Moderna Reports $2.8 Billion Loss as FDA Rejects Flu Vaccine Filing

2026-02-13 companies

Cambridge, Friday, 13 February 2026.
Moderna reported a $2.8 billion loss for 2025 while facing a major setback: the FDA refused its flu vaccine filing, even as international regulators accepted the application.

Mixed Signals: Fiscal Discipline Meets Regulatory Headwinds

On Friday, February 13, 2026, Moderna (MRNA) released its fiscal year 2025 financial results, presenting a narrative of operational tightening amidst significant revenue contraction [1][3]. While the company successfully reduced its operating expenses and beat Wall Street’s fourth-quarter expectations, the report was overshadowed by a critical regulatory standoff in the United States regarding its seasonal influenza vaccine [1][7]. For the full year 2025, Moderna reported total revenue of $1.944 billion, a sharp decline of -39.926% from the $3.236 billion recorded in 2024 [3]. Despite this top-line pressure, the company demonstrated improved cost management, posting a net loss of $2.822 billion, which represents an improvement of -20.753% compared to the $3.561 billion loss in the previous year [3][5].

Financial Performance and Cost Structure

In the fourth quarter of 2025 alone, Moderna generated $678 million in revenue, surpassing analyst estimates of approximately $660 million to $662 million, though this figure still marked a year-over-year decline of approximately 30% [7][8]. The company’s net loss for the quarter stood at $0.8 billion, translating to a GAAP earnings per share (EPS) of -$2.11 [1]. This performance was notably better than the -$2.60 to -$2.62 loss per share anticipated by analysts [7][8]. CEO Stéphane Bancel highlighted the company’s fiscal discipline, noting that Moderna lowered its annual operating expenses by approximately $2.2 billion in 2025, significantly surpassing its initial cost-reduction targets [1][7]. As of December 31, 2025, the company maintained a liquidity position of $8.1 billion in cash, cash equivalents, and investments, down from $9.5 billion at the end of 2024 [3][7].

The Regulatory Divide: FDA Rejection vs. Global Acceptance

While financial metrics showed stabilization, Moderna disclosed a significant regulatory obstacle in its home market. On February 3, 2026, the company received a Refusal-to-File (RTF) letter from the U.S. Food and Drug Administration (FDA) regarding its mRNA-1010 influenza vaccine application [2]. The FDA cited that the Phase 3 trial’s control arm, which used a standard-dose seasonal flu vaccine, did not reflect the “best-available standard of care” [2][4]. This rejection, reportedly signed by CBER Director Vinay Prasad, M.D., contrasts sharply with the regulatory landscape abroad; Moderna confirmed that applications for the same vaccine have been accepted for review in the European Union, Canada, and Australia [1][2]. Moderna has requested a Type A meeting with the FDA to clarify the path forward, with CEO Bancel stating that the decision “does not further our shared goal of enhancing America’s leadership in developing innovative medicines” [2].

Pipeline Progress and 2026 Outlook

Looking ahead, Moderna reiterated its guidance for 2026, targeting revenue growth of up to 10%, driven by a split of approximately 50% from U.S. markets and 50% from international sales [3][5]. The company projects year-end 2026 cash and investments to settle between $5.5 billion and $6.0 billion, assuming research and development expenses of approximately $3.0 billion [7]. Beyond the influenza hurdle, the pipeline continues to advance; the company announced that its Phase 3 Norovirus trial is fully enrolled with data expected later in 2026, and its Phase 2 trial for the intismeran autogene therapy in bladder cancer is also fully enrolled [1][7]. Despite the earnings beat, the regulatory uncertainty weighed on investor sentiment, with shares trading down 1.5% to $39.52 following the news [8].

Sources

Biotechnology Earnings