Amgen outperformed expectations in the fourth quarter of 2024, but revealed an FDA hold on early-stage obesity asset AMG 513 and the discontinuation of other programs.
In its fourth-quarter and full-year 2024 business report on Tuesday, Amgen touted revenues that topped analyst expectations, while also revealing several pipeline issues and adjustments.
In the fourth quarter, Amgen logged $9.1 billion in total revenues, representing an 11% year-on-year increase—and a 3% beat of the consensus forecast of $8.85 billion. For the entire year 2024, Amgen surged 19% to bring in $33.4 billion.
Most notably for its pipeline, the pharma disclosed that its early-stage obesity asset AMG 513 was placed on clinical hold by the FDA—though CEO Robert Bradway said in an investor call that the reason for the hold is likely not related to the drug. Amgen is currently in talks with the FDA to reopen the study.
According to its clinicaltrials.gov page, AMG 513 is an injectable drug that is currently being studied in a Phase I single- and multiple-ascending dose trial, primarily to assess its safety and tolerability in adults with obesity. During the call, chief scientific officer Jay Bradner declined to reveal AMG 513’s mechanism of action, pointing to the competitiveness of the obesity space.
Amgen on Tuesday also revealed that it is discontinuing the development of fipaxalparant in diffuse cutaneous systemic sclerosis after disappointing Phase II data, as well as a Phase III study of its antibody Tezspire in asthma due to “limited enrollment.”
Despite the hold on AMG 513, Amgen remains optimistic about its obesity pipeline, anchored by its closely watched bispecific molecule MariTide. The company has “several new Phase III trials” involving that candidate slated to launch in the first half of this year, Bradway said during Tuesday’s call. The late-stage program, dubbed MARITIME, will focus on chronic weight management, kidney disease, type 2 diabetes, cardiovascular disease and sleep apnea.
In November 2024, Amgen revealed early Phase II data for MariTide that disappointed many investors. At the time, the pharma announced that the obesity drug could reduce body weight by up to 20% on average at 52 weeks, an outcome that fell on the lower end of shareholders’ expected range. Amgen’s shares dropped 11% in the aftermath of the readout.
On Tuesday, the company announced that additional Phase II data for MariTide are expected in the second half of 2025. The company is also running a mid-stage trial of the asset in type 2 diabetes patients with and without obesity. This study is currently enrolling and is also set to return a readout later this year.
“Our obesity efforts fit very well with our strengths in cardiovascular disease, nephrology, and more generally, the emerging presence in primary care,” Bradner said during the call, asserting that the pharma is working toward a diverse weight-loss portfolio, with treatments that can be taken orally or given subcutaneously. “We’re very confident in MariTide and very confident in the pipeline behind it.”
Key drivers of growth in the fourth quarter included the hyperlipidemia drug Repatha, which jumped 45% to hit worldwide earnings of $606 million, and postmenopausal osteoporosis therapy Evenity, with rose 36% to $431 million. The pharma’s top-performing assets were Prolia, also for postmenopausal osteoporosis, and the TNF blocker Enbrel, which earned $1.165 billion and $1.015 billion in the fourth quarter, respectively.
Analysts at BMO Capital Markets wrote in an investor note on Tuesday that Amgen’s Q4 performance “illustrated that mature products like Repatha still have some runway for growth which goes under the radar because of a heavier focus on its more recent launches.”
Pavblu, Amgen’s biosimilar to Regeneron’s Eylea, could also see revenues “growing more substantively in 2025,” according to the BMO analysts, particularly as other biosimilars “are likely to be prevented from launching by injunction.”
Looking ahead to the rest of the year, Amgen forecasts total revenues to fall between $34.3 billion and $35.7 billion, a range that Jefferies analysts called “solid” in an investor note, especially given “heightened uncertainty” due to the impending second-quarter entry of biosimilar competition to Prolia. Amgen projected a full-year earnings-per-share outlook at $20 to $21.20.
