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Axsome Therapeutics(AXSM) - 2025 Q2 - Earnings Call Presentation

Financial Performance & Projections - Axsome reported Net Product Revenue of $150 million in 2Q 2025, a 72% increase compared to $872 million in 2Q 2024 [21] - AUVELITY Net Product Sales reached $1196 million in 2Q 2025, an 84% increase from $650 million in 2Q 2024 [21] - SUNOSI Net Product Revenue was $30 million in 2Q 2025, a 40% increase compared to $221 million in 2Q 2024 [21] - SYMBRAVO Net Product Sales were $04 million in 2Q 2025 [21] - The company estimates a combined peak sales potential of $165 billion across its differentiated portfolio [16] Clinical & Regulatory Milestones - The company commercially launched SYMBRAVO in the US in June 2025 [20] - Positive topline results were achieved from the EMERGE Phase 3 trial of SYMBRAVO in oral CGRP non-responders in 1Q 2025 [20] - Positive topline results were achieved from the FOCUS Phase 3 trial of solriamfetol in ADHD in adults in 1Q 2025 [20] - Topline results were achieved from the PARADIGM Phase 3 trial of solriamfetol in MDD in 1Q 2025 [20] - An sNDA submission for AXS-05 in Alzheimer's disease agitation is expected in 3Q 2025 [20] - An NDA submission for AXS-12 in narcolepsy is expected in 4Q 2025 [20] Market & Pipeline - The company is developing new indications across approved products and has Phase 3 development programs ongoing [13] - The company plans to initiate a Phase 3 trial of solriamfetol in ADHD in pediatric patients in 4Q 2025 [20] - The company plans to initiate a Phase 3 trial of solriamfetol in MDD with EDS in 4Q 2025 [20] - The company plans to initiate a Phase 3 trial of AXS-14 in fibromyalgia in 4Q 2025 [20] - The company plans to initiate a Phase 2/3 trial of AXS-05 in smoking cessation in 4Q 2025 [20]