ACADIA reported a net loss of
At
“2013 was an extraordinary year for ACADIA, highlighted by theestablishment of an expedited path to an NDA filing for pimavanserin,our strengthened balance sheet, and the publication in The Lancetof our pivotal Phase III trial," said Uli Hacksell, Ph.D., ChiefExecutive Officer of ACADIA. "Additionally, we closed the year byinitiating our Phase II trial in Alzheimer's disease psychosis, whichrepresents an integral part of our strategy to broaden the pimavanserinfranchise to address a range of major neurological and psychiatricdisorders. These achievements set the stage for what we expect will bean exciting 2014. Importantly, we have continued to advance our PhaseIII Parkinson's disease psychosis program towards registration andremain on track for our planned NDA submission near the end of thisyear. In parallel, we are conducting pre-commercial activities toprepare for the planned future launch of pimavanserin and we areplanning additional studies in our life cycle management program. Welook forward to building on this momentum as we pursue our ultimate goalof bringing innovative medicines to market to improve the lives ofpatients 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 willincrease in 2014, relative to 2013, in order to fund ongoing and planneddevelopment and pre-commercial activities for pimavanserin. ACADIAcurrently expects that its cash, cash equivalents, and investmentsecurities will be greater than
2013 Highlights
Pipeline
- Presented data from pivotal Phase III -020 Study with pimavanserin inParkinson’s disease psychosis at the
American Academy of NeurologyMeeting inMarch 2013 . - Established an expedited path to an NDA filing for pimavanserin in
April 2013 . - Advanced novel glaucoma compound into preclinical development through
Allergan collaboration inMay 2013 . - Presented data from Phase III Parkinson’s disease psychosis program atthe
International Congress of Parkinson’sDisease and Movement Disorders inJune 2013 . - Published results from pivotal Phase III -020 Study with pimavanserinin The Lancet in
November 2013 . - Initiated Phase II trial with pimavanserin in Alzheimer’s diseasepsychosis in
November 2013 .
Business and Other
- Completed a public offering of common stock raising net proceeds of
$107.9 million inMay 2013 . - Added to NASDAQ Biotechnology Index and Russell 2000 Index in
May 2013 andJune 2013 , respectively. - Appointed
Terrence Moore as Executive Vice President and ChiefCommercial Officer inAugust 2013 , and strengthened ACADIA’sdevelopment, regulatory, medical affairs, and commercial capabilitiesduring 2013.
Conference Call and Webcast Information
ACADIA management will review its fourth quarter financial results anddevelopment programs via conference call and webcast later today at
About ACADIA Pharmaceuticals
ACADIA is a biopharmaceutical company focused on the development andcommercialization of innovative medicines that address unmet medicalneeds in neurological and related central nervous system disorders.ACADIA has a pipeline of product candidates led by pimavanserin, whichis in Phase III development as a potential first-in-class treatment forParkinson’s disease psychosis. Pimavanserin is also in Phase IIdevelopment for Alzheimer’s disease psychosis and has successfullycompleted a Phase II trial as a co-therapy for schizophrenia. ACADIAalso has clinical-stage programs for chronic pain and glaucoma incollaboration with
Forward-Looking Statements
Statements in this press release that are not strictly historical innature are forward-looking statements. These statements include but arenot limited to statements related to the progress and timing of ACADIA’sdrug discovery and development programs, either alone or with a partner,including the progress and expected timing of clinical trials, and theclinical benefits to be derived from ACADIA’s product candidates, ineach case including pimavanserin, the timing of an NDA submission forpimavanserin and, if approved, any related launch therefor, the strengthof ACADIA’s balance sheet, strategic broadening of the pimavanserinprogram, planned pre-commercial activities, ACADIA’s growth potential,and ACADIA’s expected 2014 cash usage and year-end balance. Thesestatements are only predictions based on current information andexpectations and involve a number of risks and uncertainties. Actualevents or results may differ materially from those projected in any ofsuch statements due to various factors, including the risks anduncertainties inherent in drug discovery, development, approval, andcommercialization, and collaborations with others, and the fact thatpast results of clinical trials may not be indicative of future trialresults. For a discussion of these and other factors, please refer toACADIA’s annual report on Form 10-K for the year ended December 31, 2013as well as ACADIA’s subsequent filings with the
ACADIA PHARMACEUTICALS INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except per share amounts) (Unaudited) | ||||||||||||||||||||||||||
Three Months Ended December 31, | Years Ended December 31, | |||||||||||||||||||||||||
| 2013 | 2012 | 2013 (1) | 2012 (1) | |||||||||||||||||||||||
| Collaborative revenues | $ | 37 | $ | 380 | $ | 1,145 | $ | 4,907 | ||||||||||||||||||
| Operating expenses | ||||||||||||||||||||||||||
| 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 | $ | (12,049 | ) | $ | (6,810 | ) | $ | (37,948 | ) | $ | (20,849 | ) | ||||||||||||||
| 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 yearsended December 31, 2013 and 2012 have been derived from the auditedfinancial statements but do not include all of the information andfootnotes required by accounting principles generally accepted inthe United States for complete financial statements. | ||
ACADIA PHARMACEUTICALS INC. CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands) (Unaudited) | |||||||||||||||||
December 31, 2013 (1) | December 31, 2012 (1) | ||||||||||||||||
| Assets | |||||||||||||||||
| 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 | |||||||||||||||
| Total assets | $ | 189,118 | $ | 108,590 | |||||||||||||
| Liabilities, redeemable common stock and stockholders’ equity | |||||||||||||||||
| Total liabilities | $ | 6,987 | $ | 5,948 | |||||||||||||
| Redeemable common stock | —- | 17,658 | |||||||||||||||
| Stockholders’ equity | 182,131 | 84,984 | |||||||||||||||
| Total liabilities, redeemable common stock and stockholders’ equity | $ | 189,118 | $ | 108,590 | |||||||||||||
(1) | The condensed consolidated balance sheets at December 31, 2013 and2012 have been derived from the audited financial statements atsuch date but do not include all of the information and footnotesrequired by accounting principles generally accepted in the UnitedStates for complete financial statements. | ||
Source:
ACADIA Pharmaceuticals Inc.
Thomas H. Aasen, ExecutiveVice President,
Chief Financial Officer and Chief BusinessOfficer
Lisa Barthelemy, Director of Investor Relations
(858)558-2871