Axsome Posts Strong Q1 Revenue Growth, Advances Late-Stage CNS Pipeline
Financial Highlights:
• Total Q1 2025 net product revenue: $121.5 million (up 62% YoY)
o AUVELITY: $96.2 million (up 80% YoY)
o SUNOSI: $25.2 million (up 17% YoY)
• Net loss: $59.4 million or $(1.22) per share, compared to $(68.4) million or $(1.44) per share in Q1 2024
• Cash and equivalents: $300.9 million as of March 31, 2025
Commercial Performance:
• AUVELITY: 167,000 prescriptions in Q1 2025 (up 76% YoY), 78% payer coverage across channels
• SUNOSI: 46,000 prescriptions (up 12% YoY), 83% payer coverage
Pipeline and Regulatory Updates:
• SYMBRAVO (for acute migraine) approved in January; U.S. commercial launch expected June 2025
• AXS-14 (fibromyalgia): NDA submitted; FDA filing decision expected Q2 2025
• AXS-05 (Alzheimer’s agitation): Supplemental NDA submission on track for Q3 2025
• AXS-12 (narcolepsy): NDA submission planned for 2H 2025
Clinical Trial Milestones:
• Solriamfetol (ADHD): Positive Phase 3 results in adults; pediatric trial planned for 2025
• Solriamfetol (MDD with EDS): Phase 3 trial to start in 2025
• Ongoing Phase 3 trials: Binge eating disorder (ENGAGE) and shift work disorder (SUSTAIN) – topline results expected in 2026
Litigation Update:
• Settlement reached with Hikma on SUNOSI patent litigation; generic entry not expected before 2040