SAN DIEGO—(BUSINESS WIRE)—Aug. 5, 2014—ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD), a biopharmaceutical companyfocused on the development and commercialization of innovative medicinesthat address unmet medical needs in neurological and related centralnervous system disorders, today announced its unaudited financialresults for the second quarter ended June 30, 2014.
ACADIA reported a net loss of $21.5 million, or $0.22 per common share,for the second quarter of 2014 compared to a net loss of $9.1 million,or $0.11 per common share, for the second quarter of 2013. Net lossesfor the second quarters of 2014 and 2013 included $4.3 million and $1.1million, respectively, in non-cash, stock-based compensation expense.For the six months ended June 30, 2014, ACADIA reported a net loss of$39.3 million, or $0.41 per common share, compared to a net loss of$15.2 million, or $0.19 per common share, for the comparable period of2013. Net losses for the six-month periods ended June 30, 2014 and 2013included $7.5 million and $1.6 million, respectively, in non-cash,stock-based compensation expense.
At June 30, 2014, ACADIA’s cash, cash equivalents, and investmentsecurities totaled $354.5 million compared to $185.8 million at December31, 2013. This increase was primarily due to $196.8 million in netproceeds raised from a public offering of common stock in March 2014,offset in part by cash used to fund ACADIA’s operations.
“During the first half of the year, we continued to make importantprogress in advancing our lead program with pimavanserin towardregistration, significantly strengthened our financial position througha follow-on offering, and made key additions to our team, including therecent appointment of Steve Davis as our Executive Vice President, ChiefFinancial Officer and Chief Business Officer,” said Uli Hacksell, Ph.D.,ACADIA’s Chief Executive Officer. “This is an exciting time as we focuson the planned submission of our NDA for pimavanserin in Parkinson’sdisease psychosis near the end of this year and continue building thecommercial infrastructure necessary to support the planned launch ofpimavanserin. Given the demonstrated antipsychotic effects, benefits onsleep, and favorable safety profile we’ve observed in the clinic todate, we are also very excited about the opportunity to advancepimavanserin in other indications. To that end, we continue to advanceenrollment of our ongoing Phase II study of pimavanserin in Alzheimer’sdisease psychosis and prepare for additional studies to evaluate theclinical utility of pimavanserin in other areas of significant unmetmedical need.”
Research and development expenses increased to $13.8 million for thesecond quarter of 2014, including $1.1 million in stock-basedcompensation expense, from $7.1 million for the comparable quarter of2013, including $473,000 in stock-based compensation expense. Thisincrease was primarily due to an increase of $5.0 million in externalservice costs, including costs associated with NDA-enabling clinical andmanufacturing activities in our pimavanserin development program.Increases in costs associated with our expanded research and developmentorganization, including $820,000 in increased personnel costs and$616,000 in increased stock-based compensation expense, also contributedto the quarter-over-quarter increase.
General and administrative expenses increased to $8.0 million for thesecond quarter of 2014, including $3.2 million in stock-basedcompensation expense, from $2.5 million for the comparable quarter of2013, including $591,000 in stock-based compensation expense. Thisincrease was primarily due to $2.6 million in increased stock-basedcompensation expense, including $1.1 million in stock-based compensationexpense associated with the retirement of our former Chief FinancialOfficer. Also contributing to the quarter-over-quarter increase ingeneral and administrative expenses was a $2.0 million increase inexternal service costs largely related to ACADIA’s preparations for theplanned launch of pimavanserin and $559,000 in increased personnel costs.
Conference Call and Webcast Information
ACADIA management will review its second quarter financial results anddevelopment programs via conference call and webcast later today at 5:00p.m. Eastern Time. The conference call may be accessed by dialing866-578-5771 for participants in the United States or Canada and617-213-8055 for international callers (reference passcode 94851179). Atelephone replay of the conference call may be accessed through August19, 2014 by dialing 888-286-8010 for callers in the United States orCanada and 617-801-6888 for international callers (reference passcode56603137). The conference call also will be webcast live on ACADIA’swebsite, www.acadia-pharm.com,under the investors section and will be archived there through August19, 2014.
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, forwhich we have reported positive Phase III trial results in Parkinson’sdisease psychosis and which has the potential to be the first drugapproved in the United States for this disorder. We are currentlycompleting NDA-enabling clinical and manufacturing activities forpimavanserin and are planning to submit an NDA with the FDA near the endof 2014. Pimavanserin is also in Phase II development for Alzheimer’sdisease psychosis and has successfully completed a Phase II trial inschizophrenia. ACADIA also has clinical-stage programs for chronic painand glaucoma in collaboration with Allergan, Inc. and two preclinicalprograms directed at Parkinson’s disease and other neurologicaldisorders. All product candidates are small molecules that emanate frominternal discoveries. ACADIA maintains a website at www.acadia-pharm.comto which we regularly post copies of our press releases as well asadditional information and through which interested parties cansubscribe to receive e-mail alerts.
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 timing of the submission of anNDA for pimavanserin, the potential for pimavanserin to be the firstdrug approved in the United States for Parkinson’s disease psychosis andthe potential timing of such approval, if approved at all; ACADIA’songoing pre-commercial activities and plans to commercially launchpimavanserin; the progress, timing and results of ACADIA’s drugdiscovery and development programs, either alone or with a partner,including the progress and expected timing of clinical trials, and theclinical utility to be derived from ACADIA’s product candidates,including the potential benefits of pimavanserin seen in clinical trialsfor Parkinson’s disease psychosis to be applicable to other indications,including Alzheimer’s disease psychosis and other indications in whichit has not yet been studied; and the progress of ACADIA’s NDA-enablingclinical and manufacturing activities. These statements are onlypredictions based on current information and expectations and involve anumber of risks and uncertainties. Actual events or results may differmaterially from those projected in any of such statements due to variousfactors, including the risks and uncertainties inherent in drugdiscovery, development, approval, and commercialization, andcollaborations with others, and the fact that past results of clinicaltrials may not be indicative of future trial results. For a discussionof these and other factors, please refer to ACADIA’s annual report onForm 10-K for the year ended December 31, 2013 as well as ACADIA’ssubsequent filings with the Securities and Exchange Commission. You arecautioned not to place undue reliance on these forward-lookingstatements, which speak only as of the date hereof. This caution is madeunder the safe harbor provisions of the Private Securities LitigationReform Act of 1995. All forward-looking statements are qualified intheir entirety by this cautionary statement and ACADIA undertakes noobligation to revise or update this press release to reflect events orcircumstances after the date hereof, except as required by law.
ACADIA PHARMACEUTICALS INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except per share amounts) (Unaudited) |
| | | | |
| | Three Months Ended
June 30, | | Six Months Ended
June 30, |
| | | 2014 | | | | 2013 | | | | 2014 | | | | 2013 | |
| | | | |
| | | | | | | | |
| Collaborative revenues | | $ | 28 | | | $ | 451 | | | $ | 58 | | | $ | 868 | |
| | | | | | | | |
| Operating expenses | | | | | | | | |
| Research and development (includes stock-based compensation expenseof $1,089, $473, $2,095, and $727, respectively) | | | 13,799 | | | | 7,112 | | | | 25,467 | | | | 11,542 | |
| General and administrative (includes stock-based compensationexpense of $3,242, $591, $5,398, and $919, respectively) | | | 7,952 | | | | 2,496 | | | | 14,272 | | | | 4,647 | |
| Total operating expenses | | | 21,751 | | | | 9,608 | | | | 39,739 | | | | 16,189 | |
| Loss from operations | | | (21,723 | ) | | | (9,157 | ) | | | (39,681 | ) | | | (15,321 | ) |
| Interest income, net | | | 228 | | | | 76 | | | | 358 | | | | 117 | |
| Net loss | | $ | (21,495 | ) | | $ | (9,081 | ) | | $ | (39,323 | ) | | $ | (15,204 | ) |
| Net loss per common share, basic and diluted | | $ | (0.22 | ) | | $ | (0.11 | ) | | $ | (0.41 | ) | | $ | (0.19 | ) |
| Weighted average common shares outstanding, basic and diluted | | | 99,048 | | | | 83,410 | | | | 96,042 | | | | 81,105 | |
| | | | | | | | | | | | | | | | |
ACADIA PHARMACEUTICALS INC. CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands) (Unaudited) |
| | | | |
| | | | |
| | June 30, 2014 | | December 31, 2013(1) |
| | | | |
| Assets | | | | |
| Cash, cash equivalents, and investment securities | | $ | 354,453 | | $ | 185,790 |
| Prepaid expenses, interest, and other receivables | | | 4,401 | | | 2,570 |
| Total current assets | | | 358,854 | | | 188,360 |
| Other non-current assets | | | 611 | | | 758 |
| Total assets | | $ | 359,465 | | $ | 189,118 |
| Liabilities and stockholders’ equity | | | | |
| Total liabilities | | $ | 9,357 | | $ | 6,987 |
| Stockholders’ equity | | | 350,108 | | | 182,131 |
| Total liabilities and stockholders’ equity | | $ | 359,465 | | $ | 189,118 |
(1) The condensed consolidated balance sheet at December 31, 2013 hasbeen derived from the audited financial statements at such date but doesnot include all of the information and footnotes required by accountingprinciples generally accepted in the United States for completefinancial statements.
Source: ACADIA Pharmaceuticals Inc.
ACADIA Pharmaceuticals Inc.
Steve Davis, Executive VicePresident,
Chief Financial Officer and Chief Business Officer
LisaBarthelemy, Director of Investor Relations
(858) 558-2871