Axsome Therapeutics has announced its first quarter 2024 financial results and provided a business update, highlighting strong financial performance and significant advancements in its neuroscience pipeline. The company's marketed products are delivering differentiated treatment options for patients living with depression, narcolepsy, and obstructive sleep apnea.
Financial Highlights
Total net product revenue for the quarter reached $75 million, representing a substantial year-over-year growth of approximately 160%. This growth was primarily driven by the strong performance of Axsome's marketed products, including Auvelity and Sunosi. Auvelity net product sales were $53.4 million, a 240% increase year-over-year. Sunosi net product revenue totaled $21.6 million, including royalty revenue.
Pipeline Progress
Axsome has made significant strides in advancing its innovative neuroscience pipeline. Key achievements include:
- AXS-07 (Migraine): The NDA resubmission for AXS-07, a novel treatment for the acute treatment of migraine, is on track for this quarter. The EMERGE study, a Phase 3 trial evaluating AXS-07 in adults with prior inadequate response to oral CGRP inhibitors, is expected to yield top-line results in the second half of 2024.
- AXS-14 (Fibromyalgia): Pre-submission activities for the NDA for AXS-14, a potential treatment for fibromyalgia, are nearing completion, with submission targeted for later this quarter.
- AXS-12 (Narcolepsy): The Phase 3 SYMPHONY trial of AXS-12 in narcolepsy met its primary endpoint, significantly reducing the frequency of cataplexy attacks compared to placebo (p<0.05). AXS-12 also reduced excessive daytime sleepiness severity, improved cognition, and reduced overall narcolepsy severity. Results from the open-label safety extension trial are expected in Q4 2024.
- AXS-05 (Alzheimer's Disease Agitation): The Phase 3 ADVANCE trial in Alzheimer's disease agitation is expected to be completed in the second half of 2024. The company has also launched the ACCORD 2 study, a double-blind, placebo-controlled, randomized withdrawal trial to further evaluate the efficacy and safety of AXS-05 in this indication. Enrollment is expected to complete around midyear.
- Solriamfetol (Major Depressive Disorder, Binge Eating Disorder, Shift Work Disorder, ADHD): The Phase 3 PARADIGM trial in major depressive disorder and the Phase 3 ENGAGE trial in binge eating disorder are underway, with results expected in 2025. A Phase 3 clinical program in shift work disorder is slated to begin this quarter. The Phase 3 FOCUS trial in ADHD is expected to yield top-line results in the second half of this year.
Commercial Performance
Auvelity prescriptions grew 12% quarter-over-quarter and 206% compared to Q1 2023, with nearly 18,000 new patients starting treatment. Sunosi prescriptions saw a slight decline versus Q4 2023 due to typical seasonality in the EDS market but grew 14% versus Q1 2023.
Financial Position
Axsome ended the first quarter with $331.4 million in cash and cash equivalents. The company believes its current cash balance is sufficient to fund anticipated operations into cash flow positivity.
Management Commentary
"First quarter of 2024 was marked by strong financial performance for our own market products, which are delivering important and differentiated treatment options for patients living with depression, narcolepsy and obstructive sleep apnea," said Dr. Herriot Tabuteau, Chief Executive Officer of Axsome Therapeutics. "We also significantly advanced our innovative neuroscience pipeline in the quarter."
Analyst Q&A Highlights
During the Q&A session, Axsome management addressed questions regarding new-to-brand vs. refill rates for Auvelity (new-to-brand accounts for roughly 25-30% of weekly prescriptions), the potential impact of the new GPO contract on volume and gross-to-net, and the responder rate anticipated from the ACCORD 2 study in Alzheimer's disease agitation.
