Axsome Therapeutics FY Conference Summary Company Overview - **Company**: Axsome Therapeutics (NasdaqGM:AXSM) - **Event**: FY Conference held on November 10, 2025 Key Points Industry and Market Performance - Axsome Therapeutics operates in the biotechnology sector, focusing on treatments for mental health and neurological disorders [1] - The company reported a strong Q3 performance with total net sales of **$171 million**, driven by their leading product for Major Depressive Disorder (MDD) which generated **$136 million**, reflecting a **69% year-over-year growth** and **14% quarter-over-quarter growth** [4][5] Product Pipeline and Development - Axsome has several products in various stages of development: - **AXS-05** for MDD - **AXS-12** for narcolepsy - Ongoing Phase III programs for other indications [3] - The company is expanding its earlier stage pipeline and has launched a direct-to-consumer (DTC) campaign to enhance product visibility [3][5] Direct-to-Consumer Campaign - The DTC campaign launched in early September has already shown positive early metrics, including increased Google searches and new prescriptions (NBRxs) [8][10] - NBRxs increased from **2,000 per week** to **2,800**, attributed largely to the DTC efforts [9][10] - The company is taking a disciplined approach to DTC spending, ensuring that sales in Q4 will meet or exceed the additional DTC expenditures [11][12] Market Access and Sales Force Expansion - Axsome has improved its gross-to-net dynamics, achieving a discount in the high **40s%** and covering **85% of total lives** [18][19] - The sales force currently consists of **300 representatives**, with plans for expansion upon receiving approval for additional indications [20][21] Regulatory and Approval Process - Axsome is preparing for an NDA submission for Alzheimer's Disease Agitation (ADA), with a robust package that includes three positive controlled trials and a standalone safety database [24][25] - The company has received breakthrough therapy designation and is eligible for priority review, although they are modeling a standard review timeline [32][33] Competitive Landscape - The market for Alzheimer's Disease treatments is evolving, with competitors like Rexulti showing growth rates of **20% to 25%** [39][40] - Despite the presence of approved products, a significant portion of patients are still treated off-label, indicating room for growth in formalized treatment protocols [42][43] Financial Outlook - Axsome achieved cash flow positivity for the first time, with approximately **$1 million** positive cash flow from operations in Q3 [60] - The company anticipates operating leverage moving into Q4 and next year, with revenue growth of **14%** and operating expenses growing at **5.5%** [61] Future Projections - Axsome projects peak sales for its products, including **$500 million to $1 billion** for Cymbravo and **$300 million to $500 million** for Sunosi [51][57] - The company is focused on maintaining a disciplined approach to its investments while preparing for potential growth in the ADA market [58][61] Conclusion - Axsome Therapeutics is positioned for significant growth with a strong product pipeline, effective marketing strategies, and a disciplined financial approach. The upcoming regulatory submissions and market expansions are critical to the company's future success.

Financial Data and Key Metrics Changes - The company reported net revenues of $102.7 million for the last quarter, indicating strong growth since the launch of XDEMVY [2][3] - Guidance for Q3 suggests distribution of 95,000 to 100,000 bottles, reflecting a steady cadence of growth despite seasonal dynamics [1][5] - Gross-to-net is expected to decrease to 43% to 45% for Q3, with a target of low 40% by year-end, driven by reduced discounts as patients progress through deductibles [8][9] Business Line Data and Key Metrics Changes - Over 20,000 eye doctors have prescribed XDEMVY, exceeding the initial target of 15,000, showcasing effective market education and engagement [14][15] - The company has achieved over 90% insurance coverage for XDEMVY, which is significantly above the industry average [11][12] Market Data and Key Metrics Changes - The total addressable market (TAM) for Demodex blepharitis is approximately 25 million Americans, with 9 million actively seeking treatment [21][22] - The company anticipates that the TAM could expand as more patients become aware of the treatment options available [21][22] Company Strategy and Development Direction - The company is focused on deepening prescribing patterns among existing prescribers and expanding the use cases for XDEMVY [15][16] - Plans for international expansion include market entry strategies for Europe and Japan, with a focus on physician education and market development [27][29] Management's Comments on Operating Environment and Future Outlook - Management noted that Q4 is expected to be a robust growth quarter as patient visits typically increase post-summer [5][6] - The company is optimistic about maintaining high insurance coverage levels and continuing to grow the prescriber base [11][12] Other Important Information - The company is preparing for the initiation of a phase 2 trial for TP-04 in ocular rosacea, with a focus on specific clinical endpoints [30][31] - The company is also exploring opportunities in Lyme disease prevention with TP-05, which is seen as a complementary program to its eye care focus [35][36] Q&A Session Summary Question: How should we think about seasonal trends on a go-forward basis? - Management explained that seasonal dynamics affect patient flow, with Q4 expected to show robust growth due to increased doctor visits post-summer [5][6] Question: Can you discuss the guidance on gross-to-net? - Management detailed that gross-to-net is expected to decrease as discounts reduce over time, with Q1 typically being the highest discount quarter [8][9] Question: What is the potential for expanding the prescriber base? - Management indicated that while the prescriber base has reached 20,000, the focus will now be on increasing the depth of prescribing among existing prescribers [14][15] Question: What are the expectations for the DTC campaign? - Management expressed confidence in the DTC campaign's effectiveness, anticipating continued growth in awareness and patient engagement [18][19] Question: What is the market potential for ocular rosacea? - Management noted that ocular rosacea affects 15 to 18 million individuals, with significant opportunities for treatment as awareness grows [33][34]