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Donnerstag, 02.05.2024 16:01 von | Aufrufe: 207

AMGEN REPORTS FIRST QUARTER 2024 FINANCIAL RESULTS

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PR Newswire

THOUSAND OAKS, Calif., May 2, 2024

THOUSAND OAKS, Calif., May 2, 2024 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced financial results for the first quarter 2024.

"With many of our innovative products delivering strong growth and promising new medicines advancing through our pipeline, we are excited about delivering attractive long-term growth," said Robert A. Bradway, chairman and chief executive officer.

Key results include:

  • For the first quarter, total revenues increased 22% to $7.4 billion in comparison to the first quarter of 2023. Product sales grew 22%, driven by 25% volume growth.
    • Ten products delivered at least double-digit volume growth in the first quarter, including Repatha® (evolocumab), TEZSPIRE® (tezepelumab-ekko), EVENITY® (romosozumab-aqqg), BLINCYTO® (blinatumomab), and TAVNEOS® (avacopan).
    • U.S. volume grew 29% and ex-U.S. volume grew 17%.
    • Our performance included $914 million of sales from our Horizon Therapeutics (Horizon) acquisition, driven by several first-in-class, early-in-lifecycle medicines, including TEPEZZA® (teprotumumab-trbw), KRYSTEXXA® (pegloticase) and UPLIZNA® (inebilizumab-cdon).
    • Excluding sales from Horizon, our product sales grew 6%, driven by volume growth of 9%.
  • GAAP loss per share was $0.21 for the first quarter of 2024 compared with GAAP earnings per share (EPS) of $5.28 for the first quarter of 2023, driven by a mark-to-market loss on our BeiGene, Ltd. equity investment and higher operating expenses, including higher amortization expense from Horizon-acquired assets and incremental expenses from Horizon, partially offset by higher revenues.
    • GAAP operating income decreased from $1.9 billion to $1.0 billion, and GAAP operating margin decreased 19.0 percentage points to 13.9%.
  • Non-GAAP EPS decreased 1% from $3.98 to $3.96, due to higher operating and interest expenses driven by the Horizon acquisition, partially offset by higher revenues.
    • Non-GAAP operating income increased from $2.8 billion to $3.1 billion, and non-GAAP operating margin decreased 5.1 percentage points to 43.2%.
  • The Company generated $0.5 billion of free cash flow for the first quarter of 2024 versus $0.7 billion in the first quarter of 2023. This decrease was driven by an $800 million tax deposit, partially offset by timing of working capital items.

References in this release to "non-GAAP" measures, measures presented "on a non-GAAP basis" and "free cash flow" (computed by subtracting capital expenditures from operating cash flow) refer to non-GAAP financial measures. Adjustments to the most directly comparable GAAP financial measures and other items are presented on the attached reconciliations. Refer to Non-GAAP Financial Measures below for further discussion.

Product Sales Performance

Total product sales increased 22% for the first quarter of 2024 versus the first quarter of 2023, driven by 25% volume growth.

General Medicine


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  • Repatha® sales increased 33% year-over-year to $517 million in the first quarter, driven by 44% volume growth, partially offset by 13% lower net selling price. Repatha remains the global proprotein convertase subtilisin/kexin type 9 (PCSK9) segment leader, with over 2.9 million patients treated since launch.
  • Prolia® (denosumab) generated $999 million of sales in the first quarter. Sales increased 8% year-over-year primarily driven by volume growth.
  • EVENITY® sales increased 35% year-over-year to $342 million for the first quarter, primarily driven by volume growth.

Oncology

  • BLINCYTO® sales increased 26% year-over-year to $244 million for the first quarter, driven by broad prescribing across academic and community segments for patients with B-cell precursor acute lymphoblastic leukemia (B-ALL).
  • Vectibix® (panitumumab) generated $247 million of sales in the first quarter. Sales increased 6% year-over-year driven by higher net selling price and volume growth, partially offset by unfavorable foreign exchange impact.
  • KYPROLIS® (carfilzomib) sales increased 5% year-over-year to $376 million for the first quarter, primarily driven by volume growth outside the U.S.
  • LUMAKRAS®/LUMYKRAS™ (sotorasib) sales increased 11% year-over-year to $82 million for the first quarter, driven by volume growth.
  • XGEVA® (denosumab) sales increased 5% year-over-year to $561 million for the first quarter, primarily driven by volume growth outside the U.S. and higher net selling price, partially offset by lower volume in the U.S.
  • Nplate® (romiplostim) generated $317 million of sales in the first quarter. Sales decreased 12% year-over-year, primarily driven by volume decline in comparison to the first quarter of 2023, which included a U.S. government order of $82 million. Excluding the U.S. government order from this comparison, Nplate sales grew 13% year-over-year, primarily driven by volume growth.
  • MVASI® (bevacizumab-awwb) generated $202 million of sales in the first quarter. Sales were flat year-over-year for the first quarter. Volume growth was largely offset by lower net selling price and unfavorable changes to estimated sales deductions. Going forward we expect continued net selling price erosion driven by competition.

Inflammation

  • TEZSPIRE® generated $173 million of sales in the first quarter. Sales increased 80% year-over-year, primarily driven by volume growth. Healthcare providers recognize TEZSPIRE's unique, differentiated profile and its broad potential to treat the 2.5 million patients worldwide with severe asthma who are uncontrolled, without any phenotypic or biomarker limitation.
  • Otezla® (apremilast) generated $394 million of sales in the first quarter. Sales increased 1% year-over-year for the first quarter.
  • Enbrel® (etanercept) generated $567 million of sales in the first quarter. Sales decreased 2% year-over-year driven by volume decline, partially offset by higher inventory levels. Moving forward, we expect modest volume growth offset by declining net selling price.

Otezla and Enbrel typically have lower sales in the first quarter relative to subsequent quarters due to the impact of benefit plan changes, insurance reverifications and increased co-pay expenses as U.S. patients work through deductibles.

  • AMJEVITA®/AMGEVITA™ (adalimumab) generated $168 million of sales in the first quarter. Sales increased 2% year-over-year primarily driven by international growth, partially offset by lower inventory levels and unfavorable change to estimated sales deductions.

Rare Disease

Except for TAVNEOS®, the products listed below were added through the acquisition of Horizon on Oct. 6, 2023.

  • TEPEZZA® (teprotumumab-trbw) generated $424 million of sales in the first quarter. TEPEZZA is the first and only FDA-approved treatment for thyroid eye disease (TED).
  • KRYSTEXXA® (pegloticase) generated $235 million of sales in the first quarter. KRYSTEXXA is the first and only FDA-approved treatment for chronic refractory gout.
  • UPLIZNA® (inebilizumab-cdon) generated $80 million of sales in the first quarter. UPLIZNA is used to treat adults with neuromyelitis optica spectrum disorders.
  • TAVNEOS® generated $51 million of sales in the first quarter. Sales increased 122% year-over-year, driven by volume growth.
  • Ultra rare products, which consist of RAVICTI® (glycerol phenylbutyrate), PROCYSBI® (cysteamine bitartrate), ACTIMMUNE® (interferon gamma-1b), BUPHENYL® (sodium phenylbutyrate) and QUINSAIR® (levofloxacin), generated $169 million of sales in the first quarter.

Established Products

  • Our established products, which consist of EPOGEN® (epoetin alfa), Aranesp® (darbepoetin alfa), Parsabiv® (etelcalcetide) and Neulasta® (pegfilgrastim), generated $613 million of sales. Sales decreased 19% year-over-year for the first quarter, driven by unfavorable changes to estimated sales deductions and volume declines. In the aggregate, we expect the year-over-year volume declines for this portfolio of products to continue.

Product Sales Detail by Product and Geographic Region

$Millions, except percentages

Q1 '24

Q1 '23

YOY Δ


US

ROW

TOTAL

TOTAL

TOTAL

Repatha®

$         273

$         244

$         517

$         388

33 %

Prolia®

657

342

999

927

8 %

EVENITY®

236

106

342

254

35 %

BLINCYTO®

153

91

244

194

26 %

Vectibix®

120

127

247

233

6 %

KYPROLIS®

234

142

376

358

5 %

LUMAKRAS®/LUMYKRAS™

53

29

82

74

11 %

XGEVA®

366

195

561

536

5 %

Nplate®

190

127

317

362

(12 %)

MVASI®

105

97

202

202

— %

TEZSPIRE®

173

—

173

96

80 %

Otezla®

293

101

394

392

1 %

Enbrel® 

561

6

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