Axsome Q1 2024 Earnings Report
Key Takeaways
Axsome Therapeutics reported a total net product revenue of $75.0 million for Q1 2024, representing a 160% year-over-year growth. The company progressed its clinical trials, including positive Phase 3 results for AXS-12 in narcolepsy, and is preparing for NDA resubmissions for AXS-07 and AXS-14.
Total net product revenue reached $75.0 million, a 160% increase year-over-year.
Auvelity net product sales were $53.4 million, reflecting a 240% year-over-year growth.
Sunosi net product revenue amounted to $21.6 million, a 64% increase year-over-year.
Positive Phase 3 trial results were announced for AXS-12 in narcolepsy.
Axsome
Axsome
Forward Guidance
Axsome believes that its current cash is sufficient to fund anticipated operations into cash flow positivity, based on the current operating plan.
Positive Outlook
- NDA resubmission for AXS-07 in migraine targeted for Q2 2024
- NDA submission for AXS-14 in fibromyalgia targeted for Q2 2024
- Phase 3 ADVANCE-2 trial of AXS-05 for Alzheimer’s disease agitation topline results expected in 2H 2024
- Phase 3 open-label safety extension trial of AXS-12 in narcolepsy topline results expected in 2H 2024
- Phase 3 FOCUS trial of solriamfetol in ADHD in adults topline results expected in 2H 2024
Challenges Ahead
- Phase 3 PARADIGM trial of solriamfetol in major depressive disorder topline results expected in 2025
- Phase 3 ENGAGE trial of solriamfetol in binge eating disorder topline results expected in 2025
- Phase 3 EMERGE trial of AXS-07 in migraine with inadequate response to oral CGRP inhibitors topline results expected in 2H 2024
- Phase 3 trial of solriamfetol in shift work disorder initiation expected in Q2 2024
- Phase 3 ACCORD-2 trial of AXS-05 for Alzheimer's disease agitation enrollment completion expected mid-year 2024