ACADIA Pharmaceuticals(ACAD) - 2019 Q1 - Quarterly Report

Product Launch and Sales - NUPLAZID (pimavanserin) was launched in the U.S. in May 2016, with a recommended dosage of 34 mg once daily [71]. - Net product sales for NUPLAZID increased to $63.0 million for the three months ended March 31, 2019, up from $48.9 million in the same period of 2018, representing a growth of approximately 28.8% [91]. - The unit sales of NUPLAZID grew by approximately 19% in the three months ended March 31, 2019, compared to the same period in 2018 [91]. - The increase in license fees and royalties to $1.6 million for the three months ended March 31, 2019, compared to $1.3 million in the same period of 2018, is attributed to the rise in net sales during the current period [93]. Research and Development - Research and development expenses for Q1 2019 totaled $52.9 million, up from $39.3 million in Q1 2018, reflecting increased investment in clinical studies [85]. - The company initiated a Phase 3 study for dementia-related psychosis (DRP) in Q4 2017, evaluating pimavanserin for psychosis in various dementia types [72]. - The Phase 3 CLARITY program for major depressive disorder (MDD) was initiated in April 2019, following positive Phase 2 results [73]. - The company acquired an exclusive North American license for trofinetide in August 2018, with plans to initiate a Phase 3 study in Q4 2019 [76]. - The FDA granted Fast Track Status and Orphan Drug Designation for trofinetide, which targets Rett syndrome, a condition with no approved treatments [76]. - The company plans to conduct post-marketing studies for NUPLAZID to enhance the safety database, involving at least 500 patients [83]. Financial Performance - As of March 31, 2019, the company had an accumulated deficit of $1.6 billion, primarily due to research and development expenditures [77]. - Selling, general and administrative expenses increased to $93.1 million for the three months ended March 31, 2019, up from $60.9 million in the same period of 2018, reflecting a rise of $32.2 million [96]. - Cash used in operating activities increased to $64.2 million for the three months ended March 31, 2019, compared to $45.2 million for the same period in 2018 [102]. - Cash, cash equivalents, and investment securities decreased to $414.3 million at March 31, 2019, down from $473.5 million at December 31, 2018, a decrease of $59.2 million [102]. - Net cash provided by investing activities was $22.8 million for the three months ended March 31, 2019, compared to $89.6 million for the same period in 2018, indicating a decrease of $66.8 million [103]. - The company anticipates increased cash usage in future periods to fund ongoing and planned commercial activities for NUPLAZID and development activities for pimavanserin and trofinetide [97]. - The company expects that its cash, cash equivalents, and investment securities will be sufficient to fund planned operations for at least the next twelve months [97]. Operating Losses - Selling, general and administrative expenses are expected to increase to support commercial activities related to NUPLAZID and further development of pimavanserin [88]. - The company expects to continue incurring operating losses for the next few years due to significant development and commercialization costs [77].