ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD) announced its unaudited financial results for the third quarter ended September 30, 2017.
“Our results this quarter reflect strong growth for NUPLAZID for Parkinson’s disease psychosis,” said Steve Davis, ACADIA’s President and Chief Executive Officer. “We also recently advanced our clinical portfolio with the initiation of our Phase III study of pimavanserin for dementia-related psychosis and were pleased to receive FDA Breakthrough Therapy Designation for this program. If this study is successful, we believe pimavanserin will provide an important benefit to patients with dementia-related psychosis who currently have no FDA-approved treatments available to them.”
- Initiated pivotal Phase III HARMONY Study with pimavanserin in dementia-related psychosis in October 2017.
- FDA granted Breakthrough Therapy Designation to pimavanserin for the treatment of dementia-related psychosis in October 2017. This is the second Breakthrough Therapy Designation for pimavanserin.
- Presented Phase II data with pimavanserin in Alzheimer’s disease psychosis at the Symposium, “The Importance of Serotonin in Alzheimer’s Disease Psychosis and the Role of Pimavanserin,” at the Clinical Trials on Alzheimer’s Disease (CTAD) meeting in Boston in November 2017.
- In addition to dementia-related psychosis, ACADIA continues to advance its broad clinical development program with ongoing studies in schizophrenia inadequate response, schizophrenia negative symptoms, and major depressive disorder.
Net product sales of NUPLAZID, which was first made available for prescription starting in May 2016, were $35.6 million for the three months ended September 30, 2017 compared to $5.3 million for the three months ended September 30, 2016. For the nine months ended September 30, 2017 and 2016, ACADIA reported NUPLAZID net product sales of $81.3 million and $5.4 million, respectively.
Research and Development
Research and development expenses for the three months ended September 30, 2017 were $36.4 million, compared to $25.8 million for the same period of 2016. For the nine months ended September 30, 2017 and 2016, research and development expenses were $106.0 million and $69.1 million, respectively. The increase in research and development expenses during the 2017 periods as compared to 2016 was primarily due to increased clinical costs related to the clinical studies initiated in the fourth quarter of each of 2016 and 2017. The company also incurred additional personnel and related costs associated with its expanded research and development organization during 2017 as compared to 2016.
Selling, General and Administrative
Selling, general and administrative expenses for the three months ended September 30, 2017 were $62.3 million, compared to $50.5 million for the same period of 2016. For the nine months ended September 30, 2017 and 2016, selling, general and administrative expenses were $189.5 million and $128.8 million, respectively. The increase in selling, general and administrative expenses during the 2017 periods as compared to 2016 was primarily due to costs incurred to support ACADIA’s commercial activities for NUPLAZID, including additional personnel and related costs and due to increased charitable contributions.
For the three months ended September 30, 2017, ACADIA reported a net loss of $65.2 million, or $0.53 per common share, compared to a net loss of $71.6 million, or $0.61 per common share, for the same period in 2016. The net losses for the three months ended September 30, 2017 and 2016 included $19.7 million and $14.0 million, respectively, of non-cash stock-based compensation expense. For the nine months ended September 30, 2017, ACADIA reported a net loss of $220.5 million, or $1.81 per common share, compared to a net loss of $192.7 million, or $1.69 per common share, for the same period in 2016. The net losses for the nine months ended September 30, 2017 and 2016 included $53.5 million and $39.8 million, respectively, of non-cash stock-based compensation expense.
Cash and Investments
At September 30, 2017, ACADIA’s cash, cash equivalents and investment securities totaled $366.6 million, compared to $529.0 million at December 31, 2016.
2017 Financial Guidance
ACADIA is increasing its revenue guidance and now expects that full-year NUPLAZID net sales for 2017 will be between $124 million and $127 million.
On the ratings front, Acadia stock has been the subject of a number of recent research reports. In a report released today, Cowen analyst Ritu Baral reiterated a Buy rating on ACAD, with a price target of $46, which implies an upside of 41% from current levels. Similary, on October 10, Jefferies’ Eun Yang reiterated a Buy rating on the stock and has a price target of $47.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Ritu Baral and Eun Yang have a yearly average return of 23.6% and 8.2% respectively. Baral has a success rate of 52% and is ranked #76 out of 4703 analysts, while Yang has a success rate of 50% and is ranked #458.
Sentiment on the street is mostly bullish on ACAD stock. Out of 7 analysts who cover the stock, 6 suggest a Buy rating and one recommends to Hold the stock. The 12-month average price target assigned to the stock is $52.60, which represents a potential upside of 61% from where the stock is currently trading.
Shares of Acadia closed today at $32.46, down $0.09 or -0.28%. ACAD has a 1-year high of $41.20 and a 1-year low of $24.31. The stock’s 50-day moving average is $36.53 and its 200-day moving average is $31.94.
ACADIA engages in the research, development and manufacture of pharmaceutical products. It focuses on the development and commercialization of innovative medicines to address unmet medical needs in central nervous system disorders.