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    Axsome Therapeutics Inc (AXSM)

    Q2 2024 Earnings Summary

    Reported on Apr 1, 2025 (Before Market Open)
    Pre-Earnings Price$73.25Open (Aug 5, 2024)
    Post-Earnings Price$73.25Open (Aug 5, 2024)
    Price Change
    $0.00(0.00%)

    What went well

    • Expansion of Auvelity's Commercial Coverage Leading to Increased Sales Opportunities: Axsome Therapeutics has expanded commercial coverage for Auvelity from 48% to 60%, adding 22 million new covered lives effective August 1, 2024, increasing total coverage to 76%. This significant expansion is expected to drive increased prescriptions and revenue as more patients gain access to Auvelity.
    • Promising Late-Stage Pipeline with Multiple Upcoming Catalysts: Axsome has a robust pipeline with five product candidates in late-stage development targeting nine indications. Key upcoming milestones include pivotal trial readouts in the second half of 2024 for AXS-05 in Alzheimer's disease agitation (ADVANCE-2 and ACCORD-2 trials) and solriamfetol in ADHD (FOCUS trial). Successful results could significantly expand Axsome's market opportunities and drive growth.
    • Strong Performance and Market Penetration of Auvelity Supported by Effective Sales Strategy: Auvelity prescriptions grew to approximately 123,000 in Q2 2024, representing 29% quarter-over-quarter growth and 131% growth compared to Q2 2023. The salesforce expansion led to increased new patient starts and growth in the primary care segment. Additionally, Auvelity demonstrates better persistence than standard antidepressants (SSRIs), supporting its competitive advantage and potential for continued market share gains.

    What went wrong

    • Sunosi's Growth May Be Limited: The company acknowledges that while pleased with Sunosi's performance, it operates in a smaller market opportunity relative to major depression, potentially limiting future growth prospects. ("...this is overall a smaller market opportunity relative to major depression..." )
    • AXS-07 Faces Challenges in Crowded Migraine Market: AXS-07 is entering a competitive acute migraine market with existing treatments like oral CGRPs and triptans. Additionally, the unfavorable payer landscape may impact its commercial success. ("...the oral CGRP space is crowded... Obviously, market access and payer dynamics is top of mind..." )
    • High Gross-to-Net Discounts May Affect Profitability: The gross-to-net discount for Auvelity is significant, remaining in the low to mid-50% range. This indicates substantial rebates are necessary to secure coverage, which could impact net revenues and profitability. ("...GTN for ability was in the low to mid-50s. We do expect it to remain in this range for the second half of the year..." )

    Q&A Summary

    1. Clinical Trial Readouts Timing
      Q: When will key Phase III trial results be announced?
      A: We expect top-line results for both the pivotal ADVANCE-2 Phase III trial of AXS-05 in Alzheimer's disease agitation and the FOCUS Phase III trial of solriamfetol in ADHD in the second half of 2024.

    2. AXS-05 Filing Strategy for Alzheimer's Agitation
      Q: When can you file AXS-05 for Alzheimer's agitation?
      A: We aim to complete the ADVANCE-2 trial, ACCORD-2 trial, and the open-label safety extension in the second half of this year, positioning us to submit an NDA for AXS-05 in Alzheimer's disease agitation.

    3. AXS-07 Migraine Launch Plans
      Q: What's your go-to-market strategy for AXS-07 in migraine?
      A: We see a meaningful opportunity for AXS-07, addressing the 70% of 6 million migraine patients dissatisfied with current therapies. We're working on pricing and payer strategies to navigate the competitive landscape.

    4. AXS-14 in Fibromyalgia
      Q: What's the opportunity for AXS-14 in fibromyalgia?
      A: Fibromyalgia affects about 17 million U.S. adults. With only three approved treatments in the last 15 years, we believe AXS-14 has the potential to become a new standard of care.

    5. Impact of Auvelity Coverage Expansion
      Q: How will expanded coverage affect Auvelity's growth and gross-to-net?
      A: With 22 million additional lives covered from August 1, we expect the impact to build over the coming months. Gross-to-net is expected to remain in the low to mid-50% range for the second half of the year.

    6. Sales Force Expansion Effect on Auvelity
      Q: What's the benefit from Auvelity's sales force expansion?
      A: We saw a clear inflection in weekly new patient starts from end of March, and solid growth in primary care utilization. Psychiatrists remain the majority, but primary care adoption is increasing.

    7. Solriamfetol's Market Potential
      Q: Which solriamfetol indications offer the best opportunity?
      A: All four indications—ADHD, MDD, binge eating disorder, and shift work disorder—represent large patient populations. We believe solriamfetol could provide superior benefits over current agents, especially in ADHD and binge eating disorder.

    8. Auvelity Persistence Over SSRIs
      Q: Is Auvelity's persistence exceeding expectations?
      A: Yes, cohort analysis shows a numerical advantage for Auvelity over widely used SSRIs, confirming feedback of greater persistence from providers.

    9. Direct-to-Consumer Advertising Plans
      Q: Will you launch DTC advertising for Auvelity?
      A: We have DTC efforts primarily focused on digital media. We're evaluating a broader campaign but considering factors like anticipated media noise during election season.

    10. First-Line Use of Auvelity Increasing
      Q: Is early-line use of Auvelity increasing?
      A: Yes, approximately 50% of Auvelity's use is now first or second line, and we continue to see progress in this area.

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