , New York 10591-6707
(Address of principal executive offices, including zip code)
( 914 ) 847-7000
(Registrant's telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Act:
Title of each class Trading Symbol Name of each exchange on which registered
Common Stock - par value $.001 per share REGN NASDAQ Global Select Market
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of "large accelerated filer," "accelerated filer," "smaller reporting company," and "emerging growth company" in Rule 12b-2 of the Exchange Act.
Large accelerated filer ☒ Accelerated filer ☐ Non-accelerated filer ☐ Smaller reporting company ☐ Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
The number of shares outstanding of each of the registrant's classes of common stock as of October 23, 2025:
Class of Common Stock Number of Shares
Class A Stock, $.001 par value 1,817,146
Common Stock, $.001 par value 103,282,318
REGENERON PHARMACEUTICALS, INC.
QUARTERLY REPORT ON FORM 10-Q
TABLE OF CONTENTS
Page Numbers
PART I
FINANCIAL INFORMATION
Item 1.
Financial Statements (unaudited)
2
Condensed Consolidated Balance Sheets
2
Condensed Consolidated Statements of Operations and Comprehensive Income
3
Condensed Consolidated Statements of Stockholders' Equity
4
Condensed Consolidated Statements of Cash Flows
6
Notes to Condensed Consolidated Financial Statements
7
Item 2.
Management's Discussion and Analysis of Financial Condition and Results of Operations
24
Item 3.
Quantitative and Qualitative Disclosures About Market Risk
45
Item 4.
Controls and Procedures
46
PART II
OTHER INFORMATION
Item 1.
Legal Proceedings
46
Item 1A.
Risk Factors
46
Item 2.
Unregistered Sales of Equity Securities and Use of Proceeds
83
Item 5.
Other Information
83
Item 6.
Exhibits
83
SIGNATURE PAGE
84
"Altibodies ™ ," "ARCALYST ® ," "Evkeeza ® ," "EYLEA ® ," "EYLEA HD ® ," "Inmazeb ® ," "Libtayo ® ," "Lynozyfic ™ ," "Ordspono ™ ," "Praluent ® " (in the United States), "REGEN-COV ® ," "Regeneron ® ," "Regeneron Genetics Center ® ," "RGC ® ," " Veloci-Bi ® ," " VelociGene ® ," " VelociHum ® ," " VelociMab ® ," " VelocImmune ® ," " VelociMouse ® ," " VelociSuite ® ," " VelociT ® ," "Veopoz ® ," and "ZALTRAP ® " are trademarks of Regeneron Pharmaceuticals, Inc. Trademarks and trade names of other companies appearing in this report are, to the knowledge of Regeneron Pharmaceuticals, Inc., the property of their respective owners. This report refers to products of Regeneron Pharmaceuticals, Inc., its collaborators, and other parties. Consult the product label in each territory for specific information about such products.
Table of Contents
PART I. FINANCIAL INFORMATION
Item 1. Financial Statements
REGENERON PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited)
(In millions, except per share data)
September 30, December 31,
2025 2024
ASSETS
Current assets:
Cash and cash equivalents $ 2,506.4 $ 2,488.2
Marketable securities 5,937.2 6,524.3
Accounts receivable, net 5,687.1 6,211.9
Inventories 3,254.4 3,087.3
Prepaid expenses and other current assets 595.6 349.2
Total current assets 17,980.7 18,660.9
Marketable securities 10,285.7 8,900.1
Property, plant, and equipment, net 5,002.3 4,599.7
Intangible assets, net 1,380.9 1,148.6
Deferred tax assets 3,846.7 3,314.1
Other noncurrent assets 1,673.1 1,136.0
Total assets $ 40,169.4 $ 37,759.4
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $ 903.8 $ 789.5
Accrued expenses and other current liabilities 2,975.7 2,527.1
Deferred revenue 545.6 627.7
Total current liabilities 4,425.1 3,944.3
Long-term debt 1,985.5 1,984.4
Finance lease liabilities 720.0 720.0
Deferred revenue 219.2 185.7
Other noncurrent liabilities 1,861.8 1,571.4
Total liabilities 9,211.6 8,405.8
Stockholders' equity:
Preferred Stock, par value $ .01 per share; 30.0 shares authorized; shares issued and outstanding - no ne
— —
Class A Stock, convertible, par value $ .001 per share; 40.0 shares authorized; shares issued and outstanding - 1.8 in 2025 and 2024
— —
Common Stock, par value $ .001 per share; 320.0 shares authorized; shares issued - 136.2 in 2025 and 136.0 in 2024
0.1 0.1
Additional paid-in capital 13,787.3 12,855.9
Retained earnings 35,045.8 31,672.9
Accumulated other comprehensive income (loss) 69.0 ( 7.9 )
Treasury Stock, at cost; 32.7 shares in 2025 and 28.2 shares in 2024
( 17,944.4 ) ( 15,167.4 )
Total stockholders' equity 30,957.8 29,353.6
Total liabilities and stockholders' equity $ 40,169.4 $ 37,759.4
The accompanying notes are an integral part of the financial statements.
2
Table of Contents
REGENERON PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (Unaudited)
(In millions, except per share data)
Three Months Ended
September 30,
Nine Months Ended
September 30,
2025
2024
2025
2024
Statements of Operations
Revenues:
Net product sales $ 1,587.7 $ 1,946.4 $ 4,634.3 $ 5,626.3
Collaboration revenue 1,968.4 1,660.1 5,360.3 4,450.9
Other revenue 198.2 114.2 464.0 335.6
3,754.3 3,720.7 10,458.6 10,412.8
Expenses:
Research and development 1,475.0 1,271.5 4,224.1 3,719.9
Acquired in-process research and development 83.1 56.2 105.4 87.2
Selling, general, and administrative 657.8 714.4 1,925.0 2,162.2
Cost of goods sold 281.0 262.3 822.1 760.5
Cost of collaboration and contract manufacturing 240.6 228.8 694.0 644.6
Other operating (income) expense, net
( 10.0 ) 8.0 ( 10.0 ) 37.9
2,727.5 2,541.2 7,760.6 7,412.3
Income from operations 1,026.8 1,179.5 2,698.0 3,000.5
Other income (expense):
Other income (expense), net
755.8 327.3 1,520.6 866.0
Interest expense ( 19.3 ) ( 13.8 ) ( 31.6 ) ( 44.7 )
736.5 313.5 1,489.0 821.3
Income before income taxes 1,763.3 1,493.0 4,187.0 3,821.8
Income tax expense
303.3 152.4 526.7 326.9
Net income $ 1,460.0 $ 1,340.6 $ 3,660.3 $ 3,494.9
Net income per share - basic $ 14.09 $ 12.40 $ 34.83 $ 32.36
Net income per share - diluted $ 13.62 $ 11.54 $ 33.61 $ 30.23
Weighted average shares outstanding - basic 103.6 108.1 105.1 108.0
Weighted average shares outstanding - diluted 107.2 116.2 108.9 115.6
Statements of Comprehensive Income
Net income $ 1,460.0 $ 1,340.6 $ 3,660.3 $ 3,494.9
Other comprehensive income (loss), net of tax:
Unrealized gain on debt securities 15.7 128.2 75.9 139.6
Gain on foreign currency translation
0.8 1.9 1.0 1.5
Comprehensive income $ 1,476.5 $ 1,470.7 $ 3,737.2 $ 3,636.0
The accompanying notes are an integral part of the financial statements.
3
Table of Contents
REGENERON PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (Unaudited)
(In millions)
Class A Stock Common Stock Additional
Paid-in Capital Retained Earnings Accumulated Other Comprehensive Income (Loss) Treasury Stock Total Stockholders' Equity
Shares Amount Shares Amount Shares Amount
Balance, December 31, 2024
1.8 $ — 136.0 $ 0.1 $ 12,855.9 $ 31,672.9 $ ( 7.9 ) ( 28.2 ) $ ( 15,167.4 ) $ 29,353.6
Issuance of Common Stock for equity awards granted under long-term incentive plans — — 0.1 — 62.9 — — — — 62.9
Common Stock tendered upon exercise of stock options and vesting of restricted stock for employee tax obligations — — — — ( 4.4 ) — — — — ( 4.4 )
Issuance/distribution of Common Stock for 401(k) Savings Plan — — — — 17.8 — — — 1.7 19.5
Repurchases of Common Stock — — — — — — — ( 1.5 ) ( 1,052.4 ) ( 1,052.4 )
Dividends declared
— — — — 1.0 ( 97.2 ) — — — ( 96.2 )
Stock-based compensation charges — — — — 258.9 — — — — 258.9
Net income — — — — — 808.7 — — — 808.7
Other comprehensive income, net of tax — — — — — — 37.0 — — 37.0
Balance, March 31, 2025
1.8 — 136.1 0.1 13,192.1 32,384.4 29.1 ( 29.7 ) ( 16,218.1 ) 29,387.6
Issuance of Common Stock for equity awards granted under long-term incentive plans — — 0.1 — 28.9 — — — — 28.9
Common Stock tendered upon exercise of stock options and vesting of restricted stock for employee tax obligations — — — — ( 5.4 ) — — — — ( 5.4 )
Issuance/distribution of Common Stock for 401(k) Savings Plan — — — — 19.2 — — — 3.3 22.5
Repurchases of Common Stock — — — — — — — ( 1.9 ) ( 1,069.9 ) ( 1,069.9 )
Dividends declared — — — — 1.1 ( 95.8 ) — — — ( 94.7 )
Stock-based compensation charges — — — — 254.9 — — — — 254.9
Net income — — — — — 1,391.6 — — — 1,391.6
Other comprehensive income, net of tax — — — — — — 23.4 — — 23.4
Balance, June 30, 2025
1.8 — 136.2 0.1 13,490.8 33,680.2 52.5 ( 31.6 ) ( 17,284.7 ) 29,938.9
Issuance of Common Stock for equity awards granted under long-term incentive plans — — 0.1 — 39.8 — — — — 39.8
Common Stock tendered upon exercise of stock options and vesting of restricted stock for employee tax obligations — — ( 0.1 ) — ( 3.0 ) — — — — ( 3.0 )
Issuance/distribution of Common Stock for 401(k) Savings Plan — — — — 17.7 — — — 3.3 21.0
Repurchases of Common Stock — — — — — — — ( 1.1 ) ( 663.0 ) ( 663.0 )
Dividends declared — — — — 1.0 ( 94.4 ) — — — ( 93.4 )
Stock-based compensation charges — — — — 241.0 — — — — 241.0
Net income — — — — — 1,460.0 — — — 1,460.0
Other comprehensive income, net of tax — — — — — — 16.5 — — 16.5
Balance, September 30, 2025
1.8 $ — 136.2 $ 0.1 $ 13,787.3 $ 35,045.8 $ 69.0 ( 32.7 ) $ ( 17,944.4 ) $ 30,957.8
4
Table of Contents
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (Unaudited) (continued)
Class A Stock Common Stock Additional
Paid-in Capital Retained Earnings Accumulated Other Comprehensive Income (Loss) Treasury Stock Total Stockholders' Equity
Shares Amount Shares Amount Shares Amount
Balance, December 31, 2023
1.8 $ — 133.1 $ 0.1 $ 11,354.0 $ 27,260.3 $ ( 80.9 ) ( 25.5 ) $ ( 12,560.4 ) $ 25,973.1
Issuance of Common Stock for equity awards granted under long-term incentive plans — — 1.5 — 672.4 — — — — 672.4
Common Stock tendered upon exercise of stock options and vesting of restricted stock for employee tax obligations — — ( 0.4 ) — ( 335.9 ) — — — — ( 335.9 )
Issuance/distribution of Common Stock for 401(k) Savings Plan — — — — 18.8 — — — 1.7 20.5
Repurchases of Common Stock — — — — — — — ( 0.3 ) ( 298.0 ) ( 298.0 )
Stock-based compensation charges — — — — 233.3 — — — — 233.3
Net income — — — — — 722.0 — — — 722.0
Other comprehensive income, net of tax
— — — — — — 3.7 — — 3.7
Balance, March 31, 2024
1.8 — 134.2 0.1 11,942.6 27,982.3 ( 77.2 ) ( 25.8 ) ( 12,856.7 ) 26,991.1
Issuance of Common Stock for equity awards granted under long-term incentive plans — — 1.0 — 436.5 — — — — 436.5
Common Stock tendered upon exercise of stock options and vesting of restricted stock for employee tax obligations — — ( 0.4 ) — ( 311.8 ) — — — — ( 311.8 )
Issuance/distribution of Common Stock for 401(k) Savings Plan — — — — 19.6 — — — 2.2 21.8
Repurchases of Common Stock — — — — — — — ( 0.6 ) ( 601.4 ) ( 601.4 )
Stock-based compensation charges — — — — 230.0 — — — — 230.0
Net income — — — — — 1,432.3 — — — 1,432.3
Other comprehensive income, net of tax — — — — — — 7.3 — — 7.3
Balance, June 30, 2024 1.8 — 134.8 0.1 12,316.9 29,414.6 ( 69.9 ) ( 26.4 ) ( 13,455.9 ) 28,205.8
Issuance of Common Stock for equity awards granted under long-term incentive plans — — 0.6 — 255.7 — — — — 255.7
Common Stock tendered upon exercise of stock options and vesting of restricted stock for employee tax obligations — — ( 0.1 ) — ( 120.2 ) — — — — ( 120.2 )
Issuance/distribution of Common Stock for 401(k) Savings Plan — — — — 20.0 — — — 1.8 21.8
Repurchases of Common Stock — — — — — — — ( 0.6 ) ( 738.3 ) ( 738.3 )
Stock-based compensation charges — — — — 230.4 — — — — 230.4
Net income — — — — — 1,340.6 — — — 1,340.6
Other comprehensive income, net of tax
— — — — — — 130.1 — — 130.1
Balance, September 30, 2024
1.8 $ — 135.3 $ 0.1 $ 12,702.8 $ 30,755.2 $ 60.2 ( 27.0 ) $ ( 14,192.4 ) $ 29,325.9
The accompanying notes are an integral part of the financial statements.
5
Table of Contents
REGENERON PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited)
(In millions)
Nine Months Ended
September 30,
2025
2024
Cash flows from operating activities:
Net income $ 3,660.3 $ 3,494.9
Adjustments to reconcile net income to net cash provided by operating activities:
Depreciation and amortization 398.7 356.5
Stock-based compensation expense 744.4 678.4
Gains on marketable and other securities, net
( 967.6 ) ( 331.2 )
Other, net
( 1.4 ) ( 31.9 )
Deferred income taxes ( 552.9 ) ( 477.1 )
Changes in assets and liabilities:
Decrease (increase) in accounts receivable 549.3 ( 436.2 )
Increase in inventories ( 277.4 ) ( 502.0 )
Increase in prepaid expenses and other assets ( 458.1 ) ( 352.2 )
(Decrease) increase in deferred revenue ( 48.6 ) 249.0
Increase in accounts payable, accrued expenses, and other liabilities 761.5 509.5
Total adjustments 147.9 ( 337.2 )
Net cash provided by operating activities 3,808.2 3,157.7
Cash flows from investing activities:
Purchases of marketable and other securities ( 8,914.6 ) ( 14,664.5 )
Sales or maturities of marketable and other securities 8,991.2 12,445.3
Capital expenditures ( 649.7 ) ( 556.3 )
Payments for intangible assets
( 273.3 ) ( 58.3 )
Proceeds from sale of property, plant, and equipment
— 20.1
Acquisitions, net of cash acquired
( 3.0 ) ( 5.0 )
Net cash used in investing activities ( 849.4 ) ( 2,818.7 )
Cash flows from financing activities:
Proceeds from issuance of Common Stock 132.4 1,374.4
Payments in connection with Common Stock tendered for employee tax obligations ( 12.9 ) ( 775.7 )
Repurchases of Common Stock ( 2,766.9 ) ( 1,630.3 )
Dividends paid
( 277.6 ) —
Other
( 10.3 ) ( 33.4 )
Net cash used in financing activities ( 2,935.3 ) ( 1,065.0 )
Effect of exchange rate changes on cash, cash equivalents, and restricted cash 0.6 —
Net increase (decrease) in cash, cash equivalents, and restricted cash
24.1 ( 726.0 )
Cash, cash equivalents, and restricted cash at beginning of period 2,489.0 2,737.8
Cash, cash equivalents, and restricted cash at end of period $ 2,513.1 $ 2,011.8
The accompanying notes are an integral part of the financial statements.
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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
September 30, Nine Months Ended
September 30,
(In millions) 2025 2024 2025 2024
EYLEA HD ®
U.S. $ 430.6 $ 392.3 $ 1,130.6 $ 896.5
EYLEA ®
U.S. 680.6 1,144.6 2,170.9 3,576.7
Total EYLEA HD and EYLEA U.S. 1,111.2 1,536.9 3,301.5 4,473.2
Libtayo ®
U.S. 219.1 194.5 659.4 536.1
Libtayo
Rest of world
146.1 94.1 367.4 313.8
Total Libtayo
Global
365.2 288.6 1,026.8 849.9
Praluent ®
U.S. 67.7 52.9 190.3 179.0
Evkeeza ®
U.S. 42.8 32.4 114.9 87.6
Inmazeb ®
U.S.
— 35.6 — 36.6
Other products
Global
0.8 — 0.8 —
$ 1,587.7 $ 1,946.4 $ 4,634.3 $ 5,626.3
As of September 30, 2025 and December 31, 2024, the Company had $ 3.471 billion and $ 4.278 billion, respectively, of trade accounts receivable that were recorded within Accounts receivable, net.
The Company had product sales to certain customers that each accounted for more than 10% of total gross product revenue for the three and nine months ended September 30, 2025 and 2024. Sales to each of these customers as a percentage of the Company's total gross product revenue are as follows:
Three Months Ended
September 30,
Nine Months Ended
September 30,
2025 2024 2025 2024
Customer A
49 % 51 % 51 % 51 %
Customer B
30 % 24 % 26 % 24 %
3. Collaboration, License, and Other Agreements
a. Sanofi
The Company is party to a global, strategic collaboration with Sanofi to research, develop, and commercialize fully human monoclonal antibodies, which currently consists of Dupixent ® (dupilumab), Kevzara ® (sarilumab), and itepekimab .
Sanofi is generally responsible for funding 80 % to 100 % of agreed-upon development costs. The Company is obligated to reimburse Sanofi for 30 % to 50 % of development expenses that were funded by Sanofi (i.e., "development balance") based on the Company's share of collaboration profits; however, the Company is only required to apply 20 % of its share of profits from the collaboration each calendar quarter to reimburse Sanofi for these development expenses. As of September 30, 2025, the Company's contingent reimbursement obligation to Sanofi in connection with the development balance was approximately $ 905 million.
Sanofi leads commercialization activities for products under the collaboration, subject to the Company's right to co-commercialize such products. The parties equally share profits from sales within the United States. The parties share profits outside the United States on a sliding scale based on sales starting at 65 % (Sanofi)/ 35 % (Regeneron) and ending at 55 % (Sanofi)/ 45 % (Regeneron).
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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
September 30,
Nine Months Ended
September 30,
(In millions) 2025 2024 2025 2024
Regeneron's share of profits
Collaboration revenue $ 1,455.5 $ 1,088.3 $ 3,755.7 $ 2,880.6
Reimbursement for manufacturing of commercial supplies Collaboration revenue $ 161.5 $ 175.1 $ 488.1 $ 438.2
Regeneron's obligation for its share of Sanofi R&D expenses, net of reimbursement of R&D expenses (R&D expense)
$ ( 23.5 ) $ ( 7.8 ) $ ( 56.9 ) $ ( 35.5 )
Reimbursement of commercialization-related expenses
Reduction of SG&A expense $ 182.6 $ 169.0 $ 535.8 $ 459.3
The following table summarizes contract balances in connection with the Company's Sanofi collaboration:
September 30, December 31,
(In millions) 2025
2024
Accounts receivable, net $ 1,493.9 $ 1,216.2
Deferred revenue
$ 423.5 $ 571.7
b. Bayer
The Company is party to a license and collaboration agreement with Bayer for the global development and commercialization of EYLEA 8 mg (aflibercept 8 mg) and EYLEA (aflibercept) outside the United States. Agreed-upon development expenses incurred by the Company and Bayer are generally shared equally. Bayer is responsible for commercialization activities outside the United States, and the companies share equally in profits from such sales. Within the United States, the Company is responsible for commercialization and retains profits from such sales.
Amounts recognized in the Company's Statements of Operations in connection with its Bayer collaboration are as follows:
Statement of Operations Classification Three Months Ended
September 30,
Nine Months Ended
September 30,
(In millions) 2025 2024 2025 2024
Regeneron's share of profits
Collaboration revenue $ 311.9 $ 367.6 $ 1,012.6 $ 1,054.5
Reimbursement for manufacturing of commercial supplies
Collaboration revenue $ 32.9 $ 23.2 $ 91.1 $ 67.4
Regeneron's obligation for its share of Bayer R&D expenses, net of reimbursement of R&D expenses (R&D expense)
$ ( 3.9 ) $ ( 11.8 ) $ ( 18.9 ) $ ( 35.2 )
The following table summarizes contract balances in connection with the Company's Bayer collaboration:
September 30, December 31,
(In millions) 2025
2024
Accounts receivable, net $ 363.2 $ 349.9
Deferred revenue
$ 317.0 $ 216.3
c. Other
In addition to the collaboration and license agreements discussed above, the Company has collaboration and license agreements that are not individually significant to its operating results or financial condition at this time. Pursuant to the terms of those agreements, the Company may (i) incur, and/or get reimbursed for, research and development costs, and/or (ii) be required to pay, and/or may receive, additional amounts contingent upon the occurrence of various future events (e.g., upon the achievement of development and commercial milestones), which in the aggregate could be significant.
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Acquired In-Process Research and Development ("IPR&D") Expenses
During the three and nine months ended September 30, 2025, the Company recorded to Acquired IPR&D expense an $ 80.0 million up-front payment in connection with its license agreement with Hansoh Pharmaceuticals Group Company Limited to acquire development and commercial rights outside mainland China, Hong Kong, and Macau for HS-20094 (a dual GLP-1/GIP receptor agonist currently in Phase 3 clinical development in China).
During the three and nine months ended September 30, 2024, the Company recorded to Acquired IPR&D expense a $ 45.0 million development milestone in connection with its collaboration agreement with Sonoma Biotherapeutics, Inc.
Other
In June 2025, the Company purchased an FDA Rare Pediatric Disease Priority Review Voucher from a third party for $ 155.0 million (which was recorded as an indefinite-lived intangible asset).
4. Net Income Per Share
The calculations of basic and diluted net income per share are as follows:
Three Months Ended
September 30,
Nine Months Ended
September 30,
(In millions, except per share data) 2025 2024 2025 2024
Net income - basic and diluted $ 1,460.0 $ 1,340.6 $ 3,660.3 $ 3,494.9
Weighted average shares - basic 103.6 108.1 105.1 108.0
Effect of dilutive securities:
Stock options 1.5 5.3 1.8 5.2
Restricted stock awards and restricted stock units 2.1 2.8 2.0 2.4
Weighted average shares - diluted 107.2 116.2 108.9 115.6
Net income per share - basic $ 14.09 $ 12.40 $ 34.83 $ 32.36
Net income per share - diluted $ 13.62 $ 11.54 $ 33.61 $ 30.23
Shares which have been excluded from diluted per share amounts because their effect would have been antidilutive include the following:
Three Months Ended
September 30,
Nine Months Ended
September 30,
(Shares in millions) 2025 2024 2025 2024
Stock options 6.3 0.1 6.3 1.5
Restricted stock awards and restricted stock units
0.9 — 1.0 —
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5. Marketable Securities
Marketable securities as of September 30, 2025 and December 31, 2024 consist of both available-for-sale debt securities of investment grade issuers (see below and Note 6) as well as equity securities of publicly traded companies (see Note 6).
The following tables summarize the Company's investments in available-for-sale debt securities:
(In millions) Amortized Unrealized Fair
As of September 30, 2025
Cost Basis Gains Losses Value
Corporate bonds $ 9,624.3 $ 78.8 $ ( 5.4 ) $ 9,697.7
U.S. government and government agency obligations 4,691.7 12.1 ( 0.5 ) 4,703.3
Commercial paper 445.1 0.2 — 445.3
Certificates of deposit 310.2 0.2 — 310.4
Asset-backed securities 293.8 1.4 — 295.2
Sovereign bonds 69.8 0.5 ( 0.1 ) 70.2
$ 15,434.9 $ 93.2 $ ( 6.0 ) $ 15,522.1
As of December 31, 2024
Corporate bonds $ 8,226.9 $ 25.1 $ ( 31.4 ) $ 8,220.6
U.S. government and government agency obligations 4,820.5 3.4 ( 6.9 ) 4,817.0
Commercial paper 548.3 0.4 — 548.7
Certificates of deposit 380.6 0.5 — 381.1
Asset-backed securities 279.0 0.6 ( 0.3 ) 279.3
Sovereign bonds 82.7 0.1 ( 0.4 ) 82.4
$ 14,338.0 $ 30.1 $ ( 39.0 ) $ 14,329.1
The Company classifies its investments in available-for-sale debt securities based on their contractual maturity dates. The available-for-sale debt securities as of September 30, 2025 mature at various dates through February 2038. The fair values of available-for-sale debt securities by contractual maturity consist of the following:
September 30, December 31,
(In millions) 2025
2024
Maturities within one year $ 5,937.2 $ 6,524.3
Maturities after one year through five years 9,518.9 7,804.8
Maturities after five years 66.0 —
$ 15,522.1 $ 14,329.1
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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 September 30, 2025
Fair Value Unrealized Losses
Fair Value Unrealized Losses
Fair Value Unrealized Losses
Corporate bonds $ 9,300.3 $ ( 1.5 ) $ 397.4 $ ( 3.9 ) $ 9,697.7 $ ( 5.4 )
U.S. government and government agency obligations 4,541.8 ( 0.4 ) 161.5 ( 0.1 ) 4,703.3 ( 0.5 )
Sovereign bonds
56.0 ( 0.1 ) 14.2 — 70.2 ( 0.1 )
$ 13,898.1 $ ( 2.0 ) $ 573.1 $ ( 4.0 ) $ 14,471.2 $ ( 6.0 )
As of December 31, 2024
Corporate bonds $ 7,175.8 $ ( 14.2 ) $ 1,044.8 $ ( 17.2 ) $ 8,220.6 $ ( 31.4 )
U.S. government and government agency obligations 4,675.3 ( 6.2 ) 141.7 ( 0.7 ) 4,817.0 ( 6.9 )
Asset-backed securities 265.4 ( 0.3 ) 13.9 — 279.3 ( 0.3 )
Sovereign bonds 63.3 ( 0.3 ) 19.1 ( 0.1 ) 82.4 ( 0.4 )
$ 12,179.8 $ ( 21.0 ) $ 1,219.5 $ ( 18.0 ) $ 13,399.3 $ ( 39.0 )
Amounts reclassified from Accumulated other comprehensive income (loss) into Other income (expense), net, related to realized gains/losses on sales of available-for-sale debt securities; such amounts were not material for the three and nine months ended September 30, 2025 and 2024.
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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 September 30, 2025
Fair Value Level 1 Level 2 Level 3
Assets:
Cash equivalents $ 1,162.5 $ 378.3 $ 784.2 $ —
Available-for-sale debt securities:
Corporate bonds 9,697.7 — 9,697.7 —
U.S. government and government agency obligations 4,703.3 — 4,703.3 —
Commercial paper 445.3 — 445.3 —
Certificates of deposit 310.4 — 310.4 —
Asset-backed securities 295.2 — 295.2 —
Sovereign bonds 70.2 — 70.2 —
Equity securities (a)
700.8 700.8 — —
Total assets
$ 17,385.4 $ 1,079.1 $ 16,306.3 $ —
Liabilities:
Contingent consideration
$ 10.3 $ — $ — $ 10.3
As of December 31, 2024
Assets:
Cash equivalents $ 1,452.2 $ 1,264.2 $ 188.0 $ —
Available-for-sale debt securities:
Corporate bonds 8,220.6 — 8,220.6 —
U.S. government and government agency obligations 4,817.0 — 4,817.0 —
Commercial paper 548.7 — 548.7 —
Certificates of deposit 381.1 — 381.1 —
Asset-backed securities 279.3 — 279.3 —
Sovereign bonds 82.4 — 82.4 —
Equity securities (a)
1,095.3 1,095.3 — —
Total assets
$ 16,876.6 $ 2,359.5 $ 14,517.1 $ —
Liabilities:
Contingent consideration
$ 52.3 $ — $ — $ 52.3
(a) Includes equity securities of $ 63.9 million and $ 43.2 million as of September 30, 2025 and December 31, 2024, respectively, that are subject to transfer restrictions expiring in April 2026
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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 September 30, 2025 and December 31, 2024, $ 316.8 million and $ 159.8 million, respectively, of equity securities that do not have a readily determinable fair value. The change in carrying value of such investments was a result of additional purchases.
• As of September 30, 2025 and December 31, 2024, equity securities held through ownership interest in an investment fund of $ 98.4 million and $ 52.0 million, respectively, which are measured at fair value based on Level 3 inputs. The change in carrying value was primarily the result of additional investments by the fund.
Amounts recognized in Other income (expense), net, related to the Company's investments in public equity securities consist of the following:
Three Months Ended
September 30, Nine Months Ended
September 30,
(In millions)
2025 2024 2025 2024
Net gains recognized during the period
$ 581.5 $ 134.5 $ 978.1 $ 330.8
Less: Net gains recognized on investments sold during the period
370.9 — 650.4 —
Net unrealized gains recognized on investments still held as of period end date
$ 210.6 $ 134.5 $ 327.7 $ 330.8
The fair value of the Company's long-term debt, which was determined based on Level 2 inputs, was estimated to be $ 1.568 billion and $ 1.484 billion as of September 30, 2025 and December 31, 2024, respectively, and the carrying value was $ 1.986 billion and $ 1.984 billion as of September 30, 2025 and December 31, 2024, respectively.
7. Inventories
Inventories consist of the following:
September 30,
December 31,
(In millions) 2025
2024
Raw materials $ 710.0 $ 879.5
Work-in-process 1,565.9 1,342.3
Finished goods 169.7 139.8
Deferred costs 808.8 725.7
$ 3,254.4 $ 3,087.3
Deferred costs represent the costs of product manufactured and shipped to the Company's collaborators for which recognition of revenue has been deferred.
8. Income Taxes
The Company is subject to U.S. federal, state, and foreign income taxes. On July 4, 2025, bill H.R. 1, commonly referred to as the "One Big Beautiful Bill Act" or "OBBBA," was signed into law, with certain provisions effective in 2025 and others in 2026. The OBBBA significantly revises U.S. corporate income tax laws by, among other things, restoring the option for immediate expense recognition for U.S.-based research and development expenditures and making permanent the ability to claim first-year bonus depreciation on qualified property. The OBBBA also modifies U.S. taxation on foreign earnings by, among other things, changing the tax rates for global intangible low-taxed income (now known as Net CFC Tested Income) and foreign-derived intangible income (now known as foreign-derived deduction eligible income), modifying the allocation of expenses in calculating foreign tax credits, as well as changing foreign tax credit limitations. As a result of the OBBBA being signed into law, the Company recognized a charge of $ 44.5 million in the third quarter of 2025 related to the re-measurement of the Company's U.S. net deferred tax assets.
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The Company's effective tax rate was 17.2 % and 10.2 % for the three months ended September 30, 2025 and 2024, respectively, and 12.6 % and 8.6 % for the nine months ended September 30, 2025 and 2024, respectively. The Company's effective tax rate for the three and nine months ended September 30, 2025 was positively impacted, compared to the U.S. federal statutory rate, primarily by income earned in foreign jurisdictions with tax rates lower than the U.S. federal statutory rate and federal tax credits for research activities, partially offset by the impact of the OBBBA being signed into law. In addition, the Company's effective tax rate for the nine months ended September 30, 2025 was positively impacted by the release of liabilities for uncertain tax positions recognized upon the effective settlement of the IRS audit of the Company's 2017 and 2018 federal income tax returns in the second quarter of 2025, which reduced the Company's effective tax rate for the nine months ended September 30, 2025 by 1.4 %.
The Company's effective tax rate for the three and nine months ended September 30, 2024 was positively impacted, compared to the U.S. federal statutory rate, primarily by income earned in foreign jurisdictions with tax rates lower than the U.S. federal statutory rate and stock-based compensation. The Company's effective tax rate for the nine months ended September 30, 2024 was negatively impacted by the remeasurement of uncertain tax positions.
9. Stockholders' Equity
a. Share Repurchase Programs
In January 2023, the Company's board of directors authorized a share repurchase program for up to $ 3.0 billion of the Company's Common Stock. In each of April 2024 and February 2025, the Company's board of directors authorized an additional share repurchase program for up to $ 3.0 billion (up to $ 6.0 billion in the aggregate). The programs have no time limit and can be discontinued at any time.
The table below summarizes the shares of the Company's Common Stock that the Company repurchased and the cost of such shares, which were recorded as Treasury Stock.
Three Months Ended
September 30,
Nine Months Ended
September 30,
(In millions) 2025 2024
2025 2024
Number of shares 1.1 0.6 4.5 1.5
Total cost of shares $ 663.0 $ 738.3 $ 2,785.3 $ 1,637.7
As of September 30, 2025, $ 2.156 billion remained available for share repurchases under the programs.
b. Dividends
In each of the first, second, and third quarters of 2025, the Company's board of directors declared quarterly cash dividends of $ 0.88 per share on its Common Stock and Class A Stock. Each quarterly dividend was paid to the Company's shareholders in the quarter in which the dividend was declared.
Additionally, in October 2025, the Company's board of directors declared a cash dividend of $ 0.88 per share on its Common Stock and Class A Stock. The dividend will be payable to the Company's shareholders in December 2025.
10. Statement of Cash Flows
The following provides a reconciliation of cash, cash equivalents, and restricted cash reported within the Condensed Consolidated Balance Sheets to the total of the same such amounts shown in the Condensed Consolidated Statements of Cash Flows:
September 30,
(In millions) 2025
2024
Cash and cash equivalents $ 2,506.4 $ 2,011.8
Restricted cash included in Other current assets
6.7 —
Total cash, cash equivalents, and restricted cash shown in the Condensed Consolidated Statements of Cash Flows
$ 2,513.1 $ 2,011.8
Restricted cash consists of amounts held pursuant to contractual arrangements and for dividends payable on certain equity awards.
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Supplemental disclosure of non-cash investing and financing activities
September 30, December 31, September 30, December 31,
(In millions) 2025
2024
2024
2023
Accrued capital expenditures $ 176.9 $ 151.6 $ 94.0 $ 75.4
Accrued contingent consideration in connection with acquisitions
$ 52.5 $ 62.7 $ 88.0 $ 71.6
11. Segment Information
The Company operates in one business segment, which includes all activities related to the discovery, development, and commercialization of medicines for serious diseases. The determination of a single business segment is consistent with the consolidated financial information regularly provided to the Company's chief operating decision maker ("CODM"). The Company's CODM is its Chief Executive Officer, who reviews and evaluates consolidated net income for purposes of assessing performance, making operating decisions, allocating resources, and planning and forecasting for future periods.
In addition to the significant expense categories included within consolidated net income presented on the Company's Condensed Consolidated Statements of Operations, see below for disaggregated amounts that comprise research and development expenses:
Three Months Ended
September 30,
Nine Months Ended
September 30,
(In millions) 2025 2024 2025 2024
Direct research and development expenses (a)
$ 454.3 $ 386.4 $ 1,296.7 $ 1,158.5
Indirect research and development expenses:
Payroll and benefits 438.3 407.8 1,339.5 1,249.2
Lab supplies and other research and development costs
67.5 63.0 192.4 175.4
Occupancy and other operating costs 166.3 158.7 479.2 434.9
Total indirect research and development expenses
672.1 629.5 2,011.1 1,859.5
Clinical manufacturing costs
381.4 306.6 1,028.8 841.3
Reimbursement of research and development expenses by collaborators ( 32.8 ) ( 51.0 ) ( 112.5 ) ( 139.4 )
Total research and development expenses
$ 1,475.0 $ 1,271.5 $ 4,224.1 $ 3,719.9
(a) Direct research and development expenses are comprised primarily of costs paid to third parties for clinical and product development activities, and the portion of research and development expenses incurred by our collaborators that we are obligated to reimburse
12. Legal Matters
From time to time, the Company is a party to legal proceedings in the course of the Company's business. The outcome of any such proceedings, regardless of the merits, is inherently uncertain. If the Company is unable to prevail in one or more of such proceedings, its consolidated financial position, results of operations, and future cash flows may be materially adversely impacted. Costs associated with the Company's involvement in legal proceedings are expensed as incurred. The Company recognizes gain contingencies associated with such proceedings when the award or recovery is realized or realizable and loss contingencies when it is probable that a liability will be incurred and the amount of loss can be reasonably estimated. As of September 30, 2025 and December 31, 2024, the Company's accruals for loss contingencies were not material. There are certain loss contingencies that the Company deems reasonably possible for which the possible loss or range of possible loss is not estimable at this time.
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Proceedings Relating to EYLEA (aflibercept) Injection
Certain of the Company's patents pertaining to EYLEA are subject to post-grant proceedings before the United States Patent and Trademark Office ("USPTO"), the European Patent Office (the "EPO"), or other comparable foreign authorities, including those described in greater detail below. In addition, the Company has filed patent infringement lawsuits in several jurisdictions alleging infringement of certain Company patents pertaining to EYLEA, including those described in greater detail below.
United States
U.S. Patent Litigation
On August 2, 2022, the Company filed a patent infringement lawsuit against Mylan Pharmaceuticals Inc. ("Mylan"), a wholly-owned subsidiary of Viatris Inc., in the United States District Court for the Northern District of West Virginia alleging that Mylan's filing for U.S. Food and Drug Administration ("FDA") approval of an aflibercept 2 mg biosimilar infringes certain Company patents. On June 5, 2023, Biocon Biologics Inc. ("Biocon"), as successor-in-interest to the aflibercept 2 mg biosimilar, was joined as a defendant to the lawsuit. On December 27, 2023, following a trial, the court issued a decision finding that (i) the asserted claims of the Company's U.S. Patent No. 11,084,865 (the "'865 Patent") were valid and infringed by Mylan and Biocon and (ii) the asserted claims of two other Company patents were infringed by Mylan and Biocon but were invalid as obvious. On June 11, 2024, the court granted the Company's motion for a permanent injunction, enjoining Mylan and Biocon from selling in the United States their aflibercept 2 mg biosimilar until the expiration of the '865 Patent. On April 14, 2025, the parties entered into a settlement agreement, pursuant to which Mylan and Biocon's appeal to the Federal Circuit and all related litigation have been dismissed and Biocon is precluded from launching its aflibercept 2 mg biosimilar until the second half of 2026.
On November 8, November 22, and November 29, 2023, respectively, the Company filed patent infringement lawsuits against Celltrion, Inc. ("Celltrion"), Samsung Bioepis Co., Ltd. ("Samsung Bioepis"), and Formycon AG ("Formycon") in the United States District Court for the Northern District of West Virginia following service on Regeneron of each company's notice of commercial marketing. The lawsuits alleged that each company had infringed certain Company patents, including based on each company's filing for FDA approval of an aflibercept 2 mg biosimilar. On December 27, 2023, the Company filed a second patent infringement lawsuit against Samsung Bioepis. On June 14, June 21, and June 28, 2024, respectively, the court granted the Company's motions for preliminary injunctions against Samsung Bioepis, Formycon, and Celltrion; each of these decisions was affirmed by the Federal Circuit on appeal. On May 23, 2025, Formycon petitioned the district court to revoke the preliminary injunction. On September 28, 2025, the Company and Formycon entered into a settlement agreement, pursuant to which Formycon's motion to revoke the preliminary injunction and all related litigation have been dismissed and Formycon is precluded from launching its aflibercept 2 mg biosimilar until the fourth quarter of 2026. On October 20, 2025, the Company and Celltrion entered into a settlement agreement, pursuant to which all litigation in the United States related to Celltrion's aflibercept 2 mg biosimilar has been dismissed and Celltrion is precluded from launching such biosimilar until December 31, 2026.
On January 10, 2024, the Company filed a patent infringement lawsuit against Amgen Inc. ("Amgen") in the United States District Court for the Central District of California alleging that Amgen's filing for FDA approval of an aflibercept 2 mg biosimilar infringed certain Company patents. On April 11, 2024, the United States Judicial Panel on Multidistrict Litigation granted the Company's motion to transfer this lawsuit to the United States District Court for the Northern District of West Virginia for coordinated and consolidated pretrial proceedings with the lawsuits described in the preceding paragraph. On September 23, 2024, the court denied the Company's motion for a preliminary injunction; and on September 25, 2024, the Federal Circuit issued an administrative stay pending its review of the Company's temporary injunction motion. On October 22, 2024, the Federal Circuit denied the Company's temporary injunction motion and lifted the administrative stay. On March 14, 2025, the Federal Circuit affirmed the district court's preliminary injunction decision. On June 17, 2025, the Company filed an additional patent infringement lawsuit against Amgen in the United States District Court for the Central District of California alleging that Amgen's continued commercialization of its aflibercept 2 mg biosimilar infringes the Company's U.S. Patent No. 12,331,099.
On August 26, 2024, the Company filed a patent infringement lawsuit against Sandoz Inc. ("Sandoz") in the United States District Court for the District of New Jersey alleging that Sandoz's filing for FDA approval of an aflibercept 2 mg biosimilar infringed certain Company patents. On September 12, 2024, the United States Judicial Panel on Multidistrict Litigation granted the Company's motion to transfer this lawsuit to the United States District Court for the Northern District of West Virginia for coordinated and consolidated pretrial proceedings with the lawsuits described in the preceding two paragraphs. On July 11, 2025, the Company filed a motion for a preliminary injunction against Sandoz based on the '865 Patent. On September 8, 2025, the Company and Sandoz entered into a settlement agreement, pursuant to which the Company's preliminary injunction motion and all related litigation have been dismissed and Sandoz is precluded from launching its aflibercept 2 mg biosimilar until the fourth quarter of 2026.
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Post-Grant Proceedings Before the USPTO
On November 20, 2024, November 29, 2024, and January 15, 2025, Samsung Bioepis, Formycon, and Celltrion, respectively, filed inter partes review ("IPR") petitions in the USPTO against the '865 Patent, each seeking a declaration that the '865 Patent is invalid. On June 6, 2025, the USPTO denied institution of Samsung and Formycon's respective IPR petitions, and on June 25, 2025, the USPTO denied institution of Celltrion's IPR petition.
On July 14, 2025, Fresenius Kabi SwissBioSim GmbH filed IPR petitions in the USPTO against the '865 Patent and U.S. Patent No. 10,828,345 (the "'345 Patent"), seeking a declaration that the '865 Patent and '345 Patent are invalid.
Europe
EPO Post-Grant Proceedings
Various parties, including Amgen and other, anonymous parties, are seeking revocation of the Company's European Patent Nos. 2,944,306 (the "'306 Patent"), 3,716,992 (the "'992 Patent"), and 3,384,049 (the "'049 Patent") before the Opposition Division ("OD") of the EPO. On November 26, 2024, following an oral hearing, the OD announced its decision to revoke the '306 Patent. On March 11, 2025, the Company appealed the OD's decision. On October 22, 2025, following an oral hearing, the OD upheld the validity of the '992 Patent's claims in amended form. An oral hearing concerning the '049 Patent has been scheduled for December 2025.
Country-Specific Proceedings
Various parties, including Samsung Bioepis and Formycon and/or their affiliated entities, are seeking revocation of the '306 Patent, the '992 Patent, and the Company's European Patent No. 2,364,691 (the "'691 Patent") and/or a declaration that its aflibercept 2 mg biosimilar would not infringe these patents in several European national courts (including those in Belgium, France, Germany, Italy, the Netherlands, and the United Kingdom). In certain of these proceedings, the Company has filed a preemptive counterclaim for infringement of one or more of such patents. In the United Kingdom, following trials held in June 2025, the High Court of England and Wales issued a decision in October 2025 that found that Formycon and Samsung Bioepis's aflibercept 2 mg biosimilar products do not infringe the '691 and '306 Patents; upheld the '691 Patent as valid; and invalidated the '306 Patent. Proceedings in the United Kingdom concerning the '992 Patent are stayed pending resolution of the EPO proceedings concerning this patent. In Germany, following a June 2025 trial concerning the revocation proceeding brought by Samsung Bioepis, the German Federal Patent Court upheld the '691 Patent as valid. In addition, in October 2025, the Munich Regional Court issued a decision that found that Formycon's aflibercept biosimilar product infringes the '691 Patent and granted the Company's motion for a permanent injunction, enjoining Formycon from selling its aflibercept 2 mg biosimilar in Germany and several other EU countries (including Spain and the Netherlands) until the expiration of the '691 Patent. In the Netherlands, following a trial held in July 2025, the District Court of the Hague issued a decision in October 2025 that upheld the '691 and '306 Patents as valid; found that Samsung Bioepis's aflibercept 2 mg biosimilar product infringes the '691 and '306 Patents; and granted the Company's request for a permanent injunction, enjoining Samsung Bioepis from selling its aflibercept 2 mg biosimilar in the Netherlands until the expiration of the '691 and '306 Patents.
The Company has commenced proceedings in Belgium against various parties, including Amgen, Celltrion, Sterigenics (Petit-Rechain) NV, and Sandoz GmbH, for infringement of the Company's European Patent No. 1,183,353 (as extended by Supplementary Protection Certificate 2013C/029).
Canada
Proceedings against Amgen Canada
On May 9, 2023, Amgen Canada Inc. ("Amgen Canada") filed invalidation proceedings against the Company in the Federal Court of Canada seeking revocation of the Company's Canadian Patent Nos. 2,654,510 (the "'510 Patent") and 3,007,276 (the "'276 Patent"). On September 14, 2023, the Company, Bayer Inc., and Bayer Healthcare LLC filed patent infringement lawsuits against Amgen Canada in the Federal Court of Canada seeking a declaration that the making, constructing, using, or selling of an aflibercept 2 mg biosimilar would directly or indirectly infringe one or more claims of Bayer Healthcare LLC's Canadian Patent No. 2,970,315 (the "'315 Patent"). On September 14, 2023, the Company and Bayer Inc. filed three separate patent infringement lawsuits against Amgen Canada in the Federal Court of Canada seeking a declaration that the making, constructing, using, or selling of an aflibercept 2 mg biosimilar would directly or indirectly infringe one or more claims of the Company's Canadian Patent Nos. 3,129,193 (the "'193 Patent"), 2,965,495 (the "'495 Patent"), and 2,906,768 (the "'768 Patent"), respectively. On October 11, 2023, the Company, Bayer Inc., and Bayer Healthcare LLC filed two separate patent infringement lawsuits against Amgen Canada in the Federal Court of Canada seeking a declaration that the making, constructing, using, or selling of an aflibercept 2 mg biosimilar would directly or indirectly infringe one or more claims of the Company's '510 Patent and '276 Patent, respectively. A trial concerning the '510 Patent and the '276 Patent was held in May–
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June 2025. On August 15, 2025, the Company, Bayer Inc., Bayer Healthcare LLC, and Amgen Canada entered into a settlement agreement concerning these patent infringement lawsuits, pursuant to which each such lawsuit has been dismissed. As a result of the settlement agreement, the Company, Bayer Inc., and Bayer Healthcare LLC are no longer seeking a declaration that Amgen Canada's aflibercept 2 mg biosimilar infringes the patents referenced in this paragraph.
Proceedings against Sandoz
On January 24, 2025, the Company, Bayer Inc., and Bayer Healthcare LLC filed patent infringement lawsuits against Sandoz Canada Inc. in the Federal Court of Canada seeking a declaration that the making, constructing, using, or selling of an aflibercept 2 mg biosimilar would directly or indirectly infringe one or more claims of the '510 Patent, the '276 Patent, the '495 Patent, the '768 Patent, the '193 Patent, the '315 Patent, and Canadian Patent No. 3,137,326 (the "'326 Patent"). On August 15, 2025, the Company, Bayer Inc., Bayer Healthcare LLC, and Sandoz Canada Inc. entered into a settlement agreement concerning these patent infringement lawsuits, pursuant to which each such lawsuit has been dismissed. As a result of the settlement agreement, the Company, Bayer Inc., and Bayer Healthcare LLC are no longer seeking a declaration that Sandoz Canada Inc.'s aflibercept 2 mg biosimilar infringes the patents referenced in this paragraph.
South Korea
On December 13, 2022, Samsung Bioepis initiated invalidation proceedings before the Intellectual Property Trial and Appeal Board of the Korean Intellectual Property Office ("KIPO") against the Company's Korean Patent No. 1406811 (the "'811 Patent"), seeking revocation of the '811 Patent in its entirety. On October 23, 2024, the KIPO maintained the '811 Patent as valid; Samsung Bioepis has appealed that decision.
The Company and, as applicable, Bayer Consumer Care AG, have also filed patent infringement lawsuits in the Seoul Central District Court against various parties including Samsung Bioepis and its parent company Samsung Biologics Co., Ltd. (collectively, "Samsung"), Sam Chun Dang Pharm. Co., Ltd. and OPTUS Pharmaceutical Co., Ltd., and Celltrion. These lawsuits seek damages and/or injunctive relief and allege that the making, constructing, using, or selling of an aflibercept 2 mg biosimilar by the relevant defendant(s) would infringe one or more claims of the '811 Patent and/or the Company's Korean Patent Nos. 659477 (the "'477 Patent") and 2519234 (the "'234 Patent"). On February 7, 2025, the Seoul Central District Court granted the Company's preliminary injunction request against Samsung on the basis of the '811 Patent; Samsung has appealed that decision. The preliminary injunction against Samsung prohibits Samsung from manufacturing and selling its aflibercept 2 mg biosimilar in South Korea. Also on February 7, 2025, the Seoul Central District Court denied Regeneron's preliminary injunction request against Celltrion; Regeneron has appealed that decision.
Australia
On June 4, 2025, the Company, Bayer Consumer Care AG, and Bayer Australia filed a patent infringement lawsuit against Sandoz Pty Ltd. and a request for a preliminary injunction in the Federal Court of Australia alleging that the importing, selling, supplying, or otherwise disposing of an aflibercept 2 mg biosimilar would infringe one or more claims of the Company's Australian Patent No. 2012205599. On September 3, 2025, the court denied the Company's request for a preliminary injunction, and this ruling has been appealed.
Proceedings Relating to EYLEA (aflibercept) Injection Pre-filled Syringe
On July 17, 2020, the Company filed an antitrust lawsuit (as amended on January 25, 2021) against Novartis Pharma AG, Novartis Pharmaceuticals Corporation, and Novartis Technology LLC (collectively, "Novartis") and Vetter Pharma International GmbH in the United States District Court for the Southern District of New York seeking a judgment that the defendants' conduct relating to Novartis's attempt to assert its U.S. Patent No. 9,220,631 against Regeneron in 2020 violated Sections 1 and 2 of the Sherman Antitrust Act of 1890, as amended, and constituted tortious interference with contract. The Company is also seeking injunctive relief and treble damages. On September 21, 2021, this lawsuit was transferred to the Northern District of New York. On June 10, 2022, the Company filed an appeal of the District Court's decision to dismiss the amended complaint with the U.S. Court of Appeals for the Second Circuit (the "Second Circuit"). On March 18, 2024, the Second Circuit reversed the District Court's decision to dismiss the amended complaint and remanded the lawsuit to the District Court for further proceedings consistent with the Second Circuit's opinion. On November 19, 2024, the Company moved to transfer the lawsuit back to the Southern District of New York, which motion was granted on December 5, 2024.
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Proceedings Relating to Praluent (alirocumab) Injection
United States
On May 27, 2022, the Company filed a lawsuit against Amgen in the United States District Court for the District of Delaware, alleging that, beginning in 2020, Amgen engaged in an anticompetitive bundling scheme which was designed to exclude Praluent from the market in violation of federal and state laws. The lawsuit seeks damages for harm caused by the alleged scheme, as well as injunctive relief restraining Amgen from continuing its alleged anticompetitive conduct. On February 10, 2023, the court denied Amgen's motion to stay these proceedings; and on March 21, 2023, the court denied Amgen's motion to dismiss the complaint. On August 28, 2023, the Company filed an amended complaint in this matter; and, as part of its response, on September 20, 2023, Amgen filed a counterclaim alleging that the Company engaged in unfair business practices in violation of state law. On April 10, 2025, the court denied Amgen's motion for summary judgment. A trial was held in May 2025. On May 15, 2025, the jury reached a verdict in Regeneron's favor on nine of the ten counts submitted to it and awarded Regeneron $ 135.6 million in compensatory damages and $ 271.2 million in punitive damages. On June 20, 2025, Amgen filed a post-trial motion for judgment as a matter of law or, in the alternative, for a new trial. Also on June 20, 2025, the Company filed a post-trial motion for (i) permanent injunctive relief, (ii) a constructive trust, and (iii) prejudgment interest. An oral hearing on Amgen's and Regeneron's respective post-trial motions was held on August 27, 2025.
Europe
On June 1, 2023, Sanofi filed an action in the Munich Central Division of the Unified Patent Court (the "UPC") seeking revocation of Amgen's European Patent No. 3,666,797 (the "'797 Patent"). The '797 Patent is a divisional patent of European Patent No. 2,215,124 (the "'124 Patent") (i.e., a patent that shares the same priority date, disclosure, and patent term of the parent '124 Patent), which was previously invalidated by the Technical Board of Appeal of the EPO. On July 16, 2024, following a trial, the Munich Central Division of the UPC issued a decision revoking the '797 Patent in its entirety. On September 16, 2024, Amgen appealed the decision of the Munich Central Division of the UPC to the Court of Appeal of the UPC. An oral hearing before the Court of Appeal of the UPC was held in August 2025.
Also on June 1, 2023, Amgen filed a lawsuit against the Company and certain of Sanofi's affiliated entities in the Munich Local Division of the UPC alleging infringement of the '797 Patent. The lawsuit seeks, among other things, a permanent injunction in several countries in Europe and monetary damages. On July 29, 2024, the Munich Local Division of the UPC ordered a stay of the infringement lawsuit in light of the decision of the Munich Central Division of the UPC to revoke the '797 Patent in its entirety (discussed above).
The Company and Sanofi are also seeking revocation of the '797 Patent at the EPO. On April 3, 2025, the OD upheld the '797 Patent as valid. The Company and Sanofi have appealed this decision to the Technical Board of Appeal of the EPO. An oral hearing before the Technical Board of Appeal of the EPO has been scheduled for April 2026.
Department of Justice Matters
On June 24, 2020, the U.S. Attorney's Office for the District of Massachusetts filed a civil complaint in the U.S. District Court for the District of Massachusetts alleging violations of the federal Anti-Kickback Statute and asserting causes of action under the federal False Claims Act and state law (the "June 2020 Civil Complaint") relating to the Company's support of 501(c)(3) organizations that provide financial assistance to patients. On September 27, 2023, the court (i) denied in part and granted in part the Company's motion for summary judgment and (ii) denied in its entirety the motion for partial summary judgment filed by the U.S. Attorney's Office for the District of Massachusetts. On October 25, 2023, the court certified for interlocutory appeal a portion of the court's September 27, 2023 order that addressed the causation standard applicable to the alleged violations of the federal Anti-Kickback Statute and federal False Claims Act. On February 18, 2025, the U.S. Court of Appeals for the First Circuit affirmed the portion of the court's September 27, 2023 order that had been certified for interlocutory appeal. On October 1, 2025, the U.S. Attorney's Office for the District of Massachusetts filed a second motion for partial summary judgment.
In September 2019, the Company and Regeneron Healthcare Solutions, Inc., a wholly-owned subsidiary of the Company, each received a civil investigative demand ("CID") from the U.S. Department of Justice pursuant to the federal False Claims Act relating to remuneration paid to physicians in the form of consulting fees, advisory boards, speaker fees, and payment or reimbursement for travel and entertainment allegedly in violation of the federal Anti-Kickback Statute. The CIDs relate to EYLEA, Praluent, Dupixent, ZALTRAP, ARCALYST, and Kevzara and cover the period from January 2015 to the present. On June 3, 2021, the United States District Court for the Central District of California unsealed a qui tam complaint filed against the Company, Regeneron Healthcare Solutions, Inc., and Sanofi-Aventis U.S. LLC by two qui tam plaintiffs (known as relators) purportedly on behalf of the United States and various states (the "State Plaintiffs"), asserting causes of action under the federal False Claims Act and state law. Also on June 3, 2021, the United States and the State Plaintiffs notified the court of their decision to decline to intervene in the case. On October 29, 2021, the qui tam plaintiffs filed an amended complaint in this
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matter. On January 14, 2022, the Company filed a motion to dismiss the amended complaint in its entirety. On July 25, 2023, the court granted in part and denied in part the Company's motion to dismiss. On September 1, 2023, the Company filed a second motion to dismiss the amended complaint or, in the alternative, a motion for judgment on the pleadings. On July 31, 2024 and August 15, 2024, respectively, the District Court granted the Company's second motion to dismiss the amended complaint with respect to the remaining causes of action under federal law and declined to exercise supplemental jurisdiction over the remaining causes of action under state law. On August 26, 2024, the qui tam plaintiffs filed a notice of appeal. Oral argument on the appeal has been scheduled for November 18, 2025.
In June 2021, the Company received a CID from the U.S. Department of Justice pursuant to the federal False Claims Act. The CID states that the investigation concerns allegations that the Company (i) violated the False Claims Act by paying kickbacks to distributors and ophthalmology practices to induce purchase of EYLEA, including through discounts, rebates, credit card fees, free units of EYLEA, and inventory management systems; and (ii) inflated reimbursement rates for EYLEA by excluding applicable discounts, rebates, and benefits from the average sales price reported to the Centers for Medicare & Medicaid Services. The CID covers the period from January 2011 through June 2021. On November 29, 2023, the U.S. Department of Justice informed the Company that it had filed a notice of partial intervention in this matter. On March 28, 2024, the Department of Justice and the U.S. Attorney's Office for the District of Massachusetts filed a civil complaint intervention (the "March 2024 Civil Complaint") in the U.S. District Court for the District of Massachusetts asserting causes of action under the federal False Claims Act and a claim for unjust enrichment. Also on March 28, 2024, the U.S. District Court for the District of Massachusetts unsealed a qui tam complaint against the Company, AmerisourceBergen, and Besse Medical by two qui tam plaintiffs (known as relators) purportedly on behalf of the United States and various states and municipalities, asserting causes of action under the federal False Claims Act and state and local laws, and alleging violations of the federal Anti-Kickback statute. On June 25, 2024, the States of Colorado, Georgia, Michigan, North Carolina, Texas, and Washington filed a civil complaint in partial intervention (the "June 2024 Civil Complaint") in the U.S. District Court for the District of Massachusetts asserting causes of action under various state laws. On July 18, 2024, the Company filed a motion to dismiss the March 2024 Civil Complaint and the June 2024 Civil Complaint. An oral hearing on the Company's motion to dismiss was held on December 16, 2024. On April 29, 2025, the court denied the Company's motion to dismiss. On May 27, 2025, the Company filed its answers to the March 2024 Civil Complaint and the June 2024 Civil Complaint. On June 17, 2025, the court granted a motion by the States of Maine, Nebraska, Ohio, Oregon, and Wyoming to intervene in the action. On June 18, 2025, those states filed a consolidated complaint asserting causes of action under their respective state laws (the "June 2025 Civil Complaint"). On July 23, 2025, the Company filed its answer and counterclaims to the June 2025 Civil Complaint. On August 14, 2025, the Company moved to amend its answer and assert counterclaims to the March 2024 Civil Complaint and June 2024 Civil Complaint.
Proceedings Initiated by Other Payors
The Company is party to several lawsuits relating to the conduct alleged in the June 2020 Civil Complaint discussed under "Department of Justice Matters" above. These lawsuits were filed by UnitedHealthcare Insurance Company and United Healthcare Services, Inc. (collectively, "UHC") and Humana Inc. ("Humana") in the United States District Court for the Southern District of New York on December 17, 2020 and July 22, 2021, respectively; and by Blue Cross and Blue Shield of Massachusetts, Inc. and Blue Cross and Blue Shield of Massachusetts HMO Blue, Inc. (collectively, "BCBS"), Medical Mutual of Ohio ("MMO"), Horizon Healthcare Services, Inc. d/b/a Horizon Blue Cross Blue Shield of New Jersey ("Horizon"), and Local 464A United Food and Commercial Workers Union Welfare Service Benefit Fund ("Local 464A") in the U.S. District Court for the District of Massachusetts on December 20, 2021, February 23, 2022, April 4, 2022, and June 17, 2022, respectively. These lawsuits allege causes of action under state law and the federal Racketeer Influenced and Corrupt Organizations Act ("RICO") and seek monetary damages and equitable relief. The MMO and Local 464A lawsuits are putative class action lawsuits. On December 29, 2021, the lawsuits filed by UHC and Humana were stayed by the United States District Court for the Southern District of New York pending resolution of the proceedings before the U.S. District Court for the District of Massachusetts concerning the allegations in the June 2020 Civil Complaint. On September 27, 2022, the lawsuits filed by BCBS, MMO, and Horizon were stayed by the U.S. District Court for the District of Massachusetts pending resolution of the proceedings before the same court concerning the allegations in the June 2020 Civil Complaint; and, in light of these stays, the parties to the Local 464A action have also agreed to stay that matter.
On June 24, 2024, a group of plaintiffs purporting to be assignees of claims by various Medicare Advantage plans and related entities filed a putative class action complaint in the U.S. District Court for the District of Columbia on behalf of Medicare Advantage plans and other payors. The lawsuit relates to the conduct alleged in the June 2020 Civil Complaint, March 2024 Civil Complaint, and June 2024 Civil Complaint discussed under "Department of Justice Matters" above. The lawsuit alleges causes of action under state law and RICO and seeks monetary damages and equitable relief. On October 22, 2024, the Company filed a motion to transfer the proceedings to the U.S. District Court for the District of Massachusetts or, in the alternative, to stay the proceedings or dismiss the proceedings. On January 28, 2025, pursuant to a stipulation among the parties, the proceedings were transferred to the U.S. District Court for the District of Massachusetts. On February 1, 2025, the
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parties jointly filed a stipulation to stay the action pending resolution of the proceedings before the same court concerning the allegations in the June 2020 Civil Complaint.
Shareholder Derivative Complaint – Department of Justice June 2020 Civil Complaint Matters
On June 29, 2021, an alleged shareholder filed a shareholder derivative complaint in the New York Supreme Court, naming the then-current and certain former members of the Company's board of directors and certain then-current and former executive officers of the Company as defendants and Regeneron as a nominal defendant. The complaint asserts that the individual defendants breached their fiduciary duties in relation to the allegations in the June 2020 Civil Complaint discussed under "Department of Justice Matters" above. The complaint seeks an award of damages allegedly sustained by the Company; an order requiring Regeneron to take all necessary actions to reform and improve its corporate governance and internal procedures; disgorgement from the individual defendants of all profits and benefits obtained by them resulting from their sales of Regeneron stock; and costs and disbursements of the action, including attorneys' fees. On July 28, 2021, the defendants filed a notice of removal, removing the case from the New York Supreme Court to the U.S. District Court for the Southern District of New York. On September 23, 2021, the plaintiff moved to remand the case to the New York Supreme Court. Also on September 23, 2021, the individual defendants moved to dismiss the complaint in its entirety. On December 19, 2022, the U.S. District Court for the Southern District of New York denied the plaintiff's motion to remand the case and granted a motion to stay the case pending resolution of the proceedings before the U.S. District Court for the District of Massachusetts concerning the allegations in the June 2020 Civil Complaint. As a result of the stay, the court also terminated the Company's motion to dismiss the complaint without prejudice. The Company can therefore renew the motion to dismiss upon conclusion of the stay.
Shareholder Derivative Complaints – Department of Justice March 2024 Civil Complaint Matters
On January 16 and January 22, 2025, purported shareholders filed two separate shareholder derivative complaints in the U.S. District Court for the Southern District of New York against members of the Company's board of directors and certain current and former executive officers of the Company as defendants and Regeneron as a nominal defendant. The complaints each allege that the individual defendants, among other things, breached their fiduciary duties to the Company by failing to properly manage and oversee the Company in connection with the conduct alleged in the March 2024 Civil Complaint discussed under "Department of Justice Matters" above. The complaints also each allege that the individual defendants breached the federal securities laws, wasted corporate assets, and unjustly enriched themselves at the expense of the Company. The complaints each seek, among other things, an award of damages allegedly sustained by the Company as a result of the alleged misconduct of the individual defendants; an order requiring the individual defendants to take all necessary actions to reform and improve the Company's corporate governance and internal procedures; and costs and disbursements of the applicable action, including attorneys' fees. On June 3, 2025, the court consolidated the two separate shareholder derivative complaints pursuant to a joint stipulation by the parties.
On June 6, 2025, two purported shareholders filed separate shareholder derivative complaints in the New York Supreme Court against members of the Company's board of directors and certain current and former executive officers of the Company as defendants and Regeneron as a nominal defendant. These complaints make similar allegations to the 2025 derivative complaints referenced above. On June 16, 2025, the Company filed notices of removal, removing both of the newly filed actions from the New York Supreme Court to the U.S. District Court for the Southern District of New York. On July 16, 2025, the purported shareholders each filed a motion to remand their respective actions back to the New York Supreme Court.
On July 30, 2025, a purported shareholder filed another shareholder derivative complaint in the U.S. District Court for the Southern District of New York against members of the Company's board of directors and certain current and former executive officers of the Company as defendants and Regeneron as a nominal defendant. This complaint makes similar allegations to the 2025 derivative complaints referenced above.
On September 2, 2025, a purported shareholder filed another shareholder derivative complaint in the New York Supreme Court against members of the Company's board of directors and certain current and former executive officers of the Company as defendants and Regeneron as a nominal defendant. This complaint makes similar allegations to the 2025 derivative complaints referenced above. On September 11, 2025, the Company filed a notice of removal, removing this action from the New York Supreme Court to the U.S. District Court for the Southern District of New York. On October 14, 2025, the purported shareholder filed a motion to remand the action back to the New York Supreme Court.
Shareholder Derivative Complaint – Director Compensation
On July 22, 2025, an alleged shareholder filed a shareholder derivative complaint in the New York Supreme Court, naming the current non-employee members of our board of directors, and the co-Chairs of our board of directors (who also serve as our President and Chief Executive Officer and our President and Chief Scientific Officer, respectively) as defendants and Regeneron as a nominal defendant. The complaint asserts that the individual defendants breached their fiduciary duties and/or
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were unjustly enriched when they approved and/or received allegedly excessive non-employee director compensation in 2024 and 2025, and that this allegedly excessive compensation was a waste of corporate assets. The complaint seeks damages in favor of Regeneron for the alleged breaches of fiduciary duties, unjust enrichment, and waste of corporate assets; improvements to Regeneron's corporate governance and internal procedures; equitable relief, including restitution from the individual defendants; and award of the costs of the action, including attorneys' fees. On September 25, 2025, the Company filed a motion to dismiss the complaint.
Class Action Civil Complaint
On January 7, 2025 (as amended on September 8, 2025), a purported shareholder filed a putative class action civil complaint, on behalf of himself and all others similarly situated, in the U.S. District Court for the Southern District of New York against the Company and certain current and former executive officers of the Company. The complaint asserts violations of federal securities laws in connection with statements or disclosures purportedly related to the conduct alleged in the March 2024 Civil Complaint discussed under "Department of Justice Matters" above. On July 10, 2025, the court appointed a lead plaintiff and lead counsel for the action.
Sanofi Litigation
On November 18, 2024, the Company filed a lawsuit (as amended on December 20, 2024) in the United States District Court for the Southern District of New York against Sanofi and certain of its affiliated entities. The lawsuit alleges that the defendants breached certain provisions of the parties' Amended and Restated License and Collaboration Agreement, dated as of November 10, 2009 (as amended, the "Collaboration Agreement"), concerning Sanofi's obligation to provide Regeneron with full access to material information relating to the commercialization of Dupixent or other products commercialized pursuant to the Collaboration Agreement and Regeneron's audit rights under the Collaboration Agreement. The lawsuit seeks a declaratory judgment, injunctive relief, damages, and other relief. On July 3, 2025, Sanofi filed a motion to dismiss the complaint.
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Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations
This Quarterly Report on Form 10-Q contains forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. (where applicable, together with its subsidiaries, "Regeneron," "Company," "we," "us," and "our"), and actual events or results may differ materially from these forward-looking statements. Words such as "anticipate," "expect," "intend," "plan," "believe," "seek," "estimate," variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others:
• competing drugs and product candidates that may be superior to, or more cost effective than, products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, "Regeneron's Products") and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, "Regeneron's Product Candidates") (including biosimilar versions of Regeneron's Products);
• uncertainty of the utilization, market acceptance, and commercial success of Regeneron's Products and Regeneron's Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary) or recommendations and guidelines from governmental authorities and other third parties or other factors beyond Regeneron's control on the commercial success of Regeneron's Products and Regeneron's Product Candidates;
• the nature, timing, and possible success and therapeutic applications of Regeneron's Products and Regeneron's Product Candidates and research and clinical programs now underway or planned, including without limitation those discussed or referenced in this report, Regeneron's and its collaborators' earlier-stage programs, and the use of human genetics in Regeneron's research programs;
• the likelihood and timing of achieving any of our anticipated development milestones referenced in this report;
• safety issues resulting from the administration of Regeneron's Products and Regeneron's Product Candidates in patients, including serious complications or side effects in connection with the use of Regeneron's Products and Regeneron's Product Candidates in clinical trials;
• the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron's Product Candidates and new indications for Regeneron's Products, including without limitation those discussed or referenced in this report;
• the extent to which the results from the research and development programs conducted by us and/or our collaborators may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval;
• ongoing regulatory obligations and oversight impacting Regeneron's Products, research and clinical programs, and business, including those relating to patient privacy;
• determinations by regulatory and administrative governmental authorities which may delay or restrict our ability to continue to develop or commercialize Regeneron's Products and Regeneron's Product Candidates;
• our ability to manufacture and manage supply chains for multiple products and product candidates and risks associated with tariffs and other trade restrictions;
• the ability of our collaborators, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regeneron's Products and Regeneron's Product Candidates;
• the availability and extent of reimbursement or copay assistance for Regeneron's Products from third-party payors and other third parties, including private payor healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid;
• coverage and reimbursement determinations by such payors and other third parties and new policies and procedures adopted by such payors and other third parties;
• changes to drug pricing regulations and requirements and our drug pricing strategy;
• other changes in laws, regulations, and policies affecting the healthcare industry;
• the costs of developing, producing, and selling products or unanticipated expenses;
• our ability to meet any of our financial projections or guidance, including without limitation capital expenditures, and changes to the assumptions underlying those projections or guidance;
• the potential for any license or collaboration agreement, including our agreements with Sanofi and Bayer (or their respective affiliated companies, as applicable), to be cancelled or terminated;
• the impact of public health outbreaks, epidemics, or pandemics on our business; and
• risks associated with litigation and other proceedings and government investigations relating to the Company and/or its operations (including without limitation those described in Note 12 to our Condensed Consolidated Financial Statements included in this report), risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings described further in Note 12 to our Condensed Consolidated Financial Statements included in this report), the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on our business, prospects, operating results, and financial condition.
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These statements are made based on management's current beliefs and judgment, and the reader is cautioned not to rely on any such statements. In evaluating such statements, shareholders and potential investors should specifically consider the various factors identified under Part II, Item 1A. "Risk Factors," which could cause actual events and results to differ materially from those indicated by such forward-looking statements. We do not undertake any obligation to update (publicly or otherwise) any forward-looking statement, whether as a result of new information, future events, or otherwise.
Overview
Regeneron Pharmaceuticals, Inc. is a fully integrated biotechnology company that invents, develops, manufactures, and commercializes medicines for people with serious diseases. Our products and product candidates in development are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases, and rare diseases.
Our core business strategy is to maintain a strong foundation in scientific research and drug development using our proprietary technologies, and to build on that foundation with our clinical development, manufacturing, and commercial capabilities. Our objective is to continue to advance as an integrated, multi-product biotechnology company that provides patients and medical professionals with important medicines for preventing and treating human diseases.
Selected financial information is summarized as follows:
Three Months Ended
September 30,
Nine Months Ended
September 30,
(In millions, except per share data) 2025 2024 2025 2024
Revenues $ 3,754.3 $ 3,720.7 $ 10,458.6 $ 10,412.8
Net income $ 1,460.0 $ 1,340.6 $ 3,660.3 $ 3,494.9
Net income per share - diluted $ 13.62 $ 11.54 $ 33.61 $ 30.23
For purposes of this report, references to our products encompass products commercialized by us and/or our collaborators or licensees and references to our product candidates encompass product candidates in development by us and/or our collaborators or licensees (in the case of collaborated or licensed products or product candidates under the terms of the applicable collaboration or license agreements), unless otherwise stated or required by the context.
Products
Products that have received marketing approval are summarized in the table below. Certain products have also received marketing approval in countries outside the United States, European Union ("EU"), or Japan.
Product Disease Territory
U.S. EU Japan
EYLEA HD ® (aflibercept) Injection 8 mg (a)
Wet age-related macular degeneration ("wAMD")
a a a
Diabetic macular edema ("DME")
a a a
Diabetic retinopathy ("DR")
a
EYLEA ® (aflibercept) Injection (a)
wAMD
a a a
DME
a a a
DR
a
Macular edema following retinal vein occlusion ("RVO"), which includes macular edema following central retinal vein occlusion ("CRVO") and macular edema following branch retinal vein occlusion ("BRVO")
a a a
Myopic choroidal neovascularization ("mCNV") a a
Neovascular glaucoma ("NVG") a
Retinopathy of prematurity ("ROP")
a a a
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Product (continued)
Disease Territory
U.S. EU Japan
Dupixent ® (dupilumab) Injection (b)
Atopic dermatitis (in adults, adolescents, and pediatrics aged 6 months and older)
a a a
Asthma (in adults and adolescents) a a a
Asthma (in pediatrics 6–11 years of age) a a
Chronic rhinosinusitis with nasal polyposis ("CRSwNP") (in adults)
a a a
CRSwNP (in adolescents)
a
Chronic obstructive pulmonary disease ("COPD")
a a a
Eosinophilic esophagitis ("EoE") (in adults, adolescents, and pediatrics aged 1 year and older)
a a
Prurigo nodularis a a a
Chronic spontaneous urticaria ("CSU") (in adults and adolescents)
a a
Bullous pemphigoid
a
Libtayo ® (cemiplimab) Injection
Metastatic or locally advanced first-line non-small cell lung cancer ("NSCLC"), monotherapy and in combination with chemotherapy
a a a
Metastatic or locally advanced basal cell carcinoma ("BCC")
a a
Metastatic or locally advanced cutaneous squamous cell carcinoma ("CSCC") a a
Adjuvant CSCC
a
Metastatic or recurrent second-line cervical cancer
a a
Praluent ® (alirocumab) Injection (c)
LDL-lowering in heterozygous familial hypercholesterolemia ("HeFH") or clinical atherosclerotic cardiovascular disease ("ASCVD") a a
HeFH in pediatrics and adolescents (8–17 years of age)
a a
Cardiovascular risk reduction in patients with established cardiovascular disease a a
Homozygous familial hypercholesterolemia ("HoFH") a
Kevzara ® (sarilumab) Injection (b)
Rheumatoid arthritis ("RA") a a a
Polymyalgia rheumatica ("PMR")
a a
Polyarticular juvenile idiopathic arthritis ("pJIA")
a a
Evkeeza ® (evinacumab) Injection (d)
HoFH (in adults, adolescents, and pediatrics)
a a a
Ordspono ™ (odronextamab)
Follicular lymphoma ("FL")
a
Diffuse large B-cell lymphoma ("DLBCL")
a
Lynozyfic ™ (linvoseltamab)
Relapsed/refractory multiple myeloma
a a
Inmazeb ® (atoltivimab, maftivimab, and odesivimab) Injection
Infection caused by Zaire ebolavirus
a
Veopoz ® (pozelimab) Injection
CD55-deficient protein-losing enteropathy ("CHAPLE") (in adults, adolescents, and pediatrics aged 1 year and older)
a
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Product (continued)
Disease Territory
U.S. EU Japan
ARCALYST ® (rilonacept) Injection (e)
Cryopyrin-associated periodic syndromes ("CAPS"), including familial cold auto-inflammatory syndrome ("FCAS") and Muckle-Wells syndrome ("MWS") (in adults and adolescents) a
Deficiency of interleukin-1 receptor antagonist ("DIRA") (in adults, adolescents, and pediatrics) a
Recurrent pericarditis (in adults and adolescents)
a
ZALTRAP ® (ziv-aflibercept) Injection for Intravenous Infusion (f)
Metastatic colorectal cancer ("mCRC") a a a
Note: Refer to table below (net product sales of Regeneron-discovered products) for information regarding whether net product sales for a particular product are recorded by us or others. In addition, unless otherwise noted, products in the table above are generally approved for use in adults in the above-referenced diseases.
(a) In collaboration with Bayer outside the United States. Aflibercept 8 mg is known as EYLEA HD in the United States and EYLEA 8 mg in other countries.
(b) In collaboration with Sanofi
(c) The Company is responsible for the development and commercialization of Praluent in the United States and Sanofi is responsible for the development and commercialization of Praluent outside the United States
(d) The Company is responsible for the development and commercialization of Evkeeza in the United States and Ultragenyx is responsible for the development and commercialization of Evkeeza outside the United States
(e) Kiniksa is responsible for the development and commercialization of ARCALYST
(f) Sanofi is responsible for the development and commercialization of ZALTRAP
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The table below includes net product sales of Regeneron-discovered products. Such net product sales are recorded by us or others, as further described in the footnotes to the table. We believe the information in the table is useful to investors as it demonstrates our pipeline productivity and our ability to innovate, discover, and develop new products, and bring those products to market either alone or based on contractual arrangements with other parties, which has a direct impact on our results of operations and financial condition. The table also shows the degree to which we, a collaborator, and/or a licensee is currently commercializing the products discovered by Regeneron. In addition, this information allows management and investors to assess the commercial trends and developments impacting Regeneron-discovered products. In arrangements where our collaborator or licensee is currently commercializing such products and is recording net product sales as a result, the net product sales shown in the table also are an important metric for management's review and assessment of (i) the revenues we record for our share of profits and/or royalties from such sales and (ii) the impact of our obligation to supply commercial product to certain of these collaborators or licensees.
Three Months Ended
September 30,
2025 2024 % Change
(In millions) U.S. ROW (f)
Total U.S. ROW Total (Total Sales)
EYLEA HD (a)
$ 430.6 $ 232.4 $ 663.0 $ 392.3 $ 75.2 $ 467.5 42 %
EYLEA (a)
$ 680.6 $ 621.4 $ 1,302.0 $ 1,144.6 $ 856.5 $ 2,001.1 (35 %)
Total EYLEA HD and EYLEA
$ 1,111.2 $ 853.8 $ 1,965.0 $ 1,536.9 $ 931.7 $ 2,468.6 (20 %)
Dupixent (b)
$ 3,618.8 $ 1,238.2 $ 4,857.0 $ 2,824.7 $ 992.5 $ 3,817.2 27 %
Libtayo (c)
$ 219.1 $ 146.1 $ 365.2 $ 194.5 $ 94.1 $ 288.6 27 %
Praluent (d)
$ 67.7 $ 148.0 $ 215.7 $ 52.9 $ 138.5 $ 191.4 13 %
Kevzara (b)
$ 102.9 $ 51.1 $ 154.0 $ 72.7 $ 47.4 $ 120.1 28 %
Other products (e)
$ 43.9 $ 28.0 $ 71.9 $ 68.2 $ 24.4 $ 92.6 (22 %)
Nine Months Ended
September 30,
2025 2024 % Change
(In millions) U.S. ROW
Total U.S. ROW Total (Total Sales)
EYLEA HD (a)
$ 1,130.6 $ 620.5 $ 1,751.1 $ 896.5 $ 149.5 $ 1,046.0 67 %
EYLEA (a)
$ 2,170.9 $ 2,068.8 $ 4,239.7 $ 3,576.7 $ 2,539.4 $ 6,116.1 (31 %)
Total EYLEA HD and EYLEA
$ 3,301.5 $ 2,689.3 $ 5,990.8 $ 4,473.2 $ 2,688.9 $ 7,162.1 (16 %)
Dupixent (b)
$ 9,453.2 $ 3,414.0 $ 12,867.2 $ 7,652.9 $ 2,797.5 $ 10,450.4 23 %
Libtayo (c)
$ 659.4 $ 367.4 $ 1,026.8 $ 536.1 $ 313.8 $ 849.9 21 %
Praluent (d)
$ 190.3 $ 440.7 $ 631.0 $ 179.0 $ 405.6 $ 584.6 8 %
Kevzara (b)
$ 271.4 $ 151.2 $ 422.6 $ 187.8 $ 136.1 $ 323.9 30 %
Other products (e)
$ 117.1 $ 81.5 $ 198.6 $ 124.4 $ 65.2 $ 189.6 5 %
(a) We record net product sales of EYLEA HD and EYLEA in the United States, and Bayer records net product sales outside the United States. We record our share of profits in connection with sales outside the United States within Collaboration revenue; refer to "Results of Operations - Revenues - Bayer Collaboration Revenue" below for such amounts.
(b) Sanofi records global net product sales of Dupixent and Kevzara, and we record our share of profits in connection with global sales of such products within Collaboration revenue. Refer to "Results of Operations - Revenues - Sanofi Collaboration Revenue" below for such amounts.
(c) We record global net product sales of Libtayo and pay Sanofi a royalty on such sales
(d) We record net product sales of Praluent in the United States. Sanofi records net product sales of Praluent outside the United States and pays us a royalty on such sales, which is recorded within Other revenue.
(e) Included in this line item are products which are sold by us and others. Refer to "Results of Operations - Revenues" below for a listing of net product sales recorded by us. Not included in this line item are net product sales of ARCALYST, which are recorded by Kiniksa.
(f) Rest of world ("ROW")
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Programs in Clinical Development
Product candidates in Phase 2 and Phase 3 clinical development, which are being developed by us and/or our collaborators, are summarized in the table below.
There are numerous uncertainties associated with drug development, including uncertainties related to safety and efficacy data from each phase of drug development (including any post-approval studies), uncertainties related to the enrollment and performance of clinical trials, changes in regulatory requirements, changes to drug pricing and reimbursement regulations and requirements, and changes in the competitive landscape affecting a product candidate. The planning, execution, and results of our clinical programs are significant factors that can affect our operating and financial results.
Refer to Part II, Item 1A. "Risk Factors" for a description of risks and uncertainties that may affect our clinical programs. Any of such risks and uncertainties may, among other matters, negatively impact the development timelines set forth in the table below.
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Clinical Program Phase 2 Phase 3 Regulatory
Review (h)
2025 Events to Date
Select Upcoming
Milestones
Ophthalmology
EYLEA HD (aflibercept) 8 mg (a)
–RVO
–RVO (U.S., EU, and Japan)
–Every 4-week dosing regimen for approved indications (U.S.)
–Presented positive three-year data from extension study of Phase 3 wAMD trial at Angiogenesis, Exudation, and Degeneration ("Angiogenesis") 2025 annual meeting
–Presented positive data from Phase 3 QUASAR trial in RVO at Angiogenesis 2025 annual meeting
–FDA issued Complete Response Letters ("CRLs") for sBLA for addition of extended dosing intervals and for regulatory application for pre-filled syringe
–Approved by European Commission ("EC") for extended dosing intervals up to 6 months (24 weeks) in wAMD and DME –U.S. Food and Drug Administration ("FDA") decision on supplemental Biologics License Application ("sBLA") for RVO (November 2025) (r)
–FDA decision on sBLA for every 4-week dosing regimen (November 2025) (r)
Pozelimab (f) (REGN3918)
Antibody to C5
–Geographic atrophy, cemdisiran combination (l)(q)
Immunology & Inflammation
Dupixent (dupilumab) (b)
Antibody to IL-4R alpha subunit
–Asthma in pediatrics (2–5 years of age)
–Chronic pruritus of unknown origin ("CPUO")
–Lichen simplex chronicus
–Asthma in pediatrics (6–11 years of age) (Japan)
–CSU in adults and adolescents (EU)
–Approved by Japan's Ministry of Health, Labour and Welfare ("MHLW") for COPD
–Approved by FDA for CSU in adults and adolescents
–EC decision on regulatory submission for CSU in adults and adolescents (fourth quarter 2025)
–EC decision on regulatory submission for bullous pemphigoid (first half 2026)
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Clinical Program (continued)
Phase 2 Phase 3 Regulatory
Review (h)
2025 Events to Date
Select Upcoming
Milestones
Dupixent (dupilumab) (b) (continued)
–CSU in pediatrics (2–11 years of age) (U.S. and EU)
–Bullous pemphigoid (EU and Japan)
–Allergic fungal rhinosinusitis ("AFRS")
– European Medicines Agency's ("EMA") Committee for Medicinal Products for Human Use ("CHMP") adopted positive opinion for CSU in adults and adolescents
–Presented positive data from Phase 2/3 bullous pemphigoid trial at 2025 American Academy of Dermatology ("AAD") Annual Meeting
–Approved by FDA for bullous pemphigoid
Kevzara (sarilumab) (b)
Antibody to IL-6R
–Systemic juvenile idiopathic arthritis ("sJIA") (pivotal study)
–Approved by EC for pJIA
Itepekimab (b) (REGN3500)
Antibody to IL-33
–Non-cystic fibrosis bronchiectasis ("NCFB")
–Chronic rhinosinusitis without nasal polyposis ("CRSsNP")
–COPD (e)
–CRSwNP
–Reported that Phase 3 trial (AERIFY-1) in COPD met its primary endpoint; second Phase 3 trial (AERIFY-2) did not meet same primary endpoint
REGN5713-5715
Multi-antibody therapy to Bet v 1
–Birch allergy –Reported that Phase 3 trial in birch allergy met its primary and key secondary endpoints
–Initiate additional Phase 3 study in birch allergy (fourth quarter 2025)
REGN1908-1909 (f)
Multi-antibody therapy to Fel d 1
–Cat allergy
–Reported that Phase 3 trial in cat allergy met its primary and key secondary endpoints
–Initiate additional Phase 3 study in cat allergy (first half 2026)
Solid Organ Oncology
Libtayo (cemiplimab) (g)
Antibody to PD-1
–Neoadjuvant CSCC
–First-line NSCLC, BNT116 (i) combination
–Neoadjuvant NSCLC
–Early-stage CSCC (intralesional)
–Adjuvant CSCC (EU)
–Approved by FDA for adjuvant CSCC
–EMA's CHMP adopted positive opinion for adjuvant CSCC
–EC decision on regulatory submission for adjuvant CSCC (fourth quarter 2025)
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Clinical Program (continued)
Phase 2 Phase 3 Regulatory
Review (h)
2025 Events to Date
Select Upcoming
Milestones
Libtayo (cemiplimab) (g) (continued)
–Neoadjuvant hepatocellular carcinoma ("HCC")
–Reported positive data from Phase 3 trial in adjuvant CSCC; results presented at 2025 American Society of Clinical Oncology ("ASCO") Annual Meeting and published in New England Journal of Medicine ("NEJM")
–Approved by MHLW for NSCLC, monotherapy and chemotherapy combination
–Reported positive five-year follow-up data from Phase 3 trial in combination with chemotherapy for NSCLC; results presented at IASLC 2025 World Conference on Lung Cancer ("WCLC")
Fianlimab (f) (REGN3767)
Antibody to LAG-3
–First-line advanced NSCLC (Phase 2/3)
–Perioperative NSCLC
–Perioperative melanoma
–First-line metastatic melanoma (e)
–Adjuvant melanoma
–Based on pre-planned interim analysis of two Phase 2/3 studies in first-line advanced NSCLC, Phase 2 portion of the studies will continue unchanged
–Report results from Phase 3 study versus pembrolizumab in first-line metastatic melanoma (first half 2026)
–Report data from Phase 2/3 studies in first-line advanced NSCLC (first half 2026)
–Initiate Phase 2 study (in combination with Libtayo) in first-line metastatic head and neck squamous cell carcinoma (first half 2026)
Vidutolimod
Immune activator targeting TLR9
Ubamatamab (f) (REGN4018)
Bispecific antibody targeting MUC16 and CD3
–Ovarian cancer
–Presented additional data from Phase 2 study in platinum-resistant ovarian cancer at European Society for Medical Oncology ("ESMO") 2025 Meeting
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Clinical Program (continued)
Phase 2 Phase 3 Regulatory
Review (h)
2025 Events to Date
Select Upcoming
Milestones
REGN5668 (p)
Bispecific antibody targeting MUC16 and CD28
–Ovarian cancer
Nezastomig (REGN5678)
Bispecific antibody targeting PSMA and CD28
–Prostate cancer –Reported additional data from study in prostate cancer at American Association for Cancer Research ("AACR") Annual Meeting
REGN7075
Bispecific antibody targeting EGFR and CD28
–Solid tumors
–Report additional data from study in solid tumors (first half 2026)
Davutamig (REGN5093)
Bispecific antibody targeting two distinct MET epitopes
–MET-altered advanced NSCLC
Hematology
Pozelimab (f) (REGN3918)
Antibody to C5
–Myasthenia gravis, cemdisiran combination (c)(l)
–Paroxysmal nocturnal hemoglobinuria ("PNH"), cemdisiran combination (c)(l)
–Reported that Phase 3 cemdisiran combination trial in myasthenia gravis met its primary and key secondary endpoints
Cemdisiran (l)
siRNA therapeutic targeting C5
–Myasthenia gravis (c)
–Reported that Phase 3 trial in myasthenia gravis met its primary and key secondary endpoints
–Submit New Drug Application ("NDA") for myasthenia gravis (first quarter 2026), pending discussions with FDA
Ordspono (odronextamab)
Bispecific antibody targeting CD20 and CD3
–B-cell non-Hodgkin lymphoma
("B-NHL") (pivotal study)
–FL (c)(e) (multiple lines and settings)
–DLBCL (c)(e) (multiple lines and settings)
–FDA issued CRL for BLA for relapsed/refractory FL
Lynozyfic (linvoseltamab) (f)
Bispecific antibody targeting BCMA and CD3
–Earlier (pre-malignant) multiple myeloma
–Monoclonal gammopathy of undetermined significance ("MGUS")
–Multiple myeloma (c)(e) (multiple lines and settings)
–Approved by FDA and EC for relapsed/refractory multiple myeloma
–Completed enrollment in Phase 3 confirmatory trial (LINKER-MM3) in relapsed/refractory multiple myeloma
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Clinical Program (continued)
Phase 2 Phase 3 Regulatory
Review (h)
2025 Events to Date
Select Upcoming
Milestones
Lynozyfic (linvoseltamab) (f) (continued)
–Light chain amyloidosis ("ALA") (Phase 1/2)
Nexiguran ziclumeran (Nex-z, NTLA-2001) (j)
TTR gene knockout using CRISPR/Cas9
–Transthyretin amyloidosis with cardiomyopathy ("ATTR-CM") (c)(m)
–Hereditary transthyretin amyloidosis with polyneuropathy ("ATTRv-PN") (c)(m)
–Intellia temporarily paused dosing and screening in Phase 3 ATTR-CM and ATTRv-PN trials due to a Grade 4 adverse event involving the liver
REGN9933
Antibody to Factor XI (A2 domain)
–Thrombosis
–Initiate Phase 3 studies (first half 2026)
REGN7508
Antibody to Factor XI (catalytic domain)
–Thrombosis
–Venous thromboembolism after total knee replacement surgery
–Initiate additional Phase 3 studies (first half 2026)
REGN7257
Antibody to IL2Rg
–Discontinued study in aplastic anemia
REGN7999
Antibody to TMPRSS6
–Iron overload in beta-thalassemia
Internal Medicine/Genetic Medicines
Garetosmab (f) (REGN2477)
Antibody to Activin A
–Fibrodysplasia ossificans progressiva
("FOP") (c)(d)(e)
–Reported that Phase 3 trial in FOP met its primary endpoint
–Submit BLA for FOP (fourth quarter 2025)
Trevogrumab (f) (REGN1033)
Antibody to myostatin (GDF8)
–Obesity (n)
–Reported 26-week results from Phase 2 study in obesity
Mibavademab (f)(o) (REGN4461)
Agonist antibody to leptin receptor ("LEPR")
–Generalized lipodystrophy (c)(d)(e)
REGN5381
Agonist antibody to NPR1
–Discontinued Phase 2 studies in heart failure and uncontrolled hypertension
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Clinical Program (continued)
Phase 2 Phase 3 Regulatory
Review (h)
2025 Events to Date
Select Upcoming
Milestones
REGN7544
Antagonist antibody to NPR1
–Postural orthostatic tachycardia syndrome ("POTS")
–Sepsis-induced hypotension
Rapirosiran (ALN-HSD) (k)
RNAi therapeutic targeting HSD17B13
–Metabolic dysfunction-associated steatohepatitis ("MASH")
DB-OTO
AAV-based gene therapy
–Hearing deficit due to variants of the otoferlin gene (c)(e)(m) (Phase 1/2) (pivotal study)
–Presented updated data from Phase 1/2 trial and published in NEJM
–FDA granted Commissioner's National Priority Voucher
–Submit BLA for hearing deficit due to variants of the otoferlin gene (fourth quarter 2025)
Note: For purposes of the table above, a program is classified in Phase 2 or 3 clinical development after recruitment for the corresponding study or studies has commenced
(a) In collaboration with Bayer outside the United States
(b) In collaboration with Sanofi
(c) FDA granted Orphan Drug designation
(d) FDA granted Breakthrough Therapy designation
(e) FDA granted Fast Track designation
(f) Sanofi is entitled to receive royalties on sales of the product, if any
(g) Studied as monotherapy and in combination with other antibodies and treatments
(h) Information in this column captures submissions to U.S., EU, and/or Japan regulatory authorities
(i) BioNTech's BNT116 is an mRNA cancer vaccine
(j) In collaboration with Intellia
(k) Alnylam elected to opt-out of the product candidate. Under the terms of our agreement, Alnylam is entitled to receive royalties on sales of the product, if any.
(l) Under the terms of our license agreement for cemdisiran, Alnylam is entitled to receive royalties on sales (if any), as well as milestone payments
(m) FDA granted Regenerative Medicine Advanced Therapy ("RMAT") designation
(n) Studied in combination with semaglutide with and without garetosmab
(o) A Phase 2 study, sponsored by Eli Lilly, is also ongoing and testing the combination of tirzepatide and mibavademab compared with tirzepatide alone in patients with obesity
(p) Studied in combination with ubamatamab
(q) Geographic atrophy also studied with cemdisiran monotherapy
(r) Refer to "Additional Information - Clinical Development Programs - EYLEA HD" for further details
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Additional Information - Clinical Development Programs
EYLEA HD
In August 2025, the FDA extended the target action dates for the Company's FDA applications for EYLEA HD (pre-filled syringe, every-four-week dosing, and for the treatment of RVO). The delay resulted from observations from a July 2025 FDA general site inspection (not specific to EYLEA HD) at Catalent Indiana, LLC ("Catalent"), part of Novo Nordisk A/S, the manufacturing filler in the EYLEA HD BLA. The FDA extended the review periods after determining that the information submitted by the manufacturing filler in August 2025 to address the observations constituted a major amendment to each regulatory application.
In October 2025, the Company was notified by Catalent that they received an official action indicated ("OAI") letter from the FDA citing unresolved issues related to a July 2025 FDA general site inspection. On October 27, 2025, the FDA issued a CRL for the pre-filled syringe sBLA. The sole approvability issue cited in the CRL relates to unresolved inspection findings at Catalent. The Company is planning to submit by January 2026 an application to include a new pre-filled syringe manufacturing filler in the EYLEA HD BLA.
In addition, the Company has submitted an application to include an additional vial filler, should this be needed for approval of every-four-week dosing and RVO label enhancements, with an FDA decision regarding this new vial filler expected by late December 2025.
Itepekimab
In May 2025, the Company and Sanofi announced that a Phase 3 trial, AERIFY-1, in adults who were former smokers with inadequately controlled COPD met the primary endpoint of significantly reducing moderate or severe acute exacerbations by 27% compared to placebo at week 52, a clinically meaningful benefit. A second Phase 3 trial, AERIFY-2, did not meet the same primary endpoint, although a benefit was seen earlier in the trial. The safety profile of itepekimab observed in the Phase 3 trials was consistent with prior clinical trials. The Company and Sanofi are evaluating next steps.
Fianlimab
In April 2025, a pre-planned interim analysis was conducted on two ongoing Phase 2/3 studies evaluating the combination of fianlimab and cemiplimab in first-line advanced NSCLC. Due to limited follow-up, the Phase 2 portion of the studies will continue unchanged until additional data are available. The next analyses for these studies are expected in the first half of 2026, at which time a decision whether to advance to Phase 3 is expected to be made. No new safety signals were observed in either study.
Ordspono (odronextamab)
On July 30, 2025, the FDA issued a CRL for the BLA for odronextamab in relapsed/refractory follicular lymphoma after two or more lines of systemic therapy, which was also impacted by the Catalent Indiana LLC site inspection (as described in the "EYLEA HD" section above).
Collaboration, License, and Other Agreements
Sanofi
We are collaborating with Sanofi on the global development and commercialization of Dupixent, Kevzara, and itepekimab (the "Antibody Collaboration"). Under the terms of the Antibody Collaboration, Sanofi is generally responsible for funding 80% to 100% of agreed-upon development costs. We are obligated to reimburse Sanofi for 30% to 50% of development expenses that were funded by Sanofi based on our share of collaboration profits; however, we are only required to apply 20% of our share of profits from the collaboration each calendar quarter to reimburse Sanofi for these development expenses. As of September 30, 2025, the total amount of our contingent reimbursement obligation to Sanofi (i.e., "development balance") in connection with such development expenses was approximately $905 million.
Under our collaboration agreement, Sanofi records product sales for commercialized products, and we have the right to co-commercialize such products on a country-by-country basis. We co-commercialize Dupixent in the United States and in certain countries outside the United States. We supply certain commercial bulk product to Sanofi. We and Sanofi equally share profits from sales within the United States, and share profits outside the United States on a sliding scale based on sales starting at 65% (Sanofi)/35% (us) and ending at 55% (Sanofi)/45% (us).
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Bayer
We and Bayer are parties to a license and collaboration agreement for the global development and commercialization of EYLEA 8 mg and EYLEA 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.
We are obligated to reimburse Bayer for 50% of the development costs that it has incurred under the agreement from our share of the collaboration profits. The reimbursement payment in any quarter will equal 5% of the then outstanding repayment obligation, but never more than our share of the collaboration profits in the quarter unless we elect to reimburse Bayer at a faster rate.
Within the United States, we retain exclusive commercialization rights and are entitled to all profits from such sales.
Alnylam
We and Alnylam Pharmaceuticals, Inc. are parties to a collaboration to discover, develop, and commercialize RNAi the rapeutics for a broad range of diseases by addressing therapeutic disease targets expressed in the eye and central nervous system, in addition to a select number of targets expressed in the liver.
Under the terms of the collaboration, the parties perform discovery research until designation of lead candidates. Following designation of a lead candidate, the parties may further advance such lead candidate under either a co-development and co-commercialization agreement or a license agreement. The initial target nomination and discovery period of five years has been automatically extended until the earlier of seven years from the effective date of the collaboration or the achievement of certain milestones (the "Research Term"). In addition, we have an option to extend the Research Term for an additional five-year period for a research extension fee of $300.0 million.
We have also entered into various license agreements with Alnylam, with us as the licensee, including for cemdisiran (a small interfering RNA ("siRNA") therapeutic ta rgeting the C5 component of the human complement pathway) as a monotherapy and for a combination consisting of cemdisiran and pozelimab.
Intellia
We and Intellia Therapeutics, Inc. are parties to a license and collaboration agreement to advance CRISPR/Cas9 gene-editing technology for in vivo therapeutic development, including therapies focused on neurological and muscular diseases. We have the right to select targets under the license and collaboration agreement until April 2026.
Intellia leads the design of the editing methodology, we lead the design of the targeted viral vector delivery approach, and the parties share costs. Each company has the opportunity to lead potential development and commercialization of product candidates for a target, and the company that is not leading development and commercialization will have the option to enter into a co-development and co-commercialization agreement for the target.
Nex-z, which is in clinical development, is subject to a co-development and co-commercialization arrangement pursuant to which Intellia leads development activities and the parties share development expenses 75% (Intellia)/25% (us). If nex-z is commercialized, Intellia will lead commercialization activities and we will be entitled to 25% of any profits.
Hansoh
In July 2025, our license agreement with Hansoh Pharmaceuticals Group Company Limited to acquire development and commercial rights outside of mainland China, Hong Kong, and Macau for HS-20094 (a dual GLP-1/GIP receptor agonist currently in Phase 3 clinical development in China) became effective. In-licensing a late-stage GLP-1/GIP agonist enables us to study combinations with our products and product candidates in order to address muscle loss and potentially other comorbidities of obesity, such as cardiovascular diseases, diabetes, and liver conditions. Under the terms of the agreement, we made an $80.0 million up-front payment in July 2025. In addition, we are obligated to make additional payments upon achievement of development, regulatory, and sales milestones, as well as a low double-digit royalty on sales.
General
Our ability to generate profits and to generate positive cash flow from operations over the next several years depends significantly on the success in commercializing our products, including EYLEA HD and Dupixent. We expect to continue to incur substantial expenses related to our research and development activities, and our research and development activities and related costs which are not reimbursed by collaborators are expected to expand and require additional resources. We also expect to incur substantial costs related to the commercialization of our marketed products. Our financial results may fluctuate from
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quarter to quarter and will depend on, among other factors, the net sales of our products; the scope and progress of our research and development efforts; the timing of certain expenses; the continuation of our collaborations, in particular with Sanofi and Bayer, including our share of collaboration profits from sales of commercialized products and the amount of reimbursement of our research and development expenses that we receive from collaborators; and the amount of income tax expense we incur, which is partly dependent on the profits or losses we earn in each of the countries in which we operate. There is uncertainty surrounding whether or when new products or new indications for marketed products will receive regulatory approval or, if any such approval is received, whether we will be able to successfully commercialize such products and whether or when they may become profitable.
Results of Operations
Net Income
Three Months Ended
September 30,
Nine Months Ended
September 30,
(In millions, except per share data) 2025 2024 2025 2024
Revenues $ 3,754.3 $ 3,720.7 $ 10,458.6 $ 10,412.8
Operating expenses 2,727.5 2,541.2 7,760.6 7,412.3
Income from operations 1,026.8 1,179.5 2,698.0 3,000.5
Other income (expense) 736.5 313.5 1,489.0 821.3
Income before income taxes 1,763.3 1,493.0 4,187.0 3,821.8
Income tax expense
303.3 152.4 526.7 326.9
Net income $ 1,460.0 $ 1,340.6 $ 3,660.3 $ 3,494.9
Net income per share - diluted $ 13.62 $ 11.54 $ 33.61 $ 30.23
Revenues
Three Months Ended
September 30,
Nine Months Ended
September 30,
(In millions) 2025 2024 $ Change 2025 2024 $ Change
Net product sales:
EYLEA HD - U.S.
$ 430.6 $ 392.3 $ 38.3 $ 1,130.6 $ 896.5 $ 234.1
EYLEA - U.S. 680.6 1,144.6 (464.0) 2,170.9 3,576.7 (1,405.8)
Total EYLEA HD and EYLEA - U.S.
1,111.2 1,536.9 (425.7) 3,301.5 4,473.2 (1,171.7)
Libtayo - U.S. 219.1 194.5 24.6 659.4 536.1 123.3
Libtayo - ROW 146.1 94.1 52.0 367.4 313.8 53.6
Total Libtayo - Global
365.2 288.6 76.6 1,026.8 849.9 176.9
Praluent - U.S. 67.7 52.9 14.8 190.3 179.0 11.3
Evkeeza - U.S. 42.8 32.4 10.4 114.9 87.6 27.3
Inmazeb - U.S.
— 35.6 (35.6) — 36.6 (36.6)
Other products - Global
0.8 — 0.8 0.8 — 0.8
Total net product sales $ 1,587.7 $ 1,946.4 $ (358.7) $ 4,634.3 $ 5,626.3 $ (992.0)
Collaboration revenue:
Sanofi $ 1,617.0 $ 1,263.4 $ 353.6 $ 4,243.8 $ 3,318.8 $ 925.0
Bayer 344.8 390.8 (46.0) 1,103.7 1,121.9 (18.2)
Other 6.6 5.9 0.7 12.8 10.2 2.6
Other revenue 198.2 114.2 84.0 464.0 335.6 128.4
Total revenues $ 3,754.3 $ 3,720.7 $ 33.6 $ 10,458.6 $ 10,412.8 $ 45.8
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Net Product Sales
Net product sales of EYLEA HD increased for the three and nine months ended September 30, 2025, compared to the same periods in 2024, due to higher sales volumes, partly offset by a lower net selling price.
Net product sales of EYLEA for the three and nine months ended September 30, 2025, compared to the same periods in 2024, were negatively impacted by (i) lower sales volumes as a result of continued competitive pressures (as described below), loss in market share to compounded bevacizumab due to patient affordability constraints, and the continued transition of patients to EYLEA HD, and (ii) a lower net selling price.
EYLEA net product sales have been, and are likely to continue to be, negatively impacted by increased competition from other anti-VEGF products, including biosimilars, as well as the transition of patients from EYLEA to EYLEA HD. The magnitude and duration of such impact is presently unknown. For more information, see Part II, Item 1A. "Risk Factors - Risks Related to Commercialization of Our Marketed Products, Product Candidates, and New Indications for Our Marketed Products - We are substantially dependent on the success of EYLEA, EYLEA HD, and Dupixent " and " The commercial success of our products and product candidates is subject to significant competition - Marketed Products." In addition, if independent not-for-profit patient assistance funds that provide copay assistance are unable to support eligible patients, this will likely have a continued negative impact on patient affordability resulting in lower utilization of higher-cost anti-VEGF agents.
Collaboration Revenue
Sanofi Collaboration Revenue
Three Months Ended
September 30,
Nine Months Ended
September 30,
(In millions) 2025 2024 2025 2024
Regeneron's share of profits
$ 1,455.5 $ 1,088.3 $ 3,755.7 $ 2,880.6
Reimbursement for manufacturing of commercial supplies (a)
161.5 175.1 488.1 438.2
Total Sanofi collaboration revenue $ 1,617.0 $ 1,263.4 $ 4,243.8 $ 3,318.8
(a) Corresponding costs incurred by the Company in connection with such manufacturing is recorded within Cost of collaboration and contract manufacturing
Global net product sales of Dupixent and Kevzara are recorded by Sanofi, and we and Sanofi share profits on such sales.
Regeneron's share of profits in connection with the commercialization of Dupixent and Kevzara is summarized below:
Three Months Ended
September 30,
Nine Months Ended
September 30,
(In millions) 2025 2024 2025 2024
Dupixent and Kevzara net product sales $ 5,011.0 $ 3,937.3 $ 13,289.8 $ 10,774.3
Regeneron's share of collaboration profits in connection with commercialization of antibodies
$ 1,723.6 $ 1,263.4 $ 4,400.5 $ 3,338.5
Reimbursement of development expenses incurred by Sanofi in accordance with Regeneron's payment obligation (a)
(268.1) (175.1) (644.8) (457.9)
Regeneron's share of profits
$ 1,455.5 $ 1,088.3 $ 3,755.7 $ 2,880.6
Regeneron's share of profits as a percentage of Dupixent and Kevzara net product sales
29% 28% 28% 27%
(a) See "Collaboration, License, and Other Agreements - Sanofi" above for additional details on our contingent reimbursement obligation
The increase in our share of profits for the three and nine months ended September 30, 2025, compared to the same periods in 2024, was driven by higher profits associated with an increase in Dupixent sales.
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Bayer Collaboration Revenue
Three Months Ended
September 30,
Nine Months Ended
September 30,
(In millions) 2025 2024 2025 2024
Regeneron's share of profits
$ 311.9 $ 367.6 $ 1,012.6 $ 1,054.5
Reimbursement for manufacturing of commercial supplies (a)
32.9 23.2 91.1 67.4
Total Bayer collaboration revenue $ 344.8 $ 390.8 $ 1,103.7 $ 1,121.9
(a) Corresponding costs incurred by the Company in connection with such manufacturing is recorded within Cost of collaboration and contract manufacturing
Bayer records net product sales of EYLEA 8 mg and EYLEA outside the United States, and we and Bayer share profits on such sales.
Regeneron's share of profits in connection with commercialization of EYLEA 8 mg and EYLEA outside the United States is summarized below:
Three Months Ended
September 30,
Nine Months Ended
September 30,
(In millions) 2025 2024 2025 2024
EYLEA 8 mg and EYLEA net product sales outside the United States $ 853.8 $ 931.7 $ 2,689.3 $ 2,688.9
Regeneron's share of collaboration profit from sales outside the United States
$ 328.0 $ 384.2 $ 1,061.5 $ 1,103.7
Reimbursement of development expenses incurred by Bayer in accordance with Regeneron's payment obligation (a)
(16.1) (16.6) (48.9) (49.2)
Regeneron's share of profits
$ 311.9 $ 367.6 $ 1,012.6 $ 1,054.5
Regeneron's share of profits as a percentage of EYLEA 8 mg and EYLEA net product sales outside the United States
37% 39% 38% 39%
(a) See "Collaboration, License, and Other Agreements - Bayer" above for additional details on our contingent reimbursement obligation
The decrease in our share of profits for the three and nine months ended September 30, 2025, compared to the same periods in 2024, was driven by lower profits associated with a decrease in EYLEA sales outside the United States.
Other Revenue
Other revenue increased for the three and nine months ended September 30, 2025, compared to the same periods in 2024. Other revenue included royalties and share of profits earned in connection with license agreements of $165.4 million and $90.7 million for the three months ended September 30, 2025 and 2024, respectively, and $353.0 million and $207.5 million for the nine months ended September 30, 2025 and 2024, respectively.
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Operating Expenses
Three Months Ended
September 30,
Nine Months Ended
September 30,
(In millions, except headcount data) 2025 2024 Change 2025 2024 Change
Research and development (a)
$ 1,475.0 $ 1,271.5 $ 203.5 $ 4,224.1 $ 3,719.9 $ 504.2
Acquired in-process research and development 83.1 56.2 26.9 105.4 87.2 18.2
Selling, general, and administrative (a)
657.8 714.4 (56.6) 1,925.0 2,162.2 (237.2)
Cost of goods sold 281.0 262.3 18.7 822.1 760.5 61.6
Cost of collaboration and contract manufacturing (b)
240.6 228.8 11.8 694.0 644.6 49.4
Other operating (income) expense, net (10.0) 8.0 (18.0) (10.0) 37.9 (47.9)
Total operating expenses $ 2,727.5 $ 2,541.2 $ 186.3 $ 7,760.6 $ 7,412.3 $ 348.3
Average headcount 15,301 14,642 659 15,222 14,165 1,057
(a) Includes costs incurred net of any cost reimbursements from collaborators
(b) Includes costs incurred in connection with manufacturing drug supplies for collaborators and others
Operating expenses included stock-based compensation expense of $237.0 million and $225.1 million for the three months ended September 30, 2025 and 2024, respectively, and $744.4 million and $678.4 million for the nine months ended September 30, 2025 and 2024, respectively.
Research and Development Expenses
The following table summarizes our direct research and development expenses by clinical development program and other significant categories of research and development expenses. Direct research and development expenses are comprised primarily of costs paid to third parties for clinical and product development activities, including costs related to preclinical research activities, clinical trials, and the portion of research and development expenses incurred by our collaborators that we are obligated to reimburse. Indirect research and development expenses have not been allocated directly to each program, and primarily consist of costs to compensate personnel, overhead and infrastructure costs to maintain our facilities, and other costs related to activities that benefit multiple projects. Clinical manufacturing costs primarily consist of costs to manufacture bulk drug product for clinical development purposes as well as related drug filling, packaging, and labeling costs. Clinical manufacturing costs also include pre-launch commercial supplies which did not meet the criteria to be capitalized as inventory. The table below also includes reimbursements of research and development expenses by collaborators, as when we are entitled to reimbursement of all or a portion of such expenses that we incur under a collaboration, we record those reimbursable amounts in the period in which such costs are incurred.
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Three Months Ended
September 30,
Nine Months Ended
September 30,
(In millions) 2025 2024 *
$ Change 2025 2024 *
$ Change
Direct research and development expenses:
Fianlimab $ 55.8 $ 53.4 $ 2.4 $ 155.3 $ 168.4 $ (13.1)
Ordspono (odronextamab)
50.1 33.8 16.3 119.1 94.1 25.0
Lynozyfic (linvoseltamab) 32.8 25.4 7.4 118.1 111.8 6.3
Itepekimab
28.1 24.2 3.9 90.9 67.8 23.1
Dupixent (dupilumab) 27.6 31.3 (3.7) 81.1 96.4 (15.3)
EYLEA HD (aflibercept) 8 mg
21.1 28.9 (7.8) 73.9 76.0 (2.1)
Libtayo (cemiplimab) 18.0 17.9 0.1 57.3 60.7 (3.4)
Trevogrumab
17.9 6.4 11.5 57.0 18.7 38.3
Pozelimab
16.5 17.6 (1.1) 45.6 49.3 (3.7)
Other product candidates in clinical development and other research programs
186.4 147.5 38.9 498.4 415.3 83.1
Total direct research and development expenses 454.3 386.4 67.9 1,296.7 1,158.5 138.2
Indirect research and development expenses:
Payroll and benefits 438.3 407.8 30.5 1,339.5 1,249.2 90.3
Lab supplies and other research and development costs
67.5 63.0 4.5 192.4 175.4 17.0
Occupancy and other operating costs 166.3 158.7 7.6 479.2 434.9 44.3
Total indirect research and development expenses
672.1 629.5 42.6 2,011.1 1,859.5 151.6
Clinical manufacturing costs
381.4 306.6 74.8 1,028.8 841.3 187.5
Reimbursement of research and development expenses by collaborators (32.8) (51.0) 18.2 (112.5) (139.4) 26.9
Total research and development expenses
$ 1,475.0 $ 1,271.5 $ 203.5 $ 4,224.1 $ 3,719.9 $ 504.2
* Certain prior year amounts have been reclassified to conform to the current year's presentation
Research and development expenses included stock-based compensation expense of $125.1 million and $123.7 million for the three months ended September 30, 2025 and 2024, respectively, and $405.1 million and $369.1 million for the nine months ended September 30, 2025 and 2024, respectively.
There are numerous uncertainties associated with drug development, including uncertainties related to safety and efficacy data from each phase of drug development, uncertainties related to the enrollment and performance of clinical trials, changes in regulatory requirements, changes in the competitive landscape affecting a product candidate, and other risks and uncertainties described in Part II, Item 1A. "Risk Factors." There is also variability in the duration and costs necessary to develop a product candidate, potential opportunities and/or uncertainties related to future indications to be studied, and the estimated cost and scope of the projects. The lengthy process of seeking FDA and other applicable approvals, and subsequent compliance with applicable statutes and regulations, require the expenditure of substantial resources. Any failure by us to obtain, or delay in obtaining, regulatory approvals could materially adversely affect our business. We are unable to reasonably estimate if our product candidates in clinical development will generate material product revenues and net cash inflows.
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Acquired In-process Research and Development ("IPR&D") Expenses
Acquired IPR&D expenses for the three and nine months ended September 30, 2025 included an $80.0 million up-front payment in connection with our license agreement with Hansoh Pharmaceuticals Group Company Limited.
Acquired IPR&D expenses for the three and nine months ended September 30, 2024 included a $45.0 million development milestone in connection with our collaboration agreement with Sonoma Biotherapeutics, Inc.
Selling, General, and Administrative Expenses
Selling, general, and administrative expenses decreased for the three and nine months ended September 30, 2025, compared to the same periods in 2024, primarily due to lower charitable contributions to an independent not-for-profit patient assistance organization. Selling, general, and administrative expenses included stock-based compensation expense of $92.0 million and $83.1 million for the three months ended September 30, 2025 and 2024, respectively, and $279.0 million and $251.9 million for the nine months ended September 30, 2025 and 2024, respectively.
Cost of Goods Sold
Three Months Ended
September 30,
Nine Months Ended
September 30,
(In millions, except gross margin on net product sales)
2025 2024 2025 2024
Cost of goods sold
$ 281.0 $ 262.3 $ 822.1 $ 760.5
Gross margin on net product sales (a)
82% 87% 82% 86%
(a) Gross margin on net product sales represents gross profit expressed as a percentage of total net product sales recorded by the Company. Gross profit is calculated as net product sales (see "Net Product Sales" section above) less cost of goods sold.
Gross margin on net product sales decreased for the three and nine months ended September 30, 2025, compared to the same periods in 2024, partly due to ongoing investments to support our manufacturing operations. In addition, gross margin on net product sales decreased due to higher amortization expense associated with our Libtayo intangible asset as each quarter we record additions to the intangible asset related to royalties due to Sanofi.
Other Operating (Income) Expense
Other operating (income) expense, net, for the nine months ended September 30, 2024 reflected a charge of $37.9 million related to the increase in the estimated fair value of the contingent consideration liability recognized in connection with our 2023 acquisition of Decibel Therapeutics, Inc.
Other Income (Expense)
Three Months Ended
September 30,
Nine Months Ended
September 30,
(In millions) 2025 2024 2025 2024
Gains on marketable and other securities, net
$ 577.7 $ 134.7 $ 967.6 $ 331.2
Interest income 175.1 187.4 523.5 528.3
Other 3.0 5.2 29.5 6.5
Other income (expense), net 755.8 327.3 1,520.6 866.0
Interest expense (19.3) (13.8) (31.6) (44.7)
Total other income (expense) $ 736.5 $ 313.5 $ 1,489.0 $ 821.3
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Income Taxes
Three Months Ended
September 30,
Nine Months Ended
September 30,
(In millions, except effective tax rate) 2025 2024 2025 2024
Income tax expense
$ 303.3 $ 152.4 $ 526.7 $ 326.9
Effective tax rate
17.2 % 10.2 % 12.6 % 8.6 %
On July 4, 2025, bill H.R. 1, commonly referred to as the "One Big Beautiful Bill Act" or "OBBBA," was signed into law, with certain provisions effective in 2025 and others in 2026. The OBBBA significantly revises U.S. corporate income tax laws by, among other things, restoring the option for immediate expense recognition for U.S.-based research and development expenditures and making permanent the ability to claim first-year bonus depreciation on qualified property. The OBBBA also modifies U.S. taxation on foreign earnings by, among other things, changing the tax rates for global intangible low-taxed income (now known as Net CFC Tested Income) and foreign-derived intangible income (now known as foreign-derived deduction eligible income), modifying the allocation of expenses in calculating foreign tax credits, as well as changing foreign tax credit limitations. As a result of the OBBBA being signed into law, we recognized a charge of $44.5 million in the third quarter of 2025 related to the re-measurement of our U.S. net deferred tax assets.
Our effective tax rate for the three and nine months ended September 30, 2025 was positively impacted, compared to the U.S. federal statutory rate, primarily by income earned in foreign jurisdictions with tax rates lower than the U.S. federal statutory rate and federal tax credits for research activities, partially offset by the impact of the OBBBA being signed into law. In addition, our effective tax rate for the nine months ended September 30, 2025 was positively impacted by the release of liabilities for uncertain tax positions recognized upon the effective settlement of the IRS audit of our 2017 and 2018 federal income tax returns in the second quarter of 2025, which reduced our effective tax rate for the nine months ended September 30, 2025 by 1.4%.
The increase in our effective tax rate for the three and nine months ended September 30, 2025, compared to the same periods in 2024, was primarily impacted by the net change in uncertain tax positions, as well as lower tax benefits from less stock option exercises and the enactment of the OBBBA.
Liquidity and Capital Resources
Our financial condition is summarized as follows:
September 30, December 31,
(In millions) 2025 2024 $ Change
Financial assets:
Cash and cash equivalents $ 2,506.4 $ 2,488.2 $ 18.2
Marketable securities - current 5,937.2 6,524.3 (587.1)
Marketable securities - noncurrent 10,285.7 8,900.1 1,385.6
$ 18,729.3 $ 17,912.6 $ 816.7
Working capital:
Current assets $ 17,980.7 $ 18,660.9 $ (680.2)
Current liabilities 4,425.1 3,944.3 480.8
$ 13,555.6 $ 14,716.6 $ (1,161.0)
Borrowings and finance lease liabilities:
Long-term debt $ 1,985.5 $ 1,984.4 $ 1.1
Finance lease liabilities $ 720.0 $ 720.0 $ —
As of September 30, 2025, we also had borrowing availability of $750.0 million under a revolving credit facility.
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Sources and Uses of Cash for the Nine Months Ended September 30, 2025 and 2024
Nine Months Ended
September 30,
(In millions) 2025 2024 $ Change
Cash flows provided by (used in):
Operating activities
$ 3,808.2 $ 3,157.7 $ 650.5
Investing activities
$ (849.4) $ (2,818.7) $ 1,969.3
Financing activities
$ (2,935.3) $ (1,065.0) $ (1,870.3)
Cash Flows from Investing Activities
Capital expenditures for the nine months ended September 30, 2025 included costs incurred in connection with the expansion of our research, preclinical manufacturing, and support facilities at our Tarrytown, New York corporate headquarters. We expect to incur capital expenditures of $850 million to $890 million for the full year of 2025.
Payments for intangible assets for the nine months ended September 30, 2025 included $155.0 million related to our purchase of an FDA Rare Pediatric Disease Priority Review Voucher from a third party in the second quarter of 2025.
Cash Flows from Financing Activities
Share Repurchase Programs
In each of April 2024 and February 2025, our board of directors authorized an additional share repurchase program for up to $3.0 billion of our Common Stock (up to $6.0 billion in the aggregate). The programs have no time limit and can be discontinued at any time. As of September 30, 2025, $2.156 billion remained available for share repurchases under the programs.
Dividends
In each of the first, second, and third quarters of 2025, our board of directors declared quarterly cash dividends of $0.88 per share on our Common Stock and Class A Stock. Each quarterly dividend was paid to our shareholders in the quarter in which the dividend was declared.
Additionally, in October 2025, our board of directors declared a cash dividend of $0.88 per share on our Common Stock and Class A Stock. The dividend will be payable on December 5, 2025 to our shareholders of record as of November 20, 2025.
Critical Accounting Estimates
A summary of critical accounting estimates is presented in Part II, Item 7. "Management's Discussion and Analysis of Financial Condition and Results of Operations" of our Annual Report on Form 10-K for the fiscal year ended December 31, 2024 (filed February 5, 2025). There have been no material changes to critical accounting estimates during the nine months ended September 30, 2025.
Future Impact of Recently Issued Accounting Standards
See Note 1 to our Condensed Consolidated Financial Statements included in this report for a description of recently issued accounting standards.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
Our market risks, and the way we manage them, are summarized in Part II, Item 7A, "Quantitative and Qualitative Disclosures About Market Risk" of our Annual Report on Form 10-K for the fiscal year ended December 31, 2024 (filed February 5, 2025). There have been no material changes to our market risks or to our management of such risks as of September 30, 2025.
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Item 4. Controls and Procedures
Our management, with the participation of our principal executive officer and principal financial officer, conducted an evaluation of the effectiveness of our disclosure controls and procedures (as such term is defined in Rules 13a-15(e) or 15d-15(e) under the Securities Exchange Act of 1934, as amended (the "Exchange Act")), as of the end of the period covered by this report. Based on this evaluation, our principal executive officer and principal financial officer each concluded that, as of the end of such period, our disclosure controls and procedures were effective in ensuring that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized, and reported on a timely basis, and is accumulated and communicated to our management, including our principal executive officer and principal financial officer, as appropriate to allow timely decisions regarding required disclosures.
There has been no change in our internal control over financial reporting (as such term is defined in Rules 13a-15(f) or 15d-15(f) under the Exchange Act) during the quarter ended September 30, 2025 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
PART II. OTHER INFORMATION
Item 1. Legal Proceedings
The information called for by this item is incorporated herein by reference to the information set forth in Note 12 to our Condensed Consolidated Financial Statements included in this report.
Item 1A. Risk Factors
We operate in an environment that involves a number of significant risks and uncertainties. We caution you to read the following risk factors, which have affected, and/or in the future could affect, our business, prospects, operating results, and financial condition. The risks described below include forward-looking statements, and actual events and our actual results may differ materially from these forward-looking statements. Additional risks and uncertainties not currently known to us or that we currently deem immaterial may also impair our business, prospects, operating results, and financial condition. Furthermore, additional risks and uncertainties are described under other captions in this report and should also be considered by our investors. For purposes of this section (as well as this report in general), references to our products encompass products marketed or otherwise commercialized by us and/or our collaborators or licensees; and references to our product candidates encompass product candidates in development by us and/or our collaborators or licensees (in the case of collaborated or licensed products or product candidates under the terms of the applicable collaboration or license agreements), unless otherwise stated or required by the context. In this section, we first provide a summary of the more significant risks and uncertainties we face and then provide a full set of risk factors and discuss them in greater detail.
Summary of Risk Factors
As noted above, we are subject to a number of risks that if realized could materially harm our business, prospects, operating results, and financial condition. Some of the more significant risks and uncertainties we face include those summarized below. The summary below is not exhaustive and is qualified by reference to the full set of risk factors set forth in this "Risk Factors" section. Please carefully consider all of the information in this Form 10-Q, including the full set of risks set forth in this "Risk Factors" section, and in our other filings with the Securities and Exchange Commission ("SEC") before making an investment decision regarding Regeneron.
Commercialization Risks
• We are substantially dependent on the success of EYLEA, EYLEA HD, and Dupixent.
• Sales of our products are dependent on the availability and extent of coverage and reimbursement or copay assistance from third-party payors and other third parties, including private payors and government programs such as Medicare and Medicaid.
• Product reimbursement and coverage policies and practices, pricing regulations and requirements, and our pricing strategy could change due to various factors beyond our control, such as drug price control measures that have been or may be enacted or introduced in the United States by various federal and state authorities.
• The commercial success of our products is subject to significant competition from products or product candidates that may be superior to, or more established or cost effective than, our products or product candidates, including biosimilars.
• We and our collaborators on which we rely to commercialize some of our marketed products may be unable to continue to successfully commercialize or co-commercialize our products, both in and outside the United States.
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