SAN DIEGO—(BUSINESS WIRE)—May 7, 2015—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 first quarter ended March 31, 2015.
ACADIA reported a net loss of $40.4 million, or $0.40 per common share,for the first quarter of 2015 compared to a net loss of $17.8 million,or $0.19 per common share, for the first quarter of 2014. The net lossfor the first quarter of 2015 included $14.5 million in non-cashstock-based compensation expense, including $9.0 million of non-cashstock-based compensation recognized in connection with the retirement ofACADIA’s former Chief Executive Officer. Non-cash stock-basedcompensation expense for the first quarter of 2014 totaled $3.2 million.At March 31, 2015, ACADIA’s cash, cash equivalents and investmentsecurities totaled $297.9 million, compared to $322.5 million atDecember 31, 2014.
“We continue to make important progress in advancing NUPLAZID™(pimavanserin) for Parkinson’s disease psychosis (PDP) towardregistration and in preparing for the planned commercial launch ofNUPLAZID in the United States,” said Steve Davis, ACADIA’s Interim ChiefExecutive Officer. “We remain on track with completing the preparationof manufacturing quality systems to support commercial manufacturing andsupply and, as previously indicated, we plan to submit our NUPLAZID NewDrug Application (NDA) to the U.S. Food and Drug Administration (FDA) inthe second half of 2015.”
“In addition, during the first quarter, we made significant strides inour foundational medical education efforts, including initiation of animportant disease awareness campaign designed to increase dialog in themedical community regarding the needs of patients suffering from PDP.This initiative, together with a further expansion of our salesmanagement team and medical affairs team, highlight the strong effortswe are putting behind addressing the significant unmet need representedby PDP.”
Research and development expenses increased to $16.3 million for thefirst quarter of 2015, including $2.4 million in stock-basedcompensation expense, from $11.7 million for the comparable quarter of2014, including $1.0 million in stock-based compensation expense. Thisincrease was partly due to an increase of $3.1 million in personnel andrelated costs and stock-based compensation expense associated withACADIA’s expanded research and development organization. Alsocontributing to the quarter-over-quarter increase was an increase inexternal service costs of $1.5 million, primarily related to ongoingwork to complete the preparation of manufacturing quality systems tosupport commercial manufacturing and supply of NUPLAZID.
General and administrative expenses increased to $24.3 million for thefirst quarter of 2015, including $12.2 million in stock-basedcompensation expense, from $6.3 million for the comparable quarter of2014, including $2.2 million in stock-based compensation expense. Thisincrease was due to increases in personnel and related costs andstock-based compensation expense of $14.2 million and increases inexternal services costs of $3.8 million. Contributing to the increase inpersonnel costs and stock-based compensation expense was $9.6 million incosts recognized in connection with the retirement of ACADIA’s formerChief Executive Officer, including $9.0 million of stock-basedcompensation expense. Excluding these costs, the increases in personnelcosts and external services costs were largely related to ACADIA’scommercial preparations for the planned launch of NUPLAZID.
Conference Call and Webcast Information
ACADIA management will review its first 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 dialing855-638-4820 for participants in the U.S. or Canada and 443-877-4067 forinternational callers (reference passcode 33769915). A telephone replayof the conference call may be accessed through May 21, 2015 by dialing855-859-2056 for callers in the U.S. or Canada and 404-537-3406 forinternational callers (reference passcode 33769915). The conference callalso will be webcast live on ACADIA’s website, www.acadia-pharm.com,under the investors section and will be archived there until May 21,2015.
About ACADIA Pharmaceuticals
ACADIA is a biopharmaceutical company focused on the development andcommercialization of innovative medicines to address unmet medical needsin neurological and related central nervous system disorders. ACADIA hasa pipeline of product candidates led by NUPLAZID™ (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. Pimavanserin is also inPhase II development for Alzheimer’s disease psychosis and hassuccessfully completed a Phase II trial in schizophrenia. ACADIA alsohas clinical-stage programs for chronic pain and glaucoma incollaboration with Allergan, Inc. All product candidates are smallmolecules that emanate from internal discoveries. ACADIA maintains awebsite 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 NUPLAZID (pimavanserin) for the treatment of PDP; the potentialfor pimavanserin to be the first drug approved in the United States forPDP and the potential timing of such approval, if approved at all; theactivities planned to be undertaken including preparation ofmanufacturing quality systems; ACADIA’s ongoing pre-commercialactivities and plans to commercially launch NUPLAZID; and the progress,timing and results of ACADIA’s drug discovery and development programs,either alone or with a partner, including the progress and expectedtiming of clinical trials, including planned trials for pimavanserin.These statements 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, 2014as well as ACADIA’s subsequent filings with the Securities and ExchangeCommission. You are cautioned not to place undue reliance on theseforward-looking statements, which speak only as of the date hereof. Thiscaution is made under the safe harbor provisions of the PrivateSecurities Litigation Reform Act of 1995. All forward-looking statementsare qualified in their entirety by this cautionary statement and ACADIAundertakes no obligation to revise or update this press release toreflect events or circumstances after the date hereof, except asrequired by law.
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ACADIA PHARMACEUTICALS INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except per share amounts) (Unaudited) |
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| | | | Three Months Ended March 31, |
| | | | 2015 | | | | | | | | | 2014 |
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Collaborative revenues | | | | $ | 4 | | | | | | | | | | $ | 30 | |
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Operating expenses | | | | | | | | | | | | | |
Research and development (includes stock-based compensation of$2,362 and $1,006, respectively) | | | | | 16,295 | | | | | | | | | | | 11,668 | |
General and administrative (includes stock-based compensation of$12,166 and $2,156, respectively) | | | | | 24,261 | | | | | | | | | | | 6,320 | |
Total operating expenses | | | | | 40,556 | | | | | | | | | | | 17,988 | |
Loss from operations | | | | | (40,552 | ) | | | | | | | | | | (17,958 | ) |
Interest income, net | | | | | 177 | | | | | | | | | | | 130 | |
Net loss | | | | $ | (40,375 | ) | | | | | | | | | $ | (17,828 | ) |
Net loss per common share, basic and diluted | | | | $ | (0.40 | ) | | | | | | | | | $ | (0.19 | ) |
Weighted average common shares outstanding, basic and diluted | | | | | 100,197 | | | | | | | | | | | 92,968 | |
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ACADIA PHARMACEUTICALS INC. CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands) (Unaudited) |
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| | | | March 31, 2015 | | | | | | | | | December 31, 2014(1) |
Assets | | | | | | | | | | | | | |
Cash, cash equivalents and investment securities | | | | $ | 297,893 | | | | | | | | | $ | 322,486 |
Prepaid expenses, receivables and other current assets | | | | | 2,006 | | | | | | | | | | 2,132 |
Total current assets | | | | | 299,899 | | | | | | | | | | 324,618 |
Other non-current assets | | | | | 2,064 | | | | | | | | | | 840 |
Total assets | | | | $ | 301,963 | | | | | | | | | $ | 325,458 |
Liabilities and stockholders’ equity | | | | | | | | | | | | | |
Total liabilities | | | | $ | 16,869 | | | | | | | | | $ | 15,969 |
Stockholders’ equity | | | | | 285,094 | | | | | | | | | | 309,489 |
Total liabilities and stockholders’ equity | | | | $ | 301,963 | | | | | | | | | $ | 325,458 |
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(1) | | | The condensed consolidated balance sheet at December 31, 2014 hasbeen derived from the audited financial statements at such datebut does not include all of the information and footnotes requiredby accounting principles generally accepted in the United Statesfor complete financial statements. |
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Source: ACADIA Pharmaceuticals Inc.
ACADIA Pharmaceuticals Inc.
Steve Davis, Interim ChiefExecutive Officer
Lisa Barthelemy, Director of InvestorRelations
(858) 558-2871