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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
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☑ | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended September 30, 2024
or
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☐ | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
Commission File Number: 001-37702
Amgen Inc.
(Exact name of registrant as specified in its charter)
| | | | | | | | |
Delaware | | 95-3540776 |
(State or other jurisdiction of incorporation or organization) | | (I.R.S. Employer Identification No.) |
| |
One Amgen Center Drive | | 91320-1799 |
Thousand Oaks | |
California | |
(Address of principal executive offices) | | (Zip Code) |
(805) 447-1000
(Registrant’s telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Act:
| | | | | | | | |
Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
Common stock, $0.0001 par value | AMGN | The Nasdaq Stock Market LLC |
2.00% Senior Notes due 2026 | AMGN26 | The Nasdaq Stock Market LLC |
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports) and (2) has been subject to such filing requirements for the past 90 days. Yes ☑ No ☐
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☑ No ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
| | | | | | | | | | | | | | | | | |
Large accelerated filer | ☑ | Accelerated filer | ☐ | Non-accelerated filer | ☐ |
Smaller reporting company | ☐ | Emerging growth company | ☐ | | |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
Yes ☐ No ☑
As of October 25, 2024, the registrant had 537,532,723 shares of common stock, $0.0001 par value, outstanding.
AMGEN INC.
INDEX
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Item 4. | | |
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Item 1A. | | |
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Item 6. | | |
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Defined Terms and Products
Defined terms
We use several terms in this Form 10-Q, including but not limited to those that are finance, regulation and disease-state related as well as names of other companies, which are given below.
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Term | Description | | | | |
AOCI | accumulated other comprehensive income (loss) | | | | |
| | | | | |
AstraZeneca | AstraZeneca plc | | | | |
| | | | | |
BeiGene | BeiGene, Ltd. | | | | |
| | | | | |
| | | | | |
CMS | Centers for Medicare & Medicaid Services | | | | |
| | | | | |
EMA | European Medicines Agency | | | | |
EPS | earnings per share | | | | |
| | | | | |
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 | | | | |
| | | | | |
HHS | U.S. Department of Health and Human Services | | | | |
Horizon | Horizon Therapeutics plc | | | | |
IPR&D | in-process research and development | | | | |
IRA | Inflation Reduction Act of 2022 | | | | |
IRS | Internal Revenue Service | | | | |
| | | | | |
| | | | | |
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 | | | | |
PDAB | Prescription Drug Affordability Board | | | | |
R&D | research and development | | | | |
RANKL | receptor activator of nuclear factor kappa-B ligand | | | | |
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 | | | | |
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U.S. Treasury | U.S. Department of Treasury | | | | |
UTB | unrecognized tax benefit | | | | |
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Products
The brand names of our products, our delivery devices and certain of our product candidates and their associated generic names are given below.
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Term | Description |
ACTIMMUNE | ACTIMMUNE® (interferon gamma-1b)(1) |
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) |
BUPHENYL | BUPHENYL® (sodium phenylbutyrate)(1) |
Corlanor | Corlanor® (ivabradine) |
DUEXIS | DUEXIS® (ibuprofen and famotidine)(1) |
ENBREL | Enbrel® (etanercept) |
EPOGEN | EPOGEN® (epoetin alfa) |
EVENITY | EVENITY® (romosozumab-aqqg) |
IMDELLTRA | IMDELLTRA™ (tarlatamab-dlle) |
IMLYGIC | IMLYGIC® (talimogene laherparepvec) |
KANJINTI | KANJINTI® (trastuzumab-anns) |
KRYSTEXXA | KRYSTEXXA® (pegloticase)(1) |
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) |
PENNSAID | PENNSAID® (diclofenac sodium topical solution) 2%(1) |
PROCYSBI | PROCYSBI® (cysteamine bitartrate)(1) |
Prolia | Prolia® (denosumab) |
QUINSAIR | QUINSAIR® (levofloxacin)(1) |
RAVICTI | RAVICTI® (glycerol phenylbutyrate)(1) |
RAYOS | RAYOS® (prednisone)(1) |
Repatha | Repatha® (evolocumab) |
RIABNI | RIABNI® (rituximab-arrx) |
Sensipar/Mimpara | Sensipar®/Mimpara™ (cinacalcet) |
TAVNEOS | TAVNEOS® (avacopan) |
TEPEZZA | TEPEZZA® (teprotumumab-trbw)(1) |
TEZSPIRE | TEZSPIRE® (tezepelumab-ekko) |
UPLIZNA | UPLIZNA® (inebilizumab-cdon)(1) |
Vectibix | Vectibix® (panitumumab) |
WEZLANA/WEZENLA | WEZLANA™ (ustekinumab-auub)/WEZENLA™ (ustekinumab) |
XGEVA | XGEVA® (denosumab) |
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(1) Products were acquired from our Horizon acquisition on October 6, 2023.
PART I—FINANCIAL INFORMATION
| | | | | |
Item 1. | FINANCIAL STATEMENTS |
AMGEN INC.
CONDENSED CONSOLIDATED STATEMENTS OF INCOME
(In millions, except per-share data)
(Unaudited)
| | | | | | | | | | | | | | | | | | | | | | | |
| Three months ended September 30, | | Nine months ended September 30, |
| 2024 | | 2023 | | 2024 | | 2023 |
Revenues: | | | | | | | |
Product sales | $ | 8,151 | | | $ | 6,548 | | | $ | 23,310 | | | $ | 19,077 | |
Other revenues | 352 | | | 355 | | | 1,028 | | | 917 | |
Total revenues | 8,503 | | | 6,903 | | | 24,338 | | | 19,994 | |
| | | | | | | |
Operating expenses: | | | | | | | |
Cost of sales | 3,310 | | | 1,806 | | | 9,746 | | | 5,339 | |
Research and development | 1,450 | | | 1,079 | | | 4,240 | | | 3,250 | |
| | | | | | | |
Selling, general and administrative | 1,625 | | | 1,353 | | | 5,218 | | | 3,905 | |
Other | 71 | | | 644 | | | 187 | | | 874 | |
Total operating expenses | 6,456 | | | 4,882 | | | 19,391 | | | 13,368 | |
| | | | | | | |
Operating income | 2,047 | | | 2,021 | | | 4,947 | | | 6,626 | |
| | | | | | | |
Other income (expense): | | | | | | | |
Interest expense, net | (776) | | | (759) | | | (2,408) | | | (2,054) | |
Other income, net | 1,830 | | | 685 | | | 1,288 | | | 2,431 | |
| | | | | | | |
Income before income taxes | 3,101 | | | 1,947 | | | 3,827 | | | 7,003 | |
| | | | | | | |
Provision for income taxes | 271 | | | 217 | | | 364 | | | 1,053 | |
| | | | | | | |
Net income | $ | 2,830 | | | $ | 1,730 | | | $ | 3,463 | | | $ | 5,950 | |
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Earnings per share: | | | | | | | |
Basic | $ | 5.27 | | | $ | 3.23 | | | $ | 6.45 | | | $ | 11.12 | |
Diluted | $ | 5.22 | | | $ | 3.22 | | | $ | 6.40 | | | $ | 11.06 | |
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Weighted-average shares used in calculation of earnings per share: | | | | | | | |
Basic | 537 | | | 535 | | | 537 | | | 535 | |
Diluted | 542 | | | 538 | | | 541 | | | 538 | |
See accompanying notes.
AMGEN INC.
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME
(In millions)
(Unaudited)
| | | | | | | | | | | | | | | | | | | | | | | |
| Three months ended September 30, | | Nine months ended September 30, |
| 2024 | | 2023 | | 2024 | | 2023 |
Net income | $ | 2,830 | | | $ | 1,730 | | | $ | 3,463 | | | $ | 5,950 | |
Other comprehensive (loss) income, net of reclassification adjustments and taxes: | | | | | | | |
Foreign currency translation adjustments | 71 | | | (44) | | | 32 | | | (5) | |
Cash flow hedges | (253) | | | 181 | | | (76) | | | 73 | |
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Other | 1 | | | 17 | | | (3) | | | 37 | |
Other comprehensive (loss) income, net of reclassification adjustments and taxes | (181) | | | 154 | | | (47) | | | 105 | |
Comprehensive income | $ | 2,649 | | | $ | 1,884 | | | $ | 3,416 | | | $ | 6,055 | |
See accompanying notes.
AMGEN INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In millions, except per-share data)
| | | | | | | | | | | |
| September 30, 2024 | | December 31, 2023 |
| (Unaudited) | | |
ASSETS |
Current assets: | | | |
Cash and cash equivalents | $ | 9,011 | | | $ | 10,944 | |
| | | |
Trade receivables, net | 7,317 | | | 7,268 | |
Inventories | 7,362 | | | 9,518 | |
Other current assets | 3,076 | | | 2,602 | |
Total current assets | 26,766 | | | 30,332 | |
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Property, plant and equipment, net | 6,156 | | | 5,941 | |
Intangible assets, net | 28,920 | | | 32,641 | |
Goodwill | 18,658 | | | 18,629 | |
Other noncurrent assets | 10,383 | | | 9,611 | |
Total assets | $ | 90,883 | | | $ | 97,154 | |
| | | |
LIABILITIES AND STOCKHOLDERS’ EQUITY |
Current liabilities: | | | |
Accounts payable | $ | 2,147 | | | $ | 1,590 | |
Accrued liabilities | 14,621 | | | 15,359 | |
Current portion of long-term debt | 3,544 | | | 1,443 | |
Total current liabilities | 20,312 | | | 18,392 | |
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Long-term debt | 56,854 | | | 63,170 | |
Long-term deferred tax liabilities | 1,711 | | | 2,354 | |
Long-term tax liabilities | 2,280 | | | 4,680 | |
Other noncurrent liabilities | 2,199 | | | 2,326 | |
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Contingencies and commitments (see Note 13) | | | |
| | | |
Stockholders’ equity: | | | |
Common stock and additional paid-in capital; $0.0001 par value; 2,750.0 shares authorized; outstanding—537.5 shares in 2024 and 535.4 shares in 2023 | 33,393 | | | 33,070 | |
Accumulated deficit | (25,530) | | | (26,549) | |
Accumulated other comprehensive loss | (336) | | | (289) | |
Total stockholders’ equity | 7,527 | | | 6,232 | |
Total liabilities and stockholders’ equity | $ | 90,883 | | | $ | 97,154 | |
See accompanying notes.
AMGEN INC.
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
(In millions, except per-share data)
(Unaudited)
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Number of shares of common stock | | Common stock and additional paid-in capital | | Accumulated deficit | | Accumulated other comprehensive loss | | Total |
Balance as of December 31, 2023 | 535.4 | | | $ | 33,070 | | | $ | (26,549) | | | $ | (289) | | | $ | 6,232 | |
| | | | | | | | | |
Net loss | — | | | — | | | (113) | | | — | | | (113) | |
Other comprehensive income, net of taxes | — | | | — | | | — | | | 99 | | | 99 | |
Dividends declared on common stock ($2.25 per share) | — | | | — | | | (1,208) | | | — | | | (1,208) | |
Issuance of common stock in connection with equity award programs | 1.0 | | | 34 | | | — | | | — | | | 34 | |
Stock-based compensation expense | — | | | 103 | | | — | | | — | | | 103 | |
Tax impact related to employee stock-based compensation expense | — | | | (125) | | | — | | | — | | | (125) | |
| | | | | | | | | |
Balance as of March 31, 2024 | 536.4 | | | 33,082 | | | (27,870) | | | (190) | | | 5,022 | |
| | | | | | | | | |
Net income | — | | | — | | | 746 | | | — | | | 746 | |
Other comprehensive income, net of taxes | — | | | — | | | — | | | 35 | | | 35 | |
Issuance of common stock in connection with equity award programs | 0.8 | | | 65 | | | — | | | — | | | 65 | |
Stock-based compensation expense | — | | | 157 | | | — | | | — | | | 157 | |
Tax impact related to employee stock-based compensation expense | — | | | (100) | | | — | | | — | | | (100) | |
| | | | | | | | | |
| | | | | | | | | |
Balance as of June 30, 2024 | 537.2 | | | 33,204 | | | (27,124) | | | (155) | | | 5,925 | |
| | | | | | | | | |
Net income | — | | | — | | | 2,830 | | | — | | | 2,830 | |
Other comprehensive loss, net of taxes | — | | | — | | | — | | | (181) | | | (181) | |
Dividends declared on common stock ($2.25 per share) | — | | | — | | | (1,236) | | | — | | | (1,236) | |
Issuance of common stock in connection with equity award programs | 0.3 | | | 67 | | | — | | | — | | | 67 | |
Stock-based compensation expense | — | | | 136 | | | — | | | — | | | 136 | |
Tax impact related to employee stock-based compensation expense | — | | | (14) | | | — | | | — | | | (14) | |
| | | | | | | | | |
| | | | | | | | | |
Balance as of September 30, 2024 | 537.5 | | | $ | 33,393 | | | $ | (25,530) | | | $ | (336) | | | $ | 7,527 | |
AMGEN INC.
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY (continued)
(In millions, except per-share data)
(Unaudited)
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 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 | 534.0 | | | $ | 32,514 | | | $ | (28,622) | | | $ | (231) | | | $ | 3,661 | |
| | | | | | | | | |
Net income | — | | | — | | | 2,841 | | | — | | | 2,841 | |
Other comprehensive loss, net of taxes | — | | | — | | | — | | | (37) | | | (37) | |
Dividends declared on common stock ($2.13 per share) | — | | | — | | | (1,138) | | | — | | | (1,138) | |
Issuance of common stock in connection with equity award programs | 0.3 | | | 11 | | | — | | | — | | | 11 | |
Stock-based compensation expense | — | | | 47 | | | — | | | — | | | 47 | |
Tax impact related to employee stock-based compensation expense | — | | | (37) | | | — | | | — | | | (37) | |
| | | | | | | | | |
Balance as of March 31, 2023 | 534.3 | | | 32,535 | | | (26,919) | | | (268) | | | 5,348 | |
| | | | | | | | | |
Net income | — | | | — | | | 1,379 | | | — | | | 1,379 | |
Other comprehensive loss, net of taxes | — | | | — | | | — | | | (12) | | | (12) | |
Issuance of common stock in connection with equity award programs | 0.6 | | | 16 | | | — | | | — | | | 16 | |
Stock-based compensation expense | — | | | 119 | | | — | | | — | | | 119 | |
Tax impact related to employee stock-based compensation expense | — | | | (69) | | | — | | | — | | | (69) | |
| | | | | | | | | |
| | | | | | | | | |
Balance as of June 30, 2023 | 534.9 | | | 32,601 | | | (25,540) | | | (280) | | | 6,781 | |
Net income | — | | | — | | | 1,730 | | | — | | | 1,730 | |
Other comprehensive income, net of taxes | — | | | — | | | — | | | 154 | | | 154 | |
Dividends declared on common stock ($2.13 per share) | — | | | — | | | (1,161) | | | — | | | (1,161) | |
Issuance of common stock in connection with equity award programs | 0.2 | | | 33 | | | — | | | — | | | 33 | |
Stock-based compensation expense | — | | | 124 | | | — | | | — | | | 124 | |
Tax impact related to employee stock-based compensation expense | — | | | (5) | | | — | | | — | | | (5) | |
| | | | | | | | | |
Balance as of September 30, 2023 | 535.1 | | | $ | 32,753 | | | $ | (24,971) | | | $ | (126) | | | $ | 7,656 | |
See accompanying notes.
AMGEN INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In millions)
(Unaudited)
| | | | | | | | | | | |
| Nine months ended September 30, |
| 2024 | | 2023 |
Cash flows from operating activities: | | | |
Net income | $ | 3,463 | | | $ | 5,950 | |
Noncash adjustments to reconcile net income to net cash provided by operating activities: | | | |
Depreciation, amortization and other | 4,195 | | | 2,691 | |
Stock-based compensation expense | 396 | | | 270 | |
Deferred income taxes | (894) | | | (650) | |
| | | |
Adjustments for equity method investments | (11) | | | (17) | |
| | | |
Gains on equity securities | (717) | | | (1,304) | |
Other items, net | 1 | | | 579 | |
Changes in operating assets and liabilities, net of acquisitions: | | | |
Trade receivables, net | (32) | | | (582) | |
Inventories | 2,209 | | | (82) | |
Other assets | (638) | | | (332) | |
Accounts payable | 544 | | | (215) | |
Accrued income taxes, net | (1,064) | | | 998 | |
Long-term tax liabilities | (561) | | | 293 | |
Accrued liabilities | (636) | | | 69 | |
Accrued sales incentives and allowance | 536 | | | 415 | |
Other liabilities | (72) | | | (150) | |
Net cash provided by operating activities | 6,719 | | | 7,933 | |
Cash flows from investing activities: | | | |
| | | |
| | | |
| | | |
Proceeds from sales of marketable securities | — | | | 1,125 | |
Proceeds from maturities of marketable securities | — | | | 550 | |
Purchases of property, plant and equipment | (725) | | | (863) | |
| | | |
Other | 81 | | | 73 | |
Net cash (used in) provided by investing activities | (644) | | | 885 | |
Cash flows from financing activities: | | | |
Net proceeds from issuance of debt | — | | | 23,781 | |
Extinguishment of debt | (659) | | | (550) | |
Repayment of debt | (3,600) | | | (1,454) | |
| | | |
Dividends paid | (3,627) | | | (3,416) | |
Other | (122) | | | (67) | |
Net cash (used in) provided by financing activities | (8,008) | | | 18,294 | |
(Decrease) increase in cash and cash equivalents | (1,933) | | | 27,112 | |
Cash and cash equivalents at beginning of period | 10,944 | | | 7,629 | |
Cash and cash equivalents at end of period | $ | 9,011 | | | $ | 34,741 | |
See accompanying notes.
AMGEN INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
September 30, 2024
(Unaudited)
1. Summary of significant accounting policies
Business
Amgen Inc. (including its consolidated 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 interim unaudited financial information for the three and nine months ended September 30, 2024 and 2023, has been prepared in accordance with GAAP and includes all adjustments (consisting of only normal, recurring adjustments unless otherwise indicated) that Amgen considers necessary for a fair presentation, in all material respects, of its condensed consolidated results of operations for those periods. Interim results are not necessarily indicative of results for the full fiscal year.
The condensed consolidated financial statements should be read in conjunction with our consolidated financial statements and the notes thereto contained in our Annual Report on Form 10-K for the year ended December 31, 2023, and with our condensed consolidated financial statements and the notes thereto contained in our Quarterly Reports on Form 10-Q for the periods ended March 31, 2024 and June 30, 2024.
Principles of consolidation
The condensed consolidated financial statements include the accounts of Amgen as well as its majority-owned subsidiaries. In determining whether we are the primary beneficiary of a variable interest entity, we consider whether we have both the power to direct activities of the entity that most significantly impact the entity’s economic performance and the obligation to absorb losses of or the right to receive benefits from the entity that could potentially be significant to that entity. We do not have any significant interests in any variable interest entities of which we are the primary beneficiary. All material intercompany transactions and balances have been eliminated in consolidation. Certain reclassifications have been made to prior periods in the condensed consolidated financial statements and accompanying notes to conform with the current presentation.
Use of estimates
The preparation of condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the condensed consolidated financial statements and accompanying notes. Actual results may differ from those estimates.
Property, plant and equipment, net
Property, plant and equipment is recorded at historical cost, net of accumulated depreciation and amortization, of $10.3 billion and $9.8 billion as of September 30, 2024 and December 31, 2023, respectively.
Recent accounting pronouncements
In December 2023, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, to improve income tax disclosure requirements by requiring more detailed information on several income tax disclosures, such as enhancing disclosure of income taxes paid and requiring disaggregation of the effective income tax rate reconciliation. The standard is effective for public business entities for annual periods beginning after December 15, 2024. Early adoption is permitted, and entities may apply the standard prospectively or may elect retrospective application. We are currently evaluating the impact of adopting this new standard on our related disclosures.
In November 2023, the FASB issued ASU No. 2023-07, Segment Reporting (Topic 280): Improving Reportable Segment Disclosures, to improve reportable segment disclosure requirements through enhanced disclosures about significant segment expenses and additional interim segment reporting disclosures, including for companies with a single reportable segment. The standard is effective for public business entities for annual periods beginning after December 15, 2023 and interim periods beginning after December 15, 2024. Early adoption is permitted, and the standard requires retrospective application to all prior
periods presented. We expect the adoption of this new standard to result in incremental disclosures to the notes to our financial statements.
2. Acquisitions
Acquisition of Horizon Therapeutics plc
On October 6, 2023, Amgen completed its acquisition of Horizon by acquiring all of the outstanding shares of Horizon for $116.50 per share in cash, representing a total consideration of approximately $27.8 billion. Horizon is a global biotechnology company focused on the discovery, development and commercialization of medicines that address critical needs of patients impacted by rare, autoimmune and severe inflammatory diseases. The acquisition, which was accounted for as a business combination, aligns with Amgen’s core strategy of delivering innovative medicines that make a significant difference for patients suffering from serious diseases and strengthens Amgen’s leading rare disease portfolio by adding first-in-class, early-in-lifecycle medicines, including TEPEZZA for thyroid eye disease, KRYSTEXXA for chronic refractory gout and UPLIZNA for neuromyelitis optica spectrum disorder. Upon its acquisition, Horizon became a wholly owned subsidiary of Amgen, and its operations have been included in our consolidated financial statements commencing on the acquisition date.
During the nine months ended September 30, 2024, the purchase price allocation of the acquisition was completed and measurement period adjustments were finalized, which included changes to the purchase price allocation that resulted in a net increase of approximately $25 million to goodwill. The measurement period adjustments resulted primarily from adjustments to acquired assets and liabilities, including deferred tax attributes, based on facts and circumstances that existed as of the acquisition date and did not result from events subsequent to the acquisition date. The adjustments did not have a significant impact on Amgen’s results of operations during the nine months ended September 30, 2024, and would not have had a significant impact on prior period results if the adjustments had been made as of the acquisition date.
The following table summarizes the final total consideration and allocated acquisition date fair values of assets acquired and liabilities assumed, inclusive of measurement period adjustments (in millions):
| | | | | | | | |
| | |
Cash and cash equivalents | | $ | 681 | |
Inventories | | 5,014 | |
Property, plant and equipment, net | | 318 | |
Finite-lived intangible assets – developed-product-technology rights | | 19,590 | |
IPR&D | | 1,060 | |
Goodwill | | 3,136 | |
Deferred tax asset | | 795 | |
Deferred tax liability | | (2,488) | |
Other assets and liabilities, net | | (273) | |
Total assets acquired, net of liabilities assumed | | $ | 27,833 | |
The $27.8 billion total consideration for this transaction consisted of (i) cash consideration transferred to common shareholders of $26.7 billion; (ii) cash consideration transferred to vested and outstanding stock options, outstanding restricted stock unit (RSU) awards and outstanding performance stock unit (PSU) awards of $523 million; (iii) the fair value of Amgen replacement awards (based on conversion of outstanding employee RSU awards) of $180 million representing noncash consideration; and (iv) a portion of Horizon’s debt, settled by Amgen on the acquisition closing date, of $382 million. Amgen issued 1.7 million replacement equity awards with the original vesting conditions, the fair value of which was determined based on the acquisition date fair value based on the conversion calculation.
The estimated fair values of $20.7 billion for the developed-product-technology rights and IPR&D intangible assets were determined using a multi-period excess earnings income approach that discounts expected future cash flows to present value by applying a discount rate that represents the estimated rate that market participants would use to value the intangible assets. The projected cash flows were based on certain assumptions attributable to the respective intangible asset, including estimates of future revenues and expenses, the time and resources needed to complete development and the probabilities of obtaining marketing approval from the FDA and other regulatory agencies. The developed-product-technology rights are being amortized on a straight-line basis over a weighted-average period of approximately 10 years from the acquisition date using the straight-line methodology.
The estimated fair value of the acquired inventory of $5.0 billion was determined using the comparative sales method, which uses actual or expected selling prices of inventory as the base amount to which adjustments for selling effort and a profit on the buyer’s effort are applied. The inventory fair value adjustment is being amortized using a weighted-average inventory turnover, which we estimate to approximate 27 months from the acquisition date.
A deferred tax liability of $2.5 billion was recognized on the temporary differences related to the book bases and tax bases of the acquired identifiable assets and assumed liabilities, primarily driven by the intangible assets acquired, as well as an associated deferred tax asset for anticipatory foreign tax credits of $795 million.
The excess of the acquisition date consideration over the fair values assigned to the assets acquired and the liabilities assumed of $3.1 billion was recorded as goodwill, which is not deductible for tax purposes. The goodwill value represents expected synergies from the marketed products acquired and other benefits.
Supplemental Pro Forma Financial Information
The following table presents the unaudited supplemental pro forma results of a hypothetical combined Amgen and Horizon entity for the three and nine months ended September 30, 2023, as if the acquisition of Horizon had occurred on January 1, 2022 (in millions):
| | | | | | | | | | | |
| Three months ended September 30, 2023 | | Nine months ended September 30, 2023 |
Total revenues | $ | 7,854 | | | $ | 22,728 | |
Net income | $ | 902 | | | $ | 3,518 | |
The unaudited supplemental pro forma combined financial information was prepared using the acquisition method of accounting and was based on the historical financial information of Amgen and Horizon. In order to reflect the occurrence of the acquisition on January 1, 2022, the unaudited supplemental pro forma financial information includes adjustments to reflect the following: (i) incremental amortization expense based on the fair values of the identifiable intangible assets and inventory step-up; (ii) the additional interest expense associated with the issuance of debt to finance the acquisition; and (iii) the income tax impact using an estimated effective tax rate applied to the combined entity. The unaudited supplemental pro forma financial information is not necessarily indicative of what the condensed consolidated results of operations would have been had the acquisition been completed on January 1, 2022. In addition, the unaudited supplemental pro forma financial information is not a projection of future results of operations of the combined company, nor does it reflect the expected realization of any synergies or cost savings associated with the acquisition.
3. Revenues
We operate in one business segment: human therapeutics. Therefore, results of our operations are reported on a consolidated basis for purposes of segment reporting, consistent with internal management reporting. Revenues by product and by geographic area, based on customers’ locations, are presented below. The majority of ROW revenues relates to products sold in Europe.
Revenues were as follows (in millions):
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| | Three months ended September 30, |
| | 2024 | | 2023 |
| | U.S. | | ROW | | Total | | U.S. | | ROW | | Total |
Prolia | | $ | 683 | | | $ | 362 | | | $ | 1,045 | | | $ | 673 | | | $ | 313 | | | $ | 986 | |
ENBREL | | 817 | | | 8 | | | 825 | | | 1,026 | | | 9 | | | 1,035 | |
XGEVA | | 373 | | | 168 | | | 541 | | | 374 | | | 145 | | | 519 | |
Repatha | | 281 | | | 286 | | | 567 | | | 183 | | | 223 | | | 406 | |
Otezla | | 460 | | | 104 | | | 564 | | | 462 | | | 105 | | | 567 | |
TEPEZZA(1) | | 482 | | | 6 | | | 488 | | | — | | | — | | | — | |
EVENITY | | 289 | | | 110 | | | 399 | | | 214 | | | 93 | | | 307 | |
KYPROLIS | | 238 | | | 140 | | | 378 | | | 231 | | | 118 | | | 349 | |
Nplate | | 345 | | | 111 | | | 456 | | | 322 | | | 97 | | | 419 | |
Aranesp | | 105 | | | 232 | | | 337 | | | 107 | | | 216 | | | 323 | |
KRYSTEXXA(1) | | 310 | | | — | | | 310 | | | — | | | — | | | — | |
BLINCYTO | | 237 | | | 90 | | | 327 | | | 147 | | | 73 | | | 220 | |
Vectibix | | 132 | | | 150 | | | 282 | | | 116 | | | 136 | | | 252 | |
TEZSPIRE(2) | | 269 | | | — | | | 269 | | | 161 | | | — | | | 161 | |
Other products(3) | | 958 | | | 405 | | | 1,363 | | | 675 | | | 329 | | | 1,004 | |
Total product sales(4) | | $ | 5,979 | | | $ | 2,172 | | | 8,151 | | | $ | 4,691 | | | $ | 1,857 | | | 6,548 | |
Other revenues | | | | | | 352 | | | | | | | 355 | |
Total revenues | | | | | | $ | 8,503 | | | | | | | $ | 6,903 | |
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| | Nine months ended September 30, |
| | 2024 | | 2023 |
| | U.S. | | ROW | | Total | | U.S. | | ROW | | Total |
Prolia | | $ | 2,110 | | | $ | 1,099 | | | $ | 3,209 | | | $ | 1,987 | | | $ | 954 | | | $ | 2,941 | |
ENBREL | | 2,280 | | 21 | | 2,301 | | | 2,645 | | 37 | | 2,682 | |
XGEVA | | 1,138 | | 526 | | 1,664 | | | 1,145 | | 440 | | 1,585 | |
Repatha | | 824 | | 792 | | 1,616 | | | 592 | | 626 | | 1,218 | |
Otezla | | 1,185 | | 317 | | 1,502 | | | 1,251 | | 308 | | 1,559 | |
TEPEZZA(1) | | 1,379 | | 12 | | 1,391 | | | — | | | — | | | — | |
EVENITY | | 806 | | 326 | | 1,132 | | | 570 | | 272 | | 842 | |
KYPROLIS | | 712 | | 419 | | 1,131 | | | 699 | | 354 | | 1,053 | |
Nplate | | 749 | | 370 | | 1,119 | | | 744 | | 347 | | 1,091 | |
Aranesp | | 296 | | 738 | | 1,034 | | | 345 | | 698 | | 1,043 | |
KRYSTEXXA(1) | | 839 | | — | | | 839 | | | — | | | — | | | — | |
BLINCYTO | | 555 | | 280 | | 835 | | | 418 | | 202 | | 620 | |
Vectibix | | 385 | | 414 | | 799 | | | 345 | | 388 | | 733 | |
TEZSPIRE(2) | | 676 | | — | | | 676 | | | 390 | | — | | | 390 | |
Other products(3) | | 2,858 | | | 1,204 | | 4,062 | | | 2,271 | | | 1,049 | | 3,320 | |
Total product sales(4) | | $ | 16,792 | | | $ | 6,518 | | | 23,310 | | | $ | 13,402 | | | $ | 5,675 | | | 19,077 | |
Other revenues | | | | | | 1,028 | | | | | | | 917 | |
Total revenues | | | | | | $ | 24,338 | | | | | | | $ | 19,994 | |
_______(1) TEPEZZA and KRYSTEXXA were acquired from the acquisition of Horizon on October 6, 2023, and include product sales in the periods after the acquisition date.
(2) TEZSPIRE is marketed by our collaborator AstraZeneca outside the United States.
(3) Consists of product sales of our non-principal products.
(4) Hedging gains and losses, which are included in product sales, were not material for the three and nine months ended September 30, 2024 and 2023.
4. Income taxes
The effective tax rates for the three and nine months ended September 30, 2024, were 8.7% and 9.5%, respectively, compared with 11.1% and 15.0%, respectively, for the corresponding periods in the prior year.
The decrease in our effective tax rate for the three months ended September 30, 2024, was primarily due to the earnings mix as a result of the inclusion of the Horizon business (including the amortization of Horizon acquired assets), partially offset by the quarter-to-date unrealized gains on our strategic equity investments (primarily BeiGene). See Note 6, Investments—BeiGene, Ltd. The decrease in our effective tax rate for the nine months ended September 30, 2024, was primarily due to the earnings mix as a result of the inclusion of the Horizon business (including the amortization of Horizon acquired assets). The effective tax rates differ from the federal statutory rate primarily due to the impact of the jurisdictional mix of income and expenses. Substantially all of the benefit to our effective tax rate from foreign earnings results from locations where the Company has significant manufacturing operations, including Singapore, Ireland and Puerto Rico, a territory of the United States that is treated as a foreign jurisdiction for U.S. tax purposes. Our operations in Puerto Rico are subject to a tax incentive grant through 2050. Additionally, the Company’s operations conducted in Singapore are subject to a tax incentive grant through 2036. Our foreign earnings are also subject to U.S. tax at a reduced rate of 10.5%. Additionally, effective January 1, 2024, selected individual countries, including the United Kingdom and EU member countries, have enacted the global minimum tax agreement. Our legal entities in such countries, along with their direct and indirect subsidiaries, are now subject to a 15% minimum tax rate on adjusted financial statement income.
Beginning on January 1, 2023, we were no longer subject to a 4% excise tax in the U.S. territory of Puerto Rico on the gross intercompany purchase price of goods and services from our manufacturer in Puerto Rico. We qualify for and are subject to the alternative income tax rate on industrial development income of our Puerto Rico affiliate. In the United States, this income tax qualifies for foreign tax credits. Both this income tax and the associated foreign tax credits are generally recognized in our provision for income taxes. We accounted for the 2022 excise tax that was capitalized in Inventories as an expense in Cost of sales when the related products were sold in the first half of 2023, and a foreign tax credit was not recognized with respect to the excise tax expense in 2023. We do not have this excise tax exposure in 2024.
One or more of our legal entities file income tax returns in the U.S. federal jurisdiction, various U.S. state jurisdictions and certain foreign jurisdictions. Our income tax returns are routinely examined by tax authorities in those jurisdictions. Significant disputes can and have arisen with tax authorities involving issues regarding the timing and amount of deductions, the use of tax credits and allocations of income and expenses among various tax jurisdictions because of differing interpretations of tax laws, regulations and relevant facts. Tax authorities, including the IRS, are becoming more aggressive and are particularly focused on such matters.
In 2017, we received an RAR and a modified RAR from the IRS for the years 2010–2012, proposing significant adjustments that primarily relate to the allocation of profits between certain of our entities in the United States and the U.S. territory of Puerto Rico. We disagreed with the proposed adjustments and calculations and pursued resolution with the IRS appeals office but were unable to reach resolution. In July 2021, we filed a petition in the U.S. Tax Court to contest two duplicate Statutory Notices of Deficiency (Notices) for the years 2010–2012 that we received in May and July 2021, which seek to increase our U.S. taxable income for the years 2010–2012 by an amount that would result in additional federal tax of approximately $3.6 billion, plus interest. Any additional tax that could be imposed for the years 2010–2012 would be reduced by up to approximately $900 million of repatriation tax previously accrued on our foreign earnings.
In 2020, we received an RAR and a modified RAR from the IRS for the years 2013–2015, also proposing significant adjustments that primarily relate to the allocation of profits between certain of our entities in the United States and the U.S. territory of Puerto Rico similar to those proposed for the years 2010–2012. We disagreed with the proposed adjustments and calculations and pursued resolution with the IRS appeals office but were unable to reach resolution. In July 2022, we filed a petition in the U.S. Tax Court to contest a Notice for the years 2013–2015 that we previously reported receiving in April 2022 that seeks to increase our U.S. taxable income for the years 2013–2015 by an amount that would result in additional federal tax of approximately $5.1 billion, plus interest. In addition, the Notice asserts penalties of approximately $2.0 billion. Any additional tax that could be imposed for the years 2013–2015 would be reduced by up to approximately $2.2 billion of repatriation tax previously accrued on our foreign earnings.
We firmly believe that the IRS positions set forth in the 2010–2012 and 2013–2015 Notices are without merit. We are contesting the 2010–2012 and 2013–2015 Notices through the judicial process. The two cases were consolidated in the U.S. Tax Court on December 19, 2022. The trial is currently scheduled to begin on November 4, 2024.
We are currently under examination by the IRS for the years 2016–2018 with respect to issues similar to those for the 2010 through 2015 period. In addition, we are under examination by a number of state and foreign tax jurisdictions.
Final resolution of these complex matters is not likely within the next 12 months. We continue to believe our accrual for income tax liabilities is appropriate based on past experience, interpretations of tax law, application of the tax law to our facts and judgments about potential actions by tax authorities; however, due to the complexity of the provision for income taxes and uncertain resolution of these matters, the ultimate outcome of any tax matters may result in payments substantially greater than amounts accrued and could have a material adverse impact on our condensed consolidated financial statements.
During the three and nine months ended September 30, 2024, the gross amounts of our UTBs increased by $40 million and $120 million, respectively, as a result of tax positions taken during the current year. Substantially all of the UTBs as of September 30, 2024, if recognized, would affect our effective tax rate.
5. Earnings per share
The computation of basic EPS is based on the weighted-average number of our common shares outstanding. The computation of diluted EPS is based on the weighted-average number of our common shares outstanding and dilutive potential common shares, which primarily include shares that may be issued under our stock option, restricted stock and performance unit award programs (collectively, dilutive securities), as determined by using the treasury stock method.
The computations for basic and diluted EPS were as follows (in millions, except per-share data):
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| Three months ended September 30, | | Nine months ended September 30, |
| 2024 | | 2023 | | 2024 | | 2023 |
Income (Numerator): | | | | | | | |
Net income for basic and diluted EPS | $ | 2,830 | | | $ | 1,730 | | | $ | 3,463 | | | $ | 5,950 | |
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Shares (Denominator): | | | | | | | |
Weighted-average shares for basic EPS | 537 | | | 535 | | | 537 | | | 535 | |
Effect of dilutive securities | 5 | | | 3 | | | 4 | | | 3 | |
Weighted-average shares for diluted EPS | 542 | | | 538 | | | 541 | | | 538 | |
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Basic EPS | $ | 5.27 | | | $ | 3.23 | | | $ | 6.45 | | | $ | 11.12 | |
Diluted EPS | $ | 5.22 | | | $ | 3.22 | | | $ | 6.40 | | | $ | 11.06 | |
For the three and nine months ended September 30, 2024 and 2023, the number of antidilutive employee stock-based awards excluded from the computation of diluted EPS was not significant.
6. Investments
Available-for-sale investments
The amortized cost, gross unrealized gains, gross unrealized losses and fair values of interest-bearing securities, which are considered available-for-sale, by type of security were as follows (in millions):
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Types of securities as of September 30, 2024 | | Amortized cost | | Gross unrealized gains | | Gross unrealized losses | | Fair values |
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U.S. Treasury bills | | $ | 996 | | | $ | — | | | $ | — | | | $ | 996 | |
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Money market mutual funds | | 7,437 | | | — | | | — | | | 7,437 | |
Other short-term interest-bearing securities | | 143 | | | — | | | — | | | 143 | |
Total interest-bearing securities | | $ | 8,576 | | | $ | — | | | $ | — | | | $ | 8,576 | |
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Types of securities as of December 31, 2023 | | Amortized cost | | Gross unrealized gains | | Gross unrealized losses | | Fair values |
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U.S. Treasury bills | | $ | — | | | $ | — | | | $ | — | | | $ | — | |
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Money market mutual funds | | 10,266 | | | — | | | — | | | 10,266 | |
Other short-term interest-bearing securities | | 138 | | | — | | | — | | | 138 | |
Total interest-bearing securities | | $ | 10,404 | | | $ | — | | | $ | — | | | $ | 10,404 | |
The fair values of interest-bearing securities by location in the Condensed Consolidated Balance Sheets were as follows (in millions):
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Condensed Consolidated Balance Sheets locations | | September 30, 2024 | | December 31, 2023 |
Cash and cash equivalents | | $ | 8,576 | | | $ | 10,404 | |
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Total interest-bearing securities | | $ | 8,576 | | | $ | 10,404 | |
Cash and cash equivalents in the above table excludes bank account cash of $435 million and $540 million as of September 30, 2024 and December 31, 2023, respectively.
All interest-bearing securities as of September 30, 2024 and December 31, 2023, mature in one year or less.
For the three and nine months ended September 30, 2024 and 2023, realized gains and losses on interest-bearing securities were not material. Realized gains and losses on interest-bearing securities are recorded in Other 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.
Our ownership interest in BeiGene was approximately 18% as of both September 30, 2024 and December 31, 2023, and the fair values of our investment were $4.3 billion and $3.4 billion, respectively, which are included in Other noncurrent assets in the Condensed Consolidated Balance Sheets. In the first quarter of 2023, we began to account for our ownership interest as an equity security with a readily determinable fair value, with changes in fair value recorded in Other income, net, in our Condensed Consolidated Statements of Income. See Note 11, Fair value measurement. During the three months ended September 30, 2024 and 2023, we recognized unrealized gains of $1.6 billion and $30 million, respectively, recorded in Other income, net, in our Condensed Consolidated Statements of Income. During the nine months ended September 30, 2024 and 2023, we recognized unrealized gains of $836 million and $1.2 billion, respectively, recorded in Other income, net, in our Condensed Consolidated Statements of Income.
Subject to certain exceptions or otherwise agreed to by BeiGene, while Amgen holds at least 5.0% of BeiGene’s outstanding common stock, (A) we may only sell our BeiGene equity investment via: (i) a registered public offering, (ii) a sale under Rule 144 of the Securities Act of 1933 (the “Securities Act”) or (iii) a private sale exempt from registration requirements under the Securities Act, and (B) we may not sell more than 5.0% of BeiGene’s outstanding common stock in any rolling 12-month period.
Other equity securities
Excluding our equity investments in BeiGene (discussed above) and Neumora (discussed below), we held investments in other equity securities with readily determinable fair values (publicly traded securities) of $336 million and $494 million as of September 30, 2024 and December 31, 2023, respectively, which are included in Other noncurrent assets in the Condensed Consolidated Balance Sheets. During the three and nine months ended September 30, 2024 and 2023, net unrealized gains and losses on these publicly traded securities were not material. Additionally, net realized gains and losses on sales of publicly traded securities for the three and nine months ended September 30, 2024 and 2023, were not material.
We held investments of $318 million and $309 million in equity securities without readily determinable fair values as of September 30, 2024 and December 31, 2023, respectively, which are included in Other noncurrent assets in the Condensed Consolidated Balance Sheets. During the three and nine months ended September 30, 2024 and 2023, upward and downward adjustments on these securities were not material. Adjustments were based on observable price transactions. Net realized gains and losses on sales of securities without readily determinable fair values for the three and nine months ended September 30, 2024 and 2023, were not material.
Equity method investments
Neumora Therapeutics, Inc.
As of September 30, 2024 and December 31, 2023, our ownership interests in Neumora were approximately 22.1% and 23.2%, respectively, and the fair values of our investment were $467 million and $603 million, respectively, which are included in Other noncurrent assets in the Condensed Consolidated Balance Sheets. Although our equity investment qualifies us for the equity method of accounting, we have elected the fair value option to account for our investment. Under the fair value option, changes in the fair value of the investment are recognized through earnings in Other income, net, in our Condensed Consolidated Statements of Income each reporting period. See Note 11, Fair value measurement. We believe the fair value option best reflects the economics of the underlying transaction. During the three months ended September 30, 2024 and 2023, we recognized unrealized gains of $119 million and $153 million, respectively, and during the nine months ended Septem