Axsome Therapeutics (AXSM) FY Conference Summary Company Overview - **Company**: Axsome Therapeutics (AXSM) - **Industry**: Biotechnology, specifically focusing on Central Nervous System (CNS) conditions - **Conference Date**: June 03, 2025 Core Points and Arguments 1. **Growth Story**: Axsome is described as a bona fide growth story with a successful launch of a novel antidepressant, Avelity, and the product Sunosi gaining traction [2][3] 2. **Innovative Treatments**: The company aims to develop transformative medicines for CNS conditions, focusing on areas of unmet need such as Alzheimer's disease agitation and migraine [3][4] 3. **Pipeline Overview**: Axsome has a broad pipeline categorized into psychiatry (e.g., depression, ADHD) and neurology (e.g., migraine, narcolepsy), impacting over 50 million lives in the US [4][5] 4. **Potential Peak Sales**: The company anticipates a potential peak sales of $16.5 billion across its pipeline, with approved products like Avelity, Sunosi, and Simbravo projected to reach peak sales of $2 to $4.5 billion [10][11] 5. **Commercial Programs**: Axsome currently has three commercial programs, with Avelity for major depressive disorder showing rapid growth and a current annual run rate of approximately $400 million [19][20] 6. **Sales Team Expansion**: The sales team has expanded to 300 account managers to enhance market penetration, particularly in primary care [20][21] 7. **Simbravo Launch**: Simbravo, approved for acute migraine treatment, is expected to launch imminently, addressing significant dissatisfaction among migraine patients with current treatment options [23][24] 8. **Clinical Trial Success**: Positive results from multiple Phase III trials for products like AXS-five (Alzheimer's agitation) and AXS-fourteen (fibromyalgia) support ongoing development and upcoming NDA submissions [15][26][35] 9. **Financial Position**: The company is well-funded and on track for cash flow positivity, with a strong financial foundation and leadership team [38] Additional Important Content 1. **Market Access Strategy**: The company is focused on improving market access and coverage, with expectations for increased utilization management in commercial channels [44][45] 2. **Gross to Net Evolution**: Avelity's gross to net ratio is expected to stabilize in the mid-50s, influenced by evolving market access dynamics [46][47] 3. **Patient Profile for Simbravo**: The initial target patient profile for Simbravo includes those with mild to severe migraines, particularly those with inadequate responses to prior treatments [52][53] 4. **Regulatory Submissions**: Upcoming submissions include an sNDA for AXS-five in Alzheimer's agitation and an NDA for AXS-twelve in narcolepsy, with timelines set for the second half of the year [15][35][28] This summary encapsulates the key insights from the Axsome Therapeutics conference, highlighting the company's strategic direction, product pipeline, and market positioning within the biotechnology sector focused on CNS conditions.

Financial Data and Key Metrics Changes - Total net product revenue for 2024 was $386 million, reflecting high double-digit year-over-year growth for Avelity and Sunosi [7][12] - Total product revenues for Q4 2024 were $118.8 million, representing a year-over-year growth of 6688% [12][13] - Net loss for Q4 2024 was $74.9 million, or $1.54 per share, compared to a net loss of $98.7 million, or $2.08 per share for Q4 2023 [17][18] - The company ended 2024 with $315.4 million in cash and cash equivalents, down from $386.2 million at the end of 2023 [18] Business Line Data and Key Metrics Changes - Avelity net product sales were $291.4 million for the full year 2024, representing a year-over-year growth of 89124% [13][14] - Sunosi net product revenues were $94.3 million for the full year 2024, reflecting a year-over-year growth of 1626% [14][15] - Avelity prescriptions reached approximately 158,000 in Q4 2024, showing a 10% quarter-over-quarter growth and 87% growth compared to Q4 2023 [20][21] - Sunosi total prescriptions were approximately 49,000 in Q4 2024, representing 4% sequential growth and 16% growth versus Q4 2023 [22] Market Data and Key Metrics Changes - Avelity access is 78% of all lives across channels and 63% of lives in commercial [21] - Payer coverage for Sunosi in Q4 was stable at 83% of lives covered across channels [22] Company Strategy and Development Direction - The company aims to commercialize seven products or indications through 2027, focusing on CNS conditions [6][9] - The company plans to submit NDAs for AXS-five and AXS-twelve in the second half of 2025 [9][10] - The launch of Simbravo is anticipated to enhance the company's portfolio in the migraine treatment market [8][24] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about continued growth in 2025, supported by sales force expansion and improved market access dynamics [7][19] - The company expects to achieve cash flow positivity based on the current operating plan [18] - Management highlighted the importance of their digital-centric commercialization platform in driving growth [19] Other Important Information - The company completed five pivotal trials and initiated three Phase III trials in 2024, positioning for several important milestones in 2025 [9][11] - The company is actively engaged with payers to expand access for its products in 2025 [21] Q&A Session Summary Question: DTC promotional activities for Avelity and Simbravo - Management plans to launch a broad-based media outreach plan for Avelity in the coming months, considering seasonality in media spending [27][28] Question: Sales force expansion for Avelity - Approximately 40 additional representatives were added to the Avelity sales team, creating potential synergies with the prescriber base for Simbravo [32][34] Question: NDA submission for AXS-five - The submission is a top priority, with updates expected in the second half of the year [35][36] Question: Alzheimer's disease agitation filing - The filing approach has not been confirmed yet, but updates will be provided soon [41][43] Question: Seasonal cadence of scripts and revenues for Avelity - Q1 is expected to be a growth quarter, albeit slower than the previous year, with sales force expansion anticipated to drive growth [52][54] Question: M&A and business development strategy - The company is open to opportunities that complement its pipeline, focusing on both commercial and development-stage assets [58][59] Question: Impact of Medicare Part D restructure on Avelity revenues - No significant impact is expected from the Medicare Part D restructure on Avelity revenues [103][104] Question: Launch trajectory for Simbravo - The company is optimistic about Simbravo's impact on the acute migraine market, with a targeted approach to headache specialists [72][73] Question: Market opportunity for AXS-twelve in narcolepsy - The company sees a compelling market opportunity for AXS-twelve, particularly among patients dissatisfied with existing treatments [100][101]