Financial Data and Key Metrics Changes - In Q2, the company achieved a milestone of $150 million in net sales for the first time, with $120 million from Avelity, indicating a trajectory towards $500 million in annualized sales [5] - The company reported a strong balance sheet with over $300 million in cash, positioning it for cash flow positivity [5][6] - The gross-to-net discount for Q2 was in the mid-50s range, showing slight improvement from Q1, and is expected to remain stable for the second half of the year [46][47] Business Line Data and Key Metrics Changes - Avelity for major depressive disorder (MDD) is tracking close to $500 million in sales, with peak sales potential estimated between $1 billion to $3 billion [30][31] - Sunosi generated $30 million in sales, with two-thirds of scripts coming from obstructive sleep apnea (OSA) [62] - The newly launched product, Symbravo, recognized approximately $400,000 in sales during its initial weeks [5] Market Data and Key Metrics Changes - The company has expanded its covered lives for Avelity to 83%, with a national direct-to-consumer campaign planned to further increase brand awareness [31][32] - The Medicare channel has shown significant growth, with Rexulti scripts growing over 40% year-over-year, indicating a robust market for Alzheimer's disease agitation treatments [14][15] Company Strategy and Development Direction - The company is focused on expanding its product portfolio with a robust pipeline, including potential indications for Alzheimer's disease agitation, smoking cessation, ADHD, and binge eating disorder [4][63] - The strategy includes optimizing the sales force by integrating Alzheimer's disease agitation into the existing MDD sales team and potentially expanding into long-term care [27][28] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the fundamentals of the company, stating that the current environment is favorable for growth [4] - The company is focused on top-line growth while also improving cash flow, with a significant reduction in losses year-over-year [84][85] Other Important Information - The company is in dialogue with the FDA regarding the submission package for Avelity in Alzheimer's disease agitation, with a focus on providing robust clinical data [18][19] - The patent for Symbravo extends to 2041, providing a strong competitive position in the market [60][61] Q&A Session Summary Question: Are you still on track to file an sNDA for Alzheimer's disease agitation in Q3? - Yes, the company is on track to file [6] Question: What is the commercial opportunity in Alzheimer's disease agitation? - There is a substantial unmet need, with potential peak sales estimated between $1 billion to $3 billion [8][9] Question: How is the sales force structured for Avelity and Alzheimer's disease agitation? - The sales force has expanded to approximately 300 reps, with plans to integrate Alzheimer's disease agitation into the existing MDD team [27][28] Question: What is the expected gross-to-net discount at steady state? - The company expects to maintain a mid-50s gross-to-net discount for the remainder of the year [46][47] Question: What are the goals for the launch of Symbravo? - The focus is on gathering clinician feedback and improving access for patients [49][51] Question: What is the peak sales potential for ADHD indications? - The peak sales potential for ADHD is estimated between $1 billion to $3 billion [71]

Financial Data and Key Metrics Changes - In Q2, Axsome Therapeutics achieved a milestone of $150 million in net sales for the first time, with $120 million from Avelity and $30 million from Sunosi, indicating strong growth potential [5] - The company has a robust balance sheet with over $300 million in cash, positioning it for cash flow positivity [5] Business Line Data and Key Metrics Changes - Avelity is on track for annualized sales of half a billion, with significant growth observed since its launch [5][37] - Sunosi generated $30 million in sales, with a focus on expanding its market presence in obstructive sleep apnea and narcolepsy [68] - The launch of Symbravo for migraine treatment is in early stages, with positive feedback on its efficacy and tolerability [54][56] Market Data and Key Metrics Changes - The market for Alzheimer's disease agitation shows substantial unmet need, with potential peak sales for Avelity estimated between $1 billion to $3 billion [11] - Avelity is currently capturing about 0.16% of the total market share, indicating significant room for growth [50] Company Strategy and Development Direction - The company is focused on expanding its sales force and enhancing its commercialization strategy, particularly for Avelity and the upcoming Alzheimer's indication [33][41] - Axsome is exploring additional indications for Sunosi, including ADHD and MDD associated with excessive daytime sleepiness, which could drive future growth [69][78] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth trajectory of Avelity, citing a strong sales force and increased market access as key drivers [38][41] - The company aims to prioritize top-line growth while also improving cash flow, with a significant reduction in losses year-over-year [90] Other Important Information - Axsome has a patent portfolio for Symbravo extending to 2041, providing a competitive edge in the market [65][66] - The company is in dialogue with the FDA regarding its clinical trial designs and submission strategies for various products, ensuring alignment with regulatory expectations [21][25] Q&A Session Summary Question: Are you still on track to file an sNDA for Alzheimer's disease agitation in Q3? - Yes, the company is on track to file [6][7] Question: What is the commercial opportunity in Alzheimer's agitation? - There is substantial unmet need, with potential peak sales estimated at $1 billion to $3 billion [11] Question: How is the sales force being optimized for Avelity? - The sales force has expanded to approximately 300 reps, with plans to integrate Alzheimer's agitation into their strategy [33][34] Question: What are the goals for the launch of Symbravo? - The focus is on gathering clinician feedback and improving access for patients [54][56] Question: What is the expected gross to net discount for Avelity? - The company expects to maintain a mid-50s range for gross to net discounting [52][53] Question: What is the potential market for ADHD indications? - The peak sales potential for ADHD is estimated at $1 billion to $3 billion [77]

Axsome Therapeutics (AXSM) 2025 Conference Summary Company Overview - Axsome Therapeutics is a CNS-focused biopharmaceutical company with three commercial programs: - **Avelity** for major depressive disorder (MDD) - **Sunosi** for excessive daytime sleepiness associated with obstructive sleep apnea (OSA) and narcolepsy - **Simbravo** for migraine, which is set to launch imminently [5][8][4] Key Programs and Developments - **Commercial Programs**: - Avelity has an annualized run rate of **$400 million** as of Q1 2025, with **15%** frontline use and **35%** second-line use among scripts [16][17] - Sunosi has approximately **75 sales reps**, while Avelity has expanded to **300 reps** from **260** earlier in the year [11][12] - Simbravo will launch with **100 reps** focused on headache centers [14][38] - **NDA Stage Programs**: - AXS-05 for Alzheimer's disease agitation - AXS-14 for fibromyalgia - AXS-12 for narcolepsy [6][8] Financial Outlook - Axsome expects to reach cash flow positivity but has not specified a timeline [8] - The company is focused on disciplined capital deployment and efficient launches due to high synergy within its sales teams [9][8] Market Strategy and Growth Drivers - Axsome plans to increase engagement with primary care physicians, which currently account for **20-25%** of scripts for Avelity [22] - A national direct-to-consumer (DTC) campaign is in development, with testing in regional markets [23][24] - The company anticipates improvements in coverage and access for patients, which could drive volume [24] Product Differentiation and Competitive Landscape - Avelity is positioned as a potential multi-billion dollar opportunity in MDD, with a unique profile compared to competitors like Rexulti and Vraylar [16][18] - The product is expected to have a distinct label and safety profile, differentiating it from atypical antipsychotics [30][32] Upcoming Approvals and Pipeline - Axsome is preparing to file an sNDA for Avelity in Q3 2025 for Alzheimer's agitation [27][35] - The company is also working on NDA submissions for AXS-14 (fibromyalgia) and AXS-12 (narcolepsy) [49][46] Clinical Data and Efficacy - AXS-14 has shown potential in addressing fatigue, a significant symptom for fibromyalgia patients, which may differentiate it from existing treatments [52] - The FOCUS Phase III trial for Sunosi in adults was positive, and a pediatric trial is planned to complete the NDA package [59] Conclusion - Axsome Therapeutics is strategically positioned for growth with multiple product launches and a robust pipeline. The focus on CNS disorders, combined with a disciplined approach to capital and market engagement, suggests a promising outlook for the company in the coming years [5][8][24]