ACADIA Pharmaceuticals Reports First Quarter 2017 Financial Results

SAN DIEGO—(BUSINESS WIRE)—May 9, 2017—ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD), a biopharmaceutical companyfocused on the development and commercialization of innovative medicinesto address unmet medical needs in central nervous system (CNS)disorders, today announced its unaudited financial results for the firstquarter ended March 31, 2017.

“We’re very pleased with our strong start to 2017,” said Steve Davis,ACADIA’s President and Chief Executive Officer. “The use of NUPLAZID^®in Parkinson’s disease psychosis continues to expand as brandawareness among neurologists, psychiatrists, and other healthcareproviders grows. We also continue to advance our ongoing clinicalstudies in Alzheimer’s disease agitation, schizophrenia inadequateresponse, schizophrenia negative symptoms, and major depressivedisorder, and we look forward to moving our Alzheimer’s diseasepsychosis program into Phase III in the second half of 2017.”

Recent Highlights

• Net revenue for the first quarter of 2017 of $15.3 million, anincrease of 28% from the fourth quarter of 2016.
• NUPLAZID (pimavanserin) available on Medicare formularies for thetreatment of Parkinson’s disease psychosis (PD Psychosis); commercialcoverage decisions grew to over 90% of commercial lives.
• Expanded penetration into the long-term care market with 25 additionallong-term care sales specialists; ACADIA currently has approximately155 total sales specialists.
• Continued to execute on broad clinical development program withongoing studies in Alzheimer’s disease agitation, schizophreniainadequate response, schizophrenia negative symptoms, and majordepressive disorder.
• Plan to advance Alzheimer’s disease psychosis (AD Psychosis) programinto Phase III in second half of 2017.
• Presented data on NUPLAZID in PD Psychosis at the American Associationfor Geriatric Psychiatry Annual Meeting.
• Appointed Michael J. Yang as Executive Vice President, ChiefCommercial Officer.

Financial Results

Revenue
ACADIA reported NUPLAZID net product sales of $15.3million for the three months ended March 31, 2017. NUPLAZID was firstmade available for prescription starting in May 2016 and there were nosimilar net product sales for the comparable period of 2016. ACADIAreports product sales when its specialty pharmacy partners dispenseNUPLAZID to a patient based on the fulfillment of a prescription or itsspecialty distributor partners sell NUPLAZID to a government facility,long-term care pharmacy or in-patient hospital pharmacy. As of March 31,2017, the company had $4.1 million of deferred product revenue, net ofdistribution fees, for product it had shipped to its distributionpartners that had not yet sold-through the distribution channel. AtDecember 31, 2016, the company had $2.6 million of deferred productrevenue, net of distribution fees.

Research and Development
Research and development expensesincreased to $35.4 million for the three months ended March 31, 2017from $22.8 million for the comparable period of 2016. This increase wasprimarily due to increased clinical costs related to studies the companyinitiated in the fourth quarter of 2016 for indications other than PDPsychosis. The company also incurred additional personnel and relatedcosts associated with its expanded research and development organizationduring the three months ended March 31, 2017 compared to the same periodin 2016.

Selling, General and Administrative
Selling, general andadministrative expenses increased to $65.7 million for the three monthsended March 31, 2017 from $27.5 million for the comparable period of2016. This increase was primarily due to costs incurred to supportACADIA’s commercial activities for NUPLAZID and costs related to itsspecialty sales force that did not exist for the comparable period of2016 prior to the launch of NUPLAZID.

Net Loss
For the three months ended March 31, 2017, ACADIAreported a net loss of $87.8 million, or $0.72 per common share,compared to a net loss of $49.8 million, or $0.45 per common share, forthe comparable period of 2016. The net loss for the three months endedMarch 31, 2017 included $15.6 million of non-cash stock-basedcompensation expense compared to $12.0 million for the comparable periodof 2016.

Cash and Investments
At March 31, 2017, ACADIA’s cash, cashequivalents, and investment securities totaled $469.5 million, comparedto $529.0 million at December 31, 2016.

Conference Call and Webcast Information
ACADIA managementwill review its first quarter financial results and operations viaconference call and webcast later today at 5:00 p.m. Eastern Time. Theconference call may be accessed by dialing 844-821-1109 for participantsin the U.S. or Canada and 830-865-2550 for international callers(reference passcode 12435244). A telephone replay of the conference callmay be accessed through May 23, 2017 by dialing 855-859-2056 for callersin the U.S. or Canada and 404-537-3406 for international callers(reference passcode 12435244). The conference call also will be webcastlive on ACADIA’s website, www.acadia-pharm.com,under the investors section and will be archived there until May 23,2017.

About NUPLAZID^® (pimavanserin)
NUPLAZIDis the first and only FDA-approved treatment for hallucinations anddelusions associated with PD Psychosis. NUPLAZID is a non-dopaminergic,selective serotonin inverse agonist preferentially targeting 5-HT_2A receptorsthat are thought to play an important role in PD Psychosis. NUPLAZID isan oral medicine taken once a day with a recommended dose of 34 mg (two17-mg tablets). ACADIA discovered this new chemical entity and holdsworldwide rights to develop and commercialize NUPLAZID.

About ACADIA Pharmaceuticals
ACADIA is a biopharmaceuticalcompany focused on the development and commercialization of innovativemedicines to address unmet medical needs in central nervous systemdisorders. 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 releasethat are not strictly historical in nature are forward-lookingstatements. These statements include but are not limited to statementsrelated to the benefits to be derived from NUPLAZID (pimavanserin); theutility of pimavanserin in indications other than hallucinations anddelusions associated with PD Psychosis; and future studies involvingpimavanserin. 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, and the fact that past results of clinical trials maynot be indicative of future trial results. For a discussion of these andother factors, please refer to ACADIA’s annual report on Form 10-K forthe year ended December 31, 2016 as well as ACADIA’s subsequent filingswith the Securities and Exchange Commission. You are cautioned not toplace undue reliance on these forward-looking statements, which speakonly as of 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.

Important Safety Information and Indication forNUPLAZID (pimavanserin) tablets
WARNING: INCREASEDMORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS
Elderlypatients with dementia-related psychosis treated with antipsychoticdrugs are at an increased risk of death. NUPLAZID is not approved forthe treatment of patients with dementia-related psychosis unrelated tothe hallucinations and delusions associated with Parkinson’s diseasepsychosis.

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

Contraindication: NUPLAZID is contraindicated in patients with a historyof hypersensitivity reaction to pimavanserin or any of its components.Reactions have included rash, urticaria, tongue swelling, circumoraledema, and throat tightness.

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.

Pregnancy: Use of NUPLAZID in pregnant women has not been evaluated andshould therefore be used in pregnancy only if the potential benefitjustifies the potential risk to the mother and fetus.

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

Dosage and Administration: Recommended dose: 34 mg per day, taken orallyas two 17-mg tablets once daily, without titration.

For additional Important Safety Information, including boxed warning,please see the full Prescribing Information for NUPLAZID at https://www.nuplazid.com/pdf/NUPLAZID_Prescribing_Information.pdf.

Source: ACADIA Pharmaceuticals Inc.

ACADIA Pharmaceuticals Inc.
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