Axsome Therapeutics has reported exceptional commercial performance and pipeline advancement for 2024, marking a transformative year in its mission to revolutionize central nervous system (CNS) disorder treatments.
The company's financial results showcase remarkable growth, with total net product revenue reaching $385.7 million for the full year 2024, an 88% increase from the previous year. This growth was primarily driven by Auvelity's strong performance, which generated $291.4 million in net product sales, representing a 124% year-over-year increase.
Commercial Performance and Market Expansion
Auvelity demonstrated robust market penetration with approximately 158,000 prescriptions in Q4 2024, reflecting an 87% increase compared to the same period in 2023. The company has successfully expanded its payer coverage to approximately 78% of all covered lives, with complete coverage in government channels.
Sunosi also showed steady growth, with net product revenues of $94.3 million for the full year, a 26% increase from 2023. The medication maintained strong prescription momentum with 49,000 prescriptions written in Q4 2024.
Strategic Pipeline Developments
A major milestone was achieved with the FDA approval of Symbravo for acute migraine treatment in adults. The drug, which incorporates Axsome's proprietary MoSEIC™ technology, is expected to be commercially available within four months.
The company has completed its Phase 3 clinical program for AXS-05 in Alzheimer's disease agitation, demonstrating statistically significant improvements across multiple trials. Based on these positive results, Axsome plans to submit a New Drug Application (NDA) in the second half of 2025.
Advancing Multiple Late-Stage Programs
Several key clinical programs are progressing rapidly:
- The FOCUS Phase 3 trial evaluating solriamfetol for ADHD in adults
- The PARADIGM study investigating solriamfetol for major depressive disorder
- The ENGAGE trial studying solriamfetol for binge eating disorder
- Development of AXS-12 for narcolepsy, with NDA submission planned for late 2025
Financial Position and Future Outlook
With $315.4 million in cash and cash equivalents as of December 31, 2024, Axsome believes it has sufficient funding to reach cash flow positivity. The company's operating expenses reflect its commitment to growth, with R&D expenses of $187.1 million for the full year, supporting its extensive clinical development programs.
"2024 was another defining year for Axsome, driven by strong commercial growth and a rapidly advancing late-stage pipeline," said Herriot Tabuteau, MD, Chief Executive Officer of Axsome Therapeutics. "With potentially five marketed products across six CNS indications of great unmet need over the next 12-18 months, we are well positioned to continue delivering innovative new medicines to patients."
