Full Breakdown
Moderna Faces Regulatory Setback Amid Promising Revenue Growth Projections
2/13/2026, 8:40:14 PM
Financial Performance and Growth Outlook
Moderna Inc. (NASDAQ:MRNA) reported a fourth-quarter revenue of $678 million, surpassing Wall Street expectations of $626.1 million, primarily driven by sales of its COVID-19 vaccine. The company recorded a loss of $2.11 per share, which was narrower than the anticipated loss of $2.54 per share and an improvement from a loss of $2.91 per share in the same quarter last year. For the full year of 2025, Moderna's revenue reached $1.94 billion, exceeding the consensus estimate of $1.89 billion. CEO Stéphane Bancel expressed optimism about the company's trajectory, stating, "We entered the new year with strong momentum despite the continued challenging environment in the U.S."
Looking ahead, Moderna aims for a 10% revenue growth in 2026, with projections indicating that approximately 50% of sales will come from U.S. markets and the other half from international markets. The company plans to achieve this growth through the expansion of its next-generation COVID vaccine and strategic partnerships abroad.
Regulatory Challenges with Influenza Vaccine
Despite the positive financial outlook, Moderna encountered a significant setback when the U.S. Food and Drug Administration (FDA) issued a refusal-to-file letter regarding its investigational influenza vaccine, mRNA-1010. The FDA's Center for Biologics Evaluation and Research cited flaws in the trial design, specifically that Moderna used a standard-dose seasonal influenza vaccine as a comparator instead of a higher-dose vaccine recommended for older adults. This decision has raised concerns about the viability of mRNA-1010 and its potential impact on the company's revenue projections for 2027 and 2028.
William Blair analysts noted that this setback poses a substantial risk to Moderna's vaccine franchise and its goal of reaching cash breakeven by 2028. The FDA's vaccine chief, Vinay Prasad, defended the decision, stating that the trial design should have included a higher-dose flu vaccine, which is not widely available in many countries where the trial was conducted.
Market Reactions and Future Prospects
Following the FDA's announcement, Moderna's stock experienced a slight decline, dropping 0.3% in premarket trading despite the positive earnings report. Investor sentiment remains cautious as the company navigates the challenges posed by the regulatory setback while attempting to stabilize its revenue streams amid declining demand for COVID vaccines.
Moderna continues to focus on developing new products to offset the revenue gap left by the diminishing demand for COVID-19 vaccines. The company is also awaiting further guidance from the FDA regarding the re-filing of its flu vaccine application, which it hopes will play a crucial role in its future growth strategy.
Verbatim Quotes
- “We entered the new year with strong momentum despite the continued challenging environment in the U.S.,” — Stéphane Bancel, CEO of Moderna.
- “William Blair on Wednesday wrote that the RTF letter for mRNA-1010 represents a big hit to the company's vaccine franchise and its prospect of achieving its breakeven guidance in 2028.” — William Blair Analyst.
Conflicting Reports & Gaps
There are discrepancies regarding the FDA's rationale for rejecting the flu vaccine application. While the FDA cited the trial design as flawed, Moderna argued that the design was initially approved by the agency. Internal FDA staff had supported the review, but their recommendations were overruled by Prasad. This conflict highlights the ongoing challenges Moderna faces in navigating regulatory processes.
