Axsome Therapeutics, Inc. Q4 FY2025 earnings call

2025 was a year of significant commercial, research, and development progress. Commercial business is strong with Auvelity, Sunosi, and Cymbravo performing well. Advancing a broad CNS pipeline including sNDA for Auvelity in Alzheimer's disease agitation with acceptance of filing and priority review designation, planned Phase III trial of AXS-05 in smoking cessation, progress with AXS-12's NDA package, advancing solriamfetol across multiple new indications, initiating FORWARD study for AXS-14 in fibromyalgia, and acquiring AZD7325 for evaluation in epilepsy. Commercial updates include Auvelity's prescription growth, sales force expansion, and formulary access; Cymbravo's prescription and patient start growth; and Sunosi's strong performance with prescription growth and prescriber base expansion.

Fourth quarter total revenue increased 65% year over year to $196,000,000; full year increased 66% to $639,000,000. Auvelity had sales over $500,000,000 in its third full year of launch, with fourth quarter net product sales of $155,100,000, up 68% year over year, and full year total of $507,100,000, up 74% year over year. Sunosi had fourth quarter net product revenue of $36,700,000, a 40% increase year over year, and full year revenue of $124,800,000, up 32% year over year. Cymbravo had fourth quarter net sales of $4,100,000 and full year of $6,600,000 following its second full quarter of launch.

Total revenue growth expected to continue. Auvelity and Sunosi gross-to-net discounts expected to increase to mid-50% range due to Q1 dynamics. Cymbravo gross-to-net discount expected to remain elevated during launch phase. Anticipate operating leverage to continue in 2026. Expect to provide updates on pipeline progress including AXS-17 and other programs.

Q: Implications of new FDA publication on one-trial policy and trials for various indications; A: Team assessing, some alignments with FDA, ADHD studies split due to sub-segmentation.

Q: AXS-17 development plan for epilepsy; A: Based on preclinical studies, working to be Phase II ready and assessing specific epilepsies.

Q: Auvelity payer coverage and ADA indication launch; A: Aspiration to get 100% access, working with plans, limited analog in market.

Q: Sunosi growth drivers; A: Growth in OSA and narcolepsy, both ends of growth, across prescriber segments.

Q: DTC campaign impact on Auvelity growth; A: Pleased with campaign impact, optimizing spend, growth from primary care and psychiatry.

Q: Auvelity ultimate reimbursement access; A: Goal to secure access for as many patients as possible.

Q: AXS-17 broader development; A: Focus on epilepsy initially, will look at other indications but stay tuned.

Q: Salesforce expansion for Auvelity; A: To accelerate growth in MDD and support ADA launch, enable engagement with target universe.

Q: Cymbravo coverage evolution; A: Focused on increasing coverage, engaged with payers/PBMs.

Q: Alzheimer's agitation launch timeline and metrics; A: Ready to go within a quarter, will share details on launch metrics.

Q: AXS-12 differentiation in narcolepsy; A: Compelling treatment option with cataplexy relief, safety profile, interest in market.

Q: AXS-17 therapeutic window in epilepsy; A: Exploring dose, working on PK/PD modeling, excited about mechanism.

Q: Auvelity label language for ADA; A: Review underway, expect safety profile described if approved, AXS-05 has multiple clinical profile elements.

Q: AXS-12 NDA priority review; A: Anticipated as standard review, GTN for Auvelity expected more favorable in Medicare part.

Q: ADA breakdown and salesforce deployment; A: 60% in community, 40% in long-term care, focus on agitation symptoms.

Q: Auvelity gross-to-net dynamics and PCP penetration; A: Anticipated GTN more positive in ADA channel, primary care growing as first-line treater, psychiatrists have higher per-patient volume.

Q: AXS-12 opportunity vs orexin-based products; A: Difficult-to-treat patient population, polypharmacy expected, AXS-12 has favorable safety and tolerability, mechanistically makes sense with narcolepsy's comorbidities