Moderna $MRNA ( ▲ 5.29% ) delivered fourth-quarter results that topped Wall Street expectations and issued an optimistic outlook for 2026, even as the company faces mounting regulatory challenges. The biotech reported a loss of $2.11 per share, narrower than the expected $2.54 loss, on revenue of $678 million, comfortably above forecasts of $635 million.
The results signal that demand for Moderna’s COVID-19 vaccine, still its primary product, remains more resilient than many analysts anticipated. Preliminary full-year 2025 sales came in around $1.9 billion, in line with prior disclosures.
Growth forecast aims to reassure investors
Looking ahead, Moderna expects revenue to rise about 10% in 2026, outpacing analyst projections of roughly 5% growth to around $2 billion. The guidance suggests the company believes vaccination demand will stabilize rather than collapse, despite political pressure and declining pandemic urgency.
Stronger-than-feared vaccination rates in 2025 helped buoy sales, providing a foundation for next year’s outlook. For a company heavily reliant on a single product, maintaining that demand is critical.
Regulatory roadblocks cloud the pipeline
The upbeat forecast arrives alongside a major setback: the FDA is refusing to review Moderna’s application for its mRNA flu vaccine. Investors have been counting on new products to diversify revenue beyond COVID shots, making the rejection a significant blow to long-term expectations.
Moderna said the decision will not affect its 2026 guidance and noted that regulators in the European Union, Canada, and Australia have accepted the filing. In fact, the company expects about half of its 2026 sales to come from international markets.
For now, Moderna’s story remains a balancing act between near-term vaccine revenue and the uncertain timeline for expanding its mRNA portfolio. Investors are betting the company can navigate regulatory turbulence long enough to bring its next wave of products to market.