Summary of Acadia Pharmaceuticals (ACAD) R&D Day - June 25, 2025 Company Overview - Acadia Pharmaceuticals focuses on advancing care for patients with underserved neurological and rare diseases, guided by a mission to address high unmet needs in these areas [4][5][11] - The company has two profitable brands, NUPLAZID and Debut, which are expected to generate over $1 billion in combined revenue for the first time in 2025 [5][11] Financial Performance - NUPLAZID is projected to achieve net sales between GBP $650 million and GBP $690 million in 2025, reflecting a 7% to 13% year-over-year growth [6] - Debut is expected to generate net sales between $380 million and $405 million, indicating a 916% growth [7] - The total peak sales potential for NUPLAZID and Debut combined could reach between $1.5 billion and $2 billion [12] Pipeline and Future Growth - Acadia has a robust pipeline with nine disclosed programs, eight of which are expected to be in clinical stages by the end of the year [17] - The company anticipates five study readouts from Phase II or Phase III trials between now and the end of 2027 [17] - The pipeline includes later-stage assets like ACP101 for Prader-Willi syndrome and ACP204 for Alzheimer's disease psychosis, with top-line data expected in 2025 and 2026, respectively [8][17] Key Pipeline Assets 1. **ACP204**: A novel 5-HT2A inverse agonist targeting Alzheimer's and Lewy body dementia psychosis, with a significant unmet need as there are currently no approved therapies for these conditions [24][60] - Approximately 3 million people are affected by psychosis related to these diseases [27] - ACP204 is designed to avoid QT prolongation, allowing for higher dosing and potentially greater efficacy [30][60] 2. **ACP211**: An oral agent with potential ketamine-like efficacy for major depressive disorder (MDD) and treatment-resistant depression (TRD), aiming to minimize sedation and dissociation [62][81] - MDD affects approximately 21 million adults in the U.S., with only 9 million receiving treatment [67] - The drug is designed to provide rapid antidepressant effects without the severe side effects associated with current treatments [81] Strategic Focus - Acadia's growth strategy is anchored in precision medicine, data innovation, globalization, and patient empowerment [4] - The company aims to expand into adjacent rare disease categories, leveraging its scientific approach and internal capabilities [11] Market Opportunity - The potential market for the pipeline assets is significant, with an estimated combined peak sales potential of up to $12 billion if all five pipeline assets succeed [12][13] - Acadia believes that the current market undervalues its clinical programs, and it is committed to delivering data and executing its strategy to unlock this potential [13] Conclusion - Acadia Pharmaceuticals is positioned for transformational growth through its innovative pipeline and strong commercial brands, addressing critical needs in neurological and rare diseases while aiming to enhance patient care and outcomes [2][4][11]

Core Viewpoint - Acadia Pharmaceuticals reported mixed financial results for Q4 2024, with earnings per share missing estimates but total revenues exceeding expectations, driven by the performance of its products Nuplazid and Daybue [1][2][9]. Financial Performance - Acadia reported Q4 2024 earnings of 17 cents per share, below the Zacks Consensus Estimate of 19 cents, while GAAP earnings per share were 86 cents [1]. - Total revenues for Q4 2024 reached $259.6 million, surpassing the Zacks Consensus Estimate of $255 million, marking a 12% year-over-year increase [2][4]. - For the full year 2024, Acadia's total revenues were $957.8 million, a 32% increase year over year, exceeding the Zacks Consensus Estimate of $953.2 million [9]. Product Performance - Nuplazid generated revenues of $162.9 million in Q4 2024, a 13% increase year over year, outperforming the Zacks Consensus Estimate of $160.4 million [5]. - Daybue recorded net product sales of $96.7 million in Q4 2024, an 11% year-over-year increase, also beating the Zacks Consensus Estimate of $94.4 million [6]. Expenses - Research and development (R&D) expenses for Q4 2024 were $100.7 million, up 51% year over year, primarily due to increased costs from clinical-stage programs [7]. - Selling, general and administrative (SG&A) expenses were $130.1 million, a 17% increase year over year, attributed to higher marketing costs for Nuplazid and Daybue [8]. Financial Outlook - For 2025, Acadia expects total revenues from U.S. sales to be between $1.030 billion and $1.095 billion, with Nuplazid sales projected at $650 million to $690 million and Daybue sales expected to be between $380 million and $405 million [10]. - R&D expenses for 2025 are projected to be between $310 million and $330 million, while SG&A expenses are expected to range from $535 million to $565 million [12]. Regulatory and Development Updates - Acadia has a regulatory filing for Daybue in the EU under review, with approval expected in Q1 2026 [13]. - The company plans to enroll the last patient in the phase III COMPASS PWS study for ACP-101 in Q4 2025, with top-line data anticipated in H1 2026 [14]. - Acadia is also preparing to initiate a mid-stage study for ACP-204 targeting Alzheimer's disease psychosis in Q1 2026 [15]. - The company signed a license agreement with Saniona to develop ACP711 for essential tremor, with plans for a mid-stage study in 2026 [16][17].

Core Insights - Acadia Pharmaceuticals reported fourth-quarter 2024 earnings of 17 cents per share, missing the Zacks Consensus Estimate of 19 cents, and adjusted for a one-time sale of a Rare Pediatric Disease Priority Review Voucher [1] - Total revenues for the quarter were $259.6 million, exceeding the Zacks Consensus Estimate of $255 million, with significant contributions from its two marketed products, Nuplazid and Daybue [2][4] Financial Performance - Revenues from Nuplazid increased 13% year over year to $162.9 million, surpassing the Zacks Consensus Estimate of $160.4 million [5] - Daybue recorded net product sales of $96.7 million, up 11% year over year, also beating the Zacks Consensus Estimate of $94.4 million [6] - For the full year 2024, Acadia's total revenues reached $957.8 million, a 32% increase year over year, exceeding the Zacks Consensus Estimate of $953.2 million [9] Expense Overview - Research and development (R&D) expenses rose 51% year over year to $100.7 million, primarily due to increased costs from clinical-stage programs [7] - Selling, general and administrative (SG&A) expenses increased 17% year over year to $130.1 million, attributed to higher marketing costs for Nuplazid and Daybue [8] Future Outlook - Acadia expects total revenues from U.S. sales of its products in 2025 to range between $1.030 billion and $1.095 billion, with Nuplazid sales projected between $650 million and $690 million, and Daybue sales expected between $380 million and $405 million [10][12] - R&D expenses for 2025 are projected to be between $310 million and $330 million, while SG&A expenses are expected to be between $535 million and $565 million [12] Product Development Updates - A regulatory filing for Daybue to treat Rett syndrome in the EU is under review, with approval expected in Q1 2026 [13] - Acadia plans to enroll the last patient in the phase III COMPASS PWS study for ACP-101 in Q4 2025, with top-line data expected in H1 2026 [14] - The company anticipates initiating a mid-stage study for ACP-204 for Lewy Body dementia psychosis in Q3 2025 [15] - Acadia signed a worldwide license agreement with Saniona to develop ACP711 for essential tremor, with a mid-stage study planned for 2026 [16][17]