Summary of ACADIA Pharmaceuticals FY Conference Call Company Overview - **Company**: ACADIA Pharmaceuticals (NasdaqGS:ACAD) - **Industry**: Neurological and Rare Diseases - **Conference**: 44th Annual J.P. Morgan Healthcare Conference - **Date**: January 13, 2026 Core Points and Arguments Company Mission and Strategy - ACADIA aims to deliver meaningful innovation to underserved patients with neurological and rare diseases, focusing on first-in-class or best-in-class products [2][4] - The company is advancing its pipeline with several candidates, including Remlifansirin (5-HT2A agonist) and ACP-211 (deuterated ketamine) for major depressive disorder [3][4] Pipeline Developments - **Neurological Franchise**: - NUPLAZID is expected to continue its momentum, with sales projected to reach $1 billion by 2028 [6][11] - Remlifansirin is anticipated to have a peak sales potential of $4 billion across indications [6] - Upcoming milestones include the initiation of phase two studies for ACP-271 and results for Remlifansirin expected between August and October 2026 [5][25] - **Rare Disease Franchise**: - DAYBUE is projected to achieve $700 million in global sales by 2028, driven by the launch of DAYBUE Sticks and expansion into the EU [14][30] - The company has treated over 2,000 patients with DAYBUE since its launch in 2023, with a 55% persistency rate at 12 months [13] Market Opportunities - There are approximately 1 million Parkinson's patients in the U.S., with 50% expected to develop hallucinations or delusions, presenting a significant market opportunity for NUPLAZID [10] - The company sees a potential growth opportunity in treating essential tremor, which affects about 7 million patients in the U.S. [23] Commercial Strategy - ACADIA plans to increase its commercial field force for NUPLAZID by 30% and leverage AI for better targeting and engagement [12][8] - The company is focused on expanding its presence in international markets, with DAYBUE already approved in three markets and anticipated approval in Europe [9][27] Financial Projections - Combined net sales for NUPLAZID and DAYBUE are projected to reach $1.7 billion by 2028 [6][30] - The company expects to see an uptick in operating expenses due to investments in commercial expansion and pipeline development [32][33] Additional Important Content - The company is committed to utilizing AI across various functions, including R&D and regulatory processes, to enhance efficiency and decision-making [7][9] - ACADIA is exploring business development opportunities in rare diseases beyond neurology, with a focus on late-stage products [34][35] - The company emphasizes the importance of patient-centric approaches in its clinical trials and product development [18][21] This summary encapsulates the key points discussed during the conference call, highlighting ACADIA Pharmaceuticals' strategic direction, pipeline developments, market opportunities, and financial outlook.

J.P. Morgan Healthcare Conference January 13, 2026 Catherine Owen Adams Chief Executive Officer 1 Forward-Looking Statements This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements other than statements of historical fact and can be identified by terms such as "may," "will," "should," "could," "would," "expects," "plans," "anticipates," "believes," "estimates," "projects," "predicts," ...

Company Overview - ACADIA Pharmaceuticals is a mid-cap biotechnology company focused on developing and commercializing therapies for central nervous system disorders, leveraging a focused pipeline and established commercial infrastructure to address significant unmet needs in neurology and psychiatry [6] - The company generates revenue primarily through the commercialization of NUPLAZID for Parkinson's disease psychosis, with an advancing pipeline that includes late-stage candidates for Alzheimer's disease psychosis and Rett syndrome [9] - As of the latest report, ACADIA's market capitalization is $4.4 billion, with a trailing twelve-month revenue of $1 billion and net income of $261.2 million [4] Recent Developments - Braidwell, a Connecticut-based fund, has established a new position in ACADIA Pharmaceuticals, acquiring nearly 2.4 million shares valued at approximately $50.8 million as of September 30, which represents 2.1% of the fund's total reportable U.S. equity assets for the quarter [2] - The stock price of ACADIA as of Wednesday is $25.88, reflecting a 59% increase over the past year, significantly outperforming the S&P 500, which has risen 13% in the same period [3] Financial Performance - ACADIA has recently delivered double-digit revenue growth, with expanding sales for both NUPLAZID and DAYBUE, and has more than doubled its net income in the third quarter [7] - The company has raised its full-year guidance and has nearly $850 million in cash on the balance sheet, positioning it well for continued growth [10] Market Position and Outlook - Despite the stock being more than 50% below its pandemic peak, the fundamentals of ACADIA appear stronger than in previous years, suggesting potential for a more durable recovery [7][12] - The confidence shown by a major biotech-focused fund stepping in indicates a positive trajectory for the company, emphasizing the importance of execution in converting late-stage assets into commercial successes [11]

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]

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]