Axsome Therapeutics, Inc. (NASDAQ: AXSM) announced its third-quarter 2024 financial results, showcasing substantial revenue growth and significant progress in its central nervous system (CNS) pipeline. The company reported total net product revenue of $104.8 million, an 81% increase compared to the same period last year. This growth is primarily driven by strong sales of Auvelity and Sunosi, positioning Axsome to potentially deliver multiple innovative new medicines.
Commercial Performance
Auvelity, a treatment for major depressive disorder, saw net product sales of $80.4 million in Q3 2024, representing a 113% year-over-year increase. Approximately 144,000 prescriptions were written for Auvelity during the quarter, a 108% increase compared to Q3 2023. In response to this strong demand, Axsome plans a second expansion of its Auvelity psychiatry sales force in the first quarter of 2025, aiming for approximately 300 sales representatives. Payer coverage for Auvelity is approximately 78% of all covered lives.
Sunosi, used in the treatment of excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea, reported net product revenue of $24.4 million, a 21% increase year-over-year. Approximately 47,000 prescriptions were written for Sunosi in the U.S. during the quarter, a 15% increase compared to the same period in 2023. Payer coverage for Sunosi is approximately 83% of all covered lives.
Pipeline Advancement
Axsome is actively advancing its pipeline of product candidates targeting various CNS disorders. Key developments include:
- AXS-07 (migraine): The New Drug Application (NDA) for AXS-07 for the acute treatment of migraine has been accepted by the FDA, with a PDUFA goal date of January 31, 2025. Topline results from the EMERGE trial, evaluating AXS-07 in patients with prior inadequate response to oral CGRP inhibitors, are expected in Q4 2024.
- AXS-05 (Alzheimer's disease agitation): Topline results from the Phase 3 ADVANCE-2 and ACCORD-2 trials of AXS-05 in Alzheimer’s disease agitation are on track for release in the fourth quarter of 2024. These trials are pivotal, placebo-controlled efficacy trials.
- AXS-12 (narcolepsy): Topline results from the Phase 3 ENCORE trial of AXS-12 in narcolepsy are anticipated in the fourth quarter of 2024. The ENCORE study is evaluating the long-term efficacy and safety of AXS-12.
- AXS-14 (fibromyalgia): Axsome anticipates submitting the NDA for AXS-14 for the management of fibromyalgia in November 2024.
- Solriamfetol (ADHD, MDD, BED, SWD): Several Phase 3 trials are underway for solriamfetol across multiple indications. Topline results from the FOCUS trial in ADHD and the PARADIGM trial in MDD are expected in the first quarter of 2025. Results from the ENGAGE trial in binge eating disorder are expected in 2025, and the SUSTAIN trial in shift work disorder is anticipated in 2026.
Financial Position
Axsome believes its current cash reserves are sufficient to fund anticipated operations into cash flow positivity, based on the current operating plan. The company reported cash and cash equivalents totaling $327.3 million as of September 30, 2024.
"In the third quarter, we continued our strong commercial performance and advanced our innovative, industry-leading, late-stage development pipeline towards important near-term milestones," said Herriot Tabuteau, MD, Chief Executive Officer of Axsome Therapeutics. "Our growth as an organization positions us well to potentially deliver multiple innovative new medicines to the millions of individuals living with central nervous system disorders in the U.S. Importantly, we have the resources in hand to execute our operating plans and create substantial value for shareholders."
