Moderna's Q4 2025 Results Confirm DeepValue Wait Thesis with Persistent Losses and FDA Hurdles

What happened

Moderna reported Q4 revenue of $0.7 billion and a full-year GAAP net loss of $2.8 billion, highlighting ongoing financial strain. The company announced that its influenza vaccine filing was accepted for review in the EU, Canada, and Australia, but received a Refusal-to-File letter from the U.S. FDA, necessitating a Type A meeting. This regulatory setback aligns with the DeepValue report's emphasis on FDA clarity as a critical risk factor for the seasonal vaccine franchise. Management's plans for revenue growth and cost reductions face headwinds from fixed manufacturing costs and volatile demand, as noted in the report. Overall, the results underscore the need to wait for key catalysts, including the FDA meeting outcome and upcoming oncology data readouts.

Implication

The persistent losses and high cash burn confirm that Moderna's transition to a seasonal model remains challenging and liquidity-dependent. The FDA's refusal-to-file on the flu vaccine increases regulatory uncertainty, potentially delaying U.S. revenue and impacting combo vaccine timelines. While international acceptances provide some diversification, the U.S. market is crucial for significant growth. Upcoming catalysts, such as the Type A meeting and norovirus data, are essential for reassessing the investment thesis. Without positive developments on these fronts, the stock lacks a margin of safety and may face further downside from sustained cash burn.

Thesis delta

The news does not alter the core thesis from the DeepValue report, which advocates waiting for regulatory clarity and data readouts. It reinforces the identified risks, particularly around FDA hurdles and fixed-cost absorption, maintaining the WAIT rating. No shift in investment stance is recommended until the Type A meeting outcome by May 2026 and the melanoma durability data by June 2026.