Amgen recently announced a strong fourth-quarter profit driven by an 11% increase in product sales. The company also confirmed that late-stage studies for its promising obesity drug candidate, MariTide, will commence before mid-year. However, an early-stage trial for a separate experimental weight-loss drug, AMG 513, has been placed on clinical hold by the FDA.
Amgen’s stock, which has seen an impressive year-to-date gain of over 11%, experienced a slight dip of around 1% in after-hours trading following the announcement. Much of the investor focus remains on the potential of MariTide, a drug designed to activate the GLP-1 hormone, known for its appetite and blood sugar-reducing properties, while simultaneously blocking the GIP gut hormone. Mid-stage trial results indicated that MariTide, administered via injection monthly or less frequently, enabled overweight and obese patients to lose up to 20% of their body weight.
Jay Bradner, Amgen’s head of research and development, stated that the complete study findings will be unveiled in June at the American Diabetes Association’s annual meeting in Chicago. Further data from this study and a separate trial involving individuals with diabetes are anticipated in the latter half of 2024.
Amgen has indicated that the initial studies within a comprehensive Phase 3 program for MariTide are expected to launch in the first half of this year. This pivotal phase aims to generate data that could pave the way for regulatory approval of the drug. Conversely, the FDA has imposed a clinical hold on a Phase 1 study of AMG 513, an obesity drug candidate whose mechanism of action Amgen has not yet disclosed. Such holds are implemented by the regulatory agency to safeguard trial participants from undue risks and to guarantee the proper conduct of studies. Amgen confirmed that discussions are ongoing to address the FDA’s concerns and resume the AMG 513 study.
CEO Bob Bradway expressed enthusiasm for the company’s obesity portfolio and the promising molecules advancing to clinical trials. Amgen reported adjusted fourth-quarter earnings of $5.31 per share, a 13% increase year-over-year, surpassing analyst estimates of $5.08, according to LSEG data. Revenue also exceeded expectations, climbing 11% to $9.1 billion.
While acknowledging a solid quarter, Edward Jones analyst John Boylan noted that investors are likely anticipating the upcoming release of further data from the MariTide mid-stage trial. Looking ahead to 2025, Amgen projects adjusted earnings per share in the range of $20.00 to $21.20, with revenue between $34.4 billion and $35.7 billion. Mizuho analyst Salim Syed described this guidance as “OK,” encompassing consensus estimates on both the upper and lower ends. Amgen’s performance and the progress of MariTide will undoubtedly remain under close scrutiny in the coming months.
