Financial Data and Key Metrics Changes - Total revenue for the second quarter was $264.6 million, representing a 9% year-over-year increase [6][28] - Debut net product sales were $96.1 million, up 14% year-over-year, with a 12% increase in volume [28] - NUPLAZID net product sales were $168.5 million, up 7% year-over-year, with 5% of that growth attributable to volume [29] - R&D expenses increased to $78 million from $76.2 million year-over-year, while SG&A expenses rose to $133.5 million from $117.1 million [29] - Cash balance at the end of the quarter was $762 million, up from $681.6 million at the end of Q1 [30] Business Line Data and Key Metrics Changes - Dayview sales were $96.1 million, with 987 unique patients receiving paid shipments, an increase from 954 in Q1 [9][10] - NUPLAZID saw a 17% year-over-year increase in referrals, with the highest number of new Puzzet bottles shipped since launch [16][17] Market Data and Key Metrics Changes - The proportion of new referrals from non-Center of Excellence (COE) accounts grew to about 75% of overall referrals, up from two-thirds the previous quarter [43] - The number of healthcare providers writing prescriptions for Debut increased to 900, with a significant portion coming from community settings [12][43] Company Strategy and Development Direction - The company is focused on accelerating the commercial trajectory of Debut and sustaining long-term growth for NUPLAZID [32] - Plans to initiate seven Phase II or Phase III studies over 2025 and 2026, with five data readouts expected between 2025 and 2027 [20][21] - The company aims to expand globally and reach more patients in need, with a strong emphasis on community engagement and patient support [7][32] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the business's performance and raised the low end of NUPLAZID's revenue guidance for the year to between $665 million and $690 million [30] - The company anticipates sustained growth through the second half of the year, driven by strong execution and ongoing direct-to-consumer campaigns [16][17] Other Important Information - The company hosted its first R&D Day, showcasing nine programs in development and highlighting the potential of new molecules [8][19] - Management noted recent litigation wins that enforce intellectual property for Neuclazid, reinforcing long-term strategy [7] Q&A Session Summary Question: Can you provide details on ACP101's top-line approach and key risks? - Management indicated that the focus will be on the primary endpoint and key safety and tolerability overview in the top-line announcement, with ongoing monitoring of trial conduct [34][35] Question: What percentage of new patients for Debut came from community settings? - Approximately 75% of referrals came from non-COE accounts, indicating successful penetration into the community [43] Question: How is the growth trajectory for Debut expected to evolve? - The company expects continued acceleration in new patient starts, supported by the new customer model and a stable base of persistent patients [49] Question: What are the key drivers for NUPLAZID's growth? - Growth is driven by increased referrals and ongoing direct-to-consumer campaigns, with strong performance across all channels [68] Question: What is the outlook for 2026 regarding growth for both brands? - The company anticipates continued growth for both Debut and NUPLAZID, leveraging recent momentum and expanding market opportunities [100][102]

Financial Data and Key Metrics Changes - Total revenue for Q2 2025 was $264.6 million, representing a 9% year-over-year increase [5][27] - Debut net product sales were $96.1 million, up 14% year-over-year, with a gross to net adjustment of 23.3% [27] - NUPLAZID net product sales were $168.5 million, up 7% year-over-year, with a gross to net adjustment of 24.6% [27][28] - R&D expenses increased to $78 million from $76.2 million in the previous year, while SG&A expenses rose to $133.5 million from $117.1 million [28] Business Line Data and Key Metrics Changes - Debut saw a patient base increase to 987 unique patients, up from 954 in Q1 2025 and 920 in Q4 2024, indicating strong growth in new patient starts and persistency [9][10] - NUPLAZID referrals increased by 17% year-over-year, with both referrals and new prescriptions rising sequentially from Q1 to Q2 [15][16] Market Data and Key Metrics Changes - The community setting accounted for approximately three-quarters of new referrals for Debut, indicating successful penetration beyond centers of excellence [41] - The company is expanding its reach in the EU, with named patient supply available in multiple countries [13] Company Strategy and Development Direction - The company is focused on accelerating the commercial trajectory of Debut and sustaining long-term growth for NUPLAZID, while advancing a deep pipeline through rigorous clinical development [31] - The company raised the low end of its NUPLAZID guidance for the year, reflecting confidence in business performance [29] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the continued growth of Debut and NUPLAZID, supported by direct-to-consumer campaigns and field execution [5][15] - The company anticipates sustained growth through the second half of the year and beyond, with several key milestones in the pipeline [16][19] Other Important Information - The company hosted its first R&D Day, showcasing nine programs in development and five Phase II or Phase III data readouts expected through 2027 [7][19] - The company is progressing through the review process with EMA for trofinetide, with a decision expected in 2026 [21] Q&A Session Summary Question: About ACP101's top line approach and key risks - Management indicated that the focus will be on the primary endpoint and key safety and tolerability overview in the top line announcement, with ongoing monitoring of assessment variability [33][34] Question: Momentum in Debut and community setting penetration - Management reported that approximately three-quarters of new referrals came from non-center of excellence accounts, indicating successful penetration [41] Question: Discontinuations for Debut and inventory changes - Discontinuations remained below 10%, reflecting a stable patient base, and there were no significant inventory changes reported [73][74] Question: Growth perspective for 2026 - Management expects continued growth for both Debut and NUPLAZID, driven by new field force models and ongoing campaigns [96][100]

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]

Summary of Acadia Pharmaceuticals (ACAD) FY Conference Call - June 09, 2025 Company Overview - **Company**: Acadia Pharmaceuticals (ACAD) - **Industry**: Biotechnology, specifically focusing on neurology and rare diseases Key Points and Arguments Management Changes and Strategic Priorities - Katherine Owen Adams has been with Acadia for eight months, implementing changes in the commercial structure, including the appointment of Tom Garner as CCO and Alison McMillan as head of the debut franchise [2][3] - Focus on accelerating clinical trial programs, with notable progress in the Prada Woolley trial, which is expected to complete earlier than anticipated [4] - Emphasis on both organic and inorganic growth strategies, including a deal signed with San Arena in December [5] Intellectual Property and Market Exclusivity - Acadia won a recent appeal on its composition of matter patent, extending exclusivity for NUPLAZID until October 2030, with total exclusivity lasting until February 2038 [8] - The company is prepared to compete with any potential generic formulations that may enter the market [10] Sales and Marketing Strategies - A new strategy to raise awareness of Parkinson's disease symptoms has been successful, leading to increased patient inquiries and the highest number of new prescriptions (NBRxs) since 2020 [14][15] - Direct-to-consumer campaigns have also contributed to patient growth, with a current market share of 20% for NUPLAZID [16] Patient Retention and Compliance - Over 50% of patients remain on NUPLAZID therapy after one year, with a reported 35% discontinuation rate in Q1, showing improvement in patient retention [30][32] - Management strategies have been enhanced to address gastrointestinal side effects, leading to better patient compliance [33] Pipeline Developments - ACP 204, a new five HT2A inverse agonist, is being developed to address limitations of NUPLAZID, with ongoing studies in Alzheimer's disease psychosis and Lewy body dementia psychosis [22][24][55] - Upcoming phase two data for ACP 204 is expected mid-next year, with a focus on efficacy and safety in a complex patient population [46][51] Regulatory and Geographic Expansion - Acadia has submitted for regulatory approval of debut in the EU, with potential approval expected in Q1 next year [34] - Plans for a phase III study in Japan are underway, indicating a strategic focus on international markets [35] Financial Position and Business Development Strategy - The company has a strong financial position with over $680 million in cash, allowing for continued investment in business development and pipeline funding [60][61] - Acadia aims to expand its focus from neurology to other rare diseases, leveraging management's experience in rare disease markets [59] Upcoming Events - An R&D Day is scheduled to showcase early data from pipeline molecules, indicating a commitment to transparency and stakeholder engagement [57] Additional Important Insights - The company is optimistic about the future growth of NUPLAZID, citing potential for increased market penetration and awareness among healthcare providers and caregivers [17][18] - The unmet need in the Alzheimer's and Lewy body dementia populations is significant, with no approved therapies currently available, highlighting the potential impact of Acadia's pipeline [53][54]

Financial Data and Key Metrics Changes - The company reported total revenues of $244.3 million for Q1 2025, representing a 19% increase year-over-year [7][28] - Debut net product sales were $84.6 million, up 11% from the previous year, while NUPLAZID sales reached $159.7 million, reflecting a 23% increase year-over-year [8][30] - R&D expenses increased to $78.3 million from $59.7 million in Q1 2024, and SG&A expenses rose to $126.4 million from $108 million in the same period [31] Business Line Data and Key Metrics Changes - Debut sales showed a significant increase in unique patients receiving shipments, reaching an all-time high of 954, up from 920 in Q4 2024 [11][12] - NUPLAZID's growth included a 6% increase in volume, with the remainder attributed to one-time changes in gross to net [8][30] - The company expects continued growth in both brands, with a focus on expanding patient engagement and community reach [7][9] Market Data and Key Metrics Changes - The company is preparing for a strong launch of Debut in Europe, anticipating EMA approval in Q1 2026, with a substantial market opportunity for Rett syndrome patients [14][15] - The U.S. market for NUPLAZID continues to show strong momentum, with a nearly 30% increase in awareness of Parkinson's-related hallucinations and delusions since the launch of the More to Parkinson's campaign [17][18] Company Strategy and Development Direction - The company is focused on executing strategic priorities, including accelerating Debut's commercial trajectory, capitalizing on NUPLAZID's momentum, and advancing its pipeline [33][34] - The upcoming R&D Day is expected to provide insights into the company's development strategy and showcase innovations across its pipeline [24][34] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the sustainability of Debut's growth and reiterated full-year sales guidance for both Debut and NUPLAZID [8][9] - The company is optimistic about the upcoming results from the COMPASS PWS Phase III study, with top-line results expected by Q4 2025 [19][33] Other Important Information - The company has a strong cash balance of $681.6 million as of March 31, 2025, despite a sequential decline due to significant payments made [31] - The company is actively looking for strategic transactions to expand its portfolio, particularly in areas of high unmet medical need [84] Q&A Session Summary Question: What does good 101 data look like and how does it relate to FDA discussions? - Management indicated that statistically significant results demonstrating a clinically meaningful impact on hyperphagia would be considered good data [39] Question: How should we model a European price for Debut? - Management expressed confidence in obtaining a strong EU price that reflects the value provided to the Rett community, while monitoring potential pricing risks [40][41] Question: What are the key growth drivers for NUPLAZID and Debut from Q1 to Q2? - Management highlighted that volume will drive performance, with expectations for continued patient engagement and operational improvements [48][49] Question: What is the confidence level for EMA approval for trofinetide? - Management expressed confidence in the EMA approval process, noting that they are on track with the timeline and have received no indications of issues [82] Question: How does the company view its positioning against competitors in the Prader Willi market? - Management believes there is room for multiple therapies in the Prader Willi space, emphasizing the complex needs of patients and the potential for combination therapies [95]

Financial Data and Key Metrics Changes - Acadia Pharmaceuticals reported total revenues of $244.3 million for Q1 2025, representing a 19% increase year-over-year [6][29] - R&D expenses increased to $78.3 million from $59.7 million in Q1 2024, driven by higher spending on clinical stage programs [32] - SG&A expenses rose to $126.4 million from $108 million in Q1 2024, primarily due to ongoing consumer activation campaigns for NUPLAZID and expansion of the Debut team [32] Business Line Data and Key Metrics Changes - Debut sales reached $84.6 million in Q1 2025, an 11% increase from the previous year, with a record number of unique patients receiving shipments [7][29] - NUPLAZID generated $159.7 million in revenue for the quarter, up 23% year-over-year, with 6% of this growth attributed to volume [7][31] Market Data and Key Metrics Changes - The number of unique patients receiving Debut shipments was 954, marking an all-time high for the brand [7][11] - NUPLAZID's gross price increased by over 2% year-over-year, with a gross-to-net adjustment of 24.1% for the quarter [31] Company Strategy and Development Direction - Acadia is focused on accelerating the commercial trajectory of Debut and capitalizing on the momentum of NUPLAZID while expanding its global presence [35] - The company plans to host its first R&D Day to provide insights into its development strategy and pipeline innovations [9][35] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the sustainability of Debut's growth and reiterated full-year sales guidance for both Debut and NUPLAZID [7][35] - The timeline for the COMPASS PWS Phase III study results is now expected by the end of 2025, indicating progress in pipeline development [9][35] Other Important Information - Acadia anticipates EMA approval for Debut in Q1 2026, with a substantial market opportunity in Europe for Rett syndrome patients [14][28] - The company has received orphan drug designation for trofinetide in Japan, which may lead to priority review [28] Q&A Session Summary Question: What does good 101 data look like and how does it relate to FDA discussions? - Management indicated that statistically significant results demonstrating a clinically meaningful impact on hyperphagia would be considered good data [40] Question: How should we model a European price for Debut? - Management expressed confidence in obtaining a strong EU price that reflects the value provided to patients in the Rett community [41] Question: What are the key growth drivers for NUPLAZID and Debut from Q1 to Q2? - Management highlighted patient demand and the impact of expanded customer models as key growth drivers for both brands [44][46] Question: What are the biggest risks to the approval process for trofinetide in the EU? - Management stated confidence in the EMA approval process, noting that they are on track with the regulatory timeline [80] Question: How does Acadia view its positioning against Celeno's product for Prader Willi? - Management believes there is room for multiple therapies in the Prader Willi space, emphasizing the complexity of patient needs [95]