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  • May 4, 2018
  • Earnings

ACADIA Pharmaceuticals Reports First Quarter 2018 Financial Results

Strong Performance for NUPLAZID® in First Quarter2018

First Quarter Net Sales Grew to $48.9 Million, Representing a 12%Sequential Increase Over 4Q17 and 220% Increase Over 1Q17

ACADIA Reiterates 2018 Net Sales Guidance of $255 Million to $270Million

SAN DIEGO—(BUSINESS WIRE)—May 4, 2018—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 financial results for the first quarterended March 31, 2018.

“NUPLAZID delivered strong performance in the first quarter of 2018.Sequential volume growth of 13.5% drove sequential revenue growth of 12%as health care providers and patients continue to experience thebenefits of NUPLAZID in treating the symptoms of Parkinson’s diseasepsychosis,” said Steve Davis, ACADIA’s President and Chief ExecutiveOfficer. “Our R&D organization also continued to advance our late-stageclinical programs in four major CNS indications and we look forward toproviding top-line results from our Phase 2 study of pimavanserin inmajor depressive disorder in the second half of 2018. We remainconfident in the tremendous opportunities ahead for NUPLAZID, which isearly in its growth phase.”

Recent Highlights

Financial Results

Revenue
Net sales of NUPLAZID were $48.9 million for thefirst quarter of 2018, an increase of 220% as compared to $15.3 millionreported for the first quarter of 2017.

Research and Development
Research and development expensesfor the first quarter of 2018 were $39.3 million, compared to $35.4million for the same period of 2017. This increase was primarily due toadditional personnel and related costs, including an additional $2.4million in non-cash stock-based compensation, associated with thecompany’s expanded research and development organization during 2018 ascompared to 2017. The company also incurred increased costs related tothe clinical studies associated with the development of pimavanserin.

Selling, General and Administrative
Selling, general andadministrative expenses for the first quarter of 2018 were $60.9million, compared to $65.7 million for the same period of 2017. Thisdecrease was primarily due to a decrease in external selling, generaland administrative expenses, partially offset by an increase in non-cashstock-based compensation expense and the costs of expanding ourspecialty sales force in the second quarter of 2017.

Net Loss
For the first quarter of 2018, ACADIA reported anet loss of $54.3 million, or $0.44 per common share, compared to a netloss of $87.8 million, or $0.72 per common share, for the same period in2017. The net loss for the first quarter of 2018 and 2017 included $20.4million and $15.6 million, respectively, of non-cash stock-basedcompensation expense.

Cash and Investments
At March 31, 2018, ACADIA’s cash, cashequivalents and investment securities totaled $298.1 million, comparedto $341.3 million at December 31, 2017.

Financial Guidance

ACADIA reiterates its 2018 NUPLAZID net sales guidance to be between$255 million and $270 million.

For the second quarter of 2018, ACADIA expects NUPLAZID net sales to bebetween $57 million and $61 million.

ACADIA reiterates its expectation to end 2018 with more than $200million of cash, cash equivalents and investment securities on itsbalance sheet.

Conference Call and Webcast Information
ACADIA managementwill review its first quarter financial results and operations viaconference call and webcast today at 8:30 a.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 3685527). A telephone replay of the conference callmay be accessed through May 18, 2018 by dialing 855-859-2056 for callersin the U.S. or Canada and 404-537-3406 for international callers(reference passcode 3685527). The conference call also will be webcastlive on ACADIA’s website, www.acadia-pharm.com,under the investors section and will be archived there through May 18,2018.

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-HT2A 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 guidance for second quarter and full-year 2018 NUPLAZID netsales; potential opportunity for and future growth of NUPLAZID; thetiming of ongoing clinical studies; and the timing of reporting ofresults from our study in major depressive disorder. These statementsare only 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 uncertainty of future commercial salesand related items that would impact net sales during 2018, the risks anduncertainties inherent in drug discovery, development, approval 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, 2017 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.

ACADIA PHARMACEUTICALS INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(in thousands, except per share amounts)

(Unaudited)

Three Months Ended March 31,
20182017
Revenues
Product sales, net$48,868$15,286
Total revenues48,86815,286
Operating expenses
Cost of product sales2,1532,263
License fees and royalties1,332675
Research and development39,27635,409
Selling, general and administrative60,92665,660
Total operating expenses103,687104,007
Loss from operations(54,819)(88,721)
Interest income, net1,170963
Loss before income taxes(53,649)(87,758)
Income tax expense64785
Net loss$(54,296)$(87,843)
Net loss per common share, basic and diluted$(0.44)$(0.72)
Weighted average common shares outstanding, basic and diluted124,727121,651

ACADIA PHARMACEUTICALS INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands)

March 31,

2018

December 31,

2017

(unaudited)
Assets
Cash, cash equivalents and investment securities$298,063$341,342
Accounts receivable, net22,44517,343
Interest and other receivables9031,087
Inventory5,5835,248
Prepaid expenses13,0208,457
Total current assets340,014373,477
Property and equipment, net2,7092,662
Intangible assets, net5,1695,538
Restricted cash2,8252,475
Other assets323354
Total assets$351,040$384,506
Liabilities and stockholders’ equity
Accounts payable$2,996$8,786
Accrued liabilities43,09340,244
Total current liabilities46,08949,030
Long-term liabilities782191
Total liabilities46,87149,221
Total stockholders’ equity304,169335,285
Total liabilities and stockholders’ equity$351,040$384,506

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 a hypersensitivity reaction to pimavanserin or any of its components.Rash, urticaria, and reactions consistent with angioedema (e.g., tongueswelling, circumoral edema, throat tightness, and dyspnea) have beenreported.

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:Themost common adverse reactions(≥2%for NUPLAZID and greater than placebo) wereperipheral 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.

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.

Investor Contact:

ACADIA Pharmaceuticals Inc.
ElenaRidloff, CFA
or
Lisa Barthelemy
(858) 558-2871
ir@acadia-pharm.com
or
MediaContact:
Taft Communications
Bob Laverty
(609)558-5570
bob@taftcommunications.com

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