Item 1. FINANCIAL STATEMENTS

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Item 1. FINANCIAL STATEMENTS

AMGEN INC.

CONDENSED CONSOLIDATED STATEMENTS OF INCOME

(In millions, except per-share data)

(Unaudited)

Three months ended September 30,Nine months ended September 30,
2023202220232022
Revenues:
Product sales$6,548$6,237$19,077$18,249
Other revenues3554159171,235
Total revenues6,9036,65219,99419,484
Operating expenses:
Cost of sales1,8061,5885,3394,659
Research and development1,0791,1123,2503,110
Selling, general and administrative1,3531,2873,9053,842
Other6445874537
Total operating expenses4,8823,99213,36812,148
Operating income2,0212,6606,6267,336
Other income (expense):
Interest expense, net(759)(368)(2,054)(991)
Other income (expense), net6851002,431(747)
Income before income taxes1,9472,3927,0035,598
Provision for income taxes2172491,053662
Net income$1,730$2,143$5,950$4,936
Earnings per share:
Basic$3.23$4.01$11.12$9.16
Diluted$3.22$3.98$11.06$9.11
Shares used in calculation of earnings per share:
Basic535535535539
Diluted538538538542

See accompanying notes.

AMGEN INC.

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME

(In millions)

(Unaudited)

Three months ended September 30,Nine months ended September 30,
2023202220232022
Net income$1,730$2,143$5,950$4,936
Other comprehensive income, net of reclassification adjustments and taxes:
Foreign currency translation(44)(109)(5)(225)
Cash flow hedges18113873378
Other17(9)37(9)
Other comprehensive income, net of reclassification adjustments and taxes15420105144
Comprehensive income$1,884$2,163$6,055$5,080

See accompanying notes.

AMGEN INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(In millions, except per-share data)

September 30, 2023December 31, 2022
(Unaudited)
ASSETS
Current assets:
Cash and cash equivalents$34,741$7,629
Marketable securities—1,676
Trade receivables, net6,1455,563
Inventories5,0264,930
Other current assets2,5652,388
Total current assets48,47722,186
Property, plant and equipment, net5,5635,427
Intangible assets, net13,15016,080
Goodwill15,50915,529
Other noncurrent assets7,8355,899
Total assets$90,534$65,121
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable$1,358$1,572
Accrued liabilities14,16812,524
Current portion of long-term debt1,4281,591
Total current liabilities16,95415,687
Long-term debt59,04037,354
Long-term tax liabilities4,5795,757
Other noncurrent liabilities2,3052,662
Contingencies and commitments
Stockholders’ equity:
Common stock and additional paid-in capital; $0.0001 par value; 2,750.0 shares authorized; outstanding—535.1 shares in 2023 and 534.0 shares in 202232,75332,514
Accumulated deficit(24,971)(28,622)
Accumulated other comprehensive loss(126)(231)
Total stockholders’ equity7,6563,661
Total liabilities and stockholders’ equity$90,534$65,121

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, 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, 2023534.332,535(26,919)(268)5,348
Net income——1,379—1,379
Other comprehensive loss, net of taxes———(12)(12)
Issuance of common stock in connection with the Company’s equity award programs0.616——16
Stock-based compensation expense—119——119
Tax impact related to employee stock-based compensation expense—(69)——(69)
Balance as of June 30, 2023534.932,601(25,540)(280)6,781
Net income——1,730—1,730
Other comprehensive income, net of taxes———154154
Dividends declared on common stock ($2.13 per share)——(1,161)—(1,161)
Issuance of common stock in connection with the Company’s equity award programs0.233——33
Stock-based compensation expense—124——124
Tax impact related to employee stock-based compensation expense—(5)——(5)
Balance as of September 30, 2023535.1$32,753$(24,971)$(126)$7,656

AMGEN INC.

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY (continued)

(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, 2021558.3$32,096$(24,600)$(796)$6,700
Net income——1,476—1,476
Other comprehensive income, net of taxes———3333
Dividends declared on common stock ($1.94 per share)——(1,034)—(1,034)
Issuance of common stock in connection with the Company’s equity award programs0.518——18
Stock-based compensation expense—78——78
Tax impact related to employee stock-based compensation expense—(45)——(45)
Repurchases of common stock(24.6)(900)(5,410)—(6,310)
Balance as of March 31, 2022534.231,247(29,568)(763)916
Net income——1,317—1,317
Other comprehensive income, net of taxes———9191
Issuance of common stock in connection with the Company’s equity award programs0.745——45
Stock-based compensation expense—120——120
Tax impact related to employee stock-based compensation expense—(69)——(69)
Other——(1)—(1)
Balance as of June 30, 2022534.931,343(28,252)(672)2,419
Net income——2,143—2,143
Other comprehensive income, net of taxes———2020
Dividends declared on common stock ($1.94 per share)——(1,057)—(1,057)
Issuance of common stock in connection with the Company’s equity award programs0.115——15
Stock-based compensation expense—121——121
Tax impact related to employee stock-based compensation expense—(8)——(8)
Repurchases of common stock(1.5)900(900)——
Balance as of September 30, 2022533.5$32,371$(28,066)$(652)$3,653

See accompanying notes.

AMGEN INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(In millions)

(Unaudited)

Nine months ended September 30,
20232022
Cash flows from operating activities:
Net income$5,950$4,936
Depreciation, amortization and other2,6912,506
Deferred income taxes(650)(847)
Adjustments for equity method investments(17)713
Loss on divestiture—565
(Gains) losses on equity securities(1,304)113
Other items, net849123
Changes in operating assets and liabilities, net of acquisitions:
Trade receivables, net(582)(566)
Inventories(82)(651)
Other assets(332)166
Accounts payable(215)(142)
Accrued income taxes, net998(492)
Long-term tax liabilities293185
Other liabilities334463
Net cash provided by operating activities7,9337,072
Cash flows from investing activities:
Purchases of marketable securities(1)(2,363)
Proceeds from sales of marketable securities1,125—
Proceeds from maturities of marketable securities550447
Purchases of property, plant and equipment(863)(596)
Other74(59)
Net cash provided by (used in) investing activities885(2,571)
Cash flows from financing activities:
Net proceeds from issuance of debt23,7816,938
Extinguishment of debt(550)(297)
Repayment of debt(1,454)—
Repurchases of common stock—(6,360)
Dividends paid(3,416)(3,156)
Other(67)(113)
Net cash provided by (used in) financing activities18,294(2,988)
Increase in cash and cash equivalents27,1121,513
Cash and cash equivalents at beginning of period7,6297,989
Cash and cash equivalents at end of period$34,741$9,502

See accompanying notes.

AMGEN INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

September 30, 2023

(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 and nine months ended September 30, 2023 and 2022, 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, 2022, and with our condensed consolidated financial statements and the notes thereto contained in our Quarterly Reports on Form 10-Q for the periods ended March 31, 2023 and June 30, 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.

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 $9.7 billion and $9.3 billion as of September 30, 2023 and December 31, 2022, respectively.

Recent accounting pronouncements

No new accounting pronouncements were issued or adopted for the nine months ended September 30, 2023, that materially impacted the Company.

2. Restructuring

In the first quarter of 2023, we initiated a restructuring plan to enhance continued innovation, including investments in first-in-class medicines, while improving our cost structure. As part of the plan, we are reallocating resources to the areas of the business that will enable long-term growth.

We now expect that we will incur $250 million to $350 million of pretax charges in 2023 in connection with our restructuring plan, including (i) separation and other headcount-related costs with respect to staff reductions and (ii) asset-related charges that consist primarily of asset impairments and other related costs resulting from rationalization of our geographic footprint.

The following tables summarize recorded charges related to the restructuring plan by type of activity and the locations recognized within the Condensed Consolidated Statements of Income (in millions):

Three months ended September 30, 2023
Separation costsAsset impairments and other chargesTotal
Cost of sales$—$1$1
Research and development———
Selling, general and administrative—1313
Other16117
Total$16$15$31
Nine months ended September 30, 2023
Separation costsAsset impairments and other chargesTotal
Cost of sales$—$36$36
Research and development—1717
Selling, general and administrative—1313
Other1824186
Total$182$70$252

As of September 30, 2023, total restructuring liability decreased to $54 million primarily due to payments related to separation costs. The total restructuring liability was included in Accrued liabilities in the Condensed Consolidated Balance Sheets.

3. Acquisitions and divestitures

Acquisition of Horizon Therapeutics plc

On October 6, 2023, Amgen completed its acquisition of Horizon for $116.50 per share in cash, representing a transaction equity value 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 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 inflammation portfolio by adding first-in-class, early-in-lifecycle medicines such as TEPEZZA® (teprotumumab-trbw), KRYSTEXXA® (pegloticase) and UPLIZNA® (inebilizumab-cdon), which treat rare inflammatory diseases.

The accounting impact of this acquisition and the results of operations for Horizon will be included in our consolidated financial statements beginning in the fourth quarter of 2023. The initial accounting for this acquisition is incomplete, pending identification and measurement of assets acquired and liabilities assumed.

In connection with our acquisition of Horizon, we entered into several debt and financing arrangements. See Note 10, Financing arrangements.

Acquisition of ChemoCentryx, Inc.

On October 20, 2022, we acquired all of the outstanding stock of ChemoCentryx, a publicly traded biotechnology company focused on orally administered therapeutics to treat autoimmune diseases, inflammatory disorders and cancer, for $52.00 per share in cash, representing a total consideration of $3.9 billion. The acquisition, which was accounted for as a business combination, includes TAVNEOS, an orally administered selective complement 5a receptor inhibitor that was approved by the FDA in October 2021 as an adjunctive therapy for adults with severe active antineutrophil cytoplasmic autoantibody-associated vasculitis (ANCA-associated vasculitis). TAVNEOS is commercialized by us in the United States; for markets outside the United States, TAVNEOS is commercialized by a collaboration partner, and Amgen is entitled to royalties and milestones based on future sales of the product. Upon its acquisition, ChemoCentryx became a wholly owned subsidiary of Amgen, and its operations became included in our consolidated financial statements commencing on the acquisition date.

Measurement period adjustments during the nine months ended September 30, 2023, included changes in the purchase price allocation and total consideration, resulting in a net decrease of approximately $18 million to goodwill. The measurement period adjustments resulted primarily from valuation inputs pertaining to the TAVNEOS intangible assets, adjustments to vendor payables and 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 nine months ended September 30, 2023, 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):

Amounts
Cash and cash equivalents$86
Marketable securities235
Inventories41
Finite-lived intangible assets**—**developed-product-technology rights3,499
Goodwill649
Other liabilities, net(83)
Deferred tax liability, net(502)
Total assets acquired, net$3,925

The $3.9 billion total consideration consisted of (i) a $3.7 billion cash payment to outstanding common stockholders of ChemoCentryx and (ii) a $181 million cash payment to equity award holders of ChemoCentryx for services rendered prior to the acquisition date of October 20, 2022, under the ChemoCentryx equity award plans.

The developed-product-technology rights acquired relates to TAVNEOS, which is approved in the United States and the EU for ANCA-associated vasculitis. The estimated fair values of $3.5 billion were determined by 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 developed-product-technology rights are being amortized on a straight-line basis over a weighted-average period of approximately 11 years using the straight-line method.

The estimated fair value of the acquired inventory of $41 million 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 as inventory turns over, which we estimate to be approximately 13 months.

A net deferred tax liability of $502 million 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.

The excess of the acquisition date consideration over the fair values assigned to the assets acquired and the liabilities assumed of $649 million was recorded as goodwill, which is not deductible for tax purposes. The goodwill value is primarily attributable to the expected synergies from the TAVNEOS asset.

Divestiture of Gensenta İlaç Sanayi ve Ticaret A.Ş.

On November 2, 2022, we sold our shares in Gensenta, a subsidiary in Turkey, to Eczacıbaşı for net cash proceeds of approximately $130 million. The transaction was accounted for as a sale of a business and did not meet the criteria to be classified as discontinued operations. Upon closing of this transaction, net assets related to Gensenta of $86 million were divested, and during the year ended December 31, 2022, we recognized a loss on divestiture of $567 million recorded in Other operating expenses in the Consolidated Statements of Income, primarily due to the reclassification of $615 million of cumulative foreign currency translation losses from AOCI into earnings.

4. 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 September 30,
20232022
U.S.ROWTotalU.S.ROWTotal
Prolia$673$313$986$590$272$862
ENBREL1,02691,0351,086201,106
XGEVA374145519363132495
Otezla46210556752998627
Repatha183223406142167309
Nplate32297419162126288
KYPROLIS231118349217101318
Aranesp107216323128230358
EVENITY2149330713665201
Other products(1)1,0995381,6371,1135601,673
Total product sales(2)$4,691$1,8576,548$4,466$1,7716,237
Other revenues355415
Total revenues$6,903$6,652
Nine months ended September 30,
20232022
U.S.ROWTotalU.S.ROWTotal
Prolia$1,987$954$2,941$1,783$853$2,636
ENBREL2,645372,6822,965543,019
XGEVA1,1454401,5851,1224081,530
Otezla1,2513081,5591,3663061,672
Repatha5926261,218461502963
Nplate7443471,091474364838
KYPROLIS6993541,053626296922
Aranesp3456981,0433976761,073
EVENITY570272842376186562
Other products(1)3,4241,6395,0633,3791,6555,034
Total product sales(2)$13,402$5,67519,077$12,949$5,30018,249
Other revenues9171,235
Total revenues$19,994$19,484

(1) Consists of product sales of our non-principal products as well as sales in prior periods of our divested Bergamo and Gensenta subsidiaries.

(2) Hedging gains and losses, which are included in product sales, were not material for the three and nine months ended September 30, 2023 and 2022.

5. Income taxes

The effective tax rates for the three and nine months ended September 30, 2023, were 11.1% and 15.0%, respectively, compared with 10.4% and 11.8%, respectively, for the corresponding periods in the prior year.

The increase in our effective tax rate for the three months ended September 30, 2023, was primarily due to the 2022 Puerto Rico tax law change that replaced the excise tax with an income tax beginning in 2023, partially offset by a prior year nondeductible loss from the divestiture of Gensenta and net earnings mix including the tax benefit from a net impairment charge related to AMG 340. See Note 9, Goodwill and other intangible assets. The increase in our effective tax rate for the nine months ended September 30, 2023, was primarily due to the 2022 Puerto Rico tax law change that replaced the excise tax with an income tax beginning in 2023 and net change in earnings mix, partially offset by a prior year nondeductible loss from the divestiture of Gensenta. The effective tax rates differ from the federal statutory rate primarily as a result of foreign earnings from the Company’s operations conducted in Puerto Rico, a territory of the United States treated as a foreign jurisdiction for U.S. tax purposes, that are currently subject to a tax incentive grant through 2050. In addition, the Company’s operations conducted in Singapore are subject to a tax incentive grant through 2036. These foreign earnings are also subject to U.S. tax at a reduced rate of 10.5%.

We are 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. As of January 1, 2023, 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 2023, and a foreign tax credit was not recognized in 2023 with respect to the excise tax.

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. On February 10, 2023, the U.S. Tax Court entered an order setting a trial date of 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.

We are no longer subject to U.S. federal income tax examinations for years ended on or before December 31, 2009.

See our Annual Report on Form 10-K for the year ended December 31, 2022, Part I, Item 1A, Risk Factors—The adoption and interpretation of new tax legislation or exposure to additional tax liabilities could affect our profitability, for further discussion.

During the three and nine months ended September 30, 2023, the gross amounts of our UTBs increased by $50 million and $160 million, respectively, as a result of tax positions taken during the current year. Substantially all of the UTBs as of September 30, 2023, if recognized, would affect our effective tax rate.

6. 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 EPS were as follows (in millions, except per-share data):

Three months ended September 30,Nine months ended September 30,
2023202220232022
Income (Numerator):
Net income for basic and diluted EPS$1,730$2,143$5,950$4,936
Shares (Denominator):
Weighted-average shares for basic EPS535535535539
Effect of dilutive securities3333
Weighted-average shares for diluted EPS538538538542
Basic EPS$3.23$4.01$11.12$9.16
Diluted EPS$3.22$3.98$11.06$9.11

For the three and nine months ended September 30, 2023 and 2022, the number of antidilutive employee stock-based awards excluded from the computation of diluted EPS was not significant.

7. 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 September 30, 2023Amortized costGross unrealized gainsGross unrealized lossesFair values
U.S. Treasury bills$—$—$—$—
Money market mutual funds34,208——34,208
Total interest-bearing securities$34,208$—$—$34,208
Types of securities as of December 31, 2022Amortized costGross unrealized gainsGross unrealized lossesFair values
U.S. Treasury bills$1,676$—$—$1,676
Money market mutual funds2,659——2,659
Total interest-bearing securities$4,335$—$—$4,335

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

Condensed Consolidated Balance Sheets locationsSeptember 30, 2023December 31, 2022
Cash and cash equivalents$34,208$2,659
Marketable securities—1,676
Total interest-bearing securities$34,208$4,335

Cash and cash equivalents in the above table excludes bank account cash of $533 million and $4,970 million as of September 30, 2023 and December 31, 2022, respectively.

Cash and cash equivalents as of September 30, 2023, was $34.7 billion, a majority of which was used to acquire Horizon in October 2023. See Note 3, Acquisitions and divestitures.

All interest-bearing securities as of September 30, 2023 and December 31, 2022, mature in one year or less.

For the three and nine months ended September 30, 2023 and 2022, realized gains and losses on interest-bearing securities were not material. Realized gains and losses on interest-bearing securities are recorded in Other income (expense), net, in the Condensed 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.

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 income (expense), net. See Note 12, Fair value measurement. During the three and nine months ended September 30, 2023, we recognized unrealized gains of $30 million and $1.2 billion, respectively, recorded in Other income (expense), net, in our Condensed Consolidated Statements of Income. As of September 30, 2023, the carrying and fair value of our investment in BeiGene was $3.4 billion and was included in Other noncurrent assets in the Condensed Consolidated Balance Sheets.

As of December 31, 2022, under the equity method of accounting, the carrying value of our investment in BeiGene was $2.2 billion and was included in Other noncurrent assets in the Condensed Consolidated Balance Sheets, and our ownership percentage was 18.2%. During the three and nine months ended September 30, 2022, under the equity method of accounting, our carrying value in BeiGene was adjusted by our share of BeiGene’s net losses of $104 million and $292 million, respectively, and amortization of the basis difference of $48 million and $143 million, respectively, recorded in Other income (expense), net, in our Condensed Consolidated Statements of Income.

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 $344 million and $480 million as of September 30, 2023 and December 31, 2022, respectively, which are included in Other noncurrent assets in the Condensed Consolidated Balance Sheets. During the three months ended September 30, 2023 and 2022, net unrealized losses and gains on these publicly traded securities were a net loss of $49 million and a net gain of $17 million, respectively. During the nine months ended September 30, 2023 and 2022, net unrealized losses on these publicly traded securities were $41 million and $259 million, respectively. Realized gains and losses on sales of publicly traded securities for the three and nine months ended September 30, 2023 and 2022, were not material.

We held investments of $293 million and $233 million in equity securities without readily determinable fair values as of September 30, 2023 and December 31, 2022, respectively, which are included in Other noncurrent assets in the Condensed Consolidated Balance Sheets. During the three and nine months ended September 30, 2023, upward and downward adjustments on these securities were not material. During the three and nine months ended September 30, 2022, downward adjustments on these securities were $55 million and $64 million, respectively, and upward adjustments for these periods were not material. Adjustments were based on observable price transactions.

Equity method investments

Neumora Therapeutics, Inc.

On September 30, 2021, we acquired an approximately 25.9% ownership interest in Neumora, a then privately held company, for $257 million, which is included in Other noncurrent assets in the Condensed Consolidated Balance Sheets, in exchange for a $100 million cash payment and $157 million in noncash consideration primarily related to future services. During the three months ended September 30, 2023, we made an additional $30 million equity investment in Neumora in connection with their initial public stock offering, and consequently, our investment now has a readily determinable fair value. Although our equity investment provides us with the ability to exercise significant influence over Neumora and therefore 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 income (expense), net, in our Condensed Consolidated Statements of Income each reporting period. We believe the fair value option best reflects the economics of the underlying transaction. As of September 30, 2023 and December 31, 2022, our ownership interests in Neumora were approximately 23.2% and 24.9%, respectively, and the fair values of our investment were $499 million and $335 million, respectively. During the three months ended September 30, 2023 and 2022, we recognized gains of $153 million and $240 million, respectively, and during the nine months ended September 30, 2023 and 2022, we recognized gains of $134 million and $152 million, respectively.

For information on determination of fair values, see Note 12, Fair value measurement.

Limited partnerships

We held limited partnership investments of $238 million and $249 million as of September 30, 2023 and December 31, 2022, 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 September 30, 2023, unfunded additional commitments to be made for these investments during the next several years amounted to $138 million. For the three months ended September 30, 2023 and 2022, net unrealized gains and losses from our limited partnership investments were an unrealized gain of $14 million and an unrealized loss of $62 million, respectively. For the nine months ended September 30, 2023 and 2022, net unrealized gains and losses from our limited partnership investments were an unrealized gain of $5 million and an unrealized loss of $282 million, respectively.

8. Inventories

Inventories consisted of the following (in millions):

September 30, 2023December 31, 2022
Raw materials$849$828
Work in process2,9923,098
Finished goods1,1851,004
Total inventories$5,026$4,930

9. Goodwill and other intangible assets

Goodwill

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

Nine months ended September 30, 2023
Beginning balance$15,529
Adjustments to goodwill resulting from acquisitions and divestitures, net(22)
Currency translation adjustment2
Ending balance$15,509

Other intangible assets

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

September 30, 2023December 31, 2022
Gross carrying amountsAccumulated amortizationOther intangible assets, netGross carrying amountsAccumulated amortizationOther intangible assets, net
Finite-lived intangible assets:
Developed-product-technology rights$29,028$(16,931)$12,097$29,028$(15,045)$13,983
Licensing rights3,864(3,233)6313,864(3,123)741
Marketing-related rights1,339(1,243)961,326(1,167)159
Research and development technology rights1,377(1,209)1681,378(1,190)188
Total finite-lived intangible assets35,608(22,616)12,99235,596(20,525)15,071
Indefinite-lived intangible assets:
In-process research and development158—1581,009—1,009
Total other intangible assets$35,766$(22,616)$13,150$36,605$(20,525)$16,080

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 September 30, 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 Condensed Consolidated Statements of Income and included in Other items, net, in the Condensed Consolidated Statements of Cash Flows. See Note 12, Fair value measurement, for the impact on the related contingent consideration liability.

During the three months ended September 30, 2023 and 2022, we recognized amortization associated with our finite-lived intangible assets of $693 million and $628 million, respectively. During the nine months ended September 30, 2023 and 2022, we recognized amortization associated with our finite-lived intangible assets of $2.1 billion and $1.9 billion, respectively. Amortization of intangible assets is primarily included in Cost of sales in the Condensed Consolidated Statements of Income. As of September 30, 2023, the total estimated amortization of our finite-lived intangible assets for the remaining three months ending December 31, 2023, and the years ending December 31, 2024, 2025, 2026, 2027 and 2028, are $0.7 billion, $2.7 billion, $2.5 billion, $2.1 billion, $2.1 billion and $1.1 billion, respectively.

10. Financing arrangements

Our borrowings consisted of the following (in millions):

September 30, 2023December 31, 2022
0.41% CHF700 million bonds due 2023 (0.41% 2023 Swiss franc Bonds)$—$757
2.25% notes due 2023 (2.25% 2023 Notes)—750
3.625% notes due 2024 (3.625% 2024 Notes)1,4001,400
1.90% notes due 2025 (1.90% 2025 Notes)500500
5.25% notes due 2025 (5.25% 2025 Notes)2,000—
3.125% notes due 2025 (3.125% 2025 Notes)1,0001,000
2.00% €750 million notes due 2026 (2.00% 2026 euro Notes)793803
5.507% notes due 2026 (5.507% 2026 Notes)1,500—
2.60% notes due 2026 (2.60% 2026 Notes)1,2501,250
5.50% £475 million notes due 2026 (5.50% 2026 pound sterling Notes)579574
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)3,750—
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)855846
2.45% notes due 2030 (2.45% 2030 Notes)1,2501,250
5.25% notes due 2030 (5.25% 2030 Notes)2,750—
2.30% notes due 2031 (2.30% 2031 Notes)1,2501,250
2.00% notes due 2032 (2.00% 2032 Notes)1,0011,051
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)4,250—
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)1,8032,000
5.75% notes due 2040 (5.75% 2040 Notes)373373
2.80% notes due 2041 (2.80% 2041 Notes)1,0911,110
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)2,750—
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)2,1322,250
4.663% notes due 2051 (4.663% 2051 Notes)3,5413,541
3.00% notes due 2052 (3.00% 2052 Notes)9991,254
4.20% notes due 2052 (4.20% 2052 Notes)9501,000
4.875% notes due 2053 (4.875% 2053 Notes)1,0001,000
5.65% notes due 2053 (5.65% 2053 Notes)4,250—
2.77% notes due 2053 (2.77% 2053 Notes)940940
4.40% notes due 2062 (4.40% 2062 Notes)1,2001,250
September 30, 2023December 31, 2022
5.75% notes due 2063 (5.75% 2063 Notes)2,750—
Other notes due 2097100100
Unamortized bond discounts, premiums and issuance costs, net(1,423)(1,246)
Fair value adjustments(494)(437)
Other1112
Total carrying value of debt60,46838,945
Less current portion(1,428)(1,591)
Total long-term debt$59,040$37,354

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.

Debt issuances and acquisition-related financing

During the three months ended March 31, 2023, in connection with the acquisition of Horizon (see Note 3, Acquisitions and divestitures*—Acquisition of Horizon Therapeutics plc*), we issued the following series of notes (in millions):

Principal Amount
5.25% 2025 Notes$2,000
5.507% 2026 Notes1,500
5.15% 2028 Notes3,750
5.25% 2030 Notes2,750
5.25% 2033 Notes4,250
5.60% 2043 Notes2,750
5.65% 2053 Notes4,250
5.75% 2063 Notes2,750
Total$24,000

In the event of a change-in-control triggering event, as defined by the terms of the notes, we may be required to purchase all or a portion of these notes at a price equal to 101% of the principal amount of the notes plus accrued and unpaid interest. In addition, these notes may be redeemed at any time at our option, in whole or in part, at the principal amount of the notes being redeemed plus accrued and unpaid interest and a make-whole amount, which are defined by the terms of the notes. Except with respect to the 5.25% 2025 Notes, the notes may be redeemed without payment of make-whole amounts if redemption occurs during a specified period of time immediately prior to the maturing of the notes. Such time periods range from two months to six months prior to maturity, except for the 5.507% 2026 Notes, which may be redeemed without payment of the make-whole amount if redemption occurs after two years prior to maturity.

In December 2022, in connection with the acquisition of Horizon, we entered into a bridge credit agreement, which provided for borrowings with an aggregate principal amount of $24.5 billion as of December 31, 2022. Subsequent to our March 2023 debt issuance described above, we terminated the bridge credit agreement. Accordingly, during the three months ended March 31, 2023, we recognized $98 million of financing cost associated with the bridge credit agreement, primarily in Other income (expense), net, in the Condensed Consolidated Statements of Income.

Also in connection with the acquisition of Horizon, we entered into a $4.0 billion term loan credit agreement in December 2022. No amounts under this agreement were outstanding as of September 30, 2023 and December 31, 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 with an interest rate of three-month SOFR plus 1.225%, of which $2.0 billion is due in April 2025 and $2.0 billion is due in October 2026.

Debt extinguishment

During the nine months ended September 30, 2023, we repurchased 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 $550 million, which resulted in the recognition of a $182 million gain on extinguishment of debt recorded in Other income (expense), net, in the Condensed Consolidated Statements of Income.

Debt repayments

During the nine months ended September 30, 2023, we repaid $750 million aggregate principal amount of the 2.25% 2023 Notes as well as the CHF700 million aggregate principal amount ($704 million upon settlement of the related cross-currency swap) of the 0.41% 2023 Swiss franc Bonds.

Shelf registration statement and other facilities

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 expires in February 2026.

During the three months ended March 31, 2023, we amended and restated our syndicated, unsecured, revolving credit agreement, under which we may borrow up to $4.0 billion (increased from $2.5 billion prior to the amendment) 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 (increased from $750 million prior to the amendment). 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 September 30, 2023 and December 31, 2022, no amounts were outstanding under this facility.

11. Stockholders’ equity

Stock repurchase program

Activity under our stock repurchase program, on a trade date basis, was as follows (in millions):

20232022
SharesDollarsSharesDollars
First quarter—$—24.6$5,410
Second quarter————
Third quarter——1.5900
Total stock repurchases—$—26.1$6,310

As of September 30, 2023, $7.0 billion of authorization remained available under our stock repurchase program.

Dividends

In August 2023, March 2023 and December 2022, our Board of Directors declared quarterly cash dividends of $2.13 per share, which were paid in September 2023, June 2023 and March 2023, respectively. In October 2023, our Board of Directors declared a quarterly cash dividend of $2.13 per share that will be paid in December 2023.

Accumulated other comprehensive income (loss)

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

Foreign currency translationCash flow hedgesOtherAOCI
Balance as of December 31, 2022$(348)$128$(11)$(231)
Foreign currency translation adjustments28——28
Unrealized losses—(71)—(71)
Reclassification adjustments to income—(30)—(30)
Other——2121
Income taxes—15—15
Balance as of March 31, 2023(320)4210(268)
Foreign currency translation adjustments11——11
Unrealized gains—50—50
Reclassification adjustments to income—(87)—(87)
Other——(1)(1)
Income taxes—15—15
Balance as of June 30, 2023(309)209(280)
Foreign currency translation adjustments(44)——(44)
Unrealized gains—177—177
Reclassification adjustments to income—53—53
Other——1717
Income taxes—(49)—(49)
Balance as of September 30, 2023$(353)$201$26$(126)

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

Three months ended September 30,
Components of AOCI20232022Condensed Consolidated Statements of Income locations
Cash flow hedges:
Foreign currency contract gains$33$69Product sales
Cross-currency swap contract losses(86)(198)Other income (expense), net
(53)(129)Income before income taxes
1128Provision for income taxes
$(42)$(101)Net income
Nine months ended September 30,
Components of AOCI20232022Condensed Consolidated Statements of Income locations
Cash flow hedges:
Foreign currency contract gains$121$149Product sales
Cross-currency swap contract losses(57)(461)Other income (expense), net
64(312)Income before income taxes
(14)67Provision for income taxes
$50$(245)Net income

12. 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 September 30, 2023, using:Total
Assets:
Available-for-sale securities:
U.S. Treasury bills$—$—$—$—
Money market mutual funds34,208——34,208
Other investments—136—136
Equity securities4,250——4,250
Derivatives:
Foreign currency forward contracts—347—347
Cross-currency swap contracts————
Total assets$38,458$483$—$38,941
Liabilities:
Derivatives:
Foreign currency forward contracts$—$29$—$29
Cross-currency swap contracts—513—513
Interest rate swap contracts—772—772
Forward interest rate contracts————
Contingent consideration obligations——9898
Total liabilities$—$1,314$98$1,412
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, 2022, using:Total
Assets:
Available-for-sale securities:
U.S. Treasury bills$1,676$—$—$1,676
Money market mutual funds2,659——2,659
Other investments—130—130
Equity securities480—335815
Derivatives:
Foreign currency forward contracts—287—287
Cross-currency swap contracts—54—54
Total assets$4,815$471$335$5,621
Liabilities:
Derivatives:
Foreign currency forward contracts$—$76$—$76
Cross-currency swap contracts—541—541
Interest rate swap contracts—776—776
Forward interest rate contracts—5—5
Contingent consideration obligations——270270
Total liabilities$—$1,398$270$1,668

Interest-bearing and equity securities

The fair values of our U.S. Treasury securities, money market mutual funds and equity investments in publicly traded securities, including our equity investments in BeiGene and Neumora, as of September 30, 2023, are based on quoted market prices in active markets, with no valuation adjustment. Other investments consist of interest-bearing deposits that are valued at amortized cost, which approximates fair value given their near-term maturity. Previously, the fair value of our equity investment in Neumora did not have a readily determinable fair value and was initially valued at the acquisition price and subsequently valued based on a combination of observable price transactions when available, market performance and publicly available market information for similar companies that have actively traded equity securities. During the three months ended September 30, 2023, Neumora became a publicly traded company, and its equity securities now have a readily determinable fair value. Accordingly, the fair value inputs of our equity investment in Neumora changed from using Level 3 inputs as of December 31, 2022, to using a Level 1 input as of September 30, 2023. See Note 7, Investments—Neumora Therapeutics, Inc.

As of the first quarter of 2023, we no longer account for our equity investment in BeiGene under the equity method of accounting. As of December 31, 2022, the fair value and carrying value were $4.2 billion and $2.2 billion, respectively, with the fair value estimated by using a Level 1 input. See Note 7, Investments—BeiGene, Ltd.

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, LIBOR, SOFR, swap rates, obligor credit default swap rates and cross-currency basis swap spreads. Certain inputs, when applicable, are at commonly quoted intervals. Starting in the third quarter of 2023, terms under our existing derivative contracts reference the SOFR benchmark consistent with the ISDA protocol. See Note 13, 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 Income.

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

Three months ended September 30,Nine months ended September 30,
2023202220232022
Beginning balance$248$310$270$342
Payments(3)(2)(7)(5)
Net changes in valuations(147)(6)(165)(35)
Ending balance$98$302$98$302

As of September 30, 2023 and December 31, 2022, our contingent consideration obligations are primarily the result of our acquisition of Teneobio in October 2021, which obligated us to pay the former shareholders up to $1.6 billion upon achieving separate development and regulatory milestones with regard to various R&D programs. During the three months ended September 30, 2023, the development of AMG 340 was terminated, resulting in a decrease of the related contingent consideration liability. The remeasurement of this liability of $147 million was recognized in Other operating expenses in the Condensed Consolidated Statements of Income and included in Other items, net, in the Condensed Consolidated Statements of Cash Flows. See Note 9, Goodwill and other intangible assets, for the impact on the related IPR&D asset. The remaining contingent consideration liability as of September 30, 2023, primarily relates to potential development and regulatory milestones for R&D programs acquired via the Teneobio acquisition that we continue to pursue.

Summary of the fair values of other financial instruments

Cash equivalents

The fair values of cash equivalents approximate 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 September 30, 2023 and December 31, 2022, the aggregate fair values of our borrowings were $56.4 billion and $35.0 billion, respectively, and the carrying values were $60.5 billion and $38.9 billion, respectively.

During the nine months ended September 30, 2023 and 2022, there were no transfers of assets or liabilities between fair value measurement levels, and except with respect to the impairment of AMG 340 discussed in Note 9, Goodwill and other intangible assets, there were no material remeasurements to the fair values of assets and liabilities that are not measured at fair value on a recurring basis.

13. 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 September 30, 2023 and December 31, 2022, we had outstanding foreign currency forward contracts with aggregate notional amounts of $6.3 billion and $6.0 billion, respectively. 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 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, pounds sterling and Swiss francs 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, pounds sterling and Swiss francs. In addition, we will pay U.S. dollars to and receive euros, pounds sterling and Swiss francs 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, pounds sterling and Swiss francs 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 income (expense), net, in the Condensed 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 September 30, 2023, 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%

During the three months ended March 31, 2023, our 0.41% 2023 Swiss franc Bonds matured, and the related cross-currency swaps were settled.

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 Income over the lives of the associated debt issuances. Amounts recognized in connection with forward interest rate contracts during the nine months ended September 30, 2023, 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 September 30,Nine months ended September 30,
Derivatives in cash flow hedging relationships2023202220232022
Foreign currency forward contracts$198$324$222$654
Cross-currency swap contracts(22)(279)(36)(486)
Forward interest rate contracts——(31)—
Total unrealized gains$176$45$155$168

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 September 30, 2023 and December 31, 2022, 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 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 locationsSeptember 30, 2023December 31, 2022September 30, 2023December 31, 2022
Current portion of long-term debt$1,426$82$27$82
Long-term debt$4,621$6,017$(521)$(519)

(1) Current portion of long-term debt includes $75 million and $82 million of carrying value with discontinued hedging relationships as of September 30, 2023 and December 31, 2022, respectively. Long-term debt includes $303 million and $357 million of carrying value with discontinued hedging relationships as of September 30, 2023 and December 31, 2022, respectively.

(2) Current portion of long-term debt includes $75 million and $82 million of hedging adjustments on discontinued hedging relationships as of September 30, 2023 and December 31, 2022, respectively. Long-term debt includes $203 million and $257 million of hedging adjustments on discontinued hedging relationships as of September 30, 2023 and December 31, 2022, 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 September 30, 2023Nine months ended September 30, 2023
Product salesOther income (expense), netInterest expense, netProduct salesOther income (expense), netInterest expense, net
Total amounts recorded in income and (expense) line items presented in the Condensed Consolidated Statements of Income$6,548$685$(759)$19,077$2,431$(2,054)
The effects of cash flow and fair value hedging:
Gains (losses) on cash flow hedging relationships reclassified out of AOCI:
Foreign currency forward contracts$33$—$—$121$—$—
Cross-currency swap contracts$—$(86)$—$—$(57)$—
Gains (losses) on fair value hedging relationships—interest rate swap agreements:
Hedged items(1)$—$—$58$—$—$63
Derivatives designated as hedging instruments$—$—$(37)$—$—$5
Three months ended September 30, 2022Nine months ended September 30, 2022
Product salesOther income (expense), netInterest expense, netProduct salesOther income (expense), netInterest expense, net
Total amounts recorded in income and (expense) line items presented in the Condensed Consolidated Statements of Income$6,237$100$(368)$18,249$(747)$(991)
The effects of cash flow and fair value hedging:
Gains (losses) on cash flow hedging relationships reclassified out of AOCI:
Foreign currency forward contracts$69$—$—$149$—$—
Cross-currency swap contracts$—$(198)$—$—$(461)$—
Gains (losses) on fair value hedging relationships—interest rate swap agreements:
Hedged items(1)$—$—$240$—$—$734
Derivatives designated as hedging instruments$—$—$(220)$—$—$(670)

(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 September 30, 2023, we expected to reclassify $200 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 September 30, 2023 and December 31, 2022, the total notional amounts of these foreign currency forward contracts were $521 million and $517 million, respectively. Gains and losses recognized in earnings for our derivative instruments not designated as hedging instruments were not material for the three and nine months ended September 30, 2023 and 2022.

Fair values of derivatives

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

Derivative assetsDerivative liabilities
September 30, 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$347Accrued liabilities/ Other noncurrent liabilities$29
Cross-currency swap contractsOther current assets/ Other noncurrent assets—Accrued liabilities/ Other noncurrent liabilities513
Interest rate swap contractsOther current assets/ Other noncurrent assets—Accrued liabilities/ Other noncurrent liabilities772
Forward interest rate contractsOther current assets/ Other noncurrent assets—Accrued liabilities/ Other noncurrent liabilities—
Total derivatives designated as hedging instruments3471,314
Total derivatives$347$1,314
Derivative assetsDerivative liabilities
December 31, 2022Condensed Consolidated Balance Sheets locationsFair valuesCondensed Consolidated Balance Sheets locationsFair values
Derivatives designated as hedging instruments:
Foreign currency forward contractsOther current assets/ Other noncurrent assets$287Accrued liabilities/ Other noncurrent liabilities$76
Cross-currency swap contractsOther current assets/ Other noncurrent assets54Accrued liabilities/ Other noncurrent liabilities541
Interest rate swap contractsOther current assets/ Other noncurrent assets—Accrued liabilities/ Other noncurrent liabilities776
Forward interest rate contractsOther current assets/ Other noncurrent assets—Accrued liabilities/ Other noncurrent liabilities5
Total derivatives designated as hedging instruments3411,398
Total derivatives$341$1,398

For additional information, see Note 12, Fair value measurement.

Our derivative contracts that were in liability positions as of September 30, 2023, 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 provided by (used in) financing activities.

14. 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, 2022, 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 19, Contingencies and commitments, to the consolidated financial statements in our Annual Report on Form 10-K for the year ended December 31, 2022; and in Note 14, Contingencies and commitments, to the condensed consolidated financial statements in our Quarterly Reports on Form 10-Q for the periods ended March 31, 2023 and June 30, 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 19, Contingencies and commitments, to the consolidated financial statements in our Annual Report on Form 10-K for the year ended December 31, 2022; and in Note 14, Contingencies and commitments, to the condensed consolidated financial statements in our Quarterly Reports on Form 10-Q for the periods ended March 31, 2023 and June 30, 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 19, Contingencies and commitments, to the consolidated financial statements in our Annual Report on Form 10-K for the year ended December 31, 2022; and in Note 14, Contingencies and commitments, to the condensed consolidated financial statements in our Quarterly Reports on Form 10-Q for the periods ended March 31, 2023 and June 30, 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

On December 6, 2023, oral proceedings will commence before the Technical Board of Appeal of the European Patent Office in the appeal from Amgen’s opposition to European Patent No. 2,756,004.

In Amgen’s lawsuit before the Unitary Patent Court against Sanofi-Aventis Deutschland GmbH, Sanofi-Aventis Groupe S.A., Sanofi Winthrop Industrie S.A. (collectively, Sanofi) and Regeneron Pharmaceuticals, Inc. (Regeneron), on August 25, 2023, the Central Division of the Unitary Patent Court in Germany rejected Amgen’s objections to the admissibility of Sanofi’s revocation action against Amgen’s European Patent No. 3,666,797. Accordingly, Amgen filed its Statement of Defense on September 12, 2023.

On September 15, 2023, the Japanese Supreme Court declined to hear Amgen’s appeal from the decision of the Japanese High Court finding Amgen’s patent claims invalid for lacking adequate support. The case will be remanded to the Japan Patent Office for further proceedings.

In Amgen’s lawsuit for patent infringement damages against Sanofi K.K., on September 27, 2023, the Tokyo District Court found Amgen’s patent claims invalid and dismissed Amgen’s lawsuit for damages.

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

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

On August 23, 2023, the U.S. District Court for the District of New Jersey (New Jersey District Court) entered a stipulation and order dismissing without prejudice Sandoz GmbH, Lek Pharmaceuticals d.d., Novartis Pharmaceutical Productions d.o.o. and Novartis AG (collectively “Foreign Defendants”) from the action. Pursuant to the stipulation entered by the New Jersey District Court, the Foreign Defendants agreed to be bound by any judgment order or decision in the matter (including appeals) as if the Foreign Defendants were named as defendants and parties to the judgment order or decision. Sandoz Inc. (Sandoz) is now the sole named defendant in the action.

On October 30, 2023, the New Jersey District Court commenced a hearing on Amgen’s motion for a preliminary injunction to prohibit Sandoz from engaging in the commercial manufacture, use, offer for sell or sale within the United States, or importation into the United States of its proposed denosumab biosimilar until judgment is entered after trial on the merits.

Antitrust Actions

Sensipar Antitrust Class Actions

On October 17, 2023, Amgen submitted its initial brief in its appeal before the U.S. Court of Appeals for the Third Circuit.

Regeneron Pharmaceuticals, Inc. Antitrust Action

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.

U.S. Tax Litigation and Related Matters

Amgen Inc. & Subsidiaries v. Commissioner of Internal Revenue

See Note 5, Income taxes, for discussion of the IRS tax dispute and the Company’s petitions in the U.S. Tax Court.

Securities Class Action Litigation

On August 31, 2023, plaintiff filed an amended complaint. Amgen’s motion to dismiss is due November 6, 2023.

Shareholder Derivative Litigation

On October 2, 2023, the U.S. District Court for the Southern District of New York granted a stay of the matter pending an outcome on the motion to dismiss in the federal securities class action filed by plaintiff.

ChemoCentryx, Inc. Securities Class Action Litigation

The due date for our subsidiary ChemoCentryx to file its opposition to class certification is November 22, 2023.

FTC Litigation re the Horizon Therapeutics plc Acquisition

On September 1, 2023, the FTC, the six state plaintiffs and Amgen announced that they entered into a consent agreement that resolved the matter, and both the federal litigation and the FTC administrative case were dismissed.

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