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]