ACADIA Pharmaceuticals(US:ACAD)2023-05-09 00:03Financial Data and Key Metrics Changes - In Q1 2023, the company recorded net sales of $118.5 million, representing a 3% increase year-over-year [26] - Gross to net adjustment for the quarter was 29.3%, with year-over-year demand growth up approximately 2% [26] - R&D expenses decreased to $69.1 million from $128.9 million in Q1 2022, primarily due to a $60 million upfront payment recorded in Q1 2022 [26] - SG&A expenses increased slightly to $101.2 million from $96.7 million in Q1 2022, with expectations for flat SG&A expenses for 2023 compared to 2022 [27] Business Line Data and Key Metrics Changes - The NUPLAZID franchise generated steady volumes, with a 2% increase in demand bottles year-over-year [18] - The launch of DAYBUE for Rett syndrome began in mid-April 2023, with positive feedback from healthcare providers and early patient enrollment forms received [13][14] - The company is seeing early indicators of growth in new patient starts for NUPLAZID, despite a contracted market [19] Market Data and Key Metrics Changes - The company is experiencing a return to growth in Parkinson's medication prescriptions and in-person patient visits, which had been negatively impacted during the pandemic [10] - The market share for new-to-therapy patients for NUPLAZID is increasing, driven by real-world evidence publications [9] Company Strategy and Development Direction - The company is focused on four strategic priorities: the launch of DAYBUE, growth of the NUPLAZID franchise, completion of the ADVANCE-2 study for schizophrenia, and development of ACP-204 for Alzheimer's disease psychosis [6][28] - The company is engaging with payers to ensure access to DAYBUE for patients, with discussions ongoing regarding reimbursement policies [32] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the launch of DAYBUE and the ongoing performance of the NUPLAZID franchise, highlighting the importance of real-world evidence in driving adoption [6][19] - The company anticipates topline results from the ADVANCE-2 study in early 2024, which could lead to a supplemental new drug application [11][24] Other Important Information - The company has completed Phase 1 development of ACP-204 and plans to meet with the FDA to discuss the clinical development plan [7][25] - The company is actively engaging with the Rett community and healthcare providers to support the launch of DAYBUE [21][22] Q&A Session Summary Question: Can you provide more color on payer discussions for DAYBUE? - Management indicated that discussions with payers have been constructive, and they are working to get early patient access through medical exceptions [32] Question: How will the Rett registry help drive adoption for DAYBUE? - Management noted that they are proactively communicating the benefits and tolerability profile of DAYBUE to clinicians and families, which has been well received [36] Question: What key metrics will be provided to gauge the health of the DAYBUE launch? - Management stated that they will provide net revenue and meaningful metrics on the next earnings call, but specific metrics are not available yet [41] Question: What is the current penetration of NUPLAZID in the PDP population? - Management reported that they have increased their share of new patient starts and are over 20% market share across both community and long-term care settings [49] Question: What are the plans for ACP-204's clinical development? - Management indicated that they are eager to move aggressively with the program and will provide more details after meeting with the FDA [58]