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Donnerstag, 27.04.2023 16:01 von | Aufrufe: 160

AMGEN REPORTS FIRST QUARTER FINANCIAL RESULTS

Wissenschaftler bei mikroskopischen Untersuchungen. (Symbolbild). © skynesher / E+ / Getty Images http://www.gettyimages.de/

PR Newswire

THOUSAND OAKS, Calif., April 27, 2023 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced financial results for the first quarter of 2023.

"We delivered 14% volume growth driven by the breadth of our portfolio and strong demand for our products globally," said Robert A. Bradway, chairman and chief executive officer. "We look forward to closing the acquisition of Horizon Therapeutics and joining forces to reach more patients around the world with their innovative medicines."

Key results include:

  • Total revenues decreased 2% to $6.1 billion in comparison to the first quarter of 2022, resulting from lower Other Revenue from our COVID-19 manufacturing collaboration, partially offset by a 2% increase in product sales. Product sales growth was driven by 14% volume growth, partially offset by 5% lower net selling price, 3% unfavorable changes to estimated sales deductions, 2% lower inventory levels and 2% negative impact from foreign exchange. Excluding the 2% negative impact of foreign exchange on product sales, total revenues were largely unchanged from Q1 2022.
    • Volume growth of 14% included double-digit volume growth from EVENITY® (romosozumab-aqqg), BLINCYTO® (blinatumomab), Nplate® (romiplostim), LUMAKRAS®/LUMYKRAS™ (sotorasib), AMJEVITA®/AMGEVITA™ (adalimumab), Repatha® (evolocumab), KYPROLIS® (carfilzomib) and Vectibix® (panitumumab). 
    • Ex-U.S. volume grew 22%, including 47% volume growth in the Asia Pacific region.
  • GAAP earnings per share (EPS) increased 97% from $2.68 to $5.28, driven by other income due to a mark-to-market gain on our investment in BeiGene, Ltd. and lower weighted-average shares outstanding in Q1 2023.
    • GAAP operating income decreased from $2.5 billion to $1.9 billion, and GAAP operating margin decreased 10.7 percentage points to 32.9%.
  • Non-GAAP EPS decreased 6% from $4.25 to $3.98, driven by decreased revenues and higher operating expenses, primarily related to research & development, in Q1 2023.
    • Non-GAAP operating income decreased from $3.1 billion to $2.8 billion, and non-GAAP operating margin decreased 6.5 percentage points to 48.3%.
  • The Company generated $0.7 billion of free cash flow for the first quarter of 2023 versus $2.0 billion in the first quarter of 2022, driven by the timing of payments for sales incentives, rebates and discounts, lower operating income, and higher capital expenditures from the build-out of our new North Carolina and Ohio facilities.

References in this release to "non-GAAP" measures, measures presented "on a non-GAAP basis," "free cash flow" (computed by subtracting capital expenditures from operating cash flow) and "total revenues and product sales adjusted for foreign exchange impact" (computed by converting our current period local currency product sales using the prior period foreign exchange rates and comparing that to our current period product sales) 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 2% for the first quarter of 2023 versus the first quarter of 2022. Unit volumes grew 14%, partially offset by 5% lower net selling price, 3% unfavorable changes to estimated sales deductions, 2% lower inventory levels and 2% negative impact from foreign exchange.

General Medicine


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  • Repatha® sales increased 18% year-over-year to a record $388 million for the first quarter. Volume growth of 33% for the quarter was partially offset by lower net selling price. In the U.S., sales grew 19%, driven by 32% volume growth, partially offset by lower net selling price and inventory levels. Outside the U.S., sales grew 16%, driven by 34% volume growth, partially offset by lower net selling price and unfavorable foreign exchange impact. Repatha remains the global proprotein convertase subtilisin/kexin type 9 (PCSK9) segment leader, with over 1.7 million patients treated since launch.

  • Prolia® (denosumab) sales increased 9% year-over-year for the first quarter, driven by 8% volume growth.

  • EVENITY® sales increased 49% year-over-year to a record $254 million for the first quarter, primarily driven by strong volume growth across our markets. U.S. volumes grew 43% year-over-year and volumes outside the U.S. grew 77%.

  • Aimovig® (erenumab-aooe) sales decreased 32% year-over-year for the first quarter, driven by unfavorable changes to estimated sales deductions and lower net selling price. For 2023, we expect continued year-over-year net selling price declines in order to maintain broad formulary access for patients in response to competitive dynamics.

Inflammation

  • TEZSPIRE® (tezepelumab-ekko) generated $96 million of sales in the first quarter, driven by strong adoption in the U.S. by both allergists and pulmonologists. Quarter-over-quarter sales increased 22%, driven by volume growth. Healthcare providers appreciate 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. During the first quarter, the U.S. Food and Drug Administration (FDA) approved TEZSPIRE for self-administration in a pre-filled, single-use pen, which improves accessibility and provides more flexibility in treatment options for patients in the U.S.

  • TAVNEOS® (avacopan) generated $23 million of sales in the first quarter. Quarter-over-quarter sales increased 10%, driven by higher net selling price and inventory levels, partially offset by lower ex-U.S. volume driven by the timing of shipments to our ex-U.S. partner in the fourth quarter of 2022. U.S volume grew 27% quarter-over-quarter, driven by an increase in new patients starting treatment.

  • Otezla® (apremilast) sales decreased 13% year-over-year for the first quarter, driven by lower inventory levels and net selling price, partially offset by 5% volume growth. Otezla followed the historical pattern of lower first quarter sales relative to the remainder of the year due to the impact of benefit plan changes, insurance reverifications and increased co-pay expenses as U.S. patients worked through deductibles. U.S. sales in the first quarter were also impacted by lower specialty pharmacy inventory levels compared to previous years, and price declines resulting from patient mix and additional rebates to improve the quality of coverage. In the U.S., Otezla new patient demand was impacted by free drug programs for newly launched topical and systemic competitors. We expect new patient demand to continue to be impacted by free drug programs from newly launched competition throughout 2023.

    We continue to see strong growth potential for Otezla given its established efficacy and safety profile, strong payor coverage with limited prior authorization requirements and ease of administration. Otezla remains the only approved oral systemic therapy with a broad indication and is well-positioned to help the 1.5 million U.S. patients with mild-to-moderate psoriasis that cannot be optimally addressed by a topical and can benefit from a systemic treatment like Otezla.

  • Enbrel® (etanercept) sales decreased 33% year-over-year for the first quarter, driven by decline in net selling price, lower inventory levels in the distribution channel compared to previous years and a 9% unfavorable impact of changes to estimated sales deductions related to prior periods. Consistent with Otezla, sales in the first quarter were also impacted by typical patterns of benefit plan changes and higher co-pay expenses. Year-over-year volume was flat in the first quarter, with U.S. volume growing 1%, supported by improved payor coverage. For the remainder of 2023, we expect low single-digit volume growth, reduced year-over-year decline in net selling price and a gradual recovery in inventory levels.

  • AMJEVITA®/AMGEVITA™ sales increased 52% year-over-year to a record $164 million for the first quarter, driven by higher inventory levels and 35% volume growth, partially offset by unfavorable foreign exchange impact. AMJEVITA launched in the U.S. early in the first quarter, and a majority of U.S. sales in the quarter were related to inventory build.

Hematology-Oncology

  • BLINCYTO® sales increased 41% year-over-year to a record $194 million for the first quarter, driven by 49% volume growth supported by strong adoption across academic and community centers.

  • Vectibix® sales increased 16% year-over-year for the first quarter, driven by 15% volume growth supported by positive data from the Phase 3 PARADIGM trial demonstrating the superiority of Vectibix over bevacizumab in combination with chemotherapy.

  • KYPROLIS® sales increased 25% year-over-year to a record $358 million for the first quarter, driven by 18% volume growth, higher net selling price and strong global execution.

  • LUMAKRAS®/LUMYKRAS™ generated $74 million of sales for the first quarter. Year-over-year sales increased 19% for the first quarter, driven by 40% volume growth, partially offset by lower net selling price. Outside the U.S., LUMYKRAS has been approved in 50 countries around the world. We are actively launching in over 30 markets and pursuing reimbursement in the remaining countries.

  • XGEVA® (denosumab) sales increased 7% year-over-year for the first quarter, driven by higher net selling price and 4% volume growth.

  • Nplate® sales increased 36% year-over-year for the first quarter, driven by 41% volume growth. Nplate sales in the first quarter included $82 million related to an order from the U.S. government.

  • MVASI® (bevacizumab-awwb) sales decreased 17% year-over-year for the first quarter, driven by lower net selling price, partially offset by 15% volume growth. The published first quarter Average Selling Price (ASP) for MVASI in the U.S. declined 27% year-over-year and increased 5% quarter-over-quarter. Going forward, we expect continued net selling price erosion driven by increased competition.

  • KANJINTI® (trastuzumab-anns) sales decreased 51% year-over-year for the first quarter, driven by lower net selling price and volume. The published first quarter ASP for KANJINTI in the U.S. declined 36% year-over-year and increased 3% quarter-over-quarter. Going forward, we expect continued net selling price erosion and declining volume driven by increased competition.

Established Products

  • Total sales of our established products, which include EPOGEN® (epoetin alfa), Aranesp® (darbepoetin alfa), Parsabiv® (etelcalcetide), and Neulasta® (pegfilgrastim), decreased 17% year-over-year for the first quarter, driven by lower net selling price, unfavorable changes to estimated sales deductions, and lower volume. The published first quarter ASP for Neulasta in the U.S. declined 26% year-over-year and increased 3% quarter-over-quarter. In the aggregate, we expect the year-over-year net selling price and volume erosion for this portfolio of products to continue.

 

Product Sales Detail by Product and Geographic Region


$Millions, except percentages


Q1 '23


Q1 '22


YOY Δ



US


ROW


TOTAL


TOTAL


TOTAL

Repatha®


197


191


388


329


18 %

Prolia®


623


304


927


852


9 %

EVENITY®


164


90


254


170


49 %

Aimovig®


64


5


69


101


(32 %)

TEZSPIRE®


96



96


7


*

TAVNEOS®


23



23



NM

Otezla®


294


98


392


451


(13 %)

Enbrel® 


564


15


579


862


(33 %)

AMJEVITA®/AMGEVITA


51


113


164


108


52 %

BLINCYTO®


126


68


194


138


41 %

Vectibix®


111


122


233


201


16 %

KYPROLIS®


234


124


358


287


25 %

LUMAKRAS®/LUMYKRAS


48


26


74


62

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