What changed in this filing

/stocks — the workspaceLOADING

Item 9A. Controls and Procedures

2026-02-04 compared with 2025-02-05 · 368 added, 425 removed, 1197 unchanged (40% of the section changed)

21 unchanged sentences

Total Number of Securities to Be Sold Under the Plan

Kathryn Guarini, Ph.D.

Jason Pitofsky

Senior Vice President, Controller

11/10/2025 5/10/2026 3,261

10/31/2025 1/29/2027 1,200

11/20/2025 1/3/2027 2,438

(a) The trading arrangement may expire on an earlier date if and when all transactions under the arrangement are completed

36 unchanged sentences

4.5 Form of 2.800% Senior Note due 2050 (included in Exhibit 4.3).

R ege neron Pharm aceuticals, Inc.

20 1 4 Long-Term I ncentiv e Plan.

(Incorporated by reference from the Registration Statement on Form S-8 for the Registrant, filed June 16, 2014.)

Form of stock option agreement and related notice of grant for use in connection with the grant of non-qualified stock options to the Registrant's executive officers under the Regeneron Pharmaceuticals, Inc.

2014 Long-Term Incentive Plan.

(Incorporated by reference from the Form 8-K for the Registrant, filed June 18, 2014.)

Form of restricted stock award agreement and related notice of grant for use in connection with the grant of restricted stock awards to the Registrant's executive officers under the Regeneron Pharmaceuticals, Inc.

2014 Long-Term Incentive Plan.

(Incorporated by reference from the Form 8-K for the Registrant, filed June 18, 2014.)

Form of stock option agreement and related notice of grant for use in connection with the grant of non-qualified stock options to the Registrant's non-employee directors under the Regeneron Pharmaceuticals, Inc.

Regeneron Pharmaceuticals, Inc.

2014 Long-Term Incentive Plan.

(Incorporated by reference from the Form 8-K for the Registrant, filed June 18, 2014.)

(Incorporated by reference from the Registration Statement on Form S-8 for the Registrant, filed June 16, 2014.)

1 unchanged sentence

(Incorporated by reference from the Form 8-K for the Registrant, filed November 19, 2015.)

2014 Long-Term Incentive Plan (revised).

(Incorporated by reference from the Form 8-K for the Registrant, filed November 19, 2015.)

7 unchanged sentences

(Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2017, filed February 8, 2018.)

2014 Long-Term Incentive Plan.

(Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2017, filed February 8, 2018.)

4 unchanged sentences

(Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2018, filed February 7, 2019.)

2014 Long-Term Incentive Plan (revised 2018).

(Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2018, filed February 7, 2019.)

7 unchanged sentences

(Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2019, filed February 7, 2020.)

2014 Long-Term Incentive Plan (revised 2019).

(Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2019, filed February 7, 2020.)

32 unchanged sentences

(Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2023, filed February 5, 2024.)

Form of stock option agreement and related notice of grant for use in connection with the grant of non-qualified stock options to the Registrant's executive officers under the Second Amended and Restated Regeneron Pharmaceuticals, Inc.

2014 Long-Term Incentive Plan (revised 202 5 ).

Form of restricted stock unit award agreement and related notice of grant for use in connection with the grant of restricted stock units to the Registrant's non-employee directors under the Second Amended and Restated Regeneron Pharmaceuticals, Inc.

2014 Long-Term Incentive Plan.

( revised 2025).

10.4 + Amended and Restated Employment Agreement, dated as of November 14, 2008, between the Registrant and Leonard S.

17 unchanged sentences

Restated Amendment Agreement, dated December 30, 2014 and entered into effective as of May 7, 2012, by and between Bayer HealthCare LLC and the Registrant.

(Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2024, filed February 5, 2025.)

Second Amendment Agreement, dated December 19, 2019, by and between Bayer HealthCare LLC and the Registrant.

6 unchanged sentences

2 to Amended and Restated License and Collaboration Agreement, dated July 27, 2015 and entered into effective as of July 1, 2015, by and between the Registrant and Sanofi Biotechnology SAS, as successor-in-interest to Aventis Pharmaceuticals, Inc.

(Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended September 30, 2015, filed November 4, 2015.)

(Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended June 30, 2025, filed August 1, 2025.)

Third Amendment to Amended and Restated License and Collaboration Agreement, dated as of April 5, 2020, and effective as of April 1, 2020, by and between the Registrant, Sanofi Biotechnology SAS, and Sanofi.

33 unchanged sentences

Amendment No.

3 to Master Agreement, dated as of August 1, 2024, by and between the R egistrant and Alnylam Pharmaceuticals, Inc.

(Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended September 30, 202 4 , filed Octob er 3 1 , 202 4 .)

I nsider Trading Policy.

3 to Master Agreement, dated as of August 1, 2024, by and between the Registrant and Alnylam Pharmaceuticals, Inc.

(Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended September 30, 2024, filed October 31, 2024.)

Insider Trading Policy.

(Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2024, filed February 5, 2025.)

21.1 Subsidiaries of the Registrant.

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/s/ JASON PITOFSKY

Vice President, Controller (Principal Accounting Officer)

Senior Vice President, Controller (Principal Accounting Officer)

February 4, 2026

36 unchanged sentences

Notes to Consolidated Financial Statements

F- 9 to F- 41

Report of Independent Registered Public Accounting Firm

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Uncertain tax positions are recorded based upon certain recognition and measurement criteria.

Management re-evaluates uncertain tax positions and considers various factors, including, but not limited to, changes in tax law, the measurement of tax positions taken or expected to be taken in tax returns, and changes in facts or circumstances related to a tax position.

Management re-evaluates uncertain tax positions and considers various factors, including, but not limited to, changes in tax law, the measurement of tax positions taken or expected to be taken in tax returns, the effective settlement of matters subject to audit, information obtained during in-process audit activities, and changes in facts or circumstances related to a tax position.

The Company adjusts the amount of the liability to reflect any subsequent changes in the relevant facts and circumstances surrounding the uncertain tax positions.

53 unchanged sentences

Retained earnings 35,797.1 31,672.9

Accumulated other comprehensive loss ( 7.9 ) ( 80.9 )

Accumulated other comprehensive income (loss) 77.5 ( 7.9 )

Treasury Stock, at cost;

20 unchanged sentences

Cost of collaboration and contract manufacturing 959.9 883.2 883.7

Other operating expense (income), net

53.4 ( 2.1 ) ( 89.9 )

Other operating (income) expense, net ( 10.0 ) 53.4 ( 2.1 )

10,765.0 10,211.3 9,070.1

14 unchanged sentences

Other comprehensive income (loss), net of tax:

Unrealized gain (loss) on debt securities

Unrealized gain on debt securities

83.0 73.6 158.2

Loss on foreign currency translation

Gain (loss) on foreign currency translation

2.4 ( 0.6 ) ( 0.3 )

Unrealized gain on cash flow hedges

Comprehensive income $ 4,590.3 $ 4,485.6 $ 4,111.5

13 unchanged sentences

Net income — — — — — 3,953.6 — — — 3,953.6

Other comprehensive loss, net of tax — — — — — — ( 212.6 ) — — ( 212.6 )

Other comprehensive income, net of tax

— — — — — — 157.9 — — 157.9

Balance, December 31, 2023

17 unchanged sentences

Repurchases of Common Stock — — — — — — — ( 5.6 ) ( 3,456.2 ) ( 3,456.2 )

Dividends declared — — — — 4.1 ( 380.7 ) — — — ( 376.6 )

Stock-based compensation charges — — — — 1,001.6 — — — — 1,001.6

16 unchanged sentences

135.5 36.1 ( 0.1 )

Other non-cash items, net 23.5 ( 0.1 ) 368.0

Deferred income taxes ( 785.4 ) ( 757.3 ) ( 837.8 )

Acquired in-process research and development in connection with asset acquisition 12.6 — 195.0

Changes in assets and liabilities:

(Increase) decrease in accounts receivable ( 554.0 ) ( 338.8 ) 707.8

Decrease (increase) in accounts receivable

498.1 ( 554.0 ) ( 338.8 )

Increase in inventories ( 275.3 ) ( 619.7 ) ( 271.7 )

Increase in prepaid expenses and other assets ( 375.3 ) ( 407.5 ) ( 120.1 )

Increase in deferred revenue

(Decrease) increase in deferred revenue

( 51.7 ) 227.8 37.9

Increase (decrease) in accounts payable, accrued expenses, and other liabilities 735.1 598.6 ( 138.4 )

Increase in accounts payable, accrued expenses, and other liabilities

736.8 735.1 598.6

Total adjustments 474.0 7.9 640.4

5 unchanged sentences

Proceeds from sale of property, plant, and equipment

Payments for Libtayo intangible asset ( 125.7 ) ( 207.8 ) ( 1,026.8 )

Payments for intangible assets

( 315.3 ) ( 125.7 ) ( 207.8 )

Acquisitions, net of cash acquired

6 unchanged sentences

Repurchases of Common Stock ( 3,438.6 ) ( 2,603.3 ) ( 2,235.0 )

Dividends paid

( 370.3 ) — —

( 10.3 ) ( 33.4 ) —

Net cash used in financing activities ( 3,715.4 ) ( 2,200.5 ) ( 1,790.1 )

Effect of exchange rate changes on cash, cash equivalents, and restricted cash 0.3 ( 0.7 ) ( 0.4 )

Net (decrease) increase in cash, cash equivalents, and restricted cash ( 248.8 ) ( 381.6 ) 221.3

Net increase (decrease) in cash, cash equivalents, and restricted cash

634.7 ( 248.8 ) ( 381.6 )

Cash, cash equivalents, and restricted cash at beginning of period 2,489.0 2,737.8 3,119.4

2 unchanged sentences

Cash paid for interest (net of amounts capitalized) $ 41.6 $ 52.6 $ 73.1

Cash paid for income taxes $ 743.0 $ 870.3 $ 1,502.4

The accompanying notes are an integral part of the financial statements.

9 unchanged sentences

The Company's business is subject to certain risks including, but not limited to, uncertainties relating to conducting research activities, product development, obtaining regulatory approvals, competition, and obtaining and enforcing patents.

Segment Reporting

The Company operates in one business segment, which includes all activities related to the discovery, development, and commercialization of medicines for serious diseases.

The determination of a single business segment is consistent with the consolidated financial information regularly provided to the Company’s chief operating decision maker (“CODM”).

The Company’s CODM is its Chief Executive Officer, who reviews and evaluates consolidated net income for purposes of assessing performance, making operating decisions, allocating resources, and planning and forecasting for future periods.

In addition to the significant expense categories included within consolidated net income presented on the Company's Consolidated Statements of Operations, see below for disaggregated amounts that comprise research and development expenses:

Year Ended December 31,

(In millions) 2024 2023

Direct research and development expenses (a)

$ 1,588.8 $ 1,295.6 $ 1,042.9

Indirect research and development expenses:

Payroll and benefits 1,681.7 1,537.0 1,195.5

Lab supplies and other research and development costs

241.5 210.6 181.0

Occupancy and other operating costs 614.9 518.2 508.5

Total indirect research and development expenses

2,538.1 2,265.8 1,885.0

Clinical manufacturing costs

1,195.9 1,053.9 938.3

Reimbursement of research and development expenses by collaborators ( 190.8 ) ( 176.3 ) ( 273.7 )

Total research and development expenses

$ 5,132.0 $ 4,439.0 $ 3,592.5

(a) Direct research and development expenses are comprised primarily of costs paid to third parties for clinical and product development activities, and the portion of research and development expenses incurred by our collaborators that we are obligated to reimburse.

Basis of Presentation

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Intercompany balances and transactions are eliminated in consolidation.

Certain reclassifications have been made to prior period amounts to conform with the current period's presentation.

Use of Estimates

The preparation of financial statements in conformity with generally accepted accounting principles requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes.

Actual results

could differ from those estimates.

Actual results could differ from those estimates.

Concentration of Credit Risk

Financial instruments which potentially expose the Company to concentrations of credit risk consist of cash, cash equivalents, certain investments, and accounts receivable.

Financial instruments which potentially expose the Company to concentrations of credit risk consist of cash, cash equivalents, and certain investments.

In accordance with the Company's policies, the Company mandates asset diversification and monitors exposure with its counterparties.

Concentrations of credit risk with respect to receivables from collaborators (see Note 3) are significant.

In addition, concentrations of credit risk with respect to customer accounts receivable are also significant.

As of December 31, 2024 and 2023, two individual customers accounted for 79 % and 83 % of the Company's net trade accounts receivable balances, respectively.

The Company has contractual payment terms with each of its collaborators and customers, and the Company monitors their financial performance and credit worthiness so that it can properly assess and respond to any changes in their credit profile.

As of and for the years ended December 31, 2024 and 2023, there were no write-offs and allowances of accounts receivable related to credit risk for the Company's collaborators or customers.

In addition, receivables from customers (see Note 2) and collaborators (see Note 3) may subject the Company to credit risk.

The Company has contractual payment terms with each of its customers and collaborators, and the Company monitors their financial performance and credit worthiness so that it can properly assess and respond to any changes in their credit profile.

Significant Accounting Policies

5 unchanged sentences

The Company invests its cash primarily in debt securities.

The Company considers its investments in debt securities to be "available-for-sale," as defined by authoritative guidance issued by the Financial Accounting Standards Board ("FASB").

These assets are carried at fair value and the unrealized gains and losses are included in accumulated other comprehensive income (loss).

The Company classifies its investments in debt securities as available-for-sale, with such investments carried at fair value and unrealized gains and losses included in accumulated other comprehensive income (loss).

Realized gains and losses on available-for-sale debt securities are included in other income (expense), net.

6 unchanged sentences

In addition, the Company records accounts receivable arising from its collaboration and licensing agreements.

The Company monitors the financial performance and credit worthiness of its counterparties so that it can properly assess and respond to changes in their credit profile.

The Company provides allowances against receivables for estimated losses, if any, that may result from a counterparty's inability to pay.

22 unchanged sentences

Leases with an initial term of 12 months or less are not recorded on the balance sheet.

The Company may include options to extend or terminate a lease within the lease term when it is reasonably certain that it will exercise that option.

The Company includes options to extend or terminate a lease when determining the lease term if it is reasonably certain that it will exercise that option.

The Company accounts for lease components (e.g., rental payments) separately from non-lease components (e.g., common area maintenance costs).

Lease liabilities are recognized at the lease commencement date based on the present value of the remaining lease payments, discounted using the rate implicit in the lease.

For leases where an implicit rate is not readily determinable, the Company uses its incremental borrowing rate based on information available at the lease commencement date to determine the present value of future lease payments.

For leases where an implicit rate is not readily determinable, the Company uses its incremental borrowing rate based on information available at the lease commencement date.

Lease expense for operating leases is recognized on a straight-line basis over the expected lease term.

1 unchanged sentence

In a business combination, the acquisition method of accounting generally requires that the assets acquired and liabilities assumed be recorded as of the date of the acquisition at their respective fair values.

Amounts allocated to acquired in-process research and development are capitalized as indefinite-lived intangible assets.

Amounts allocated to acquired in-process research and

development are capitalized as indefinite-lived intangible assets.

Any excess of the purchase price (consideration transferred) over the fair values of net assets acquired is recorded as goodwill.

15 unchanged sentences

Revenue from product sales is recognized at a point in time when the Company's customer is deemed to have obtained control of the product, which generally occurs upon receipt or acceptance by its customer.

The amount of revenue the Company recognizes from product sales may vary due to rebates, chargebacks, and discounts provided under governmental and other programs, distribution-related fees, and other sales-related deductions.

The amount of revenue the Company recognizes from product sales may vary due to rebates, chargebacks, discounts, distribution-related fees, and other sales-related deductions.

In order to determine the transaction price, the Company estimates, utilizing the expected value method, the amount of variable consideration to which the Company will be entitled.

1 unchanged sentence

The Company reviews its estimates of rebates, chargebacks, and other applicable provisions each period and records any necessary adjustments in the current period's net product sales.

The Company's rebates include amounts paid to managed care organizations, group purchasing organizations, state Medicaid programs, and other rebate programs.

The Company's rebates include amounts paid to managed care organizations, group purchasing organizations, state Medicaid programs, the Medicare Part D program, and other rebate programs.

Outside the United States, the Company's rebates are generally contractual or legislatively mandated.

The Company estimates reductions to product sales for each type of rebate and records an allowance for rebates in the same period in which the related product sales are recognized.

1 unchanged sentence

• Chargebacks and Discounts:

The Company's reserves related to discounted pricing to eligible physicians, Veterans' Administration ("VA"), Public Health Services, and others (collectively, "qualified healthcare providers") represent the Company's estimated obligations resulting from contractual commitments to sell products to qualified healthcare providers at prices lower than the list prices the Company charges to its customers (i.e., distributors and specialty pharmacies).

The Company's customers charge the Company for the difference between what they pay for the products and the discounted selling price to the qualified healthcare providers.

5 unchanged sentences

• Other Sales-Related Deductions :

The Company's other sales-related deductions include co-pay assistance programs and product returns.

The Company's other sales-related deductions include copay assistance programs and product returns.

The Company estimates and records other sales-related deductions generally based on gross sales, written contracts, and other relevant factors.

Consistent with industry practice, the Company generally offers its customers a limited right to return product purchased directly from the Company, which is principally based upon the

product's expiration date.

Consistent with industry practice, the Company generally offers its customers a limited right to return product purchased directly from the Company, which is principally based upon the product's expiration date.

Product returned is generally not resalable given the nature of the Company's products and method of administration.

5 unchanged sentences

Although each of these arrangements is unique in nature, such arrangements involve a joint operating activity where both parties are active participants in the activities of the collaboration and exposed to significant risks and rewards dependent on the commercial success of the activities.

In arrangements where the Company does not deem its collaborator to be its customer, payments to and from its collaborator are presented in the Company's statement of operations based on the nature of our business operations, the nature of the arrangement, including the contractual terms, and the nature of the payments.

In arrangements where the Company does not deem its collaborator to be its customer, payments to and from its collaborator are presented in the Company's statement of operations based on the nature of Regeneron's business operations, the nature of the arrangement, including the contractual terms, and the nature of the payments.

In general, the presentation of such amounts is summarized below.

9 unchanged sentences

Research and development expense

Up-front, opt-in, and development milestone payments;

and premiums paid on equity securities

Acquired in-process research and development expense

Reimbursement of Regeneron's commercialization-related expenses

Reduction to Selling, general, and administrative expense

Regeneron's obligation for its share of collaborator's commercialization-related expenses

Selling, general, and administrative expense

Regeneron's obligation to pay collaborator for its share of gross profits when Regeneron is deemed to be the principal

Cost of goods sold

Up-front and development milestones earned (when there is a combined unit of account which includes a license and providing research and development services) Other operating income

In agreements involving multiple goods or services promised to be transferred to the Company's collaborator, the Company assesses, at the inception of the contract, whether each promise represents a separate obligation (i.e., is "distinct"), or whether such promises should be combined as a single unit of account.

When the Company has a combined unit of account which includes a license and providing research and development services to its collaborator, recognition of up-front payments and development milestones earned from its collaborator is deferred (as a liability) and recognized over the development period (i.e., over time) typically using an input method on the basis of the Company's research and development costs incurred relative to the total expected cost which determines the extent of the Company's progress toward completion.

The Company reviews its estimates each period and makes revisions to such estimates as necessary.

When the Company is entitled to reimbursement of all or a portion of the expenses (e.g., research and development expenses) that it incurs under a collaboration, it records those reimbursable amounts in the period in which such costs are incurred.

When the Company enters into an arrangement with another party to fund its research and development costs, the Company considers whether the costs that it may be obligated to repay represent a liability within the scope of Accounting Standards Codification ("ASC") 730-20, Research and Development .

When the Company enters into an arrangement with another party to fund its research and development expenses, the Company considers whether the costs that it may be obligated to repay represent a liability within the scope of Accounting Standards

Codification ("ASC") 730-20, Research and Development .

If the Company concludes that such funding does not represent a substantive and genuine transfer of risk, a liability is recorded.

If the Company's collaborator performs research and development work or commercialization-related activities and the parties share the related costs, the Company also recognizes, as expense (e.g., research and development expense or selling, general, and administrative expense, as applicable) in the period when its collaborator incurs such expenses, the portion of the collaborator's

expenses that the Company is obligated to reimburse.

The Company's collaborators provide the Company with estimated expenses for the most recent fiscal quarter.

9 unchanged sentences

Research and development expenses include costs attributable to the conduct of research and development programs, including the cost of salaries, payroll taxes, employee benefits, materials, supplies, depreciation on and maintenance of research equipment, costs related to research collaboration and licensing agreements, clinical trial expenses, the cost of services provided by outside contractors, including services related to the Company's clinical trials, the cost of manufacturing drug for use in research and development, amounts that the Company is obligated to reimburse to collaborators for research and development expenses that they incur, and the allocable portions of facility costs.

Costs associated with research and development are expensed.

Costs associated with research and development are expensed as incurred.

For each clinical trial that the Company conducts, certain clinical trial costs are expensed immediately, while others are expensed over time based on the expected total number of patients in the trial, the rate at which patients enter and remain in the trial, and/or the period over which clinical investigators, contract research organizations ("CROs"), or other third-party service providers are expected to provide services.

In the event of early termination of a clinical trial, the Company accrues and recognizes expenses in an amount based on its estimate of the remaining noncancelable obligations associated with the winding-down of the clinical trial, including any applicable penalties.

Acquired In-Process Research and Development ("IPR&D") Expenses

Acquired IPR&D expenses may include in-process research and development acquired in connection with asset acquisitions, as well as up-front, opt-in, development milestone payments, and premiums paid on equity securities related to collaboration and licensing agreements.

Stock-based Compensation

The Company recognizes stock-based compensation expense for equity grants under the Company's long-term incentive plans (including stock options, restricted stock awards, and restricted stock units (both time-based and performance-based)) to employees and non-employee members of the Company's board of directors (as applicable) based on the grant-date fair value of those awards.

The Company recognizes stock-based compensation expense for equity grants under the Company's long-term incentive plans (including stock options, restricted stock awards, and restricted stock units (both time-based and performance-based)) to employees and non-employee members of the Company's board of directors based on the grant-date fair value of those awards.

The grant-date fair value of an award is generally recognized as compensation expense over the award's requisite service period.

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Income taxes are accounted for under the liability method.

Deferred tax assets and liabilities are recognized for the expected future tax consequences of events that have been included in the financial statements or tax returns, including deferred tax assets and liabilities for expected amounts of global intangible low-taxed income ("GILTI") inclusions.

Deferred tax assets and liabilities are recognized for the expected future tax consequences of events that have been included in the financial statements or tax returns, including deferred tax assets and liabilities for expected amounts of Net CFC Tested Income (“NCTI”) (formerly known as global intangible low-taxed income ("GILTI")) inclusions.

Deferred tax assets and liabilities are determined as the difference between the tax basis of assets and liabilities and their respective financial reporting amounts ("temporary differences") at enacted tax rates in effect for the years in which the differences are expected to reverse.

18 unchanged sentences

January 1, 2025

No significant impact expected

Adopted prospectively;

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

January 1, 2027 for annual reporting periods and January 1, 2028 for interim reporting periods Currently evaluating impact

In September 2025, the FASB issued new guidance to modernize the accounting for software costs by updating the criteria as to when entities are required to start capitalizing internal-use software (by removing all references to software development "projects stages").

January 1, 2028 Early adopted January 1, 2026;

no significant impact expected

Product Sales

14 unchanged sentences

37.4 76.8 69.8

Other products

$ 6,309.1 $ 7,629.2 $ 7,078.0

(a) Effective July 1, 2022, the Company obtained the exclusive right to develop, commercialize, and manufacture Libtayo worldwide and, as a result, began recording net product sales of Libtayo outside the United States.

See Note 3 for further details.

As of December 31, 2025 and 2024, the Company had $ 3.458 billion and $ 4.278 billion, respectively, of trade accounts receivable that were recorded within Accounts receivable, net.

As of December 31, 2025 and 2024, two individual customers accounted for 87 % and 79 %, respectively, of the Company's net trade accounts receivable balances.

The Company had product sales to certain customers that each accounted for more than 10% of total gross product revenue for the years ended December 31, 2025, 2024, and 2023.

2 unchanged sentences

2025 2024 2023

Besse Medical, a subsidiary of Cencora, Inc.

50 % 50 % 51 %

McKesson Corporation 24 % 25 % 28 %

27 % 24 % 25 %

Revenue from product sales is recorded net of applicable provisions for rebates, chargebacks, and discounts, distribution-related fees, and other sales-related deductions.

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Collaboration, License, and Other Agreements

Amounts recognized in the Company's Statements of Operations in connection with its collaborations with Sanofi are as follows:

The Company is party to a global, strategic collaboration with Sanofi to research, develop, and commercialize fully human monoclonal antibodies, which currently consists of Dupixent ® (dupilumab), Kevzara ® (sarilumab), and itepekimab .

Sanofi is generally responsible for funding 80 % to 100 % of agreed-upon development expenses as incurred.

The Company is obligated to reimburse Sanofi for 30 % to 50 % of development expenses that were funded by Sanofi (i.e., "development balance") based on the Company's share of collaboration profits.

The Company is required to apply 20 % of its share of profits from the collaboration each calendar quarter to reimburse Sanofi for these development expenses.

The Company's contingent reimbursement obligation to Sanofi in connection with the development balance was approximately $ 595 million as of December 31, 2025.

Sanofi leads commercialization activities for products under the collaboration, subject to the Company's right to co-commercialize such products.

The Company co-commercializes Dupixent in the United States and in certain countries outside the United States.

The Company supplies certain commercial bulk product to Sanofi.

The parties equally share profits from sales within the United States.

The parties share profits outside the United States on a sliding scale based on sales starting at 65 % (Sanofi)/ 35 % (Regeneron) and ending at 55 % (Sanofi)/ 45 % (Regeneron).

In addition to profit sharing, the Company was entitled to receive sales milestone payments from Sanofi.

During the year ended December 31, 2023, the Company earned the final $ 50.0 million sales-based milestone from Sanofi upon aggregate annual sales of antibodies outside the United States exceeding $ 3.0 billion on a rolling twelve-month basis.

Amounts recognized in the Company's Statements of Operations in connection with its Sanofi collaboration are as follows:

Statement of Operations Classification Year Ended December 31,

(In millions) 2025 2024 2023

Regeneron's share of profits

Collaboration revenue

Regeneron's share of profits Collaboration revenue

$ 5,241.6 $ 3,923.5 $ 3,136.5

3 unchanged sentences

$ 642.4 $ 607.9 $ 613.0

Other Collaboration revenue

Regeneron's obligation for its share of Sanofi R&D expenses, net of reimbursement of R&D expenses (R&D expense)

$ ( 69.5 ) $ ( 46.8 ) $ ( 83.7 )

Regeneron's obligation for its share of Sanofi R&D expenses, net of reimbursement of R&D expenses (R&D expense)/Reduction of R&D expense $ ( 46.8 ) $ ( 83.7 ) $ 43.0

Reimbursement of commercialization-related expenses Reduction of SG&A expense $ 729.3 $ 655.4 $ 534.4

Immuno-oncology (a) :

Regeneron's share of profits in connection with commercialization of Libtayo outside the United States

Collaboration revenue

$ — $ — $ 6.7

Reimbursement for manufacturing of ex-U.S.

commercial supplies Collaboration revenue

$ — $ — $ 4.6

Reimbursement of R&D expenses Reduction of R&D expense $ — $ — $ 42.7

Reimbursement of commercialization-related expenses, net of Regeneron's obligation for its share of Sanofi commercialization-related expenses

Reduction of SG&A expense

$ — $ — $ 21.5

Regeneron's obligation for Sanofi's share of Libtayo U.S.

gross profits Cost of goods sold $ — $ — $ ( 70.1 )

Amounts recognized in connection with up-front payments received Other operating income $ — $ — $ 35.1

* Net of one-time payment of $ 56.9 million to Sanofi in connection with the amendment to the Antibody License and Collaboration Agreement

(a) As described within the " Immuno-Oncology " section below, effective July 1, 2022, the Company obtained the exclusive right to develop, commercialize, and manufacture Libtayo worldwide.

The Company is party to a global, strategic collaboration with Sanofi to research, develop, and commercialize fully human monoclonal antibodies (the "Antibody Collaboration"), which currently consists of Dupixent ® (dupilumab), Kevzara ® (sarilumab), and itepekimab .

Under the terms of the Antibody License and Collaboration Agreement (the "LCA"), Sanofi is generally responsible for funding 80 % to 100 % of agreed-upon development costs.

The Company is obligated to reimburse Sanofi for 30 % to 50 % of worldwide development expenses that were funded by Sanofi based on the Company's share of collaboration profits from commercialization of collaboration products.

Under the terms of the LCA, the Company was required to apply 10 % of its share of the profits from the Antibody Collaboration in any calendar quarter to reimburse Sanofi for these development costs.

On July 1, 2022, an amendment to the LCA became effective, which had been entered into in connection with our acquisition of exclusive worldwide rights to Libtayo (cemiplimab).

Pursuant to this amendment, the percentage of the Company's share of profits used to reimburse Sanofi for such development costs has increased from 10 % to 20 %.

The estimated net present value differential between the 10 % repayment rate and the 20 % repayment rate was deemed to be contingent consideration attributable to the Company's acquisition of the Libtayo rights described within the " Immuno-Oncology " section below;

this portion is recorded as an increase to the Libtayo intangible asset over time as the Company repays such development costs to Sanofi.

The Company's contingent reimbursement obligation (i.e., "development balance") to Sanofi under the Antibody Collaboration was approximately $ 1.635 billion as of December 31, 2024.

Sanofi leads commercialization activities for products under the Antibody 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 parties equally share profits from sales within the United States.

The parties share profits outside the United States on a sliding scale based on sales starting at 65 % (Sanofi)/ 35 % (Regeneron) and ending at 55 % (Sanofi)/ 45 % (Regeneron).

In addition to profit sharing, the Company was entitled to receive sales milestone payments from Sanofi.

In 2023, the Company earned the final $ 50.0 million sales-based milestone from Sanofi upon aggregate annual sales of antibodies outside the United States exceeding $ 3.0 billion on a rolling twelve-month basis.

In 2022, the Company earned two $ 50.0 million sales-based milestones from Sanofi, upon aggregate annual sales of antibodies outside the United States exceeding $ 2.0 billion and $ 2.5 billion, respectively, on a rolling twelve-month basis.

The Company's significant promised goods and services in connection with the Antibody Collaboration consist of providing research and development services, including the manufacturing of clinical supplies, and providing commercial-related services, including the manufacturing of commercial supplies.

The Company recognizes amounts in connection with the Antibody Collaboration based on the amount it has the right to invoice and such amount corresponds directly with the Company's performance to date.

The following table summarizes contract balances in connection with the Company's Antibody Collaboration with Sanofi:

The following table summarizes contract balances in connection with the Company's Sanofi collaboration:

As of December 31,

3 unchanged sentences

$ 442.3 $ 571.7

Immuno-Oncology

The Company was previously a party to a collaboration with Sanofi for antibody-based cancer treatments in the field of immuno-oncology, including for the co-development and co-commercialization of Libtayo.

The parties shared equally, on an ongoing basis, development and commercialization expenses for Libtayo.

The Company had principal control over the development of Libtayo and led commercialization activities in the United States, while Sanofi led commercialization activities outside the United States.

The parties shared equally in profits and losses in connection with the commercialization of Libtayo.

Effective July 1, 2022, the Company obtained the exclusive right to develop, commercialize, and manufacture Libtayo worldwide.

In connection with this agreement, in 2022, the Company made a $ 900.0 million up-front payment to Sanofi, as well as a $ 100.0 million regulatory milestone payment.

In addition, Sanofi was eligible to earn an aggregate of $ 100.0 million in Libtayo sales-based milestones, of which it earned $ 65.0 million in 2022 and $ 35.0 million in 2023.

The Company also pays Sanofi an 11 % royalty on net product sales of Libtayo through March 31, 2034.

The transaction was accounted for as an asset acquisition and amounts paid to Sanofi in connection with obtaining the worldwide rights to Libtayo, including the up-front payment and any contingent consideration, are recorded as an intangible asset.

See Note 8 for additional information related to the intangible asset.

The Company is party to a license and collaboration agreement with Bayer for the global development and commercialization of EYLEA 8 mg (aflibercept 8 mg) and EYLEA (aflibercept) outside the United States.

Agreed-upon development expenses incurred by the Company and Bayer are generally shared equally.

The Company is also obligated to use commercially reasonable efforts to supply clinical and commercial bulk product.

The parties generally share equally agreed-upon development expenses as incurred.

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.

8 unchanged sentences

$ 1,282.7 $ 1,403.3 $ 1,376.4

Reimbursement for manufacturing of ex-U.S.

commercial supplies Collaboration revenue

Reimbursement for manufacturing of commercial supplies

Collaboration revenue

$ 139.7 $ 95.7 $ 111.1

One-time payment in connection with change in Japan arrangement Collaboration revenue

Regeneron's obligation for its share of Bayer R&D expenses, net of reimbursement of R&D expenses (R&D expense)

$ ( 20.0 ) $ ( 48.5 ) $ ( 44.0 )

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 $ ( 48.5 ) $ ( 44.0 ) $ 16.7

The following table summarizes contract balances in connection with the Company's Bayer collaboration:

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$ 295.7 $ 216.3

The Company is a party to a collaboration agreement with Roche to develop, manufacture, and distribute the casirivimab and imdevimab antibody cocktail (known as REGEN-COV ® in the United States and Ronapreve ™ in other countries).

Under the terms of the collaboration agreement, the Company has the right to distribute the product in the United States while Roche has the right to distribute the product outside the United States.

The parties share gross profits from worldwide sales based on a pre-specified formula.

Amounts recognized in the Company's Statements of Operations in connection with its Roche collaboration are as follows:

Statement of Operations Classification Year Ended December 31,

(In millions) 2024 2023 2022

Regeneron's share of profits

Collaboration revenue

$ 1.4 $ 224.3 $ 627.3

Collaboration revenue

$ — $ ( 13.3 ) $ —

Reimbursement of research and development expenses from Roche was not material for the years ended December 31, 2024, 2023, and 2022.

Contract balances in the Company's Balance Sheets in connection with the Roche collaboration were not material as of December 31, 2024 and 2023.

In addition to the collaboration and license agreements discussed above, the Company has various other collaboration and license agreements that are not individually significant to its operating results or financial condition at this time.

Pursuant to the terms of those agreements, the Company may be required to pay, or it may receive, additional amounts contingent upon the occurrence of various future events (e.g., upon the achievement of various development and commercial milestones), which in the aggregate could be significant.

The Company may also incur, or get reimbursed for, research and development costs.

Acquired In-process Research and Development ("IPR&D") Expenses

During the year ended December 31, 2024, the Company recorded as Acquired IPR&D expense a $ 45.0 million development milestone in connection with the Company's collaboration agreement with Sonoma Biotherapeutics, Inc.

During the year ended December 31, 2023, the Company recorded as Acquired IPR&D expense a $ 100.0 million development milestone in connection with its collaboration agreement with Alnylam Pharmaceuticals, Inc., a $ 45.0 million up-front payment in connection with its collaboration agreement with Sonoma, and a $ 30.0 million extension payment under its collaboration agreement with Intellia Therapeutics, Inc.

During the year ended December 31, 2022, the Company recorded as Acquired IPR&D expense a $ 195.0 million charge related to its acquisition of Checkmate Pharmaceuticals, Inc.

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.

In January 2026, the Company's 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.

Under the terms of the agreement, the Company made aggregate payments of $ 150.0 million in January 2026, consisting of an up-front payment and the purchase of Tessera preferred stock.

The portion related to the up-front payment will be recorded to Acquired IPR&D expense in the first quarter of 2026.

Acquired IPR&D Expenses

During the year ended December 31, 2025, the Company recorded to Acquired IPR&D expense an $ 80.0 million up-front payment in connection with its license agreement with Hansoh Pharmaceuticals Group Company Limited to acquire development and commercial rights outside mainland China, Hong Kong, and Macau for HS-20094 (a dual GLP-1/GIP receptor agonist currently in Phase 3 clinical development in China).

During the year ended December 31, 2024, the Company recorded to Acquired IPR&D expense a $ 45.0 million development milestone in connection with its collaboration agreement with Sonoma Biotherapeutics, Inc.

During the year ended December 31, 2023, the Company recorded to Acquired IPR&D expense a $ 100.0 million development milestone in connection with its collaboration agreement with Alnylam Pharmaceuticals, Inc., a $ 45.0 million up-front payment in connection with its collaboration agreement with Sonoma, and a $ 30.0 million extension payment under its collaboration agreement with Intellia Therapeutics, Inc.

The Company has also in-licensed patent and/or technology pursuant to agreements which contain provisions that require the Company to pay royalties, as defined, at rates that range from 0.5 % to 12.5 %, in the event the Company sells or licenses any proprietary products developed under the respective agreements.

As described above, as a result of obtaining worldwide rights to Libtayo, the Company pays Sanofi a royalty on net product sales of Libtayo.

In addition, in 2018, the Company and Sanofi entered into a license agreement with Bristol-Myers Squibb Company, E.

Squibb & Sons, L.L.C., and Ono Pharmaceutical Co., Ltd.

to obtain a license under certain patents owned and/or exclusively licensed by one or more of those parties that includes the right to develop and sell Libtayo.

Under the agreement, the Company paid royalties of 8.0 % on worldwide sales of Libtayo through December 31, 2023, and is obligated to pay royalties of 2.5 % from January 1, 2024 through December 31, 2026.

For the years ended December 31, 2025, 2024, and 2023, the Company recorded royalty expense (net of reimbursements from collaborators, as applicable) of $ 81.3 million, $ 82.9 million, and $ 117.6 million, respectively, based on product sales under various licensing agreements.

28 unchanged sentences

$ 15,713.4 $ 14,329.1

The following table shows the fair value and gross unrealized losses by category and disaggregated by the length of time that the Company's available-for-sale debt securities have been in a continuous unrealized loss position.

Less than 12 Months 12 Months or Greater Total

(In millions)

As of December 31, 2024

Fair Value Unrealized Losses

Corporate bonds $ 7,175.8 $ ( 14.2 ) $ 1,044.8 $ ( 17.2 ) $ 8,220.6 $ ( 31.4 )

government and government agency obligations 4,675.3 ( 6.2 ) 141.7 ( 0.7 ) 4,817.0 ( 6.9 )

Sovereign bonds 63.3 ( 0.3 ) 19.1 ( 0.1 ) 82.4 ( 0.4 )

Asset-backed securities 265.4 ( 0.3 ) 13.9 — 279.3 ( 0.3 )

$ 12,179.8 $ ( 21.0 ) $ 1,219.5 $ ( 18.0 ) $ 13,399.3 $ ( 39.0 )

As of December 31, 2023

Corporate bonds $ 2,363.3 $ ( 2.4 ) $ 4,034.7 $ ( 102.5 ) $ 6,398.0 $ ( 104.9 )

government and government agency obligations 4,780.6 ( 6.0 ) 52.7 ( 2.6 ) 4,833.3 ( 8.6 )

Sovereign bonds 12.4 ( 0.1 ) 44.8 ( 0.8 ) 57.2 ( 0.9 )

Commercial paper

636.8 ( 0.2 ) — — 636.8 ( 0.2 )

Asset-backed securities 61.8 ( 0.3 ) 25.3 ( 0.9 ) 87.1 ( 1.2 )

$ 7,854.9 $ ( 9.0 ) $ 4,157.5 $ ( 106.8 ) $ 12,012.4 $ ( 115.8 )

The unrealized losses on corporate bonds were primarily driven by changes in interest rates.

The Company has reviewed its portfolio of available-for-sale debt securities and determined that the decline in fair value below cost did not result from credit-related factors.

In addition, the Company does not intend to sell, and it is not more likely than not that the Company will be required to sell, such securities before recovery of their amortized cost bases.

With respect to marketable securities, for the years ended December 31, 2024, 2023, and 2022, amounts reclassified from Accumulated other comprehensive loss into Other income (expense), net were related to realized gains/losses on sales of available-for-sale debt securities.

For the years ended December 31, 2024, 2023, and 2022, realized gains/losses on sales of marketable securities were not material.

Amounts reclassified from Accumulated other comprehensive income (loss) into Other income (expense), net related to realized gains/losses on sales of available-for-sale debt securities;

such amounts were not material for the years ended December 31, 2025, 2024, and 2023.

The Company recognized interest income of $ 716.8 million, $ 711.4 million, and $ 495.9 million for the years ended December 31, 2025, 2024, and 2023, respectively, in Other income (expense), net.

15 unchanged sentences

Sovereign bonds 76.8 — 76.8 —

Equity securities (unrestricted) 1,052.1 1,052.1 — —

Equity securities (restricted) (a)

Equity securities (a)

34.3 34.3 — —

11 unchanged sentences

Sovereign bonds 82.4 — 82.4 —

Equity securities (unrestricted) 864.5 864.5 — —

Equity securities (restricted) 112.9 112.9 — —

Equity securities (a)

1,095.3 1,095.3 — —

$ 16,876.6 $ 2,359.5 $ 14,517.1 $ —

Contingent consideration

$ 52.3 $ — $ — $ 52.3

(a) Includes equity securities which are subject to transfer restrictions that expire in April 2026

In addition to the investments summarized in the table above, as of December 31, 2024 and 2023, the Company had $ 159.8 million and $ 74.3 million, respectively, in equity investments that do not have a readily determinable fair value.

investments are recorded within Other noncurrent assets.

Also recorded within Other noncurrent assets as of December 31, 2024 were equity investments of $ 52.0 million which are measured at fair value based on Level 3 inputs;

no such investments were held by the Company as of December 31, 2023.

During the year ended December 31, 2024, the Company recorded $ 117.7 million of net unrealized gains on equity securities in Other income (expense), net.

During the years ended December 31, 2023 and 2022, the Company recorded $ 237.8 million and $ 39.8 million, respectively, of net unrealized losses on equity securities in Other income (expense), net.

In addition, during the year ended December 31, 2023, the Company recorded a write-down of $ 29.0 million in Other income (expense), net related to the Company's investments in private companies.

(a) Includes equity securities of $ 33.3 million and $ 43.2 million as of December 31, 2025 and 2024, respectively, that are subject to transfer restrictions expiring in April 2026

In addition to the investments summarized in the table above, the Company classified the following investments within Other noncurrent assets:

• As of December 31, 2025 and 2024, $ 334.0 million and $ 159.8 million, respectively, of equity securities that do not have a readily determinable fair value.

The change in carrying value of such investments was a result of additional purchases.

• As of December 31, 2025 and 2024, equity securities held through ownership interest in an investment fund of $ 147.5 million and $ 52.0 million, respectively, which are measured at fair value based on Level 3 inputs.

The change in carrying value was primarily the result of additional purchases by the fund.

Amounts recognized in Other income (expense), net, related to the Company's investments in public equity securities consist of the following:

Year Ended December 31,

(In millions)

2025 2024 2023

Net gains (losses) recognized during the period

$ 955.6 $ 117.7 $ ( 235.6 )

Net gains recognized on investments sold during the period 966.2 — 6.0

Net unrealized gains (losses) recognized on investments still held as of period end date

$ ( 10.6 ) $ 117.7 $ ( 241.6 )

Other Fair Value Disclosures

The fair value of the Company's long-term debt (see Note 10), which was determined based on Level 2 inputs, was estimated to be $ 1.576 billion and $ 1.484 billion as of December 31, 2025 and 2024, respectively.

9 unchanged sentences

For the years ended December 31, 2025, 2024, and 2023, Cost of goods sold included inventory write-offs and reserves of $ 172.9 million, $ 126.3 million, and $ 102.3 million, respectively.

Inventory write-offs and reserves for the year ended December 31, 2022 primarily related to REGEN-COV.

Property, Plant, and Equipment

25 unchanged sentences

$ 1,698.1 $ ( 440.7 ) $ 1,257.4 $ 1,410.5 $ ( 261.9 ) $ 1,148.6

During the years ended December 31, 2024 and 2023, the Company recorded additions to the Libtayo intangible asset related to contingent consideration due to Sanofi (see Note 3).

In addition, during the years ended December 31, 2024 and 2023, the Company recorded indefinite-lived intangible assets in connection with the acquisition of in-process and research and development programs.

During the years ended December 31, 2025 and 2024, the Company recorded additions to the Libtayo intangible asset related to contingent consideration due to Sanofi in connection with the acquisition of worldwide rights to Libtayo in 2022.

Amortization expense on intangible assets was $ 178.8 million, $ 128.9 million, and $ 92.2 million for the years ended December 31, 2025, 2024, and 2023, respectively.

As of December 31, 2025, assuming no changes in the gross carrying amount of intangible assets, amortization expense is estimated to be approximately $ 124 million for each of the years ending December 31, 2026 through December 31, 2030.

In addition to the intangible assets summarized in the table above, during the second quarter of 2025, the Company recorded an indefinite-lived intangible asset in connection with the purchase of a U.S.

Food and Drug Administration ("FDA") Rare Pediatric Disease Priority Review Voucher ("PRV") from a third party for $ 155.0 million.

During the fourth quarter of 2025, the Company made the decision to utilize the PRV for a regulatory submission, and as a result, the carrying amount was expensed to Research and development.

Accrued Expenses and Other Current Liabilities

108 unchanged sentences

Share Repurchase Programs

In November 2021, the Company's board of directors authorized a share repurchase program to repurchase up to $ 3.0 billion of the Company's Common Stock.

As of June 30, 2023, the Company had repurchased the entire $ 3.0 billion of its Common Stock it was authorized to repurchase under the program.

In January 2023, the Company's board of directors authorized a share repurchase program to repurchase up to an additional $ 3.0 billion of the Company's Common Stock.

As of September 30, 2024, the Company had repurchased the entire $ 3.0 billion of its Common Stock that it was authorized to repurchase under the program.

In April 2024, the Company's board of directors authorized a share repurchase program to repurchase up to an additional $ 3.0 billion of the Company's Common Stock.

The share repurchase program permits the Company to make repurchases through a variety of methods, including open-market transactions (including pursuant to a trading plan adopted in accordance with Rule 10b5-1 of the Securities Exchange Act of 1934, as amended (the "Exchange Act")), privately negotiated transactions, accelerated share repurchases, block trades, and other transactions in compliance with Rule 10b-18 of the Exchange Act.

The table below summarizes the shares of the Company's Common Stock that the Company repurchased and the cost of such shares, which were recorded as Treasury Stock.

The Company's board of directors has authorized share repurchase programs, including a share repurchase program for up to $ 3.0 billion of the Company's Common Stock which was authorized in February 2025.

The programs have no time limit and can be discontinued at any time.

The table below summarizes the shares of the Company's Common Stock that the Company repurchased under its share repurchase programs and the cost of such shares, which were recorded as Treasury Stock.

Year Ended December 31,

2 unchanged sentences

Total cost of shares $ 3,456.2 $ 2,613.9 $ 2,214.6

As of December 31, 2024, $ 1.917 billion remained available for share repurchases under the April 2024 program.

In February 2025, the Company's board of directors authorized a share repurchase program to repurchase up to an additional $ 3.0 billion of the Company's Common Stock.

The share repurchase program was approved under terms substantially similar to the repurchase programs described above.

In February 2025, the Company's board of directors declared the Company's first quarterly cash dividend, in the amount of $ 0.88 per share on its Common Stock and Class A Stock.

The cash dividend will be payable on March 20, 2025 to shareholders of record as of February 20, 2025.

As of December 31, 2025, $ 1.486 billion remained available for share repurchases under the Company's share repurchase programs.

In 2025, the Company's board of directors declared quarterly cash dividends of $ 0.88 per share on its Common Stock and Class A Stock.

Each quarterly dividend was paid to the Company's shareholders in the quarter in which the dividend was declared.

Additionally, in January 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 March 2026.

Long-Term Incentive Plans

42 unchanged sentences

The Company satisfies stock option exercises with newly issued shares of the Company's Common Stock.

The total intrinsic value of stock options exercised during 2024, 2023, and 2022 was $ 1.682 billion, $ 1.096 billion, and $ 1.214 billion, respectively.

The total intrinsic value of stock options exercised during 2025, 2024, and 2023 was $ 193.6 million, $ 1.682 billion, and $ 1.096 billion, respectively.

The intrinsic value represents the amount by which the market price of the underlying stock exceeds the exercise price of an option.

The table below summarizes the weighted-average exercise prices and weighted-average grant-date fair values of options issued during the years ended December 31, 2024, 2023, and 2022.

The table below summarizes the weighted-average exercise prices and weighted-average grant-date fair values of options granted during the years ended December 31, 2025, 2024, and 2023.

Number of Options Granted

15 unchanged sentences

Expected volatility has been estimated based on actual movements in the Company's stock price over the most recent historical periods equivalent to the options' expected lives.

Expected lives are principally based on the Company's historical exercise experience with previously issued employee and board of directors' option grants.

Expected lives are principally based on the Company's historical exercise experience with previously issued option grants.

Expected dividend yield is based on the Company's historical practice and expectation of future dividend payments.

During 2024 and 2023, the expected dividend yield was zero as the Company had not paid dividends nor did it expect to at the time of option grants.

19 unchanged sentences

Depending on the terms of the PSUs and the outcome of the pre-established performance criteria, a recipient may ultimately earn the target number of PSUs granted or a specified multiple thereof at the end of a 4 – 6 year vesting period, as applicable.

As of December 31, 2024 and 2023, 1.4 million PSUs were unvested with a weighted-average grant date fair value of $ 247.91 per unit.

The table below summarizes activity related to PSUs during 2025.

The number of unvested PSUs represents the maximum number of units that are eligible to be earned.

During the year ended December 31, 2024, the Company did not grant new PSUs and no PSUs were vested, forfeited, or cancelled.

Number of Shares/Units

(In millions)

Weighted-Average Grant

Date Fair Value

Unvested as of December 31, 2024

Vested ( 1.2 ) $ 209.59

Unvested as of December 31, 2025

For each of the years ended December 31, 2025, 2024, and 2023 the Company recognized $ 52.0 million of stock-based compensation expense related to PSUs.

As of December 31, 2024, there was $ 52.0 million of stock-based compensation cost related to unvested PSUs which had not yet been recognized.

The Company expects to recognize this compensation cost on a straight-line basis over a weighted average period of 1.0 year.

Fair Value Assumptions:

The following table summarizes the weighted average values of the assumptions used in computing the fair value of PSUs that were granted during 2022.

The Company did not grant PSUs during 2024 and 2023.

Expected volatility 32 %

Expected dividend yield 0 %

Risk-free interest rate 3.3 %

As of December 31, 2025, there was no stock-based compensation cost expected to be recognized related to unvested PSUs.

Employee Savings Plans

27 unchanged sentences

$ 725.8 $ 367.3 $ 245.7

Cash paid for income taxes, net of refunds received, by jurisdiction for the year ended December 31, 2025 is as follows:

(In millions) 2025

Cash paid for income taxes, net of refunds received, were $ 743.0 million and $ 870.3 million for the years ended December 31, 2024 and 2023, respectively.

On July 4, 2025, bill H.R.

1, commonly referred to as the "One Big Beautiful Bill Act" or "OBBBA," was signed into law, with certain provisions effective in 2025 and others in 2026.

The OBBBA significantly revises U.S.

corporate income tax laws by, among other things, restoring the option for immediate expense recognition for U.S.-based research and development expenditures and making permanent the ability to claim first-year bonus depreciation on qualified property.

The OBBBA also modifies U.S.

taxation on foreign earnings by, among other things, changing the tax rates for Net CFC Tested Income (formerly known as global intangible low-taxed income ("GILTI")) and foreign-derived intangible income (now known as foreign-derived deduction eligible income), modifying the allocation of expenses in calculating foreign tax credits, as well as changing foreign tax credit limitations.

As a result of the OBBBA being signed into law, the Company recognized a charge of $ 44.5 million in 2025 related to the re-measurement of the Company's U.S.

net deferred tax assets.

A reconciliation of the U.S.

statutory income tax rate to the Company's effective income tax rate is as follows:

Year Ended December 31,

federal statutory tax rate to the Company's effective tax rate for the year ended December 31, 2025 is as follows:

(In millions, except percent)

federal statutory tax rate

$ 1,098.4 21.0 %

Foreign tax effects:

Statutory tax rate difference between Ireland and United States

( 480.3 ) ( 9.2 )

Domestic top-up tax

( 5.8 ) ( 0.1 )

Other foreign jurisdictions 7.7 0.1

Research and development and orphan drug tax credits ( 133.3 ) ( 2.5 )

Effect of cross-border tax laws:

Foreign-derived deduction eligible income

( 20.6 ) ( 0.4 )

Net CFC tested income ("NCTI"), net of foreign tax credit ("FTC")

( 82.7 ) ( 1.6 )

Subpart F income, net of FTC

Changes in unrecognized tax benefits (a)

Effect of changes in tax laws or rates enacted in the current period 44.5 0.9

Nontaxable or nondeductible items:

Stock-based compensation

Other permanent differences

Other adjustments

Effective tax rate

$ 725.8 13.9 %

(a) Changes in unrecognized tax benefits for all jurisdictions are aggregated within this category

A reconciliation of the U.S.

federal statutory tax rate to the Company's effective tax rate for the years ended December 31, 2024 and 2023 is as follows:

federal statutory tax rate 21.0 % 21.0 %

Stock-based compensation

( 4.9 ) ( 4.6 )

Taxation of non-U.S.

operations ( 4.0 ) ( 6.6 ) ( 5.5 )

Income tax credits ( 3.5 ) ( 3.2 ) ( 2.0 )

Foreign-derived intangible income deduction ( 0.8 ) ( 0.3 ) ( 1.0 )

( 4.0 ) ( 6.6 )

( 3.5 ) ( 3.2 )

Foreign-derived deduction eligible income

( 0.8 ) ( 0.3 )

Other permanent differences ( 0.1 ) ( 0.4 )

Effective income tax rate 7.7 % 5.9 % 10.7 %

Effective tax rate 7.7 % 5.9 %

Deferred income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes.

5 unchanged sentences

Deferred compensation 452.0 419.7

Accrued expenses 185.0 214.1

Fixed assets and intangible assets 192.6 145.1

Accrued expenses 158.8 185.0

Tax attribute carryforwards 79.6 84.1

15 unchanged sentences

Gross increases related to current year tax positions 401.9 353.5 153.4

Gross increases (decreases) related to prior year tax positions 264.8 3.2 ( 5.0 )

Gross (decreases) increases related to prior year tax positions

( 43.1 ) 264.8 3.2

Gross decreases due to settlements and lapse of statutes of limitations ( 94.6 ) ( 1.0 ) ( 3.0 )

1 unchanged sentence

In 2025, 2024, and 2023, the increases in unrecognized tax benefits primarily related to the Company's calculation of certain tax credits and other items related to the Company's international operations.

In 2025, the Company released liabilities for uncertain tax positions in connection with the settlement of the IRS audit of the Company's 2017 and 2018 federal income tax returns.

Interest expense related to unrecognized tax benefits was $ 201.7 million, $ 165.4 million, and $ 77.2 million in 2025, 2024, and 2023, respectively.

The Company expects the IRS to conclude its examination of the Company's 2017 and 2018 federal income tax returns within the next twelve months, and, as a result, the Company may be required to make a payment of approximately $ 120 million.

The Company's unrecognized tax benefits for the years under examination exceed the expected payment amount, which would result in the Company recognizing a net tax benefit within the next twelve months.

The amount of net unrecognized tax benefits that, if settled, would impact the effective tax rate is $ 520.9 million, $ 635.4 million, and $ 442.5 million as of December 31, 2025, 2024, and 2023, respectively.

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Costs associated with the Company's involvement in legal proceedings are expensed as incurred.

The Company recognizes accruals for loss contingencies associated with such proceedings when it is probable that a liability will be incurred and the amount of loss can be reasonably estimated.

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 December 31, 2025 and 2024, the Company's accruals for loss contingencies were not material.

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Proceedings Relating to EYLEA (aflibercept) Injection

Certain of the Company's patents pertaining to EYLEA are subject to post-grant proceedings before the United States Patent and Trademark Office ("USPTO"), the European Patent Office (the "EPO"), or other comparable foreign authorities, including those described in greater detail below.

In addition, the Company has filed patent infringement lawsuits in several jurisdictions alleging infringement of certain Company patents pertaining to EYLEA, including those described in greater detail below.

(1) United States

As described in greater detail below, the Company has filed several patent infringement lawsuits against various parties in the United States alleging infringement of certain Company patents pertaining to EYLEA, and certain of these patents have also been subject to post-grant proceedings before the United States Patent and Trademark Office ("USPTO").

Patent Litigation

On August 2, 2022, the Company filed a patent infringement lawsuit against Mylan, a wholly-owned subsidiary of Viatris Inc., in the United States District Court for the Northern District of West Virginia alleging that Mylan's filing for U.S.

Food and Drug Administration ("FDA") approval of an aflibercept 2 mg biosimilar infringes certain Company patents.

On June 5, 2023, Biocon, as successor-in-interest to the aflibercept 2 mg biosimilar, was joined as a defendant to the lawsuit.

A trial was held from June 12, 2023 through June 23, 2023 concerning certain claims of the '601 Patent, the '572 Patent, and the Company's U.S.

In 2025, the Company entered into settlement agreements resulting in the dismissal of the previously disclosed patent infringement lawsuits before the United States District Court for the Northern District of West Virginia against Mylan Pharmaceuticals Inc.

("Mylan") and Biocon Biologics Inc.

Celltrion, Inc.

("Celltrion");

Formycon AG ("Formycon");

and Sandoz Inc.

The lawsuits each alleged infringement of certain Company patents, including the Company's U.S.

11,084,865 (the "'865 Patent").

On December 27, 2023, the court issued a decision finding that (i) the asserted claims of the '865 Patent were valid and infringed by Mylan and Biocon and (ii) the asserted claims of the '601 and '572 Patents were infringed by Mylan and Biocon but were invalid as obvious.

On June 11, 2024, the court granted the Company's motion for a permanent injunction, enjoining Mylan and Biocon from selling in the United States their aflibercept 2 mg biosimilar until the expiration of the '865 Patent.

On June 21, 2024, Mylan and Biocon filed a notice of appeal of the court's December 27, 2023 and June 11, 2024 decisions to the Federal Circuit.

An oral hearing concerning Mylan and Biocon's appeal has been scheduled for February 7, 2025.

On November 8, November 22, and November 29, 2023, respectively, the Company filed patent infringement lawsuits against Celltrion, Samsung Bioepis, and Formycon AG in the United States District Court for the Northern District of West Virginia following service on Regeneron of each company's notice of commercial marketing.

The lawsuits allege that each company has infringed certain Company patents, including based on each company's filing for FDA approval of an aflibercept 2 mg biosimilar.

On December 27, 2023, the Company filed a second patent infringement lawsuit against Samsung Bioepis in the United States District Court for the Northern District of West Virginia alleging that Samsung's filing for FDA approval of an aflibercept 2 mg biosimilar infringes certain Company patents.

On June 14, June 21, and June 28, 2024, respectively, the court granted the Company's motions for preliminary injunctions against Samsung Bioepis, Formycon, and Celltrion.

On June 14, June 25, and July 8, 2024, respectively, Samsung Bioepis, Formycon, and Celltrion filed notices of appeal of the court's preliminary injunction decisions to the Federal Circuit.

An oral hearing concerning the respective appeals of Samsung Bioepis and Formycon was held on December 5, 2024.

On January 29, 2025, the Federal Circuit affirmed the lower court's preliminary injunction decisions against Samsung Bioepis and Formycon.

An oral hearing concerning Celltrion's appeal has been scheduled for February 7, 2025.

On January 10, 2024, the Company filed a patent infringement lawsuit against Amgen in the United States District Court for the Central District of California alleging that Amgen's filing for FDA approval of an aflibercept 2 mg biosimilar infringes certain Company patents.

On April 11, 2024, the United States Judicial Panel on Multidistrict Litigation granted the Company's motion to transfer this lawsuit to the United States District Court for the Northern District of West Virginia for coordinated and consolidated pretrial proceedings with the lawsuits described in the preceding paragraph.

On June 7, 2024, the Company filed a motion for a preliminary injunction against Amgen.

On September 23, 2024, the court denied the Company's motion for a preliminary injunction, and the Company filed (i) a notice of appeal of such decision to the Federal Circuit, (ii) a motion for an immediate administrative stay, and (iii) a motion for a temporary injunction preventing Amgen from launching its aflibercept 2 mg biosimilar during the pendency of such appeal.

On September 25, 2024, the Federal Circuit issued an administrative stay pending its review of the Company's temporary injunction motion.

On October 22, 2024, the Federal Circuit denied the Company's temporary injunction motion and lifted the administrative stay.

An expedited oral hearing concerning the Company's appeal of the court's preliminary injunction decision was held on January 14, 2025.

On August 26, 2024, the Company filed a patent infringement lawsuit against Sandoz Inc.

in the United States District Court for the District of New Jersey alleging that Sandoz's filing for FDA approval of an aflibercept 2 mg biosimilar infringes certain Company patents.

On September 12, 2024, the United States Judicial Panel on Multidistrict Litigation granted the Company's motion to transfer this lawsuit to the United States District Court for the Northern District of West Virginia for coordinated and consolidated pretrial proceedings with the lawsuits described in the preceding paragraphs.

Post-Grant Proceedings Before the USPTO

On November 20, 2024, November 29, 2024, and January 15, 2025, Samsung Bioepis Co., Ltd., Formycon AG, and Celltrion Inc., respectively, filed inter partes review ("IPR") petitions in the USPTO against the Company's U.S.

11,084,865 (the "'865 Patent"), each seeking a declaration that the '865 Patent is invalid.

EPO Post-Grant Proceedings

Pursuant to the settlement agreements, these parties are precluded from launching their respective aflibercept 2 mg biosimilars until the second half of 2026 (Mylan/Biocon), fourth quarter of 2026 (Sandoz and Formycon), and December 31, 2026 (Celltrion).

On January 10, 2024, the Company filed a patent infringement lawsuit against Amgen Inc.

("Amgen") in the United States District Court for the Central District of California (subsequently transferred to the United States District Court for the Northern District of West Virginia) alleging that Amgen's filing for FDA approval of an aflibercept 2 mg biosimilar infringed certain Company patents.

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.

On September 12, 2025, Amgen filed its answer and counterclaims 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 Amgen's affirmative defenses and counterclaims.

(ii) Post-Grant Proceedings Before the USPTO

On November 20, 2024, November 29, 2024, and January 15, 2025, Samsung Bioepis, Formycon, and Celltrion, respectively, filed inter partes review ("IPR") petitions in the USPTO against the '865 Patent, each seeking a declaration that the '865 Patent is invalid.

On June 6, 2025, the USPTO denied institution of Samsung and Formycon's respective IPR petitions, and on June 25, 2025, the USPTO denied institution of Celltrion's IPR petition.

On July 14, 2025, Fresenius Kabi SwissBioSim GmbH filed IPR petitions in the USPTO against the '865 Patent and U.S.

10,828,345 (the "'345 Patent"), seeking a declaration that the '865 Patent and '345 Patent are invalid.

On November 20, 2025, and January 6, 2026, the USPTO denied institution of Fresenius' IPR petitions against the '865 Patent and the '345 Patent, respectively.

(2) Outside the United States

As described in greater detail below, the Company has filed patent infringement lawsuits against various parties in several jurisdictions outside the United States alleging infringement of certain Company patents pertaining to EYLEA, and certain of these patents have also been subject to post-grant proceedings before the European Patent Office (the "EPO") and/or other comparable foreign authorities.

(i) Multijurisdictional Settlements

On December 13, 2025, the Company and Bayer entered into a settlement agreement with Biocon and its affiliated entities in respect of all jurisdictions outside the United States with the exception of Canada (separately settled in March 2024, as previously disclosed).

Pursuant to the settlement agreement, all pending judicial and administrative proceedings related to Biocon's aflibercept 2 mg biosimilar product has been dismissed and Biocon is permitted to launch such biosimilar product in the United Kingdom in January 2026 and in the rest of the jurisdictions covered by the settlement in March 2026 or, in each case, earlier in certain circumstances.

On January 21, 2026, the Company and Bayer entered into a settlement agreement with Celltrion in respect of all jurisdictions outside the United States with the exceptions of Canada (separately settled in July 2024, as previously disclosed) and Singapore (separately settled in November 2025).

Pursuant to the settlement agreement, all pending judicial and administrative proceedings related to Celltrion's aflibercept 2 mg biosimilar product, including the previously disclosed litigation in South Korea, has or will be dismissed and Celltrion is permitted to launch such biosimilar product in South Korea and the United Kingdom in January 2026 and in the rest of the jurisdictions covered by the settlement in the second quarter of 2026, or earlier in certain circumstances.

On January 28, 2026, the Company and Bayer entered into a settlement agreement with Alvotech HF ("Alvotech") in respect of all jurisdictions outside the United States.

Pursuant to the settlement agreement, all pending judicial and administrative proceedings related to Alvotech's aflibercept 2 mg biosimilar product, including the litigation in Germany discussed below, has or will be dismissed and Alvotech is permitted to launch such biosimilar product in Canada, the United Kingdom, and Japan in January 2026 (November 2026 in the case of the DME indication in Japan) and in the rest of the jurisdictions covered by the settlement in May 2026.

Samsung Bioepis .

On January 29, 2026, the Company and Bayer entered into a settlement agreement with Samsung Bioepis in respect of all jurisdictions outside the United States with the exception of Canada (separately settled in October 2024, as previously disclosed).

Pursuant to the settlement agreement, all pending judicial and administrative proceedings related to Samsung Bioepis' aflibercept 2 mg biosimilar product, including the litigation in the United Kingdom, Germany, the Netherlands, and South Korea discussed below, has or will be dismissed and Samsung Bioepis is permitted to maintain its biosimilar on the market in South Korea and launch such biosimilar product in the United Kingdom in January 2026, the rest of Europe in April 2026, and the rest of the jurisdictions covered by the settlement in May 2026.

(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 of the EPO.

On November 26, 2024, following an oral hearing, the Opposition Division ("OD") of the EPO announced its decision to revoke the '306 Patent.

The Company plans to appeal the OD's decision.

Oral proceedings concerning the '992 Patent are scheduled for October 2025.

Country-Specific Proceedings

Various parties, including Amgen, Samsung Bioepis, and Formycon and/or their affiliated entities, are seeking revocation of the '306 Patent, the '992 Patent, and the Company's European Patent No.

2,364,691 (the "'691 Patent") and/or a declaration that its aflibercept 2 mg biosimilar would not infringe these patents in several European national courts (including those in France, Germany, Italy, the Netherlands, and the United Kingdom).

In the United Kingdom, the Company has filed a preemptive counterclaim against Formycon AG and Klinge Biopharma GmbH, Samsung Bioepis UK Limited, and Amgen Inc.

for infringement of the '306 Patent and the '691 Patent.

In Germany, a trial concerning the '691 Patent has been scheduled to begin in June 2025.

In the United Kingdom, trials concerning the '691 and '306 Patents have been scheduled to begin in June 2025, and the '992 Patent proceedings are stayed pending resolution of the EPO proceedings concerning this patent.

In the Netherlands, a trial concerning the '691 and '306 Patents has been scheduled to begin in July 2025.

The Company has commenced proceedings in Belgium against various parties, including Amgen Inc., Celltrion Inc., Sterigenics (Petit-Rechain) NV, and Sandoz GmbH, for infringement of the Company's European Patent No.

1,183,353 (as extended by Supplementary Protection Certificate 2013C/029).

Proceedings against Amgen Canada

On May 9, 2023, Amgen Canada Inc.

("Amgen Canada") filed invalidation proceedings against the Company in the Federal Court of Canada seeking revocation of the Company's Canadian Patent Nos.

2,654,510 (the "'510 Patent") and 3,007,276 (the "'276 Patent").

On September 14, 2023, the Company, Bayer Inc., and Bayer Healthcare LLC filed patent infringement lawsuits against Amgen Canada in the Federal Court of Canada seeking a declaration that the making, constructing, using, or selling of an aflibercept 2 mg biosimilar would directly or indirectly infringe one or more claims of Bayer Healthcare LLC's Canadian Patent No.

2,970,315 (the "'315 Patent").

On September 14, 2023, the Company and Bayer Inc.

filed three separate patent infringement lawsuits against Amgen Canada in the Federal Court of Canada seeking a declaration that the making, constructing, using, or selling of an aflibercept 2 mg biosimilar would directly or indirectly infringe one or more claims of the Company's Canadian Patent Nos.

3,129,193 (the "'193 Patent"), 2,965,495 (the "'495 Patent"), and 2,906,768 (the "'768 Patent"), respectively.

On October 11, 2023, the Company, Bayer Inc., and Bayer Healthcare LLC filed two separate patent infringement lawsuits against Amgen Canada in the Federal Court of Canada seeking a declaration that the making, constructing, using, or selling of an aflibercept 2 mg biosimilar would directly or indirectly infringe one or more claims of the Company's '510 Patent and '276 Patent, respectively.

On May 7, 2024 and June 28, 2024, respectively, Amgen filed a summary trial motion with respect to the '510 Patent and a motion to delist the '276 Patent from the Canada Patent Register.

On November 20, 2024, the court granted Amgen's motion to delist the '276 Patent from the Canada Patent Register, which decision has been appealed by the Company and Bayer.

A trial for the lawsuits concerning the '510 Patent and the '276 Patent has been scheduled for May–June 2025;

and a trial for the lawsuits concerning the '315 Patent and the '193 Patent has been scheduled for August–September 2025.

Proceedings against Sandoz

On January 24, 2025, the Company, Bayer Inc., and Bayer Healthcare LLC filed patent infringement lawsuits against Sandoz Canada Inc.

in the Federal Court of Canada seeking a declaration that the making, constructing, using, or selling of an aflibercept 2 mg biosimilar would directly or indirectly infringe one or more claims of the '510 Patent, the '276 Patent, the '495 Patent, the '768 Patent, the '193 Patent, the '315 Patent, and Canadian Patent No.

3,137,326 (the "'326 Patent").

On October 31, 2022 and December 13, 2022, Samsung Bioepis Co., Ltd.

initiated invalidation proceedings before the Intellectual Property Trial and Appeal Board of the Korean Intellectual Property Office ("KIPO") against the Company's Korean Patent Nos.

1131429 (the "'429 Patent") and 1406811 (the "'811 Patent"), respectively, seeking revocation of each such patent in its entirety.

On October 23, 2024, the KIPO maintained the '811 Patent as valid, and Samsung appealed this decision on November 6, 2024.

On November 20, 2024, the KIPO maintained the '429 Patent as valid in an amended form that no longer contains claims to aflibercept.

The Company and, as applicable, Bayer Consumer Care AG, have also filed patent infringement lawsuits in the Seoul Central District Court against various parties including Samsung Bioepis Co., Ltd.

and its parent company Samsung Biologics Co., Ltd., Sam Chun Dang Pharm.

and OPTUS Pharmaceutical Co., Ltd, and Celltrion Inc.

2,944,306 (the "'306 Patent"), 3,716,992 (the "'992 Patent"), and 3,384,049 (the "'049 Patent") before the Opposition Division ("OD") of the EPO.

On November 26, 2024, following an oral hearing, the OD announced its decision to revoke the '306 Patent.

On March 11, 2025, the Company appealed the OD's decision, and an oral hearing concerning the appeal 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.

An oral hearing concerning the '049 Patent has been scheduled for April 2026.

(II) Country-Specific Proceedings

The Company is also party to proceedings against various parties, including Samsung Bioepis, Formycon, Amgen, Alvotech, Celltrion, Sandoz, and/or their affiliated entities, before several European national courts (including those in Belgium, France, Germany, Italy, the Netherlands, and the United Kingdom).

In certain of these proceedings, the counterparties are seeking revocation of one or more Company patents pertaining to EYLEA, including the '306 Patent, the '992 Patent, the Company's European Patent No.

2,364,691 (the "'691 Patent"), and the Company's European Patent No.

1,183,353 (as extended by Supplementary Protection Certificate 2013C/029), and/or a declaration that their respective aflibercept 2 mg biosimilars would not infringe these patents, and in the same or other proceedings, the Company is alleging infringement of such patents.

As noted above, the Company and Bayer recently entered into settlement agreements with Samsung Bioepis, Alvotech, and Celltrion, pursuant to which the proceedings discussed below have been or will be dismissed with respect to these parties.

Key recent developments in the proceedings set forth below are as follows:

• United Kingdom :

◦ Following trials held in June 2025, the High Court of England and Wales issued a decision in October 2025 that found that Formycon and Samsung Bioepis's aflibercept 2 mg biosimilar products do not infringe the '691 and '306 Patents;

upheld the '691 Patent as valid;

and invalidated the '306 Patent.

In December 2025, the Company appealed this decision.

◦ Proceedings in the United Kingdom concerning the '992 Patent are stayed pending resolution of the EPO proceedings concerning this patent.

◦ Following a June 2025 trial concerning the revocation proceeding brought by Samsung Bioepis, the German Federal Patent Court upheld the '691 Patent as valid.

◦ In October 2025, the Munich Regional Court issued a decision that found that Formycon's aflibercept biosimilar product infringes the '691 Patent and granted the Company's motion for a permanent injunction, enjoining Formycon from selling its aflibercept 2 mg biosimilar in Germany and several other EU countries (including Spain and the Netherlands) until the expiration of the '691 Patent.

◦ In January 2026, the Munich Regional Court issued decisions that found that each of Alvotech's, Celltrion's, and Sandoz's aflibercept 2 mg biosimilar products infringes the '691 Patent and granted the Company's motions for preliminary injunctions, enjoining such parties from selling their aflibercept 2 mg biosimilars in Germany and, in the case of Alvotech, also several other EU countries (including France, Spain, Italy, and the Netherlands).

• Netherlands :

◦ Following a trial held in July 2025, the District Court of the Hague issued a decision in October 2025 that upheld the '691 and '306 Patents as valid;

found that Samsung Bioepis's aflibercept 2 mg biosimilar product infringes the '691 and '306 Patents;

and granted the Company's request for a permanent injunction, enjoining Samsung Bioepis from selling its aflibercept 2 mg biosimilar in the Netherlands until the expiration of the '691 and '306 Patents.

In 2025, the Company, Bayer Inc., and Bayer Healthcare LLC entered into settlement agreements resulting in the dismissal of the previously disclosed patent infringement lawsuits and/or invalidation proceedings before the Federal Court of Canada against Amgen Canada Inc.

("Amgen Canada") and Sandoz Canada Inc.

Pursuant to the settlement agreements, the Company, Bayer Inc., and Bayer Healthcare LLC are no longer seeking a declaration that Amgen Canada's or Sandoz's respective aflibercept 2 mg biosimilar products infringe the asserted Company patents.

(iv) South Korea

As noted above, the Company and Bayer recently entered into settlement agreements with Samsung Bioepis and Celltrion, pursuant to which the proceedings discussed below have been or will be dismissed with respect to these parties.

On December 13, 2022, Samsung Bioepis initiated invalidation proceedings before the Intellectual Property Trial and Appeal Board of the Korean Intellectual Property Office ("KIPO") against the Company's Korean Patent No.

1406811 (the "'811 Patent"), seeking revocation of the '811 Patent in its entirety.

On October 23, 2024, the KIPO maintained the '811 Patent as valid.

On October 30, 2025, the IP High Court overturned the decision of the KIPO and invalidated the '811 Patent;

the Company has appealed that decision.

The Company and, as applicable, Bayer Consumer Care AG, have also filed patent infringement lawsuits in the Seoul Central District Court against various parties including Samsung Bioepis and its parent company Samsung Biologics Co., Ltd.

(collectively, "Samsung"), Sam Chun Dang Pharm.

and OPTUS Pharmaceutical Co., Ltd., and Celltrion.

These lawsuits seek damages and/or injunctive relief and allege that the making, constructing, using, or selling of an aflibercept 2 mg biosimilar by the relevant defendant(s) would infringe one or more claims of the '811 Patent and/or the Company's Korean Patent Nos.

659477 (the "'477 Patent") and 2519234 (the "'234 Patent").

On February 7, 2025, the Seoul Central District Court granted the Company's preliminary injunction request against Samsung on the basis of the '811 Patent.

Also on February 7, 2025, the Seoul Central District Court denied Regeneron's preliminary injunction request against Celltrion.

In light of the decision of the IP High Court discussed above, on December 3, 2025, the Seoul High Court issued a decision lifting the preliminary injunction against Samsung.

(v) Australia

On June 4, 2025, the Company, Bayer Consumer Care AG, and Bayer Australia filed a patent infringement lawsuit against Sandoz Pty Ltd.

and a request for a preliminary injunction in the Federal Court of Australia alleging that the importing, selling, supplying, or otherwise disposing of an aflibercept 2 mg biosimilar would infringe one or more claims of the Company's Australian Patent No.

On September 3, 2025, the court denied the Company's request for a preliminary injunction.

On November 26, 2025, the parties entered into a settlement agreement, pursuant to which this lawsuit has been dismissed.

On October 10, 2025, the Company filed a patent infringement lawsuit in the Osaka District Court against Fuji Pharma Co., Ltd.

alleging that the making, constructing, using, or selling of an aflibercept 2 mg biosimilar by the defendant would infringe one or more claims of the Company's Japanese Patent No.

Proceedings Relating to EYLEA (aflibercept) Injection Pre-filled Syringe

On June 19, 2020, Novartis Pharma AG, Novartis Pharmaceuticals Corporation, and Novartis Technology LLC (collectively, "Novartis") filed a patent infringement lawsuit (as amended on August 2, 2021) in the U.S.

District Court for the Northern District of New York asserting claims of Novartis's U.S.

9,220,631 (the "'631 Patent").

On November 13, 2024, this lawsuit was dismissed in light of the final resolution of the IPR proceeding discussed below.

On July 16, 2020, the Company initiated two IPR petitions in the USPTO seeking a declaration that the '631 Patent is invalid on two separate grounds.

On October 25, 2022, the Patent Trial and Appeal Board ("PTAB") of the USPTO issued a final written decision invalidating all claims of the '631 Patent;

and on September 23, 2024, the Federal Circuit affirmed the PTAB's decision invalidating all claims of the '631 Patent.

On July 17, 2020, the Company filed an antitrust lawsuit against Novartis and Vetter Pharma International Gmbh ("Vetter") in the United States District Court for the Southern District of New York seeking a declaration that the '631 Patent is unenforceable and a judgment that the defendants' conduct violates Sections 1 and 2 of the Sherman Antitrust Act of 1890, as amended (the "Sherman Antitrust Act").

On July 17, 2020, the Company filed an antitrust lawsuit (as amended on January 25, 2021) against Novartis Pharma AG, Novartis Pharmaceuticals Corporation, and Novartis Technology LLC (collectively, "Novartis") and Vetter Pharma International GmbH in the United States District Court for the Southern District of New York seeking a judgment that the defendants' conduct relating to Novartis's attempt to assert its U.S.

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.

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Proceedings Relating to Praluent (alirocumab) Injection

United States

On May 27, 2022, the Company filed a lawsuit against Amgen Inc.

in the United States District Court for the District of Delaware, alleging that, beginning in 2020, Amgen engaged in an anticompetitive bundling scheme which was designed to exclude Praluent from the market in violation of federal and state laws.

On May 27, 2022, the Company filed a lawsuit against Amgen in the United States District Court for the District of Delaware, alleging that, beginning in 2020, Amgen engaged in an anticompetitive bundling scheme which was designed to exclude Praluent from the market in violation of federal and state laws.

The lawsuit seeks damages for harm caused by the alleged scheme, as well as injunctive relief restraining Amgen from continuing its alleged anticompetitive conduct.

On August 1 and 11, 2022, Amgen filed a motion to dismiss the complaint and a motion to stay these proceedings, respectively.

On February 10, 2023, the court denied Amgen's motion to stay;

and on March 21, 2023, the court denied Amgen's motion to dismiss.

On August 28, 2023, the Company filed an amended complaint in this matter;

and, as part of its response, on September 20, 2023, Amgen filed a counterclaim alleging that the Company engaged in unfair business practices in violation of state law.

On May 22, 2024, Amgen filed a motion for summary judgment.

An oral hearing on Amgen's motion for summary judgment was held on November 20, 2024.

A trial has been scheduled to begin in May 2025.

On June 1, 2023, Sanofi filed an action in the Munich Central Division of the Unified Patent Court (the "UPC") seeking revocation of Amgen's European Patent No.

3,666,797 (the "'797 Patent").

The '797 Patent is a divisional patent of European Patent No.

2,215,124 (the "'124 Patent") (i.e., a patent that shares the same priority date, disclosure, and patent term of the parent '124 Patent), which was previously invalidated by the Technical Board of Appeal of the EPO.

On July 16, 2024, following a trial, the Munich Central Division of the UPC issued a decision revoking the '797 Patent in its entirety.

On September 16, 2024, Amgen appealed the decision of the Munich Central Division of the UPC to the Court of Appeal of the UPC.

An oral hearing before the Court of Appeal of the UPC has been scheduled for May 2025.

Also on June 1, 2023, Amgen filed a lawsuit against the Company and certain of Sanofi's affiliated entities in the Munich Local Division of the UPC alleging infringement of the '797 Patent.

The lawsuit seeks, among other things, a permanent injunction in several countries in Europe and monetary damages.

On July 29, 2024, the Munich Local Division of the UPC ordered a stay of the infringement lawsuit in light of the decision of the Munich Central Division of the UPC to revoke the '797 Patent in its entirety (discussed above).

Proceedings Relating to REGEN-COV (casirivimab and imdevimab)

On October 5, 2020, Allele Biotechnology and Pharmaceuticals, Inc.

("Allele") filed a lawsuit (as amended on April 8, 2021 and December 12, 2022) against the Company in the United States District Court for the Southern District of New York, asserting infringement of U.S.

Effective December 5, 2024, the parties entered into a settlement agreement, pursuant to which this lawsuit has been dismissed.

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.

Department of Justice Matters

In January 2017, the Company received a subpoena from the U.S.

Attorney's Office for the District of Massachusetts requesting documents relating to its support of 501(c)(3) organizations that provide financial assistance to patients;

documents concerning its provision of financial assistance to patients with respect to products sold or developed by Regeneron (including EYLEA, Praluent, ARCALYST ® , and ZALTRAP ® );

and certain other related documents and communications.

On June 24, 2020, the U.S.

Attorney's Office for the District of Massachusetts filed a civil complaint in the U.S.

District Court for the District of Massachusetts alleging violations of the federal Anti-Kickback Statute, and asserting causes of action under the federal False Claims Act and state law (the "June 2020 Civil Complaint").

On August 24, 2020, the Company filed a motion to dismiss the June 2020 Civil Complaint in its entirety.

On December 4, 2020, the court denied the motion to dismiss.

On December 28, 2022, the U.S.

Attorney's Office for the District of Massachusetts filed a motion for partial summary judgment.

On January 31, 2023, the Company filed a motion for summary judgment.

An oral hearing on the parties' respective motions for summary judgment was held on July 21, 2023.

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.

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On October 25, 2023, the court certified for interlocutory appeal a portion of the court's September 27, 2023 order that addressed the causation standard applicable to the alleged violations of the federal Anti-Kickback Statute and federal False Claims Act.

and on December 11, 2023, the U.S.

Court of Appeals for the First Circuit certified for appeal (i.e., accepted for review) the court's September 27, 2023 order.

An oral hearing concerning the appeal to the U.S.

Court of Appeals for the First Circuit was held on July 22, 2024.

In September 2019, the Company and Regeneron Healthcare Solutions, Inc., a wholly-owned subsidiary of the Company, each received a civil investigative demand ("CID") from the U.S.

Department of Justice pursuant to the federal False Claims Act relating to remuneration paid to physicians in the form of consulting fees, advisory boards, speaker fees, and payment or reimbursement for travel and entertainment allegedly in violation of the federal Anti-Kickback Statute.

The CIDs relate to EYLEA, Praluent, Dupixent, ZALTRAP, ARCALYST, and Kevzara and cover the period from January 2015 to the present.

On June 3, 2021, the United States District Court for the Central District of California unsealed a qui tam complaint filed against the Company, Regeneron Healthcare Solutions, Inc., and Sanofi-Aventis U.S.

LLC by two qui tam plaintiffs (known as relators) purportedly on behalf of the United States and various states (the "State Plaintiffs"), asserting causes of action under the federal False Claims Act and state law.

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 October 29, 2021, the qui tam plaintiffs filed an amended complaint in this matter.

On January 14, 2022, the Company filed a motion to dismiss the amended complaint in its entirety.

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On August 26, 2024, the qui tam plaintiffs filed a notice of appeal.

In June 2021, the Company received a CID from the U.S.

Department of Justice pursuant to the federal False Claims Act.

The CID states that the investigation concerns allegations that the Company (i) violated the False Claims Act by paying kickbacks to distributors and ophthalmology practices to induce purchase of EYLEA, including through discounts, rebates, credit card fees, free units of EYLEA, and inventory management systems;

and (ii) inflated reimbursement rates for EYLEA by excluding applicable discounts, rebates, and benefits from the average sales price reported to the Centers for Medicare & Medicaid Services.

The CID covers the period from January 2011 through June 2021.

On November 29, 2023, the U.S.

Department of Justice informed the Company that it had filed a notice of partial intervention in this matter.

On March 28, 2024, the Department of Justice and the U.S.

Attorney's Office for the District of Massachusetts filed a civil complaint intervention (the "March 2024 Civil Complaint") in the U.S.

District Court for the District of Massachusetts asserting causes of action under the federal False Claims Act and a claim for unjust enrichment.

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.

District Court of the District of Massachusetts unsealed a qui tam complaint against the Company, AmerisourceBergen, and Besse Medical by two qui tam plaintiffs (known as relators) purportedly on behalf of the United States and various states and municipalities, asserting causes of action under the federal False Claims Act and state and local laws, and alleging violations of the federal Anti-Kickback statute.

On June 25, 2024, the States of Colorado, Georgia, Michigan, North Carolina, Texas, and Washington filed a civil complaint in partial intervention (the "June 2024 Civil Complaint") in the U.S.

District Court for the District of Massachusetts asserting causes of action under various state laws.

On July 18, 2024, the Company filed a motion to dismiss the March 2024 Civil Complaint and the June 2024 Civil Complaint.

An oral hearing on the Company's motion to dismiss was held on December 16, 2024.

Department of Justice and the U.S.

Attorney's Office for the District of Massachusetts filed a civil complaint in partial intervention (the "March 2024 Civil Complaint") of the qui tam action, in the same court, asserting causes of action under the federal False Claims Act and a claim for unjust enrichment related to the alleged conduct described above.

On June 25, 2024, the States of Colorado, Georgia, Michigan, North Carolina, Texas, and Washington filed a civil complaint in partial intervention (the "June 2024 Civil Complaint") in the same court asserting causes of action under various state laws related to the same alleged conduct.

On April 29, 2025, the court denied the Company's motion to dismiss the March 2024 Civil Complaint and the June 2024 Civil Complaint.

On June 18, 2025, the States of Maine, Nebraska, Ohio, Oregon, and Wyoming intervened in the action and filed a consolidated complaint asserting causes of action under their respective state laws.

Proceedings Initiated by Other Payors

The Company is party to several lawsuits relating to the conduct alleged in the June 2020 Civil Complaint discussed under "Department of Justice Matters" above.

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.

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District Court for the District of Columbia on behalf of Medicare Advantage plans and other payors.

The lawsuit relates to the conduct alleged in the June 2020 Civil Complaint, March 2024 Civil Complaint, and June 2024 Civil Complaint discussed under "Department of Justice Matters" above.

The lawsuit 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.

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District Court for the District of Massachusetts.

2021 Shareholder Derivative Complaint

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.

Shareholder Derivative Complaint – Department of Justice June 2020 Civil Complaint Matters

On June 29, 2021, an alleged shareholder filed a shareholder derivative complaint in the New York Supreme Court, naming the then-current and certain former members of the Company's board of directors and certain then-current and former executive officers of the Company as defendants and Regeneron as a nominal defendant.

The complaint asserts that the individual defendants breached their fiduciary duties in relation to the allegations in the June 2020 Civil Complaint discussed under "Department of Justice Matters" above.

The complaint 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;

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The Company can therefore renew the motion to dismiss upon conclusion of the stay.

Class Action Civil Complaint

On January 7, 2025, a purported shareholder filed a putative class action civil complaint, on behalf of himself and all others similarly situated, in the U.S.

District Court for the Southern District of New York against the Company and certain current and former executive officers of the Company.

The complaint asserts violations of federal securities laws in connection with statements or disclosures purportedly related to the conduct alleged in the March 2024 Civil Complaint discussed under "Department of Justice Matters" above.

2025 Shareholder Derivative Complaints

On January 16 and January 22, 2025, purported shareholders filed two separate shareholder derivative complaints in the U.S.

District Court for the Southern District of New York against members of the Company's board of directors and certain current and former executive officers of the Company as defendants and Regeneron as a nominal defendant.

The complaints each allege that the individual defendants, among other things, breached their fiduciary duties to the Company by failing to properly manage and oversee the Company in connection with the conduct alleged in the March 2024 Civil Complaint discussed under "Department of Justice Matters" above.

The complaints also each allege that the individual defendants breached the federal securities laws, wasted corporate assets, and unjustly enriched themselves at the expense of the Company.

The complaints each seek, among other things, an award of damages allegedly sustained by the Company as a result of the alleged misconduct of the individual defendants;

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 U.S.

District Court for the Southern District of New York or the Supreme Court of the State of New York against members of the Company's board of directors and certain current and former executive officers of the Company as defendants and Regeneron as a nominal defendant.

The complaints 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.

Certain of these shareholder derivative complaints have been consolidated by the U.S.

District Court for the Southern District of New York.

The shareholder derivative complaints filed in the Supreme Court of the State of New York have been removed to the U.S.

District Court for the Southern District of New York and motions to remand are pending.

Shareholder Derivative Complaint – Director Compensation

On July 22, 2025, an alleged shareholder filed a shareholder derivative complaint in the New York Supreme Court, naming the current non-employee members of our board of directors, and the co-Chairs of our board of directors (who also serve as our President and Chief Executive Officer and our President and Chief Scientific Officer, respectively) as defendants and Regeneron as a nominal defendant.

The complaint asserts that the individual defendants breached their fiduciary duties and/or were unjustly enriched when they approved and/or received allegedly excessive non-employee director compensation in 2024 and 2025, and that this allegedly excessive compensation was a waste of corporate assets.

The complaint seeks damages in favor of Regeneron for the alleged breaches of fiduciary duties, unjust enrichment, and waste of corporate assets;

improvements to Regeneron's corporate governance and internal procedures;

equitable relief, including restitution from the individual defendants;

and award of the costs of the action, including attorneys' fees.

On September 25, 2025, the Company filed a motion to dismiss the complaint.

Class Action Civil Complaint

On January 7, 2025 (as amended on September 8, 2025 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 U.S.

District Court for the Southern District of New York against the Company and certain current and former executive officers of the Company.

The 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.

Sanofi Litigation

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The lawsuit seeks a declaratory judgment, injunctive relief, damages, and other relief.

On July 3, 2025, Sanofi filed a motion to dismiss the complaint.

Net Income Per Share

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Stock options 6.2 1.6 1.8

Restricted stock awards and restricted stock units

Statement of Cash Flows

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$ 3,123.7 $ 2,489.0 $ 2,737.8

Restricted cash consists of amounts held by financial institutions pursuant to contractual arrangements.

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

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$ 58.9 $ 62.7 $ 71.6

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.

Year Ended December 31,

(In millions) 2025 2024

Direct research and development expenses (a)

$ 1,758.1 $ 1,588.8 $ 1,295.6

Indirect research and development expenses:

Payroll and benefits 1,800.8 1,681.7 1,537.0

Lab supplies and other research and development costs

258.2 241.5 210.6

Occupancy and other operating costs 635.4 614.9 518.2

Total indirect research and development expenses

2,694.4 2,538.1 2,265.8

Clinical manufacturing costs

1,391.2 1,195.9 1,053.9

Priority review voucher

Reimbursement of research and development expenses by collaborators ( 148.5 ) ( 190.8 ) ( 176.3 )

Total research and development expenses

$ 5,850.2 $ 5,132.0 $ 4,439.0

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 9A. Controls and Procedures