Moderna falls after FDA flu vaccine setback, mixed Q4 results
Regulatory refusal delays seasonal flu vaccine as company aims to return to growth by 2026
Moderna shares extended their decline on Friday after the biotechnology company reported fourth-quarter financial results showing ongoing challenges in its post-pandemic transition, while a regulatory setback for its seasonal influenza vaccine clouds the path toward its growth targets.
The Cambridge, Massachusetts-based company reported fourth-quarter revenue of $678 million, down 30% year-over-year as COVID-19 vaccine sales continue to normalize. The GAAP net loss for the quarter narrowed to $2.11 per share, beating analyst expectations that had projected a loss of $2.60 to $2.79 per share. For the full year 2025, Moderna recorded revenue of $1.9 billion with a GAAP net loss of $2.8 billion.
The earnings report followed a regulatory blow earlier in the week, when the U.S. Food and Drug Administration issued a Refusal-to-File letter for Moderna's mRNA-1010 seasonal influenza vaccine on February 10. The FDA cited the company's choice of a licensed standard-dose seasonal flu vaccine as the comparator in its Phase 3 efficacy study, stating it did not reflect the "best-available standard of care" required for an "adequate and well-controlled" study.
Moderna publicly disputed the decision, noting that federal regulations and FDA guidance do not explicitly require such a comparator. The company highlighted that the FDA had previously deemed the study design acceptable during pre-Phase 3 consultations in April 2024. Moderna has requested a Type A meeting with the FDA's Center for Biologics Evaluation and Research to discuss a path forward.
The FDA's refusal sent Moderna shares down as much as 9.3% in premarket trading on February 11, with the stock closing at $40.11 on February 12. Analysts responded with downgrades, as BofA Securities lowered its price target to $24 from $27 while maintaining an "Underperform" rating. Leerink Partners cut its target more aggressively, to $12 from $17, also rating the shares "Underperform."
Despite the setback, Moderna reaffirmed its 2026 guidance, projecting revenue growth of up to 10% for the year. The company ended 2025 with $8.1 billion in cash and investments and expects to finish 2026 with $5.5 billion to $6.0 billion in liquidity, excluding any further draws on its credit facility. GAAP operating expenses for 2026 are projected at approximately $4.9 billion, with further reductions targeting a range of $4.2 billion to $4.6 billion by 2027.
The company achieved substantial cost-cutting progress in 2025, reducing annual operating expenses by approximately $2 billion and surpassing its cost-reduction targets. These efforts are part of Moderna's broader strategy to achieve cash flow breakeven by 2028, a timeline some analysts now question given the flu vaccine delay.
While the U.S. review remains stalled, Moderna noted that its seasonal influenza vaccine is under regulatory review in the European Union, Canada, and Australia. The company anticipates potential approvals in those markets could begin in late 2026 or early 2027. Importantly, the FDA's Refusal-to-File letter did not identify any concerns regarding the safety, immunogenicity, or efficacy of mRNA-1010 itself.
The flu vaccine represents a critical component of Moderna's diversification strategy beyond COVID-19. The company is also advancing its respiratory syncytial virus (RSV) vaccine and an influenza/COVID-19 combination candidate, though analysts have raised questions about whether the FDA's stance on the flu vaccine comparator could impact those programs.
Moderna's pivot to a broader vaccine franchise comes as its COVID-19 vaccine franchise faces sustained pressure. The 30% year-over-year decline in fourth-quarter COVID sales reflects the ongoing transition from pandemic demand to a more competitive commercial market for coronavirus boosters.
The company's stock has experienced heightened volatility, with an average 8.6% swing in either direction following earnings reports, according to Forbes analysis. That pattern reflects investor uncertainty about Moderna's ability to successfully transition from a one-product pandemic success story to a diversified biotechnology company with multiple commercial products.
Looking ahead, investors will be focused on the outcome of Moderna's Type A meeting with the FDA and any clarity on regulatory requirements for the influenza vaccine program. The company's ability to execute on its 2026 revenue growth target while managing cash burn toward its 2028 breakeven goal will be key metrics for assessing the turnaround progress.