Axsome Q4 2023 Earnings Report
Key Takeaways
Axsome Therapeutics reported a transformational year in 2023, marked by successful commercial execution and substantial pipeline advancement. Total net product revenues for Q4 2023 were $71.5 million, a 193% increase year-over-year, driven by Auvelity and Sunosi sales. The company is advancing its pipeline with multiple Phase 3 trials and anticipates NDA submissions for AXS-07 and AXS-14 in the first half of 2024.
Total net product revenues reached $71.5 million in Q4 2023, representing a 193% year-over-year growth.
Auvelity net product sales were $49.0 million in Q4 2023, its first full year of launch.
Sunosi net product revenues were $22.5 million in Q4 2023, a 17% increase year-over-year.
The company anticipates NDA submissions for AXS-07 in migraine and AXS-14 in fibromyalgia in the first half of 2024.
Axsome
Axsome
Forward Guidance
Axsome anticipates continued momentum in 2024, focusing on driving growth for Auvelity and Sunosi, potential NDA submissions for migraine and fibromyalgia, and Phase 3 trial readouts in narcolepsy, Alzheimer's disease agitation, and ADHD. The company also plans to initiate new pivotal trials in depression, binge eating disorder, and shift work disorder.
Positive Outlook
- NDA resubmission for AXS-07 for migraine is expected in 1H 2024.
- NDA submission for AXS-14 for fibromyalgia is expected in 1H 2024.
- Topline results from the Phase 3 SYMPHONY trial of AXS-12 in narcolepsy are anticipated in 1Q 2024.
- Phase 3 trials of solriamfetol in major depressive disorder, binge eating disorder, and shift work disorder are expected to be initiated in 1Q 2024.
- Topline results from the Phase 3 ADVANCE-2 trial of AXS-05 for Alzheimer’s disease agitation and the Phase 3 FOCUS trial of solriamfetol in ADHD are expected in 2H 2024.