ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD), a biopharmaceutical company focused on the development and commercialization of innovative medicines to address unmet medical needs in central nervous system disorders, today announced its financial results for the fourth quarter and year ended December 31, 2015.

“2015 was highlighted by the filing of our NUPLAZID™ (pimavanserin) New Drug Application for Parkinson’s disease psychosis and the designation of Priority Review by the FDA with a PDUFA date of May 1, 2016,” saidSteve Davis, ACADIA’s President and Chief Executive Officer. “We also continued to advance our preparations for the 2016 launch of NUPLAZID, if approved, in the United States and to execute on our life cycle development of pimavanserin highlighted by our ongoing Phase II study in Alzheimer’s disease psychosis and the planned commencement of a Phase II study in Alzheimer’s disease agitation scheduled for the first half of 2016. We have set the foundation for what we believe will be a pivotal year for ACADIA.”

ACADIA reported a net loss of $45.8 million, or $0.45 per common share, for the fourth quarter of 2015, compared to a net loss of $28.4 million, or $0.28 per common share, for the fourth quarter of 2014. The net losses for the fourth quarters of 2015 and 2014 included $8.9 million and $4.6 million, respectively, in non-cash, stock-based compensation expense. For the year ended December 31, 2015, ACADIA reported a net loss of $164.4 million, or $1.63 per common share, compared to a net loss of $92.5 million, or $0.95 per common share, for 2014. The net losses for 2015 and 2014 included $40.2 million and $16.0 million, respectively, in non-cash, stock-based compensation expense. At December 31, 2015, ACADIA’s cash, cash equivalents, and investment securities totaled $215.1 million compared to $322.5 million at December 31, 2014. Net proceeds of approximately $281.6 million received from ACADIA’s follow-on public offering inJanuary 2016 are not reflected in the balance sheet as of December 31, 2015.

Research and development expenses increased to $20.5 million for the fourth quarter of 2015, including$3.0 million in stock-based compensation, from $18.2 million for the comparable quarter of 2014, including$1.7 million in stock-based compensation. This increase was due to an increase in personnel and related costs of $3.5 million associated with ACADIA’s expanded research and development organization, partially offset by reduced external service costs related to the preparation of the Company’s NDA for NUPLAZID and manufacturing development costs incurred in the fourth quarter of 2014 not incurred in the fourth quarter of 2015.

General and administrative expenses increased to $22.6 million for the fourth quarter of 2015, including$5.9 million in stock-based compensation, from $10.4 million for the comparable quarter of 2014, including$2.9 million in stock-based compensation. This increase was due to an increase in personnel and related costs of $5.9 million and an increase in external service costs of $6.3 million, all largely related to ACADIA’s commercial preparations for the planned launch of NUPLAZID.

2015 and Recent Highlights

NUPLAZID (pimavanserin)

  • Submitted NDA for NUPLAZID in September 2015, which was accepted for filing with Priority Review by the FDA in October 2015 with a PDUFA goal date of May 1, 2016.
  • Launched an integrated awareness campaign for Parkinson’s disease psychosis, or PDP, including educational programs with over 12,000 health care professionals, a PDP educational website targeting physicians, neurology journal and digital placements, and PDP educational booths at major medical meetings.
  • Continued to enroll patients in the ongoing Phase II study with pimavanserin in Alzheimer’s disease psychosis, or ADP.
  • Conducted a comprehensive life cycle management review of pimavanserin to lay the foundation for additional development in multiple areas of significant unmet medical need beyond PDP and ADP.
  • Selected Alzheimer’s disease agitation as the next indication for development of pimavanserin.

Business and Other Highlights

  • Completed a follow-on public offering in January 2016, raising net proceeds of approximately $281.6 million.
  • Appointed Steve Davis as President and Chief Executive Officer.
  • Appointed Serge Stankovic, M.D., M.S.P.H., as Executive Vice President, Head of R&D, Randall Owen, M.D., as Senior Vice President, Clinical Development and Chief Medical Officer, Jim Nash, as Senior Vice President, Technology Development and Operations, and Bob Mischler, as Vice President, Strategy and Business Development.
  • Daniel Soland, Edmund Harrigan, M.D., Julian Baker, and Jim Daly added to the Board of Directors.. (Original Source)

Shares of Acadia closed last Friday at $18.73, up $0.25 or 1.35%. ACAD has a 1-year high of $51.99 and a 1-year low of $16.64. The stock’s 50-day moving average is $20.98 and its 200-day moving average is $32.32.

On the ratings front, Acadia has been the subject of a number of recent research reports. In a report issued on February 23, Raymond James analyst John Ransom reiterated a Buy rating on ACAD, with a price target of $75, which represents a potential upside of 300.4% from where the stock is currently trading. Separately, on February 19, Stephens Inc’s Dana Hambly maintained a Buy rating on the stock and has a price target of $78.

According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, John Ransom and Dana Hambly have a total average return of 24.8% and -1.4% respectively. Ransom has a success rate of 75.9% and is ranked #44 out of 3682 analysts, while Hambly has a success rate of 40.0% and is ranked #2308.

The street is mostly Bullish on ACAD stock. Out of 4 analysts who cover the stock, 4 suggest a Buy rating . The 12-month average price target assigned to the stock is $75.00, which implies an upside of 300.4% from current levels.

ACADIA Pharmaceuticals Inc is a biopharmaceutical company. It is engaged in the business of development and commercialization of small molecule drugs for the treatment of central nervous system disorders.