QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
(State or other jurisdiction of incorporation or organization) | (I.R.S. Employer Identification No.) | |||||||
(Address of principal executive offices) | (Zip Code) |
Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||||||
☑ | Accelerated filer | ☐ | Non-accelerated filer | ☐ | |||||||||||||
Smaller reporting company | Emerging growth company |
Page No. | ||||||||
Item 1. | ||||||||
Item 2. | ||||||||
Item 3. | ||||||||
Item 4. | ||||||||
Item 1. | ||||||||
Item 1A. | ||||||||
Item 2. | ||||||||
Item 5. | ||||||||
Item 6. | ||||||||
Term | Description | ||||
AOCI | accumulated other comprehensive income (loss) | ||||
ASR | accelerated share repurchase | ||||
BeiGene | BeiGene, Ltd. | ||||
Bergamo | Laboratorio Quimico Farmaceutico Bergamo Ltda | ||||
ChemoCentryx | ChemoCentryx, Inc. | ||||
CMS | Centers for Medicare & Medicaid Services | ||||
COVID-19 | coronavirus disease 2019 | ||||
Eczacıbaşı | EIS Eczacıbaşı İlaç, Sınai ve Finansal Yatırımlar Sanayi ve Ticaret A.Ş. | ||||
EPS | earnings per share | ||||
ESG | environmental, social and governance | ||||
EU | European Union | ||||
FDA | U.S. Food and Drug Administration | ||||
Fitch | Fitch Ratings, Inc. | ||||
FTC | Federal Trade Commission | ||||
GAAP | U.S. generally accepted accounting principles | ||||
Gensenta | Gensenta İlaç Sanayi ve Ticaret A.Ş. | ||||
HHS | U.S. Department of Health & Human Services | ||||
Horizon | Horizon Therapeutics plc | ||||
IPR&D | in-process research and development | ||||
IRA | Inflation Reduction Act of 2022 | ||||
IRS | Internal Revenue Service | ||||
ISDA | International Swaps and Derivatives Association, Inc. | ||||
LIBOR | London Interbank Offered Rate | ||||
MD&A | management’s discussion and analysis | ||||
Moody’s | Moody’s Investors Service, Inc. | ||||
Neumora | Neumora Therapeutics, Inc. | ||||
OECD | Organisation for Economic Co-operation and Development | ||||
PBM | pharmacy benefit manager | ||||
R&D | research and development | ||||
RAR | Revenue Agent Report | ||||
ROW | rest of world | ||||
S&P | Standard & Poor’s Financial Services LLC | ||||
SEC | U.S. Securities and Exchange Commission | ||||
SG&A | selling, general and administrative | ||||
SOFR | Secured Overnight Financing Rate | ||||
Teneobio | Teneobio, Inc. | ||||
U.S. Treasury | U.S. Department of Treasury | ||||
UTB | unrecognized tax benefit | ||||
Term | Description | |||||||
Aimovig | Aimovig® (erenumab-aooe) | |||||||
AMJEVITA/AMGEVITA | AMJEVITA® (adalimumab-atto) /AMGEVITA™ (adalimumab) | |||||||
Aranesp | Aranesp® (darbepoetin alfa) | |||||||
AVSOLA | AVSOLA® (infliximab-axxq) | |||||||
BEKEMV | BEKEMV™ (eculizumab) | |||||||
BLINCYTO | BLINCYTO® (blinatumomab) | |||||||
Corlanor | Corlanor® (ivabradine) | |||||||
ENBREL | Enbrel® (etanercept) | |||||||
EPOGEN | EPOGEN® (epoetin alfa) | |||||||
EVENITY | EVENITY® (romosozumab-aqqg) | |||||||
IMLYGIC | IMLYGIC® (talimogene laherparepvec) | |||||||
KANJINTI | KANJINTI® (trastuzumab-anns) | |||||||
KYPROLIS | KYPROLIS® (carfilzomib) | |||||||
LUMAKRAS/LUMYKRAS | LUMAKRAS®/LUMYKRAS™ (sotorasib) | |||||||
MVASI | MVASI® (bevacizumab-awwb) | |||||||
Neulasta | Neulasta® (pegfilgrastim) | |||||||
NEUPOGEN | NEUPOGEN® (filgrastim) | |||||||
Nplate | Nplate® (romiplostim) | |||||||
Otezla | Otezla® (apremilast) | |||||||
Parsabiv | Parsabiv® (etelcalcetide) | |||||||
Prolia | Prolia® (denosumab) | |||||||
Repatha | Repatha® (evolocumab) | |||||||
RIABNI | RIABNI® (rituximab-arrx) | |||||||
Sensipar/Mimpara | Sensipar®/Mimpara™ (cinacalcet) | |||||||
TAVNEOS | TAVNEOS® (avacopan) | |||||||
TEZSPIRE | TEZSPIRE® (tezepelumab-ekko) | |||||||
Vectibix | Vectibix® (panitumumab) | |||||||
XGEVA | XGEVA® (denosumab) |
Item 1. | FINANCIAL STATEMENTS |
Three months ended June 30, | Six months ended June 30, | ||||||||||||||||||||||
2023 | 2022 | 2023 | 2022 | ||||||||||||||||||||
Revenues: | |||||||||||||||||||||||
Product sales | $ | $ | $ | $ | |||||||||||||||||||
Other revenues | |||||||||||||||||||||||
Total revenues | |||||||||||||||||||||||
Operating expenses: | |||||||||||||||||||||||
Cost of sales | |||||||||||||||||||||||
Research and development | |||||||||||||||||||||||
Selling, general and administrative | |||||||||||||||||||||||
Other | |||||||||||||||||||||||
Total operating expenses | |||||||||||||||||||||||
Operating income | |||||||||||||||||||||||
Other income (expense): | |||||||||||||||||||||||
Interest expense, net | ( | ( | ( | ( | |||||||||||||||||||
Other (expense) income, net | ( | ( | ( | ||||||||||||||||||||
Income before income taxes | |||||||||||||||||||||||
Provision for income taxes | |||||||||||||||||||||||
Net income | $ | $ | $ | $ | |||||||||||||||||||
Earnings per share: | |||||||||||||||||||||||
Basic | $ | $ | $ | $ | |||||||||||||||||||
Diluted | $ | $ | $ | $ | |||||||||||||||||||
Shares used in calculation of earnings per share: | |||||||||||||||||||||||
Basic | |||||||||||||||||||||||
Diluted |
Three months ended June 30, | Six months ended June 30, | ||||||||||||||||||||||
2023 | 2022 | 2023 | 2022 | ||||||||||||||||||||
Net income | $ | $ | $ | $ | |||||||||||||||||||
Other comprehensive (loss) income, net of reclassification adjustments and taxes: | |||||||||||||||||||||||
Foreign currency translation | ( | ( | |||||||||||||||||||||
Cash flow hedges | ( | ( | |||||||||||||||||||||
Other | ( | ||||||||||||||||||||||
Other comprehensive (loss) income, net of reclassification adjustments and taxes | ( | ( | |||||||||||||||||||||
Comprehensive income | $ | $ | $ | $ |
June 30, 2023 | December 31, 2022 | ||||||||||
(Unaudited) | |||||||||||
ASSETS | |||||||||||
Current assets: | |||||||||||
Cash and cash equivalents | $ | $ | |||||||||
Marketable securities | |||||||||||
Trade receivables, net | |||||||||||
Inventories | |||||||||||
Other current assets | |||||||||||
Total current assets | |||||||||||
Property, plant and equipment, net | |||||||||||
Intangible assets, net | |||||||||||
Goodwill | |||||||||||
Other noncurrent assets | |||||||||||
Total assets | $ | $ | |||||||||
LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||||||||
Current liabilities: | |||||||||||
Accounts payable | $ | $ | |||||||||
Accrued liabilities | |||||||||||
Current portion of long-term debt | |||||||||||
Total current liabilities | |||||||||||
Long-term debt | |||||||||||
Long-term tax liabilities | |||||||||||
Other noncurrent liabilities | |||||||||||
Contingencies and commitments | |||||||||||
Stockholders’ equity: | |||||||||||
Common stock and additional paid-in capital; $ | |||||||||||
Accumulated deficit | ( | ( | |||||||||
Accumulated other comprehensive loss | ( | ( | |||||||||
Total stockholders’ equity | |||||||||||
Total liabilities and stockholders’ equity | $ | $ |
Number of shares of common stock | Common stock and additional paid-in capital | Accumulated deficit | Accumulated other comprehensive loss | Total | |||||||||||||||||||||||||
Balance as of December 31, 2022 | $ | $ | ( | $ | ( | $ | |||||||||||||||||||||||
Net income | — | — | — | ||||||||||||||||||||||||||
Other comprehensive loss, net of taxes | — | — | — | ( | ( | ||||||||||||||||||||||||
Dividends declared on common stock ($ | — | — | ( | — | ( | ||||||||||||||||||||||||
Issuance of common stock in connection with the Company’s equity award programs | — | — | |||||||||||||||||||||||||||
Stock-based compensation expense | — | — | — | ||||||||||||||||||||||||||
Tax impact related to employee stock-based compensation expense | — | ( | — | — | ( | ||||||||||||||||||||||||
Balance as of March 31, 2023 | ( | ( | |||||||||||||||||||||||||||
Net income | — | — | — | ||||||||||||||||||||||||||
Other comprehensive loss, net of taxes | — | — | — | ( | ( | ||||||||||||||||||||||||
Issuance of common stock in connection with the Company’s equity award programs | — | — | |||||||||||||||||||||||||||
Stock-based compensation expense | — | — | — | ||||||||||||||||||||||||||
Tax impact related to employee stock-based compensation expense | — | ( | — | — | ( | ||||||||||||||||||||||||
Balance as of June 30, 2023 | $ | $ | ( | $ | ( | $ | |||||||||||||||||||||||
Number of shares of common stock | Common stock and additional paid-in capital | Accumulated deficit | Accumulated other comprehensive loss | Total | |||||||||||||||||||||||||
Balance as of December 31, 2021 | $ | $ | ( | $ | ( | $ | |||||||||||||||||||||||
Net income | — | — | — | ||||||||||||||||||||||||||
Other comprehensive income, net of taxes | — | — | — | ||||||||||||||||||||||||||
Dividends declared on common stock ($ | — | — | ( | — | ( | ||||||||||||||||||||||||
Issuance of common stock in connection with the Company’s equity award programs | — | — | |||||||||||||||||||||||||||
Stock-based compensation expense | — | — | — | ||||||||||||||||||||||||||
Tax impact related to employee stock-based compensation expense | — | ( | — | — | ( | ||||||||||||||||||||||||
Repurchases of common stock | ( | ( | ( | — | ( | ||||||||||||||||||||||||
Balance as of March 31, 2022 | ( | ( | |||||||||||||||||||||||||||
Net income | — | — | — | ||||||||||||||||||||||||||
Other comprehensive income, net of taxes | — | — | — | ||||||||||||||||||||||||||
Issuance of common stock in connection with the Company’s equity award programs | — | — | |||||||||||||||||||||||||||
Stock-based compensation expense | — | — | — | ||||||||||||||||||||||||||
Tax impact related to employee stock-based compensation expense | — | ( | — | — | ( | ||||||||||||||||||||||||
Other | — | — | ( | — | ( | ||||||||||||||||||||||||
Balance as of June 30, 2022 | $ | $ | ( | $ | ( | $ | |||||||||||||||||||||||
Six months ended June 30, | |||||||||||
2023 | 2022 | ||||||||||
Cash flows from operating activities: | |||||||||||
Net income | $ | $ | |||||||||
Depreciation, amortization and other | |||||||||||
Deferred income taxes | ( | ( | |||||||||
Adjustments for equity method investments | ( | ||||||||||
Loss on divestiture | |||||||||||
(Gains) losses on equity securities | ( | ||||||||||
Other items, net | |||||||||||
Changes in operating assets and liabilities, net of acquisitions: | |||||||||||
Trade receivables, net | ( | ( | |||||||||
Inventories | ( | ( | |||||||||
Other assets | ( | ||||||||||
Accounts payable | ( | ( | |||||||||
Accrued income taxes, net | ( | ||||||||||
Long-term tax liabilities | |||||||||||
Other liabilities | |||||||||||
Net cash provided by operating activities | |||||||||||
Cash flows from investing activities: | |||||||||||
Purchases of marketable securities | ( | ||||||||||
Proceeds from sales of marketable securities | |||||||||||
Proceeds from maturities of marketable securities | |||||||||||
Purchases of property, plant and equipment | ( | ( | |||||||||
Other | |||||||||||
Net cash provided by (used in) investing activities | ( | ||||||||||
Cash flows from financing activities: | |||||||||||
Net proceeds from issuance of debt | |||||||||||
Extinguishment of debt | ( | ||||||||||
Repayment of debt | ( | ||||||||||
Repurchases of common stock | ( | ||||||||||
Dividends paid | ( | ( | |||||||||
Other | ( | ( | |||||||||
Net cash provided by (used in) financing activities | ( | ||||||||||
Increase (decrease) in cash and cash equivalents | ( | ||||||||||
Cash and cash equivalents at beginning of period | |||||||||||
Cash and cash equivalents at end of period | $ | $ |
Three months ended June 30, 2023 | |||||||||||||||||
Separation costs | Asset impairments and other charges | Total | |||||||||||||||
Cost of sales | $ | $ | $ | ||||||||||||||
Research and development | |||||||||||||||||
Other | |||||||||||||||||
Total | $ | $ | $ |
Six months ended June 30, 2023 | |||||||||||||||||
Separation costs | Asset impairments and other charges | Total | |||||||||||||||
Cost of sales | $ | $ | $ | ||||||||||||||
Research and development | |||||||||||||||||
Other | |||||||||||||||||
Total | $ | $ | $ |
Amounts | ||||||||
Cash and cash equivalents | $ | |||||||
Marketable securities | ||||||||
Inventories | ||||||||
Finite-lived intangible assets—developed-product-technology rights | ||||||||
Goodwill | ||||||||
Other liabilities, net | ( | |||||||
Deferred tax liability, net | ( | |||||||
Total assets acquired, net | $ |
Three months ended June 30, | ||||||||||||||||||||||||||||||||||||||
2023 | 2022 | |||||||||||||||||||||||||||||||||||||
U.S. | ROW | Total | U.S. | ROW | Total | |||||||||||||||||||||||||||||||||
Prolia | $ | $ | $ | $ | $ | $ | ||||||||||||||||||||||||||||||||
ENBREL | ||||||||||||||||||||||||||||||||||||||
XGEVA | ||||||||||||||||||||||||||||||||||||||
Otezla | ||||||||||||||||||||||||||||||||||||||
Repatha | ||||||||||||||||||||||||||||||||||||||
Aranesp | ||||||||||||||||||||||||||||||||||||||
KYPROLIS | ||||||||||||||||||||||||||||||||||||||
Nplate | ||||||||||||||||||||||||||||||||||||||
EVENITY | ||||||||||||||||||||||||||||||||||||||
Other products(1) | ||||||||||||||||||||||||||||||||||||||
Total product sales(2) | $ | $ | $ | $ | ||||||||||||||||||||||||||||||||||
Other revenues | ||||||||||||||||||||||||||||||||||||||
Total revenues | $ | $ | ||||||||||||||||||||||||||||||||||||
Six months ended June 30, | ||||||||||||||||||||||||||||||||||||||
2023 | 2022 | |||||||||||||||||||||||||||||||||||||
U.S. | ROW | Total | U.S. | ROW | Total | |||||||||||||||||||||||||||||||||
Prolia | $ | $ | $ | $ | $ | $ | ||||||||||||||||||||||||||||||||
ENBREL | ||||||||||||||||||||||||||||||||||||||
XGEVA | ||||||||||||||||||||||||||||||||||||||
Otezla | ||||||||||||||||||||||||||||||||||||||
Repatha | ||||||||||||||||||||||||||||||||||||||
Aranesp | ||||||||||||||||||||||||||||||||||||||
KYPROLIS | ||||||||||||||||||||||||||||||||||||||
Nplate | ||||||||||||||||||||||||||||||||||||||
EVENITY | ||||||||||||||||||||||||||||||||||||||
Other products(1) | ||||||||||||||||||||||||||||||||||||||
Total product sales(2) | $ | $ | $ | $ | ||||||||||||||||||||||||||||||||||
Other revenues | ||||||||||||||||||||||||||||||||||||||
Total revenues | $ | $ | ||||||||||||||||||||||||||||||||||||
Three months ended June 30, | Six months ended June 30, | ||||||||||||||||||||||
2023 | 2022 | 2023 | 2022 | ||||||||||||||||||||
Income (Numerator): | |||||||||||||||||||||||
Net income for basic and diluted EPS | $ | $ | $ | $ | |||||||||||||||||||
Shares (Denominator): | |||||||||||||||||||||||
Weighted-average shares for basic EPS | |||||||||||||||||||||||
Effect of dilutive securities | |||||||||||||||||||||||
Weighted-average shares for diluted EPS | |||||||||||||||||||||||
Basic EPS | $ | $ | $ | $ | |||||||||||||||||||
Diluted EPS | $ | $ | $ | $ |
Types of securities as of June 30, 2023 | Amortized cost | Gross unrealized gains | Gross unrealized losses | Fair values | ||||||||||||||||||||||
U.S. Treasury bills | $ | $ | $ | $ | ||||||||||||||||||||||
Money market mutual funds | ||||||||||||||||||||||||||
Total interest-bearing securities | $ | $ | $ | $ |
Types of securities as of December 31, 2022 | Amortized cost | Gross unrealized gains | Gross unrealized losses | Fair values | ||||||||||||||||||||||
U.S. Treasury bills | $ | $ | $ | $ | ||||||||||||||||||||||
Money market mutual funds | ||||||||||||||||||||||||||
Total interest-bearing securities | $ | $ | $ | $ |
Condensed Consolidated Balance Sheets locations | June 30, 2023 | December 31, 2022 | ||||||||||||
Cash and cash equivalents | $ | $ | ||||||||||||
Marketable securities | ||||||||||||||
Total interest-bearing securities | $ | $ |
June 30, 2023 | December 31, 2022 | ||||||||||
Raw materials | $ | $ | |||||||||
Work in process | |||||||||||
Finished goods | |||||||||||
Total inventories | $ | $ |
Six months ended June 30, 2023 | |||||
Beginning balance | $ | ||||
Adjustments to goodwill resulting from acquisitions and divestitures, net | ( | ||||
Currency translation adjustment | |||||
Ending balance | $ |
June 30, 2023 | December 31, 2022 | ||||||||||||||||||||||||||||||||||
Gross carrying amounts | Accumulated amortization | Other intangible assets, net | Gross carrying amounts | Accumulated amortization | Other intangible assets, net | ||||||||||||||||||||||||||||||
Finite-lived intangible assets: | |||||||||||||||||||||||||||||||||||
Developed-product-technology rights | $ | $ | ( | $ | $ | $ | ( | $ | |||||||||||||||||||||||||||
Licensing rights | ( | ( | |||||||||||||||||||||||||||||||||
Marketing-related rights | ( | ( | |||||||||||||||||||||||||||||||||
Research and development technology rights | ( | ( | |||||||||||||||||||||||||||||||||
Total finite-lived intangible assets | ( | ( | |||||||||||||||||||||||||||||||||
Indefinite-lived intangible assets: | |||||||||||||||||||||||||||||||||||
In-process research and development | — | — | |||||||||||||||||||||||||||||||||
Total other intangible assets | $ | $ | ( | $ | $ | $ | ( | $ |
June 30, 2023 | December 31, 2022 | ||||||||||
$ | — | $ | |||||||||
— | |||||||||||
— | |||||||||||
— | |||||||||||
June 30, 2023 | December 31, 2022 | ||||||||||
Other notes due 2097 | |||||||||||
Unamortized bond discounts, premiums and issuance costs, net | ( | ( | |||||||||
Fair value adjustments | ( | ( | |||||||||
Other | |||||||||||
Total carrying value of debt | |||||||||||
Less current portion | ( | ( | |||||||||
Total long-term debt | $ | $ |
Principal Amount | |||||
$ | |||||
Total | $ |
2023 | 2022 | ||||||||||||||||||||||
Shares | Dollars | Shares | Dollars | ||||||||||||||||||||
First quarter | $ | $ | |||||||||||||||||||||
Second quarter | |||||||||||||||||||||||
Total stock repurchases | $ | $ |
Foreign currency translation | Cash flow hedges | Other | AOCI | ||||||||||||||||||||
Balance as of December 31, 2022 | $ | ( | $ | $ | ( | $ | ( | ||||||||||||||||
Foreign currency translation adjustments | — | — | |||||||||||||||||||||
Unrealized losses | — | ( | ( | ||||||||||||||||||||
Reclassification adjustments to income | — | ( | — | ( | |||||||||||||||||||
Other | — | — | |||||||||||||||||||||
Income taxes | — | ||||||||||||||||||||||
Balance as of March 31, 2023 | ( | ( | |||||||||||||||||||||
Foreign currency translation adjustments | — | — | |||||||||||||||||||||
Unrealized gains | — | ||||||||||||||||||||||
Reclassification adjustments to income | — | ( | — | ( | |||||||||||||||||||
Other | — | — | ( | ( | |||||||||||||||||||
Income taxes | — | ||||||||||||||||||||||
Balance as of June 30, 2023 | $ | ( | $ | $ | $ | ( | |||||||||||||||||
Three months ended June 30, | ||||||||||||||||||||
Components of AOCI | 2023 | 2022 | Condensed Consolidated Statements of Income locations | |||||||||||||||||
Cash flow hedges: | ||||||||||||||||||||
Foreign currency contract gains | $ | $ | Product sales | |||||||||||||||||
Cross-currency swap contract gains (losses) | ( | Other (expense) income, net | ||||||||||||||||||
( | Income before income taxes | |||||||||||||||||||
( | Provision for income taxes | |||||||||||||||||||
$ | $ | ( | Net income | |||||||||||||||||
Six months ended June 30, | ||||||||||||||||||||
Components of AOCI | 2023 | 2022 | Condensed Consolidated Statements of Income locations | |||||||||||||||||
Cash flow hedges: | ||||||||||||||||||||
Foreign currency contract gains | $ | $ | Product sales | |||||||||||||||||
Cross-currency swap contract gains (losses) | ( | Other (expense) income, net | ||||||||||||||||||
( | Income before income taxes | |||||||||||||||||||
( | Provision for income taxes | |||||||||||||||||||
$ | $ | ( | Net income | |||||||||||||||||
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 |
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 June 30, 2023, using: | Total | |||||||||||||||||||||||||
Assets: | ||||||||||||||||||||||||||
Available-for-sale securities: | ||||||||||||||||||||||||||
U.S. Treasury bills | $ | $ | $ | $ | ||||||||||||||||||||||
Money market mutual funds | ||||||||||||||||||||||||||
Other investments | ||||||||||||||||||||||||||
Equity securities | ||||||||||||||||||||||||||
Derivatives: | ||||||||||||||||||||||||||
Foreign currency forward contracts | ||||||||||||||||||||||||||
Cross-currency swap contracts | ||||||||||||||||||||||||||
Total assets | $ | $ | $ | $ | ||||||||||||||||||||||
Liabilities: | ||||||||||||||||||||||||||
Derivatives: | ||||||||||||||||||||||||||
Foreign currency forward contracts | $ | $ | $ | $ | ||||||||||||||||||||||
Cross-currency swap contracts | ||||||||||||||||||||||||||
Interest rate swap contracts | ||||||||||||||||||||||||||
Forward interest rate contracts | ||||||||||||||||||||||||||
Contingent consideration obligations | ||||||||||||||||||||||||||
Total liabilities | $ | $ | $ | $ |
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 | $ | $ | $ | $ | ||||||||||||||||||||||
Money market mutual funds | ||||||||||||||||||||||||||
Other investments | ||||||||||||||||||||||||||
Equity securities | ||||||||||||||||||||||||||
Derivatives: | ||||||||||||||||||||||||||
Foreign currency forward contracts | ||||||||||||||||||||||||||
Cross-currency swap contracts | ||||||||||||||||||||||||||
Total assets | $ | $ | $ | $ | ||||||||||||||||||||||
Liabilities: | ||||||||||||||||||||||||||
Derivatives: | ||||||||||||||||||||||||||
Foreign currency forward contracts | $ | $ | $ | $ | ||||||||||||||||||||||
Cross-currency swap contracts | ||||||||||||||||||||||||||
Interest rate swap contracts | ||||||||||||||||||||||||||
Forward interest rate contracts | ||||||||||||||||||||||||||
Contingent consideration obligations | ||||||||||||||||||||||||||
Total liabilities | $ | $ | $ | $ |
Three months ended June 30, | Six months ended June 30, | |||||||||||||||||||||||||
2023 | 2022 | 2023 | 2022 | |||||||||||||||||||||||
Beginning balance | $ | $ | $ | $ | ||||||||||||||||||||||
Payments | ( | ( | ( | ( | ||||||||||||||||||||||
Net changes in valuations | ( | ( | ( | ( | ||||||||||||||||||||||
Ending balance | $ | $ | $ | $ |
Foreign currency | U.S. dollars | |||||||||||||||||||||||||
Hedged notes | Notional amounts | Interest rates | Notional amounts | Interest rates | ||||||||||||||||||||||
2.00% 2026 euro Notes | € | % | $ | % | ||||||||||||||||||||||
5.50% 2026 pound sterling Notes | £ | % | $ | % | ||||||||||||||||||||||
4.00% 2029 pound sterling Notes | £ | % | $ | % |
Three months ended June 30, | Six months ended June 30, | |||||||||||||||||||||||||
Derivatives in cash flow hedging relationships | 2023 | 2022 | 2023 | 2022 | ||||||||||||||||||||||
Foreign currency forward contracts | $ | $ | $ | $ | ||||||||||||||||||||||
Cross-currency swap contracts | ( | ( | ( | |||||||||||||||||||||||
Forward interest rate contracts | ( | |||||||||||||||||||||||||
Total unrealized gains (losses) | $ | $ | $ | ( | $ |
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 locations | June 30, 2023 | December 31, 2022 | June 30, 2023 | December 31, 2022 | ||||||||||||||||||||||
Current portion of long-term debt | $ | $ | $ | $ | ||||||||||||||||||||||
Long-term debt | $ | $ | $ | ( | $ | ( |
Three months ended June 30, 2023 | Six months ended June 30, 2023 | |||||||||||||||||||||||||||||||||||||
Product sales | Other (expense) income, net | Interest expense, net | Product sales | Other (expense) income, net | Interest expense, net | |||||||||||||||||||||||||||||||||
Total amounts recorded in income and (expense) line items presented in the Condensed Consolidated Statements of Income | $ | $ | ( | $ | ( | $ | $ | $ | ( | |||||||||||||||||||||||||||||
The effects of cash flow and fair value hedging: | ||||||||||||||||||||||||||||||||||||||
Gains on cash flow hedging relationships reclassified out of AOCI: | ||||||||||||||||||||||||||||||||||||||
Foreign currency forward contracts | $ | $ | — | $ | — | $ | $ | — | $ | — | ||||||||||||||||||||||||||||
Cross-currency swap contracts | $ | — | $ | $ | — | $ | — | $ | $ | — | ||||||||||||||||||||||||||||
Gains (losses) on fair value hedging relationships—interest rate swap agreements: | ||||||||||||||||||||||||||||||||||||||
Hedged items(1) | $ | — | $ | — | $ | $ | — | $ | — | $ | ||||||||||||||||||||||||||||
Derivatives designated as hedging instruments | $ | — | $ | — | $ | ( | $ | — | $ | — | $ |
Three months ended June 30, 2022 | Six months ended June 30, 2022 | |||||||||||||||||||||||||||||||||||||
Product sales | Other (expense) income, net | Interest expense, net | Product sales | Other (expense) income, net | Interest expense, net | |||||||||||||||||||||||||||||||||
Total amounts recorded in income and (expense) line items presented in the Condensed Consolidated Statements of Income | $ | $ | ( | $ | ( | $ | $ | ( | $ | ( | ||||||||||||||||||||||||||||
The effects of cash flow and fair value hedging: | ||||||||||||||||||||||||||||||||||||||
Gains (losses) on cash flow hedging relationships reclassified out of AOCI: | ||||||||||||||||||||||||||||||||||||||
Foreign currency forward contracts | $ | $ | — | $ | — | $ | $ | — | $ | — | ||||||||||||||||||||||||||||
Cross-currency swap contracts | $ | — | $ | ( | $ | — | $ | — | $ | ( | $ | — | ||||||||||||||||||||||||||
Gains (losses) on fair value hedging relationships—interest rate swap agreements: | ||||||||||||||||||||||||||||||||||||||
Hedged items(1) | $ | — | $ | — | $ | $ | — | $ | — | $ | ||||||||||||||||||||||||||||
Derivatives designated as hedging instruments | $ | — | $ | — | $ | ( | $ | — | $ | — | $ | ( |
Derivative assets | Derivative liabilities | |||||||||||||||||||||||||
June 30, 2023 | Condensed Consolidated Balance Sheets locations | Fair values | Condensed Consolidated Balance Sheets locations | Fair values | ||||||||||||||||||||||
Derivatives designated as hedging instruments: | ||||||||||||||||||||||||||
Foreign currency forward contracts | Other current assets/ Other noncurrent assets | $ | Accrued liabilities/ Other noncurrent liabilities | $ | ||||||||||||||||||||||
Cross-currency swap contracts | Other current assets/ Other noncurrent assets | Accrued liabilities/ Other noncurrent liabilities | ||||||||||||||||||||||||
Interest rate swap contracts | Other current assets/ Other noncurrent assets | Accrued liabilities/ Other noncurrent liabilities | ||||||||||||||||||||||||
Forward interest rate contracts | Other current assets/ Other noncurrent assets | Accrued liabilities/ Other noncurrent liabilities | ||||||||||||||||||||||||
Total derivatives designated as hedging instruments | ||||||||||||||||||||||||||
Total derivatives | $ | $ |
Derivative assets | Derivative liabilities | |||||||||||||||||||||||||
December 31, 2022 | Condensed Consolidated Balance Sheets locations | Fair values | Condensed Consolidated Balance Sheets locations | Fair values | ||||||||||||||||||||||
Derivatives designated as hedging instruments: | ||||||||||||||||||||||||||
Foreign currency forward contracts | Other current assets/ Other noncurrent assets | $ | Accrued liabilities/ Other noncurrent liabilities | $ | ||||||||||||||||||||||
Cross-currency swap contracts | Other current assets/ Other noncurrent assets | Accrued liabilities/ Other noncurrent liabilities | ||||||||||||||||||||||||
Interest rate swap contracts | Other current assets/ Other noncurrent assets | Accrued liabilities/ Other noncurrent liabilities | ||||||||||||||||||||||||
Forward interest rate contracts | Other current assets/ Other noncurrent assets | Accrued liabilities/ Other noncurrent liabilities | ||||||||||||||||||||||||
Total derivatives designated as hedging instruments | ||||||||||||||||||||||||||
Total derivatives | $ | $ |
Item 2. | MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS |
Three months ended June 30, | Six months ended June 30, | ||||||||||||||||||||||||||||||||||
2023 | 2022 | Change | 2023 | 2022 | Change | ||||||||||||||||||||||||||||||
Product sales | |||||||||||||||||||||||||||||||||||
U.S. | $ | 4,736 | $ | 4,446 | 7 | % | $ | 8,711 | $ | 8,483 | 3 | % | |||||||||||||||||||||||
ROW | 1,947 | 1,835 | 6 | % | 3,818 | 3,529 | 8 | % | |||||||||||||||||||||||||||
Total product sales | 6,683 | 6,281 | 6 | % | 12,529 | 12,012 | 4 | % | |||||||||||||||||||||||||||
Other revenues | 303 | 313 | (3) | % | 562 | 820 | (31) | % | |||||||||||||||||||||||||||
Total revenues | $ | 6,986 | $ | 6,594 | 6 | % | $ | 13,091 | $ | 12,832 | 2 | % | |||||||||||||||||||||||
Operating expenses | $ | 4,302 | $ | 4,418 | (3) | % | $ | 8,486 | $ | 8,156 | 4 | % | |||||||||||||||||||||||
Operating income | $ | 2,684 | $ | 2,176 | 23 | % | $ | 4,605 | $ | 4,676 | (2) | % | |||||||||||||||||||||||
Net income | $ | 1,379 | $ | 1,317 | 5 | % | $ | 4,220 | $ | 2,793 | 51 | % | |||||||||||||||||||||||
Diluted EPS | $ | 2.57 | $ | 2.45 | 5 | % | $ | 7.86 | $ | 5.13 | 53 | % | |||||||||||||||||||||||
Diluted shares | 537 | 537 | — | % | 537 | 544 | (1) | % |
Three months ended June 30, | Six months ended June 30, | ||||||||||||||||||||||||||||||||||
2023 | 2022 | Change | 2023 | 2022 | Change | ||||||||||||||||||||||||||||||
Prolia | $ | 1,028 | $ | 922 | 11 | % | $ | 1,955 | 1,774 | 10 | % | ||||||||||||||||||||||||
ENBREL | 1,068 | 1,051 | 2 | % | 1,647 | 1,913 | (14) | % | |||||||||||||||||||||||||||
XGEVA | 530 | 533 | (1) | % | 1,066 | 1,035 | 3 | % | |||||||||||||||||||||||||||
Otezla | 600 | 594 | 1 | % | 992 | 1,045 | (5) | % | |||||||||||||||||||||||||||
Repatha | 424 | 325 | 30 | % | 812 | 654 | 24 | % | |||||||||||||||||||||||||||
Aranesp | 365 | 357 | 2 | % | 720 | 715 | 1 | % | |||||||||||||||||||||||||||
KYPROLIS | 346 | 317 | 9 | % | 704 | 604 | 17 | % | |||||||||||||||||||||||||||
Nplate | 310 | 284 | 9 | % | 672 | 550 | 22 | % | |||||||||||||||||||||||||||
EVENITY | 281 | 191 | 47 | % | 535 | 361 | 48 | % | |||||||||||||||||||||||||||
Other products(1) | 1,731 | 1,707 | 1 | % | 3,426 | 3,361 | 2 | % | |||||||||||||||||||||||||||
Total product sales | $ | 6,683 | $ | 6,281 | 6 | % | $ | 12,529 | $ | 12,012 | 4 | % |
Three months ended June 30, | Six months ended June 30, | ||||||||||||||||||||||||||||||||||
2023 | 2022 | Change | 2023 | 2022 | Change | ||||||||||||||||||||||||||||||
Prolia — U.S. | $ | 691 | $ | 611 | 13 | % | $ | 1,314 | $ | 1,193 | 10 | % | |||||||||||||||||||||||
Prolia — ROW | 337 | 311 | 8 | % | 641 | 581 | 10 | % | |||||||||||||||||||||||||||
Total Prolia | $ | 1,028 | $ | 922 | 11 | % | $ | 1,955 | $ | 1,774 | 10 | % |
Three months ended June 30, | Six months ended June 30, | ||||||||||||||||||||||||||||||||||
2023 | 2022 | Change | 2023 | 2022 | Change | ||||||||||||||||||||||||||||||
ENBREL — U.S. | $ | 1,055 | $ | 1,036 | 2 | % | $ | 1,619 | $ | 1,879 | (14) | % | |||||||||||||||||||||||
ENBREL — Canada | 13 | 15 | (13) | % | 28 | 34 | (18) | % | |||||||||||||||||||||||||||
Total ENBREL | $ | 1,068 | $ | 1,051 | 2 | % | $ | 1,647 | $ | 1,913 | (14) | % |
Three months ended June 30, | Six months ended June 30, | ||||||||||||||||||||||||||||||||||
2023 | 2022 | Change | 2023 | 2022 | Change | ||||||||||||||||||||||||||||||
XGEVA — U.S. | $ | 387 | $ | 391 | (1) | % | $ | 771 | $ | 759 | 2 | % | |||||||||||||||||||||||
XGEVA — ROW | 143 | 142 | 1 | % | 295 | 276 | 7 | % | |||||||||||||||||||||||||||
Total XGEVA | $ | 530 | $ | 533 | (1) | % | $ | 1,066 | $ | 1,035 | 3 | % |
Three months ended June 30, | Six months ended June 30, | ||||||||||||||||||||||||||||||||||
2023 | 2022 | Change | 2023 | 2022 | Change | ||||||||||||||||||||||||||||||
Otezla — U.S. | $ | 495 | $ | 487 | 2 | % | $ | 789 | $ | 837 | (6) | % | |||||||||||||||||||||||
Otezla — ROW | 105 | 107 | (2) | % | 203 | 208 | (2) | % | |||||||||||||||||||||||||||
Total Otezla | $ | 600 | $ | 594 | 1 | % | $ | 992 | $ | 1,045 | (5) | % |
Three months ended June 30, | Six months ended June 30, | ||||||||||||||||||||||||||||||||||
2023 | 2022 | Change | 2023 | 2022 | Change | ||||||||||||||||||||||||||||||
Repatha — U.S. | $ | 212 | $ | 154 | 38 | % | $ | 409 | $ | 319 | 28 | % | |||||||||||||||||||||||
Repatha — ROW | 212 | 171 | 24 | % | 403 | 335 | 20 | % | |||||||||||||||||||||||||||
Total Repatha | $ | 424 | $ | 325 | 30 | % | $ | 812 | $ | 654 | 24 | % |
Three months ended June 30, | Six months ended June 30, | ||||||||||||||||||||||||||||||||||
2023 | 2022 | Change | 2023 | 2022 | Change | ||||||||||||||||||||||||||||||
Aranesp — U.S. | $ | 123 | $ | 132 | (7) | % | $ | 238 | $ | 269 | (12) | % | |||||||||||||||||||||||
Aranesp — ROW | 242 | 225 | 8 | % | 482 | 446 | 8 | % | |||||||||||||||||||||||||||
Total Aranesp | $ | 365 | $ | 357 | 2 | % | $ | 720 | $ | 715 | 1 | % |
Three months ended June 30, | Six months ended June 30, | ||||||||||||||||||||||||||||||||||
2023 | 2022 | Change | 2023 | 2022 | Change | ||||||||||||||||||||||||||||||
KYPROLIS — U.S. | $ | 234 | $ | 213 | 10 | % | $ | 468 | $ | 409 | 14 | % | |||||||||||||||||||||||
KYPROLIS — ROW | 112 | 104 | 8 | % | 236 | 195 | 21 | % | |||||||||||||||||||||||||||
Total KYPROLIS | $ | 346 | $ | 317 | 9 | % | $ | 704 | $ | 604 | 17 | % |
Three months ended June 30, | Six months ended June 30, | ||||||||||||||||||||||||||||||||||
2023 | 2022 | Change | 2023 | 2022 | Change | ||||||||||||||||||||||||||||||
Nplate — U.S. | $ | 176 | $ | 156 | 13 | % | $ | 422 | $ | 312 | 35 | % | |||||||||||||||||||||||
Nplate — ROW | 134 | 128 | 5 | % | 250 | 238 | 5 | % | |||||||||||||||||||||||||||
Total Nplate | $ | 310 | $ | 284 | 9 | % | $ | 672 | $ | 550 | 22 | % |
Three months ended June 30, | Six months ended June 30, | ||||||||||||||||||||||||||||||||||
2023 | 2022 | Change | 2023 | 2022 | Change | ||||||||||||||||||||||||||||||
EVENITY — U.S. | $ | 192 | $ | 130 | 48 | % | $ | 356 | $ | 240 | 48 | % | |||||||||||||||||||||||
EVENITY — ROW | 89 | 61 | 46 | % | 179 | 121 | 48 | % | |||||||||||||||||||||||||||
Total EVENITY | $ | 281 | $ | 191 | 47 | % | $ | 535 | $ | 361 | 48 | % |
Three months ended June 30, | Six months ended June 30, | ||||||||||||||||||||||||||||||||||
2023 | 2022 | Change | 2023 | 2022 | Change | ||||||||||||||||||||||||||||||
Neulasta — U.S. | $ | 199 | $ | 263 | (24) | % | $ | 410 | $ | 567 | (28) | % | |||||||||||||||||||||||
Neulasta — ROW | 37 | 47 | (21) | % | 75 | 91 | (18) | % | |||||||||||||||||||||||||||
Vectibix — U.S. | 118 | 96 | 23 | % | 229 | 181 | 27 | % | |||||||||||||||||||||||||||
Vectibix — ROW | 130 | 111 | 17 | % | 252 | 227 | 11 | % | |||||||||||||||||||||||||||
BLINCYTO — U.S. | 145 | 77 | 88 | % | 271 | 156 | 74 | % | |||||||||||||||||||||||||||
BLINCYTO — ROW | 61 | 62 | (2) | % | 129 | 121 | 7 | % | |||||||||||||||||||||||||||
MVASI — U.S. | 123 | 161 | (24) | % | 244 | 329 | (26) | % | |||||||||||||||||||||||||||
MVASI — ROW | 74 | 82 | (10) | % | 155 | 158 | (2) | % | |||||||||||||||||||||||||||
AMJEVITA — U.S. | 19 | — | NM | 70 | — | NM | |||||||||||||||||||||||||||||
AMGEVITA — ROW | 131 | 116 | 13 | % | 244 | 224 | 9 | % | |||||||||||||||||||||||||||
TEZSPIRE — U.S. | 133 | 29 | * | 229 | 36 | * | |||||||||||||||||||||||||||||
Parsabiv — U.S. | 54 | 71 | (24) | % | 112 | 128 | (13) | % | |||||||||||||||||||||||||||
Parsabiv — ROW | 33 | 32 | 3 | % | 66 | 61 | 8 | % | |||||||||||||||||||||||||||
Aimovig — U.S. | 78 | 88 | (11) | % | 142 | 186 | (24) | % | |||||||||||||||||||||||||||
Aimovig — ROW | 4 | 4 | — | % | 9 | 7 | 29 | % | |||||||||||||||||||||||||||
LUMAKRAS — U.S. | 50 | 51 | (2) | % | 98 | 99 | (1) | % | |||||||||||||||||||||||||||
LUMYKRAS — ROW | 27 | 26 | 4 | % | 53 | 40 | 33 | % | |||||||||||||||||||||||||||
EPOGEN — U.S. | 61 | 136 | (55) | % | 121 | 256 | (53) | % | |||||||||||||||||||||||||||
KANJINTI — U.S. | 38 | 69 | (45) | % | 71 | 149 | (52) | % | |||||||||||||||||||||||||||
KANJINTI — ROW | 12 | 16 | (25) | % | 26 | 32 | (19) | % | |||||||||||||||||||||||||||
TAVNEOS — U.S. | 29 | — | NM | 52 | — | NM | |||||||||||||||||||||||||||||
TAVNEOS — ROW | 1 | — | NM | 1 | — | NM | |||||||||||||||||||||||||||||
Other — U.S.(1) | 124 | 95 | 31 | % | 276 | 179 | 54 | % | |||||||||||||||||||||||||||
Other — ROW(1) | 50 | 75 | (33) | % | 91 | 134 | (32) | % | |||||||||||||||||||||||||||
Total other products | $ | 1,731 | $ | 1,707 | 1 | % | $ | 3,426 | $ | 3,361 | 2 | % | |||||||||||||||||||||||
Total U.S. — other products | $ | 1,171 | $ | 1,136 | 3 | % | $ | 2,325 | $ | 2,266 | 3 | % | |||||||||||||||||||||||
Total ROW — other products | 560 | 571 | (2) | % | 1,101 | 1,095 | 1 | % | |||||||||||||||||||||||||||
Total other products | $ | 1,731 | $ | 1,707 | 1 | % | $ | 3,426 | $ | 3,361 | 2 | % |
Three months ended June 30, | Six months ended June 30, | ||||||||||||||||||||||||||||||||||
2023 | 2022 | Change | 2023 | 2022 | Change | ||||||||||||||||||||||||||||||
Operating expenses: | |||||||||||||||||||||||||||||||||||
Cost of sales | $ | 1,813 | $ | 1,510 | 20 | % | $ | 3,533 | $ | 3,071 | 15 | % | |||||||||||||||||||||||
% of product sales | 27.1 | % | 24.0 | % | 28.2 | % | 25.6 | % | |||||||||||||||||||||||||||
% of total revenues | 26.0 | % | 22.9 | % | 27.0 | % | 23.9 | % | |||||||||||||||||||||||||||
Research and development | $ | 1,113 | $ | 1,039 | 7 | % | $ | 2,171 | $ | 1,998 | 9 | % | |||||||||||||||||||||||
% of product sales | 16.7 | % | 16.5 | % | 17.3 | % | 16.6 | % | |||||||||||||||||||||||||||
% of total revenues | 15.9 | % | 15.8 | % | 16.6 | % | 15.6 | % | |||||||||||||||||||||||||||
Selling, general and administrative | $ | 1,294 | $ | 1,327 | (2) | % | $ | 2,552 | $ | 2,555 | — | % | |||||||||||||||||||||||
% of product sales | 19.4 | % | 21.1 | % | 20.4 | % | 21.3 | % | |||||||||||||||||||||||||||
% of total revenues | 18.5 | % | 20.1 | % | 19.5 | % | 19.9 | % | |||||||||||||||||||||||||||
Other | $ | 82 | $ | 542 | (85) | % | $ | 230 | $ | 532 | (57) | % | |||||||||||||||||||||||
Total operating expenses | $ | 4,302 | $ | 4,418 | (3) | % | $ | 8,486 | $ | 8,156 | 4 | % |
Three months ended June 30, | Six months ended June 30, | ||||||||||||||||||||||
2023 | 2022 | 2023 | 2022 | ||||||||||||||||||||
Interest expense, net | $ | (752) | $ | (328) | $ | (1,295) | $ | (623) | |||||||||||||||
Other (expense) income, net | $ | (318) | $ | (317) | $ | 1,746 | $ | (847) | |||||||||||||||
Provision for income taxes | $ | 235 | $ | 214 | $ | 836 | $ | 413 | |||||||||||||||
Effective tax rate | 14.6 | % | 14.0 | % | 16.5 | % | 12.9 | % |
June 30, 2023 | December 31, 2022 | ||||||||||
Cash, cash equivalents and marketable securities | $ | 34,248 | $ | 9,305 | |||||||
Total assets | $ | 90,269 | $ | 65,121 | |||||||
Current portion of long-term debt | $ | 2,167 | $ | 1,591 | |||||||
Long-term debt | $ | 59,377 | $ | 37,354 | |||||||
Stockholders’ equity | $ | 6,781 | $ | 3,661 |
Six months ended June 30, | |||||||||||
2023 | 2022 | ||||||||||
Net cash provided by operating activities | $ | 5,173 | $ | 4,094 | |||||||
Net cash provided by (used in) investing activities | $ | 1,147 | $ | (2,304) | |||||||
Net cash provided by (used in) financing activities | $ | 20,299 | $ | (4,576) |
Item 3. | QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK |
Item 4. | CONTROLS AND PROCEDURES |
Item 1. | LEGAL PROCEEDINGS |
Item 1A. | RISK FACTORS |
Item 2. | UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS |
Period | Total number of shares purchased | Average price paid per share | Total number of shares purchased as part of publicly announced program | Maximum dollar value that may yet be purchased under the program(1) | ||||||||||||||||||||||
April 1–30 | — | — | — | $ | 6,979,263,848 | |||||||||||||||||||||
May 1–31 | — | — | — | $ | 6,979,263,848 | |||||||||||||||||||||
June 1–30 | — | — | — | $ | 6,979,263,848 | |||||||||||||||||||||
Total | — | — |
Item 5. | OTHER INFORMATION |
Item 6. | EXHIBITS |
Exhibit No. | Description | ||||||||||
2.1 | Asset Purchase Agreement, dated August 25, 2019, by and between Amgen Inc. and Celgene Corporation. (Filed as an exhibit to Form 8-K on August 26, 2019 and incorporated herein by reference.) | ||||||||||
2.1.1 | Amendment No. 1 to the Asset Purchase Agreement, dated October 17, 2019, by and between Amgen Inc. and Celgene Corporation. (Filed as an exhibit to Form 8-K on October 17, 2019 and incorporated herein by reference.) | ||||||||||
2.1.2 | Amendment No. 2 to the Asset Purchase Agreement, dated October 17, 2019, by and between Amgen Inc. and Celgene Corporation. (Filed as an exhibit to Form 10-K for the year ended December 31, 2019 on February 12, 2020 and incorporated herein by reference.) | ||||||||||
2.2 | Letter Agreement, dated November 21, 2019, by and between Amgen Inc. and the parties named therein re: Treatment of Certain Product Inventory in connection with Amgen’s acquisition of Otezla. (Filed as an exhibit to Form 10-K for the year ended December 31, 2019 on February 12, 2020 and incorporated herein by reference.) | ||||||||||
2.3 | Irrevocable Guarantee, dated August 25, 2019, by and between Amgen Inc. and Bristol-Myers Squibb Company. (Filed as an exhibit to Form 8-K on August 26, 2019 and incorporated herein by reference.) | ||||||||||
2.4 | Agreement and Plan of Merger, dated July 27, 2021, by and among Amgen Inc., Teneobio, Inc., Tuxedo Merger Sub, Inc., and Fortis Advisors LLC. (portions of the exhibit have been omitted because they are both (i) not material and (ii) is the type of information that the Company treats as private or confidential)(Filed as an exhibit to Form 10-Q for the quarter ended September 30, 2021 on November 3, 2021 and incorporated herein by reference.) | ||||||||||
2.5 | Agreement and Plan of Merger, dated as of August 3, 2022, among ChemoCentryx, Inc., Amgen Inc. and Carnation Merger Sub, Inc. (Filed as an exhibit to Form 8-K on August 4, 2022 and incorporated herein by reference.) | ||||||||||
2.6 | Transaction Agreement, dated as of December 11, 2022, by and among Amgen Inc., Pillartree Limited and Horizon Therapeutics plc. (Filed as an exhibit to Form 8-K on December 12, 2022 and incorporated herein by reference.) | ||||||||||
2.7 | Appendix 3 to the Rule 2.7 Announcement, dated as of December 12, 2022 (Conditions Appendix). (Filed as an exhibit to Form 8-K on December 12, 2022 and incorporated herein by reference.) | ||||||||||
3.1 | Restated Certificate of Incorporation of Amgen Inc. (As Restated March 6, 2013.) (Filed as an exhibit to Form 10-Q for the quarter ended March 31, 2013 on May 3, 2013 and incorporated herein by reference.) | ||||||||||
3.2 | Amended and Restated Bylaws of Amgen Inc. (As Amended and Restated February 15, 2016.) (Filed as an exhibit to Form 8-K on February 17, 2016 and incorporated herein by reference.) | ||||||||||
4.1 | Form of stock certificate for the common stock, par value $.0001 of the Company. (Filed as an exhibit to Form 10-Q for the quarter ended March 31, 1997 on May 14, 1997 and incorporated herein by reference.) | ||||||||||
4.2 | Form of Indenture, dated January 1, 1992. (Filed as an exhibit to Form S-3 Registration Statement filed on December 19, 1991 and incorporated herein by reference.) | ||||||||||
4.3 | Agreement of Resignation, Appointment and Acceptance dated February 15, 2008. (Filed as an exhibit to Form 10-K for the year ended December 31, 2007 on February 28, 2008 and incorporated herein by reference.) | ||||||||||
4.4 | First Supplemental Indenture, dated February 26, 1997. (Filed as an exhibit to Form 8-K on March 14, 1997 and incorporated herein by reference.) | ||||||||||
4.5 | 8-1/8% Debentures due April 1, 2097. (Filed as an exhibit to Form 8-K on April 8, 1997 and incorporated herein by reference.) | ||||||||||
4.6 | Officer’s Certificate of Amgen Inc., dated April 8, 1997, establishing a series of securities entitled “8 1/8% Debentures due April 1, 2097.” (Filed as an exhibit to Form 8-K on April 8, 1997 and incorporated herein by reference.) | ||||||||||
4.7 | Indenture, dated August 4, 2003. (Filed as an exhibit to Form S-3 Registration Statement on August 4, 2003 and incorporated herein by reference.) | ||||||||||
Exhibit No. | Description | ||||||||||
10.18.1 | Amendment No. 2 to Collaboration and License Agreement, effective November 14, 2016, between Amgen Inc. and Celltech R&D Limited (portions of the exhibit have been omitted pursuant to a request for confidential treatment). (Filed as an exhibit to Form 10-K for the year ended December 31, 2016 on February 14, 2017 and incorporated herein by reference.) | ||||||||||
10.19 | Letter Agreement, dated June 25, 2019, by and between Amgen Inc. and UCB Celltech (portions of the exhibit have been omitted because they are both (i) not material and (ii) would be competitively harmful if publicly disclosed). (Filed as an exhibit to Form 10-Q for the quarter ended June 30, 2019 on July 31, 2019 and incorporated herein by reference.) | ||||||||||
10.20 | Collaboration Agreement, dated October 31, 2019, by and between Amgen Inc. and BeiGene Switzerland GmbH, a wholly-owned subsidiary of BeiGene, Ltd. (portions of the exhibit have been omitted because they are both (i) not material and (ii) would be competitively harmful if publicly disclosed). (Filed as an exhibit to Form 10-K for the year ended December 31, 2019 on February 12, 2020 and incorporated herein by reference.) | ||||||||||
10.20.1 | First Amendment to Collaboration Agreement, dated April 20, 2022, by and between Amgen Inc. and BeiGene Switzerland GmbH, and BeiGene, Ltd. (portions of the exhibit have been omitted because they are both (i) not material and (ii) is the type of information that the Company treats as private or confidential.) (Filed as an exhibit to Form 10-Q for the quarter ended June 30, 2022 on August 5, 2022 and incorporated herein by reference.) | ||||||||||
10.20.2 | Second Amendment to Collaboration Agreement, entered into as of February 26, 2023, by and between Amgen Inc. and BeiGene Switzerland GmbH, and BeiGene, Ltd. (portions of the exhibit have been omitted because they are both (i) not material and (ii) is the type of information that the Company treats as private or confidential.) (Filed as an exhibit to Form 10-Q for the quarter ended March 31, 2023 on April 28, 2023 and incorporated herein by reference.) | ||||||||||
10.21 | Guarantee, dated as of October 31, 2019, made by and among BeiGene, Ltd. and Amgen Inc. (Filed as an exhibit to Form 10-K for the year ended December 31, 2019 on February 12, 2020 and incorporated herein by reference.) | ||||||||||
10.22 | Share Purchase Agreement, dated October 31, 2019, by and between Amgen Inc. and BeiGene, Ltd. (portions of the exhibit have been omitted because they are both (i) not material and (ii) would be competitively harmful if publicly disclosed). (Filed as an exhibit to Schedule 13D on January 8, 2020 and incorporated herein by reference.) | ||||||||||
10.22.1 | Amendment No. 1 to Share Purchase Agreement, dated December 6, 2019, by and among BeiGene, Ltd. and Amgen Inc. (Filed as an exhibit to Schedule 13D on January 8, 2020 and incorporated herein by reference.) | ||||||||||
10.22.2 | Restated Amendment No. 2 to Share Purchase Agreement, dated September 24, 2020, by and among BeiGene, Ltd. and Amgen Inc. (Filed as an exhibit to Form 10-Q for the quarter ended September 30, 2020 on October 29, 2020 and incorporated herein by reference.) | ||||||||||
10.22.3 | Amendment No. 3 to Share Purchase Agreement, dated January 30, 2023, by and among BeiGene, Ltd. and Amgen Inc. (Filed as an exhibit to Form 8-K on January 31, 2023 and incorporated herein by reference.) | ||||||||||
10.23 | Collaboration Agreement dated March 30, 2012 by and between Amgen Inc. and AstraZeneca Collaboration Ventures, LLC, a wholly owned subsidiary of AstraZeneca Pharmaceuticals LP (portions of the exhibit have been omitted because they are both (i) not material and (ii) is the type of information that the Company treats as private or confidential.) (Filed as an exhibit to Form 10-Q for the quarter ended June 30, 2022 on August 5, 2022 and incorporated herein by reference.) | ||||||||||
10.23.1 | Amendment No. 1 to the Collaboration Agreement, dated October 1, 2014, by and among Amgen Inc., AstraZeneca Collaboration Ventures, LLC and AstraZeneca Pharmaceuticals LP (portions of the exhibit have been omitted because they are both (i) not material and (ii) is the type of information that the Company treats as private or confidential.) (Filed as an exhibit to Form 10-Q for the quarter ended June 30, 2022 on August 5, 2022 and incorporated herein by reference.) | ||||||||||
10.23.2 | Amendment Nos. 2 through 6 to the March 30, 2012 Collaboration Agreement between Amgen Inc. and AstraZeneca Collaboration Ventures, LLC, dated May 2 and 27 and October 2, 2016, January 31, 2018, and May 15, 2020, respectively (portions of the exhibit have been omitted because they are both (i) not material and (ii) would be competitively harmful if publicly disclosed.) (Filed as an exhibit to Form 10-Q for the quarter ended June 30, 2020 on July 29, 2020 and incorporated herein by reference.) | ||||||||||
Exhibit No. | Description | ||||||||||
10.23.3 | Amendment No. 7 to the Collaboration Agreement, dated December 17, 2020, by and between Amgen Inc. and AstraZeneca Collaboration Ventures, LLC (portions of the exhibit have been omitted because they are both (i) not material and (ii) would be competitively harmful if publicly disclosed.) (Filed as an exhibit to Form 10-K for the year ended December 31, 2020 on February 9, 2021 and incorporated herein by reference.) | ||||||||||
10.23.4 | Amendment No. 8 to the Collaboration Agreement, dated November 19, 2021, by and between Amgen Inc. and AstraZeneca Collaboration Ventures, LLC (portions of the exhibit have been omitted because they are both (i) not material and (ii) is the type of information that the Company treats as private or confidential.)(Filed as an exhibit to Form 10-K for the year ended December 31, 2021 on February 16, 2022 and incorporated herein by reference.) | ||||||||||
10.24 | License and Collaboration Agreement, dated June 1, 2021, by and between Amgen Inc. and Kyowa Kirin Co., Ltd. (portions of the exhibit have been omitted because they are both (i) not material and (ii) would be competitively harmful if publicly disclosed). (Filed as an exhibit to Form 10-Q for the quarter ended June 30, 2021 on August 4, 2021 and incorporated herein by reference.) | ||||||||||
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101.INS | Inline XBRL Instance Document - The instance document does not appear in the interactive data file because its XBRL tags are embedded within the Inline XBRL document. | ||||||||||
101.SCH* | Inline XBRL Taxonomy Extension Schema Document. | ||||||||||
101.CAL* | Inline XBRL Taxonomy Extension Calculation Linkbase Document. | ||||||||||
101.DEF* | Inline XBRL Taxonomy Extension Definition Linkbase Document. | ||||||||||
101.LAB* | Inline XBRL Taxonomy Extension Label Linkbase Document. | ||||||||||
101.PRE* | Inline XBRL Taxonomy Extension Presentation Linkbase Document. | ||||||||||
104 | Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101). |
Amgen Inc. | ||||||||||||||
(Registrant) | ||||||||||||||
Date: | August 3, 2023 | By: | /S/ PETER H. GRIFFITH | |||||||||||
Peter H. Griffith | ||||||||||||||
Executive Vice President and Chief Financial Officer | ||||||||||||||
(Principal Financial Officer) |
August 3, 2023 | /s/ ROBERT A. BRADWAY | ||||
Robert A. Bradway | |||||
Chairman of the Board, | |||||
Chief Executive Officer and President |
August 3, 2023 | /s/ PETER H. GRIFFITH | ||||
Peter H. Griffith | |||||
Executive Vice President and Chief Financial Officer |
August 3, 2023 | /s/ ROBERT A. BRADWAY | ||||
Robert A. Bradway | |||||
Chairman of the Board, | |||||
Chief Executive Officer and President |
August 3, 2023 | /s/ PETER H. GRIFFITH | ||||
Peter H. Griffith | |||||
Executive Vice President and Chief Financial Officer |
Condensed Consolidated Statements of Comprehensive Income - USD ($) $ in Millions |
3 Months Ended | 6 Months Ended | ||
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Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
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Statement of Comprehensive Income [Abstract] | ||||
Net income | $ 1,379 | $ 1,317 | $ 4,220 | $ 2,793 |
Other comprehensive (loss) income, net of reclassification adjustments and taxes: | ||||
Foreign currency translation | 11 | (65) | 39 | (116) |
Cash flow hedges | (22) | 156 | (108) | 240 |
Other | (1) | 0 | 20 | 0 |
Other comprehensive (loss) income, net of reclassification adjustments and taxes | (12) | 91 | (49) | 124 |
Comprehensive income | $ 1,367 | $ 1,408 | $ 4,171 | $ 2,917 |
Condensed Consolidated Statements of Income - USD ($) shares in Millions, $ in Millions |
3 Months Ended | 6 Months Ended | ||
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Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
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Revenues: | ||||
Total revenues | $ 6,986 | $ 6,594 | $ 13,091 | $ 12,832 |
Operating expenses: | ||||
Cost of sales | 1,813 | 1,510 | 3,533 | 3,071 |
Research and development | 1,113 | 1,039 | 2,171 | 1,998 |
Selling, general and administrative | 1,294 | 1,327 | 2,552 | 2,555 |
Other | 82 | 542 | 230 | 532 |
Total operating expenses | 4,302 | 4,418 | 8,486 | 8,156 |
Operating income | 2,684 | 2,176 | 4,605 | 4,676 |
Interest expense, net | (752) | (328) | (1,295) | (623) |
Other (expense) income, net | (318) | (317) | 1,746 | (847) |
Income before income taxes | 1,614 | 1,531 | 5,056 | 3,206 |
Provision for income taxes | 235 | 214 | 836 | 413 |
Net income | $ 1,379 | $ 1,317 | $ 4,220 | $ 2,793 |
Earnings per share: | ||||
Basic (in usd per share) | $ 2.58 | $ 2.46 | $ 7.90 | $ 5.16 |
Diluted (in usd per share) | $ 2.57 | $ 2.45 | $ 7.86 | $ 5.13 |
Shares used in calculation of earnings per share: | ||||
Basic (in shares) | 535 | 535 | 534 | 541 |
Diluted (in shares) | 537 | 537 | 537 | 544 |
Product sales | ||||
Revenues: | ||||
Total revenues | $ 6,683 | $ 6,281 | $ 12,529 | $ 12,012 |
Other revenues | ||||
Revenues: | ||||
Total revenues | $ 303 | $ 313 | $ 562 | $ 820 |
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares shares in Millions |
Jun. 30, 2023 |
Dec. 31, 2022 |
---|---|---|
Statement of Financial Position [Abstract] | ||
Common stock and additional paid-in capital, par value (in usd per share) | $ 0.0001 | $ 0.0001 |
Common stock and additional paid-in capital, shares authorized (in shares) | 2,750.0 | 2,750.0 |
Common stock and additional paid-in capital, shares outstanding (in shares) | 534.9 | 534.0 |
Condensed Consolidated Statements of Stockholders' Equity (Parenthetical) - $ / shares |
1 Months Ended | 3 Months Ended | ||
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Mar. 31, 2023 |
Dec. 31, 2022 |
Mar. 31, 2023 |
Mar. 31, 2022 |
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Statement of Stockholders' Equity [Abstract] | ||||
Common stock, dividends declared per share (in usd per share) | $ 2.13 | $ 2.13 | $ 2.13 | $ 1.94 |
Summary of significant accounting policies |
6 Months Ended |
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Jun. 30, 2023 | |
Accounting Policies [Abstract] | |
Summary of significant accounting policies | 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 six months ended June 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 Report on Form 10-Q for the period ended March 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. 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 $9.5 billion and $9.3 billion as of June 30, 2023 and December 31, 2022, respectively. Recent accounting pronouncements No new accounting pronouncements were issued or adopted for the six months ended June 30, 2023, that materially impacted the Company.
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Restructuring |
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Restructuring and Related Activities [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Restructuring | 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 estimate that we will incur $300 million to $400 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, accelerated depreciation 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):
As of June 30, 2023, total restructuring liability decreased to $82 million primarily due to payments related to separation costs. The total restructuring liability was included in Accrued liabilities in the Condensed Consolidated Balance Sheets.
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Acquisitions and divestitures |
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Acquisitions and divestitures | Acquisitions and divestitures Proposed acquisition of Horizon Therapeutics plc On December 12, 2022, we announced that we had entered into a transaction agreement under which Amgen will acquire all shares of Horizon for $116.50 per share in cash for a transaction equity value of approximately $27.8 billion. Horizon is a global biotechnology company headquartered in Dublin, Ireland and is focused on the discovery, development and commercialization of medicines that address critical needs for people impacted by rare, autoimmune and severe inflammatory diseases. Horizon has 12 marketed medicines and a pipeline with more than 20 development programs. In May 2023, the FTC filed a complaint in the U.S. District Court for the Northern District of Illinois seeking a temporary restraining order and preliminary injunction enjoining our proposed acquisition of Horizon. See Note 14, Contingencies and commitments. In connection with our proposed 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 anti-neutrophil 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 six months ended June 30, 2023, included changes in the purchase price allocation and total consideration, resulting in a net decrease of approximately $4 million to goodwill. The measurement period adjustments resulted primarily from valuation inputs pertaining to the TAVNEOS intangible assets and adjustments to vendor payables 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 six months ended June 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 total consideration and allocated acquisition date fair values of assets acquired and liabilities assumed, inclusive of measurement period adjustments (in millions):
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 $516 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 $663 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. 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. 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.
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Revenues |
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Jun. 30, 2023 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Revenue from Contract with Customer [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Revenues | 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):
____________ (1) Consists of product sales of our non-principal products as well as our Bergamo and Gensenta subsidiaries. (2) Hedging gains and losses, which are included in product sales, were not material for the three and six months ended June 30, 2023 and 2022.
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Income taxes |
6 Months Ended |
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Jun. 30, 2023 | |
Income Tax Disclosure [Abstract] | |
Income taxes | Income taxes The effective tax rates for the three and six months ended June 30, 2023, were 14.6% and 16.5%, respectively, compared with 14.0% and 12.9%, respectively, for the corresponding periods in the prior year. The increase in our effective tax rate for the three months ended June 30, 2023, was primarily due to the new Puerto Rico income tax beginning in 2023, partially offset by the current period change in the fair value of our equity investments and net favorable items. The increase in our effective tax rate for the six months ended June 30, 2023, was primarily due to the new Puerto Rico income tax beginning in 2023, current year change in the fair value of our equity investments and an increase in interest expense on tax reserves, partially offset by net favorable items. 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 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 account for the 2022 excise tax that was capitalized in Inventories as an expense in Cost of sales when the related products are sold in 2023, and a foreign tax credit will not be 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 six months ended June 30, 2023, the gross amounts of our UTBs increased by $50 million and $110 million, respectively, as a result of tax positions taken during the current year. Substantially all of the UTBs as of June 30, 2023, if recognized, would affect our effective tax rate.
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Earnings per share |
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Earnings Per Share [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Earnings per share | 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):
For the three and six months ended June 30, 2023 and 2022, the number of antidilutive employee stock-based awards excluded from the computation of diluted EPS was not significant.
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Investments |
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Investments, Debt and Equity Securities [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Investments | 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):
The fair values of interest-bearing securities by location in the Condensed Consolidated Balance Sheets were as follows (in millions):
Cash and cash equivalents in the above table excludes bank account cash of $630 million and $4,970 million as of June 30, 2023 and December 31, 2022, respectively. Cash and cash equivalents as of June 30, 2023 was $34.2 billion, of which $27.8 billion is anticipated to be used for the proposed acquisition of Horizon. See Note 3, Acquisitions and divestitures. All interest-bearing securities as of June 30, 2023 and December 31, 2022, mature in one year or less. For the three and six months ended June 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 (expense) income, 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 (expense) income, net. See Note 12, Fair value measurement. During the three and six months ended June 30, 2023, we recognized an unrealized loss of $705 million and an unrealized gain of $1.2 billion, respectively, recorded in Other (expense) income, net, in our Condensed Consolidated Statements of Income. As of June 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 six months ended June 30, 2022, under the equity method of accounting, our carrying value in BeiGene was adjusted by our share of BeiGene’s net losses of $80 million and $188 million, respectively, and amortization of the basis difference of $48 million and $95 million, respectively, recorded in Other (expense) income, net, in our Condensed Consolidated Statements of Income. Other equity securities Excluding our equity investment in BeiGene, we held investments in other equity securities with readily determinable fair values (publicly traded securities) of $397 million and $480 million as of June 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 June 30, 2023 and 2022, net unrealized gains and losses on these publicly traded securities were a gain of $3 million and a loss of $106 million, respectively. During the six months ended June 30, 2023 and 2022, net unrealized gains and losses on these publicly traded securities were a net gain of $8 million and a net loss of $276 million, respectively. Realized gains and losses on sales of publicly traded securities for the three and six months ended June 30, 2023 and 2022, were not material. We held investments of $291 million and $233 million in equity securities without readily determinable fair values as of June 30, 2023 and December 31, 2022, respectively, which are included in Other noncurrent assets in the Condensed Consolidated Balance Sheets. During the three and six months ended June 30, 2023 and 2022, upward and downward adjustments on these securities 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 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. Although our equity investment provides us with the ability to exercise significant influence over Neumora, we have elected the fair value option to account for our equity 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 Income each reporting period. We believe the fair value option best reflects the economics of the underlying transaction. As of June 30, 2023 and December 31, 2022, our ownership interest in Neumora was approximately 24.5% and 24.9%, respectively, and the fair values of our investment were $316 million and $335 million, respectively. During the three months ended June 30, 2023 and 2022, we recognized a gain of $28 million and a loss of $39 million, respectively, and during the six months ended June 30, 2023 and 2022, we recognized losses of $19 million and $89 million, respectively. For information on determination of fair values, see Note 12, Fair value measurement. Limited partnerships We held limited partnership investments of $226 million and $249 million as of June 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 June 30, 2023, unfunded additional commitments to be made for these investments during the next several years amounted to $157 million. For the three months ended June 30, 2023 and 2022, net unrealized losses from our limited partnership investments were $29 million and $60 million, respectively. For the six months ended June 30, 2023 and 2022, net unrealized losses from our limited partnership investments were $9 million and $220 million, respectively.
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Inventories |
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Jun. 30, 2023 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Inventory Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Inventories | Inventories Inventories consisted of the following (in millions):
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Goodwill and other intangible assets |
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Goodwill and Intangible Assets Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Goodwill and other intangible assets | Goodwill and other intangible assets Goodwill The change in the carrying amount of goodwill was as follows (in millions):
Other intangible assets Other intangible assets consisted of the following (in millions):
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 June 30, 2023 and 2022, we recognized amortization associated with our finite-lived intangible assets of $693 million and $629 million, respectively. During the six months ended June 30, 2023 and 2022, we recognized amortization associated with our finite-lived intangible assets of $1.4 billion and $1.3 billion, respectively. Amortization of intangible assets is primarily included in Cost of sales in the Condensed Consolidated Statements of Income. The total estimated amortization of our finite-lived intangible assets for the remaining six months ending December 31, 2023, and the years ending December 31, 2024, 2025, 2026, 2027 and 2028, are $1.4 billion, $2.7 billion, $2.5 billion, $2.1 billion, $2.1 billion and $1.1 billion, respectively.
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Financing arrangements |
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Debt Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Financing arrangements | Financing arrangements Our borrowings consisted of the following (in millions):
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 proposed acquisition of Horizon (see Note 3, Acquisitions and divestitures—Proposed acquisition of Horizon Therapeutics plc), we issued the following series of notes (in millions):
If consummation of the proposed acquisition of Horizon does not occur on or before the later of (i) January 31, 2024, or such later date to which the agreement to acquire Horizon (Transaction Agreement) may be extended in accordance with its terms, (ii) the Transaction Agreement is terminated, or (iii) we otherwise notify the trustee of the notes that consummation of the acquisition will not be pursued, we will be required to redeem each series of notes, other than the 5.75% 2063 Notes, at a price equal to 101% of the principal amount of the notes plus accrued and unpaid interest. 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 proposed 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 (expense) income, net, in the Condensed Consolidated Statements of Income. Also in connection with the proposed 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 June 30, 2023 and December 31, 2022. Debt extinguishment During the three months ended March 31, 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 $420 million, which resulted in the recognition of a $113 million gain on extinguishment of debt recorded in Other (expense) income, net, in the Condensed Consolidated Statements of Income. Debt repayments During the three months ended March 31, 2023, we repaid 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 June 30, 2023 and December 31, 2022, no amounts were outstanding under this facility.
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Stockholders' equity |
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Equity [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Stockholders' equity | Stockholders’ equity Stock repurchase program Activity under our stock repurchase program, on a trade date basis, was as follows (in millions):
As of June 30, 2023, $7.0 billion of authorization remained available under our stock repurchase program. Dividends In March 2023 and December 2022, our Board of Directors declared quarterly cash dividends of $2.13 per share, which were paid in June 2023 and March 2023, respectively. In August 2023, our Board of Directors declared a quarterly cash dividend of $2.13 per share that will be paid in September 2023. Accumulated other comprehensive income (loss) The components of AOCI were as follows (in millions):
Reclassifications out of AOCI and into earnings, including related income tax expenses, were as follows (in millions):
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Fair value measurement |
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Fair Value Disclosures [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Fair value measurement | 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:
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):
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 investment in BeiGene as of June 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. The fair values of equity securities without readily determinable fair values are initially valued at the transaction prices 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. 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. The fair value of our investment in BeiGene was estimated by using Level 1 inputs. 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 will 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):
As of June 30, 2023 and December 31, 2022, our contingent consideration obligations are primarily the result of our acquisition of Teneobio, in October 2021, which obligates 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. 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 June 30, 2023 and December 31, 2022, the aggregate fair values of our borrowings were $59.1 billion and $35.0 billion, respectively, and the carrying values were $61.5 billion and $38.9 billion, respectively. During the six months ended June 30, 2023 and 2022, 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.
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Derivative instruments |
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Derivative Instruments and Hedging Activities Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Derivative instruments | 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 June 30, 2023 and December 31, 2022, we had outstanding foreign currency forward contracts with aggregate notional amounts of $6.1 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 (expense) income, 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 June 30, 2023, were as follows (notional amounts in millions):
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 six months ended June 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):
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 June 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):
____________ (1) Current portion of long-term debt includes $80 million and $82 million of carrying value with discontinued hedging relationships as of June 30, 2023 and December 31, 2022, respectively. Long-term debt includes $318 million and $357 million of carrying value with discontinued hedging relationships as of June 30, 2023 and December 31, 2022, respectively. (2) Current portion of long-term debt includes $80 million and $82 million of hedging adjustments on discontinued hedging relationships as of June 30, 2023 and December 31, 2022, respectively. Long-term debt includes $218 million and $257 million of hedging adjustments on discontinued hedging relationships as of June 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):
__________ (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 June 30, 2023, we expected to reclassify $108 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 June 30, 2023 and December 31, 2022, the total notional amounts of these foreign currency forward contracts were $557 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 six months ended June 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):
For additional information, see Note 12, Fair value measurement. Our derivative contracts that were in liability positions as of June 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.
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Contingencies and commitments |
6 Months Ended |
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Jun. 30, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Contingencies and commitments | 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 Report on Form 10-Q for the period ended March 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 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 Report on Form 10-Q for the period ended March 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 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 Report on Form 10-Q for the period ended March 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 Amgen Inc., et al. v. Sanofi, et al. On May 18, 2023, the U.S. Supreme Court entered final judgment affirming the lower court’s decision invalidating claims 19 and 29 of U.S. Patent No. 8,829,165 and claim 7 of the U.S. Patent No. 8,859,741 as lacking an enabling disclosure of the invention claimed. Patent Disputes in the International Region On June 1, 2023, Amgen filed an action 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. alleging that the importation, marketing, sale and use of PRALUENT® infringes European Patent 3,666,797 (the EP’797 Patent) seeking an injunction and damages for past infringement. On June 29, 2023, the Unitary Patent Court served us with an action filed by Sanofi before the Unitary Patent Court seeking revocation of Amgen’s EP’797 Patent. On July 20, 2023, Amgen filed objections to the admissibility of Sanofi’s revocation action before the Unitary Patent Court’s Central Division and Local Divisions on the grounds that Amgen’s infringement action was filed prior to Sanofi’s revocation action. On November 14, 2023, the Regional Court of Dusseldorf is scheduled to hear argument on Sanofi Biotechnology SAS’ lawsuit alleging that our marketing of Repatha infringes European Patent 2,756,004. The Munich Regional Court scheduled a hearing for February 28, 2024 on Sanofi’s action against Amgen in which Sanofi seeks damages arising from the provisional enforcement of an injunction against PRALUENT® that was lifted after an October 29, 2020 ruling by the Technical Board of Appeal that broader claims in Amgen’s European Patent 2,215,125 encompassing PRALUENT® were invalid. Prolia/XGEVA Biologics Price Competition and Innovation Act (BPCIA) Litigation Amgen Inc. et al. v. Sandoz Inc., et al. On May 1, 2023, Amgen Inc. and Amgen Manufacturing Limited filed a lawsuit in the U.S. District Court for the District of New Jersey (New Jersey District Court) against Sandoz Inc., Sandoz GmbH, Lek Pharmaceuticals d.d., Novartis Pharmaceutical Productions d.o.o., and Novartis AG (collectively, Defendants) based on the 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. The complaint asserts infringement of the following 21 patents, which are listed in the FDA’s Purple Book for Amgen’s Prolia and XGEVA products: U.S. Patent Nos. 7,364,736; 7,928,205; 8,058,418; 9,012,178; 9,133,493; 9,228,168; 9,320,816; 9,328,134; 9,359,435; 9,481,901; 10,167,492; 10,513,723; 10,583,397; 10,822,630; 10,894,972; 11,077,404; 11,098,079; 11,130,980; 11,254,963; 11,299,760; and 11,434,514 (collectively, the Asserted Patents). Amgen seeks a judgment from the New Jersey District Court that Defendants have infringed or will infringe one or more claims of each of the Asserted Patents and based on that judgment, a permanent injunction prohibiting the commercial manufacture, use, offer to sell, or sale within the United States or importation into the United States of Defendants’ proposed denosumab biosimilar before expiration of each of the Asserted Patents found to infringe. Amgen also seeks monetary remedies for any past acts of infringement. On June 16, 2023, Amgen filed an amended and supplemental complaint to include additional information regarding the completion of the BPCIA information exchange after the filing of the original complaint. Sandoz Inc. responded to the amended and supplemental complaint on July 7, 2023, denying infringement and asserting counterclaims seeking a declaratory judgment that asserted patents are invalid and/or unenforceable. On July 21, 2023, the New Jersey District Court granted Amgen’s request for a briefing schedule to present and hear a motion to be filed by Amgen on or before September 1, 2023 seeking a preliminary injunction to prohibit patent infringement by Sandoz’s denosumab product until the court is able to reach judgment on the merits of Amgen’s lawsuit. On August 2, 2023, the New Jersey District Court scheduled a preliminary injunction hearing that will commence on October 30, 2023. ABP 654 (ustekinumab) Patent Litigation Janssen Biotech, Inc. v. Amgen Inc. On May 22, 2023, pursuant to a confidential settlement agreement, the parties filed a joint stipulation of dismissal with prejudice of the U.S. litigation. On May 23, 2023, the U.S. District Court for the District of Delaware (Delaware District Court) issued an order dismissing the U.S. litigation with prejudice. Janssen Biotech Inc. v. Amgen Technology (Ireland) Unlimited Company On May 22, 2023, pursuant to a confidential settlement agreement, the parties requested that the Irish proceedings be struck out and on the same day the Irish High Court issued an order striking out the proceedings and vacating all previous orders in those proceedings. Antitrust Class Action Sensipar Antitrust Class Actions On June 26, 2023, the U.S. Court of Appeals for the Third Circuit entered an order granting defendants’ (including Amgen’s) petition for interlocutory appeal and denying plaintiffs’ cross-petition. The questions certified are whether (1) the statute for interlocutory decisions authorizes a district court judge to certify for interlocutory appeal an order issued in the same case by a predecessor district court judge; and (2) the settlement of a patent infringement claim that involves the forgiveness of damages associated with that patent’s alleged infringement, on its own or combined with an acceleration clause, constitutes a reverse payment. On July 3, 2023, Amgen and Teva Pharmaceuticals USA, Inc. filed a notice of appeal. Regeneron Pharmaceuticals, Inc. Antitrust Action The Delaware District Court scheduled the trial to begin on November 12, 2024. U.S. Tax Litigation 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. Shareholder Derivative Litigation On August 2, 2023, Leon Martin filed a derivative action, purportedly on behalf of Amgen, against Amgen, Robert Bradway, Peter Griffith and Amgen’s independent board members. The action was filed in the U.S. District Court for the Southern District of New York as related to the pending federal securities class action filed by Roofers Local No. 149 Pension Fund on March 13, 2023 (the Roofers securities class action). The complaint in this matter alleges claims for violations of the Securities Exchange Act of 1934, breach of fiduciary duty, aiding and abetting breach of fiduciary duty, unjust enrichment and waste of corporate assets. The factual allegations that form the basis for these claims are essentially the same as the allegations asserted in the Roofers securities class action regarding purportedly false and misleading statements and omissions made from July 29, 2020 through April 27, 2022 relating to Amgen’s tax liabilities, business and finances, and the adequacy and maintenance of its internal controls. FTC Litigation re the Proposed Horizon Therapeutics plc Acquisition On May 16, 2023, the FTC filed a complaint and motion for preliminary injunction in the U.S. District Court for the Northern District of Illinois (Northern Illinois District Court) seeking to enjoin Amgen’s proposed acquisition of Horizon. The FTC alleges that the deal would allow Amgen to leverage its portfolio of blockbuster drugs someday to entrench the monopoly positions of Horizon medications used to treat two serious conditions, thyroid eye disease and chronic refractory gout, if competitors eventually come to market. The preliminary injunction hearing in the case is set to begin on September 11, 2023. On June 1, 2023, Amgen, Horizon and the FTC submitted a stipulated proposed temporary restraining order (TRO) to the Northern Illinois District Court providing that Horizon and Amgen would not close the acquisition until the earlier of October 31, 2023 or the second business day after the Northern Illinois District Court rules on the FTC’s request for a preliminary injunction. On June 2, 2023, the Northern Illinois District Court issued an order granting the stipulated TRO. Amgen and Horizon filed their answer to the complaint on June 9, 2023. On June 22, 2023, an amended complaint was filed adding six states to the lawsuit, and on June 29, 2023, Amgen filed an answer and counterclaims to the amended complaint. On June 22, 2023, the FTC filed an administrative complaint before the FTC’s administrative judge, and on July 7, 2023 Amgen and Horizon filed an answer to the administrative complaint. The Transaction Agreement provides that Amgen will be required to pay Horizon a termination fee of $974.4 million if the Transaction Agreement is terminated under certain circumstances in which there was a failure to obtain regulatory approvals by December 12, 2023, as described in Amgen’s Form 8-K filed December 12, 2022, and in the Transaction Agreement filed therewith. One of those circumstances would likely arise if the above-described preliminary injunction hearing is not decided favorably to Amgen and Horizon.
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Pay vs Performance Disclosure - USD ($) $ in Millions |
3 Months Ended | 6 Months Ended | ||||
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Jun. 30, 2023 |
Mar. 31, 2023 |
Jun. 30, 2022 |
Mar. 31, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
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Pay vs Performance Disclosure | ||||||
Net income for basic and diluted EPS | $ 1,379 | $ 2,841 | $ 1,317 | $ 1,476 | $ 4,220 | $ 2,793 |
Insider Trading Arrangements |
3 Months Ended |
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Jun. 30, 2023 | |
Trading Arrangements, by Individual | |
Rule 10b5-1 Arrangement Adopted | false |
Non-Rule 10b5-1 Arrangement Adopted | false |
Rule 10b5-1 Arrangement Terminated | false |
Non-Rule 10b5-1 Arrangement Terminated | false |
Summary of significant accounting policies (Policies) |
6 Months Ended |
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Jun. 30, 2023 | |
Accounting Policies [Abstract] | |
Business | 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.
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Basis of presentation | Basis of presentation The financial information for the three and six months ended June 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 Report on Form 10-Q for the period ended March 31, 2023.
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Principles of consolidation | 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.
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Use of estimates | 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.
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Property, plant and equipment, net | Property, plant and equipment, net Property, plant and equipment is recorded at historical cost, net of accumulated depreciation and amortization, of $9.5 billion and $9.3 billion as of June 30, 2023 and December 31, 2022, respectively.
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Recent accounting pronouncements | Recent accounting pronouncements No new accounting pronouncements were issued or adopted for the six months ended June 30, 2023, that materially impacted the Company.
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Restructuring and Related Activities (Tables) |
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Restructuring and Related Activities [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Restructuring and Related Costs | 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):
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Acquisitions and divestitures (Tables) |
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Business Combination and Asset Acquisition [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Business Acquisitions, by Acquisition | 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):
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Revenues (Tables) |
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Revenue from Contract with Customer [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Disaggregation of revenue by product and by geographic area | Revenues were as follows (in millions):
____________ (1) Consists of product sales of our non-principal products as well as our Bergamo and Gensenta subsidiaries. (2) Hedging gains and losses, which are included in product sales, were not material for the three and six months ended June 30, 2023 and 2022.
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Earnings per share (Tables) |
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Earnings Per Share [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Computation for basic and diluted earnings per share | The computations for basic and diluted EPS were as follows (in millions, except per-share data):
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Investments (Tables) |
6 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Jun. 30, 2023 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Investments, Debt and Equity Securities [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Amortized cost, gross unrealized gains, gross unrealized losses and estimated fair values of available-for-sale investments by type of security | 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):
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Fair values of available-for-sale investments by classification in the Consolidated Balance Sheets | The fair values of interest-bearing securities by location in the Condensed Consolidated Balance Sheets were as follows (in millions):
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Inventories (Tables) |
6 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Jun. 30, 2023 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Inventory Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Inventories | Inventories consisted of the following (in millions):
|
Goodwill and other intangible assets (Tables) |
6 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Jun. 30, 2023 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Goodwill and Intangible Assets Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of goodwill | The change in the carrying amount of goodwill was as follows (in millions):
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Schedule of identifiable intangible assets | Other intangible assets consisted of the following (in millions):
|
Financing arrangements (Tables) |
6 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Jun. 30, 2023 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Debt Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of borrowings | Our borrowings consisted of the following (in millions):
During the three months ended March 31, 2023, in connection with the proposed acquisition of Horizon (see Note 3, Acquisitions and divestitures—Proposed acquisition of Horizon Therapeutics plc), we issued the following series of notes (in millions):
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Stockholders' equity (Tables) |
6 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Jun. 30, 2023 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Equity [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Summary of activity under our stock repurchase program | Activity under our stock repurchase program, on a trade date basis, was as follows (in millions):
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Components of accumulated other comprehensive income | The components of AOCI were as follows (in millions):
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Reclassifications out of accumulated other comprehensive income | Reclassifications out of AOCI and into earnings, including related income tax expenses, were as follows (in millions):
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Fair value measurement (Tables) |
6 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Jun. 30, 2023 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Fair Value Disclosures [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Fair value of each major class of financial assets and liabilities measured at fair value on a recurring basis | 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):
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Schedule of Business Acquisitions by Acquisition, Contingent Consideration | Changes in the carrying amounts of contingent consideration obligations were as follows (in millions):
|
Derivative instruments (Tables) |
6 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Jun. 30, 2023 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Derivative Instruments and Hedging Activities Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of notional amounts and interest rates for cross-currency swaps | The notional amounts and interest rates of our cross-currency swaps as of June 30, 2023, were as follows (notional amounts in millions):
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Unrealized gain (loss) recognized in Other Comprehensive Income for our derivative instruments designated as cash flow hedges | Gains and losses recognized in AOCI for our derivative instruments designated as cash flow hedges were as follows (in millions):
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Derivatives in fair value hedging relationships | 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):
____________ (1) Current portion of long-term debt includes $80 million and $82 million of carrying value with discontinued hedging relationships as of June 30, 2023 and December 31, 2022, respectively. Long-term debt includes $318 million and $357 million of carrying value with discontinued hedging relationships as of June 30, 2023 and December 31, 2022, respectively. (2) Current portion of long-term debt includes $80 million and $82 million of hedging adjustments on discontinued hedging relationships as of June 30, 2023 and December 31, 2022, respectively. Long-term debt includes $218 million and $257 million of hedging adjustments on discontinued hedging relationships as of June 30, 2023 and December 31, 2022, respectively.
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Summary of amounts of income and expense line items | 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):
__________ (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.
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Fair values of derivatives included in the Condensed Consolidated Balance Sheets | The fair values of derivatives included in the Condensed Consolidated Balance Sheets were as follows (in millions):
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Summary of significant accounting policies (Details) $ in Billions |
6 Months Ended | |
---|---|---|
Jun. 30, 2023
USD ($)
segment
|
Dec. 31, 2022
USD ($)
|
|
Accounting Policies [Abstract] | ||
Number of operating segments | segment | 1 | |
Accumulated depreciation and amortization on property, plant and equipment | $ | $ 9.5 | $ 9.3 |
Restructuring - Narrative (Details) $ in Millions |
Jun. 30, 2023
USD ($)
|
---|---|
Accrued liabilities | |
Restructuring Cost and Reserve [Line Items] | |
Restructuring Reserve, Current | $ 82 |
Minimum | |
Restructuring Cost and Reserve [Line Items] | |
Expected pre-tax accounting charges | 300 |
Maximum | |
Restructuring Cost and Reserve [Line Items] | |
Expected pre-tax accounting charges | $ 400 |
Acquisitions and divestitures - Narrative: Proposed Acquisition of Horizon Therapeutics plc (Details) $ / shares in Units, $ in Billions |
6 Months Ended | |
---|---|---|
Jun. 30, 2023
USD ($)
|
Dec. 12, 2022
program
product
$ / shares
|
|
Business Acquisition [Line Items] | ||
Cash payment | $ 27.8 | |
Horizon Therapeutics | ||
Business Acquisition [Line Items] | ||
Business acquisition, share price (in dollars per share) | $ / shares | $ 116.50 | |
Cash payment | $ 27.8 | |
Approved products | product | 12 | |
Development programs | program | 20 |
Acquisitions and divestitures - Aggregate Consideration Paid (Details) - USD ($) $ in Millions |
Jun. 30, 2023 |
Dec. 31, 2022 |
---|---|---|
Business Acquisition [Line Items] | ||
Goodwill | $ 15,531 | $ 15,529 |
ChemoCentryx, Inc. | ||
Business Acquisition [Line Items] | ||
Cash and cash equivalents | 86 | |
Marketable securities | 235 | |
Inventories | 41 | |
Finite-lived intangible assets—developed-product-technology rights | 3,499 | |
Goodwill | 663 | |
Other liabilities, net | (83) | |
Deferred tax liability, net | (516) | |
Total assets acquired, net | $ 3,925 |
Acquisitions and divestitures - Narrative: Divestiture of Gensenta Ilac Sanayi ve Ticaret A.s. (Details) - Gensenta - USD ($) $ in Millions |
12 Months Ended | |
---|---|---|
Nov. 02, 2022 |
Dec. 31, 2022 |
|
Business Acquisition [Line Items] | ||
Proceeds from Divestiture of Businesses | $ 130 | |
Including discontinued operation, assets | $ 86 | |
Foreign currency translation, loss on divestiture of a business | $ 615 | |
Other general expense | ||
Business Acquisition [Line Items] | ||
Gain (Loss) on Disposition of Business | $ (567) |
Revenues - Narrative (Details) |
6 Months Ended |
---|---|
Jun. 30, 2023
segment
| |
Revenue from Contract with Customer [Abstract] | |
Number of operating segments | 1 |
Income taxes (Details) $ in Millions |
3 Months Ended | 6 Months Ended | |||||
---|---|---|---|---|---|---|---|
Jun. 30, 2023
USD ($)
|
Jun. 30, 2022 |
Jun. 30, 2023
USD ($)
|
Jun. 30, 2022 |
Dec. 19, 2022
Case
|
Apr. 28, 2022
USD ($)
|
May 31, 2021
USD ($)
numberOfNotices
|
|
Income Tax Examination [Line Items] | |||||||
Effective income tax rate | 14.60% | 14.00% | 16.50% | 12.90% | |||
Increase in unrecognized tax benefits resulting from tax positions taken during the current period | $ 50 | $ 110 | |||||
Domestic Tax Authority | |||||||
Income Tax Examination [Line Items] | |||||||
Number of notices on proposed additional tax | numberOfNotices | 2 | ||||||
Proposed additional income tax | $ 3,600 | ||||||
Repatriation tax on proposed additional tax | $ 900 | ||||||
Proposed additional income tax 2013-2015 | $ 5,100 | ||||||
Penalties on proposed additional income tax 2013-2015 | 2,000 | ||||||
Repatriation tax on proposed additional tax 2013-2015 | $ 2,200 | ||||||
Number Of Notices Consolidated | Case | 2 |
Earnings per share (Details) - USD ($) $ / shares in Units, shares in Millions, $ in Millions |
3 Months Ended | 6 Months Ended | ||||
---|---|---|---|---|---|---|
Jun. 30, 2023 |
Mar. 31, 2023 |
Jun. 30, 2022 |
Mar. 31, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
|
Income (Numerator): | ||||||
Net income for basic and diluted EPS | $ 1,379 | $ 2,841 | $ 1,317 | $ 1,476 | $ 4,220 | $ 2,793 |
Shares (Denominator): | ||||||
Weighted-average shares for basic EPS (in shares) | 535 | 535 | 534 | 541 | ||
Effect of dilutive securities (in shares) | 2 | 2 | 3 | 3 | ||
Weighted-average shares for diluted EPS (in shares) | 537 | 537 | 537 | 544 | ||
Basic EPS (in usd per share) | $ 2.58 | $ 2.46 | $ 7.90 | $ 5.16 | ||
Diluted EPS (in usd per share) | $ 2.57 | $ 2.45 | $ 7.86 | $ 5.13 |
Investments - Amortized Cost, Gross Unrealized Gains & Losses, and Fair Value of Interest-bearing Securities (Details) - USD ($) $ in Millions |
Jun. 30, 2023 |
Dec. 31, 2022 |
---|---|---|
Marketable Securities [Line Items] | ||
Amortized cost | $ 33,618 | $ 4,335 |
Gross unrealized gains | 0 | 0 |
Gross unrealized losses | 0 | 0 |
Fair values | 33,618 | 4,335 |
U.S. Treasury bills | ||
Marketable Securities [Line Items] | ||
Amortized cost | 0 | 1,676 |
Gross unrealized gains | 0 | 0 |
Gross unrealized losses | 0 | 0 |
Fair values | 0 | 1,676 |
Money market mutual funds | ||
Marketable Securities [Line Items] | ||
Amortized cost | 33,618 | 2,659 |
Gross unrealized gains | 0 | 0 |
Gross unrealized losses | 0 | 0 |
Fair values | $ 33,618 | $ 2,659 |
Investments - Fair Values of Interest-bearing Securities by Balance Sheet Location (Details) - USD ($) $ in Millions |
Jun. 30, 2023 |
Dec. 31, 2022 |
---|---|---|
Marketable Securities [Line Items] | ||
Marketable securities | $ 0 | $ 1,676 |
Total interest-bearing securities | 33,618 | 4,335 |
Available-for-sale investments | ||
Marketable Securities [Line Items] | ||
Cash and cash equivalents | 33,618 | 2,659 |
Marketable securities | 0 | 1,676 |
Total interest-bearing securities | $ 33,618 | $ 4,335 |
Investments - Narrative: Available-for-sale Investments (Details) - USD ($) $ in Millions |
6 Months Ended | |
---|---|---|
Jun. 30, 2023 |
Dec. 31, 2022 |
|
Debt Securities, Available-for-sale [Line Items] | ||
Cash | $ 630 | $ 4,970 |
Cash and Cash Equivalents, at Carrying Value | 34,248 | $ 7,629 |
Cash payment | 27,800 | |
Horizon Therapeutics | ||
Debt Securities, Available-for-sale [Line Items] | ||
Cash payment | $ 27,800 |
Investments - Narrative: Equity Method Investments (Details) - USD ($) $ in Millions |
3 Months Ended | 6 Months Ended | ||||
---|---|---|---|---|---|---|
Sep. 30, 2021 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Dec. 31, 2022 |
|
Fair Value Measured at Net Asset Value Per Share | Limited Partnership | ||||||
Net Investment Income [Line Items] | ||||||
Alternative investments | $ 226 | $ 226 | $ 249 | |||
Unfunded additional commitments | 157 | 157 | ||||
Net gains (losses) from limited partnership investments | $ (29) | $ (60) | $ (9) | $ (220) | ||
Neumora Therapeutics, Inc. | ||||||
Net Investment Income [Line Items] | ||||||
Ownership percentage | 25.90% | 24.50% | 24.50% | 24.90% | ||
Aggregate cost | $ 257 | |||||
Cash payment | 100 | |||||
Noncash consideration | $ 157 | |||||
Fair value of investments | $ 316 | $ 316 | $ 335 | |||
Change in carrying value | $ 28 | $ (39) | $ (19) | $ (89) |
Inventories (Details) - USD ($) $ in Millions |
Jun. 30, 2023 |
Dec. 31, 2022 |
---|---|---|
Inventory Disclosure [Abstract] | ||
Raw materials | $ 855 | $ 828 |
Work in process | 3,048 | 3,098 |
Finished goods | 1,075 | 1,004 |
Total inventories | $ 4,978 | $ 4,930 |
Goodwill and other intangible assets (Goodwill Roll Forward) (Details) $ in Millions |
6 Months Ended |
---|---|
Jun. 30, 2023
USD ($)
| |
Goodwill [Roll Forward] | |
Beginning balance | $ 15,529 |
Adjustments to goodwill resulting from acquisitions and divestitures, net | (8) |
Currency translation adjustment | 10 |
Ending balance | $ 15,531 |
Goodwill and other intangible assets (Details Textual) - USD ($) $ in Millions |
3 Months Ended | 6 Months Ended | ||
---|---|---|---|---|
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
|
Goodwill and Intangible Assets Disclosure [Abstract] | ||||
Amortization charges associated with finite-lived intangible assets | $ 693 | $ 629 | $ 1,400 | $ 1,300 |
Total estimated amortization of finite-lived intangible assets for the remainder of the year | 1,400 | 1,400 | ||
Total estimated amortization of finite-lived intangible assets for year one | 2,700 | 2,700 | ||
Total estimated amortization of finite-lived intangible assets for year two | 2,500 | 2,500 | ||
Total estimated amortization of finite-lived intangible assets for year three | 2,100 | 2,100 | ||
Total estimated amortization of finite-lived intangible assets for year four | 2,100 | 2,100 | ||
Total estimated amortization of finite-lived intangible assets for year five | $ 1,100 | $ 1,100 |
Stockholders' equity (Share Repurchase Program) (Details) - USD ($) shares in Millions, $ in Millions |
3 Months Ended | 6 Months Ended | ||||
---|---|---|---|---|---|---|
Jun. 30, 2023 |
Mar. 31, 2023 |
Jun. 30, 2022 |
Mar. 31, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
|
Equity [Abstract] | ||||||
Stock repurchased (in shares) | 0.0 | 0.0 | 0.0 | 24.6 | 0.0 | 24.6 |
Stock repurchased | $ 0 | $ 0 | $ 0 | $ 5,410 | $ 0 | $ 5,410 |
Fair value measurement (Details Textual) - USD ($) $ in Millions |
Jun. 30, 2023 |
Dec. 31, 2022 |
---|---|---|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Long-term debt, fair value | $ 59,100 | $ 35,000 |
Carrying value of debt | 61,544 | 38,945 |
Teneobio Inc. | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Maximum additional consideration due contingent on certain milestones | $ 1,600 | 1,600 |
BeiGene | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Equity Method Investments,Quoted Market Price | 4,200 | |
Carrying value of equity method investment | $ 2,200 |
Fair value measurement (Contingent Consideration Obligations) (Details) - USD ($) $ in Millions |
3 Months Ended | 6 Months Ended | ||
---|---|---|---|---|
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
|
Business Combination, Contingent Consideration [Roll Forward] | ||||
Beginning balance | $ 273 | $ 330 | $ 270 | $ 342 |
Payments | (2) | (1) | (4) | (3) |
Net changes in valuations | (23) | (19) | (18) | (29) |
Ending balance | $ 248 | $ 310 | $ 248 | $ 310 |
Derivative instruments - Narrative (Details) - USD ($) $ in Millions |
Jun. 30, 2023 |
Dec. 31, 2022 |
---|---|---|
Derivative [Line Items] | ||
Amounts expected to be reclassified from AOCI into earnings over the next 12 months, foreign currency and cross-currency swaps | $ 108 | |
Forward interest rate contracts | Designated as Hedging Instrument | ||
Derivative [Line Items] | ||
Notional amounts | 6,100 | $ 6,000 |
Forward interest rate contracts | Derivatives not designated as hedging instrument | ||
Derivative [Line Items] | ||
Notional amounts | 557 | 517 |
Interest Rate Swap | Designated as Hedging Instrument | ||
Derivative [Line Items] | ||
Notional amounts | $ 6,700 | $ 6,700 |
Derivative instruments - Gains and Losses Recognized in AOCI for our Derivative Instruments Designated as Cash Flow Hedges (Details) - Cash flow hedge - USD ($) $ in Millions |
3 Months Ended | 6 Months Ended | ||
---|---|---|---|---|
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
|
Derivative Instruments, Gain (Loss) [Line Items] | ||||
Total unrealized gains (losses) | $ 50 | $ 67 | $ (21) | $ 123 |
Foreign currency forward contracts | ||||
Derivative Instruments, Gain (Loss) [Line Items] | ||||
Total unrealized gains (losses) | 24 | 252 | 24 | 330 |
Cross-currency swap contracts | ||||
Derivative Instruments, Gain (Loss) [Line Items] | ||||
Total unrealized gains (losses) | 26 | (185) | (14) | (207) |
Forward interest rate contracts | ||||
Derivative Instruments, Gain (Loss) [Line Items] | ||||
Total unrealized gains (losses) | $ 0 | $ 0 | $ (31) | $ 0 |
Derivative instruments - Hedged Liabilities and Related Cumulative Basis Adjustments (Details) - USD ($) $ in Millions |
Jun. 30, 2023 |
Dec. 31, 2022 |
---|---|---|
Derivative [Line Items] | ||
Cumulative amounts of fair value hedging adjustments related to the carrying amounts of the hedged liabilities | $ (436) | $ (437) |
Current portion of long-term debt | ||
Derivative [Line Items] | ||
Hedged Liability, Fair Value Hedge | 1,416 | 82 |
Cumulative amounts of fair value hedging adjustments related to the carrying amounts of the hedged liabilities | 16 | 82 |
Carrying value with discontinued hedging relationships | 80 | 82 |
Hedging adjustments on discontinued hedging relationships | 80 | 82 |
Long-term debt | ||
Derivative [Line Items] | ||
Hedged Liability, Fair Value Hedge | 4,688 | 6,017 |
Cumulative amounts of fair value hedging adjustments related to the carrying amounts of the hedged liabilities | (452) | (519) |
Carrying value with discontinued hedging relationships | 318 | 357 |
Hedging adjustments on discontinued hedging relationships | $ 218 | $ 257 |
Contingencies and commitments - Narrative (Details) $ in Millions |
Dec. 12, 2022
USD ($)
|
---|---|
Horizon Therapeutics Inc. | |
Loss Contingencies [Line Items] | |
Termination fee | $ 974.4 |
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