Second Quarter 2025 Earnings Call | Welcome | Al Kildani Senior Vice President, Investor Relations and Corporate Communications | | --- | --- | | CEO Opening Remarks | Catherine Owen Adams Chief Executive Officer | | Commercial Update | Tom Garner Executive Vice President, Chief Commercial Officer | | R&D Update | Elizabeth H.Z. Thompson Executive Vice President, Head of Research and Development | | Financial Update | Mark Schneyer Executive Vice President, Chief Financial Officer | | Closing Remarks | Cath ...

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, 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]