Axsome Therapeutics' Q1 2025: Unraveling Contradictions in Auvelity Marketing and AD Submission Strategies
Generated by AI AgentAinvest Earnings Call Digest
Monday, May 5, 2025 7:41 pm ET1min read
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DTCDTEC-- 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 TherapeuticsAXSM-- 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.
Revenue Growth and Product Performance:
- Axsome TherapeuticsAXSM-- 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.
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