SAN DIEGO—(BUSINESS WIRE)—Nov. 10, 2014—ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD), a biopharmaceutical companyfocused on the development and commercialization of innovative medicinesto address unmet medical needs in neurological and related centralnervous system disorders, today announced its unaudited financialresults for the third quarter ended September 30, 2014 and provided anupdate on the timing of its NUPLAZID™ (pimavanserin) New DrugApplication (NDA) submission.
ACADIA plans to submit its NUPLAZID NDA for Parkinson’sdisease psychosis in the first quarter of 2015. The company hadpreviously planned to submit the NDA near the end of 2014. The decisionto move back the planned submission is based on additional time requiredto complete preparations needed to support the U.S. Food and DrugAdministration’s (FDA) review of NUPLAZID. The change in submissiontiming is not a result of any change to NUPLAZID’s clinical or safetyprofile, nor is it a result of any interaction with or request forinformation from the FDA. Additionally, ACADIA reported that it hassuccessfully completed its drug-drug interaction program and itsregistration stability program.
“While we had hoped to submit our NDA for NUPLAZID near the end of thisyear, we believe it is prudent to push back our planned submission tothe first quarter of 2015,” said Uli Hacksell, Ph.D., Chief ExecutiveOfficer of ACADIA. “We are confident in our safety and efficacy datapackage supporting the NUPLAZID NDA and are working diligently oncompleting preparations for the NDA submission and review.
“Additionally, the recent decision by the FDA to grant BreakthroughTherapy designation for NUPLAZID reinforces the large unmet medical needfor the treatment of Parkinson’s disease psychosis and the importance ofthe NUPLAZID program. With no FDA-approved treatment for Parkinson’sdisease psychosis, NUPLAZID has the potential to transform the treatmentlandscape for patients with this debilitating disorder.”
Third Quarter Financial Results
ACADIA reported a net loss of $24.8 million, or $0.25 per common share,for the third quarter of 2014 compared to a net loss of $10.7 million,or $0.12 per common share, for the third quarter of 2013. Net losses forthe third quarters of 2014 and 2013 included $3.9 million and $1.9million, respectively, in non-cash, stock-based compensation expense.For the nine months ended September 30, 2014, ACADIA reported a net lossof $64.1 million, or $0.66 per common share, compared to a net loss of$25.9 million, or $0.31 per common share, for the comparable period of2013. Net losses for the nine-month periods ended September 30, 2014 and2013 included $11.4 million and $3.5 million, respectively, in non-cash,stock-based compensation expense.
At September 30, 2014, ACADIA’s cash, cash equivalents, and investmentsecurities totaled $337.8 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.
Research and development expenses increased to $17.0 million for thethird quarter of 2014, including $1.4 million in stock-basedcompensation expense, from $7.3 million for the comparable quarter of2013, including $690,000 in stock-based compensation expense. Thisincrease was primarily due to an increase of $8.4 million in externalservice costs, including increased development costs incurred in ourPhase III program for NUPLAZID. Increases in costs associated with ourexpanded research and development organization, including $882,000 inincreased personnel costs and $668,000 in increased stock-basedcompensation expense, also contributed to the quarter-over-quarterincrease.
General and administrative expenses increased to $8.1 million for thethird quarter of 2014, including $2.5 million in stock-basedcompensation expense, from $3.8 million for the comparable quarter of2013, including $1.2 million in stock-based compensation expense. Thisincrease was due to a $1.4 million increase in external service costslargely related to ACADIA’s commercial preparations for the plannedlaunch of NUPLAZID. Also contributing to the quarter-over-quarterincrease in general and administrative expenses was a $1.4 millionincrease in personnel expenses largely related to ACADIA’s preparationsfor the planned launch of NUPLAZID, as well as a $1.3 million increasein stock-based compensation expense.
Conference Call and Webcast Information
ACADIA management will review its third 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 dialing866-318-8615 for participants in the United States or Canada and617-399-5134 for international callers (reference passcode 86826740). Atelephone replay of the conference call may be accessed through November24, 2014 by dialing 888-286-8010 for callers in the United States orCanada and 617-801-6888 for international callers (reference passcode62605343). 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 November24, 2014.
About NUPLAZID™ (pimavanserin)
NUPLAZID is ACADIA’s proprietary small molecule that is a selectiveserotonin inverse agonist preferentially targeting 5-HT2A receptorsthat play an important role in psychosis. ACADIA has reported positivePhase III trial results with NUPLAZID, which has the potential to be thefirst drug approved in the United States for psychosis associated withParkinson’s disease. NUPLAZID is administered orally once-a-day. ACADIAdiscovered NUPLAZID and holds worldwide rights to this new chemicalentity. The trade name NUPLAZID has been provisionally accepted by theFDA.
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. and two preclinical programs directedat Parkinson’s disease and other neurological disorders. All productcandidates are small molecules that emanate from internal 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 NUPLAZID (pimavanserin); the potential for pimavanserin to bethe first drug approved in the United States for Parkinson’s diseasepsychosis (PDP) and the potential timing of such approval, if approvedat all; the importance of the NUPLAZID program based on the BreakthroughTherapy designation; the potential for NUPLAZID to transform thetreatment landscape for patients with PDP; ACADIA’s ongoingpre-commercial activities and plans to commercially launch pimavanserin;and the progress, timing and results of ACADIA’s drug discovery anddevelopment programs, either alone or with a partner, including theprogress and expected timing of clinical trials. These statements areonly predictions based on current information and expectations andinvolve a number of risks and uncertainties. Actual events or resultsmay differ materially from those projected in any of such statements dueto various factors, including the risks and uncertainties inherent indrug discovery, 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.
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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 September 30, | | | | Nine Months Ended September 30, |
| | | | 2014 | | | | 2013 | | | | 2014 | | | | 2013 |
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| Collaborative revenues | | | | $ | 15 | | | | | $ | 240 | | | | | $ | 72 | | | | | $ | 1,108 | |
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| Operating expenses | | | | | | | | | | | | | | | | |
| Research and development (includes stock-based compensation expenseof $1,358, $690, $3,452, and $1,417, respectively) | | | | | 16,952 | | | | | | 7,254 | | | | | | 42,420 | | | | | | 18,797 | |
| General and administrative (includes stock-based compensationexpense of $2,544, $1,201, $7,942, and $2,120, respectively) | | | | | 8,057 | | | | | | 3,797 | | | | | | 22,328 | | | | | | 8,444 | |
| Total operating expenses | | | | | 25,009 | | | | | | 11,051 | | | | | | 64,748 | | | | | | 27,241 | |
| Loss from operations | | | | | (24,994 | ) | | | | | (10,811 | ) | | | | | (64,676 | ) | | | | | (26,133 | ) |
| Interest income, net | | | | | 208 | | | | | | 116 | | | | | | 567 | | | | | | 234 | |
| Net loss | | | | $ | (24,786 | ) | | | | $ | (10,695 | ) | | | | $ | (64,109 | ) | | | | $ | (25,899 | ) |
| Net loss per common share, basic and diluted | | | | $ | (0.25 | ) | | | | $ | (0.12 | ) | | | | $ | (0.66 | ) | | | | $ | (0.31 | ) |
| Weighted average common shares outstanding, basic and diluted | | | | | 99,497 | | | | | | 89,504 | | | | | | 97,210 | | | | | | 83,946 | |
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ACADIA PHARMACEUTICALS INC. CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands) (Unaudited) |
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| | | | September 30, 2014 | | | | | | | | | December 31, 2013(1) |
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| Assets | | | | | | | | | | | | | |
| Cash, cash equivalents, and investment securities | | | | $ | 337,799 | | | | | | | | | $ | 185,790 |
| Prepaid expenses, interest, and other receivables | | | | | 3,266 | | | | | | | | | | 2,570 |
| Total current assets | | | | | 341,065 | | | | | | | | | | 188,360 |
| Other non-current assets | | | | | 698 | | | | | | | | | | 758 |
| Total assets | | | | $ | 341,763 | | | | | | | | | $ | 189,118 |
| Liabilities and stockholders’ equity | | | | | | | | | | | | | |
| Total liabilities | | | | $ | 11,274 | | | | | | | | | $ | 6,987 |
| Stockholders’ equity | | | | | 330,489 | | | | | | | | | | 182,131 |
| Total liabilities and stockholders’ equity | | | | $ | 341,763 | | | | | | | | | $ | 189,118 |
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(1) | | | The condensed consolidated balance sheet at December 31, 2013 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.
Investor Contacts:
ACADIA Pharmaceuticals Inc.
SteveDavis, Executive Vice President,
Chief Financial Officer andChief Business Officer
Lisa Barthelemy, Director of InvestorRelations
(858) 558-2871
or
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David Schull
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