Amgen's Q4 Success Overshadowed by Pipeline Setbacks

Amgen, a leading pharmaceutical company, reported strong financial performance in the fourth quarter of 2024, but faces challenges in its drug development pipeline. The company's mixed results highlight the ongoing complexities in the pharmaceutical industry, where financial success and clinical setbacks often go hand in hand.

Q4 Financial Performance Exceeds Expectations

Amgen's fourth-quarter revenues reached $9.1 billion, marking an 11% year-on-year increase and surpassing analyst expectations of $8.85 billion. For the full year 2024, the company's revenues soared by 19% to $33.4 billion. Key growth drivers included Repatha, a hyperlipidemia drug, which saw a 45% increase to $606 million in worldwide earnings, and Evenity, a postmenopausal osteoporosis therapy, which rose 36% to $431 million.

The company's top-performing assets were Prolia, another postmenopausal osteoporosis treatment, and Enbrel, a TNF blocker, earning $1.165 billion and $1.015 billion in the fourth quarter, respectively. Analysts at BMO Capital Markets noted that mature products like Repatha still have growth potential, which is often overshadowed by newer launches.

Pipeline Challenges and Adjustments

Despite the financial success, Amgen faced several setbacks in its drug development pipeline. The FDA placed a clinical hold on AMG 513, an early-stage obesity asset, although CEO Robert Bradway suggested that the reason for the hold is likely unrelated to the drug itself. The company is currently in discussions with the FDA to resume the study.

Additionally, Amgen announced the discontinuation of fipaxalparant development for diffuse cutaneous systemic sclerosis due to disappointing Phase II data. The company also halted a Phase III study of its antibody Tezspire in asthma, citing "limited enrollment."

Focus on Obesity and Future Outlook

Despite these setbacks, Amgen remains optimistic about its obesity pipeline, particularly its bispecific molecule MariTide. The company plans to launch several new Phase III trials for MariTide in the first half of 2025, focusing on chronic weight management, kidney disease, type 2 diabetes, cardiovascular disease, and sleep apnea.

Early Phase II data for MariTide, revealed in November 2024, showed a body weight reduction of up to 20% on average at 52 weeks. While this result fell on the lower end of investor expectations, Amgen continues to express confidence in the drug's potential. Additional Phase II data for MariTide is expected in the second half of 2025.

Looking ahead, Amgen forecasts total revenues for 2025 to be between $34.3 billion and $35.7 billion, with a full-year earnings-per-share outlook of $20 to $21.20. These projections come amid uncertainty surrounding the impending second-quarter entry of biosimilar competition to Prolia.