What changed in this filing

/stocks — the workspaceLOADING

Item 9A. Controls and Procedures

2025-02-05 compared with 2024-02-05 · 375 added, 534 removed, 1247 unchanged (42% of the section changed)

21 unchanged sentences

Total Number of Securities to Be Sold Under the Plan

Executive Vice President, Finance and Chief Financial Officer 11/9/2023 5/6/2024 14,337

Kathryn Guarini, Ph.D.

11/1/2024 11/14/2025 1,000

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

28 unchanged sentences

4.1 Description of Securities Registered Pursuant to Section 12 of the Securities Exchange Act of 1934.

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

4.2 Indenture, dated August 12, 2020, between the Registrant and U.S.

6 unchanged sentences

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

10.1 + Regeneron Pharmaceuticals, Inc.

Second Amended and Restated 2000 Long-Term Incentive Plan.

(Incorporated by reference from the Registration Statement on Form S-8 for the Registrant, filed June 13, 2011.)

10.1.1 + Form of option agreement and related notice of grant for use in connection with the grant of time based vesting stock options to the Registrant's non-employee directors and executive officers under the Regeneron Pharmaceuticals, Inc.

Second Amended and Restated 2000 Long-Term Incentive Plan.

(Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended March 31, 2009, filed April 30, 2009.)

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

Second Amended and Restated 2000 Long-Term Incentive Plan (revised).

(Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2011, filed February 21, 2012.)

10.1.3 + Amendment No.

1 to the Regeneron Pharmaceuticals, Inc.

Second Amended and Restated 2000 Long-Term Incentive Plan.

(Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2013, filed February 13, 2014.)

10.2 + Amended and Restated Regeneron Pharmaceuticals, Inc.

2014 Long-Term Incentive Plan.

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.)

17 unchanged sentences

(Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2015, filed February 11, 2016.)

10.2 + Amended and Restated Regeneron Pharmaceuticals, Inc.

2014 Long-Term Incentive Plan.

(Incorporated by reference from the Registration Statement on Form S-8 for the Registrant, filed June 12, 2017.)

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 Amended and Restated Regeneron Pharmaceuticals, Inc.

55 unchanged sentences

2014 Long-Term Incentive Plan (revised 2023).

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

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

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 Second Amended and Restated Regeneron Pharmaceuticals, Inc.

2014 Long-Term Incentive Plan (revised 2023).

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

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

4 unchanged sentences

(Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended June 30, 2023, filed August 3, 2023.)

Offer Letter for Robert E.

Landry effective September 9, 2013.

(Incorporated by reference from the Form 8-K for the Registrant, filed September 12, 2013.)

Regeneron Pharmaceuticals, Inc.

11 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, 2014, filed February 12, 2015.)

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

38 unchanged sentences

(Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended June 30, 2023, filed August 3, 2023.)

Amendment No.

2 to Master Agreement, dated as of March 7, 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 March 3 1 , 202 4 , filed May 2 , 202 4 .)

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.

21.1 Subsidiaries of the Registrant.

5 unchanged sentences

Section 1350.

Cl awback Policy.

Clawback Policy.

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

101 Interactive Data Files pursuant to Rule 405 of Regulation S-T formatted in Inline Extensible Business Reporting Language ("Inline XBRL"):

27 unchanged sentences

Schleifer, M.D., Ph.D.

/s/ ROBERT E.

LANDRY Executive Vice President, Finance and Chief Financial Officer (Principal Financial Officer) February 5, 2024

/s/ CHRISTOPHER FENIMORE

Senior Vice President, Controller (Principal Accounting Officer) February 5, 2024

Executive Vice President, Finance and Chief Financial Officer (Principal Financial Officer)

February 5, 2025

Christopher Fenimore

/s/ JASON PITOFSKY

Vice President, Controller (Principal Accounting Officer)

February 5, 2025

Jason Pitofsky

/s/ GEORGE D.

66 unchanged sentences

The communication of critical audit matters does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates.

Reserve for an Uncertain Tax Position

Certain Reserves for Uncertain Tax Positions

As described in Notes 1 and 15 to the consolidated financial statements, the Company's reserves for uncertain tax positions were $ 1,313.7 million as of December 31, 2024.

A reserve for an individual uncertain tax position represents a portion of the consolidated balance.

Certain reserves for uncertain tax positions represent a significant portion of the consolidated balance.

The Company recognizes the financial statement effects of a tax position when management's assessment is that there is more than a 50% probability that the position will be sustained upon examination by a taxing authority based upon its technical merits.

2 unchanged sentences

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

The principal considerations for our determination that performing procedures relating to the reserve for an uncertain tax position is a critical audit matter are (i) the significant judgment by management when determining the reserve for the uncertain tax position;

(ii) a high degree of auditor judgment, subjectivity and effort in performing procedures and evaluating management's determination of the reserve for the uncertain tax position;

(iii) the assessment and evaluation of audit evidence available to support the reserve for the uncertain tax position is complex, and (iv) the audit effort involved the use of professionals with specialized skill and knowledge.

The principal considerations for our determination that performing procedures relating to certain reserves for uncertain tax positions is a critical audit matter are (i) the significant judgment by management when determining certain reserves for uncertain tax positions;

(ii) a high degree of auditor judgment, subjectivity, and effort in performing procedures and evaluating management's determination of certain reserves for uncertain tax positions;

(iii) the assessment and evaluation of audit evidence available to support certain reserves for uncertain tax positions is complex;

and (iv) the audit effort involved the use of professionals with specialized skill and knowledge.

Addressing the matter involved performing procedures and evaluating audit evidence in connection with forming our overall opinion on the consolidated financial statements.

These procedures included testing the effectiveness of controls relating to the recognition of reserves for uncertain tax positions.

These procedures also included, among others, (i) testing the information used in the calculation of the reserve for the individual uncertain tax position, such as international and federal filing positions, and the related final tax returns;

(ii) testing the calculation of the reserve for the uncertain tax position;

and (iii) evaluating management's assessment of the technical merits of tax positions and estimates of the amount of tax benefit expected to be sustained, as well as the likelihood of the possible outcome.

Professionals with specialized skills and knowledge were used to assist in evaluating the technical merits and the tax benefit expected to be sustained and the application of relevant tax laws.

These procedures also included, among others (i) testing the information used in the calculation of certain reserves for uncertain tax positions, such as international and federal filing positions, and the related final tax returns;

(ii) testing the calculation of certain reserves for uncertain tax positions;

and (iii) evaluating management's assessment of the technical merits of the tax positions and estimates of the amount of tax benefits expected to be sustained, as well as the likelihood of the possible outcomes, for certain reserves for uncertain tax positions.

Professionals with specialized skill and knowledge were used to assist in evaluating the technical merits and the tax benefits expected to be sustained and the application of relevant tax laws.

/s/ PricewaterhouseCoopers LLP

65 unchanged sentences

Cost of collaboration and contract manufacturing 883.2 883.7 760.4

Other operating (income) expense, net ( 2.1 ) ( 89.9 ) ( 45.6 )

Other operating expense (income), net

53.4 ( 2.1 ) ( 89.9 )

10,211.3 9,070.1 7,434.0

Income from operations 3,990.7 4,047.1 4,738.9

16 unchanged sentences

Loss on foreign currency translation

( 0.6 ) ( 0.3 ) —

Unrealized gain on cash flow hedges

7 unchanged sentences

Balance, December 31, 2021

1.8 $ — 126.2 $ 0.1 $ 8,087.5 $ 18,968.3 $ ( 26.2 ) ( 19.4 ) $ ( 8,260.9 ) $ 18,768.8

Issuance of Common Stock for equity awards granted under long-term incentive plans — — 4.8 — 1,517.4 — — — — 1,517.4

6 unchanged sentences

Balance, December 31, 2022

1.8 — 130.4 0.1 9,949.3 23,306.7 ( 238.8 ) ( 22.6 ) ( 10,353.3 ) 22,664.0

Issuance of Common Stock for equity awards granted under long-term incentive plans — — 3.5 — 1,152.2 — — — — 1,152.2

4 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

1.8 — 133.1 0.1 11,354.0 27,260.3 ( 80.9 ) ( 25.5 ) ( 12,560.4 ) 25,973.1

CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (continued)

8 unchanged sentences

Other comprehensive income, net of tax — — — — — — 73.0 — — 73.0

— — — — — — 157.9 — — 157.9

Balance, December 31, 2024

11 unchanged sentences

Stock-based compensation expense 982.8 885.0 725.0

Losses (gains) on marketable and other securities, net 266.4 36.8 ( 387.0 )

(Gains) losses on marketable and other securities, net

( 118.3 ) 266.4 36.8

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

3 unchanged sentences

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

( 338.8 ) 707.8 ( 1,927.4 )

Increase in inventories ( 619.7 ) ( 271.7 ) ( 696.5 )

Increase in prepaid expenses and other assets ( 407.5 ) ( 120.1 ) ( 148.6 )

Increase in deferred revenue

227.8 37.9 32.4

Increase (decrease) in deferred revenue 37.9 32.4 ( 120.2 )

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

598.6 ( 138.4 ) 866.1

Total adjustments 7.9 640.4 676.5

4 unchanged sentences

Capital expenditures ( 755.9 ) ( 718.6 ) ( 590.1 )

Proceeds from sale of property, plant, and equipment

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

10 unchanged sentences

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

( 381.6 ) 221.3 690.8

Cash, cash equivalents, and restricted cash at beginning of period 2,737.8 3,119.4 2,898.1

10 unchanged sentences

and its subsidiaries ("Regeneron," "Company," "we," "us," and "our") is a fully integrated biotechnology company that invents, develops, manufactures, and commercializes medicines for people with serious diseases.

The Company's products and product candidates in development are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, hematologic conditions, infectious diseases, and rare diseases.

The Company's research and development efforts have led to eleven products that have received marketing approval by the U.S.

Food and Drug Administration ("FDA").

In addition, REGEN-COV ® was authorized under an Emergency Use Authorization ("EUA") from November 2020 until January 2022 when the EUA was revised to exclude its use in geographic regions where infection or exposure is likely due to a variant that is not susceptible to the treatment;

as a result, REGEN-COV is not currently authorized for use in any U.S.

states, territories, or jurisdictions.

The Company is a party to collaboration agreements to develop and commercialize, as applicable, certain products and product candidates (see Note 3).

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

The Company's products and product candidates in development are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases, and rare diseases.

The Company's research and development efforts have led to numerous products that have received marketing approval.

The Company is a party to collaboration and license agreements to develop and commercialize, as applicable, certain products and product candidates (see Note 3).

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

4 unchanged sentences

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

1 unchanged sentence

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 collaborator (see Note 3) and customer accounts receivable are significant.

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 December 31, 2023 and 2022, there were no write-offs and allowances of accounts receivable related to credit risk for the Company's collaborators or customers.

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.

Significant Accounting Policies

7 unchanged sentences

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

Realized gains and losses on available-for-sale debt securities are included in other income

(expense), net.

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

The Company reviews its portfolio of available-for-sale debt securities, using both quantitative and qualitative factors, to determine if declines in fair value below cost have resulted from a credit-related loss or other factors.

10 unchanged sentences

The Company determines the cost of inventory using the first-in, first-out, or FIFO, method.

The Company capitalizes inventory costs associated with the Company's products prior to regulatory approval when, based on management's judgment, future commercialization is considered probable and the future economic benefit is expected to be realized;

The Company capitalizes inventory costs associated with the Company's products prior to regulatory approval when, based on management's judgment, future commercialization is considered probable and future economic benefit is expected to be realized;

otherwise, such costs are expensed.

The determination to capitalize inventory costs is based on various factors, including status and expectations of the regulatory approval process, any known safety or efficacy concerns, potential labeling restrictions, and any other impediments to obtaining regulatory approval.

The Company periodically analyzes its inventory levels to identify inventory that may expire prior to expected sale or has a cost basis in excess of its estimated realizable value, and writes down such inventories as appropriate.

The Company periodically analyzes its inventory levels to identify inventory that may expire prior to expected sale or has a cost basis in excess of its estimated realizable value.

In addition, the Company's products are subject to strict quality control and monitoring which the Company performs throughout the manufacturing process.

23 unchanged sentences

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

In a business combination, contingent consideration obligations are recorded at fair value as of the acquisition date and remeasured each subsequent reporting period until the contingencies have been resolved, with any changes in fair value recorded in Other operating (income) expense, net.

Contingent consideration obligations are recorded at fair value as of the acquisition date and remeasured each subsequent reporting period until the contingencies have been resolved, with any changes in fair value recorded in Other operating (income) expense, net.

If it is determined that the assets acquired do not meet the definition of a business, or if substantially all of the fair value of the assets acquired are concentrated in a single identifiable asset, then the transaction is accounted for as an asset acquisition rather than a business combination.

10 unchanged sentences

If an indicator of impairment exists, the Company compares the projected undiscounted cash flows to be generated by the asset to the intangible asset's carrying amount.

If the projected undiscounted cash flows of the intangible asset are less than the carrying amount, the intangible asset is written down to its fair value in the period in which the impairment occurs.

If the projected undiscounted cash flows of the intangible asset are less than the carrying amount, an impairment loss is recognized within operating expenses and the intangible asset is written down to its fair value in the period in which the impairment occurs.

Product Revenue

2 unchanged sentences

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.

This estimate is based upon contracts with customers, healthcare providers, payors, and government agencies, statutorily-defined discounts applicable to government-funded programs, historical experience, estimated payor mix,

and other relevant factors.

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.

13 unchanged sentences

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.

14 unchanged sentences

Reimbursement of Regeneron's research and development expenses

Reduction to Research and development expenses

Reduction to Research and development expense

Regeneron's obligation for its share of collaborator's research and development expenses

Research and development expense

Up-front/opt-in and development milestone payments to collaborators Acquired in-process 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

9 unchanged sentences

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.

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.

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 .

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

expenses that the Company is obligated to reimburse.

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

8 unchanged sentences

Research and Development Expenses

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.

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.

5 unchanged sentences

Stock-based compensation expense also includes an estimate, which is made at the time of grant, of the number of awards that are expected to be forfeited.

This estimate is revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates.

In addition, the Company reassesses its forfeiture rate assumptions at least annually, considering both historical forfeiture experience and an estimate of future forfeitures for currently outstanding unvested awards.

The forfeiture rate estimate is calculated by considering both historical forfeiture experience and an estimate of expected future forfeitures for currently outstanding unvested awards.

This estimate is reviewed at least annually and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates.

The Company uses the Black-Scholes model to compute the estimated fair value of stock option awards.

22 unchanged sentences

Recently Issued Accounting Standards

In November 2023, the FASB issued Accounting Standards Update No.

2023-07, Segment Reporting - Improvements to Reportable Segment Disclosures .

The amendments require disclosure of incremental segment information on an annual and interim basis.

The amendments also require companies with a single reportable segment to provide all disclosures required by this amendment and all existing segment disclosures in Accounting Standards Codification 280, Segment Reporting .

The amendments are effective for fiscal years beginning after December 15, 2023, and interim periods beginning after December 15, 2024.

The Company does not expect the adoption of the amendments to have a significant impact on its financial statements.

In December 2023, the FASB issued Accounting Standards Update No.

2023-09, Income Taxes - Improvements to Income Tax Disclosures .

The amendments require (i) enhanced disclosures in connection with an entity's effective tax rate reconciliation and (ii) income taxes paid disaggregated by jurisdiction.

The amendments are effective for annual periods beginning after December 15, 2024.

The Company does not expect the adoption of the amendments to have a significant impact on its financial statements.

Standard/Description

Effective Date

Impact of Adoption on the Company's Financial Statements

In December 2023, the FASB issued amended guidance related to improvements to income tax disclosures .

The amendments require annually (i) enhanced disclosures in connection with an entity's effective tax rate reconciliation and (ii) income taxes paid disaggregated by jurisdiction.

January 1, 2025

No significant impact expected

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

Product Sales

7 unchanged sentences

787.3 538.8 374.5

Rest of world

429.5 324.3 73.0

Total Libtayo

1 unchanged sentence

241.7 182.4 130.0

REGEN-COV ®(c)

125.7 77.3 48.6

ARCALYST ®(d)

76.8 69.8 3.0

(a) Prior to July 1, 2022, Regeneron recorded net product sales of Libtayo in the United States and Sanofi recorded net product sales of Libtayo outside the United States.

Effective July 1, 2022, the Company records global net product sales of Libtayo.

See Note 3 for further details.

(b) Rest of world ("ROW")

(c) Net product sales of REGEN-COV in the United States relate to product sold in connection with the Company's agreements with the U.S.

$ 7,629.2 $ 7,078.0 $ 6,893.7

(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.

(d) Effective April 1, 2021, Kiniksa records net product sales of ARCALYST in the United States.

Previously, the Company recorded net product sales of ARCALYST in the United States.

As of December 31, 2024 and 2023, the Company had $ 4.278 billion and $ 3.888 billion, respectively, of trade accounts receivable that were recorded within Accounts receivable, net.

The Company had product sales to certain customers that accounted for more than 10% of total gross product revenue for each of the years ended December 31, 2023, 2022, and 2021.

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, 2024, 2023, and 2022.

Sales to each of these customers as a percentage of the Company's total gross product revenue are as follows:

4 unchanged sentences

McKesson Corporation 24 % 25 % 28 %

government * * 43 %

* Sales to the U.S.

government represented less than 10% of total gross product revenue during the period.

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

21 unchanged sentences

Collaboration, License, and Other Agreements

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

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

Statement of Operations Classification Year Ended December 31,

(In millions) 2024 2023 2022

Regeneron's share of profits in connection with commercialization of antibodies Collaboration revenue

Regeneron's share of profits

Collaboration revenue

$ 3,923.5 $ 3,136.5 $ 2,082.0 *

8 unchanged sentences

Immuno-oncology (a) :

Regeneron's share of profits (losses) in connection with commercialization of Libtayo outside the United States Collaboration revenue

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

Collaboration revenue

$ — $ — $ 6.7

3 unchanged sentences

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

Reimbursement of commercialization-related expenses Reduction of SG&A expense $ — $ 41.4 $ 89.6

Regeneron's obligation for its share of Sanofi commercial expenses SG&A expense $ — $ ( 19.9 ) $ ( 36.3 )

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.

7 unchanged sentences

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, pursuant to which the percentage of the Company's share of profits used to reimburse Sanofi for such development costs increased from 10 % to 20 %.

A portion of the value associated with the increase in reimbursement percentage was deemed to be contingent consideration attributable to the Company's acquisition of the Libtayo (cemiplimab) rights described within the " Immuno-Oncology " section below;

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 to Sanofi under the Antibody Collaboration was approximately $ 2.330 billion as of December 31, 2023.

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.

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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 (including Praluent, which was previously included in the LCA) 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 (including Praluent) exceeding $ 2.0 billion and $ 2.5 billion, respectively, on a rolling twelve-month basis.

In 2021, the Company earned a $ 50.0 million sales-based milestone from Sanofi, upon aggregate annual sales of antibodies outside the United States (including Praluent) exceeding $ 1.5 billion, on a rolling twelve-month basis.

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.

7 unchanged sentences

Immuno-Oncology

The Company was previously a party to a collaboration with Sanofi for antibody-based cancer treatments in the field of immuno-oncology (the "IO Collaboration").

The IO Collaboration was governed by an Amended and Restated Immuno-oncology Discovery and Development Agreement ("Amended IO Discovery Agreement"), and an Immuno-oncology License and Collaboration Agreement ("IO License and Collaboration Agreement").

In connection with the execution of the original Immuno-oncology Discovery and Development Agreement in 2015 ("2015 IO Discovery Agreement"), which was subsequently replaced by the Amended IO Discovery Agreement (as discussed below), Sanofi made a $ 265.0 million non-refundable up-front payment to the Company.

Pursuant to the 2015 IO Discovery Agreement, the Company was to identify and validate potential immuno-oncology targets and develop therapeutic antibodies against such targets through clinical proof-of-concept.

Effective December 31, 2018, the Company and Sanofi entered into the Amended IO Discovery Agreement, which narrowed the scope of the existing discovery and development activities conducted by the Company under the 2015 IO Discovery Agreement to developing therapeutic bispecific antibodies targeting (i) BCMA and CD3 and (ii) MUC16 and CD3 through clinical proof-of-concept.

During 2021, Sanofi did not exercise its options to license rights to these product candidates;

as a result, the Company retains the exclusive right to develop and commercialize such product candidates and Sanofi will receive a royalty on sales (if any).

In addition, the Company has no further obligations to develop drug product candidates under the Amended IO Discovery Agreement.

In connection with the execution of the IO License and Collaboration Agreement in 2015, Sanofi made a $ 375.0 million non-refundable up-front payment to the Company.

Under the terms of the IO License and Collaboration Agreement, the parties were co-developing and co-commercializing Libtayo.

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.

1 unchanged sentence

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

Recognition of the up-front payments received from Sanofi had been deferred (recorded within Other liabilities), and such amounts were being recognized over the remaining period in which the Company was obligated to perform development activities.

During 2021, the Company updated its estimate of the total research and development costs expected to be incurred (which resulted in a change to the estimate of the stage of completion) in connection with the IO Collaboration, and, as a result, recorded a cumulative catch-up adjustment of $ 66.9 million as a reduction to other operating income.

In connection with the Amended and Restated Immuno-oncology License and Collaboration Agreement with Sanofi (the "A&R IO LCA") described below, the remaining IO Collaboration Other liabilities balance of $ 241.0 million as of July 1, 2022 was recognized as a reduction to the intangible asset recorded in connection with the transaction during 2022.

Effective July 1, 2022, the Company obtained the exclusive right to develop, commercialize, and manufacture Libtayo worldwide under the A&R IO LCA.

In connection with the A&R IO LCA, 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 under the terms of the A&R IO LCA, of which they earned $ 65.0 million in 2022 and $ 35.0 million in 2023.

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.

1 unchanged sentence

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

In accordance with the Amended IO Discovery Agreement, the Company was obligated to reimburse Sanofi for half of the development costs it funded that were attributable to clinical development of product candidates from the Company's share of profits from commercialized IO Collaboration products.

Under the A&R IO LCA, the amount of development costs incurred under the IO Collaboration for which the Company was obligated to reimburse Sanofi was $ 35.0 million as of the effective date of the A&R IO LCA, and the Company pays Sanofi a 0.5 % royalty on net product sales of Libtayo until all such development costs have been reimbursed by Regeneron.

The Company's contingent reimbursement obligation to Sanofi under the A&R IO LCA was approximately $ 28 million as of December 31, 2023.

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.

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

Within the United States, the Company is responsible for commercialization and retains profits from such sales.

Bayer is responsible for commercialization activities outside the United States, and the companies share equally in profits from such sales.

In Japan, the Company was entitled to receive a tiered percentage of between 33.5 % and 40.0 % of EYLEA net product sales through 2021, and effective January 1, 2022, the companies share equally in profits from sales in Japan.

The Company is obligated to reimburse Bayer out of its share of the collaboration profits for 50 % of the agreed-upon development expenses that Bayer has incurred in accordance with a formula based on the amount of development expenses that Bayer has incurred and the Company's share of the collaboration profits, or at a faster rate at the Company's option.

Within the United States, the Company is responsible for commercialization and retains profits from such sales.

The Company is obligated to reimburse Bayer out of the Company's share of the collaboration profits for 50 % of the agreed-upon development expenses that Bayer has incurred in accordance with a formula based on the amount of development expenses that Bayer has incurred and the Company's share of the collaboration profits, or at a faster rate at the Company's option.

The Company's contingent reimbursement obligation to Bayer was approximately $ 315 million as of December 31, 2024.

2 unchanged sentences

(In millions) 2024 2023 2022

Regeneron's share of profits in connection with commercialization of EYLEA outside the United States Collaboration revenue

Regeneron's share of profits

Collaboration revenue

$ 1,403.3 $ 1,376.4 $ 1,317.4

11 unchanged sentences

$ 216.3 $ 138.2

In 2019, the Company and Alnylam Pharmaceuticals, Inc.

entered into a global, strategic collaboration to discover, develop, and commercialize RNA interference ("RNAi") therapeutics for a broad range of diseases by addressing therapeutic disease targets expressed in the eye and central nervous system ("CNS"), in addition to a select number of targets expressed in the liver.

In connection with entering into the collaboration, the Company made an up-front payment of $ 400.0 million to Alnylam, and also purchased shares of Alnylam common stock for $ 400.0 million.

For each program, the Company provides Alnylam with a specified amount of funding at program initiation and at lead candidate designation.

Under the terms of the collaboration, the parties perform discovery research until designation of lead candidates.

Following designation of a lead candidate, the parties may further advance such lead candidate under either a co-development/co-commercialization collaboration agreement (under which the parties are advancing ALN-APP and ALN-PNP, which are currently in clinical development) or a license agreement.

The initial target nomination and discovery period is five years (which may under certain situations automatically be extended for up to seven years in the aggregate) (the "Research Term").

In addition, the Company has the option to extend the Research Term for an additional five-year period for a research extension fee of $ 300.0 million.

During 2023, the Company paid a $ 100.0 million development milestone to Alnylam, which was recorded to Acquired in-process research and development expense, upon the achievement of specified proof-of-principle criteria for the ALN-APP program.

Alnylam is eligible to receive an additional $ 100.0 million clinical proof-of-principle milestone in connection with an eye program.

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

Statement of Operations Classification Year Ended December 31,

(In millions) 2023 2022 2021

Regeneron's obligation for its share of Alnylam R&D expenses, net of reimbursement of R&D expenses

(R&D expense)

$ ( 74.1 ) $ ( 55.8 ) $ ( 60.5 )

Development milestone

Acquired in-process research and development $ ( 100.0 ) $ — $ —

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

As of December 31,

(In millions) 2023 2022

Accrued expenses and other current liabilities

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 parties jointly fund certain studies, and 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, depending on the amount of manufactured product supplied by each party to the market.

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:

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(In millions) 2024 2023 2022

Global gross profit payment from Roche in connection with sales of REGEN-COV and Ronapreve Collaboration revenue

Regeneron's share of profits

Collaboration revenue

$ 1.4 $ 224.3 $ 627.3

1 unchanged sentence

$ — $ ( 13.3 ) $ —

Reimbursement of R&D expenses

(R&D expense)/Reduction of R&D expense $ ( 1.5 ) $ 6.8 $ 128.1

Global gross profit payment to Roche in connection with sales of REGEN-COV and Ronapreve Cost of goods sold $ — $ — $ 259.6

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

As of December 31,

(In millions) 2023 2022

Accounts receivable, net $ — $ 396.6

In 2016, the Company entered into a license and collaboration agreement with Intellia Therapeutics, Inc.

to advance CRISPR/Cas9 gene-editing technology for in vivo therapeutic development.

The parties collaborate to conduct research for the discovery, development, and commercialization of new therapies, in addition to the research and technology development of the CRISPR/Cas9 platform.

Under the terms of the 2016 agreement, the parties agreed to a target selection process, whereby the Company may obtain exclusive rights in up to 10 targets to be chosen by the Company during the collaboration term, subject to various adjustments and limitations set forth in the agreement.

Certain targets that either the Company or Intellia selects may be subject to a co-development and co-commercialization arrangement at the Company's option or Intellia’s option, as applicable.

NTLA-2001, which is in clinical development, is subject to a co-development and co-commercialization arrangement pursuant to which Intellia will lead development and commercialization activities and the parties share an agreed-upon percentage of development expenses and profits (if commercialized).

In 2020, the Company expanded its existing collaboration with Intellia to provide the Company with rights to develop products for additional in vivo CRISPR/Cas9-based therapeutic targets and for the parties to jointly develop potential products for the treatment of hemophilia A and B, with Regeneron leading development and commercialization activities.

In addition, the Company also received non-exclusive rights to independently develop and commercialize ex vivo gene edited products.

In connection with the agreement, in 2020, the Company made a $ 70.0 million up-front payment.

In September 2023, the Company further expanded its existing collaboration to develop additional in vivo CRISPR-based gene editing therapies focused on neurological and muscular diseases.

Intellia will lead the design of the editing methodology, the Company will lead the design of the targeted viral vector delivery approach, and the parties share costs equally.

Each company will have the opportunity to lead potential development and commercialization of product candidates for one target, and the company that is not leading development and commercialization will have the option to enter into a co-development and co-commercialization agreement for the target.

In October 2023, the Company elected to extend the period for selecting targets under the 2016 license and collaboration agreement for an additional two years until April 2026;

as a result, the Company became obligated to make a $ 30.0 million extension payment to Intellia (which was recorded to Acquired in-process research and development expense in 2023).

Amounts recognized in the Company's Statements of Operations in connection with research and development activities co-funded under the Intellia agreements were not material for the years ended December 31, 2023, 2022, and 2021.

In addition, contract balances in the Company's Balance Sheets in connection with the Intellia agreements were not material as of December 31, 2023 and 2022.

In March 2023, the Company and Sonoma Biotherapeutics, Inc.

entered into a license and collaboration agreement to bring together the Company's VelociSuite ® technologies with Sonoma's technology platform for the discovery, development, and commercialization of novel regulatory T cell ("Treg") therapies for autoimmune diseases.

In connection with the agreement, the Company made a $ 45.0 million up-front payment (which was recorded to Acquired in-process research and development expense in 2023) and, in April 2023, the Company purchased an aggregate of $ 30.0 million of Sonoma preferred stock.

Sonoma is also eligible to receive a $ 45.0 million development milestone payment.

The Company and Sonoma will co-fund research and development activities and share equally any future commercial expenses and profits.

The Company will have the option to lead late-stage development and commercialization on all products globally, with Sonoma retaining rights to co-promote all such products in the United States.

Amounts recognized in the Company's Statements of Operations in connection with research and development activities co-funded under the Sonoma agreement were not material for the year ended December 31, 2023.

In addition, contract balances in the Company's Balance Sheets in connection with the Sonoma agreement were not material as of December 31, 2023.

In 2021, the Company entered into agreements with the U.S.

Department of Defense and the U.S.

Department of Health and Human Services ("HHS") to manufacture and deliver filled and finished drug product of REGEN-COV to the U.S.

Roche supplied a portion of the doses to Regeneron to fulfill the Company's agreement with the U.S.

government (see "Roche" above for further details regarding the Company's collaboration agreement with Roche).

As of December 31, 2021, the Company had completed its final deliveries of drug product under these agreements.

See Note 2 for REGEN-COV net product sales recognized during the year ended December 31, 2021 in connection with these agreements.

In August 2023, the Company expanded its Other Transaction Agreement ("OTA") with the Biomedical Advanced Research and Development Authority ("BARDA"), pursuant to which the HHS is obligated to fund up to 70 % of the Company's costs incurred for certain development activities related to a next-generation COVID-19 monoclonal antibody therapy for the prevention of SARS-CoV-2 infection.

Pursuant to the terms of the expanded agreement, the Company could receive payments of up to approximately $ 326 million in the aggregate to support clinical development, clinical manufacturing, and the regulatory licensure process.

Amounts recognized within Other revenue in the Company's Statements of Operations in connection with the expanded BARDA agreement were $ 50.4 million for the year ended December 31, 2023.

The following table summarizes the Company's contract balances in connection with this BARDA agreement:

As of December 31,

(In millions) 2023

Accounts receivable, net

In 2017, the Company entered into an agreement with Decibel Therapeutics, Inc.

to discover and develop new potential therapeutics to protect, repair and restore hearing (including DB-OTO, which is currently in clinical development, and preclinical programs for GJB2-related and stereocilin-related hearing loss).

In connection with the agreement, the Company also purchased shares of Decibel stock.

In August 2023, the Company entered into an Agreement and Plan of Merger to acquire Decibel, and in September 2023, the Company completed its acquisition of Decibel (which was accounted for as a business combination).

The Company paid $ 101.3 million in cash (or $ 4.00 per share of Decibel common stock), of which $ 6.6 million was attributed to post-combination services to be rendered by Decibel equity award holders, and as a result, was excluded from the amount of consideration transferred for purchase accounting.

In addition, Decibel shareholders received one non-tradeable contingent value right ("CVR") per share of Decibel common stock, which entitles the holder to receive up to $ 3.50 per share in cash upon achievement of certain clinical development and regulatory milestones for DB-OTO within specified time periods.

At closing, the Company recorded a liability related to the fair value of the CVRs of $ 43.7 million (see Note 5).

The maximum aggregate amount that holders of the CVRs may be entitled to receive if all the milestones contemplated by the CVRs are achieved is approximately $ 97 million.

The fair value of the Company's investment in Decibel stock immediately before the acquisition date was $ 10.3 million.

The following table summarizes the amounts recognized for assets acquired and liabilities assumed based on their estimated fair values as of the acquisition date:

September 25,

(In millions) 2023

Cash and cash equivalents $ 42.2

Marketable securities 12.1

Deferred tax assets, net

Indefinite-lived intangible asset related to in-process research and development 42.5

Other assets and liabilities, net

The final determination of fair values of assets acquired, liabilities assumed, and tax-related items will be completed no later than one year from the acquisition date.

In 2022, the Company completed its acquisition of Checkmate Pharmaceuticals, Inc.

for a total equity value of approximately $ 250 million.

As a result of the transaction, which was accounted for as an asset acquisition, the Company recorded, during 2022, (i) a charge of $ 195.0 million to Acquired in-process research and development and (ii) net assets of $ 61.7 million, including $ 26.4 million of cash and cash equivalents acquired, related to the assets acquired (including deferred tax assets and investments) and liabilities assumed.

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

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, significant research and development costs.

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.

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 12.0 %, in the event the Company sells or licenses any proprietary products developed under the respective agreements.

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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.

Prior to July 1, 2022, royalties on such sales were shared equally by the Company and Sanofi.

For the years ended December 31, 2023, 2022, and 2021, the Company recorded royalty expense (net of reimbursements from collaborators, as applicable) in its Statements of Operations of $ 117.6 million, $ 84.5 million, and $ 66.9 million, respectively, based on product sales under various licensing agreements.

For the years ended December 31, 2024, 2023, and 2022, the Company recorded royalty expense (net of reimbursements from collaborators, as applicable) of $ 82.9 million, $ 117.6 million, and $ 84.5 million, respectively, based on product sales under various licensing agreements.

Marketable Securities

5 unchanged sentences

government and government agency obligations 4,820.5 3.4 ( 6.9 ) 4,817.0

Sovereign bonds 58.1 — ( 0.9 ) 57.2

Commercial paper 548.3 0.4 — 548.7

1 unchanged sentence

Asset-backed securities 279.0 0.6 ( 0.3 ) 279.3

Sovereign bonds 82.7 0.1 ( 0.4 ) 82.4

$ 14,338.0 $ 30.1 $ ( 39.0 ) $ 14,329.1

2 unchanged sentences

government and government agency obligations 4,839.6 2.4 ( 8.6 ) 4,833.4

Sovereign bonds 67.1 — ( 3.0 ) 64.1

Commercial paper 636.8 0.2 ( 0.2 ) 636.8

1 unchanged sentence

Asset-backed securities 88.2 0.1 ( 1.2 ) 87.1

Sovereign bonds 58.1 — ( 0.9 ) 57.2

$ 12,636.0 $ 13.7 $ ( 115.8 ) $ 12,533.9

The Company classifies its investments in available-for-sale debt securities based on their contractual maturity dates.

The available-for-sale debt securities as of December 31, 2023 mature at various dates through April 2029.

The available-for-sale debt securities as of December 31, 2024 mature at various dates through December 2029.

The fair values of available-for-sale debt securities by contractual maturity consist of the following:

5 unchanged sentences

$ 14,329.1 $ 12,533.9

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

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

1 unchanged sentence

As of December 31, 2024

Fair Value Unrealized Loss Fair Value Unrealized Loss Fair Value Unrealized Loss

Fair Value Unrealized Losses

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

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

Commercial paper

636.8 ( 0.2 ) — — 636.8 ( 0.2 )

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

4 unchanged sentences

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

Certificates of deposit 40.2 ( 0.1 ) — — 40.2 ( 0.1 )

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 as of December 31, 2023 and 2022 were primarily driven by increased interest rates.

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.

1 unchanged sentence

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.

Realized gains and losses on sales of marketable securities were not material for the years ended December 31, 2023, 2022, and 2021.

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

The Company recognized interest income of $ 711.4 million, $ 495.9 million, and $ 160.1 million for the years ended December 31, 2024, 2023, and 2022, respectively, in Other income (expense), net.

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government and government agency obligations 4,817.0 — 4,817.0 —

Sovereign bonds 57.2 — 57.2 —

Commercial paper 548.7 — 548.7 —

1 unchanged sentence

Asset-backed securities 279.3 — 279.3 —

Sovereign bonds 82.4 — 82.4 —

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

Equity securities (restricted) 112.9 112.9 — —

Equity securities (restricted) (a)

43.2 43.2 — —

Contingent consideration - CVRs

$ 16,876.6 $ 2,359.5 $ 14,517.1 $ —

Contingent consideration

$ 52.3 $ — $ — $ 52.3

As of December 31, 2023

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government and government agency obligations 4,833.4 — 4,833.4 —

Sovereign bonds 64.1 — 64.1 —

Commercial paper 636.8 — 636.8 —

1 unchanged sentence

Asset-backed securities 87.1 — 87.1 —

Sovereign bonds 57.2 — 57.2 —

Equity securities (unrestricted) 864.5 864.5 — —

1 unchanged sentence

$ 14,439.4 $ 983.8 $ 13,455.6 $ —

The Company held certain restricted equity securities as of December 31, 2023 which are subject to transfer restrictions that expire at various dates throug h 2024 .

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.

Contingent consideration

$ 43.7 $ — $ — $ 43.7

(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.

In addition to the investments summarized in the table above, as of December 31, 2023 and 2022, the Company had $ 74.3 million and $ 48.3 million, respectively, in equity investments that do not have a readily determinable fair value.

These investments are recorded within Other noncurrent assets.

As described in Note 3, in September 2023, the Company acquired Decibel and recorded a liability for the CVRs within other liabilities.

The fair value of the CVR liability is determined based on the probability of achieving certain clinical development and regulatory milestones and estimated discount rates.

Through December 31, 2023, there were no changes in the fair value of the CVRs subsequent to the date of acquisition.

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 $ 1.484 billion and $ 1.528 billion as of December 31, 2024 and 2023, respectively.

8 unchanged sentences

Deferred costs represent the costs of product manufactured and shipped to the Company's collaborators for which recognition of revenue has been deferred.

Inventory balances in the table above are net of reserves of $ 705.9 million and $ 720.7 million as of December 31, 2023 and 2022, respectively.

For the years ended December 31, 2024, 2023, and 2022, Cost of goods sold included inventory write-offs and reserves of $ 126.3 million, $ 102.3 million, and $ 258.7 million, respectively.

Inventory write-offs and reserves for the years ended 2022 and 2021 primarily related to REGEN-COV.

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

Property, Plant, and Equipment

13 unchanged sentences

$ 4,599.7 $ 4,146.4

Property, plant, and equipment in the table above includes leased property under the Company's finance lease at its Tarrytown, New York facility.

Property, plant, and equipment in the table above includes leased property under the Company's finance lease at its Tarrytown, New York corporate headquarters.

Depreciation and amortization expense on property, plant, and equipment was $ 354.1 million, $ 328.8 million, and $ 303.9 million for the years ended December 31, 2024, 2023, and 2022, respectively.

1 unchanged sentence

Intangible Assets

Intangible assets.

net consist of the following:

Intangible assets, net consist of the following:

As of December 31,

1 unchanged sentence

Acquired product rights - Libtayo 13 years $ 1,347.7 $ ( 254.3 ) $ 1,093.4 $ 1,119.1 $ ( 126.7 ) $ 992.4

$ 1,119.1 $ ( 126.7 ) $ 992.4 $ 946.3 $ ( 35.7 ) $ 910.6

Other intangibles 8 years 10.0 ( 7.6 ) 2.4 10.0 ( 6.3 ) 3.7

10.0 ( 6.3 ) 3.7 10.0 ( 5.1 ) 4.9

Acquired in-process research and development

1 unchanged sentence

$ 1,410.5 $ ( 261.9 ) $ 1,148.6 $ 1,171.6 $ ( 133.0 ) $ 1,038.6

As described in Note 3, during the year ended December 31, 2023, the Company recorded an indefinite-lived intangible asset of $ 42.5 million in connection with its acquisition of Decibel.

During the year ended December 31, 2022, the Company recorded an intangible asset in connection with obtaining the exclusive right to develop, commercialize, and manufacture Libtayo worldwide.

The intangible asset recognized upon the effective date of the A&R IO LCA primarily consisted of the $ 900.0 million up-front payment, offset by the remaining IO Collaboration other liabilities balance of $ 241.0 million.

Additionally, during the years ended December 31, 2023 and 2022, the Company recorded additions to the Libtayo intangible asset related to contingent consideration (including regulatory and sales-based milestones) due to Sanofi.

Amortization expense on intangible assets was $ 92.2 million and $ 37.6 million for the years ended December 31, 2023 and 2022, respectively.

Amortization expense for the year ended December 31, 2021 was no t material.

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.

Amortization expense on intangible assets was $ 128.9 million, $ 92.2 million, and $ 37.6 million for the years ended December 31, 2024, 2023, and 2022, respectively.

As of December 31, 2024, assuming no changes in the gross carrying amount of intangible assets, amortization expense is estimated to be approximately $ 102 million for each of the years ending December 31, 2025 through December 31, 2029.

6 unchanged sentences

Accrued sales-related costs 786.2 780.8

Income tax-related costs

Other accrued expenses and liabilities 571.1 655.0

$ 2,527.1 $ 2,357.9

Long-term debt, net of underwriting discounts and offering expenses (which are being amortized as additional interest expense over the period of issuance through maturity), consists of the following:

As of December 31,

(In millions) 2024 2023

1.750 % Senior Notes due September 2030

$ 1,243.3 $ 1,242.2

2.800 % Senior Notes due September 2050

$ 1,984.4 $ 1,982.9

Interest on each series of senior notes is payable semi-annually until the applicable maturity dates.

Interest expense related to the debt was $ 44.4 million in each of the years ended December 31, 2024, 2023, and 2022.

Credit Facility

In December 2022, the Company entered into an agreement with a syndicate of lenders (the "2022 Credit Agreement") which provides for a $ 750.0 million senior unsecured five-year revolving credit facility (the "2022 Credit Facility") and replaced the Company's then-existing credit agreement, which was contemporaneously terminated.

The Company is party to an agreement with a syndicate of lenders (the "Credit Agreement") which provides for a $ 750.0 million senior unsecured five-year revolving credit facility (the "Credit Facility").

The Credit Agreement includes an option for the Company to elect to increase the commitments under the Credit Facility and/or to enter into one or more tranches of term loans in the aggregate principal amount of up to $ 500.0 million, subject to the consent of the lenders providing the additional commitments or term loans, as applicable, and certain other conditions.

7 unchanged sentences

The Company was in compliance with all covenants of the Credit Agreement as of December 31, 2024.

In 2020, the Company issued and sold $ 1.250 billion aggregate principal amount of senior unsecured notes due 2030 and $ 750 million aggregate principal amount of senior unsecured notes due 2050 (collectively, the "Notes").

The underwriting discounts and offering expenses are being amortized as additional interest expense over the period from issuance through maturity.

Long-term debt in connection with the Notes, net of underwriting discounts and offering expenses, consists of the following:

As of December 31,

(In millions) 2023 2022

1.750 % Senior Notes due September 2030

$ 1,242.2 $ 1,241.0

2.800 % Senior Notes due September 2050

$ 1,982.9 $ 1,981.4

Interest on each series of Notes is payable semi-annually in arrears on March 15 and September 15 of each year until their respective maturity dates.

Interest expense related to the Notes was $ 44.4 million in each of the years ended December 31, 2023, 2022, and 2021.

The Notes may be redeemed at the Company’s option at any time at 100 % of the principal amount plus accrued and unpaid interest, and, until a specified period before maturity, a specified make-whole amount.

The Notes contain a change-of-control provision that, under certain circumstances, may require the Company to offer to repurchase the Notes at a price equal to 101 % of the principal amount plus accrued and unpaid interest.

The Notes also contain certain limitations on the Company's ability to incur liens and enter into sale and leaseback transactions, as well as customary events of default.

The Company conducts certain of its research, development, and administrative activities at leased facilities.

The Company also leases vehicles and other assets.

Tarrytown, New York Lease

The Company is party to a Third Amended and Restated Lease and Remedies Agreement (the "Third Amended and Restated Lease") with BA Leasing BSC, LLC, an affiliate of Banc of America Leasing & Capital, LLC ("BAL"), as lessor, which relates to the Company’s lease of laboratory and office facilities in Tarrytown, New York (the “Facility”);

and a Third Amended and Restated Participation Agreement (the "Third Amended and Restated Participation Agreement") with Bank of America, N.A., as administrative agent (the "Administrative Agent"), and a syndicate of lenders (collectively with BAL, the "Participants"), as rent assignees.

The Third Amended and Restated Lease and Third Amended and Restated Participation Agreement provide for a March 2027 maturity date of the $ 720.0 million lease financing (previously advanced by the Participants in March 2017 in connection with the acquisition by BAL of the Facility and the Company's lease of the Facility from BAL) and the end of the term

of the Company's lease of the Facility from BAL, at which time all amounts outstanding thereunder will become due and payable in full.

In accordance with the terms of the Third Amended and Restated Lease, the Company pays all maintenance, insurance, taxes, and other costs arising out of the use of the Facility.

The Company is also required to make monthly payments of basic rent during the remaining term of the Third Amended and Restated Lease to satisfy the yield payable to the Participants on their outstanding advances under the Third Amended and Restated Participation Agreement.

Tarrytown, New York Corporate Headquarters

The Company leases laboratory and office facilities for its corporate headquarters in Tarrytown, New York (the "Facility") under the Third Amended and Restated Lease and Remedies Agreement (the "Lease") with BA Leasing BSC, LLC, an affiliate of Banc of America Leasing & Capital, LLC ("BAL"), as lessor, and the Third Amended and Restated Participation Agreement (the "Participation Agreement") with Bank of America, N.A., as administrative agent, and a syndicate of lenders (collectively with BAL, the "Participants"), as rent assignees.

The Lease, Participation Agreement, and certain related agreements provide for $ 720.0 million of lease financing (previously advanced by the Participants in March 2017 in connection with the acquisition by BAL of the Facility and the Company's lease of the Facility from BAL), which matures when the term of the Lease expires in March 2027, at which time all amounts outstanding thereunder will become payable in full.

The Company has the option to further extend the maturity date of the Participation Agreement and the term of the Lease for an additional five-year period, subject to the consent of the Participants and certain other conditions.

The Company also has the option to (a) purchase the Facility by paying an amount equal to the outstanding principal amount of the Participants' advances under the Participation Agreement, all accrued and unpaid yield thereon, and all other outstanding amounts under the Participation Agreement, Lease, and certain related documents or (b) sell the Facility to a third party on behalf of BAL.

Pursuant to the Lease, the Company pays all maintenance, insurance, taxes, and other costs arising out of the use of the Facility.

The Company is also required to make monthly payments of basic rent to satisfy the yield payable to the Participants on their outstanding advances under the Participation Agreement.

Such advances accrue yield at a variable rate per annum based on the one-month forward-looking Secured Overnight Financing Rate ("SOFR") term rate, plus a spread adjustment, plus an applicable margin that varies with the Company's debt rating and total leverage ratio.

The Third Amended and Restated Participation Agreement and Third Amended and Restated Lease include an option for the Company to elect to further extend the maturity date of the Third Amended and Restated Participation Agreement and the term of the Third Amended and Restated Lease for an additional five-year period, subject to the consent of all the Participants and certain other conditions.

The Company also has the option prior to the end of the term of the Third Amended and Restated Lease to (a) purchase the Facility by paying an amount equal to the outstanding principal amount of the Participants' advances under the Third Amended and Restated Participation Agreement, all accrued and unpaid yield thereon, and all other outstanding amounts under the Third Amended and Restated Participation Agreement, Third Amended and Restated Lease, and certain related documents or (b) sell the Facility to a third party on behalf of BAL.

The Third Amended and Restated Lease is classified as a finance lease as the Company has the option to purchase the Facility under terms that make it reasonably certain to be exercised.

The agreements governing the Third Amended and Restated Lease financing contain financial and operating covenants.

The Lease is classified as a finance lease as the Company has the option to purchase the Facility under terms that make it reasonably certain to be exercised.

The agreements governing the Lease financing contain financial and operating covenants.

Such financial covenants and certain of the operating covenants are substantially similar to the covenants set forth in the Credit Agreement.

66 unchanged sentences

Share Repurchase Programs

In January 2021, the Company's board of directors authorized a share repurchase program to repurchase up to $ 1.5 billion of the Company's Common Stock.

As of December 31, 2021, the Company had repurchased the entire $ 1.5 billion of its Common Stock that it was authorized to repurchase under the program.

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 that it was authorized to repurchase under the program.

In January 2023, the Company's board of directors authorized an additional share repurchase program to repurchase up to $ 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 Exchange Act), privately negotiated transactions, accelerated share repurchases, block trades, and other transactions in compliance with Rule 10b-18 of the Exchange Act.

Repurchases may be made from time to time at management's discretion, and the timing and amount of any such repurchases will be determined based on share price, market conditions, legal requirements, and other relevant factors.

The program has no time limit and can be discontinued at any time.

There can be no assurance as to the timing or number of shares of any repurchases in the future.

As of December 31, 2023, $ 1.531 billion remained available for share repurchases under the program.

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

Year Ended December 31,

2 unchanged sentences

Total cost of shares $ 2,613.9 $ 2,214.6 $ 2,099.8

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.

Long-Term Incentive Plans

15 unchanged sentences

The maximum term of options that have been awarded under the 2000 Incentive Plan, the Original 2014 Incentive Plan, the Amended and Restated 2014 Incentive Plan, and the Second Amended and Restated 2014 Incentive Plan (collectively, the "Incentive Plans") is ten years .

Restricted stock awards grant Participants shares of restricted Common Stock or allow Participants to purchase such shares at a price determined by the Committee.

Restricted stock awards grant Participants shares of restricted Common Stock.

Such shares are nontransferable for a period determined by the Committee ("vesting period").

13 unchanged sentences

Outstanding as of December 31, 2023

14.2 $ 534.13

Granted 1.9 $ 786.79

1 unchanged sentence

Exercised ( 3.2 ) $ 454.70

Outstanding as of December 31, 2023 14.2 $ 534.13 6.0 years $ 4,918.6

Vested and expected to vest as of December 31, 2023 13.8 $ 526.95 5.9 years $ 4,852.2

Exercisable as of December 31, 2023 9.6 $ 450.01 4.7 years $ 4,118.0

Outstanding as of December 31, 2024

12.7 $ 588.47 6.1 years $ 1,891.0

Vested and expected to vest as of December 31, 2024

12.3 $ 582.36 6.0 years $ 1,888.5

Exercisable as of December 31, 2024

8.3 $ 495.19 4.7 years $ 1,834.8

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

20 unchanged sentences

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

The expected dividend yield is zero as the Company has never paid dividends and does not currently have plans to do so.

During 2024, 2023, and 2022, the expected dividend yield was zero as the Company had not paid dividends nor did it expect to at the time of option grants.

The risk-free interest rates are based on quoted U.S.

12 unchanged sentences

For the years ended December 31, 2024, 2023, and 2022, the Company recognized $ 554.7 million, $ 475.9 million, and $ 331.1 million, respectively, of stock-based compensation expense related to restricted stock (net of amounts capitalized as inventory, which were not material for each of the three years).

As of December 31, 2023, there was $ 1.023 billion of stock-based

compensation cost related to unvested restricted stock which had not yet been recognized.

As of December 31, 2024, there was $ 1.219 billion of stock-based compensation cost related to unvested restricted stock which had not yet been recognized.

The Company expects to recognize this compensation cost over a weighted-average period of 2.3 years.

3 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.

The table below summarizes activity related to PSUs during 2023.

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

Number of Shares/Units

(In millions)

Weighted-Average Grant

Date Fair Value

Unvested as of December 31, 2022 1.5 $ 245.94

( 0.1 ) $ 198.10

Unvested as of December 31, 2023 1.4 $ 247.91

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

For each of the years ended December 31, 2024, 2023, and 2022 the Company recognized $ 52.1 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 2.3 years.

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:

38 unchanged sentences

federal statutory tax rate 21.0 % 21.0 % 21.0 %

Stock-based compensation ( 4.9 ) ( 4.6 ) ( 2.9 )

Taxation of non-U.S.

operations ( 4.0 ) ( 6.6 ) ( 5.5 )

Stock-based compensation ( 4.6 ) ( 2.9 ) ( 2.4 )

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

29 unchanged sentences

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

3.2 ( 5.0 ) 2.9

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

1 unchanged sentence

In 2024, 2023, and 2022, 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 2021, the decrease in unrecognized tax benefits due to settlements and lapse of statutes of limitations was related to the closing of audits for the Company's federal income tax returns for 2015 and 2016.

Interest expense related to unrecognized tax benefits was not material in 2023, 2022, and 2021.

The Company does not believe that it is reasonably possible that the resolution of tax exposures within the next twelve months would have a material impact on the consolidated financial statements as of December 31, 2023.

Interest expense related to unrecognized tax benefits was $ 165.4 million, $ 77.2 million, and $ 38.0 million in 2024, 2023, and 2022, 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 $ 635.4 million, $ 442.5 million, and $ 373.7 million as of December 31, 2024, 2023, and 2022, respectively.

In August 2022, the Inflation Reduction Act of 2022 ("IRA") was signed into law in the United States.

The IRA created a new corporate alternative minimum tax of 15% on adjusted financial statement income and an excise tax of 1% of the value of certain stock repurchases.

The provisions of the IRA became effective for periods beginning after December 31, 2022.

The IRA did not have a material impact on the Company's financial statements as of and for the periods ended December 31, 2023 and 2022.

Legal Matters

1 unchanged sentence

The outcome of any such proceedings, regardless of the merits, is inherently uncertain.

If the Company were unable to prevail in any such proceedings, its consolidated financial position, results of operations, and future cash flows may be materially impacted.

If the Company is unable to prevail in one or more of such proceedings, its consolidated financial position, results of operations, and future cash flows may be materially adversely impacted.

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

2 unchanged sentences

There are certain loss contingencies that the Company deems reasonably possible for which the possible loss or range of possible loss is not estimable at this time.

Proceedings Relating to Praluent (alirocumab) Injection

As described below, the Company is currently a party to patent infringement actions initiated by Amgen Inc.

(and/or its affiliated entities) against the Company and/or Sanofi (and/or the Company's and Sanofi's respective affiliated entities) in a number of jurisdictions relating to Praluent.

In addition, as described below, the Company filed a lawsuit against Amgen alleging that Amgen engaged in an anticompetitive bundling scheme which was designed to exclude Praluent from the market in violation of U.S.

federal and state laws.

United States

In the United States, Amgen asserted claims of U.S.

8,829,165 (the "'165 Patent") and 8,859,741 (the "'741 Patent"), and sought a permanent injunction to prevent the Company and the Sanofi defendants from commercial manufacturing, using, offering to sell, or selling within the United States (as well as importing into the United States) Praluent.

Amgen also sought a judgment of patent infringement of the asserted patents, monetary damages (together with interest), costs and expenses of the lawsuits, and attorneys' fees.

As previously reported, on February 11, 2021, the United States Court of Appeals for the Federal Circuit (the "Federal Circuit") affirmed the lower court's decision that certain of Amgen's asserted patent claims are invalid based on lack of enablement.

On April 14, 2021, Amgen filed a petition for a rehearing en banc with the Federal Circuit, which was denied on June 21, 2021.

On November 4, 2022, the United States Supreme Court granted Amgen's petition for writ of certiorari.

An oral hearing was held on March 27, 2023.

On May 28, 2023, the United States Supreme Court affirmed the Federal Circuit's decision that certain of Amgen's asserted patent claims are invalid based on lack of enablement.

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, 2022, Amgen filed a motion to dismiss the complaint.

On August 11, 2022, Amgen filed a motion to stay these proceedings pending resolution of the patent litigation described in the preceding paragraph.

An oral hearing on Amgen's motion to dismiss and motion to stay was held on January 6, 2023.

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.

A trial has been scheduled to begin in November 2024.

Amgen has asserted European Patent No.

2,215,124 (the "'124 Patent"), which pertains to PCSK9 monoclonal antibodies, in certain countries in Europe.

In October 2020, the '124 Patent claims directed to compositions of matter and medical use relevant to Praluent were ruled invalid based on a lack of inventive step by the Technical Board of Appeal (the "TBA") of the European Patent Office (the "EPO").

Following the EPO's decision, each of the '124 Patent infringement proceedings initiated by Amgen against the Company and certain of Sanofi's affiliated entities in these countries was dismissed, including in Germany.

The dismissal in Germany followed an earlier finding of infringement and granting of an injunction, both of which were subsequently overturned.

As a result of the overturned injunction in Germany, the Company and/or certain of Sanofi's affiliated entities are seeking damages caused by Amgen's enforcement of the injunction.

An oral hearing has been scheduled for February 28, 2024.

As part of its opposition to these damages claims, on March 23, 2022, Amgen filed a counterclaim that asserted the German designation of European Patent No.

2,641,917 (the "'917 Patent") and seeks, among other things, a judgment of patent infringement, injunctive relief, and monetary damages.

The '917 Patent is a divisional patent of the '124 Patent discussed above (i.e., a patent that shares the same priority date, disclosure, and patent term of the parent '124 Patent but contains claims to a different invention).

An oral hearing before the Munich Regional Court was held on November 29, 2023, at which Amgen's counterclaim was dismissed.

The '917 Patent is also subject to opposition proceedings in the EPO, which were initiated by Sanofi on May 5, 2021.

An oral hearing before the EPO was held on February 21, 2023, at which the '917 Patent was revoked.

Amgen filed a notice to appeal to the TBA of the EPO on February 27, 2023.

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 Unified Patent Court (the "UPC") alleging infringement of Amgen's European Patent No.

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

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

The '797 Patent is a divisional patent of the '124 Patent discussed above.

A trial has been scheduled for October 16–17, 2024.

Also on June 1, 2023, Sanofi filed an action in the Munich Central Division of the UPC seeking revocation of the '797 Patent.

A trial has been scheduled for June 4–5, 2024.

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"), EPO, or other comparable foreign authorities, including those described in greater detail below.

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

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

United States

Post-Grant Proceedings Before USPTO

Company Patent(s)

Challenger(s)

Type of Challenge

Date of Challenge

Latest Events/Current Status

10,406,226 (the "'226 Patent") and 10,464,992 (the "'992 Patent") Anonymous parties Ex parte reexamination

February 11, 2020 On September 11, 2023, the USPTO dismissed the '226 Patent reexamination proceedings following the Company's filing of a Notice of Disclaimer, disclaiming all claims of the '226 Patent.

On September 8, 2023, the '992 Patent reexamination proceedings were stayed by the USPTO pending resolution of the inter partes review ("IPR") of the '992 Patent initiated by Celltrion, Inc., as discussed further below.

On January 17, 2024, the Company filed a Notice of Disclaimer with the USPTO, disclaiming all claims of the '992 Patent.

Company Patent(s) (continued)

Challenger(s)

Type of Challenge

Date of Challenge

Latest Events/Current Status

9,254,338 (the "'338 Patent") and 9,669,069 (the "'069 Patent") Mylan Pharmaceuticals Inc., joined by Apotex Inc.

and Celltrion

IPR petitions seeking declarations of invalidity May 5, 2021 On November 9, 2022, the USPTO issued final written decisions finding that the challenged claims of the '338 and '069 Patents are unpatentable and, therefore, invalid.

On January 10, 2023, the Company filed notices of appeal of the USPTO written decisions concerning the '338 and '069 Patents with the Federal Circuit.

10,130,681 (the "'681 Patent"), 10,888,601 (the "'601 Patent"), and 10,857,205 (the "'205 Patent") Mylan, joined by Celltrion ('601 and '681 Patents) and Samsung Bioepis Co., Ltd.

('601 Patent)

IPR petitions seeking declarations of invalidity July 1, 2022 ('681 Patent and '601 Patent)

October 28, 2022 ('205 Patent)

On January 9, 2024, the USPTO issued final written decisions finding that that the challenged claims of the '681 and '601 Patents are unpatentable and, therefore, invalid.

On March 1, 2023, the USPTO denied institution of Mylan's IPR petition against the '205 Patent following the Company's filing of a Notice of Disclaimer with the USPTO, disclaiming all claims of the '205 Patent.

'681 Patent and '601 Patent

Samsung Bioepis, joined by Biocon Biologics Inc.

('601 Patent)

IPR petitions seeking declarations of invalidity January 6, 2023 ('681 Patent)

March 26, 2023 ('601 Patent)

On July 19, 2023 and October 20, 2023, the USPTO instituted IPR proceedings concerning the '681 Patent and the '601 Patent, respectively.

11,253,572 (the "'572 Patent") Apotex

IPR petition seeking declaration of invalidity

September 9, 2022

On March 10, 2023, the USPTO declined to institute an IPR proceeding based on the Apotex IPR petition.

Samsung Bioepis

IPR petition seeking declaration of invalidity

April 27, 2023

On November 17, 2023, the USPTO instituted IPR proceedings concerning the '572 Patent based on the Samsung IPR petition.

'992 Patent and '226 Patent

Celltrion, joined by Samsung Bioepis ('992 Patent)

IPR petitions seeking declarations of invalidity

January 17, 2023 ('992 Patent)

February 28, 2023 ('226 Patent)

On July 20, 2023, the USPTO instituted an IPR proceeding concerning the '992 Patent.

On January 17, 2024, the Company filed a Notice of Disclaimer with the USPTO, disclaiming all claims of the '992 Patent.

On September 1, 2023, the USPTO denied institution of Celltrion's IPR petition against the '226 Patent following the Company's filing of a Notice of Disclaimer with the USPTO, disclaiming all claims of the '226 Patent.

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 FDA approval of an aflibercept 2 mg biosimilar infringes certain Company patents.

On April 20, 2023, Mylan filed a motion for summary judgment or partial summary judgment concerning four of the asserted patents.

On April 26, 2023, the Company filed a stipulation accepting summary judgment of noninfringement of all asserted claims of the Company's 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.

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

Closing arguments were presented on August 3, 2023.

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 (ii) the asserted claims of the '601 and '572 Patents were infringed by Mylan but were invalid as obvious.

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.

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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.

A preliminary injunction hearing concerning each of these lawsuits has been scheduled for May 2, 2024.

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 January 11, 2024, the Company filed a motion with the United States Judicial Panel on Multidistrict Litigation seeking to transfer this lawsuit to the United States District Court for the Northern District of West Virginia for coordinated pretrial proceedings with the lawsuits described in the preceding paragraph.

A hearing on the motion to transfer has been scheduled for March 28, 2024.

Post-Grant Proceedings

Authority/Court

Company Patent(s)

Challenger(s)

Type of Challenge

Date of Challenge

Latest Events/Current Status

European Patent No.

2,944,306 (the "'306 Patent") Anonymous parties Opposition proceedings October 26 and October 27, 2021 Oral hearing to be scheduled.

European Patent No.

3,716,992 (the "EP '992 Patent") Amgen and three anonymous parties Opposition proceedings May 5-10, 2023 Oral hearing to be scheduled.

German Federal Patent Court

German designation of European Patent No.

2,364,691 (the "'691 Patent") Samsung Bioepis NL B.V.

Invalidation proceedings June 22, 2023 Trial has been scheduled to begin in June 2025.

On June 15, July 15, August 30, and October 4, 2022, the Company and Bayer Inc.

filed patent infringement lawsuits against BGP Pharma ULC d.b.a Viatris Canada ("Viatris 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.

2,654,510 (the "'510 Patent") and 3,007,276 (the "'276 Patent") (in the lawsuit filed on June 15, 2022);

the Company's Canadian Patent No.

2,965,495 (the "'495 Patent") (in the lawsuit filed on July 15, 2022);

the Company's Canadian Patent No.

2,906,768 (the "'768 Patent") (in the lawsuit filed on August 30, 2022, which has been joined with the lawsuit filed on July 15, 2022);

and the Company's Canadian Patent No.

3,129,193 (the "'193 Patent") (in the lawsuit filed on October 4, 2022).

A trial for the lawsuit concerning the '510 Patent and the '276 Patent (the "Viatris Canada 510/276 Lawsuit") has been scheduled for March 2024;

a trial for the lawsuit concerning the '193 Patent has been scheduled for May 2024;

and a trial for the lawsuit concerning the '495 Patent and the '768 Patent has been scheduled for November/December 2024.

The filing of the Viatris Canada 510/276 Lawsuit resulted in a statutory 24-month stay of regulatory approval of Viatris Canada's aflibercept 2 mg

biosimilar in Canada unless the lawsuit is resolved earlier.

On March 27, 2023, in light of the transfer of Viatris Canada's New Drug Submission ("NDS") of its aflibercept 2 mg biosimilar to Biosimilar Collaborations Ireland Limited ("BCIL"), the Company filed a motion in the Federal Court of Canada seeking termination of the Viatris Canada 510/276 Lawsuit.

On June 5, 2023, BCIL was added as a defendant in the Viatris Canada 510/276 Lawsuit.

On March 23, 2023 and June 14, 2023, the Company and Bayer Inc.

filed patent infringement lawsuits against BCIL 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 and '276 Patents.

The June 14, 2023 lawsuit was filed after BCIL served Bayer Inc.

with a statutory notification in relation to the NDS on May 23, 2023.

On September 14, 2023, the Company, Bayer Inc., and Bayer Healthcare LLC filed patent infringement lawsuits against Viatris Canada and BCIL 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 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

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 '510 Patent and 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 the '315 Patent.

("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").

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 '193 Patent, '495 Patent, and '768 Patent, respectively.

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

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

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

On January 15, 2024, the Company and Bayer Inc.

filed patent infringement lawsuits against Celltrion, Inc., Celltrion Healthcare Co, Ltd., Celltrion Pharma Inc., and Celltrion Healthcare Canada Ltd.

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, and the '315 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 against the Company's Korean Patent Nos.

1131429 and 1406811, respectively, seeking revocation of each of such patents in its entirety.

On January 16, 2023, the Company filed patent infringement lawsuits against Samsung Bioepis Co., Ltd.

and its parent company Samsung Biologics Co., Ltd.

before the Seoul Central District Court seeking a declaration that the making, constructing, using, or selling of an aflibercept 2 mg biosimilar would infringe one or more claims of the Company's Korean Patent No.

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.

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

On July 20, 2023, the Company filed a preliminary injunction petition against Samsung Bioepis Co., Ltd.

and its parent company Samsung Biologics Co., Ltd.

before the Seoul Central District Court seeking a court order enjoining the manufacture, use, and assignment of an aflibercept 2 mg biosimilar that infringes one or more claims of the '477 Patent;

and on December 20, 2023, the Seoul Central District Court granted a preliminary injunction.

On January 10, 2024, the injunction was lifted against the Samsung entities following the expiration of the '477 Patent.

On March 2, 2023, the Company filed an affirmative scope confirmation action against Samsung Bioepis Co., Ltd.

before the Intellectual Property Tribunal and Appeal Board of the Korean Intellectual Property Office seeking a ruling that Samsung Bioepis's aflibercept 2 mg biosimilar is covered by the claims of the '477 Patent.

On March 7, 2023, the action was designated for expedited proceedings.

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.

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").

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

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

9,220,631 (the "'631 Patent") and seeking preliminary and permanent injunctions to prevent the Company from continuing to infringe the '631 Patent.

Novartis also seeks a judgment of patent infringement of the '631 Patent, monetary damages (together with interest), an order of willful infringement of the '631 Patent (which would allow the court in its discretion to award damages up to three times the amount assessed), costs and expenses of the

lawsuits, and attorneys' fees.

On November 7, 2022, the Company and Novartis entered into a stipulation staying the lawsuit in light of the decision in the IPR proceeding discussed below.

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

On October 26, 2021, the USPTO issued a decision instituting the IPR proceeding.

An oral hearing was held on July 21, 2022.

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;

On December 23, 2022, Novartis filed a notice of appeal of the PTAB's decision to the Federal Circuit.

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").

The Company is also seeking injunctive relief and treble damages.

On September 4, 2020, Novartis filed, and Vetter moved to join, a motion to dismiss the complaint, to transfer the lawsuit to the Northern District of New York, or to stay the suit;

and on October 19, 2020, Novartis filed, and Vetter moved to join, a second motion to dismiss the complaint on different grounds.

On January 25, 2021, the Company filed an amended complaint seeking a judgment that Novartis's conduct violates Section 2 of the Sherman Antitrust Act based on additional grounds, as well as a judgment of tortious interference with contract.

On February 22, 2021, Novartis filed, and Vetter moved to join, a motion to dismiss the amended complaint.

On September 21, 2021, the court granted Novartis and Vetter's motion to transfer this lawsuit to the Northern District of New York.

As a result, this lawsuit was transferred to the same judge that had been assigned to the patent infringement lawsuit discussed above.

On November 5, 2021, the Company filed a motion to stay these proceedings in light of the pending IPR proceeding discussed above.

On January 31, 2022, the court denied the Company's motion to stay these proceedings and granted Novartis and Vetter's motion to dismiss the amended complaint.

On September 21, 2021, this lawsuit was transferred to the Northern District of New York.

On June 10, 2022, the Company filed an appeal of the District Court's decision to dismiss the amended complaint with the U.S.

Court of Appeals for the Second Circuit.

An oral hearing before the U.S.

Court of Appeals for the Second Circuit was held on October 11, 2023.

Court of Appeals for the Second Circuit (the "Second Circuit").

On March 18, 2024, the Second Circuit reversed the District Court's decision to dismiss the amended complaint and remanded the lawsuit to the District Court for further proceedings consistent with the Second Circuit's opinion.

On November 19, 2024, the Company moved to transfer the lawsuit back to the Southern District of New York, which motion was granted on December 5, 2024.

Proceedings Relating to Praluent (alirocumab) Injection

United States

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

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)

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("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.

10,221,221 (the "'221 Patent").

Allele seeks a judgment of patent infringement of the '221 Patent, an award of monetary damages (together with interest), an order of willful infringement of the '221 Patent (which would allow the court in its discretion to award damages up to three times the amount assessed), costs and expenses of the lawsuit, and attorneys' fees.

On July 16, 2021, the Company filed a motion to dismiss the complaint, which motion was denied on March 2, 2022.

On September 18, 2023, the parties entered into a stipulation that narrowed the case to (i) whether any safe harbor defense under federal law applies to Regeneron's use of the invention covered, based on the court's claim construction, by the '221 Patent;

(ii) damages for any use by Regeneron found to not be covered by such safe harbor defense;

and (iii) whether any use referred to in clause (ii) above was willful.

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

Department of Justice Matters

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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.

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

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.

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

Court of Appeals for the First Circuit certified for appeal the court's September 27, 2023 order.

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.

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.

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

On July 25, 2023, the court in part granted and in part denied the Company's motion to dismiss.

On July 25, 2023, the court granted in part and denied in part the Company's motion to dismiss.

On September 1, 2023, the Company filed a second motion to dismiss the amended complaint or, in the alternative, a motion for judgment on the pleadings.

A trial has been scheduled for April 2025.

On July 31, 2024 and August 15, 2024, respectively, the District Court granted the Company's second motion to dismiss the amended complaint with respect to the remaining causes of action under federal law and declined to exercise supplemental jurisdiction over the remaining causes of action under state law.

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

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

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

The Company is cooperating with this investigation.

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.

California Department of Insurance Subpoena

In September 2022, the Company received a subpoena from the Insurance Commissioner for the State of California pursuant to the California Insurance Code.

The subpoena seeks information relating to the marketing, sale, and distribution of EYLEA, including (i) discounts, rebates, credit card fees, and inventory management systems;

(ii) Regeneron's relationships with distributors;

(iii) price reporting;

(iv) speaker programs;

and (v) patient support programs.

The subpoena covers the period from January 1, 2014 through August 1, 2021.

The Company is cooperating with this investigation.

Proceedings Initiated by Other Payors Relating to Patient Assistance Organization Support

The Company is party to several lawsuits relating to the conduct alleged in the civil complaint filed by the U.S.

Attorney's Office for the District of Massachusetts discussed under "Department of Justice Matters" above.

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

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

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

Also on March 28, 2024, the U.S.

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

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

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

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

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

Proceedings Initiated by Other Payors

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

These lawsuits were filed by UnitedHealthcare Insurance Company and United Healthcare Services, Inc.

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District Court for the District of Massachusetts on December 20, 2021, February 23, 2022, April 4, 2022, and June 17, 2022, respectively.

These lawsuits allege causes of action under state law and the federal Racketeer Influenced and Corrupt Organizations Act and seek monetary damages and equitable relief.

These lawsuits allege causes of action under state law and the federal Racketeer Influenced and Corrupt Organizations Act ("RICO") and seek monetary damages and equitable relief.

The MMO and Local 464A lawsuits are putative class action lawsuits.

On December 29, 2021, the lawsuits filed by UHC and Humana were stayed by the United States District Court for the Southern District of New York pending resolution of the proceedings before the U.S.

District Court for the District of Massachusetts discussed under "Department of Justice Matters" above.

District Court for the District of Massachusetts concerning the allegations in the June 2020 Civil Complaint.

On September 27, 2022, the lawsuits filed by BCBS, MMO, and Horizon were stayed by the U.S.

District Court for the District of Massachusetts pending resolution of the proceedings before the same court discussed under "Department of Justice Matters" above;

District Court for the District of Massachusetts pending resolution of the proceedings before the same court concerning the allegations in the June 2020 Civil Complaint;

and, in light of these stays, the parties to the Local 464A action have also agreed to stay that matter.

Proceedings Relating to Shareholder Derivative Complaint

On June 29, 2021, an alleged shareholder filed a shareholder derivative complaint in the New York Supreme Court, naming the current and certain former 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 complaint asserts that the individual defendants breached their fiduciary duties in relation to the allegations in the civil complaint filed by the U.S.

Attorney's Office for the District of Massachusetts discussed under "Department of Justice Matters" above.

On June 24, 2024, a group of plaintiffs purporting to be assignees of claims by various Medicare Advantage plans and related entities filed a putative class action complaint in the U.S.

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

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

The lawsuit alleges causes of action under state law and RICO and seeks monetary damages and equitable relief.

On October 22, 2024, the Company filed a motion to transfer the proceedings to the U.S.

District Court for the District of Massachusetts or, in the alternative, to stay the proceedings or dismiss the proceedings.

On January 28, 2025, pursuant to a stipulation among the parties, the proceedings were transferred to the U.S.

District Court for the District of Massachusetts.

2021 Shareholder Derivative Complaint

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

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

The complaint seeks an award of damages allegedly sustained by the Company;

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District Court for the Southern District of New York denied the plaintiff's motion to remand the case and granted a motion to stay the case pending resolution of the proceedings before the U.S.

District Court for the District of Massachusetts discussed under "Department of Justice Matters" above.

District Court for the District of Massachusetts concerning the allegations in the June 2020 Civil Complaint.

As a result of the stay, the court also terminated the Company's motion to dismiss the complaint without prejudice.

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

Class Action Civil Complaint

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

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

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

2025 Shareholder Derivative Complaints

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

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

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

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

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

an order requiring the individual defendants to take all necessary actions to reform and improve the Company’s corporate governance and internal procedures;

and costs and disbursements of the applicable action, including attorneys' fees.

Sanofi Litigation

On November 18, 2024, the Company filed a lawsuit (as amended on December 20, 2024) in the United States District Court for the Southern District of New York against Sanofi and certain of its affiliated entities.

The lawsuit alleges that the defendants breached certain provisions of the parties' Amended and Restated License and Collaboration Agreement, dated as of November 10, 2009 (as amended, the "Collaboration Agreement"), concerning Sanofi's obligation to provide Regeneron with full access to material information relating to the commercialization of Dupixent or other products commercialized pursuant to the Collaboration Agreement and Regeneron's audit rights under the Collaboration Agreement.

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

Net Income Per Share

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Statement of Cash Flows

The following provides a reconciliation of cash, cash equivalents, and restricted cash reported within the Consolidated Balance Sheet to the total of the same such amounts shown in the Consolidated Statement of Cash Flows:

The following provides a reconciliation of cash, cash equivalents, and restricted cash reported within the Consolidated Balance Sheets to the total of the same such amounts shown in the Consolidated Statements of Cash Flows:

(In millions) 2024 2023 2022

Cash and cash equivalents $ 2,488.2 $ 2,730.0 $ 3,105.9

Restricted cash included in Other current assets

Restricted cash included in Other noncurrent assets

7.8 13.5 12.5

Total cash, cash equivalents, and restricted cash shown in the Consolidated Statement of Cash Flows

Total cash, cash equivalents, and restricted cash shown in the Consolidated Statements of Cash Flows

$ 2,489.0 $ 2,737.8 $ 3,119.4

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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