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Moderna Beats Q4 Estimates, Reaffirms 2026 Outlook as FDA Blocks U.S. Flu Filing

Management expects 2026 growth to come largely from outside the U.S., with flu and combo shots excluded from guidance.

Overview

  • Moderna reported Q4 2025 revenue of $678 million and a loss per share of $2.11, both better than Wall Street estimates.
  • Full‑year 2025 sales totaled about $1.9 billion, with the U.S. accounting for more than 60% despite a steep quarter‑to‑quarter decline late in the year.
  • The company maintained its target of 10% revenue growth in 2026 and forecast roughly half of sales from international markets.
  • The FDA issued a refuse‑to‑file for Moderna’s mRNA flu vaccine over trial comparator design; the company requested a Type A meeting, and a report said internal FDA reviewers supported review before being overruled by vaccine chief Vinay Prasad.
  • Flu and COVID‑plus‑flu filings were accepted in the EU, Canada, and Australia, 2026 guidance assumes no revenue from those products, and R&D spending is projected at about $3 billion.