What changed in this filing

/stocks — the workspaceLOADING

Item 1. Financial Statements

2023-08-04 compared with 2023-04-28 · 247 added, 155 removed, 674 unchanged (37% of the section changed)

3 unchanged sentences

Three months ended

June 30, Six months ended

2023 2022 2023 2022

Product sales $ 6,683 $ 6,281 $ 12,529 $ 12,012

10 unchanged sentences

Interest expense, net ( 752 ) ( 328 ) ( 1,295 ) ( 623 )

Other income (expense), net 2,064 ( 530 )

Other (expense) income, net ( 318 ) ( 317 ) 1,746 ( 847 )

Income before income taxes 1,614 1,531 5,056 3,206

11 unchanged sentences

Three months ended

June 30, Six months ended

2023 2022 2023 2022

Net income $ 1,379 $ 1,317 $ 4,220 $ 2,793

2 unchanged sentences

Cash flow hedges ( 22 ) 156 ( 108 ) 240

Other ( 1 ) — 20 —

Other comprehensive (loss) income, net of reclassification adjustments and taxes ( 12 ) 91 ( 49 ) 124

3 unchanged sentences

(In millions, except per-share data)

March 31, 2023 December 31, 2022

June 30, 2023 December 31, 2022

Current assets:

50 unchanged sentences

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 the Company’s 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

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY (continued)

(In millions, except per-share data)

paid-in capital Accumulated

15 unchanged sentences

534.2 31,247 ( 29,568 ) ( 763 ) 916

Net income — — 1,317 — 1,317

Other comprehensive income, net of taxes — — — 91 91

Issuance of common stock in connection with the Company’s equity award programs

0.7 45 — — 45

Stock-based compensation expense — 120 — — 120

Tax impact related to employee stock-based compensation expense

— ( 69 ) — — ( 69 )

Other — — ( 1 ) — ( 1 )

Balance as of June 30, 2022

534.9 $ 31,343 $ ( 28,252 ) $ ( 672 ) $ 2,419

See accompanying notes.

1 unchanged sentence

(In millions)

Three months ended

Six months ended

Cash flows from operating activities:

3 unchanged sentences

Adjustments for equity method investments ( 3 ) 497

Loss on divestiture — 560

(Gains) losses on equity securities ( 1,169 ) 322

10 unchanged sentences

Cash flows from investing activities:

Purchases of marketable securities — ( 1,976 )

Proceeds from sales of marketable securities 1,125 —

15 unchanged sentences

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

March 31, 2023

June 30, 2023

Summary of significant accounting policies

3 unchanged sentences

Basis of presentation

The financial information for the three months ended March 31, 2023 and 2022, is unaudited but includes all adjustments (consisting of only normal, recurring adjustments unless otherwise indicated), which Amgen considers necessary for a fair presentation of its condensed consolidated results of operations for those periods.

The financial information for the three and six months ended June 30, 2023 and 2022, is unaudited but includes all adjustments (consisting of only normal, recurring adjustments unless otherwise indicated), which Amgen considers necessary for a fair presentation of its condensed consolidated results of operations for those periods.

Interim results are not necessarily indicative of results for the full fiscal year.

The condensed consolidated financial statements should be read in conjunction with our consolidated financial statements and the notes thereto contained in our Annual Report on Form 10-K for the year ended December 31, 2022, and with our condensed consolidated financial statements and the notes thereto contained in our Quarterly Report on Form 10-Q for the period ended March 31, 2023.

Principles of consolidation

7 unchanged sentences

Property, plant and equipment, net

Property, plant and equipment is recorded at historical cost, net of accumulated depreciation and amortization, of $ 9.4 billion and $ 9.3 billion as of March 31, 2023 and December 31, 2022, respectively.

Property, plant and equipment is recorded at historical cost, net of accumulated depreciation and amortization, of $ 9.5 billion and $ 9.3 billion as of June 30, 2023 and December 31, 2022, respectively.

Recent accounting pronouncements

No new accounting pronouncements were issued or adopted for the three months ended March 31, 2023, that materially impacted the Company.

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

Restructuring

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As part of the plan, we are reallocating resources to the areas of the business that will enable long-term growth.

We estimate that we will incur $ 300 million to $ 400 million of pretax charges in 2023 in connection with our restructuring plan, including (i) separation and other headcount-related costs with respect to staff reductions and (ii) asset-related charges that consist primarily of asset impairments, accelerated depreciation and other related costs resulting from the rationalization of our geographic footprint.

During the three months ended March 31, 2023, we incurred total separation and other headcount-related costs of $ 141 million recorded in Other operating expenses in the Condensed Consolidated Statements of Income and asset-related and other charges of $ 38 million, consisting primarily of asset-related impairments recorded in Cost of sales in the Condensed Consolidated Statements of Income.

As of March 31, 2023, the total restructuring liability of $ 132 million was included in Accrued liabilities in the Condensed Consolidated Balance Sheets.

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

Three months ended June 30, 2023

Separation costs Asset impairments and other charges Total

Cost of sales $ — $ — $ —

Research and development — 17 17

Other 25 — 25

Total $ 25 $ 17 $ 42

Six months ended June 30, 2023

Separation costs Asset impairments and other charges Total

Cost of sales $ — $ 35 $ 35

Research and development — 17 17

Other 166 3 169

Total $ 166 $ 55 $ 221

As of June 30, 2023, total restructuring liability decreased to $ 82 million primarily due to payments related to separation costs.

The total restructuring liability was included in Accrued liabilities in the Condensed Consolidated Balance Sheets.

Acquisitions and divestitures

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Horizon has 12 marketed medicines and a pipeline with more than 20 development programs.

The closing of this transaction is contingent upon satisfaction of certain regulatory (including FTC review) and other customary closing conditions.

On January 30, 2023, the Company and Horizon each received a request for additional information and documentary materials (Second Request) from the FTC in connection with the FTC’s review of the Company’s proposed acquisition of Horizon.

We and Horizon have been working cooperatively with the FTC and will continue to do so.

Additionally, the Irish High Court set a court hearing date of May 22, 2023, to consider the application to sanction our proposed acquisition of Horizon.

The Irish High Court will be informed in advance if the hearing date needs to be adjourned to a later date as a result of a condition to closing, including required regulatory clearances, not having been satisfied by the scheduled hearing date.

In May 2023, the FTC filed a complaint in the U.S.

District Court for the Northern District of Illinois seeking a temporary restraining order and preliminary injunction enjoining our proposed acquisition of Horizon.

See Note 14, Contingencies and commitments.

In connection with our proposed acquisition of Horizon, we entered into several debt and financing arrangements.

1 unchanged sentence

Acquisition of ChemoCentryx, Inc.

On October 20, 2022, we acquired all the outstanding stock of ChemoCentryx, a publicly traded biotechnology company focused on orally-administered therapeutics to treat autoimmune diseases, inflammatory disorders and cancer, for $ 52.00 per share in cash, representing a total consideration of $ 3.9 billion.

On October 20, 2022, we acquired all of the outstanding stock of ChemoCentryx, a publicly traded biotechnology company focused on orally administered therapeutics to treat autoimmune diseases, inflammatory disorders and cancer, for $ 52.00 per share in cash, representing a total consideration of $ 3.9 billion.

The acquisition, which was accounted for as a business combination, includes TAVNEOS, an orally administered selective complement 5a receptor inhibitor that was approved by the FDA in October 2021 as an adjunctive therapy for adults with severe active anti-neutrophil cytoplasmic autoantibody-associated vasculitis (ANCA-associated vasculitis).

TAVNEOS is commercialized by us in the United States;

for markets outside the United States, TAVNEOS is commercialized by a collaboration partner, and Amgen is entitled to royalties and milestones based off future sales of the product.

Upon its acquisition, ChemoCentryx became a wholly owned subsidiary of Amgen, and its operations have been included in our consolidated financial statements commencing on the acquisition date.

Measurement period adjustments during the three months ended March 31, 2023, included changes to the purchase price allocation and total consideration, resulting in a net decrease of approximately $ 4 million to goodwill.

for markets outside the United States, TAVNEOS is commercialized by a collaboration partner, and Amgen is entitled to royalties and milestones based on future sales of the product.

Upon its acquisition, ChemoCentryx became a wholly owned subsidiary of Amgen, and its operations became included in our consolidated financial statements commencing on the acquisition date.

Measurement period adjustments during the six months ended June 30, 2023, included changes in the purchase price allocation and total consideration, resulting in a net decrease of approximately $ 4 million to goodwill.

The measurement period adjustments resulted primarily from valuation inputs pertaining to the TAVNEOS intangible assets and adjustments to vendor payables based on facts and circumstances that existed as of the acquisition date and did not result from events subsequent to the acquisition date.

The adjustments did not have a significant impact on Amgen’s results of operations during the three months ended March 31, 2023, and would not have had a significant impact on prior-period results if the adjustments had been made as of the acquisition date.

The adjustments did not have a significant impact on Amgen’s results of operations during the six months ended June 30, 2023, and would not have had a significant impact on prior-period results if the adjustments had been made as of the acquisition date.

The following table summarizes the total consideration and allocated acquisition date fair values of assets acquired and liabilities assumed, inclusive of measurement period adjustments (in millions):

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

The developed-product-technology rights acquired relates to TAVNEOS, which is approved in the United States and European Union for ANCA-associated vasculitis.

The developed-product-technology rights acquired relates to TAVNEOS, which is approved in the United States and the EU for ANCA-associated vasculitis.

The estimated fair values of $ 3.5 billion were determined by using a multi-period excess earnings income approach that discounts expected future cash flows to present value by applying a discount rate that represents the estimated rate that market participants would use to value the intangible assets.

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Revenues were as follows (in millions):

Three months ended March 31,

Three months ended June 30,

ROW Total U.S.

4 unchanged sentences

Repatha 212 212 424 154 171 325

Nplate 246 116 362 156 110 266

Aranesp 123 242 365 132 225 357

KYPROLIS 234 112 346 213 104 317

Nplate 176 134 310 156 128 284

EVENITY 192 89 281 130 61 191

Other products (1)

1,171 560 1,731 1,136 571 1,707

Total product sales (2)

$ 4,736 $ 1,947 6,683 $ 4,446 $ 1,835 6,281

Other revenues 303 313

Total revenues $ 6,986 $ 6,594

Six months ended June 30,

ROW Total U.S.

Prolia $ 1,314 $ 641 $ 1,955 $ 1,193 $ 581 $ 1,774

ENBREL 1,619 28 1,647 1,879 34 1,913

XGEVA 771 295 1,066 759 276 1,035

Otezla 789 203 992 837 208 1,045

Repatha 409 403 812 319 335 654

Aranesp 238 482 720 269 446 715

KYPROLIS 468 236 704 409 195 604

Nplate 422 250 672 312 238 550

EVENITY 356 179 535 240 121 361

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

(2) Hedging gains and losses, which are included in product sales, were not material for the three months ended March 31, 2023 and 2022.

The effective tax rates for the three months ended March 31, 2023 and 2022, were 17.5 % and 11.9 %, respectively.

The increase in our effective tax rate for the three months ended March 31, 2023, was primarily due to the new Puerto Rico income tax beginning in 2023 and an increase in interest expense on tax reserves.

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

The effective tax rates for the three and six months ended June 30, 2023, were 14.6 % and 16.5 %, respectively, compared with 14.0 % and 12.9 %, respectively, for the corresponding periods in the prior year.

The increase in our effective tax rate for the three months ended June 30, 2023, was primarily due to the new Puerto Rico income tax beginning in 2023, partially offset by the current period change in the fair value of our equity investments and net favorable items.

The increase in our effective tax rate for the six months ended June 30, 2023, was primarily due to the new Puerto Rico income tax beginning in 2023, current year change in the fair value of our equity investments and an increase in interest expense on tax reserves, partially offset by net favorable items.

The effective tax rates differ from the federal statutory rate primarily as a result of foreign earnings from the Company’s operations conducted in Puerto Rico, a territory of the United States treated as a foreign jurisdiction for U.S.

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

During the three months ended March 31, 2023, the gross amounts of our UTBs increased by $ 60 million as a result of tax positions taken during the current year.

Substantially all of the UTBs as of March 31, 2023, if recognized, would affect our effective tax rate.

During the three and six months ended June 30, 2023, the gross amounts of our UTBs increased by $ 50 million and $ 110 million, respectively, as a result of tax positions taken during the current year.

Substantially all of the UTBs as of June 30, 2023, if recognized, would affect our effective tax rate.

Earnings per share

3 unchanged sentences

Three months ended

June 30, Six months ended

2023 2022 2023 2022

Income (Numerator):

6 unchanged sentences

Diluted EPS $ 2.57 $ 2.45 $ 7.86 $ 5.13

For the three months ended March 31, 2023 and 2022, the number of antidilutive employee stock-based awards excluded from the computation of diluted EPS was not significant.

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

Available-for-sale investments

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

Types of securities as of March 31, 2023 Amortized

Types of securities as of June 30, 2023 Amortized

Treasury bills $ — $ — $ — $ —

Money market mutual funds 33,618 — — 33,618

Other short-term interest-bearing securities 1 — — 1

Total interest-bearing securities $ 33,618 $ — $ — $ 33,618

2 unchanged sentences

Money market mutual funds 2,659 — — 2,659

Other short-term interest-bearing securities — — — —

Total interest-bearing securities $ 4,335 $ — $ — $ 4,335

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

Condensed Consolidated Balance Sheets locations March 31, 2023 December 31, 2022

Condensed Consolidated Balance Sheets locations June 30, 2023 December 31, 2022

Cash and cash equivalents $ 33,618 $ 2,659

1 unchanged sentence

Total interest-bearing securities $ 33,618 $ 4,335

Cash and cash equivalents in the above table excludes bank account cash of $ 496 million and $ 4,970 million as of March 31, 2023 and December 31, 2022, respectively.

Cash and cash equivalents as of March 31, 2023 was $ 31.6 billion, of which $ 27.8 billion is anticipated to be used for the proposed acquisition of Horizon.

Cash and cash equivalents in the above table excludes bank account cash of $ 630 million and $ 4,970 million as of June 30, 2023 and December 31, 2022, respectively.

Cash and cash equivalents as of June 30, 2023 was $ 34.2 billion, of which $ 27.8 billion is anticipated to be used for the proposed acquisition of Horizon.

See Note 3, Acquisitions and divestitures.

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

For the three months ended March 31, 2023 and 2022, realized gains and losses on interest-bearing securities were not material.

Realized gains and losses on interest-bearing securities are recorded in Other income (expense), net, in the Condensed Consolidated Statements of Income.

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

For the three and six months ended June 30, 2023 and 2022, realized gains and losses on interest-bearing securities were not material.

Realized gains and losses on interest-bearing securities are recorded in Other (expense) income, net, in the Condensed Consolidated Statements of Income.

The cost of securities sold is based on the specific-identification method.

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We no longer have the ability to exert significant influence over BeiGene.

As a result, in the first quarter of 2023, we began to account for our ownership interest as an equity security with a readily determinable fair value, with changes in fair value recorded in Other income (expense), net.

See Note 12, Fair value measurement.

During the three months ended March 31, 2023, we recognized a net unrealized gain of $ 1.9 billion recorded to Other income (expense), net, in our Condensed Consolidated Statements of Income.

As of March 31, 2023, the carrying and fair value of our investment in BeiGene was $ 4.1 billion and was included in Other noncurrent assets in the Condensed Consolidated Balance Sheets.

During the three and six months ended June 30, 2023, we recognized an unrealized loss of $ 705 million and an unrealized gain of $ 1.2 billion, respectively, recorded in Other (expense) income, net, in our Condensed Consolidated Statements of Income.

As of June 30, 2023, the carrying and fair value of our investment in BeiGene was $ 3.4 billion and was included in Other noncurrent assets in the Condensed Consolidated Balance Sheets.

As of December 31, 2022, under the equity method of accounting, the carrying value of our investment in BeiGene was $ 2.2 billion and was included in Other noncurrent assets in the Condensed Consolidated Balance Sheets, and our ownership percentage was 18.2 %.

During the three months ended March 31, 2022, under the equity method of accounting, our carrying value in BeiGene was adjusted by our share of BeiGene’s net losses of $ 108 million and amortization of the basis difference of $ 47 million.

During the three and six months ended June 30, 2022, under the equity method of accounting, our carrying value in BeiGene was adjusted by our share of BeiGene’s net losses of $ 80 million and $ 188 million, respectively, and amortization of the basis difference of $ 48 million and $ 95 million, respectively, recorded in Other (expense) income, net, in our Condensed Consolidated Statements of Income.

Other equity securities

Excluding our equity investment in BeiGene, we held investments in other equity securities with readily determinable fair values (publicly traded securities) of $ 462 million and $ 480 million as of March 31, 2023 and December 31, 2022, respectively, which are included in Other noncurrent assets in the Condensed Consolidated Balance Sheets.

During the three months ended March 31, 2023 and 2022, net unrealized gains and losses on these publicly traded securities were a gain of $ 5 million and a loss of $ 170 million, respectively.

Realized gains and losses on sales of publicly traded securities for the three months ended March 31, 2023 and 2022, were not material.

We held investments of $ 250 million and $ 233 million in equity securities without readily determinable fair values as of March 31, 2023 and December 31, 2022, respectively, which are included in Other noncurrent assets in the Condensed Consolidated Balance Sheets.

During the three months ended March 31, 2023 and 2022, upward and downward adjustments on these securities were not material.

Excluding our equity investment in BeiGene, we held investments in other equity securities with readily determinable fair values (publicly traded securities) of $ 397 million and $ 480 million as of June 30, 2023 and December 31, 2022, respectively, which are included in Other noncurrent assets in the Condensed Consolidated Balance Sheets.

During the three months ended June 30, 2023 and 2022, net unrealized gains and losses on these publicly traded securities were a gain of $ 3 million and a loss of $ 106 million, respectively.

During the six months ended June 30, 2023 and 2022, net unrealized gains and losses on these publicly traded securities were a net gain of $ 8 million and a net loss of $ 276 million, respectively.

Realized gains and losses on sales of publicly traded securities for the three and six months ended June 30, 2023 and 2022, were not material.

We held investments of $ 291 million and $ 233 million in equity securities without readily determinable fair values as of June 30, 2023 and December 31, 2022, respectively, which are included in Other noncurrent assets in the Condensed Consolidated Balance Sheets.

During the three and six months ended June 30, 2023 and 2022, upward and downward adjustments on these securities were not material.

Adjustments were based on observable price transactions.

3 unchanged sentences

Although our equity investment provides us with the ability to exercise significant influence over Neumora, we have elected the fair value option to account for our equity investment.

Under the fair value option, changes in the fair value of the investment are recognized through earnings each reporting period.

Under the fair value option, changes in the fair value of the investment are recognized through earnings in Other (expense) income, net, in our Condensed Consolidated Statements of Income each reporting period.

We believe the fair value option best reflects the economics of the underlying transaction.

As of March 31, 2023 and December 31, 2022, our ownership interest in Neumora was approximately 24.5 % and 24.9 %, respectively, and the fair values of our investment were $ 288 million and $ 335 million, respectively.

Accordingly, during the three months ended March 31, 2023 and 2022, we recognized a loss of $ 47 million and $ 50 million, respectively, in Other income (expense), net, in the Condensed Consolidated Statements of Income.

As of June 30, 2023 and December 31, 2022, our ownership interest in Neumora was approximately 24.5 % and 24.9 %, respectively, and the fair values of our investment were $ 316 million and $ 335 million, respectively.

During the three months ended June 30, 2023 and 2022, we recognized a gain of $ 28 million and a loss of $ 39 million, respectively, and during the six months ended June 30, 2023 and 2022, we recognized losses of $ 19 million and $ 89 million, respectively.

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

Limited partnerships

We held limited partnership investments of $ 268 million and $ 249 million as of March 31, 2023 and December 31, 2022, respectively, which are included in Other noncurrent assets in the Condensed Consolidated Balance Sheets.

We held limited partnership investments of $ 226 million and $ 249 million as of June 30, 2023 and December 31, 2022, respectively, which are included in Other noncurrent assets in the Condensed Consolidated Balance Sheets.

These investments, primarily investment funds of early-stage biotechnology companies, are accounted for by using the equity method of accounting and are measured by using our proportionate share of the net asset values of the underlying investments held by the limited partnerships as a practical expedient.

These investments are typically redeemable only through distributions upon liquidation of the underlying assets.

As of March 31, 2023, unfunded additional commitments to be made for these investments during the next several years were $ 160 million.

For the three months ended March 31, 2023 and 2022, we recognized net gains of $ 20 million and net losses of $ 160 million, respectively, in Other income (expense), net, in the Condensed Consolidated Statements of Income on these investments.

As of June 30, 2023, unfunded additional commitments to be made for these investments during the next several years amounted to $ 157 million.

For the three months ended June 30, 2023 and 2022, net unrealized losses from our limited partnership investments were $ 29 million and $ 60 million, respectively.

For the six months ended June 30, 2023 and 2022, net unrealized losses from our limited partnership investments were $ 9 million and $ 220 million, respectively.

Inventories consisted of the following (in millions):

March 31, 2023 December 31, 2022

June 30, 2023 December 31, 2022

Raw materials $ 855 $ 828

4 unchanged sentences

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

Three months ended

March 31, 2023

Six months ended

June 30, 2023

Beginning balance $ 15,529

2 unchanged sentences

Ending balance $ 15,531

(1) For the three months ended March 31, 2023, adjustments to goodwill consisted of a measurement period adjustment related to our acquisition of ChemoCentryx.

See Note 3, Acquisitions and divestitures.

Other intangible assets

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

March 31, 2023 December 31, 2022

June 30, 2023 December 31, 2022

amounts Accumulated

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We review IPR&D projects for impairment annually, whenever events or changes in circumstances indicate that the carrying amounts may not be recoverable and upon the establishment of technological feasibility or regulatory approval.

During the three months ended March 31, 2023 and 2022, we recognized amortization associated with our finite-lived intangible assets of $ 693 million and $ 637 million, respectively.

During the three months ended June 30, 2023 and 2022, we recognized amortization associated with our finite-lived intangible assets of $ 693 million and $ 629 million, respectively.

During the six months ended June 30, 2023 and 2022, we recognized amortization associated with our finite-lived intangible assets of $ 1.4 billion and $ 1.3 billion, respectively.

Amortization of intangible assets is primarily included in Cost of sales in the Condensed Consolidated Statements of Income.

The total estimated amortization of our finite-lived intangible assets for the remaining nine months ending December 31, 2023, and the years ending December 31, 2024, 2025, 2026, 2027 and 2028, are $ 2.1 billion, $ 2.7 billion, $ 2.5 billion, $ 2.2 billion, $ 2.1 billion and $ 1.1 billion, respectively.

The total estimated amortization of our finite-lived intangible assets for the remaining six months ending December 31, 2023, and the years ending December 31, 2024, 2025, 2026, 2027 and 2028, are $ 1.4 billion, $ 2.7 billion, $ 2.5 billion, $ 2.1 billion, $ 2.1 billion and $ 1.1 billion, respectively.

Financing arrangements

Our borrowings consisted of the following (in millions):

March 31, 2023 December 31, 2022

June 30, 2023 December 31, 2022

0.41 % CHF 700 million bonds due 2023 (0.41% 2023 Swiss franc Bonds)

43 unchanged sentences

4.40 % notes due 2062 (4.40% 2062 Notes)

March 31, 2023 December 31, 2022

June 30, 2023 December 31, 2022

5.75 % notes due 2063 (5.75% 2063 Notes)

18 unchanged sentences

Total $ 24,000

If the consummation of the proposed acquisition of Horizon does not occur on or before the later of:

(i) January 31, 2024, or such later date to which the agreement to acquire Horizon (Transaction Agreement) may be extended in accordance with its terms, (ii) the Transaction Agreement is terminated, or (iii) we otherwise notify the trustee of the notes that consummation of the acquisition will not be pursued, we will be required to redeem each series of notes, other than the 5.75 % 2063 Notes, at a price equal to 101 % of the principal amount of the notes plus accrued and unpaid interest.

In the event of a change-in-control triggering event, as defined in the terms of the notes, we may be required to purchase all or a portion of these notes at a price equal to 101 % of the principal amount of the notes plus accrued and unpaid interest.

If consummation of the proposed acquisition of Horizon does not occur on or before the later of (i) January 31, 2024, or such later date to which the agreement to acquire Horizon (Transaction Agreement) may be extended in accordance with its terms, (ii) the Transaction Agreement is terminated, or (iii) we otherwise notify the trustee of the notes that consummation of the acquisition will not be pursued, we will be required to redeem each series of notes, other than the 5.75 % 2063 Notes, at a price equal to 101 % of the principal amount of the notes plus accrued and unpaid interest.

In the event of a change-in-control triggering event, as defined by the terms of the notes, we may be required to purchase all or a portion of these notes at a price equal to 101 % of the principal amount of the notes plus accrued and unpaid interest.

In addition, these notes may be redeemed at any time at our option, in whole or in part, at the principal amount of the notes being redeemed plus accrued and unpaid interest and a make-whole amount, which are defined by the terms of the notes.

3 unchanged sentences

Subsequent to our March 2023 debt issuance described above, we terminated the bridge credit agreement.

Accordingly, during the three months ended March 31, 2023, we recognized $ 98 million of financing cost associated with the bridge credit agreement, primarily in Other income (expense), net, in the Condensed Consolidated Statements of Income.

Accordingly, during the three months ended March 31, 2023, we recognized $ 98 million of financing cost associated with the bridge credit agreement, primarily in Other (expense) income, net, in the Condensed Consolidated Statements of Income.

Also in connection with the proposed acquisition of Horizon, we entered into a $ 4.0 billion term loan credit agreement in December 2022.

No amounts under this agreement were outstanding as of March 31, 2023 and December 31, 2022.

No amounts under this agreement were outstanding as of June 30, 2023 and December 31, 2022.

Debt extinguishment

During the three months ended March 31, 2023, we repurchased portions of the 2.00 % 2032 Notes, 3.15 % 2040 Notes, 2.80 % 2041 Notes, 3.375 % 2050 Notes, 3.00 % 2052 Notes, 4.20 % 2052 Notes and 4.40 % 2062 Notes for an aggregate cost of $ 420 million, which resulted in the recognition of a $ 113 million gain on extinguishment of debt recorded in Other income (expense), net, in the Condensed Consolidated Statements of Income.

During the three months ended March 31, 2023, we repurchased portions of the 2.00 % 2032 Notes, 3.15 % 2040 Notes, 2.80 % 2041 Notes, 3.375 % 2050 Notes, 3.00 % 2052 Notes, 4.20 % 2052 Notes and 4.40 % 2062 Notes for an aggregate cost of $ 420 million, which resulted in the recognition of a $ 113 million gain on extinguishment of debt recorded in Other (expense) income, net, in the Condensed Consolidated Statements of Income.

Debt repayments

17 unchanged sentences

Generally, we would be charged interest for any amounts borrowed under this facility, based on our current credit rating, at (i) SOFR plus 1.01 % or (ii) the highest of (A) the administrative agent bank base commercial lending rate, (B) the overnight federal funds rate plus 0.50 % or (C) one-month SOFR plus 1.1 %.

As of March 31, 2023 and December 31, 2022, no amounts were outstanding under this facility.

As of June 30, 2023 and December 31, 2022, no amounts were outstanding under this facility.

Stockholders’ equity

3 unchanged sentences

First quarter — $ — 24.6 $ 5,410

As of March 31, 2023, $ 7.0 billion of authorization remained available under our stock repurchase program.

In March 2023, the Board of Directors declared a quarterly cash dividend of $ 2.13 per share, which will be paid in June 2023.

In December 2022, the Board of Directors declared a quarterly cash dividend of $ 2.13 per share, which was paid in March 2023.

Second quarter — — — —

Total stock repurchases — $ — 24.6 $ 5,410

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

In March 2023 and December 2022, our Board of Directors declared quarterly cash dividends of $ 2.13 per share, which were paid in June 2023 and March 2023, respectively.

In August 2023, our Board of Directors declared a quarterly cash dividend of $ 2.13 per share that will be paid in September 2023.

Accumulated other comprehensive income (loss)

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( 320 ) 42 10 ( 268 )

Foreign currency translation adjustments 11 — — 11

Unrealized gains — 50 — 50

Reclassification adjustments to income — ( 87 ) — ( 87 )

Other — — ( 1 ) ( 1 )

Income taxes — 15 — 15

Balance as of June 30, 2023

$ ( 309 ) $ 20 $ 9 $ ( 280 )

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

Three months ended March 31,

Three months ended June 30,

Components of AOCI 2023 2022 Condensed Consolidated

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Foreign currency contract gains $ 36 $ 53 Product sales

Cross-currency swap contract losses ( 22 ) ( 78 ) Other income (expense), net

Cross-currency swap contract gains (losses) 51 ( 185 ) Other (expense) income, net

87 ( 132 ) Income before income taxes

1 unchanged sentence

$ 68 $ ( 104 ) Net income

Six months ended June 30,

Components of AOCI 2023 2022 Condensed Consolidated

Statements of Income locations

Cash flow hedges:

Foreign currency contract gains $ 88 $ 80 Product sales

Cross-currency swap contract gains (losses) 29 ( 263 ) Other (expense) income, net

117 ( 183 ) Income before income taxes

( 25 ) 39 Provision for income taxes

$ 92 $ ( 144 ) Net income

Fair value measurement

17 unchanged sentences

(Level 2) Significant

Fair value measurement as of March 31, 2023, using:

Fair value measurement as of June 30, 2023, using:

Available-for-sale securities:

1 unchanged sentence

Money market mutual funds 33,618 — — 33,618

Other short-term interest-bearing securities — 1 — 1

Other investments — 137 — 137

Equity securities

3,775 — 316 4,091

Foreign currency forward contracts — 251 — 251

17 unchanged sentences

Money market mutual funds 2,659 — — 2,659

Other short-term interest-bearing securities — — — —

Other investments — 130 — 130

11 unchanged sentences

The fair values of our U.S.

Treasury securities, money market mutual funds and equity investments in publicly traded securities, including our equity investment in BeiGene as of March 31, 2023, are based on quoted market prices in active markets, with no valuation adjustment.

Treasury securities, money market mutual funds and equity investments in publicly traded securities, including our equity investment in BeiGene as of June 30, 2023, are based on quoted market prices in active markets, with no valuation adjustment.

Other investments consist of interest-bearing deposits that are valued at amortized cost, which approximates fair value given their near-term maturity.

The fair value of equity securities without readily determinable fair values is initially valued at the transaction price and subsequently valued based on a combination of observable price transactions when available, market performance and publicly available market information for similar companies that have actively traded equity securities.

The fair values of equity securities without readily determinable fair values are initially valued at the transaction prices and subsequently valued based on a combination of observable price transactions when available, market performance and publicly available market information for similar companies that have actively traded equity securities.

See Note 7, Investments— Neumora Therapeutics, Inc.

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We estimate the fair values of these contracts by taking into consideration valuations obtained from a third-party valuation service that uses an income-based industry-standard valuation model for which all significant inputs are observable either directly or indirectly.

These inputs, as applicable, include foreign currency exchange rates, LIBOR, swap rates, obligor credit default swap rates and cross-currency basis swap spreads.

These inputs, as applicable, include foreign currency exchange rates, LIBOR, SOFR, swap rates, obligor credit default swap rates and cross-currency basis swap spreads.

Certain inputs, when applicable, are at commonly quoted intervals.

Starting in the third quarter of 2023, terms under our existing derivative contracts will reference the SOFR benchmark consistent with the ISDA protocol.

See Note 13, Derivative instruments.

8 unchanged sentences

Three months ended

June 30, Six months ended

2023 2022 2023 2022

Beginning balance $ 273 $ 330 $ 270 $ 342

2 unchanged sentences

Ending balance $ 248 $ 310 $ 248 $ 310

As of March 31, 2023 and December 31, 2022, 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 up to $ 1.6 billion upon achieving separate development and regulatory milestones with regard to various R&D programs.

As of June 30, 2023 and December 31, 2022, our contingent consideration obligations are primarily the result of our acquisition of Teneobio, in October 2021, which obligates us to pay the former shareholders up to $ 1.6 billion upon achieving separate development and regulatory milestones with regard to various R&D programs.

Summary of the fair values of other financial instruments

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We estimated the fair values of our borrowings by using Level 2 inputs.

As of March 31, 2023 and December 31, 2022, the aggregate fair values of our borrowings were $ 59.8 billion and $ 35.0 billion, respectively, and the carrying values were $ 61.6 billion and $ 38.9 billion, respectively.

During the three months ended March 31, 2023 and 2022, there were no transfers of assets or liabilities between fair value measurement levels, and there were no material remeasurements to the fair values of assets and liabilities that are not measured at fair value on a recurring basis.

As of June 30, 2023 and December 31, 2022, the aggregate fair values of our borrowings were $ 59.1 billion and $ 35.0 billion, respectively, and the carrying values were $ 61.5 billion and $ 38.9 billion, respectively.

During the six months ended June 30, 2023 and 2022, there were no transfers of assets or liabilities between fair value measurement levels, and there were no material remeasurements to the fair values of assets and liabilities that are not measured at fair value on a recurring basis.

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.

As of March 31, 2023 and December 31, 2022, we had outstanding foreign currency forward contracts with aggregate notional amounts of $ 6.1 billion and $ 6.0 billion, respectively.

As of June 30, 2023 and December 31, 2022, we had outstanding foreign currency forward contracts with aggregate notional amounts of $ 6.1 billion and $ 6.0 billion, respectively.

We have designated these foreign currency forward contracts, which are primarily euro based, as cash flow hedges.

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We have designated these cross-currency swap contracts as cash flow hedges.

Accordingly, the unrealized gains and losses on these contracts are reported in AOCI in the Condensed Consolidated Balance Sheets and reclassified to Other income (expense), net, in the Condensed Consolidated Statements of Income in the same periods during which the hedged debt affects earnings.

The notional amounts and interest rates of our cross-currency swaps as of March 31, 2023, were as follows (notional amounts in millions):

Accordingly, the unrealized gains and losses on these contracts are reported in AOCI in the Condensed Consolidated Balance Sheets and reclassified to Other (expense) income, net, in the Condensed Consolidated Statements of Income in the same periods during which the hedged debt affects earnings.

The notional amounts and interest rates of our cross-currency swaps as of June 30, 2023, were as follows (notional amounts in millions):

Foreign currency U.S.

6 unchanged sentences

Gains 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.

Amounts recognized in connection with forward interest rate contracts during the three months ended March 31, 2023, and amounts expected to be recognized during the subsequent 12 months, are not material.

Amounts recognized in connection with forward interest rate contracts during the six months ended June 30, 2023, and amounts expected to be recognized during the subsequent 12 months are not material.

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

Three months ended

June 30, Six months ended

Derivatives in cash flow hedging relationships 2023 2022 2023 2022

2 unchanged sentences

Forward interest rate contracts — — ( 31 ) —

Total unrealized (losses) gains $ ( 71 ) $ 56

Total unrealized gains (losses) $ 50 $ 67 $ ( 21 ) $ 123

Fair value hedges

To achieve a desired mix of fixed-rate and floating-rate debt, we entered into interest rate swap contracts that qualified for and were designated as fair value hedges.

These interest rate swap contracts effectively convert fixed-rate coupons to floating-rate LIBOR-based coupons over the terms of the related hedge contracts.

As of March 31, 2023 and December 31, 2022, we had interest rate swap contracts with aggregate notional amounts of $ 6.7 billion that hedge certain portions of our long-term debt issuances.

These interest rate swap contracts effectively convert fixed-rate coupons to floating-rate coupons over the terms of the related hedge contracts.

As of both June 30, 2023 and December 31, 2022, we had interest rate swap contracts with aggregate notional amounts of $ 6.7 billion that hedge certain portions of our long-term debt issuances.

For interest rate swap contracts that qualify for and are designated as fair value hedges, we recognize in Interest expense, net, in the Condensed Consolidated Statements of Income the unrealized gain or loss on the derivative resulting from the change in fair value during the period, as well as the offsetting unrealized loss or gain of the hedged item resulting from the change in fair value during the period attributable to the hedged risk.

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Cumulative amounts of fair value hedging adjustments related to the carrying amounts of the hedged liabilities (2)

Condensed Consolidated Balance Sheets locations March 31, 2023 December 31, 2022 March 31, 2023 December 31, 2022

Condensed Consolidated Balance Sheets locations June 30, 2023 December 31, 2022 June 30, 2023 December 31, 2022

Current portion of long-term debt $ 1,416 $ 82 $ 16 $ 82

Long-term debt $ 4,688 $ 6,017 $ ( 452 ) $ ( 519 )

(1) Current portion of long-term debt includes $ 82 million of carrying value with discontinued hedging relationships as of both March 31, 2023 and December 31, 2022.

Long-term debt includes $ 337 million and $ 357 million of carrying value with discontinued hedging relationships as of March 31, 2023 and December 31, 2022, respectively.

(2) Current portion of long-term debt includes $ 82 million of hedging adjustments on discontinued hedging relationships as of both March 31, 2023 and December 31, 2022.

Long-term debt includes $ 237 million and $ 257 million of hedging adjustments on discontinued hedging relationships as of March 31, 2023 and December 31, 2022, respectively.

(1) Current portion of long-term debt includes $ 80 million and $ 82 million of carrying value with discontinued hedging relationships as of June 30, 2023 and December 31, 2022, respectively.

Long-term debt includes $ 318 million and $ 357 million of carrying value with discontinued hedging relationships as of June 30, 2023 and December 31, 2022, respectively.

(2) Current portion of long-term debt includes $ 80 million and $ 82 million of hedging adjustments on discontinued hedging relationships as of June 30, 2023 and December 31, 2022, respectively.

Long-term debt includes $ 218 million and $ 257 million of hedging adjustments on discontinued hedging relationships as of June 30, 2023 and December 31, 2022, respectively.

Impact of hedging transactions

The following tables summarize the amounts recorded in income and expense line items and the effects thereon from fair value and cash flow hedging, including discontinued hedging relationships (in millions):

Three months ended March 31, 2023

Product sales Other income (expense), net Interest expense, net

Three months ended June 30, 2023 Six months ended June 30, 2023

Product sales Other (expense) income, net Interest expense, net Product sales Other (expense) income, net Interest expense, net

Total amounts recorded in income and (expense) line items presented in the Condensed Consolidated Statements of Income $ 6,683 $ ( 318 ) $ ( 752 ) $ 12,529 $ 1,746 $ ( 1,295 )

The effects of cash flow and fair value hedging:

Gains (losses) on cash flow hedging relationships reclassified out of AOCI:

Gains on cash flow hedging relationships reclassified out of AOCI:

Foreign currency forward contracts $ 36 $ — $ — $ 88 $ — $ —

Cross-currency swap contracts $ — $ 51 $ — $ — $ 29 $ —

(Losses) gains on fair value hedging relationships—interest rate swap agreements:

Gains (losses) on fair value hedging relationships—interest rate swap agreements:

Hedged items (1)

1 unchanged sentence

Derivatives designated as hedging instruments $ — $ — $ ( 72 ) $ — $ — $ 42

Three months ended March 31, 2022

Product sales Other income (expense), net Interest expense, net

Three months ended June 30, 2022 Six months ended June 30, 2022

Product sales Other (expense) income, net Interest expense, net Product sales Other (expense) income, net Interest expense, net

Total amounts recorded in income and (expense) line items presented in the Condensed Consolidated Statements of Income $ 6,281 $ ( 317 ) $ ( 328 ) $ 12,012 $ ( 847 ) $ ( 623 )

9 unchanged sentences

No portions of our cash flow hedge contracts were excluded from the assessment of hedge effectiveness.

As of March 31, 2023, 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.

As of June 30, 2023, we expected to reclassify $ 108 million of net gains on our foreign currency and cross-currency swap contracts out of AOCI and into earnings during the next 12 months.

Derivatives not designated as hedges

1 unchanged sentence

Most of these exposures are hedged on a month-to-month basis.

As of March 31, 2023 and December 31, 2022, the total notional amounts of these foreign currency forward contracts were $ 582 million and $ 517 million, respectively.

Gains and losses recognized in earnings for our derivative instruments not designated as hedging instruments were not material for the three months ended March 31, 2023 and 2022.

As of June 30, 2023 and December 31, 2022, the total notional amounts of these foreign currency forward contracts were $ 557 million and $ 517 million, respectively.

Gains and losses recognized in earnings for our derivative instruments not designated as hedging instruments were not material for the three and six months ended June 30, 2023 and 2022.

Fair values of derivatives

1 unchanged sentence

Derivative assets Derivative liabilities

March 31, 2023 Condensed Consolidated

June 30, 2023 Condensed Consolidated

Balance Sheets locations Fair values Condensed Consolidated

20 unchanged sentences

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

Our derivative contracts that were in liability positions as of March 31, 2023, contain certain credit-risk-related contingent provisions that would be triggered if (i) we were to undergo a change-in-control and (ii) our or the surviving entity’s creditworthiness deteriorates, which is generally defined as having either a credit rating that is below investment grade or a materially weaker creditworthiness after the change-in-control.

Our derivative contracts that were in liability positions as of June 30, 2023, contain certain credit-risk-related contingent provisions that would be triggered if (i) we were to undergo a change-in-control and (ii) our or the surviving entity’s creditworthiness deteriorates, which is generally defined as having either a credit rating that is below investment grade or a materially weaker creditworthiness after the change-in-control.

If these events were to occur, the counterparties would have the right, but not the obligation, to close the contracts under early-termination provisions.

9 unchanged sentences

and in Note 19, Contingencies and commitments, to the consolidated financial statements in our Annual Report on Form 10-K for the year ended December 31, 2022;

and in Note 14, Contingencies and commitments, to the condensed consolidated financial statements in our Quarterly Report on Form 10-Q for the period ended March 31, 2023.

We record accruals for loss contingencies to the extent that we conclude it is probable that a liability has been incurred and the amount of the related loss can be reasonably estimated.

2 unchanged sentences

In each of the matters described in this filing;

and in Note 19, Contingencies and commitments, to the consolidated financial statements in our Annual Report on Form 10-K for the year ended December 31, 2022, 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.

and in Note 19, Contingencies and commitments, to the consolidated financial statements in our Annual Report on Form 10-K for the year ended December 31, 2022;

and in Note 14, Contingencies and commitments, to the condensed consolidated financial statements in our Quarterly Report on Form 10-Q for the period ended March 31, 2023, in which we could incur a liability, our opponents seek an award of a not-yet-quantified amount of damages or an amount that is not material.

In addition, a number of the matters pending against us are at very early stages of the legal process, which in complex proceedings of the sort we face often extend for several years.

As a result, none of the matters described in this filing;

and in Note 19, Contingencies and commitments, to the consolidated financial statements in our Annual Report on Form 10-K for the year ended December 31, 2022, 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.

and in Note 19, Contingencies and commitments, to the consolidated financial statements in our Annual Report on Form 10-K for the year ended December 31, 2022;

and in Note 14, Contingencies and commitments, to the condensed consolidated financial statements in our Quarterly Report on Form 10-Q for the period ended March 31, 2023, in which we could incur a liability, have progressed sufficiently through discovery and/or the development of important factual information and legal issues to enable us to estimate a range of possible loss, if any, or such amounts are not material.

While it is not possible to accurately predict or determine the eventual outcomes of these matters, an adverse determination in one or more of these matters currently pending could have a material adverse effect on our consolidated results of operations, financial position or cash flows.

Certain recent developments concerning our legal proceedings and other matters are discussed below:

ANDA Patent Litigation

Otezla ANDA Patent Litigation

Sandoz Inc., et al.

On April 19, 2023, the U.S.

Court of Appeals for the Federal Circuit affirmed the permanent injunction entered by the U.S.

District Court for the District of New Jersey prohibiting Sandoz and Zydus Pharmaceuticals (USA) Inc.

from making, using, selling, offering to sell, or importing each of the generic versions of Otezla until February 2028.

Repatha Patent Litigation

1 unchanged sentence

Sanofi, et al.

Oral argument before the U.S.

Supreme Court took place on March 27, 2023.

On May 18, 2023, the U.S.

Supreme Court entered final judgment affirming the lower court’s decision invalidating claims 19 and 29 of U.S.

8,829,165 and claim 7 of the U.S.

8,859,741 as lacking an enabling disclosure of the invention claimed.

Patent Disputes in the International Region

In Amgen’s counterclaim litigation alleging that PRALUENT ® infringes Amgen’s European Patent No.

2,641,917 (the ’917 Patent), on February 27, 2023, Amgen filed a notice of appeal of the European Patent Office’s Opposition Division order invalidating the claims of the ’917 Patent.

On March 13, 2023, Amgen appealed to the Japanese Supreme Court the High Court’s decision that Amgen’s Japanese patent claims relating to PCSK9 were invalid for lacking adequate support.

On April 24, 2023, Amgen filed its Grounds for Acceptance of Appeal and Grounds for Appeal with the Japanese Supreme Court.

On June 1, 2023, Amgen filed an action before the Unitary Patent Court against Sanofi-Aventis Deutschland GmbH, Sanofi-Aventis Groupe S.A., Sanofi Winthrop Industrie S.A.

(collectively, Sanofi) and Regeneron Pharmaceuticals, Inc.

alleging that the importation, marketing, sale and use of PRALUENT ® infringes European Patent 3,666,797 (the EP’797 Patent) seeking an injunction and damages for past infringement.

On June 29, 2023, the Unitary Patent Court served us with an action filed by Sanofi before the Unitary Patent Court seeking revocation of Amgen’s EP’797 Patent.

On July 20, 2023, Amgen filed objections to the admissibility of Sanofi’s revocation action before the Unitary Patent Court’s Central Division and Local Divisions on the grounds that Amgen’s infringement action was filed prior to Sanofi’s revocation action.

On November 14, 2023, the Regional Court of Dusseldorf is scheduled to hear argument on Sanofi Biotechnology SAS’ lawsuit alleging that our marketing of Repatha infringes European Patent 2,756,004.

The Munich Regional Court scheduled a hearing for February 28, 2024 on Sanofi’s action against Amgen in which Sanofi seeks damages arising from the provisional enforcement of an injunction against PRALUENT ® that was lifted after an October 29, 2020 ruling by the Technical Board of Appeal that broader claims in Amgen’s European Patent 2,215,125 encompassing PRALUENT ® were invalid.

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

Sandoz Inc., et al.

On May 1, 2023, Amgen Inc.

and Amgen Manufacturing Limited filed a lawsuit in the U.S.

District Court for the District of New Jersey (New Jersey District Court) against Sandoz Inc., Sandoz GmbH, Lek Pharmaceuticals d.d., Novartis Pharmaceutical Productions d.o.o., and Novartis AG (collectively, Defendants) based on the submission to the FDA of a Biologics License Application seeking approval to market and sell a biosimilar version of Amgen’s Prolia and XGEVA products.

The complaint asserts infringement of the following 21 patents, which are listed in the FDA’s Purple Book for Amgen’s Prolia and XGEVA products:

and 11,434,514 (collectively, the Asserted Patents).

Amgen seeks a judgment from the New Jersey District Court that Defendants have infringed or will infringe one or more claims of each of the Asserted Patents and based on that judgment, a permanent injunction prohibiting the commercial manufacture, use, offer to sell, or sale within the United States or importation into the United States of Defendants’ proposed denosumab biosimilar before expiration of each of the Asserted Patents found to infringe.

Amgen also seeks monetary remedies for any past acts of infringement.

On June 16, 2023, Amgen filed an amended and supplemental complaint to include additional information regarding the completion of the BPCIA information exchange after the filing of the original complaint.

responded to the amended and supplemental complaint on July 7, 2023, denying infringement and asserting counterclaims seeking a declaratory judgment that asserted patents are invalid and/or unenforceable.

On July 21, 2023, the New Jersey District Court granted Amgen’s request for a briefing schedule to present and hear a motion to be filed by Amgen on or before September 1, 2023 seeking a preliminary injunction to prohibit patent infringement by Sandoz’s denosumab product until the court is able to reach judgment on the merits of Amgen’s lawsuit.

On August 2, 2023, the New Jersey District Court scheduled a preliminary injunction hearing that will commence on October 30, 2023.

ABP 654 (ustekinumab) Patent Litigation

Janssen Biotech, Inc.

On February 21, 2023, Janssen filed a first amended complaint adding, among other things, a request for declaratory judgment that four additional patents, together with the two patents it previously asserted, would be infringed by Amgen’s submission of an application for FDA licensure of ABP 654, Amgen’s biosimilar version of Janssen’s STELARA ® (ustekinumab).

On March 5, 2023, Janssen filed a motion for preliminary injunction based on the alleged infringement of the two patents it had originally asserted, specifically U.S.

9,217,168 and 9,475,858, seeking to enjoin Amgen from manufacturing or using in commercial quantities, offering to sell, or selling within the United States, or importing for commercial purposes into the United States, ABP 654.

On March 23, 2023, the District Court Judge issued a scheduling order for this preliminary injunction proceedings, setting such hearing for August 4, 2023.

On May 22, 2023, pursuant to a confidential settlement agreement, the parties filed a joint stipulation of dismissal with prejudice of the U.S.

On May 23, 2023, the U.S.

District Court for the District of Delaware (Delaware District Court) issued an order dismissing the U.S.

litigation with prejudice.

Janssen Biotech Inc.

Amgen Technology (Ireland) Unlimited Company

On March 22, 2023, Janssen initiated an action in the Irish High Court alleging infringement of Irish Supplementary Protection Certificate No.

2009/015, indicating intent to seek an interlocutory injunction restraining ABP 654 manufacturing activities in Ireland.

The trial date for preliminary Supplementary Protection Certificate issues, potentially followed by a hearing with respect to interlocutory injunction, has been set to begin on July 4, 2023.

Antitrust Actions

On May 22, 2023, pursuant to a confidential settlement agreement, the parties requested that the Irish proceedings be struck out and on the same day the Irish High Court issued an order striking out the proceedings and vacating all previous orders in those proceedings.

Antitrust Class Action

Sensipar Antitrust Class Actions

On February 16, 2023, the U.S.

District Court for the District of Delaware (the Delaware District Court) denied Amgen’s motion for interlocutory appeal.

On March 2, 2023, Amgen filed a motion for reargument, which the Delaware District Court denied while also certifying a question regarding whether the current judge has the authority to certify a question decided by a predecessor judge.

On April 17, 2023, Amgen filed a petition with the U.S.

Court of Appeals for the Third Circuit, seeking a grant of our request for interlocutory appeal of the certified question as well as the Delaware District Court’s denial of our motion to dismiss the reverse payment claim.

Amgen’s response to the class action complaints are due 30 days after resolution or denial of the interlocutory appeal.

On June 26, 2023, the U.S.

Court of Appeals for the Third Circuit entered an order granting defendants’ (including Amgen’s) petition for interlocutory appeal and denying plaintiffs’ cross-petition.

The questions certified are whether (1) the statute for interlocutory decisions authorizes a district court judge to certify for interlocutory appeal an order issued in the same case by a predecessor district court judge;

and (2) the settlement of a patent infringement claim that involves the forgiveness of damages associated with that patent’s alleged infringement, on its own or combined with an acceleration clause, constitutes a reverse payment.

On July 3, 2023, Amgen and Teva Pharmaceuticals USA, Inc.

filed a notice of appeal.

Regeneron Pharmaceuticals, Inc.

Antitrust Action

On February 10, 2023, the Delaware District Court denied Amgen’s motion to stay this action but left open the possibility of Amgen re-raising the motion if the U.S.

Supreme Court rules in Amgen’s favor in its patent infringement cases against Sanofi and Regeneron Pharmaceuticals, Inc.

On March 21, 2023, the Delaware District Court denied Amgen’s motion to dismiss the complaint.

The Delaware District Court scheduled the trial to begin on November 12, 2024.

Tax Litigation

2 unchanged sentences

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

Securities Class Action Litigation

On March 13, 2023, Roofers Local No.

149 Pension Fund filed a purported class action against Amgen, Robert Bradway and Peter Griffith.

The action was brought on behalf of an alleged class of Amgen shareholders who owned stock between July 29, 2020 and April 27, 2022 (the alleged class period).

Plaintiffs allege that the defendants made a series of materially false and misleading statements and omissions during the alleged class period regarding the failure to timely disclose the potential tax liability claimed by the IRS.

Plaintiffs further allege that they and other purported class members suffered losses and damages resulting from declines in the market value of Amgen’s common stock after the potential tax liability claimed by the IRS was disclosed.

On April 4, 2023, the U.S.

District Court for the Southern District of New York entered an order setting May 12, 2023 as the deadline for filing motions for appointment of lead counsel.

ChemoCentryx, Inc.

Securities Class Action Litigation

In May 2022, ChemoCentryx, which was acquired by Amgen in October 2022 and is now a subsidiary of Amgen, filed a motion to dismiss the shareholder class action claims.

On February 23, 2023, the U.S.

District Court for the Northern District of California (Northern District Court of California) substantially denied ChemoCentryx’s motion to dismiss the matter in its entirety, while granting the motion to dismiss with respect to certain allegations of the plaintiffs.

On April 4, 2023, the parties submitted a case management statement to the Northern District Court of California , and on April 10, 2023, the Northern District Court of California entered an order setting dates for amendment of pleadings and briefing on class certification.

On April 27, 2023, ChemoCentryx submitted its answer to the complaint.

Shareholder Derivative Litigation

On August 2, 2023, Leon Martin filed a derivative action, purportedly on behalf of Amgen, against Amgen, Robert Bradway, Peter Griffith and Amgen’s independent board members.

The action was filed in the U.S.

District Court for the Southern District of New York as related to the pending federal securities class action filed by Roofers Local No.

149 Pension Fund on March 13, 2023 (the Roofers securities class action).

The complaint in this matter alleges claims for violations of the Securities Exchange Act of 1934, breach of fiduciary duty, aiding and abetting breach of fiduciary duty, unjust enrichment and waste of corporate assets.

The factual allegations that form the basis for these claims are essentially the same as the allegations asserted in the Roofers securities class action regarding purportedly false and misleading statements and omissions made from July 29, 2020 through April 27, 2022 relating to Amgen’s tax liabilities, business and finances, and the adequacy and maintenance of its internal controls.

FTC Litigation re the Proposed Horizon Therapeutics plc Acquisition

On May 16, 2023, the FTC filed a complaint and motion for preliminary injunction in the U.S.

District Court for the Northern District of Illinois (Northern Illinois District Court) seeking to enjoin Amgen’s proposed acquisition of Horizon.

The FTC alleges that the deal would allow Amgen to leverage its portfolio of blockbuster drugs someday to entrench the monopoly positions of Horizon medications used to treat two serious conditions, thyroid eye disease and chronic refractory gout, if competitors eventually come to market.

The preliminary injunction hearing in the case is set to begin on September 11, 2023.

On June 1, 2023, Amgen, Horizon and the FTC submitted a stipulated proposed temporary restraining order (TRO) to the Northern Illinois District Court providing that Horizon and Amgen would not close the acquisition until the earlier of October 31, 2023 or the second business day after the Northern Illinois District Court rules on the FTC’s request for a preliminary injunction.

On June 2, 2023, the Northern Illinois District Court issued an order granting the stipulated TRO.

Amgen and Horizon filed their answer to the complaint on June 9, 2023.

On June 22, 2023, an amended complaint was filed adding six states to the lawsuit, and on June 29, 2023, Amgen filed an answer and counterclaims to the amended complaint.

On June 22, 2023, the FTC filed an administrative complaint before the FTC’s administrative judge, and on July 7, 2023 Amgen and Horizon filed an answer to the administrative complaint.

The Transaction Agreement provides that Amgen will be required to pay Horizon a termination fee of $ 974.4 million if the Transaction Agreement is terminated under certain circumstances in which there was a failure to obtain regulatory approvals by December 12, 2023, as described in Amgen’s Form 8-K filed December 12, 2022, and in the Transaction Agreement filed therewith.

One of those circumstances would likely arise if the above-described preliminary injunction hearing is not decided favorably to Amgen and Horizon.

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.

What changed 10-Q

Item 1. Financial Statements