Moderna Reports Fourth Quarter and Fiscal Year 2025 Financial Results and Provides Business Updates

Core Insights - The company reported fourth quarter revenue of $0.7 billion, with a GAAP net loss of $(0.8) billion and a GAAP EPS of $(2.11) [1] - For the full year, revenue was $1.9 billion, with a GAAP net loss of $(2.8) billion and a GAAP diluted EPS of $(7.26) [1] - The company reiterated its plan to achieve up to 10% revenue growth and reduce GAAP operating expenses by 2026 [1] Regulatory and Clinical Updates - The company announced that its influenza vaccine filing has been accepted for regulatory review in the EU, Canada, and Australia; however, it received a Refusal-to-File letter from the U.S. FDA and has requested a Type A meeting to clarify the path forward [1] - The Norovirus Phase 3 trial is fully enrolled, with data readout expected in 2026 [1] - Full enrollment of the Phase 2 intismeran autogene trial in muscle invasive bladder cancer has been achieved [1] Business Developments - In 2025, the company focused on sharpening its commercial execution, launched its third product, and brought online three international manufacturing sites while advancing its mRNA pipeline [1]