ACADIA Pharmaceuticals Reports 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
ACADIA reported a net loss of
Research and development expenses increased to
General and administrative expenses increased to
2015 and Recent Highlights
Submitted NDA for NUPLAZID in
September 2015, which was accepted for filing with Priority Review by the FDAin October 2015with 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 $281.6 million.
Steve Davisas President and Chief Executive Officer.
Serge Stankovic, M.D., M.S.P.H., as Executive Vice President, Head of R&D, Randall Owen, M.D., as Senior Vice President, Clinical Development and Chief Medical Officer, Jim Nash, as Senior Vice President, Technology Developmentand Operations, and Bob Mischler, as Vice President, Strategy and Business Development.
Daniel Soland, Edmund Harrigan, M.D., Julian Baker, and Jim Dalyadded to the Board of Directors.
Conference Call and Webcast Information
ACADIA management will review its fourth quarter and year-end financial
results and development programs via conference call and webcast this
ACADIA is a biopharmaceutical company focused on the development and
commercialization of innovative medicines to address unmet medical needs
in central nervous system disorders. ACADIA has a pipeline of product
candidates led by NUPLAZID™ (pimavanserin), for which we have submitted
a New Drug Application (NDA) for psychosis associated with Parkinson’s
disease to the
Statements in this press release that are not strictly historical in
nature are forward-looking statements. These statements include but are
not limited to statements related to the potential for NUPLAZID
(pimavanserin) to be the first drug approved in
|ACADIA PHARMACEUTICALS INC.|
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
(in thousands, except per share amounts)
Three Months Ended
|2015||2014||2015 (1)||2014 (1)|
|Research and development||20,466||18,182||73,869||60,602|
|General and administrative||22,616||10,420||88,304||32,748|
|Total operating expenses||45,582||28,602||164,673||93,350|
|Loss from operations||(45,565||)||(28,555||)||(164,612||)||(93,230||)|
|Interest income, net||111||189||499||755|
|Loss before income taxes||(45,454||)||(28,366||)||(164,113||)||(92,475||)|
|Income tax expense||330||-||330||-|
|Net loss per common share, basic and diluted||$||(0.45||)||$||(0.28||)||$||(1.63||)||$||(0.95||)|
|Weighted average common shares outstanding, basic and diluted||101,207||99,850||100,630||97,248|
|(1)||The condensed consolidated statements of operations for the years ended December 31, 2015 and 2014 have been derived from the audited financial statements but do not include all of the information and footnotes required by accounting principles generally accepted in the United States for complete financial statements.|
|ACADIA PHARMACEUTICALS INC.|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|Cash, cash equivalents, and investment securities||$||215,132||$||322,486|
|Prepaid expenses, receivables and other current assets||3,857||2,132|
|Total current assets||218,989||324,618|
|Other non-current assets||2,532||840|
|Liabilities and stockholders’ equity|
|Total liabilities and stockholders’ equity||$||221,896||$||325,458|
The condensed consolidated balance sheets at December 31, 2015 and 2014 have been derived from the audited financial statements at such date but do not include all of the information and footnotes required by accounting principles generally accepted in the United States for complete financial statements.
ACADIA Pharmaceuticals Inc.
Lisa Barthelemy, Senior Director, Investor Relations