SAN DIEGO—(BUSINESS WIRE)—Nov. 5, 2015—ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD), a biopharmaceutical companyfocused on the development and commercialization of innovative medicinesto address unmet medical needs in central nervous system disorders,today announced its unaudited financial results for the third quarterended September 30, 2015.
ACADIA reported a net loss of $38.9 million, or $0.39 per common share,for the third quarter of 2015 compared to a net loss of $24.8 million,or $0.25 per common share, for the third quarter of 2014. Net losses forthe third quarters of 2015 and 2014 included $9.2 million and $3.9million, respectively, in non-cash stock-based compensation expense. Forthe nine months ended September 30, 2015, ACADIA reported a net loss of$118.7 million, or $1.18 per common share, compared to a net loss of$64.1 million, or $0.66 per common share, for the comparable period of2014. Net losses for the nine-month periods ended September 30, 2015 and2014 included $31.3 million and $11.4 million, respectively, innon-cash, stock-based compensation expense. At September 30, 2015,ACADIA’s cash, cash equivalents and investment securities totaled $240.7million, compared to $322.5 million at December 31, 2014.
“Our third quarter was highlighted by the September submission to theFDA of our New Drug Application for the use of NUPLAZID™ in thetreatment of Parkinson’s disease psychosis, a condition for which thereis no FDA-approved therapy,” said Steve Davis, ACADIA’s President andChief Executive Officer. “We’re pleased by the FDA’s recent decision togrant Priority Review status to our NUPLAZID application, resulting in aprojected accelerated timeline for review and an FDA goal of May 1, 2016for taking action under the Prescription Drug User Fee Act, or PDUFA. Wecontinue to advance our preparations for the planned commercial launchof NUPLAZID in the United States and to lay the foundation foradditional development with pimavanserin in other areas of significantunmet medical need.”
Research and development expenses increased to $18.7 million for thethird quarter of 2015, including $3.9 million in stock-basedcompensation expense, from $17.0 million for the comparable quarter of2014, including $1.4 million in stock-based compensation expense. Thisincrease was primarily due to an increase in personnel and related costsof $4.9 million associated with ACADIA’s expanded research anddevelopment organization, largely offset by pimavanserin manufacturingdevelopment costs incurred during the third quarter of 2014 that werenot incurred during the third quarter of 2015.
General and administrative expenses increased to $20.3 million for thethird quarter of 2015, including $5.3 million in stock-basedcompensation expense, from $8.1 million for the comparable quarter of2014, including $2.5 million in stock-based compensation expense. Thisincrease was due to increases in personnel and related costs of $7.0million and increases in external services costs of $5.2 million, alllargely related to ACADIA’s commercial preparations for the plannedlaunch of NUPLAZID.
Conference Call and Webcast Information
ACADIA management will review its third quarter financial results andoperations via conference call and webcast later today at 5:00 p.m.Eastern Time. The conference call may be accessed by dialing844-821-1109 for participants in the U.S. or Canada and 830-865-2550 forinternational callers (reference passcode 69545890). A telephone replayof the conference call may be accessed through November 19, 2015 bydialing 855-859-2056 for callers in the U.S. or Canada and 404-537-3406for international callers (reference passcode 69545890). The conferencecall also will be webcast live on ACADIA’s website, www.acadia-pharm.com,under the investors section and will be archived there until November19, 2015.
About ACADIA Pharmaceuticals
ACADIA is a biopharmaceutical company focused on the development andcommercialization of innovative medicines to address unmet medical needsin central nervous system disorders. ACADIA has a pipeline of productcandidates led by NUPLAZID™ (pimavanserin), for which we have submitteda New Drug Application (NDA) in Parkinson’s disease psychosis to the FDAand which has the potential to be the first drug approved in the UnitedStates for this condition. The FDA has classified the NUPLAZID NDA ashaving Priority Review status. Pimavanserin is also in Phase IIdevelopment for Alzheimer’s disease psychosis and has successfullycompleted a Phase II trial in schizophrenia. ACADIA also hasclinical-stage programs for glaucoma and, in collaboration withAllergan, Inc., for chronic pain. 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 potential for NUPLAZID(pimavanserin) to be the first drug approved in the United States forParkinson’s disease psychosis (PDP) and the potential timing of suchapproval, if approved at all, by the FDA; ACADIA’s progress in preparingto commercially launch NUPLAZID; the progress, timing and results ofACADIA’s drug discovery and development programs, either alone or with apartner, including the progress and expected timing of clinical trials,including additional planned trials for pimavanserin; and the benefitsto be derived from ACADIA’s product candidates, including 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 and past regulatory decisions may not beindicative of future trial results or future regulatory decisions,respectively. For a discussion of these and other factors, please referto ACADIA’s annual report on Form 10-K for the year ended December 31,2014 as well as ACADIA’s subsequent filings with the Securities andExchange Commission. You are cautioned not to place undue reliance onthese forward-looking statements, which speak only as of the datehereof. This caution is made under the safe harbor provisions of thePrivate Securities Litigation Reform Act of 1995. All forward-lookingstatements are qualified in their entirety by this cautionary statementand ACADIA undertakes no obligation to revise or update this pressrelease to reflect events or circumstances after the date hereof, exceptas required by law.
| | | | | | | | |
ACADIA PHARMACEUTICALS INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except per share amounts) (Unaudited) |
| | | | | | | | |
| | | | Three Months Ended September 30, | | | | Nine Months Ended September 30, |
| | | | 2015 | | | | 2014 | | | | 2015 | | | | 2014 |
| | | | | | | | | | | | | | | | |
Collaborative revenues | | | | $ | 39 | | | | | $ | 15 | | | | | $ | 44 | | | | | $ | 72 | |
| | | | | | | | | | | | | | | | |
Operating expenses | | | | | | | | | | | | | | | | |
Research and development (includes stock-based compensation expenseof $3,938, $1,358, $9,139, and $3,452, respectively) | | | | | 18,729 | | | | | | 16,952 | | | | | | 53,403 | | | | | | 42,420 | |
General and administrative (includes stock-based compensationexpense of $5,327, $2,544, $22,153, and $7,942, respectively) | | | | | 20,308 | | | | | | 8,057 | | | | | | 65,688 | | | | | | 22,328 | |
Total operating expenses | | | | | 39,037 | | | | | | 25,009 | | | | | | 119,091 | | | | | | 64,748 | |
Loss from operations | | | | | (38,998 | ) | | | | | (24,994 | ) | | | | | (119,047 | ) | | | | | (64,676 | ) |
Interest income, net | | | | | 92 | | | | | | 208 | | | | | | 388 | | | | | | 567 | |
Net loss | | | | $ | (38,906 | ) | | | | $ | (24,786 | ) | | | | $ | (118,659 | ) | | | | $ | (64,109 | ) |
Net loss per common share, basic and diluted | | | | $ | (0.39 | ) | | | | $ | (0.25 | ) | | | | $ | (1.18 | ) | | | | $ | (0.66 | ) |
Weighted average common shares outstanding, basic and diluted | | | | | 100,756 | | | | | | 99,497 | | | | | | 100,436 | | | | | | 97,210 | |
| | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | |
ACADIA PHARMACEUTICALS INC. CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands) (Unaudited) |
| | | | | | | | | | | | | |
| | | | September 30, 2015 | | | | | | | | | December 31, 2014(1) |
| | | | | | | | | | | | | |
Assets | | | | | | | | | | | | | |
Cash, cash equivalents, and investment securities | | | | $ | 240,691 | | | | | | | | | $ | 322,486 |
Prepaid expenses, receivables and other current assets | | | | | 2,156 | | | | | | | | | | 2,132 |
Total current assets | | | | | 242,847 | | | | | | | | | | 324,618 |
Other non-current assets | | | | | 2,473 | | | | | | | | | | 840 |
Total assets | | | | $ | 245,320 | | | | | | | | | $ | 325,458 |
Liabilities and stockholders’ equity | | | | | | | | | | | | | |
Total liabilities | | | | $ | 17,974 | | | | | | | | | $ | 15,969 |
Stockholders’ equity | | | | | 227,346 | | | | | | | | | | 309,489 |
Total liabilities and stockholders’ equity | | | | $ | 245,320 | | | | | | | | | $ | 325,458 |
| | | | | | | | | | | | | |
(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. |
| | | |

Source: ACADIA Pharmaceuticals Inc.
ACADIA Pharmaceuticals Inc.
Lisa Barthelemy, Director ofInvestor Relations
(858) 558-2871