SEC EDGAR · 10-Q
10-Q – 2026-07-30 – regn-20260630.htm
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Omsättning
- Item 2. | Unregistered Sales of Equity Securities and Use of Proceeds | 81
- Finance lease liabilities 720.0 — | Deferred revenue 684.8 553.0 | Total current liabilities 5,530.6 4,368.4
- Finance lease liabilities — 720.0 | Deferred revenue 220.4 208.7 | Other noncurrent liabilities 2,281.6 2,018.8
- Revenues: | Net product sales $ 1,642.4 $ 1,631.0 $ 3,176.9 $ 3,046.6 | Collaboration revenue 2,455.0 1,860.7 4,354.7 3,391.9
- Net product sales $ 1,642.4 $ 1,631.0 $ 3,176.9 $ 3,046.6 | Collaboration revenue 2,455.0 1,860.7 4,354.7 3,391.9 | Other revenue 193.3 183.9 364.5 265.8
- Collaboration revenue 2,455.0 1,860.7 4,354.7 3,391.9 | Other revenue 193.3 183.9 364.5 265.8 | 4,290.7 3,675.6 7,896.1 6,704.3
- Increase in prepaid expenses and other assets ( 517.7 ) ( 410.2 ) | Increase (decrease) in deferred revenue 143.5 ( 125.2 ) | Increase in accounts payable, accrued expenses, and other liabilities 600.4 2.3
- Purchases of marketable and other securities ( 4,706.0 ) ( 5,394.4 ) | Sales or maturities of marketable and other securities 4,755.1 5,626.2 | Capital expenditures ( 470.8 ) ( 448.3 )
Periodens resultat
- Net income $ 1,296.9 $ 1,391.6 $ 2,024.1 $ 2,200.3
- Net income per share - basic $ 12.62 $ 13.24 $ 19.58 $ 20.78 | Net income per share - diluted $ 12.23 $ 12.81 $ 18.95 $ 20.02
- Statements of Comprehensive Income | Net income $ 1,296.9 $ 1,391.6 $ 2,024.1 $ 2,200.3 | Other comprehensive income (loss), net of tax:
- Stock-based compensation charges — — — — 246.9 — — — — 246.9 | Net income — — — — — 727.2 — — — 727.2 | Other comprehensive loss, net of tax
- Stock-based compensation charges — — — — 242.5 — — — — 242.5 | Net income — — — — — 1,296.9 — — — 1,296.9 | Other comprehensive loss, net of tax — — — — — — ( 47.7 ) — — ( 47.7 )
- Stock-based compensation charges — — — — 258.9 — — — — 258.9 | Net income — — — — — 808.7 — — — 808.7 | Other comprehensive income, net of tax — — — — — — 37.0 — — 37.0
- 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
- Cash flows from operating activities: | Net income $ 2,024.1 $ 2,200.3 | Adjustments to reconcile net income to net cash provided by operating activities:
Kassaflöde
- 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 are expected to expand and require additional resources. We also expect to incur substantial costs related to the commer | 35
- • limit our ability to access capital markets and incur additional debt in the future; | • require us to dedicate a substantial portion of our cash flow from operations to payments on our indebtedness, thereby reducing the availability of our cash flow for other purposes, including business development efforts, research and development, and mergers and acquisitions; and | • limit our flexibility in planning for, or reacting to, changes in our business and the industry in which we operate, thereby placing us at a competitive disadvantage compared to competitors that have less debt.
Likvida medel
- Current assets: | Cash and cash equivalents $ 2,455.8 $ 3,118.1 | Marketable securities 5,538.8 5,487.1
- Cash and cash equivalents $ 2,455.8 $ 1,995.8 | Restricted cash included in Other current assets
- Financial assets: | Cash and cash equivalents $ 2,455.8 $ 3,118.1 $ (662.3) | Marketable securities - current 5,538.8 5,487.1 51.7
- Our investments are subject to risks and other external factors that may result in losses or affect the liquidity of these investments. | As of June 30, 2026, we had $2.456 billion in cash and cash equivalents and $16.168 billion in marketable and other securities, as further described in Note 5 and Note 6 to our Condensed Consolidated Financial Statements included in this report. Our investments consist primarily of debt securities, including investment-grade corporate bonds. These fixed-income investments are subject to external factors that may adversely affect their market value or liquidity, such as interest rate, liquidity, | 77
Nettoskuld
- Net income $ 2,024.1 $ 2,200.3 | Adjustments to reconcile net income to net cash provided by operating activities: | Depreciation and amortization 246.9 262.0
- Total adjustments ( 132.2 ) ( 10.8 ) | Net cash provided by operating activities 1,891.9 2,189.5
- ( 99.9 ) ( 230.0 ) | Net cash used in investing activities ( 521.6 ) ( 446.5 )
- — ( 10.3 ) | Net cash used in financing activities ( 2,026.8 ) ( 2,217.4 )
- Research and development expenses included stock-based compensation expense of $130.8 million and $139.0 million for the three months ended June 30, 2026 and 2025, respectively, and $265.9 million and $280.0 million for the six months ended June 30, 2026 and 2025, 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 | 40
Eget kapital
- Condensed Consolidated Statements of Stockholders' Equity | 4
- LIABILITIES AND STOCKHOLDERS' EQUITY | Current liabilities:
- Stockholders' equity: | Preferred Stock, par value $ .01 per share; 30.0 shares authorized; shares issued and outstanding - no ne
- ( 20,574.9 ) ( 18,612.8 ) | Total stockholders' equity 31,711.4 31,256.9 | Total liabilities and stockholders' equity $ 41,730.6 $ 40,558.7
- Total stockholders' equity 31,711.4 31,256.9 | Total liabilities and stockholders' equity $ 41,730.6 $ 40,558.7
- 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
- CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (Unaudited) (continued)
Antal aktier
- The number of shares outstanding of each of the registrant's classes of common stock as of July 23, 2026:
- Class of Common Stock Number of Shares
- Weighted average shares outstanding - basic 102.8 105.1 103.4 105.9 | Weighted average shares outstanding - diluted 106.0 108.6 106.8 109.9
- Weighted average shares - basic 102.8 105.1 103.4 105.9 | Effect of dilutive securities:
- Restricted stock awards and restricted stock units 1.1 2.0 1.1 2.0 | Weighted average shares - diluted 106.0 108.6 106.8 109.9
- Number of shares 1.7 1.9 2.7 3.4 | Total cost of shares $ 1,164.5 $ 1,069.9 $ 1,967.7 $ 2,122.3
- Period Total Number of Shares Purchased Average Price Paid per Share Total Number of Shares Purchased as Part of Publicly Announced Programs Approximate Dollar Value of Shares that May Yet Be Purchased Under the Programs | (In millions)
- (a) The difference between the total number of shares purchased and the total number of shares purchased as part of publicly announced programs relates to Common Stock withheld by us for employees to satisfy their tax withholding obligations arising upon the vesting of restricted stock granted under one of our long-term incentive plans
Antal anställda
- On January 7, 2025 (as amended on September 8, 2025 and October 30, 2025), a purported shareholder filed a putative class action civil complaint, on behalf of himself and all others similarly situated, in the SDNY against the Company and certain current and former executive officers of the Company. The second amended complaint asserts violations of federal securities laws in connection with statements or disclosures purportedly related to the conduct alleged in the March 2024 Civil Complaint dis | On July 16, 2026, a purported shareholder filed a putative class action civil complaint, on behalf of herself and all others similarly situated, in the SDNY against the Company and certain employees of the Company. The complaint asserts violations of federal securities laws in connection with statements or disclosures purportedly related to the Company's fianlimab clinical development program. | j. Sanofi Litigation
- • If we fail to comply with our reporting and payment obligations under the Medicaid Drug Rebate program or other governmental pricing programs, we could be subject to additional reimbursement requirements, penalties, sanctions, and fines. | • We face risks from the improper conduct of our employees, agents, contractors, or collaborators, including those relating to potential non-compliance with relevant laws and regulations such as the Foreign Corrupt Practices Act and the U.K. Bribery Act. | • Our operations are subject to environmental, health, and safety laws and regulations, including those governing the use of hazardous materials.
- Pursuant to applicable law, knowing provision of false information in connection with price reporting or contract‑based requirements under the VA FSS and/or Tricare programs can subject a manufacturer to civil monetary penalties. These program and contract-based obligations also contain extensive disclosure and certification requirements. If we overcharge the government in connection with our arrangements with FSS or Tricare, we are required to refund the difference to the government. Failure to | Risks from the improper conduct of employees, agents, contractors, or collaborators could adversely affect our reputation and our business, prospects, operating results, and financial condition. | We cannot ensure that our compliance controls, policies, and procedures will in every instance protect us from acts committed by our employees, agents, contractors, or collaborators that would violate the laws or regulations of the jurisdictions in which we operate, including without limitation healthcare, employment, foreign corrupt practices, trade restrictions and sanctions, environmental, competition, and privacy laws and regulations. Such improper actions could subject us to civil or crimin
- Risks from the improper conduct of employees, agents, contractors, or collaborators could adversely affect our reputation and our business, prospects, operating results, and financial condition. | We cannot ensure that our compliance controls, policies, and procedures will in every instance protect us from acts committed by our employees, agents, contractors, or collaborators that would violate the laws or regulations of the jurisdictions in which we operate, including without limitation healthcare, employment, foreign corrupt practices, trade restrictions and sanctions, environmental, competition, and privacy laws and regulations. Such improper actions could subject us to civil or crimin | In particular, our business activities outside the United States (which have recently expanded and continue to expand due to, in part, our efforts to establish further commercialization and co-commercialization capabilities in certain jurisdictions outside the United States) are subject to the Foreign Corrupt Practices Act, or FCPA, and similar anti-bribery or anti-corruption laws, regulations or rules of other countries in which we operate, including the U.K. Bribery Act. The FCPA generally pro
- We cannot ensure that our compliance controls, policies, and procedures will in every instance protect us from acts committed by our employees, agents, contractors, or collaborators that would violate the laws or regulations of the jurisdictions in which we operate, including without limitation healthcare, employment, foreign corrupt practices, trade restrictions and sanctions, environmental, competition, and privacy laws and regulations. Such improper actions could subject us to civil or crimin | In particular, our business activities outside the United States (which have recently expanded and continue to expand due to, in part, our efforts to establish further commercialization and co-commercialization capabilities in certain jurisdictions outside the United States) are subject to the Foreign Corrupt Practices Act, or FCPA, and similar anti-bribery or anti-corruption laws, regulations or rules of other countries in which we operate, including the U.K. Bribery Act. The FCPA generally pro | 69
- these laws and regulations could result in fines, criminal sanctions against us, our officers, or our employees, requirements to obtain export licenses, cessation of business activities in sanctioned countries, implementation of compliance programs, and prohibitions on the conduct of our business. Any such violations could include prohibitions on our ability to offer our products in one or more countries and could materially damage our reputation, our brand, our ability to expand internationally | Our operations are subject to environmental, health, and safety laws and regulations, including those governing the use of hazardous materials. Compliance with these laws and regulations is costly, and we may incur substantial liability arising from our activities involving the use of hazardous materials.
- • unfamiliar foreign laws or regulatory requirements or unexpected changes to those laws or requirements, including those with which we and/or our collaborators must comply in order to maintain our marketing authorizations outside the United States, and the cost of compliance with such foreign laws and regulatory requirements; | • other laws and regulatory and industry trade association requirements to which our business activities abroad are subject, such as the FCPA and the U.K. Bribery Act (discussed in greater detail above under " Risks from the improper conduct of employees, agents, contractors, or collaborators could adversely affect our reputation and our business, prospects, operating results, and financial condition "), as well as labor and employment laws and regulations; | • changes in the political or economic condition of a specific country or region, including as a result of the Russia-Ukraine war, or armed conflicts in the Middle East;
- We face risks related to the personal data we collect, process, and share. | Our ability to conduct our business is significantly dependent on the data that we collect, process, and share in discovering, developing, and commercializing drug products. These data are often considered personal data and are therefore regulated by privacy and data protection laws in and outside the United States, including health privacy laws, data breach notification laws, consumer protection laws, data localization laws, biometric privacy laws, and genetic privacy laws. Such laws may apply | In the United States, there are numerous federal and state laws and regulations governing data privacy of personal data and the collection, use, disclosure, and protection of health data, genetic data, consumer data, and children's data. At the federal level, most U.S. healthcare providers, including research institutions from which we or our collaborators obtain clinical trial data, are subject to privacy and security regulations promulgated under the Health Insurance Portability and Accountabi
Bruttomarginal
- June 30, | (In millions, except gross margin on net product sales) | 2026 2025 2026 2025
- $ 360.7 $ 275.6 $ 734.1 $ 541.1 | Gross margin on net product sales (a) | 78% 83% 77% 82%
- (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 six months ended June 30, 2026, compared to the same periods in 2025, primarily due to unabsorbed manufacturing costs as a result of a temporary interruption of bulk manufacturing production at our facility in Limerick, Ireland, due to unanticipated facility repairs that commenced during the first quarter of 2026. As of June 30, 2026, bulk manufacturing production returned to normal levels. The interruption did not impact the availabi | Other Income (Expense)
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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 June 30, 2026
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 July 23, 2026:
Class of Common Stock Number of Shares
Class A Stock, $.001 par value 1,817,146
Common Stock, $.001 par value 101,137,842
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
22
Item 3.
Quantitative and Qualitative Disclosures About Market Risk
43
Item 4.
Controls and Procedures
43
PART II
OTHER INFORMATION
Item 1.
Legal Proceedings
44
Item 1A.
Risk Factors
44
Item 2.
Unregistered Sales of Equity Securities and Use of Proceeds
81
Item 5.
Other Information
81
Item 6.
Exhibits
81
SIGNATURE PAGE
82
"Altibodies ™ ," "ARCALYST ® ," "Evkeeza ® ," "EYLEA ® ," "EYLEA HD ® ," "Inmazeb ® ," "Libtayo ® ," "Lynozyfic ® ," "Ordspono ™ ," "Otarmeni ™ ," "Praluent ® " (in the United States), "REGEN-COV ® ," "Regeneron ® ," "Regeneron Genetics Center ® ," "RGC ® ," "STEM-Fueled ™ ," " 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)
June 30, December 31,
2026 2025
ASSETS
Current assets:
Cash and cash equivalents $ 2,455.8 $ 3,118.1
Marketable securities 5,538.8 5,487.1
Accounts receivable, net 6,565.4 5,741.1
Inventories 3,084.3 3,200.8
Prepaid expenses and other current assets 801.7 474.8
Total current assets 18,446.0 18,021.9
Marketable securities 9,828.3 10,260.6
Property, plant, and equipment, net 5,458.9 5,120.4
Intangible assets, net 1,309.8 1,257.4
Deferred tax assets 4,381.4 4,077.2
Other noncurrent assets 2,306.2 1,821.2
Total assets $ 41,730.6 $ 40,558.7
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $ 1,159.3 $ 939.0
Accrued expenses and other current liabilities 2,966.5 2,876.4
Finance lease liabilities 720.0 —
Deferred revenue 684.8 553.0
Total current liabilities 5,530.6 4,368.4
Long-term debt 1,986.6 1,985.9
Finance lease liabilities — 720.0
Deferred revenue 220.4 208.7
Other noncurrent liabilities 2,281.6 2,018.8
Total liabilities 10,019.2 9,301.8
Stockholders' equity:
Preferred Stock, par value $ .01 per share; 30.0 shares authorized; shares issued and outstanding - no ne
— —
Class A Stock, convertible, par value $ .001 per share; 40.0 shares authorized; shares issued and outstanding - 1.8 in 2026 and 2025
— —
Common Stock, par value $ .001 per share; 320.0 shares authorized; shares issued - 138.0 in 2026 and 137.6 in 2025
0.1 0.1
Additional paid-in capital 14,700.6 13,995.0
Retained earnings 37,621.4 35,797.1
Accumulated other comprehensive (loss) income ( 35.8 ) 77.5
Treasury Stock, at cost; 36.4 shares in 2026 and 33.7 shares in 2025
( 20,574.9 ) ( 18,612.8 )
Total stockholders' equity 31,711.4 31,256.9
Total liabilities and stockholders' equity $ 41,730.6 $ 40,558.7
The accompanying notes are an integral part of the financial statements.
2
Table of Contents
REGENERON PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (Unaudited)
(In millions, except per share data)
Three Months Ended
June 30, Six Months Ended
June 30,
2026
2025
2026
2025
Statements of Operations
Revenues:
Net product sales $ 1,642.4 $ 1,631.0 $ 3,176.9 $ 3,046.6
Collaboration revenue 2,455.0 1,860.7 4,354.7 3,391.9
Other revenue 193.3 183.9 364.5 265.8
4,290.7 3,675.6 7,896.1 6,704.3
Expenses:
Research and development 1,631.6 1,421.7 3,175.1 2,749.1
Acquired in-process research and development 127.0 10.0 228.9 22.3
Selling, general, and administrative 662.1 634.2 1,309.8 1,267.2
Cost of goods sold 360.7 275.6 734.1 541.1
Cost of collaboration and contract manufacturing 215.8 254.6 511.8 453.4
2,997.2 2,596.1 5,959.7 5,033.1
Income from operations 1,293.5 1,079.5 1,936.4 1,671.2
Other income (expense):
Other income (expense), net
245.3 442.8 446.5 764.8
Interest expense ( 11.0 ) ( 3.6 ) ( 23.9 ) ( 12.3 )
234.3 439.2 422.6 752.5
Income before income taxes 1,527.8 1,518.7 2,359.0 2,423.7
Income tax expense
230.9 127.1 334.9 223.4
Net income $ 1,296.9 $ 1,391.6 $ 2,024.1 $ 2,200.3
Net income per share - basic $ 12.62 $ 13.24 $ 19.58 $ 20.78
Net income per share - diluted $ 12.23 $ 12.81 $ 18.95 $ 20.02
Weighted average shares outstanding - basic 102.8 105.1 103.4 105.9
Weighted average shares outstanding - diluted 106.0 108.6 106.8 109.9
Statements of Comprehensive Income
Net income $ 1,296.9 $ 1,391.6 $ 2,024.1 $ 2,200.3
Other comprehensive income (loss), net of tax:
Unrealized (loss) gain on debt securities ( 48.0 ) 22.1 ( 113.8 ) 60.2
Gain on foreign currency translation 0.3 1.3 0.5 0.2
Comprehensive income $ 1,249.2 $ 1,415.0 $ 1,910.8 $ 2,260.7
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, 2025
1.8 $ — 137.6 $ 0.1 $ 13,995.0 $ 35,797.1 $ 77.5 ( 33.7 ) $ ( 18,612.8 ) $ 31,256.9
Issuance of Common Stock for equity awards granted under long-term incentive plans — — 0.3 — 167.0 — — — — 167.0
Common Stock tendered upon exercise of stock options and vesting of restricted stock for employee tax obligations — — — — ( 29.1 ) — — — — ( 29.1 )
Issuance/distribution of Common Stock for 401(k) Savings Plan — — — — 21.5 — — — 2.5 24.0
Repurchases of Common Stock — — — — — — — ( 1.0 ) ( 803.2 ) ( 803.2 )
Dividends declared
— — — — — ( 100.5 ) — — — ( 100.5 )
Stock-based compensation charges — — — — 246.9 — — — — 246.9
Net income — — — — — 727.2 — — — 727.2
Other comprehensive loss, net of tax
— — — — — — ( 65.6 ) — — ( 65.6 )
Balance, March 31, 2026
1.8 — 137.9 0.1 14,401.3 36,423.8 11.9 ( 34.7 ) ( 19,413.5 ) 31,423.6
Issuance of Common Stock for equity awards granted under long-term incentive plans — — 0.1 — 43.4 — — — — 43.4
Common Stock tendered upon exercise of stock options and vesting of restricted stock for employee tax obligations — — — — ( 7.7 ) — — — — ( 7.7 )
Issuance/distribution of Common Stock for 401(k) Savings Plan — — — — 21.1 — — — 3.1 24.2
Repurchases of Common Stock — — — — — — — ( 1.7 ) ( 1,164.5 ) ( 1,164.5 )
Dividends declared — — — — — ( 99.3 ) — — — ( 99.3 )
Stock-based compensation charges — — — — 242.5 — — — — 242.5
Net income — — — — — 1,296.9 — — — 1,296.9
Other comprehensive loss, net of tax — — — — — — ( 47.7 ) — — ( 47.7 )
Balance, June 30, 2026 1.8 $ — 138.0 $ 0.1 $ 14,700.6 $ 37,621.4 $ ( 35.8 ) ( 36.4 ) $ ( 20,574.9 ) $ 31,711.4
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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, 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
The accompanying notes are an integral part of the financial statements.
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REGENERON PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited)
(In millions)
Six Months Ended
June 30,
2026
2025
Cash flows from operating activities:
Net income $ 2,024.1 $ 2,200.3
Adjustments to reconcile net income to net cash provided by operating activities:
Depreciation and amortization 246.9 262.0
Stock-based compensation expense 500.4 507.4
Gains on marketable and other securities, net ( 86.9 ) ( 389.9 )
Other, net
110.5 ( 17.7 )
Deferred income taxes ( 290.4 ) ( 274.3 )
Changes in assets and liabilities:
(Increase) decrease in accounts receivable ( 837.3 ) 629.6
Increase in inventories ( 1.6 ) ( 194.8 )
Increase in prepaid expenses and other assets ( 517.7 ) ( 410.2 )
Increase (decrease) in deferred revenue 143.5 ( 125.2 )
Increase in accounts payable, accrued expenses, and other liabilities 600.4 2.3
Total adjustments ( 132.2 ) ( 10.8 )
Net cash provided by operating activities 1,891.9 2,189.5
Cash flows from investing activities:
Purchases of marketable and other securities ( 4,706.0 ) ( 5,394.4 )
Sales or maturities of marketable and other securities 4,755.1 5,626.2
Capital expenditures ( 470.8 ) ( 448.3 )
Payments for intangible assets
( 99.9 ) ( 230.0 )
Net cash used in investing activities ( 521.6 ) ( 446.5 )
Cash flows from financing activities:
Proceeds from issuance of Common Stock 212.3 92.1
Payments in connection with Common Stock tendered for employee tax obligations ( 80.8 ) ( 9.9 )
Repurchases of Common Stock ( 1,963.7 ) ( 2,102.9 )
Dividends paid
( 194.6 ) ( 186.4 )
Other
— ( 10.3 )
Net cash used in financing activities ( 2,026.8 ) ( 2,217.4 )
Effect of exchange rate changes on cash, cash equivalents, and restricted cash ( 1.2 ) 1.0
Net decrease in cash, cash equivalents, and restricted cash ( 657.7 ) ( 473.4 )
Cash, cash equivalents, and restricted cash at beginning of period 3,123.7 2,489.0
Cash, cash equivalents, and restricted cash at end of period $ 2,466.0 $ 2,015.6
The accompanying notes are an integral part of the financial statements.
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REGENERON PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
1. Interim Financial Statements
Basis of Presentation
The interim Condensed Consolidated Financial Statements of Regeneron Pharmaceuticals, Inc. and its subsidiaries ("Regeneron," "Company," "we," "us," and "our") have been prepared in accordance with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all information and disclosures necessary for a presentation of the Company's financial position, results of operations, and cash flows in conformity with accounting principles generally accepted in the United States of America. In the opinion of management, these financial statements reflect all normal recurring adjustments and accruals necessary for a fair statement of the Company's condensed consolidated financial statements for such periods. The results of operations for any interim period are not necessarily indicative of the results for the full year. The December 31, 2025 Condensed Consolidated Balance Sheet data were derived from audited financial statements, but do not include all disclosures required by accounting principles generally accepted in the United States of America. These financial statements should be read in conjunction with the financial statements and notes thereto contained in the Company's Annual Report on Form 10-K for the year ended December 31, 2025.
Recently Issued Accounting Standards
Standard/Description
Effective Date
Impact of Adoption on the Company's Financial Statements
ASU 2024-03: In November 2024, the FASB issued new guidance which requires disclosure of disaggregated income statement expense information about specific categories (including purchases of inventory, employee compensation, depreciation, and intangible asset amortization) in the notes to financial statements.
January 1, 2027 for annual reporting periods and January 1, 2028 for interim reporting periods Currently evaluating impact
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2. Product Sales
Net product sales consist of the following:
Three Months Ended
June 30, Six Months Ended
June 30,
(In millions) 2026 2025 2026 2025
EYLEA HD ®
U.S. $ 596.3 $ 393.2 $ 1,064.7 $ 700.0
EYLEA ®
U.S. 412.2 754.3 885.3 1,490.3
Total EYLEA HD and EYLEA U.S. 1,008.5 1,147.5 1,950.0 2,190.3
Libtayo ®
U.S. 342.6 247.8 628.7 440.3
Libtayo
Rest of world
146.8 128.7 298.9 221.3
Total Libtayo
Global
489.4 376.5 927.6 661.6
Praluent ®
U.S. 74.7 65.8 141.3 122.6
Evkeeza ®
U.S. 53.3 41.2 99.0 72.1
Lynozyfic ®
Global
16.5 — 27.7 —
Other products
Global
— — 31.3 —
$ 1,642.4 $ 1,631.0 $ 3,176.9 $ 3,046.6
As of June 30, 2026 and December 31, 2025, the Company had $ 3.784 billion and $ 3.458 billion, respectively, of trade accounts receivable that were recorded within Accounts receivable, net.
The Company had product sales to certain customers that each accounted for more than 10% of total gross product revenue for the three and six months ended June 30, 2026 and 2025. Sales to each of these customers as a percentage of the Company's total gross product revenue are as follows:
Three Months Ended
June 30, Six Months Ended
June 30,
2026 2025 2026 2025
Customer A
45 % 52 % 45 % 52 %
Customer B
32 % 24 % 31 % 24 %
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3. Collaboration, License, and Other Agreements
a. Sanofi
The Company is party to a global collaboration with Sanofi to research, develop, and commercialize fully human monoclonal antibodies, which currently consists of Dupixent ® (dupilumab), Kevzara ® (sarilumab), and itepekimab . Agreed-upon development expenses incurred by the Company and Sanofi are generally shared equally. Sanofi leads commercialization activities for products under the collaboration, subject to the Company's right to co-commercialize such products. The Company co-commercializes Dupixent in the United States and in certain countries outside the United States. The Company also supplies certain commercial bulk product to Sanofi. The parties 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 % (Regeneron) and ending at 55 % (Sanofi)/ 45 % (Regeneron).
Amounts recognized in the Company's Statements of Operations in connection with its Sanofi collaboration are as follows:
Statement of Operations Classification Three Months Ended
June 30, Six Months Ended
June 30,
(In millions) 2026 2025 2026 2025
Regeneron's share of profits
Collaboration revenue $ 2,032.6 $ 1,282.1 $ 3,483.4 $ 2,300.2
Reimbursement for manufacturing of commercial supplies Collaboration revenue $ 141.7 $ 161.5 $ 296.0 $ 326.6
Regeneron's obligation for its share of Sanofi R&D expenses, net of reimbursement of R&D expenses (R&D expense)
$ ( 19.4 ) $ ( 18.0 ) $ ( 36.1 ) $ ( 33.5 )
Reimbursement of commercialization-related expenses
Reduction of SG&A expense $ 188.8 $ 194.0 $ 372.9 $ 353.2
As of June 30, 2026, the "development balance," which represented the Company's obligation to reimburse Sanofi for development expenses that were previously funded by Sanofi, was fully repaid and will no longer reduce Sanofi collaboration revenue beginning in the third quarter of 2026.
The following table summarizes contract balances in connection with the Company's Sanofi collaboration:
June 30, December 31,
(In millions) 2026
2025
Accounts receivable, net $ 2,272.4 $ 1,610.6
Deferred revenue
$ 607.5 $ 442.3
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b. Bayer
The Company is party to a license and collaboration agreement with Bayer for the development and commercialization of EYLEA 8 mg (aflibercept 8 mg) and EYLEA (aflibercept). Agreed-upon development expenses incurred by the Company and Bayer are generally shared equally. The Company is also obligated to use commercially reasonable efforts to supply clinical and commercial bulk product to Bayer.
Bayer is responsible for commercialization activities outside the United States, and the companies share equally in profits from such sales. Within the United States, the Company is responsible for commercialization and retains profits from such sales.
Amounts recognized in the Company's Statements of Operations in connection with its Bayer collaboration are as follows:
Statement of Operations Classification Three Months Ended
June 30, Six Months Ended
June 30,
(In millions) 2026 2025 2026 2025
Regeneron's share of profits
Collaboration revenue $ 227.3 $ 383.4 $ 467.3 $ 700.7
Reimbursement for manufacturing of commercial supplies
Collaboration revenue $ 48.9 $ 31.6 $ 96.2 $ 58.2
Regeneron's obligation for its share of Bayer R&D expenses, net of reimbursement of R&D expenses (R&D expense)/Reduction of R&D expense $ ( 0.6 ) $ ( 5.6 ) $ 0.4 $ ( 15.0 )
The following table summarizes contract balances in connection with the Company's Bayer collaboration:
June 30, December 31,
(In millions) 2026
2025
Accounts receivable, net $ 223.4 $ 287.6
Deferred revenue
$ 276.9 $ 295.7
c. Other
In addition to the collaboration and license agreements discussed above, the Company has collaboration and license agreements that are not individually significant to its operating results or financial condition at this time. Pursuant to the terms of those agreements, the Company may (i) incur, and/or get reimbursed for, research and development expenses, and/or (ii) be required to pay, and/or may receive, additional amounts contingent upon the occurrence of various future events (e.g., upon the achievement of development and commercial milestones), which in the aggregate could be significant.
Acquired In-Process Research and Development ("IPR&D") Expenses
Acquired IPR&D expenses for the three and six months ended June 30, 2026 were $ 127.0 million and $ 228.9 million, respectively, and included up-front and opt-in payments in connection with collaboration and licensing agreements. In addition, Acquired IPR&D expenses for the six months ended June 30, 2026 included the premium on equity securities purchased and development milestone payments in connection with collaboration and licensing agreements.
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4. Net Income Per Share
The calculations of basic and diluted net income per share are as follows:
Three Months Ended
June 30, Six Months Ended
June 30,
(In millions, except per share data) 2026 2025 2026 2025
Net income - basic and diluted $ 1,296.9 $ 1,391.6 $ 2,024.1 $ 2,200.3
Weighted average shares - basic 102.8 105.1 103.4 105.9
Effect of dilutive securities:
Stock options 2.1 1.5 2.3 2.0
Restricted stock awards and restricted stock units 1.1 2.0 1.1 2.0
Weighted average shares - diluted 106.0 108.6 106.8 109.9
Net income per share - basic $ 12.62 $ 13.24 $ 19.58 $ 20.78
Net income per share - diluted $ 12.23 $ 12.81 $ 18.95 $ 20.02
Shares which have been excluded from diluted per share amounts because their effect would have been antidilutive include the following:
Three Months Ended
June 30, Six Months Ended
June 30,
(Shares in millions) 2026 2025 2026 2025
Stock options 4.9 6.3 4.9 6.2
Restricted stock awards and restricted stock units
— 1.0 — 1.0
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5. Marketable Securities
Marketable securities as of June 30, 2026 and December 31, 2025 consist of both available-for-sale debt securities of investment grade issuers (see below and Note 6) as well as equity securities of publicly traded companies (see Note 6).
The following tables summarize the Company's investments in available-for-sale debt securities:
(In millions) Amortized Unrealized Fair
As of June 30, 2026
Cost Basis Gains Losses Value
Corporate bonds $ 10,768.4 $ 19.7 $ ( 36.2 ) $ 10,751.9
U.S. government and government agency obligations 3,317.6 1.0 ( 15.1 ) 3,303.5
Commercial paper 558.6 — ( 0.3 ) 558.3
Certificates of deposit 304.4 — ( 0.3 ) 304.1
Asset-backed securities 193.2 0.2 ( 0.3 ) 193.1
Sovereign bonds 78.5 0.1 ( 0.3 ) 78.3
$ 15,220.7 $ 21.0 $ ( 52.5 ) $ 15,189.2
As of December 31, 2025
Corporate bonds $ 10,141.0 $ 80.9 $ ( 2.4 ) $ 10,219.5
U.S. government and government agency obligations 4,352.2 15.2 ( 0.1 ) 4,367.3
Commercial paper 540.8 0.3 — 541.1
Certificates of deposit 265.7 0.2 — 265.9
Asset-backed securities 241.4 1.4 — 242.8
Sovereign bonds 76.3 0.5 — 76.8
$ 15,617.4 $ 98.5 $ ( 2.5 ) $ 15,713.4
The Company classifies its investments in available-for-sale debt securities based on their contractual maturity dates. The available-for-sale debt securities as of June 30, 2026 mature at various dates through December 2032. The fair values of available-for-sale debt securities by contractual maturity consist of the following:
June 30, December 31,
(In millions) 2026
2025
Maturities within one year $ 5,538.8 $ 5,487.1
Maturities after one year through five years 9,643.1 10,224.8
Maturities after five years 7.3 1.5
$ 15,189.2 $ 15,713.4
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6. Fair Value Measurements
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
The following tables summarize the Company's assets that are measured at fair value on a recurring basis:
(In millions) Fair
Fair Value Measurements at Reporting Date
As of June 30, 2026
Value
Level 1 Level 2
Cash equivalents $ 1,336.0 $ 1,205.3 $ 130.7
Available-for-sale debt securities:
Corporate bonds 10,751.9 — 10,751.9
U.S. government and government agency obligations 3,303.5 — 3,303.5
Commercial paper 558.3 — 558.3
Certificates of deposit 304.1 — 304.1
Asset-backed securities 193.1 — 193.1
Sovereign bonds 78.3 — 78.3
Equity securities (a)
177.9 177.9 —
$ 16,703.1 $ 1,383.2 $ 15,319.9
As of December 31, 2025
Cash equivalents $ 2,121.6 $ 1,127.7 $ 993.9
Available-for-sale debt securities:
Corporate bonds 10,219.5 — 10,219.5
U.S. government and government agency obligations 4,367.3 — 4,367.3
Commercial paper 541.1 — 541.1
Certificates of deposit 265.9 — 265.9
Asset-backed securities 242.8 — 242.8
Sovereign bonds 76.8 — 76.8
Equity securities 34.3 34.3 —
$ 17,869.3 $ 1,162.0 $ 16,707.3
(a) Includes equity securities of $ 114.0 million as of June 30, 2026 which were subject to transfer restrictions that expire in December 2026
In addition to the investments summarized in the table above, the Company recorded the following investments within Other noncurrent assets:
• As of June 30, 2026 and December 31, 2025, $ 597.3 million and $ 334.0 million, respectively, of equity securities that do not have a readily determinable fair value. The change in carrying value of such investments was primarily the result of additional purchases.
• As of June 30, 2026 and December 31, 2025, equity and other securities held through ownership interest in an investment fund of $ 203.9 million and $ 147.5 million, respectively, which are primarily measured at fair value based on Level 3 inputs. The change in carrying value was primarily the result of additional purchases by the fund.
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Other income (expense), net included net unrealized gains related to investments in equity securities that were still held as of the period end date of $ 61.4 million and $ 85.4 million for the three and six months ended June 30, 2026, respectively, and $ 249.8 million and $ 389.5 million for the three and six months ended June 30, 2025, respectively.
Other Fair Value Disclosures
The fair value of the Company's long-term debt, which was determined based on Level 2 inputs, was estimated to be $ 1.561 billion and $ 1.576 billion as of June 30, 2026 and December 31, 2025, respectively. The carrying value was $ 1.987 billion as of June 30, 2026 and $ 1.986 billion as of December 31, 2025.
7. Inventories
Inventories consist of the following:
June 30, December 31,
(In millions) 2026
2025
Raw materials $ 610.9 $ 641.5
Work-in-process 1,510.5 1,641.6
Finished goods 142.0 190.2
Deferred costs 820.9 727.5
$ 3,084.3 $ 3,200.8
Deferred costs represent the costs of product manufactured and shipped to the Company's collaborators for which recognition of revenue has been deferred.
8. Income Taxes
The Company's effective tax rate was 15.1 % and 8.4 % for the three months ended June 30, 2026 and 2025, respectively, and 14.2 % and 9.2 % for the six months ended June 30, 2026 and 2025, respectively.
The Company's effective tax rate for the three and six months ended June 30, 2026 and 2025 was positively impacted, compared to the U.S. federal statutory rate, primarily by income earned in foreign jurisdictions with tax rates lower than the U.S. federal statutory rate and, to a lesser extent, tax benefits from cross-border tax laws and federal tax credits for research activities, partly offset by changes in unrecognized tax benefits. In addition, the Company's effective tax rate for the three and six months ended June 30, 2025 was positively impacted by the release of liabilities associated with unrecognized tax benefits upon the settlement of the IRS audit of the Company's 2017 and 2018 federal income tax returns.
9. Stockholders' Equity
a. Share Repurchase Programs
The Company's board of directors has authorized share repurchase programs, including a share repurchase program for up to $ 3.0 billion of the Company's Common Stock which was authorized in April 2026. The programs have no time limit and can be discontinued at any time.
The table below summarizes the shares of the Company's Common Stock that the Company repurchased under its share repurchase programs and the cost of such shares, which were recorded as Treasury Stock.
Three Months Ended
June 30, Six Months Ended
June 30,
(In millions) 2026 2025
2026
2025
Number of shares 1.7 1.9 2.7 3.4
Total cost of shares $ 1,164.5 $ 1,069.9 $ 1,967.7 $ 2,122.3
As of June 30, 2026, $ 2.534 billion remained available for share repurchases under the Company's share repurchase programs.
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b. Dividends
In each of the first and second quarters of 2026, the Company's board of directors declared a quarterly cash dividend of $ 0.94 per share on its Common Stock and Class A Stock. Each quarterly dividend was paid to the Company's shareholders in the quarter in which the dividend was declared.
Additionally, in July 2026, the Company's board of directors declared a cash dividend of $ 0.94 per share on its Common Stock and Class A Stock. The dividend will be payable to the Company's shareholders in August 2026.
10. Statement of Cash Flows
The following provides a reconciliation of cash, cash equivalents, and restricted cash reported within the Condensed Consolidated Balance Sheets to the total of the same such amounts shown in the Condensed Consolidated Statements of Cash Flows:
June 30,
(In millions) 2026
2025
Cash and cash equivalents $ 2,455.8 $ 1,995.8
Restricted cash included in Other current assets
10.2 19.8
Total cash, cash equivalents, and restricted cash shown in the Condensed Consolidated Statements of Cash Flows
$ 2,466.0 $ 2,015.6
Restricted cash consists of amounts held pursuant to contractual arrangements and for dividends payable on certain equity awards.
Supplemental disclosure of non-cash investing and financing activities
June 30, December 31, June 30, December 31,
(In millions) 2026
2025
2025
2024
Accrued capital expenditures $ 182.4 $ 178.8 $ 126.1 $ 151.6
Accrued contingent consideration in connection with acquisitions
$ 67.2 $ 58.9 $ 53.6 $ 62.7
11. Segment Information
The Company operates in one business segment, which includes all activities related to the discovery, development, and commercialization of medicines for serious diseases. The determination of a single business segment is consistent with the consolidated financial information regularly provided to the Company's chief operating decision maker ("CODM"). The Company's CODM is its Chief Executive Officer, who reviews and evaluates consolidated net income for purposes of assessing performance, making operating decisions, allocating resources, and planning and forecasting for future periods.
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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
June 30, Six Months Ended
June 30,
(In millions) 2026 2025 2026 2025
Direct research and development expenses (a)
$ 539.2 $ 454.1 $ 1,037.8 $ 842.5
Indirect research and development expenses:
Payroll and benefits 460.4 449.4 944.5 901.1
Lab supplies and other research and development costs
71.5 64.9 130.8 124.9
Occupancy and other operating costs 182.0 158.6 352.9 313.0
Total indirect research and development expenses
713.9 672.9 1,428.2 1,339.0
Clinical manufacturing costs
404.7 337.0 768.9 647.3
Reimbursement of research and development expenses by collaborators ( 26.2 ) ( 42.3 ) ( 59.8 ) ( 79.7 )
Total research and development expenses
$ 1,631.6 $ 1,421.7 $ 3,175.1 $ 2,749.1
(a) Direct research and development expenses are comprised primarily of costs paid to third parties for clinical development activities, and the portion of research and development expenses incurred by our collaborators that we are obligated to reimburse
12. Legal Matters
The Company is a party to legal proceedings that arise in the ordinary course of its 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.
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 June 30, 2026 and December 31, 2025, the Company's accruals for loss contingencies were not material. There are certain loss contingencies that the Company deems reasonably possible for which the possible loss or range of possible loss is not estimable at this time. Costs associated with the Company's involvement in legal proceedings are expensed as incurred.
a. Proceedings Relating to EYLEA (aflibercept) Injection
(1) United States
In addition to the patent infringement proceedings in the United States alleging infringement of certain Company patents pertaining to EYLEA discussed below, certain of these patents have also been subject to post-grant proceedings before the United States Patent and Trademark Office.
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On January 10, 2024, the Company filed a patent infringement lawsuit (as amended on January 7, 2026) against Amgen Inc. ("Amgen") in the United States District Court for the Central District of California (subsequently transferred to the United States District Court for the Northern District of West Virginia) alleging that Amgen's filing for U.S. Food and Drug Administration ("FDA") approval of an aflibercept 2 mg biosimilar infringed certain Company patents (as amended, the "2024 lawsuit"). On September 23, 2024, the court denied the Company's motion for a preliminary injunction, which decision was affirmed by the Federal Circuit on March 14, 2025. On June 17, 2025, the Company filed an additional patent infringement lawsuit against Amgen in the United States District Court for the Central District of California alleging that Amgen's continued commercialization of its aflibercept 2 mg biosimilar infringes the Company's U.S. Patent No. 12,331,099 (the "2025 lawsuit"). On September 12, 2025, Amgen filed its answer and counterclaims in the 2025 lawsuit alleging, among other things, that the Company obtained numerous patents fraudulently, rendering them unenforceable, and that obtaining and enforcing certain Company patents violated Section 2 of the Sherman Antitrust Act of 1890, as amended (the "Sherman Antitrust Act"). On November 12, 2025, the Company filed a motion to dismiss certain of Amgen's affirmative defenses and counterclaims in the 2025 lawsuit, and an oral hearing on the motion was held on April 7, 2026. On March 9, 2026, Amgen filed its answer and counterclaims in the 2024 lawsuit; and, on April 20, 2026, the Company filed a motion to dismiss certain of Amgen's affirmative defenses and counterclaims in the 2024 lawsuit. On July 7, 2026, the court granted the Company's motion to dismiss Amgen's affirmative defenses and counterclaims challenged in the 2025 lawsuit with the exception of Amgen's prosecution delay affirmative defense and counterclaim.
(2) Outside the United States
As described in greater detail below, the Company has filed patent infringement lawsuits against various parties in several jurisdictions outside the United States alleging infringement of certain Company patents pertaining to EYLEA, and certain of these patents have also been subject to post-grant proceedings before the European Patent Office (the "EPO") and/or other comparable foreign authorities.
(i) Europe
(I) EPO Post-Grant Proceedings
Various parties, including Amgen and other, anonymous parties, are seeking revocation of the Company's European Patent Nos. 2,944,306 (the "'306 Patent"), 3,716,992 (the "'992 Patent"), and 3,384,049 (the "'049 Patent") before the Opposition Division ("OD") of the EPO. On November 26, 2024, following an oral hearing, the OD announced its decision to revoke the '306 Patent. An oral hearing concerning the Company's appeal of this decision has been scheduled for October 2026. On October 22, 2025, following an oral hearing, the OD upheld the validity of the '992 Patent's claims in amended form, which decision has been appealed by Amgen. On April 21, 2026, following an oral hearing, the OD invalidated the '049 Patent.
(II) Country-Specific Proceedings
The Company is also party to proceedings against various parties, including Sandoz Inc. ("Sandoz"), Sam Chun Dang Pharm. Co., Ltd ("Sam Chun Dang"), and/or their affiliated entities, before several European national courts. In Germany, in a January 2026 preliminary injunction proceeding, the Munich Regional Court issued a decision that found that Sandoz's aflibercept 2 mg biosimilar product infringes the Company's European Patent No. 2,364,691 (the "'691 Patent") and granted the Company's motion for a preliminary injunction, enjoining Sandoz from selling its aflibercept 2 mg biosimilar in Germany until the expiration of the '691 Patent. Following an appeal by Sandoz, in February 2026 the Munich Higher Regional Court suspended enforcement of, and the Company subsequently withdrew its request for, the preliminary injunction. In March–June 2026, the Company initiated patent infringement lawsuits in the Munich Regional Court against each of Sandoz and Sam Chun Dang alleging that their respective aflibercept 2 mg biosimilars infringe the '691 Patent and seeking damages for past infringement and injunctions to enjoin such parties and their commercialization partners from continuing to sell their respective aflibercept 2 mg biosimilars in Germany and several other countries in the European Union.
(ii) South Korea
The Company and Bayer Consumer Care AG have filed patent infringement lawsuits in the Seoul Central District Court against Sam Chun Dang and OPTUS Pharmaceutical Co., Ltd. These lawsuits seek damages and/or injunctive relief and allege that the making, constructing, using, or selling of an aflibercept 2 mg biosimilar by the defendants would infringe one or more claims of the Company's Korean Patent Nos. 1406811, 659477, and 2519234.
b. Proceedings Relating to EYLEA (aflibercept) Injection Pre-filled Syringe
On July 17, 2020, the Company filed an antitrust lawsuit (as amended on January 25, 2021) against Novartis Pharma AG, Novartis Pharmaceuticals Corporation, and Novartis Technology LLC (collectively, "Novartis") and Vetter Pharma International GmbH in the United States District Court for the Southern District of New York (the "SDNY") seeking a
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judgment that the defendants' conduct relating to Novartis's attempt to assert its U.S. Patent No. 9,220,631 against Regeneron in 2020 violated Sections 1 and 2 of the Sherman Antitrust Act, and constituted tortious interference with contract. The Company is also seeking injunctive relief and treble damages. On September 21, 2021, this lawsuit was transferred to the Northern District of New York. On June 10, 2022, the Company filed an appeal of the District Court's decision to dismiss the amended complaint with the U.S. Court of Appeals for the Second Circuit (the "Second Circuit"). On March 18, 2024, the Second Circuit reversed the District Court's decision to dismiss the amended complaint and remanded the lawsuit to the District Court for further proceedings consistent with the Second Circuit's opinion. On November 19, 2024, the Company moved to transfer the lawsuit back to the SDNY, which motion was granted on December 5, 2024.
c. Proceedings Relating to Praluent (alirocumab) Injection
On May 27, 2022, the Company filed a lawsuit against Amgen in the United States District Court for the District of Delaware, alleging that, beginning in 2020, Amgen engaged in an anticompetitive bundling scheme which was designed to exclude Praluent from the market in violation of federal and state laws. The lawsuit seeks damages for harm caused by the alleged scheme, as well as injunctive relief restraining Amgen from continuing its alleged anticompetitive conduct. A trial was held in May 2025. On May 15, 2025, the jury reached a verdict in Regeneron's favor on nine of the ten counts submitted to it and awarded Regeneron $ 135.6 million in compensatory damages and $ 271.2 million in punitive damages. On June 20, 2025, Amgen filed a post-trial motion for judgment as a matter of law or, in the alternative, for a new trial. Also on June 20, 2025, the Company filed a post-trial motion for (i) permanent injunctive relief, (ii) a constructive trust, and (iii) prejudgment interest. An oral hearing on Amgen's and Regeneron's respective post-trial motions was held on August 27, 2025.
d. Department of Justice Matters
On June 24, 2020, the U.S. Attorney's Office for the District of Massachusetts filed a civil complaint in the U.S. District Court for the District of Massachusetts alleging violations of the federal Anti-Kickback Statute and asserting causes of action under the federal False Claims Act and state law (the "June 2020 Civil Complaint") relating to the Company's support of 501(c)(3) organizations that provide financial assistance to patients. On September 27, 2023, the court (i) denied in part and granted in part the Company's motion for summary judgment and (ii) denied in its entirety the motion for partial summary judgment filed by the U.S. Attorney's Office for the District of Massachusetts. On October 25, 2023, the court certified for interlocutory appeal a portion of the court's September 27, 2023 order that addressed the causation standard applicable to the alleged violations of the federal Anti-Kickback Statute and federal False Claims Act. On February 18, 2025, the U.S. Court of Appeals for the First Circuit affirmed the portion of the court's September 27, 2023 order that had been certified for interlocutory appeal. On October 1, 2025, the U.S. Attorney's Office for the District of Massachusetts filed a second motion for partial summary judgment.
On June 3, 2021, the United States District Court for the Central District of California unsealed a qui tam complaint (as amended on October 29, 2021) filed against the Company, Regeneron Healthcare Solutions, Inc., and Sanofi-Aventis U.S. LLC by two qui tam plaintiffs (known as relators) purportedly on behalf of the United States and various states (the "State Plaintiffs"). The amended complaint alleges violations of the federal Anti-Kickback Statute and asserts causes of action under the federal False Claims Act and state law relating to allegedly unlawful remuneration and assistance provided to prescribers. Also on June 3, 2021, the United States and the State Plaintiffs notified the court of their decision to decline to intervene in the case. On January 14, 2022, the Company filed a motion to dismiss the amended complaint in its entirety. On July 25, 2023, the court granted in part and denied in part the Company's motion to dismiss. On September 1, 2023, the Company filed a second motion to dismiss the amended complaint or, in the alternative, a motion for judgment on the pleadings. On July 31, 2024 and August 15, 2024, respectively, the District Court granted the Company's second motion to dismiss the amended complaint with respect to the remaining causes of action under federal law and declined to exercise supplemental jurisdiction over the remaining causes of action under state law. On August 26, 2024, the qui tam plaintiffs filed a notice of appeal. Oral argument on the appeal was held on November 18, 2025.
In June 2021, the Company received a civil investigative demand ("CID") from the U.S. Department of Justice pursuant to the federal False Claims Act relating to, among other things, alleged inflated reimbursement rates for EYLEA by excluding applicable discounts, rebates, and benefits from the average sales price reported to the Centers for Medicare & Medicaid Services. On March 28, 2024, the U.S. District Court for the District of Massachusetts unsealed a qui tam complaint against the Company and others by two qui tam plaintiffs, purportedly on behalf of the United States and various states and municipalities, asserting causes of action under the federal False Claims Act and state and local laws, and alleging violations of the federal Anti-Kickback statute related to, among other things, the alleged conduct described above. Also on March 28, 2024, the U.S. Department of Justice and the U.S. Attorney's Office for the District of Massachusetts filed a civil complaint in partial intervention (the "March 2024 Civil Complaint") of the qui tam action, in the same court, asserting causes of action under the federal False Claims Act and a claim for unjust enrichment related to the alleged conduct described above. On June 25, 2024, the States of Colorado, Georgia, Michigan, North Carolina, Texas, and Washington filed a civil complaint in partial intervention (the "June 2024 Civil Complaint") in the same court asserting causes of action under various state laws related to
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the same alleged conduct. On April 29, 2025, the court denied the Company's motion to dismiss the March 2024 Civil Complaint and the June 2024 Civil Complaint. On June 18, 2025, the States of Maine, Nebraska, Ohio, Oregon, and Wyoming intervened in the action and filed a consolidated complaint asserting causes of action under their respective state laws.
On January 20, 2026, a qui tam plaintiff filed a complaint under seal against the Company and other pharmaceutical companies purportedly on behalf of the United States and various states. The complaint alleges violations of the federal Anti-Kickback Statute and other laws and asserts causes of action under the federal False Claims Act and various state laws relating to allegedly unlawful remuneration and assistance provided to prescribers. On May 22, 2026 and June 17, 2026, respectively, the United States and the applicable states notified the court of their decisions to decline to intervene in the case. On June 18, 2026, the United States District Court for the Central District of California unsealed the qui tam complaint. On July 20, 2026, the plaintiff filed an amended complaint.
e. Proceedings Initiated by Other Payors
The Company is party to several lawsuits relating to the conduct alleged in the June 2020 Civil Complaint discussed under "d. Department of Justice Matters" above. These lawsuits were filed by UnitedHealthcare Insurance Company and United Healthcare Services, Inc. (collectively, "UHC") and Humana Inc. ("Humana") in the SDNY on December 17, 2020 and July 22, 2021, respectively; and by Blue Cross and Blue Shield of Massachusetts, Inc. and Blue Cross and Blue Shield of Massachusetts HMO Blue, Inc. (collectively, "BCBS"), Medical Mutual of Ohio ("MMO"), Horizon Healthcare Services, Inc. d/b/a Horizon Blue Cross Blue Shield of New Jersey ("Horizon"), and Local 464A United Food and Commercial Workers Union Welfare Service Benefit Fund ("Local 464A") in the U.S. District Court for the District of Massachusetts on December 20, 2021, February 23, 2022, April 4, 2022, and June 17, 2022, respectively. These lawsuits allege causes of action under state law and the federal Racketeer Influenced and Corrupt Organizations Act ("RICO") and seek monetary damages and equitable relief. The MMO and Local 464A lawsuits are putative class action lawsuits. On December 29, 2021, the lawsuits filed by UHC and Humana were stayed by the SDNY pending resolution of the proceedings before the U.S. District Court for the District of Massachusetts concerning the allegations in the June 2020 Civil Complaint. On September 27, 2022, the lawsuits filed by BCBS, MMO, and Horizon were stayed by the U.S. District Court for the District of Massachusetts pending resolution of the proceedings before the same court concerning the allegations in the June 2020 Civil Complaint; and, in light of these stays, the parties to the Local 464A action have also agreed to stay that matter.
On June 24, 2024, a group of plaintiffs purporting to be assignees of claims by various Medicare Advantage plans and related entities filed a putative class action complaint in the U.S. District Court for the District of Columbia on behalf of Medicare Advantage plans and other payors. The lawsuit relates to the conduct alleged in the June 2020 Civil Complaint, March 2024 Civil Complaint, and June 2024 Civil Complaint discussed under "d. Department of Justice Matters" above. The lawsuit alleges causes of action under state law and RICO and seeks monetary damages and equitable relief. On October 22, 2024, the Company filed a motion to transfer the proceedings to the U.S. District Court for the District of Massachusetts or, in the alternative, to stay the proceedings or dismiss the proceedings. On January 28, 2025, pursuant to a stipulation among the parties, the proceedings were transferred to the U.S. District Court for the District of Massachusetts. On February 1, 2025, the parties jointly filed a stipulation to stay the action pending resolution of the proceedings before the same court concerning the allegations in the June 2020 Civil Complaint.
f. Shareholder Derivative Complaint – Department of Justice June 2020 Civil Complaint Matters
On June 29, 2021, an alleged shareholder filed a shareholder derivative complaint in the Supreme Court of the State of New York (the "NY Supreme Court"), naming the then-current and certain former members of the Company's board of directors and certain then-current and former executive officers of the Company as defendants and Regeneron as a nominal defendant. The complaint asserts that the individual defendants breached their fiduciary duties in relation to the allegations in the June 2020 Civil Complaint discussed under "d. Department of Justice Matters" above. The complaint seeks an award of damages allegedly sustained by the Company; an order requiring Regeneron to take all necessary actions to reform and improve its corporate governance and internal procedures; disgorgement from the individual defendants of all profits and benefits obtained by them resulting from their sales of Regeneron stock; and costs and disbursements of the action, including attorneys' fees. On July 28, 2021, the defendants filed a notice of removal, removing the case from the NY Supreme Court to the SDNY. On September 23, 2021, the plaintiff moved to remand the case to the NY Supreme Court. Also on September 23, 2021, the individual defendants moved to dismiss the complaint in its entirety. On December 19, 2022, the SDNY denied the plaintiff's motion to remand the case and granted a motion to stay the case pending resolution of the proceedings before the U.S. District Court for the District of Massachusetts concerning the allegations in the June 2020 Civil Complaint. As a result of the stay, the court also terminated the Company's motion to dismiss the complaint without prejudice. The Company can therefore renew the motion to dismiss upon conclusion of the stay.
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g. Shareholder Derivative Complaints – Department of Justice March 2024 Civil Complaint Matters
In 2025, various purported shareholders of the Company filed several shareholder derivative complaints in the SDNY or the NY Supreme Court against members of the Company's board of directors and certain current and former executive officers of the Company as defendants and Regeneron as a nominal defendant. The complaints allege that the individual defendants, among other things, breached their fiduciary duties to the Company by failing to properly manage and oversee the Company in connection with the conduct alleged in the March 2024 Civil Complaint discussed under "d. Department of Justice Matters" above, and one lawsuit also alleges a breach of fiduciary duty relating to the conduct alleged in the second amended putative class action civil complaint discussed under "i. Class Action Civil Complaint" below. The complaints also allege that the individual defendants breached the federal securities laws, wasted corporate assets, and unjustly enriched themselves at the expense of the Company. The complaints seek, among other things, an award of damages allegedly sustained by the Company as a result of the alleged misconduct of the individual defendants; an order requiring the individual defendants to take all necessary actions to reform and improve the Company's corporate governance and internal procedures; and costs and disbursements of the applicable action, including attorneys' fees. The cases filed in the SDNY were consolidated and stayed pending resolution of the motion to dismiss filed in the putative class action discussed under "i. Class Action Civil Complaint" below. The shareholder derivative complaints filed in the NY Supreme Court were removed to the SDNY, and the purported shareholders filed motions to remand. On March 16, 2026, the SDNY denied the motions to remand and consolidated the cases with the other shareholder derivative lawsuits pending in the SDNY (which, as noted above, are subject to a stay).
h. Shareholder Derivative Complaint – Director Compensation
On July 22, 2025, an alleged shareholder filed a shareholder derivative complaint in the NY Supreme Court, naming the current non-employee members of the Company's board of directors, and the co-Chairs of the Company's board of directors (who also serve as Regeneron's President and Chief Executive Officer and Regeneron's President and Chief Scientific Officer, respectively) as defendants and Regeneron as a nominal defendant. The complaint asserts that the individual defendants breached their fiduciary duties and/or were unjustly enriched when they approved and/or received allegedly excessive non-employee director compensation in 2024 and 2025, and that this allegedly excessive compensation was a waste of corporate assets. The complaint seeks damages in favor of Regeneron for the alleged breaches of fiduciary duties, unjust enrichment, and waste of corporate assets; improvements to Regeneron's corporate governance and internal procedures; equitable relief, including restitution from the individual defendants; and award of the costs of the action, including attorneys' fees. An oral hearing on the Company's motion to dismiss the complaint was held on April 17, 2026. On June 22, 2026, plaintiff's counsel filed a motion to substitute the named plaintiff.
i. Class Action Civil Complaints
On January 7, 2025 (as amended on September 8, 2025 and October 30, 2025), a purported shareholder filed a putative class action civil complaint, on behalf of himself and all others similarly situated, in the SDNY against the Company and certain current and former executive officers of the Company. The second amended complaint asserts violations of federal securities laws in connection with statements or disclosures purportedly related to the conduct alleged in the March 2024 Civil Complaint discussed under "d. Department of Justice Matters" above as well as allegations relating to the launch of EYLEA HD. On July 10, 2025, the court appointed a lead plaintiff and lead counsel for the action. On November 17, 2025, the Company filed a motion to dismiss the second amended complaint. An oral hearing on the Company's motion to dismiss was held on June 25, 2026.
On July 16, 2026, a purported shareholder filed a putative class action civil complaint, on behalf of herself and all others similarly situated, in the SDNY against the Company and certain employees of the Company. The complaint asserts violations of federal securities laws in connection with statements or disclosures purportedly related to the Company's fianlimab clinical development program.
j. Sanofi Litigation
On November 18, 2024, the Company filed a lawsuit (as amended on December 20, 2024) in the SDNY against Sanofi and certain of its affiliated entities (collectively, "Sanofi"). The lawsuit alleges that the defendants breached certain provisions of the parties' Amended and Restated License and Collaboration Agreement, dated as of November 10, 2009 (as amended, the "Collaboration Agreement"), concerning Sanofi's obligation to provide Regeneron with full access to material information relating to the commercialization of Dupixent or other products commercialized pursuant to the Collaboration Agreement and Regeneron's audit rights under the Collaboration Agreement. The lawsuit seeks a declaratory judgment, injunctive relief, damages, and other relief. On March 17, 2026, the court denied Sanofi's motion to dismiss the complaint.
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k. Dupixent Product Liability Litigation
Since 2025, a number of product liability lawsuits have been filed in various U.S. district and state courts against the Company and certain of Sanofi's affiliated entities claiming that Dupixent either caused or exacerbated the patients' T-cell lymphoma, and asserting causes of action under various state laws. On February 13, 2026, several of the plaintiffs filed a motion with the United States Judicial Panel on Multidistrict Litigation (the "JPML") seeking to consolidate the federal lawsuits for coordinated pretrial proceedings. On June 4, 2026, the JPML issued an order transferring the federal lawsuits to the District of New Jersey for coordinated pretrial proceedings.
On July 17, 2026, two plaintiffs filed a putative class action lawsuit in the United States District Court for the District of Maryland, alleging that the Company failed to warn that Dupixent allegedly causes or is linked to the development of cutaneous T-cell lymphoma. The complaint asserts causes of action under various state laws and seeks damages and equitable relief, including the creation of a fund to finance Dupixent medical monitoring and treatment services.
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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 products and product candidates (including biosimilar products) 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");
• 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, including in connection with our April 2026 agreements with the U.S. government discussed in this report;
• 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 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
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of any such proceedings and investigations, and the impact any of the foregoing may have on our business, prospects, operating results, and financial condition.
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
June 30, Six Months Ended
June 30,
(In millions, except per share data) 2026 2025
2026 2025
Revenues $ 4,290.7 $ 3,675.6 $ 7,896.1 $ 6,704.3
Net income $ 1,296.9 $ 1,391.6 $ 2,024.1 $ 2,200.3
Net income per share - diluted $ 12.23 $ 12.81 $ 18.95 $ 20.02
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
Macular edema following retinal vein occlusion ("RVO")
a a
EYLEA ® (aflibercept) Injection (a)
wAMD
a a a
DME
a a a
DR
a
RVO
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 patients aged 6 months and older)
a a a
Asthma (in patients aged 6 years and older)
a 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 patients aged 1 year and older)
a a
Prurigo nodularis a a a
Chronic spontaneous urticaria ("CSU") (in adults and adolescents)
a a a
CSU (in pediatrics 2–11 years of age)
a a
Bullous pemphigoid a a
Allergic fungal rhinosinusitis ("AFRS") (in patients aged 6 years and older)
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 a
Metastatic or recurrent second-line cervical cancer
a a
Praluent ® (alirocumab) Injection (c)
Cardiovascular risk reduction in patients at increased risk of cardiovascular events
a a
Hypercholesterolemia
a a
Heterozygous familial hypercholesterolemia ("HeFH") (in patients aged 8 years and older)
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 patients aged 1 year and older)
a
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Product (continued)
Disease Territory
U.S. EU Japan
Otarmeni ™ (lunsotogene parvec)
Hearing loss associated with variants in the OTOF gene (in adults, adolescents, and pediatrics)
a
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
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.
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Three Months Ended
June 30,
2026 2025 % Change
(In millions) U.S. ROW (f)
Total U.S. ROW Total (Total Sales)
Dupixent (a)
$ 4,561.1 $ 1,437.1 $ 5,998.2 $ 3,205.0 $ 1,139.6 $ 4,344.6 38 %
EYLEA HD (b)
$ 596.3 $ 366.3 $ 962.6 $ 393.2 $ 241.7 $ 634.9 52 %
EYLEA (b)
$ 412.2 $ 300.2 $ 712.4 $ 754.3 $ 736.0 $ 1,490.3 (52 %)
Total EYLEA HD and EYLEA
$ 1,008.5 $ 666.5 $ 1,675.0 $ 1,147.5 $ 977.7 $ 2,125.2 (21 %)
Libtayo (c)
$ 342.6 $ 146.8 $ 489.4 $ 247.8 $ 128.7 $ 376.5 30 %
Praluent (d)
$ 74.7 $ 190.9 $ 265.6 $ 65.8 $ 156.2 $ 222.0 20 %
Kevzara (a)
$ 143.4 $ 62.5 $ 205.9 $ 95.7 $ 56.5 $ 152.2 35 %
Lynozyfic $ 16.2 $ 0.3 $ 16.5 $ — $ — $ — *
Other products (e)
$ 54.0 $ 30.6 $ 84.6 $ 42.1 $ 30.0 $ 72.1 17 %
Six Months Ended
June 30,
2026 2025 % Change
(In millions) U.S. ROW Total U.S. ROW Total (Total Sales)
Dupixent (a)
$ 8,119.5 $ 2,758.8 $ 10,878.3 $ 5,834.4 $ 2,175.8 $ 8,010.2 36 %
EYLEA HD (b)
$ 1,064.7 $ 698.8 $ 1,763.5 $ 700.0 $ 388.1 $ 1,088.1 62 %
EYLEA (b)
$ 885.3 $ 696.4 $ 1,581.7 $ 1,490.3 $ 1,447.4 $ 2,937.7 (46 %)
Total EYLEA HD and EYLEA
$ 1,950.0 $ 1,395.2 $ 3,345.2 $ 2,190.3 $ 1,835.5 $ 4,025.8 (17 %)
Libtayo (c)
$ 628.7 $ 298.9 $ 927.6 $ 440.3 $ 221.3 $ 661.6 40 %
Praluent (d)
$ 141.3 $ 370.0 $ 511.3 $ 122.6 $ 292.7 $ 415.3 23 %
Kevzara (a)
$ 243.9 $ 106.8 $ 350.7 $ 168.5 $ 100.1 $ 268.6 31 %
Lynozyfic $ 26.9 $ 0.8 $ 27.7 $ — $ — $ — *
Other products (e)
$ 131.1 $ 59.9 $ 191.0 $ 73.2 $ 53.5 $ 126.7 51 %
* Percentage not meaningful or greater than 100%
(a) 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.
(b) 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.
(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. A program is classified in Phase 2 or 3 clinical development after enrollment for the corresponding study or studies has commenced.
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)
2026 Events to Date
Select Upcoming
Milestones
Ophthalmology
EYLEA HD (aflibercept) 8 mg (a)
–Pre-filled syringe (U.S.)
–RVO (Japan)
–Approved by European Commission ("EC") for RVO
–Approved by U.S. Food and Drug Administration ("FDA") for extension of dosing intervals up to 20 weeks in wAMD and DME
–FDA decisions for pre-filled syringe
Cemdisiran (k) (RNAi therapeutic targeting C5) ± pozelimab (f) (antibody to C5)
–Geographic atrophy
–Report initial results from lead-in cohort of Phase 3 study in geographic atrophy (combination and cemdisiran monotherapy) (fourth quarter 2026)
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")
–CSU in pediatrics (2–11 years of age) (Japan)
–Approved by FDA for AFRS
–Approved by FDA and EC for CSU in pediatrics
–Approved by Japan's Ministry of Health, Labour and Welfare ("MHLW") for bullous pemphigoid
–Withdrew regulatory application in EU for bullous pemphigoid
–Phase 3 studies in lichen simplex chronicus did not meet primary endpoints
Kevzara (sarilumab) (b)
Antibody to IL-6R
–Systemic juvenile idiopathic arthritis ("sJIA") (pivotal study)
Bremzalerbart-atisnolerbart (REGN5713-5715)
Multi-antibody therapy to Bet v 1
–Birch allergy
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Clinical Program (continued)
Phase 2 Phase 3 Regulatory
Review (h)
2026 Events to Date
Select Upcoming
Milestones
Freneslerbart-mevonlerbart (f) (REGN1908-1909)
Multi-antibody therapy to Fel d 1
–Cat allergy
–Initiate second Phase 3 study in cat allergy (second half 2026)
Solid Tumor Oncology
Libtayo (cemiplimab) (f)(g)
Antibody to PD-1
–Neoadjuvant CSCC
–First-line NSCLC, BNT116 (i) combination
–Neoadjuvant NSCLC
–Neoadjuvant hepatocellular carcinoma ("HCC")
–Early-stage CSCC (intralesional)
–Adjuvant and advanced CSCC (Japan)
Fianlimab (f) (REGN3767)
(antibody to LAG-3) + Libtayo (cemiplimab) (f)
–Perioperative NSCLC
–Perioperative melanoma
–First-line metastatic head and neck squamous cell carcinoma
–First-line metastatic melanoma (e)
–Adjuvant melanoma
–Reported that Phase 3 study versus pembrolizumab in first-line metastatic melanoma did not reach statistical significance for primary endpoint
–Phase 3 adjuvant melanoma study passed both pre-planned interim analyses conducted by Independent Data Monitoring Committee; study will continue to final analysis
–Phase 2 data in first-line advanced NSCLC did not support advancement to Phase 3
–Report results from Phase 3 study versus pembrolizumab in adjuvant melanoma (fourth quarter 2026)
Vidutolimod
Immune activator targeting TLR9
Ubamatamab (f) (REGN4018)
Bispecific antibody targeting MUC16 and CD3
–Serous ovarian cancer
–Advanced NSCLC (l)
REGN5668 (p)
Bispecific antibody targeting MUC16 and CD28
–Ovarian cancer
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Clinical Program (continued)
Phase 2 Phase 3 Regulatory
Review (h)
2026 Events to Date
Select Upcoming
Milestones
Nezastomig (REGN5678)
Bispecific antibody targeting PSMA and CD28
–Prostate cancer
Marlotamig (REGN7075)
Bispecific antibody targeting EGFR and CD28
–Solid tumors
Davutamig (REGN5093)
Bispecific antibody targeting two distinct MET epitopes
–MET-altered advanced NSCLC
Hematology-Oncology
Ordspono (odronextamab)
Bispecific antibody targeting CD20 and CD3
–B-cell non-Hodgkin lymphoma
("B-NHL") (pivotal study)
–Lymphoma (c)(e) (multiple lines and settings)
Lynozyfic (linvoseltamab) (f)
Bispecific antibody targeting BCMA and CD3
–Multiple myeloma precursor and related conditions
–Multiple myeloma (c)(e) (multiple lines and settings)
–Reported positive data from Phase 1/2 trial in amyloid light chain amyloidosis; results presented at American Society of Clinical Oncology ("ASCO") 2026 Annual Meeting
Cardiometabolic/Internal Medicine
Cenvacibart (REGN7508)
Antibody to Factor XI (catalytic domain)
–Thrombosis –Venous thromboembolism ("VTE") after total knee replacement surgery
–Cancer-associated VTE
–Stroke prevention in atrial fibrillation ("SPAF")
–Peripheral artery disease ("PAD")
–Initiate additional Phase 3 studies in anticoagulation (second half 2026)
Amrecibart (REGN9933)
Antibody to Factor XI (A2 domain)
–Thrombosis –SPAF
–PAD
–Initiate additional Phase 3 studies in anticoagulation (second half 2026)
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Clinical Program (continued)
Phase 2 Phase 3 Regulatory
Review (h)
2026 Events to Date
Select Upcoming
Milestones
Mibavademab (f)(o) (REGN4461)
Agonist antibody to leptin receptor ("LEPR")
–Functional hypothalamic amenorrhea
Trevogrumab (f) (REGN1033)
Antibody to myostatin (GDF8)
–Obesity (n)
–Report additional data from Phase 2 study in obesity (second half 2026)
Olatorepatide (q) (HS-20094)
GLP-1/GIP receptor agonist
–Obesity
–Initiate Phase 3 program in obesity in patients with and without Type 2 diabetes (second half 2026)
Baloncibart (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")
ALN-CIDEB (k)
RNAi therapeutic targeting CIDEB
–MASH (e)
ALN-PNP (k)
RNAi therapeutic targeting PNPLA3
–MASH
ALN-ANG3 (k)(r)
RNAi therapeutic targeting ANGPTL3
–Diabetic kidney disease
REGN13335
Antagonist antibody to PDGF-B
–Pulmonary arterial
hypertension
("PAH") (c)
Neurology/Rare Diseases
Garetosmab (f) (REGN2477)
Antibody to Activin A
–Fibrodysplasia ossificans progressiva
("FOP") (c)(d)(e)
–FOP (U.S. and EU)
–FDA decision on Biologics License Application ("BLA") (August 2026) and EC decision on Marketing Authorization Application ("MAA") (first half 2027) for FOP
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Clinical Program (continued)
Phase 2 Phase 3 Regulatory
Review (h)
2026 Events to Date
Select Upcoming
Milestones
Cemdisiran (k)
RNAi therapeutic targeting C5
–Generalized myasthenia gravis ("gMG") (c)
–gMG (U.S. and EU)
–FDA decision on New Drug Application ("NDA") (November 2026) and EC decision on MAA (second half 2027) for gMG
Cemdisiran (k) (RNAi therapeutic targeting C5) + pozelimab (f) (antibody to C5)
–Paroxysmal nocturnal hemoglobinuria ("PNH") (c)
–Report results from Phase 3 study in PNH (fourth quarter 2026)
Mibavademab (f) (REGN4461)
Agonist antibody to leptin receptor ("LEPR")
–Generalized lipodystrophy (c)(d)(e)
–Monogenic obesity
Nexiguran ziclumeran (nex-z) (j)
TTR gene knockout using CRISPR/Cas9
–Transthyretin amyloidosis with cardiomyopathy ("ATTR-CM") (c)(m)
–Hereditary transthyretin amyloidosis with polyneuropathy ("ATTRv-PN") (c)(m)
–FDA removed clinical hold on Phase 3 trials in ATTR-CM and ATTRv-PN
Otarmeni (lunsotogene parvec, formerly known as DB-OTO)
AAV-based gene therapy
–Hearing loss due to variants of otoferlin (" OTOF ") gene (c)(e)(m) (pivotal study)
–Hearing loss associated with variants in OTOF gene (EU and Japan)
–Approved by FDA for hearing loss associated with variants in OTOF gene
–EC decision on MAA for hearing loss associated with variants in OTOF gene (first quarter 2027)
ALN-SOD (s)
RNAi therapeutic targeting SOD1
–Amyotrophic lateral sclerosis (ALS)
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Note: We and Sanofi have discontinued further clinical development of itepekimab, an antibody to IL-33, in COPD, CRSwNP, and chronic rhinosinusitis without nasal polyposis ("CRSsNP"). In addition, we have discontinued further clinical development of REGN7999, an antibody to TMPRSS6, which was previously being studied in iron overload in beta-thalassemia.
(a) In collaboration with Bayer outside the United States
(b) In collaboration with Sanofi
(c) FDA granted Orphan Drug designation for one or more indications
(d) FDA granted Breakthrough Therapy designation for one or more indications
(e) FDA granted Fast Track designation for one or more indications
(f) Sanofi is entitled to receive royalties on sales of the product
(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) In-licensed from Alnylam
(l) Also studied in combination with marlotamig
(m) FDA granted Regenerative Medicine Advanced Therapy ("RMAT") designation for one or more indications
(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 or fianlimab
(q) In-licensed from Hansoh
(r) Studied as monotherapy and in combination with Evkeeza (evinacumab)
(s) In collaboration with Alnylam. Study on clinical hold in the U.S. by the FDA; continuing to enroll ex-U.S.
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Additional Information - Clinical Development Programs
EYLEA HD
The Company is working with the FDA and multiple third-party filling manufacturers to potentially achieve regulatory approval for the pre-filled syringe by the end of 2026.
Select Early-Stage Clinical Development Updates
In 2026, a Phase 1 study for REGN20423, a long-acting IL-13 antibody, in healthy volunteers and patients with atopic dermatitis was initiated.
Recent Developments – U.S. Government Agreements
In April 2026, we announced agreements with the U.S. government (the "U.S. Government Agreements") pursuant to which we have agreed, among other matters, to provide certain of our products that we wholly own in the United States to the Medicaid program at prices no greater than prices determined based on benchmarking against a defined group of other developed countries ("Most-Favored-Nation Pricing"). We have also agreed to price certain future medicines in the United States at prices no greater than Most-Favored-Nation Pricing; to participate in a direct purchasing platform, TrumpRx.gov, that will allow eligible patients to purchase Praluent directly; and to provide our recently FDA-approved gene therapy Otarmeni ™ for free in the United States. The U.S. Government Agreements further provide that Regeneron's products will not face tariffs as a result of the U.S. Department of Commerce's recent investigation under Section 232 of the Trade Expansion Act of 1962, as amended, through January 2029 so long as the Company continues its commitments to invest in manufacturing and research and development infrastructure in the United States.
Collaboration, License, and Other Agreements
Sanofi
We are party to a global collaboration with Sanofi to research, develop, and commercialize fully human monoclonal antibodies, which currently consists of Dupixent, Kevzara, and itepekimab. As described above, during 2026 we and Sanofi discontinued further clinical development of itepekimab.
Agreed-upon development expenses incurred by the parties are generally shared equally. 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 also 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).
Bayer
We and Bayer are parties to a license and collaboration agreement for the development and commercialization of EYLEA 8 mg and EYLEA. Agreed-upon development expenses incurred by the parties 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 expenses 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 therapeutics 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.
For each target nominated, we provide Alnylam with a specified amount of funding at program initiation and at lead candidate designation. 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 collaboration agreement ("Co-Co Collaboration Agreement") or a license agreement. The target nomination period of the collaboration agreement ended in May 2026.
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For CNS programs and liver programs, under a Co-Co Collaboration Agreement, the party designated as the lead party will lead development and commercialization of the program and the parties will split profits and share costs equally, subject to certain co-funding opt-outs at specified clinical trial phases or under other conditions.
We have also entered into various license agreements with Alnylam, with us as the licensee, including for cemdisiran as a monotherapy and for a combination consisting of cemdisiran and pozelimab. Under a license agreement, the lead party is designated as the licensee and has the right to develop and commercialize the product under such program. The licensee will be responsible for its own expenses incurred. The licensee will pay to the licensor certain development and/or commercialization milestone payments, as well as tiered royalty payments to the licensor based on the aggregate annual sales of the product.
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 had 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 share in 25% of any profits or losses.
Hansoh
We have licensed from Hansoh Pharmaceuticals Group Company Limited the development and commercial rights for olatorepatide (a dual GLP-1/GIP receptor agonist) outside of mainland China, Hong Kong, and Macau. 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 pay a low double-digit royalty on sales.
Tessera
In January 2026, our collaboration agreement with Tessera Therapeutics, Inc. to develop and commercialize TSRA-196 (Tessera's investigational program for the treatment of alpha-1 antitrypsin deficiency ("AATD")) became effective. Tessera will lead the initial first-in-human trial, while we will lead subsequent global development and commercialization. The parties will share worldwide development expenses and, if commercialized, any future profits or losses equally. Under the terms of the agreement, the Company made aggregate payments of $150.0 million in the first quarter of 2026, consisting of an up-front payment and the purchase of Tessera preferred stock. In addition, we are obligated to make additional payments upon achievement of certain development milestones.
Parabilis
In May 2026, we entered into a collaboration agreement with Parabilis Medicines to discover and develop multiple therapeutic candidates based on Parabilis’ Helicon ™ peptide platform. Under the terms of the agreement, we made a $50.0 million up-front payment and purchased $75.0 million of Parabilis common stock. We will lead development and commercialization, and Parabilis will be eligible to receive milestone payments for development, regulatory and commercial milestones, as well as tiered royalties up to low double-digits on sales. Under the terms of the agreement, additional targets may be pursued upon additional option payments made by us.
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 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 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 in each of the countries in which we operate. There is uncertainty surrounding whether or when new products
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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
June 30, Six Months Ended
June 30,
(In millions, except per share data) 2026 2025 2026 2025
Revenues $ 4,290.7 $ 3,675.6 $ 7,896.1 $ 6,704.3
Operating expenses 2,997.2 2,596.1 5,959.7 5,033.1
Income from operations 1,293.5 1,079.5 1,936.4 1,671.2
Other income (expense) 234.3 439.2 422.6 752.5
Income before income taxes 1,527.8 1,518.7 2,359.0 2,423.7
Income tax expense
230.9 127.1 334.9 223.4
Net income $ 1,296.9 $ 1,391.6 $ 2,024.1 $ 2,200.3
Net income per share - diluted $ 12.23 $ 12.81 $ 18.95 $ 20.02
Revenues
Three Months Ended
June 30, Six Months Ended
June 30,
(In millions) 2026 2025 $ Change 2026
2025
$ Change
Net product sales:
EYLEA HD - U.S. $ 596.3 $ 393.2 $ 203.1 $ 1,064.7 $ 700.0 $ 364.7
EYLEA - U.S. 412.2 754.3 (342.1) 885.3 1,490.3 (605.0)
Total EYLEA HD and EYLEA - U.S. 1,008.5 1,147.5 (139.0) 1,950.0 2,190.3 (240.3)
Libtayo - U.S. 342.6 247.8 94.8 628.7 440.3 188.4
Libtayo - ROW 146.8 128.7 18.1 298.9 221.3 77.6
Total Libtayo - Global 489.4 376.5 112.9 927.6 661.6 266.0
Praluent - U.S. 74.7 65.8 8.9 141.3 122.6 18.7
Evkeeza - U.S. 53.3 41.2 12.1 99.0 72.1 26.9
Lynozyfic - Global
16.5 — 16.5 27.7 — 27.7
Other products - Global — — — 31.3 — 31.3
Total net product sales $ 1,642.4 $ 1,631.0 $ 11.4 $ 3,176.9 $ 3,046.6 $ 130.3
Collaboration revenue:
Sanofi $ 2,174.3 $ 1,443.6 $ 730.7 $ 3,779.4 $ 2,626.8 $ 1,152.6
Bayer 276.2 415.0 (138.8) 563.5 758.9 (195.4)
Other 4.5 2.1 2.4 11.8 6.2 5.6
Other revenue 193.3 183.9 9.4 364.5 265.8 98.7
Total revenues $ 4,290.7 $ 3,675.6 $ 615.1 $ 7,896.1 $ 6,704.3 $ 1,191.8
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Net Product Sales
Net product sales of EYLEA HD increased for the three and six months ended June 30, 2026, compared to the same periods in 2025, primarily due to higher sales volumes, partly offset by a lower net selling price.
Net product sales of EYLEA decreased for the three and six months ended June 30, 2026, compared to the same periods in 2025, due to (i) lower sales volumes as a result of continued competitive pressures (as described below) 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 revenues derived from net product sales of EYLEA HD, EYLEA, and Dupixent " and " The commercial success of our products and product candidates is subject to significant competition - Marketed Products."
Global net product sales of Libtayo increased for the three and six months ended June 30, 2026, compared to the same periods in 2025, primarily due to higher sales volumes.
Collaboration Revenue
Sanofi Collaboration Revenue
Three Months Ended
June 30, Six Months Ended
June 30,
(In millions) 2026 2025 2026 2025
Regeneron's share of profits
$ 2,032.6 $ 1,282.1 $ 3,483.4 $ 2,300.2
Reimbursement for manufacturing of commercial supplies (a)
141.7 161.5 296.0 326.6
Total Sanofi collaboration revenue $ 2,174.3 $ 1,443.6 $ 3,779.4 $ 2,626.8
(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
June 30, Six Months Ended
June 30,
(In millions) 2026 2025 2026 2025
Dupixent and Kevzara net product sales $ 6,204.1 $ 4,496.8 $ 11,229.0 $ 8,278.8
Regeneron's share of collaboration profits in connection with commercialization of antibodies $ 2,285.6 $ 1,496.7 $ 4,013.4 $ 2,676.9
Reimbursement of development expenses incurred by Sanofi in accordance with Regeneron's payment obligation (a)
(253.0) (214.6) (530.0) (376.7)
Regeneron's share of profits $ 2,032.6 $ 1,282.1 $ 3,483.4 $ 2,300.2
Regeneron's share of profits as a percentage of Dupixent and Kevzara net product sales 33% 29% 31% 28%
(a) The Sanofi development balance, which represented our obligation to reimburse Sanofi for development expenses that were previously funded by Sanofi, was fully repaid as of June 30, 2026 and will no longer reduce our share of profits beginning in the third quarter of 2026
The increase in our share of profits for the three and six months ended June 30, 2026, compared to the same periods in 2025, was driven by higher profits primarily associated with an increase in Dupixent net product sales.
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Bayer Collaboration Revenue
Three Months Ended
June 30, Six Months Ended
June 30,
(In millions) 2026 2025 2026 2025
Regeneron's share of profits
$ 227.3 $ 383.4 $ 467.3 $ 700.7
Reimbursement for manufacturing of commercial supplies (a)
48.9 31.6 96.2 58.2
Total Bayer collaboration revenue $ 276.2 $ 415.0 $ 563.5 $ 758.9
(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
June 30, Six Months Ended
June 30,
(In millions) 2026 2025 2026 2025
EYLEA 8 mg and EYLEA net product sales outside the United States $ 666.5 $ 977.7 $ 1,395.2 $ 1,835.5
Regeneron's share of collaboration profit from sales outside the United States
$ 242.4 $ 399.9 $ 497.8 $ 733.5
Reimbursement of development expenses incurred by Bayer in accordance with Regeneron's payment obligation (a)
(15.1) (16.5) (30.5) (32.8)
Regeneron's share of profits
$ 227.3 $ 383.4 $ 467.3 $ 700.7
Regeneron's share of profits as a percentage of EYLEA 8 mg and EYLEA net product sales outside the United States
34% 39% 33% 38%
(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 six months ended June 30, 2026, compared to the same periods in 2025, was driven by lower profits primarily associated with a decrease in EYLEA sales outside the United States.
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Other Revenue
Three Months Ended
June 30, Six Months Ended
June 30,
(In millions) 2026 2025 2026 2025
Share of profits and royalties in connection with license and other agreements
$ 156.6 $ 108.6 $ 257.3 $ 172.0
Other (a)
36.7 75.3 107.2 93.8
Total other revenue $ 193.3 $ 183.9 $ 364.5 $ 265.8
(a) Consists primarily of amounts earned in connection with manufacturing product for others; corresponding costs incurred by the Company in connection with such manufacturing is recorded within Cost of collaboration and contract manufacturing
Operating Expenses
Three Months Ended
June 30, Six Months Ended
June 30,
(In millions) 2026 2025 $ Change 2026 2025 $ Change
Research and development (a)
$ 1,631.6 $ 1,421.7 $ 209.9 $ 3,175.1 $ 2,749.1 $ 426.0
Acquired in-process research and development 127.0 10.0 117.0 228.9 22.3 206.6
Selling, general, and administrative (a)
662.1 634.2 27.9 1,309.8 1,267.2 42.6
Cost of goods sold 360.7 275.6 85.1 734.1 541.1 193.0
Cost of collaboration and contract manufacturing (b)
215.8 254.6 (38.8) 511.8 453.4 58.4
Total operating expenses $ 2,997.2 $ 2,596.1 $ 401.1 $ 5,959.7 $ 5,033.1 $ 926.6
(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 $243.0 million and $251.7 million for the three months ended June 30, 2026 and 2025, respectively, and $500.4 million and $507.4 million for the six months ended June 30, 2026 and 2025, 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 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
June 30, Six Months Ended
June 30,
(In millions) 2026 2025 *
$ Change 2026
2025 *
$ Change
Direct research and development expenses:
Fianlimab $ 72.7 $ 47.9 $ 24.8 $ 115.0 $ 99.4 $ 15.6
Lynozyfic (linvoseltamab) 63.9 53.6 10.3 137.7 85.3 52.4
Ordspono (odronextamab)
49.3 42.8 6.5 97.9 69.0 28.9
Cenvacibart & amrecibart 44.9 11.1 33.8 78.1 20.1 58.0
Dupixent (dupilumab) 24.3 28.1 (3.8) 53.6 53.6 —
Pozelimab/cemdisiran
23.7 16.3 7.4 41.2 29.1 12.1
Itepekimab
23.6 34.5 (10.9) 45.4 62.8 (17.4)
Libtayo (cemiplimab) 15.7 18.5 (2.8) 35.4 39.3 (3.9)
Trevogrumab
11.5 23.6 (12.1) 27.8 39.1 (11.3)
Other product candidates in clinical development and other research programs
209.6 177.7 31.9 405.7 344.8 60.9
Total direct research and development expenses 539.2 454.1 85.1 1,037.8 842.5 195.3
Indirect research and development expenses:
Payroll and benefits 460.4 449.4 11.0 944.5 901.1 43.4
Lab supplies and other research and development costs
71.5 64.9 6.6 130.8 124.9 5.9
Occupancy and other operating costs 182.0 158.6 23.4 352.9 313.0 39.9
Total indirect research and development expenses
713.9 672.9 41.0 1,428.2 1,339.0 89.2
Clinical manufacturing costs
404.7 337.0 67.7 768.9 647.3 121.6
Reimbursement of research and development expenses by collaborators (26.2) (42.3) 16.1 (59.8) (79.7) 19.9
Total research and development expenses
$ 1,631.6 $ 1,421.7 $ 209.9 $ 3,175.1 $ 2,749.1 $ 426.0
* 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 $130.8 million and $139.0 million for the three months ended June 30, 2026 and 2025, respectively, and $265.9 million and $280.0 million for the six months ended June 30, 2026 and 2025, 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 six months ended June 30, 2026 included up-front and opt-in payments in connection with collaboration and licensing agreements. In addition, Acquired IPR&D expenses for the six months ended June 30, 2026 included the premium on equity securities purchased and development milestone payments in connection with collaboration and licensing agreements.
Selling, General, and Administrative Expenses
Selling, general, and administrative expenses increased for the six months ended June 30, 2026, compared to the same period in 2025, partly due to an increase in commercialization-related expenses and higher headcount and headcount-related costs, offset in part by lower charitable contributions to an independent non-profit patient assistance organization. Selling, general, and administrative expenses included stock-based compensation expense of $85.5 million and $91.8 million for the three months ended June 30, 2026 and 2025, respectively, and $174.7 million and $187.0 million for the six months ended June 30, 2026 and 2025, respectively.
Cost of Goods Sold
Three Months Ended
June 30, Six Months Ended
June 30,
(In millions, except gross margin on net product sales)
2026 2025 2026 2025
Cost of goods sold
$ 360.7 $ 275.6 $ 734.1 $ 541.1
Gross margin on net product sales (a)
78% 83% 77% 82%
(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 six months ended June 30, 2026, compared to the same periods in 2025, primarily due to unabsorbed manufacturing costs as a result of a temporary interruption of bulk manufacturing production at our facility in Limerick, Ireland, due to unanticipated facility repairs that commenced during the first quarter of 2026. As of June 30, 2026, bulk manufacturing production returned to normal levels. The interruption did not impact the availability of any of our products. See Part II, Item 1A. "Risk Factors - Risks Related to Manufacturing and Supply - Third-party service or supply failures, or other failures, business interruptions, or other disasters affecting our manufacturing facilities in Rensselaer, New York and Limerick, Ireland, the manufacturing facilities of our collaborators or contract manufacturers, or the facilities of any other party participating in the supply chain, could adversely affect our ability to supply our products. "
Other Income (Expense)
Three Months Ended
June 30, Six Months Ended
June 30,
(In millions) 2026 2025 *
2026 2025 *
Gains on marketable and other securities, net $ 61.9 $ 250.0 $ 86.9 $ 389.9
Interest income 183.3 174.8 366.8 348.3
Other 0.1 18.0 (7.2) 26.6
Other income (expense), net 245.3 442.8 446.5 764.8
Interest expense (11.0) (3.6) (23.9) (12.3)
Total other income (expense) $ 234.3 $ 439.2 $ 422.6 $ 752.5
* Certain prior year amounts have been reclassified to conform to the current year's presentation
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Income Taxes
Three Months Ended
June 30, Six Months Ended
June 30,
(In millions, except effective tax rate) 2026 2025 2026 2025
Income tax expense
$ 230.9 $ 127.1 $ 334.9 $ 223.4
Effective tax rate
15.1 % 8.4 % 14.2 % 9.2 %
Our effective tax rate for the three and six months ended June 30, 2026 and 2025 was positively impacted, compared to the U.S. federal statutory rate, primarily by income earned in foreign jurisdictions with tax rates lower than the U.S. federal statutory rate and, to a lesser extent, tax benefits from cross-border tax laws and federal tax credits for research activities, partly offset by changes in unrecognized tax benefits. In addition, our effective tax rate increased for the three and six months ended June 30, 2026, compared to the same periods in 2025, primarily due to the release of liabilities associated with unrecognized tax benefits upon the settlement of an IRS audit.
Liquidity and Capital Resources
Our financial condition is summarized as follows:
June 30, December 31,
(In millions) 2026 2025 $ Change
Financial assets:
Cash and cash equivalents $ 2,455.8 $ 3,118.1 $ (662.3)
Marketable securities - current 5,538.8 5,487.1 51.7
Marketable securities - noncurrent 9,828.3 10,260.6 (432.3)
$ 17,822.9 $ 18,865.8 $ (1,042.9)
Working capital:
Current assets $ 18,446.0 $ 18,021.9 $ 424.1
Current liabilities 5,530.6 * 4,368.4 1,162.2
$ 12,915.4 $ 13,653.5 $ (738.1)
Borrowings and finance lease liabilities:
Long-term debt $ 1,986.6 $ 1,985.9 $ 0.7
Finance lease liabilities $ 720.0 * $ 720.0 $ —
* The $720.0 million related to finance lease liabilities is classified within current liabilities as of June 30, 2026
As of June 30, 2026, we also had borrowing availability of $750.0 million under a revolving credit facility.
Sources and Uses of Cash
Six Months Ended
June 30,
(In millions) 2026 2025 $ Change
Cash flows provided by (used in):
Operating activities
$ 1,891.9 $ 2,189.5 $ (297.6)
Investing activities
$ (521.6) $ (446.5) $ (75.1)
Financing activities
$ (2,026.8) $ (2,217.4) $ 190.6
Cash Flows from Investing Activities
Capital expenditures for the six months ended June 30, 2026 included costs incurred in connection with the expansion of our research and support facilities at our Tarrytown, New York corporate headquarters, as well as costs associated with the
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expansion of our manufacturing facilities. We expect to incur capital expenditures of $1.030 billion to $1.100 billion for the full year of 2026, including in connection with the continued expansion of our facilities in Tarrytown, New York, and the continued expansion of our manufacturing facilities, including in connection with developing our property in Saratoga Springs, New York for production support activities and additional manufacturing capacity.
Cash Flows from Financing Activities
Share Repurchase Programs
Our board of directors has authorized share repurchase programs, including a share repurchase program for up to $3.0 billion of our Common Stock which was authorized in April 2026. The programs have no time limit and can be discontinued at any time. As of June 30, 2026, $2.534 billion remained available for share repurchases under the program.
Dividends
In each of the first and second quarters of 2026, our board of directors declared a quarterly cash dividend of $0.94 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 July 2026, our board of directors declared a cash dividend of $0.94 per share on our Common Stock and Class A Stock. The dividend will be payable on August 31, 2026 to our shareholders of record as of August 18, 2026.
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, 2025 (filed February 4, 2026). There have been no material changes to critical accounting estimates during the six months ended June 30, 2026.
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, 2025 (filed February 4, 2026). There have been no material changes to our market risks or to our management of such risks as of June 30, 2026.
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 June 30, 2026 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
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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. References to past events are provided as examples only and are not intended to be a complete listing or representation as to whether or not such factors have occurred in the past or their likelihood of occurring in the future. 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 revenues derived from net product sales of EYLEA HD, EYLEA, 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 (including those 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 or agreements we have entered into or may in the future enter into with the U.S. government or other governmental 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.
Regulatory and Development Risks
• Drug development and obtaining and maintaining regulatory approval for drug and biological products is costly, time-consuming, and highly uncertain.
• Serious complications or side effects in connection with the use or development of our products or product candidates could cause our regulatory approvals to be revoked or limited or lead to delay or discontinuation of development of our product candidates or new indications for our marketed products.
• We may be unable to formulate or manufacture our product candidates in a way that is suitable for clinical or commercial use, which would delay or prevent continued development of such candidates and/or receipt of regulatory approval or commercial sale.
• Many of our products are intended to be used in combination with drug-delivery devices, which may result in additional regulatory, commercialization, and other risks.
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Intellectual Property and Market Exclusivity Risks
• We may not be able to protect the confidentiality of our trade secrets, and our patents or other means of defending our intellectual property may be insufficient to protect our proprietary rights.
• Patents or proprietary rights of others may restrict our development, manufacturing, and/or commercialization efforts and subject us to patent litigation and other proceedings that could find us liable for damages.
• Loss or limitation of patent rights, and regulatory pathways for biosimilar competition, have in the past reduced and could reduce in the future the duration of market exclusivity for our products.
Manufacturing and Supply Risks
• We rely on limited internal and contracted manufacturing and supply chain capacity, which could adversely affect our ability to commercialize our products and to advance our clinical pipeline. As we increase our production in response to higher product demand or in anticipation of potential regulatory approvals, our current manufacturing capacity will likely not be sufficient, and our dependence on our collaborators and/or contract manufacturers may increase, to produce adequate quantities of drug material for both commercial and clinical purposes.
• Expanding our manufacturing capacity and establishing fill/finish capabilities has been and will continue to be costly and we may be unsuccessful in doing so in a timely manner, which could delay or prevent the launch and successful commercialization of our products approved for marketing and could jeopardize our clinical development programs.
• Our ability to manufacture products may be impaired if any of our or our collaborators' manufacturing activities, or the activities of other third parties involved in our manufacture and supply chain, are found to infringe patents of others.
• If sales of our marketed products do not meet the levels currently expected, or if the launch of any of our product candidates is delayed or unsuccessful, we may face costs related to excess inventory or unused capacity at our manufacturing facilities and at the facilities of third parties or our collaborators.
• Third-party service or supply failures, failures at our manufacturing facilities in Rensselaer, New York and Limerick, Ireland, or failures at the facilities of any other party participating in the supply chain could adversely affect our ability to supply our products.
• Our or our collaborators' or contract manufacturers' failure to meet the stringent requirements of governmental regulation in the manufacture of drug products or product candidates could result in incurring substantial remedial costs, delays in the development or approval of our product candidates or new indications for our marketed products and/or in their commercial launch if regulatory approval is obtained, and a reduction in sales.
Other Regulatory and Litigation Risks
• If the testing or use of our products harms people, or is perceived to harm them even when such harm is unrelated to our products, we could be subject to costly and damaging product liability claims.
• Our business activities have been, and may in the future be, challenged under U.S. federal or state and foreign healthcare laws, which may subject us to civil or criminal proceedings, investigations, or penalties.
• If we fail to comply with our reporting and payment obligations under the Medicaid Drug Rebate program or other governmental pricing programs, we could be subject to additional reimbursement requirements, penalties, sanctions, and fines.
• We face risks from the improper conduct of our employees, agents, contractors, or collaborators, including those relating to potential non-compliance with relevant laws and regulations such as the Foreign Corrupt Practices Act and the U.K. Bribery Act.
• Our operations are subject to environmental, health, and safety laws and regulations, including those governing the use of hazardous materials.
• Changes in laws, regulations, and policies affecting the healthcare industry could adversely affect our business.
• Tax liabilities, tariffs and other trade restrictions, and other risks associated with our operations outside the United States could adversely affect our business.
• We face risks related to the personal data we collect, process, and share.
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Risks Related to Our Reliance on or Transactions with Third Parties
• If our collaborations with Sanofi or Bayer or other third parties are terminated or breached, our ability to develop, manufacture, and commercialize certain of our products and product candidates in the time expected, or at all, may be materially harmed.
• Our collaborators and service providers may fail to perform adequately in their efforts to support the development, manufacture, and commercialization of our drug candidates and current and future products.
• We have undertaken and may in the future undertake strategic acquisitions, and any difficulties from integrating such acquisitions or failure to realize the expected benefits from such acquisitions could adversely affect our business, operating results, and financial condition.
Other Risks Related to Our Business and Our Common Stock
• Our business is dependent on our key personnel and will be harmed if we cannot recruit or retain key members of our senior management team, including leaders in our research, development, manufacturing, and commercial organizations.
• Significant disruptions of information technology systems or breaches of data security could adversely affect our business.
• Public health outbreaks, epidemics, or pandemics have adversely affected and may in the future adversely affect our business.
• Our indebtedness could adversely impact our business.
• Our stock price is extremely volatile.
• Our existing shareholders may be able to exert substantial influence over matters requiring shareholder approval and over our management.
* * *
Risks Related to Commercialization of Our Marketed Products, Product Candidates, and New Indications for Our Marketed Products
We are substantially dependent on revenues derived from net product sales of EYLEA HD, EYLEA, and Dupixent.
We are substantially dependent on revenues derived from net product sales of EYLEA HD and EYLEA. Net product sales of these products have historically represented a substantial portion of our revenues, and we expect net sales of these products to continue to be a significant contributor to our revenues and operating results, with an increasing dependence on EYLEA HD relative to our historical dependence on EYLEA. For the six months ended June 30, 2026 and 2025, our aggregate EYLEA HD and EYLEA net product sales in the United States represented 25% and 33% of our total revenues, respectively. For the six months ended June 30, 2026, EYLEA HD U.S. net product sales represented 55% of our aggregate EYLEA HD and EYLEA U.S. net product sales. If we experience difficulty with the commercialization of EYLEA HD or EYLEA in the United States or if Bayer experiences any difficulty with the commercialization of EYLEA HD or EYLEA outside the United States beyond what has been experienced to date as described below, if EYLEA HD net product sales do not sufficiently offset any sustained decline of EYLEA net product sales in or outside the United States, or if we and Bayer are unable to maintain or obtain marketing approvals of these products (as applicable), we may experience a reduction in revenue and may not be able to stay profitable at the levels we previously achieved or at all, and our business, prospects, operating results, and financial condition may be materially harmed.
Commercialization of EYLEA HD and EYLEA in the United States and elsewhere is subject to significant competition (as described further below under " The commercial success of our products and product candidates is subject to significant competition "), which we expect to continue to increase in the future. For the three and six months ended June 30, 2026, EYLEA U.S. net product sales declined by 45% and 41%, respectively, compared to the corresponding periods in 2025 as a result of competitive pressures and other factors described under Part I, Item 2. "Management's Discussion and Analysis of Financial Condition and Results of Operations – Results of Operations." Following the expiration of the U.S. regulatory exclusivity period for EYLEA in May 2024, several biosimilar versions of EYLEA have been approved by the FDA, and one such product has launched in the United States. EYLEA and/or EYLEA HD net product sales recorded by us are likely to continue to be negatively impacted by biosimilar competition in the United States, including competition from additional biosimilar versions of EYLEA expected to launch in the United States in the near future, which may have a material adverse impact on our results of operations. In addition, we expect that competition for EYLEA and/or EYLEA HD outside the United States will continue to increase as biosimilar versions of EYLEA (including those already approved but not yet launched) are brought to market in additional countries, which may continue to negatively impact the amount of collaboration revenue we earn from Bayer. While the FDA recently approved EYLEA HD for the treatment of RVO and for additional dosing regimens and we continue to work toward FDA approval of the EYLEA HD pre-filled syringe as discussed under Part I, Item 2. "Management's Discussion and
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Analysis of Financial Condition and Results of Operations - Overview - Additional Information - Clinical Development Programs - EYLEA HD," there can be no assurance that these enhancements (including potential FDA approval of the EYLEA HD pre-filled syringe) will help accelerate any potential future growth of EYLEA HD net product sales. The degree to which EYLEA HD net product sales may offset further potential decreases in EYLEA net product sales, resulting from the factors discussed above or otherwise, is uncertain.
We also are substantially dependent on our share of profits from the commercialization of Dupixent under our collaboration with Sanofi (the "Antibody Collaboration"). For the six months ended June 30, 2026 and 2025, Sanofi collaboration revenue (most of which is attributable to our share of profits from the commercialization of Dupixent) represented 48% and 39% of our total revenues, respectively. If we or Sanofi were to experience any difficulty with the commercialization of Dupixent or if we or Sanofi are unable to maintain current marketing approvals of Dupixent, we may experience a reduction in revenue and our business, prospects, operating results, and financial condition may be materially harmed.
If we or our collaborators are unable to continue to successfully commercialize our products, our business, prospects, operating results, and financial condition will be materially harmed.
We expect that the degree of commercial success of our marketed products will continue to depend on many factors, including the following (as applicable):
• effectiveness of the commercial strategy in and outside the United States for the marketing of our products, including pricing strategy;
• sufficient coverage of, and reimbursement or copay assistance for, our marketed products by third-party payors and other third parties, including Medicare and Medicaid in the United States and other government and private payors in the United States and foreign jurisdictions, as well as U.S. and foreign payor restrictions on eligible patient populations and the reimbursement process (including drug price control measures that have been or may be enacted or introduced in the United States by various federal and state authorities or agreements we have entered into or may in the future enter into with the U.S. government or other governmental authorities);
• our ability and our collaborators' ability to maintain sales of our marketed products in the face of competitive products and to differentiate our marketed products from competitive products, including as applicable product candidates currently in clinical development; and, in the case of EYLEA HD and EYLEA, the existing and potential new branded and biosimilar competition (discussed further under " The commercial success of our products and product candidates is subject to significant competition - Marketed Products" below) and the willingness of retinal specialists and patients to start or continue treatment with such products or to switch from a competitive product to one of our products;
• the safety and efficacy of our marketed products seen in a broader patient group (i.e., real-world use);
• the effect of existing and new healthcare laws and regulations, pricing mandates, and agreements with government entities (including the U.S. Government Agreements) currently being considered or implemented in the United States and globally, including measures requiring the U.S. government in the future to negotiate the prices of certain drugs and price reporting and other disclosure requirements and the potential impact of such requirements on physician prescribing practices and payor coverage;
• serious complications or side effects in connection with the use of our marketed products, as discussed under "Risks Related to Maintaining Approval of Our Marketed Products and the Development and Obtaining Approval of Our Product Candidates and New Indications for Our Marketed Products - Serious complications or side effects in connection with the use or development of our products or product candidates could cause our regulatory approvals to be revoked or limited or lead to delay or discontinuation of development of our product candidates or new indications for our marketed products, which could severely harm our business, prospects, operating results, and financial condition " below;
• maintaining and successfully monitoring commercial manufacturing arrangements for our marketed products with third parties who perform fill/finish and bulk product manufacturing or other steps in the manufacture of such products to ensure that they meet our standards and those of regulatory authorities, including the FDA, which extensively regulate and monitor, and have been increasing their focus on, pharmaceutical manufacturing facilities;
• our ability to meet the demand for commercial supplies of our marketed products;
• the outcome of the pending proceedings relating to EYLEA (described further in Note 12 to our Condensed Consolidated Financial Statements included in this report), as well as other risks relating to our marketed products and product candidates associated with intellectual property of other parties and pending or future litigation relating thereto (as discussed under "Risks Related to Intellectual Property and Market Exclusivity" below);
• the outcome of the pending government proceedings and investigations and other matters described in Note 12 to our Condensed Consolidated Financial Statements included in this report (including the civil proceedings initiated or joined by the U.S. Department of Justice and the U.S. Attorney's Office for the District of Massachusetts); and
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• the results of post-approval studies, whether conducted by us or by others and whether mandated by regulatory agencies or voluntary, and studies of other products that could implicate an entire class of products or are perceived to do so.
More detailed information about the risks related to the commercialization of our marketed products is provided in the risk factors below.
We and our collaborators are subject to significant ongoing regulatory obligations and oversight with respect to the products we or our collaborators commercialize. If we or our collaborators fail to maintain regulatory compliance for any of such products, the applicable marketing approval may be withdrawn, which would materially harm our business, prospects, operating results, and financial condition.
We and our collaborators are subject to significant ongoing regulatory obligations and oversight with respect to the products we or they commercialize in the United States, EU, Japan, and other countries. If we or our collaborators fail to maintain regulatory compliance or satisfy other obligations for such products (including because the product does not meet the relevant endpoints of any required post-approval studies (such as those required under an accelerated approval by the FDA or other similar type of approval), or for any of the reasons discussed below under "Risks Related to Maintaining Approval of Our Marketed Products and the Development and Obtaining Approval of Our Product Candidates and New Indications for Our Marketed Products - Obtaining and maintaining regulatory approval for drug and biological products is costly, time-consuming, and highly uncertain. If we or our collaborators do not maintain regulatory approval for our marketed products, or obtain regulatory approval for our product candidates, we will not be able to market or sell them; and if we do not obtain approvals for new indications for our marketed products, we may not be able to realize the full commercial potential of such products. Any of the foregoing may materially and negatively impact our business, prospects, operating results, and financial condition. "), the applicable marketing approval may be withdrawn, which would materially harm our business, prospects, operating results, and financial condition. Failure to comply may also subject us to sanctions, product recalls, or withdrawals of previously approved marketing applications. See also "Risks Related to Manufacturing and Supply - Our or our collaborators' or contract manufacturers' failure to meet the stringent requirements of governmental regulation in the manufacture of drug products or product candidates could result in incurring substantial remedial costs, delays in the development or approval of our product candidates or new indications for our marketed products and/or in their commercial launch if regulatory approval is obtained, and a reduction in sales " below.
Sales of our marketed products are dependent on the availability and extent of coverage and reimbursement and copay assistance from third-party payors and other third parties.
Sales of our marketed products in the United States are dependent, in large part, on the availability and extent of coverage and reimbursement from third-party payors, including private payor healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies ("PBMs"), and government programs such as Medicare and Medicaid. Such sales are also impacted by the ability of patients to afford copays and the availability and extent of copay assistance, including copay assistance provided by other third parties (such as not-for-profit patient assistance funds). Sales of our marketed products in other countries are also dependent, in large part, on complex coverage and reimbursement mechanisms and programs in those countries.
Our revenues and profitability will be materially adversely affected if such third-party payors and other third parties do not adequately defray or reimburse the cost of our marketed products. If third-party payors do not provide coverage and reimbursement with respect to our marketed products or provide an insufficient level of coverage and reimbursement, such products may be too costly for many patients to afford them, and physicians may not prescribe them. Many third-party payors cover only selected drugs, or may prefer selected drugs, making drugs that are not covered or preferred by such payors more expensive for patients. Third-party payors may also require prior authorization for reimbursement, require failure on another type of treatment, or impose other utilization management restrictions before covering a particular drug, particularly with respect to higher-priced drugs. Further, sales of our marketed products (such as EYLEA HD and EYLEA) in the United States may be adversely impacted by the lack of sufficient copay assistance from not-for-profit patient assistance funds. For example, a loss in market share to compounded bevacizumab due to patient affordability constraints impacted U.S. net product sales of EYLEA for the year ended December 31, 2025, as further described under Part II, Item 7. "Management's Discussion and Analysis of Financial Condition and Results of Operations – Results of Operations" of our Annual Report on Form 10-K for the fiscal year ended December 31, 2025 (filed February 4, 2026). If independent not-for-profit patient assistance funds that provide patient 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.
As our currently marketed products and our product candidates are biologics, genetics medicines, peptides, or other complex therapeutics, bringing them to market may cost more than bringing traditional, small-molecule drugs to market due to the complexity associated with the research, development, production, supply, and regulatory review of such products. Given cost
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sensitivities in many healthcare systems, our currently marketed products and product candidates are likely to be subject to continued pricing pressures, which may have an adverse impact on our business, prospects, operating results, and financial condition.
In addition, in order for private insurance and governmental payors (such as Medicare and Medicaid in the United States) to reimburse the cost of our marketed products, we must maintain, among other things, our FDA registration and our National Drug Code, formulary approval by PBMs, and recognition by insurance companies and Centers for Medicare & Medicaid Services ("CMS"). There is no certainty that we will be able to obtain or maintain the applicable requirements for reimbursement (including relevant formulary coverage, as discussed further below) of our current and future marketed products, which may have a material adverse effect on our business.
In addition, PBMs and other managed-care organizations often develop formularies to reduce their cost for medications. The breadth of the products covered by formularies varies considerably from one PBM to another. Failure to be included in such formularies or to achieve favorable formulary status may negatively impact the utilization and market share of our marketed products. If our marketed products are not included within an adequate number of formularies, adequate reimbursement levels are not provided, the eligible insured patient population for our products is limited, or a key payor refuses to provide reimbursement for our products in a particular jurisdiction altogether, this could have a material adverse effect on our and our collaborators' ability to commercialize the applicable product.
In many countries outside the United States, pricing, coverage, and level of reimbursement of prescription drugs are subject to governmental control, and we and our collaborators may be unable to obtain coverage, pricing, and/or reimbursement on terms that are favorable to us or necessary for us or our collaborators to successfully commercialize our marketed products in those countries. In some of these countries, the proposed pricing for a drug must be approved before it may be lawfully marketed. The requirements governing drug pricing and reimbursement vary widely from country to country, and may take into account the clinical effectiveness, cost, and service impact of existing, new, and emerging drugs and treatments. For example, the EU provides options for its member states to restrict the range of medicinal products for which their national health insurance systems provide reimbursement and to control the prices of medicinal products for human use. A member state may approve a specific price for the medicinal product or it may instead adopt a system of direct or indirect limitations on the profitability of the medicinal product placed on the market. In addition, in many countries outside the United States, we or our collaborators must participate in a tender process for public procurement of our products, and any failure to obtain acceptable pricing in the tender process could adversely affect our business. Our results of operations may suffer if we or our collaborators are unable to market our products in countries outside the United States or if coverage and reimbursement for our marketed products in such countries is limited or delayed. As discussed below under " If we are unable to maintain or establish sufficient commercial capabilities outside the United States for products we currently commercialize or co-commercialize, or intend to commercialize or co-commercialize in the future, outside the United States, our business, prospects, operating results, and financial condition may be adversely affected, " we will need to manage these and other commercialization-related risks in order for us to successfully maintain and/or further develop sufficient commercial capabilities outside the United States.
Product reimbursement and coverage policies and practices, pricing regulations and requirements, and our pricing strategy could change due to various factors beyond our control, which may adversely impact our business, prospects, operating results, and financial condition.
Government and other third-party payors (including PBMs) are challenging the prices charged for healthcare products and increasingly limiting, and attempting to limit, both coverage and level of reimbursement for prescription drugs, such as by requiring outcomes-based or other pay-for-performance pricing arrangements. They are also imposing restrictions on eligible patient populations and the reimbursement process, including by means of required prior authorizations and utilization management criteria, such as step therapy (i.e., requiring the use of less costly medications before more costly medications are approved for coverage). Private payor healthcare and insurance providers, health maintenance organizations, and PBMs are increasingly requiring significant discounts and rebates from manufacturers as a condition to including products on formulary with favorable coverage and copayment/coinsurance. In addition, many payors continue to adopt benefit plan changes that shift a greater portion of prescription costs to patients, including more limited benefit plan designs, higher patient copay or coinsurance obligations, and limitations on patients' use of commercial manufacturer copay payment assistance programs (including through copay accumulator adjustment or maximization programs). Some states have also enacted or are considering legislation to control the prices and reimbursement of prescription drugs, including by establishing Prescription Drug Affordability Boards (or similar entities) to review high-cost drugs, setting upper payment limits, and/or implementing marketing cost disclosure and transparency measures. Additionally, state Medicaid programs have been increasingly requesting that manufacturers, including Regeneron, pay supplemental rebates and requiring prior authorization by the state program for use of any prescription drug for which supplemental rebates are not being paid. It is likely that federal and state legislatures and health agencies will continue to focus on additional healthcare reform measures in the future that will impose additional constraints on prices and reimbursements for our marketed products.
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