Financial Data and Key Metrics Changes - ACADIA reported adjusted total revenues of $298 million in Q4 2025, a 16% increase from the prior year, and annual revenues exceeded $1 billion for the first time, reaching $1.08 billion, representing a 14% growth from the previous year [6][24] - Adjusted NUPLAZID net sales were $189 million in Q4 and $692 million for the full year, reflecting a 17% and 15% increase year-over-year, respectively [7][26] - DAYBUE achieved net product sales of $110 million in Q4 and $391 million for the full year, representing 13% and 12% year-over-year growth, respectively [8][27] Business Line Data and Key Metrics Changes - NUPLAZID's volume growth was 13% in Q4 and 9% for the full year, with new prescriptions growing 18% year-over-year in Q4 [13][15] - DAYBUE's sales growth was driven by expanded reach into community physician settings and international patient supply programs [8][18] - The launch of DAYBUE STIX, a new powder formulation, is generating significant interest and is expected to unlock additional patient opportunities [17][19] Market Data and Key Metrics Changes - The company expects NUPLAZID net sales of $760 million to $790 million in 2026, indicating a growth of 10% to 14% over 2025 [7][29] - DAYBUE is projected to achieve global net sales between $460 million and $490 million in 2026, representing an 18% to 25% growth over 2025 [9][30] Company Strategy and Development Direction - ACADIA aims to achieve blockbuster status for NUPLAZID with $1 billion in net sales by 2028, supported by strong commercial execution and pipeline advancements [7][32] - The company is committed to advancing access to trofinetide in the EU despite recent regulatory challenges, with plans for reexamination [9][22] - The R&D pipeline includes four unique molecules targeting large addressable markets with a combined peak sales potential of $11 billion [11][23] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth trajectory of both NUPLAZID and DAYBUE, with expectations for continued strong performance in 2026 and beyond [6][32] - The company highlighted the importance of upcoming milestones, including phase 2 study results for remlifanserin, which could significantly impact long-term growth [20][32] Other Important Information - The company reported a one-time non-cash income tax benefit of approximately $250 million due to the release of the valuation allowance on deferred tax assets [28] - Cash balance at the end of 2025 was $820 million, providing flexibility for future growth initiatives [28] Q&A Session Summary Question: How should we think about ramp to your 2028 global net sales targets? - Management indicated confidence in achieving low to mid-teens growth for NUPLAZID and low 20% growth for DAYBUE, projecting a CAGR of about 16% through 2028 [36][37] Question: What does good remlifanserin ADP data look like later this year? - Management is looking for evidence of efficacy and a good safety profile, with a focus on compliance and ease of use for patients [44][47] Question: Can you provide insights on DAYBUE's persistency and patient compliance? - Discontinuation rates remain low in the single-digit range, and the company is optimistic about growth driven by the new STIX formulation [52][56] Question: What are the specific concerns regarding the EU opinion for DAYBUE? - Management anticipates questions related to the relevance of endpoints and clinical meaningfulness, and plans to address these in the re-examination process [61][66]

Financial Data and Key Metrics Changes - The company reported adjusted total revenues of $298 million in Q4 2025, a 16% increase from the prior year, and annual revenues exceeded $1 billion for the first time, reaching $1.08 billion, representing a 14% growth from the previous year [5][24] - Adjusted NUPLAZID net sales were $189 million in Q4 and $692 million for the full year, reflecting a 17% and 15% increase year-over-year, respectively [6][26] - DAYBUE achieved net product sales of $110 million in Q4 and $391 million for the full year, representing 13% and 12% year-over-year growth, respectively [7][27] Business Line Data and Key Metrics Changes - NUPLAZID's volume growth was 13% in Q4 and 9% for the full year, with new prescriptions growing 18% year-over-year in Q4 [11][12] - DAYBUE's sales growth was driven by expanded reach into community physician settings and international patient supply programs [7][17] - The company expects NUPLAZID net sales of $760 million to $790 million in 2026, indicating 10%-14% growth over 2025 [6][29] Market Data and Key Metrics Changes - The company anticipates global net sales for DAYBUE between $460 million and $490 million in 2026, driven by the launch of DAYBUE STIX and continued growth in named patient supply programs [8][30] - The company projects 2028 global net sales for DAYBUE of $700 million, with EU sales representing less than 15% of the total [9] Company Strategy and Development Direction - The company is focused on advancing its R&D pipeline, with several key catalysts expected in 2026, including the phase 2 readout of remlifanserin [10][23] - The company aims to achieve blockbuster status for NUPLAZID with $1 billion in net sales by 2028 [6][14] - The company is committed to expanding access to trofinetide in the EU and has active named patient supply programs [8][22] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's growth trajectory, supported by strong commercial execution and a robust pipeline [33] - The company anticipates continued growth in both NUPLAZID and DAYBUE, with foundational investments in SG&A expected to deliver meaningful top-line growth [29][31] - Management highlighted the importance of regulatory developments and the potential for reexamination of trofinetide in the EU [22][23] Other Important Information - The company reported a one-time non-cash income tax benefit of approximately $250 million in Q4 due to the release of the valuation allowance on deferred tax assets [28] - The cash balance at the end of 2025 was $820 million, providing flexibility for future growth initiatives [28] Q&A Session Summary Question: How should we think about ramp to your 2028 global net sales targets? - Management indicated confidence in achieving low to mid-teens growth for NUPLAZID and low 20% growth for DAYBUE, projecting a CAGR of about 16% through 2028 [35][36] Question: What does good remlifanserin ADP data look like later this year? - Management is looking for evidence of efficacy and a good safety profile, with a focus on not negatively impacting motor or cognitive functions [44][48] Question: Can you provide insight into DAYBUE's persistency and patient compliance? - Discontinuation rates remain in the low single-digit range, and the company is seeing benefits from its community expansion strategy [53][55] Question: What are the specific concerns regarding the EU opinion for DAYBUE? - Management anticipates questions related to the relevance of endpoints and clinical meaningfulness, and plans to address these in the re-examination process [62][66]