AMGEN INC
For the period ended Sep 30, 2024. Filed Oct 31, 2024.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2024 · Filed Oct 31, 2024
AMGN$460.42+0.0%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2024-06-30; filed 2024-08-07.
0000318154-24-000035
Item 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONSCurrent report: 10-Q
Period ended 2024-09-30; filed 2024-10-31.
0000318154-24-000044
Item 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONSThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 141 previous paragraphs and 144 current paragraphs.
86 unchanged; 44 reworded; 10 added; 9 removed; 2 previous and 4 current paragraphs rearranged.
Tables are not compared: 22 previous and 22 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (10)
Current report
In September 2024, we announced TEPEZZA was approved for the treatment of active or high clinical activity score (CAS) thyroid eye disease (TED) in Japan.
Current report
In September 2024, we announced top-line results of the Phase 3 MINT trial of UPLIZNA, an anti-CD19 humanized monoclonal antibody. MINT is a Phase 3, randomized, placebo-controlled, double-blind trial assessing the efficacy and safety of UPLIZNA in patients with generalized myasthenia gravis (gMG). The trial met its primary endpoint, with a statistically significant change from baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) score for UPLIZNA compared with placebo at week 26 of the combined patient population. UPLIZNA demonstrated a statistically significant and clinically meaningful change from baseline compared to placebo for four out of five key secondary endpoints. The overall safety results during the placebo-controlled period of the trial were consistent with the known safety profile of UPLIZNA.
Current report
Rocatinlimab
Current report
In September 2024, we announced top-line results of the Phase 3 ROCKET HORIZON trial of rocatinlimab, an investigational therapy targeting the OX40 receptor. ROCKET HORIZON is a Phase 3, randomized, placebo-controlled, double-blind trial assessing the efficacy, safety and tolerability of rocatinlimab monotherapy in adults with moderate to severe atopic dermatitis. The study met its co-primary endpoints and reached statistically significant difference from placebo for all key secondary endpoints. Overall safety findings in the study were comparable to those seen in the Phase 2b study.
Current report
The decrease in ENBREL sales for the three months ended September 30, 2024 was primarily driven by unfavorable changes to estimated sales deductions of 13% and lower net selling price of 12%.
Current report
The increase in global Repatha sales for the three months ended September 30, 2024 was driven by volume growth of 41% and favorable changes to estimated sales deductions of 8%, partially offset by lower net selling price of 10%.
Current report
TEPEZZA
Current report
Global Nplate sales for the nine months ended September 30, 2024 increased 3% and included U.S. government orders of $128 million and $224 million for the nine months ended September 30, 2024 and 2023, respectively. Excluding the U.S. government orders from this comparison, global Nplate sales increased 14% for the nine months ended September 30, 2024, driven by volume growth of 9% and higher net selling price.
Current report
The increase in SG&A expense for the three months ended September 30, 2024, was primarily driven by commercial expenses related to Horizon-acquired products.
Current report
Other income, net
Removed paragraphs (9)
Previous report
IMDELLTRA
Previous report
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.
Previous report
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).
Previous report
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.
Previous report
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,
Previous report
2024, driven by higher net selling price and volume growth.
Previous report
BLINCYTO
Previous report
(1)U.S. AMJEVITA product sales for the three and six months ended June 30, 2024, included unfavorable changes to estimated sales deductions.
Previous report
Other (expense) income, net
Reworded paragraphs (44)
Previous wording
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.
Current wording
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 Reports on Form 10-Q for the periods ended March 31, 2024 and June 30, 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.
Previous wording
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.
Current wording
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 Reports on Form 10-Q for the periods ended March 31, 2024 and June 30, 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.
Previous wording
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.
Current wording
Our principal products are Prolia, ENBREL, XGEVA, Repatha, Otezla, TEPEZZA, EVENITY, KYPROLIS, Nplate, Aranesp, KRYSTEXXA, BLINCYTO, Vectibix and TEZSPIRE. We also market a number of other products, including but not limited to MVASI, AMJEVITA/AMGEVITA, Neulasta, RAVICTI, Parsabiv, UPLIZNA, LUMAKRAS/LUMYKRAS, Aimovig, TAVNEOS, PROCYSBI, EPOGEN and IMDELLTRA.
Previous wording
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.
Current wording
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, provisions of the IRA, as well as the 340B Drug Pricing Program, 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.
Previous wording
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.
Current wording
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 June 30, 2024. For additional developments, see our Annual Report on Form 10-K for the year ended December 31, 2023, and our Quarterly Reports on Form 10-Q for the periods ended March 31, 2024 and June 30, 2024.
Previous wording
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.
Current wording
Total product sales increased 24% and 22% for the three and nine months ended September 30, 2024, respectively, primarily driven by volume growth of 29% and 27%, respectively, partially offset by declines in net selling price of 2% and 3%, respectively.
Previous wording
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.
Current wording
For the three months ended September 30, 2024, U.S. volume grew 34% and ROW volume grew 18%. Product sales from acquired Horizon products contributed $1.1 billion, with volume growth of 12% from our other brands, including Repatha, TEZSPIRE, EVENITY, BLINCYTO and Prolia.
Previous wording
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.
Current wording
For the nine months ended September 30, 2024, U.S. volume grew 31% and ROW volume grew 17%. Product sales from acquired Horizon products contributed $3.1 billion, with volume growth of 10% from our other brands, including Repatha, TEZSPIRE, EVENITY, Prolia and BLINCYTO.
Previous wording
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.
Current wording
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, the 340B Drug Pricing Program 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, June 30, 2024 and September 30, 2024.
Previous wording
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.
Current wording
Other revenues remained relatively unchanged for the three months ended September 30, 2024. Other revenues increased for the nine months ended September 30, 2024, driven by higher royalty income and corporate partner revenue from licensed products.
Previous wording
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.
Current wording
Operating expenses increased for the three and nine months ended September 30, 2024, primarily driven by higher amortization expense from Horizon acquisition-related assets and expenses from the acquired Horizon business.
Previous wording
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
Current wording
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 Reports on Form 10-Q for the periods ended March 31, 2024 and June 30, 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.
Previous wording
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.
Current wording
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.
Previous wording
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.
Current wording
The decrease in ENBREL sales for the nine months ended September 30, 2024 was 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.
Previous wording
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.
Current wording
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.
Previous wording
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.
Current wording
The increase in global Repatha sales for the nine months ended September 30, 2024 was driven by volume growth of 44%, partially offset by lower net selling price of 13%.
Previous wording
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%.
Current wording
The decrease in global Otezla sales for the three months ended September 30, 2024 was primarily driven by lower net selling price of 7%, partially offset by volume growth of 5%.
Previous wording
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%.
Current wording
The decrease in global Otezla sales for the nine months ended September 30, 2024 was driven by lower net selling price of 8%, partially offset by higher inventory of 3% and volume growth of 2%.
Previous wording
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.
Current wording
TEPEZZA was acquired on October 6, 2023 from our Horizon acquisition and generated $488 million and $1.4 billion in product sales for the three and nine months ended September 30, 2024, respectively. As TEPEZZA was acquired on October 6, 2023, there were no recorded product sales for the comparative prior periods.
Previous wording
The increase in global EVENITY sales for the three and six months ended June 30, 2024 was primarily driven by volume growth.
Current wording
The increase in global EVENITY sales for the three and nine months ended September 30, 2024 was driven by volume growth.
Previous wording
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.
Current wording
The increase in global KYPROLIS sales for the three and nine months ended September 30, 2024 was primarily driven by volume growth outside the United States.
Previous wording
The increase in global Nplate sales for the three months ended June 30, 2024 was driven by higher net selling price and volume growth.
Current wording
Global Nplate sales for the three months ended September 30, 2024 increased 9% and included U.S. government orders of $128 million and $142 million for the three months ended September 30, 2024 and 2023, respectively. Excluding the U.S. government orders from this comparison, global Nplate sales increased 18% for the three months ended September 30, 2024, driven by volume growth of 14% and higher net selling price.
Previous wording
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.
Current wording
The decrease in global Aranesp sales for the nine months ended September 30, 2024 was driven by unfavorable changes to estimated sales deductions and unfavorable changes to foreign currency exchange rates, partially offset by volume growth outside the United States.
Previous wording
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.
Current wording
KRYSTEXXA was acquired on October 6, 2023 from our Horizon acquisition and generated $310 million and $839 million in product sales for the three and nine months ended September 30, 2024, respectively. As KRYSTEXXA was acquired on October 6, 2023, there were no recorded product sales for the comparative prior periods.
Previous wording
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.
Current wording
The increase in global BLINCYTO sales for the three and nine months ended September 30, 2024 was primarily driven by volume growth.
Previous wording
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.
Current wording
The increase in global Vectibix sales for the three and nine months ended September 30, 2024 was primarily driven by volume growth.
Previous wording
The increase in TEZSPIRE sales for the three and six months ended June 30, 2024 was primarily driven by volume growth.
Current wording
The increase in TEZSPIRE sales for the three and nine months ended September 30, 2024 was primarily driven by volume growth.
Previous wording
(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.
Current wording
(1)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.
Previous wording
(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.
Current wording
(2)Consists of product sales from (i) KANJINTI, RIABNI, Corlanor, AVSOLA, NEUPOGEN, IMLYGIC, BEKEMV, WEZLANA/WEZENLA and Sensipar/Mimpara; and (ii) ACTIMMUNE, RAYOS, BUPHENYL, QUINSAIR, PENNSAID and DUEXIS in the periods after our Horizon acquisition on October 6, 2023.
Previous wording
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.
Current wording
Cost of sales increased to 38.9% and 40.0% of total revenues for the three and nine months ended September 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 increase for the nine months ended September 30, 2024 was partially offset by the prior year 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.
Previous wording
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.
Current wording
The increase in R&D expense for the three and nine months ended September 30, 2024, was driven by higher spend in later-stage clinical programs, marketed product support and research and early pipeline, including Horizon-acquired programs. We expect to continue to grow our spend on later-stage clinical programs as we advance our pipeline.
Previous wording
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.
Current wording
The increase in SG&A expense for the nine months ended September 30, 2024, was driven by expenses from the acquired Horizon business and other commercial expenses.
Previous wording
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.
Current wording
Other operating expenses for the three and nine months ended September 30, 2024, consisted primarily of impairment charges associated with IPR&D assets and changes in the fair values of contingent consideration liabilities, both related to our Teneobio, Inc. acquisition from 2021.
Previous wording
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.
Current wording
Other operating expenses for the three and nine months ended September 30, 2023, consisted of a net impairment charge resulting from the termination of AMG 340 and expenses related to our restructuring plan initiated in the first quarter of 2023.
Previous wording
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.
Current wording
Interest expense, net, remained relatively unchanged for the three months ended September 30, 2024. The increase in Interest expense, net, for the nine months ended September 30, 2024, was primarily due to higher average debt outstanding and higher weighted-average fixed and floating interest rates on the debt.
Previous wording
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.
Current wording
The increase in Other income, net, for the three months ended September 30, 2024, was primarily due to higher unrealized gains on our strategic equity investments, primarily BeiGene, partially offset by reduced interest income as a result of lower average cash balances.
Previous wording
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.
Current wording
The decrease in Other income, net, for the nine months ended September 30, 2024, was primarily due to lower current year net unrealized gains on our strategic equity investments, primarily BeiGene, and reduced interest income as a result of lower average cash balances. Prior period net gains on our strategic equity investments 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.
Previous wording
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.
Current wording
The decrease in our effective tax rate for the three months ended September 30, 2024, was primarily due to the earnings mix as a result of the inclusion of the Horizon business (including the amortization of Horizon acquired assets), partially offset by the quarter-to-date unrealized gains on our strategic equity investments (primarily BeiGene). See Note 6, Investments—BeiGene, Ltd., to the condensed consolidated financial statements. The decrease in our effective tax rate for the nine months ended September 30, 2024, was primarily due to the earnings mix as a result of the inclusion of the Horizon business (including the amortization of Horizon acquired assets).
Previous wording
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.
Current wording
Our balance of cash and cash equivalents was $9.0 billion as of September 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.
Previous wording
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.
Current wording
During the nine months ended September 30, 2024, we did not repurchase any of our common stock under our stock repurchase program. As of September 30, 2024, $7.0 billion of authorization remained available under our stock repurchase program.
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Rearranged current paragraphs (4)
Current report — wording carried from elsewhere
The increase in global Prolia sales for the three months ended September 30, 2024 was driven by volume growth of 9%, partially offset by lower inventory.
Current report — wording carried from elsewhere
The increase in global Prolia sales for the nine months ended September 30, 2024 was driven by volume growth.
Current report — wording carried from elsewhere
The increase in global XGEVA sales for the three and nine months ended September 30, 2024 was driven by higher net selling price.
Current report — wording carried from elsewhere
The increase in global Aranesp sales for the three months ended September 30, 2024 was driven by volume growth outside the United States.
Rearranged previous paragraphs (2)
Previous report — wording carried elsewhere
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.
Previous report — wording carried elsewhere
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.