ACADIA Pharmaceuticals(ACAD) - 2024 Q4 - Earnings Call Transcript

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]