Amgen 8-K

EarningsNew guidance

FDA proposes withdrawing TAVNEOS approval; Amgen plans to contest as the drug stays on the market during the process.

Filed 2026-04-30 16:03 ET

Summary

Q1 2026 results and FY2026 guidance. Revenue rose 6% Y/Y, with 9% product-sales volume growth partly offset by lower net selling prices and inventory. Separately, the FDA proposed withdrawing TAVNEOS approval; Amgen plans to contest the proposal, and the product remains on the market while the process proceeds.

Key Figures

Metric Q1 2026 Q1 2025 Y/Y
Revenue $8.62B $8.15B 6%
Operating income, GAAP $2.67B $1.18B 126%
Operating income, non-GAAP $3.72B $3.60B 3%
Net income, GAAP $1.82B $1.73B 5%
Net income, non-GAAP $2.80B $2.65B 6%
Diluted EPS, GAAP $3.34 $3.20 4%
Diluted EPS, non-GAAP $5.15 $4.90 5%
Operating cash flow $2.19B $1.39B 57%
Free cash flow $1.48B $0.98B 51%
  • Product sales increased 4%; 9% volume growth was partly offset by 2% lower net selling price and 2% lower inventory levels. Sixteen brands achieved double-digit growth.
  • Operating margin rose 17.4 percentage points to 32.4% on a GAAP basis and declined 0.4 percentage points to 45.3% on a non-GAAP basis. Free cash flow growth reflected business performance and working-capital timing, partly offset by higher capital expenditures.
  • Cash was $12.0B and debt outstanding was $57.3B at 3/31/2026. Amgen made no share repurchases in the quarter; average diluted shares were 544M vs 541M. The $2.52-per-share dividend paid in the quarter was up 6% Y/Y.

Guidance

Metric Period Guidance Prior Direction
Revenue FY2026 $37.1B-$38.5B — —
EPS, GAAP FY2026 $15.62-$17.10 — —
Tax rate, GAAP FY2026 14.5%-16.0% — —
EPS, non-GAAP FY2026 $21.70-$23.10 — —
Tax rate, non-GAAP FY2026 15.0%-16.5% — —
Capital expenditures FY2026 ≈$2.6B — —
Share repurchases FY2026 Not to exceed $3.0B — —

Investor Takeaways

  • Watch the FDA’s decision on whether to hold a hearing and the eventual outcome of the proposed TAVNEOS withdrawal; Amgen says TAVNEOS will remain available during the process.
  • Track full-year revenue and EPS against the FY2026 ranges, particularly as biosimilar competition is expected to accelerate sales erosion for Prolia and XGEVA.
  • Watch progress in the MariTide Phase 3 program, including three studies in people with type 2 diabetes slated to begin in 2026.

The summary is written by an AI model reading the filing.

Model 005 · prompt 01d34d48e3

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