Company Overview - ACADIA Pharmaceuticals Inc. is a biopharmaceutical company focusing on therapies for central nervous system disorders and rare diseases [2] - Key approved products include NUPLAZID for Parkinson's disease psychosis and DAYBUE for Rett syndrome, both showing commercial growth [2] Financial Performance - In Q2 2025, NUPLAZID net sales increased by 7% year-over-year to $168.5 million, while DAYBUE sales grew by 14% to $96.1 million, reaching nearly 1,000 unique patients in the U.S. [2] Pipeline Development - A significant catalyst for 2025 is the upcoming Phase 3 readout of the COMPASS trial for ACP-101 in Prader-Willi Syndrome, with top-line results expected in early Q4 [3] - Positive trial outcomes could lead to a New Drug Application filing in Q1 2026 and potential approval by Q3 2026, expanding the company's pipeline into rare neurodevelopmental disorders [3] Research and Development Initiatives - The company is advancing multiple programs targeting neuropsychiatric symptoms and rare neurological diseases, including Alzheimer's disease and psychosis [4] - During its R&D Day in June 2025, ACADIA unveiled nine disclosed programs, with seven planned to enter Phase 2 or 3 stages from 2025 to 2026, and five anticipated readouts through 2027 [4] Market Position and Legal Developments - Recent patent litigation wins have secured market exclusivity for NUPLAZID through 2030 and extended formulations through 2038, providing stability for the commercial franchise [5] - With strong product momentum and a deepening pipeline, ACADIA is positioned for continued growth in CNS and rare disease therapies [5]

Core Insights - Acadia Pharmaceuticals reported Q2 2025 earnings with a slight beat on both GAAP earnings and revenue, driven by growth in NUPLAZID and DAYBUE product lines [1][5] - GAAP EPS reached $0.16, exceeding analyst expectations of $0.14, while revenue stood at $264.6 million, above the consensus of $262.0 million [1][2] - Revenue increased by 9.3% compared to Q2 2024, although GAAP net income declined due to higher tax and selling expenses [1][8] Financial Performance - Q2 2025 EPS (GAAP) was $0.16, down 20.0% from $0.20 in Q2 2024 [2] - Revenue for Q2 2025 was $264.6 million, with NUPLAZID net product sales at $168.5 million (up 7.0% year-over-year) and DAYBUE sales at $96.1 million (up 14% year-over-year) [2][6] - Research & Development expenses rose by 2.4% to $78.0 million, while Selling, General & Administrative expenses increased by 14.0% to $133.5 million [2][7] Business Overview - Acadia Pharmaceuticals focuses on developing treatments for central nervous system disorders, with primary products being NUPLAZID for Parkinson's disease psychosis and DAYBUE for Rett syndrome [3][4] - The company's strategy includes maximizing its drug franchises in the U.S., expanding internationally, and advancing its pipeline of new drug candidates [4] Market Position and Strategy - Acadia's drug pipeline includes nine experimental programs, with seven expected to enter Phase 2 or Phase 3 studies in the next two years [10] - Recent patent litigation victories have strengthened NUPLAZID's market protection, extending product exclusivity until at least 2030 [11] - The company is progressing its international plans for DAYBUE, with regulatory submissions in Europe under review and commercial launch activities ramping up ahead of anticipated approvals in 2026 [12] Guidance and Future Outlook - Management updated its full-year 2025 financial outlook, raising the lower bound of projected revenue and NUPLAZID net product sales guidance [13] - Total U.S. revenue guidance for FY2025 is set at $1.045 billion to $1.095 billion, with R&D expense guidance maintained at $330 million to $350 million [13] - Investors should monitor DAYBUE's patient ramp-up and retention rates, NUPLAZID's market share, and the progress of late-stage development programs [14]

Financial Performance - Total revenue for Q2 2025 reached $264.6 million, a 9% increase year-over-year compared to $242.0 million in Q2 2024[10, 41] - NUPLAZID net sales in Q2 2025 were $168.5 million, up 7% year-over-year from $157.4 million in Q2 2024[10, 41] - DAYBUE net sales in Q2 2025 amounted to $96.1 million, reflecting a 14% increase compared to $84.6 million in Q2 2024[10, 15, 41] - The company's cash and investments balance stands at $762.0 million[41] - The company updates the full year 2025 total revenue guidance to $1.045 to $1.095 billion[44] DAYBUE Updates - 987 unique patients in the U S received DAYBUE in Q2, an increase from 954 in Q1[16] - More than 50% of patients persistency at 12 months and above 45% at 18 months[16] - 70% of active patients have been on therapy for 12 months or longer[16] NUPLAZID Updates - Referrals for NUPLAZID increased by 17% year-over-year[23] - Traffic to NUPLAZID com increased 17 times year-over-year[23] Research and Development - Top-line results from the COMPASS PWS Phase 3 study of ACP-101 are expected in early Q4 2025[11, 35] - The company anticipates filing an NDA for ACP-101 in Q1 2026, assuming positive data from the Phase 3 trial[35] - Phase 2 initiation of ACP-204 in Lewy Body Dementia Psychosis is expected in 3Q25[32]

Financial Performance and Expectations - Acadia Pharmaceuticals expects to generate over $1 Billion in total U S revenues in 2025[12] - The company estimates a risk-adjusted peak sales potential of $25 Billion from its pipeline molecules[17] - The full potential peak sales for pipeline molecules is estimated at $12 Billion, assuming successful approval and commercialization[17] - Potential peak sales of current products are projected to be in the range of $15-$2 Billion[19] Pipeline Development and Strategy - Acadia Pharmaceuticals is focused on advancing care for underserved neurological and rare diseases[11] - The company has a late-stage pipeline with ACP-101 (P3-PWS) data expected in early Q4 2025 and ACP-204 (P2-ADP) data expected in mid-2026[12] - Acadia has 2 approved medicines and 9 disclosed and multiple undisclosed programs[30] - The company anticipates 7 Phase 2 or Phase 3 study starts in 2025 and 2026, and 5 Phase 2 or Phase 3 study readouts between 2025 and 2027[30] Key Programs and Indications - ACP-204 is being developed for Alzheimer's Disease Psychosis (ADP) and Lewy Body Dementia with Psychosis (LBDP), targeting approximately 3 million patients with psychosis across PDP, LBDP, and ADP in the US[45] - ACP-211 is in development for Major Depressive Disorder (MDD), a condition affecting approximately 21 million adults in the US[93, 125] - ACP-711 is being investigated for Essential Tremor (ET), which affects an estimated 7 million people or 22% of the US population[136, 171] - DAYBUE, approved for Rett syndrome, has seen >50% of patients remain on treatment at 12 months and 65% on treatment for 12+ months[271]

Financial Performance - Total Q1 revenue reached $244.3 million, a 19% increase year-over-year[10, 44] - NUPLAZID sales in Q1 were $159.7 million, up 23% year-over-year, marking the highest ever quarterly sales[11, 23, 44] - DAYBUE sales in Q1 were $84.6 million, an 11% increase compared to Q1 2024[11, 17, 44] - Net income for Q1 was $19.0 million, a 14% increase year-over-year[44] - Earnings per share (EPS) for Q1 was $0.11, a 10% increase year-over-year[44] Product Updates - DAYBUE saw 954 unique patients receiving the therapy in Q1[18] - DAYBUE discontinuations decreased by 35% compared to Q4 2024 and 66% compared to Q1 2024[18] - 65% of active DAYBUE patients have been on therapy for 12 months or longer, with persistency rates above 50% at 12 months[18] Research and Development - Topline results from the COMPASS PWS Phase 3 trial with ACP-101 are now expected in early Q4 2025[12, 29] - The last patient-in for the COMPASS PWS Phase 3 trial is now expected in Q2 2025[29] - A Phase 2 study of ACP-204 in Lewy Body Dementia Psychosis (LBDP) is on track to initiate in Q3 2025[37] - Last patient-in for the Phase 2 study of ACP-204 in Alzheimer's Disease Psychosis (ADP) is expected in Q1 2026, with topline results expected mid-2026[38] Financial Guidance - The company anticipates total revenue between $1.03 billion and $1.095 billion for FY 2025[45] - NUPLAZID net sales are projected to be between $650 million and $690 million for FY 2025[45] - DAYBUE net sales are projected to be between $380 million and $405 million for FY 2025[45] - R&D expense is expected to be between $330 million and $350 million for FY 2025[45] - SG&A expense is expected to be between $535 million and $565 million for FY 2025[45]

Financial Data and Key Metrics Changes - In Q4 2024, total revenue was $259.6 million, up 12% year-over-year. For the full year, total revenue reached $957.8 million, up 32% from the prior year [59] - DAYBUE net product sales in Q4 were $96.7 million, an 11% increase year-over-year, and full-year sales were $348.4 million, up 97% from $177.2 million in 2023 [60] - NUPLAZID net product sales in Q4 were $162.9 million, a 13% increase year-over-year, with full-year sales of $609.4 million, up 11% from $549.2 million in the prior year [61] Business Line Data and Key Metrics Changes - DAYBUE generated sales of $96.7 million in Q4, with a full-year total of $348.4 million, indicating strong growth driven by volume [12][60] - NUPLAZID achieved Q4 sales of $162.9 million, with full-year sales of $609.4 million, reflecting growth primarily from volume [35][61] Market Data and Key Metrics Changes - The company anticipates over $1 billion in revenue in the U.S. for 2025, driven by growth in both DAYBUE and NUPLAZID [8] - NUPLAZID's market share increased from 20% to 25% among patients receiving atypical antipsychotics for Parkinson's-related hallucinations and delusions [37][112] Company Strategy and Development Direction - The corporate strategy focuses on expanding neuroscience and neuro rare disease franchises, with plans to explore additional investments in rare diseases [11] - The company aims to achieve significant milestones in 2025 and 2026, including the anticipated approval of trofinetide in Europe [73] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's future, citing strong financial results and a robust pipeline as key factors [7][8] - The company expects to see continued growth in both DAYBUE and NUPLAZID, with specific strategies to enhance market penetration and patient engagement [20][39] Other Important Information - The company plans to hold its first R&D Day on June 25, 2025, to provide more insights into its pipeline and development programs [57] - The cash balance at the end of 2024 was $756 million, significantly up from $438.9 million at the end of 2023, primarily due to operational cash flows and the sale of a priority review voucher [63] Q&A Session Summary Question: How should we think about the evolution of growth-to-net for DAYBUE and NUPLAZID? - Management indicated that DAYBUE's growth-to-net is expected to remain in the low 20% range, influenced by Medicare Part D redesign [79] - For NUPLAZID, a 300 basis points price benefit is anticipated, with growth-to-net expected to improve over the next several years [81] Question: Is there a target number of patients for DAYBUE by year-end? - Management stated that the patient base is stable, with no expected meaningful decline in patients sequentially [87] - The focus will be on expanding the reach to the 70% of the Rett population that has yet to try DAYBUE [91] Question: Can you discuss the increase in diagnosed U.S. Rett patients? - The increase in diagnosed patients is attributed to better tracking and diagnostics, with a current estimate of 5,500 to 5,800 patients [95] Question: How does ACP-711 compare with SAGE-324? - Management highlighted that ACP-711 targets GABA-Alpha-3 receptors specifically, which may reduce potential safety side effects compared to SAGE-324 [98] Question: What are the secondary endpoints for ACP-101 in Prader-Willi syndrome? - Management expressed confidence that multiple mechanisms of action will be effective in treating Prader-Willi syndrome, with ongoing trials focusing on specific endpoints [118]

Financial Data and Key Metrics Changes - In Q4 2024, total revenue was $259.6 million, up 12% year-over-year, while full year revenue reached $957.8 million, up 32% from the prior year [59] - DAYBUE sales in Q4 were $96.7 million, an 11% increase year-over-year, and full year sales were $348.4 million, a 97% increase compared to $177.2 million in 2023 [60] - NUPLAZID sales in Q4 were $162.9 million, a 13% increase year-over-year, with full year sales of $609.4 million, up 11% from $549.2 million in the prior year [61] Business Line Data and Key Metrics Changes - DAYBUE's gross-to-net was 18.8% for the year, with a sequential growth of 5% in volume and 1% in net price in Q4 [60] - NUPLAZID's gross-to-net for Q4 was 23.2%, with full year gross-to-net at 26.1%, indicating a balanced growth from both volume and net price [61] Market Data and Key Metrics Changes - The company anticipates U.S. net sales for DAYBUE in 2025 to be between $380 million and $405 million, with expected volume growth of 9% to 16% year-over-year [63] - NUPLAZID's 2025 net sales are projected to be in the range of $650 million to $690 million, with growth expected to be split evenly between volume and net price [68] Company Strategy and Development Direction - The corporate strategy focuses on expanding neuroscience and neuro rare disease franchises, with plans to explore additional investments in rare diseases [11] - The company aims to achieve over $1 billion in annual net sales by 2025, joining a select group of biotech companies [73] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth potential of both DAYBUE and NUPLAZID, highlighting the importance of expanding the prescriber base and patient engagement [20][25] - The company plans to initiate a Phase 2 study for ACP-204 in Lewy body dementia psychosis and expects to see top-line results for ACP-101 in Prader-Willi syndrome in the first half of 2026 [74] Other Important Information - The company has submitted a marketing application for trofinetide in the EU, anticipating approval in Q1 2026 [42] - The cash balance at the end of 2024 was $756 million, significantly up from $438.9 million at the end of 2023, driven by operational cash flows and the sale of a priority review voucher [63] Q&A Session Summary Question: How should we think about the evolution of growth-to-net for DAYBUE and NUPLAZID? - Management indicated that DAYBUE's growth-to-net is expected to remain in the low 20% range, influenced by Medicare Part D redesign [80] - For NUPLAZID, a 300 basis points price benefit is expected in growth-to-net, with gradual increases anticipated over the next several years [81] Question: Is there a target number of patients for DAYBUE by year-end? - Management stated that the patient base is stable, with around 70% of the Rett population yet to try DAYBUE, indicating significant growth potential [91] Question: Can you discuss the increase in diagnosed U.S. Rett patients? - The increase in diagnosed patients from 5,000 to 5,800 is attributed to improved diagnostics and awareness driven by the launch of DAYBUE [95] Question: What are the secondary endpoints for ACP-101 in Prader-Willi syndrome? - Management expressed confidence that multiple mechanisms of action will be needed to treat patients in areas of unmet medical need like Prader-Willi syndrome [118]