Stock Markets April 30, 2026 04:14 PM

Amgen posts modest revenue and EPS gains in Q1 as FDA review and pipeline moves shape outlook

Cholesterol and rare disease products bolster quarterly results while regulatory scrutiny of Tavneos and Phase 3 expansion for MariTide mark key near-term developments

By Derek Hwang AMGN
Amgen posts modest revenue and EPS gains in Q1 as FDA review and pipeline moves shape outlook
AMGN

Amgen reported first-quarter product sales up 4% and adjusted EPS rising 5% to $5.15, with revenue of $8.6 billion. Growth was supported by Repatha and rare disease medicines, even as Prolia sales fell amid patent-related competition. The company said it submitted a label amendment for Tavneos following recent FDA action and is advancing broad Phase 3 programs for experimental GLP-1 candidate MariTide. Full-year 2026 guidance was nudged higher for both adjusted EPS and revenue.

Key Points

  • Amgen’s adjusted EPS rose 5% to $5.15 in Q1, beating analyst expectations of $4.76, and quarterly revenue was $8.6 billion, up 6% year-over-year.
  • Product sales increased 4% overall, driven by a 9% rise in sales volume; net prices and inventory levels each decreased by 2%. Sectors impacted include biotechnology, pharmaceuticals, and broader healthcare markets.
  • Repatha and rare disease medicines posted strong growth, while Prolia sales declined amid patent expirations and increased competition; regulatory scrutiny and pipeline progress are material near-term factors.

Amgen reported a modest improvement in first-quarter results, driven by stronger demand for its cholesterol and rare disease treatments even as some legacy products faced pressure from competition. Adjusted earnings per share rose 5% to $5.15, exceeding the LSEG analyst consensus of $4.76. Quarterly revenue was $8.6 billion, a 6% increase from the year-ago period and in line with the average Wall Street estimate.

Product-level performance showed mixed trends. Overall product sales increased 4% in the quarter. Volume growth contributed significantly, with product sales up 9% by volume, while net prices and inventory levels each declined by 2% - factors that together yielded the reported 4% quarter-over-quarter sales advance.

Certain franchises stood out. Sales of the cholesterol therapy Repatha climbed 34% to $876 million, outpacing the average analyst forecast of $835 million. Amgen also saw a notable rise in sales for its autoimmune-targeted medicine Tavneos, which increased 32% to $114 million in the quarter.

At the same time, demand for Amgen’s osteoporosis treatment Prolia softened substantially, with sales falling 34% to $727 million. That result missed analyst estimates of $831 million and reflected intensifying competition following patent expirations.


Regulatory and safety update

Earlier this week, the U.S. Food and Drug Administration proposed withdrawing approval of Tavneos, citing a lack of proven effectiveness and concerns about false statements in the original application. In response, Amgen said it is engaging with the agency and has submitted a label amendment intended to provide additional information on liver toxicity associated with the drug.


Pipeline developments

On the investigational front, Amgen said it is pressing forward with a broad development program for its experimental GLP-1 candidate MariTide, evaluating the drug across obesity and related conditions, including studies focused on heart disease and sleep apnea. The company plans to initiate three Phase 3 studies of an injected formulation of MariTide in patients with diabetes later this year.


Guidance

For full-year 2026, Amgen modestly raised its adjusted earnings-per-share outlook to a range of $21.70 to $23.10, up from a prior forecast of $21.60 to $23.00. The company also nudged its revenue guidance higher to $37.1 billion to $38.5 billion, from a previous range of $37 billion to $38.4 billion.


Implications

The quarter underlines a transition in Amgen’s revenue base, with growth concentrated in newer or growth-stage medicines while older biologic franchises face pricing and competitive pressures. Regulatory actions affecting Tavneos and the progression of MariTide’s Phase 3 program are likely to be focal points for investors and industry watchers in the near term.

Risks

  • Regulatory uncertainty for Tavneos following the FDA's proposal to withdraw approval - this presents a risk to sales and regulatory standing in the biotech and pharmaceutical sectors.
  • Patent expirations and ensuing competition have materially reduced sales of legacy products such as Prolia, posing revenue risk to Amgen and affecting the osteoporosis treatment market.
  • Downward pressure on net prices and inventory reductions, evidenced by the 2% declines in each category, may constrain near-term sales growth and margins in the healthcare and pharmaceutical sectors.

More from Stock Markets

Brockman Reveals Near-$30 Billion OpenAI Stake and Financial Links to Altman During Musk Trial May 4, 2026 California Launches Probe into Federal Deal That Scrapped Central Coast Offshore Wind Project May 4, 2026 Pilots Union Praises Kirby’s Merger Vision, Stops Short of Endorsing Deal May 4, 2026 Embraer Sees Follow-On Middle East Defense Sales After UAE C-390 Agreement May 4, 2026 Intel hires long-serving Qualcomm executive to oversee PCs and physical AI unit May 4, 2026