SAN DIEGO—(BUSINESS WIRE)—Feb. 29, 2016—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 financial results for the fourth quarter and yearended December 31, 2015.
“2015 was highlighted by the filing of our NUPLAZID™ (pimavanserin) NewDrug Application for Parkinson’s disease psychosis and the designationof Priority Review by the FDA with a PDUFA date of May 1, 2016,” saidSteve Davis, ACADIA’s President and Chief Executive Officer. “We alsocontinued to advance our preparations for the 2016 launch of NUPLAZID,if approved, in the United States and to execute on our life cycledevelopment of pimavanserin highlighted by our ongoing Phase II study inAlzheimer’s disease psychosis and the planned commencement of a Phase IIstudy in Alzheimer’s disease agitation scheduled for the first half of2016. We have set the foundation for what we believe will be a pivotalyear for ACADIA.”
ACADIA reported a net loss of $45.8 million, or $0.45 per common share,for the fourth quarter of 2015, compared to a net loss of $28.4 million,or $0.28 per common share, for the fourth quarter of 2014. The netlosses for the fourth quarters of 2015 and 2014 included $8.9 millionand $4.6 million, respectively, in non-cash, stock-based compensationexpense. For the year ended December 31, 2015, ACADIA reported a netloss of $164.4 million, or $1.63 per common share, compared to a netloss of $92.5 million, or $0.95 per common share, for 2014. The netlosses for 2015 and 2014 included $40.2 million and $16.0 million,respectively, in non-cash, stock-based compensation expense. At December31, 2015, ACADIA’s cash, cash equivalents, and investment securitiestotaled $215.1 million compared to $322.5 million at December 31, 2014.Net proceeds of approximately $281.6 million received from ACADIA’sfollow-on public offering in January 2016 are not reflected in thebalance sheet as of December 31, 2015.
Research and development expenses increased to $20.5 million for thefourth quarter of 2015, including $3.0 million in stock-basedcompensation, from $18.2 million for the comparable quarter of 2014,including $1.7 million in stock-based compensation. This increase wasdue to an increase in personnel and related costs of $3.5 millionassociated with ACADIA’s expanded research and development organization,partially offset by reduced external service costs related to thepreparation of the Company’s NDA for NUPLAZID and manufacturingdevelopment costs incurred in the fourth quarter of 2014 not incurred inthe fourth quarter of 2015.
General and administrative expenses increased to $22.6 million for thefourth quarter of 2015, including $5.9 million in stock-basedcompensation, from $10.4 million for the comparable quarter of 2014,including $2.9 million in stock-based compensation. This increase wasdue to an increase in personnel and related costs of $5.9 million and anincrease in external service costs of $6.3 million, all largely relatedto ACADIA’s commercial preparations for the planned launch of NUPLAZID.
2015 and Recent Highlights
NUPLAZID (pimavanserin)
- Submitted NDA for NUPLAZID in September 2015, which was accepted forfiling with Priority Review by the FDA in October 2015 with a PDUFAgoal date of May 1, 2016.
- Launched an integrated awareness campaign for Parkinson’s diseasepsychosis, or PDP, including educational programs with over 12,000health care professionals, a PDP educational website targetingphysicians, neurology journal and digital placements, and PDPeducational booths at major medical meetings.
- Continued to enroll patients in the ongoing Phase II study withpimavanserin in Alzheimer’s disease psychosis, or ADP.
- Conducted a comprehensive life cycle management review of pimavanserinto lay the foundation for additional development in multiple areas ofsignificant unmet medical need beyond PDP and ADP.
- Selected Alzheimer’s disease agitation as the next indication fordevelopment of pimavanserin.
Business and Other Highlights
- Completed a follow-on public offering in January 2016, raising netproceeds of approximately $281.6 million.
- Appointed Steve Davis as President and Chief Executive Officer.
- Appointed Serge Stankovic, M.D., M.S.P.H., as Executive VicePresident, Head of R&D, Randall Owen, M.D., as Senior Vice President,Clinical Development and Chief Medical Officer, Jim Nash, as SeniorVice President, Technology Development and Operations, and BobMischler, as Vice President, Strategy and Business Development.
- Daniel Soland, Edmund Harrigan, M.D., Julian Baker, and Jim Daly addedto the Board of Directors.
Conference Call and Webcast Information
ACADIA management will review its fourth quarter and year-end financialresults and development programs via conference call and webcast thismorning at 8:00 a.m. Eastern Time. The conference call may be accessedby dialing 844-821-1109 for participants in the U.S. or Canadaand 830-865-2550 for international callers (reference passcode53442032). A telephone replay of the conference call may be accessedthrough March 14, 2016 by dialing 855-859-2056 for callers in the U.S.or Canada and 404-537-3406 for international callers (reference passcode53442032). The conference call also will be webcast live on ACADIA’swebsite, www.acadia-pharm.com,under the investors section and will be archived there until March 14,2016.
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) for psychosis associated with Parkinson’sdisease to the FDA and which has the potential to be the first drugapproved in the United States for this condition. The FDA has classifiedthe NUPLAZID NDA as having Priority Review status. Pimavanserin is alsoin Phase II development for Alzheimer’s disease psychosis and hassuccessfully completed a Phase II trial in schizophrenia. ACADIA alsohas clinical-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 forPDP and the potential timing of such approval, if approved at all; thepotential outlook for 2016 and the activities planned to be undertakenin the next year, including the commercial launch of NUPLAZID in theUnited States; ACADIA’s plans to explore pimavanserin in indicationsother than PDP and ADP; and the progress, timing and results of ACADIA’sdrug discovery and development programs, either alone or with a partner,including the progress and expected timing of clinical trials, includingplanned trials for pimavanserin. These statements are only predictionsbased on current information and expectations and involve a number ofrisks and uncertainties. Actual events or results may differ materiallyfrom those projected in any of such statements due to various factors,including the risks and uncertainties inherent in drug discovery,development, regulatory approval and commercialization, and incollaborations 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, 2015 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.
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ACADIA PHARMACEUTICALS INC. |
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS |
(in thousands, except per share amounts) |
(Unaudited) |
| | | | | | |
| | | Three Months Ended December 31, | | | Years Ended December 31, |
| | | 2015 | | | 2014 | | | 2015 (1) | | | 2014 (1) |
| | | | | | |
| | | | | | | | | | | | |
Revenues | | | | | | | | | | | | |
Collaborative revenues | | | $ | 17 | | | | $ | 47 | | | | $ | 61 | | | | $ | 120 | |
| | | | | | | | | | | | |
Operating expenses | | | | | | | | | | | | |
License fees | | | | 2,500 | | | | | - | | | | | 2,500 | | | | | - | |
Research and development | | | | 20,466 | | | | | 18,182 | | | | | 73,869 | | | | | 60,602 | |
General and administrative | | | | 22,616 | | | | | 10,420 | | | | | 88,304 | | | | | 32,748 | |
Total operating expenses | | | | 45,582 | | | | | 28,602 | | | | | 164,673 | | | | | 93,350 | |
Loss from operations | | | | (45,565 | ) | | | | (28,555 | ) | | | | (164,612 | ) | | | | (93,230 | ) |
Interest income, net | | | | 111 | | | | | 189 | | | | | 499 | | | | | 755 | |
Loss before income taxes | | | | (45,454 | ) | | | | (28,366 | ) | | | | (164,113 | ) | | | | (92,475 | ) |
Income tax expense | | | | 330 | | | | | - | | | | | 330 | | | | | - | |
Net loss | | | $ | (45,784 | ) | | | $ | (28,366 | ) | | | $ | (164,443 | ) | | | $ | (92,475 | ) |
Net loss per common share, basic and diluted | | | $ | (0.45 | ) | | | $ | (0.28 | ) | | | $ | (1.63 | ) | | | $ | (0.95 | ) |
Weighted average common shares outstanding, basic and diluted | | | | 101,207 | | | | | 99,850 | | | | | 100,630 | | | | | 97,248 | |
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(1) | | The condensed consolidated statements of operations for the yearsended December 31, 2015 and 2014 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. |
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ACADIA PHARMACEUTICALS INC. |
CONDENSED CONSOLIDATED BALANCE SHEETS |
(in thousands) |
(Unaudited) |
| | | | | | |
| | | December 31, 2015 (1) | | | December 31, 2014 (1) |
| | | | | | |
Assets | | | | | | |
Cash, cash equivalents, and investment securities | | | $ | 215,132 | | | $ | 322,486 |
Prepaid expenses, receivables and other current assets | | | | 3,857 | | | | 2,132 |
Total current assets | | | | 218,989 | | | | 324,618 |
Restricted cash | | | | 375 | | | | - |
Other non-current assets | | | | 2,532 | | | | 840 |
Total assets | | | $ | 221,896 | | | $ | 325,458 |
Liabilities and stockholders’ equity | | | | | | |
Total liabilities | | | $ | 22,134 | | | $ | 15,969 |
Stockholders’ equity | | | | 199,762 | | | | 309,489 |
Total liabilities and stockholders’ equity | | | $ | 221,896 | | | $ | 325,458 |
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(1) | | The condensed consolidated balance sheets at December 31, 2015 and2014 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.
ACADIA Pharmaceuticals Inc.
Lisa Barthelemy, SeniorDirector, Investor Relations
(858) 558-2871