One fund is quietly buying into ACADIA — just as the company posts one of its strongest quarters in years.Connecticut-based fund Braidwell established a new position in ACADIA Pharmaceuticals (ACAD +1.77%), adding nearly 2.4 million shares, a stake valued at about $50.8 million as of September 30.What HappenedAccording to a filing with the U.S. Securities and Exchange Commission dated November 14, Braidwell disclosed a new stake in ACADIA Pharmaceuticals, acquiring nearly 2.4 million shares valued at approx ...

ACADIA Pharmaceuticals (NasdaqGS:ACAD) FY 2025 Conference December 02, 2025 09:45 AM ET Company ParticipantsMark Schneyer - CFOConference Call ParticipantsYigal Nochomovitz - Biotech AnalystYigal NochomovitzWelcome to the second session of the Biotech conference. I'm Yigal Nochomovitz, one of the biotech analysts here at Citigroup. The next session is with Acadia Pharmaceuticals with Mark Schneyer, the CFO. Welcome. Thank you so much.Mark SchneyerYeah, thanks for having us.Yigal NochomovitzWe just started c ...

Summary of ACADIA Pharmaceuticals Conference Call Company Overview - **Company**: ACADIA Pharmaceuticals (NasdaqGS:ACAD) - **Focus**: Building a leading neurological and rare disease company with aspirations to become a global biotech powerhouse [2][3] Core Industry Insights - **Market Position**: ACADIA is focused on long-term growth in neurological and rare diseases, leveraging its existing product NUPLAZID for Parkinson's disease psychosis and expanding its pipeline [2][3] - **Pipeline Development**: The company is advancing several promising candidates, including ACP-204 for Alzheimer's disease psychosis and DAYBUE for Rett syndrome, with plans for global expansion [3][4] Financial Highlights - **Revenue Projections**: Expected revenues for 2025 are over $1 billion, with peak potential for NUPLAZID and DAYBUE estimated between $1.5 billion and $2 billion [4][5] - **Sales Growth**: NUPLAZID reported record sales of $177.5 million in Q3, reflecting a 12% year-over-year growth, with significant increases in prescriptions and referrals [9][10] - **DAYBUE Performance**: DAYBUE achieved over $100 million in sales in Q3, with over 1,000 patients treated globally since its launch [11][12] Pipeline and Product Development - **Key Products**: - **NUPLAZID**: First FDA-approved treatment for hallucinations and delusions associated with Parkinson's disease, with a market share of approximately 25% [8][9] - **DAYBUE**: First treatment for Rett syndrome, with a growing diagnosis rate and strong efficacy data [10][11] - **Upcoming Milestones**: - Phase two study initiation for ACP-211 in major depressive disorder and phase one study for ACP-271 in Q1 2026 [6][20] - Anticipated CHMP opinion for DAYBUE in Q1 2026 [11][24] Strategic Focus Areas - **Precision Medicine**: Emphasis on using biomarkers in trials and integrating AI and machine learning into development processes [4] - **Global Expansion**: Strong focus on expanding operations beyond the U.S. into Europe and Japan [4] - **Patient Empowerment**: Centering patient journeys in the development and delivery of treatments [4] Unmet Medical Needs - **Alzheimer's Disease Psychosis**: Approximately 800,000-850,000 patients in the U.S. experience hallucinations or delusions, with no approved treatments available [14][17] - **Lewy Body Dementia**: A significant portion of patients (50%-70%) experience psychosis, highlighting the need for effective therapies [17][18] - **Major Depressive Disorder**: 21 million adults diagnosed in the U.S., with only 9 million currently treated, indicating a large market opportunity [19][20] Conclusion - **Future Outlook**: ACADIA is positioned for growth with a strong pipeline and financial health, aiming to address significant unmet needs in neurological and rare diseases while expanding its market presence [24]

Financial Performance - Total revenue for Q3 2025 reached $278.6 million, an 11% increase year-over-year compared to $250.4 million in Q3 2024[31] - NUPLAZID net sales in Q3 2025 were $177.5 million, a 12% increase year-over-year from $159.2 million in Q3 2024[31] - DAYBUE net sales in Q3 2025 hit a record $101.1 million, an 11% increase year-over-year compared to $91.2 million in Q3 2024[31, 13] - The company's EPS (diluted) increased by 110% to $0.42 in Q3 2025, compared to $0.20 in Q3 2024[31] - The company updated its full-year 2025 revenue guidance to $1.07 to $1.095 billion[32] Commercial Updates - NUPLAZID referrals grew by 21% year-over-year[17] - New prescriptions for NUPLAZID increased by 23% year-over-year[19] - 74% of new prescriptions (NBRx) for DAYBUE came from community physicians in Q3[16, 15] - Over 1,006 patients have been treated with DAYBUE globally[14] Research and Development - A Phase 2 study of ACP-204 for Lewy Body Dementia Psychosis was initiated[10, 27] - A Phase 3 trial of trofinetide for Rett syndrome in Japan was initiated[10, 27]

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]