Axsome Therapeutics (NasdaqGM:AXSM) FY Conference Transcript

Axsome Therapeutics FY Conference Summary Company Overview - Company: Axsome Therapeutics (NasdaqGM:AXSM) - Event: FY Conference held on February 25, 2026 Core Business and Product Performance - Product: Auvelity for Major Depressive Disorder (MDD) - Sales Achievement: Over $500 million in sales in 2025, three years post-launch [2] - Salesforce Expansion: Increased from 300 to 600 sales representatives to enhance market penetration, particularly in primary care [4] - Market Access: Improved access with 86% of covered lives, including 100% in the government channel [7][8] - First Line Prescriptions: 50% of total prescriptions are for first line or first switch patients [8] Market Dynamics and Growth Drivers - Uptake Drivers: Increased awareness, trial engagement, and a differentiated product profile leading to positive patient outcomes [9] - Retention Rates: Currently tracking in line with typical antidepressant persistence, with over 50% of patients being first line or first switch [11][12] - Alzheimer's Disease Agitation (ADA) Opportunity: Anticipation of FDA's PDUFA date on April 30, 2026, for Auvelity's indication in Alzheimer's agitation [15] Clinical Data and Regulatory Insights - Clinical Trials: Four controlled trials conducted, with three positive outcomes supporting efficacy and safety [22][23] - Safety Profile: No significant safety concerns noted, particularly regarding falls or mortality in the elderly population [24] - Market Size for ADA: Approximately 5 million Alzheimer's patients experience agitation, with 20 million scripts written annually, predominantly off-label [20] Go-to-Market Strategy - Pre-launch Activities: Non-branded campaigns to raise awareness about Alzheimer's agitation and education for healthcare providers [27] - Reimbursement Strategy: Full coverage anticipated for Medicare Part D, which constitutes over 70% of total scripts for Alzheimer's agitation [28] - Expected GTN Improvement: Anticipated better gross-to-net (GTN) for ADA scripts compared to MDD due to the nature of Medicare Part D [28] Future Catalysts and Pipeline - Upcoming Trials: Ongoing trials for binge eating disorder (BED) and shift work disorder, with top-line results expected in the second half of 2026 [35][36] - New Product AXS-12: NDA submission imminent, leveraging existing sales force for potential launch in narcolepsy [39] - New Asset AXS-17: Recently in-licensed for epilepsy, complementing the existing CNS pipeline [42] Financial Outlook - Cash Flow Positivity: Near-term expectations for cash flow positivity remain unchanged, with recent quarters showing close to cash flow positive results [53][54] - Sales Projections: Peak sales for Auvelity projected between $2.5 billion and $6 billion, viewed as achievable based on current market dynamics [34] Conclusion - Axsome Therapeutics is positioned for significant growth with its product Auvelity, particularly in the MDD and Alzheimer's agitation markets. The company is actively expanding its sales force, improving market access, and preparing for upcoming product launches and regulatory approvals. The financial outlook remains positive, with a focus on achieving cash flow positivity and leveraging its robust pipeline for future growth.