FINANCIAL STATEMENTS
−Removed: CONDENSED CONSOLIDATED STATEMENTS OF (LOSS) INCOME
+Added: CONDENSED CONSOLIDATED STATEMENTS OF INCOME
(In millions, except per-share data)
Three months ended
+Added: June 30, Six months ended
+Added: 2024 2023 2024 2023
Product sales $ 8,041 $ 6,683 $ 15,159 $ 12,529
11 unchanged sentences
Other (expense) income, net ( 307 ) ( 318 ) ( 542 ) 1,746
−Removed: (Loss) income before income taxes ( 68 ) 3,442
+Added: Income before income taxes 794 1,614 726 5,056
Provision for income taxes 48 235 93 836
−Removed: Net (loss) income $ ( 113 ) $ 2,841
−Removed: (Loss) earnings per share:
+Added: Net income $ 746 $ 1,379 $ 633 $ 4,220
+Added: Earnings per share:
Basic $ 1.39 $ 2.58 $ 1.18 $ 7.90
Diluted $ 1.38 $ 2.57 $ 1.17 $ 7.86
−Removed: Shares used in calculation of (loss) earnings per share:
+Added: Shares used in calculation of earnings per share:
Basic 537 535 537 534
1 unchanged sentence
See accompanying notes.
−Removed: CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE (LOSS) INCOME
+Added: CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME
(In millions)
Three months ended
−Removed: Net (loss) income $ ( 113 ) $ 2,841
+Added: June 30, Six months ended
+Added: 2024 2023 2024 2023
+Added: Net income $ 746 $ 1,379 $ 633 $ 4,220
Other comprehensive income (loss), net of reclassification adjustments and taxes:
3 unchanged sentences
Other comprehensive income (loss), net of reclassification adjustments and taxes 35 ( 12 ) 134 ( 49 )
−Removed: Comprehensive (loss) income $ ( 14 ) $ 2,804
+Added: Comprehensive income $ 781 $ 1,367 $ 767 $ 4,171
See accompanying notes.
1 unchanged sentence
(In millions, except per-share data)
−Removed: March 31, 2024 December 31, 2023
+Added: June 30, 2024 December 31, 2023
Current assets:
49 unchanged sentences
536.4 33,082 ( 27,870 ) ( 190 ) 5,022
+Added: Net income — — 746 — 746
+Added: Other comprehensive income, net of taxes — — — 35 35
+Added: Issuance of common stock in connection with the Company’s equity award programs
+Added: 0.8 65 — — 65
+Added: Stock-based compensation expense — 157 — — 157
+Added: Tax impact related to employee stock-based compensation expense
+Added: — ( 100 ) — — ( 100 )
+Added: Balance as of June 30, 2024
+Added: 537.2 $ 33,204 $ ( 27,124 ) $ ( 155 ) $ 5,925
+Added: CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY (continued)
+Added: (In millions, except per-share data)
paid-in capital Accumulated
14 unchanged sentences
534.3 32,535 ( 26,919 ) ( 268 ) 5,348
+Added: Net income — — 1,379 — 1,379
+Added: Other comprehensive loss, net of taxes — — — ( 12 ) ( 12 )
+Added: Issuance of common stock in connection with the Company’s equity award programs
+Added: 0.6 16 — — 16
+Added: Stock-based compensation expense — 119 — — 119
+Added: Tax impact related to employee stock-based compensation expense
+Added: — ( 69 ) — — ( 69 )
+Added: Balance as of June 30, 2023
+Added: 534.9 $ 32,601 $ ( 25,540 ) $ ( 280 ) $ 6,781
See accompanying notes.
1 unchanged sentence
(In millions)
−Removed: Three months ended
+Added: Six months ended
Cash flows from operating activities:
−Removed: Net (loss) income $ ( 113 ) $ 2,841
+Added: Net income $ 633 $ 4,220
Depreciation, amortization and other 2,799 1,796
32 unchanged sentences
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
−Removed: March 31, 2024
+Added: June 30, 2024
Summary of significant accounting policies
3 unchanged sentences
Basis of presentation
−Removed: The financial information for the three months ended March 31, 2024 and 2023, is unaudited but includes all adjustments (consisting of only normal, recurring adjustments unless otherwise indicated), which Amgen considers necessary for a fair presentation of its condensed consolidated results of operations for those periods.
+Added: The financial information for the three and six months ended June 30, 2024 and 2023, is unaudited but includes all adjustments (consisting of only normal, recurring adjustments unless otherwise indicated), which Amgen considers necessary for a fair presentation of its condensed consolidated results of operations for those periods.
Interim results are not necessarily indicative of results for the full fiscal year.
−Removed: 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.
+Added: 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 Report on Form 10-Q for the period ended March 31, 2024.
Principles of consolidation
8 unchanged sentences
Property, plant and equipment, net
−Removed: Property, plant and equipment is recorded at historical cost, net of accumulated depreciation and amortization, of $ 9.9 billion and $ 9.8 billion as of March 31, 2024 and December 31, 2023, respectively.
+Added: Property, plant and equipment is recorded at historical cost, net of accumulated depreciation and amortization, of $ 10.1 billion and $ 9.8 billion as of June 30, 2024 and December 31, 2023, respectively.
Recent accounting pronouncements
12 unchanged sentences
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.
−Removed: Measurement period adjustments during the three months ended March 31, 2024, included changes to the purchase price allocation, resulting in a net decrease of approximately $ 49 million to goodwill.
+Added: Measurement period adjustments during the six months ended June 30, 2024, included changes to the purchase price allocation, resulting in a net decrease of approximately $ 1 million to goodwill.
The measurement period adjustments resulted primarily from adjustments to acquired assets and liabilities, including sales reserve and allowances as well as right-of-use assets and liabilities based on facts and circumstances that existed as of the acquisition date and did not result from events subsequent to the acquisition date.
−Removed: The adjustments did not have a significant impact on Amgen’s results of operations during the three months ended March 31, 2024, and would not have had a significant impact on prior period results if the adjustments had been made as of the acquisition date.
+Added: The adjustments did not have a significant impact on Amgen’s results of operations during the six months ended June 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 total consideration and allocated acquisition date fair values of assets acquired and liabilities assumed, inclusive of measurement period adjustments (in millions):
21 unchanged sentences
The goodwill value represents expected synergies from the marketed products acquired and other benefits.
−Removed: 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.
+Added: 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 tax-related items as we obtain additional information during the measurement period of up to one year from the acquisition date.
Supplemental Pro Forma Financial Information
−Removed: The following table presents the unaudited supplemental pro forma results of a hypothetical combined Amgen and Horizon entity for the three months ended March 31, 2023, as if the acquisition of Horizon had occurred on January 1, 2022 (in millions):
+Added: The following table presents the unaudited supplemental pro forma results of a hypothetical combined Amgen and Horizon entity for the three and six months ended June 30, 2023, as if the acquisition of Horizon had occurred on January 1, 2022 (in millions):
Three months ended
−Removed: March 31, 2023
+Added: June 30, 2023 Six months ended
+Added: June 30, 2023
Total revenue $ 7,933 $ 14,874
13 unchanged sentences
Revenues were as follows (in millions):
−Removed: Three months ended March 31,
+Added: Three months ended June 30,
ROW Total U.S.
3 unchanged sentences
Repatha 270 262 532 212 212 424
−Removed: 419 5 424 — — —
Otezla 432 112 544 495 105 600
+Added: 478 1 479 — — —
KYPROLIS 240 137 377 234 112 346
−Removed: Aranesp 100 249 349 115 240 355
EVENITY 281 110 391 192 89 281
+Added: Aranesp 91 257 348 123 242 365
Nplate 214 132 346 176 134 310
+Added: KRYSTEXXA (1)
+Added: 294 — 294 — — —
Vectibix 133 137 270 118 130 248
BLINCYTO 165 99 264 145 61 206
+Added: 234 — 234 133 — 133
+Added: Other products (3)
+Added: 937 389 1,326 775 369 1,144
+Added: Total product sales (4)
+Added: $ 5,840 $ 2,201 8,041 $ 4,736 $ 1,947 6,683
+Added: Other revenues 347 303
+Added: Total revenues $ 8,388 $ 6,986
+Added: Six months ended June 30,
+Added: ROW Total U.S.
+Added: Prolia $ 1,427 $ 737 $ 2,164 $ 1,314 $ 641 $ 1,955
+Added: ENBREL 1,463 13 1,476 1,619 28 1,647
+Added: XGEVA 765 358 1,123 771 295 1,066
+Added: Repatha 543 506 1,049 409 403 812
+Added: Otezla 725 213 938 789 203 992
+Added: 897 6 903 — — —
+Added: KYPROLIS 474 279 753 468 236 704
+Added: EVENITY 517 216 733 356 179 535
+Added: Aranesp 191 506 697 238 482 720
+Added: Nplate 404 259 663 422 250 672
KRYSTEXXA (1)
529 — 529 — — —
+Added: Vectibix 253 264 517 229 252 481
+Added: BLINCYTO 318 190 508 271 129 400
407 — 407 229 — 229
8 unchanged sentences
(3) Consists of product sales of our non-principal products.
−Removed: (4) Hedging gains and losses, which are included in product sales, were not material for the three months ended March 31, 2024 and 2023.
−Removed: The income tax provisions for the three months ended March 31, 2024 and 2023, were tax expenses of $ 45 million and $ 601 million, respectively, on a pretax loss of $ 68 million and a pretax income of $ 3,442 million, respectively.
−Removed: The effective tax rates for the three months ended March 31, 2024 and 2023, were ( 66.2 )% and 17.5 %, respectively.
−Removed: The decrease in our effective tax rate for the three months ended March 31, 2024, was primarily due to the earnings mix as a result of the inclusion of the Horizon business, amortization of Horizon acquired assets and the first quarter 2024 unrealized loss on our BeiGene investment.
+Added: (4) Hedging gains and losses, which are included in product sales, were not material for the three and six months ended June 30, 2024 and 2023.
+Added: The effective tax rates for the three and six months ended June 30, 2024, were 6.0 % and 12.8 %, respectively, compared with 14.6 % and 16.5 %, respectively, for the corresponding periods in the prior year.
+Added: The decrease in our effective tax rate for the three months ended June 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).
+Added: The decrease in our effective tax rate for the six months ended June 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) and the year-to-date 2024 unrealized losses on our equity investments.
See Note 6, Investments —BeiGene, Ltd .
+Added: and Neumora Therapeutics, Inc.
The effective tax rates differ from the federal statutory rate primarily due to impacts of the jurisdictional mix of income and expenses.
45 unchanged sentences
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.
−Removed: During the three months ended March 31, 2024, the gross amounts of our UTBs increased by $ 40 million as a result of tax positions taken during the current year.
−Removed: Substantially all of the UTBs as of March 31, 2024, if recognized, would affect our effective tax rate.
+Added: During the three and six months ended June 30, 2024, the gross amounts of our UTBs increased by $ 40 million and $ 80 million, respectively, as a result of tax positions taken during the current year.
+Added: Substantially all of the UTBs as of June 30, 2024, if recognized, would affect our effective tax rate.
Earnings per share
1 unchanged sentence
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.
−Removed: As the Company recorded a net loss for the three months ended March 31, 2024, 5 million shares of employee stock-based awards were excluded in the computation of diluted loss per share because the effect would have been antidilutive.
−Removed: The computations for basic and diluted (loss) earnings per share were as follows (in millions, except per-share data):
+Added: The computations for basic and diluted EPS were as follows (in millions, except per-share data):
Three months ended
+Added: June 30, Six months ended
+Added: 2024 2023 2024 2023
Income (Numerator):
−Removed: Net (loss) income for basic and diluted (loss) earnings per share $ ( 113 ) $ 2,841
+Added: Net income for basic and diluted EPS $ 746 $ 1,379 $ 633 $ 4,220
Shares (Denominator):
−Removed: Weighted-average shares for basic (loss) earnings per share 536 534
+Added: Weighted-average shares for basic EPS 537 535 537 534
Effect of dilutive securities 4 2 4 3
−Removed: Weighted-average shares for diluted (loss) earnings per share 536 538
−Removed: Basic (loss) earnings per share $ ( 0.21 ) $ 5.32
−Removed: Diluted (loss) earnings per share $ ( 0.21 ) $ 5.28
−Removed: For the three months ended March 31, 2023, the number of antidilutive employee stock-based awards excluded from the computation of diluted EPS was not significant.
+Added: Weighted-average shares for diluted EPS 541 537 541 537
+Added: Basic EPS $ 1.39 $ 2.58 $ 1.18 $ 7.90
+Added: Diluted EPS $ 1.38 $ 2.57 $ 1.17 $ 7.86
+Added: For the three and six months ended June 30, 2024 and 2023, the number of antidilutive employee stock-based awards excluded from the computation of diluted EPS was not significant.
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):
−Removed: Types of securities as of March 31, 2024 Amortized
+Added: Types of securities as of June 30, 2024 Amortized
+Added: Treasury bills $ 995 $ — $ — $ 995
Money market mutual funds 7,678 — — 7,678
2 unchanged sentences
Types of securities as of December 31, 2023 Amortized
+Added: Treasury bills $ — $ — $ — $ —
Money market mutual funds 10,266 — — 10,266
2 unchanged sentences
The fair values of interest-bearing securities by location in the Condensed Consolidated Balance Sheets were as follows (in millions):
−Removed: Condensed Consolidated Balance Sheets locations March 31, 2024 December 31, 2023
+Added: Condensed Consolidated Balance Sheets locations June 30, 2024 December 31, 2023
Cash and cash equivalents $ 8,812 $ 10,404
Total interest-bearing securities $ 8,812 $ 10,404
−Removed: Cash and cash equivalents in the above table excludes bank account cash of $ 471 million and $ 540 million as of March 31, 2024 and December 31, 2023, respectively.
−Removed: All interest-bearing securities as of March 31, 2024 and December 31, 2023, mature in one year or less.
−Removed: For the three months ended March 31, 2024 and 2023, realized gains and losses on interest-bearing securities were not material.
−Removed: Realized gains and losses on interest-bearing securities are recorded in Other (expense) income, net, in the Condensed Consolidated Statements of (Loss) Income.
+Added: Cash and cash equivalents in the above table excludes bank account cash of $ 489 million and $ 540 million as of June 30, 2024 and December 31, 2023, respectively.
+Added: All interest-bearing securities as of June 30, 2024 and December 31, 2023, mature in one year or less.
+Added: For the three and six months ended June 30, 2024 and 2023, realized gains and losses on interest-bearing securities were not material.
+Added: 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.
3 unchanged sentences
BeiGene, Ltd.
−Removed: Effective January 30, 2023, we relinquished our right to appoint a director to BeiGene’s Board of Directors.
−Removed: We no longer have the ability to exert significant influence over BeiGene.
−Removed: 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.
+Added: Our ownership interest in BeiGene was approximately 18 % as of both June 30, 2024 and December 31, 2023, and the fair values of our investment were $ 2.7 billion and $ 3.4 billion, respectively, which are included in Other noncurrent assets in the Condensed Consolidated Balance Sheets.
+Added: In the first quarter of 2023, we began to account for our ownership interest as an equity security with a readily determinable fair value, with changes in fair value recorded in Other (expense) income, net.
See Note 11, Fair value measurement.
−Removed: During the three months ended March 31, 2024 and 2023, we recognized an unrealized loss of $ 454 million and an unrealized gain of $ 1.9 billion, respectively, recorded in Other (expense) income, net, in our Condensed Consolidated Statements of (Loss) Income.
−Removed: As of March 31, 2024 and December 31, 2023, the carrying and fair values of our equity investment in BeiGene were $ 3.0 billion and $ 3.4 billion, respectively, and were included in Other noncurrent assets in the Condensed Consolidated Balance Sheets.
+Added: During the three months ended June 30, 2024 and 2023, we recognized unrealized losses of $ 260 million and $ 705 million, respectively, recorded in Other (expense) income, net, in our Condensed Consolidated Statements of Income.
+Added: During the six months ended June 30, 2024 and 2023, we recognized unrealized losses of $ 714 million and unrealized gains of $ 1.2 billion, respectively, recorded in Other (expense) 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:
1 unchanged sentence
Other equity securities
−Removed: Excluding our equity investments in BeiGene and Neumora (discussed below), we held investments in other equity securities with readily determinable fair values (publicly traded securities) of $ 536 million and $ 494 million as of March 31, 2024 and December 31, 2023, respectively, which are included in Other noncurrent assets in the Condensed Consolidated Balance Sheets.
−Removed: During the three months ended March 31, 2024 and 2023, net unrealized gains on these publicly traded securities were $ 50 million and $ 5 million, respectively.
−Removed: Realized gains and losses on sales of publicly traded securities for the three months ended March 31, 2024 and 2023, were not material.
−Removed: We held investments of $ 333 million and $ 309 million in equity securities without readily determinable fair values as of March 31, 2024 and December 31, 2023, respectively, which are included in Other noncurrent assets in the Condensed Consolidated Balance Sheets.
−Removed: During the three months ended March 31, 2024 and 2023, upward and downward adjustments on these securities were not material.
+Added: 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 $ 419 million and $ 494 million as of June 30, 2024 and December 31, 2023, respectively, which are included in Other noncurrent assets in the Condensed Consolidated Balance Sheets.
+Added: During the three months ended June 30, 2024 and 2023, net unrealized losses and gains on these publicly traded securities were a net loss of $ 50 million and net gain of $ 3 million, respectively.
+Added: During the six months ended June 30, 2024 and 2023, net unrealized gains and losses on these publicly traded securities were not material.
+Added: Net realized gains and losses on sales of publicly traded securities for the three and six months ended June 30, 2024 and 2023 were not material.
+Added: We held investments of $ 330 million and $ 309 million in equity securities without readily determinable fair values as of June 30, 2024 and December 31, 2023, respectively, which are included in Other noncurrent assets in the Condensed Consolidated Balance Sheets.
+Added: During the three and six months ended June 30, 2024 and 2023, upward and downward adjustments on these securities were not material.
Adjustments were based on observable price transactions.
+Added: Net realized gains and losses on sales of securities without readily determinable fair values for the three and six months ended June 30, 2024 and 2023, were not material.
Equity method investments
Neumora Therapeutics, Inc.
−Removed: As of March 31, 2024 and December 31, 2023, our ownership interests in Neumora were approximately 22.3 % and 23.2 %, respectively, and the fair values of our investment were $ 486 million and $ 603 million, respectively.
−Removed: During the three months ended March 31, 2024 and 2023, we recognized net losses of $ 117 million and $ 47 million, respectively.
+Added: As of June 30, 2024 and December 31, 2023, our ownership interests in Neumora were approximately 22.2 % and 23.2 %, respectively, and the fair values of our investment were $ 348 million and $ 603 million, respectively, which are included in Other noncurrent assets in the Condensed Consolidated Balance Sheets.
+Added: During the three months ended June 30, 2024 and 2023, we recognized unrealized losses and gains of $ 138 million loss and $ 28 million gain, respectively, and during the six months ended June 30, 2024 and 2023, we recognized unrealized losses of $ 255 million and $ 19 million, respectively.
Although our equity investment qualifies us for the equity method of accounting, we have elected the fair value option to account for our investment.
−Removed: Under the fair value option, changes in the fair value of the investment are recognized through earnings in Other (expense) income, net, in our Condensed Consolidated Statements of (Loss) Income each reporting period.
+Added: 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.
See Note 11, Fair value measurement.
2 unchanged sentences
Limited partnerships
−Removed: We held limited partnership investments of $ 278 million and $ 251 million as of March 31, 2024 and December 31, 2023, respectively, which are included in Other noncurrent assets in the Condensed Consolidated Balance Sheets.
+Added: We held limited partnership investments of $ 290 million and $ 251 million as of June 30, 2024 and December 31, 2023, respectively, which are included in Other noncurrent assets in the Condensed Consolidated Balance Sheets.
These investments, primarily investment funds of early-stage biotechnology companies, are accounted for by using the equity method of accounting and are measured by using our proportionate share of the net asset values of the underlying investments held by the limited partnerships as a practical expedient.
These investments are typically redeemable only through distributions upon liquidation of the underlying assets.
−Removed: As of March 31, 2024, unfunded additional commitments to be made for these investments during the next several years amounted to $ 164 million.
−Removed: For the three months ended March 31, 2024 and 2023, net unrealized gains from our limited partnership investments were $ 27 million and $ 20 million, respectively, recorded in Other (expense) income, net, in our Condensed Consolidated Statements of (Loss) Income.
+Added: As of June 30, 2024, unfunded additional commitments to be made for these investments during the next several years amounted to $ 153 million.
+Added: For the three and six months ended June 30, 2024 and 2023, net unrealized gains and losses from our limited partnership investments were not material.
Inventories consisted of the following (in millions):
−Removed: March 31, 2024 December 31, 2023
+Added: June 30, 2024 December 31, 2023
Raw materials $ 884 $ 993
4 unchanged sentences
The change in the carrying amount of goodwill was as follows (in millions):
−Removed: Three months ended
−Removed: March 31, 2024
+Added: Six months ended
+Added: June 30, 2024
Beginning balance $ 18,629
2 unchanged sentences
Ending balance $ 18,616
−Removed: (1) For the three months ended March 31, 2024, adjustments to goodwill consisted of a measurement period adjustment related to our Horizon acquisition.
+Added: (1) For the six months ended June 30, 2024, adjustments to goodwill consisted of measurement period adjustments related to our Horizon acquisition.
See Note 2, Acquisitions.
1 unchanged sentence
Other intangible assets consisted of the following (in millions):
−Removed: March 31, 2024 December 31, 2023
+Added: June 30, 2024 December 31, 2023
amounts Accumulated
20 unchanged sentences
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.
−Removed: During the three months ended March 31, 2024 and 2023, we recognized amortization associated with our finite-lived intangible assets of $ 1.2 billion and $ 693 million, respectively.
−Removed: Amortization of intangible assets is primarily included in Cost of sales in the Condensed Consolidated Statements of (Loss) Income.
−Removed: As of March 31, 2024, the total estimated amortization of our finite-lived intangible assets for the remaining nine months ending December 31, 2024, and the years ending December 31, 2025, 2026, 2027, 2028 and 2029, are $ 3.6 billion, $ 4.5 billion, $ 3.9 billion, $ 3.9 billion, $ 2.9 billion and $ 2.2 billion, respectively.
+Added: During the three months ended June 30, 2024 and 2023, we recognized amortization associated with our finite-lived intangible assets of $ 1.2 billion and $ 693 million, respectively.
+Added: During the six months ended June 30, 2024 and 2023, we recognized amortization associated with our finite-lived intangible assets of $ 2.4 billion and $ 1.4 billion, respectively.
+Added: Amortization of intangible assets is primarily included in Cost of sales in the Condensed Consolidated Statements of Income.
+Added: As of June 30, 2024, the total estimated amortization of our finite-lived intangible assets for the remaining six months ending December 31, 2024, and the years ending December 31, 2025, 2026, 2027, 2028 and 2029, are $ 2.4 billion, $ 4.5 billion, $ 3.9 billion, $ 3.9 billion, $ 2.9 billion and $ 2.2 billion, respectively.
Financing arrangements
Our borrowings consisted of the following (in millions):
−Removed: March 31, 2024 December 31, 2023
+Added: June 30, 2024 December 31, 2023
3.625 % notes due 2024 ( 3.625 % 2024 Notes)
−Removed: $ 1,400 $ 1,400
1.90 % notes due 2025 ( 1.90 % 2025 Notes)
42 unchanged sentences
4.40 % notes due 2062 ( 4.40 % 2062 Notes)
−Removed: March 31, 2024 December 31, 2023
+Added: June 30, 2024 December 31, 2023
5.75 % notes due 2063 ( 5.75 % 2063 Notes)
7 unchanged sentences
The Term loans have an interest rate of three-month SOFR plus 1.225 %.
+Added: Debt repayments
+Added: During the three months ended June 30, 2024, we repaid the $ 1.4 billion aggregate principal amount of the 3.625 % 2024 Notes.
Debt extinguishment
−Removed: During the three months ended March 31, 2024, we repurchased portions of the 3.15 % 2040 Notes, 2.80 % 2041 Notes, 3.375 % 2050 Notes, 3.00 % 2052 Notes, 4.20 % 2052 Notes and 4.40 % 2062 Notes for an aggregate cost of $ 410 million, which resulted in the recognition of a $ 133 million gain on extinguishment of debt recorded in Other (expense) income, net, in the Condensed Consolidated Statements of (Loss) Income.
+Added: During the three months ended March 31, 2024, we repurchased portions of the 3.15 % 2040 Notes, 2.80 % 2041 Notes, 3.375 % 2050 Notes, 3.00 % 2052 Notes, 4.20 % 2052 Notes and 4.40 % 2062 Notes for an aggregate cost of $ 410 million, which resulted in the recognition of a $ 133 million gain on extinguishment of debt recorded in Other (expense) income, net, in the Condensed Consolidated Statements of Income.
Stockholders’ equity
Stock repurchase program
−Removed: During the three months ended March 31, 2024 and 2023, we did not repurchase shares under our stock repurchase program.
−Removed: As of March 31, 2024, $ 7.0 billion of authorization remained available under our stock repurchase program.
−Removed: In March 2024, the Board of Directors declared a quarterly cash dividend of $ 2.25 per share, which will be paid in June 2024.
−Removed: In December 2023, the Board of Directors declared a quarterly cash dividend of $ 2.25 per share, which was paid in March 2024.
+Added: During the six months ended June 30, 2024 and 2023, we did not repurchase shares under our stock repurchase program.
+Added: As of June 30, 2024, $ 7.0 billion of authorization remained available under our stock repurchase program.
+Added: In March 2024 and December 2023, our Board of Directors declared quarterly cash dividends of $ 2.25 per share, which were paid in June 2024 and March 2024, respectively.
+Added: In August 2024, our Board of Directors declared a quarterly cash dividend of $ 2.25 per share that will be paid in September 2024.
Accumulated other comprehensive income (loss)
10 unchanged sentences
( 322 ) 104 28 ( 190 )
+Added: Foreign currency translation adjustments ( 15 ) — — ( 15 )
+Added: Unrealized gains — 117 — 117
+Added: Reclassification adjustments to income — ( 52 ) — ( 52 )
+Added: Other — — ( 1 ) ( 1 )
+Added: Income taxes — ( 14 ) — ( 14 )
+Added: Balance as of June 30, 2024
+Added: $ ( 337 ) $ 155 $ 27 $ ( 155 )
Reclassifications out of AOCI and into earnings, including related income tax expenses, were as follows (in millions):
−Removed: Three months ended March 31,
+Added: Three months ended June 30,
Components of AOCI 2024 2023 Condensed Consolidated
−Removed: Statements of (Loss) Income locations
+Added: Statements of Income locations
Cash flow hedges:
Foreign currency contract gains $ 55 $ 36 Product sales
−Removed: Cross-currency swap contract losses ( 31 ) ( 22 ) Other (expense) income, net
−Removed: 20 30 (Loss) income before income taxes
+Added: Cross-currency swap contract (losses) gains ( 3 ) 51 Other (expense) income, net
+Added: 52 87 Income before income taxes
( 11 ) ( 19 ) Provision for income taxes
−Removed: $ 16 $ 24 Net (loss) income
+Added: $ 41 $ 68 Net income
+Added: Six months ended June 30,
+Added: Components of AOCI 2024 2023 Condensed Consolidated
+Added: Statements of Income locations
+Added: Cash flow hedges:
+Added: Foreign currency contract gains $ 106 $ 88 Product sales
+Added: Cross-currency swap contract (losses) gains ( 34 ) 29 Other (expense) income, net
+Added: 72 117 Income before income taxes
+Added: ( 15 ) ( 25 ) Provision for income taxes
+Added: $ 57 $ 92 Net income
Fair value measurement
−Removed: 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.
+Added: To estimate the fair value of our financial assets and liabilities, we use valuation approaches within a hierarchy that maximize 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.
15 unchanged sentences
(Level 2) Significant
−Removed: Fair value measurement as of March 31, 2024, using:
+Added: Fair value measurement as of June 30, 2024, using:
Available-for-sale securities:
+Added: Treasury bills $ — $ 995 $ — $ 995
Money market mutual funds 7,678 — — 7,678
16 unchanged sentences
Available-for-sale securities:
+Added: Treasury bills $ — $ — $ — $ —
Money market mutual funds 10,266 — — 10,266
9 unchanged sentences
Interest-bearing and equity securities
−Removed: The fair values of our money market mutual funds and equity investments in publicly traded securities, including our equity investments in BeiGene and Neumora, as of March 31, 2024 and December 31, 2023, are based on quoted market prices in active markets, with no valuation adjustment.
+Added: The fair values of our money market mutual funds and equity investments in publicly traded securities, including our equity investments in BeiGene and Neumora, as of June 30, 2024 and December 31, 2023, are based on quoted market prices in active markets, with no valuation adjustment.
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.
9 unchanged sentences
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.
−Removed: Changes in the fair values of contingent consideration obligations are recognized in Other operating expenses in the Condensed Consolidated Statements of (Loss) Income.
+Added: Changes in the fair values of contingent consideration obligations are recognized in Other operating expenses in the Condensed Consolidated Statements of Income.
Changes in the carrying amounts of contingent consideration obligations were as follows (in millions):
Three months ended
+Added: June 30, Six months ended
+Added: 2024 2023 2024 2023
Beginning balance $ 96 $ 273 $ 96 $ 270
2 unchanged sentences
Ending balance $ 107 $ 248 $ 107 $ 248
−Removed: As of March 31, 2024 and December 31, 2023, our contingent consideration obligations are primarily the result of our acquisition of Teneobio, Inc.
+Added: As of June 30, 2024 and December 31, 2023, our contingent consideration obligations are primarily the result of our acquisition of Teneobio, Inc.
in October 2021, which obligates us to pay the former shareholders payments upon achieving separate development and regulatory milestones with regard to various R&D programs.
3 unchanged sentences
We estimated the fair values of our borrowings by using Level 2 inputs.
−Removed: As of March 31, 2024 and December 31, 2023, the aggregate fair values of our borrowings were $ 57.8 billion and $ 59.2 billion, respectively, and the carrying values were $ 64.0 billion and $ 64.6 billion, respectively.
−Removed: During the three months ended March 31, 2024 and 2023, there were no transfers of assets or liabilities between fair value measurement levels, and there were no material remeasurements to the fair values of assets and liabilities that are not measured at fair value on a recurring basis.
+Added: As of June 30, 2024 and December 31, 2023, the aggregate fair values of our borrowings were $ 59.3 billion and $ 59.2 billion, respectively, and the carrying values were $ 62.6 billion and $ 64.6 billion, respectively.
+Added: During the six months ended June 30, 2024 and 2023, there were no transfers of assets or liabilities between fair value measurement levels, and there were no material remeasurements to the fair values of assets and liabilities that are not measured at fair value on a recurring basis.
Derivative instruments
9 unchanged sentences
and at any given point in time, a higher percentage of nearer-term projected product sales is being hedged than in successive periods.
−Removed: As of both March 31, 2024 and December 31, 2023, we had outstanding foreign currency forward contracts with aggregate notional amounts of $ 6.6 billion.
+Added: As of both June 30, 2024 and December 31, 2023, we had outstanding foreign currency forward contracts with aggregate notional amounts of $ 6.6 billion.
We have designated these foreign currency forward contracts, which are primarily euro based, as cash flow hedges.
−Removed: Accordingly, we report the unrealized gains and losses on these contracts in AOCI in the Condensed Consolidated Balance Sheets, and we reclassify them to Product sales in the Condensed Consolidated Statements of (Loss) Income in the same periods during which the hedged transactions affect earnings.
+Added: 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.
7 unchanged sentences
We have designated these cross-currency swap contracts as cash flow hedges.
−Removed: Accordingly, the unrealized gains and losses on these contracts are reported in AOCI in the Condensed Consolidated Balance Sheets and reclassified to Other (expense) income, net, in the Condensed Consolidated Statements of (Loss) Income in the same periods during which the hedged debt affects earnings.
−Removed: The notional amounts and interest rates of our cross-currency swaps as of March 31, 2024, were as follows (notional amounts in millions):
+Added: 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.
+Added: The notional amounts and interest rates of our cross-currency swaps as of June 30, 2024, were as follows (notional amounts in millions):
Foreign currency U.S.
8 unchanged sentences
Treasury rate between the time we enter into these contracts and the time the related debt is issued.
−Removed: Ga ins and losses on forward interest rate contracts, which are designated as cash flow hedges, are recognized in AOCI i n the Condensed Consolidated Balance Sheets and are amortized into Interest expense, net, in the Condensed Consolidated Statements of (Loss) Income over the lives of the associated debt issuances.
−Removed: Amounts recognized in connection with forward interest rate contracts during the three months ended March 31, 2024, and amounts expected to be recognized during the subsequent 12 months are not material.
+Added: Ga ins and losses on forward interest rate contracts, which are designated as cash flow hedges, are recognized in AOCI i n 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.
+Added: Amounts recognized in connection with forward interest rate contracts during the six months ended June 30, 2024, and amounts expected to be recognized during the subsequent 12 months are not material.
Gains and losses recognized in AOCI for our derivative instruments designated as cash flow hedges were as follows (in millions):
Three months ended
+Added: June 30, Six months ended
Derivatives in cash flow hedging relationships 2024 2023 2024 2023
6 unchanged sentences
These interest rate swap contracts effectively convert fixed-rate coupons to floating-rate coupons over the terms of the related hedge contracts.
−Removed: As of both March 31, 2024 and December 31, 2023, we had interest rate swap contracts with aggregate notional amounts of $ 6.7 billion that hedge certain portions of our long-term debt issuances.
−Removed: For interest rate swap contracts that qualify for and are designated as fair value hedges, we recognize in Interest expense, net, in the Condensed Consolidated Statements of (Loss) Income the unrealized gain or loss on the derivative resulting from the change in fair value during the period, as well as the offsetting unrealized loss or gain of the hedged item resulting from the change in fair value during the period attributable to the hedged risk.
+Added: As of June 30, 2024 and December 31, 2023, we had interest rate swap contracts with aggregate notional amounts of $ 5.3 billion and $ 6.7 billion, respectively, that hedge certain portions of our long-term debt issuances.
+Added: The reduction in aggregate notional amount of these contracts during the six months ended June 30, 2024, was due to the termination of swaps that occurred in connection with the repayment of the 3.625 % 2024 Notes (see Note 9, Financing arrangements).
+Added: 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.
2 unchanged sentences
Cumulative amounts of fair value hedging adjustments related to the carrying amounts of the hedged liabilities (2)
−Removed: Condensed Consolidated Balance Sheets locations March 31, 2024 December 31, 2023 March 31, 2024 December 31, 2023
+Added: Condensed Consolidated Balance Sheets locations June 30, 2024 December 31, 2023 June 30, 2024 December 31, 2023
Current portion of long-term debt $ 1,026 $ 1,441 $ 26 $ 41
Long-term debt $ 3,776 $ 4,788 $ ( 371 ) $ ( 355 )
−Removed: (1) Current portion of long-term debt includes $ 64 million and $ 69 million of carrying value with discontinued hedging relationships as of March 31, 2024 and December 31, 2023, respectively.
−Removed: Long-term debt includes $ 273 million and $ 288 million of carrying value with discontinued hedging relationships as of March 31, 2024 and December 31, 2023, respectively.
−Removed: (2) Current portion of long-term debt includes $ 64 million and $ 69 million of hedging adjustments on discontinued hedging relationships as of March 31, 2024 and December 31, 2023, respectively.
−Removed: Long-term debt includes $ 173 million and $ 188 million of hedging adjustments on discontinued hedging relationships as of March 31, 2024 and December 31, 2023, respectively.
+Added: (1) Current portion of long-term debt includes $ 60 million and $ 69 million of carrying value with discontinued hedging relationships as of June 30, 2024 and December 31, 2023, respectively.
+Added: Long-term debt includes $ 259 million and $ 288 million of carrying value with discontinued hedging relationships as of June 30, 2024 and December 31, 2023, respectively.
+Added: (2) Current portion of long-term debt includes $ 60 million and $ 69 million of hedging adjustments on discontinued hedging relationships as of June 30, 2024 and December 31, 2023, respectively.
+Added: Long-term debt includes $ 159 million and $ 188 million of hedging adjustments on discontinued hedging relationships as of June 30, 2024 and December 31, 2023, respectively.
Impact of hedging transactions
The following tables summarize the amounts recorded in income and expense line items and the effects thereon from fair value and cash flow hedging, including discontinued hedging relationships (in millions):
−Removed: Three months ended March 31, 2024
−Removed: Product sales Other (expense) income, net Interest expense, net
−Removed: Total amounts recorded in income and (expense) line items presented in the Condensed Consolidated Statements of (Loss) Income
+Added: Three months ended June 30, 2024 Six months ended June 30, 2024
+Added: Product sales Other (expense) income, net Interest expense, net Product sales Other (expense) income, net Interest expense, net
+Added: Total amounts recorded in income and (expense) line items presented in the Condensed Consolidated Statements of Income
$ 8,041 $ ( 307 ) $ ( 808 ) $ 15,159 $ ( 542 ) $ ( 1,632 )
3 unchanged sentences
Cross-currency swap contracts $ — $ ( 3 ) $ — $ — $ ( 34 ) $ —
−Removed: Gains (losses) on fair value hedging relationships—interest rate swap agreements:
+Added: (Losses) gains on fair value hedging relationships—interest rate swap agreements:
Hedged items (1)
+Added: $ — $ — $ ( 18 ) $ — $ — $ 31
Derivatives designated as hedging instruments $ — $ — $ 36 $ — $ — $ 8
−Removed: Three months ended March 31, 2023
−Removed: Product sales Other (expense) income, net Interest expense, net
−Removed: Total amounts recorded in income and (expense) line items presented in the Condensed Consolidated Statements of (Loss) Income
+Added: Three months ended June 30, 2023 Six months ended June 30, 2023
+Added: Product sales Other (expense) income, net Interest expense, net Product sales Other (expense) income, net Interest expense, net
+Added: Total amounts recorded in income and (expense) line items presented in the Condensed Consolidated Statements of Income
$ 6,683 $ ( 318 ) $ ( 752 ) $ 12,529 $ 1,746 $ ( 1,295 )
The effects of cash flow and fair value hedging:
−Removed: Gains (losses) on cash flow hedging relationships reclassified out of AOCI:
+Added: Gains on cash flow hedging relationships reclassified out of AOCI:
Foreign currency forward contracts $ 36 $ — $ — $ 88 $ — $ —
Cross-currency swap contracts $ — $ 51 $ — $ — $ 29 $ —
−Removed: (Losses) gains on fair value hedging relationships—interest rate swap agreements:
+Added: Gains (losses) on fair value hedging relationships—interest rate swap agreements:
Hedged items (1)
3 unchanged sentences
No portions of our cash flow hedge contracts were excluded from the assessment of hedge effectiveness.
−Removed: As of March 31, 2024, we expected to reclassify $ 97 million of net gains on our foreign currency and cross-currency swap contracts out of AOCI and into earnings during the next 12 months.
+Added: As of June 30, 2024, we expected to reclassify $ 119 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
1 unchanged sentence
Most of these exposures are hedged on a month-to-month basis.
−Removed: As of March 31, 2024 and December 31, 2023, the total notional amounts of these foreign currency forward contracts were $ 300 million and $ 457 million, respectively.
−Removed: Gains and losses recognized in earnings for our derivative instruments not designated as hedging instruments were not material for the three months ended March 31, 2024 and 2023.
+Added: As of June 30, 2024 and December 31, 2023, the total notional amounts of these foreign currency forward contracts were $ 145 million and $ 457 million, respectively.
+Added: 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, 2024 and 2023.
Fair values of derivatives
1 unchanged sentence
Derivative assets Derivative liabilities
−Removed: March 31, 2024 Condensed Consolidated
+Added: June 30, 2024 Condensed Consolidated
Balance Sheets locations Fair values Condensed Consolidated
20 unchanged sentences
For additional information, see Note 11, Fair value measurement.
−Removed: Our derivative contracts that were in liability positions as of March 31, 2024, contain certain credit-risk-related contingent provisions that would be triggered if (i) we were to undergo a change-in-control and (ii) our or the surviving entity’s creditworthiness deteriorates, which is generally defined as having either a credit rating that is below investment grade or a materially weaker creditworthiness after the change-in-control.
+Added: Our derivative contracts that were in liability positions as of June 30, 2024, contain certain credit-risk-related contingent provisions that would be triggered if (i) we were to undergo a change-in-control and (ii) our or the surviving entity’s creditworthiness deteriorates, which is generally defined as having either a credit rating that is below investment grade or a materially weaker creditworthiness after the change-in-control.
If these events were to occur, the counterparties would have the right, but not the obligation, to close the contracts under early-termination provisions.
8 unchanged sentences
We describe our legal proceedings and other matters that are significant or that we believe could become significant in this footnote;
−Removed: and in Note 20, Contingencies and commitments, to the consolidated financial statements in our Annual Report on Form 10-K for the year ended December 31, 2023.
+Added: in Note 20, Contingencies and commitments, to the consolidated financial statements in our Annual Report on Form 10-K for the year ended December 31, 2023;
+Added: and in Note 13, Contingencies and commitments, to the condensed consolidated financial statements in our Quarterly Report on Form 10-Q for the period ended March 31, 2024.
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.
2 unchanged sentences
In each of the matters described in this filing;
−Removed: and in Note 20, Contingencies and commitments, to the consolidated financial statements in our Annual Report on Form 10-K for the year ended December 31, 2023, in which we could incur a liability, our opponents seek an award of a not-yet-quantified amount of damages or an amount that is not material.
+Added: in Note 20, Contingencies and commitments, to the consolidated financial statements in our Annual Report on Form 10-K for the year ended December 31, 2023;
+Added: and in Note 13, Contingencies and commitments, to the condensed consolidated financial statements in our Quarterly Report on Form 10-Q for the period ended March 31, 2024, 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;
−Removed: and in Note 20, Contingencies and commitments, to the consolidated financial statements in our Annual Report on Form 10-K for the year ended December 31, 2023, in which we could incur a liability, have progressed sufficiently through discovery and/or the development of important factual information and legal issues to enable us to estimate a range of possible loss, if any, or such amounts are not material.
+Added: in Note 20, Contingencies and commitments, to the consolidated financial statements in our Annual Report on Form 10-K for the year ended December 31, 2023;
+Added: and in Note 13, Contingencies and commitments, to the condensed consolidated financial statements in our Quarterly Report on Form 10-Q for the period ended March 31, 2024, 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.
2 unchanged sentences
Patent Disputes in the International Region
−Removed: On February 29, 2024, in Amgen’s Nullity Action before the German Federal Patent Court seeking invalidation of Regeneron Pharmaceuticals, Inc.’s (Regeneron) European Patent No.
−Removed: 2,756,004 (the EP’004 Patent), the Federal Patent Court issued a preliminary opinion that the EP’004 Patent is likely to be invalid and scheduled the main hearing for November 25, 2025.
−Removed: European Patent Office
−Removed: On November 16, 2023 and February 29, 2024, Sanofi-Aventis and Regeneron each filed a notice of opposition against Amgen’s European Patent No.
−Removed: 3,666,797 before the European Patent Office’s Opposition Division.
−Removed: On February 29, 2024, Amgen filed a Notice of Opposition and Grounds of Opposition before the European Patent Office against Regeneron’s European Patent No.
+Added: On May 13, 2024, the Regional Court of Dusseldorf stayed the hearing on Sanofi Biotechnology SAS’ infringement action pending the outcome of Amgen’s Nullity Action against the European Patent No.
+Added: 2,756,004 before the German Federal Patent Court.
+Added: Unified Patent Court of the European Union
+Added: On July 16, 2024, the Central Division of the Unified Patent Court in Munich (UPC) rendered its decision on Sanofi-Aventis Deutschland GmbH’s action seeking revocation of Amgen’s European Patent 3,666,797 (the EP’797 Patent).
+Added: In its decision, the Court concluded that the patent claims are invalid and revoked the patent.
+Added: Subsequently, on July 29, 2024, the Local Division of the UPC stayed Amgen’s action against Sanofi-Aventis Deutschland GmbH, et al.
+Added: alleging that the importation, marketing, sale and use of PRALUENT ® infringes the EP’797 Patent.
Prolia/XGEVA Biologics Price Competition and Innovation Act (BPCIA) Litigation
−Removed: Sandoz Inc., et al.
−Removed: On April 29, 2024, the U.S.
−Removed: District Court for the District of New Jersey (the New Jersey District Court) entered judgment in the lawsuit pending against Sandoz Inc.
−Removed: based on Sandoz’s submission to the FDA of a Biologics License Application seeking approval to market and sell a biosimilar version of Amgen’s Prolia and XGEVA products (“Sandoz’s biosimilar denosumab products”).
−Removed: The complaint asserted infringement of patents listed in the FDA’s Purple Book for Amgen’s Prolia and XGEVA products.
−Removed: A preliminary injunction hearing, held between October 30 and December 21, 2023, focused on a composition of matter patent U.S.
−Removed: 7,364,736 (the ‘736 Patent) and two manufacturing patents.
−Removed: The judgment entered by the New Jersey District Court found the asserted claims of Amgen’s ‘736 Patent valid, enforceable and infringed by Sandoz’s biosimilar denosumab products and included an injunction prohibiting Sandoz and third parties acting on behalf of or in active concert with Sandoz from making, using, selling, or offering to sell in the United States or importing into the United States Sandoz’s biosimilar denosumab products before the expiry of the ’736 Patent on February 19, 2025, except as specifically authorized by a confidential settlement agreement.
−Removed: As a result of the settlement, the parties’ remaining claims and counterclaims related to the other asserted patents were dismissed with prejudice and Sandoz is permitted to launch the Sandoz biosimilar denosumab products in the United States on May 31, 2025, unless accelerated pursuant to the terms of a confidential settlement agreement, and subject to confidential financial terms stated therein.
+Added: Celltrion Inc., et al.
+Added: On May 28, 2024, Amgen Inc.
+Added: and Amgen Manufacturing Limited LLC filed a lawsuit in the U.S.
+Added: District Court for the District of New Jersey (New Jersey District Court) against Celltrion Inc.
+Added: and Celltrion USA, Inc.
+Added: (collectively, Celltrion) based on the submission to the FDA of a Biologics License Application (BLA) seeking approval to market and sell a biosimilar version of Amgen’s Prolia and XGEVA products.
+Added: The complaint asserts infringement of the following 29 patents:
+Added: and 11,952,605 (collectively, the Asserted Patents).
+Added: Amgen seeks a judgment from the New Jersey District Court that Celltrion has 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 Celltrion’s proposed denosumab biosimilar before expiration of each of the Asserted Patents found infringed.
+Added: Amgen also seeks monetary remedies for any past acts of infringement.
ABP 938 (aflibercept) Patent Litigation
−Removed: On April 11, 2024, the Judicial Panel on Multidistrict Litigation granted Regeneron’s motion to transfer Regeneron’s patent infringement lawsuit pending against Amgen in the U.S.
−Removed: District Court for the Central District of California to the U.S.
−Removed: District Court for the Northern District of West Virginia for coordinated and consolidated pretrial proceedings.
+Added: On June 7, 2024, Regeneron Pharmaceuticals, Inc.
+Added: (Regeneron) filed a motion for a preliminary injunction to prohibit Amgen from engaging in the manufacture, use, offer for sell or sale within the United States, or importation into the United States, of ABP 938 until resolution of this lawsuit or the entry of a permanent injunction, whichever comes first.
+Added: Regeneron’s motion focuses on U.S.
+Added: 11,084,865, a formulation patent.
+Added: On July 3, 2024, Amgen filed its opposition to Regeneron’s motion.
+Added: On July 24, 2024, Regeneron filed its reply brief.
+Added: Oral argument on Regeneron’s motion has been scheduled by the U.S.
+Added: District Court for the Northern District of West Virginia for August 13, 2024.
Antitrust Class Action
Sensipar Antitrust Class Actions
−Removed: On February 17, 2024, Amgen and the indirect purchasers filed a stipulation in the U.S.
−Removed: District Court for the District of Delaware (the Delaware District Court) to dismiss the indirect purchasers’ claims.
−Removed: On February 22, 2024, Amgen and the indirect purchasers filed a stipulation in the U.S.
−Removed: Court of Appeals for the Third Circuit (the Third Circuit Court) dismissing the portion of the Third Circuit Court’s appeal relating to the claims of the indirect purchasers.
−Removed: Amgen and the direct purchasers filed a stipulation on April 12, 2024 in the Delaware District Court, dismissing with prejudice the direct purchasers’ claims that were at issue in the appeal and seeking entry of final judgment in Amgen’s favor.
−Removed: On April 15, 2024, the Delaware District Court entered an order pursuant to the stipulation and closed the case.
−Removed: The direct purchasers retain a right to appeal the claims that were dismissed by the Delaware District Court on March 11, 2022.
+Added: On May 14, 2024, the putative class of direct purchasers of Sensipar (Sensipar Plaintiffs) appealed the claims that were dismissed with prejudice by the U.S.
+Added: District Court for the District of Delaware.
+Added: Court of Appeals for the Third Circuit has set a schedule for the Sensipar Plaintiffs to file their opening brief by September 9, 2024.
+Added: Amgen has until October 9, 2024 to file its response and the Sensipar Plaintiffs must file their reply by November 7, 2024.
+Added: Regeneron Pharmaceuticals, Inc.
+Added: Antitrust Action
+Added: On May 22, 2024, Amgen filed a motion for summary judgment.
Tax Litigation and Related Matters
2 unchanged sentences
See Note 4, Income taxes, for discussion of the IRS tax dispute and the Company’s petitions in the U.S.
+Added: Securities Class Action Litigation
+Added: On July 18, 2024, the U.S.
+Added: District Court for the Southern District of New York held a hearing on Amgen’s motion to dismiss.
ChemoCentryx, Inc.
Securities Matters
−Removed: On March 6, 2024, the U.S.
−Removed: District Court for the Northern District of California certified a class of all persons who purchased or otherwise acquired the common stock of ChemoCentryx between November 26, 2019 and May 6, 2021.
+Added: On May 24, 2024, the United States Court of Appeals for the Ninth Circuit denied ChemoCentryx’s petition to appeal the class certification order.
Trial is scheduled to begin on September 22, 2025.
−Removed: On March 20, 2024, ChemoCentryx filed a petition with the U.S.
−Removed: Court of Appeals for the Ninth Circuit, seeking permission to have the district court’s order on class certification heard on appeal.
−Removed: The lead plaintiff’s response to ChemoCentryx’s petition was submitted on April 2, 2024.
+Added: While the U.S.
+Added: District Court for the Northern District of California (Northern District Court of California) has not yet set a deadline by which members of the class must opt out, on May 2, 2024, RA Capital Healthcare Fund, LP filed two similar securities cases, in the California Superior Court in Ventura County and in the Northern District Court of California, against ChemoCentryx and its former Chief Executive Officer, Dr.
+Added: Thomas Schall.
+Added: On July 2, 2024, the state court stayed the case pending an order on summary judgment in the federal class action.
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.