Axsome Therapeutics' Q1 2025: Unraveling Contradictions in Auvelity Marketing and AD Submission Strategies

DTC advertising for Auvelity, AD aggression trial and submission timeline, ADA launch strategy, sales force expansion for Auvelity, and ADA meeting and NDA filing strategy for AXS-05 are the key contradictions discussed in Axsome Therapeutics' latest 2025Q1 earnings call.



Revenue Growth and Product Performance:
- Axsome Therapeutics reported total product revenues of $121.5 million for Q1 2025, representing a 62% year-over-year growth.
- The growth was primarily driven by robust underlying demand for Auvelity and Sunosi, with Auvelity net product sales up 80% year-over-year and Sunosi net product revenues up 17% year-over-year.

Clinical and R&D Advancements:
- Axsome submitted its NDA for AXS-14 for the management of fibromyalgia, with a decision on the acceptance of the filing expected in Q2.
- The company anticipates submitting an sNDA for AXS-05 in Alzheimer's disease agitation in Q3, with potential approval and launch in 2026.

Pipeline Expansion and Development:
- Axsome announced the completion of its registration program for AXS-12, with plans for an NDA submission in the second half of this year.
- The company also plans to initiate Phase III trials for Solriamfetol in ADHD and MDD with EDS later this year.

Commercial Execution and Market Coverage:
- Auvelity led the market in TRx growth in Q1, with a 76% year-over-year increase in prescriptions.
- The company activated 4,100 new prescribers for Auvelity in Q1, with continued expansion of the sales force expected to contribute to growth.