ACADIA Pharmaceuticals Reports Financial Results for the Fourth Quarter and Year Ended December 31, 2013
ACADIA reported a net loss of
“2013 was an extraordinary year for ACADIA, highlighted by the establishment of an expedited path to an NDA filing for pimavanserin, our strengthened balance sheet, and the publication in The Lancet of our pivotal Phase III trial," said Uli Hacksell, Ph.D., Chief Executive Officer of ACADIA. "Additionally, we closed the year by initiating our Phase II trial in Alzheimer's disease psychosis, which represents an integral part of our strategy to broaden the pimavanserin franchise to address a range of major neurological and psychiatric disorders. These achievements set the stage for what we expect will be an exciting 2014. Importantly, we have continued to advance our Phase III Parkinson's disease psychosis program towards registration and remain on track for our planned NDA submission near the end of this year. In parallel, we are conducting pre-commercial activities to prepare for the planned future launch of pimavanserin and we are planning additional studies in our life cycle management program. We look forward to building on this momentum as we pursue our ultimate goal of bringing innovative medicines to market to improve the lives of patients with neurological and related central nervous system disorders."
Research and development expenses increased to
General and administrative expenses increased to
Revenues decreased to
ACADIA anticipates that the level of cash used in its operations will
increase in 2014, relative to 2013, in order to fund ongoing and planned
development and pre-commercial activities for pimavanserin. ACADIA
currently expects that its cash, cash equivalents, and investment
securities will be greater than
Presented data from pivotal Phase III -020 Study with pimavanserin in
Parkinson’s disease psychosis at the
American Academy of Neurology Meetingin March 2013.
Established an expedited path to an NDA filing for pimavanserin in
Advanced novel glaucoma compound into preclinical development through
Allergancollaboration in May 2013.
Presented data from Phase III Parkinson’s disease psychosis program at
International Congressof Parkinson’s Disease and MovementDisorders in June 2013.
Published results from pivotal Phase III -020 Study with pimavanserin
in The Lancet in
Initiated Phase II trial with pimavanserin in Alzheimer’s disease
Business and Other
Completed a public offering of common stock raising net proceeds of
$107.9 millionin May 2013.
Added to NASDAQ Biotechnology Index and Russell 2000 Index in
May 2013and June 2013, respectively.
Terrence Mooreas Executive Vice President and Chief Commercial Officer in August 2013, and strengthened ACADIA’s development, regulatory, medical affairs, and commercial capabilities during 2013.
Conference Call and Webcast Information
ACADIA management will review its fourth quarter financial results and
development programs via conference call and webcast later today at
ACADIA is a biopharmaceutical company focused on the development and
commercialization of innovative medicines that address unmet medical
needs in neurological and related central nervous system disorders.
ACADIA has a pipeline of product candidates led by pimavanserin, which
is in Phase III development as a potential first-in-class treatment for
Parkinson’s disease psychosis. Pimavanserin is also in Phase II
development for Alzheimer’s disease psychosis and has successfully
completed a Phase II trial as a co-therapy for schizophrenia. ACADIA
also has clinical-stage programs for chronic pain and glaucoma in
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 progress and timing of ACADIA’s
drug discovery and development programs, either alone or with a partner,
including the progress and expected timing of clinical trials, and the
clinical benefits to be derived from ACADIA’s product candidates, in
each case including pimavanserin, the timing of an NDA submission for
pimavanserin and, if approved, any related launch therefor, the strength
of ACADIA’s balance sheet, strategic broadening of the pimavanserin
program, planned pre-commercial activities, ACADIA’s growth potential,
and ACADIA’s expected 2014 cash usage and year-end balance. These
statements are only predictions based on current information and
expectations and involve a number of risks and uncertainties. Actual
events or results may differ materially from those projected in any of
such statements due to various factors, including the risks and
uncertainties inherent in drug discovery, development, approval, and
commercialization, and collaborations with others, and the fact that
past results of clinical trials may not be indicative of future trial
results. For a discussion of these and other factors, please refer to
ACADIA’s annual report on Form 10-K for the year ended December 31, 2013
as well as ACADIA’s subsequent filings with the
ACADIA PHARMACEUTICALS INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
Three Months Ended
|2013||2012||2013 (1)||2012 (1)|
|Research and development (includes stock-based compensation of $791, $230, $2,208, and $680, respectively)||7,926||4,901||26,722||18,794|
|General and administrative (includes stock-based compensation of $1,383, $322, $3,503, and $1,250, respectively)||4,276||2,298||12,720||6,999|
|Total operating expenses||12,202||7,199||39,442||25,793|
|Loss from operations||(12,165||)||(6,819||)||(38,297||)||(20,886||)|
|Interest income, net||116||9||349||37|
|Net loss per common share, basic and diluted||$||(0.13||)||$||(0.11||)||$||(0.44||)||$||(0.38||)|
|Weighted average common shares outstanding, basic and diluted||90,947||60,618||85,715||55,116|
|(1)||The condensed consolidated statements of operations for the years ended December 31, 2013 and 2012 have been derived from the audited financial statements but do not include all of the information and footnotes required by accounting principles generally accepted in the United States for complete financial statements.|
ACADIA PHARMACEUTICALS INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
|Cash, cash equivalents, and investment securities||$||185,790||$||107,967|
|Prepaid expenses, receivables and other current assets||2,570||581|
|Total current assets||188,360||108,548|
|Other non-current assets||758||42|
|Liabilities, redeemable common stock and stockholders’ equity|
|Redeemable common stock||---||17,658|
|Total liabilities, redeemable common stock and stockholders’ equity||$||189,118||$||108,590|
The condensed consolidated balance sheets at December 31, 2013 and 2012 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.
Thomas H. Aasen, Executive Vice President,
Chief Financial Officer and Chief Business Officer
Lisa Barthelemy, Director of Investor Relations