Item 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

65K characters. Original on sec.gov · Markdown

Item 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

The following MD&A is intended to assist the reader in understanding Amgen’s business. MD&A is provided as a supplement to and should be read in conjunction with our Annual Report on Form 10-K for the year ended December 31, 2023, and our Quarterly Report on Form 10-Q for the period ended March 31, 2024. Our results of operations discussed in MD&A are presented in conformity with GAAP. Amgen operates in one business segment: human therapeutics. Therefore, our results of operations are discussed on a consolidated basis.

Forward-looking statements

This report and other documents we file with the SEC contain forward-looking statements that are based on current expectations, estimates, forecasts and projections about us, our future performance, our business, our beliefs and our management’s assumptions. In addition, we, or others on our behalf, may make forward-looking statements in press releases, written statements or our communications and discussions with investors and analysts in the normal course of business through meetings, webcasts, phone calls and conference calls. Such words as “expect,” “anticipate,” “outlook,” “could,” “target,” “project,” “intend,” “plan,” “believe,” “seek,” “estimate,” “should,” “may,” “assume” and “continue” as well as variations of such words and similar expressions are intended to identify such forward-looking statements. These statements are not guarantees of future performance, and they involve certain risks, uncertainties and assumptions that are difficult to predict. We describe our respective risks, uncertainties and assumptions that could affect the outcome or results of operations in Item 1A. Risk Factors in Part II herein and in Part I, Item 1A. Risk Factors of our Annual Report on Form 10-K for the year ended December 31, 2023, and in Part II, Item 1A. Risk Factors of our Quarterly Report on Form 10-Q for the period ended March 31, 2024. We have based our forward-looking statements on our management’s beliefs and assumptions based on information available to our management at the time the statements are made. We caution you that actual outcomes and results may differ materially from what is expressed, implied or forecasted by our forward-looking statements. Reference is made in particular to forward-looking statements regarding product sales, regulatory activities, clinical trial results, reimbursement, expenses, EPS, liquidity and capital resources, trends, planned dividends, stock repurchases, and collaborations. Except as required under the federal securities laws and the rules and regulations of the SEC, we do not have any intention or obligation to update publicly any forward-looking statements after the distribution of this report, whether as a result of new information, future events, changes in assumptions or otherwise.

Overview

Amgen Inc. (including its subsidiaries, referred to as “Amgen,” “the Company,” “we,” “our” or “us”) discovers, develops, manufactures and delivers innovative medicines to fight some of the world’s toughest diseases. Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that dramatically improve people’s lives, while also reducing the social and economic burden of disease. We helped launch the biotechnology industry more than 40 years ago and have grown to be one of the world’s leading independent biotechnology companies. Our robust pipeline includes potential first-in-class medicines at all stages of development.

Our principal products are Prolia, ENBREL, XGEVA, Repatha, Otezla, TEPEZZA, KYPROLIS, EVENITY, Aranesp, Nplate, KRYSTEXXA, Vectibix, BLINCYTO and TEZSPIRE. We also market a number of other products, including but not limited to MVASI, AMJEVITA/AMGEVITA, Neulasta, Parsabiv, RAVICTI, UPLIZNA, LUMAKRAS/LUMYKRAS, Aimovig, TAVNEOS, PROCYSBI, EPOGEN and IMDELLTRA.

Macroeconomic and other challenges

Uncertain macroeconomic conditions, including the risk of inflation, higher interest rates and instability in the financial system, as well as rising healthcare costs continue to pose challenges to our business. Further, ongoing geopolitical conflicts continue to create additional uncertainty in global macroeconomic conditions. Additionally, with public and private healthcare-provider focus, the industry continues to be subject to cost containment measures and significant pricing pressures, resulting in net price declines. Moreover, legislation enacted to reduce healthcare expenditures, including provisions of the IRA, have affected, and are likely to continue to affect, our business. Finally, wholesale and end-user buying patterns can affect our product sales. These buying patterns can cause fluctuations in quarterly product sales but have generally not been significant to date when comparing full-year product performance to the prior year. See Part II, Item 1A. Risk Factors, of this Quarterly Report on Form 10-Q.

Significant developments

Following is a summary of selected significant developments affecting our business that occurred since the filing of our Quarterly Report on Form 10-Q for the period ended March 31, 2024. For additional developments, see our Annual Report on Form 10-K for the year ended December 31, 2023, and our Quarterly Report on Form 10-Q for the period ended March 31, 2024.

Products/pipeline

IMDELLTRA

In May 2024, we announced IMDELLTRA received accelerated approval from the FDA for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy.

BLINCYTO

In June 2024, we announced BLINCYTO received approval from the FDA in frontline consolidation for patients with CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (B-ALL).

UPLIZNA

In June 2024, we announced positive topline results from our Phase 3 registrational trial evaluating UPLIZNA for the treatment of Immunoglobulin G4-related disease (IgG4-RD). The trial met its primary endpoint, showing a statistically significant 87% reduction in the risk of IgG4-RD flare compared to placebo during the 52-week placebo-controlled period. All key secondary endpoints were also met, which were annualized flare rate; flare-free, treatment-free complete remission; and flare-free, corticosteroid-free complete remission. No new safety signals were identified.

Selected financial information

The following is an overview of our results of operations (in millions, except percentages and per-share data):

Three months ended June 30,Six months ended June 30,
20242023Change20242023Change
Product sales
U.S.$5,840$4,73623%$10,813$8,71124%
ROW2,2011,94713%4,3463,81814%
Total product sales8,0416,68320%15,15912,52921%
Other revenues34730315%67656220%
Total revenues$8,388$6,98620%$15,835$13,09121%
Operating expenses$6,479$4,30251%$12,935$8,48652%
Operating income$1,909$2,684(29)%$2,900$4,605(37)%
Net income$746$1,379(46)%$633$4,220(85)%
Diluted EPS$1.38$2.57(46)%$1.17$7.86(85)%
Diluted shares5415371%5415371%

In the following discussion of changes in product sales, any reference to unit demand growth or decline refers to changes in purchases of our products by healthcare providers (such as physicians or their clinics), dialysis centers, hospitals and pharmacies. In addition, any reference to increases or decreases in inventory refers to changes in inventory held by wholesaler customers and end users (such as pharmacies) as may be noted.

Total product sales increased 20% and 21% for the three and six months ended June 30, 2024, respectively, driven by volume growth of 26% for both periods, partially offset by declines in net selling price of 3% and 2%, respectively.

For the three months ended June 30, 2024, U.S. volume grew 30% and ROW volume grew 15%. Product sales from acquired Horizon products contributed $1.1 billion, with volume growth of 10% from our other brands, including Repatha, TEZSPIRE, Prolia and EVENITY.

For the six months ended June 30, 2024, U.S. volume grew 30% and ROW volume grew 16%. Product sales from

acquired Horizon products contributed $2.0 billion, with volume growth of 9% from our other brands, including Repatha, TEZSPIRE, EVENITY and Prolia.

For the remainder of 2024, we expect product sales growth from acquired Horizon products and volume growth from our other brands to be partially offset by net selling price declines on a year-over-year basis at a portfolio level.

Uncertain macroeconomic conditions, changes in the healthcare ecosystem and geopolitical conflicts have the potential to introduce variability into product sales. Furthermore, product sales continue to be impacted by actions from governments and other entities to curb high inflation, provisions of the IRA and growth in numbers of Medicaid enrollees and uninsured individuals. See Part I, Item 1A. Risk Factors of our Annual Report on Form 10-K for the year ended December 31, 2023, and Part II, Item 1A. Risk Factors, of our Quarterly Reports on Form 10-Q for the periods ended March 31, 2024 and June 30, 2024.

Other revenues increased for the three months ended June 30, 2024, driven by higher royalty income from licensed products. Other revenues increased for the six months ended June 30, 2024, driven by higher royalty income and corporate partner revenue from licensed products.

Operating expenses increased for the three and six months ended June 30, 2024, primarily driven by higher amortization expense from Horizon acquisition-related assets and expenses from the acquired Horizon business.

Results of operations

Product sales

Worldwide product sales were as follows (dollar amounts in millions):

Three months ended June 30,Six months ended June 30,
20242023Change20242023Change
Prolia$1,165$1,02813%$2,164$1,95511%
ENBREL9091,068(15)%1,4761,647(10)%
XGEVA5625306%1,1231,0665%
Repatha53242425%1,04981229%
Otezla544600(9)%938992(5)%
TEPEZZA(1)479—N/A903—N/A
KYPROLIS3773469%7537047%
EVENITY39128139%73353537%
Aranesp348365(5)%697720(3)%
Nplate34631012%663672(1)%
KRYSTEXXA(1)294—N/A529—N/A
Vectibix2702489%5174817%
BLINCYTO26420628%50840027%
TEZSPIRE(2)23413376%40722978%
Other products(3)1,3261,14416%2,6992,31617%
Total product sales$8,041$6,68320%$15,159$12,52921%

N/A = not applicable

(1) TEPEZZA and KRYSTEXXA were acquired from the acquisition of Horizon on October 6, 2023, and include product sales in the periods after the acquisition date.

(2) TEZSPIRE is marketed by our collaborator AstraZeneca outside the United States.

(3) Consists of product sales of our non-principal products.

Future sales of our products will depend in part on the factors discussed below and in the following sections of this report: (i) Part I, Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations—Overview, and Selected financial information; and (ii) Part II, Item 1A. Risk Factors, and in the following sections of our Annual Report on Form 10-K for the year ended December 31, 2023: (i) Part I, Item 1. Business—Marketing, Distribution and Selected Marketed

Products; (ii) Part I, Item 1A. Risk Factors; and (iii) Part II, Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations—Overview, and Results of operations—Product sales, as well as in our Quarterly Report on Form 10-Q for the period ended March 31, 2024: (i) Part I, Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations—Results of operations—Product sales; and (ii) Part II, Item 1A. Risk Factors.

Prolia

Total Prolia sales by geographic region were as follows (dollar amounts in millions):

Three months ended June 30,Six months ended June 30,
20242023Change20242023Change
Prolia — U.S.$770$69111%$1,427$1,3149%
Prolia — ROW39533717%73764115%
Total Prolia$1,165$1,02813%$2,164$1,95511%

The increase in global Prolia sales for the three and six months ended June 30, 2024 was primarily driven by volume growth. As disclosed in our Annual Report on Form 10-K for the year ended December 31, 2023, Part I, Item 1. Business—Marketing, Distribution and Selected Marketed Products—Patents, our U.S. patent for RANKL antibodies (including sequences) for Prolia and XGEVA expires in February 2025. For information about our settlement with Sandoz Inc., see 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.

For a discussion of litigation related to Prolia, see Part IV—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; and Note 13, Contingencies and commitments, to the condensed consolidated financial statements in our Quarterly Reports on Form 10-Q for the periods ended March 31, 2024 and June 30, 2024.

ENBREL

Total ENBREL sales by geographic region were as follows (dollar amounts in millions):

Three months ended June 30,Six months ended June 30,
20242023Change20242023Change
ENBREL — U.S.$902$1,055(15)%$1,463$1,619(10)%
ENBREL — Canada713(46)%1328(54)%
Total ENBREL$909$1,068(15)%$1,476$1,647(10)%

The decrease in ENBREL sales for the three and six months ended June 30, 2024 was primarily driven by lower net selling price. Going forward, we expect relatively flat volumes with continued declines in net selling price, including the impact from the IRA Medicare Part D price set by CMS beginning in 2026.

XGEVA

Total XGEVA sales by geographic region were as follows (dollar amounts in millions):

Three months ended June 30,Six months ended June 30,
20242023Change20242023Change
XGEVA — U.S.$399$3873%$765$771(1)%
XGEVA — ROW16314314%35829521%
Total XGEVA$562$5306%$1,123$1,0665%

The increase in global XGEVA sales for the three and six months ended June 30, 2024 was driven by higher net selling price. As disclosed in our Annual Report on Form 10-K for the year ended December 31, 2023, Part I, Item 1. Business—Marketing, Distribution and Selected Marketed Products—Patents, our U.S. patent for RANKL antibodies (including sequences) for Prolia and XGEVA expires in February 2025. For information about our settlement with Sandoz Inc., see 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.

For a discussion of litigation related to XGEVA, see Part IV—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; and Note 13, Contingencies and commitments, to the condensed consolidated financial statements in our Quarterly Reports on Form 10-Q for the periods ended March 31, 2024 and June 30, 2024.

Repatha

Total Repatha sales by geographic region were as follows (dollar amounts in millions):

Three months ended June 30,Six months ended June 30,
20242023Change20242023Change
Repatha — U.S.$270$21227%$543$40933%
Repatha — ROW26221224%50640326%
Total Repatha$532$42425%$1,049$81229%

The increase in global Repatha sales for the three and six months ended June 30, 2024 was driven by volume growth of 46% and 45%, respectively, partially offset by lower net selling price of 20% and 16%, respectively.

For a discussion of ongoing litigation related to Repatha, see Part IV—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, and Note 13, Contingencies and commitments, to the condensed consolidated financial statements in our Quarterly Reports on Form 10-Q for the periods ended March 31, 2024 and June 30, 2024.

Otezla

Total Otezla sales by geographic region were as follows (dollar amounts in millions):

Three months ended June 30,Six months ended June 30,
20242023Change20242023Change
Otezla — U.S.$432$495(13)%$725$789(8)%
Otezla — ROW1121057%2132035%
Total Otezla$544$600(9)%$938$992(5)%

The decrease in global Otezla sales for the three months ended June 30, 2024 was driven by lower net selling price of 7% and unfavorable changes to estimated sales deductions of 6%, partially offset by volume growth of 2%.

The decrease in global Otezla sales for the six months ended June 30, 2024 was driven by lower net selling price of 7% and unfavorable changes to estimated sales deductions of 4%, partially offset by higher inventory of 4%.

TEPEZZA

Total TEPEZZA sales by geographic region were as follows (dollar amounts in millions):

Three months ended June 30,Six months ended June 30,
20242023Change20242023Change
TEPEZZA — U.S.$478$—N/A$897$—N/A
TEPEZZA — ROW1—N/A6—N/A
Total TEPEZZA$479$—N/A$903$—N/A

N/A = not applicable

TEPEZZA was acquired on October 6, 2023 from our Horizon acquisition and generated $479 million and $903 million in product sales for the three and six months ended June 30, 2024, respectively. As TEPEZZA was acquired on October 6, 2023, there were no recorded product sales for the comparative prior periods.

KYPROLIS

Total KYPROLIS sales by geographic region were as follows (dollar amounts in millions):

Three months ended June 30,Six months ended June 30,
20242023Change20242023Change
KYPROLIS — U.S.$240$2343%$474$4681%
KYPROLIS — ROW13711222%27923618%
Total KYPROLIS$377$3469%$753$7047%

The increase in global KYPROLIS sales for the three and six months ended June 30, 2024 was primarily driven by volume growth outside the United States.

EVENITY

Total EVENITY sales by geographic region were as follows (dollar amounts in millions):

Three months ended June 30,Six months ended June 30,
20242023Change20242023Change
EVENITY — U.S.$281$19246%$517$35645%
EVENITY — ROW1108924%21617921%
Total EVENITY$391$28139%$733$53537%

The increase in global EVENITY sales for the three and six months ended June 30, 2024 was primarily driven by volume growth.

Aranesp

Total Aranesp sales by geographic region were as follows (dollar amounts in millions):

Three months ended June 30,Six months ended June 30,
20242023Change20242023Change
Aranesp — U.S.$91$123(26)%$191$238(20)%
Aranesp — ROW2572426%5064825%
Total Aranesp$348$365(5)%$697$720(3)%

The decrease in global Aranesp sales for the three and six months ended June 30, 2024 was driven by unfavorable changes to estimated sales deductions of 8% and 5%, respectively, partially offset by volume growth outside the United States and higher net selling price.

Nplate

Total Nplate sales by geographic region were as follows (dollar amounts in millions):

Three months ended June 30,Six months ended June 30,
20242023Change20242023Change
Nplate — U.S.$214$17622%$404$422(4)%
Nplate — ROW132134(1)%2592504%
Total Nplate$346$31012%$663$672(1)%

The increase in global Nplate sales for the three months ended June 30, 2024 was driven by higher net selling price and volume growth.

Global Nplate sales for the six months ended June 30, 2024 decreased 1%. Excluding a U.S. government order of $82 million in the first quarter of 2023 from this comparison, Nplate sales increased 12% for the six months ended June 30,

2024, driven by higher net selling price and volume growth.

KRYSTEXXA

Total KRYSTEXXA sales by geographic region were as follows (dollar amounts in millions):

Three months ended June 30,Six months ended June 30,
20242023Change20242023Change
KRYSTEXXA — U.S.$294$—N/A$529$—N/A
KRYSTEXXA — ROW——N/A——N/A
Total KRYSTEXXA$294$—N/A$529$—N/A

N/A = not applicable

KRYSTEXXA was acquired on October 6, 2023 from our Horizon acquisition and generated $294 million and $529 million in product sales for the three and six months ended June 30, 2024, respectively. As KRYSTEXXA was acquired on October 6, 2023, there were no recorded product sales for the comparative prior periods.

Vectibix

Total Vectibix sales by geographic region were as follows (dollar amounts in millions):

Three months ended June 30,Six months ended June 30,
20242023Change20242023Change
Vectibix — U.S.$133$11813%$253$22910%
Vectibix — ROW1371305%2642525%
Total Vectibix$270$2489%$517$4817%

The increase in global Vectibix sales for the three and six months ended June 30, 2024 was driven by higher net selling price and volume growth, partially offset by unfavorable changes to foreign currency exchange rates.

BLINCYTO

Total BLINCYTO sales by geographic region were as follows (dollar amounts in millions):

Three months ended June 30,Six months ended June 30,
20242023Change20242023Change
BLINCYTO — U.S.$165$14514%$318$27117%
BLINCYTO — ROW996162%19012947%
Total BLINCYTO$264$20628%$508$40027%

The increase in global BLINCYTO sales for the three and six months ended June 30, 2024 was driven by volume growth resulting from broad prescribing across academic and community segments for patients with B-ALL. In June 2024, BLINCYTO was granted approval by the FDA in frontline consolidation for patients with CD-19 positive Philadelphia chromosome-negative B-ALL.

TEZSPIRE

Total TEZSPIRE sales by geographic region were as follows (dollar amounts in millions):

Three months ended June 30,Six months ended June 30,
20242023Change20242023Change
TEZSPIRE — U.S.$234$13376%$407$22978%

The increase in TEZSPIRE sales for the three and six months ended June 30, 2024 was primarily driven by volume growth.

Other products

Other product sales by geographic region were as follows (dollar amounts in millions):

Three months ended June 30,Six months ended June 30,
20242023Change20242023Change
MVASI — U.S.$100$123(19)%$205$244(16)%
MVASI — ROW5774(23)%154155(1)%
AMJEVITA — U.S.(1)(9)19N/A2170(70)%
AMGEVITA — ROW1421318%28024415%
Neulasta — U.S.75199(62)%162410(60)%
Neulasta — ROW3037(19)%6175(19)%
Parsabiv — U.S.675424%13211218%
Parsabiv — ROW393318%796620%
RAVICTI — U.S.(2)96—N/A188—N/A
RAVICTI — ROW(2)1—N/A3—N/A
UPLIZNA — U.S.(2)77—N/A147—N/A
UPLIZNA — ROW(2)15—N/A25—N/A
LUMAKRAS — U.S.555010%1089810%
LUMYKRAS — ROW302711%595311%
Aimovig — U.S.80783%1451422%
Aimovig — ROW5425%10911%
TAVNEOS — U.S.6129*10652*
TAVNEOS — ROW101*161*
PROCYSBI — U.S.(2)54—N/A103—N/A
PROCYSBI — ROW(2)4—N/A5—N/A
EPOGEN — U.S.3261(48)%73121(40)%
IMDELLTRA — U.S.12—N/A12—N/A
Other — U.S.(3)23716246%49834744%
Other — ROW(3)5662(10)%107117(9)%
Total other products$1,326$1,14416%$2,699$2,31617%
Total U.S. — other products$937$77521%$1,900$1,59619%
Total ROW — other products3893695%79972011%
Total other products$1,326$1,14416%$2,699$2,31617%

N/A = not applicable

  • Change in excess of 100%

(1) U.S. AMJEVITA product sales for the three and six months ended June 30, 2024, included unfavorable changes to estimated sales deductions.

(2) RAVICTI, UPLIZNA and PROCYSBI were acquired from our Horizon acquisition on October 6, 2023, and include product sales in the periods after the acquisition date.

(3) Consists of product sales from (i) KANJINTI, RIABNI, Corlanor, NEUPOGEN, AVSOLA, IMLYGIC, BEKEMV, Sensipar/Mimpara and WEZLANA/WEZENLA; and (ii) ACTIMMUNE, RAYOS, BUPHENYL, PENNSAID, QUINSAIR and DUEXIS in the periods after our Horizon acquisition on October 6, 2023.

Operating expenses

Operating expenses were as follows (dollar amounts in millions):

Three months ended June 30,Six months ended June 30,
20242023Change20242023Change
Operating expenses:
Cost of sales$3,236$1,81378%$6,436$3,53382%
% of product sales40.2%27.1%42.5%28.2%
% of total revenues38.6%26.0%40.6%27.0%
Research and development$1,447$1,11330%$2,790$2,17129%
% of product sales18.0%16.7%18.4%17.3%
% of total revenues17.3%15.9%17.6%16.6%
Selling, general and administrative$1,785$1,29438%$3,593$2,55241%
% of product sales22.2%19.4%23.7%20.4%
% of total revenues21.3%18.5%22.7%19.5%
Other$11$82(87)%$116$230(50)%
Total operating expenses$6,479$4,30251%$12,935$8,48652%

Cost of sales

Cost of sales increased to 38.6% and 40.6% of total revenues for the three and six months ended June 30, 2024, respectively, driven by higher amortization expense from Horizon acquisition-related assets and, to a lesser extent, higher royalty and profit share expense. The increases were partially offset by the impact of the 2022 Puerto Rico tax law change, which replaced an excise tax with an income tax beginning in 2023. See Note 4, Income taxes, to the condensed consolidated financial statements.

Research and development

The increase in R&D expense for the three months ended June 30, 2024, was driven by higher spend in later-stage clinical programs and research and early pipeline, including Horizon-acquired programs.

The increase in R&D expense for the six months ended June 30, 2024, was driven by higher spend in later-stage clinical programs, marketed product support and research and early pipeline, including Horizon-acquired programs.

Selling, general and administrative

The increase in SG&A expense for the three and six months ended June 30, 2024, was primarily driven by expenses from the acquired Horizon business and other commercial expenses.

Other

Other operating expenses for the three months ended June 30, 2024, consisted primarily of changes in the fair values of contingent consideration liabilities related to our Teneobio, Inc. acquisition from 2021. Other operating expenses for the six months ended June 30, 2024, consisted primarily of a net impairment charge associated with an IPR&D asset and changes in the fair values of contingent consideration liabilities, both related to our Teneobio, Inc. acquisition.

Other operating expenses for the three and six months ended June 30, 2023, consisted primarily of expenses related to our restructuring plan initiated in the first quarter of 2023 and a net impairment charge associated with an IPR&D asset.

Nonoperating expense/income and income taxes

Nonoperating expense/income and income taxes were as follows (dollar amounts in millions):

Three months ended June 30,Six months ended June 30,
2024202320242023
Interest expense, net$(808)$(752)$(1,632)$(1,295)
Other (expense) income, net$(307)$(318)$(542)$1,746
Provision for income taxes$48$235$93$836
Effective tax rate6.0%14.6%12.8%16.5%

Interest expense, net

The increase in Interest expense, net, for the three and six months ended June 30, 2024, was primarily due to higher average debt outstanding and higher weighted-average fixed and variable interest rates on the debt.

Other (expense) income, net

The change in Other (expense) income, net, for the three months ended June 30, 2024, was primarily due to lower unrealized losses on our strategic equity investments, primarily BeiGene and Neumora, offset by reduced interest income as a result of lower average cash balances.

The change in Other (expense) income, net, for the six months ended June 30, 2024, was primarily due to current year unrealized losses on our strategic equity investments, primarily BeiGene and Neumora, compared with net unrealized gains in the prior comparative period. Prior period net gains were principally composed of amounts recognized on our BeiGene investment in the first quarter of 2023 as a result of a change from the equity method of accounting to recording this investment at fair value, with changes in fair value recognized in earnings. See Note 6, Investments, to the condensed consolidated financial statements.

Income taxes

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). 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.* and Neumora Therapeutics, Inc., to the condensed consolidated financial statements.

As previously reported, the OECD reached an agreement to align countries on a minimum corporate tax rate and an expansion of the taxing rights of market countries. Effective January 1, 2024, selected individual countries, including the United Kingdom and EU member countries, have enacted the global minimum tax agreement. Our legal entities in the countries that have enacted the agreement, along with their direct and indirect subsidiaries, are now subject to a 15% minimum tax rate on adjusted financial statement income. Other countries, including the United States and the U.S. territory of Puerto Rico, have not yet enacted the OECD agreement, and implementation remains highly uncertain. The continued enactment of the agreement, either by all OECD participants or unilaterally by individual countries, could result in tax increases or double taxation in the United States or foreign jurisdictions.

As of January 1, 2023, we are no longer subject to a 4% excise tax in the U.S. territory of Puerto Rico on the gross intercompany purchase price of goods and services from our manufacturer in Puerto Rico. We qualify for and are subject to the alternative income tax rate on industrial development income of our Puerto Rico affiliate. In the United States, this income tax qualifies for foreign tax credits under the U.S. Treasury final foreign tax credit regulations. See Note 4, Income taxes, to the condensed consolidated financial statements.

In 2017, we received an RAR and a modified RAR from the IRS for the years 2010–2012, proposing significant adjustments that primarily relate to the allocation of profits between certain of our entities in the United States and the U.S. territory of Puerto Rico. We disagreed with the proposed adjustments and calculations and pursued resolution with the IRS appeals office but were unable to reach resolution. In July 2021, we filed a petition in the U.S. Tax Court to contest two duplicate Statutory Notices of Deficiency (Notices) for the years 2010–2012 that we received in May and July 2021, which seek to increase our U.S. taxable income for the years 2010–2012 by an amount that would result in additional federal tax of approximately $3.6 billion plus interest. Any additional tax that could be imposed for the years 2010–2012 would be reduced by up to approximately $900 million of repatriation tax previously accrued on our foreign earnings.

In 2020, we received an RAR and a modified RAR from the IRS for the years 2013–2015, also proposing significant adjustments that primarily relate to the allocation of profits between certain of our entities in the United States and the U.S. territory of Puerto Rico similar to those proposed for the years 2010–2012. We disagreed with the proposed adjustments and calculations and pursued resolution with the IRS appeals office but were unable to reach resolution. In July 2022, we filed a petition in the U.S. Tax Court to contest a Notice for the years 2013–2015 that we previously reported receiving in April 2022 that seeks to increase our U.S. taxable income for the years 2013–2015 by an amount that would result in additional federal tax of approximately $5.1 billion, plus interest. In addition, the Notice asserts penalties of approximately $2.0 billion. Any additional tax that could be imposed for the years 2013–2015 would be reduced by up to approximately $2.2 billion of repatriation tax previously accrued on our foreign earnings.

We firmly believe that the IRS positions set forth in the 2010–2012 and 2013–2015 Notices are without merit. We are contesting the 2010–2012 and 2013–2015 Notices through the judicial process. The two cases were consolidated in the U.S. Tax Court on December 19, 2022. The trial is currently scheduled to begin on November 4, 2024.

We are currently under examination by the IRS for the years 2016–2018 with respect to issues similar to those for the 2010 through 2015 period. In addition, we are under examination by a number of state and foreign tax jurisdictions.

Final resolution of these complex matters is not likely within the next 12 months. We continue to believe our accrual for income tax liabilities is appropriate based on past experience, interpretations of tax law, application of the tax law to our facts and judgments about potential actions by tax authorities; however, due to the complexity of the provision for income taxes and uncertain resolution of these matters, the ultimate outcome of any tax matters may result in payments substantially greater than amounts accrued and could have a material adverse impact on our condensed consolidated financial statements.

See our Annual Report on Form 10-K for the year ended December 31, 2023, Part I, Item 1A, Risk Factors—We could be subject to additional tax liabilities, including from an adverse outcome in our ongoing tax dispute with the IRS and other tax examinations, enactment of the OECD minimum corporate tax rate agreement and the adoption and interpretation of new tax legislation, and we anticipate additional tax liabilities from certain provisions of the 2017 Tax Act that will go into effect in 2026; such tax liabilities could adversely affect our profitability and results of operations, and Note 4, Income taxes, to the condensed consolidated financial statements in this filing for further discussion.

Financial condition, liquidity and capital resources

Selected financial data were as follows (in millions):

June 30, 2024December 31, 2023
Cash and cash equivalents$9,301$10,944
Total assets$90,907$97,154
Current portion of long-term debt$5,528$1,443
Long-term debt$57,117$63,170
Stockholders’ equity$5,925$6,232

Cash and cash equivalents

Our balance of cash and cash equivalents was $9.3 billion as of June 30, 2024. The primary objective of our investment portfolio is to maintain safety of principal, prudent levels of liquidity and acceptable levels of risk. Our investment policy limits interest-bearing security investments to certain types of debt and money market instruments issued by institutions with primarily investment-grade credit ratings, and it places restrictions on maturities and concentration by asset class and issuer.

Capital allocation

Consistent with the objective to optimize our capital structure, we deploy our accumulated cash balances in a strategic manner and consider a number of alternatives, including investments in innovation both internally and externally (including investments that expand our portfolio of products in areas of therapeutic interest), capital expenditures, repayment of debt, payment of dividends and stock repurchases.

We intend to continue investing in our business while reducing our debt and returning capital to stockholders through the payment of cash dividends and stock repurchases. This reflects our desire to optimize our cost of capital and our confidence in the future cash flows of our business. The timing and amount of future dividends and stock repurchases will vary based on a number of factors, including future capital requirements for strategic transactions, debt levels and debt service requirements, our credit rating, availability of financing on acceptable terms, changes to applicable tax laws or corporate laws, changes to our business model and periodic determination by our Board of Directors that cash dividends and/or stock repurchases are in the best interests of stockholders and are in compliance with applicable laws and the Company’s agreements. In addition, the timing and amount of stock repurchases may also be affected by our overall level of cash, stock price and blackout periods, during which we are restricted from repurchasing stock. The manner of stock repurchases may include block purchases, tender offers, accelerated share repurchases and market transactions.

In March 2024 and December 2023, our Board of Directors declared quarterly cash dividends of $2.25 per share of common stock, which were paid in June 2024 and March 2024, respectively, and was an increase of 6% over the quarterly cash dividends paid each quarter in 2023. In August 2024, our Board of Directors declared a quarterly cash dividend of $2.25 per share of common stock that will be paid in September 2024.

During the six months ended June 30, 2024, we did not repurchase any of our common stock under our stock repurchase program. As of June 30, 2024, $7.0 billion of authorization remained available under our stock repurchase program.

As a result of stock repurchases and quarterly dividend payments, we have an accumulated deficit as of June 30, 2024 and December 31, 2023. Our accumulated deficit is not anticipated to affect our future ability to operate, repurchase stock, pay dividends or repay our debt given our strong financial position.

During the six months ended June 30, 2024 and 2023, debt repayments totaled $1.4 billion and $704 million, respectively. In addition, we opportunistically repurchase our debt when market conditions are favorable. During the six months ended June 30, 2024 and 2023, we spent $410 million and $420 million, respectively, to extinguish principal amounts of debt of $544 million and $539 million, respectively.

We believe that existing funds, cash generated from operations and existing sources of and access to financing are adequate to satisfy our needs for working capital, capital expenditure and debt service requirements, as well as our plans to reduce debt, pay dividends and repurchase stock, and other business initiatives we plan to strategically pursue, including acquisitions and licensing activities. We anticipate that our liquidity needs can be met through a variety of sources, including cash provided by operating activities, sales of marketable securities, borrowings through commercial paper and/or syndicated credit facilities and access to other domestic and foreign debt markets and equity markets. See our Annual Report on Form 10-K for the year ended December 31, 2023, Part I, Item 1A. Risk Factors—Global economic conditions may negatively affect us and may magnify certain risks that affect our business.

Certain of our financing arrangements contain nonfinancial covenants. In addition, our revolving credit agreement and term loan credit agreement include a financial covenant that requires us to maintain a specified minimum interest coverage ratio of (i) the sum of consolidated net income, interest expense, provision for income taxes, depreciation expense, amortization expense, unusual or nonrecurring charges and other noncash items (consolidated earnings before interest, taxes, depreciation and amortization) to (ii) Consolidated Interest Expense, each as defined and described in the respective agreements. We were in compliance with all applicable covenants under these arrangements as of June 30, 2024.

Cash flows

Our summarized cash flow activity was as follows (in millions):

Six months ended June 30,
20242023
Net cash provided by operating activities$3,148$5,173
Net cash (used in) provided by investing activities$(434)$1,147
Net cash (used in) provided by financing activities$(4,357)$20,299

Operating

Cash provided by operating activities has been and is expected to continue to be our primary recurring source of funds. Cash provided by operating activities during the six months ended June 30, 2024, decreased compared with the prior year period due to timing of payments to the IRS, including repatriation taxes of $1.5 billion paid in the second quarter of 2024 and an advance deposit of $800 million paid in the first quarter of 2024.

Investing

Cash used in investing activities during the six months ended June 30, 2024, was primarily due to capital expenditures of $468 million, including construction costs of new plants in North Carolina and Ohio. Cash provided by investing activities during the six months ended June 30, 2023, was primarily due to net cash inflows from sales and maturities of marketable securities of $1.7 billion, partially offset by capital expenditures of $615 million. We currently estimate 2024 spending on capital projects to be approximately $1.3 billion.

Financing

Cash used in financing activities during the six months ended June 30, 2024, was primarily due to the payment of dividends of $2.4 billion and the repayment and extinguishment of debt of $1.4 billion and $410 million, respectively. Cash provided by financing activities during the six months ended June 30, 2023, was primarily due to proceeds from the issuance of debt of $23.8 billion, partially offset by the payment of dividends of $2.3 billion as well as the repayment and extinguishment of debt of $704 million and $420 million, respectively. See Note 9, Financing arrangements, and Note 10, Stockholders’ equity, to the condensed consolidated financial statements for further discussion.

Critical Accounting Policies and Estimates

The preparation of our condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and the notes to the financial statements. Some of those judgments can be subjective and complex, and therefore, actual results could differ materially from those estimates under different assumptions or conditions. A summary of our critical accounting policies and estimates is presented in Part II, Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations, of our Annual Report on Form 10-K for the year ended December 31, 2023.

Previous: Item 1. FINANCIAL STATEMENTS · Next: Item 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK