Amgen takes Q3 profit hit after scrapping prostate cancer drug

2023-10-31

·Firstwordpharma

临床2期并购临床1期上市批准临床结果

Headline results for the third quarter:

Revenue: $6.9 billion, up 4%

Product sales: $6.5 billion, up 5%

Profit: $1.7 billion, versus $2.1 billion in the year-ago period

Note: All changes are versus the prior-year period unless otherwise stated

What the company said:

"We are excited about our pipeline progress and our operating performance in the third quarter. With the completion of the Horizon acquisition, Amgen has added rare disease medicines that fit well with our broad innovative portfolio," remarked Amgen CEO Robert Bradway.

The company said earnings were negatively impacted by an impairment charge of roughly $650 million following a decision to discontinue development of AMG 340, a PSMAxCD3 bispecific T-cell engager (BiTE) it was evaluating for prostate cancer (see more below).

Meanwhile, the company reported an overall 11% volume growth, primarily driven by double-digit gains for Blincyto, Evenity, Repatha, and Nplate. US volumes also increased by 11%, while ex-US volumes grew by 12%, with the Asia Pacific region experiencing 27% growth in volume.

Other results: Enbrel: $1 billion, down 6%

Prolia: $986 million, up 14%

Otezla: $567 million, down 10%, with demand in the quarter continuing to be impacted by free drug programmes for newly launched competition

Xgeva: $519 million, up 5%

Repatha: $406 million, up 31%, with US sales up 29% to $183 million

Kyprolis: $349 million, up 10%

Aranesp: $323 million, down 10%

Evenity: $307 million, up 53%

Blincyto: $220 million, up 55%

Mvasi: $213 million, up 2%

Tezspire: $161 million, benefitting from the introduction of a self-administered, pre-filled, single-use pen approved by the FDA earlier this year

Amgevita/Amjevita: $152 million, up 30%

Neulasta: $124 million, down 50%

Aimovig: $94 million, down 12%

Lumakras/Lumykras: $52 million, down 31%, primarily influenced by adverse changes to estimated sales deductions linked to ongoing reimbursement negotiations in France

Epogen: $50 million, down 63%

Kanjinti: $20 million, down 72%

Looking ahead:

Amgen is now anticipating sales this year will come in between $28 billion and $28.4 billion, up from an earlier estimate of between $26.6 billion to $27.4 billion. It also lifted the lower end of its profit outlook by $0.40 and now expects to earn $18.20 to $18.80 per share.

Pipeline update:

Amgen said it ended a Phase I dose-escalation study of AMG 340 in metastatic castration-resistant prostate cancer. The company had acquired the drug via its acquisition of Teneobio in 2021 for up to $2.5 billion.

This marks the latest in several BiTE candidates Amgen has discontinued, including the BCMA-targeting molecule pavurutamab last year. The company continues to develop its DLL3-targeting BiTE drug tarlatamab, having recently reported that it produced an objective response rate (ORR) of 40% in patients with advanced stage small-cell lung cancer who had failed two or more prior lines of treatment.

Meanwhile, Amgen is testing the weight-loss drug AMG 133, also known as maridebart cafraglutide. The multispecific molecule, which inhibits GIP and GLP-1 receptors, is being evaluated in a Phase II study in overweight or obese adults with or without type 2 diabetes, with top-line results due in "late 2024."

What analysts said:

Analysts are looking ahead to the company's efforts in obesity. "Management…noted that they have a suite of preclinical obesity assets that they plan to bring forward 'over the next few years,'" remarked Salim Syed of Mizuho Securities.

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