Item 1. FINANCIAL STATEMENTS

116K characters. Original on sec.gov · Markdown

Item 1. FINANCIAL STATEMENTS

AMGEN INC.

CONDENSED CONSOLIDATED STATEMENTS OF (LOSS) INCOME

(In millions, except per-share data)

(Unaudited)

Three months ended March 31,
20242023
Revenues:
Product sales$7,118$5,846
Other revenues329259
Total revenues7,4476,105
Operating expenses:
Cost of sales3,2001,720
Research and development1,3431,058
Selling, general and administrative1,8081,258
Other105148
Total operating expenses6,4564,184
Operating income9911,921
Other income (expense):
Interest expense, net(824)(543)
Other (expense) income, net(235)2,064
(Loss) income before income taxes(68)3,442
Provision for income taxes45601
Net (loss) income$(113)$2,841
(Loss) earnings per share:
Basic$(0.21)$5.32
Diluted$(0.21)$5.28
Shares used in calculation of (loss) earnings per share:
Basic536534
Diluted536538

See accompanying notes.

AMGEN INC.

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE (LOSS) INCOME

(In millions)

(Unaudited)

Three months ended March 31,
20242023
Net (loss) income$(113)$2,841
Other comprehensive income (loss), net of reclassification adjustments and taxes:
Foreign currency translation(24)28
Cash flow hedges126(86)
Other(3)21
Other comprehensive income (loss), net of reclassification adjustments and taxes99(37)
Comprehensive (loss) income$(14)$2,804

See accompanying notes.

AMGEN INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(In millions, except per-share data)

March 31, 2024December 31, 2023
(Unaudited)
ASSETS
Current assets:
Cash and cash equivalents$9,708$10,944
Trade receivables, net6,7767,268
Inventories8,7249,518
Other current assets2,8212,602
Total current assets28,02930,332
Property, plant and equipment, net6,0025,941
Intangible assets, net31,37232,641
Goodwill18,57018,629
Other noncurrent assets9,0079,611
Total assets$92,980$97,154
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable$1,628$1,590
Accrued liabilities14,12715,359
Current portion of long-term debt3,9591,443
Total current liabilities19,71418,392
Long-term debt60,06163,170
Long-term deferred tax liabilities1,8622,354
Long-term tax liabilities3,9644,680
Other noncurrent liabilities2,3572,326
Contingencies and commitments
Stockholders’ equity:
Common stock and additional paid-in capital; $0.0001 par value; 2,750.0 shares authorized; outstanding—536.4 shares in 2024 and 535.4 shares in 202333,08233,070
Accumulated deficit(27,870)(26,549)
Accumulated other comprehensive loss(190)(289)
Total stockholders’ equity5,0226,232
Total liabilities and stockholders’ equity$92,980$97,154

See accompanying notes.

AMGEN INC.

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY

(In millions, except per-share data)

(Unaudited)

Number of shares of common stockCommon stock and additional paid-in capitalAccumulated deficitAccumulated other comprehensive lossTotal
Balance as of December 31, 2023535.4$33,070$(26,549)$(289)$6,232
Net loss——(113)—(113)
Other comprehensive income, net of taxes———9999
Dividends declared on common stock ($2.25 per share)——(1,208)—(1,208)
Issuance of common stock in connection with the Company’s equity award programs1.034——34
Stock-based compensation expense—103——103
Tax impact related to employee stock-based compensation expense—(125)——(125)
Balance as of March 31, 2024536.4$33,082$(27,870)$(190)$5,022
Number of shares of common stockCommon stock and additional paid-in capitalAccumulated deficitAccumulated other comprehensive lossTotal
Balance as of December 31, 2022534.0$32,514$(28,622)$(231)$3,661
Net income——2,841—2,841
Other comprehensive loss, net of taxes———(37)(37)
Dividends declared on common stock ($2.13 per share)——(1,138)—(1,138)
Issuance of common stock in connection with the Company’s equity award programs0.311——11
Stock-based compensation expense—47——47
Tax impact related to employee stock-based compensation expense—(37)——(37)
Balance as of March 31, 2023534.3$32,535$(26,919)$(268)$5,348

See accompanying notes.

AMGEN INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(In millions)

(Unaudited)

Three months ended March 31,
20242023
Cash flows from operating activities:
Net (loss) income$(113)$2,841
Depreciation, amortization and other1,399900
Stock-based compensation expense10347
Deferred income taxes(401)(49)
Adjustments for equity method investments(27)(31)
Losses (gains) on equity securities515(1,830)
Other items, net(95)(60)
Changes in operating assets and liabilities, net of acquisitions:
Trade receivables, net486(144)
Inventories806(58)
Other assets(89)(139)
Accounts payable23(253)
Accrued income taxes, net223443
Long-term tax liabilities(715)107
Accrued liabilities(1,054)(230)
Accrued sales incentives and allowance(316)(402)
Other liabilities(56)(78)
Net cash provided by operating activities6891,064
Cash flows from investing activities:
Proceeds from sales of marketable securities—1,124
Proceeds from maturities of marketable securities—550
Purchases of property, plant and equipment(230)(344)
Other1328
Net cash (used in) provided by investing activities(217)1,358
Cash flows from financing activities:
Net proceeds from issuance of debt—23,798
Extinguishment of debt(410)(420)
Repayment of debt—(704)
Dividends paid(1,208)(1,137)
Other(90)(28)
Net cash (used in) provided by financing activities(1,708)21,509
(Decrease) increase in cash and cash equivalents(1,236)23,931
Cash and cash equivalents at beginning of period10,9447,629
Cash and cash equivalents at end of period$9,708$31,560

See accompanying notes.

AMGEN INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

March 31, 2024

(Unaudited)

1. Summary of significant accounting policies

Business

Amgen Inc. (including its subsidiaries, referred to as “Amgen,” “the Company,” “we,” “our” or “us”) is a global biotechnology pioneer that discovers, develops, manufactures and delivers innovative human therapeutics. We operate in one business segment: human therapeutics.

Basis of presentation

The financial information for the three months ended March 31, 2024 and 2023, is unaudited but includes all adjustments (consisting of only normal, recurring adjustments unless otherwise indicated), which Amgen considers necessary for a fair presentation of its condensed consolidated results of operations for those periods. Interim results are not necessarily indicative of results for the full fiscal year.

The condensed consolidated financial statements should be read in conjunction with our consolidated financial statements and the notes thereto contained in our Annual Report on Form 10-K for the year ended December 31, 2023.

Principles of consolidation

The condensed consolidated financial statements include the accounts of Amgen as well as its majority-owned subsidiaries. In determining whether we are the primary beneficiary of a variable interest entity, we consider whether we have both the power to direct activities of the entity that most significantly impact the entity’s economic performance and the obligation to absorb losses of or the right to receive benefits from the entity that could potentially be significant to that entity. We do not have any significant interests in any variable interest entities of which we are the primary beneficiary. All material intercompany transactions and balances have been eliminated in consolidation. Certain reclassifications have been made to prior periods in the condensed consolidated financial statements and accompanying notes to conform with the current presentation.

Use of estimates

The preparation of condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the condensed consolidated financial statements and accompanying notes. Actual results may differ from those estimates.

Property, plant and equipment, net

Property, plant and equipment is recorded at historical cost, net of accumulated depreciation and amortization, of $9.9 billion and $9.8 billion as of March 31, 2024 and December 31, 2023, respectively.

Recent accounting pronouncements

In November 2023, the Financial Accounting Standards Board (FASB) issued a new accounting standard that improves reportable segment disclosure requirements. The new standard requires enhanced disclosures about a public company’s significant segment expenses and more timely and detailed segment information reporting throughout the fiscal period, including for companies with a single reportable segment. The standard is effective for public business entities for annual periods beginning after December 15, 2023 and interim periods beginning after December 15, 2024, and early adoption is permitted. We are currently evaluating the impact of this new standard on our related disclosures.

In December 2023, the FASB issued a new accounting standard that improves income tax disclosure requirements. The new standard requires more detailed information on several income tax disclosures, such as income taxes paid and the income tax rate reconciliation table. The standard is effective for public business entities for annual periods beginning after December 15, 2024, and early adoption is permitted. We are currently evaluating the impact of this new standard on our related disclosures.

2. Acquisitions

Acquisition of Horizon Therapeutics plc

On October 6, 2023, Amgen completed its acquisition 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 thyroid eye disease, 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.

Measurement period adjustments during the three months ended March 31, 2024, included changes to the purchase price allocation, resulting in a net decrease of approximately $49 million to goodwill. The measurement period adjustments resulted primarily from adjustments to acquired assets and liabilities, including sales reserve and allowances as well as right-of-use assets and liabilities 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 three months ended March 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 total consideration and allocated acquisition date fair values of assets acquired and liabilities assumed, inclusive of measurement period adjustments (in millions):

Amounts
Cash and cash equivalents$681
Inventories5,025
Property, plant and equipment, net318
Finite-lived intangible assets – developed-product-technology rights19,590
IPR&D1,060
Goodwill3,062
Deferred tax asset834
Deferred tax liability(2,492)
Other assets and liabilities, net(245)
Total assets acquired, net$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 restricted stock unit (RSU) awards, and outstanding performance share unit (PSU) awards of $523 million; (iii) fair value of Amgen replacement awards (based on conversion of outstanding employee RSU awards) of $180 million representing non-cash consideration; and (iv) a portion of Horizon’s debt, settled by Amgen on the closing date, of $382 million. Amgen issued 1.7 million replacement equity awards with the original vesting conditions, and fair value was determined based on acquisition date fair value based on the conversion calculation.

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.

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 $834 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.

Our accounting for this acquisition is preliminary and will be finalized upon completion of our analysis to determine the acquisition date fair values of certain assets acquired, liabilities assumed and tax-related items as we obtain additional information during the measurement period of up to one year from the acquisition date.

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 three months ended March 31, 2023, as if the acquisition of Horizon had occurred on January 1, 2022 (in millions):

Three months ended March 31, 2023
Total revenue$6,941
Net income$2,182

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 the following: (i) incremental amortization expense based on the current preliminary 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; and (iii) 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 condensed consolidated results of operations would have been had the acquisition been completed on January 1, 2022. In addition, the unaudited supplemental 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.

3. Revenues

We operate in one business 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. The majority of ROW revenues relates to products sold in Europe.

Revenues were as follows (in millions):

Three months ended March 31,
20242023
U.S.ROWTotalU.S.ROWTotal
Prolia$657$342$999$623$304$927
ENBREL561656756415579
XGEVA366195561384152536
Repatha273244517197191388
TEPEZZA(1)4195424———
Otezla29310139429498392
KYPROLIS234142376234124358
Aranesp100249349115240355
EVENITY23610634216490254
Nplate190127317246116362
Vectibix120127247111122233
BLINCYTO1539124412668194
KRYSTEXXA(1)235—235———
TEZSPIRE(2)173—17396—96
Other products(3)9634101,3738213511,172
Total product sales(4)$4,973$2,1457,118$3,975$1,8715,846
Other revenues329259
Total revenues$7,447$6,105

(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 three months ended March 31, 2024 and 2023.

4. Income taxes

The income tax provisions for the three months ended March 31, 2024 and 2023, were tax expenses of $45 million and $601 million, respectively, on a pretax loss of $68 million and a pretax income of $3,442 million, respectively. The effective tax rates for the three months ended March 31, 2024 and 2023, were (66.2)% and 17.5%, respectively.

The decrease in our effective tax rate for the three months ended March 31, 2024, was primarily due to the earnings mix as a result of the inclusion of the Horizon business, amortization of Horizon acquired assets and the first quarter 2024 unrealized loss on our BeiGene investment. See Note 6, Investments*—BeiGene, Ltd*. The effective tax rates 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 where 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 a tax incentive grant through 2050. Additionally, the Company’s operations conducted in Singapore are subject to a tax incentive grant through 2036. Our foreign earnings are also subject to U.S. tax at a reduced rate of 10.5%. Additionally, effective January 1, 2024, selected individual countries, including the United Kingdom and EU member countries, have enacted the global minimum tax agreement. Our legal entities in such countries, along with their direct and indirect subsidiaries, are now subject to a 15% minimum tax rate on adjusted financial statement income.

Beginning on January 1, 2023, we were no longer subject to a 4% excise tax in the U.S. territory of Puerto Rico on the gross intercompany purchase price of goods and services from our manufacturer in Puerto Rico. We qualify for and are subject to the alternative income tax rate on industrial development income of our Puerto Rico affiliate. In the United States, this income tax qualifies for foreign tax credits. Both this income tax and the associated foreign tax credits are generally recognized in our provision for income taxes. We accounted for the 2022 excise tax that was capitalized in Inventories as an expense in Cost of sales when the related products were sold in the first half of 2023, and a foreign tax credit was not recognized with respect to the excise tax expense in 2023. We do not have this excise tax exposure in 2024.

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 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 pursued resolution with the IRS appeals office but were unable to reach resolution. In July 2021, we filed a petition in the U.S. Tax Court to contest two duplicate Statutory Notices of Deficiency (Notices) for the years 2010–2012 that we received in May and July 2021, which 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 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 pursued resolution with the IRS appeals office but were unable to reach resolution. In July 2022, we filed a petition in the U.S. Tax Court to contest a Notice for the years 2013–2015 that we previously reported receiving in April 2022 that 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. In addition, the Notice 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 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 are contesting the 2010–2012 and 2013–2015 Notices through the judicial process. The two cases were consolidated in the U.S. Tax Court on December 19, 2022. The trial is currently scheduled to begin on November 4, 2024.

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. 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 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 condensed consolidated financial statements.

During the three months ended March 31, 2024, the gross amounts of our UTBs increased by $40 million as a result of tax positions taken during the current year. Substantially all of the UTBs as of March 31, 2024, if recognized, would affect our effective tax rate.

5. 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. As the Company recorded a net loss for the three months ended March 31, 2024, 5 million shares of employee stock-based awards were excluded in the computation of diluted loss per share because the effect would have been antidilutive.

The computations for basic and diluted (loss) earnings per share were as follows (in millions, except per-share data):

Three months ended March 31,
20242023
Income (Numerator):
Net (loss) income for basic and diluted (loss) earnings per share$(113)$2,841
Shares (Denominator):
Weighted-average shares for basic (loss) earnings per share536534
Effect of dilutive securities—4
Weighted-average shares for diluted (loss) earnings per share536538
Basic (loss) earnings per share$(0.21)$5.32
Diluted (loss) earnings per share$(0.21)$5.28

For the three months ended March 31, 2023, the number of antidilutive employee stock-based awards excluded from the computation of diluted EPS was not significant.

6. Investments

Available-for-sale investments

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

Types of securities as of March 31, 2024Amortized costGross unrealized gainsGross unrealized lossesFair values
Money market mutual funds$9,099$—$—$9,099
Other short-term interest-bearing securities138——138
Total interest-bearing securities$9,237$—$—$9,237
Types of securities as of December 31, 2023Amortized costGross unrealized gainsGross unrealized lossesFair values
Money market mutual funds$10,266$—$—$10,266
Other short-term interest-bearing securities138——138
Total interest-bearing securities$10,404$—$—$10,404

The fair values of interest-bearing securities by location in the Condensed Consolidated Balance Sheets were as follows (in millions):

Condensed Consolidated Balance Sheets locationsMarch 31, 2024December 31, 2023
Cash and cash equivalents$9,237$10,404
Total interest-bearing securities$9,237$10,404

Cash and cash equivalents in the above table excludes bank account cash of $471 million and $540 million as of March 31, 2024 and December 31, 2023, respectively.

All interest-bearing securities as of March 31, 2024 and December 31, 2023, mature in one year or less.

For the three months ended March 31, 2024 and 2023, realized gains and losses on interest-bearing securities were not material. Realized gains and losses on interest-bearing securities are recorded in Other (expense) income, net, in the Condensed Consolidated Statements of (Loss) 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.

Equity securities

BeiGene, Ltd.

Effective January 30, 2023, we relinquished our right to appoint a director to BeiGene’s Board of Directors. We no longer have the ability to exert significant influence over BeiGene. As a result, in the first quarter of 2023, we began to account for our ownership interest as an equity security with a readily determinable fair value, with changes in fair value recorded in Other (expense) income, net. See Note 11, Fair value measurement. During the three months ended March 31, 2024 and 2023, we recognized an unrealized loss of $454 million and an unrealized gain of $1.9 billion, respectively, recorded in Other (expense) income, net, in our Condensed Consolidated Statements of (Loss) Income. As of March 31, 2024 and December 31, 2023, the carrying and fair values of our equity investment in BeiGene were $3.0 billion and $3.4 billion, respectively, and were included in Other noncurrent assets in the Condensed Consolidated Balance Sheets.

Subject to certain exceptions or otherwise agreed to by BeiGene, while Amgen holds at least 5.0% of BeiGene’s outstanding common stock, (A) we may only sell our BeiGene 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 BeiGene’s outstanding common stock in any rolling 12-month period.

Other equity securities

Excluding our equity investments in BeiGene and Neumora (discussed below), we held investments in other equity securities with readily determinable fair values (publicly traded securities) of $536 million and $494 million as of March 31, 2024 and December 31, 2023, respectively, which are included in Other noncurrent assets in the Condensed Consolidated Balance Sheets. During the three months ended March 31, 2024 and 2023, net unrealized gains on these publicly traded securities were $50 million and $5 million, respectively. Realized gains and losses on sales of publicly traded securities for the three months ended March 31, 2024 and 2023, were not material.

We held investments of $333 million and $309 million in equity securities without readily determinable fair values as of March 31, 2024 and December 31, 2023, respectively, which are included in Other noncurrent assets in the Condensed Consolidated Balance Sheets. During the three months ended March 31, 2024 and 2023, upward and downward adjustments on these securities were not material. Adjustments were based on observable price transactions.

Equity method investments

Neumora Therapeutics, Inc.

As of March 31, 2024 and December 31, 2023, our ownership interests in Neumora were approximately 22.3% and 23.2%, respectively, and the fair values of our investment were $486 million and $603 million, respectively. During the three months ended March 31, 2024 and 2023, we recognized net losses of $117 million and $47 million, respectively. Although our equity investment qualifies us for the equity method of accounting, we have elected the fair value option to account for our investment. Under the fair value option, changes in the fair value of the investment are recognized through earnings in Other (expense) income, net, in our Condensed Consolidated Statements of (Loss) Income each reporting period. See Note 11, Fair value measurement. We believe the fair value option best reflects the economics of the underlying transaction.

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 $278 million and $251 million as of March 31, 2024 and December 31, 2023, respectively, which are included in Other noncurrent assets in the Condensed Consolidated Balance Sheets. These investments, 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 March 31, 2024, unfunded additional commitments to be made for these investments during the next several years amounted to $164 million. For the three months ended March 31, 2024 and 2023, net unrealized gains from our limited partnership investments were $27 million and $20 million, respectively, recorded in Other (expense) income, net, in our Condensed Consolidated Statements of (Loss) Income.

7. Inventories

Inventories consisted of the following (in millions):

March 31, 2024December 31, 2023
Raw materials$928$993
Work in process5,2705,747
Finished goods2,5262,778
Total inventories$8,724$9,518

8. Goodwill and other intangible assets

Goodwill

The change in the carrying amount of goodwill was as follows (in millions):

Three months ended March 31, 2024
Beginning balance$18,629
Adjustments to goodwill resulting from acquisitions (1)(49)
Currency translation adjustment(10)
Ending balance$18,570

(1) For the three months ended March 31, 2024, adjustments to goodwill consisted of a measurement period adjustment related to our Horizon acquisition. See Note 2, Acquisitions.

Other intangible assets

Other intangible assets consisted of the following (in millions):

March 31, 2024December 31, 2023
Gross carrying amountsAccumulated amortizationOther intangible assets, netGross carrying amountsAccumulated amortizationOther intangible assets, net
Finite-lived intangible assets:
Developed-product-technology rights$48,625$(19,184)$29,441$48,631$(18,049)$30,582
Licensing rights3,864(3,297)5673,865(3,265)600
Marketing-related rights1,203(1,148)551,339(1,264)75
Research and development technology rights1,388(1,229)1591,394(1,228)166
Total finite-lived intangible assets55,080(24,858)30,22255,229(23,806)31,423
Indefinite-lived intangible assets:
In-process research and development1,150—1,1501,218—1,218
Total other intangible assets$56,230$(24,858)$31,372$56,447$(23,806)$32,641

Developed-product-technology rights consists of rights related to marketed products. 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. Marketing-related rights primarily consists of rights related to the sale and distribution of marketed products. R&D technology rights pertains to technologies used in R&D that have alternative future uses.

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. 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 three months ended March 31, 2024 and 2023, we recognized amortization associated with our finite-lived intangible assets of $1.2 billion and $693 million, respectively. Amortization of intangible assets is primarily included in Cost of sales in the Condensed Consolidated Statements of (Loss) Income. As of March 31, 2024, the total estimated amortization of our finite-lived intangible assets for the remaining nine months ending December 31, 2024, and the years ending December 31, 2025, 2026, 2027, 2028 and 2029, are $3.6 billion, $4.5 billion, $3.9 billion, $3.9 billion, $2.9 billion and $2.2 billion, respectively.

9. Financing arrangements

Our borrowings consisted of the following (in millions):

March 31, 2024December 31, 2023
3.625% notes due 2024 (3.625% 2024 Notes)$1,400$1,400
1.90% notes due 2025 (1.90% 2025 Notes)500500
5.25% notes due 2025 (5.25% 2025 Notes)2,0002,000
Term loan due April 20252,0002,000
3.125% notes due 2025 (3.125% 2025 Notes)1,0001,000
2.00% €750 million notes due 2026 (2.00% 2026 euro Notes)809828
5.507% notes due 2026 (5.507% 2026 Notes)1,5001,500
2.60% notes due 2026 (2.60% 2026 Notes)1,2501,250
Term loan due October 20262,0002,000
5.50% £475 million notes due 2026 (5.50% 2026 pound sterling Notes)600605
2.20% notes due 2027 (2.20% 2027 Notes)1,7241,724
3.20% notes due 2027 (3.20% 2027 Notes)1,0001,000
5.15% notes due 2028 (5.15% 2028 Notes)3,7503,750
1.65% notes due 2028 (1.65% 2028 Notes)1,2341,234
3.00% notes due 2029 (3.00% 2029 Notes)750750
4.05% notes due 2029 (4.05% 2029 Notes)1,2501,250
4.00% £700 million notes due 2029 (4.00% 2029 pound sterling Notes)884892
2.45% notes due 2030 (2.45% 2030 Notes)1,2501,250
5.25% notes due 2030 (5.25% 2030 Notes)2,7502,750
2.30% notes due 2031 (2.30% 2031 Notes)1,2501,250
2.00% notes due 2032 (2.00% 2032 Notes)1,0011,001
3.35% notes due 2032 (3.35% 2032 Notes)1,0001,000
4.20% notes due 2033 (4.20% 2033 Notes)750750
5.25% notes due 2033 (5.25% 2033 Notes)4,2504,250
6.375% notes due 2037 (6.375% 2037 Notes)478478
6.90% notes due 2038 (6.90% 2038 Notes)254254
6.40% notes due 2039 (6.40% 2039 Notes)333333
3.15% notes due 2040 (3.15% 2040 Notes)1,7681,803
5.75% notes due 2040 (5.75% 2040 Notes)373373
2.80% notes due 2041 (2.80% 2041 Notes)828949
4.95% notes due 2041 (4.95% 2041 Notes)600600
5.15% notes due 2041 (5.15% 2041 Notes)729729
5.65% notes due 2042 (5.65% 2042 Notes)415415
5.60% notes due 2043 (5.60% 2043 Notes)2,7502,750
5.375% notes due 2043 (5.375% 2043 Notes)185185
4.40% notes due 2045 (4.40% 2045 Notes)2,2502,250
4.563% notes due 2048 (4.563% 2048 Notes)1,4151,415
3.375% notes due 2050 (3.375% 2050 Notes)1,9142,132
4.663% notes due 2051 (4.663% 2051 Notes)3,5413,541
3.00% notes due 2052 (3.00% 2052 Notes)919999
4.20% notes due 2052 (4.20% 2052 Notes)895950
4.875% notes due 2053 (4.875% 2053 Notes)1,0001,000
5.65% notes due 2053 (5.65% 2053 Notes)4,2504,250
2.77% notes due 2053 (2.77% 2053 Notes)940940
4.40% notes due 2062 (4.40% 2062 Notes)1,1651,200
March 31, 2024December 31, 2023
5.75% notes due 2063 (5.75% 2063 Notes)2,7502,750
Other notes due 2097100100
Unamortized bond discounts, premiums and issuance costs, net(1,404)(1,420)
Fair value adjustments(363)(314)
Other3317
Total carrying value of debt64,02064,613
Less current portion(3,959)(1,443)
Total long-term debt$60,061$63,170

There are no material differences between the effective interest rates and coupon rates of any of our borrowings, 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.

The Term loans have an interest rate of three-month SOFR plus 1.225%.

Debt extinguishment

During the three months ended March 31, 2024, we repurchased 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 cost of $410 million, which resulted in the recognition of a $133 million gain on extinguishment of debt recorded in Other (expense) income, net, in the Condensed Consolidated Statements of (Loss) Income.

10. Stockholders’ equity

Stock repurchase program

During the three months ended March 31, 2024 and 2023, we did not repurchase shares under our stock repurchase program. As of March 31, 2024, $7.0 billion of authorization remained available under our stock repurchase program.

Dividends

In March 2024, the Board of Directors declared a quarterly cash dividend of $2.25 per share, which will be paid in June 2024. In December 2023, the Board of Directors declared a quarterly cash dividend of $2.25 per share, which was paid in March 2024.

Accumulated other comprehensive income (loss)

The components of AOCI were as follows (in millions):

Foreign currency translationCash flow hedgesOtherAOCI
Balance as of December 31, 2023$(298)$(22)$31$(289)
Foreign currency translation adjustments(24)——(24)
Unrealized gains—178—178
Reclassification adjustments to income—(20)—(20)
Other——(3)(3)
Income taxes—(32)—(32)
Balance as of March 31, 2024$(322)$104$28$(190)

Reclassifications out of AOCI and into earnings, including related income tax expenses, were as follows (in millions):

Three months ended March 31,
Components of AOCI20242023Condensed Consolidated Statements of (Loss) Income locations
Cash flow hedges:
Foreign currency contract gains$51$52Product sales
Cross-currency swap contract losses(31)(22)Other (expense) income, net
2030(Loss) income before income taxes
(4)(6)Provision for income taxes
$16$24Net (loss) income

11. Fair value measurement

To estimate the fair value 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 sources 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 different 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, 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):

Quoted prices in active markets for identical assets (Level 1)Significant other observable inputs (Level 2)Significant unobservable inputs (Level 3)
Fair value measurement as of March 31, 2024, using:Total
Assets:
Available-for-sale securities:
Money market mutual funds$9,099$—$—$9,099
Other short-term interest-bearing securities—138—138
Equity securities3,985——3,985
Derivatives:
Foreign currency forward contracts—225—225
Total assets$13,084$363$—$13,447
Liabilities:
Derivatives:
Foreign currency forward contracts$—$43$—$43
Cross-currency swap contracts—429—429
Interest rate swap contracts—600—600
Contingent consideration obligations——9696
Total liabilities$—$1,072$96$1,168
Quoted prices in active markets for identical assets (Level 1)Significant other observable inputs (Level 2)Significant unobservable inputs (Level 3)
Fair value measurement as of December 31, 2023, using:Total
Assets:
Available-for-sale securities:
Money market mutual funds$10,266$—$—$10,266
Other short-term interest-bearing securities—138—138
Equity securities4,514——4,514
Derivatives:
Foreign currency forward contracts—145—145
Total assets$14,780$283$—$15,063
Liabilities:
Derivatives:
Foreign currency forward contracts$—$116$—$116
Cross-currency swap contracts—405—405
Interest rate swap contracts—571—571
Contingent consideration obligations——9696
Total liabilities$—$1,092$96$1,188

Interest-bearing and equity securities

The fair values of our money market mutual funds and equity investments in publicly traded securities, including our equity investments in BeiGene and Neumora, as of March 31, 2024 and December 31, 2023, 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 12, Derivative instruments.

Contingent consideration obligations

As a result of our business acquisitions, 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 in business combinations, 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 Condensed Consolidated Statements of (Loss) Income.

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

Three months ended March 31,
20242023
Beginning balance$96$270
Payments(2)(2)
Net changes in valuations25
Ending balance$96$273

As of March 31, 2024 and December 31, 2023, our contingent consideration obligations are primarily the result of our acquisition of Teneobio, Inc. in October 2021, which obligates us to pay the former shareholders payments upon achieving separate development and regulatory milestones with regard to various R&D programs.

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 estimated the fair values of our borrowings by using Level 2 inputs. As of March 31, 2024 and December 31, 2023, the aggregate fair values of our borrowings were $57.8 billion and $59.2 billion, respectively, and the carrying values were $64.0 billion and $64.6 billion, respectively.

During the three months ended March 31, 2024 and 2023, there were no transfers of assets or liabilities between fair value measurement levels, and there were no material remeasurements to the fair values of assets and liabilities that are not measured at fair value on a recurring basis.

12. 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 our 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 both March 31, 2024 and December 31, 2023, we had outstanding foreign currency forward contracts with aggregate notional amounts of $6.6 billion. We have designated these foreign currency forward contracts, which are primarily euro based, as cash flow hedges. Accordingly, we report the unrealized gains and losses on these contracts in AOCI in the Condensed Consolidated Balance Sheets, and we reclassify them to Product sales in the Condensed Consolidated Statements of (Loss) Income in the same periods during which the hedged transactions affect earnings.

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 lives 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 reported in AOCI in the Condensed Consolidated Balance Sheets and reclassified to Other (expense) income, net, in the Condensed Consolidated Statements of (Loss) 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 March 31, 2024, were as follows (notional amounts in millions):

Foreign currencyU.S. dollars
Hedged notesNotional amountsInterest ratesNotional amountsInterest rates
2.00% 2026 euro Notes€7502.0%$8333.9%
5.50% 2026 pound sterling Notes£4755.5%$7476.0%
4.00% 2029 pound sterling Notes£7004.0%$1,1114.6%

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 Condensed Consolidated Balance Sheets and are amortized into Interest expense, net, in the Condensed Consolidated Statements of (Loss) Income over the lives of the associated debt issuances. Amounts recognized in connection with forward interest rate contracts during the three months ended March 31, 2024, and amounts expected to be recognized during the subsequent 12 months are not material.

Gains and losses recognized in AOCI for our derivative instruments designated as cash flow hedges were as follows (in millions):

Three months ended March 31,
Derivatives in cash flow hedging relationships20242023
Foreign currency forward contracts$202$—
Cross-currency swap contracts(24)(40)
Forward interest rate contracts—(31)
Total unrealized gains (losses)$178$(71)

Fair value hedges

To achieve a desired mix of fixed-rate and floating-rate debt, we entered into interest rate swap contracts that qualified for and were designated as fair value hedges. These interest rate swap contracts effectively convert fixed-rate coupons to floating-rate coupons over the terms of the related hedge contracts. As of both March 31, 2024 and December 31, 2023, we had interest rate swap contracts with aggregate notional amounts of $6.7 billion that hedge certain portions of our long-term debt issuances.

For interest rate swap contracts that qualify for and are designated as fair value hedges, we recognize in Interest expense, net, in the Condensed Consolidated Statements of (Loss) 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 life of the previously hedged debt.

The hedged liabilities and related cumulative-basis adjustments for fair value hedges of those liabilities were recorded in the Condensed 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)**
Condensed Consolidated Balance Sheets locationsMarch 31, 2024December 31, 2023March 31, 2024December 31, 2023
Current portion of long-term debt$1,454$1,441$54$41
Long-term debt$4,728$4,788$(417)$(355)

(1) Current portion of long-term debt includes $64 million and $69 million of carrying value with discontinued hedging relationships as of March 31, 2024 and December 31, 2023, respectively. Long-term debt includes $273 million and $288 million of carrying value with discontinued hedging relationships as of March 31, 2024 and December 31, 2023, respectively.

(2) Current portion of long-term debt includes $64 million and $69 million of hedging adjustments on discontinued hedging relationships as of March 31, 2024 and December 31, 2023, respectively. Long-term debt includes $173 million and $188 million of hedging adjustments on discontinued hedging relationships as of March 31, 2024 and December 31, 2023, respectively.

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):

Three months ended March 31, 2024
Product salesOther (expense) income, netInterest expense, net
Total amounts recorded in income and (expense) line items presented in the Condensed Consolidated Statements of (Loss) Income$7,118$(235)$(824)
The effects of cash flow and fair value hedging:
Gains (losses) on cash flow hedging relationships reclassified out of AOCI:
Foreign currency forward contracts$51$—$—
Cross-currency swap contracts$—$(31)$—
Gains (losses) on fair value hedging relationships—interest rate swap agreements:
Hedged items(1)$—$—$49
Derivatives designated as hedging instruments$—$—$(28)
Three months ended March 31, 2023
Product salesOther (expense) income, netInterest expense, net
Total amounts recorded in income and (expense) line items presented in the Condensed Consolidated Statements of (Loss) Income$5,846$2,064$(543)
The effects of cash flow and fair value hedging:
Gains (losses) on cash flow hedging relationships reclassified out of AOCI:
Foreign currency forward contracts$52$—$—
Cross-currency swap contracts$—$(22)$—
(Losses) gains on fair value hedging relationships—interest rate swap agreements:
Hedged items(1)$—$—$(88)
Derivatives designated as hedging instruments$—$—$114

(1) Gains on hedged items do not exactly offset losses 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.

No portions of our cash flow hedge contracts were excluded from the assessment of hedge effectiveness. As of March 31, 2024, we expected to reclassify $97 million of net gains on our foreign currency and cross-currency swap contracts out of AOCI and into earnings during the next 12 months.

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 March 31, 2024 and December 31, 2023, the total notional amounts of these foreign currency forward contracts were $300 million and $457 million, respectively. Gains and losses recognized in earnings for our derivative instruments not designated as hedging instruments were not material for the three months ended March 31, 2024 and 2023.

Fair values of derivatives

The fair values of derivatives included in the Condensed Consolidated Balance Sheets were as follows (in millions):

Derivative assetsDerivative liabilities
March 31, 2024Condensed Consolidated Balance Sheets locationsFair valuesCondensed Consolidated Balance Sheets locationsFair values
Derivatives designated as hedging instruments:
Foreign currency forward contractsOther current assets/ Other noncurrent assets$225Accrued liabilities/ Other noncurrent liabilities$43
Cross-currency swap contractsOther current assets/ Other noncurrent assets—Accrued liabilities/ Other noncurrent liabilities429
Interest rate swap contractsOther current assets/ Other noncurrent assets—Accrued liabilities/ Other noncurrent liabilities600
Forward interest rate contractsOther current assets/ Other noncurrent assets—Accrued liabilities/ Other noncurrent liabilities—
Total derivatives designated as hedging instruments2251,072
Total derivatives$225$1,072
Derivative assetsDerivative liabilities
December 31, 2023Condensed Consolidated Balance Sheets locationsFair valuesCondensed Consolidated Balance Sheets locationsFair values
Derivatives designated as hedging instruments:
Foreign currency forward contractsOther current assets/ Other noncurrent assets$145Accrued liabilities/ Other noncurrent liabilities$116
Cross-currency swap contractsOther current assets/ Other noncurrent assets—Accrued liabilities/ Other noncurrent liabilities405
Interest rate swap contractsOther current assets/ Other noncurrent assets—Accrued liabilities/ Other noncurrent liabilities571
Forward interest rate contractsOther current assets/ Other noncurrent assets—Accrued liabilities/ Other noncurrent liabilities—
Total derivatives designated as hedging instruments1451,092
Total derivatives$145$1,092

For additional information, see Note 11, Fair value measurement.

Our derivative contracts that were in liability positions as of March 31, 2024, 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.

The cash flow effects of our derivative contracts in the Condensed Consolidated Statements of Cash Flows are 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.

13. 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 our Annual Report on Form 10-K for the year ended December 31, 2023, 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; and in Note 20, Contingencies and commitments, to the consolidated financial statements in our Annual Report on Form 10-K for the year ended December 31, 2023.

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. In each of the matters described in this filing; and in Note 20, Contingencies and commitments, to the consolidated financial statements in our Annual Report on Form 10-K for the year ended December 31, 2023, in which we could incur a liability, our opponents seek an award of a not-yet-quantified amount of damages or an amount that is not material. In addition, a number of the matters pending against us are at very early stages of the legal process, which in complex proceedings of the sort we face often extend for several years. As a result, none of the matters described in this filing; and in Note 20, Contingencies and commitments, to the consolidated financial statements in our Annual Report on Form 10-K for the year ended December 31, 2023, in which we could incur a liability, have progressed sufficiently through discovery and/or the development of important factual information and legal issues to enable us to estimate a range of possible loss, if any, or such amounts are 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

Germany

On February 29, 2024, in Amgen’s Nullity Action before the German Federal Patent Court seeking invalidation of Regeneron Pharmaceuticals, Inc.’s (Regeneron) European Patent No. 2,756,004 (the EP’004 Patent), the Federal Patent Court issued a preliminary opinion that the EP’004 Patent is likely to be invalid and scheduled the main hearing for November 25, 2025.

European Patent Office

On November 16, 2023 and February 29, 2024, Sanofi-Aventis and Regeneron each filed a notice of opposition against Amgen’s European Patent No. 3,666,797 before the European Patent Office’s Opposition Division.

On February 29, 2024, Amgen filed a Notice of Opposition and Grounds of Opposition before the European Patent Office against Regeneron’s European Patent No. 3,536,712.

Prolia/XGEVA Biologics Price Competition and Innovation Act (BPCIA) Litigation

Amgen Inc. et al. v. Sandoz Inc., et al.

On April 29, 2024, the U.S. District Court for the District of New Jersey (the New Jersey District Court) entered judgment in the lawsuit pending against Sandoz Inc. based on Sandoz’s submission to the FDA of a Biologics License Application seeking approval to market and sell a biosimilar version of Amgen’s Prolia and XGEVA products (“Sandoz’s biosimilar denosumab products”). The complaint asserted infringement of patents listed in the FDA’s Purple Book for Amgen’s Prolia and XGEVA products. A preliminary injunction hearing, held between October 30 and December 21, 2023, focused on a composition of matter patent U.S. Patent No. 7,364,736 (the ‘736 Patent) and two manufacturing patents. The judgment entered by the New Jersey District Court found the asserted claims of Amgen’s ‘736 Patent valid, enforceable and infringed by Sandoz’s biosimilar denosumab products and included an injunction prohibiting Sandoz and third parties acting on behalf of or in active concert with Sandoz from making, using, selling, or offering to sell in the United States or importing into the United States Sandoz’s biosimilar denosumab products before the expiry of the ’736 Patent on February 19, 2025, except as specifically authorized by a confidential settlement agreement. As a result of the settlement, the parties’ remaining claims and counterclaims related to the other asserted patents were dismissed with prejudice and Sandoz is permitted to launch the Sandoz biosimilar denosumab products in the United States on May 31, 2025, unless accelerated pursuant to the terms of a confidential settlement agreement, and subject to confidential financial terms stated therein.

ABP 938 (aflibercept) Patent Litigation

On April 11, 2024, the Judicial Panel on Multidistrict Litigation granted Regeneron’s motion to transfer Regeneron’s patent infringement lawsuit pending against Amgen in the U.S. District Court for the Central District of California to the U.S. District Court for the Northern District of West Virginia for coordinated and consolidated pretrial proceedings.

Antitrust Class Action

Sensipar Antitrust Class Actions

On February 17, 2024, Amgen and the indirect purchasers filed a stipulation in the U.S. District Court for the District of Delaware (the Delaware District Court) to dismiss the indirect purchasers’ claims. On February 22, 2024, Amgen and the indirect purchasers filed a stipulation in the U.S. Court of Appeals for the Third Circuit (the Third Circuit Court) dismissing the portion of the Third Circuit Court’s appeal relating to the claims of the indirect purchasers. Amgen and the direct purchasers filed a stipulation on April 12, 2024 in the Delaware District Court, dismissing with prejudice the direct purchasers’ claims that were at issue in the appeal and seeking entry of final judgment in Amgen’s favor. On April 15, 2024, the Delaware District Court entered an order pursuant to the stipulation and closed the case. The direct purchasers retain a right to appeal the claims that were dismissed by the Delaware District Court on March 11, 2022.

U.S. Tax Litigation and Related Matters

Amgen Inc. & Subsidiaries v. Commissioner of Internal Revenue

See Note 4, Income taxes, for discussion of the IRS tax dispute and the Company’s petitions in the U.S. Tax Court.

ChemoCentryx, Inc. Securities Matters

On March 6, 2024, the U.S. District Court for the Northern District 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. Trial is scheduled to begin on September 22, 2025.

On March 20, 2024, ChemoCentryx filed a petition with the U.S. Court of Appeals for the Ninth Circuit, seeking permission to have the district court’s order on class certification heard on appeal. The lead plaintiff’s response to ChemoCentryx’s petition was submitted on April 2, 2024.

Previous: Cover and table of contents · Next: Item 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS