Axsome Therapeutics(US:AXSM)2025-05-05 13:10Financial Performance & Pipeline - Axsome reported a total net product revenue of $121.5 million in 1Q 2025, representing a 62% year-over-year growth compared to 1Q 2024[16] - AUVELITY net product sales reached $96.2 million in 1Q 2025, reflecting an 80% year-over-year growth[16, 18] - SUNOSI net product revenue was $25.2 million in 1Q 2025, a 17% increase year-over-year[16, 18] - The company's cash and cash equivalents stood at $300.9 million as of March 31, 2025, expected to fund operations into cash flow positivity[16] - Axsome anticipates peak sales potential of $16.5 billion driven by current commercial and late-stage assets[13] Regulatory & Clinical Milestones - SYMBRAVO was approved in the U S for the acute treatment of migraine in January 2025, with commercial launch anticipated in June 2025[16, 17, 23] - An NDA for AXS-14 for fibromyalgia was submitted to the FDA[16] - A supplemental NDA submission for AXS-05 in Alzheimer's disease agitation is on track for 3Q 2025[16, 61] - An NDA submission for AXS-12 for cataplexy in patients with narcolepsy is anticipated in 2H 2025[16, 96] - Positive topline results were announced for the FOCUS Phase 3 trial of solriamfetol in ADHD and the EMERGE Phase 3 trial of SYMBRAVO in oral CGRP non-responders[16, 70] Market & Therapeutic Areas - Approximately 7 million people in the U S are affected by Alzheimer's disease[56] - Agitation is reported in approximately 70% of people with Alzheimer's disease[58] - An estimated 22 million people in the U S are affected by ADHD, including approximately 7 million children aged 3-17 years old[7, 67] - Approximately 17 million people in the U S are affected by fibromyalgia[7, 101]