Amgen's Strong Performance and Setback in Obesity Drug Development

On February 4, Amgen announced its fourth-quarter and full-year 2024 earnings: total annual revenue increased by 19%, reaching $33.4 billion, surpassing the annual forecast of $33.19 billion, with strong financial performance.

Notably, in the report, Amgen's early-stage obesity drug, AMG 513, had its research halted by the FDA.

Amgen's Strong 2024 Financial Performance

Amgen's substantial growth in 2024 was mainly driven by significant product sales increases, specifically:

• Repatha? (evolocumab), a cholesterol-lowering drug, saw Q4 sales grow by 45% year-over-year, reaching $606 million. Annual sales grew 36% to $2.22 billion.
• Prolia? (denosumab), an osteoporosis drug, saw Q4 sales increase by 5%, reaching $1.2 billion, with annual growth of 8%.
• Enbrel, an arthritis drug, maintained sales at about $1 billion, consistent with last year.
• In the rare disease field, Amgen's acquisition of Horizon's thyroid eye disease drug, Tepezza, saw Q4 sales increase by 3% to $460 million, with annual sales approaching $1.9 billion. TEPEZZA is the first and only approved treatment for thyroid eye disease (TED) in the U.S. and Japan.
• Krystexxa, a gout treatment, saw Q4 sales increase by 27% to $346 million, with annual sales nearing $1.2 billion. Krystexxa is the first and only FDA-approved treatment for chronic refractory gout.

Biologic drug competition continues to pose challenges, especially impacting traditional products like Neulasta and Enbrel. Sales of these drugs have declined due to competitive pricing from biosimilar rivals. However, Amgen has actively launched its own biosimilars, such as Rayos and Pennsaid, to maintain market share in these profitable drug categories, particularly around well-known treatments like Avastin.

In terms of cash flow, Amgen's fourth-quarter cash flow reached $4.4 billion, positioning the company well for debt reduction and other strategic initiatives. Its rigorous capital management supports continued investment in R&D and manufacturing capabilities.

Amgen expects its 2025 revenue to range between $34.3 billion and $35.7 billion.

Behind the Dazzling Performance – Setback in Obesity Drug Development

However, after reporting its impressive results, Amgen made a notable decision to pause the development of its obesity drug, AMG 513.

The obesity drug market has long been an important focus for biopharmaceutical companies. Amgen launched an obesity drug in 2022, further expanding its presence in this market. Currently, Amgen has three obesity drugs in the clinical stage, but two of them are facing setbacks:

• AMG133: This drug, a GLP-1R agonist/GIPR antagonist, has completed Phase 2 clinical trials and is the only obesity drug candidate making progress.
• AMG786: A small-molecule oral drug that completed Phase 1 trials but was terminated. Amgen did not disclose the specific reason for termination, but mentioned that AMG 786 did not meet the differentiation criteria compared to MariTide.
• AMG513: Registered for Phase 1 clinical trials, but the mechanism of action has not been disclosed. This drug is now paused.

On February 4, the FDA paused a Phase 1 clinical trial for AMG 513, a drug targeting obesity patients. The pause was made to protect participants from unreasonable risks and ensure the proper conduct of the trial. This means Amgen can no longer continue testing the AMG 513 drug.

At present, the company has not explained the reason for the clinical pause, only stating that it is “discussing ways to restart the study.” Under the current market conditions, it may be difficult for this project to achieve the expected return on investment.

Despite the setback in the obesity drug field, Amgen's highly anticipated obesity candidate, MariTide, continues to make progress. MariTide is a GLP-1R agonist/GIPR antagonist, which, compared to semaglutide and tirzepatide, has a lower dosing frequency, with injections once a month or less. Mid-stage trials show it can help overweight or obese patients lose up to 20% of their body weight.

Amgen stated that Phase 3 clinical trials for MariTide will begin in the first half of this year, and follow-up data from the study, including trials for diabetes patients, will be released in the second half of the year.