10-K – 2026-02-13 – amgn-20251231.htm

2. Segment and other information
We operate our business in one operating segment, which also represents one reportable segment: human therapeutics. Therefore, results of our operations are reported on a consolidated basis for purposes of segment reporting, consistent with internal management reporting.
The human therapeutics segment is engaged in the discovery, development, manufacturing and delivery of innovative medicines to fight some of the world’s toughest diseases. The Company’s Chief Executive Officer has been identified as the chief operating decision maker (CODM). The CODM manages and allocates resources on a consolidated basis. The determination of a single segment is consistent with the financial information regularly reviewed by the CODM for purposes of evaluating performance and allocating resources, which is reviewed on a consolidated basis.
As the Company’s CODM evaluates the financial performance of the Company’s human therapeutics segment on a consolidated basis, the measure of segment performance is net income, as reflected in the Consolidated Statements of Income. The CODM uses net income to allocate resources on a consolidated basis, which enables the CODM to assess both the overall level of resources available and optimize distribution of resources across functions, therapeutic areas, regions and R&D programs in line with our long-term corporate-wide strategic goals. In addition, the CODM may also evaluate financial performance based on net income adjusted for certain items that are unusual and non-recurring. As the Company manages its assets on a consolidated basis, the measure of segment assets is total assets, as reflected in the Consolidated Balance Sheets. See Note 10, Investments, for further information regarding equity method investments, and Net cash used in investing activities in the Consolidated Statements of Cash Flows for further information regarding capital expenditures.
F-14

The following table provides segment revenues, significant segment expenses, other segment items and reported segment net income for the Company’s one reportable segment, as well as a reconciliation of segment net income to the Company’s total consolidated net income for the years ended December 31, 2025, 2024 and 2023 (in millions):

Years ended December 31,
2025 2024 2023
Revenues:
Product sales $ 35,148   $ 32,026   $ 26,910  
Other revenues 1,603   1,398   1,280  
Total revenues 36,751   33,424   28,190  

Less:
Manufacturing cost of sales (1)(2)
9,845   11,118   7,347  
Profit share and royalties in cost of sales (1)
2,192   1,740   1,104  
Research and development (1)
7,272   5,964   4,784  
Sales and marketing (1)
4,590   4,713   3,784  
General and administrative (1)
2,460   2,383   2,395  
Other segment items (3)
( 931 ) 252   ( 729 )

Interest income
( 408 ) ( 510 ) ( 1,225 )
Interest expense, net 2,755   3,155   2,875  
Provision for income taxes
1,265   519   1,138  
Segment net income 7,711   4,090   6,717  
Reconciliation of profit or loss:

Adjustments and reconciling items —   —   —  
Consolidated net income $ 7,711   $ 4,090   $ 6,717  

____________
(1)     During the years ended December 31, 2025, 2024 and 2023, we recognized amortization expense on our intangible assets of $ 4.3 billion, $ 4.8 billion and $ 3.2 billion, respectively. Amortization of intangible assets is primarily included in Cost of sales in the Consolidated Statements of Income. In addition, during the years ended December 31, 2025, 2024 and 2023, we recognized depreciation and ROU asset amortization expense of $ 887 million, $ 805 million and $ 824 million, respectively.
(2)     During the years ended December 31, 2025, 2024 and 2023, manufacturing cost of sales included amortization of step-up to fair value of inventory acquired in business combinations of $ 1.3 billion, $ 2.4 billion and $ 656 million, respectively.
(3)     Other segment items included in Segment net income primarily consists of: (i) fair value adjustments on equity securities (see Note 10, Investments); (ii) net impairment charges on intangible assets (see Note 13, Goodwill and other intangible assets); and (iii) expenses related to restructuring and cost-savings initiatives.
F-15

3. Revenues
We operate our business in one operating segment, which also represents one reportable segment: human therapeutics. Therefore, results of our operations are reported on a consolidated basis for purposes of segment reporting, consistent with internal management reporting. Revenues by product and by geographic area, based on customers’ locations, are presented below. A substantial portion of ROW product sales relates to products sold in Europe.
Revenues were as follows (in millions):

Year ended December 31, 2025 Year ended December 31, 2024 Year ended December 31, 2023
U.S. ROW Total U.S. ROW Total U.S. ROW Total
Prolia $ 2,978   $ 1,436   $ 4,414   $ 2,885   $ 1,489   $ 4,374   $ 2,733   $ 1,315   $ 4,048  
Repatha
1,663   1,353   3,016   1,139   1,083   2,222   793   842   1,635  
Otezla 1,839   426   2,265   1,699   427   2,126   1,777   411   2,188  
ENBREL 2,199   27   2,226   3,288   28   3,316   3,650   47   3,697  
EVENITY 1,600   500   2,100   1,131   432   1,563   809   351   1,160  
XGEVA 1,355   729   2,084   1,507   718   2,225   1,527   585   2,112  
TEPEZZA (1)
1,758   145   1,903   1,835   16   1,851   441   7   448  
BLINCYTO 1,049   510   1,559   800   416   1,216   566   295   861  
Nplate 1,027   497   1,524   970   486   1,456   996   481   1,477  
TEZSPIRE (2)
1,478   —   1,478   972   —   972   567   —   567  
KYPROLIS 913   499   1,412   948   555   1,503   921   482   1,403  
Aranesp 416   973   1,389   386   956   1,342   452   910   1,362  
KRYSTEXXA (1)
1,340   —   1,340   1,185   —   1,185   272   —   272  
Vectibix 604   571   1,175   519   526   1,045   461   523   984  
Other products (3)
5,437   1,826   7,263   4,037   1,593   5,630   3,307   1,389   4,696  
Total product sales (4)
25,656   9,492   35,148   23,301   8,725   32,026   19,272   7,638   26,910  
Other revenues 763   840   1,603   562   836   1,398   534   746   1,280  
Total revenues $ 26,419   $ 10,332   $ 36,751   $ 23,863   $ 9,561   $ 33,424   $ 19,806   $ 8,384   $ 28,190  

____________
(1)     TEPEZZA and KRYSTEXXA were acquired from the acquisition of Horizon on October 6, 2023, and include product sales in the periods after the acquisition date.
(2)     TEZSPIRE is marketed by our collaborator AstraZeneca outside the United States.
(3)     Consists of product sales of our non-principal products.
(4)     Hedging gains and losses, which are included in product sales, were not material for the years ended December 31, 2025, 2024 and 2023.
In the United States, we sell primarily to pharmaceutical wholesale distributors that we use as the principal means of distributing our products to healthcare providers. Outside the United States, we sell principally to healthcare providers and/or pharmaceutical wholesale distributors depending on the distribution practice in each country. We monitor the financial condition of our larger customers and limit our credit exposure by setting credit limits and, in certain circumstances, by requiring letters of credit or obtaining credit insurance.
F-16

For each of the years ended December 31, 2025, 2024 and 2023, we had product sales to three customers that individually accounted for more than 10% of total revenues. For the year ended December 31, 2025, on a combined basis, these customers accounted for 77 % of total gross revenues as shown in the following table. Certain information with respect to these customers was as follows (dollar amounts in millions):

Years ended December 31,
2025 2024 2023
McKesson Corporation:
Gross product sales $ 26,253   $ 22,173   $ 19,035  
% of total gross revenues 34   % 33   % 33   %
Cencora, Inc.:

Gross product sales $ 20,986   $ 18,387   $ 16,625  
% of total gross revenues 27   % 27   % 29   %
Cardinal Health, Inc.:
Gross product sales $ 12,562   $ 11,278   $ 9,775  
% of total gross revenues 16   % 17   % 17   %

As of December 31, 2025 and 2024, amounts due from these three customers each exceeded 10% of gross trade receivables and accounted for 75 % and 70 %, respectively, of net trade receivables on a combined basis. As of December 31, 2025 and 2024, 21 % and 26 %, respectively, of net trade receivables were due from customers located outside the United States, the majority of which were from Europe. Our total allowance for doubtful accounts as of December 31, 2025 and 2024, was not material.
F-17

4. Acquisition
Acquisition of Horizon Therapeutics plc
On October 6, 2023, Amgen completed its acquisition of Horizon by acquiring all of the outstanding shares of Horizon for $ 116.50 per share in cash, representing a total consideration of approximately $ 27.8  billion. Horizon is a global biotechnology company focused on the discovery, development and commercialization of medicines that address critical needs of patients impacted by rare, autoimmune and severe inflammatory diseases. The acquisition, which was accounted for as a business combination, aligns with Amgen’s core strategy of delivering innovative medicines that make a significant difference for patients suffering from serious diseases and strengthens Amgen’s leading rare disease portfolio by adding first-in-class, early-in-lifecycle medicines, including TEPEZZA for TED, KRYSTEXXA for chronic refractory gout and UPLIZNA for neuromyelitis optica spectrum disorder. Upon its acquisition, Horizon became a wholly owned subsidiary of Amgen, and its operations have been included in our consolidated financial statements commencing on the acquisition date.
During the year ended December 31, 2024, the purchase price allocation of the acquisition was completed and measurement period adjustments were finalized, which included changes to the purchase price allocation that resulted in a net increase of approximately $ 25  million to goodwill. The measurement period adjustments resulted primarily from adjustments to acquired assets and liabilities, including deferred tax attributes, based on facts and circumstances that existed as of the acquisition date and did not result from events subsequent to the acquisition date. The adjustments did not have a significant impact on Amgen’s results of operations during the year ended December 31, 2024, and would not have had a significant impact on prior-period results if the adjustments had been made as of the acquisition date.
The following table summarizes the final total consideration and allocated acquisition date fair values of assets acquired and liabilities assumed, inclusive of measurement-period adjustments (in millions):

Cash and cash equivalents $ 681  
Inventories 5,014  
Property, plant and equipment, net 318  
Finite-lived intangible assets—developed-product-technology rights
19,590  
IPR&D 1,060  
Goodwill 3,136  
Deferred tax asset 795  
Deferred tax liability ( 2,488 )
Other assets and liabilities, net ( 273 )
Total assets acquired, net of liabilities assumed
$ 27,833  

The $ 27.8  billion total consideration for this transaction consisted of (i) cash consideration transferred to common shareholders of $ 26.7  billion; (ii) cash consideration transferred to vested and outstanding options, outstanding RSU awards and outstanding performance share unit awards of $ 523  million; (iii) fair value of Amgen replacement awards (based on conversion of outstanding employee RSU awards) of $ 180  million representing noncash consideration; and (iv) a portion of Horizon’s debt, settled by Amgen on the acquisition closing date, of $ 382  million. Amgen issued 1.7  million replacement equity awards with the original vesting conditions, the fair value of which was determined based on the acquisition date fair value based on the conversion calculation. See Note 5, Stock-based compensation.
The estimated fair values of $ 20.7  billion for the developed-product-technology rights and IPR&D intangible assets were determined using a multi-period excess earnings income approach that discounts expected future cash flows to present value by applying a discount rate that represents the estimated rate that market participants would use to value the intangible assets. The projected cash flows were based on certain assumptions attributable to the respective intangible asset, including estimates of future revenues and expenses, the time and resources needed to complete development and the probabilities of obtaining marketing approval from the FDA and other regulatory agencies. The developed-product-technology rights are being amortized on a straight-line basis over a weighted-average period of approximately 10 years from the acquisition date using the straight-line methodology.
F-18

The estimated fair value of the acquired inventory of $ 5.0  billion was determined using the comparative sales method, which uses actual or expected selling prices of inventory as the base amount to which adjustments for selling effort and a profit on the buyer’s effort are applied. The inventory fair value adjustment is being amortized using a weighted-average inventory turnover, which we estimate to approximate 27 months from the acquisition date.
A deferred tax liability of $ 2.5  billion was recognized on the temporary differences related to the book bases and tax bases of the acquired identifiable assets and assumed liabilities, primarily driven by the intangible assets acquired, as well as associated deferred tax asset for anticipatory foreign tax credits of $ 795  million.
The excess of the acquisition date consideration over the fair values assigned to the assets acquired and the liabilities assumed of $ 3.1  billion was recorded as goodwill, which is not deductible for tax purposes. The goodwill value represents expected synergies from the marketed products acquired and other benefits.
During the three months ended December 31, 2023, the Company incurred approximately $ 487  million of acquisition costs related to the closing of our Horizon acquisition, consisting of $ 167  million for share-based payments to settle non-vested equity awards attributable to post-combination services, severance and other employee-related expenses and $ 320  million for transaction costs. These costs were included primarily in SG&A expense in the Consolidated Statements of Income.
Supplemental Pro Forma Financial Information
The following table presents the unaudited supplemental pro forma results of a hypothetical combined Amgen and Horizon entity for the years ended December 31, 2023 and 2022, as if the acquisition of Horizon had occurred on January 1, 2022 (in millions):

Years ended December 31,
2023 2022
Total revenues
$ 30,969   $ 29,964  
Net income $ 5,383   $ 2,381  

The unaudited supplemental pro forma combined financial information was prepared using the acquisition method of accounting and was based on the historical financial information of Amgen and Horizon. In order to reflect the occurrence of the acquisition on January 1, 2022, the unaudited supplemental pro forma financial information includes adjustments to reflect: (i) incremental amortization expense based on the fair values of the identifiable intangible assets and inventory step-up; (ii) the additional interest expense associated with the issuance of debt to finance the acquisition; (iii) the reclassification of transaction and other acquisition-related costs incurred during the three months ended December 31, 2023, to the year ended December 31, 2022; and (iv) the income tax impact using an estimated effective tax rate applied to the combined entity. The unaudited supplemental pro forma financial information is not necessarily indicative of what the consolidated results of operations would have been had the acquisition been completed on January 1, 2022. In addition, the unaudited pro forma financial information is not a projection of future results of operations of the combined company, nor does it reflect the expected realization of any synergies or cost savings associated with the acquisition.
F-19

5. Stock-based compensation
Our Amended 2009 Plan authorizes for issuance to employees of Amgen and nonemployee members of our Board of Directors shares of our common stock pursuant to grants of equity-based awards, including RSUs, stock options and performance units. The pool of shares available under the Amended 2009 Plan is reduced by one share for each stock option granted and by 1.9 shares for other types of awards granted, including full-value awards. In general, if any shares subject to an award granted under the Amended 2009 Plan expire or become forfeited, terminated or canceled without the issuance of shares, the shares subject to such awards are added back into the authorized pool on the same basis that they were removed. In addition, under the Amended 2009 Plan, shares withheld to pay for minimum statutory tax obligations with respect to full-value awards are added back into the authorized pool on the basis of 1.9 shares. As of December 31, 2025, the Amended 2009 Plan provides for future grants and/or issuances of up to approximately 35 million shares of our common stock. Stock-based awards under our employee compensation plans are made with newly issued shares reserved for this purpose.
The following table reflects the components of stock-based compensation expense recognized in our Consolidated Statements of Income (in millions):

Years ended December 31,
2025 2024 2023
RSUs $ 333   $ 351   $ 309  
Performance units 112   133   121  
Stock options 49   46   43  
Total stock-based compensation expense, pretax 494   530   473  
Tax benefit from stock-based compensation expense ( 106 ) ( 114 ) ( 102 )
Total stock-based compensation expense, net of tax $ 388   $ 416   $ 371  

Restricted stock units and stock options
Eligible employees generally receive an annual grant of RSUs and, for certain executive-level employees, stock options, with the size and type of award generally determined by the employee’s salary grade and performance level. Certain management and professional-level employees typically receive RSU grants upon commencement of employment. Nonemployee members of our Board of Directors also receive an annual grant of RSUs.
Our RSU and stock option grants provide for accelerated or continued vesting in certain circumstances as defined in the plans and related grant agreements, including upon death, disability, termination in connection with a change in control and the retirement of employees who meet certain service and/or age requirements. For awards granted prior to April 1, 2025, RSUs and stock options generally vest in equal amounts on the second, third and fourth anniversaries of the grant date. Effective for awards granted on or after April 1, 2025, RSUs and stock options generally vest in equal amounts on the first, second, third and fourth anniversaries of the grant date. RSUs accrue dividend equivalents, which are typically payable in shares only when and to the extent the underlying RSUs vest and are issued to the recipient.
Restricted stock units
The grant date fair value of an RSU equals the closing price of our common stock on the grant date, as RSUs accrue dividend equivalents during their vesting period, except with respect to certain holders of Horizon unvested RSUs who were granted replacement Amgen RSUs in 2023 under the original terms of the awards in connection with the Horizon acquisition based on the terms of the transaction. See Note 4, Acquisition. Subsequent to the Horizon acquisition, $ 42  million of the RSUs were accelerated and cash settled in 2023. The weighted-average grant date fair values per unit of RSUs granted (excluding replacement awards granted to Horizon RSU holders) during the years ended December 31, 2025, 2024 and 2023, were $ 273.10 , $ 301.36 and $ 237.70 , respectively.
F-20

The following table summarizes information regarding our RSUs:

Year ended December 31, 2025
Units
(in millions) Weighted-average
grant date
fair value
Balance nonvested as of December 31, 2024
3.5   $ 265.07  
Granted 1.6   $ 273.10  
Vested ( 1.2 ) $ 243.73  
Forfeited ( 0.2 ) $ 277.14  
Balance nonvested as of December 31, 2025
3.7   $ 274.23  

The total grant date fair values of RSUs that vested during the years ended December 31, 2025, 2024 and 2023, were $ 283 million, $ 401 million and $ 309 million, respectively.
Stock options
The exercise price of stock options is set as the closing price of our common stock on the grant date, and the related number of shares granted is fixed at that point in time. Awards expire 10 years from the date of grant. We use the Black–Scholes option valuation model to estimate the grant date fair value of stock options.
The weighted-average assumptions used in the option valuation model and the resulting weighted-average grant date fair values of stock options granted were as follows:

Years ended December 31,
2025 2024 2023
Closing price of our common stock on grant date $ 270.44 $ 300.30   $ 235.97  
Expected volatility (average of implied and historical volatility) 27.8   % 26.9   % 23.3   %
Expected life (in years) 5.7 5.7 5.7
Risk-free interest rate 4.0   % 4.4   % 3.4   %
Expected dividend yield 3.2   % 3.2   % 3.5   %
Fair value of stock options granted $ 62.76 $ 69.34   $ 41.86  

The following table summarizes information regarding our stock options:

Year ended December 31, 2025
Options
(in millions) Weighted-
average
exercise price Weighted-
average
remaining
contractual
life (in years) Aggregate
intrinsic
value
(in millions)
Balance unexercised as of December 31, 2024
5.9   $ 225.84  
Granted 0.9   $ 270.44  
Exercised ( 0.6 ) $ 202.34  
Expired/forfeited ( 0.1 ) $ 258.80  
Balance unexercised as of December 31, 2025
6.1   $ 234.45   6.0 $ 563  
Vested or expected to vest as of December 31, 2025
5.9   $ 233.42   5.9 $ 555  
Exercisable as of December 31, 2025
3.5   $ 211.48   4.4 $ 401  

The total intrinsic values of options exercised during the years ended December 31, 2025, 2024 and 2023, were $ 70 million, $ 70 million and $ 33 million, respectively. The actual tax benefits realized from tax deductions from option exercises during the years ended December 31, 2025, 2024 and 2023, were $ 15 million, $ 15 million and $ 7 million, respectively.
As of December 31, 2025, $ 537 million of unrecognized compensation cost was related to nonvested RSUs and unvested stock options, which is expected to be recognized over a weighted-average period of 1.7 years.
F-21

Performance units
Certain management-level employees also receive annual grants of performance units, which give the recipient the right to receive common stock that is contingent upon achievement of specified preestablished goals over the performance period, which is generally three years . The performance goals for the units granted during the years ended December 31, 2025, 2024 and 2023, which are accounted for as equity awards, are based on (i) Amgen’s total stockholder return compared with a comparator group of companies, which are considered market conditions and are therefore reflected in the grant date fair values of the units, and (ii) Amgen’s stand-alone financial performance measures, which are considered performance conditions. The expense recognized for awards is based on the grant date fair value of a unit multiplied by the number of units expected to be earned with respect to the related performance conditions, net of estimated forfeitures. Depending on the outcome of these performance goals, a recipient may ultimately earn a number of units greater or less than the number of units granted. Shares of our common stock are issued on a one -for-one basis for each performance unit earned. In general, performance unit awards vest at the end of the performance period. The performance award program provides for accelerated or continued vesting in certain circumstances as defined in the plan, including upon death, disability, a change in control and retirement of employees who meet certain service and/or age requirements. Performance units accrue dividend equivalents that are typically payable in shares only when and to the extent the underlying performance units vest and are issued to the recipient, including with respect to market and performance conditions that affect the number of performance units earned.
We use a payout simulation model to estimate the grant date fair value of performance units. The weighted-average assumptions used in the payout simulation model and the resulting weighted-average grant date fair values of performance units granted were as follows:

Years ended December 31,
2025 2024 2023
Closing price of our common stock on grant date $ 270.44   $ 300.30   $ 235.97  
Volatility 24.2   % 22.1   % 21.6   %
Risk-free interest rate 3.7   % 4.6   % 3.7   %
Fair value of units granted $ 290.24   $ 321.61   $ 252.49  

The payout simulation model assumes correlations of returns of the stock prices of our common stock and the common stocks of the comparator groups of companies and stock price volatilities of the comparator groups of companies to simulate stockholder returns over the performance periods and their resulting impact on the payout percentages based on the contractual terms of the performance units.
As of December 31, 2025 and 2024, 1.2 million and 1.4 million performance units were outstanding, respectively, with weighted-average grant date fair values per unit of $ 278.62 and $ 263.86 per unit, respectively. During the year ended December 31, 2025, 0.3 million performance units with a weighted-average grant date fair value per unit of $ 290.24 were granted, and 0.1 million performance units with a weighted-average grant date fair value per unit of $ 278.87 were forfeited.
The total fair values of performance units paid during the years ended December 31, 2025, 2024 and 2023, were $ 163 million, $ 182 million and $ 109 million, respectively, based on the number of performance units earned multiplied by the closing stock price of our common stock on the last day of the performance period.
As of December 31, 2025, $ 64 million of unrecognized compensation cost was related to nonvested performance units, which is expected to be recognized over a weighted-average period of one year .

6. Defined contribution plan
The Company has defined contribution plans to which certain employees of the Company and participating subsidiaries may defer compensation for income tax purposes. Participants are eligible to receive matching contributions based on their contributions, in addition to other Company contributions. Defined contribution plan expenses were $ 407  million, $ 375 million and $ 311 million for the years ended December 31, 2025, 2024 and 2023, respectively.

F-22

7. Income taxes
Income before income taxes included the following (in millions):

Years ended December 31,
2025 2024 2023
Domestic $ 8,220   $ 4,040   $ 4,047  
Foreign 756   569   3,808  
Total income before income taxes $ 8,976   $ 4,609   $ 7,855  

The provision for income taxes included the following (in millions):

Years ended December 31,
2025 2024 2023
Current provision:
Federal $ 959   $ 965   $ 1,524  
State 35   33   43  
Foreign 971   759   786  
Total current provision 1,965   1,757   2,353  
Deferred benefit:
Federal ( 465 ) ( 860 ) ( 1,124 )
State 7   ( 18 ) ( 25 )
Foreign ( 242 ) ( 360 ) ( 66 )
Total deferred benefit ( 700 ) ( 1,238 ) ( 1,215 )
Total provision for income taxes $ 1,265   $ 519   $ 1,138  

F-23

Deferred income taxes reflect the tax effect of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes, tax credit carryforwards and the tax effects of NOL carryforwards. As of December 31, 2022, we elected to establish deferred taxes with respect to the U.S. tax on the earnings of our foreign subsidiaries for the reversal of temporary items in future years. Significant components of our deferred tax assets and liabilities were as follows (in millions):

December 31,
2025 2024
Deferred income tax assets:
NOL and credit carryforwards $ 1,368   $ 1,352  
Accrued expenses 890   693  
Capitalized research and development expenses 1,655   1,762  
Investments —   1  
Expenses capitalized for tax 218   200  
Earnings of foreign subsidiaries 2,305   1,496  
Stock-based compensation 138   130  
Other 349   361  
Total deferred income tax assets 6,923   5,995  
Valuation allowance ( 1,299 ) ( 1,019 )
Net deferred income tax assets 5,624   4,976  

Deferred income tax liabilities:
Acquired intangible assets ( 2,065 ) ( 2,573 )
Debt ( 260 ) ( 264 )
Fixed assets ( 192 ) ( 143 )
Fair value of acquired inventory
( 28 ) ( 114 )
Investments
( 422 ) —  
Other ( 271 ) ( 244 )
Total deferred income tax liabilities ( 3,238 ) ( 3,338 )
Total deferred income taxes, net $ 2,386   $ 1,638  

The Company has determined that unremitted foreign earnings are not considered indefinitely reinvested to the extent foreign earnings can be distributed without a significant tax cost.
Valuation allowances are provided to reduce the amounts of our deferred tax assets to an amount that is more likely than not to be realized based on an assessment of positive and negative evidence, including estimates of future taxable income necessary to realize future deductible amounts.
The valuation allowance increased in 2025, primarily driven by the Company’s expectation that certain foreign amortization deductions are expected to expire unutilized.
As of December 31, 2025, we had $ 109 million of federal tax credit carryforwards available to reduce future federal income taxes and have provided a $ 31 million valuation allowance on those federal tax credit carryforwards. The federal tax credit carryforwards expire between 2032 and 2041. We had $ 1.3 billion of state tax credit carryforwards available to reduce future state income taxes and have provided a valuation allowance for $ 1.2 billion of those state tax credit carryforwards. We had $ 148  million of tax credit carryforwards related to our foreign jurisdictions available to offset future foreign income taxes for which we have provided a $ 123  million valuation allowance.
As of December 31, 2025, we had $ 34 million of federal NOL carryforwards available to reduce future federal income taxes and have provided no valuation allowance on those federal NOL carryforwards. Additionally, $ 12  million of those federal NOL carryforwards have no expiration; the remainder begin to expire between 2027 and 2033. We had $ 971 million of state NOL carryforwards available to reduce future state income taxes and have provided a valuation allowance for $ 836  million of those state NOL carryforwards. We had $ 1.4 billion of foreign NOL carryforwards available to reduce future foreign income
F-24

taxes and have provided a valuation allowance for $ 239 million of those foreign NOL carryforwards. For the foreign NOLs with no valuation allowance provided, $ 120 million have no expiration; and the remainder will expire between 2026 and 2034.
The reconciliations of the total gross amounts of UTBs were as follows (in millions):

Years ended December 31,
2025 2024 2023
Beginning balance $ 4,184   $ 4,012   $ 3,770  
Additions based on tax positions related to the current year 190   188   196  
Additions based on tax positions related to prior years 14   9   56  
Reductions for tax positions of prior years ( 13 ) ( 12 ) —  
Reductions for expiration of statute of limitations —   ( 9 ) ( 4 )
Settlements ( 4 ) ( 4 ) ( 6 )
Ending balance $ 4,371   $ 4,184   $ 4,012  

Substantially all of the UTBs as of December 31, 2025, if recognized, would affect our effective tax rate. As a result, we remeasured our UTBs accordingly.
Interest and penalties related to UTBs are included in our provision for income taxes. During the years ended December 31, 2025, 2024 and 2023, we recognized $ 264 million, $ 282 million and $ 287 million, respectively, of interest and penalties through the income tax provision in the Consolidated Statements of Income. The decrease in interest expense for the year ended December 31, 2025, was primarily due to lower interest rates in 2025 compared to those in 2024. As of December 31, 2025 and 2024, accrued interest and penalties associated with UTBs were $ 1.9 billion and $ 1.6 billion, respectively.
F-25

The reconciliations between the federal statutory tax rate applied to income before income taxes and our effective tax rate for 2025 were as follows (in millions, except percentages):

Year ended December 31, 2025
Tax Effect
Effective Tax Rate

Federal statutory tax rate
$ 1,885   21.0   %
Foreign tax effects:

Ireland:

Tax rate differential
316   3.5   %
Valuation allowance
119   1.3   %
Other
22   0.2   %
Puerto Rico:

Tax rate differential
469   5.2   %
Act 52 - withholding tax
456   5.1   %
Act 52 - income tax
( 968 ) ( 10.8 ) %
Singapore:

Tax incentive grant
( 122 ) ( 1.4 ) %
Pillar Two minimum tax 147   1.6   %
Other
( 29 ) ( 0.3 ) %
Other foreign jurisdictions
199   2.2   %
Effect of cross-border tax laws:

U.S. tax on foreign subsidiaries (net of credits and deferred taxes)
( 545 ) ( 6.0 ) %
Foreign-derived intangible income
( 222 ) ( 2.5 ) %
Other
( 18 ) ( 0.2 ) %
Tax credits:

Credit on foreign taxes imposed on U.S. income
( 456 ) ( 5.0 ) %
Research and development tax credits
( 272 ) ( 3.0 ) %
Other adjustments
86   1.0   %
Changes in unrecognized tax benefits (primarily interest)
198   2.2   %
Effective tax rate
$ 1,265   14.1   %

The reconciliations between the federal statutory tax rate applied to income before income taxes and our effective tax rate for 2024 and 2023 were as follows:

Years ended December 31,
2024 2023
Federal statutory tax rate 21.0   % 21.0   %
Foreign earnings ( 5.8 ) % ( 5.1 ) %
Foreign-derived intangible income ( 3.0 ) % ( 1.3 ) %
Credits, Puerto Rico excise tax —   % 0.3   %

Interest on uncertain tax positions 4.2   % 2.6   %
Credits, primarily federal R&D ( 5.4 ) % ( 3.5 ) %

Other, net 0.3   % 0.5   %
Effective tax rate 11.3   % 14.5   %

The effective tax rates for the years ended December 31, 2025, 2024 and 2023, differ from the federal statutory rate primarily due to impacts of the jurisdictional mix of income and expenses. Substantially all of the benefit to our effective tax rate from foreign earnings results from locations in which the Company has significant manufacturing operations, including Singapore, Ireland and Puerto Rico, a territory of the United States that is treated as a foreign jurisdiction for U.S. tax purposes. Our operations in Puerto Rico are subject to tax incentive grants through 2050 and the Company’s operations in Singapore are
F-26

subject to a tax incentive grant through 2036. Effective January 1, 2024, selected individual countries, including the United Kingdom and EU member countries, have enacted the global minimum tax agreement. Additional countries, including Singapore, enacted the minimum tax agreement effective January 1, 2025. Singapore’s enactment of the agreement applies irrespective of the Company’s incentive grant. Due to the currently enacted scope of the agreement, the Company and its subsidiaries are now subject to a 15% minimum tax rate on adjusted financial statement income. Our foreign earnings are also subject to U.S. tax at a reduced rate of 10.5%.
Income taxes paid (net of refunds received) included the following (in millions):

Year ended December 31, 2025
U.S. payments (federal and state) $ 3,390  
Puerto Rico payments 610  
Other foreign payments 300  
Total income taxes paid (net of refunds received) $ 4,300  

Income taxes paid (net of refunds received) during the years ended December 31, 2024 and 2023, were $ 2.9 billion and $ 3.4 billion, respectively.
On July 4, 2025, OB3 was enacted in the United States. OB3 has various provisions, including the permanent extension of certain expiring provisions of the 2017 Tax Act, and modifications to the international tax framework. The legislation has multiple effective dates, with certain provisions effective in 2026 and beyond. The impact of these changes was recorded in 2025.
One or more of our legal entities file income tax returns in the U.S. federal jurisdiction, various U.S. state jurisdictions and certain foreign jurisdictions. Our income tax returns are routinely examined by tax authorities in those jurisdictions. Significant disputes can arise and have arisen with tax authorities involving issues regarding the timing and amount of deductions, the use of tax credits and allocations of income and expenses among various tax jurisdictions because of differing interpretations of tax laws, regulations and relevant facts. Tax authorities, including the IRS, are becoming more aggressive and are particularly focused on such matters.
In 2017, we received an RAR and a modified RAR from the IRS for the years 2010–2012, proposing significant adjustments that primarily relate to the allocation of profits between certain of our entities in the United States and the U.S. territory of Puerto Rico. We disagreed with the proposed adjustments and calculations, and in 2021, filed a petition in the U.S. Tax Court to contest two duplicate Statutory Notices of Deficiency (Notices) for the years 2010–2012. The Notices seek to increase our U.S. taxable income for the years 2010–2012 by an amount that would result in additional federal tax of approximately $ 3.6  billion plus interest. Any additional tax that could be imposed for the years 2010–2012 would be reduced by up to approximately $ 900  million of repatriation tax previously accrued and paid on our foreign earnings.
In 2020, we received an RAR and a modified RAR from the IRS for the years 2013–2015, also proposing significant adjustments that primarily relate to the allocation of profits between certain of our entities in the United States and the U.S. territory of Puerto Rico similar to those proposed for the years 2010–2012. We disagreed with the proposed adjustments and calculations, and in 2022, filed a petition in the U.S. Tax Court to contest a Notice for the years 2013–2015. The Notice seeks to increase our U.S. taxable income for the years 2013–2015 by an amount that would result in additional federal tax of approximately $ 5.1  billion, plus interest, and asserts penalties of approximately $ 2.0  billion. Any additional tax that could be imposed for the years 2013–2015 would be reduced by up to approximately $ 2.2  billion of repatriation tax previously accrued and paid on our foreign earnings.
We firmly believe that the IRS positions set forth in the 2010–2012 and 2013–2015 Notices are without merit. We continue to contest the 2010–2012 and 2013–2015 Notices through the judicial process. The two cases were consolidated in the U.S. Tax Court in 2022. The trial began on November 4, 2024 and concluded on January 17, 2025. The parties filed opening post-trial briefs on June 13, 2025, and the Court held oral argument on July 16, 2025. The parties filed post-trial reply briefs on October 10, 2025. The Company expects a decision from the U.S. Tax Court no earlier than the second half of 2026.
We are currently under examination by the IRS for the years 2016–2018 with respect to issues similar to those for the 2010 through 2015 period. We expect that the IRS will begin its audit of 2019-2022 in the first half of 2026, and we believe that it may seek to continue to audit similar issues related to the allocation of income between the United States and our foreign jurisdictions. In addition, we are under examination by a number of state and foreign tax jurisdictions.
Final resolution of these complex matters is not likely within the next 12 months. We continue to believe our accrual for income tax liabilities is appropriate based on past experience, interpretations of tax law, application of the tax law to our facts
F-27

and judgments about potential actions by tax authorities; however, due to the complexity of the provision for income taxes and uncertain resolution of these matters, the ultimate outcome of any tax matters may result in payments substantially greater than amounts accrued and could have a material adverse impact on our consolidated financial statements.
We are no longer subject to U.S. federal income tax examinations for years ended on or before December 31, 2009.

8. Earnings per share
The computation of basic EPS is based on the weighted-average number of our common shares outstanding. The computation of diluted EPS is based on the weighted-average number of our common shares outstanding and dilutive potential common shares, which primarily include shares that may be issued under our stock option, restricted stock and performance unit award programs (collectively, dilutive securities), as determined by using the treasury stock method.
The computations for basic and diluted earnings per share were as follows (in millions, except per-share data):

Years ended December 31,
2025 2024 2023
Income (Numerator):
Net income for basic and diluted earnings per share $ 7,711   $ 4,090   $ 6,717  

Shares (Denominator):
Weighted-average shares for basic earnings per share 538   537   535  
Effect of dilutive securities 4   4   3  
Weighted-average shares for diluted earnings per share 542   541   538  

Basic earnings per share $ 14.33   $ 7.62   $ 12.56  
Diluted earnings per share $ 14.23   $ 7.56   $ 12.49  

For each of the three years ended December 31, 2025, the number of antidilutive employee stock-based awards excluded from the computation of diluted EPS was not significant.

9. Collaborations
A collaborative arrangement is a contractual arrangement that involves a joint operating activity. Such arrangements involve two or more parties that are both (i) active participants in the activity and (ii) exposed to significant risks and rewards dependent on the commercial success of the activity.
From time to time, we enter into collaborative arrangements for the R&D, manufacture and/or commercialization of products and/or product candidates. These collaborations generally provide for nonrefundable upfront license fees, development and commercial-performance milestone payments, cost sharing, royalties and/or profit sharing. Our collaboration arrangements are performed with no guarantee of either technological or commercial success, and each arrangement is unique in nature. See Note 1, Summary of significant accounting policies, for additional discussion of revenues recognized under these types of arrangements. Operating expenses for costs incurred pursuant to these arrangements are reported in their respective expense line items in the Consolidated Statements of Income, net of any payments due to or reimbursements due from our collaboration partners, with such reimbursements being recognized at the time the party becomes obligated to pay. Our significant arrangements are discussed below.
AstraZeneca plc
We are in a collaboration with AstraZeneca for the development and commercialization of TEZSPIRE. Under our collaboration, both companies share global costs, profits and losses equally after payment by AstraZeneca of a mid-single-digit royalty to Amgen. AstraZeneca leads global development. In North America, Amgen, as the principal, recognizes product sales of TEZSPIRE in the United States, and AstraZeneca, as the principal, recognizes product sales of TEZSPIRE in Canada. AstraZeneca leads commercialization for TEZSPIRE outside North America. Amgen manufactures and supplies TEZSPIRE worldwide.
During the years ended December 31, 2025, 2024 and 2023, global profit and loss share expenses were $ 587  million, $ 412  million and $ 310 million, respectively, and were recorded primarily in Cost of sales in the Consolidated Statements of
F-28

Income. Net costs due to AstraZeneca for global development and commercialization were not material during the years ended December 31, 2025, 2024 and 2023.
UCB
We are in a collaboration with UCB for the development and commercialization of EVENITY. Under our collaboration, UCB has rights to lead commercialization for EVENITY in most countries in Europe. Amgen, as the principal, leads commercialization for EVENITY and recognizes product sales in all other territories, including the United States. Global development costs and commercialization profits and losses related to the collaboration are shared equally. Amgen manufactures and supplies EVENITY worldwide.
During the years ended December 31, 2025, 2024 and 2023, global profit and loss share expenses were $ 721  million, $ 547 million and $ 396 million, respectively, and were recorded primarily in Cost of sales in the Consolidated Statements of Income. Net costs recovered from and due to UCB during the years ended December 31, 2025, 2024 and 2023, were not material.
BeOne Medicines Ltd.
In January 2020, we acquired an equity stake in BeOne for approximately $ 2.8  billion in cash as part of a collaboration agreement to expand our oncology presence in China. For additional information regarding our equity investment in BeOne, see Note 10, Investments. Under the collaboration, BeOne began selling XGEVA in 2020, BLINCYTO in 2021 and KYPROLIS in 2022 in China, and Amgen shares profits and losses equally during the product-specific commercialization periods. Following entry into an amendment by Amgen and BeOne on November 11, 2025, BeOne will retain the right to commercialize XGEVA, BLINCYTO and KYPROLIS in China for so long as such products are sold in China. Amgen manufactures and supplies the collaboration products to BeOne.
In addition, we jointly develop a portion of our oncology portfolio with BeOne, which shares in global R&D costs by providing cash and development services of up to $ 1.25  billion. Upon regulatory approval, BeOne will assume commercialization rights in China for a specified period, and Amgen and BeOne will share profits and losses equally until certain of these product rights revert to Amgen. Upon return of the product rights, Amgen will pay royalties to BeOne on sales in China for a specified period. For product sales outside China, Amgen also pays royalties to BeOne.
During the years ended December 31, 2025, 2024 and 2023, net costs recovered from BeOne for oncology product candidates were $ 181  million, $ 122  million and $ 109  million, respectively, and were recorded as an offset to R&D expense in the Consolidated Statements of Income. During the years ended December 31, 2025, 2024 and 2023, product sales from Amgen to BeOne under the collaboration were $ 266  million, $ 259  million and $ 125  million, respectively, and were recorded in Product sales in the Consolidated Statements of Income. Profit and loss share expenses related to the product-specific commercialization period were not material during the years ended December 31, 2025, 2024 and 2023. Royalties on product sales of oncology portfolio products outside of China were not material for the years ended December 31, 2025, 2024 and 2023.
Kyowa Kirin Co., Ltd.
Since 2021, we have been in a collaboration agreement with Kyowa Kirin to jointly develop and commercialize rocatinlimab, an anti-OX40 fully human monoclonal antibody, worldwide, except in Japan. Rocatinlimab is for the treatment of atopic dermatitis, with potential for treatment of other autoimmune diseases.
Amgen and Kyowa Kirin share equally the global development costs, except in Japan, and the U.S. commercialization costs. Outside the United States and Japan, any commercialization costs incurred by Kyowa Kirin will be reimbursed by Amgen. We may also be required to make milestone payments of up to $ 850  million contingent upon the achievement of certain regulatory events and commercial thresholds. We will also pay Kyowa Kirin significant double-digit royalties on global sales, except in Japan.
In January 2026, we and Kyowa Kirin agreed to terminate the rocatinlimab collaboration agreement and to transition control of the global development and commercialization program to Kyowa Kirin, subject to receipt of clearance under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. In February 2026, we received such regulatory clearance. In the first quarter of 2026, Kyowa Kirin will assume full responsibility for rocatinlimab worldwide, except that Amgen will continue to manufacture rocatinlimab and perform other transition activities for an agreed upon period of time.
During the years ended December 31, 2025, 2024 and 2023, net costs recovered from Kyowa Kirin were $ 117  million, $ 166  million and $ 93  million, respectively, and were recorded as an offset to R&D expense in the Consolidated Statements of Income.

F-29

Other
In addition to the collaborations discussed above, we have various other collaborations that are not individually significant to our business at this time. Pursuant to the terms of those agreements, we may be required to pay additional amounts, or we may receive additional amounts upon the achievement of various development and commercial milestones that in the aggregate could be significant. We may also incur or have reimbursed to us significant R&D costs if a related product candidate were to advance to late-stage clinical trials. In addition, if any products related to these collaborations are approved for sale, we may be required to pay significant royalties, or we may receive significant royalties on future sales. The payments of these amounts, however, are contingent upon the occurrence of various future events that have high degrees of uncertainty of occurrence.

10. Investments
Available-for-sale investments
The amortized cost, gross unrealized gains, gross unrealized losses and fair values of interest-bearing securities, which are classified as available for sale, by type of security were as follows (in millions):

Types of securities as of December 31, 2025 Amortized
cost Gross
unrealized
gains Gross
unrealized
losses Fair
values

U.S. Treasury bills $ 998   $ —   $ —   $ 998  

Money market mutual funds 7,395   —   —   7,395  
Other short-term interest-bearing securities 132   —   —   132  
Total available-for-sale investments $ 8,525   $ —   $ —   $ 8,525  

Types of securities as of December 31, 2024 Amortized
cost Gross
unrealized
gains Gross
unrealized
losses Fair
values

U.S. Treasury bills $ 997   $ —   $ —   $ 997  

Money market mutual funds 10,354   —   —   10,354  
Other short-term interest-bearing securities 135   —   —   135  

Total available-for-sale investments $ 11,486   $ —   $ —   $ 11,486  

The fair values of available-for-sale investments by location in the Consolidated Balance Sheets were as follows (in millions):

December 31,
Consolidated Balance Sheets locations 2025 2024
Cash and cash equivalents $ 8,525   $ 11,486  

Total available-for-sale investments $ 8,525   $ 11,486  

Cash and cash equivalents in the above table excludes bank account cash of $ 604 million and $ 487 million as of December 31, 2025 and 2024, respectively.
All interest-bearing securities as of December 31, 2025 and 2024, mature in one year or less. For the years ended December 31, 2025, 2024 and 2023, interest income on these investments was $ 408  million, $ 510  million and $ 1.2 billion, respectively.
For the years ended December 31, 2025, 2024 and 2023, realized gains and losses on interest-bearing securities were not material and were recorded in Other income, net, in the Consolidated Statements of Income. The cost of securities sold is based on the specific-identification method.
The primary objective of our investment portfolio is to maintain safety of principal, prudent levels of liquidity and acceptable levels of risk. Our investment policy limits interest-bearing security investments to certain types of debt and money market instruments issued by institutions with investment-grade credit ratings, and it places restrictions on maturities and concentration by asset class and issuer.
F-30

Equity securities
BeOne Medicines Ltd.
As of December 31, 2025 and 2024, our ownership interest in BeOne was approximately 17.1 % and 17.8 %, respectively, and the fair values of our investment were $ 5.8 billion and $ 3.5 billion, respectively, which were included in Other noncurrent assets in the Consolidated Balance Sheets. We account for our ownership interest as an equity security with a readily determinable fair value, which is carried at fair value with changes in fair value recorded in Other income, net, in the Consolidated Statements of Income. See Note 18, Fair value measurement. During the years ended December 31, 2025, 2024 and 2023, we recognized unrealized gains of $ 2.3 billion, $ 82  million, and $ 1.2 billion respectively, in Other income, net, in the Consolidated Statements of Income. For information on a collaboration agreement we entered into with BeOne in connection with this investment, see Note 9, Collaborations.
Subject to certain exceptions or otherwise agreed to by BeOne, while Amgen holds at least 5.0 % of BeOne’s outstanding common stock, (A) we may only sell our BeOne equity investment via: (i) a registered public offering, (ii) a sale under Rule 144 of the Securities Act of 1933 (the “Securities Act”) or (iii) a private sale exempt from registration requirements under the Securities Act, and (B) we may not sell more than 5.0 % of BeOne’s outstanding common stock in any rolling 12-month period.
Other equity securities
Excluding our equity investments in BeOne (discussed above) and Neumora (discussed below), we held investments in other equity securities with readily determinable fair values (publicly traded securities) of $ 326 million and $ 314  million as of December 31, 2025 and 2024, respectively, which were included in Other noncurrent assets in the Consolidated Balance Sheets. For the years ended December 31, 2025, 2024 and 2023, net unrealized gains and losses on publicly traded securities resulted in a net gain of $ 109 million , a net loss of $ 21 million and a net gain of $ 98 million , respectively. Realized gains and losses on publicly traded securities for the years ended December 31, 2025, 2024 and 2023, were not material.
We held investments of $ 362 million and $ 319 million in equity securities without readily determinable fair values as of December 31, 2025 and 2024, respectively, which were included in Other noncurrent ass ets in the Consolidated Balance Sheets. For the years ended December 31, 2025, 2024 and 2023 , gains due to upward adjustments and gains realized upon dispositions of these securities were not material. For the years ended December 31, 2025, 2024 and 2023 downward adjustments were not material. Adjustments were based on observable price transactions.
Equity Method Investments
Neumora Therapeutics, Inc.
As of December 31, 2025 and 2024, our ownership interest in Neumora was approximately 21.2 % and 21.9 %, respectively, and the fair values of our investment were $ 63 million and $ 375 million, respectively, which were included in Other noncurrent assets in the Consolidated Balance Sheets. Although our equity investment qualifies us for the equity method of accounting, we have elected the fair value option to account for our investment. See Note 18, Fair value measurement. Under the fair value option, changes in the fair value of the investment are recognized through earnings in Other income, net, in the Consolidated Statements of Income each reporting period. We believe the fair value option best reflects the economics of the underlying transaction. During the years ended December 31, 2025, 2024 and 2023 , we recognized unrealized losses of $ 312 million and $ 228 million and an unrealized gain of $ 238 million, respectively, for the change in fair values in Other income, net, in the Consolidated Statements of Income.
We are contractually restricted from selling more than 5.0 % of Neumora’s outstanding common stock in any rolling 12-month period for as long as we hold at least 10.0 % of their outstanding common stock, subject to certain exceptions or otherwise agreed to by Neumora.
Limited partnerships
We held limited partnership investments of $ 253 million and $ 262 million as of December 31, 2025 and 2024, respectively, which were included in Other noncurrent assets in the Consolidated Balance Sheets. These investments, which are primarily investment funds of early-stage biotechnology companies, are accounted for by using the equity method of accounting and are measured by using our proportionate share of the net asset values of the underlying investments held by the limited partnerships as a practical expedient. These investments are typically redeemable only through distributions upon liquidation of the underlying assets. As of December 31, 2025, we had $ 134 million of unfunded additional commitments to be made for these investments during the next several years. For the years ended December 31, 2025, 2024 and 2023, net gains and losses recognized from our limited partnership investments were not material.

F-31

11. Inventories
Inventories consisted of the following (in millions):

December 31,
2025 2024
Raw materials $ 915   $ 818  
Work in process 3,425   4,120  
Finished goods 1,885   2,060  
Total inventories
$ 6,225   $ 6,998  

12. Property, plant and equipment
Property, plant and equipment consisted of the following (dollar amounts in millions):

December 31,
Useful life (in years) 2025 2024
Land — $ 348   $ 346  
Buildings and improvements 10 - 40
4,932   4,803  
Manufacturing equipment 8 - 12
3,589   3,291  
Laboratory equipment 8 - 12
1,438   1,345  
Fixed equipment 12 2,668   2,592  
Capitalized software 3 - 5
1,554   1,442  
Other 5 - 10
1,114   1,059  
Construction in progress — 3,390   2,053  
Property, plant and equipment, gross 19,033   16,931  
Less accumulated depreciation and amortization ( 11,120 ) ( 10,388 )
Property, plant and equipment, net $ 7,913   $ 6,543  

During the years ended December 31, 2025, 2024 and 2023, we recognized depreciation and amortization expense associated with our property, plant and equipment of $ 763 million, $ 694 million and $ 685 million, respectively.
Geographic information
Certain geographic information with respect to property, plant and equipment, net, was as follows (in millions):

  December 31,
  2025 2024
U.S. $ 5,188   $ 4,156  
Puerto Rico 1,273   1,174  
ROW 1,452   1,213  
Total property, plant and equipment, net $ 7,913   $ 6,543  

F-32

13. Goodwill and other intangible assets
Goodwill
The changes in the carrying amounts of goodwill were as follows (in millions):

December 31,
2025 2024
Beginning balance $ 18,637   $ 18,629  
Changes to goodwill resulting from acquisitions, net (1)
—   25  
Foreign currency translation adjustments
43   ( 17 )
Ending balance $ 18,680   $ 18,637  

____________
(1)     For 2024, changes to Goodwill consisted of measurement-period adjustments related to our Horizon acquisition.
Other intangible assets
Other intangible assets consisted of the following (in millions):

December 31,
  2025 2024
  Gross
carrying
amounts Accumulated
amortization Other intangible
assets, net Gross
carrying
amounts Accumulated
amortization Other intangible
assets, net
Finite-lived intangible assets:
Developed-product-technology rights $ 47,805   $ ( 26,754 ) $ 21,051   $ 48,611   $ ( 22,594 ) $ 26,017  
Licensing rights 3,917   ( 3,522 ) 395   3,875   ( 3,392 ) 483  
R&D technology rights 1,425   ( 1,305 ) 120   1,374   ( 1,235 ) 139  
Marketing-related rights 1,203   ( 1,203 ) —   1,202   ( 1,202 ) —  
Total finite-lived intangible assets 54,350   ( 32,784 ) 21,566   55,062   ( 28,423 ) 26,639  
Indefinite-lived intangible assets:
In-process research and development
710   —  710   1,060   —  1,060  
Total other intangible assets $ 55,060   $ ( 32,784 ) $ 22,276   $ 56,122   $ ( 28,423 ) $ 27,699  

Developed-product-technology rights consists of rights related to marketed products acquired in business combinations. Licensing rights primarily consists of contractual rights to receive future milestone, royalty and profit-sharing payments; capitalized payments to third parties for milestones related to regulatory approvals to commercialize products; and upfront payments associated with royalty obligations for marketed products. R&D technology rights pertains to technologies used in R&D that have alternative future uses. Marketing-related rights primarily consists of rights related to the sale and distribution of marketed products.
The Company monitors intangible assets for impairment on a quarterly basis. In January 2025, as part of the IRA, the Company’s product Otezla was selected by CMS for Medicare price setting that will be applicable beginning on January 1, 2027. The earlier than anticipated selection resulted in a decrease in the estimated future cash flows for the product in the United States. This selection represented a triggering event that required the Company to evaluate the underlying developed-product-technology rights for impairment. In the first quarter of 2025, the Company utilized a discounted cash flow analysis based on Level 3 inputs, including estimated product sales, operating expenses and a discount rate, that resulted in an intangible asset fair value of $ 4.0  billion, which was lower than the carrying value of $ 4.8  billion, and a partial impairment of $ 800  million. In the third quarter of 2025, new facts and circumstances, primarily from the CMS price setting process, indicated a further triggering event that required the Company to evaluate the underlying developed-product-technology rights for impairment. A subsequent discounted cash flow analysis, prepared using the same Level 3 input framework and updated assumptions, resulted in a revised intangible asset fair value of $ 3.0  billion, which was lower than the carrying value of $ 3.4  billion, and an additional impairment of $ 400  million. The aggregate impairment charges of $ 1.2  billion during the year ended December 31, 2025 were recognized in Other operating expenses in the Consolidated Statements of Income. See Note 18, Fair value measurement.
F-33

The developed-product-technology rights intangible assets related to TAVNEOS have a carrying value of $ 2.5  billion as of December 31, 2025 with $ 2.4  billion related to the U.S. market. On January 16, 2026, the FDA requested that ChemoCentryx voluntarily withdraw TAVNEOS from the U.S. market. Amgen is confident that TAVNEOS demonstrates effectiveness and a favorable benefit–risk profile. On January 28, 2026, following FDA regulatory process, Amgen informed the FDA that it did not intend to withdraw TAVNEOS from the market. Amgen is evaluating next steps with the FDA to determine a path forward. Future changes to estimated TAVNEOS cash flows could unfavorably impact the Company’s ability to recover the carrying value of the related intangible asset.
IPR&D consists of R&D projects acquired in a business combination that are not complete at the time of acquisition due to remaining technological risks and/or lack of receipt of required regulatory approvals. All IPR&D projects have major risks and uncertainties associated with the timely and successful completion of the development and commercialization of product candidates, including our ability to confirm safety and efficacy based on data from clinical trials, our ability to obtain necessary regulatory approvals and our ability to successfully complete these tasks within budgeted costs. We are not permitted to market a human therapeutic without obtaining regulatory approvals, and such approvals require the completion of clinical trials that demonstrate that a product candidate is safe and effective. In addition, the availability and extent of coverage and reimbursement from third-party payers, including government healthcare programs and private insurance plans as well as competitive product launches, affect the revenues a product can generate. Consequently, the eventual realized values, if any, of acquired IPR&D projects may vary from their estimated fair values. We review IPR&D projects for impairment annually, whenever events or changes in circumstances indicate that the carrying amounts may not be recoverable and upon the establishment of technological feasibility or regulatory approval. During the year ended December 31, 2023, the development of AMG 340 acquired in connection with our Teneobio acquisition was terminated, resulting in an impairment charge of $ 783  million, which was recognized in Other operating expenses in the Consolidated Statements of Income.
During the second quarter of 2025, the FDA approved UPLIZNA for the IgG4-RD indication, and commercialization commenced in the United States. As a result, the Company reclassified the related intangible asset with a gross carrying value of $ 350  million from IPR&D to developed-product-technology rights and began amortizing it on a straight-line basis over its estimated useful life of approximately 11 years from the date placed in service.
During the years ended December 31, 2025, 2024 and 2023, we recognized amortization of our finite-lived intangible assets of $ 4.3 billion, $ 4.8 billion and $ 3.2 billion, respectively. Amortization of intangible assets is primarily included in Cost of sales in the Consolidated Statements of Income. As of December 31, 2025, the total estimated future amortization of our finite-lived intangible assets for the years ending December 31, 2026, 2027, 2028, 2029 and 2030, was $ 3.6 billion, $ 3.5 billion, $ 2.8 billion, $ 2.3 billion and $ 2.2 billion, respectively.

14. Leases
We lease certain facilities and equipment related primarily to R&D, administrative and commercial activities. Leases with terms of 12 months or less are expensed as incurred and are not recorded in the Consolidated Balance Sheets.
Most leases include one or more options to renew, with renewal terms that may extend the lease term up to ten years . The exercise of lease renewal options is at our sole discretion. In addition, some of our lease agreements include rental payments adjusted periodically for inflation. Our lease agreements neither contain residual value guarantees nor impose significant restrictions or covenants. We sublease certain real estate to third parties. Our sublease portfolio consists of operating leases from former R&D and administrative spaces.
The following table summarizes information related to our leases, all of which are classified as operating, included in our Consolidated Balance Sheets (in millions):

December 31,
Consolidated Balance Sheets locations 2025 2024
Assets:
Other noncurrent assets $ 602   $ 557  
Liabilities:
Accrued liabilities $ 135   $ 107  
Other noncurrent liabilities 696   673  
Total lease liabilities $ 831   $ 780  

F-34

The components of net lease costs were as follows (in millions):

Years ended December 31,
Lease costs 2025 2024 2023
Operating (1)
$ 265   $ 219   $ 208  

Sublease income ( 9 ) ( 17 ) ( 28 )
Total net lease costs $ 256   $ 202   $ 180  

____________
(1)     Includes short-term leases and variable lease costs, which were not material for the years ended December 31, 2025, 2024 and 2023.
Maturities of lease liabilities as of December 31, 2025, were as follows (in millions):

Maturity dates Amounts
2026 $ 148  
2027 153  
2028 128  
2029 99  
2030 77  
Thereafter 362  
Total lease payments (1)
967  
Less imputed interest ( 136 )
Present value of lease liabilities $ 831  

____________
(1)     Includes future rental commitments for properties that have been subleased in the amount of $ 99  million. We expect to receive total future rental income of $ 54  million related to noncancellable subleases.
The weighted-average remaining lease terms and weighted-average discount rates were as follows:

December 31,
2025 2024
Weighted-average remaining lease term (in years) 8.7 9.3
Weighted-average discount rate 4.0   % 3.7   %

Cash and noncash information related to our leases was as follows (in millions):

Years ended December 31,
2025 2024 2023
Cash paid for amounts included in the measurement of lease liabilities:
Operating cash flows for operating leases $ 157   $ 156   $ 182  

ROU assets obtained in exchange for lease obligations:
Operating leases $ 217   $ 126   $ 245  

As of December 31, 2025, there were no future lease payments for leases that have not yet commenced.

F-35

15. Other current assets and accrued liabilities
Other current assets consisted of the following (in millions):

December 31,
2025 2024
Prepaid expenses $ 2,945   $ 2,139  

Other 1,188   1,138  
Total other current assets $ 4,133   $ 3,277  

Accrued liabilities consisted of the following (in millions):

December 31,
2025 2024
Sales deductions $ 10,606   $ 8,405  
Employee compensation and benefits 1,437   1,329  
Dividends payable 1,358   1,278  
Income taxes payable 379   2,583  
Other 4,743   4,046  
Total accrued liabilities $ 18,523   $ 17,641  

F-36

16. Financing arrangements
Our borrowings consisted of the following (in millions):

December 31,
2025 2024
1.90 % notes due 2025 ( 1.90 % 2025 Notes)
$ —  $ 500  
5.25 % notes due 2025 ( 5.25 % 2025 Notes)
—  2,000  
3.125 % notes due 2025 ( 3.125 % 2025 Notes)
—   1,000  
2.00 % € 750 million notes due 2026 ( 2.00 % 2026 euro Notes)
881   777  
5.507 % notes due 2026 ( 5.507 % 2026 Notes)
—   1,500  
2.60 % notes due 2026 ( 2.60 % 2026 Notes)
1,250   1,250  
Term loan due October 2026 1,800   1,800  
5.50 % £ 475 million notes due 2026 ( 5.50 % 2026 pound sterling Notes)
640   595  
2.20 % notes due 2027 ( 2.20 % 2027 Notes)
1,724   1,724  
3.20 % notes due 2027 ( 3.20 % 2027 Notes)
1,000   1,000  
5.15 % notes due 2028 ( 5.15 % 2028 Notes)
3,750   3,750  
1.65 % notes due in 2028 ( 1.65 % 2028 Notes)
1,234   1,234  
3.00 % notes due 2029 ( 3.00 % 2029 Notes)
750   750  
4.05 % notes due 2029 ( 4.05 % 2029 Notes)
1,250   1,250  
4.00 % £ 700 million notes due 2029 ( 4.00 % 2029 pound sterling Notes)
944   876  
2.45 % notes due 2030 ( 2.45 % 2030 Notes)
1,250   1,250  
5.25 % notes due 2030 ( 5.25 % 2030 Notes)
2,750   2,750  
2.30 % notes due 2031 ( 2.30 % 2031 Notes)
1,250   1,250  
2.00 % notes due 2032 ( 2.00 % 2032 Notes)
987   1,001  
3.35 % notes due 2032 ( 3.35 % 2032 Notes)
1,000   1,000  
4.20 % notes due 2033 ( 4.20 % 2033 Notes)
750   750  
5.25 % notes due 2033 ( 5.25 % 2033 Notes)
4,250   4,250  
6.375 % notes due 2037 ( 6.375 % 2037 Notes)
478   478  
6.90 % notes due 2038 ( 6.90 % 2038 Notes)
254   254  
6.40 % notes due 2039 ( 6.40 % 2039 Notes)
333   333  
3.15 % notes due 2040 ( 3.15 % 2040 Notes)
1,478   1,668  
5.75 % notes due 2040 ( 5.75 % 2040 Notes)
373   373  
2.80 % notes due 2041 ( 2.80 % 2041 Notes)
568   776  
4.95 % notes due 2041 ( 4.95 % 2041 Notes)
600   600  
5.15 % notes due 2041 ( 5.15 % 2041 Notes)
729   729  
5.65 % notes due 2042 ( 5.65 % 2042 Notes)
415   415  
5.60 % notes due 2043 ( 5.60 % 2043 Notes)
2,750   2,750  
5.375 % notes due 2043 ( 5.375 % 2043 Notes)
185   185  
4.40 % notes due 2045 ( 4.40 % 2045 Notes)
2,250   2,250  
4.563 % notes due 2048 ( 4.563 % 2048 Notes)
1,415   1,415  
3.375 % notes due 2050 ( 3.375 % 2050 Notes)
1,462   1,764  
4.663 % notes due 2051 ( 4.663 % 2051 Notes)
3,541   3,541  
3.00 % notes due 2052 ( 3.00 % 2052 Notes)
703   890  
4.20 % notes due 2052 ( 4.20 % 2052 Notes)
882   895  
4.875 % notes due 2053 ( 4.875 % 2053 Notes)
1,000   1,000  
5.65 % notes due 2053 ( 5.65 % 2053 Notes)
4,250   4,250  
2.77 % notes due 2053 ( 2.77 % 2053 Notes)
940   940  
4.40 % notes due 2062 ( 4.40 % 2062 Notes)
1,128   1,165  
5.75 % notes due 2063 ( 5.75 % 2063 Notes)
2,750   2,750  

F-37

December 31,
2025 2024
Other notes due 2097 100   100  
Total principal amount of debt
56,044   61,778  
Unamortized bond discounts, premiums and issuance costs, net ( 1,306 ) ( 1,360 )
Fair value adjustments ( 161 ) ( 343 )
Other 27   24  
Total carrying value of debt 54,604   60,099  
Less current portion ( 4,599 ) ( 3,550 )
Total long-term debt $ 50,005   $ 56,549  

There are no material differences between the effective interest rates and coupon rates of our notes, except for the 4.563 % 2048 Notes, the 4.663 % 2051 Notes and the 2.77 % 2053 Notes, which have effective interest rates of 6.3 %, 5.6 % and 5.2 %, respectively.
Under the terms of all of our outstanding notes, except our Other notes due 2097, in the event of a change-in-control triggering event we may be required to purchase all or a portion of these debt securities at prices equal to 101 % of the principal amounts of the notes plus accrued and unpaid interest. In addition, all of our outstanding notes—except our Other notes due 2097—may be redeemed at any time at our option—in whole or in part—at the principal amounts of the notes being redeemed plus accrued and unpaid interest and make-whole amounts, which are defined by the terms of the notes. Certain of the redeemable notes do not require the payment of make-whole amounts if redeemed during a specified period of time immediately prior to the maturity of the notes. Such time periods range from one month to six months prior to maturity.
Debt issuances and acquisition-related financing
We did not issue debt securities during the years ended December 31, 2025 and 2024.
In March 2023, in connection with the acquisition of Horizon (see Note 4, Acquisition), we issued the following series of notes (in millions):

Principal Amount
5.25 % 2025 Notes
$ 2,000  
5.507 % 2026 Notes
1,500  
5.15 % 2028 Notes
3,750  
5.25 % 2030 Notes
2,750  
5.25 % 2033 Notes
4,250  
5.60 % 2043 Notes
2,750  
5.65 % 2053 Notes
4,250  
5.75 % 2063 Notes
2,750  
Total $ 24,000  

Also in connection with the acquisition of Horizon, we entered into a $ 4.0  billion term loan credit agreement in December 2022. In October 2023, in connection with the completion of the acquisition of Horizon, we borrowed $ 4.0  billion under the term loan credit agreement, of which $ 2.2  billion was repaid during 2024. As of December 31, 2025, we had $ 1.8  billion of borrowings outstanding under the term loan credit agreement, which has an interest rate of three-month SOFR plus 1.225 % and is due in October 2026.
Debt extinguishment
In 2025, we repurchased an aggregate principal amount of our debt of $ 1.0 billion, including portions of the 2.00 % 2032 Notes, 3.15 % 2040 Notes, 2.80 % 2041 Notes, 3.375 % 2050 Notes, 3.00 % 2052 Notes, 4.20 % 2052 Notes and 4.40 % 2062 Notes, for an aggregate cost of $ 683 million, which resulted in a $ 264 million gain on extinguishment of debt recorded in Other income, net, in the Consolidated Statements of Income.
In 2024, we repurchased an aggregate principal amount of our debt of $ 875 million, including portions of the 3.15 % 2040 Notes, 2.80 % 2041 Notes, 3.375 % 2050 Notes, 3.00 % 2052 Notes, 4.20 % 2052 Notes and 4.40 % 2062 Notes, for an aggregate
F-38

cost of $ 659 million, which resulted in a $ 215 million gain on extinguishment of debt recorded in Other income, net, in the Consolidated Statements of Income.
In 2023, we repurchased an aggregate principal amount of our debt of $ 881 million, including portions of the 2.00 % 2032 Notes, 3.15 % 2040 Notes, 2.80 % 2041 Notes, 3.375 % 2050 Notes, 3.00 % 2052 Notes, 4.20 % 2052 Notes and 4.40 % 2062 Notes, for an aggregate cost of $ 647 million, which resulted in a $ 225 million gain on extinguishment of debt recorded in Other income, net, in the Consolidated Statements of Income.
Debt repayments
In 2025, debt repayments totaled $ 5.0 billion, including repayments in full of the $ 500 million aggregate principal amount of the 1.90 % 2025 Notes, $ 2.0 billion aggregate principal amount of the 5.25 % 2025 Notes, $ 1.0 billion aggregate principal amount of the 3.125 % 2025 Notes and $ 1.5 billion aggregate principal amount of the 5.507 % 2026 Notes.
In 2024, debt repayments totaled $ 3.6 billion, including the full $ 2.0 billion aggregate principal amount on the term loan due April 2025, $ 200 million of the aggregate principal amount on the term loan due October 2026 and the full $ 1.4  billion aggregate principal amount of the 3.625 % 2024 Notes.
In 2023, debt repayments totaled $ 1.5 billion, including the full $ 750 million aggregate principal amount of the 2.25 % 2023 Notes and the full CHF 700  million aggregate principal amount ($ 704 million upon settlement of the related cross-currency swap) of the 0.41 % 2023 Swiss franc Bonds.
Interest rate swaps
To achieve a desired mix of fixed-rate and floating-rate debt, we enter into interest rate swap contracts that effectively convert fixed-rate interest coupons for certain of our debt instruments to floating SOFR-based coupons over the terms of the respective debt instruments. These interest rate swap contracts qualify and are designated as fair value hedges. For information regarding the terms of these contracts, see Note 19, Derivative instruments.
Cross-currency swaps
To hedge our exposure to foreign currency exchange rate risk associated with certain of our long-term notes denominated in foreign currencies, we entered into cross-currency swap contracts. The terms of these contracts outstanding as of December 31, 2025, effectively convert the interest payments and principal repayments on our 2.00 % 2026 euro Notes, 5.50 % 2026 pound sterling Notes and 4.00 % 2029 pound sterling Notes from euros and pounds sterling to U.S. dollars. These cross-currency swap contracts have been designated as cash flow hedges. For information regarding the terms of these contracts, see Note 19, Derivative instruments. Cross-currency swap contracts associated with other foreign denominated debt previously outstanding were settled in connection with the repayment of such debt, as discussed above.
Shelf registration statement and other facilities
As of December 31, 2025, we have a commercial paper program that allows us to issue up to $ 4.0 billion of unsecured commercial paper to fund working capital needs. As of December 31, 2025 and 2024, we had no amounts outstanding under our commercial paper program.
In the first quarter of 2023, we amended and restated our syndicated, unsecured, revolving credit agreement, under which we may borrow up to $ 4.0  billion for general corporate purposes, including as a liquidity backstop for our commercial paper program. The commitments under the revolving credit agreement may be increased by up to $ 1.25  billion with the agreement of the banks. Each bank that is a party to the agreement has an initial commitment term of five years . This term may be extended for up to two additional one-year periods with the agreement of the banks. Annual commitment fees for this agreement are 0.09 % of the unused portion of the facility based on our current credit rating. Generally, we would be charged interest for any amounts borrowed under this facility, based on our current credit rating, at (i) SOFR plus 1.01 % or (ii) the highest of (A) the administrative agent bank base commercial lending rate, (B) the overnight federal funds rate plus 0.50 % or (C) one-month SOFR plus 1.1 %. As of December 31, 2025 and 2024, no amounts were outstanding under this facility.
In February 2023, we filed a shelf registration statement with the SEC that allows us to issue unspecified amounts of debt securities; common stock; preferred stock; warrants to purchase debt securities, common stock, preferred stock or depositary shares; rights to purchase common stock or preferred stock; securities purchase contracts; securities purchase units; and depositary shares. Under this shelf registration statement, all of the securities available for issuance may be offered from time to time, with terms to be determined at the time of issuance. This shelf registration statement expired in February 2026, and our Board has approved a new shelf registration statement to replace it.
F-39

Certain of our financing arrangements contain nonfinancial covenants. In addition, our revolving credit agreement and term loan agreement include a financial covenant, which requires us to maintain a specified minimum interest coverage ratio of (i) the sum of consolidated net income, interest expense, provision for income taxes, depreciation expense, amortization expense, unusual or nonrecurring charges and other noncash items (Consolidated EBITDA) to (ii) Consolidated Interest Expense, each as defined and described in the respective agreements. We were in compliance with all applicable covenants under these arrangements as of December 31, 2025.
Contractual maturities of debt obligations
The aggregate contractual maturities of our debt obligations as of December 31, 2025, were as follows (in millions):

Maturity dates Amounts
2026 $ 4,571  
2027 2,724  
2028 4,984  
2029 2,943  
2030 4,000  
Thereafter 36,822  
Total $ 56,044  

Interest costs
Interest costs are expensed as incurred except to the extent such interest is related to construction in progress, in which case interest is capitalized. Interest costs capitalized for the years ended December 31, 2025, 2024 and 2023, were not material. Interest paid, net of amounts capitalized and including the ongoing impact of interest rate and cross-currency swap contracts, during the years ended December 31, 2025, 2024 and 2023 was $ 2.9  billion, $ 3.3  billion and $ 2.4  billion, respectively.

17. Stockholders’ equity
Stock repurchase program
During the years ended December 31, 2025 and 2023, we did not repurchase shares under our stock repurchase program. During the year ended December 31, 2024, we repurchased 0.7 million shares of our common stock for a total cost of $ 200 million under our stock repurchase program. As of December 31, 2025, $ 6.8 billion of authorization remained available under the stock repurchase program.
Dividends
Our Board of Directors declared quarterly dividends per share of $ 2.38 , $ 2.25 and $ 2.13 , which were paid in each of the four quarters of 2025, 2024 and 2023, respectively.
Historically, we have declared dividends in December of each year, which were paid in the first quarter of the following fiscal year and in March, July and October, which were paid in the second, third and fourth quarters, respectively, of the same fiscal year. Additionally, in December 2025, the Board of Directors declared a quarterly cash dividend of $ 2.52 per share of common stock, which will be paid in March 2026, to all stockholders of record as of the close of business on February, 13 2026.
F-40

Accumulated other comprehensive loss
The components of AOCI were as follows (in millions):

Foreign
currency
translation adjustments
Cash flow
hedges Other AOCI
Balance as of December 31, 2022 $ ( 348 ) $ 128   $ ( 11 ) $ ( 231 )
Foreign currency translation adjustments 50   —   —   50  
Unrealized gains —   28   —   28  
Reclassification adjustments into earnings —   ( 222 ) —   ( 222 )
Other
—   —   42   42  
Income taxes —   44   —   44  
Balance as of December 31, 2023 ( 298 ) ( 22 ) 31   ( 289 )

Foreign currency translation adjustments ( 76 ) —   —   ( 76 )
Unrealized gains —   506   —   506  
Reclassification adjustments into earnings —   ( 117 ) —   ( 117 )
Other
—   —   ( 10 ) ( 10 )
Income taxes —   ( 80 ) —   ( 80 )
Balance as of December 31, 2024 ( 374 ) 287   21   ( 66 )

Foreign currency translation adjustments 172   —   —   172  
Unrealized losses —   ( 250 ) —   ( 250 )
Reclassification adjustments into earnings —   ( 231 ) —   ( 231 )
Other
—   —   13   13  
Income taxes —   104   —   104  
Balance as of December 31, 2025 $ ( 202 ) $ ( 90 ) $ 34   $ ( 258 )

With respect to the table above, income tax expenses or benefits for unrealized gains and losses and the related reclassification adjustments to earnings for cash flow hedges were a $ 53 million benefit and a $ 51 million benefit in 2025, a $ 105 million expense and a $ 25 million benefit in 2024, and a $ 6 million expense and a $ 50 million benefit in 2023, respectively.
Reclassifications out of AOCI and into earnings were as follows (in millions):

Years ended December 31,
Components of AOCI 2025 2024 2023 Consolidated Statements of Income locations
Cash flow hedges:
Foreign currency forward contract gains $ 10   $ 192   $ 180   Product sales
Cross-currency swap contract gains (losses) 221   ( 75 ) 42   Other income, net

231   117   222   Income before income taxes
( 51 ) ( 25 ) ( 50 ) Provision for income taxes
$ 180   $ 92   $ 172   Net income

Other
In addition to common stock, our authorized capital includes 5 million shares of preferred stock, $ 0.0001 par value. As of December 31, 2025 and 2024, no shares of preferred stock were issued or outstanding.
F-41

18. Fair value measurement
To estimate the fair values of our financial assets and liabilities, we use valuation approaches within a hierarchy that maximizes the use of observable inputs and minimizes the use of unobservable inputs by requiring that observable inputs be used when available. Observable inputs are inputs that market participants would use in pricing an asset or liability based on market data obtained from sources independent of the Company. Unobservable inputs are inputs that reflect the Company’s assumptions about the inputs that market participants would use in pricing an asset or liability and are developed based on the best information available in the circumstances. The fair value hierarchy is divided into three levels based on the source of inputs as follows:

Level 1 — Valuations based on unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability to access
Level 2 — Valuations for which all significant inputs are observable either directly or indirectly—other than Level 1 inputs
Level 3 — Valuations based on inputs that are unobservable and significant to the overall fair value measurement

The availability of observable inputs can vary among the various types of financial assets and liabilities. To the extent that the valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. In certain cases, the inputs used for measuring fair value may fall into different levels of the fair value hierarchy. In such cases, for financial statement disclosure purposes, the level in the fair value hierarchy within which the fair value measurement is categorized is based on the lowest level of input used that is significant to the overall fair value measurement.
The fair values of each major class of the Company’s financial assets and liabilities measured at fair value on a recurring basis were as follows (in millions):

Fair value measurement as of December 31, 2025, using:
Quoted prices in
active markets for
identical assets
(Level 1) Significant other
observable
inputs
(Level 2) Significant
unobservable
inputs
(Level 3) Total
Assets:
Available-for-sale securities:

U.S. Treasury bills $ —   $ 998   $ —   $ 998  

Money market mutual funds 7,395   —   —   7,395  
Other short-term interest-bearing securities —   132   —   132  

Equity securities 6,144   —   —   6,144  
Derivatives:
Foreign currency forward contracts —   196   —   196  
Cross-currency swap contracts —   48   —   48  

Total assets $ 13,539   $ 1,374   $ —   $ 14,913  
Liabilities:
Derivatives:
Foreign currency forward contracts $ —   $ 214   $ —   $ 214  
Cross-currency swap contracts —   320   —   320  
Interest rate swap contracts —   293   —   293  

Contingent consideration obligations —   —   161   161  
Total liabilities $ —   $ 827   $ 161   $ 988  

F-42

Fair value measurement as of December 31, 2024, using:
Quoted prices in
active markets for
identical assets
(Level 1) Significant other
observable
inputs
(Level 2) Significant
unobservable
inputs
(Level 3) Total
Assets:
Available-for-sale securities:

U.S. Treasury bills $ —   $ 997   $ —   $ 997  

Money market mutual funds 10,354   —   —   10,354  
Other short-term interest-bearing securities —   135   —   135  

Equity securities 4,188   —   —   4,188  
Derivatives:
Foreign currency forward contracts —   420   —   420  

Total assets $ 14,542   $ 1,552   $ —   $ 16,094  

Liabilities:
Derivatives:
Foreign currency forward contracts $ —   $ 8   $ —   $ 8  
Cross-currency swap contracts —   483   —   483  
Interest rate swap contracts —   531   —   531  

Contingent consideration obligations —   —   106   106  
Total liabilities $ —   $ 1,022   $ 106   $ 1,128  

Interest-bearing and equity securities
The fair values of our U.S. Treasury bills are determined by utilizing third-party pricing services, which obtain pricing data from active market makers and brokers. The fair values of our money market mutual funds and equity investments in publicly traded securities, including our equity investments in BeOne and Neumora, as of December 31, 2025 and 2024, are based on quoted market prices in active markets, with no valuation adjustment .
Derivatives
All of our foreign currency forward contracts, cross-currency swap contracts and interest rate swap contracts are with counterparties that have minimum credit ratings of A– or equivalent by S&P, Moody’s or Fitch. We estimate the fair values of these contracts by taking into consideration valuations obtained from a third-party valuation service that uses an income-based industry-standard valuation model for which all significant inputs are observable either directly or indirectly. These inputs, as applicable, include foreign currency exchange rates, SOFR, swap rates, obligor credit default swap rates and cross-currency basis swap spreads. Certain inputs, when applicable, are at commonly quoted intervals. See Note 19, Derivative instruments.
Contingent consideration obligations
As a result of business development activity, we have incurred contingent consideration obligations as discussed below. The contingent consideration obligations are recorded at their fair values by using probability-adjusted discounted cash flows, and we revalue these obligations each reporting period until the related contingencies have been resolved. The fair value measurements of these obligations are based on significant unobservable inputs related to licensing rights and product candidates acquired through business development activity, and they are reviewed quarterly by management in our R&D and commercial sales organizations. The inputs include, as applicable, estimated probabilities and the timing of achieving specified development, regulatory and commercial milestones as well as estimated annual sales. Significant changes that increase or decrease the probabilities of achieving the related development, regulatory and commercial events or that shorten or lengthen the time required to achieve such events or that increase or decrease estimated annual sales would result in corresponding increases or decreases in the fair values of the obligations, as applicable. Changes in the fair values of contingent consideration obligations are recognized in Other operating expenses in the Consolidated Statements of Income.
F-43

Changes in the carrying amounts of contingent consideration obligations were as follows (in millions):

Years ended December 31,
2025 2024
Beginning balance $ 106   $ 96  
Additions 68   —  
Payments ( 7 ) ( 8 )
Net changes in valuations ( 6 ) 18  
Ending balance $ 161   $ 106  

As of December 31, 2025 and 2024, our contingent consideration obligations were primarily the result of our acquisition of Teneobio in October 2021, which obligates us to make payments to the former shareholders upon achievement of separate development and regulatory milestones with regard to various R&D programs, and other business development activity in 2025.
Summary of the fair values of other financial instruments
Cash equivalents
The fair values of cash equivalents are approximated at their carrying values due to the short-term nature of such financial instruments.
Borrowings
We estimate the fair values of our fixed-rate debt by using Level 2 inputs. As of December 31, 2025 and 2024, the aggregate fair values of our fixed-rate debt were $ 51.0 billion and $ 54.9 billion, respectively, and the carrying values of our fixed-rate debt were $ 52.8 billion and $ 58.3 billion, respectively. The estimate of the fair value of our term loan is approximated at its carrying value as of December 31, 2025 and 2024, as this debt instrument bears interest at a floating rate.
During the years ended December 31, 2025 and 2024, there were no transfers of assets or liabilities between fair value measurement levels. Except with respect to the partial impairments of the Otezla intangible asset in 2025 and the IPR&D intangible impairment of AMG 340 in 2023 as disclosed in Note 13, Goodwill and other intangible assets, there were no material remeasurements of the fair values of assets and liabilities that are not measured at fair value on a recurring basis.

19. Derivative instruments
The Company is exposed to foreign currency exchange rate and interest rate risks related to its business operations. To reduce our risks related to such exposures, we use or have used certain derivative instruments, including foreign currency forward, foreign currency option, cross-currency swap, forward interest rate and interest rate swap contracts. We have designated certain of our derivatives as cash flow and fair value hedges; we also have derivatives not designated as hedges. We do not use derivatives for speculative trading purposes.
Cash flow hedges
We are exposed to possible changes in the values of certain anticipated foreign currency cash flows resulting from changes in foreign currency exchange rates primarily associated with our euro-denominated international product sales. The foreign currency exchange rate fluctuation exposure associated with cash inflows from our international product sales is partially offset by corresponding cash outflows from our international operating expenses. To further reduce this exposure, we enter into foreign currency forward contracts to hedge a portion of our projected international product sales up to a maximum of three years into the future; and at any given point in time, a higher percentage of nearer-term projected product sales is being hedged than in successive periods.
As of December 31, 2025 and 2024, we had outstanding foreign currency forward contracts with aggregate notional amounts of $ 7.8 billion and $ 7.2 billion, respectively. We have designated these foreign currency forward contracts, which are primarily euro based, as cash flow hedges. Accordingly, we record unrealized gains and losses on these contracts in AOCI in the Consolidated Balance Sheets, and we reclassify them to Product sales in the Consolidated Statements of Income in the same periods during which the hedged transactions affect earnings.
F-44

To hedge our exposure to foreign currency exchange rate risk associated with certain of our long-term debt denominated in foreign currencies, we enter into cross-currency swap contracts. Under the terms of such contracts, we paid euros and pounds sterling and received U.S. dollars for the notional amounts at the inception of the contracts; and based on these notional amounts, we exchange interest payments at fixed rates over the terms of the contracts by paying U.S. dollars and receiving euros and pounds sterling. In addition, we will pay U.S. dollars to and receive euros and pounds sterling from the counterparties at the maturities of the contracts for these same notional amounts. The terms of these contracts correspond to the related hedged debt, thereby effectively converting the interest payments and principal repayment on the debt from euros and pounds sterling to U.S. dollars. We have designated these cross-currency swap contracts as cash flow hedges. Accordingly, the unrealized gains and losses on these contracts are recorded in AOCI in the Consolidated Balance Sheets and reclassified to Other income, net, in the Consolidated Statements of Income in the same periods during which the hedged debt affects earnings.
The notional amounts and interest rates of our cross-currency swaps as of December 31, 2025, were as follows (notional amounts in millions):

Foreign currency U.S. dollars
Hedged notes Notional amounts Interest rates Notional amounts Interest rates

2.00 % 2026 euro Notes
€ 750   2.0   % $ 833   3.9   %
5.50 % 2026 pound sterling Notes
£ 475   5.5   % $ 747   6.0   %
4.00 % 2029 pound sterling Notes
£ 700   4.0   % $ 1,111   4.7   %

In connection with the anticipated issuance of long-term fixed-rate debt, we occasionally enter into forward interest rate contracts in order to hedge the variability in cash flows due to changes in the applicable U.S. Treasury rate between the time we enter into these contracts and the time the related debt is issued. Gains and losses on forward interest rate contracts, which are designated as cash flow hedges, are recognized in AOCI in the Consolidated Balance Sheets and are amortized into Interest expense, net, in the Consolidated Statements of Income over the terms of the associated debt issuances. In 2025, we entered into forward interest rate contracts with an aggregate notional amount of $ 500  million. Amounts recognized in connection with forward interest rate contracts during the years ended December 31, 2025, 2024 and 2023, and amounts expected to be recognized during the next 12 months on forward interest rate contracts were not material.
Unrealized gains and losses recognized in AOCI for our derivative instruments designated as cash flow hedges were as follows (in millions):

Years ended December 31,
Derivatives in cash flow hedging relationships 2025 2024 2023
Foreign currency forward contracts $ ( 464 ) $ 585   $ ( 14 )
Cross-currency swap contracts 214   ( 79 ) 73  
Forward interest rate contracts —   —   ( 31 )
Total unrealized (losses) gains $ ( 250 ) $ 506   $ 28  

Fair value hedges
To achieve a desired mix of fixed-rate and floating-rate debt, we enter into interest rate swap contracts that qualify for and are designated as fair value hedges. These interest rate swap contracts effectively convert fixed-rate coupons to floating-rate SOFR-based coupons over the terms of the related hedge contracts. As of both December 31, 2025 and 2024, we had interest rate swap contracts with an aggregate notional amount of $ 6.7  billion that hedge certain portions of our long-term debt. In 2025, interest rate swap contracts with an aggregate notional amount of $ 1.0  billion matured in connection with the repayment of the 3.125 % 2025 Notes. Also in 2025, we entered into $ 1.0  billion of new interest rate swap contracts to hedge a portion of our 5.25 % 2033 Notes.
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As of December 31, 2025 and 2024, the interest rates on the portion of notes for which we have entered into interest rate swap contracts and the related notional amounts of these contracts were as follows (dollar amounts in millions):

December 31,
2025 2024
Notes Notional amounts Interest rates
Notional amounts Interest rates

3.125 % 2025 Notes
$ —   N/A
$ 1,000   SOFR + 2.1 %

2.60 % 2026 Notes
1,250   SOFR + 2.1 %
1,250   SOFR + 2.1 %

2.45 % 2030 Notes
1,000   SOFR + 1.3 %
1,000   SOFR + 1.3 %

2.30 % 2031 Notes
500   SOFR + 1.1 %
500   SOFR + 1.1 %

5.25 % 2033 Notes
2,400   SOFR + 1.8 %
1,400   SOFR + 1.8 %

4.663 % 2051 Notes
1,500   SOFR + 4.3 %
1,500   SOFR + 4.3 %

Total notional amounts $ 6,650   $ 6,650  

N/A = not applicable
For interest rate swap contracts that qualify for and are designated as fair value hedges, we recognize in Interest expense, net, in the Consolidated Statements of Income the unrealized gain or loss on the derivative resulting from the change in fair value during the period, as well as the offsetting unrealized loss or gain of the hedged item resulting from the change in fair value during the period attributable to the hedged risk. If a hedging relationship involving an interest rate swap contract is terminated, the gain or loss realized on contract termination is recorded as an adjustment to the carrying value of the debt and amortized into Interest expense, net, over the remaining term of the previously hedged debt.
The hedged liabilities and related cumulative-basis adjustments for fair value hedges of those liabilities were recorded in the Consolidated Balance Sheets as follows (in millions):

Carrying amounts of hedged liabilities (1)
Cumulative amounts of fair value hedging adjustments related to the carrying amounts of the hedged liabilities (2)

December 31, December 31,
Consolidated Balance Sheets locations 2025 2024 2025 2024
Current portion of long-term debt $ 1,273   $ 1,045   $ 23   $ 45  
Long-term debt $ 5,112   $ 5,152   $ ( 184 ) $ ( 388 )

____________
(1) Current portion of long-term debt includes $ 47 million and $ 56 million of carrying value with discontinued hedging relationships as of December 31, 2025 and 2024, respectively. Long-term debt includes $ 185 million and $ 232 million of carrying value with discontinued hedging relationships as of December 31, 2025 and 2024, respectively.
(2) Current portion of long-term debt includes $ 47 million and $ 56 million of hedging adjustments on discontinued hedging relationships as of December 31, 2025 and 2024, respectively. Long-term debt includes $ 85 million and $ 132 million of hedging adjustments on discontinued hedging relationships as of December 31, 2025 and 2024, respectively.

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Impact of hedging transactions
The following tables summarize the amounts recorded in income and expense line items and the effects thereon from fair value and cash flow hedging, including discontinued hedging relationships (in millions):

Year ended December 31, 2025
Product sales Other income, net Interest expense, net
Total amounts recorded in income and (expense) line items presented in the Consolidated Statements of Income $ 35,148   $ 2,651   $ ( 2,755 )
The effects of cash flow and fair value hedging:
Gains on cash flow hedging relationships reclassified out of AOCI:
Foreign currency forward contracts $ 10   $ —  $ — 
Cross-currency swap contracts $ —  $ 221   $ — 
(Losses) gains on fair value hedging relationships—interest rate swap agreements:
Hedged items (1)
$ —  $ —  $ ( 182 )
Derivatives designated as hedging instruments $ —  $ —  $ 238  

Year ended December 31, 2024
Product sales Other income, net Interest expense, net
Total amounts recorded in income and (expense) line items presented in the Consolidated Statements of Income $ 32,026   $ 506   $ ( 3,155 )
The effects of cash flow and fair value hedging:
Gains (losses) on cash flow hedging relationships reclassified out of AOCI:
Foreign currency forward contracts $ 192   $ —  $ — 
Cross-currency swap contracts $ —  $ ( 75 ) $ — 
Gains on fair value hedging relationships—interest rate swap agreements:
Hedged items (1)
$ —  $ —  $ 29  
Derivatives designated as hedging instruments $ —  $ —  $ 40  

Year ended December 31, 2023
Product sales Other income, net Interest expense, net
Total amounts recorded in income and (expense) line items presented in the Consolidated Statements of Income $ 26,910   $ 2,833   $ ( 2,875 )
The effects of cash flow and fair value hedging:
Gains on cash flow hedging relationships reclassified out of AOCI:
Foreign currency forward contracts $ 180   $ —  $ — 
Cross-currency swap contracts $ —  $ 42   $ — 

(Losses) gains on fair value hedging relationships—interest rate swap agreements:
Hedged items (1)
$ —  $ —  $ ( 118 )
Derivatives designated as hedging instruments $ —  $ —  $ 205  

__________
(1)     Gains (losses) on hedged items do not exactly offset losses (gains) on the related designated hedging instruments due to amortization of the cumulative amounts of fair value hedging adjustments included in the carrying amount of the hedged debt for discontinued hedging relationships and the recognition of gains on terminated hedges when the corresponding hedged item was paid down in the period.
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No portions of our cash flow hedge contracts were excluded from the assessment of hedge effectiveness. As of December 31, 2025, the amount of net losses on our foreign currency forward and cross-currency swap contracts expected to be reclassified out of AOCI and recognized into earnings during the next 12 months was $ 120 million.
Derivatives not designated as hedges
To reduce our exposure to foreign currency fluctuations in certain assets and liabilities denominated in foreign currencies, we enter into foreign currency forward contracts that are not designated as hedging transactions. Most of these exposures are hedged on a month-to-month basis. As of December 31, 2025 and 2024, the total notional amounts of these foreign currency forward contracts were $ 240 million and $ 148 million, respectively. Gains and losses recognized in earnings for our derivative instruments not designated as hedging instruments were not material for the years ended December 31, 2025, 2024 and 2023.
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Fair values of derivatives
The fair values of derivatives included in the Consolidated Balance Sheets were as follows (in millions):

  Derivative assets Derivative liabilities
December 31, 2025 Consolidated Balance Sheets locations Fair values Consolidated Balance Sheets locations Fair values
Derivatives designated as hedging instruments:
Foreign currency forward contracts Other current assets/ Other noncurrent assets $ 195   Accrued liabilities/ Other noncurrent liabilities
$ 213  
Cross-currency swap contracts Other current assets/ Other noncurrent assets 48   Accrued liabilities/ Other noncurrent liabilities
320  
Interest rate swap contracts
Other current assets/ Other noncurrent assets —   Accrued liabilities/ Other noncurrent liabilities
293  

Total derivatives designated as hedging instruments
243   826  
Derivatives not designated as hedging instruments:
Foreign currency forward contracts
Other current assets 1   Accrued liabilities 1  
Total derivatives not designated as hedging instruments
1   1  
Total derivatives $ 244   $ 827  

  Derivative assets Derivative liabilities
December 31, 2024 Consolidated Balance Sheets locations Fair values Consolidated Balance Sheets locations Fair values
Derivatives designated as hedging instruments:
Foreign currency forward contracts Other current assets/ Other noncurrent assets $ 420   Accrued liabilities/ Other noncurrent liabilities
$ 8  
Cross-currency swap contracts Other current assets/ Other noncurrent assets —   Accrued liabilities/ Other noncurrent liabilities
483  
Interest rate swap contracts
Other current assets/ Other noncurrent assets —   Accrued liabilities/ Other noncurrent liabilities
531  

Total derivatives designated as hedging instruments
420   1,022  
Derivatives not designated as hedging instruments:
Foreign currency forward contracts
Other current assets —   Accrued liabilities —  
Total derivatives not designated as hedging instruments
—   —  
Total derivatives $ 420   $ 1,022  

For additional information, see Note 18, Fair value measurement.
Our derivative contracts that were in liability positions as of December 31, 2025, contain certain credit-risk-related contingent provisions that would be triggered if (i) we were to undergo a change in control and (ii) our or the surviving entity’s creditworthiness deteriorates, which is generally defined as having either a credit rating that is below investment grade or a materially weaker creditworthiness after the change in control. If these events were to occur, the counterparties would have the right, but not the obligation, to close the contracts under early-termination provisions. In such circumstances, the counterparties could request immediate settlement of these contracts for amounts that approximate the then current fair values of the contracts. In addition, our derivative contracts are not subject to any type of master netting arrangement, and amounts due either to or from a counterparty under the contracts may be offset against other amounts due either to or from the same counterparty only if an event of default or termination, as defined, were to occur.
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The cash flow effects of our derivative contracts in the Consolidated Statements of Cash Flows are primarily included in Net cash provided by operating activities, except for the settlement of notional amounts of cross-currency swaps, which are included in Net cash (used in) provided by financing activities.

20. Contingencies and commitments
Contingencies
In the ordinary course of business, we are involved in various legal proceedings, government investigations and other matters that are complex in nature and have outcomes that are difficult to predict. See Part I, Item 1A. Risk Factors— Our business may be affected by litigation and government investigations. We describe our legal proceedings and other matters that are significant or that we believe could become significant in this footnote.
We record accruals for loss contingencies to the extent that we conclude it is probable that a liability has been incurred and the amount of the related loss can be reasonably estimated. We evaluate, on a quarterly basis, developments in legal proceedings and other matters that could cause an increase or decrease in the amount of the liability that has been accrued previously.
Our legal proceedings involve various aspects of our business and a variety of claims, some of which present novel factual allegations and/or unique legal theories. The outcomes of these proceedings are inherently uncertain and depend on a variety of factors, including the development of the factual record, judicial or administrative rulings, and, in certain cases, the outcome of appellate review. Further, certain of the matters pending against us are at earlier stages of the legal process, which in complex proceedings of the sort we face often extend for several years, and have not progressed sufficiently through discovery and/or the development of important factual information and legal issues to enable us to estimate. Accordingly, except for amounts accrued, in each of the matters described in this filing in which we could incur a liability, our opponents seek an award of a not-yet-estimable amount of damages or an amount that is not material. While it is not possible to accurately predict or determine the eventual outcomes of these matters, an adverse determination in one or more of these matters currently pending could have a material adverse effect on our consolidated results of operations, financial position or cash flows.
Certain recent developments concerning our legal proceedings and other matters are discussed below.
Repatha Patent Litigation
Patent Disputes in the International Region
We are involved in and expect future involvement in additional disputes regarding our PCSK9 patents in other jurisdictions and regions. This includes matters filed against us and that we have filed in Germany and Japan.
Germany
In February 2016, the EPO granted European Patent No. 2,215,124 (the EP’124 Patent) to Amgen. This patent describes and claims monoclonal antibodies to PCSK9 and methods of treatment and Sanofi filed an opposition to the patent in the EPO seeking to invalidate it. In November 2016, Sanofi-Aventis Deutschland GmbH, Sanofi-Aventis Groupe S.A. and Sanofi Winthrop Industrie S.A. filed a joint opposition against Amgen’s patent, and each of Eli Lilly and Company, Regeneron Pharmaceuticals, Inc. (Regeneron) and Strawman Ltd. also filed oppositions to Amgen’s patent. In November 2018, the EPO confirmed the validity of Amgen’s EP’124 Patent, which was appealed to the Technical Board of Appeal (TBA). On October 29, 2020, the TBA upheld the validity of certain claims, including claims that protect Repatha, but ruled that broader claims encompassing PRALUENT ® were invalid. As a result of the TBA’s decision, any national litigations regarding infringement of the EP`124 Patent by PRALUENT ® were terminated.
In Germany, Sanofi-Aventis Deutschland GmbH and Regeneron filed actions in the Regional Court of Munich seeking damages arising from the provisional enforcement of an injunction against PRALUENT ® that was lifted after the TBA’s October 2020 ruling on the EP’124 Patent. On May 8, 2024, the Regional Court of Munich issued a preliminary decision. The case is still pending, but further proceedings were stayed on December 9, 2025.
Also in Germany, on July 21, 2022, Sanofi Biotechnology SAS filed an action against Amgen GmbH and Amgen (Europe) B.V. before the Regional Court of Dusseldorf alleging that the marketing and sale of Repatha infringes European Patent No. 2,756,004 (the EP’004 Patent), which Sanofi Biotechnology SAS licensed from Regeneron. Sanofi Biotechnology SAS is seeking infringement damages and injunctive relief. On May 13, 2024, the Regional Court of Dusseldorf stayed the hearing on Sanofi Biotechnology SAS’ infringement action pending the outcome of Amgen’s nullity action against the EP’004 Patent before the German Federal Patent Court. On December 29, 2025, the Regional Court of Dusseldorf lifted the stay and scheduled an oral hearing on May 12, 2026 to address whether Amgen infringes the EP’004 Patent in Germany.
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On August 3, 2023, Amgen GmbH filed a nullity action before the German Federal Patent Court seeking invalidation of Regeneron’s EP’004 Patent. On November 25, 2025, the German Federal Patent Court upheld the validity of Regeneron’s EP’004 Patent.
Unified Patent Court of the European Union
Actions concerning Amgen’s European Patent 3,666,797 (the EP’797 Patent)
On June 1, 2023, Amgen filed an action before the Munich Local Division of the Unified Patent Court (UPC) against Sanofi-Aventis Deutschland GmbH, Sanofi-Aventis Groupe S.A., Sanofi Winthrop Industrie S.A. (collectively, Sanofi-Aventis), and Regeneron alleging that the importation, marketing, sale and use of PRALUENT ® infringes Amgen’s EP’797 Patent seeking an injunction and damages for past infringement. Regeneron filed counterclaims for revocation, but on February 5, 2024, the court transferred the counterclaims to the Central Division of the UPC that is presiding over Sanofi’s revocation action. The Munich Local Division of the UPC scheduled the hearing on Amgen’s EP’797 Patent infringement action to begin on October 16, 2024.
On June 29, 2023, the Central Division of the UPC served Amgen with an action that was filed by Sanofi-Aventis that seeks revocation of the EP’797 Patent. The Central Division of the UPC scheduled a hearing on the revocation action and on July 16, 2024, the Central Division of the UPC rendered its decision, concluding that the patent claims are invalid and revoked the EP’797 Patent. Subsequently, on July 29, 2024, the Munich Local Division of the UPC stayed Amgen’s action against Sanofi-Aventis alleging that the importation, marketing, sale and use of PRALUENT ® infringes the EP’797 Patent. On September 13, 2024, Amgen filed a statement of appeal with the Court of Appeals of the UPC to set aside the Central Division of the UPC’s decision to revoke the EP’797 Patent. On August 12, 2025, the Court of Appeals of the UPC heard oral argument on Amgen’s appeal seeking to set aside the Central Division of the UPC’s decision to revoke Amgen’s EP’797 Patent and on November 25, 2025, the Court of Appeals of the UPC issued a decision upholding the validity of Amgen’s EP’797 Patent. On January 26, 2026, Sanofi and Regeneron filed an application for rehearing and sought an order from the Court of Appeals of the UPC that the lodging of its application for rehearing suspends the UPC’s decision upholding the validity of the EP’797 Patent. On January 29, 2026, the Court of Appeals of the UPC issued an order giving Amgen the opportunity to respond to the request for rehearing by February 26, 2026. On February 5, 2026, Amgen filed its reply to Sanofi’s request for suspension.
On December 30, 2025, following on the Court of Appeals of the UPC’s decision finding the EP’797 Patent valid, the Munich Local Division of the UPC lifted the stay on Amgen’s case alleging that PRALUENT ® infringes Amgen’s EP’797 Patent. The Court scheduled an interim conference to take place on June 26, 2026, and an oral argument to take place on November 19, 2026.
Actions concerning Regeneron’s European Patent 3,536,712 (the EP’712 Patent)
On January 10, 2024, Sanofi Biotechnologies SAS (Sanofi Biotechnologies) and Regeneron filed an action (the UPC Action Concerning the EP’712 Patent) against Amgen Inc., Amgen Europe B.V., Amgen N.V., Amgen GmbH, Amgen B.V., Amgen SAS, and Amgen S.R.L before the Dusseldorf Local Division of the UPC, alleging infringement of Regeneron’s EP’712 Patent, which Sanofi Biotechnology SAS licensed from Regeneron. Sanofi and Regeneron are seeking an injunction against the sale, marketing, use, importation, or storage of Repatha for certain specified uses in Belgium, France, Germany, Italy and the Netherlands. Amgen filed counterclaims for invalidity and non-infringement. On February 25, 2025, a hearing on the validity and infringement of the EP’712 Patent was held before the Dusseldorf Local Division of the UPC.
On May 13, 2025, the Dusseldorf Local Division of the UPC issued a decision that the EP’712 Patent is valid but not infringed by Amgen. On July 11, Amgen filed its statement of appeal against the part of the Dusseldorf Local Division of the UPC’s decision finding that the EP’712 Patent is valid. On July 14, 2025, Sanofi and Regeneron filed their statement of appeal against the decision of the Dusseldorf Local Division of the UPC finding the EP’712 Patent not infringed by Amgen. On September 15, 2025, Amgen and Sanofi and Regeneron filed their respective grounds of appeal. On December 15, 2025, the parties filed responses to the grounds of appeal.
Actions concerning Regeneron’s European Patent 4,252,857 (the EP’857 Patent)
On September 25, 2024, Sanofi Biotechnologies and Regeneron filed a brief seeking to expand the ongoing action before the Dusseldorf Local Division of the UPC concerning the EP’712 Patent, alleging that Amgen’s Repatha infringes a newly-issued patent, European Patent No. 4,252,857 (the EP’857 Patent) and seeking an injunction against the marketing, use, or importation of Repatha in 18 countries (Austria, Belgium, Bulgaria, Denmark, Estonia, Finland, France, Germany, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Portugal, Romania, Slovenia and Sweden) and damages for past infringement (the UPC Action Concerning the EP’857 Patent). On December 13, 2024, the Dusseldorf Local Division of the UPC denied Sanofi and Regeneron’s request to extend the complaint. On February 4, 2025, the Dusseldorf Local Division of the UPC formally ordered separation of the EP’857 Patent from the ongoing EP’712 Patent litigation.
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On June 9, 2025, Sanofi filed a motion seeking to stay the UPC Action Concerning the EP’857 Patent, which Amgen opposed. On August 6, 2025, the Dusseldorf Local Division of the UPC stayed the UPC Action Concerning the EP’857 Patent until the Court of Appeals of the UPC reaches a decision on the appeal from the UPC Action Concerning the EP’712 Patent.
European Patent Office
Proceedings concerning Amgen’s EP’797 Patent
On November 16, 2023 and February 29, 2024, Sanofi-Aventis and Regeneron each filed a notice of opposition against Amgen’s EP’797 Patent before the EPO’s Opposition Division. A hearing was held beginning on March 31, 2025 and on April 3, 2025, the Opposition Division determined the claims of the EP’797 Patent are valid.
On April 16, 2025, Sanofi-Aventis and Regeneron filed notices of appeal and requested expedited appeal proceedings. The EPO TBA has scheduled a hearing on Sanofi’s and Regeneron’s appeals against the Opposition Division’s decision upholding the validity of Amgen’s EP’797 Patent to take place on April 13-15, 2026. On January 26, 2026, Amgen filed its reply to Sanofi-Aventis’s and Regeneron’s grounds of appeal.
Proceedings concerning Regeneron’s EP’712 Patent
On February 29, 2024, Amgen filed a notice of opposition and grounds of opposition before the EPO against Regeneron’s EP’712 Patent. On March 15, 2024, the EPO notified the parties that the opposition will be accelerated in view of the infringement action pending against Amgen on the EP’712 Patent in the Dusseldorf Local Division of the UPC. On March 12, 2025, following a hearing on Amgen’s opposition to Regeneron’s EP’712 Patent, the Opposition Division determined that the claims of the EP’712 Patent are valid, and issued its written decision on April 24, 2025.
On April 25, 2025, Amgen filed a notice of appeal and request for expedited appeal proceedings. On June 2, 2025, the EPO TBA accelerated Amgen’s appeal from the EPO’s decision that Regeneron’s EP’712 Patent is valid and scheduled oral argument to take place on March 25, 2026.
Proceedings concerning Regeneron’s EP’857 Patent
On June 23, 2025, Amgen filed a notice of opposition and grounds of opposition before the EPO against Regeneron’s EP’857 Patent. On July 7, 2025, the EPO notified the parties that the opposition proceedings concerning the EP’857 Patent have been accelerated due to the pending parallel proceedings before the UPC, and Regeneron’s response to Amgen’s grounds of opposition must accordingly be filed by October 7, 2025. The EPO Opposition Division scheduled a hearing to take place on Amgen’s opposition against Regeneron’s EP’857 Patent on June 9-10, 2026.
Japan
On April 24, 2020, the Supreme Court of Japan declined to hear Sanofi K.K.’s appeals making final the Intellectual Property High Court’s (IP High Court) decisions that PRALUENT ® infringes Amgen’s valid patent rights in Japan.
On June 24, 2020, Amgen filed written answers to the invalidity trials initiated by Regeneron on February 12, 2020 before the Japan Patent Office (JPO) seeking to invalidate Amgen’s Japanese patents that were previously held infringed by PRALUENT ® and valid over challenges filed by Sanofi K.K. On April 15, 2021, the JPO dismissed Regeneron’s invalidity trials, and in August 2021 Regeneron appealed the decisions to the IP High Court. On January 26, 2023, the IP High Court found Amgen’s patent claims invalid for lacking adequate support and Amgen appealed to the Supreme Court of Japan on March 13, 2023. On September 15, 2023, the Supreme Court of Japan declined to hear Amgen’s appeal. The case was remanded to the JPO for further proceedings, however the case is currently stayed.
On March 31, 2021, Amgen initiated damages proceedings against Sanofi K.K. and Sanofi K.K. raised new validity challenges to Amgen patents. On September 27, 2023, the Tokyo District Court found Amgen’s patent claims invalid and dismissed Amgen’s lawsuit for damages. Amgen appealed the Tokyo District Court’s decision to the IP High Court on December 28, 2023. The IP High Court rejected Amgen’s appeal and remanded the case to the JPO. Amgen then sought amended patent claims before the JPO. The JPO rejected Amgen’s amended claims, and Amgen appealed the JPO’s decision to the IP High Court on September 16, 2024. On April 15, 2025, the IP High Court dismissed Amgen’s appeal and, on May 27, 2025, Amgen filed petition for acceptance of an appeal before the Supreme Court of Japan.
Prolia/XGEVA Biologics Price Competition and Innovation Act (BPCIA) Litigation
Amgen Inc. et al. v. Shanghai Henlius Biotech Inc. et al.
On June 25, 2025, Amgen Inc. and Amgen Manufacturing Limited LLC filed a lawsuit in the U.S. District Court for the District of New Jersey (New Jersey District Court) against Shanghai Henlius Biotech Inc., Shanghai Henlius Biologics Co., Ltd,
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Organon LLC and Organon & Co. (collectively, the Shanghai Henlius and Organon Defendants) based on the submission to the FDA of a BLA seeking approval to market and sell a biosimilar version of Amgen’s Prolia and XGEVA products. The complaint asserts infringement of the following patents: U.S. Patent Nos. 7,364,736; 7,888,101; 7,928,205; 8,053,236; 8,217,153; 8,460,896; 8,680,248; 9,228,168; 9,359,435; 10,106,829; 10,227,627; 10,513,723; 10,583,397; 10,655,156; 10,894,972; 11,077,404; 11,098,079; 11,192,919; 11,254,963; 11,319,568; 11,434,514; 11,459,595; 11,492,372; 11,946,085; 11,952,605; and 12,084,686 (collectively, the Asserted Patents against the Shanghai Henlius and Organon Defendants). Amgen seeks a judgment from the New Jersey District Court that the Shanghai Henlius and Organon Defendants have infringed or will infringe one or more claims of each of the Asserted Patents against the Shanghai Henlius and Organon Defendants and based on that judgment, a permanent injunction prohibiting the commercial manufacture, use, offer to sell, or sale within the United States or importation into the United States of the accused proposed denosumab biosimilar by the Shanghai Henlius and Organon Defendants before expiration of each of the patents found to be infringed. Amgen also seeks monetary remedies for any past acts of infringement.
On June 25, 2025, this litigation became a member of In Re: Denosumab Patent Litigation multi-district litigation with other cases involving Prolia/XGEVA biosimilars pending in the district. On September 5, 2025, the Shanghai Henlius and Organon Defendants responded to the complaint, asserting counterclaims for invalidity and non-infringement and affirmative defenses. On October 10, 2025, Amgen responded to those counterclaims and asserted its affirmative defenses. A claim construction hearing will be scheduled after June 23, 2027, and the joint pretrial order is due April 28, 2028. A trial date has not yet been set.
Amgen Inc. et al. v. Hikma Pharmaceuticals USA Inc. et al.
On June 25, 2025, Amgen Inc. and Amgen Manufacturing Limited LLC filed a lawsuit in the New Jersey District Court against Hikma Pharmaceuticals USA Inc., Gedeon Richter Plc., and Gedeon Richter USA, Inc. (collectively, the Hikma and Gedeon Richter Defendants) based on the submission to the FDA of a BLA seeking approval to market and sell a biosimilar version of Amgen’s Prolia and XGEVA products. The complaint asserts infringement of the following patents: U.S. Patent Nos. 7,364,736; 7,888,101; 7,928,205; 8,053,236; 8,058,418; 8,460,896; 8,680,248; 9,012,178; 9,228,168; 9,328,134; 9,359,435; 9,371,554; 10,106,829; 10,167,492; 10,227,627; 10,513,723; 10,583,397; 10,822,630; 10,894,972; 11,077,404; 11,098,079; 11,130,980; 11,192,919; 11,254,963; 11,299,760; 11,319,568; 11,434,514; 11,459,595; 11,492,372; 11,946,085; 11,952,605; and 12,084,686 (collectively, the Asserted Patents against the Hikma and Gedeon Richter Defendants). Amgen seeks a judgment from the New Jersey District Court that the Hikma and Gedeon Richter Defendants have infringed or will infringe one or more claims of each of the Asserted Patents against the Hikma and Gedeon Richter Defendants and based on that judgment, a permanent injunction prohibiting the commercial manufacture, use, offer to sell, or sale within the United States or importation into the United States of the accused proposed denosumab biosimilar before expiration of each of the patents found to be infringed. Amgen also seeks monetary remedies for any past acts of infringement. On June 25, 2025, this litigation became a member of In Re: Denosumab Patent Litigation multi-district litigation with other cases involving Prolia/XGEVA biosimilars pending in the district. A trial date has not yet been set.
On September 5, 2025, the Hikma and Gedeon Richter Defendants responded to the complaint, asserting counterclaims and affirmative defenses on September 5, 2025. On October 10, 2025, Amgen responded to those counterclaims and asserted its affirmative defenses. Pursuant to a consent order providing leave to amend, Amgen filed an Amended Complaint on November 14, 2025, adding Gedeon Richter (Schweiz) AG as a defendant to the litigation.
The parties entered into a settlement agreement that resolves the patent litigation related to the Hikma denosumab biosimilar products in the United States. Accordingly, the New Jersey District Court entered a Consent Judgment and Injunction on November 24, 2025, finding the claims of Amgen’s U.S. patents asserted against the Hikma and Gedeon Richter Defendants valid, enforceable and infringed by Hikma’s denosumab biosimilars in the United States and enjoining Defendants from importing, making, using, offering to sell or selling the Hikma denosumab biosimilar products in the United States before January 1, 2026, except as may be permitted by the agreement or by statue.
Amgen Inc. et al. v. Amneal Pharmaceuticals, Inc. et al.
On November 6, 2025, Amgen Inc. and Amgen Manufacturing Limited LLC filed a lawsuit in the New Jersey District Court against Amneal Pharmaceuticals, Inc., Amneal Pharmaceuticals LLC, GH Genhelix S.A., Universal Farma S.L., and Mabxience Research S.L., (collectively, the Amneal and Mabxience Defendants) based on the submission to the FDA of a BLA seeking approval to market and sell a biosimilar version of Amgen’s Prolia and XGEVA products. The complaint asserts infringement of the following patents: U.S. Patent Nos. 7,364,736; 7,888,101; 7,928,205; 8,053,236; 8,058,418; 8,460,896; 8,680,248; 9,012,178; 9,228,168; 9,320,816; 9,328,134; 9,359,435; 10,106,829; 10,167,492; 10,227,627; 10,513,723; 10,583,397; 10,655,156; 10,822,630; 10,894,972; 11,077,404; 11,098,079; 11,130,980; 11,254,963; 11,299,760; 11,319,568; 11,434,514; 11,459,595; 11,946,085; 11,952,605; 12,084,686 (collectively, the Asserted Patents against the Amneal and Mabxience Defendants). Amgen seeks a judgment from the New Jersey District Court that the Amneal and Mabxience
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Defendants have infringed or will infringe one or more claims of each of the Asserted Patents against the Amneal and Mabxience Defendants and based on that judgment, a permanent injunction prohibiting the commercial manufacture, use, offer to sell, or sale within the United States or importation into the United States of the accused denosumab biosimilar by the Amneal and Mabxience Defendants before expiration of each of the patents found to be infringed. Amgen also seeks monetary remedies for any past acts of infringement. On January 9, 2026 and January 23, 2026, respectively, the Amneal and Mabxience Defendants responded to the complaint asserting affirmative defenses.
This litigation is part of the In Re: Denosumab Patent Litigation multi-district litigation with other patent cases involving Prolia/XGEVA biosimilars pending in the district. A claim construction hearing will be scheduled after June 23, 2027, and the joint pretrial order is due April 28, 2028. A trial date has not yet been set.
Amgen Inc. et al. v. Dr. Reddy’s Laboratories Ltd., et al.
On November 6, 2025, Amgen Inc. and Amgen Manufacturing Limited LLC filed a lawsuit in the New Jersey District Court against Dr. Reddy’s Laboratories Ltd., Dr. Reddy’s Laboratories SA, Dr. Reddy’s Laboratories Inc., Alvotech Hf, and Alvotech Swiss AG (collectively, the Dr. Reddy’s and Alvotech Defendants) based on the submission to the FDA of a BLA seeking approval to market and sell a biosimilar version of Amgen’s Prolia and XGEVA products. The complaint asserts infringement of the following patents: U.S. Patent Nos. 7,364,736; 7,888,101; 7,928,205; 8,053,236; 8,058,418; 8,460,896; 8,680,248; 9,012,178; 9,228,168; 9,328,134; 9,359,435; 10,106,829; 10,167,492; 10,227,627; 10,513,723; 10,583,397; 10,822,630; 10,894,972; 11,077,404; 11,098,079; 11,130,980; 11,192,919; 11,254,963; 11,299,760; 11,319,568; 11,434,514; 11,459,595; 11,492,372; 11,946,085; 11,952,605; 12,084,686 (collectively, the Asserted Patents against the Dr. Reddy’s and Alvotech Defendants). Amgen seeks a judgment from the New Jersey District Court that the Dr. Reddy’s and Alvotech Defendants have infringed or will infringe one or more claims of each of the Asserted Patents against the Dr. Reddy’s and Alvotech Defendants and based on that judgment, a permanent injunction prohibiting the commercial manufacture, use, offer to sell, or sale within the United States or importation into the United States of the accused proposed denosumab biosimilar by the Dr. Reddy’s and Alvotech Defendants before expiration of each of the patents found to be infringed. Amgen also seeks monetary remedies for any past acts of infringement. On January 9, 2026, the Dr. Reddy’s and Alvotech Defendants responded to the complaint asserting counterclaims for invalidity and non-infringement and affirmative defenses. On January 30, 2026, Amgen responded to those counterclaims and asserted its affirmative defenses.
This litigation is part of the In Re: Denosumab Patent Litigation multi-district litigation with other patent cases involving Prolia/XGEVA biosimilars pending in the district. A claim construction hearing will be scheduled after June 23, 2027, and the joint pretrial order is due April 28, 2028. A trial date has not yet been set.
Amgen Inc. et al. v Alkem Laboratories Ltd., et al.
On November 14, 2025, Amgen Inc. and Amgen Manufacturing Limited LLC filed a lawsuit in the New Jersey District Court against Alkem Laboratories Ltd., Ascend Laboratories, LLC, and Enzene Biosciences (collectively, the Alkem Defendants) based on the submission to the FDA of a BLA seeking approval to market and sell a biosimilar version of Amgen’s Prolia and XGEVA products. The complaint asserts infringement of the following patents: U.S. Patent Nos. 7,364,736; 7,662,930; 7,888,101; 7,928,205; 8,053,236; 8,058,418; 8,247,210; 8,460,896; 8,680,248; 9,012,178; 9,228,168; 9,328,134; 9,359,435; 10,106,829; 10,167,492; 10,227,627; 10,513,723; 10,583,397; 10,655,156; 10,822,630; 10,894,972; 10,907,186; 11,077,404; 11,098,079; 11,130,980; 11,192,919; 11,254,963; 11,299,760; 11,319,568; 11,434,514; 11,459,595; 11,492,372; 11,946,085; 11,952,605; 12,084,686 (collectively, the Asserted Patents against the Alkem Defendants). Amgen seeks a judgment from the New Jersey District Court that the Alkem Defendants have infringed or will infringe one or more claims of each of the Asserted Patents against the Alkem Defendants and based on that judgment, a permanent injunction prohibiting the commercial manufacture, use, offer to sell, or sale within the United States or importation into the United States of the accused proposed denosumab biosimilar by the Alkem Defendants before expiration of each of the patents found to be infringed. Amgen also seeks monetary remedies for any past acts of infringement. On January 23, 2026, the Alkem Defendants responded to the complaint asserting affirmative defenses and counterclaims. On February 12, 2026, the Alkem Defendants filed an amended answer asserting affirmative defenses and counterclaims.
This litigation is part of the In Re: Denosumab Patent Litigation multi-district litigation with other patent cases involving Prolia/XGEVA biosimilars pending in the district. A claim construction hearing will be scheduled after June 23, 2027, and the joint pretrial order is due April 28, 2028. A trial date has not yet been set.
PAVBLU ® (aflibercept-ayyh) Patent Litigation
On January 10, 2024, Regeneron filed a lawsuit in the U.S. District Court for the Central District of California (California Central District Court) against Amgen alleging infringement of 32 patents listed by Regeneron in the BPCIA exchange (the 2024 Complaint). The lawsuit stems from Amgen’s submission of an application under the BPCIA for FDA licensure of
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PAVBLU as biosimilar to Regeneron’s EYLEA ® . By its complaint, Regeneron seeks, among other remedies, an injunction prohibiting the commercial manufacture, use, offer for sale or sale in the United States or import into the United States of PAVBLU before the expiration of each of the patents found to be infringed. Amgen responded to Regeneron’s complaint on February 2, 2024, denying infringement and asserting counterclaims seeking a declaratory judgment that the asserted patents are not infringed, invalid, and/or unenforceable.
On April 11, 2024, the Judicial Panel on Multidistrict Litigation granted a motion filed by Regeneron requesting transfer of Regeneron’s patent infringement lawsuit pending against Amgen in the California Central District Court to the U.S. District Court for the Northern District of West Virginia (West Virginia District Court) for coordinated and consolidated pretrial proceedings with the five other cases involving EYLEA ® biosimilars pending in that district.
On June 7, 2024, Regeneron filed a motion in the West Virginia District Court for a preliminary injunction to prohibit Amgen from engaging in the manufacture, use, offer for sell or sale within the United States, or importation into the United States, of PAVBLU until resolution of this lawsuit or the entry of a permanent injunction, whichever comes first. Regeneron’s motion focused on U.S. Patent No. 11,084,865, a formulation patent. On September 23, 2024, the West Virginia District Court denied Regeneron’s motion for a preliminary injunction, and Regeneron filed a notice of appeal, a motion to expedite the appeal, and an emergency motion for an injunction pending resolution of the appeal and for an administrative stay with the U.S. Court of Appeals for the Federal Circuit (Federal Circuit Court). On September 25, 2024, the Federal Circuit Court issued an order temporarily enjoining the launch of PAVBLU on an administrative basis while it considered Regeneron’s motion for an injunction pending appeal. On October 22, 2024, the Federal Circuit Court denied Regeneron’s motion for an injunction pending appeal and lifted the temporary injunction that was entered on September 25, 2024. Oral argument for the appeal was held on January 14, 2025. On March 14, 2025, the U.S. Court of Appeals for the Federal Circuit affirmed the denial by the West Virginia District Court of Regeneron’s motion for a preliminary injunction.
On June 17, 2025, Regeneron filed a second lawsuit in the California Central District Court against Amgen alleging infringement of U.S. Patent No. 12,331,099 (the ’099 Patent), also a formulation patent. By its complaint, Regeneron seeks, among other remedies, damages and an injunction prohibiting the commercial manufacture, use, offer for sale or sale in the United States or import into the United States of PAVBLU before the expiration of the ’099 Patent. In July 2025, the Judicial Panel on Multidistrict Litigation issued an Order transferring the case from the California Central District Court to the West Virginia District Court for coordinated and consolidated pretrial proceedings with the other cases involving EYLEA ® biosimilars pending in the district, and on July 31, 2025 the case was opened in the West Virginia District Court.
On September 12, 2025, Amgen responded to Regeneron’s complaint asserting infringement of the ’099 Patent, denying infringement and asserting counterclaims seeking a declaratory judgment that the ’099 Patent is not infringed, invalid, and/or unenforceable, and counterclaims for Sherman Act (15 U.S.C. § 2) monopolization through Walker Process fraud, Sherman Act (15 U.S.C. § 2) attempted monopolization through Walker Process fraud, and unlawful and unfair practices under the California Unfair Competition Law. By its counterclaims, Amgen seeks, among other remedies, damages and an injunction against conduct by Regeneron. On September 29, 2025, the West Virginia District Court entered a scheduling order for the matters pending in the multidistrict litigation, including a claim construction hearing for November 23, 2026. On November 12, 2025, Regeneron filed a motion to strike certain of Amgen’s affirmative defenses and to dismiss certain of Amgen’s counterclaims, including the counterclaim seeking a declaratory judgment that the ’099 Patent is unenforceable, the counterclaims for Sherman Act monopolization and attempted monopolization, and the counterclaim for unlawful and unfair practices under the California Competition Law.
On January 7, 2026, the West Virginia District Court entered a stipulation and order of dismissal that dismissed with prejudice Regeneron’s claims with respect to 15 of the patents asserted in the 2024 Complaint and dismissed without prejudice Amgen’s counterclaims and affirmative defenses with respect to those patents. Also on January 7, 2026, the West Virginia District Court granted Regeneron’s motion for leave to amend the 2024 Complaint. The 2024 Complaint as amended alleges infringement of 19 patents and seeks, among other remedies, damages and an injunction prohibiting the commercial manufacture, use, offer for sale or sale in the United States or import into the United States of PAVBLU before the expiration of each of the patents found to be infringed.
KYPROLIS ® (carfilzomib) Abbreviated New Drug Application (ANDA) Patent Litigation
Onyx Therapeutics, Inc. v. Amneal Pharmaceuticals of New York, LLC and Amneal EU, Limited.
On September 4, 2025, Onyx Therapeutics, Inc. (Onyx Therapeutics, a wholly-owned subsidiary of Amgen) filed a lawsuit in the U.S. District Court for the District of Delaware (Delaware District Court) against Amneal Pharmaceuticals of New York, LLC and Amneal EU, Limited (collectively, Amneal), asserting infringement of U.S. Patent No. 7,737,112 (the ’112 Patent) based on Amneal’s submission of an application pursuant to Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act seeking FDA approval to market a generic version of KYPROLIS. Onyx Therapeutics seeks an order from the
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Delaware District Court making any FDA approval of Amneal’s application effective no earlier than the expiration of the ’112 Patent.
On November 6, 2025, Amneal answered the complaint and counterclaimed, seeking a declaration of non-infringement, and filed a motion for judgment on the pleadings of non-infringement. On December 8, 2025, Onyx answered Amneal’s counterclaim, and on December 11, 2025, Onyx opposed Amneal’s motion for judgment on the pleadings. On February 3, 2026, the Delaware District Court denied Amneal’s motion for judgment on the pleadings.
TAVNEOS ® (avacopan) Abbreviated New Drug Application (ANDA) Patent Litigation
ChemoCentryx, Inc. v. Zydus Pharmaceuticals (USA) Inc., Zydus Lifesciences Global FZE, and Zydus Lifesciences Limited
On January 16, 2026, ChemoCentryx, Inc. (ChemoCentryx, a wholly-owned subsidiary of Amgen) filed a lawsuit in the New Jersey District Court against Zydus Pharmaceuticals (USA) Inc., Zydus Lifesciences Global FZE, and Zydus Lifesciences Limited (collectively, Zydus) asserting infringement of U.S. Patent Nos. 11,603,356 (the ’356 Patent) and 11,951,214 (the ’214 Patent) based on Zydus’s submission of an ANDA seeking FDA approval to market a generic version of TAVNEOS. ChemoCentryx seeks, among other things, an order from the New Jersey District Court making any FDA approval of Zydus’s ANDA effective no earlier than the expiration of the ’356 and ’214 Patents.
ChemoCentryx, Inc. v. Annora Pharma Private Limited, Hetero USA Inc., and Hetero Labs Limited
On February 9, 2026, ChemoCentryx filed a lawsuit in the New Jersey District Court against Annora Pharma Private Limited, Hetero USA Inc., and Hetero Labs Limited (collectively, Annora) asserting infringement of the ’356 Patent and the ’214 Patent based on Annora’s submission of an ANDA seeking FDA approval to market a generic version of TAVNEOS. ChemoCentryx seeks, among other things, an order from the New Jersey District Court making any FDA approval of Annora’s ANDA effective no earlier than the expiration of the ’356 and ’214 Patents.
Antitrust Class Action
Regeneron Pharmaceuticals, Inc. Antitrust Action
On May 27, 2022, Regeneron filed suit against Amgen in the Delaware District Court for federal and state antitrust and unfair competition violations and tortious interference with prospective business relations. Regeneron alleges that Amgen’s sales contracting practices for Repatha, ENBREL and Otezla with key insurers, third-party payers and PBMs have harmed the sales of its product PRALUENT ® and focuses on two primary arguments: that Amgen improperly bundled sales of Repatha with ENBREL, Otezla and potentially other products and sought exclusive or de facto exclusive formulary positioning for Repatha. Amgen’s initial responsive pleading, a motion to dismiss, was filed on August 1, 2022. The Delaware District Court denied Amgen’s motion to dismiss the complaint.
On August 28, 2023, Regeneron filed its amended complaint, and on September 20, 2023, Amgen filed a counterclaim, alleging Regeneron’s own anticompetitive conduct with respect to formulary position for Regeneron’s drug, PRALUENT ® , at CVS. Amgen notified the Delaware District Court that it would not be pursuing its counterclaim on April 24, 2025.
A jury trial was held in the Delaware District Court from May 5, 2025 to May 14, 2025. On May 15, 2025, the jury returned a verdict finding for Regeneron on its federal and state antitrust law and tortious interference claims but finding for Amgen on its below-cost pricing claim under California’s Unfair Practices Act. The jury awarded Regeneron $ 135.6  million in compensatory damages on its antitrust claims (which are subject to trebling under applicable law), or in the alternative, in compensatory damages plus $ 271.2  million in punitive damages on its tortious interference claim, with such damages under either alternative claim totaling $ 406.8  million. As Regeneron must elect between recovery under the antitrust or tortious interference claims, any potential damages award would be limited to one of these claims. Although we cannot predict with certainty the ultimate outcome of this litigation, Amgen believes that the jury’s decision and amounts awarded are inconsistent with the law and evidence at trial.
Both parties have filed post-trial motions. On June 12, 2025, Amgen filed a renewed motion for judgment as a matter of law or, in the alternative, for a new trial. Also on June 12, 2025, Regeneron filed a motion for permanent injunctive relief, a constructive trust, and prejudgment interest. Both motions were fully briefed and a hearing on the post-trial motions was held on August 27, 2025.
In assessing whether we should accrue a liability for this litigation in our consolidated financial statements, we considered various factors, including the legal and factual circumstances of the case, the jury’s award, the court’s post-trial proceedings, applicable law, and the likelihood that the jury’s award will be upheld after post-trial briefing and potentially on appeal. As a
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result of this review, we have determined, in accordance with applicable accounting standards, that it is not probable that we will incur a loss as a result of this litigation, and we have therefore not recorded a liability for this matter.
The ultimate result of this litigation, however, is uncertain because it is reasonably possible that by settlement or final court judgment that none, some, or all of the jury’s verdict and other relief sought might ultimately be awarded but the size of an award, if any, is not estimable at this time.
CareFirst of Maryland Antitrust Class Action
On August 6, 2024, CareFirst of Maryland, Inc., Group Hospitalization and Medical Services, Inc., and CareFirst BlueChoice, Inc. (collectively, CareFirst), filed a proposed class action lawsuit against Amgen Inc., Amgen Manufacturing, Limited (corrected to Amgen Manufacturing Limited LLC in CareFirst’s amended complaint on filed October 11, 2024), and Immunex Corporation in the U.S. District Court for the Eastern District of Virginia (District Court for the Eastern District of Virginia), alleging federal and state antitrust claims and state consumer protection and unjust enrichment claims. CareFirst alleges that, in 2004, Amgen entered into an anticompetitive agreement with certain F. Hoffman-La Roche AG entities (Roche) and other parties that provided Amgen with rights to Roche’s patents in a manner that enabled Amgen to allegedly unlawfully extend the life of patents applicable to ENBREL and, thereby, delay biosimilar entry. On November 4, 2024, Amgen filed a motion to dismiss, and CareFirst thereafter filed a second amended complaint on November 25, 2024. On January 8, 2025, Amgen filed a motion to dismiss the second amended complaint.
On September 30, 2025, the District Court for the Eastern District of Virginia issued an order granting in part and denying in part Amgen’s motion to dismiss. The court dismissed CareFirst’s antitrust claim under Puerto Rico law and its unjust enrichment claims under the laws of seven states and Puerto Rico, but otherwise permitted the claims to proceed. On October 20, 2025, Amgen filed a motion asking the district court to certify its order on the motion to dismiss for interlocutory appeal to the U.S. Court of Appeals for the Fourth Circuit. On November 3, 2025, CareFirst filed its opposition to Amgen’s motion to certify for interlocutory appeal. On November 7, 2025, Amgen filed its answer to the second amended complaint, and on November 10, 2025, Amgen filed its reply in support of its motion to certify for interlocutory appeal.
Sandoz Inc. Antitrust Action
On April 11, 2025, Sandoz Inc. (Sandoz) filed a complaint in the U.S. District Court for the Eastern District of Virginia against Amgen Inc., Amgen Manufacturing Limited LLC, and Immunex Corporation claiming violations of the antitrust laws and tortious interference related to Amgen’s patent rights to ENBREL, and seeking damages, injunctive relief and attorneys’ fees. The factual allegations that form the basis for the claims of Sandoz’s complaint are substantially similar to those asserted in the lawsuit filed against Amgen in the same court by CareFirst.
On June 20, 2025, Amgen filed a motion to dismiss the complaint. Sandoz filed its opposition to the motion to dismiss on July 21, 2025, and on August 21, 2025, Amgen filed its reply in support of the motion to dismiss.
Other Similar Antitrust Actions
In July and August 2025, seven lawsuits were filed in the California Superior Court in Ventura County, each alleging state law antitrust, consumer protection, and unjust enrichment claims, based on allegations substantially similar to those in the CareFirst class action. The cases were filed by: Centene Corporation, WellCare Health Plans, Inc., New York Quality Healthcare Corporation d/b/a Fidelis Care, and Health Net, LLC (collectively, Centene) on July 29, 2025; Humana Inc. (Humana) on July 29, 2025; Molina Healthcare, Inc. (Molina) on July 29, 2025; Blue Cross and Blue Shield of Florida, Inc. and Health Options, Inc. d/b/a Florida Blue HMO (collectively, BCBSFL) on July 29, 2025; Blue Cross and Blue Shield of Kansas City (BCBSKC) on July 29, 2025; Blue Cross and Blue Shield of Massachusetts, Inc. and Blue Cross and Blue Shield of Massachusetts HMO Blue, Inc. (collectively, BCBSMA) on August 8, 2025; and Health Care Services Corp. (HCSC) on August 21, 2025. Amgen subsequently removed the cases filed by BCBSFL, BCBSKC, BCBSMA, and HCSC to the California Central District Court. On September 29, 2025, HCSC voluntarily dismissed its case without prejudice. On October 1, 2025, BCBSFL, BCBSKC, and BCBSMA voluntarily dismissed their cases without prejudice.
On January 8, 2026, Amgen filed demurrers to the complaints filed by Centene, Humana, and Molina, seeking the dismissal of the claims in those complaints, with prejudice. On February 2, 2026, the complaint in the Centene case was amended to join BCBSFL, BCBSKC, BCBSMA, and HCSC as additional plaintiffs. Humana and Molina filed their opposition to Amgen’s demurrers on February 5, 2026, and Amgen’s replies are due on February 26, 2026. On February 5, Amgen filed a demurrer to the amended Centene complaint; Centene’s opposition to the demurrer was filed February 9, 2026 and Amgen’s reply is due February 26, 2026.
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U.S. Tax Litigation and Related Matters
Amgen Inc. & Subsidiaries v. Commissioner of Internal Revenue
See Note 7, Income taxes, for discussion of the IRS tax dispute and the Company’s petitions in the U.S. Tax Court.
Securities Class Action Litigation (Roofers Local No. 149 Pension Fund)
On March 13, 2023, Roofers Local No. 149 Pension Fund filed a purported class action (Roofers Securities Class Action) against Amgen, Robert Bradway and Peter Griffith in the U.S. District Court for the Southern District of New York (Southern District Court of New York). The action was brought on behalf of an alleged class of Amgen shareholders who owned stock between July 29, 2020 and April 27, 2022 (the alleged class period). Plaintiffs allege that the defendants made a series of materially false and misleading statements and omissions during the alleged class period regarding the failure to timely disclose the potential tax liability claimed by the IRS. Plaintiffs further allege that they and other purported class members suffered losses and damages resulting from declines in the market value of Amgen’s common stock after the potential tax liability claimed by the IRS was disclosed.
On August 31, 2023, plaintiff filed an amended complaint and Amgen filed a motion to dismiss on November 6, 2023, which the Southern District Court of New York denied on September 30, 2024. On November 20, 2024, Amgen filed an answer to the amended complaint.
Pursuant to the Southern District Court of New York’s order on September 11, 2025, the class certification briefing is due by April 24, 2026. The last day to file summary judgment motions is December 21, 2026, but no briefing schedule has been set and no trial date has been set.
On December 9, 2025, plaintiffs filed their motion for class certification. Amgen’s opposition is due on March 9, 2026 and plaintiffs’ reply is due May 8, 2026.
Shareholder Derivative Actions (Martin, Clearwater and DM Cohen)
On August 2, 2023, Leon Martin filed a derivative action (the Martin Derivative Action) captioned Leon Martin v. Robert A. Bradway, et al., No. 1:23-cv-06754 (S.D.N.Y. Aug. 2, 2023), purportedly on behalf of Amgen, against Amgen, Robert Bradway, Peter Griffith and Amgen’s independent Board members. The action was filed in the Southern District Court of New York as related to the pending Roofers Securities Class Action. The complaint in this matter alleges claims for violations of the Securities Exchange Act of 1934, breach of fiduciary duty, aiding and abetting breach of fiduciary duty, unjust enrichment and waste of corporate assets.
On December 7, 2023, Plaintiff filed a Notice of Voluntary Dismissal as to Board member Michael Drake.
On December 1, 2023, a second derivative action (the Clearwater Derivative Action) was filed, captioned Cheri Clearwater v. Robert A. Bradway, et al., No. 1:23-cv-10538 (S.D.N.Y. Dec. 1, 2023), in the same court as the earlier-filed Martin Derivative Action. The second action is largely duplicative of the Martin Derivative Action, asserting the same claims purportedly on behalf of the Company against the individual directors that sat on Amgen’s Board during the relevant time period (July 29, 2020 through April 27, 2022). The complaint asserts claims for breach of fiduciary duty, unjust enrichment, waste of corporate assets, abuse of control, gross mismanagement, and violations of Section 10(b) of the Exchange Act arising out of Amgen’s disclosures with respect to its transfer pricing dispute with the IRS. However, the Clearwater Derivative Action complaint adds (1) two additional claims for violations of Sections 14(a) and 20(a) of the Exchange Act; (2) allegations that Amgen repurchased its own stock at artificially inflated prices during the relevant period; and (3) more detailed allegations as to why first making a demand on the Board would have been futile.
On January 16, 2024, the Southern District Court of New York consolidated the Martin Derivative Action and Clearwater Derivative Action (the Consolidated Action). The Southern District Court of New York entered an Order staying the Consolidated Action until a final judgment is entered in the Roofers Securities Class Action.
On February 12, 2025, DM Cohen, Inc. filed a third derivative action (the DM Cohen Derivative Action) captioned DM Cohen, Inc. v. Robert A. Bradway, et al, No. 1:25-mc-00062 (S.D.N.Y. Feb. 12, 2025), purportedly on behalf of Amgen, against Amgen, Robert Bradway, Peter Griffith and Amgen’s independent Board members. The DM Cohen Derivative Action was filed in the same court as the earlier filed Roofers Securities Class Action and the Consolidated Action. The complaint asserts claims for violations of the Securities Exchange Act of 1934, breach of fiduciary duty, waste of corporate assets and unjust enrichment.
The factual allegations that form the basis for the claims in the Consolidated Action and the DM Cohen Derivative Action are essentially the same as the allegations asserted in the Roofers Securities Class Action regarding purportedly false and
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misleading statements and omissions made from July 29, 2020 through April 27, 2022 relating to Amgen’s tax liabilities, business and finances, and the adequacy and maintenance of its internal controls.
On April 21, 2025, the Southern District Court of New York consolidated the derivative action filed by DM Cohen, Inc. with the Consolidated Action.
The case is stayed pending entry of a final judgment in the Roofers Securities Class action.
Shareholder Derivative Actions (Hamilton, Blackburn, Bryla)
On October 16, 2024, David Hamilton filed a derivative action in the Delaware Court of Chancery purportedly on behalf of Amgen, against nominal defendant Amgen, Robert Bradway, Peter Griffith and Amgen’s Board members during the relevant time period (the Hamilton Derivative Action). The complaint in this matter alleges claims for breach of fiduciary duty and unjust enrichment.
On November 7, 2024, Charles Blackburn filed a derivative action in the Delaware Court of Chancery purportedly on behalf of Amgen, against nominal defendant Amgen, Robert Bradway, Peter Griffith and Amgen’s Board members during the relevant time period (the Blackburn Derivative Action). The complaint alleges a claim for breach of fiduciary duty.
On December 6, 2024, Robert Bryla filed a derivative action in the Delaware Court of Chancery purportedly on behalf of Amgen, against nominal defendant Amgen, Robert Bradway, Peter Griffith and Amgen’s Board members during the relevant time period (the Bryla Derivative Action). The complaint alleges claims for breach of fiduciary duty and unjust enrichment.
The factual allegations that form the basis for the claims in the Hamilton Derivative Action, Blackburn Derivative Action and Bryla Derivative Action are fundamentally the same as those asserted by the Roofers Local No. 149 Pension Fund on March 13, 2023 (alleging false and misleading statements and omissions made from July 29, 2020 through April 27, 2022 relating to Amgen’s tax liabilities, business and finances, and the adequacy and maintenance of its internal controls).
On April 9, 2025, the Delaware Court of Chancery consolidated the derivative actions filed by each of David Hamilton, Charles Blackburn and Robert Bryla purportedly on behalf of Amgen against nominal defendant Amgen, Robert Bradway, Peter Griffith and Amgen’s independent Board members.
The case is stayed pending entry of a final judgment in the Roofers Securities Class Action.
Shareholder Derivative Actions (Sieveking, Tierney)
On April 2, 2025, Carolyn Sieveking and James P. Tierney filed a derivative action (the Sieveking Derivative Action) in the Delaware District Court purportedly on behalf of Amgen, against nominal defendant Amgen, Robert Bradway, Peter Griffith, Linda Louie and Amgen’s Board members during the relevant time period (the Sieveking Derivative Action). The complaint alleges claims for violations of Section 10(b), Rule 10b5 and Section 20(a) of the Securities Exchange Act of 1934, and breach of fiduciary duty.
The factual allegations that form the basis for the claims in the Sieveking Derivative Action is fundamentally the same as those asserted by the Roofers Local No. 149 Pension Fund.
On June 9, 2025, the Delaware District Court stayed the case pending entry of a final judgment in the Roofers Securities Class Action.
ChemoCentryx, Inc. Securities Matters
On May 5 and June 8 of 2021, ChemoCentryx and its Chief Executive Officer were named as defendants in two putative shareholder class actions filed in the U.S. District Court for the Northern District of California (Northern District Court of California). These cases were consolidated into Homyk v. ChemoCentryx, Inc. in which the plaintiffs allege violations of Sections 10(b) and 20(a) of the Securities Exchange Act in connection with statements regarding the New Drug Application for TAVNEOS and the underlying Phase 3 clinical trial, seeking an award of damages, interest and attorneys’ fees. On March 28, 2022, the plaintiffs filed their consolidated amended complaint, and on May 19, 2022, ChemoCentryx moved to dismiss these claims.
On February 23, 2023, the Northern District Court of California substantially denied ChemoCentryx’s motion to dismiss the matter in its entirety, while granting the motion to dismiss with respect to certain allegations of the plaintiffs. On August 25, 2023, the lead plaintiff moved to certify a class composed of all purchasers of ChemoCentryx stock between November 25, 2019 and May 6, 2021.
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On March 6, 2024, the Northern District Court of California certified a class of all persons who purchased or otherwise acquired the common stock of ChemoCentryx between November 26, 2019 and May 6, 2021. The deadline for class members to opt out of the class action was January 14, 2025.
On August 15, 2025, the Northern District Court of California granted defendants’ motion for summary judgment in its entirety and denied lead plaintiff’s motion for partial summary judgment. On September 12, 2025, the lead plaintiff filed a notice of appeal to the Ninth Circuit Court of Appeals, and filed its opening brief on January 5, 2026.
On January 27, 2026, the parties informed the Court of Appeals they had reached an agreement to settle the case on a class-wide basis, subject to approval by the district court.
Opt-Out Cases
Prior to the opt-out deadline, on May 2, 2024, RA Capital Healthcare Fund, LP filed two securities cases (which are similar to the class action), in the California Superior Court in Ventura County and in the Northern District Court of California, against ChemoCentryx and its former Chief Executive Officer, Dr. Thomas Schall. On July 2, 2024, the state court stayed the case pending an order on summary judgment in the federal class action. Defendants, including ChemoCentryx, moved to dismiss the complaint, and on June 13, 2025, the court issued an order staying the federal case pending resolution of the class action. The court did not reach the merits of defendants’ motion to dismiss.
Commitments – U.S. repatriation tax
Under the 2017 Tax Act, we elected to pay in eight annual installments the repatriation tax related primarily to prior indefinitely invested earnings of our foreign operations. The final U.S. repatriation tax payment of $ 1.8 billion was made in 2025.
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SCHEDULE II
AMGEN INC.
VALUATION AND QUALIFYING ACCOUNTS
Years ended December 31, 2025, 2024 and 2023
(In millions)

Allowance for doubtful accounts Balance
at beginning
of period Additions
charged to
costs and
expenses Deductions
Other changes
Balance
at end
of period
2025
$ 38   $ 1   $ —   $ 4   $ 43  
2024
$ 28   $ 13   $ —   $ ( 3 ) $ 38  
2023
$ 22   $ 6   $ —   $ —   $ 28  

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