TLDR

• Moderna reported Q4 revenue of $678 million, beating Wall Street estimates of $626.1 million, driven by COVID-19 vaccine sales
• The company posted a quarterly loss of $2.11 per share, narrower than the $2.54 per share loss analysts expected
• Moderna reiterated its 2026 revenue growth target of 10% and expects 50% of sales from U.S. markets and 50% from international
• FDA refused to review Moderna’s flu vaccine application this week, citing trial design flaws, despite internal staff reviewers supporting the review
• Moderna stock slipped 0.3% in premarket trading Friday despite beating earnings, after rising 36% year-to-date through Thursday

Moderna shares dipped 0.3% in premarket trading Friday even after the biotech company delivered quarterly results that topped Wall Street expectations. The mixed reaction highlights investor concerns about the company’s path forward after a rough week.

The Cambridge-based vaccine maker reported fourth-quarter revenue of $678 million. That beat analyst estimates of $626.1 million.

Full-year 2025 sales reached $1.94 billion, surpassing the $1.89 billion consensus estimate. COVID-19 vaccine sales drove the better-than-expected performance.

Moderna, Inc., MRNA

Moderna posted a quarterly loss of $2.11 per share. Analysts had projected a steeper loss of $2.54 per share. The latest loss was narrower than the $2.91 per share loss recorded in the same quarter last year.

CEO Stéphane Bancel said the company entered the year “with strong momentum despite the continued challenging environment in the U.S.” The company reaffirmed its expectation for 10% revenue growth in 2026 compared to 2025.

Wall Street currently expects revenue growth of about 6% for the year. Moderna forecast research and development expenses of roughly $3 billion for 2026, matching analyst estimates.

FDA Setback Casts Shadow

The earnings beat came days after a setback with regulators. The FDA refused Tuesday to review Moderna’s seasonal flu vaccine application.

FDA vaccine chief Vinay Prasad said the company should have compared its vaccine to standard high-dose flu shots for older adults. Moderna ran its trial using regular-dose comparisons, which the company says FDA approved 18 months ago.

Internal FDA staff reviewers had supported moving forward with the review. Prasad overruled them, according to a Wednesday report from Stat.

Moderna criticized the decision and said it was awaiting further guidance on refiling. The company has been counting on its flu vaccine and a future COVID-flu combination shot to drive future growth.

Looking Ahead to 2026

The company expects about 50% of 2026 sales to come from U.S. markets. International markets will account for the remaining half.

Bancel said Moderna expects to meet its 2026 targets through expansion of its next-generation COVID vaccine. Strategic partnerships in international markets will also play a role.

Shares had climbed 36% year-to-date through Thursday’s close. Positive Phase 2b trial results for an intismeran autogene vaccine used in melanoma treatment drove much of the rally.

The company continues working on newer products to offset declining COVID vaccine demand. Sales have struggled since the pandemic windfall years when demand for COVID shots collapsed.

Moderna’s full-year 2025 revenue of $1.94 billion came in above the $1.89 billion analyst consensus, while the company maintains its 10% revenue growth target for 2026.