ACADIA Pharmaceuticals Reports First Quarter 2016 Financial Results

SAN DIEGO—(BUSINESS WIRE)—May 5, 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 unaudited financial results for the first quarterended March 31, 2016.

“We are very excited about the recent FDA approval of NUPLAZID™, thefirst and only drug approved for the treatment of hallucinations anddelusions associated with Parkinson’s disease psychosis,” said SteveDavis, ACADIA’s President and Chief Executive Officer. “Parkinson’spsychosis tends to strike in the more advanced stages of Parkinson’sdisease – at a time when patients are often experiencing significantchallenges in controlling their motor symptoms such as tremor, slowmovement and muscle rigidity. For the first time, physicians will have adrug to treat hallucinations and delusions without worsening motorfunction in Parkinson’s psychosis patients. We look forward to makingNUPLAZID available to physicians and patients in June.”

ACADIA reported a net loss of $49.8 million, or $0.45 per common share,for the first quarter of 2016 compared to a net loss of $40.4 million,or $0.40 per common share, for the first quarter of 2015. The net lossesfor the first quarters of 2016 and 2015 included $12.0 million and $14.5million, respectively, in non-cash stock-based compensation expense. AtMarch 31, 2016, ACADIA’s cash, cash equivalents and investmentsecurities totaled $457.2 million, compared to $215.1 million atDecember 31, 2015.

Research and development expenses increased to $22.8 million for thefirst quarter of 2016, including $4.4 million in stock-basedcompensation expense, from $16.3 million for the comparable quarter of2015, including $2.4 million in stock-based compensation expense. Thisincrease was due to an increase in personnel and related costs of $4.8million associated with ACADIA’s expanded research and developmentorganization and an increase of $1.7 million in external service costs.The increase in external service costs was primarily due to increasedcosts in connection with the FDA’s Psychopharmacologic Drugs AdvisoryCommittee meeting that occurred in March 2016 and increased costsrelated to the development of pimavanserin in additional indicationsother than in Parkinson’s disease psychosis, largely offset bypimavanserin manufacturing development costs incurred in the firstquarter of 2015 not incurred in the first quarter of 2016.

General and administrative expenses increased to $27.5 million for thefirst quarter of 2016, including $7.6 million in stock-basedcompensation expense, from $24.3 million for the comparable quarter of2015, including $12.2 million in stock-based compensation expense. Thisincrease was due to an increase of $4.8 million in external servicecosts offset by a decrease of $1.6 million in personnel and relatedcosts and stock-based compensation expense. The decrease in personnelcosts and stock-based compensation expense was driven by a one-timeexpense of $9.6 million incurred in the first quarter of 2015 inconnection with the retirement of ACADIA’s former Chief ExecutiveOfficer, including $9.0 million of stock-based compensation expense.Excluding these one-time costs, the increases in personnel costs andexternal service costs were largely related to ACADIA’s commercialpreparations for the upcoming launch of NUPLAZID.

Conference Call and Webcast Information

ACADIA management will review its first 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 5151879). A telephone replayof the conference call may be accessed through May 19, 2016 by dialing855-859-2056 for callers in the U.S. or Canada and 404-537-3406 forinternational callers (reference passcode 5151879). 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 19,2016.

About NUPLAZID™ (pimavanserin)

NUPLAZID is the first FDA-approved treatment for hallucinations anddelusions associated with Parkinson’s disease psychosis. NUPLAZID is anon-dopaminergic, selective serotonin inverse agonist preferentiallytargeting 5-HT2A receptors that are thought to play an important role inParkinson’s disease psychosis. NUPLAZID is an oral medicine taken once aday with a recommended dose of 34 mg (two 17 mg tablets). ACADIAdiscovered this new chemical entity and holds worldwide rights todevelop and commercialize NUPLAZID.

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 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 benefits to be derived fromNUPLAZID (pimavanserin); and ACADIA’s plans to make NUPLAZIDcommercially available in the United States, including the timingthereof. These statements are only predictions based on currentinformation and expectations and involve a number of risks anduncertainties. Actual events or results may differ materially from thoseprojected in any of such statements due to various factors, includingthe risks and uncertainties inherent in drug discovery, development, andcommercialization, whether NUPLAZID receives adequate reimbursement fromthird-party payors, ACADIA’s ability to establish an adequate specialtypharmacy network to distribute NUPLAZID, the degree to which NUPLAZIDreceives acceptance from patients and physicians for its approvedindication, and the fact that past results of clinical trials may not beindicative of future trial results. For a discussion of these and otherfactors, please refer to ACADIA’s annual report on Form 10-K for theyear ended December 31, 2015 as well as ACADIA’s subsequent filings withthe Securities and Exchange Commission. You are cautioned not to placeundue reliance on these forward-looking statements, which speak only asof the date hereof. This caution is made under the safe harborprovisions of the Private Securities Litigation Reform Act of 1995. Allforward-looking statements are qualified in their entirety by thiscautionary statement and ACADIA undertakes no obligation to revise orupdate this press release to reflect events or circumstances after thedate hereof, except as required by law.

NUPLAZID is an atypical antipsychotic indicated for the treatment ofhallucinations and delusions associated with Parkinson’s diseasepsychosis.

QT Interval Prolongation: NUPLAZID prolongs the QT interval. The use ofNUPLAZID should be avoided in patients with known QT prolongation or incombination with other drugs known to prolong QT interval includingClass 1A antiarrhythmics or Class 3 antiarrhythmics, certainantipsychotic medications, and certain antibiotics. NUPLAZID should alsobe avoided in patients with a history of cardiac arrhythmias, as well asother circumstances that may increase the risk of the occurrence oftorsade de pointes and/or sudden death, including symptomaticbradycardia, hypokalemia or hypomagnesemia, and presence of congenitalprolongation of the QT interval.

Adverse Reactions: The most common adverse reactions (≥2%for NUPLAZID and greater than placebo) were peripheral edema (7%vs 2%), nausea (7% vs 4%), confusional state (6% vs 3%), hallucination(5% vs 3%), constipation (4% vs 3%), and gait disturbance (2% vs <1%).

Drug Interactions: Strong CYP3A4 inhibitors (eg, ketoconazole)increase NUPLAZID concentrations. Reduce the NUPLAZID dose by one-half.

Strong CYP3A4 inducers may reduce NUPLAZID exposure, monitor for reducedefficacy. Increase in NUPLAZID dosage may be needed.

Renal Impairment: No dosage adjustment for NUPLAZID is needed inpatients with mild to moderate renal impairment. Use of NUPLAZID is notrecommended in patients with severe renal impairment.

Hepatic Impairment: Use of NUPLAZID is not recommended in patients withhepatic impairment. NUPLAZID has not been evaluated in this patientpopulation.

Pediatric Use: Safety and efficacy have not been established inpediatric patients.

Dosage and Administration: Recommended dose: 34 mg per day, takenorally as two 17 mg tablets once daily, without titration.

Source: ACADIA Pharmaceuticals Inc.

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