Axsome Therapeutics FY Conference Summary Company Overview - **Company**: Axsome Therapeutics (NasdaqGM:AXSM) - **Event**: FY Conference on December 03, 2025 Key Points Industry and Product Updates - **Auvelity and Alzheimer's Disease (AD) Agitation**: - Axsome is awaiting an acceptance decision for the supplemental new drug application (SNDA) for Auvelity in AD agitation, which was submitted in early November [3][5][10] - The expectation is for a standard review due to FDA resource constraints, despite having three positive trials and breakthrough therapy designation [10][11] - The company believes the trial package is robust, consisting of one randomized parallel group study and two randomized withdrawal studies [10][12][22] Commercialization Strategy - **Sales Force Expansion**: - Currently, Axsome has approximately 300 sales representatives detailing for Major Depressive Disorder (MDD) and plans to expand the team upon approval for AD agitation [24][26] - The peak sales opportunity for AD agitation is estimated between $1.5 billion and $3 billion, while MDD is estimated at $1 billion to $3 billion, totaling $2.5 billion to $6 billion [30][32] - A discrete field force team will be established for long-term care facilities, recognizing the comorbidity between MDD and AD agitation [32][34] Market Access and Coverage - **Access to Auvelity**: - Currently, there is 100% access in the government channel and 75% in the commercial channel, leading to an overall 85% total covered lives [47][47] - The majority of prescriptions are expected to come from the government channel, with high-quality access anticipated for the AD agitation indication [47][123] Direct-to-Consumer (DTC) Campaign - **DTC Campaign for Auvelity**: - A national TV DTC campaign launched in September has shown positive results, with new prescriptions (NBRXs) increasing from 2,000 to over 2,800 per week [75][78] - The campaign is expected to continue through 2026, with adjustments made based on market conditions [79][100] Product Performance and Market Position - **Auvelity in MDD**: - Over 50% of prescriptions are now for monotherapy, with 15% first-line and 35% second-line usage [103][108] - The gross-to-net (GTN) improved from mid-50s% in Q1 and Q2 to high 40s% in Q3, with expectations for a slight uptick in Q4 [122][123] Pipeline Developments - **Solriamfetol**: - Axsome is excited about the potential of Solriamfetol in various CNS settings, with studies underway for ADHD, MDD with excessive daytime sleepiness, and binge eating disorder [159][161][186] - The company anticipates starting a pediatric ADHD study this quarter and expects top-line results for binge eating disorder next year [174][190] New Product Development - **GABA-A Alpha 2/3 Modulator**: - Axsome is exploring the value proposition of a new GABA-A modulator for epilepsy and psychiatric indications, with preclinical work already underway [200][206] - The company is taking an opportunistic approach to expand its early-stage pipeline [211][220] Conclusion - Axsome Therapeutics is strategically positioned with a robust pipeline and commercialization plans, focusing on expanding its market presence in both existing and new indications while maintaining a strong emphasis on data-driven decision-making and market access strategies.

Financial Data and Key Metrics Changes - The company expects over $1 billion in sales from its two commercial products, NUPLAZID and DAYBUE, for the current year [5] - NUPLAZID's sales guidance for the year has been narrowed to a range of $685 million to $695 million, indicating an upward shift from previous estimates [23][24] - The company maintains a strong balance sheet with over $800 million in cash and no debt, allowing for continued investment in business development [6][105] Business Line Data and Key Metrics Changes - NUPLAZID has seen a 20% increase in both referrals and new patient starts, marking the strongest quarter in new patient starts in a long time [10] - DAYBUE has experienced significant increases in new referrals, the largest since Q3 2024, indicating early success from increased investment in U.S. infrastructure [12] - The company plans to expand its customer-facing field force to further drive growth and profitability for both NUPLAZID and DAYBUE [11] Market Data and Key Metrics Changes - The company is preparing for European approval of DAYBUE next year, aiming to expand its market presence outside the U.S. [12][55] - The market for Alzheimer's disease psychosis (ADP) is significantly larger than that for Parkinson's disease psychosis (PDP), presenting a substantial growth opportunity [70] Company Strategy and Development Direction - The company is focused on expanding its commercial footprint and increasing investments in marketing and sales to enhance product awareness and penetration [11][12] - A robust pipeline is in place, with ACP-204 being the most advanced program targeting Alzheimer's disease psychosis and Lewy body dementia psychosis [6][61] - The company is committed to maintaining profitability while navigating potential price decreases due to future negotiations under the IRA [34] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in continued meaningful growth for both franchises, with plans to provide guidance on peak sales for NUPLAZID next year [28] - The company is mindful of potential legislative impacts but does not anticipate significant disruptions to its growth strategy in the near term [34] Other Important Information - The company has a stable patient base for DAYBUE, with over 70% of patients on therapy for 12 months or longer, indicating strong treatment adherence [40] - The company is actively building a team in Europe to prepare for the launch of DAYBUE, with a focus on establishing scientific conversations and market access [55] Q&A Session Summary Question: Can you provide an overview of the commercial performance for NUPLAZID and DAYBUE? - Management highlighted a strong quarter for NUPLAZID with a 20% increase in new patient starts and significant growth for DAYBUE due to increased referrals [10][12] Question: What is the sales guidance for NUPLAZID this year? - The sales guidance has been narrowed to a range of $685 million to $695 million, reflecting an upward adjustment [23][24] Question: How does the IRA impact the company? - Management indicated that while there may be price decreases in the future, the company expects to remain profitable and continue driving growth [34] Question: What is the strategy for expanding DAYBUE in Europe? - The company plans to market DAYBUE independently in Europe, starting with Germany, and has begun building a team to support this effort [55] Question: What are the expectations for the upcoming phase II readout for ACP-204? - Management expressed excitement about the phase II readout for ACP-204, viewing it as a higher probability of success due to prior learnings from pimavanserin [61][62]

Financial Data and Key Metrics Changes - For Q3 2025, revenue was $2.4 million, a slight decrease from $2.5 million in Q3 2024. For the nine months ended September 30, 2025, revenue was $6.9 million, compared to $6.6 million for the same period in 2024 [10] - Gross profit for the nine months ended September 30, 2025, was approximately $4.9 million, reflecting no material year-over-year change [10] - Operating expenses were approximately $1.1 million for Q3 2025, down over $500,000 compared to the same period last year [5][10] Business Line Data and Key Metrics Changes - In the dental segment, international sales increased year-over-year, partially offsetting a decline in domestic revenue [7] - Utilization of CompuFlow disposables rebounded slightly, indicating a re-engagement with current customers [7] Market Data and Key Metrics Changes - The company has a market share of approximately 1.5%-2% in both domestic and international markets, indicating significant room for growth [16] Company Strategy and Development Direction - The company is focused on three strategic priorities: streamlining operations, strengthening commercial execution in dental and medical sectors, and advancing reimbursement strategies for CompuFlow [6][8] - The addition of Dr. Dawood Syed to the board aims to enhance clinical and payer expertise, supporting the strategy for broader adoption within hospital systems [8] Management's Comments on Operating Environment and Future Outlook - Management emphasized the importance of disciplined execution and operational excellence to build value for shareholders and customers [12] - The company plans to focus on a handful of states for CompuFlow's rollout, ensuring proper data collection for Medicare reimbursement [21][22] Other Important Information - As of September 30, 2025, the company had cash and cash equivalents of approximately $1.3 million and working capital of approximately $3.1 million [11] Q&A Session Summary Question: How to convince dental clinics to invest in new equipment? - Management acknowledged the need to reconnect with old customers and expand digital marketing efforts to raise awareness about the benefits of their products [15][16] Question: Update on the medical side and broader commercialization plans? - The focus is on supporting current clinics using CompuFlow and collecting data for Medicare reimbursement, with plans for broader commercialization in the near future [21][22] Question: Impact of tariffs on supply chain and customer behavior? - Management reported minimal impact from tariffs and is considering a bonded warehouse in the U.S. to mitigate potential issues [29] Question: Structure of the salesforce and reimbursement specialists? - The company plans to ramp up the salesforce and is considering pursuing reimbursement codes for pediatric use [31] Question: Is there a seasonality pattern in sales? - Management indicated that the business is steady without significant seasonal fluctuations, expecting a similar performance in Q4 [32] Question: Future prospects and challenges for Milestone Scientific? - Management acknowledged past challenges but emphasized a focused approach with strong technology and a structured plan for growth [39][40] Question: Current cash position and capital needs? - The company has sufficient cash to operate for several quarters and is looking for opportunities to improve its financial position [47]

Financial Data and Key Metrics Changes - Acadia Pharmaceuticals reported total revenues of $244.3 million for Q1 2025, representing a 19% increase year-over-year [6][29] - R&D expenses increased to $78.3 million from $59.7 million in Q1 2024, driven by higher spending on clinical stage programs [32] - SG&A expenses rose to $126.4 million from $108 million in Q1 2024, primarily due to ongoing consumer activation campaigns for NUPLAZID and expansion of the Debut team [32] Business Line Data and Key Metrics Changes - Debut sales reached $84.6 million in Q1 2025, an 11% increase from the previous year, with a record number of unique patients receiving shipments [7][29] - NUPLAZID generated $159.7 million in revenue for the quarter, up 23% year-over-year, with 6% of this growth attributed to volume [7][31] Market Data and Key Metrics Changes - The number of unique patients receiving Debut shipments was 954, marking an all-time high for the brand [7][11] - NUPLAZID's gross price increased by over 2% year-over-year, with a gross-to-net adjustment of 24.1% for the quarter [31] Company Strategy and Development Direction - Acadia is focused on accelerating the commercial trajectory of Debut and capitalizing on the momentum of NUPLAZID while expanding its global presence [35] - The company plans to host its first R&D Day to provide insights into its development strategy and pipeline innovations [9][35] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the sustainability of Debut's growth and reiterated full-year sales guidance for both Debut and NUPLAZID [7][35] - The timeline for the COMPASS PWS Phase III study results is now expected by the end of 2025, indicating progress in pipeline development [9][35] Other Important Information - Acadia anticipates EMA approval for Debut in Q1 2026, with a substantial market opportunity in Europe for Rett syndrome patients [14][28] - The company has received orphan drug designation for trofinetide in Japan, which may lead to priority review [28] Q&A Session Summary Question: What does good 101 data look like and how does it relate to FDA discussions? - Management indicated that statistically significant results demonstrating a clinically meaningful impact on hyperphagia would be considered good data [40] Question: How should we model a European price for Debut? - Management expressed confidence in obtaining a strong EU price that reflects the value provided to patients in the Rett community [41] Question: What are the key growth drivers for NUPLAZID and Debut from Q1 to Q2? - Management highlighted patient demand and the impact of expanded customer models as key growth drivers for both brands [44][46] Question: What are the biggest risks to the approval process for trofinetide in the EU? - Management stated confidence in the EMA approval process, noting that they are on track with the regulatory timeline [80] Question: How does Acadia view its positioning against Celeno's product for Prader Willi? - Management believes there is room for multiple therapies in the Prader Willi space, emphasizing the complexity of patient needs [95]