ACADIA Pharmaceuticals Reports First Quarter 2019 Financial Results

- 1Q19 Net Sales Grew to $63.0 Million, a 29% Increase Over 1Q18

-Updated 2019 Net Sales Guidance to $280 Million to $300 Million

-Completed Enrollment in Two Late-Stage Adjunctive Schizophrenia Studieswith Pimavanserin

SAN DIEGO—(BUSINESS WIRE)—May 1, 2019—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 first quarter ended March31, 2019.

“We’ve commenced 2019 with significant momentum. The commercialinitiatives implemented by our team have driven continued sales growthof NUPLAZID,” said Steve Davis, ACADIA’s Chief Executive Officer. “Thispast month, we initiated our Phase 3 CLARITY program evaluatingpimavanserin as an adjunctive treatment for patients with majordepressive disorder. We also completed enrollment in our twoschizophrenia studies and are on track to announce top-line data fromour ENHANCE schizophrenia inadequate response study mid-year andtop-line data from our ADVANCE schizophrenia negative symptoms studyaround year-end 2019.”

Recent Highlights

• Initiated Phase 3 CLARITY program with pimavanserin for adjunctivetreatment in patients with major depressive disorder (MDD) in April2019.
• Completed enrollment in April 2019 in our Phase 3 ENHANCE studyevaluating pimavanserin as an adjunctive treatment in schizophreniainadequate response patients.
• Completed enrollment in April 2019 in our Phase 2 ADVANCE studyevaluating pimavanserin for adjunctive treatment in schizophrenianegative symptoms patients.
• Announced the March 2019Neurology^®publication of the positive Phase 2 study results for trofinetide inpediatric Rett syndrome.

• Appointed Elena Ridloff, CFA, as Executive Vice President and ChiefFinancial Officer in March 2019.

Financial Results

Revenue

Net sales of NUPLAZID^® (pimavanserin) were $63.0 million forthe first quarter of 2019, an increase of 29% as compared to $48.9million reported for the first quarter of 2018.

Research and Development

Research and development expenses for the first quarter of 2019 were$52.9 million, compared to $39.3 million for the same period of 2018.The increase was primarily due to additional clinical study costs forpimavanserin as well as development costs for trofinetide.

Selling, General and Administrative

Selling, general and administrative expenses for the first quarter of2019 were $93.1 million, compared to $60.9 million for the same periodof 2018. The increase was primarily due to an increase in marketingexpenses related to our direct-to-consumer advertising campaign as wellas increased charitable contributions.

Net Loss

For the first quarter of 2019, ACADIA reported a net loss of $85.3million, or $0.59 per common share, compared to a net loss of $54.3million, or $0.44 per common share, for the same period in 2018. The netlosses in the first quarter of 2019 and 2018 included $19.9million and $20.4 million, respectively, of non-cash stock-basedcompensation expense.

Cash and Investments

At March 31, 2019, ACADIA’s cash, cash equivalents, and investmentsecurities totaled $414.3 million, compared to $473.5 million atDecember 31, 2018.

2019 Financial Guidance

• ACADIA is updating 2019 NUPLAZID net sales guidance to be between $280million and $300 million from a previous range of $275 million to $300million.
• ACADIA reiterates GAAP R&D guidance to be between $250 million and$265 million.
• ACADIA reiterates GAAP SG&A guidance to be between $280 million and$295 million.
• ACADIA reiterates non-cash stock-based compensation expense guidanceto be between $80 million and $90 million.

Conference Call and Webcast Information

ACADIA management will review its first quarter financial results andoperations via conference call and webcast today at 4:30 p.m. EasternTime. The conference call may be accessed by dialing 855-638-4820 forparticipants in the U.S. or Canada and 443-877-4067 for internationalcallers (reference passcode 6759227). A telephone replay of theconference call may be accessed through May 8, 2019 by dialing855-859-2056 for callers in the U.S. or Canada and 404-537-3406 forinternational callers (reference passcode6759227). Theconference call also will be webcast live on ACADIA’s website, www.acadia-pharm.com,under the investors section and will be archived there through June 1,2019.

About NUPLAZID^® (pimavanserin)

NUPLAZID is the first and only FDA-approved treatment for hallucinationsand delusions associated with Parkinson’s disease psychosis. NUPLAZID isa non-dopaminergic, selective serotonin inverse agonist (SSIA)preferentially targeting 5-HT_2A receptors that are thought toplay an important role in Parkinson’s disease psychosis. NUPLAZID is anoral medicine taken once a day with a recommended dose of 34 mg. ACADIAdiscovered and developed this new chemical entity and holds worldwiderights to develop 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 has developed andcommercialized the first and only medicine approved for the treatment ofhallucinations and delusions associated with Parkinson’s diseasepsychosis. ACADIA also has ongoing clinical development efforts inadditional areas with significant unmet need, including dementia-relatedpsychosis, schizophrenia inadequate response, schizophrenia-negativesymptoms, major depressive disorder, and Rett syndrome. This pressrelease and further information about ACADIA can be found at: www.acadia-pharm.com.

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 opportunity forfuture growth in sales of NUPLAZID, including through sales of newdosages and forms; the timing of ongoing and future clinical studies forpimavanserin; the development and commercialization of trofinetide; andguidance for full-year 2019 NUPLAZID net sales and certain expense lineitems. 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 uncertainty of future commercial sales and related items that wouldimpact net sales during 2019, the risks and uncertainties inherent indrug development, approval and commercialization, and the fact that pastresults of clinical trials may not be indicative of future trialresults. For a discussion of these and other factors, please refer toACADIA’s annual report on Form 10-K for the year ended December 31, 2018as well as ACADIA’s subsequent filings with the Securities and ExchangeCommission. You are cautioned not to place undue reliance on theseforward-looking statements, which speak only as of the date hereof. Thiscaution is made under the safe harbor provisions of the PrivateSecurities Litigation Reform Act of 1995. All forward-looking statementsare qualified in their entirety by this cautionary statement and ACADIAundertakes no obligation to revise or update this press release toreflect events or circumstances after the date hereof, except asrequired by law.

Source: ACADIA Pharmaceuticals Inc.

Investor Contact:

ACADIA Pharmaceuticals Inc.
MarkJohnson, CFA
(858) 261-2771
ir@acadia-pharm.com

Media Contact:

ACADIA Pharmaceuticals Inc.
MaurissaMessier
(858) 768-6068
media@acadia-pharm.com