Amgen Q1 Results: Tavneos Update as Sales Rise
Amgen Q1 results showed stronger sales and an EPS beat that lifted FY2026 guidance and may shift positioning amid a Tavneos FDA withdrawal proposal.
KEY TAKEAWAYS
- Amgen reported Q1 revenue of $8.6B and product sales rose 4% driven by volume gains.
- Adjusted EPS was $5.15 and Amgen raised FY2026 revenue guidance to $37.1B-$38.5B.
- FDA proposed withdrawal of Tavneos; Amgen filed a CBE-30 label update addressing hepatotoxicity concerns.
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Amgen’s Q1 results disclosed April 30 showed product sales rose, driven by cholesterol and rare-disease medicines. The company filed a Tavneos label update with the FDA after a proposed withdrawal and raised its fiscal-year outlook.
First-Quarter Results and Product Performance
Amgen (AMGN) reported total revenues of $8.6 billion for the quarter ended March 31, 2026, up 6% year on year, the company said in a press release. Product sales increased 4%, supported by a 9% volume gain that offset 2% declines from net selling price and inventory reductions. Adjusted earnings per share (EPS) rose 5% to $5.15, beating consensus estimates.
Management highlighted 16 brands with double-digit sales growth and 17 products annualizing more than $1 billion on current sales. The company raised its full-year 2026 guidance, projecting revenues between $37.1 billion and $38.5 billion and adjusted EPS from $21.70 to $23.10.
Repatha (evolocumab), Amgen’s cholesterol therapy, led growth with $876 million in sales, up 34% year on year on a 35% volume increase. Rare-disease medicines also contributed strongly: UPLIZNA (inebilizumab-cdon) reached $262 million, a 188% increase, while IMDELLTRA/IMDYLLTRA (tarlatamab) posted $258 million, up 219%, both driven by volume gains.
Prolia (denosumab) sales declined 34% to $727 million, with management noting accelerated erosion from biosimilar competition through 2026.
Tavneos Regulatory Developments and Pipeline Progress
Tavneos (avacopan) sales rose 32% to $119 million, supported by a 55% volume increase. However, regulatory uncertainty has increased after the FDA’s Center for Drug Evaluation and Research proposed withdrawing Tavneos approval on April 27, citing insufficient evidence of effectiveness and material inaccuracies in the original application. The FDA issued a Drug Safety Communication on March 31 and a Federal Register notice on April 30 allowing the original sponsor to request a hearing.
In response, Amgen submitted a Changes Being Effected (CBE-30) supplement on April 29 to amend the Tavneos label with warnings about vanishing bile duct syndrome and hepatotoxicity, including post-marketing fatal cases. The company said it will engage with the FDA on the matter.
Amgen also discussed pipeline momentum, emphasizing its broad MariTide Phase 3 program (AMG-133) targeting obesity and related conditions such as heart disease and sleep apnea, a focus highlighted on the April 30 earnings call.
The quarter’s results and updated guidance reflect volume-driven gains in cholesterol and rare-disease medicines offsetting pricing and inventory pressures, even as regulatory action around Tavneos adds uncertainty to the commercial outlook.
