ACADIA Pharmaceuticals(ACAD) - 2025 Q1 - Quarterly Report

Financial Performance - Net product sales for the three months ended March 31, 2025, were $244.3 million, an increase of 18.6$205.8 million for the same period in 2024[101]. - Net product sales of NUPLAZID increased to $159.7 million for the three months ended March 31, 2025, up from$129.9 million in 2024, reflecting a growth of 22.9%[102]. - Net product sales of DAYBUE reached $84.6 million for the three months ended March 31, 2025, compared to$75.9 million in 2024, marking an increase of 11.6%[102]. - Cost of product sales for the three months ended March 31, 2025, was $20.4 million, approximately 8$23.0 million or 11% for the same period in 2024[104]. Research and Development - Total research and development expenses for the three months ended March 31, 2025, were $78.3 million, compared to$59.7 million in 2024, representing a 31.1% increase[95]. - The company initiated a Phase 3 study for ACP-101 in November 2023, targeting hyperphagia in Prader-Willi syndrome[85]. - A Phase 2 study for ACP-204 was also initiated in November 2023, focusing on Alzheimer's disease psychosis, with plans for an additional study in Lewy Body Dementia with Psychosis in Q3 2025[86]. - The company expects substantial ongoing research and development expenses as it conducts post-marketing studies and advances early-stage product candidates[96]. - Research and development expenses increased to $78.3 million for the three months ended March 31, 2025, from$59.7 million in the same period of 2024[107]. Operating Expenses - Selling, general and administrative expenses rose to $126.4 million for the three months ended March 31, 2025, compared to$108.0 million in the same period of 2024[108]. Cash Flow and Financing - Cash, cash equivalents, and investment securities decreased to $681.6 million at March 31, 2025, from$756.0 million at December 31, 2024, a decrease of $74.4 million[119]. - Net cash provided by operating activities totaled$20.3 million for the three months ended March 31, 2025, down from $29.1 million in the same period of 2024[119]. - Net cash used in investing activities increased to$124.0 million for the three months ended March 31, 2025, compared to $14.0 million in the same period of 2024[120]. - The company anticipates cash used in operations will fluctuate based on ongoing and planned commercial activities and development activities for various product candidates[109]. - The company may require additional financing in the future, influenced by factors such as the costs of acquiring product candidates and the scope of research and development programs[110]. Regulatory and Market Considerations - The FDA approved DAYBUE in March 2023, with the product launched in the U.S. in April 2023, and Health Canada granted marketing authorization in October 2024[90]. - The company anticipates fluctuations in operating results due to various factors, including geopolitical developments and market dynamics[100]. - The company expects to finish selling zero cost inventories of DAYBUE in 2025, with future cost of product sales estimated to be in the mid-single to high-single digit percentage range[106]. - The company expects to receive its first invoice for rebates under the Inflation Reduction Act of 2022 from Medicare Part D unit sales in 2025[118].