SAN DIEGO—(BUSINESS WIRE)—Feb. 26, 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 financial results for thefourth quarter and year ended December 31, 2014.
ACADIA reported a net loss of $28.4 million, or $0.28 per common share,for the fourth quarter of 2014, compared to a net loss of $12.0 million,or $0.13 per common share, for the fourth quarter of 2013. The netlosses for the fourth quarters of 2014 and 2013 included $4.6 millionand $2.2 million, respectively, in non-cash, stock-based compensationexpense. For the year ended December 31, 2014, ACADIA reported a netloss of $92.5 million, or $0.95 per common share, compared to a net lossof $37.9 million, or $0.44 per common share, for 2013. The net lossesfor 2014 and 2013 included $16.0 million and $5.7 million, respectively,in non-cash, stock-based compensation expense.
At December 31, 2014, ACADIA’s cash, cash equivalents, and investmentsecurities totaled $322.5 million compared to $185.8 million at December31, 2013. This increase was primarily due to net proceeds from sales ofequity securities, including $196.8 million raised in a public offeringin March 2014, offset in part by cash used to fund ACADIA’s operations.
“Our accomplishments in 2014, highlighted by NUPLAZIDTMreceiving Breakthrough Therapy designation from the FDA, ourstrengthened balance sheet, and our commercial preparations, set thestage for a promising 2015,” said Uli Hacksell, Ph.D., Chief ExecutiveOfficer of ACADIA. “Importantly, we continue to advance our Parkinson’sdisease psychosis program towards registration and remain on track tosubmit our New Drug Application to the FDA in the first quarter of 2015.”
“We have an important year ahead of us as we continue to add to ourcommercial capabilities and prepare for the planned launch of NUPLAZIDin the United States. We also plan to initiate studies with pimavanserinwhere new therapies are greatly needed, including schizophrenia andsleep disturbances in Parkinson’s patients, as well as continuing ourongoing Phase II study with pimavanserin in Alzheimer’s diseasepsychosis. Additionally, we will prepare a Marketing AuthorizationApplication for NUPLAZID for submission in Europe. In all, 2015 will bea pivotal year for ACADIA as we advance NUPLAZID towardscommercialization in the United States and broaden the program intoadditional neurological and psychiatric indications for which there arelarge unmet medical needs.”
Research and development expenses increased to $18.2 million for thefourth quarter of 2014, including $1.7 million in stock-basedcompensation, from $7.9 million for the comparable quarter of 2013,including $791,000 in stock-based compensation. This increase wasprimarily due to an increase of $7.8 million in external service costsassociated with the development of pimavanserin. Increases in costsassociated with ACADIA’s expanded research and development organization,including $1.5 million in increased personnel costs and $948,000 inincreased stock-based compensation expense, also contributed to thequarter-over-quarter increase.
General and administrative expenses increased to $10.4 million for thefourth quarter of 2014, including $2.9 million in stock-basedcompensation, from $4.3 million for the comparable quarter of 2013,including $1.4 million in stock-based compensation. This increase wasdue to a $2.1 million increase in external service costs largely relatedto ACADIA’s commercial preparations for the planned launch of NUPLAZID.Also contributing to the quarter-over-quarter increase in general andadministrative expenses was a $1.7 million increase in personnelexpenses largely related to ACADIA’s preparations for the planned launchof NUPLAZID, as well as a $1.5 million increase in stock-basedcompensation expense.
ACADIA anticipates that the level of cash used in its operations willincrease in future periods in order to fund its work related to the NewDrug Application (NDA) submission and review and commercial activitiesfor NUPLAZID, and its ongoing and planned development activities forpimavanserin for other indications. ACADIA currently expects that itscash, cash equivalents, and investment securities will be sufficient tofund its planned operations at least into the second half of 2016.
2014 Highlights
NUPLAZID (pimavanserin)
- FDA granted Breakthrough Therapy designation to NUPLAZID for thetreatment of Parkinson’s disease psychosis (PDP).
- Conducted successful pre-NDA meetings with the FDA for NUPLAZID.
- FDA provisionally accepted the trade name “NUPLAZID”™ for pimavanserin.
- Presented caregiver burden data from Phase III PDP program at the 10thAnnual International Congress of Non-Motor Dysfunctions in Parkinson’sDisease and Related Disorders.
- Continued to enroll patients in the ongoing Phase II study withpimavanserin in Alzheimer’s disease psychosis.
- Advanced commercial preparations for the planned launch of NUPLAZID,comprising extensive market research, foundational access andreimbursement research, national and regional scientific advisoryboards, pricing analysis, sales force sizing, and adding to theleadership of the commercial team.
Business and Other
- Completed a public offering of common stock raising net proceeds of$196.8 million.
- Appointed Steve Davis as Executive Vice President, Chief FinancialOfficer and Chief Business Officer.
Conference Call and Webcast Information
ACADIA management will review its fourth 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 dialing866-825-1709 for participants in the U.S. or Canada and617-213-8060 for international callers (reference passcode 61156625). Atelephone replay of the conference call may be accessed through March12, 2015 by dialing 888-286-8010 for callers in the U.S. or Canada and617-801-6888 for international callers (reference passcode 58941986).The conference call also will be webcast live on ACADIA’s website, www.acadia-pharm.com,under the investors section and will be archived there until March 12,2015.
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; thepotential outlook for 2015 and the activities planned to be undertakenin the next year; ACADIA’s plans to explore NUPLAZID (pimavanserin) inindications other than PDP and to file a Marketing AuthorizationApplication in Europe; ACADIA’s future cash usage, including the areasof such usage, and the cash runway; 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 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.
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| ACADIA PHARMACEUTICALS INC. |
| CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS |
| (in thousands, except per share amounts) |
| (Unaudited) |
|
| | | Three Months Ended | | | | Years Ended |
| | | December 31, | | | | December 31, |
| | | 2014 | | | 2013 | | | | 2014 (1) | | 2013 (1) |
| | | | | | | | | | | | | |
| | | | | | | | | | | | | |
| Collaborative revenues | | | $ | 47 | | | | $ | 37 | | | | | $ | 120 | | | | $ | 1,145 | |
| | | | | | | | | | | | | |
| Operating expenses | | | | | | | | | | | | | |
| Research and development (includes stock-based compensation of$1,739, $791, $5,191, and $2,208, respectively) | | | | 18,182 | | | | | 7,926 | | | | | | 60,602 | | | | | 26,722 | |
| General and administrative (includes stock-based compensation of$2,906, $1,383, $10,848, and $3,503, respectively) | | | | 10,420 | | | | | 4,276 | | | | | | 32,748 | | | | | 12,720 | |
| Total operating expenses | | | | 28,602 | | | | | 12,202 | | | | | | 93,350 | | | | | 39,442 | |
| Loss from operations | | | | (28,555 | ) | | | | (12,165 | ) | | | | | (93,230 | ) | | | | (38,297 | ) |
| Interest income, net | | | | 189 | | | | | 116 | | | | | | 755 | | | | | 349 | |
| Net loss | | | $ | (28,366 | ) | | | $ | (12,049 | ) | | | | $ | (92,475 | ) | | | $ | (37,948 | ) |
| Net loss per common share, basic and diluted | | | $ | (0.28 | ) | | | $ | (0.13 | ) | | | | $ | (0.95 | ) | | | $ | (0.44 | ) |
| Weighted average common shares outstanding, basic and diluted | | | | 99,850 | | | | | 90,947 | | | | | | 97,248 | | | | | 85,715 | |
| | | | | | | | | | | | | | | | | | | | | |
| (1) | | | The condensed consolidated statements of operations for the yearsended December 31, 2014 and 2013 have been derived from thefinancial statements but do not include all of the information andfootnotes required by accounting principles generally accepted inthe United States for complete financial statements. |
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| ACADIA PHARMACEUTICALS INC. |
| CONDENSED CONSOLIDATED BALANCE SHEETS |
| (in thousands) |
| (Unaudited) |
|
| | | | December 31, | | | | December 31, |
| | | | 2014 (1) | | | | 2013 (1) |
| | | | | | | | |
| Assets | | | | | | | | |
| Cash, cash equivalents, and investment securities | | | | $ | 322,486 | | | | $ | 185,790 |
| Prepaid expenses, receivables and other current assets | | | | | 2,132 | | | | | 2,570 |
| Total current assets | | | | | 324,618 | | | | | 188,360 |
| Other non-current assets | | | | | 840 | | | | | 758 |
| Total assets | | | | $ | 325,458 | | | | $ | 189,118 |
| Liabilities and stockholders’ equity | | | | | | | | |
| Total liabilities | | | | $ | 15,969 | | | | $ | 6,987 |
| Stockholders’ equity | | | | | 309,489 | | | | | 182,131 |
| Total liabilities and stockholders’ equity | | | | $ | 325,458 | | | | $ | 189,118 |
| | | | | | | | | | |
(1) | | | The condensed consolidated balance sheets at December 31, 2014 and2013 have been derived from the financial statements at such datebut do 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.
Steve Davis, Executive VicePresident,
Chief Financial Officer and Chief Business Officer
LisaBarthelemy, Director of Investor Relations
858-558-2871